SECURITIES AND
EXCHANGE COMMISSION

Washington, D.C.
20549



Form 20-F/A

(Amendment No. 1)



☐ REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934



Or



☒ ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



For the fiscal
year ended December 31, 2018



Or



☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



Or



☐ SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



Commission File No.
001-36203



Can-Fite BioPharma
Ltd.

(Exact name of
Registrant as specified in its charter)



Can-Fite BioPharma
Ltd., an Israeli Limited Company

(Translation of
the Registrant’s name into English)



Israel

(Jurisdiction
of incorporation)



10 Bareket Street,

Kiryat Matalon,

P.O. Box 7537,

Petah-Tikva

4951778, Israel

(Address of principal
executive offices)



Motti Farbstein

Chief Operating
and Financial Officer

Tel: +972 (3)
924-1114

Fax: +972 (3)
924-9378

motti@canfite.co.il



10 Bareket Street,

Kiryat Matalon,

P.O. Box 7537,

Petah-Tikva

4951778, Israel

(Name, Telephone,
E-mail and/or Facsimile number and Address of Company Contact Person)



Securities registered
or to be registered pursuant to Section 12(b) of the Act:



American Depositary
Shares, each representing 2 Ordinary Shares, par value NIS 0.25 per share

(Title of Class)



Ordinary Shares,
par value NIS 0.25 per share*

(Title of Class)



Securities registered
or to be registered pursuant to Section 12(g) of the Act:

None



Securities for which
there is a reporting obligation pursuant to Section 15(d) of the Act:

None



*
Not for trading, but only in connection with the registration of the American Depositary Shares.













Indicate the number
of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by
the annual report (December 31, 2018): 40,399,290 ordinary shares are outstanding.



Indicate by check
mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒



If this report is
an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☒



Indicate by check
mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months (or for such a shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐



Indicate by check
mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐



Indicate by check
mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth
company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.



|Large
    accelerated filer | ☐ | Accelerated
    filer | ☐ | Non-accelerated
    filer | ☒
|--------------------------- | - | --------------------- | - | ------------------------- | -
|                            |   |                       |   | Emerging growth company   | ☒



If an emerging growth
company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 7(a)(2)(B) of the Securities Act. ☐



Indicate by check
mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:



|U.S.
    GAAP ☐ | International
    Financial Reporting Standards                 | Other
    ☐
|--------------- | --------------------------------------------------------------- | -----------
|                | as
    issued by the International Accounting Standards Board ☒ |            



If “Other”
has been checked in response to the previous question, indicate by check mark which financial statement item the Registrant has
elected to follow: Item 17 ☐ Item 18 ☐



If this is an annual
report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒


















Explanatory
Note



This Amendment
No. 1 to the Annual Report on Form 20-F of Can-Fite BioPharma Ltd. (the “Company”) for the year ended December 31,
2018 filed with the Securities and Exchange Commission on March 29, 2019 (the “Original Filing”) is being filed to
correct the number of ordinary shares issuable upon exercise of outstanding warrants on page 24 in “Item 3.D. Risk Factors”.
This Amendment No. 1 also includes an updated signature page, the certifications of the Company’s Principal Executive Officer
and Principal Financial Officer in Exhibits 12 and 13, and the consent of the Company’s independent registered public accounting
firm in Exhibit 15.1. No other changes have been made to the Original Filing. For the convenience of the reader, this Amendment
No. 1 restates in its entirety the Original Filing. This Amendment No. 1 speaks as of the filing date of the Original Filing,
does not reflect events that may have occurred subsequent to the filing date of the Original Filing, and does not modify or update
in any way disclosures made in the Original Filing, except as noted above.













TABLE OF CONTENTS



|PART I                                                                                | 1  
|------------------------------------------------------------------------------------- | ---
|ITEM 1. Identity of Directors, Senior Management and Advisers.                        | 1  
|ITEM 2. Offer Statistics and Expected Timetable                                       | 1  
|ITEM 3. Key Information                                                               | 1  
|ITEM 4. Information on the Company                                                    | 31 
|ITEM 4A. Unresolved Staff Comments                                                    | 76 
|ITEM 5. Operating and Financial Review and Prospects                                  | 76 
|ITEM 6. Directors, Senior Management and Employees                                    | 90 
|ITEM 7. Major Shareholders and Related Party Transactions                             | 109
|ITEM 8. Financial Information                                                         | 111
|ITEM 9. The Offer and Listing                                                         | 112
|ITEM 10. Additional Information                                                       | 112
|ITEM 11. Quantitative and Qualitative Disclosures About Market Risk                   | 127
|ITEM 12. Description of Securities Other Than Equity Securities                       | 128
|                                                                                      |    
|PART II                                                                               | 130
|ITEM 13. Defaults, Dividend Arrearages and Delinquencies                              | 130
|ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds | 130
|ITEM 15. Controls and Procedures                                                      | 130
|ITEM 16. [RESERVED]                                                                   | 131
|ITEM 16A. Audit Committee Financial Expert                                            | 131
|ITEM 16B. Code of Ethics                                                              | 131
|ITEM 16C. Principal Accountant Fees and Services                                      | 131
|ITEM 16D. Exemptions from the Listing Standards for Audit Committees                  | 131
|ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers      | 131
|ITEM 16F. Change in Registrant’s Certifying Accountant                                | 132
|ITEM 16G. Corporate Governance                                                        | 132
|ITEM 16H. Mine Safety Disclosure                                                      | 132
|                                                                                      |    
|PART III                                                                              | 133
|ITEM 17. Financial Statements                                                         | 133
|ITEM 18. Financial Statements                                                         | 133
|ITEM 19. Exhibits                                                                     | 133



i


Table of Contents




INTRODUCTION



Can-Fite is a clinical-stage
biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment of cancer,
inflammatory disease and sexual dysfunction. Our platform technology utilizes the Gi protein associated A3 adenosine receptor,
or A3AR, as a therapeutic target. A3AR is highly expressed in inflammatory and cancer cells, and not significantly expressed in
normal cells, suggesting that the receptor could be a unique target for pharmacological intervention. Our pipeline of drug candidates
are synthetic, highly specific agonists and allosteric modulators, or ligands or molecules that initiate molecular events when
binding with target proteins, targeting the A3AR.



Our ordinary shares
have been trading on the Tel Aviv Stock Exchange, or TASE, under the symbol “CFBI” since October 2005. On October
2, 2012, our ADSs began trading over the counter, or OTC, in the United States under the symbol “CANFY” and on November
19, 2013, our ADSs began trading on the NYSE American under the symbol “CANF.”



Unless otherwise indicated,
all references to the “Company,” “we,” “our” and “Can-Fite” refer to Can-Fite
BioPharma Ltd. and its consolidated subsidiaries. References to “ordinary shares”, “ADSs”, “warrants”
and “share capital” refer to the ordinary shares, ADSs, warrants and share capital, respectively, of Can-Fite.



References to “U.S.
dollars”, “USD”, and “$” are to currency of the United States of America, and references to “NIS”
are to New Israeli Shekels. References to “ordinary shares” are to our ordinary shares, par value of NIS 0.25 per
share. We report financial information under International Financial Reporting Standards, or IFRS, as issued by the International
Accounting Standards Board, or the IASB, and none of the financial statements were prepared in accordance with generally accepted
accounting principles in the United States.



Unless otherwise indicated,
U.S. dollar translations of NIS amounts presented in this Annual Report on Form 20-F for the year ended on December 31, 2018 are
translated using the rate of NIS 3.748 to $1.00, the exchange rate reported by the Bank of Israel on December 31, 2018, U.S. dollar
translations of NIS amounts presented in this Annual Report on Form 20-F for the year ended on December 31, 2017 are translated
using the rate of NIS 3.467 to $1.00, the exchange rate reported by the Bank of Israel on December 31, 2017, and U.S. dollar translations
of NIS amounts presented in this Annual Report on Form 20-F for the year ended on December 31, 2016 are translated using the rate
of NIS 3.845 to $1.00, the exchange rate reported by the Bank of Israel on December 31, 2016.





ii


Table of Contents




FORWARD LOOKING STATEMENTS



This Annual Report
on Form 20-F contains forward-looking statements, about our expectations, beliefs or intentions regarding, among other things,
our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from
time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,”
“plan,” “may,” “should” or “anticipate” or their negatives or other variations
of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current
matters. These forward-looking statements may be included in, but are not limited to, various filings made by us with the U.S.
Securities and Exchange Commission, or the SEC, press releases or oral statements made by or with the approval of one of our authorized
executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the
date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently
subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed
or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below.



This Annual Report
on Form 20-F identifies important factors which could cause our actual results to differ materially from those indicated by the
forward-looking statements, particularly those set forth under the heading “Risk Factors.” The risk factors included
in this Annual Report on Form 20-F are not necessarily all of the important factors that could cause actual results to differ
materially from those expressed in any of our forward-looking statements. Given these uncertainties, readers are cautioned not
to place undue reliance on such forward-looking statements. Factors that could cause our actual results to differ materially from
those expressed or implied in such forward-looking statements include, but are not limited to:



| | ● | our history of losses
    and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms,
    or at all;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                     
| | ● | uncertainties of
    cash flows and inability to meet working capital needs;                                                                                        
| |   |                                                                                                                                                                     
| | ● | the initiation,
    timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts;                       



| | ● | our ability to advance
    our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------



| | ● | our receipt of regulatory
    approvals for our product candidates, and the timing of other regulatory filings and approvals;
| | - | -----------------------------------------------------------------------------------------------------------------------------



| | ● | the clinical development,
    commercialization and market acceptance of our product candidates;
| | - | ------------------------------------------------------------------------------------------------



| | ● | our ability to establish
    and maintain strategic partnerships and other corporate collaborations;
| | - | ----------------------------------------------------------------------------------------------------



| | ● | the implementation
    of our business model and strategic plans for our business and product candidates;
| | - | ---------------------------------------------------------------------------------------------------------



| | ● | the scope of protection
    we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to
    operate our business without infringing the intellectual property rights of others;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | competitive companies,
    technologies and our industry; and
| | - | -------------------------------------------------------------



| | ● | statements as to
    the impact of the political and security situation in Israel on our business.
| | - | --------------------------------------------------------------------------------------------------



All forward-looking
statements attributable to us or persons acting on our behalf speak only as of the date of this Annual Report on Form 20-F and
are expressly qualified in their entirety by the cautionary statements included in this Annual Report on Form 20-F. We undertake
no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made
or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks
and uncertainties.



EXPLANATORY NOTE



Market data and certain
industry data and forecasts used throughout this Annual Report on Form 20-F were obtained from internal company surveys, market
research, consultant surveys, publicly available information, reports of governmental agencies and industry publications and surveys.
Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been
obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. We
have not independently verified any of the data from third-party sources, nor have we ascertained the underlying economic assumptions
relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based
upon our management’s knowledge of the industry, have not been independently verified. Forecasts are particularly likely
to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general
economic growth were used in preparing the forecasts we cite. Statements as to our market position are based on the most currently
available data. While we are not aware of any misstatements regarding the industry data presented in this Annual Report on Form
20-F, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed
under the heading “Risk Factors” in this Annual Report on Form 20-F.





iii


Table of Contents




PART
I



ITEM 1. Identity of Directors, Senior
Management and Advisers.



Not applicable.



ITEM 2. Offer Statistics and Expected
Timetable.



Not applicable.



ITEM 3. Key Information.



A. Selected Financial Data.



The following table
sets forth our selected consolidated financial data for the periods ended and as of the dates indicated. The following selected
consolidated financial data for our company should be read in conjunction with the financial information, “Item 5. Operating
and Financial Review and Prospects” and other information provided elsewhere in this Annual Report on Form 20-F and our
consolidated financial statements and related notes. The selected consolidated financial data in this section is not intended
to replace the consolidated financial statements and is qualified in its entirety thereby.



The selected consolidated
statements of operations data for the years ended December 31, 2018, 2017 and 2016, and the selected consolidated balance sheet
data as of December 31, 2018 and 2017, have been derived from our audited consolidated financial statements set forth elsewhere
in this Annual Report on Form 20-F. The selected consolidated statements of operations data for the years ended December 31, 2015
and 2014, and the selected consolidated balance sheet data as of December 31, 2016, 2015 and 2014, have been derived from our
audited consolidated financial statements not included in this Form 20-F.



Our consolidated financial
statements included in this Annual Report on Form 20-F were prepared in accordance with IFRS as issued by the IASB.



From our inception
through January 1, 2018, our functional and presentation currency was the New Israeli Shekel, or NIS. Effective January 1, 2018,
our functional and reporting currency is the U.S. dollar which is the primary currency of the economic environment in which we
operate. Due to the change in our functional and reporting currency from the NIS to the U.S. dollar, effective January 1, 2018,
the amounts for 2015 have been restated in U.S. dollars using the methodology set forth in Note 2d to our consolidated financial
statements for the year ended December 31, 2018.



|                                                                                                                |  | Year Ended December 31,                                 |           
|--------------------------------------------------------------------------------------------------------------- |  | ------------------------------------------------------- | ----------
|Consolidated Statements Of Operations Data:                                                                     |  | 2014                                                    |           
|                                                                                                                |  | (USD in thousands, except share and per share
    data) |           
|                                                                                                                |  |                                                         |           
|Revenues                                                                                                        |  |                                                         | -         
|Operating expenses:                                                                                             |  |                                                         |           
|Research and development expenses, net                                                                          |  |                                                         | 4,536     
|General and administrative expenses                                                                             |  |                                                         | 3,099     
|                                                                                                                |  |                                                         |           
|Operating loss                                                                                                  |  |                                                         | 7,635     
|Other income                                                                                                    |  |                                                         | -         
|Financial expenses                                                                                              |  |                                                         | 17        
|Financial income                                                                                                |  |                                                         | (618      
|Taxes on income                                                                                                 |  |                                                         | 6         
|Net loss                                                                                                        |  |                                                         | 7,040     
|Adjustments arising from translating financial statements
    from functional currency to presentation currency |  |                                                         | 135       
|Remeasurements loss (gain) from defined benefit plan                                                            |  |                                                         | 27        
|Comprehensive loss                                                                                              |  |                                                         | 7,202     
|Net loss per ordinary share                                                                                     |  |                                                         | 0.39      
|Number of ordinary shares used in computing loss per
    ordinary share                                         |  |                                                         | 17,545,663





1


Table of Contents




|                                     |  | As
    of December 31, |       
|------------------------------------ |  | ---------------------- | ------
|Consolidated
    Balance Sheet Data: |  | 2014                   |       
|                                     |  | USD
    in thousands   |       
|Cash and cash equivalents            |  |                        | 9,280 
|Other receivables and lease deposit  |  |                        | 946   
|Short-term investment                |  |                        | -     
|long-term investments                |  |                        | -     
|Fixed assets                         |  |                        | 22    
|Total assets                         |  |                        | 10,248
|Total liabilities                    |  |                        | 2,276 
|Total shareholders’
    equity       |  |                        | 7,972 



B. Capitalization and Indebtedness.



Not applicable.



C. Reasons for the Offer and Use of Proceeds.



Not applicable.



D. Risk Factors



You should carefully
consider the risks we describe below, in addition to the other information set forth elsewhere in this Annual Report on Form 20-F,
including our consolidated financial statements and the related notes beginning on page F-1, before deciding to invest in our
ordinary shares and American Depositary Shares, or ADSs. These material risks could adversely impact our results of operations,
possibly causing the trading price of our ordinary shares and ADSs to decline, and you could lose all or part of your investment.



Risks Related to Our Financial Position
and Capital Requirements



We have incurred
operating losses since our inception and anticipate that we will continue to incur substantial operating losses for the foreseeable
future.



We are a
clinical stage biopharmaceutical company that develops orally bioavailable small molecule therapeutic products for the
treatment of cancer, liver and inflammatory diseases and sexual dysfunction. Since our incorporation in 1994, we have been
focused on research and development activities with a view to developing our product candidates, CF101, also known as
Piclidenoson, CF102, also known as Namodenoson, and CF602. We have financed our operations primarily through the sale of
equity securities (both in private placements and in public offerings on the TASE and NYSE American) and payments received
under out-licensing agreements and have incurred losses in each year since our inception in 1994. We have historically
incurred substantial net losses, including net losses of approximately $6.5 million in 2018, $6.4 million in 2017, and $8.4
million in 2016. As of December 31, 2018, we had an accumulated deficit of approximately $100.6 million. We do not know
whether or when we will become profitable. To date, we have not commercialized any products or generated any revenues from
product sales and accordingly we do not have a revenue stream to support our cost structure. Our losses have resulted
principally from costs incurred in development and discovery activities. We expect to continue to incur losses for the
foreseeable future, and these losses will likely increase as we:



| | ● | initiate and manage
    pre-clinical development and clinical trials for our current and new product candidates;
| | - | ----------------------------------------------------------------------------------------------------------------



| | ● | seek regulatory
    approvals for our product candidates;
| | - | ---------------------------------------------------------





2


Table of Contents




| | ● | implement internal
    systems and infrastructures;
| | - | ---------------------------------------------------



| | ● | seek to license
    additional technologies to develop;
| | - | -------------------------------------------------------



| | ● | hire management
    and other personnel; and
| | - | --------------------------------------------



| | ● | move towards commercialization.
| | - | -------------------------------



If our product candidates
fail in clinical trials or do not gain regulatory clearance or approval, or if our product candidates do not achieve market acceptance,
we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on
a quarterly or annual basis. Our inability to achieve and then maintain profitability would negatively affect our business, financial
condition, results of operations and cash flows. Moreover, our prospects must be considered in light of the risks and uncertainties
encountered by an early-stage company and in highly regulated and competitive markets, such as the biopharmaceutical market, where
regulatory approval and market acceptance of our products are uncertain. There can be no assurance that our efforts will ultimately
be successful or result in revenues or profits.



We will need
to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult
to obtain and will dilute current shareholders’ ownership interests.



As of December 31,
2018 we had cash and cash equivalents of $3.6 million. In January 2019 we raised approximately $2.35 million in a registered direct offering and concurrent
private placement. We believe that our existing financial resources will be sufficient to meet our requirements for the next twelve
months from the date of issuance of this Annual Report on Form 20-F. We have expended and believe that we will continue to expend
substantial resources for the foreseeable future developing our product candidates. These expenditures will include costs associated
with research and development, manufacturing, conducting preclinical experiments and clinical trials and obtaining regulatory
approvals, as well as commercializing any products approved for sale. Because the outcome of our planned and anticipated clinical
trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development
and commercialization of our product candidates. In addition, other unanticipated costs may arise. As a result of these and other
factors currently unknown to us, we will require additional funds, through public or private equity or debt financings or other
sources, such as strategic partnerships and alliances and licensing arrangements. In addition, we may seek additional capital
due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or
future operating plans.



Our future capital
requirements will depend on many factors, including the progress and results of our clinical trials, the duration and cost of
discovery and preclinical development, and laboratory testing and clinical trials for our product candidates, the timing and outcome
of regulatory review of our product candidates, the number and development requirements of other product candidates that we pursue,
and the costs of activities, such as product marketing, sales, and distribution. Because of the numerous risks and uncertainties
associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased
capital outlays and operating expenditures associated with our anticipated clinical trials.





3


Table of Contents




Our future capital requirements depend
on many factors, including:



| | ● | the level of research
    and development investment required to develop our product candidates;                                                     
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                      
| | ● | the failure to obtain
    regulatory approval or achieve commercial success of our product candidates, including Piclidenoson, Namodenoson and CF602;



| | ● | the results of our
    preclinical studies and clinical trials for our earlier stage product candidates, and any decisions to initiate clinical trials
    if supported by the preclinical results;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the costs, timing
    and outcome of regulatory review of our product candidates that progress to clinical trials;
| | - | ------------------------------------------------------------------------------------------------------------------



| | ● | the costs of preparing,
    filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related
    claims;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the cost of commercialization
    activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the cost of manufacturing
    our product candidates and any products we successfully commercialize;
| | - | ----------------------------------------------------------------------------------------------------



| | ● | the timing, receipt
    and amount of sales of, or royalties on, our future products, if any;
| | - | ---------------------------------------------------------------------------------------------



| | ● | the expenses needed
    to attract and retain skilled personnel;
| | - | ----------------------------------------------------------------



| | ● | any product liability
    or other lawsuits related to our products;
| | - | --------------------------------------------------------------------



| | ● | the extent to which
    we acquire or invest in businesses, products or technologies and other strategic relationships;
| | - | -----------------------------------------------------------------------------------------------------------------------



| | ● | the costs of financing
    unanticipated working capital requirements and responding to competitive pressures; and                                      
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                         
| | ● | maintaining minimum
    shareholders’ equity requirements and complying with other continue listing standards under the NYSE American Company
    Guide.



Additional funds may
not be available when we need them, on terms that are acceptable to us, or at all. If adequate funds are not available to us on
a timely basis, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials or other research
and development activities for one or more of our product candidates or delay, limit, reduce or terminate our establishment of
sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates.



We may incur substantial
costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities law compliance
fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection
with certain securities we issue, such as convertible notes and warrants, which may adversely impact our financial condition.



Raising additional
capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies
or product candidates.



We may seek additional
capital through a combination of private and public equity offerings, debt financings, strategic partnerships and alliances and
licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities,
the ownership interests of existing shareholders will be diluted, and the terms may include liquidation or other preferences that
adversely affect shareholder rights. Debt financing, if available, may involve agreements that include covenants limiting or restricting
our ability to take certain actions, such as incurring debt, making capital expenditures or declaring dividends. If we raise additional
funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable
rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. If we are unable to
raise additional funds through equity or debt financing when needed, we may be required to delay, limit, reduce or terminate our
product development or commercialization efforts or grant rights to develop and market product candidates that we would otherwise
prefer to develop and market ourselves.





4


Table of Contents




Risks Related to Our Business and Regulatory
Matters



We have not
yet commercialized any products or technologies, and we may never become profitable.



We have not yet commercialized
any products or technologies, and we may never be able to do so. We do not know when or if we will complete any of our product
development efforts, obtain regulatory approval for any product candidates incorporating our technologies or successfully commercialize
any approved products. Even if we are successful in developing products that are approved for marketing, we will not be successful
unless these products gain market acceptance for appropriate indications at favorable reimbursement rates. The degree of market
acceptance of these products will depend on a number of factors, including:



| | ● | the timing of regulatory
    approvals in the countries, and for the uses, we seek;
| | - | -----------------------------------------------------------------------------------



| | ● | the competitive
    environment;
| | - | --------------------------------



| | ● | the establishment
    and demonstration in the medical community of the safety and clinical efficacy of our products and their potential advantages
    over existing therapeutic products;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | our ability to enter
    into distribution and other strategic agreements with pharmaceutical and biotechnology companies with strong marketing and
    sales capabilities;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the adequacy and
    success of distribution, sales and marketing efforts; and
| | - | ------------------------------------------------------------------------------



| | ● | the pricing and
    reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations
    and other plan administrators.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Physicians, patients,
thirty-party payors or the medical community in general may be unwilling to accept, utilize or recommend, and in the case of third-party
payors, cover any of our products or products incorporating our technologies. As a result, we are unable to predict the extent
of future losses or the time required to achieve profitability, if at all. Even if we successfully develop one or more products
that incorporate our technologies, we may not become profitable.



Our product
candidates are at various stages of clinical and preclinical development and may never be commercialized.



Our product candidates
are at various stages of clinical development and may never be commercialized. The progress and results of any future pre-clinical
testing or future clinical trials are uncertain, and the failure of our product candidates to receive regulatory approvals will
have a material adverse effect on our business, operating results and financial condition to the extent we are unable to commercialize
any products. None of our product candidates has received regulatory approval for commercial sale. In addition, we face the risks
of failure inherent in developing therapeutic products. Our product candidates are not expected to be commercially available for
several years, if at all.



In addition, our product
candidates must satisfy rigorous standards of safety and efficacy before they can be approved by the U.S. Food and Drug Administration,
or the FDA, the European Medicines Agency, or the EMA, and foreign regulatory authorities for commercial use. The FDA, the EMA
and foreign regulatory authorities have full discretion over this approval process. We will need to conduct significant additional
research, involving testing in animals and in humans, before we can file applications for product approval. Typically, in the
pharmaceutical industry, there is a high rate of attrition for product candidates in pre-clinical testing and clinical trials.
Also, satisfying regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the
product and requires the expenditure of substantial resources. In addition, delays or rejections may be encountered based upon
additional government regulation, including any changes in FDA policy, during the process of product development, clinical trials
and regulatory reviews.





5


Table of Contents




In order to receive
FDA approval or approval from foreign regulatory authorities to market a product candidate or to distribute our products, we must
demonstrate thorough pre-clinical testing and thorough human clinical trials that the product candidate is safe and effective
for its intended uses (e.g., treatment of a specific condition in a specific way subject to contradictions and other limitations).
Even if we comply with all FDA requests, the FDA may ultimately reject one or more of our New Drug Applications, or NDA, or grant
approval for a narrowly intended use that is not commercially feasible. We might not obtain regulatory approval for our drug candidates
in a timely manner, if at all. Failure to obtain FDA approval of any of our drug candidates in a timely manner or at all will
severely undermine our business by reducing the number of salable products and, therefore, corresponding product revenues.



Results of earlier
clinical trials may not be predictive of the results of later-stage clinical trials.



The results of preclinical
studies and early clinical trials of product candidates may not be predictive of the results of later-stage clinical trials. Also,
interim results, if at all, during a clinical trial do not necessarily predict final results. Product candidates in later stages
of clinical trials may fail to show the desired safety and efficacy results despite having progressed through preclinical studies
and initial clinical trials. For example, in December 2013, our former subsidiary OphthaliX Inc. (since renamed Wize Pharma, Inc.),
or OphthaliX, announced top-line results of a Phase III study with Piclidenoson for dry-eye syndrome in which Piclidenoson did
not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints and in July
2016, OphthaliX released top-line results from its Phase II clinical trial of Piclidenoson for the treatment of glaucoma in which
no statistically significant differences were found between the Piclidenoson treated group and the placebo group in the primary
endpoint of lowering intraocular pressure, or IOP. In addition, two Phase IIb studies in rheumatoid arthritis, or rheumatoid arthritis,
utilizing Piclidenoson in combination with methotrexate, a generic drug commonly used for treating rheumatoid arthritis patients,
or MTX, failed to reach their primary endpoints. A Phase II/III study of Piclidenoson for psoriasis did not meet its primary endpoint
although positive data from further analysis of the Phase II/III study suggests Piclidenoson as a potential systemic therapy for
patients with moderate-severe psoriasis. Furthermore, a Phase II study for advanced HCC in subjects with Child-Pugh B who failed
Nexavar as a first line treatment did not meet its primary endpoint although it showed superiority in overall survival in the
largest study subpopulation.





Many companies in
the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to adverse safety profiles or lack
of efficacy, notwithstanding promising results in earlier studies. Any delay in, or termination or suspension of, our clinical
trials will delay the requisite filings with the FDA, the EMA or other foreign regulatory authorities and, ultimately, our ability
to commercialize our product candidates and generate product revenues. If the clinical trials do not support our product claims,
the completion of development of such product candidates may be significantly delayed or abandoned, which will significantly impair
our ability to generate product revenues and will materially adversely affect our results of operations.



This drug candidate
development risk is heightened by any changes in the planned clinical trials compared to the completed clinical trials. As product
candidates are developed from preclinical through early to late stage clinical trials towards approval and commercialization,
it is customary that various aspects of the development program, such as manufacturing and methods of administration, are altered
along the way in an effort to optimize processes and results. While these types of changes are common and are intended to optimize
the product candidates for late stage clinical trials, approval and commercialization, such changes do carry the risk that they
will not achieve these intended objectives.



Changes in our planned
clinical trials or future clinical trials could cause our product candidates to perform differently, including causing toxicities,
which could delay completion of our clinical trials, delay approval of our product candidates, and/or jeopardize our ability to
commence product sales and generate revenues.





6


Table of Contents




We might be
unable to develop product candidates that will achieve commercial success in a timely and cost-effective manner, or ever.



Even if regulatory
authorities approve our product candidates, they may not be commercially successful. Our product candidates may not be commercially
successful because government agencies and other third-party payors may not cover the product or the coverage may be too limited
to be commercially successful; physicians and others may not use or recommend our products, even following regulatory approval.
A product approval, assuming one issues, may limit the uses for which the product may be distributed thereby adversely affecting
the commercial viability of the product. Third parties may develop superior products or have proprietary rights that preclude
us from marketing our products. We also expect that at least some of our product candidates will be expensive, if approved. Patient
acceptance of and demand for any product candidates for which we obtain regulatory approval or license will depend largely on
many factors, including but not limited to the extent, if any, of reimbursement of costs by government agencies and other third-party
payors, pricing, the effectiveness of our marketing and distribution efforts, the safety and effectiveness of alternative products,
and the prevalence and severity of side effects associated with our products. If physicians, government agencies and other third-party
payors do not accept our products, we will not be able to generate significant revenue.



Our current
pipeline is based on our platform technology utilizing the Gi protein associated A3AR, as a potent therapeutic target and currently
includes three molecules, Piclidenoson, Namodenoson and CF602 product candidates, of which Piclidenoson is the most advanced.
Failure to develop these molecules will have a material adverse effect on us.



Our current pipeline
is based on a platform technology where we target the A3AR with highly selective ligands, or small signal triggering molecules
that bind to specific cell surface receptors, such as the A3AR, including Piclidenoson, Namodenoson and CF602. A3ARs are structures
found in cell surfaces that record and transfer messages from small molecules or ligands, such as Piclidenoson, Namodenoson and
CF602 to the rest of the cell. Piclidenoson is the most advanced of our drug candidates. As such, we are currently dependent on
only three molecules for our potential commercial success, and any safety or efficacy concerns related to such molecules would
have a significant impact on our business. Failure to develop our drug candidates, in whole or in part, will have a material adverse
effect on us.



Clinical trials
are very expensive, time-consuming and difficult to design and implement, and, as a result, we may suffer delays or suspensions
in future trials which would have a material adverse effect on our ability to generate revenues.



Human clinical trials
are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
Regulatory authorities, such as the FDA, may preclude clinical trials from proceeding. Additionally, the clinical trial process
is time-consuming, failure can occur at any stage of the trials, and we may encounter problems that cause us to abandon or repeat
clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:



| | ● | unforeseen safety
    issues;
| | - | -----------------------------



| | ● | determination of
    dosing issues;
| | - | -----------------------------------



| | ● | lack of effectiveness
    or efficacy during clinical trials;
| | - | -------------------------------------------------------------



| | ● | failure of third-party suppliers to perform final manufacturing steps for the drug substance;
| | - | ---------------------------------------------------------------------------------------------



| | ● | slower than expected
    rates of patient recruitment and enrollment;
| | - | ---------------------------------------------------------------------



| | ● | lack of healthy
    volunteers and patients to conduct trials;
| | - | --------------------------------------------------------------



| | ● | inability to monitor
    patients adequately during or after treatment;
| | - | -----------------------------------------------------------------------



| | ● | failure of third-party contract research organizations to properly implement or monitor the clinical trial protocols;
| | - | ---------------------------------------------------------------------------------------------------------------------





7


Table of Contents




| | ● | failure of institutional
    review boards to approve our clinical trial protocols;
| | - | -----------------------------------------------------------------------------------



| | ● | inability or unwillingness
    of medical investigators and institutional review boards to follow our clinical trial protocols; and
| | - | -----------------------------------------------------------------------------------------------------------------------------------



| | ● | lack of sufficient
    funding to finance the clinical trials.
| | - | --------------------------------------------------------------



We have experienced
the risks involved with conducting clinical trials, including but not limited to, increased expense and delay and failure to meet
end points of the trial. For example, in December 2013, OphthaliX, announced top-line results of a Phase III study with CF101
for dry-eye syndrome in which Piclidenoson did not meet the primary efficacy endpoint of complete clearing of corneal staining,
nor the secondary efficacy endpoints and in July 2016, OphthaliX released top-line results from its Phase II clinical trial of
Piclidenoson for the treatment of glaucoma in which no statistically significant differences were found between the Piclidenoson
treated group and the placebo group in the primary endpoint of lowering IOP. In addition, two Phase IIb studies in rheumatoid
arthritis, utilizing Piclidenoson in combination with MTX failed to reach their primary end points. A Phase II/III study of Piclidenoson
for psoriasis did not meet its primary endpoint although positive data from further analysis of the Phase II/III study suggests
Piclidenoson as a potential systemic therapy for patients with moderate-severe psoriasis. Furthermore,
a Phase II study for advanced HCC in subjects with Child-Pugh B who failed Nexavar as a first line treatment did not meet its
primary endpoint although it showed superiority in overall survival in the largest study subpopulation.



In addition, we or
regulatory authorities may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable
health risks or if the regulatory authorities find deficiencies in our regulatory submissions or the conduct of these trials.
Any suspension of clinical trials will delay possible regulatory approval, if any, and adversely impact our ability to develop
products and generate revenue.



If we acquire
or license additional technology or product candidates, we may incur a number of costs, may have integration difficulties and
may experience other risks that could harm our business and results of operations.



We may acquire and
license additional product candidates and technologies. Any product candidate or technology we license from others or acquire
will likely require additional development efforts prior to commercial sale, including extensive pre-clinical or clinical testing,
or both, and approval by the FDA and applicable foreign regulatory authorities, if any. All product candidates are prone to risks
of failure inherent in pharmaceutical product development, including the possibility that the product candidate or product developed
based on licensed technology will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In
addition, we cannot assure you that any product candidate that we develop based on acquired or licensed technology that is granted
regulatory approval will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace.
Moreover, integrating any newly acquired product candidates could be expensive and time-consuming. If we cannot effectively manage
these aspects of our business strategy, our business may not succeed.



The manufacture
of our product candidates is a chemical synthesis process and if one of our materials suppliers encounters problems manufacturing
our products, our business could suffer.



The FDA and foreign
regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities
to confirm compliance with requirements that the FDA or foreign regulators establish. We do not intend to engage in the manufacture
of our products other than for pre-clinical and clinical studies, but we or our materials suppliers may face manufacturing or
quality control problems causing product production and shipment delays or a situation where we or the supplier may not be able
to maintain compliance with the FDA’s or foreign regulators’ requirements necessary to continue manufacturing our
drug substance. Drug manufacturers are subject to ongoing periodic unannounced inspections by the FDA, the U.S. Drug Enforcement
Agency, or DEA, and corresponding foreign regulators to ensure strict compliance with requirements and other governmental regulations
and corresponding foreign standards. Any failure to comply with DEA requirements or FDA or foreign regulatory requirements could
adversely affect our clinical research activities and our ability to market and develop our product candidates.





8


Table of Contents




We do not currently
have sales, marketing or distribution capabilities or experience, and we are unable to effectively sell, market or distribute
our product candidates now and we do not expect to be able to do so in the future. The failure to enter into agreements with third
parties that are capable of performing these functions would have a material adverse effect on our business and results of operations.



We do not currently
have and we do not expect to develop sales, marketing and distribution capabilities. If we are unable to enter into agreements
with third parties to perform these functions, we will not be able to successfully market any of our platforms or product candidates.
In order to successfully market any of our platform or product candidates, we must make arrangements with third parties to perform
these services.



As we do not intend
to develop a marketing and sales force with technical expertise and supporting distribution capabilities, we will be unable to
market any of our product candidates directly. To promote any of our potential products through third parties, we will have to
locate acceptable third parties for these functions and enter into agreements with them on acceptable terms, and we may not be
able to do so. Any third-party arrangements we are able to enter into may result in lower revenues than we could achieve by directly
marketing and selling our potential products. In addition, to the extent that we depend on third parties for marketing and distribution,
any revenues we receive will depend upon the efforts of such third parties, as well as the terms of our agreements with such third
parties, which cannot be predicted in most cases at this time. As a result, we might not be able to market and sell our products
in the United States or overseas, which would have a material adverse effect on us.



We will to some
extent rely on third parties to implement our manufacturing and supply strategies. Failure of these third parties in any respect
could have a material adverse effect on our business, results of operations and financial condition.



If our current and
future manufacturing and supply strategies are unsuccessful, then we may be unable to conduct and complete any future pre-clinical
or clinical trials or commercialize our product candidates in a timely manner, if at all. Completion of any potential future pre-clinical
or clinical trials and commercialization of our product candidates will require access to, or development of, facilities to manufacture
a sufficient supply of our product candidates. We do not have the resources, facilities or experience to manufacture our product
candidates for commercial purposes on our own and do not intend to develop or acquire facilities for the manufacture of product
candidates for commercial purposes in the foreseeable future. We may rely on contract manufacturers to produce sufficient quantities
of our product candidates necessary for any pre-clinical or clinical testing we undertake in the future. Such contract manufacturers
may be the sole source of production and they may have limited experience at manufacturing, formulating, analyzing, filling and
finishing our types of product candidates.



We also intend to
rely on third parties to supply the requisite materials needed for the manufacturing of our active pharmaceutical ingredients,
or API. There may be a limited supply of these requisite materials. We might not be able to enter into agreements that provide
us assurance of availability of such components in the future from any supplier. Our potential suppliers may not be able to adequately
supply us with the components necessary to successfully conduct our pre-clinical and clinical trials or to commercialize our product
candidates. If we cannot acquire an acceptable supply of the requisite materials to produce our product candidates, we will not
be able to complete pre-clinical and clinical trials and will not be able to market or commercialize our product candidates.



We depend on
key members of our management and key consultants and will need to add and retain additional leading experts. Failure to retain
our management and consulting team and add additional leading experts could have a material adverse effect on our business, results
of operations or financial condition.



We are highly dependent
on our executive officers and other key management and technical personnel. Our failure to retain our Chief Executive Officer,
Pnina Fishman, Ph.D., who has developed much of the technology we utilize today, or any other key management and technical personnel,
could have a material adverse effect on our future operations. Our success is also dependent on our ability to attract, retain
and motivate highly trained technical, and management personnel, among others, to continue the development and commercialization
of our current and future products. We presently maintain a life insurance policy on our Chief Executive Officer, Pnina Fishman,
Ph.D.





9


Table of Contents




Our success also depends
on our ability to attract, retain and motivate personnel required for the development, maintenance and expansion of our activities.
There can be no assurance that we will be able to retain our existing personnel or attract additional qualified employees or consultants.
The loss of key personnel or the inability to hire and retain additional qualified personnel in the future could have a material
adverse effect on our business, financial condition and results of operation.



We face significant
competition and continuous technological change, and developments by competitors may render our products or technologies obsolete
or non-competitive. If we cannot successfully compete with new or existing products, our marketing and sales will suffer and we
may not ever be profitable.



We will compete against
fully integrated pharmaceutical and biotechnology companies and smaller companies that are collaborating with larger pharmaceutical
companies, academic institutions, government agencies and other public and private research organizations. In addition, many of
these competitors, either alone or together with their collaborative partners, operate larger research and development programs
than we do, and have substantially greater financial resources than we do, as well as significantly greater experience in:



| | ● | developing drugs;
| | - | -----------------



| | ● | undertaking pre-clinical
    testing and human clinical trials;
| | - | ---------------------------------------------------------------



| | ● | obtaining FDA approval,
    addressing various regulatory matters and other regulatory approvals of drugs;
| | - | ----------------------------------------------------------------------------------------------------------



| | ● | formulating and
    manufacturing drugs; and
| | - | --------------------------------------------



| | ● | launching, marketing
    and selling drugs.
| | - | -------------------------------------------



If our competitors
develop and commercialize products faster than we do, or develop and commercialize products that are superior to our product candidates,
our commercial opportunities will be reduced or eliminated. The extent to which any of our product candidates achieve market acceptance
will depend on competitive factors, many of which are beyond our control. Competition in the biotechnology and biopharmaceutical
industry is intense and has been accentuated by the rapid pace of technology development. Our competitors include large integrated
pharmaceutical companies, biotechnology companies that currently have drug and target discovery efforts, universities, and public
and private research institutions. Almost all of these entities have substantially greater research and development capabilities
and financial, scientific, manufacturing, marketing and sales resources than we do. These organizations also compete with us to:



| | ● | attract parties
    for acquisitions, joint ventures or other collaborations;
| | - | -----------------------------------------------------------------------------



| | ● | license proprietary
    technology that is competitive with the technology we are developing;
| | - | ---------------------------------------------------------------------------------------------



| | ● | attract funding;
    and
| | - | ------------------------



| | ● | attract and hire
    scientific talent and other qualified personnel.
| | - | ---------------------------------------------------------------------



Our competitors may
succeed in developing and commercializing products earlier and obtaining regulatory approvals from the FDA or foreign regulators
more rapidly than we do. Our competitors may also develop products or technologies that are superior to those we are developing,
and render our product candidates or technologies obsolete or non-competitive. If we cannot successfully compete with new or existing
products, our marketing and sales will suffer and we may not ever be profitable.



Our competitors currently
include companies with marketed products and/or an advanced research and development pipeline. The major competitors in the rheumatoid
arthritis and psoriasis therapeutic field include Amgen, J&J, Pfizer, Novartis, Abbvie, Celgene, Eli Lilly, Bristol-Myers,
and more. Competitors in the HCC field include companies such as Bayer, Exelixis, Merck, and Bristol-Myers. Competitors in the
NASH field include companies such as Gilead, Genfit, Galmed, Allergan, Intercept, and Madrigal. Competitors in the erectile dysfunction
field include Pfizer, Eli Lilly and Bayer. See “Item 4. Information on the Company—B. Business Overview—Competition.”





10


Table of Contents




Moreover, several
companies have reported the commencement of research projects related to the A3AR. Such companies include CV Therapeutics Inc.
(which was acquired by Gilead), King Pharmaceuticals R&D Inv. (which was acquired by Pfizer), Hoechst Marion Roussel Inc.
(which was acquired by Aventis), Novo Nordisk A/S and Inotek Pharmaceuticals. However, to the best of our knowledge, there is
no approved drug currently on the market, which is similar to our A3AR agonists, nor are we aware of any allosteric modulator
in the A3AR product pipeline similar to our allosteric modulator with respect to chemical profile and mechanism of action.



We may suffer
losses from product liability claims if our product candidates cause harm to patients.



Any of our product
candidates could cause adverse events. Although data from a pooled analysis of approximately 1,200 patients with inflammatory
disease treated with Piclidenoson, indicates that Piclidenoson has a good safety profile and is well tolerated at doses up to
4.0 mg administered twice daily for up to 12-32 weeks, there were incidences (albeit less than or equal to 5%) of adverse events
in eight completed and fully analyzed trials in inflammatory disease. Such adverse events included nausea, diarrhea, abdominal
pain, vomiting, constipation, common bacterial and viral syndromes (such as tonsillitis, otitis and respiratory and urinary tract
infections), abdominal pain, vomiting, myalgia, arthralgia, dizziness, headache and pruritus. We observed an even lower incidence
(less than or equal to 2%) of serious adverse events, although only one type of event was reported in more than a single Piclidenoson-treated
subject, which was exacerbation of chronic obstructive lung disease reported in two subjects. Notwithstanding the foregoing, the
placebo group in such studies had a higher incidence of overall adverse events than the pooled Piclidenoson groups. In addition,
in normal volunteers, Piclidenoson at doses 3-4-fold higher than those to be used in therapeutic trials, but not at therapeutic
doses, was associated with prolongation of the electrocardiographic QT intervals. No new safety concerns have been identified
and no novel or unexpected safety concerns have appeared over 32 weeks of treatment in more recent trials.



There is also a risk
that certain adverse events may not be observed in clinical trials, but may nonetheless occur in the future. If any of these adverse
events occur, they may render our product candidates ineffective or harmful in some patients, and our sales would suffer, materially
adversely affecting our business, financial condition and results of operations.



In addition, potential
adverse events caused by our product candidates could lead to product liability lawsuits. If product liability lawsuits are successfully
brought against us, we may incur substantial liabilities and may be required to limit the marketing and commercialization of our
product candidates. Our business exposes us to potential product liability risks, which are inherent in the testing, manufacturing,
marketing and sale of pharmaceutical products. We may not be able to avoid product liability claims. Product liability insurance
for the pharmaceutical and biotechnology industries is generally expensive, if available at all. If, at any time, we are unable
to obtain sufficient insurance coverage on reasonable terms or to otherwise protect against potential product liability claims,
we may be unable to clinically test, market or commercialize our product candidates. A successful product liability claim brought
against us in excess of our insurance coverage, if any, may cause us to incur substantial liabilities, and, as a result, our business,
liquidity and results of operations would be materially adversely affected.



Our product
candidates will remain subject to ongoing regulatory requirements even if they receive marketing approval, and if we fail to comply
with these requirements, we could lose these approvals, and the sales of any approved commercial products could be suspended.



Even if we receive
regulatory approval to market a particular product candidate, the product will remain subject to extensive regulatory requirements,
including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion,
distribution and recordkeeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations
on the uses for which the product may be marketed or the conditions of approval, or may contain requirements for costly post-marketing
testing and surveillance to monitor the safety or efficacy of the product, which could negatively impact us or our collaboration
partners by reducing revenues or increasing expenses, and cause the approved product candidate not to be commercially viable.
In addition, as clinical experience with a drug expands after approval, typically because it is used by a greater number and more
diverse group of patients after approval than during clinical trials, side effects and other problems may be observed after approval
that were not seen or anticipated during pre-approval clinical trials or other studies. Any adverse effects observed after the
approval and marketing of a product candidate could result in limitations on the use of or withdrawal of any approved products
from the marketplace. Absence of long-term safety data may also limit the approved uses of our products, if any. If we fail to
comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, or previously
unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could be subject
to administrative or judicially imposed sanctions or other setbacks, including the following:



| | ● | Restrictions on
    the products, manufacturers or manufacturing process;
| | - | -------------------------------------------------------------------------



| | ● | Warning letters;
| | - | ----------------





11


Table of Contents




| | ● | Civil or criminal
    penalties, fines and injunctions;
| | - | -------------------------------------------------------



| | ● | Product seizures
    or detentions;
| | - | -----------------------------------



| | ● | Import or export
    bans or restrictions;
| | - | ------------------------------------------



| | ● | Voluntary or mandatory
    product recalls and related publicity requirements;
| | - | ------------------------------------------------------------------------------



| | ● | Suspension or withdrawal
    of regulatory approvals;
| | - | -----------------------------------------------------



| | ● | Total or partial
    suspension of production; and
| | - | --------------------------------------------------



| | ● | Refusal to approve
    pending applications for marketing approval of new products or supplements to approved applications.
| | - | ---------------------------------------------------------------------------------------------------------------------------



If we or our collaborators
are slow or unable to adapt to changes in existing regulatory requirements or adoption of new regulatory requirements or policies,
marketing approval for our product candidates may be lost or cease to be achievable, resulting in decreased revenue from milestones,
product sales or royalties, which would have a material adverse effect on our results of operations.



We deal with
hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive and restrict
how we do business.



Our activities and
those of our third-party manufacturers on our behalf involve the controlled storage, use and disposal of hazardous materials,
including corrosive, explosive and flammable chemicals and other hazardous compounds. We and our manufacturers are subject to
U.S. federal, state, and local, and Israeli and other foreign laws and regulations governing the use, manufacture, storage, handling
and disposal of these hazardous materials. Although we believe that our safety procedures for handling and disposing of these
materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination
or injury from these materials. In addition, if we develop a manufacturing capacity, we may incur substantial costs to comply
with environmental regulations and would be subject to the risk of accidental contamination or injury from the use of hazardous
materials in our manufacturing process.



In the event of an
accident, government authorities may curtail our use of these materials and interrupt our business operations. In addition, we
could be liable for any civil damages that result, which may exceed our financial resources and may seriously harm our business.
Although our Israeli insurance program covers certain unforeseen sudden pollutions, we do not maintain a separate insurance policy
for any of the foregoing types of risks. In addition, although the general liability section of our life sciences policy covers
certain unforeseen, sudden environmental issues, pollution in the United States and Canada is excluded from the policy. In the
event of environmental discharge or contamination or an accident, we may be held liable for any resulting damages, and any liability
could exceed our resources. In addition, we may be subject to liability and may be required to comply with new or existing environmental
laws regulating pharmaceuticals or other medical products in the environment.





12


Table of Contents




Our business
and operations may be materially adversely affected in the event of computer system failures or security breaches.



Despite the implementation
of security measures, our internal computer systems, and those of our contract research organizations, or CROs, and other third
parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, natural disasters,
fire, terrorism, war, and telecommunication and electrical failures.  If such an event were to occur and interrupt our
operations, it could result in a material disruption of our drug development programs.  For example, the loss of clinical
trial data from ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly
increase our costs to recover or reproduce the data.  To the extent that any disruption or security breach results in
a loss of or damage to our data or applications, loss of trade secrets or inappropriate disclosure of confidential or proprietary
information, including protected health information or personal data of employees or former employees, access to our clinical
data, or disruption of the manufacturing process, we could incur liability and the further development of our drug candidates
could be delayed.  We may also be vulnerable to cyber-attacks by hackers or other malfeasance.  This type
of breach of our cybersecurity may compromise our confidential information and/or our financial information and adversely affect
our business or result in legal proceedings.  Further, these cybersecurity breaches may inflict reputational harm upon
us that may result in decreased market value and erode public trust.



We may not be
able to successfully grow and expand our business. Failure to manage our growth effectively will have a material adverse effect
on our business, results of operations and financial condition.



We may not be able
to successfully grow and expand. Successful implementation of our business plan will require management of growth, including potentially
rapid and substantial growth, which will result in an increase in the level of responsibility for management personnel and place
a strain on our human and capital resources. To manage growth effectively, we will be required to continue to implement and improve
our operating and financial systems and controls to expand, train and manage our employee base. Our ability to manage our operations
and growth effectively requires us to continue to expend funds to enhance our operational, financial and management controls,
reporting systems and procedures and to attract and retain sufficient numbers of talented personnel. If we are unable to scale
up and implement improvements to our control systems in an efficient or timely manner, or if we encounter deficiencies in existing
systems and controls, then we will not be able to make available the products required to successfully commercialize our technology.
Failure to attract and retain sufficient numbers of talented personnel will further strain our human resources and could impede
our growth or result in ineffective growth. Moreover, the management, systems and controls currently in place or to be implemented
may not be adequate for such growth, and the steps taken to hire personnel and to improve such systems and controls might not
be sufficient. If we are unable to manage our growth effectively, it will have a material adverse effect on our business, results
of operations and financial condition.



If we are unable
to obtain adequate insurance, our financial condition could be adversely affected in the event of uninsured or inadequately insured
loss or damage. Our ability to effectively recruit and retain qualified officers and directors could also be adversely affected
if we experience difficulty in obtaining adequate directors’ and officers’ liability insurance.



We may not be able
to obtain insurance policies on terms affordable to us that would adequately insure our business and property against damage,
loss or claims by third parties. To the extent our business or property suffers any damages, losses or claims by third parties,
which are not covered or adequately covered by insurance, our financial condition may be materially adversely affected.



We may be unable to
maintain sufficient insurance as a public company to cover liability claims made against our officers and directors. If we are
unable to adequately insure our officers and directors, we may not be able to retain or recruit qualified officers and directors
to manage us.





13


Table of Contents




Risks Related to Our Intellectual Property



The termination
of the National Institute of Health, or NIH, license agreement between us and NIH due to patent expiration may diminish our proprietary
position.



As a result of the
termination of the NIH license agreement between us and NIH in June 2015 due to patent expiration, we no longer hold rights to
a family of composition of matter patents relating to Piclidenoson that were licensed from NIH. Nevertheless, because Piclidenoson
may be a new chemical entity, or NCE, following approval of an NDA, we, if we are the first applicant to obtain NDA approval,
may be entitled to five years of data exclusivity in the United States with respect to such NCEs. Analogous data and market exclusivity
provisions, of varying duration, may be available in Europe and other foreign jurisdictions. We also have rights under our pharmaceutical
use issued patents with respect to Piclidenoson and Namodenoson, which provide patent exclusivity within our field of activity
until the mid- to late-2020s. While we believe that we may be able to protect our exclusivity through such use patent portfolio
and such period of exclusivity, the lack of composition of matter patent protection may diminish our ability to maintain a proprietary
position for our intended uses of Piclidenoson. Moreover, we cannot be certain that we will be the first applicant to obtain an
FDA approval for any indication of Piclidenoson and we cannot be certain that we will be entitled to NCE exclusivity. In addition,
we have discontinued the prosecution of a family of pending patent applications under joint ownership of us and NIH pertaining
to the use of A3AR agonists for the treatment of uveitis. Such diminution of our proprietary position could have a material adverse
effect on our business, results of operation and financial condition.



We license from
Leiden University intellectual property, which protects certain small molecules which target the A3AR, in furtherance of our platform
technology, and we could lose our rights to this license if a dispute with Leiden University arises or if we fail to comply with
the financial and other terms of the license.



We have licensed intellectual
property from Leiden University pursuant to a license agreement. The license agreement imposes certain payment, reporting, confidentiality
and other obligations on us. In the event that we were to breach any of the obligations and fail to cure, Leiden University would
have the right to terminate the license agreement. In addition, Leiden University has the right to terminate the license agreement
upon our bankruptcy, insolvency, or receivership. If any dispute arises with respect to our arrangements with Leiden University,
such dispute may disrupt our operations and may have a material adverse impact on us if resolved in a manner that is unfavorable
to us.



The failure
to obtain or maintain patents, licensing agreements, including our current licensing agreements, and other intellectual property
could impact our ability to compete effectively.



To compete effectively,
we need to develop and maintain a proprietary position with regard to our own technologies, intellectual property, licensing agreements,
product candidates and business. Legal standards relating to the validity and scope of claims in the biotechnology and biopharmaceutical
fields are still evolving. Therefore, the degree of future protection for our proprietary rights in our core technologies and
any products that might be made using these technologies is also uncertain. The risks and uncertainties that we face with respect
to our patents and other proprietary rights include the following:



| | ● | while the patents
    we license have been issued, the pending patent applications we have filed may not result in issued patents or may take longer
    than we expect to result in issued patents;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | we may be subject
    to interference proceedings;
| | - | --------------------------------------------------



| | ● | we may be subject
    to opposition proceedings in foreign countries;
| | - | ---------------------------------------------------------------------



| | ● | any patents that
    are issued may not provide meaningful protection;
| | - | ----------------------------------------------------------------------



| | ● | we may not be able
    to develop additional proprietary technologies that are patentable;
| | - | ------------------------------------------------------------------------------------------



| | ● | other companies
    may challenge patents licensed or issued to us or our customers;
| | - | ------------------------------------------------------------------------------------



| | ● | other companies
    may independently develop similar or alternative technologies, or duplicate our technologies;
| | - | -----------------------------------------------------------------------------------------------------------------



| | ● | other companies
    may design around technologies we have licensed or developed; and
| | - | -------------------------------------------------------------------------------------



| | ● | enforcement of patents
    is complex, uncertain and expensive.
| | - | ---------------------------------------------------------------





14


Table of Contents




If patent rights covering
our products and methods are not sufficiently broad, they may not provide us with any protection against competitors with similar
products and technologies. Furthermore, if the United States Patent and Trademark Office, or the USPTO, or foreign patent officers
issue patents to us or our licensors, others may challenge the patents or design around the patents, or the patent office or the
courts may invalidate the patents. Thus, any patents we own or license from or to third parties may not provide any protection
against our competitors.



We cannot be certain
that patents will be issued as a result of any pending applications, and we cannot be certain that any of our issued patents will
give us adequate protection from competing products. For example, issued patents, including the patents licensed by us, may be
circumvented or challenged, declared invalid or unenforceable, or narrowed in scope. In addition, since publication of discoveries
in the scientific or patent literature often lags behind actual discoveries, we cannot be certain that we were the first to make
our inventions or to file patent applications covering those inventions.



It is also possible
that others may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses
requiring the payment of significant fees or royalties in order to enable us to conduct our business. As to those patents that
we have licensed, our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and
we may be unable to do so.



In addition to patents
and patent applications, we depend upon trade secrets and proprietary know-how to protect our proprietary technology. We require
our employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure of
confidential information to any other parties. We require our employees and consultants to disclose and assign to us their ideas,
developments, discoveries and inventions. These agreements may not, however, provide adequate protection for our trade secrets,
know-how or other proprietary information in the event of any unauthorized use or disclosure.



Costly litigation
may be necessary to protect our intellectual property rights and we may be subject to claims alleging the violation of the intellectual
property rights of others.



We may face significant
expense and liability as a result of litigation or other proceedings relating to patents and other intellectual property rights
of others. In the event that another party has also filed a patent application or been issued a patent relating to an invention
or technology claimed by us in pending applications, we may be required to participate in an interference proceeding declared
by the USPTO to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the
eventual outcome were favorable to us. We, or our licensors, also could be required to participate in interference proceedings
involving issued patents and pending applications of another entity. An adverse outcome in an interference proceeding could require
us to cease using the technology or to license rights from prevailing third parties.



The cost to us of
any patent litigation or other proceeding relating to our licensed patents or patent applications, even if resolved in our favor,
could be substantial. Our ability to enforce our patent protection could be limited by our financial resources, and may be subject
to lengthy delays. If we are unable to effectively enforce our proprietary rights, or if we are found to infringe the rights of
others, we may be in breach of our License Agreement.



A third party may
claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal operations
and activities, such as research, development and the sale of any future products. Such lawsuits are expensive and would consume
time and other resources. There is a risk that the court will decide that we are infringing the third party’s patents and
will order us to stop the activities claimed by the patents, redesign our products or processes to avoid infringement or obtain
licenses (which may not be available on commercially reasonable terms). In addition, there is a risk that a court will order us
to pay the other party damages for having infringed their patents.



Moreover, there is
no guarantee that any prevailing patent owner would offer us a license so that we could continue to engage in activities claimed
by the patent, or that such a license, if made available to us, could be acquired on commercially acceptable terms. In addition,
third parties may, in the future, assert other intellectual property infringement claims against us with respect to our product
candidates, technologies or other matters.





15


Table of Contents




We rely on confidentiality
agreements that could be breached and may be difficult to enforce, which could result in third parties using our intellectual
property to compete against us.



Although we believe
that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure
of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us
of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them, the
agreements can be difficult and costly to enforce. Although we seek to obtain these types of agreements from our contractors,
consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop
intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated
with our products. If a dispute arises, a court may determine that the right belongs to a third party. In addition, enforcement
of our rights can be costly and unpredictable. We also rely on trade secrets and proprietary know-how that we seek to protect
in part by confidentiality agreements with our employees, contractors, consultants, advisors or others. Despite the protective
measures we employ, we still face the risk that:



| | ● | these agreements
    may be breached;
| | - | -------------------------------------



| | ● | these agreements
    may not provide adequate remedies for the applicable type of breach;
| | - | -----------------------------------------------------------------------------------------



| | ● | our trade secrets
    or proprietary know-how will otherwise become known; or
| | - | -----------------------------------------------------------------------------



| | ● | our competitors
    will independently develop similar technology or proprietary information.
| | - | ---------------------------------------------------------------------------------------------



International
patent protection is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have
to expend substantial sums and management resources.



Patent law outside
the United States is different than in the United States. Further, the laws of some foreign countries may not protect our intellectual
property rights to the same extent as the laws of the United States, if at all. A failure to obtain sufficient intellectual property
protection in any foreign country could materially and adversely affect our business, results of operations and future prospects.
Moreover, we may participate in opposition proceedings to determine the validity of our foreign patents or our competitors’
foreign patents, which could result in substantial costs and divert management’s resources and attention.



Although most jurisdictions
in which we have applied for, intend to apply for, or have been issued patents have patent protection laws similar to those of
the United States, some of them do not. For example, we expect to do business in Brazil and India in the future. However, the
Brazilian drug regulatory agency, ENVISA, has the authority to nullify patents on the basis of its perceived public interest and
the Indian patent law does not allow patent protection for new uses of pharmaceuticals (many of our current patent applications
are of such nature). Additionally, due to uncertainty in patent protection law, we have not filed applications in many countries
where significant markets exist, including Indonesia, Pakistan, Russia, African countries and Taiwan.



We may be unable
to protect the intellectual property rights of the third parties from whom we license certain of our intellectual property or
with whom we have entered into other strategic relationships.



Certain of our intellectual
property rights are currently licensed from Leiden University, and, in the future, we intend to continue to license intellectual
property from Leiden University and/or other universities and/or strategic partners. Such third parties may determine not to protect
the intellectual property rights that we license from them and we may be unable to defend such intellectual property rights on
our own or we may have to undertake costly litigation to defend the intellectual property rights of such third parties. There
can be no assurances that we will continue to have proprietary rights to any of the intellectual property that we license from
such third parties or otherwise have the right to use through similar strategic relationships. Any loss or limitations on use
with respect to our right to use such intellectual property licensed from third parties or otherwise obtained from third parties
with whom we have entered into strategic relationships could have a material adverse effect on our business, results of operations
and financial condition.







16


Table of Contents




Under applicable
U.S. and Israeli law, we may not be able to enforce covenants not to compete and therefore, may be unable to prevent our competitors
from benefiting from the expertise of some of our former employees. In addition, employees may be entitled to seek compensation
for their inventions irrespective of their agreements with us, which in turn could impact our future profitability.



We generally enter
into non-competition agreements with our employees and certain key consultants, or our employment and consulting agreements contain
non-competition provisions. These agreements, to the extent they are in place and in effect, prohibit our employees and certain
key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a
limited period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees
work and it may be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants
developed while working for us. For example, Israeli courts have required employers seeking to enforce non-compete undertakings
of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of
material interests of the employer which have been recognized by the courts, such as the secrecy of a company’s confidential
commercial information or the protection of its intellectual property. If we cannot demonstrate that such interests will be harmed,
we may be unable to prevent our competitors from benefiting from the expertise of our former employees or consultants and our
ability to remain competitive may be diminished.



In addition, Chapter
8 to the Israeli Patents Law, 5727-1967, or the Patents Law, deals with inventions made in the course of an employee’s service
and during his or her term of employment, whether or not the invention is patentable, or service inventions. Section 134 of the
Patents Law provides that if there is no agreement that explicitly determines whether the employee is entitled to compensation
for the service inventions and the extent and terms of such compensation, such determination will be made by the Compensation
and Rewards Committee, a statutory committee of the Israeli Patents Office. Although our employees have agreed to assign to us
service invention rights, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence
of such claims, we could be required to pay additional remuneration or royalties to our current and/or former employees, or be
forced to litigate such claims, which could negatively affect our business.



Intellectual
property rights do not necessarily address all potential threats to our competitive advantage.



The degree of future
protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and
may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:



| | ● | Others may be able
    to make compounds that are the same as or similar to our product candidates but that are not covered by the claims of the
    patents that we own or have exclusively licensed;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | We or our licensors
    or any future strategic partners might not have been the first to make the inventions covered by the issued patent or pending
    patent application that we own or have exclusively licensed;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | We or our licensors
    or any future strategic partners might not have been the first to file patent applications covering certain of our inventions;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Others may independently
    develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property
    rights;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | It is possible that
    our pending patent applications will not lead to issued patents;
| | - | ----------------------------------------------------------------------------------------



| | ● | Issued patents that
    we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable,
    as a result of legal challenges by our competitors;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Our competitors
    might conduct research and development activities in countries where we do not have patent rights and then use the information
    learned from such activities to develop competitive products for sale in our major commercial markets; and
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | We may not develop
    additional proprietary technologies that are patentable.
| | - | -------------------------------------------------------------------------------





17


Table of Contents




We may be subject to claims challenging
the inventorship of our patents and other intellectual property.



We may be subject
to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property
as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants
or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other
claims challenging inventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose
valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an
outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation
could result in substantial costs and be a distraction to management and other employees.



Risks Related to Our Industry



We are subject
to government regulations and we may experience delays in obtaining required regulatory approvals in the United States to market
our proposed product candidates.



Various aspects of
our operations are subject to federal, state or local laws, and rules and regulations, any of which may change from time to time.
Costs arising out of any regulatory developments could be time-consuming and expensive and could divert management resources and
attention and, consequently, could adversely affect our business operations and financial performance.





Delays in regulatory
approval, limitations in regulatory approval and withdrawals of regulatory approval may have a material adverse effect on us.
If we experience significant delays in testing or receiving approvals or sign-offs to conduct clinical trials, our product development
costs, or our ability to license product candidates, will increase. If the FDA grants regulatory approval to market a product,
this approval will be limited to those disease states and conditions for which the product has demonstrated, through clinical
trials, to be safe and effective. Any product approvals that we receive in the future could also include significant restrictions
on the use or marketing of our products. Product approvals, if granted, can be withdrawn for failure to comply with regulatory
requirements or upon the occurrence of adverse events following commercial introduction of the products. Failure to comply with
applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure
of products, total or partial suspension of production or injunction, as well as other regulatory action against our product candidates
or us. If approval is withdrawn for a product, or if a product were seized or recalled, we would be unable to sell or license
that product and our revenues would suffer. In addition, outside the United States, our ability to market any of our potential
products is contingent upon receiving market application authorizations from the appropriate regulatory authorities and these
foreign regulatory approval processes include all of the risks associated with the FDA approval process described above.



We expect the
healthcare industry to face increased limitations on reimbursement as a result of healthcare reform, which could adversely affect
third-party coverage of our products and how much or under what circumstances healthcare providers will prescribe or administer
our products.



In both the United
States and other countries, sales of our products will depend in part upon the availability of reimbursement from third-party
payors, which include governmental authorities, managed-care organizations and other private-health insurers. Third-party payors
are increasingly challenging the price and examining the cost effectiveness of medical products and services.



Increasing expenditures
for healthcare have been the subject of considerable public attention in the United States. Both private and government entities
are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare system
have been introduced or proposed in Congress and in some state legislatures, including reducing reimbursement for prescription
products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products.





18


Table of Contents




In 2010, the U.S.
Congress enacted the Patient Protection and Affordable Care Act of 2010, or the Affordable Care Act. The Affordable Care Act seeks
to reduce the federal deficit and the rate of growth in healthcare spending through, among other things, stronger prevention and
wellness measures, increased access to primary care, changes in healthcare delivery systems and the creation of health insurance
exchanges. Enrollment in the health insurance exchanges began in October 2013. The Affordable Care Act requires the pharmaceutical
industry to share in the costs of reform, by, among other things, increasing Medicaid rebates and expanding Medicaid rebates to
cover Medicaid managed-care programs. Other components of healthcare reform include funding of pharmaceutical costs for Medicare
patients in excess of the prescription drug coverage limit and below the catastrophic coverage threshold. Under the Affordable
Care Act, pharmaceutical companies are now obligated to fund 50% of the patient obligation for branded prescription pharmaceuticals
in this gap, or “donut hole.”



There have been judicial
and congressional challenges to the Affordable Care Act, as well as efforts by the Trump Administration to repeal or replace certain
aspects of the Affordable Care Act. Since January 2017, President Trump has signed two Executive Orders and other directives designed
to delay the implementation of certain provisions of the Affordable Care Act or otherwise circumvent some of the requirements
for health insurance mandated by the Affordable Care Act. However, to date, the Executive Orders have had limited effect and the
Congressional activities have not resulted in the passage of a law. If a law is enacted, many if not all of the provisions of
the Affordable Care Act may no longer apply to prescription drugs. While we are unable to predict what changes may ultimately
be enacted, to the extent that future changes affect how any future products are paid for and reimbursed by government and private
payers, our business could be adversely impacted. On December 14, 2018, a federal district court in Texas ruled that the Affordable
Care Act is unconstitutional as a result of the Tax Cuts and Jobs Act and the federal income tax reform legislation previously
passed by Congress and signed by President Trump on December 22, 2017, that eliminated the individual mandate portion of the Affordable
Care Act. The case, Texas, et al, v. United States of America, et al., (N.D. Texas), is an outlier, and the ruling has been stayed
by the ruling judge. We are not able to state with any certainty what will be the impact of this court decision on our business
pending further court action and possible appeals.



In addition, other
legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, President Obama
signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction
to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction
of an amount greater than $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction
to several government programs. This includes aggregate reductions to Medicare payments to healthcare providers of up to 2.0%
per fiscal year, starting in 2013. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012,
which, among other things, reduced Medicare payments to several categories of healthcare providers and increased the statute of
limitations period for the government to recover overpayments to providers from three to five years. If we ever obtain regulatory
approval and commercialization of our products, these laws may result in additional reductions in Medicare and other healthcare
funding, which could have a material adverse effect on our customers and accordingly, our financial operations. Legislative and
regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical
products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or
interpretations will be changed, or what the impact of such changes on the marketing approvals of our products may be. Further,
the Deficit Reduction Act of 2010, directed CMS to contract a vendor to determine “retail survey prices for covered outpatient
drugs that represent a nationwide average of consumer purchase prices for such drugs, net of all discounts and rebates (to the
extent any information with respect to such discounts and rebates is available).” This survey information can be used to
determine the National Average Drug Acquisition Cost, or NADAC. Some states have indicated that they will reimburse based on the
NADAC and this can result in further reductions in the prices paid for various outpatient drugs.



In the fourth quarter
of 2018, the Trump Administration announced initiatives that it asserted are intended to result in purportedly lower drug prices.
The first initiative, announced on October 15, 2018, involved the plan to a new federal regulation that would require pharmaceutical
manufacturers to disclose the list prices of their respective prescription drugs in their television advertisements for their
products if the list price is greater than $35. With respect to the second initiative, on October 25, 2018, the Centers for Medicaid
and Medicare Services gave Advance Notice of Proposed Rulemaking to propose the implementation of an “International Pricing
Index” model for Medicare Part B drugs and biologicals (single source drugs, biologicals and biosimilars). Public comments
were due on December 31, 2018 with a proposed rule theoretically being offered as early as Spring 2019 with target implementation
of a 5 year pilot program beginning in Spring 2020. While these initiatives have not been put into effect, we are not in a position
to know at this time whether they will ever become law or what impact the enactment either of these proposals would have on our
business.





19


Table of Contents




In February 2019,
the Department of Health and Human Services, or HHS, has proposed a regulation that would significantly restrict the availability
of certain regulatory safe harbors under the federal Anti-Kickback Statute that are used to facilitate certain types of transactions
between manufacturers and pharmacy benefits managers that play a significant role in the pharmaceutical distribution chain. These
changes to the Discount Safe Harbors available under the Anti-Kickback Statute would reduce some of the protections currently
available to manufacturers that pay negotiated rebates to pharmacy benefits managers, or PBMs, in exchange for these PBMs agreeing
to include drugs and biologics on the formularies of the PBM’s downstream customers, primarily the health plans that insure
patients for both private commercial plans and government-sponsored plans. While we do not know whether the Trump Administration
will be successful in implementing this proposed regulation, its successful implementation could have an impact on both our commercial
supply arrangements with health plans and our supply arrangements to health plans that serve beneficiaries of federal health care
programs such as Medicare Part D.



As part of its reform
of the 340B discount drug program, on October 31, 2018, the Health Resources and Services Administration, or HRSA, at the HHS,
issued a notice of proposed rulemaking to move up the effective date of a final rule that would give HHS authority to impose Civil
Monetary Penalties on pharmaceutical manufacturers who knowingly and intentionally charged a covered entity more than the statutorily
allowed ceiling price for a covered outpatient drug. The final rule is intended to encourage compliance by manufacturers in offering
the mandatory 340B ceiling purchase price to eligible purchasers, such as certain qualified health systems or individual hospitals.



Various states, such
as California, have also taken steps to consider and enact laws or regulations that are intended to increase the visibility of
the pricing of pharmaceutical products with the goal of reducing the prices at which we are able to sell our products. Because
these various actual and proposed legislative changes are intended to operate on a state-by-state level rather than a national
one, we cannot predict what the full effect of these legislative activities may be on our business in the future.



Although we cannot
predict the full effect on our business of the implementation of existing legislation, including the Affordable Care Act or the
enactment of additional legislation, we believe that legislation or regulations that reduce reimbursement for or restrict coverage
of our products could adversely affect how much or under what circumstances healthcare providers will prescribe or administer
our products. This could materially and adversely affect our business by reducing our ability to generate revenue, raise capital,
obtain additional collaborators and market our products, following marketing approval. In addition, we believe the increasing
emphasis on managed care in the United States has and will continue to put pressure on the price and usage of pharmaceutical products,
which may adversely impact any future product sales.



If we or any
of our independent contractors, consultants, collaborators, manufacturers, or service providers fail to comply with healthcare
and data privacy laws and regulations, we or they could be subject to enforcement actions, which could result in penalties and
affect our ability to develop, market and sell our product candidates and may harm our reputation.



We are or may in the
future be subject to federal, state, and foreign healthcare and data privacy laws and regulations pertaining to, among other things,
fraud and abuse of patients’ rights. These laws and regulations include:



| | ● | The federal Anti-Kickback
    Statute prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or paying any remuneration,
    directly or indirectly, in cash or in kind, to induce or reward purchasing, ordering or arranging for or recommending the
    purchase or order of any item or service for which payment may be made, in whole or in part, under a federal healthcare program
    such as Medicare and Medicaid. Liability may be established without a person or entity having actual knowledge of the federal
    Anti-Kickback Statute or specific intent to violate it. This statute has been interpreted to apply broadly to arrangements
    between pharmaceutical manufacturers on the one hand and prescribers, patients, purchasers and formulary managers on the other.
    In addition, the Affordable Care Act amended the Social Security Act to provide that the U.S. government may assert that a
    claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent
    claim for purposes of the federal civil False Claims Act, or the FCA. A conviction for violation of the Anti-Kickback Statute
    requires mandatory exclusion from participation in federal healthcare programs. Although there are a number of statutory exemptions
    and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn
    narrowly, and those activities may be subject to scrutiny or penalty if they do not qualify for an exemption or safe harbor;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





20


Table of Contents




| | ● | The FCA prohibits,
    among other things, knowingly presenting, or causing to be presented claims for payment of government funds that are false
    or fraudulent, or knowingly making, using or causing to be made or used a false record or statement material to such a false
    or fraudulent claim, or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation
    to pay money to the federal government. This statute also permits a private individual acting as a “whistleblower”
    to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery.
    The FCA prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present, or
    causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including
    drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary
    items or services.  This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program.
    Increasingly, U.S. federal agencies are requiring nonmonetary remedial measures, such as corporate integrity agreements in
    FCA settlements. The U.S. Department of Justice announced in 2016 its intent to follow the “Yates Memo,” taking
    a far more aggressive approach in pursuing individuals as FCA defendants in addition to the corporations. FCA liability is
    potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties
    of $5,500 to $11,000 per false claim or statement ($10,781 to $21,563 per false claim or statement for penalties assessed
    after August 1, 2016 for violations occurring after November 2, 2015, and $10,957 to $21,916 per false claim or statement
    for penalties assessed after February 3, 2017 for violations occurring after November 2, 2015). Government enforcement agencies
    and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety
    of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the
    customers would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce
    them to prescribe products; engaging in promotion for “off-label” uses; and submitting inflated best price information
    to the Medicaid Rebate Program;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The federal False
    Statements Statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any
    materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing
    the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of
    or payment for healthcare benefits, items, or services;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The federal Civil
    Monetary Penalties Law authorizes the imposition of substantial civil monetary penalties against an entity, such as a pharmaceutical
    manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim
    for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting
    with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services
    reimbursable by a federal healthcare program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report
    and return a known overpayment;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The federal Health
    Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly and willfully
    executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying,
    concealing or covering up a material fact or making any materially false statement in connection with the delivery of, or
    payment for, healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does
    not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





21


Table of Contents




| | ● | HIPAA, as amended
    by the Health Information Technology for Economic and Clinical Health Act, which imposes requirements on certain types of
    people and entities relating to the privacy, security, and transmission of individually identifiable health information, and
    requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable
    health information;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The federal Physician
    Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment
    is available under Medicare, Medicaid, or the Children’s Health Insurance Program, to report annually to the Centers
    for Medicare & Medicaid Services information related to payments and other transfers of value to physicians, other
    healthcare providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare
    providers and their immediate family members, which is published in a searchable form on an annual basis;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | State laws comparable
    to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader in scope
    and also apply to commercial insurers and other non-federal;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Payors requirements
    for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security. Other state
    laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and
    the relevant compliance guidance promulgated by the federal government; require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state
    and foreign laws govern the privacy and security of health information in some circumstances, many of which differ from each
    other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | In the European
    Union, the General Data Protection Regulation, or the GDPR—Regulation EU 2016/679—which was adopted in May 2016
    and has become applicable on May 25, 2018. The GDPR is further intended to harmonize data protection requirements across the
    European Union member states by establishing new and expanded operational requirements for entities that collect, process
    or use personal data generated in the European Union, including consent requirements for disclosing the way personal information
    will be used, information retention requirements, and notification requirements in the event of a data breach.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



If our operations
are found to be in violation of any such healthcare laws and regulations, we may be subject to penalties, including administrative,
civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment or restructuring of our operations,
loss of eligibility to obtain approvals from the FDA or foreign regulatory authorities, or exclusion from participation in government
contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely
our financial results. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses
and could divert our management’s attention from the operation of our business, even if our defense is successful. In addition,
achieving and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.



Our employees,
principal investigators, consultants, commercial partners or vendors may engage in misconduct or other improper activities, including
non-compliance with regulatory standards.



We are also exposed
to the risk of employees, independent contractors, principal investigators, consultants, commercial partners or vendors engaging
in fraud or other misconduct. Misconduct by employees, independent contractors, principal investigators, consultants, commercial
partners and vendors could include intentional failures to comply with EU regulations, to provide accurate information to the
EMA or EU Member States authorities or to comply with manufacturing or quality standards we have or will have established. In
particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations
intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices such as promotion of products by medical
practitioners. The EU Member States in which we operate have different statutory provisions regulating the cooperation of pharmaceutical
companies with healthcare professionals. In addition to these statutory provisions, codes of conduct issued by business associations
or other non-statutory standards may be applicable to our activities. Both statutory provisions and non-statutory codes or standards
restrict payments or other benefits provided to healthcare professionals, and in case of non-compliance, may result in severe
sanctions such as bans, administrative fines, criminal fines or even imprisonment. The advertising of medicinal products for human
use in the EU is regulated by Title VIII of European Directive 2001/83/EC. These provisions have been implemented into the law
of the EU member States. Such laws inter alia restrict or prohibit a wide range of pricing, discounting, marketing and promotion,
sales commission, customer incentive programs and other business arrangements. Misconduct could also involve the improper use
of information obtained in the course of clinical studies, which could result in regulatory sanctions and serious and irreparable
harm to our reputation.





22


Table of Contents




This could also apply
with respect to data privacy. In the EU, the EU Directive 95/46/EEC was replaced by the GDPR on May 25, 2018. The GDPR as an EU
regulation does not have to be implemented into Member States’ national law, but applies directly in all Member States since
May 25, 2018. It applies to companies with an establishment in the European Economic Area (EEA) and to certain other companies
not in the EEA that offer or provide goods or services to individuals located in the EEA or monitor individuals located in the
EEA. The GDPR implements more stringent operational requirements for controllers of personal data, including, for example, expanded
disclosures about how personal information is to be used, limitations on retention of information, increased requirements pertaining
to health data and pseudonymized (i.e., key-coded) data, increased cyber security requirements, mandatory data breach notification
requirements and higher standards for controllers to demonstrate that they have obtained a valid legal basis for certain data
processing activities. The GDPR provides that EU Member States may continue to make their own further laws and regulations in
relation to the processing of genetic, biometric or health data, which could result in continued or new differences between Member
States, limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial
condition. We are also subject to evolving and strict rules on the transfer of personal data out of the European Union to the
United States. Further prospective revision of the Directive on privacy and electronic communications (Directive 2002/58/EC),
or ePrivacy Directive, may affect our marketing communications.



We are in the process
of implementing policies and procedures to ensure compliance with the GDPR and its requirements. Our actual or alleged failure
to comply with this regulation, or to protect personal data, could result in enforcement actions and significant penalties against
us, which could result in negative publicity, increase our operating costs, subject us to claims or other remedies and have a
material adverse effect on our business, financial condition, and results of operations. It is not always possible to identify
and deter misconduct by employees or other parties. The precautions we take to detect and prevent such activity may not protect
us from legal or regulatory action resulting from a failure to comply with applicable laws or regulations. Misconduct by our employees,
principal investigators, consultants, commercial partners or vendors could result in significant financial penalties, criminal
sanctions, civil law claims and/or negative media coverage, and thus have a material adverse effect on our business, including
through the imposition of significant fines or other sanctions, and our reputation. In particular, failure to comply with EU laws,
including failure under the GDPR, ePrivacy Directive and other laws relating to the security of personal data may result in fines
up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, if greater, and other
administrative penalties including criminal liability, which may be onerous and adversely affect our business, financial condition,
results of operations and prospects. Failure to comply with the GDPR and related laws may also give risk to increase risk of private
actions, including a new form of class action that is available under the GDPR.





23


Table of Contents




Risks Related to Our Ordinary Shares
and ADSs



There can
be no assurance that we will not be a passive foreign investment company, or PFIC, for U.S. federal income tax purposes
in 2019 or in any subsequent year. There may be negative tax consequences for U.S. taxpayers that are holders of our
ordinary shares or our ADSs.



We will be treated
as a PFIC for U.S. federal income tax purposes in any taxable year in which either (i) at least 75% of our gross income is “passive
income” or (ii) on average at least 50% of our assets by value produce passive income or are held for the production of
passive income. Passive income for this purpose generally includes, among other things, certain dividends, interest, royalties,
rents and gains from commodities and securities transactions and from the sale or exchange of property that gives rise to passive
income. Passive income also includes amounts derived by reason of the temporary investment of funds, including those raised in
a public offering. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of
each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account. If we were
to be characterized as a PFIC for U.S. federal income tax purposes in any taxable year during which a U.S. shareholder owns our
ordinary shares or ADSs, and such U.S. shareholder does not make an election to treat us as a “qualified electing fund,”
or QEF, or make a “mark-to-market” election, then “excess distributions” to such U.S. shareholder, and
any gain realized on the sale or other disposition of our ordinary shares or ADSs will be subject to special rules. Under these
rules: (i) the excess distribution or gain would be allocated ratably over the U.S. shareholder’s holding period for the
ordinary shares (or ADSs, as the case may be); (ii) the amount allocated to the current taxable year and any period prior to the
first day of the first taxable year in which we were a PFIC would be taxed as ordinary income; and (iii) the amount allocated
to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer
for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable
to each such other taxable year. In addition, if the U.S. Internal Revenue Service determines that we are a PFIC for a year with
respect to which we have determined that we were not a PFIC, it may be too late for a U.S. shareholder to make a timely QEF or
mark-to-market election. U.S. shareholders who hold our ordinary shares or ADSs during a period when we are a PFIC will be subject
to the foregoing rules, even if we cease to be a PFIC in subsequent years, subject to exceptions for U.S. shareholders who made
a timely QEF or mark-to-market election. A U.S. shareholder can make a QEF election by completing the relevant portions of and
filing IRS Form 8621 in accordance with the instructions thereto. Upon request, we will annually furnish U.S. shareholders with
information needed in order to complete IRS Form 8621 (which form would be required to be filed with the IRS on an annual basis
by the U.S. shareholder) and to make and maintain a valid QEF election for any year in which we or any of our subsidiaries that
we control is a PFIC.



Issuance of
additional equity securities may adversely affect the market price of our ADSs or ordinary shares.



We are currently
authorized to issue 500,000,000 ordinary shares. As of March 21, 2019, we had 44,875,482 ordinary shares issued and outstanding
and we had no preferred shares outstanding. As of March 21, 2019, we also had warrants to purchase 18,035,006 ordinary shares
and options to purchase 2,177,400 ordinary shares outstanding, of which options to purchase 880,529 ordinary shares are currently
fully vested or vest within the next 60 days.



To the extent that
ADSs or ordinary shares are issued or options and warrants are exercised, holders of our ADSs and our ordinary shares will experience
dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable
for ADSs or ordinary shares, holders of our ADSs or our ordinary shares may experience dilution. We also consider from time to
time various strategic alternatives that could involve issuances of additional ADSs or ordinary shares, including but not limited
to acquisitions and business combinations, but do not currently have any definitive plans to enter into any of these transactions.



We have no plans
to pay dividends on our ordinary shares, and you may not receive funds without selling our ADSs or ordinary shares.



We have not declared
or paid any cash dividends on our ordinary shares, nor do we expect to pay any cash dividends on our ordinary shares for the foreseeable
future. We currently intend to retain any additional future earnings to finance our operations and growth and for future stock
repurchases and, therefore, we have no plans to pay cash dividends on our ordinary shares at this time. Any future determination
to pay cash dividends on our ordinary shares will be at the discretion of our board of directors and will be dependent on our
earnings, financial condition, operating results, capital requirements, any contractual restrictions, and other factors that our
board of directors deems relevant. Accordingly, you may have to sell some or all of our ADSs or ordinary shares in order to generate
cash from your investment. You may not receive a gain on your investment when you sell our ADSs or ordinary shares and may lose
the entire amount of your investment.





24


Table of Contents




The market price
of our ordinary shares and ADSs is subject to fluctuation, which could result in substantial losses by our investors.



The stock market in
general and the market price of our ordinary shares on the TASE and our ADSs on the NYSE American is subject to fluctuation, and
changes in our share price may be unrelated to our operating performance. The market price of our ordinary shares and ADSs are
and will be subject to a number of factors, including:



| | ● | announcements of
    technological innovations or new products by us or others;                                                                 
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                 
| | ● | announcements by
    us of significant strategic partnerships, out-licensing, in-licensing, joint ventures, acquisitions or capital commitments;
| |   |                                                                                                                                                 
| | ● | expiration or terminations
    of licenses, research contracts or other collaboration agreements;                                               
| |   |                                                                                                                                                 
| | ● | public concern as
    to the safety of drugs we, our licensees or others develop;                                                               
| |   |                                                                                                                                                 
| | ● | general market conditions;                                                                                                                      
| |   |                                                                                                                                                 
| | ● | the volatility of
    market prices for shares of biotechnology companies generally;                                                            
| |   |                                                                                                                                                 
| | ● | success of research
    and development projects;                                                                                               
| |   |                                                                                                                                                 
| | ● | success in clinical
    and preclinical studies;                                                                                                
| |   |                                                                                                                                                 
| | ● | departure of key
    personnel;                                                                                                                 
| |   |                                                                                                                                                 
| | ● | developments concerning
    intellectual property rights or regulatory approvals;                                                               
| |   |                                                                                                                                                 
| | ● | variations in our
    and our competitors’ results of operations;                                                                               
| |   |                                                                                                                                                 
| | ● | changes in earnings
    estimates or recommendations by securities analysts, if our ordinary shares or ADSs are covered by analysts;            
| |   |                                                                                                                                                 
| | ● | changes in government
    regulations or patent decisions;                                                                                      
| |   |                                                                                                                                                 
| | ● | developments by
    our licensees; and                                                                                                          
| |   |                                                                                                                                                 
| | ● | general market conditions
    and other factors, including factors unrelated to our operating performance.                                      



These factors and
any corresponding price fluctuations may materially and adversely affect the market price of our ordinary shares and our ADSs
and result in substantial losses by our investors.



Additionally, market
prices for securities of biotechnology and pharmaceutical companies historically have been very volatile. The market for these
securities has from time to time experienced significant price and volume fluctuations for reasons unrelated to the operating
performance of any one company. In the past, following periods of market volatility, shareholders have often instituted securities
class action litigation and we have been named in the past in a lawsuit requesting recognition as a class action, in which we
ultimately prevailed. If we were involved in securities litigation, it could have a substantial cost and divert resources and
attention of management from our business, even if we are successful.



Future sales of our ordinary shares or
ADSs could reduce the market price of our ordinary shares and ADSs.





25


Table of Contents




Substantial
sales of our ordinary shares or our ADSs either on the TASE or on the NYSE American, as applicable, may cause the market price
of our ordinary shares or our ADSs to decline.



Sales by us or our
security-holders of substantial amounts of our ordinary shares or our ADSs, or the perception that these sales may occur in the
future, could cause a reduction in the market price of our ordinary shares or our ADSs. The issuance of any additional ordinary
shares or ADSs, or any securities that are exercisable for or convertible into our ordinary shares or our ADSs, may have an adverse
effect on the market price of our ordinary shares or our ADSs, as applicable, and will have a dilutive effect on our shareholders.



We
may not satisfy the NYSE American requirements for continued listing. If we cannot satisfy these requirements, the NYSE American
could delist our securities.



Our
ADSs are listed on the NYSE American under the symbol “CANF.” To continue to be listed on the NYSE American, we are
required to satisfy a number of conditions, including maintaining a share price and shareholders’ equity above certain thresholds. 
If we are delisted from the NYSE American, trading in our securities may be conducted, if available, on the OTC Markets or, if
available, via another market. In the event of such delisting, our shareholders would likely find it significantly more
difficult to dispose of, or to obtain accurate quotations as to the value of our securities, and our ability to raise future capital
through the sale of our securities could be severely limited. In addition, if our securities were delisted from the NYSE American,
our ADSs could be considered a “penny stock” under the U.S. federal securities laws. Additional regulatory requirements
apply to trading by broker-dealers of penny stocks that could result in the loss of an effective trading market for our securities.
Moreover, if our ADSs were delisted from the NYSE American, we will no longer be exempt from certain provisions of the Israeli
Securities Law, and therefore will have increased disclosure requirements.





ADS holders
are not shareholders and do not have shareholder rights.



The Bank of New York
Mellon, as Depositary, delivers our ADSs. Each ADS represents two of our ordinary shares. ADS holders will not be treated as shareholders
and do not have the rights of shareholders. The Depositary will be the holder of the shares underlying our ADSs. Holders of ADSs
will have ADS holder rights. A deposit agreement among us, the Depositary, ADS holders and the beneficial owners of ADSs sets
out ADS holder rights as well as the rights and obligations of the Depositary. New York law governs the deposit agreement and
our ADSs. Our shareholders have shareholder rights. Israeli law and our Amended and Restated Articles of Association govern shareholder
rights. ADS holders do not have the same voting rights as our shareholders. Shareholders are entitled to our notices of general
meetings and to attend and vote at our general meetings of shareholders. At a general meeting, every shareholder present (in person
or by proxy, attorney or representative) and entitled to vote has one vote. This is subject to any other rights or restrictions
which may be attached to any shares. ADS holders may instruct the Depositary how to vote the number of deposited shares their
ADSs represent. Otherwise, you won’t be able to exercise your right to vote unless you withdraw the shares. However,
you may not know about the meeting enough in advance to withdraw the shares. The Depositary will notify ADS holders of shareholders’
meetings and arrange to deliver our voting materials to them if we ask it to. Those materials will describe the matters to be
voted on and explain how ADS holders may instruct the Depositary how to vote. For instructions to be valid, they must reach the
Depositary by a date set by the Depositary. The Depositary will try, as far as practical, subject to the laws of Israel and our
Amended and Restated Articles of Association or similar documents, to vote or to have its agents vote the shares or other deposited
securities as instructed by ADS holders. The Depositary will only vote or attempt to vote as instructed. We cannot assure you
that you will receive the voting materials in time to ensure that you can instruct the Depositary to vote your shares. In addition,
the Depositary and its agents are not responsible for failing to carry out voting instructions or for the matter of carrying out
voting instructions. This means that you may not be able to exercise your right to vote and there may be nothing you can do
if your shares are not voted as requested.



ADS holders do not
have the same rights to receive dividends or other distributions as our shareholders. Subject to any special rights or restrictions
attached to a share, the directors may determine that a dividend will be payable on a share and fix the amount, the time for payment
and the method for payment (although we have never declared or paid any cash dividends on our ordinary shares and we do not anticipate
paying any cash dividends in the foreseeable future). Dividends and other distributions payable to our shareholders with respect
to our ordinary shares generally will be payable directly to them. Any dividends or distributions payable with respect to ordinary
shares deposited in the ADS facility will be paid to the Depositary, which has agreed to pay to ADS holders the cash dividends
or other distributions it or the custodian receives on shares or other deposited securities, after deducting its fees and expenses.
ADS holders will receive these distributions in proportion to the number of ordinary shares their ADSs represent. In addition,
there may be certain circumstances in which the Depositary may not pay ADS holder’s amounts distributed by us as a dividend
or distribution.







26


Table of Contents




Our ordinary shares and our ADSs
are traded on different markets and this may result in price variations.



Our ordinary shares
have traded on the TASE since October 2005 and our ADSs have been listed on the NYSE American since November 2013. Trading on
these markets will take place in different currencies (U.S. dollars on the NYSE American and NIS on the TASE), and at different
times (resulting from different time zones, different trading days and different public holidays in the United States and Israel).
The trading prices of our securities on these two markets may differ due to these and other factors. Any decrease in the price
of our securities on one of these markets could cause a decrease in the trading price of our securities on the other market.



We have incurred
significant additional increased costs as a result of the listing of our ADSs for trading on the NYSE American, and our management
is required to devote substantial time to new compliance initiatives as well as to compliance with ongoing U.S. and Israeli reporting
requirements.



As a public company
in the United States, we incur additional significant accounting, legal and other expenses that we did not incur before becoming
a reporting company in the United States. We also incur costs associated with corporate governance requirements of the SEC and
the NYSE American Company Guide, as well as requirements under Section 404 and other provisions of the Sarbanes-Oxley Act of 2002,
or the Sarbanes-Oxley Act as a result of our ADSs being listed on the NYSE American. These rules and regulations have increased
our legal and financial compliance costs, introduced new costs such as investor relations, stock exchange listing fees and shareholder
reporting, and made some activities more time consuming and costly. The implementation and testing of such processes and systems
may require us to hire outside consultants and incur other significant costs. Any future changes in the laws and regulations affecting
public companies in the United States and Israel, including Section 404 and other provisions of the Sarbanes-Oxley Act, the rules
and regulations adopted by the SEC and the NYSE American Company Guide, as well as applicable Israeli reporting requirements,
for so long as they apply to us, may result in increased costs to us as we respond to such changes. These laws, rules and regulations
could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability
insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the
same or similar coverage. The impact of these requirements could also make it more difficult for us to attract and retain qualified
persons to serve on our Board of Directors, our board committees or as executive officers.



As a foreign
private issuer, we are permitted to follow certain home country corporate governance practices instead of applicable SEC and NYSE
American requirements, which may result in less protection than is accorded to investors under rules applicable to domestic issuers.



As a foreign private
issuer, we will be permitted to follow certain home country corporate governance practices instead of those otherwise required
under the NYSE American Company Guide for domestic issuers. For instance, we may follow home country practice in Israel with regard
to, among other things, composition and function of the audit committee and other committees of our Board of Directors and certain
general corporate governance matters. In addition, in certain instances we will follow our home country law, instead of the NYSE
American Company Guide, which requires that we obtain shareholder approval for certain dilutive events, such as an issuance that
will result in a change of control of the company, certain transactions other than a public offering involving issuances of a
20% or more interest in the company and certain acquisitions of the stock or assets of another company. We comply with the director
independence requirements of the NYSE American Company Guide, including the requirement that a majority of the Board of Directors
be independent. Following our home country governance practices as opposed to the requirements that would otherwise apply to a
U.S. company listed on the NYSE American may provide less protection than is accorded to investors under the NYSE American Company
Guide applicable to domestic issuers.



In addition, as a
foreign private issuer, we are exempt from the rules and regulations under the U.S. Securities Exchange Act of 1934, as amended,
or the Exchange Act, related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders
are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition,
we will not be required under the Exchange Act to file annual, quarterly and current reports and financial statements with the
SEC as frequently or as promptly as domestic companies whose securities are registered under the Exchange Act.





27


Table of Contents




Because we became
a reporting company under the Exchange Act by means of filing a Form 20-F, we may have difficulty attracting the attention of
research analysts at major brokerage firms.



Because we did not
become a reporting company by conducting an underwritten initial public offering in the United States, we may have difficulty
attracting the attention of security analysts at major brokerage firms in order for them to provide coverage of our company. The
failure to receive research coverage or support in the market for our shares will have an adverse effect on our ability to develop
a liquid market for our ADSs.



If we are unable
to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act as they apply to a foreign private issuer that is listed
on a U.S. exchange, or our internal control over financial reporting is not effective, the reliability of our financial statements
may be questioned and our share price and the ADS price may suffer.



We are subject to
the requirements of the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act requires companies subject to the reporting
requirements of the U.S. securities laws to do a comprehensive evaluation of its and its subsidiaries’ internal control
over financial reporting. To comply with this statute, we must document and test our internal control procedures and our management
and issue a report concerning our internal control over financial reporting. In addition, under the Jumpstart Our Business Startups
Act of 2012, or the JOBS Act, emerging growth companies, like ourselves, are exempt from certain reporting requirements, including
the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. Under this exemption, our auditor will not be
required to attest to and report on our management’s assessment of our internal control over financial reporting until the
date we are no longer an emerging growth company as defined in the JOBS Act, because we are taking advantage of the exemptions
contained in the JOBS Act. We will need to prepare for compliance with Section 404 by strengthening, assessing and testing our
system of internal controls to provide the basis for our report. However, the continuous process of strengthening our internal
controls and complying with Section 404 is complicated and time-consuming. Furthermore, as our business continues to grow both
domestically and internationally, our internal controls will become more complex and will require significantly more resources
and attention to ensure our internal controls remain effective overall. During the course of the testing, our management may identify
material weaknesses or significant deficiencies, which may not be remedied in a timely manner to meet the deadline imposed by
the Sarbanes-Oxley Act. If our management cannot favorably assess the effectiveness of our internal control over financial reporting,
or our independent registered public accounting firm identifies material weaknesses in our internal controls, investor confidence
in our financial results may weaken, and the market price of our securities may suffer.



While we currently
qualify as an “emerging growth company” under the JOBS Act, we will cease to be an emerging growth company on or before
the end of 2019, and at such time our costs and the demands placed upon our management will increase.



As an “emerging
growth company” under the JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.
We are an emerging growth company until the earliest of: (i) the last day of the fiscal year during which we had total annual
gross revenues of $1.07 billion or more, (ii) the last day of the fiscal year following the fifth anniversary of the date of the
first sale of our common stock pursuant to an effective registration statement (i.e., December 31, 2019), (iii) the date on which
we have, during the previous three-year period, issued more than $1 billion in non-convertible debt or (iv) the date on which
we are deemed a “large accelerated issuer” as defined in Regulation S-K of the Securities Act. For so long as we remain
an emerging growth company, we will not be required to:





| | ● | have an auditor
    report on our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
| | - | ---------------------------------------------------------------------------------------------------------------------------------



| | ● | comply with any
    requirement that may be adopted by the Public Company Accounting Oversight Board, or the PCAOB, regarding mandatory audit
    firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial
    statements (auditor discussion and analysis);
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





28


Table of Contents




| | ● | submit certain executive
    compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay”
    provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say
    on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for
    certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street
    Reform and Consumer Protection Act of 2010; and
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | include detailed
    compensation discussion and analysis in our filings under the Exchange Act, and instead may provide a reduced level of disclosure
    concerning executive compensation.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



We cannot predict
if investors will find our ordinary shares or ADSs less attractive because we may rely on these exemptions. If some investors
find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares, and our
share price may become more volatile and decline.



Risks Related to Our Operations in Israel



We conduct our
operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel
and its region.



Our headquarters,
all of our operations and some of our suppliers and third party contractors are located in central Israel and our key employees,
officers and most of our directors are residents of Israel. Accordingly, political, economic and military conditions in Israel
and the surrounding region may directly affect our business. Since the establishment of the State of Israel in 1948, a number
of armed conflicts have taken place between Israel and its Arab neighbors. Any hostilities involving Israel or the interruption
or curtailment of trade within Israel or between Israel and its trading partners could adversely affect our operations and results
of operations and could make it more difficult for us to raise capital. During the winter of 2008, winter of 2012 and the summer
of 2014, Israel was engaged in an armed conflict with Hamas, a militia group and political party operating in the Gaza Strip,
and during the summer of 2006, Israel was engaged in an armed conflict with Hezbollah, a Lebanese Islamist Shiite militia group
and political party. Israel faces political tension with respect to its relationships with Turkey, Iran and certain Arab neighbor
countries. In addition, recent conflicts involved missile strikes against civilian targets in various parts of Israel, and negatively
affected business conditions in Israel. Recent political uprisings and social unrest in various countries in the Middle East and
North Africa are affecting the political stability of those countries. This instability may lead to deterioration of the political
relationships that exist between Israel and these countries, and have raised concerns regarding security in the region and the
potential for armed conflict. Any armed conflicts, terrorist activities or political instability in the region could adversely
affect business conditions and could harm our results of operations. For example, any major escalation in hostilities in the region
could result in a portion of our employees and service providers being called up to perform military duty for an extended period
of time. Parties with whom we do business have sometimes declined to travel to Israel during periods of heightened unrest or tension,
forcing us to make alternative arrangements when necessary. In addition, the political and security situation in Israel may result
in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their
commitments under those agreements pursuant to force majeure provisions in such agreements. Any future deterioration in the political
and security situation in Israel will negatively impact our business.



Our commercial insurance
does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although
the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts
of war, we cannot assure you that this government coverage will be maintained. Any losses or damages incurred by us could have
a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively
affect business conditions and could harm our results of operations.





29


Table of Contents




Further, in the past,
the State of Israel and Israeli companies have been subjected to an economic boycott. Several countries still restrict business
with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating
results, financial condition or the expansion of our business.



Our operations
may be disrupted as a result of the obligation of Israeli citizens to perform military service.



Many Israeli citizens,
including Motti Farbstein, our Chief Operating and Financial Officer, are obligated to perform one month, and in some cases more,
of annual military reserve duty until they reach the age of 40 (or older, for reservists with certain occupations) and, in the
event of a military conflict, may be called to active duty. In response to increases in terrorist activity, there have been periods
of significant call-ups of military reservists. It is possible that there will be military reserve duty call-ups in the future.
Our operations could be disrupted by such call-ups, which may include the call-up of Motti Farbstein. Such disruption could materially
adversely affect our business, financial condition and results of operations.



Because a certain
portion of our expenses is incurred in currencies other than U.S. dollars, our results of operations may be harmed by currency
fluctuations and inflation.





From our inception
through January 1, 2018, our functional and presentation currency was the NIS. Management conducted a review of the functional
currency and decided to change its functional and presentation currency to U.S. dollars from the NIS effective January 1, 2018.
These changes were based on an assessment by our management that U.S. dollars is the primary currency of the economic environment
in which we operate. Part of our expenses are payable in U.S. dollars or in Euros as well as the revenues from our licensing arrangements
that are payable in U.S. dollars and Canadian dollars, we expect our revenues from future licensing arrangements to be denominated
in U.S. dollars or in Euros. To date, we have not engaged in hedging transactions. Although the Israeli rate of inflation has
not had a material adverse effect on our financial condition during 2016, 2017, or 2018 to date, we may, in the future, decide
to enter into currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates
of the currencies mentioned above in relation to U.S. dollars. These measures, however, may not adequately protect us from material
adverse effects.





Provisions of
Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our Company, which could prevent a change
of control, even when the terms of such a transaction are favorable to us and our shareholders.



Israeli corporate
law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals
for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to
these types of transactions. For example, a merger may not be consummated unless at least 50 days have passed from the date that
a merger proposal was filed by each merging company with the Israel Registrar of Companies and at least 30 days from the date
that the shareholders of both merging companies approved the merger. In addition, a majority of each class of securities of the
target company must approve a merger. Moreover, a full tender offer can only be completed if the acquirer receives at least 95%
of the issued share capital; provided that, pursuant to an amendment to the Companies Law, 5759-1999, as amended, or the Israeli
Companies Law, effective as of May 15, 2011, a majority of the offerees that do not have a personal interest in such tender offer
shall have approved the tender offer; except that, if the total votes to reject the tender offer represent less than 2% of our
issued and outstanding share capital, in the aggregate, approval by a majority of the offerees that do not have a personal interest
in such tender offer is not required to complete the tender offer, and the shareholders, including those who indicated their acceptance
of the tender offer, may, at any time within six months following the completion of the tender offer, petition the court to alter
the consideration for the acquisition (unless the acquirer stipulated in the tender offer that a shareholder that accepts the
offer may not seek appraisal rights).



Furthermore, Israeli
tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not
have a tax treaty with Israel exempting such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free
share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain
circumstances but makes the deferral contingent on the fulfillment of numerous conditions, including a holding period of two years
from the date of the transaction during which sales and dispositions of shares of the participating companies are restricted.
Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the
tax becomes payable even if no actual disposition of the shares has occurred.





30


Table of Contents




These and other similar
provisions could delay, prevent or impede an acquisition of us or our merger with another company, even if such an acquisition
or merger would be beneficial to us or to our shareholders. See “Item 10. Additional Information—B. Memorandum and
Articles of Association.”



It may be difficult
to enforce a U.S. judgment against us and our officers and directors named in this Annual Report on Form 20-F in Israel or the
United States, or to serve process on our officers and directors.



We are incorporated
in Israel. All of our executive officers and directors listed in this Annual Report on Form 20-F reside outside of the United
States, and all of our assets and most of the assets of our executive officers and directors are located outside of the United
States. Therefore, a judgment obtained against us or most of our executive officers and all of our directors in the United States,
including one based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United
States and may not be enforced by an Israeli court. It also may be difficult for you to effect service of process on these persons
in the United States or to assert U.S. securities law claims in original actions instituted in Israel.



Your rights
and responsibilities as a shareholder will be governed by Israeli law which may differ in some respects from the rights and responsibilities
of shareholders of U.S. companies.



We are incorporated
under Israeli law. The rights and responsibilities of the holders of our shareholders are governed by our Amended and Restated
Articles of Association and Israeli law. These rights and responsibilities differ in some respects from the rights and responsibilities
of shareholders in typical U.S.-based corporations. In particular, a shareholder of an Israeli company has a duty to act in good
faith toward the company and other shareholders and to refrain from abusing its power in the company, including, among other things,
in voting at the general meeting of shareholders on matters such as amendments to a company’s articles of association, increases
in a company’s authorized share capital, mergers and acquisitions and interested party transactions requiring shareholder
approval. In addition, a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to
appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company.
There is limited case law available to assist us in understanding the implications of these provisions that govern shareholders’
actions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our shareholders that
are not typically imposed on shareholders of U.S. corporations.



ITEM 4. Information on the Company



A. History and Development of the Company



Our legal name is
Can-Fite BioPharma Ltd. and our commercial name is “Can-Fite.” We are a company limited by shares organized under
the laws of the State of Israel. Our principal executive offices are located at 10 Bareket Street, Kiryat Matalon, Petah-Tikva
4951778 Israel. Our telephone number is +972 (3) 924-1114.



We were founded on
September 11, 1994 by Pnina Fishman, Ph.D., our Chief Executive Officer and a director, and Ilan Cohn, Ph.D., our Chairman of
the Board of Directors, under the name Can-Fite Technologies Ltd. On January 7, 2001, we changed our name to Can-Fite BioPharma
Ltd. We completed our initial public offering in Israel in October 2005 and our ordinary shares are traded on the TASE under the
symbol “CFBI.” On October 2, 2012, our ADSs began trading over the counter in the United States under the symbol “CANFY”
and on November 19, 2013, our ADSs began trading on the NYSE American under the symbol “CANF.”







31


Table of Contents




In November 2011,
through a series of transactions, we spun-off our activity in the ophthalmic field to our now former subsidiary, OphthaliX, a
Delaware corporation and successor-in-interest to Denali Concrete Management, Inc., a Nevada corporation, whose common shares
were traded in the United States on OTC under the symbol “OPLI.” In the spin-off transactions, we granted an exclusive
license for the use of our Piclidenoson drug candidate in the ophthalmic field, or the License Agreement, to Eye-Fite Ltd., an
Israel limited company, or Eye-Fite, and transferred our issued and outstanding ordinary shares in Eye-Fite to OphthaliX in exchange
for an 86.7% interest in OphthaliX. In connection with the spin-off transactions, OphthaliX completed a series of private placement
financing transactions. Following the spin-off transactions and the private placement financing transactions, we held approximately
82% interest in OphthaliX. In July 2016, OphthaliX released top-line results from its Phase II clinical trial of Piclidenoson
for the treatment of glaucoma. In this trial, no statistically significant differences were found between the Piclidenoson treated
group and the placebo group in the primary endpoint of lowering IOP. High IOP is a characteristic of glaucoma. Piclidenoson was
found to have a favorable safety profile and was well tolerated. Based on these overall results, OphthaliX saw no immediate path
forward in glaucoma and ceased active business operations. Subsequently, on May 21, 2017, OphthaliX and a wholly owned private
Israeli subsidiary of OphthaliX, Bufiduck Ltd, or the Merger Sub, and Wize Pharma Ltd., or Wize Israel, an Israeli company formerly
listed on the TASE entered into an Agreement and Plan of Merger, or the Merger Agreement, providing for the merger of the Merger
Sub with and into Wize Israel, with Wize Israel becoming a wholly-owned subsidiary of OphthaliX and the surviving corporation
of the merger, or the Merger. On November 16, 2017, the Merger was completed. As a result of the Merger, our ownership of OphthaliX,
immediately post-Merger, became approximately 8% of the outstanding shares of common stock. In addition, immediately prior to
the Merger, OphthaliX sold on an “as is” basis to us all the ordinary shares of Eye-Fite in exchange for the irrevocable
cancellation and waiver of all indebtedness owed by OphthaliX and Eye-Fite to us, including approximately $5 million of deferred
payments owed by OphthaliX and Eye-Fite to us and, as part of the purchase of Eye-Fite, we also assumed certain accrued milestone
payments in the amount of $175,000 under a license agreement previously entered into with NIH. In addition, that certain License
Agreement granted to OphthaliX by us and a related services agreement was terminated. See “Item 7. Major Shareholders and
Related Party Transactions—B. Related Party Transactions.”





Our capital expenditures
for the years ended December 31, 2018, 2017 and 2016 were $33,000, $7,000, and $10,000, respectively. Our current capital expenditures
are made solely within Israel and primarily consist of the acquisition of computers and related communications equipment. Such
capital expenditures are financed internally.



We qualify as an “emerging
growth company,” as defined in the JOBS Act. For as long as we are deemed an emerging growth company, we may take advantage
of specified reduced reporting and other regulatory requirements that are generally unavailable to other public companies. These
provisions include:



| | ● | an exemption from
    the auditor attestation requirement in the assessment of our internal controls over financial reporting required by Section
    404 of the Sarbanes-Oxley Act of 2002;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | an exemption from
    compliance with any new requirements adopted by the PCAOB requiring mandatory audit firm rotation or a supplement to the auditor’s
    report in which the auditor would be required to provide additional information about our audit and our financial statements;
    and
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | reduced disclosure
    about our executive compensation arrangements.
| | - | ---------------------------------------------------------------------



We expect to continue
to be deemed an emerging growth company until at least December 31, 2019.



We use our website
(http://www.canfite.com) as a channel of distribution of Company information. The information we post on our website may
be deemed material. Accordingly, investors should monitor the website, in addition to following our press releases, SEC filings
and public conference calls and webcasts. The contents of our website are not, however, a part of this Annual Report on Form 20-F.



B.
Business Overview



We are a clinical-stage
biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment of cancer,
liver and inflammatory disease and sexual dysfunction. Our platform technology utilizes the Gi protein associated A3AR as a therapeutic
target. A3AR is highly expressed in inflammatory and cancer cells, and not significantly expressed in normal cells, suggesting
that the receptor could be a unique target for pharmacological intervention. Our pipeline of drug candidates are synthetic, highly
specific agonists and allosteric modulators, or ligands or molecules that initiate molecular events when binding with target proteins,
targeting the A3AR.





32


Table of Contents




Our product pipeline
is based on the research of Dr. Pnina Fishman, who investigated a clinical observation that tumor metastasis can be found in most
body tissues, but are rarely found in muscle tissue, which constitutes approximately 60% of human body weight. Dr. Fishman’s
research revealed that one reason that striated muscle tissue is resistant to tumor metastasis is that muscle cells release small
molecules which bind with high selectivity to the A3AR. As part of her research, Dr. Fishman also discovered that A3ARs have significant
expression in tumor and inflammatory cells, whereas normal cells have low or no expression of this receptor. The A3AR agonists
and allosteric modulators, currently our pipeline of drug candidates, bind with high selectivity and affinity to the A3ARs and
upon binding to the receptor initiate down-stream signal transduction pathways resulting in apoptosis, or programmed cell death,
of tumors and inflammatory cells and to the inhibition of inflammatory cytokines. Cytokines are proteins produced by cells that
interact with cells of the immune system in order to regulate the body’s response to disease and infection. Overproduction
or inappropriate production of certain cytokines by the body can result in disease.



Our product candidates,
CF101, CF102 and CF602, are being developed to treat autoimmune inflammatory indications, oncology and liver diseases as well
as sexual dysfunction. CF101, also known as Piclidenoson, is in an advanced stage of clinical development for the treatment of
autoimmune-inflammatory diseases, including rheumatoid arthritis and psoriasis. CF102, also known as Namodenoson, is being developed
for the treatment of HCC and has orphan drug designation for the treatment of HCC in the United States and Europe. Namodenoson
was granted Fast Track designation by the FDA as a second line treatment to improve survival for patients with advanced HCC who
have previously received Nexavar (sorafenib). Namodenoson is also being developed for the treatment of NASH, following our study
which revealed compelling pre-clinical data on Namodenoson in the treatment of NASH, a disease for which no FDA approved therapies
currently exist. CF602 is our second generation allosteric drug candidate for the treatment of sexual dysfunction, which has shown
efficacy in the treatment of erectile dysfunction in preclinical studies and we are investigating additional compounds, targeting
A3AR, for the treatment of sexual dysfunction. Preclinical studies revealed that our drug candidates have potential to treat
additional inflammatory diseases, such as Crohn’s disease, oncological diseases and viral diseases, such as the JC virus,
and obesity.





We believe our pipeline
of drug candidates represent a significant market opportunity. For instance, according to Visiongain, the world rheumatoid arthritis
market size is predicted to generate revenues of $34.6 billion in 2020 and the psoriasis drug market is forecasted to be worth
$11.4 billion by 2020. According to DelveInsight, the HCC drug market in the G8 countries (U.S., Germany, France, Italy, Spain,
UK, Japan and China) is expected to reach $3.8 billion by 2027.



We have in-licensed
an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed the following:



| | ● | Piclidenoson for
    the treatment of (i) rheumatoid arthritis to Kwang Dong Pharmaceutical Co. Ltd., or KD, for Korea, (ii) psoriasis and
    rheumatoid     arthritis to Cipher Pharmaceuticals for Canada, (iii) rheumatoid arthritis and psoriasis to Gebro Holding, or
    Gebro, for     Spain,     Switzerland     and Austria, and (iv) rheumatoid arthritis and psoriasis to CMS Medical Venture
    Investment     or CMS     Medical,     for China     (including Hong     Kong, Macao and Taiwan);     and
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Namodenoson for
    the treatment of (i) liver cancer and NASH to Chong Kun Dang Pharmaceuticals, or CKD, for South Korea, and (ii) advanced
    liver     cancer     and NAFLD/NASH to CMS Medical for China (including Hong Kong, Macao and Taiwan).
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



We believe that our
drug candidates have certain unique characteristics and advantages over drugs currently available on the market and under development
to treat these indications. To date, we have generated our pipeline by in-licensing, researching and developing two synthetic
A3AR agonists, Piclidenoson and Namodenoson, and an allosteric modulator, CF602. For example, our technology platform is based
on the finding that the A3AR is highly expressed in pathological cells, such as various tumor cell types and inflammatory cells.
High A3AR expression levels are also found in peripheral blood mononuclear cells, or PBMCs, of patients with cancer, inflammatory
and viral diseases. PBMCs are a critical part of the immune system required to fight infection. We believe that targeting the
A3AR with synthetic and highly selective A3AR agonists, such as Piclidenoson and Namodenoson, and allosteric modulators, such
as CF602, induces anti-cancer and anti-inflammatory effects. In addition, our human clinical data suggests that the A3AR is a
biological marker and that high A3AR expression prior to treatment may be predictive of good patient response to our drug treatment.
In fact, as a result of our research we have developed a simple blood assay to test for A3AR expression as a predictive biological
marker. We have been granted a U.S. patent with respect to the intellectual property related to such assay and utilized this assay
in our Phase IIb study of Piclidenoson for the treatment of rheumatoid arthritis.





33


Table of Contents




Moreover, we believe
characteristics of Piclidenoson, as exhibited in our clinical studies to date, including its good safety profile, clinical activity,
simple and less frequent delivery through oral administration and its low cost of production, position it well against the competition
in the autoimmune-inflammatory markets, including the rheumatoid arthritis and psoriasis markets, where treatments, when available,
often include injectable drugs, many of which can be highly toxic, expensive and not always effective. Furthermore, pre-clinical
pharmacology studies in different experimental animal models of arthritis revealed that Piclidenoson acts as a disease modifying
anti-rheumatic drug, or a DMARD, which, when coupled with its good safety profile, makes it competitive in the psoriasis and rheumatoid
arthritis markets. Our recent findings also demonstrate that a biological predictive marker can be utilized prior to treatment
with Piclidenoson, which may allow it to be used as a personalized medicine therapeutic approach for the treatment of rheumatoid
arthritis.



Like Piclidenoson,
Namodenoson has a good safety profile, is orally administered and has a low cost of production, which we believe positions it
well in the HCC market, where only one drug, Nexavar, has been approved by the FDA. In addition, pre-clinical studies show Namodenoson’s
novel mechanism of action which entails de-regulation of three key signaling pathways which mediate the etiology and pathology
of NAFLD/NASH and are responsible for the anti-inflammatory and anti-fibrogenic effect in the liver. Most recently, pre-clinical
data support Namodenoson’s potential utilization as an anti-obesity drug.



Nevertheless, other
drugs on the market, new drugs under development (including drugs that are in more advanced stages of development in comparison
to our drug candidates) and additional drugs that were originally intended for other purposes, but were found effective for purposes
targeted by us, may all be competitive to the current drugs in our pipeline. In fact, some of these drugs are well established
and accepted among patients and physicians in their respective markets, are orally bioavailable, can be efficiently produced and
marketed, and are relatively safe. None of our product candidates have been approved for sale or marketing and, to date, there
have been no commercial sales of any of our product candidates.



Our research further
suggests that A3AR affects pathological and normal cells differently. While specific A3AR agonists, such as Piclidenoson and Namodenoson,
and allosteric modulators, such as CF602, appear to inhibit growth and induce apoptosis of cancer and inflammatory cells, normal
cells are refractory, or unresponsive to the effects of these drugs. To date, the A3AR agonists have had a positive safety profile
as a result of this differential effect.



We are currently:
(i) conducting a Phase III trial for Piclidenoson in the treatment of rheumatoid arthritis, (ii) conducting a Phase III trial
for Piclidenoson in the treatment of psoriasis, (iii) completing the analysis of the results of our Phase II advanced liver cancer
study having recently released top-line results, (iv) conducting a Phase II trial of Namodenoson in the treatment of NASH with
top-line results expected in the second half of 2019, and (v) investigating additional compounds, targeting the A3 adenosine receptor,
for the treatment of sexual dysfunction and have therefore postponed a planned Investigational New Drug (IND) submission for this
indication.







34


Table of Contents




Our Strategy



Our strategy is to
build a fully integrated biotechnology company that discovers, in-licenses and develops an innovative and effective small molecule
drug portfolio of ligands that bind to a specific therapeutic target for the treatment of cancer, liver and inflammatory disease
and sexual dysfunction. We continue to develop and test our existing pipeline, while also testing other indications for our existing
drugs and examining, from time to time, the potential of other small molecules that may fit our platform technology of utilizing
small molecules to target the A3AR. We generally focus on drugs with global market potential and we seek to create global partnerships
to effectively assist us in developing our portfolio and to market our products. Our approach allows us to:



| | ● | continue to advance
    our clinical and preclinical pipeline;
| | - | --------------------------------------------------------------



| | ● | test our products
    for additional indications which fit our molecules’ mechanism of action;
| | - | ----------------------------------------------------------------------------------------------



| | ● | identify other small
    molecule drugs or ligands;
| | - | ---------------------------------------------------



| | ● | focus on our product
    candidates closest to realizing their potential; and
| | - | -----------------------------------------------------------------------------



| | ● | avoid dependency
    on a small number of small molecules and indications.
| | - | --------------------------------------------------------------------------



Using this approach,
we have successfully advanced our product candidates for a number of indications into various stages of clinical development.
Specific elements of our current strategy include the following:



Successful development
of our existing portfolio of small molecule orally bioavailable drugs for the treatment of various diseases. We intend to
continue to develop our existing portfolio of small molecule orally bioavailable drugs, both for existing targeted diseases, as
well as other potential indications. Our drug development will continue to focus on cancer, liver and inflammatory disease and
sexual dysfunction. We intend to focus most prominently on advancing our product candidates that are in the most advanced stages,
i.e., rheumatoid arthritis and psoriasis with respect to Piclidenoson, and HCC and NASH with respect to Namodenoson.



Use our expertise
with our platform technology to evaluate in-licensing opportunities. We continuously seek attractive product candidates and
innovative technologies to in-license or acquire. We intend to focus on product candidates that would be synergistic with our
A3AR expertise. We believe that by pursuing selective acquisitions of technologies in businesses that complement our own, we will
be able to enhance our competitiveness and strengthen our market position. We intend to utilize our expertise in A3AR and our
pharmacological expertise to validate new classes of small molecule orally bioavailable drugs. We will then seek to grow our product
candidate portfolio by attempting to in-license those various candidates and to develop them for a variety of indications.



Primarily develop
products that target major global markets. Our existing product candidates are almost all directed at diseases that have major
global markets. Our intent is to continue to develop products that target diseases that affect significant populations using our
platform technology. We believe these arrangements will allow us to share the high development cost, minimize the risk of failure
and enjoy our partners’ marketing capabilities, while also enabling us to treat a more significant number of persons. We
believe further that this strategy will increase the likelihood of advancing clinical development and potential commercialization
of our product candidates.



Commercialize our
product candidates through out-licensing arrangements. We have entered into several out-licensing arrangements with leading
pharmaceutical companies in the Far East, Canada and Europe. We intend to continue to commercialize our product candidates through
out-licensing arrangements with third parties who may perform any or all of the following tasks: completing development, securing
regulatory approvals, manufacturing, marketing and sales. We do not intend to develop our own manufacturing facilities or sales
forces. If appropriate, we may enter into co-development and similar arrangements with respect to any product candidate with third
parties or commercialize a product candidate ourselves. We believe these arrangements will allow us to share the high development
cost, minimize the risk of failure and enjoy our partners’ marketing capabilities. We believe further that this strategy
will increase the likelihood of advancing clinical development and potential commercialization of our product candidates.





35


Table of Contents




Our Product Pipeline



The table below sets forth our current
pipeline of product candidates, including the target indication and status of each.



|Clinical
    Application/Drug      | Pre-Clinical                                 | Phase I | Phase
    II | Phase III
|---------------------------------- | -------------------------------------------- | ------- | ------------ | ---------
|Autoimmune-Inflammatory            |                                              |         |              |          
|                                   | Rheumatoid Arthritis
    -  Piclidenoson (1) |         |              |          
|                                   |                                              |         |              |          
|                                   | Psoriasis -  Piclidenoson
    (2)            |         |              |          
|                                   |                                              |         |              |          
|Oncology/Liver
    diseases        |                                              |         |              |          
|                                   | HCC – Namodenoson
    (3)                    |         |              |          
|                                   |                                              |         |              |          
|                                   | NASH – Namodenoson
    (4)                   |         |              |          
|                                   |                                              |         |              |          
|Sexual
    Dysfunction - CF602 (5) |                                              |         |              |          
|                                   |                                              |         |              |          
|                                   |                                              |         |              |          
|                                   | Completed                                    |         |              |          
|                                   |                                              |         |              |          
|                                   | On-going                                     |         |              |          
|                                   |                                              |         |              |          
|                                   | Preparatory
    work                         |         |              |          
|                                   |                                              |         |              |          

|(1) | We are conducting
    a Phase III trial for Piclidenoson in the treatment of rheumatoid arthritis.                                                                                       
|--- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                          
|(2) | We are conducting
    a Phase III trial for Piclidenoson in the treatment of psoriasis.                                                                                                  
|    |                                                                                                                                                                                          
|(3) | We recently announced
    top-line results of a Phase II study with respect to the development of Namodenoson for the treatment of HCC with approximately
    78 patients.               
|    |                                                                                                                                                                                          
|(4) | We are conducting a Phase II trial of Namodenoson in the treatment of NASH. Top-line results are expected
in the second half of 2019.                                                    
|    |                                                                                                                                                                                          
|(5) | We are investigating
    additional compounds, targeting the A3AR, for the treatment of sexual dysfunction and have therefore postponed a planned IND
    submission for this indication.





36


Table of Contents




Piclidenoson (CF101)



Piclidenoson, our
lead therapeutic product candidate, is in development for the treatment of autoimmune-inflammatory diseases. In certain of our
pharmacological studies, Piclidenoson has also shown potential for development for the treatment of Crohn’s disease. Piclidenoson
is a highly-selective, orally bioavailable small molecule synthetic drug, which targets the A3AR. Based on our clinical studies
to date, we believe that Piclidenoson has a favorable safety profile and significant anti-inflammatory effects as a result of
its capability to inhibit the production of inflammatory cytokines, such as TNF-α, IL-6 and IL-1, and chemokines, or small
cytokines, such as MMPs, by signaling key proteins such as NF-кB and PKB/AKT. Overall, these up-stream events result in
apoptosis of inflammatory cells. See Figure 1 below. Piclidenoson’s anti-inflammatory effect is mediated via the A3AR, which
is highly expressed in inflammatory cells.







Figure 1: Piclidenoson anti-inflammatory
mechanism of action



Set forth below are
general descriptions of the inflammatory diseases with respect to which Piclidenoson is currently undergoing, or is in preparation
for clinical trials.



Rheumatoid Arthritis:
Rheumatoid arthritis is a chronic, systemic autoimmune-inflammatory disease that may affect many tissues and organs, but principally
attacks flexible synovial, or joints, on both sides of the body. This symmetry helps distinguish rheumatoid arthritis from other
types of arthritis, which is the general term for joint inflammation. Although the cause of rheumatoid arthritis is unknown, autoimmunity
plays a pivotal role in both its chronicity and progression. The disease involves abnormal B cell–T cell interaction, which
results in the release of cytokines. The cytokines signal the release of inflammatory cells. The inflammatory cells migrate from
the blood into the joints and joint-lining tissue. There, the cells produce inflammatory substances that cause irritation, wearing
down of cartilage, or the cushioning material at the end of bones, swelling and inflammation of the joint lining, which is caused
by excess synovial fluid, the development of pannus, or fibrous tissue, in the joint, and ankylosis, or fusion of the joints.
Joint inflammation is characterized by redness, warmth, swelling and pain within the joint. As the cartilage wears down, the space
between the bones narrows. If the condition worsens, the bones could rub against each other. As the lining expands due to inflammation
from excess fluid, it may erode the adjacent bone, resulting in bone damage. Rheumatoid arthritis can also produce diffuse inflammation
in the lungs, membrane around the heart, the membranes of the lungs, and white of the eye, and also nodular lesions, most common
in subcutaneous tissue.





Psoriasis:
Psoriasis is an autoimmune hereditary disease that affects the skin. In psoriasis, immune cells move from the dermis to the epidermis,
where they stimulate keratinocytes, or skin cells, to proliferate. DNA acts as an inflammatory stimulus to stimulate receptors
which produce cytokines, such as IL-1, IL-6, and TNF-α, and antimicrobial peptides. These cytokines and antimicrobial peptides
signal more inflammatory cells to arrive and produce further inflammation. In other words, psoriasis occurs when the immune system
overreacts and mistakes the skin cells as a pathogen, and sends out faulty signals that speed up the growth cycle of skin cells.
Normally, skin cells grow gradually and flake off approximately every four weeks. New skin cells grow to replace the outer layers
of the skin as they shed. But in psoriasis, new skin cells move rapidly to the surface of the skin in days rather than weeks.
They build up and form thick patches called plaques.





37


Table of Contents




There are five types
of psoriasis: plaque, guttate, inverse, pustular and erythrodermic. The most common form, plaque psoriasis, is commonly seen as
red and white hues of scaly patches appearing on the top first layer of the epidermis, or skin. In plaque psoriasis, skin rapidly
accumulates at these sites, which gives it a silvery-white appearance. Plaques frequently occur on the skin of the lower back,
elbows and knees, but can affect any area, including the scalp, palms of hands, soles of feet and genitals. The plaques range
in size from small to large. In contrast to eczema, psoriasis is more likely to be found on the outer side of the joint. Some
patients, though, have no dermatological symptoms.



Psoriasis is a chronic
recurring condition that varies in severity from minor localized patches to complete body coverage. Fingernails and toenails are
frequently affected, known as psoriatic nail dystrophy, and can be seen as an isolated symptom. Psoriasis can also cause inflammation
of the joints, which is known as psoriatic arthritis.



Pre-Clinical Studies of Piclidenoson



The information below
is based on the various studies conducted with Piclidenoson, including preclinical studies. All of the studies were conducted
by Can-Fite and/or by Can-Fite’s partners or affiliates.



Pre-clinical studies
are a set of experiments carried out in animals to show that a certain drug does not evoke toxicity. Based on the animal studies
and safety data, one can approach the FDA and request permission to conduct a Phase I study in human beings.



The toxicity of Piclidenoson
has been evaluated following 28-day, 90-day, six-month and nine-month good laboratory practice repeated-dose toxicity studies
in male and female mice (28-day, 90-day and six-month), dogs (single-dose only), and monkeys (28-day, 90-day and nine-month).
Even though the dose of Piclidenoson in these studies was escalated to an exposure that is many folds higher than the dose used
in human clinical studies, no toxic side effects were identified.



Effects on cardiovascular
parameters were evaluated in conscious instrumented monkeys and anesthetized dogs. These studies demonstrated no significant cardiovascular
risk.



Genotoxicity studies
were conducted in bacterial and mammalian mutation assays in vitro (i.e., laboratory) and in an in vivo (i.e., animal)
mouse micronucleus assay. These studies were all negative, indicating no deleterious action on cellular genetic material.



Reproductive toxicology
studies that we completed in mice and rabbits did not reveal evidence of negative effects on male or female fertility. In mouse
teratology studies, or studies for abnormalities of physiological developments, craniofacial and skeletal abnormalities were observed
at doses greater than 10 mg/kg; however, no such effects were observed at 3 mg/kg demonstrating the safety of the drug in this
concentration range. Teratogenicity, or any developmental anomaly in a fetus, was not observed in rabbits given doses (greater
than 13 mg/kg) that induced severe maternal toxicity in such rabbits.



Studies of P450 enzymes,
or enzymes that participate in the metabolism of drugs, showed that Piclidenoson caused no P450 enzyme inhibition, or increased
drug activity, or induction, or reduced drug activity. Studies carried out with radiolabeled (C14) Piclidenoson in
rats showed that the drug is excreted essentially unchanged. These studies also showed that the drug is widely distributed in
all body parts, except the central nervous system.



Clinical Studies of Piclidenoson



The information below
is based on the various studies conducted with Piclidenoson, including clinical studies in patients with autoimmune-inflammatory
and ophthalmic diseases. All of the studies were conducted by Can-Fite and/or by Can-Fite’s partners or affiliates.



Phase I Clinical
Studies of Piclidenoson



Piclidenoson has been
studied comprehensively in normal volunteer trials to assess safety, pharmacokinetic metabolism and food interaction. Two Phase
I studies in 40 healthy volunteers, single dose and repeated dose, indicated that Piclidenoson is rapidly absorbed (reaching a
maximal concentration within one to two hours) with a half-life of eight to nine hours. Some mild adverse events (principally,
increased heart rate) were observed at doses higher than single doses of 10.0 mg and twice-daily doses of 5.0 mg. Such increase
in heart rate was not accompanied by any change in QT intervals. The drug showed linear kinetics, in that the concentration that
results from the dose is proportional to the dose and the rate of elimination of the drug is proportional to the concentration,
and low inter-subject variability, meaning that the same dose of the drug does not produce large differences in pharmacological
responses in different individuals. A fed-fast Phase I study (with and without food) demonstrated that food causes some attenuation
in Piclidenoson absorption; accordingly, Piclidenoson is administered to patients on an empty stomach in our trials. An additional
Phase I study of the absorption, metabolism, excretion and mass balance of 4.0 mg (C14) Piclidenoson was conducted
in six healthy male subjects and demonstrated that Piclidenoson was generally well-tolerated in this group.





38


Table of Contents




Based on the findings
from Phase I clinical studies, 4.0 mg twice daily, or BID, was selected as the upper limit for initial Phase II clinical trials.



Additionally, in preparation
for Phase III studies of Piclidenoson to establish cardiac safety in humans prior to registration for marketing approval, we conducted
a cardiodynamic trial that was a placebo-controlled crossover study using precise methodology to determine the effect of Piclidenoson
on electrocardiograms of healthy volunteers. The primary objective of the trial was to assess whether Piclidenoson causes a delay
in cardiac repolarization, as manifested by prolongation of the QT interval of the electrocardiogram. A drug-induced delay in
cardiac repolarization creates an electrophysiological environment that can lead to the development of ventricular cardiac arrhythmias.
In this study, Piclidenoson doses were up to 3-fold higher than the highest dose expected to be used in our registration-directed
clinical trials. Trial results showed that our highest projected Piclidenoson dose had no clinically significant adverse electrocardiographic
effects.



Phase II, Phase
II/III and Phase III Clinical Studies of Piclidenoson



Piclidenoson has completed
eleven Phase II studies, one Phase II/III study and one Phase III study in different clinical indications including psoriasis,
rheumatoid arthritis, glaucoma and dry eye syndrome, or DES, in approximately 1,500 patients. These studies indicate that Piclidenoson
has a favorable safety profile at doses up to 4.0 mg BID for up to 32 weeks. In these studies, we did not observe a dose-response
relationship between Piclidenoson and adverse events. Moreover, we did not observe any clinically significant changes in vital
signs, electrocardiograms, blood chemistry or hematology.



Piclidenoson given
as a standalone therapy reached the primary endpoint in Phase II clinical studies in DES; however, a Phase III study of Piclidenoson
for DES failed to reach the primary endpoint. We have observed positive data utilizing Piclidenoson as a standalone drug in a
Phase IIa clinical study in rheumatoid arthritis. In this study, we also observed a significant direct correlation between A3AR
expression prior to treatment and the patients’ responses to Piclidenoson. However, we did not fully attain the primary
endpoint in this study as we did not observe a significant difference in responses between Piclidenoson and the placebo (which
for this study was 0.1 mg of Piclidenoson). Moreover, two Phase IIb studies in rheumatoid arthritis utilizing Piclidenoson in
combination with MTX, also failed to reach the primary endpoints. Based on this data, we believe that the failures in the Phase
IIb studies in rheumatoid arthritis may have been due to low A3AR expression in the MTX-treated patients. A Phase IIb of Piclidenoson
given as a standalone therapy in patients with A3AR expression levels above a certain threshold reached the primary endpoint in
rheumatoid arthritis in December 2013. Piclidenoson has been tested in Phase II trials to establish dose and activity (first,
orally administered capsules and then tablets in formulations of 1.0, 2.0 and 4.0 mg of Piclidenoson BID) in psoriasis (moderate
to severe plaque psoriasis), rheumatoid arthritis and DES (moderate to severe). A Phase II/III study of Piclidenoson for psoriasis
did not meet its primary endpoint although positive data from further analysis of the Phase II/III study suggests Piclidenoson
as a potential systemic therapy for patients with moderate-severe psoriasis. In addition, a Phase II study of Piclidenoson for
glaucoma showed no statistically significant differences between the Piclidenoson treated group and the placebo group in the primary
endpoint of lowering IOP.



Psoriasis:
The rationale for utilizing Piclidenoson to treat psoriasis stems from our pre-clinical pharmacology studies showing that Piclidenoson
acts as an anti-inflammatory agent via the inhibition of inflammatory cytokines, including TNF-α, which plays a major role
in the pathogenesis of psoriasis. In addition, the A3AR is over-expressed in the tissue and PBMCs of patients with psoriasis.





39


Table of Contents




We completed an exploratory
Phase II trial in ten European and Israeli medical centers involving 76 patients. This study was a randomized, double-blind, placebo
controlled and included four cohorts of 1.0, 2.0, and 4.0 mg of Piclidenoson and a placebo for a 12-week period. The study objectives
were efficacy and safety of daily doses of Piclidenoson administered orally in patients with moderate-to-severe plaque-type psoriasis
and the efficacy endpoints were improvements in both the Psoriasis Area Sensitivity Index score, or PASI score, and the Physicians’
Global Assessment score, or PGA score. We concluded that Piclidenoson met such efficacy endpoints and was well tolerated and effective
in ameliorating disease manifestations in these patients. The patient group receiving 2.0 mg Piclidenoson BID showed progressive
improvement over the course of the 12-week study in the PGA and PASI scores. Analysis of the mean change from baseline in the
PASI score at week 12 revealed a statistically significant difference between the 2.0 mg Piclidenoson BID treated group and the
placebo group (p<0.001 versus baseline and p=0.031 versus placebo). Analysis of the PGA score revealed that 23.5% of the patients
treated with the 2.0 mg Piclidenoson BID achieved a score of 0 or 1, in comparison to 0% in the placebo group (p<0.05). The
study also demonstrated linear improvement in patients in both PASI and PGA. See Figure 2. No drug-related serious adverse
events were evident during the study.







Figure 2: Psoriasis efficacy by PGA
and PASI





40


Table of Contents




Set forth below are
representative pictures of a patient with plaque-type psoriasis on the upper and lower back treated with 2.0 mg Piclidenoson BID,
both baseline and week 12.







A comparison between baseline and week
12 of a patient treated with 2.0 mg CF101



In February 2015,
we completed a Phase II/III randomized, double-blind, placebo-controlled, dose-finding study of the efficacy and safety of Piclidenoson
administered daily orally in patients with moderate-to-severe plaque psoriasis. This clinical trial enrolled 326 patients in 17
clinical centers in the United States, Europe and Israel, of which 103 patients were enrolled in the first study cohort and were
treated for 6 months and 223 patients were enrolled in the second study cohort and were treated for 8 months. The first study
cohort was comprised of three arms with patients receiving: 1.0 mg of Piclidenoson; 2.0 mg of Piclidenoson; and placebo. All patients
receiving placebo were switched to either 1.0 mg or 2.0 mg of Piclidenoson after 12 weeks. Based on a positive safety and efficacy
interim analysis of the first 103 patients who completed 24 weeks of treatment in the trial, we decided to continue patient enrollment
for the second stage of the study and the study protocol was amended to extend the Piclidenoson 2.0 mg BID and placebo administration
for a period of 32 weeks. The positive clinical effects of the Piclidenoson 2.0 mg BID dose relative to a placebo were observed
in a variety of standard psoriasis assessment parameters, including PASI 75 and PGA scores, with the responses accumulating steadily
over the 24-week treatment period.



In March 2015, we
announced the study did not meet its primary endpoint of a statistically significant improvement in the PASI 75 score relative
to placebo after 12 weeks of treatment. Further analysis of the entire study period revealed that by 32 weeks of treatment with
Piclidenoson, 33% of the patients achieved PASI 75 while the mean percent of improvement in PASI score was 57% (p<0.001). This
was a statistically significant cumulative and linear improvement during weeks 16 to 32. Most significantly, by week 32 of the
study, 20% of the study patients reached PASI 90, a result demonstrating a response rate of 90% clearing of skin lesions. PASI
90 is one of the most stringent and difficult to meet clinical endpoints for measuring responses to psoriasis treatments. Moreover,
the PASI 90 subset analysis further suggests a higher and significant (p=0.026) Piclidenoson response rate of 27% among patients
previously untreated with systemic psoriasis therapy compared to patients pre-treated with systemic drugs. We believe this presents
the opportunity that Piclidenoson can be developed as a first-line systemic therapy for patients with moderate-severe psoriasis
and for patients who do not want to be treated with the current systemic drugs due to safety issues.







Figure 3: Linear Effect of Piclidenoson
on PASI Scores through 32 Weeks of Treatment



41


Table of Contents




We are currently conducting
our pivotal COMFORT Phase III trial for Piclidenoson for the treatment of psoriasis. The trial is a randomized, double-blind,
placebo- and active-controlled study that is investigating the efficacy and safety of daily Piclidenoson 2.0 mg or 3.0 mg administered
twice daily orally as compared to placebo as its primary endpoint and as compared to apremilast (Otezla®) as a secondary endpoint
in approximately 400 patients with moderate-to-severe plaque psoriasis. Medication is to be taken orally twice daily for 32 weeks
in a double-blinded fashion. The primary end point is the proportion of subjects who achieve a PASI score response of ≥75%
(PASI 75) vs. placebo at week 16. The secondary endpoints include non-inferiority to Otezla® on weeks 16 and 32, achievement
of PASI 50 at week 16 and efficacy and safety data for Piclidenoson through the extension period of up to 48 weeks of treatment.
Patients are being selected to the study based on over expression of the A3AR biomarker. In August 2018, we announced enrollment
of the first patient. We expect COMFORT will serve as the first of two pivotal studies required for EMA-drug approval.



Rheumatoid Arthritis:We conducted a Phase IIa blinded to dose study in 74 patients with rheumatoid arthritis, randomized to receive Piclidenoson
as a monotherapy in one of three doses—0.1 mg, 1.0 mg and 4.0 mg. The primary efficacy endpoint was ACR20 response at week
12, a criterion determined by the American College of Rheumatology that reflects 20% improvement in inflammation parameters. The
study data revealed maximal response at the 1.0 mg group, showing 55.6% with ACR20, 33.3% with 50% improvement, or ACR50, and
11.5% with 70% improvement, or ACR70. Piclidenoson administered BID for 12 weeks resulted in improvement in signs and symptoms
of rheumatoid arthritis and was well-tolerated. See Figure 4. Studies in the United States were conducted pursuant to an open
IND, which was received by the FDA in 2005.







Figure 4: Rheumatoid Arthritis efficacy
by ACR



Subsequently, two
Phase IIb studies with Piclidenoson in combination with MTX were conducted. The study protocols were multicenter, randomized,
double-blind, placebo-controlled, parallel-group and dose-finding to determine the safety and efficacy of daily Piclidenoson administered
orally when added to weekly MTX in patients with active rheumatoid arthritis. The objectives of both studies were improvement
in ACR20, ACR50, ACR70 and DAS28, or the Disease Activity Score of 28 Joints, and EULAR, or the European League Against Rheumatism,
response criteria, as well as a positive safety profile. The trials’ primary endpoints were both ACR20.



The first Phase IIb
trial showed that the combined treatment had an excellent safety profile, but no significant ACR20 response was observed between
the rheumatoid arthritis group treated with Piclidenoson and MTX and the group treated with MTX alone (the placebo group). However,
the ACR50, ACR70 and the EULAR Good Values in the combined treatment group were higher than those of the MTX placebo group. The
study also indicated that the 1.0 mg Piclidenoson dose was the most favorable dose, i.e., the dose yielded the highest ACR50 and
EULAR Good Values as compared to the MTX placebo group. The most commonly reported adverse events in this study included nausea,
dizziness, headache and common bacterial and viral infections and infestations.



Following a decision
of our Clinical Advisory Board in October 2007, an additional Phase IIb study was initiated. This study was conducted in medical
centers in Europe and Israel and included 230 patients who received the drug orally BID (0.1 and 1.0 mg Piclidenoson tablets plus
MTX versus a placebo, which was MTX alone) for 12 weeks. On April 30, 2009, we published preliminary results of the Phase IIb
study, which were later confirmed as the final results, also indicating that the study’s objectives were not achieved. The
most commonly reported adverse events in this study included nausea, myalgia and dizziness.





42


Table of Contents




The two Phase IIb
studies failed to achieve the primary endpoint of ACR20. A cross study analysis of the three rheumatoid arthritis clinical studies
revealed that in the first Phase IIa study, where Piclidenoson had been administered as a standalone drug, A3AR had been over-expressed
in the patients’ PBMCs prior to Piclidenoson treatment, whereas A3AR had not been over-expressed in the Phase IIb patient
population. We believe, based on the foregoing data, that there may be a direct and statistically significant correlation between
A3AR over-expression at baseline and patients’ response to Piclidenoson, and that Piclidenoson should be administered as
a standalone drug and not in combination with MTX. Furthermore, the correlation between A3AR expression levels prior to treatment
and patients’ response to the drug suggest that the A3AR may be a predictive biomarker to be analyzed prior to Piclidenoson
treatment. See Figures 5 and 6.







Figure 5: Direct correlation between
A3AR at baseline and response to Piclidenoson







Figure 6: Direct correlation between
A3AR at baseline and response to Piclidenoson





43


Table of Contents




Based on the results
of the two Phase IIb studies, we conducted an additional Phase IIb clinical study with Piclidenoson as a stand-alone, monotherapy
treatment and not in combination with MTX. The trial was a 12-week multicenter, randomized, double-blind, placebo-controlled,
parallel-group study involving 79 patients to determine the safety and efficacy of Piclidenoson administered orally daily in patients
with active rheumatoid arthritis and elevated baseline expression levels of the A3AR in PBMCs. Enrolled patients had high baseline
A3AR biomarker expression (determined at 1.5-fold over a predetermined age-matched standard). This selection criteria was made
following the findings during previous Phase IIa and IIb rheumatoid arthritis studies showing a positive correlation between A3AR
expression at baseline and patients’ response to the drug, potentially rendering A3AR expression as a predictive biomarker.
The primary objectives of this study were to determine the efficacy of oral Piclidenoson when administered daily as a standalone
treatment for 12 weeks to patients with active rheumatoid arthritis and elevated baseline expression levels of the A3AR in the
patients’ PBMCs, in comparison to a placebo treatment, and to assess the safety of daily oral Piclidenoson under the circumstances
of the trial. In December 2013, we announced the results of the study in which Piclidenoson met all primary efficacy endpoints,
showing statistically significant superiority over placebo in reducing signs and symptoms of rheumatoid arthritis as compared
to the placebo. The treatment had an ACR20 response rate of 49% for Piclidenoson compared to 25% for placebo (p=0.035), an ACR50
response rate of 19% for Piclidenoson compared to 9% for placebo, and an ACR70 response rate of 11% for Piclidenoson compared
to 3% for placebo. See Figure 7. Similar to our observations in the previously reported Piclidenoson psoriasis trials, the response
of patients with rheumatoid arthritis was cumulative over time, suggesting a consistent anti-inflammatory effect of Piclidenoson.
Moreover, half of the rheumatoid arthritis patients treated with Piclidenoson showed clinically meaningful improvement. Piclidenoson
was very well-tolerated and showed no evidence of immunosuppression, and there were no severe treatment-emergent adverse events
during the study. A subgroup analysis of 16 patients with no prior systemic therapy showed a dramatic increase in the response
showing ACR20 of 75%, ACR50 of 50%, and ACR70 of 50%. See Figure 7. We believe this may be related to the fact that in this patient
population there is a full receptor expression since they had not been treated earlier with any systemic drugs.



| |  | 
| |  | 

Figure 7: ACR response data –
Rheumatoid Arthritis phase IIb



We are currently conducting
our pivotal ACRobat Phase III trial of Piclidenoson to evaluate Piclidenoson as a first line treatment and replacement for
MTX. The trial is a randomized, double-blind, active and placebo-controlled, parallel-group study in approximately 500 patients
in Europe, Israel and Canada. The primary endpoint of ACRobat is low disease activity after 12 weeks of treatment in patients
dosed with Piclidenoson compared to those dosed with MTX. Piclidenoson at 1.0 mg and 2.0 mg, or placebo, will be administered
twice daily, and MTX or placebo will be administered once weekly. Secondary endpoints include disease activity remission at week
24, ACR 20/50/70 response rates, European League Against Rheumatism good and moderate response rates and change from baseline
for disease activity and ACR responses. The total study duration will be 24 weeks in order to provide more data on long term efficacy
and safety. In the fourth quarter of 2017, we announced the enrollment and dosing of the first patient in the trial. We expect
ACRobat will serve as the first of two pivotal studies required for EMA-drug approval.





44


Table of Contents




DES: DES is
an eye disease caused by eye dryness, which, in turn, is caused by either decreased tear production or increased tear film evaporation.
A Phase II study in DES was conducted by Can-Fite after discovering that patients in the Phase IIa study for another condition
also experienced improvement in DES symptoms. The results of the Phase II trial demonstrated the ability of Piclidenoson to improve
signs of ocular surface inflammation of the patients studied. Following positive results in the Phase II study, we initiated a
Phase III DES trial, under an IND with the FDA, which was conducted by OphthaliX in the United States, Europe and Israel. The
randomized, double-masked Phase III clinical trial enrolled 237 patients with moderate-to-severe DES who were randomized to receive
two oral doses of Piclidenoson (0.1 and 1.0 mg) and a placebo, for a period of 24 weeks. The primary efficacy endpoint was complete
clearing of corneal staining. In December 2013, we announced the results of this Phase III study of Piclidenoson for the treatment
of DES. In the study, Piclidenoson did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the
secondary efficacy endpoints. Nonetheless, Piclidenoson was found to be well tolerated. In 2014, we decided to end the development
of Piclidenoson for the DES indication. This decision was based on a lack of correlation between patients’ response to Piclidenoson
and over-expression of the drug target, the A3AR in this patient population.



Glaucoma: Glaucoma
is an eye disease in which the optic nerve is damaged.  This optic nerve damage involves loss of retinal ganglion cells,
or neurons located near the inner surface of the retina, in a characteristic pattern. There are many different subtypes of glaucoma,
but they can all be considered to be a type of optic neuropathy. Raised IOP is the most important and only modifiable risk factor
for glaucoma. However, some individuals may have high IOP for years and never develop optic nerve damage. This is known as ocular
hypertension. Others may develop optic nerve damage at a relatively low IOP, and, thus, glaucoma. Untreated glaucoma can lead
to permanent damage of the optic nerve and resultant visual field loss, which over time can progress to blindness. A Phase II
clinical trial of Piclidenoson for the treatment of glaucoma was conducted by OphthaliX. The randomized, double-masked, placebo-controlled,
parallel-group Phase II clinical trial was designed to evaluate the safety and efficacy of Piclidenoson when administered
orally twice daily for up to 16 weeks in patients with elevated IOP. A total of 89 patients were enrolled in the study. The study
was conducted with two cohorts. In the first cohort, treatment was randomized in a 3:1 ratio of 1.0 mg Piclidenoson to placebo.
In the second cohort, which was also randomized in a 3:1 Piclidenoson to placebo ratio, the Piclidenoson dose was increased to
2.0 mg. In July 2016, top line results were announced. In this trial, no statistically significant differences were found between
the Piclidenoson treated group and the placebo group in the primary endpoint of lowering IOP. Piclidenoson was found to have a
favorable safety profile and was well tolerated. Based on these overall results, OphthaliX saw no immediate path forward in glaucoma
and we have since terminated the License Agreement that we granted to OphthaliX, following the Merger with Wize Pharma. See “Item
4. Information on the Company—A. History and Development of the Company.”





Additional Developments with Piclidenoson



Osteoarthritis



According to the Arthritis
Foundation, osteoarthritis, or OA, is the most common arthritic disease. Currently, there is a shortage of effective drugs for
treating OA patients. Piclidenoson has induced a significant anti-inflammatory effect in experimental animal models with respect
to the treatment of OA and, as such, we are currently preparing for a Phase II study. We have not yet filed an IND for this indication
as Piclidenoson for the treatment of OA is not currently being clinically tested in the United States and there are no near-term
plans to do so.



Crohn’s Disease



Crohn’s disease
is an inflammatory bowel disease that may affect any portion of the gastrointestinal tract, causing a wide variety of symptoms.
It primarily causes abdominal pain, diarrhea, vomiting and weight loss; however, it may also cause complications outside the gastrointestinal
tract, such as skin rashes, arthritis, inflammation of the eye, tiredness and lack of concentration. Pre-clinical pharmacology
studies that we have conducted demonstrated the efficacy of Piclidenoson for the treatment of Crohn’s disease. We do not
presently have plans for the treatment of Crohn’s disease.





45


Table of Contents




Namodenoson (CF102)



Namodenoson is our
second drug candidate and is under development for the treatment of HCC, hepatitis C virus, or HCV, or NAFLD, the precursor to
NASH. Namodenoson is also a small, orally bioavailable molecule, and an A3AR agonist, with high affinity and selectivity to the
A3AR. In comparison to the expression in adjacent normal liver tissue, the A3AR is over-expressed in tumor tissues of patients
with HCC, and the over-expression is also reflected in the patients’ PBMCs. A3AR over-expression in the patients’
tumor cells and PBMCs is attributed to high expression of certain A3AR transcription factors. The binding of Namodenoson to the
A3AR results in down-regulation, or a decrease in the quantity of a cellular component, such as the number of receptors on a cell’s
surface, of certain A3AR transcription factors. Our studies have shown that this down-regulation leads to apoptosis of HCC cells.
In our pre-clinical and clinical studies, Namodenoson demonstrated anti-cancer, anti-viral and liver protective effects. As a
result, we believe that Namodenoson can be used to treat a variety of oncological and liver-related diseases and viruses.



In February 2012,
the FDA granted an orphan drug status for the active moiety, or the part of the drug that is responsible for the physiological
or pharmacological action of the drug substance, of Namodenoson for the treatment of HCC. Subsequently, in October 2015, the EMA
granted Namodenoson orphan drug designation for the treatment of HCC.



An orphan drug designation
is a special designation for drug approval and marketing. The special designation is granted to companies that develop a given
drug for unique populations and for incurable and relatively rare diseases. The FDA orphan drug designation program provides orphan
status to drugs and biologics, which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases
or disorders that affect fewer than 200,000 people in the United States and in the EU not more than 5 per 10,000. Orphan drug
designations have enabled companies to achieve medical breakthroughs that may not have otherwise been achieved due to the economics
of drug research and development as this status lessens some of the regulatory burdens, for approval, including statistical requirements
for efficacy, safety and stability, in an effort to maintain development momentum. Orphan drug designation also results in additional
marketing exclusivity and could result in certain financial incentives.



In September 2015,
the FDA granted Fast Track designation to Namodenoson as a second line treatment to improve survival for patients with advanced
HCC who have previously received Nexavar (sorafenib). Fast Track, aimed at getting important new drugs that meet an unmet need
to patients earlier, is expected to expedite the development of Namodenoson. Drugs that receive Fast Track designation benefit
from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It
also allows us to submit parts of the NDA on a rolling basis for review as data becomes available.



Israel’s Ministry
of Health has previously approved Namodenoson for Compassionate Use for HCC.



Set forth below are
general descriptions of the diseases with respect to which Namodenoson has underwent or is currently undergoing or being prepared
for clinical trials.



HCC:HCC is
an oncological disease characterized by malignant tumors that grow on the surface or inside of the liver. This type of tumor is
refractory to chemotherapy and to other anti-cancer agents. HCC, like any other cancer, develops when there is a mutation to the
cellular machinery that causes the cell to replicate at a higher rate and/or results in the cell avoiding apoptosis. Chronic infections
of Hepatitis B and/or C can aid the development of HCC by repeatedly causing the body’s own immune system to attack the
liver cells, some of which are infected by the virus. While this constant cycle of damage followed by repair can lead to mistakes
during repair which in turn lead to carcinogenesis, this hypothesis is more applicable, at present, to HCV. Chronic HCV causes
HCC through cirrhosis. In chronic Hepatitis B, however, the integration of the virus into infected cells can directly induce a
non-cirrhotic liver to develop HCC. Alternatively, repeated consumption of large amounts of ethanol can have a similar effect.



Hepatitis C:
HCV is an infectious disease affecting primarily the liver, caused by the Hepatitis C virus. The infection is often asymptomatic,
but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years,
and chronic liver disease. The virus also increases the chance for HCC development. In some cases, those with cirrhosis will develop
liver failure, liver cancer or life-threatening esophageal and gastric varices, or dilated submucosal veins, which can be life-threatening.
HCV is spread primarily by blood-to-blood contact often associated with intravenous drug use, poorly sterilized medical equipment,
transfusions, and sexual intercourse.





46


Table of Contents




NAFLD/NASH:
NASH, also called “fatty liver,” is a condition in which fat builds up inside the liver causing inflammation. Prior
to the presence of inflammation, the disease is simply referred to as NAFLD, the most common form of liver disorder in the United
States. The accumulation of macroglobular fat inside the liver causes oxidative stress that reduces the efficiency of the liver
and can lead to increased liver enzymes such as alanine aminotransferase and aspartate aminotransferase. Loss of liver efficiency
and oxidative stress leads to inflammation, liver cell ballooning, and the development of NASH. Prolonged inflammation results
in cirrhosis (scar tissue), liver failure, or liver cancer. There are currently no drugs approved for the treatment of NASH.





Pre-Clinical Studies with Namodenoson



We conducted several
pre-clinical studies demonstrating robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting the development
of Namodenoson for the NAFLD/NASH indication. Furthermore, the results indicated that Namodenoson was very well tolerated.



In pre-clinical studies,
we evaluated the toxicity, stability, metabolism and other safety parameters of Namodenoson at doses much higher than the doses
that we currently administer to humans in our clinical trials of Namodenoson.



In pre-clinical pharmacology
studies, Namodenoson inhibited the growth of HCC via the induction of tumor cell apoptosis. In addition, in collaboration with
leading virology labs, we observed that Namodenoson inhibited viral replication of HCV through the down-regulation of viral proteins.
Both of these findings served as a basis to further explore development of this drug for HCC.



In a preclinical study,
Namodenoson also revealed its capability to improve liver pathology in a NAFLD/NASH animal model. The data showed:



| | ● | Namodenoson had
    a statistically significant reduction in NAFLD activity score compared to vehicle treated group;
| | - | --------------------------------------------------------------------------------------------------------------------



| | ● | Namodenoson reduced
    liver-to-body weight compared to vehicle treated group;
| | - | -------------------------------------------------------------------------------



| | ● | Representative photomicrographs
    of H&E-stained liver sections showed improved pathology in animals receiving Namodenoson vs. vehicle;
| | - | -----------------------------------------------------------------------------------------------------------------------------------------



| | ● | Namodenoson decreased
    plasma serum alanine aminotransferase, or ALT, and triglycerides levels compared to vehicle treated group; and
| | - | ----------------------------------------------------------------------------------------------------------------------------------------



| | ● | Liver sections from
    the vehicle treated group exhibited severe micro- and macrovesicular fat deposits, ballooning and inflammatory cell infiltration,
    whereas the Namodenoson treated group showed a significant decrease in steatosis, ballooning and lobular inflammation compared
    to the vehicle group.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



In further pre-clinical
studies conducted, the following was observed:



| | ● | In vivo studies
    showed that Namodenoson protected the liver against ischemic reperfusion manifested by a statistically significant (p<0.05)
    reduction in key liver enzymes, SGOT and SGPT. In addition, in studies where partial liver hepatectomy was conducted, a 45%
    increase in the regeneration rate of the remaining liver was observed after Namodenoson treatment, compared to placebo which
    regenerated only by 24%;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | In an in vitrostudy with hepato-stellate cells, Namodenoson inhibited, in a dose dependent manner, the growth and proliferation of the
    liver cells, supporting an anti-fibrogenic effect of the drug;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





47


Table of Contents




| | ● | In a CCL4 mouse
    model of liver fibrosis, Namodenoson induced an anti-inflammatory effect, lower serum levels of ALT, no accumulation of peritoneal
    fluid (ascites) and reduced fibrosis in liver sections stained by Sirius Red. In addition, liver protein and mRNA extracts
    revealed a significant decrease of α-SMA (α-smooth muscle actin) demonstrating an anti-fibrotic effect. Furthermore,
    the expression level of PI3K and p-STAT-1 were markedly decreased as well as the NKT cells;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Namodenoson’s
    anti-inflammatory and anti-fibrogenic effect was also demonstrated in a STAM-NASH mouse model manifested by a marked reduction
    in NAFLD activity score (NAS) and fibrosis area. Namodenoson treatment induced a decrease in CK-18 levels suggesting hepato-protective
    effect and at the same time up-regulated adiponectin levels, reflecting anti-fibrogenic and anti-inflammatory effects;                                                                                                                                                                                                                                                                                                                        
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
| | ● | Namodenoson’s
    novel mechanism of action which entails de-regulation of three key signaling pathways which mediate the etiology and pathology
    of NAFLD/NASH and are responsible for the anti-inflammatory and anti-fibrogenic effect in the liver. Pre-clinical studies
    were conducted in hepato-stellate cells in vitro and in an experimental NASH CCL4 model, showing that in both systems, the
    molecular mechanism of action of Namodenoson was conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate,
    or PI3K, which controls 3 downstream signal transduction pathways, the Wnt, NF-kB and α-SMA, all of which are responsible
    for liver inflammation and liver fibrosis;
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
| | ● | In an experimental
    non-alcoholic steatohepatitis (NASH) CCL4 model, Namodenoson had a highly significant effect against inflammation, necrosis,
    fibrosis and biliary hyperplasia, upon oral treatment with the drug. More specifically, the liver enzymes ALT and AST were
    dramatically reduced and reversed to normal values upon treatment of the NASH bearing animals with Namodenoson; and                                                                                                                                                                                                                                                                                                                                    
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
| | ● | Namodenoson showed
    a significant decrease in lipid production and fat accumulation utilizing 3T3-L1 adipocytes, functioning as lipid producing
    cells and are also responsible for fat storage. Namodenoson was also shown to inhibit the proliferation of adipocytes, further
    hampering the expansion of fat producing cells.                                                                                                                                                                                                                                                                                                                                                                                                     



48


Table of Contents




Clinical Studies of Namodenoson



The information discussed
below is based on the various studies conducted by Can-Fite with Namodenoson, including clinical studies in patients with oncological
and liver-related diseases and viruses.



Phase I Clinical Study



Namodenoson completed
a Phase I double-blind, randomized, placebo-controlled, ascending single dose trial to evaluate the safety, tolerability, and
pharmacokinetics of orally administered Namodenoson in healthy volunteers. The study was conducted in the United States under
an open IND. Namodenoson was found to be safe and well-tolerated with a half-life time of 12 hours. See Figure 8.







Figure 8: Half-life of orally administered
Namodenoson – Phase I Clinical Study



Phase I/II and Phase II Clinical Studies



HCC/HCV



Namodenoson completed
two Phase I/II studies in Israel, one in patients with HCC and another in patients with HCV. The HCC Phase I/II study was an open-label,
dose-escalation study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered Namodenoson
in patients with advanced HCC. The primary objectives of the study were to determine the safety and tolerability, dose-limiting
toxicities, maximum tolerated dose, and recommended Phase II dose of orally administered Namodenoson in patients with advanced
HCC; and to assess the repeat-dose pharmacokinetics behavior of Namodenoson in those patients. The secondary objectives were to
document any observed therapeutic effect of Namodenoson in patients with HCC and to evaluate the relationship between PBMCs and
the A3AR expression at baseline, as a biomarker, and the effects of Namodenoson in patients with HCC. The study included 18 patients,
nine of which were also carriers of HCV. The initial dose of Namodenoson was 1.0 mg BID, with planned dose escalations in subsequent
cohorts to 5.0 and 25.0 mg BID. This Phase I/II study achieved its objectives, showing a good safety profile, or no material differences
versus a placebo with respect to observed and patient-indicated side effects, for Namodenoson and a linear pharmacokinetic drug
profile, with no dose-limiting toxicities at any dose level. The median overall survival time for the patients in this study was
7.8 months, which is encouraging data considering that (i) 67% of the patient population in the study had previously progressed
on Nexavar, produced by Onyx Pharmaceuticals and Bayer, and that Namodenoson was a second line therapy for these patients and
(ii) 28% of the patient population were Child-Pugh Class B patients (patients classified on the Child Pugh scoring system for
chronic liver disease as having significantly impaired liver function) whose overall survival time is usually 3.5 to 5.5 months.
Accordingly, we may also consider Namodenoson as a drug to be developed for this patient sub-population of Child-Pugh Class B
patients. Namodenoson had no adverse effect on routine measures of liver function over a six-month period in 12 patients treated
for at least that duration. These findings are consistent with our pre-clinical Namodenoson data which demonstrated a protective
effect on normal liver tissue in an experimental model of liver inflammation. As such, Namodenoson may potentially be a safer
alternative to patients with cirrhosis and/or hepatic impairment. The study also demonstrated a direct relationship between A3AR
expression at baseline and patients’ response to Namodenoson, suggesting A3AR as a predictive biological marker. We also
observed a decrease in the viral load of seven out of nine patients who were also carriers of HCV. The most commonly reported
adverse events included loss of appetite, ascites, nausea, diarrhea, constipation and pain. However, many of these events are
expected in a population of patients with advanced HCC. The most frequently reported drug-related adverse events included diarrhea,
fatigue, loss of appetite, pain and weakness.





49


Table of Contents




Our second Phase I/II
study was a randomized, double-blind, placebo-controlled, dose-escalation study evaluating the safety, tolerability, biological
activity, and pharmacokinetics of orally administered Namodenoson in 32 subjects with chronic HCV genotype 1. Eligible subjects
were assigned in a 3:1 ratio (eight subjects in each cohort) to receive QD or BID treatment (1.0, 5.0 and 25.0 mg of Namodenoson)
for 15 days with oral Namodenoson or with a placebo. Dose escalation occurred in four sequential cohorts. The study’s primary
objectives were to determine the safety and tolerability of orally administered Namodenoson in patients with chronic HCV genotype
1, to assess the effects on HCV load during 15 days of treatment with Namodenoson and to assess the repeat-dose pharmacokinetic
behavior of Namodenoson under the conditions of this trial. The secondary objective of this trial was to perform an exploratory
evaluation of the relationship between A3AR in PBMCs at baseline and the clinical effects of Namodenoson on the study’s
patients. Following the decrease in HCV load that had been observed in HCV patients treated with Namodenoson in the parallel HCC
study and the good safety profile of Namodenoson, we received Israeli Institutional Review Board, or IRB, approval to extend the
treatment period of the Phase I/II in patients with HCV to four months with the 1.0 mg dose vs. the placebo. The results of this
Phase I/II HCV study demonstrated a good safety profile and a linear pharmacokinetic drug profile, however, no significant decrease
in the viral load was observed. Notwithstanding, we did observe in the parallel HCC study that seven out of the nine patients
with both HCC and HCV experienced a decrease in viral load and that these seven patients were treated with higher Namodenoson
dosages than what was administered to the patients with chronic HCV genotype 1 only, and not HCC, possibly explaining the difference
in results. The most commonly reported adverse events included loss of appetite, ascites, nausea, diarrhea, constipation and pain.
However, many of these events are expected in a population of patients with advanced HCV. The most frequently reported drug-related
adverse events included diarrhea, fatigue, loss of appetite, pain and weakness.





We are conducting a
Phase II study in HCC patients. In January 2013, as part of our preparatory work for such study, we announced that we believe that
the optimal drug dose for the upcoming study is Namodenoson 25.0 mg. This dose was found to be the most effective dose out of the
three dosages tested (1.0 mg, 5.0 mg and 25.0 mg) in the previous Phase I/II study. We filed a patent application protecting such
optimal dose of Namodenoson for HCC. A publication summarizing the results of the Phase I/II study was published in “The
Oncologist,” a leading oncology scientific journal. We also highlighted that one patient has been treated with Namodenoson
for over five years. Also as part of the Phase II study, we plan to examine the viral load of HCC patients who are also infected
with HCV. If we observe a decrease in the viral load in the HCV sub-population during this forthcoming study, we intend to commence
a separate Phase II study for the HCV indication.



The
Phase II study is a randomized, double-blind, placebo controlled trial conducted in the United States, Europe and Israel to evaluate
the efficacy and safety of Namodenoson as a second-line treatment for advanced HCC in subjects with Child-Pugh B who failed Nexavar
as a first line treatment. Advanced HCC in patients
with underlying cirrhosis is categorized into three subclasses based on the severity of cirrhosis, starting with Child Pugh A,
or CPA, mostly treated with Nexavar and progressing to Child Pugh B, or CPB, and Child Pugh C, or CPC, for which there are no drugs
on market with proven efficacy. In the study, we enrolled only patients with CPB stage liver cancer with CBP stage patients being
further divided into three categories of increasing severity, namely CPB7, CPB8, and CPB9. These patients already failed first
line Nexavar and were treated with Namodenoson (25mg), or placebo, as a second line treatment, twice daily, using a 2:1 randomization.
The primary endpoint of the study was median overall survival. Secondary endpoints included progression free survival, partial
response, and disease control rate. In March 2014, the study protocol was approved by the IRB at the Rabin Medical Center in Israel
and in December 2014, we dosed the first patient at the study’s Israeli site. In the third quarter of 2017, we announced
that we completed enrollment and randomization of all 78 patients and in March 2019, we announced top-line results.



While the study did
not achieve the primary end point of overall survival in the whole population (n=78), superiority in overall survival was found
in the largest study subpopulation of CPB7 (n=56) and in secondary end points in the whole population, including objective response
measured by CT or MRI. Findings from the study include the following: (i) for the whole population (n=78), median overall survival
was 4.1 months for Namodenoson vs. 4.3 months for placebo (HR: 0.82), (ii) pre-planned subpopulation analysis of the CPB7 patients
(n=56), revealed that the Namodenoson treated group (n=34) showed median overall survival of 6.8 months vs 4.3 months in placebo
(n=22) [HR: 0.77 (95% CI 0.49-1.40)]. Similarly, for this subgroup of patients, progression free survival was 3.5 months for the
Namodenoson treated group vs 1.9 (HR: 0.87) in the placebo group; (iii) objective response in the whole patient population measured
by CT or MRI, demonstrated that 9% treated by Namodenoson achieved partial response vs 0% in the placebo group, (iv) consistent
with safety results from previously completed clinical trials, Namodenoson was generally well-tolerated, with no treated patients
being withdrawn for toxicity and no cases of treatment-related deaths, (v) disease control rate was 18.0% in the Namodenoson group
vs 7.1% in the placebo group (p=0.013) after four months of treatment, (vi) 32.0% of patients treated with Namodenoson completed
at least 12 months of treatment vs 14.3% who were treated with placebo (p=0.058), (vii) as of March 26, 2019, two patients in the
Namodenoson group are ongoing after 19 and 28 months of treatment, respectively. These patients will continue to receive Namodenoson,
and (viii) all nine patients with CBP9 cirrhosis, the most severe grade allowed into the trial, were randomly assigned to the Namodenoson
treatment group (OS=3.5 months), a fact which has distorted the results in the whole population.



We believe these data strongly support
the progression into Phase III.



NAFLD/NASH



We are conducting a
Phase II multicenter, randomized, double-blind, placebo-controlled, dose-finding study of the efficacy and safety of Namodenoson
in the treatment of NAFLD and NASH. We plan to enroll approximately 60 patients with NAFLD, with or without NASH, in three arms,
including two different dosages of Namodenoson (12.5 mg and 25 mg) and a placebo, given via oral tablets twice daily.



The study’s primary
endpoints are the mean percent change from baseline in ALT levels and safety. The secondary endpoint includes percent change from
baseline in hepatic steatosis measured by magnetic resonance imaging determined by proton-density fat-fraction and additional
metabolic parameters. In addition, an assessment of the pharmacokinetics of Namodenoson and the A3AR biomarker will be evaluated
prior to treatment and its correlation to patients’ response to the drug will be analyzed upon study conclusion. Furthermore,
the exploratory objective of this study is to evaluate the effects of Namodenoson on relevant biomarkers, such as adiponectin,
leptin, C-reactive protein, and liver stiffness as determined by Fibroscan. The study is being conducted at the Hadassah Medical
Center and Rabin Medical Center and we aim to release data in the second half of 2019.





50


Table of Contents




Additional Developments with Namodenoson



Anti-Obesity



In January 2019, we
announced new pre-clinical findings demonstrating that Namodenoson, inhibits lipid production and fat accumulation in adipocytes
(lipid producing cells). More specifically, Namodenoson showed a significant decrease in lipid production and fat accumulation
utilizing 3T3-L1 adipocytes, functioning as lipid producing cells and are also responsible for fat storage. Namodenoson was also
shown to inhibit the proliferation of adipocytes, further hampering the expansion of fat producing cells. These findings, together
with the excellent safety profile of Namodenoson, support its potential utilization as an anti-obesity drug. A patent application
for the utilization of Namodenoson as an anti-obesity drug has been filed.





JC Virus



In April 2011, we
announced that, in laboratory study, Namodenoson inhibited the reproduction of the JC virus, a type of polyomavirus, which is
dormant in approximately 70% to 90% of the world population. However, in patients treated with biological drugs, including monoclonal
antibody therapeutics, such as anti-TNFs or anti-CD20, JC virus replication may occur, resulting in development of progressive
multifocal leukoencephalopathy, or PML, which is characterized by progressive damage or inflammation of the white matter of the
brain and, eventually, death. The ability of Namodenoson to suppress the JC virus culture, as indicated in the laboratory study,
may indicate that it may be used for the treatment of PML as a combination therapy with biological drugs. As Namodenoson is already
in various stages of clinical development for other indications, its efficacy for this new application may be tested in clinical
trials.



CF602



The allosteric modulator,
CF602, is our third drug candidate in its pipeline. CF602 is an orally bioavailable small molecule, which enhances the affinity
of the natural ligand, adenosine, to its A3AR. The advantage of this molecule is its capability to target specific areas where
adenosine levels are increased. Normal body cells and tissues are refractory to allosteric modulators. This approach complements
the basic platform technology of Can-Fite, utilizing the Gi coupled protein A3AR as a potent target in inflammatory diseases.
CF602 has demonstrated proof of concept for anti-inflammatory activity in in vitro and in vivo studies performed
by us.



During clinical studies
conducted with our product candidates, other than CF602, patients suffering from sexual dysfunction reported that they returned
to normal functioning following the treatment with such drugs. We believe that these findings are correlated with our platform
technology, which is the targeting of the A3AR. Adenosine, like nitric oxide, is a potent and short-lived vaso-relaxant that functions
via intracellular signaling (in particular, through cAMP) to promote smooth muscle relaxation. Recent studies conducted by others
show that adenosine functions to relax the corpus cavernosum and thereby promote penile erection.



CF602 was tested in
an experimental animal model of diabetic rats, which similar to diabetic patients, suffer from sexual dysfunction. Erectile dysfunction
was assessed by monitoring the ratio between intra-cavernosal pressure, or ICP, and mean arterial pressure, or MAP, as a physiological
index of erectile function. The ICP/MAP for the CF602 treated group improved by 118% over the placebo group. This data is similar
to that achieved earlier by sildenafil (Viagra) in preclinical studies. In addition, treatment with CF602 reversed smooth muscle
and endothelial damage, in a dose dependent manner, leading to the improvement in erectile dysfunction.



Further studies of
CF602 have revealed that CF602 restores the impaired vascular endothelial growth factor system in the penis of diabetes mellitus
rats, thereby inducing an increase in nitric oxide resulting in significant improvement of penile erection compared to placebo.
This mechanism of action is similar to that of sildenafil, with CF602 demonstrating effects on erection superior to that demonstrated
by sildenafil in animal studies. Among the most important factors to affect erectile function is nitric oxide, which is released
by endothelial cells that line the corpus cavernosum and control smooth muscle relaxation and vascular inflow. It has been well
established that release of nitric oxide is diminished in diabetes.



In addition, CF602
induced a dose-dependent, linear effect in a diabetic mellitus rat model after treatment with one single dose of CF602. One hour
after dosing, sexual function was measured. Statistically significant full recovery from erectile dysfunction took place in rats
treated with a 500 μ/kg dose.





51


Table of Contents




According to the American
Diabetes Association, approximately 30 million children and adults have diabetes mellitus in the United States. It is estimated
that 35-75% of men with diabetes mellitus suffer from erectile dysfunction.



In November 2016,
a Notice of Allowance was granted to us by the USPTO for our patent covering A3AR ligands for use in the treatment of erectile
dysfunction. The patent addresses methods for treating erectile dysfunction with different A3AR ligands including our erectile
dysfunction drug candidate, CF602. With this new broader patent protection, we made a strategic decision to investigate additional
compounds, owned by us, for the most effective and safest profile in this indication.  As such, we postponed our planned
IND submission for this indication and are currently conducting efficacy and safety IND enabling studies with two additional compounds
that belong to the family of allosteric molecules, similar to CF602, for the treatment of sexual dysfunction.



Commercial Biomarker Test



In March 2015, we
completed the development of a commercial predictive biomarker blood test kit for A3AR. The biomarker test can be used at any
molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results
indicate if the patient would benefit from treatment with our drugs, which are currently in clinical trials for rheumatoid arthritis,
psoriasis, and liver cancer.



The USPTO previously
issued to us a patent for the utilization of A3AR as a biomarker to predict patient response to our drug Piclidenoson in autoimmune
inflammatory indications.



In-Licensing Agreements



The following is a
summary description of our in-licensing agreement with Leiden University. Our previously granted license with NIH expired in June
2015 with the expiration of certain patents. The description provided below does not purport to be complete and is qualified in
its entirety by the complete agreement, which is attached as an exhibit to this Annual Report on Form 20-F.



Leiden University Agreements



On November 2, 2009,
we entered into a license agreement, or the Leiden University Agreement, with Leiden University. Leiden University is affiliated
with NIH and is the joint owner with NIH of the patents licensed pursuant to the Leiden University Agreement. The Leiden University
Agreement grants an exclusive license for the use of the patents of several compounds, including CF602, that comprise certain
allosteric compound drugs, and for the use, sale, production and distribution of products derived from such patents in the territory,
i.e., China and certain countries in Europe (Austria, Belgium, Denmark, France, Germany, Italy, Spain, Sweden, Switzerland, Holland
and England). Subject to certain conditions, we may sublicense the Leiden University Agreement. However, the U.S. government has
an irrevocable, royalty-free, paid-up right to practice the patent rights throughout the territory on behalf of itself or any
foreign government or international organization pursuant to any existing or future treaty or agreement to which the U.S. government
is a signatory and the U.S. government may require us to grant sublicenses when necessary to fulfill health or safety needs.



Pursuant to the Leiden
University Agreement, we are committed to make the following payments: (i) a one-time concession commission of 25,000 Euros; (ii)
annual royalties of 10,000 Euros until clinical trials commence; (iii) 2% to 3% of net sales value, as defined in the Leiden University
Agreement, received by us; (iv) royalties of up to 850,000 Euros based on certain progress milestones in the clinical stages of
the products which are the subject of the patent under the Leiden University Agreement; and (v) if we sublicense the agreement,
we will provide Leiden University royalties at a rate of 2-3% of net sales value, as defined in the Leiden University Agreement,
and 10% of certain consideration received for granting the sublicense. In the event that we transfer to a transferee the aspect
of our business involving the Leiden University Agreement, we must pay to Leiden University an assignment royalty of 10% of the
consideration received for the transfer of the agreement. However, a merger, consolidation or any other change in ownership will
not be viewed as an assignment of the agreement. In addition, we have agreed to bear all costs associated with the prosecution
of the patents and patent applications to which we are granted a license under the Leiden University Agreement. As of December
31, 2018, we have paid approximately 115,000 Euros in royalties to Leiden University in connection with the Leiden University
Agreement.





52


Table of Contents




The Leiden University
Agreement expires when the last of the patents expires in each country of the territory, unless earlier terminated in accordance
with the terms of the Leiden University Agreement. The last of such patents is set to expire on 2027. The termination rights of
the parties include, but are not limited to, (i) the non-defaulting party’s right to terminate if the defaulting party does
not cure within 90 days of written notice identifying the default and requesting remedy of the same; and (ii) Leiden University’s
right to terminate if we become insolvent, have a receiver appointed over our assets or initiate a winding-up. In addition, Leiden
University may terminate the agreement when it is determined, in consultation with NIH, that termination is necessary to alleviate
health and safety needs and certain other similar circumstances.



Out-Licensing and Distribution Agreements



The following are
summary descriptions of certain out-licensing and distribution agreements to which we are a party.



Kwang Dong Agreements



On December 22, 2008,
we entered into a license agreement with KD, or the Kwang Dong License Agreement, for the use, development and marketing of Piclidenoson
in the Republic of Korea with respect to rheumatoid arthritis. In addition, the Kwang Dong License Agreement grants to KD an exclusive,
royalty-free license to use certain of our trademarks, as determined from time to time, in connection with the distribution, marketing,
promotion and sale of any products derived from Piclidenoson pursuant to the Kwang Dong License Agreement.



The Kwang Dong License
Agreement also provides for the creation of a four member joint committee consisting of two members from each party for the purpose
of serving as a joint source of experience and knowledge in Piclidenoson development and to facilitate communication and coordination
between the parties with respect to such development. The joint committee will, among other things specifically identified in
the Kwang Dong License Agreement, provide to the parties opinions, proposals, ideas and updates with respect to the Piclidenoson
development processes conducted separately by each party.



According to the Kwang
Dong License Agreement, we are entitled to receive or have received the following payments: (i) a non-refundable amount of $300,000
paid within 30 days of the effective date of the agreement; (ii) an amount of up to $1.2 million based on our compliance with
certain milestones, including but not limited to, the conclusion of the Phase II clinical trial for Piclidenoson for treating
rheumatoid arthritis and the receipt of various regulatory authorizations; and (iii) annual royalties of 7% of annual net sales
of the licensed drug in the Republic of Korea. In addition to the amounts detailed above, we will be entitled to additional payments
based on sales of raw materials to KD for the purpose of developing, producing and marketing Piclidenoson. To date, we have received
a total of $500,000 from KD in an upfront payment.



The Kwang Dong License
Agreement is effective until KD completes all payments required thereunder, unless it is earlier terminated as a result of a material
breach not cured within the specified time frame, the breach by KD of the Kwang Dong Purchase Agreement (as defined below) or
the initiation of bankruptcy or insolvency related proceedings.



Pursuant to a share
purchase agreement entered into with KD at the same time as the Kwang Dong License Agreement, KD purchased 95,304 of our ordinary
shares, representing approximately 1.0% of our share capital on a fully diluted basis, as of the date of the purchase, or the
Kwang Dong Purchase Agreement. The shares were purchased for a premium of 50% on the shares’ average closing price for the
ten days preceding December 11, 2008, or a purchase price of NIS 0.455 per share.



After the TASE approved
such shares for the listing for trade on January 5, 2009, the shares were allocated to KD and the transaction was finalized in
January 2009. To date, KD had paid us approximately $1.3 million, which represents milestone payments pursuant to the Kwang Dong
License Agreement, an advance of certain amounts to become due under the Kwang Dong License Agreement and the purchase price for
the shares.





53


Table of Contents




Cipher Pharmaceuticals Agreement



On March 20, 2015,
we entered into a Distribution and Supply Agreement with Cipher granting Cipher the exclusive right to distribute Piclidenoson
in Canada for the treatment of psoriasis and rheumatoid arthritis.



Under the Distribution
and Supply Agreement, we are entitled to CAD 1.65 million upon execution of the agreement plus milestone payments upon receipt
of regulatory approval by the Therapeutic Products Directorate of Health Canada, or Health Canada, for Piclidenoson and the first
delivery of commercial launch quantities as follows (i) CAD 1 million upon the first approved indication for either psoriasis
or rheumatoid arthritis, and (ii) CAD 1 million upon the second approved indication for either psoriasis or rheumatoid arthritis.
In addition, following regulatory approval, we shall be entitled to a royalty of 16.5% of net sales of Piclidenoson in Canada
and reimbursement for the cost of manufacturing Piclidenoson. We are also entitled to a royalty payment for any authorized generic
of Piclidenoson that Cipher distributes in Canada. To date, we have received a total of $1.3 million from Cipher in an upfront
payment.



We are responsible
for supplying Cipher with finished product for distribution and conducting product development activities while Cipher is responsible
for distributing, marketing and obtaining applicable regulatory approvals in Canada. The Distribution and Supply Agreement has
an initial term of fifteen years, automatically renewable for additional five-year periods and may be terminated in certain limited
circumstances including certain breaches of the agreement and failure to achieve certain minimum quantities of sales during the
contract period.



The timeline to regulatory
submissions to Health Canada will be determined by the completion of the remaining clinical trial program.



CKD Agreement



On October 25, 2016,
we entered into an exclusive Distribution Agreement with CKD for the exclusive right to distribute Namodenoson for the treatment
of liver cancer in South Korea, upon receipt of regulatory approvals. On February 25, 2019, the Distribution Agreement was amended
to expand the exclusive right to distribute Namodenoson for the treatment of NASH in South Korea. The Distribution Agreement further
provides that we will deliver finished product to CKD and grant CKD a right of first refusal to distribute Namodenoson for other
indications for which we develop Namodenoson.



The Distribution Agreement
provides for up to $3,000,000 in upfront and milestone payments payable with respect to the liver cancer indication and up to
$3,000,000 with respect to the NASH indication. In addition, we are entitled to a transfer price of the higher of the manufacturing
cost plus 10% or 23% of net sales of Namodenoson following commercial launch in South Korea. To date, we have received a total
of $1,000,000 from CKD, $500,000 in upfront payments and a further $500,000 for a milestone payment received in the third quarter
of 2017 upon receipt by CKD of a positive result from the preliminary review by the MFDS on obtaining orphan drug designation
in South Korea.



The Distribution Agreement
has an initial term of 10 years from first commercial sale of Namodenoson for the treatment of liver cancer or NASH and is renewable
for additional 3-year periods unless either party gives notice of termination at least 6 months prior to the then current term.
The Distribution Agreement may be terminated by CKD upon 30 days prior written notice if we fail to successfully complete our
ongoing Phase II clinical trial for Namodenoson and we may terminate the Distribution Agreement upon 30 days prior written notice
if certain commercialization milestones are not met by CKD or certain minimum quantities of sales are not made during the contract
period. In addition, either party may terminate the Distribution Agreement in the event of an uncured material breach or insolvency.





54


Table of Contents




Gebro Agreement



On January 8, 2018,
we entered into a Distribution and Supply Agreement with Gebro, granting Gebro the exclusive right to distribute Piclidenoson
in Spain, Switzerland, Liechtenstein and Austria for the treatment of psoriasis and rheumatoid arthritis.



Under the Distribution
and Supply Agreement, we are entitled to €1,500,000 upon execution of the agreement plus milestone payments upon achieving
certain clinical, launch and sales milestones, as follows: (i) €300,000 upon initiation of the ACRobat Phase III clinical
trial for the treatment of rheumatoid arthritis and €300,000 upon the initiation of the COMFORT Phase III clinical trial
for the treatment of psoriasis, (ii) between €750,000 and €1,600,000 following first delivery of commercial launch quantities
of Piclidenson for either the treatment of rheumatoid arthritis or psoriasis, and (iii) between €300,000 and up to €4,025,000
upon meeting certain net sales. In addition, following regulatory approval, we shall be entitled to double digit percentage royalties
on net sales of Piclidenoson in the territories and payment for the manufacturing Piclidenoson. To date, we have received
a total of €2,100,000 from Gebro in upfront and milestone payments.



We are initially responsible
for supplying Gebro with finished product for distribution and obtaining EMA and Swissmedic marketing approval while Gebro is
responsible for distributing, marketing and obtaining pricing and reimbursement approvals in the territories. The Distribution
and Supply Agreement has an initial term of fifteen years, automatically renewable for additional five-year periods and may be
terminated in certain limited circumstances including certain breaches of the agreement and failure to achieve certain minimum
quantities of sales during the contract period.



CMS Medical



On August 6, 2018,
we entered into a License, Collaboration and Distribution Agreement with CMS Medical, for the exclusive right to develop, manufacture
and commercialize Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of HCC
and NAFLD/NASH in China (including Hong Kong, Macau and Taiwan).



Under the License,
Collaboration and Distribution Agreement, we are entitled to $2,000,000 upon execution of the agreement plus milestone payments
of up to $14,000,000 upon achieving certain regulatory milestones and payments of up to $58,500,000 upon achieving certain sales
milestones, as follows: (i) $500,000 upon the granting of the marketing authorization of Piclidenoson in the United States for
rheumatoid arthritis; (ii) $500,000 upon the granting of the marketing authorization of Piclidenoson in the European Union for
rheumatoid arthritis; (iii) $500,000 upon the granting of the marketing authorization of Piclidenoson in the United States for
psoriasis; (iv) $500,000 upon the granting of the marketing authorization of Piclidenoson in the European Union for psoriasis;
(v) $500,000 upon the granting of the marketing authorization of Namodenoson in the United States for HCC; (vi) $500,000 upon
the granting of the marketing authorization of Namodenoson in the European Union for HCC; (vii) $500,000 upon the granting of
the marketing authorization of Namodenoson in the United States for NAFLD/NASH; (viii) $500,000 upon the granting of the marketing
authorization of Namodenoson in the European Union for NAFLD/NASH; (ix) $2,500,000 upon the issuance of an imported drug license
permitting the product to be imported into and marketed in China, or the IDL and granting of marketing authorization of Piclidenoson
in China for rheumatoid arthritis; (x) $2,500,000 upon the issuance of the IDL and granting of marketing authorization of Piclidenoson
in China for for psoriasis; (xi) $2,500,000 upon the issuance of the IDL and granting of marketing authorization of Namodenoson
in China for HCC; (xii) $2,500,000 upon the issuance of the IDL and granting of marketing authorization of Namodenoson in China
for NAFLD/NASH; and (xiii) between $1,000,000 and up to $30,000,000 upon meeting certain net sales.  In addition, following
regulatory approval, we shall be entitled to double-digit percentage royalties on net sales of Piclidenoson and Namodenoson in
the licensed territories. To date, we have received a total of $2,000,000 from CMS Medical in upfront and milestone payments.



According to the agreement,
CMS Medical will be responsible for the development of Piclidenoson and Namodenoson to obtain regulatory approval in China and
shall be further responsible for obtaining and maintaining regulatory approval in China for the indications described above. We
may, at the option of CMS Medical, supply finished product to CMS Medical.



The License, Collaboration
and Distribution Agreement shall continue in force unless earlier terminated and may be terminated in certain limited circumstances
including certain breaches of the agreement and failure to achieve certain minimum quantities of sales during the contract period.
Following expiration of the term of the agreement, the license granted shall become non-exclusive, fully paid, royalty free and
irrevocable.





55


Table of Contents




SKK Agreement



On August 27, 2015,
we entered into an agreement with Japan-based Seikagaku Corporation, or SKK, terminating its license agreement with us. SKK informed
us that it is strategically focused on expanding its core research and development activities in the field of glyco-science. Under
the license agreement, SKK was granted a license for the use, development and marketing of Piclidenoson in Japan with respect
to inflammatory indications, except for ophthalmic disease indications. The termination agreement provides, among other things,
that all licenses and rights granted to SKK terminate and all clinical and non-clinical studies conducted by SKK shall be transferred
free of charge to us. Over the life of the license, we received an aggregate of approximately $8.5 million from SKK.



Total Revenues by Category of Activity and Geographic Markets



Historically, we have
generated revenues from payments received pursuant to our out-licensing agreements with Gebro, Cipher, KD, CMS Medical and SKK
with respect to Piclidenoson and CKD with respect to Namodenoson. See “Item 4. Information on the Company—B. Business
Overview—Out-Licensing and Distribution Agreements”. We recorded revenues of $2 million for the year ended December
31, 2018 as a result from advance payment received in August 2018 under the distribution agreement with CMS Medical. We recorded
revenues of $1.3 million for the year ended December 31, 2018 as a result from recognition a portion of an advance payment received
in January 2018 under the distribution agreement with Gebro. We recorded revenues of $0.1 million for the year ended December
31, 2018 under the Distribution Agreement with CKD which was due to the recognition of a portion of the $0.5 million advance payment
received in December 2016 under the Distribution Agreement with CKD. We recorded revenues of $0.6 million for the year ended December
31, 2017 under the Distribution Agreement with CKD which was due to the recognition of a portion of the $0.5 million advance payment
received in December 2016 under the Distribution Agreement with CKD and a payment of $0.5 million as a result of a milestone achievement.
We recorded revenues of $0.4 million for the year ended December 31, 2018 and $0.2 million for the year ended December 31, 2017
which was due to the recognition of a portion of the CAD 1.65 million advance payment received in March 2015 under the Distribution
and Supply Agreement with Cipher. We expect to generate future revenues through our current and potential future out-licensing
arrangements with respect to Piclidenoson and Namodenoson based on the progress we make in our clinical trials.



Seasonality



Our business and operations
are generally not affected by seasonal fluctuations or factors.



Raw Materials and Suppliers



We believe that the
raw materials that we require to manufacture Piclidenoson, Namodenoson and CF602 are widely available from numerous suppliers
and are generally considered to be generic industrial chemical supplies. We do not rely on a single or unique supplier for the
current production of any therapeutic small molecule in our pipeline.



Manufacturing



We are currently manufacturing
our API through a leading CRO. The relevant suppliers of our drug products are compliant with both current Good Manufacturing
Practices, or cGMP, and current Good Laboratory Practices, or cGLP, and allow us to manufacture drug products for our current
clinical trials. We anticipate that we will continue to rely on third parties to produce our drug products for clinical trials
and commercialization.



There can be no assurance
that our drug candidates, if approved, can be manufactured in sufficient commercial quantities, in compliance with regulatory
requirements and at an acceptable cost. We and our contract manufacturers are, and will be, subject to extensive governmental
regulation in connection with the manufacture of any pharmaceutical products or medical devices. We and our contract manufacturers
must ensure that all of the processes, methods and equipment are compliant with cGMP for drugs on an ongoing basis, as mandated
by the FDA and other regulatory authorities, and conduct extensive audits of vendors, contract laboratories and suppliers.





56


Table of Contents




Contract Research Organizations



We outsource certain
preclinical and clinical development activities to CROs, which in pre-clinical studies work according to cGMP and cGLP. We believe
our clinical CROs comply with guidelines from the International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use, which attempt to harmonize the FDA and the EMA regulations and guidelines. We create and implement
the drug development plans and, during the preclinical and clinical phases of development, manage the CROs according to the specific
requirements of the drug candidate under development.



Marketing and Sales



We do not currently
have any marketing or sales capabilities. We intend to license to, or enter into strategic alliances with, larger companies in
the pharmaceutical business, which are equipped to market and/or sell our products, if any, through their well-developed marketing
capabilities and distribution networks. We intend to out-license some or all of our worldwide patent rights to more than one party
to achieve the fullest development, marketing and distribution of any products we develop.



Intellectual Property



Our success depends
in part on our ability to obtain and maintain proprietary protection for our product candidates, technology and know-how, to operate
without infringing the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is
to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our
proprietary technology, inventions and improvements that we believe are important to the development of our business. We also
rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary position.



Patents



As of March 21, 2019,
we owned or exclusively licensed (from Leiden University) 13 patent families that, collectively, contain approximately 188 issued
patents and pending patent applications in various countries around the world relating to our two clinical candidates, Piclidenoson
and Namodenoson, and our preclinical candidate, CF602. Patents related to our drug candidates may provide future competitive advantages
by providing exclusivity related to the composition of matter, formulation and method of administration of the applicable compounds
and could materially improve their value. The patent positions for our leading drug candidates are described below.



With respect to our
product candidates, we currently own patents and/or have patent applications pending in several countries around the world for
the following families of patents:



| | ● | A3AR ligands
    to treat proliferative diseases (inflammation/cancer) - a family of patents which pertains to the use of substances
    that bind to the A3AR, including Piclidenoson and Namodenoson; the pharmaceutical uses to which such family relates include
    the treatment of proliferative diseases, such as cancer, psoriasis and autoimmune diseases. Such patents were granted in the
    United States, Europe (by the European Patent Office, or the EPO, and validated in Austria, Belgium, Denmark, Finland, France,
    Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and the
    United Kingdom), Australia, Canada, Israel, China, Japan, South Korea, Mexico, Russia and Hong Kong. These patents are set
    to expire in 2020, other than the U.S. patent that will expire in 2022;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | A3AR
    ligands to treat viral diseases - a family of patents and a patent application which
    pertain to use of substances that bind to the A3AR for the treatment of viral diseases, such as AIDS and hepatitis, and which
    inhibit viral replication. Such patents were granted in the United States, in Europe (by the EPO and validated in France,
    Germany, Italy, Switzerland and the United Kingdom), Australia, China, Israel, Japan, Singapore, Canada and Hong Kong. These
    patents have a filing date of January 1, 2002 and a priority date of January 16, 2001 and are set to expire in 2022, other
    than the U.S. patent that will expire in 2023;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





57


Table of Contents




| | ● | A3AR ligands
    to treat RA - a patent which pertains to the use of A3AR agonists for the treatment of inflammatory arthritis, in
    particular rheumatoid arthritis. This patent was granted in the United States and is set to expire in 2023;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | A3AR as a
    predictive and follow up biomarker - a family of patents and patent applications which pertain to a method of identifying
    inflammation, determining its severity, and determining and monitoring the efficacy of the anti-inflammatory treatment by
    determining the level of A3AR expression in white blood cells as a biological marker for inflammation. These patents were
    granted in certain countries in the United States, Europe (by the EPO and validated in France, Germany, Italy, Spain, Switzerland
    and the United Kingdom), Australia, Israel, Japan, China, Mexico and Canada. The patents are set to expire in 2025. There
    is a patent application pending in Brazil. Each of the patents and the  patent application has a filing date of November
    30, 2005 and a priority date of December 2, 2004;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Specific dose
    to protect psoriasis - a family of patents and patent applications which pertains to the use of a specific dose level
    of Piclidenoson (total daily dose of 4.0 mg) for the treatment of psoriasis. Such a patent was granted in Israel, Japan, the
    United States, South Korea and Europe (by the EPO and validated in in Austria, Belgium, Denmark, France, Germany, Italy, the
    Netherlands, Spain, Sweden, Switzerland and the United Kingdom). The patent is set to expire in 2030. The patent applications
    are pending in the China, Hong Kong, and India each with a filing date of September 6, 2010 and a priority date of September
    6, 2009;                                                      
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
| | ● | Piclidenoson
    method of synthesis - a family of patents and patent applications which pertain to the method for producing Piclidenoson.
    Such patents were granted in the United States, India, China, Japan, Israel and Europe (by the EPO and validated in in Austria,
    Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Norway,
    Poland, Portugal, Spain, Sweden, Switzerland, Turkey and the United Kingdom. These patents are set to expire in 2028. Each
    patent and patent application has a filing date of March 13, 2008 and a priority date of March 14, 2007;                                                                                       
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
| | ● | Osteoarthritis
    indication - a family of patents and patent applications which pertain to the use of A3AR agonists for the treatment
    of OA. Such patents were granted in Europe (by the EPO and validated in Austria, Belgium, Denmark, France, Germany, Italy,
    Spain, Sweden, Switzerland, Netherlands and the United Kingdom), Australia, Canada, South Korea, China, Israel, Japan and
    Mexico. The patents are set to expire in 2026. Patent applications are pending in the United States and Brazil with the United
    States application being recently allowed (issue fee due Apr 03, 2019). These patents and patent applications have a filing
    date of November 29, 2006 and a priority date of November 30, 2005;
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
| | ● | Liver protection- a family of patents and patent applications which pertains to the use of A3AR agonists for increasing liver cell
    division, intended to induce liver regeneration following injury or surgery. Such patents were granted in China, Israel, Japan,
    USA and Europe (by the EPO and validated in Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Poland, Spain,
    Sweden, Switzerland, United Kingdom and Turkey). Each patent in this family has a filing date of October 22, 2007 and a priority
    date of October 15, 2007;                                                                                                                                                                   
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
| | ● | Sexual dysfunction-a family of patent applications which pertain to treatment of sexual dysfunction. This family includes granted patents
    in the United States, Australia, China, Hong Kong, and Japan and patent applications in Israel, Canada, Europe, Mexico, and
    South Korea with the applications in Europe and South Korea being recently allowed. The patent applications have a filing
    date of August 8, 2013 with priority dates of August 8, 2012 and November 12, 2012;                                                                                                                                                                                                                                                





58


Table of Contents




| | ● | CAR T induced
    cytokine release syndrome - a family of patent applications which pertains to the use of A3AR ligands for managing
    cytokine release syndrome. This family includes a patent application in Israel and a PCT claiming priority from this Israeli
    application. The PCT application has a filing date of September 16, 2018 and the Israeli patent application has a filing date
    of September 17, 2017 and
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                      
| | ● | NAFLD/NASH- a family of patent applications which pertain to the use of A3AR ligands for treatment of ectopic fat accumulation.
    This family includes patent applications in Israel, China, Europe, USA, Brazil, Canada, Japan, Mexico and South Korea. The
    patent applications have a filing date of November 22, 2016.                                                                                                      
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                      
| | ● | Obesity-a patent application in Israel which pertains to the use of A3AR ligand for reducing level of adipocytes. This patent
    application has a filing date of January 6, 2019 and will serve as a priority document to an International PCT application
    due to be filed no later than January 6, 2020.                                                                                                                      



We currently hold
an exclusive license from Leiden University of the Netherlands to a family of patents and patent applications that relate to the
allosteric modulators of the A3AR, which includes the allosteric modulator CF602. This exclusive license relates to patents that
were granted in the United States, China, Japan, South Korea, India and in Europe (validated in, Austria, Belgium, Denmark, France,
Germany, Italy, the Netherlands, Spain, Sweden, Switzerland and United Kingdom). These granted patents are set to expire in 2027.



We believe that our
owned and licensed patents provide broad and comprehensive coverage of our technology, and we intend to aggressively enforce our
intellectual property rights if necessary to preserve such rights and to gain the benefit of our investment. However, as a result
of the termination of the NIH license agreement between Can-Fite and NIH in June 2015 due to patent expiration, we no longer hold
rights to a family of composition of matter patents relating to Piclidenoson that were licensed from NIH. Nevertheless, because
Piclidenoson may be a NCE following approval of an NDA, we, if we are the first applicant to obtain NDA approval, may be entitled
to five years of data exclusivity in the United States with respect to such NCEs. Analogous data and market exclusivity provisions,
of varying duration, may be available in Europe and other foreign jurisdictions. We may also be entitled to the rights under Can-Fite’s
pharmaceutical use issued patents with respect to Piclidenoson, which provide patent exclusivity within the ophthalmic field until
the mid-2020s. While we believe that we may be able to protect our exclusivity in the ophthalmic field through such use patent
portfolio and such period of exclusivity, the lack of composition of matter patent protection may diminish our ability to maintain
a proprietary position for our intended uses of Piclidenoson. Moreover, we cannot be certain that we will be the first applicant
to obtain an FDA approval for any indication of Piclidenoson and we cannot be certain that we will be entitled to NCE exclusivity.
In addition, we have discontinued the prosecution of a family of pending patent applications under joint ownership of Can-Fite
and NIH pertaining to the use of A3AR agonists for the treatment of uveitis. Such diminution of our proprietary position could
have a material adverse effect on our business, results of operation and financial condition.



The patent positions
of companies like ours are generally uncertain and involve complex legal and factual questions. Our ability to maintain and solidify
our proprietary position for our technology will depend on our success in obtaining effective claims and enforcing those claims
once granted. We do not know whether any of our patent applications or those patent applications that we license will result in
the issuance of any patents. Our issued patents and those that may issue in the future, or those licensed to us, may be challenged,
narrowed, circumvented or found to be invalid or unenforceable, which could limit our ability to stop competitors from marketing
related products or the length of term of patent protection that we may have for our products. Neither we nor our licensors can
be certain that we were the first to invent the inventions claimed in our owned or licensed patents or patent applications. In
addition, our competitors may independently develop similar technologies or duplicate any technology developed by us, and the
rights granted under any issued patents may not provide us with any meaningful competitive advantages against these competitors.
Furthermore, because of the extensive time required for development, testing and regulatory review of a potential product, before
any of our products can be commercialized, any related patent may expire or remain in force for only a short period following
commercialization, thereby reducing any advantage of the patent.





59


Table of Contents




Trade Secrets



We may rely, in some
circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to protect. We seek to protect
our proprietary technology and processes, in part, by confidentiality agreements and assignment of inventions agreements with
our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of
our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information
technology systems. While we have confidence in these individuals, organizations and systems, such agreements or security measures
may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known
or be independently discovered by competitors or others.



Scientific Advisory Board



We seek advice from
our Scientific Advisory Board on scientific and medical matters generally. We call for Scientific Advisory Board meetings on an
as-needed basis. The following table sets forth certain information with respect to our Scientific Advisory Board member.



|Name               |  | Position/Institutional
    Affiliation         
|------------------ |  | -----------------------------------------------
|Nabil Hanna, Ph.D. |  | Former Chief Science
    Officer of Biogen-Idec



Clinical Advisory Board



Our Clinical Advisory
Board, which consists of six members, a leading U.S.-based rheumatologist, oncologist, dermatologist, and three hepatologists,
who play an active role in consulting with us with respect to clinical drug development. We call for Clinical Advisory Board meetings
on an as-needed basis. The following table sets forth certain information with respect to our Clinical Advisory Board members.



|Name                  |  | Position/Institutional
    Affiliation                                                                                                                                                                                                
|--------------------- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|Dr. Michael Weinblatt |  | Head, Division of
    Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital                                                                                                                                              
|                      |  |                                                                                                                                                                                                                                       
|Dr. Keith Stuart      |  | Chairman, Department
    of Hematology and Oncology; Professor of Medicine, Tufts University School of Medicine; Lahey Clinic Medical Center                                                                                          
|                      |  |                                                                                                                                                                                                                                       
|Dr. Jonathan Wilkin   |  | Former Head, Dermatology
    Division, FDA                                                                                                                                                                                            
|                      |  |                                                                                                                                                                                                                                       
|Dr. Scott Friedman    |  | Dean for Therapeutic
    Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York                                                                                             
|                      |  |                                                                                                                                                                                                                                       
|Dr. Arun Sanyal       |  | Professor of Medicine,
    Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine                                                                                                                  
|                      |  |                                                                                                                                                                                                                                       
|Dr. Rifaat Safadi     |  | Head of the Liver
    Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and Professor of Internal Medicine,
    Bowel, Liver Disease, and Metabolic Syndrome at Hadassah University in Israel





60


Table of Contents




Competition



The pharmaceutical
industry is characterized by rapidly evolving technology, intense competition and a highly risky, costly and lengthy research
and development process. Adequate protection of intellectual property, successful product development, adequate funding and retention
of skilled, experienced and professional personnel are among the many factors critical to success in the pharmaceutical industry.



Our technology platform
is based on the finding that the A3AR is highly expressed in pathological cells, such as various tumor cell types and inflammatory
cells. We believe that targeting the A3AR with synthetic and highly selective A3AR agonists, such as Piclidenoson and Namodenoson,
and allosteric modulators, such as CF602, induces anti-cancer and anti-inflammatory effects. Currently, our drug candidates, Piclidenoson,
Namodenoson and CF602 are being developed to treat autoimmune inflammatory indications, oncology and liver diseases as well as
sexual dysfunction, including but not limited to psoriasis, rheumatoid arthritis, HCC and NASH. Preclinical studies have also
indicated that our drug candidates have the potential to treat additional inflammatory diseases, such as sexual dysfunction, Crohn’s
disease, oncological diseases and viral diseases, such as the JC virus, and obesity.



Despite the competition,
however, we believe that our drug candidates have unique characteristics and advantages over certain drugs currently available
on the market and under development to treat these indications. We believe that our pipeline of drug candidates has exhibited
a potential for therapeutic success with respect to the treatment of autoimmune-inflammatory, oncological and liver diseases.
We believe that targeting the A3AR with synthetic and highly selective A3AR agonists, such as Piclidenoson and Namodenoson, and
allosteric modulators, such as CF602, induces anti-cancer and anti-inflammatory effects.



We believe the characteristics
of Piclidenoson, as exhibited in our clinical studies to date, including its good safety profile, clinical activity, simple and
less frequent delivery through oral administration and its low cost of production, position it well against the competition in
the autoimmune-inflammatory markets, including the psoriasis and rheumatoid arthritis markets, where treatments, when available,
often include injectable drugs, many of which can be highly toxic, expensive and not always effective. For example, while TNF
inhibitor therapies transformed the treatment for many patients, a substantial percentage of patients (40% to 60%) do not respond
to either a DMARD or biologic therapies (Simsek, 2010).



Pre-clinical pharmacology
studies in different experimental animal models of arthritis revealed that Piclidenoson acts as a DMARD, which, when coupled with
its good safety profile, makes it competitive in the psoriasis, rheumatoid arthritis and OA markets. Our recent findings also
demonstrate that a biological predictive marker can be utilized prior to treatment with Piclidenoson, which may allow it to be
used as a personalized medicine therapeutic approach for the treatment of rheumatoid arthritis, potentially leading to an improvement
in response rate for patients. Like Piclidenoson, Namodenoson has a good safety profile, is orally administered and has a low
cost of production, which we believe positions it well in the HCC market, where only one drug, Nexavar (sorafenib), has been approved
by the FDA.



In addition, our human
clinical data suggests that A3AR may be a biological marker in that high A3AR expression prior to treatment has been predictive
of good patient response to our drug treatment. In fact, as a result of our research we have developed a simple blood assay to
test for A3AR expression as a predictive biological marker. We hold a patent with respect to the intellectual property related
to such assay and are currently utilizing this assay in our ongoing Phase IIb study of Piclidenoson for the treatment of rheumatoid
arthritis.



On the other hand,
other drugs on the market, new drugs under development (including drugs that are in more advanced stages of development in comparison
to our drug pipeline) and additional drugs that were originally intended for other purposes, but were found effective for purposes
targeted by us, may all be competitive to the current drug candidates in our pipeline. In fact, some of these drugs are well established
and accepted among patients and physicians in their respective markets, are orally bioavailable, can be efficiently produced and
marketed, and are relatively safe. Moreover, other companies of various sizes engage in activities similar to ours. Most, if not
all, of our competitors have substantially greater financial and other resources available to them. Competitors include companies
with marketed products and/or an advanced research and development pipeline. The major competitors in the arthritis and psoriasis
therapeutic field include Amgen, J&J, Pfizer, Novartis, Abbvie, Celgene, Eli Lilly, Bristol-Myers, and more. Competitors in
the HCC field include companies such as Bayer, Exelixis, Merck, and Bristol-Myers. Competitors in the NASH field include companies
such as Gilead, Genfit, Galmed, Allergan, Intercept, and Madrigal. Competitors in the erectile dysfunction field include Pfizer,
Eli Lilly and Bayer.





61


Table of Contents




Moreover, several
companies have reported the commencement of research projects related to the A3AR. Such companies include CV Therapeutics Inc.
(which was acquired by Gilead), King Pharmaceuticals R&D Inv. (which was acquired by Pfizer), Hoechst Marion Roussel Inc.,
Novo Nordisk A/S and Inotek Pharmaceuticals. However, to the best of our knowledge, there is no approved drug currently on the
market which is similar to our A3AR agonists, nor are we aware of any allosteric modulator in the A3AR product pipeline similar
to our allosteric modulator with respect to chemical profile and mechanism of action.



Piclidenoson for the Treatment of Psoriasis



Psoriasis is a skin
condition that affects 2% to 3% of the general population according to the National Psoriasis Foundation. The disease is manifested
by scaly plaques on the skin and in the severe form has a major effect on the physical and emotional well-being of the patients.
Topical agents are typically used for mild disease, phototherapy for moderate disease, and systemic agents for severe disease.
For moderate to severe cases, systemic biologic drugs, delivered via intravenous injection, or IV, have dominated the market.
According to the National Psoriasis Foundation, common side effects of biologics include respiratory infections, flu-like symptoms,
and injection site reactions while rare side effects include serious nervous system disorders, such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes, blood disorders, and certain types of cancer. We believe a significant need remains
for novel oral and safe drugs for patients who do not respond to existing therapies or for whom these therapies are unsuitable.



The psoriasis therapeutic
market is dominated by biological drugs that are primarily administered via IV and have potential side effects. Recently, a new
oral small molecule inhibitor of phosphodiesterase 4, Celgene’s Otezla, has gained sizable market share as a result in part
due to its convenience of oral dose and comparable efficacy to the biologic drugs. In January 2015, the FDA approved Cosentyx
(secukinumab) by Novartis. In March 2016, the FDA approved Taltz (ixekizumab) by Eli Lilly. The psoriasis drug market is forecast
to grow to $11.4 billion in 2020, according to estimates of Visiongain.



The current common
treatments for psoriasis include topical and systemic drugs, steroids, immunosuppressive drugs such as Cyclosporine A by Novartis,
MTX and biological drugs. Biological drugs, such as Enbrel (etanercept) by Amgen and Pfizer, Remicade (infliximab) by Centocor,
Humira (adalimumab) by Abbvie, Stelara (ustekinumab) by Janssen, Otezla (aprelimast) by Celgene, Cosentyx (secukinumab) by Novartis
and Taltz (ixekizumab) by Eli Lilly have significant side effects, are expensive and patients are often not responsive. For example,
some of these drugs have received an FDA “black box” warning for increased risk of cancer in children and adolescents
and risk of infection with Legionella and Listeria bacteria.



Many of the current
rheumatoid arthritis drugs on the market or in development are also used for the treatment of psoriasis. See “Item 4. Information
on the Company—B. Business Overview—Piclidenoson for the Treatment of Rheumatoid Arthritis.” In addition, several
therapies are in advanced clinical development for psoriasis and many others are in Phase II or earlier stages of development.



Piclidenoson for the Treatment of Rheumatoid Arthritis



Rheumatoid arthritis
is a severe disease that attacks approximately 0.6% of the U.S. population, mainly women and, in particular, postmenopausal women.
According to Visiongain, the world rheumatoid arthritis market size is predicted to generate revenues of $47 billion by 2024.



Many drugs are used
to treat rheumatoid arthritis, including DMARDs. These include MTX, plaquenil, sulfasalazine and leflunomide, all of which are
small molecule drugs with mild effectiveness. MTX is the most commonly administered DMARD for rheumatoid arthritis. It is a generic
chemotherapeutic agent marketed by several manufacturers that is administered orally. Due to its relatively toxic nature, however,
MTX may result in severe side effects including sores, anemia, diarrhea, nausea/vomiting, abdominal pain, bruising/bleeding, and
liver problems.





62


Table of Contents




The second class of
DMARD includes biological drugs, such as Enbrel (etanercept) by Amgen, Remicade (infliximab) by Centocor, and Humira (adalimumab)
by Abbvie. These drugs are usually administered in combination with MTX and are more effective in combination, but may have severe
side effects, including risk of lymphoma and serious infection. Biological drugs are administered through injection, are generally
expensive and there is no biomarker to predict the response, if any. As such, response rates typically range between 40-60% (Simsek,
2010). Steroidal drugs are also used to reduce the general activity of the immune system and for pain relief. In addition, the
FDA recently approved Pfizer’s Xeljanz (tofacitinib) small molecule drug, which is the first JAK inhibitor drug, or a drug
that inhibits the effect of one or more of the enzymes in the janus kinase family, or a family enzymes that transfer cytokine-mediated
signals, to treat rheumatoid arthritis. Moreover, several therapies, including biological drugs and small molecule drugs, are
in advanced clinical development for rheumatoid arthritis including baricitninib by Eli Lilly which is pending FDA approval, while
others are in Phase II or earlier stages of development.



Namodenoson for the Treatment of
HCC



According to the American
Cancer Society, HCC is the fifth most common form of cancer death in the U.S., the most common form of liver cancer in adults
and the third most common cause of cancer-related mortality worldwide, particularly in Asia. According to the American Cancer
Society, more than 700,000 people are diagnosed with liver cancer each year throughout the world and more than 600,000 persons
die from liver cancer each year. Nexavar (sorafenib) by Bayer is the only approved drug for HCC and prolongs patient survival
time by only a few months. According to Grand View Research, the HCC drug market is expected to reach $1.5 billion by 2022.



Several therapies
are in advanced clinical development for HCC. Some drugs under development act as a single agent and some act in combination with
Nexavar or approved checkpoint inhibitors pembrolizumab and/or nivolumab. Moreover, some are first line treatments while others
are second line treatments. In addition, many existing approaches are used in the treatment of unresectable liver cancer, including
alcohol injection, radiofrequency ablation, chemoembolization, cryoablation and radiation therapy.





Namodenoson for the Treatment of NASH



Rates of NAFLD and
NASH are increasing in the United States in concert with increasing rates of obesity and diabetes. In fact, NASH is now the third
leading cause of liver transplant in the United States. It is estimated that 17-33% of Americans have fatty liver, with approximately
one-third going on to develop NASH. NASH is believed to affect 2-5% of adult Americans. Despite the progression of several interesting
clinical-stage candidates by companies such as Gilead, Genfit, Madrigal, Conatus, Galmed, Allergan and Intercept as well as others,
there are currently no FDA approved treatment options for NASH. In February 2019, Intercept announced positive topline results
in its pivotal Phase 3 results of its NASH drug and as a consequence announced that it intends to file for regulatory approval
in the U.S. and Europe in the second half of 2019.



By 2025, Deutsche
Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size.



CF602 for the Treatment of Erectile Dysfunction



According to the Massachusetts
Male Aging Study in 1994, 52% of the respondents between the ages of 40 and 70 years old reported some degree of erectile dysfunction.



The most popular class
of drug to treat erectile dysfunction is the phosphodiesterase type 5, or PDE5, inhibitors. These drugs block the degradative
action of cyclic guanosine monophosphate, or GMP, specific PDE5 on cyclic GMP in the smooth muscle cells lining the blood vessels
supplying the corpus cavernosum of the penis. An erection is caused by increased blood flow into the penis resulting from the
relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide from
nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells. The inhibition of
PDE5 enhances erectile function by increasing the concentration of cyclic GMP in the corpus cavernosum and pulmonary arteries.





63


Table of Contents




Unfortunately, the
systemic side effects of PDE5 inhibitors include a decrease in sitting blood pressure. This has resulted in warnings and precautions
and contraindications of use in patients already taking antihypertensive agents like nitrates or alpha-blockers. A study published
in the American Journal of Medicine (Selvin E., et al., 2007) found that persons with a history of heart disease, hypertension,
and diabetes had a higher probability of impotence. A second study published in the same journal (Shah NP., et al, 2015) notes
that vascular erectile dysfunction is a powerful marker of increased cardiovascular risk. We believe a significant market opportunity
exists targeting erectile dysfunction patients contraindicated for use of the market leading products, Viagra and Cialis.



Grand View Research
Inc. estimates the value of the erectile dysfunction therapeutic market to be approximately $3.2 billion by 2022.



Insurance



We maintain insurance
for our offices and laboratory in Petah-Tikva, Israel. Our insurance program covers approximately $0.375 million of equipment
and lease improvements against risk of loss, excluding damage from inventory theft. In addition, we maintain the following insurance:
employer liability with coverage of approximately $5.0 million; third party liability with coverage of approximately $0.75 million;
fire insurance coverage of approximately $0.725 million; natural disaster coverage of approximately $1.1 million; all risk coverage
of approximately $0.02 million for electronic equipment and machinery insurance for laboratory refrigerators; and directors’
and officers’ liability insurance with coverage of $20.0 million per claim and $20.0 million in the aggregate and also D&O
Side A DIC insurance with coverage of $5.0 million per claim and in the aggregate.



We also maintain worldwide
product and clinical trial liability insurance with coverage of approximately $5 million with respect to the Piclidenoson and
Namodenoson drugs used in clinical trials. We also procure additional insurance for each specific clinical trial which covers
a certain number of trial participants and which varies based on the particular clinical trial. Certain of such policies are based
on the Declaration of Helsinki, which is a set of ethical principles regarding human experimentation developed for the medical
community by the World Medical Association, and certain protocols of the Israeli Ministry of Health.



We procure cargo marine
coverage when we ship substances for our clinical studies. Such insurance is custom-fit to the special requirements of the applicable
shipment, such as temperature and/or climate sensitivity. If required, we insure the substances to the extent they are stored
in central depots and at clinical sites.



We believe that our
insurance policies are adequate and customary for a business of our kind. However, because of the nature of our business, we cannot
assure you that we will be able to maintain insurance on a commercially reasonable basis or at all, or that any future claims
will not exceed our insurance coverage.



Environmental Matters



We are subject
to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater
discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological materials and wastes and
the cleanup of contaminated sites. We believe that our business, operations and facilities are being operated in compliance in
all material respects with applicable environmental and health and safety laws and regulations. Our laboratory personnel in Israel
have ongoing communication with the Israeli Ministry of Environmental Protection in order to verify compliance with relevant instructions
and regulations. In addition, all of our laboratory personnel participate in instruction on the proper handling of chemicals,
including hazardous substances before commencing employment, and during the course of their employment with us. In addition, all
information with respect to any chemical substance that we use is filed and stored as a Material Safety Data Sheet, as required
by applicable environmental regulations. Based on information currently available to us, we do not expect environmental costs
and contingencies to have a material adverse effect on us. The operation of our testing facilities, however, entails risks in
these areas. Significant expenditures could be required in the future if these facilities are required to comply with new or more
stringent environmental or health and safety laws, regulations or requirements. See “Item 4. Information on the Company—B.
Business Overview—Government Regulation and Funding—Israel Ministry of the Environment—Toxin Permit.”







64


Table of Contents




Government Regulation and Funding



We operate in a highly
controlled regulatory environment. Stringent regulations establish requirements relating to analytical, toxicological and clinical
standards and protocols in respect of the testing of pharmaceuticals. Regulations also cover research, development, manufacturing
and reporting procedures, both pre- and post-approval. In many markets, especially in Europe, marketing and pricing strategies
are subject to national legislation or administrative practices that include requirements to demonstrate not only the quality,
safety and efficacy of a new product, but also its cost-effectiveness relating to other treatment options. Failure to comply with
regulations can result in stringent sanctions, including product recalls, withdrawal of approvals, seizure of products and criminal
prosecution.





Before obtaining regulatory
approvals for the commercial sale of our product candidates, we must demonstrate through preclinical studies and clinical trials
that our product candidates are safe and effective. Historically, the results from preclinical studies and early clinical trials
often have not accurately predicted results of later clinical trials. In addition, a number of pharmaceutical products have shown
promising results in clinical trials but subsequently failed to establish sufficient safety and efficacy results to obtain necessary
regulatory approvals. We have incurred, and will continue to incur substantial expense for and devote a significant amount of time
to, preclinical studies and clinical trials. Many factors can delay the commencement and rate of completion of clinical trials,
including the inability to recruit patients at the expected rate, the inability to follow patients adequately after treatment,
the failure to manufacture sufficient quantities of materials used for clinical trials, and the emergence of unforeseen safety
issues and governmental and regulatory delays. If a product candidate fails to demonstrate safety and efficacy in clinical trials,
this failure may delay development of other product candidates and hinder our ability to conduct related preclinical studies and
clinical trials. Additionally, as a result of these failures, we may also be unable to obtain additional financing.



Governmental authorities
in all major markets require that a new pharmaceutical product be approved or exempted from approval before it is marketed, and
have established high standards for technical appraisal which can result in an expensive and lengthy approval process. The time
to obtain approval varies by country and some products are never approved. The lengthy process of conducting clinical trials, seeking
approval and subsequent compliance with applicable statutes and regulations, if approval is obtained, are very costly and require
the expenditure of substantial resources.



A summary of the United
States, European Union and Israeli regulatory processes follow below.



United States



In the United States,
the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FDCA), as amended, and the regulations promulgated
thereunder, and other federal and state statutes and regulations govern, among other things, the safety and effectiveness standards
for our products and the raw materials and components used in the production of, testing, manufacture, labeling, storage, record
keeping, approval, advertising and promotion of our products on a product-by-product basis.



Preclinical tests include in vitro and in vivo evaluation of the product candidate, its
chemistry, formulation and stability, and animal studies to assess potential safety and efficacy. Certain preclinical tests must
be conducted in compliance with good laboratory practice regulations. Violations of these regulations can, in some cases, lead
to invalidation of the studies, requiring them to be replicated. After laboratory analysis and preclinical testing, a sponsor
files an IND to begin human testing. Typically, a manufacturer conducts a three-phase human clinical testing program which itself
is subject to numerous laws and regulatory requirements, including adequate monitoring, reporting, record keeping and informed
consent. In Phase I, small clinical trials are conducted to determine the safety and proper dose ranges of our product candidates.
In Phase II, clinical trials are conducted to assess safety and gain preliminary evidence of the efficacy of our product candidates.
In Phase III, clinical trials are conducted to provide sufficient data for the statistically valid evidence of safety and efficacy.
The time and expense required for us to perform this clinical testing can vary and is substantial. We cannot be certain that we
will successfully complete Phase I, Phase II or Phase III testing of our product candidates within any specific time period, if
at all. Furthermore, the FDA, the Institutional Review Board responsible for approving and monitoring the clinical trials at a
given site, the Data Safety Monitoring Board, where one is used, or we may suspend the clinical trials at any time on various
grounds, including a finding that subjects or patients are exposed to unacceptable health risk.





65


Table of Contents




If the clinical data
from these clinical trials (Phases I, II and III) are deemed to support the safety and effectiveness of the candidate product
for its intended use, then we may proceed to seek to file with the FDA an NDA seeking approval to market a new drug for one or
more specified intended uses. We have not completed our clinical trials for any candidate product for any intended use and therefore,
we cannot ascertain whether the clinical data will support and justify filing an NDA. Nevertheless, if and when we are able to
ascertain that the clinical data supports and justifies filing an NDA, we intend to make such appropriate filings.



The purpose of the
NDA is to provide the FDA with sufficient information so that it can assess whether it ought to approve the candidate product
for marketing for specific intended uses. The fact that the FDA has designated a drug as an orphan drug for a particular intended
use does not mean that the drug has been approved for marketing. Only after an NDA has been approved by the FDA is marketing appropriate.
A request for orphan drug status must be filed before the NDA is filed. The orphan drug designation, though, provides certain
benefits, including a seven-year period of market exclusivity subject to certain exceptions. In February 2012, the FDA granted
an orphan drug status for the active moiety, or the part of the drug that is responsible for the physiological or pharmacological
action of the drug substance, of Namodenoson for the treatment of HCC. Subsequently, in October 2015, the EMA granted Namodenoson
orphan drug designation for the treatment of HCC. See “Item 4. Information on the Company—B. Business Overview—Namodenoson”.



The NDA normally contains,
among other things, sections describing the chemistry, manufacturing, and controls, non-clinical pharmacology and toxicology,
human pharmacokinetics and bioavailability, microbiology, the results of the clinical trials, and the proposed labeling which
contains, among other things, the intended uses of the candidate product.



We cannot take any
action to market any new drug or biologic product in the United States until our appropriate marketing application has been approved
by the FDA. The FDA has substantial discretion over the approval process and may disagree with our interpretation of the data
submitted. The process may be significantly extended by requests for additional information or clarification regarding information
already provided. As part of this review, the FDA may refer the application to an appropriate advisory committee, typically a
panel of clinicians. Satisfaction of these and other regulatory requirements typically takes several years, and the actual time
required may vary substantially based upon the type, complexity and novelty of the product. Government regulation may delay or
prevent marketing of potential products for a considerable period of time and impose costly procedures on our activities. We cannot
be certain that the FDA or other regulatory agencies will approve any of our products on a timely basis, if at all. Success in
preclinical or early stage clinical trials does not assure success in later-stage clinical trials. Even if a product receives
regulatory approval, the approval may be significantly limited to specific indications or uses and these limitations may adversely
affect the commercial viability of the product. Delays in obtaining, or failures to obtain regulatory approvals, would have a
material adverse effect on our business.



Even after we obtain
FDA approval, we may be required to conduct further clinical trials (i.e., Phase IV trials) and provide additional data on safety
and effectiveness. We are also required to gain separate approval for the use of an approved product as a treatment for indications
other than those initially approved. In addition, side effects or adverse events that are reported during clinical trials can
delay, impede or prevent marketing approval. Similarly, adverse events that are reported after marketing approval can result in
additional limitations being placed on the product’s use and, potentially, withdrawal of the product from the market. Any
adverse event, either before or after marketing approval, can result in product liability claims against us.





66


Table of Contents




As an alternate path
for FDA approval of new indications or new formulations of previously-approved products, a company may file a Section 505(b)(2)
NDA, instead of a “stand-alone” or “full” NDA. Section 505(b)(2) of the FDCA, was enacted as part of the
Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2)
permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted
by or for the applicant and for which the applicant has not obtained a right of reference. Some examples of products that may
be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation
or indication. The Hatch-Waxman Amendments permit the applicant to rely upon certain published nonclinical or clinical studies
conducted for an approved product or the FDA’s conclusions from prior review of such studies. The FDA may require companies
to perform additional studies or measurements to support any changes from the approved product. The FDA may then approve the new
product for all or some of the labeled indications for which the reference product has been approved, as well as for any new indication
supported by the NDA. While references to nonclinical and clinical data not generated by the applicant or for which the applicant
does not have a right of reference are allowed, all development, process, stability, qualification and validation data related
to the manufacturing and quality of the new product must be included in an NDA submitted under Section 505(b)(2).



To the extent that
the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved
product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s
Orange Book publication. Specifically, the applicant must certify that: (i) the required patent information has not been filed;
(ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval
is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The Section
505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of
a new chemical entity, listed in the Orange Book for the reference product has expired. Thus, the Section 505(b)(2) applicant
may invest a significant amount of time and expense in the development of its products only to be subject to significant delay
and patent litigation before its products may be commercialized.





In addition to regulating
and auditing human clinical trials, the FDA regulates and inspects equipment, facilities, laboratories and processes used in the
manufacturing and testing of such products prior to providing approval to market a product. If, after receiving FDA approval, we
make a material change in manufacturing equipment, location or process, additional regulatory review and approval may be required.
We also must adhere to cGMP regulations and product-specific regulations enforced by the FDA through its facilities inspection
program. The FDA also conducts regular, periodic visits to re-inspect our equipment, facilities, laboratories and processes following
the initial approval. If, as a result of these inspections, the FDA determines that our equipment, facilities, laboratories or
processes do not comply with applicable FDA regulations and conditions of product approval, the FDA may seek civil, criminal or
administrative sanctions and/or remedies against us, including the suspension of our manufacturing operations.



We have currently received
no approvals to market our products from the FDA or other foreign regulators.



We are also subject
to various federal, state and international laws pertaining to healthcare “fraud and abuse,” including anti-kickback
laws and false claims laws. The federal anti-kickback law, which governs federal healthcare programs (e.g., Medicare, Medicaid),
makes it illegal to solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including
the purchase or prescription of a particular drug. Many states have similar laws that are not restricted to federal healthcare
programs. Federal and state false claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented
for payment to third party payers (including Medicare and Medicaid), claims for reimbursement, including claims for the sale of
drugs or services, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically
unnecessary items or services. If the government or a whistleblower were to allege that we violated these laws there could be
a material adverse effect on us, including our stock price. Even an unsuccessful challenge could cause adverse publicity and be
costly to respond to, which could have a materially adverse effect on our business, results of operations and financial condition.
A finding of liability under these laws can have significant adverse financial implications for us and can result in payment of
large penalties and possible exclusion from federal healthcare programs. We will consult counsel concerning the potential application
of these and other laws to our business and our sales, marketing and other activities and will make good faith efforts to comply
with them. However, given their broad reach and the increasing attention given by law enforcement authorities, we cannot assure
you that some of our activities will not be challenged or deemed to violate some of these laws.





67


Table of Contents




European Union



Regulation and Marketing Authorization in the European
Union



The process governing
approval of medicinal products in the European Union follows essentially the same lines as in the United States and, likewise,
generally involves satisfactorily completing each of the following:



| | ● | preclinical
    laboratory tests, animal studies and formulation studies all performed in accordance with the applicable E.U. Good Laboratory
    Practice regulations;                                                                                                                                
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                        
| | ● | submission
    to the relevant national authorities of a clinical trial application, or CTA, which must be approved before human clinical
    trials may begin;                                                                                                                                        
| |   |                                                                                                                                                                                                                                                                                                        
| | ● | performance
    of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;                                                                                                                                                      
| |   |                                                                                                                                                                                                                                                                                                        
| | ● | submission
    to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting
    safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development
    and proposed labelling;



| | ● | satisfactory
    completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those
    of third parties, at which the product is produced to assess compliance with strictly enforced current cGMP;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                
| | ● | potential
    audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and                                                                                                                                           



| | ● | review
    and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------



Preclinical Studies



Preclinical tests
include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal
studies, in order to assess the potential safety and efficacy of the product. The conduct of the preclinical tests and formulation
of the compounds for testing must comply with the relevant E.U. and/or Member States’ regulations and requirements. The
results of the preclinical tests, together with relevant manufacturing information and analytical data, are submitted as part
of the CTA.



Clinical Trial Approval



Requirements
for the conduct of clinical trials in the European Union including Good Clinical Practice, or GCP, are implemented in the Clinical
Trials Directive 2001/20/EC and the GCP Directive 2005/28/EC. Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as amended,
a system for the approval of clinical trials in the European Union has been implemented through national legislation of the member
states. Under this system, approval must be obtained from the competent national authority of an E.U. member state in which a
study is planned to be conducted or in multiple member states if the clinical trial is to be conducted in a number of member states.
To this end, a CTA is submitted, which must be supported by an investigational medicinal product dossier, or IMPD, and further
supporting information prescribed by Directive 2001/20/EC and Directive 2005/28/EC and other applicable guidance documents. Furthermore,
a clinical trial may only be started after a competent ethics committee has issued a favorable opinion on the clinical trial application
in that country.







68


Table of Contents




In April 2014,
a new Clinical Trials Regulation, (EU) No 536/2014 was adopted which will replace the current Clinical Trials Directive 2001/20/EC.
To ensure that the rules for clinical trials are identical throughout the European Union, the new E.U. clinical trials legislation
was passed as a “regulation” that is directly applicable in all E.U. member states. All clinical trials performed
in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC until the new Clinical
Trials Regulation (EU) No 536/2014 becomes applicable, which is connected to the functioning of the new E.U. Clinical Trials Database
and has therefore been postponed several times. It is currently expected to be in late 2019 or 2020.





The new Regulation
(EU) No 536/2014 aims to harmonize, simplify and streamline the approval of clinical trials in the European Union. The main characteristics
of the Regulation include:



| | ● | A
    streamlined application procedure via a single entry point, the E.U. portal;                                                                                                                                                                            
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                               
| | ● | A
    single set of documents to be prepared and submitted for the application as well as simplified reporting procedures that will
    spare sponsors from submitting broadly identical information separately to various bodies and different member states;
| |   |                                                                                                                                                                                                                                                               
| | ● | A
    harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed
    jointly by all member states concerned. Part II is assessed separately by each member state concerned;               
| |   |                                                                                                                                                                                                                                                               
| | ● | Strictly
    defined deadlines for the assessment of clinical trial application; and                                                                                                                                                                          
| |   |                                                                                                                                                                                                                                                               
| | ● | The
    involvement of the ethics committees in the assessment procedure in accordance with the national law of the member state concerned
    but within the overall timelines defined by the Regulation (EU) No 536/2014.                                   



Marketing Authorization



Authorization to market
a product in the member states of the European Union proceeds under one of four procedures: a centralized authorization procedure,
a mutual recognition procedure, a decentralized procedure or a national procedure.



Centralized Authorization Procedure



The centralized
procedure enables applicants to obtain a marketing authorization that is valid in all E.U. member states based on a single application.
Certain medicinal products, including products developed by means of biotechnological processes, must undergo the centralized
authorization procedure for marketing authorization which, if granted by the European Commission, is automatically valid in all
28 E.U. member states. The EMA and the European Commission administer this centralized authorization procedure pursuant to Regulation
(EC) No 726/2004.





Pursuant to Regulation
(EC) No 726/2004, this procedure is inter alia mandatory for:



| | ● | medicinal
    products developed by means of one of the following biotechnological processes:
| | - | ---------------------------------------------------------------------------------------------



| | ● | recombinant
    DNA technology;                                                                                                                        
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                        
| | ● | controlled
    expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian
    cells; and
| |   |                                                                                                                                                        
| | ● | hybridoma
    and monoclonal antibody methods;                                                                                                         



| | ● | advanced
    therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 on advanced therapy medicinal products;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------





69


Table of Contents




| | ● | medicinal
    products for human use containing a new active substance that, on the date of effectiveness of this regulation, was not authorized
    in the European Union, and for which the therapeutic indication is the treatment of any of the following diseases:
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | acquired
    immune deficiency syndrome;                   
| | - | -----------------------------------------------------------
| |   |                                                            
| | ● | cancer;                                                    
| |   |                                                            
| | ● | neurodegenerative
    disorder;                            
| |   |                                                            
| | ● | diabetes;                                                  
| |   |                                                            
| | ● | auto-immune
    diseases and other immune dysfunctions; and
| |   |                                                            
| | ● | viral
    diseases; and                                    



| | ● | medicinal
    products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
| | - | ----------------------------------------------------------------------------------------------------------------



The centralized authorization
procedure is optional for other medicinal products if they contain a new active substance or if the applicant shows that the medicinal
product concerned constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization
is in the interest of patients in the European Union.



Administrative Procedure



Under the centralized
authorization procedure, the EMA’s Committee for Human Medicinal Products, or CHMP, serves as the scientific committee that
renders opinions about the safety, efficacy and quality of medicinal products for human use on behalf of the EMA. The CHMP is
composed of experts nominated by each member state’s national authority for medicinal products, with expert appointed to
act as Rapporteur for the co-ordination of the evaluation with the possible assistance of a further member of the Committee acting
as a Co-Rapporteur. After approval, the Rapporteur(s) continue to monitor the product throughout its life cycle. The CHMP has
210 days to adopt an opinion as to whether a marketing authorization should be granted. The process usually takes longer
in case additional information is requested, which triggers clock-stops in the procedural timelines. The process is complex and
involves extensive consultation with the regulatory authorities of member states and a number of experts. When an application
is submitted for a marketing authorization in respect of a drug that is of major interest from the point of view of public health
and in particular from the viewpoint of therapeutic innovation, the applicant may pursuant to Article 14(9) Regulation (EC) No
726/2004 request an accelerated assessment procedure. If the CHMP accepts such request, the time-limit of 210 days will be reduced
to 150 days but it is possible that the CHMP can revert to the standard time-limit for the centralized procedure if it considers
that it is no longer appropriate to conduct an accelerated assessment. Once the procedure is completed, a European Public Assessment
Report, or EPAR, is produced. If the opinion is negative, information is given as to the grounds on which this conclusion was
reached. After the adoption of the CHMP opinion, a decision on the MAA must be adopted by the European Commission, after consulting
the E.U. member states.



Conditional Approval



In specific circumstances,
E.U. legislation (Article 14(7) Regulation (EC) No 726/2004 and Regulation (EC) No 507/2006 on Conditional Marketing Authorisations
for Medicinal Products for Human Use) enables applicants to obtain a conditional marketing authorization prior to obtaining the
comprehensive clinical data required for an application for a full marketing authorization. Such conditional approvals may be
granted for product candidates (including medicines designated as orphan medicinal products) if (1) the risk-benefit balance
of the product candidate is positive, (2) it is likely that the applicant will be in a position to provide the required comprehensive
clinical trial data, (3) the product fulfills unmet medical needs and (4) the benefit to public health of the immediate
availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are
still required. A conditional marketing authorization may contain specific obligations to be fulfilled by the marketing authorization
holder, including obligations with respect to the completion of ongoing or new studies, and with respect to the collection of
pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit
balance remains positive, and after an assessment of the need for additional or modified conditions and/or specific obligations.
The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications
for a conditional marketing authorization.





70


Table of Contents




Marketing Authorization under Exceptional
Circumstances



Under Article 14(8)
Regulation (EC) No 726/2004, products for which the applicant can demonstrate that comprehensive data (in line with the requirements
laid down in Annex I of Directive 2001/83/EC, as amended) cannot be provided (due to specific reasons foreseen in the legislation)
might be eligible for marketing authorization under exceptional circumstances. This type of authorization is reviewed annually
to reassess the risk-benefit balance. The fulfillment of any specific procedures/obligations imposed as part of the marketing
authorization under exceptional circumstances is aimed at the provision of information on the safe and effective use of the product
and will normally not lead to the completion of a full dossier/approval.



Market Authorizations Granted by Authorities
of E.U. Member States



In general, if the
centralized procedure is not followed, there are three alternative procedures as prescribed in Directive 2001/83/EC:



| | ● | The
    decentralized procedure allows applicants to file identical applications to several E.U. member states and receive simultaneous
    national approvals based on the recognition by E.U. member states of an assessment by a reference member state;
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                            
| | ● | The
    national procedure is only available for products intended to be authorized in a single E.U. member state; and                                                                                                                                     
| |   |                                                                                                                                                                                                                                                            
| | ● | A
    mutual recognition procedure similar to the decentralized procedure is available when a marketing authorization has already
    been obtained in at least one E.U. member state.                                                                     



A marketing authorization
may be granted only to an applicant established in the European Union.



Pediatric Studies



Prior to obtaining
a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included in an EMA-approved
Paediatric Investigation Plan, or PIP, covering all subsets of the paediatric population, unless the EMA has granted a product-specific
waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. The respective requirements for all
marketing authorization procedures are set forth in Regulation (EC) No 1901/2006, which is referred to as the Pediatric Regulation.
This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of administration for
a medicine that is already authorized. The Pediatric Committee of the EMA, or PDCO, may grant deferrals for some medicines, allowing
a company to delay development of the medicine in children until there is enough information to demonstrate its effectiveness
and safety in adults. The PDCO may also grant waivers when development of a medicine in children is not needed or is not appropriate,
such as for diseases that only affect the elderly population.



Before a marketing
authorization application can be filed, or an existing marketing authorization can be amended, the EMA determines that companies
actually comply with the agreed studies and measures listed in each relevant PIP.





71


Table of Contents




Periods of Authorization and Renewals



A marketing authorization
is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation
of the risk-benefit balance by the competent authority of the authorizing member state. To this end, the marketing authorization
holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and
efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing
authorization ceases to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European
Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional
five-year renewal. Any authorization which is not followed by the actual placing of the drug on the E.U. market (in case of centralized
procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called
sunset clause).



Orphan Drug Designation and Exclusivity



Pursuant to Regulation
(EC) No 141/2000 and Regulation (EC) No. 847/2000, the European Commission can grant such orphan medicinal product designation
to products for which the sponsor can establish that it is intended for the diagnosis, prevention or treatment of a life-threatening
or chronically debilitating condition affecting not more than five in 10,000 people in the European Union, or a life threatening,
seriously debilitating or serious and chronic condition in the European Union and with regards to that without incentives it is
unlikely that sales of the drug in the European Union would generate a sufficient return to justify the necessary investment.
In addition, the sponsor must establish that there is no other satisfactory method approved in the European Union of diagnosing,
preventing or treating the condition, or if such a method exists, the proposed orphan drug will be of significant benefit to patients.



Orphan drug
designation is not a marketing authorization. It is a designation that provides a number of benefits, including fee reductions,
regulatory assistance, and the possibility to apply for a centralized E.U. marketing authorization, as well as ten years of market
exclusivity following a marketing authorization. During this market exclusivity period, neither the EMA, the European Commission
nor the member states can accept an application or grant a marketing authorization for a “similar medicinal product.”
A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances
as those contained in an authorized orphan medicinal product and that is intended for the same therapeutic indication. The market
exclusivity period for the authorized therapeutic indication may be reduced to six years if, at the end of the fifth year, it
is established that the orphan designation criteria are no longer met, including where it is shown that the product is sufficiently
profitable not to justify maintenance of market exclusivity. In addition, a competing similar medicinal product may in limited
circumstances be authorized prior to the expiration of the market exclusivity period, including if the marketing authorization
holder is unable to supply sufficient quantities of the product or if the competing product is shown to be safer, more effective
or otherwise clinically superior to the already approved orphan drug. Furthermore, a product can lose orphan designation, and
the related benefits, prior to us obtaining a marketing authorization if it is demonstrated that the orphan designation criteria
are no longer met.





Regulatory Data Protection



E.U. legislation
also provides for a system of regulatory data and market exclusivity. According to Article 14(11) of Regulation (EC) No 726/2004,
as amended, and Article 10(1) of Directive 2001/83/EC, as amended, upon receiving marketing authorization, new chemical entities
approved on the basis of a complete independent data package benefit from eight years of data exclusivity and an additional two
years of market exclusivity. Data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s
data to assess a generic (abbreviated) application. During the additional two-year period of market exclusivity, a generic marketing
authorization can be submitted, and the innovator’s data may be referenced, but no generic medicinal product can be marketed
until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of 11 years if, during
the first eight years of those ten years, the marketing authorization holder, or MAH, obtains an authorization for one or more
new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant
clinical benefit in comparison with existing therapies. Even if a compound is considered to be a new chemical entity and the innovator
is able to gain the period of data exclusivity, another company nevertheless could also market another version of the drug if
such company obtained marketing authorization based on an MAA with a complete independent data package of pharmaceutical tests,
preclinical tests and clinical trials. However, products designated as orphan medicinal products enjoy, upon receiving marketing
authorization, a period of ten years of orphan market exclusivity—see also Orphan Drug Designation and Exclusivity.
Depending upon the timing and duration of the E.U. marketing authorization process, products may be eligible for up to five years’
supplementary protection certificates, or SPCs, pursuant to Regulation (EC) No 469/2009. Such SPCs extend the rights under the
basic patent for the drug (see below sub Patent Term Extension).





72


Table of Contents




Regulatory Requirements After a Marketing
Authorization has been Obtained



If we obtain authorization
for a medicinal product in the European Union, we will be required to comply with a range of requirements applicable to the manufacturing,
marketing, promotion and sale of medicinal products:



Pharmacovigilance and other requirements



We will, for example,
have to comply with the E.U.’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization
studies and additional monitoring obligations can be imposed. Other requirements relate, for example, to the manufacturing of
products and APIs in accordance with good manufacturing practice standards. E.U. regulators may conduct inspections to verify
our compliance with applicable requirements, and we will have to continue to expend time, money and effort to remain compliant.
Non-compliance with E.U. requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development
of products for the pediatric population, can also result in significant financial penalties in the European Union. Similarly,
failure to comply with the E.U.’s requirements regarding the protection of individual personal data can also lead to significant
penalties and sanctions. Individual E.U. member states may also impose various sanctions and penalties in case we do not comply
with locally applicable requirements.



Manufacturing



The manufacturing
of authorized drugs, for which a separate manufacturer’s license is mandatory, must be conducted in strict compliance with
the EMA’s Good Manufacturing Practices, or cGMP, requirements and comparable requirements of other regulatory bodies in
the European Union, which mandate the methods, facilities and controls used in manufacturing, processing and packing of drugs
to assure their safety and identity. The EMA enforces its current cGMP requirements through mandatory registration of facilities
and inspections of those facilities. The EMA may have a coordinating role for these inspections while the responsibility for carrying
them out rests with the member states competent authority under whose responsibility the manufacturer falls. Failure to comply
with these requirements could interrupt supply and result in delays, unanticipated costs and lost revenues, and could subject
the applicant to potential legal or regulatory action, including but not limited to warning letters, suspension of manufacturing,
seizure of product, injunctive action or possible civil and criminal penalties.



Marketing and Promotion



The marketing and
promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers
of drugs and/or the general public, are strictly regulated in the European Union under Directive 2001/83/EC. The applicable regulations
aim to ensure that information provided by holders of marketing authorizations regarding their products is truthful, balanced
and accurately reflects the safety and efficacy claims authorized by the EMA or by the competent authority of the authorizing
member state. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising
and potential civil and criminal penalties.



Patent Term Extension



In order to compensate
the patentee for delays in obtaining a marketing authorization for a patented product, a supplementary certificate, or SPC, may
be granted extending the exclusivity period for that specific product by up to five years. Applications for SPCs must be made
to the relevant patent office in each E.U. member state and the granted certificates are valid only in the member state of grant.
An application has to be made by the patent owner within six months of the first marketing authorization being granted in the
European Union (assuming the patent in question has not expired, lapsed or been revoked) or within six months of the grant of
the patent (if the marketing authorization is granted first). In the context of SPCs, the term “product” means the
active ingredient or combination of active ingredients for a medicinal product and the term “patent” means a patent
protecting such a product or a new manufacturing process or application for it. The duration of an SPC is calculated as the difference
between the patent’s filing date and the date of the first marketing authorization, minus five years, subject to a maximum
term of five years.



A six month pediatric
extension of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized
product information includes information on the results of the studies and the product is authorized in all member states of the
European Union.



73


Table of Contents




Israel



Israel Ministry of the Environment — Toxin Permit



In accordance with
the Israeli Dangerous Substance Law — 1993, the Ministry of the Environment may grant a permit in order to use toxic materials.
Because we utilize toxic materials in the course of operation of our laboratories, we were required to apply for a permit to use
these materials. Our current toxin permit will remain in effect until January 2020.



Other Licenses and Approvals



We have a business
license from the municipality of Petah-Tikva for a drug development research laboratory located at our offices in Petah Tikva,
Israel. In order to obtain this license, we also received approval from the Petah-Tikva Association of Towns Fire Department.
The business license is valid until December 31, 2019. We also have a radioactive materials or products containing radioactive
materials license, which is valid until July 25, 2019.



In 2002, we received approval from the
National Council on Animal Experiments, approving us as an institution authorized to conduct experiments on animals.



Clinical Testing in Israel



In order to conduct
clinical testing on humans in Israel, special authorization must first be obtained from the ethics committee and general manager
of the institution in which the clinical studies are scheduled to be conducted, as required under the Guidelines for Clinical
Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as
amended from time to time, and other applicable legislation. These regulations also require authorization from the Israeli Ministry
of Health, except in certain circumstances, and in the case of genetic trials, special fertility trials and similar trials, an
additional authorization of the overseeing institutional ethics committee. The institutional ethics committee must, among other
things, evaluate the anticipated benefits that are likely to be derived from the project to determine if it justifies the risks
and inconvenience to be inflicted on the human subjects, and the committee must ensure that adequate protection exists for the
rights and safety of the participants as well as the accuracy of the information gathered in the course of the clinical testing.
Since we intend to perform a portion of the clinical studies on certain of our product candidates in Israel, we will be required
to obtain authorization from the ethics committee and general manager of each institution in which we intend to conduct our clinical
trials, and in most cases, from the Israeli Ministry of Health.



Israel Ministry of Health



Israel’s Ministry
of Health, which regulates medical testing, has adopted protocols that correspond, generally, to those of the FDA and the EMA,
making it comparatively straightforward for studies conducted in Israel to satisfy FDA and the European Medicines Agency requirements,
thereby enabling medical technologies subjected to clinical trials in Israel to reach U.S. and EU commercial markets in an expedited
fashion. Many members of Israel’s medical community have earned international prestige in their chosen fields of expertise
and routinely collaborate, teach and lecture at leading medical centers throughout the world. Israel also has free trade agreements
with the United States and the European Union.





74


Table of Contents




Other Countries



In addition to regulations
in the United States, the EU and Israel, we are subject to a variety of other regulations governing clinical trials and commercial
sales and distribution of drugs in other countries. Whether or not our products receive approval from the FDA, approval of such
products must be obtained by the comparable regulatory authorities of countries other than the United States before we can commence
clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time
may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials and product
licensing vary greatly from country to country.



The requirements that
we and our collaborators must satisfy to obtain regulatory approval by government agencies in other countries prior to commercialization
of our products in such countries can be rigorous, costly and uncertain. In Canada and Australia, regulatory requirements and
approval processes are similar in principle to those in the United States. For example, in Canada, pharmaceutical product candidates
are regulated by the Food and Drugs Act and the rules and regulations promulgated thereunder, which are enforced by Health Canada.
Before commencing clinical trials in Canada, an applicant must complete preclinical studies and file a clinical trial application
with Health Canada. After filing a clinical trial application, the applicant must receive different clearance authorizations to
proceed with Phase 1 clinical trials, which can then lead to Phase 2 and Phase 3 clinical trials. To obtain regulatory approval
to commercialize a new drug in Canada, a new drug submission, or NDS, must be filed with Health Canada. If the NDS demonstrates
that the product was developed in accordance with the regulatory authorities’ rules, regulations and guidelines and demonstrates
favorable safety and efficacy and receives a favorable risk/benefit analysis, Health Canada issues a notice of compliance which
allows the applicant to market the product. Facilities, procedures, operations and/or testing of products are subject to periodic
inspection by Health Canada and the Health Products and Food Branch Inspectorate. In addition, Health Canada conducts pre-approval
and post-approval reviews and plant inspections to determine whether systems are in compliance with the good manufacturing practices
in Canada, Drug Establishment Licensing requirements and other provisions of the Food and Drug Regulations.



Foreign governments
also have stringent post-approval requirements including those relating to manufacture, labeling, reporting, record keeping and
marketing. Failure to substantially comply with these on-going requirements could lead to government action against the product,
our company and/or our representatives.



Related Matters



From time to time,
legislation is drafted, introduced and passed in governmental bodies that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA, the EMA, the Israeli Ministry of Health
and other applicable regulatory bodies to which we are subject. In addition, regulations and guidance are often revised or reinterpreted
by the national agency in ways that may significantly affect our business and our product candidates. It is impossible to predict
whether such legislative changes will be enacted, whether FDA, EMA or Israeli Ministry of Health regulations, guidance or interpretations
will change, or what the impact of such changes, if any, may be. We may need to adapt our business and product candidates and
products to changes that occur in the future.



C. Organizational Structure



Our corporate structure
consists of Can-Fite and two wholly owned subsidiaries which are both inactive: Ultratrend Limited, incorporated in England and
Wales, and Eye-Fite Limited, incorporated in Israel.



D. Property, Plants and Equipment



We are headquartered
in Petah-Tikva, Israel. We lease one floor in one facility pursuant to a lease agreement with Eshkolit Nihul Nadlan LTD, an Israeli
limited company. Pursuant to a verbal agreement with the lessor, the lease expires on December 31, 2019. The Petah-Tikva headquarters
consists of approximately 300 square meters of space. Lease payments are approximately NIS 20,447, or $5,318, per month. If our
lease is terminated, we do not foresee significant difficulty in leasing another suitable facility. The current facility houses
our administrative, clinical and research operations. The research laboratory consists of approximately 150 square meters and
includes a tissue culture laboratory and a molecular biology laboratory.







75


Table of Contents




ITEM 4A. Unresolved Staff Comments



Not Applicable.



ITEM 5. Operating and Financial Review and Prospects



The information in
this section should be read in conjunction with our consolidated financial statements and related notes beginning on page F-1
and the related information included elsewhere in this Annual Report on Form 20-F. Our financial statements are prepared in accordance
with IFRS as issued by the International Accounting Standards Board, and reported in U.S. dollars. We maintain our accounting
books and records in U.S. dollars and our functional currency is the U.S. dollar. Certain amounts presented herein may not sum
due to rounding.



Overview



We are a clinical-stage
biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment of cancer,
liver and inflammatory disease and sexual dysfunction. Our platform technology utilizes the Gi protein associated A3AR as a therapeutic
target. A3AR is highly expressed in inflammatory and cancer cells, and not significantly expressed in normal cells, suggesting
that the receptor could be a unique target for pharmacological intervention. Our pipeline of drug candidates are synthetic, highly
specific agonists and allosteric modulators, or ligands or molecules that initiate molecular events when binding with target proteins,
targeting the A3AR.



Our product candidates,
CF101, CF102 and CF602, are being developed to treat autoimmune inflammatory indications, oncology and liver diseases as well as
sexual dysfunction. CF101, also known as Piclidenoson, is in an advance stage of clinical development for the treatment of autoimmune-inflammatory
diseases, including rheumatoid arthritis and psoriasis. CF102, also known as Namodenoson, is being developed for the treatment
of HCC and has orphan drug designation for the treatment of HCC in the United States and Europe. Namodenoson was granted Fast Track
designation by the FDA as a second line treatment to improve survival for patients with advanced HCC who have previously received
Nexavar (sorafenib). Namodenoson is also being developed for the treatment of NASH, following our study which revealed compelling
pre-clinical data on Namodenoson in the treatment of NASH, a disease for which no FDA approved therapies currently exist. CF602
is our second generation allosteric drug candidate for the treatment of sexual dysfunction, which has shown efficacy in the treatment
of erectile dysfunction in preclinical studies and we are investigating additional compounds, targeting A3AR, for the treatment
of sexual dysfunction. Preclinical studies revealed that our drug candidates have potential to treat additional inflammatory
diseases, such as Crohn’s disease, oncological diseases, viral diseases, such as the JC virus, and obesity.



We believe our pipeline
of drug candidates represent a significant market opportunity. For instance, according to Visiongain, the world rheumatoid arthritis
market size is predicted to generate revenues of $34.6 billion in 2020 and the psoriasis drug market is forecasted to be worth
$11.4 billion by 2020. According to DelveInsight, the HCC drug market in the G8 countries (U.S., Germany, France, Italy, Spain,
UK, Japan and China) is expected to reach $3.8 billion by 2027.



We have in-licensed
an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed the following:



| | ● | Piclidenoson for
    the treatment of (i) rheumatoid arthritis to Kwang Dong Pharmaceutical Co. Ltd. for Korea, (ii) psoriasis and rheumatoid
    arthritis to Cipher Pharmaceuticals for Canada, (iii) rheumatoid arthritis and psoriasis to Gebro Holding, for Spain, Switzerland
    and Austria, and (iv) rheumatoid arthritis and psoriasis to CMS Medical for China (including Hong Kong, Macao and Taiwan);
    and
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Namodenoson for
    the treatment of (i) liver cancer and NASH to Chong Kun Dang Pharmaceuticals for South Korea, and (ii) advanced liver cancer
    and NAFLD/NASH to CMS Medical for China (including Hong Kong, Macao and Taiwan).
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





76


Table of Contents




We are currently: (i)
conducting a Phase III trial for Piclidenoson in the treatment of rheumatoid arthritis, (ii) conducting a Phase III trial for Piclidenoson
in the treatment of psoriasis, (iii) completing the analysis of the results of our Phase II advanced liver cancer study having
recently released top-line results, (iv) conducting a Phase II trial of Namodenoson in the
treatment of NASH top-line results expected in the second half of 2019, and (v) investigating additional compounds, targeting the
A3 adenosine receptor, for the treatment of sexual dysfunction and have therefore postponed a planned Investigational New Drug
(IND) submission for this indication.



Since inception, we
have incurred significant losses in connection with our research and development. As of December 31, 2018, we had an accumulated
deficit of approximately $100.6 million. Although we have recognized revenues in connection with our existing out-licensing agreements
with KD, Cipher, CKD, Gebro and CMS and our historic out-licensing agreement with SKK, we expect to generate losses in connection
with the research and development activities relating to our pipeline of drug candidates. Such research and development activities
are budgeted to expand over time and will require further resources if we are to be successful. As a result, we expect to incur
operating losses, which may be substantial over the next several years, and we will need to obtain additional funds to further
develop our research and development programs.



We have funded our
operations primarily through the sale of equity securities (both in private placements and in public offerings) and payments received
under our existing out-licensing agreements with KD, Cipher, CKD, Gebro and CMS and our historic out-licensing agreement with
SKK. We expect to continue to fund our operations over the next several years through our existing cash resources, potential future
milestone payments that we expect to receive from our licensees, interest earned on our investments, if any, and additional capital
to be raised through public or private equity offerings or debt financings. As of December 31, 2018, we had approximately $3.61
million of cash and cash equivalents.



Revenues



Our revenues to date
have been generated primarily from payments under our existing out-licensing agreements with KD, Cipher, CKD, Gebro and CMS and
our historic out-licensing agreement with SKK.



Under the Kwang Dong
License Agreement, we are entitled to up-front and milestone payments of up to $1.5 million. In accordance with the Kwang Dong
License Agreement, we received an up-front payment of $0.3 million and a payment of $0.048 million as consideration for KD’s
purchase of our ordinary shares in 2009 and a milestone payment of $0.2 million in 2010. Under the terms of the Kwang Dong License
Agreement, in addition to the payments mentioned above, we are entitled to certain additional payments based on the sale of raw
materials, subject to the terms and conditions of the respective agreements. To date, we have received a total of $500,000 from
Kwang Dong in an upfront payment. See “Item 4. Information on the Company—B. Business Overview—Out-Licensing
and Distribution Agreements”.



Under the Distribution
and Supply Agreement with Cipher we received CAD 1.65 million upon execution of the agreement and are entitled to milestone payments
upon receipt of regulatory approval by Health Canada for Piclidenoson and the first delivery of commercial launch quantities as
follows (i) CAD 1 million upon the first approved indication for either psoriasis or rheumatoid arthritis, and (ii) CAD 1 million
upon the second approved indication for either psoriasis or rheumatoid arthritis. In addition, following regulatory approval,
we shall be entitled to a royalty of 16.5% of net sales of Piclidenoson in Canada and reimbursement for the cost of manufacturing
Piclidenoson. We are also entitled to a royalty payment for any authorized generic of Piclidenoson that Cipher distributes in
Canada. To date, we have received a total of $1.3 million from Cipher in an upfront payment. See “Item 4. Information on
the Company—B. Business Overview—Out-Licensing and Distribution Agreements”.



The Distribution Agreement
with CKD provides for up to $3,000,000 in upfront and milestone payments payable with respect to the liver cancer indication and
up to $3,000,000 with respect to the NASH indication. In addition, we are entitled to a transfer price of the higher of the manufacturing
cost plus 10% or 23% of net sales of Namodenoson following commercial launch in South Korea. To date, we have received a total
of $1,000,000 from CKD, $500,000 in upfront payments and a further $500,000 for a milestone payment received in the third quarter
of 2017 upon receipt by CKD of a positive result from the preliminary review by the MFDS on obtaining orphan drug designation
in South Korea. See “Item 4. Information on the Company—B. Business Overview—Out-Licensing and Distribution
Agreements”.





77


Table of Contents




In January 2018, we
entered into a Distribution and Supply Agreement with Gebro. The Distribution and Supply Agreement with Gebro provides that we
are entitled to €1,500,000 upon execution of the agreement plus milestone payments upon achieving certain clinical, launch
and sales milestones, as follows: (i) €300,000 upon initiation of the ACRobat Phase III clinical trial for the treatment
of rheumatoid arthritis and €300,000 upon the initiation of the COMFORT Phase III clinical trial for the treatment of psoriasis,
(ii) between €750,000 and €1,600,000 following first delivery of commercial launch quantities of Piclidenson for either
the treatment of rheumatoid arthritis or psoriasis, and (iii) between €300,000 and up to €4,025,000 upon meeting certain
net sales. In addition, following regulatory approval, we shall be entitled to double digit percentage royalties on net sales
of Piclidenoson in the territories and payment for the manufacturing Piclidenoson. To date, we have received a total of €2,100,000
from Gebro in upfront and milestone payments. See “Item 4. Information on the Company—B. Business Overview—Out-Licensing
and Distribution Agreements”.



In August 2018, we
entered into a License, Collaboration and Distribution Agreement with CMS Medical. Under the License, Collaboration and Distribution
Agreement, we are entitled to $2,000,000 upon execution of the agreement plus milestone payments of up to $14,000,000 upon achieving
certain regulatory milestones and payments of up to $58,500,000 upon achieving certain sales milestones. In addition, following
regulatory approval, we shall be entitled to double-digit percentage royalties on net sales of Piclidenoson and Namodenoson in
the licensed territories. To date, we have received a total of $2,000,000 from CMS Medical in upfront and milestone payments.
See “Item 4. Information on the Company—B. Business Overview—Out-Licensing and Distribution Agreements”.



Under the terminated
SKK license agreement we received an aggregate of approximately $8.5 million from SKK. See “tem 4. Information on the Company—B.
Business—Out-Licensing and Distribution Agreements”.



Certain payments we
have received from SKK and KD have been subject to a 10% and 5% withholding tax in Japan and Korea, respectively, and certain
payments we may receive in the future, if at all, may also be subject to the same withholding tax in Korea. Receipt of any milestone
payment under our out-licensing agreements depends on many factors, some of which are beyond our control. We cannot assure you
that we will receive any of these future payments. We expect our revenues for the next several years, if any, to be derived primarily
from payments under our current out-license agreements and our public capital raising activities, as well as additional collaborations
that we may enter into in the future with respect to our drug candidates.



Research and Development



Our research and development
expenses consist primarily of salaries and related personnel expenses, fees paid to external service providers, up-front and milestone
payments under our license agreements, patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory
supplies and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred.
We expect our research and development expense to remain our primary expense in the near future as we continue to develop our
products. Increases or decreases in research and development expenditures are attributable to the number and/or duration of the
pre-clinical and clinical studies that we conduct.



The following table
identifies our current major research and development projects:



|Project      |  | Status                                          |  | Expected or Recent Near Term Milestone          
|------------ |  | ----------------------------------------------- |  | ------------------------------------------------
|Piclidenoson |  | ACRobat Phase III study in rheumatoid arthritis |  | Enrolling patients to the study                 
|             |  | COMFORT Phase III study in psoriasis            |  | Enrolling patients to the study                 
|             |  |                                                 |  |                                                 
|Namodenoson  |  | Phase II in HCC                                 |  | Top-line results announced in March 2019        
|             |  | Phase II study in NASH                          |  | Top-line results expected in second half of 2019





78


Table of Contents




We record certain
costs for each development project on a “direct cost” basis, as they are recorded to the project for which such costs
are incurred. Such costs include, but are not limited to, CRO expenses, drug production for pre-clinical and clinical studies
and other pre-clinical and clinical expenses. However, certain other costs, including but not limited to, salary expenses (including
salaries for research and development personnel), facilities, depreciation, share-based compensation and other overhead costs
are recorded on an “indirect cost” basis, i.e., they are shared among all of our projects and are not recorded to
the project for which such costs are incurred. We do not allocate direct salaries to projects due to the fact that our project
managers are generally involved in several projects at different stages of development, and the related salary expense is not
significant to the overall cost of the applicable projects. In addition, indirect labor costs relating to our support of the research
and development process, such as manufacturing, controls, pre-clinical analysis, laboratory testing and initial drug sample production,
as well as rent and other administrative overhead costs, are shared by many different projects and have never been considered
by management to be of significance in its decision-making process with respect to any specific project. Accordingly, such costs
have not been specifically allocated to individual projects.



Set forth below is
a summary of the gross direct costs allocated to our main projects on an individual basis, as well as the gross direct costs allocated
to our less significant projects on an aggregate basis, for the years ended December 31, 2016, 2017 and 2018; and on an aggregate
basis since project inception:



|                                         |  | (USD in thousands)      |       |  | Total Costs   | 
|---------------------------------------- |  | ----------------------- | ----- |  | ------------- | 
|                                         |  | Year Ended December 31, |       |  | Since Project | 
|                                         |  | 2016                    |       |  | 2017          | 
|Piclidenoson                             |  |                         | 1,946 |  |               | 
|Namodenoson                              |  |                         | 1,907 |  |               | 
|CF602                                    |  |                         | 1,126 |  |               | 
|                                         |  |                         |       |  |               | 
|Other projects                           |  |                         | -     |  |               | 
|Total
    gross direct project costs (1) |  |                         | 4,979 |  |               | 



| | (1) | Does
                                         not include indirect project costs and overhead, such as payroll and related expenses
                                         (including stock-based compensation), facilities, depreciation and impairment of intellectual
                                         property, which are included in total research and development expenses in our financial
                                         statements.
| | --- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



From our inception
through December 31, 2018, we have incurred research and development expenses of approximately $99.8 million. We expect that a
large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical
and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes
and given the early stage of our preclinical product development projects, we are unable to estimate with any certainty the costs
we will incur in the continued development of the product candidates in our pipeline for potential commercialization. Clinical
development timelines, the probability of success and development costs can differ materially from expectations. We expect to
continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional
clinical trials for each product candidate. If we are not able to enter into an out-licensing arrangement with respect to any
product candidate prior to the commencement of later stage clinical trials, we may fund the trials for the product candidates
ourselves.



While we are currently
focused on advancing each of our product development projects, our future research and development expenses will depend on the
clinical success of each product candidate, as well as ongoing assessments of each product candidate’s commercial potential.
In addition, we cannot forecast with any degree of certainty which product candidates may be subject to future out-licensing arrangements,
when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development
plans and capital requirements.



As we obtain results
from clinical trials, we may elect to discontinue or delay clinical trials for certain product candidates or projects in order
to focus our resources on more promising product candidates or projects. Completion of clinical trials by us or our licensees
may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended
use of a product candidate.





79


Table of Contents




The cost of clinical
trials may vary significantly over the life of a project as a result of differences arising during clinical development, including,
among others:



| | ● | the number of sites
    included in the clinical trials;
| | - | --------------------------------------------------------



| | ● | the length of time
    required to enroll suitable patients;
| | - | ------------------------------------------------------------



| | ● | the number of patients
    that participate in the clinical trials;
| | - | -------------------------------------------------------------------



| | ● | the duration of
    patient follow-up;
| | - | --------------------------------------



| | ● | the development
    stage of the product candidate; and
| | - | -------------------------------------------------------



| | ● | the efficacy and
    safety profile of the product candidate.
| | - | -------------------------------------------------------------



We expect our research
and development expenses to increase in the future from current levels as we continue the advancement of our clinical trials and
preclinical product development and to the extent we in-license new product candidates. The lengthy process of completing clinical
trials and seeking regulatory approval for our product candidates requires expenditure of substantial resources. Any failure or
delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and
cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because
of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from
our projects.



General and Administrative Expenses



General and administrative
expenses consist primarily of compensation for employees in executive and operational functions, including accounting, finance,
legal, business development, investor relations, information technology and human resources. Other significant general and administration
costs include facilities costs, professional fees for outside accounting and legal services, travel costs, insurance premiums
and depreciation.



Financial Expense and Income



Financial expense
and income consists of interest earned on our cash and cash equivalents; bank fees and other transactional costs; expense or income
resulting from fluctuations of the NIS and other currencies, in which a portion of our assets and liabilities are denominated,
against the U.S. dollar (our functional currency).



Critical Accounting Policies and Estimates



Our accounting policies
and their effect on our financial condition and results of operations are more fully described in our audited consolidated financial
statements included elsewhere in this Annual Report on Form 20-F. The preparation of financial statements in conformity with IFRS
as issued by the IASB requires management to make estimates and assumptions that in certain circumstances affect the reported
amounts of assets and liabilities, revenues and expenses and disclosure of contingent assets and liabilities. These estimates
are prepared using our best judgment, after considering past and current events and economic conditions. While management believes
the factors evaluated provide a meaningful basis for establishing and applying sound accounting policies, management cannot guarantee
that the estimates will always be consistent with actual results. In addition, certain information relied upon by us in preparing
such estimates includes internally generated financial and operating information, external market information, when available,
and when necessary, information obtained from consultations with third party experts. Actual results could differ from these estimates
and could have a material adverse effect on our reported results.





80


Table of Contents




We believe that the
accounting policies discussed below are critical to our financial results and to the understanding of our past and future performance,
as these policies relate to the more significant areas involving management’s estimates and assumptions. We consider an
accounting estimate to be critical if: (1) it requires us to make assumptions because information was not available at the time
or it included matters that were highly uncertain at the time we were making our estimate; and (2) changes in the estimate could
have a material impact on our financial condition or results of operations.



Functional and Presentation Currency



From our inception
through January 1, 2018, our functional and presentation currency was the NIS. Management conducted a review of our functional
currency and decided to change our functional and presentation currency to the USD from the NIS effective January 1, 2018. These
changes were based on an assessment by our management that the USD is the primary currency of the economic environment in which
we operate.



In determining the
appropriate functional currency to be used, we followed the guidance in International Accounting Standard 21 - The Effects of
Changes in Foreign Exchange Rates, or IAS 21, which states that factors relating to sales, costs and expenses, financing activities
and cash flows, as well as other potential factors, should be considered. In this regard, we are incurring and expect to continue
to incur a majority of our expenses in USD as a result of our expanded clinical trials including Phase III trials. These changes,
as well as the fact that the majority of our available funds are in U.S. dollars, our principal source of financing is the U.S.
capital market, and all of our budgeting is conducted solely in U.S. dollars, led to the decision to make the change in functional
currency as of January 1, 2018, as indicated above.



At the date of change
of functional currency, we also changed the presentation currency of our financial statements. This change was retrospectively
implemented. In accordance with IAS 21, since our presentation currency was different than our functional currency our results
and financial position were translated using the following principles: (i) all assets and liabilities were translated using the
current exchange rates, (ii) equity accounts were translated using the historical rates, and (iii) income and expenses for each
statement of comprehensive income or separate income statement presented were translated at exchange rates at the dates of the
transactions.



Principles of Consolidation



Our
financial statements reflect the consolidation of the financial statements of companies that we control based on legal control
or effective control. We fully consolidate into our financial statements the results of operations of companies that we control.
Legal control exists when we have the power, directly or indirectly, to govern the financial and operating policies of an entity.
The effect of potential voting rights that are exercisable at the balance sheet date are considered when assessing whether we
have legal control. In addition, we consolidate on the basis of effective control even if we do not have voting control. The determination
that effective control exists involves significant judgment.



In
evaluating the effective control on our investees we consider the following criteria to determine if effective control exists:



| | ● | whether we hold
    a significant voting interest (but less than half the voting rights);                                                                                                                          
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                    
| | ● | whether there is
    a wide diversity of public holdings of the remaining shares conferring voting rights;                                                                                                         
|
| | ● | whether in the past
    we had the majority of the voting power participating in the general meetings of shareholders and, therefore, have in fact
    had the right to nominate the majority of the board members;
| |   |                                                                                                                                                                                                                    
| | ● | the absence of a
    single entity that holds a significant portion of the investee’s shares;                                                                                                                      
| |   |                                                                                                                                                                                                                    
| | ● | our ability to establish
    policies and guide operations by appointing the remainder of the investee’s senior management; and                                                                                    
| |   |                                                                                                                                                                                                                    
| | ● | whether the minority
    shareholders have participation rights or other preferential rights, excluding traditional shareholder protective rights.                                                                 





81


Table of Contents




Entities
we control are fully consolidated in our financial statements. All significant intercompany balances and transactions are eliminated
in consolidation. Non-controlling interests of subsidiaries represent the non-controlling shareholders’ proportionate interest
in the comprehensive income (loss) of the subsidiaries and fair value of the net assets or the net identifiable assets upon the
acquisition of the subsidiaries.



Revenue Recognition



We generate income
from distribution agreements. See “Item 4. Information on the Company—B. Business—Out-Licensing and Distribution
Agreements”. Such income comprises of upfront license fees, milestone payments and potential royalty payments.



We identified four
components in the agreements: (i) performing the research and development services through regulatory approval; (ii) exclusive
license to distribute; (iii) participation in joint steering committee; and, (iv) royalties resulting from future sales of the
product.



We recognize revenue
in accordance with IFRS 15, “Revenue” pursuant to which each required deliverable is evaluated to determine whether
it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer.
The arrangement’s consideration that is fixed or determinable is then allocated to each separate unit of accounting based
on the relative selling price of each deliverable which is based on the Estimated Selling Price.



Components (i) –
(iii) were analyzed as one unit of accounting. Consequently, revenue from these components is recorded based on the term of the
research and development services (which is the last deliverable in the arrangement). We estimate these services will spread over
a period of 24 quarters.



Revenues from milestone payments:



Contingent payments
related to milestones will be recognized immediately upon satisfaction of the milestone and contingent payments related to royalties
will be recognized in the period that the related sales have occurred.



Revenues from royalties:



Revenues
from royalties will be recognized as they accrue in accordance with the terms of the relevant agreement.



Share-based Compensation



We account for share-based
compensation arrangements in accordance with the provisions of IFRS 2. IFRS 2 requires companies to recognize share-based compensation
expense for awards of equity instruments based on the grant-date fair value of those awards. The cost is recognized as compensation
expense over the vesting period, based upon the grant-date fair value of the equity or liability instruments issued. We selected
the binomial option pricing model as the most appropriate method for determining the estimated fair value of our share-based awards
without market conditions. The determination of the grant date fair value of options using an option pricing model is affected
by estimates and assumptions regarding a number of complex and subjective variables. These variables include the expected volatility
of our share price over the expected term of the options, share option exercise and forfeiture rate, risk-free interest rates,
expected dividends and the price of our ordinary shares on the TASE. As our ordinary shares are publicly traded on the TASE, we
do not need to estimate the fair value of our ordinary shares. Rather, we use the actual closing market price of our ordinary
shares on the date of grant, as reported by the TASE although in the future may use the closing market price of our ADSs on the
date of grant, as reported by the NYSE American.



If any of the assumptions
used in the binomial option pricing model change significantly, share-based compensation for future awards may differ materially
compared with the awards previously granted.





82


Table of Contents




As for other service
providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity
instruments. In cases where the fair value of the goods or services received as consideration of equity instruments cannot be
measured, they are measured by reference to the fair value of the equity instruments granted.



The cost of equity-settled
transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the service
are to be satisfied, ending on the date on which the relevant employees or other service providers become fully entitled to the
award.



If we modify the conditions
on which equity-instruments are granted, an additional expense is recognized for any modification that increases the total fair
value of the share-based payment arrangement or is otherwise beneficial to the employee or other service provider at the modification
date.



Liability Related to Certain Warrants



The fair value of
the liability for warrants exercisable into shares issued to investors in connection with our financings to date was calculated
using the Black-Scholes-Merton option-pricing model. We accounted for these warrants as liabilities due to the dollar exercise
price terms and in accordance with IAS 39, measured at fair value each reporting period until they will be exercised or expired,
with changes in the fair values being recognized in our statement of comprehensive loss as financial income or expense.



Fair value for each
reporting period was calculated based on the following assumptions:





| | 1. | Risk-free interest rate - based on yield rate of non-index linked U.S. Federal Reserve treasury bonds.                                                                               
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |    |                                                                                                                                                                                      
| | 2. | Expected volatility - was calculated based on our actual historical stock price movements over a term that is equivalent to the expected term of the option.                         
| |    |                                                                                                                                                                                      
| | 3. | Expected life - the expected life was based on the expiration date of the warrants.                                                                                                  
| |    |                                                                                                                                                                                      
| | 4. | Expected dividend yield - was based on the fact that we have not paid dividends to our shareholders in the past and do not expect to pay dividends to our shareholders in the future.



Our net loss for the
year ended December 31, 2018 and 2017 included finance income in the amount of $0 and $564,000, respectively, in connection with
the above-mentioned warrants.



Recently Issued Accounting Pronouncements



|IFRS 16 - Leases:
|-----------------



In January 2016, the
IASB issued IFRS 16, “Leases” (“IFRS 16”). According to IFRS 16, a lease is a contract, or part of a contract,
that conveys the right to use an asset for a period of time in exchange for consideration.



The effects of the
adoption of the new standard are as follows:



| | ● | According
                                         to IFRS 16, lessees are required to recognize all leases in the statement of financial
                                         position (excluding certain exceptions, see below). Lessees will recognize a liability
                                         for lease payments with a corresponding right-of-use asset, similar to the accounting
                                         treatment for finance leases under the existing standard, IAS 17, “Leases”.
                                         Lessees will also recognize interest expense and depreciation expense separately.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Variable
                                         lease payments that are not dependent on changes in the Consumer Price Index (“CPI”)
                                         or interest rates, but are based on performance or use are recognized as an expense by
                                         the lessees as incurred and recognized as income by the lessors as earned.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





83


Table of Contents




| | ● | In
                                         the event of change in variable lease payments that are CPI-linked, lessees are required
                                         to remeasure the lease liability and record the effect of the remeasurement as an adjustment
                                         to the carrying amount of the right-of-use asset.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The
                                         accounting treatment by lessors remains substantially unchanged from the existing standard,
                                         namely classification of a lease as a finance lease or an operating lease.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | IFRS
                                         16 includes two exceptions which allow lessees to account for leases based on the existing
                                         accounting treatment for operating leases - leases for which the underlying asset is
                                         of low financial value and short-term leases (up to one year).
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



IFRS 16 is
effective for annual periods beginning on or after January 1, 2019.



IFRS 16 permits lessees
to use one of the following approaches:



| | 1. | Full retrospective approach - according
                                         to this approach, a right-of-use asset and the corresponding liability will be presented
                                         in the statement of financial position as if they had always been measured according
                                         to the provisions of IFRS 16. Accordingly, the effect of the adoption of IFRS 16 at the
                                         beginning of the earliest period presented will be recorded in equity. Also, we will
                                         restate the comparative data in its financial statements. Under this approach, the balance
                                         of the liability as of the date of initial application of IFRS 16 will be calculated
                                         using the interest rate implicit in the lease, unless this rate cannot be easily determined
                                         in which case the lessee’s incremental borrowing rate of interest on the commencement
                                         date of the lease will be used.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2. | Modified retrospective approach
                                         - this approach does not require restatement of comparative data. The balance of the
                                         liability as of the date of initial application of IFRS 16 will be calculated using the
                                         lessee’s incremental borrowing rate of interest on the date of initial application of
                                         IFRS 16. As for the measurement of the right-of-use asset, we may choose, on a lease-by-lease
                                         basis, to apply one of the two following alternatives:
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Recognize
                                         an asset in an amount equal to the lease liability, with certain adjustments.
| | - | --------------------------------------------------------------------------------------------------------------------------------



| | ● | Recognize
                                         an asset as if the new standard had always been applied.
| | - | -----------------------------------------------------------------------------------------------------------



Any difference arising
on the date of first-time is recorded in equity.



We believe, based on
an assessment of the impact of the adoption of IFRS 16, that its application is not expected to have a material effect on the
financial statements.



Recent Offerings



On September 21, 2015,
we sold to certain institutional investors providing for the issuance of an aggregate of 2,068,966 ADSs in a registered direct
offering at $4.35 per ADS resulting in gross proceeds of $9,000,002. In addition, we issued to the investors unregistered warrants
to purchase 1,034,483 ADSs in a private placement. The warrants may be exercised after six months from issuance for a period of
five and a half years from issuance and have an exercise price of $5.25 per ADS, subject to adjustment as set forth therein. The
warrants may be exercised on a cashless basis if six months after issuance there is no effective registration statement registering
our ADSs underlying the warrants. We paid an aggregate of $792,379 in placement agent fees and expenses and issued unregistered
placement agent warrants to purchase 103,448 ADS on the same terms as the warrants except they have a term of five years.



On October 15, 2015,
we sold to certain institutional investors providing for the issuance of an aggregate of 1,109,196 ADSs in a registered direct
offering at $4.35 per ADS resulting in gross proceeds of approximately $4,825,000. In addition, we issued to the investors unregistered
warrants to purchase 443,678 ADSs in a private placement. The warrants may be exercised after six months from issuance for a period
of five and a half years from issuance and have an exercise price of $5.25 per ADS, subject to adjustment as set forth therein.
The warrants may be exercised on a cashless basis if six months after issuance there is no effective registration statement registering
our ADSs underlying the warrants. We paid an aggregate of $524,621 in placement agent fees and expenses and issued unregistered
placement agent warrants to purchase 55,460 ADS on the same terms as the warrants except they have a term of five years.





84


Table of Contents




On January 24, 2017,
we sold to certain institutional investors providing for the issuance of an aggregate of 2,500,000 ADSs in a registered direct
offering at $2.00 per ADS resulting in gross proceeds of $5,000,000. In addition, we issued to the
investors unregistered warrants to purchase 1,250,000 ADSs in a private placement. The warrants may be exercised after six months
from issuance for a period of five and a half years from issuance and have an exercise price of $2.25 per ADS, subject to adjustment
as set forth therein. The warrants may be exercised on a cashless basis if six months after issuance there is no effective registration
statement registering our ADSs underlying the warrants. We paid an aggregate of $360,000 in placement agent fees and expenses and
issued unregistered placement agent warrants to purchase 125,000 ADS on the same terms as the warrants except they have a term
of five years.



On March 13, 2018,
we sold to certain institutional investors providing for the issuance of an aggregate of 3,333,336 ADSs in a registered direct
offering at $1.50 per ADS resulting in gross proceeds of approximately $5,000,000. In addition, we
issued to the investors unregistered warrants to purchase 2,500,002 ADSs in a private placement. The warrants may be exercised
after six months from issuance for a period of five and a half years from issuance and have an exercise price of $2.00 per ADS,
subject to adjustment as set forth therein. The warrants may be exercised on a cashless basis if six months after issuance there
is no effective registration statement registering our ADSs underlying the warrants. We paid an aggregate of $350,000 in placement
agent fees and expenses and issued unregistered placement agent warrants to purchase 166,667 ADS on the same terms as the warrants
except they have a term of five years.



On January 18, 2019,
we sold to a single institutional investor an aggregate 2,238,096 ADSs in a registered direct offering at $1.05 per ADS, resulting
in gross proceeds of $2,350,000. In addition, we issued to the investor unregistered warrants to
purchase 2,238,096 ADSs in a private placement. The warrants are immediately exercisable from the date of issuance for a period
of five and a half years and have an exercise price of $1.30 per ADS, subject to adjustment as set forth therein. The warrants
may be exercised on a cashless basis if six months after issuance there is no effective registration statement registering the
ADSs underlying the warrants. We paid an aggregate of $191,000 in placement agent fees and expenses and issued unregistered placement
agent warrants to purchase 111,905 ADS on the same terms as the warrants except they have a term of five years.



Jumpstart Our Business Startups Act
of 2012



We are an emerging
growth company within the meaning of the rules under the Securities Act, and we will utilize certain exemptions from various reporting
requirements that are applicable to public companies that are not emerging growth companies. The JOBS Act permits us, as an “emerging
growth company,” to take advantage of an extended transition period to comply with certain new or revised accounting standards
if such standards apply to companies that are not issuers. We are choosing to “opt out” of this provision and, as
a result, we will comply with new or revised accounting standards when they are required to be adopted by issuers. This decision
to opt out of the extended transition period under the JOBS Act is irrevocable.



A.
Results of Operations



Comparison of the Year Ended December 31, 2018 to Year Ended
December 31, 2017



Revenues



Revenues
for the year ended December 31, 2018 were $3.8 million, an increase of $3.0 million, or 384%, compared to $0.8 million for the
year ended December 31, 2017. The increase in revenue was mainly due to the recognition of a $2 million advance payment received
in August 2018 under the Distribution Agreement with CMS Medical and from the recognition of a portion of the $2.2 million advance
payment received in January 2018 under the Distribution and Supply Agreement with Gebro.





85


Table of Contents




Research
and development expenses



Research
and development expenses for the year ended December 31, 2018 were $6.0 million, an increase of $0.9 million, or 19%, compared
to $5.1 million for the year ended December 31, 2017. Research and developments expenses for the year ended 2018 comprised primarily
of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The
increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for
the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2019 and beyond.



General
and administrative expenses



General
and administrative expenses were $3.1 million for the year ended December 31, 2018 an increase of $0.3 million, or 10%, compared
to $2.8 million for the year ended December 31, 2017. The increase is primarily due to an increase in professional services and
investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2019.



Financial
expenses, net



Financial
expenses, net for the year ended December 31, 2018 aggregated $1.1 million compared to immaterial financial income, net for the
same period in 2017. The increase in financial expense, net was mainly due to a loss from long-term investment revaluation and
from recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the
same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses
from exchange rate differences.



Comparison of the Year Ended December 31, 2017 to Year Ended
December 31, 2016



Revenues



Revenues
for the year ended December 31, 2017 were $0.8 million, an increase of $0.6 million, or 300%, compared to $0.2 million for the
year ended December 31, 2016. The revenues during 2017 were mainly due to recognition of a portion of the $0.2 million advance
payment received in March 2015 under the Distribution and Supply Agreement with Cipher and from the recognition of the milestone
payment of $0.5 million and a portion of the $0.1 million advance payment received in December 2016 under the Distribution Agreement
with CKD.



Research
and development expenses



Research
and development expenses for the year ended December 31, 2017 were $5.1 million, a decrease of $1.0 million, or 16%, compared
to $6.1 million for the year ended December 31, 2016. Research and developments expenses for the year ended 2017 comprised primarily
of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The
decrease is primarily due to costs associated with CF602 expenses that decreased since the postponement of a planned IND submission
for this indication and a decrease in costs associated with the ongoing clinical trial of Namodenoson for treatment in liver cancer.



General
and administrative expenses



General
and administrative expenses were $2.8 million for the year ended December 31, 2017, an increase of $0.1 million, or 4.5%, compared
to $2.7 million for the year ended December 31, 2016. The minor increase is primarily due to an increase in salary and related
expenses.



Financial
expenses, net



Financial
income, net for the year ended December 31, 2017 aggregated $0.01 million compared to financial income, net of $0.3 million for
the same period in 2016. The decrease in financial income, net was mainly due to an increase in financial expenses from exchange
rate offset by a decrease in fair value revaluation of warrants.





86


Table of Contents




Comparison of the Year Ended December 31, 2016 to Year Ended
December 31, 2015



Revenues



Revenues
for the year ended December 31, 2016 were $0.2 million compared to $0.2 million for the year ended December 31, 2015. The revenues
during 2016 were mainly due to the recognition of a portion of the $1.3 million (CAD 1.65 million) advance payment received in
March 2015 under the Distribution and Supply Agreement with Cipher and a minor amount due to the recognition of a portion of the
$0.5 million advance payment received in December 2016 under the Distribution Agreement with CKD.



Research
and development expenses



Research
and development expenses for the year ended December 31, 2016 were $6.1 million, an increase of $2.2 million, or 56%, compared
to $3.9 million for the year ended December 31, 2015. Research and developments expenses for the year ended 2016 comprised primarily
of expenses associated with the Phase II study for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase
is primarily due to costs associated with preparations of the Piclidenoson Phase III studies in the treatment of rheumatoid arthritis
and psoriasis and costs associated with the ongoing clinical trial of Namodenoson for treatment in liver cancer.



General
and administrative expenses



General
and administrative expenses were $2.7 million for the year ended December 31, 2016 compared to $2.7 million for the year ended
December 31, 2015. The increase considered immaterial.



Financial
expenses, net



Financial
income, net for the year ended December 31, 2016 aggregated $0.3 million compared to financial expense, net of $0.02 million for
the same period in 2015. The increase in financial income, net in the year ended December 31, 2016 considered immaterial.



B. Liquidity and Capital Resources



Since inception, we
have funded our operations primarily through public (in Israel and the United States) and private offerings of our equity securities
and payments received under our strategic licensing arrangements. As of December 31, 2018, we had approximately $3.6 million in
cash and cash equivalents, and have invested most of our available cash funds in ongoing cash accounts. In January 2019, we raised
$2.35 million in a registered direct offering and concurrent private placement.



We may be able to
use U.S. taxes withheld as credits against Israeli corporate income tax when we have income, if at all, but there can be no assurance
that we will be able to realize the credits. In addition, we believe that we may be entitled to a refund of such withholding tax
from the U.S. government but there can be no assurance that we will be entitled to such a refund. For information regarding the
revenues and expenses associated with our licensing agreements, see “Item 4. Information on the Company—B. Business
Overview—Out-Licensing and Distribution Agreements”, “Item 4. Information on the Company—B. Business Overview—In-Licensing
Agreements” and “Item 5. Operating and Financial Review and Prospects—Revenues.”



Net cash used in operating
activities was $4.1 million for the year ended December 31, 2018, compared with net cash used in operating activities of $8.9
million and $8.7 million for the years ended December 31, 2017 and 2016, respectively. The $4.8 million decrease in the net cash
used in operating activities during 2018, compared to 2017, was primarily the result of an increase in accounts receivable, prepaid
expenses and lease deposit, an increase in deferred revenues and a change in fair value of short-term investment. The $0.2 million
increase in the net cash used in operating activities during 2017, compared to 2016, is immaterial.



Net cash used in investing
activities for the year ended December 31, 2018 was $0.03 million compared to net cash used in investing activities of $0.03 million
for the year ended December 31, 2017 and net cash used in investing activities of $0.01 million for the year ended December 31,
2016. The changes in cash flows from investing activities are immaterial.





87


Table of Contents




Net cash provided by
financing activities for the year ended December 31, 2018 was $4.4 million, compared to $4.5 million for the year ended December
31, 2017 and no net cash provided by financing activities for the year ended December 31, 2016. Net cash provided by financing
activities during 2018 and 2017 was due to issuance of shares and warrants, net of issuance expenses, and the decrease of $0.1
million compared to 2017 is immaterial. In January 2017, we raised gross proceeds of $5.0 million in a registered direct offering,
and in March 2018, we raised gross proceeds of approximately $5 million in a registered direct offering. The $4.5 million increase
in the net cash provided by financing activities during 2017, compared to 2016, was primarily due to issuance of shares and warrants,
net of issuance expenses.



Developing drugs,
conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to
achieve our strategic objectives. Although we believe our existing financial resources as of the date of issuance of this Annual
Report on Form 20-F, will be sufficient to fund our projected cash requirements at least through the next twelve months, we will
require significant additional financing to fund our operations. Additional financing may not be available on acceptable terms,
if at all. Our future capital requirements will depend on many factors, including:



| | ● | the level of research
    and development investment required to develop our product candidates;                                                     
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                      
| | ● | the failure to obtain
    regulatory approval or achieve commercial success of our product candidates, including Piclidenoson, Namodenoson and CF602;



| | ● | the results of our
    preclinical studies and clinical trials for our earlier stage product candidates, and any decisions to initiate clinical trials
    if supported by the preclinical results;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the costs, timing
    and outcome of regulatory review of our product candidates that progress to clinical trials;
| | - | ------------------------------------------------------------------------------------------------------------------



| | ● | the costs of preparing,
    filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related
    claims;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the cost of commercialization
    activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the cost of manufacturing
    our product candidates and any products we successfully commercialize;
| | - | ----------------------------------------------------------------------------------------------------



| | ● | the timing, receipt
    and amount of sales of, or royalties on, our future products, if any;
| | - | ---------------------------------------------------------------------------------------------



| | ● | the expenses needed
    to attract and retain skilled personnel;
| | - | ----------------------------------------------------------------



| | ● | any product liability
    or other lawsuits related to our products;
| | - | --------------------------------------------------------------------



| | ● | the extent to which
    we acquire or invest in businesses, products or technologies and other strategic relationships;
| | - | -----------------------------------------------------------------------------------------------------------------------



| | ● | the costs of financing
    unanticipated working capital requirements and responding to competitive pressures; and
| | - | ------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                   
| | ● | maintaining minimum
    shareholders’ equity requirements under the NYSE American Company Guide.                  



Until we can generate
significant continuing revenues, we expect to satisfy our future cash needs through payments received under our license agreements,
debt or equity financings, or by out-licensing other product candidates. We cannot be certain that additional funding will be
available to us on acceptable terms, or at all. If funds are not available, we may be required to delay, reduce the scope of,
or eliminate one or more of our research or development programs or our commercialization efforts.





88


Table of Contents




Research
and Development, Patents and Licenses, Etc.



For information concerning
our research and development policies and a description of the amount spent during each of the last three fiscal years on company-sponsored
research and development activities, see “Item 5. Operating and Financial Review and Prospects— Results of Operation.”



Trend
Information.



We are a development
stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research, development or
commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties,
demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from
continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily
be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties,
demands, commitments and events are identified in the preceding subsections of this Operating and Financial Review and Prospects.



Off-Balance
Sheet Arrangements.



We have no off-balance
sheet arrangements that have had or are reasonably likely to have a current or future effect on our financial condition, changes
in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that
are material to investors.



Contractual
Obligations.



The following table
summarizes our significant contractual obligations in U.S. dollars as of December 31, 2018:



|                                |  | Total |         |  | Less than 1 year |  |         | 1-3 years |  |  | 3-5 years |  |  | More than 5 years |  
|------------------------------- |  | ----- | ------- |  | ---------------- |  | ------- | --------- |  |  | --------- |  |  | ----------------- | -
|Contractual Obligations         |  |       |         |  |                  |  |         |           |  |  |           |  |  |                   |  
|                                |  |       |         |  |                  |  |         |           |  |  |           |  |  |                   |  
|NIH milestones(1)               |  |       | 425,000 |  |                  |  | 425,000 |           |  |  | -         |  |  |                   | -
|Leiden University milestones(2) |  |       | 91,603  |  |                  |  | 11,450  |           |  |  | 80,153    |  |  |                   | -
|Car lease obligations           |  |       | 30,048  |  |                  |  | 19,709  |           |  |  | 10,339    |  |  |                   | -
|                                |  |       |         |  |                  |  |         |           |  |  |           |  |  |                   |  
|Total                           |  |       | 564,651 |  |                  |  | 456,159 |           |  |  | 90,492    |  |  |                   | -



| | (1) | Includes
                                         $425,000 in milestone payments.
| | --- | ---------------------------------------------------------------------------------



| | (2) | Includes
                                         a €10,000 annual royalty and €50,000 upon the initiation of a Phase I study.
                                         We will update our milestone payment obligations upon releasing the Phase I data from
                                         such study. As such, the obligations above do not include a potential milestone payment
                                         of €100,000 upon the initiation of a Phase II study, €200,000 upon the initiation
                                         of a Phase III study or €500,000 upon marketing approval by any regulatory authority.
| | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Other than as described
above, we did not have any material commitments for capital expenditures, including any anticipated material acquisition of plant
and equipment or interests in other companies, as of December 31, 2018.





89


Table of Contents




ITEM 6. Directors, Senior Management and Employees



A. Directors and Senior Management.



The following table sets forth our directors
and senior management:



|Member                    |  | Age |  | Position                                                       
|------------------------- |  | --- |  | ---------------------------------------------------------------
|Ilan
    Cohn, Ph.D.      |  | 63  |  | Chairman
    of the Board                                      
|                          |  |     |  |                                                                
|Pnina
    Fishman, Ph.D.  |  | 70  |  | Chief
    Executive Officer, Director                          
|                          |  |     |  |                                                                
|Motti
    Farbstein       |  | 55  |  | Chief
    Operating and Financial Officer                      
|                          |  |     |  |                                                                
|Sari
    Fishman, Ph.D.   |  | 47  |  | VP
    of Business Development                                 
|                          |  |     |  |                                                                
|Guy
    Regev             |  | 49  |  | Director,
    Audit Committee and Compensation Committee member
|                          |  |     |  |                                                                
|Abraham
    Sartani, M.D. |  | 72  |  | Director                                                       
|                          |  |     |  |                                                                
|Israel
    Shamay         |  | 54  |  | Director,
    Audit Committee and Compensation Committee member
|                          |  |     |  |                                                                
|Yaacov
    Goldman        |  | 63  |  | Director,
    Audit Committee and Compensation Committee member



Ilan Cohn, Ph.D. Ilan
Cohn, Ph.D. is a patent attorney and senior partner at the patent attorney firm Reinhold Cohn and Partners, where he has been an
attorney since 1986. Dr. Cohn co-founded Can-Fite, served as its Chief Executive Officer until September 2004, served on our Board
of Directors since 1994 and since May 30, 2013 serves as the Chairman of the Can-Fite Board of Directors. Dr. Cohn has also been
a director of OphthaliX since November 21, 2011. Dr. Cohn holds a Ph.D. in biology and is a patent attorney with many years of
experience in the biopharmaceutical field. He has served on the Board of Directors of a number of life science companies, including
Discovery Laboratories Inc. (formerly Ansan Pharmaceuticals), a U.S. public company. Dr. Cohn has also been involved in the past
in management of venture capital funds focused on investments in the life sciences industry. Dr. Cohn served a number of years
as a co-chairman of the Biotech Committee of the US-Israeli Science and Technology Commission. Dr. Cohn is also currently a member
of the Board of Directors of I.C.R.C. Management Ltd, Famillion BVI Ltd. and Famillion Ltd. (a subsidiary of Famillion BVI Ltd.).Dr.
Cohn holds a Ph.D. in Biology from the Hebrew University of Jerusalem.



Pnina Fishman,
Ph.D. Pnina Fishman, Ph.D. co-founded Can-Fite and has served as our Chief Executive Officer and served on our Board
of Directors since September 2005. Dr. Fishman is the scientific founder of Can-Fite and was previously a professor of Life Sciences
and headed the Laboratory of Clinical and Tumor Immunology at the Felsenstein Medical Research Institute, Rabin Medical Center,
Israel. Dr. Fishman has authored or co-authored over 150 publications and presented the findings of her research at many major
scientific meetings. Her past managerial experience included seven years as Chief Executive Officer of Mor Research Application,
the technology transfer arm of Clalit Health Services, the largest healthcare provider in Israel. Mor Research Application was
also the first clinical research organization in Israel. Dr. Fishman currently also serves as a member of the Board of Directors
of F.D Consulting Ltd., Ultratrend Ltd., and Eye-Fite Ltd. Dr. Fishman holds a Ph.D. in Immunology from the Bar Ilan University
in Ramat Gan, Israel.



Motti Farbstein.
Motti Farbstein has been with Can-Fite since 2003. Mr. Farbstein served as our Chief Operating Officer from August 2003 until
May 2005 and from that date onwards he served as Chief Operating and Financial Officer. Mr. Farbstein also serves as a director
of Eye-Fite Ltd. since July 2011. Mr. Farbstein’s past managerial experience includes seven years as Vice President of Mor
Research Application, a company that managed the commercialization of the intellectual property of all hospitals and research
centers affiliated with Clalit Health Services, which is the largest healthcare provider in Israel and was Israel’s first
clinical CRO. Mr. Farbstein also has extensive experience in the data management of clinical trials.





90


Table of Contents




Sari Fishman,
Ph.D.Sari Fishman, Ph.D. has served as our Director Clinical Affairs from 2004 to 2014, Director of Business Development
from 2014 to 2017 and since 2017 serves as VP of Business Development. Dr. Fishman gained her Ph.D. at the Bar-Ilan University,
Ramat-Gan, Israel.



Abraham Sartani,
M.D. Abraham Sartani has served on our Board of Directors since 2001. Dr. Sartani has over 30 years of experience
in the pharmaceuticals industry and currently acts as a consultant to pharmaceutical and medical device companies. Dr. Sartani
is a member of a number of scientific and management societies and the author or co-author of numerous publications and patents
in the urology, pain treatment and hypertension fields. Dr. Sartani previously served on the Board of Directors of Akkadeas Pharma
Srl (formerly Arkadia Pharma) and was a co-founder. From 1985 until 2008, Dr. Sartani was the Vice-President of R&D and Licensing
and Group coordinator of B&D of Recordati, a European specialty pharmaceutical company. Prior to joining Recordati, from 1980
until 1985, Dr. Sartani was employed at Farmitalia-Carlo Erba, serving in a number of capacities, including as the Medical Director
for Europe.



Guy Regev.Guy
Regev has over twelve years of experience in accounting, financial management and control and general management of commercial
enterprises. He has served on our Board of Directors since July 2011 and has served as a member of our Audit Committee and Compensation
Committee since February 2014. Mr. Regev has also been a director of OphthaliX since November 2011. Mr. Regev is currently the
Chief Executive Officer of Gaon Holdings Ltd, a publicly traded Israeli holding company traded on the TASE which focuses on three
areas of operation - Cleantech / Water, Financial Services, Retail/Trading. Mr. Regev is currently also the Chief Executive Officer
of Middle East Tube Company Ltd a publicly traded Israeli company traded on the TASE which focuses on steel pipe manufacturing
and galvanization services. Mr. Regev was the Chief Executive Officer of Shaked Global Group Ltd, a privately-held equity investment
firm that provides value added capital to environmental-related companies and technologies. Prior to joining Shaked, from 2001
to 2008, Mr. Regev was Vice President of Commercial Business at Housing & Construction Holding, or HCH, Israel’s largest
infrastructure company. His duties included being responsible for the consolidation and financial recovery of various business
units within HCH. Prior to that, Mr. Regev carried several roles within the group including as a Chief Financial Officer and later
the Chief Executive Officer of Blue-Green Ltd., the environmental services subsidiary of HCH. Between 1999 and 2001, Mr. Regev
was a manager at Deloitte & Touche, Israel. Mr. Regev holds an LLB degree in Law (Israel) and is a licensed attorney and has
been a licensed CPA since 1999. Mr. Regev is also a director of, The Green Way Ltd, Shtang Construction and Engineering Ltd, R.I.B.E.
Consulting & Investment Ltd., Middle East Tube Company Ltd, Middle East Tube - Industries 2001 Ltd, Middle East Tubes - Galvanizing
(1994) Ltd, I-Solar Greentech Ltd, Plassim Infrastructure Ltd, Plassim Advanced Solutions in Sanitation Ltd, Hakohav Valves Industries
Metal (1987) Ltd, Metzerplas Agriculture Cooperative Ltd, B. Gaon Retail & Trading Ltd, Gaon Agro - Rimon Management Services
Ltd, B. Gaon Business (2004) Ltd, Gaon Antan Investments Ltd, Or Asaf Investments Ltd, Hamashbir Holdings (1999) Ltd, and AHAVA
Holdings LTD.



Israel Shamay.Israel Shamay has served as external director since December 2014 and serves as a member on both the Audit Committee
and Compensation Committee. Since 2012 Mr. Shamay has served as Executive Director, Strategic Initiatives and Head of the Americas
Operations of MATIMOP (Israeli Industry Center for R&D), the International Operations agency of the Israeli Office of the
Israel Innovation Authority (formerly the Office of Chief Scientist), focusing on developing and implementing cooperation platforms
for industrial R&D and innovation projects in the Americas region. From 2006 until 2012 Mr. Shamay served as Executive Director
of European Cooperations at MATIMOP, where he was in charge of architecting, realizing and evaluating industrial innovation cooperation
frameworks at bilateral and European level, making them a major R&D cooperation instrument for Israeli industry with Europe.
Between 2010 and 2011, Mr. Shamay was Head of the Israeli EUREKA Chairmanship Program (EUREKA is Europe’s largest innovation
network with nearly 40 member states). The Israeli EUREKA Chairmanship focused on developing new financial instruments for innovative
small and medium sized enterprises and on expanding EUREKA’s international dimension. From 2002 Mr. Shamay served as Israel’s
National Representative in several international R&D programs, from 2005 as an expert evaluator for the EU Framework Programs
for R&D and from 2006 until 2009 managed the Israeli R&D collaboration with the EU Global Satellite Navigation Program
– GALILEO. From 1991 until 2001, Mr. Shamay served in senior technical, marketing and executive positions in Israeli hi-tech
companies operating globally, including the RAD group and Comverse Technologies. Mr. Shamay is an MBA graduate of the Recanati
School of Business at the Tel-Aviv University and a graduate of the Technion in Haifa, faculty of Information Systems Engineering.





91


Table of Contents




Yaacov Goldman. Yaacov
Goldman has served as external director since August 2017. Mr. Goldman provides consulting services to companies in strategic-financial
areas, through his wholly owned company, Maanit-Goldman Management & Investments (2002) Ltd. Mr. Goldman also serves as a
director of Avgol Industries 1953 Ltd., Meitav Dash Investments Ltd., Industrial Buildings Corporation Ltd., IceCure Medical Ltd.
and Fattal Properties (Europe) Ltd. Mr. Goldman served as the Professional Secretary of the Peer Review Institute of the Certified
Public Accountants Institute in Israel from October 2004 until September 2008. Commencing in 1981, Mr. Goldman worked for Kesselman
& Kesselman (Israeli member firm of PricewaterhouseCoopers) for 19 years, and from 1991 until 2000, as a partner and then
senior partner of such firm. From September 2000 until November 2001, Mr. Goldman served as managing director of Argoquest Holdings,
LLC. Mr. Goldman holds a B.A. degree in Economics and Accounting from Tel Aviv University and is a Certified Public Accountant
(Israel).



B. Compensation.



Compensation of Directors and Senior Management



The following table
presents in the aggregate all compensation we paid to all of our office holders as a group for the year ended December 31, 2018.
It does not include any business travel, relocation, professional, and business association dues and expenses reimbursed to office
holders, and other benefits commonly reimbursed or paid by companies in Israel.



The term ‘office
holder’ as defined in the Companies Law includes a general manager, chief business manager, deputy general manager, vice
general manager, any other person fulfilling or assuming the responsibilities of any of the foregoing positions without regard
to such person’s title, as well as a director, or a manager directly subordinate to the general manager or the chief executive
officer. As of March 21, 2018, in addition to the six members of the Board of Directors (including the Company’s Chief Executive
Officer), the Company considers two other individuals, including its Chief Financial Officer and its VP Business Development to
be office holders.



|                                                       |  | Salaries, fees, commissions,
    bonuses and options (thousand NIS) |      
|------------------------------------------------------ |  | ------------------------------------------------------------------- | -----
|All office holders as a group, consisting of 8 persons |  |                                                                     | 3,024





92


Table of Contents




The following table
presents information regarding compensation reflected in our financial statements for five most highly compensated office holders,
as of December 31, 2018.



|Name and Position                        |  | Salary             |       |     | Bonus(4) |  |     | Value of Options Granted(5) |  |  | Other(6) |  |  | Total |   
|---------------------------------------- |  | ------------------ | ----- | --- | -------- |  | --- | --------------------------- |  |  | -------- |  |  | ----- | --
|                                         |  | (NIS in thousands) |      
|Pnina Fishman  Chief Executive Officer   |  |                    | 1,301 | (1) |          |  | 337 |                             |  |  | 57       |  |  |       | 50
|                                         |  |                    |       |     |          |  |     |                             |  |  |          |  |  |       |   
|Motti Farbstein  Chief Financial Officer |  |                    | 694   | (2) |          |  | 240 |                             |  |  | 255      |  |  |       | 50
|                                         |  |                    |       |     |          |  |     |                             |  |  |          |  |  |       |   
|Sari FishmanVP Business Development      |  |                    | 529   | (2) |          |  | 200 |                             |  |  | 212      |  |  |       | 50
|                                         |  |                    |       |     |          |  |     |                             |  |  |          |  |  |       |   
|Yaacov GoldmanExternal Director          |  |                    | 112   | (3) |          |  | -   |                             |  |  | 37       |  |  |       | - 
|                                         |  |                    |       |     |          |  |     |                             |  |  |          |  |  |       |   
|Guy RegevExternal Director               |  |                    | 108   | (3) |          |  | -   |                             |  |  | 37       |  |  |       | - 



|(1) | Amount represents
    consulting fee.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
|--- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|(2) | Salary includes
    gross salary plus payment of social benefits made by us on behalf of such person. Such benefits may include, to the extent
    applicable, payments, contributions and/or allocations for savings funds (e.g., managers’ life insurance policy), education
    funds (referred to in Hebrew as “keren hishtalmut”), pension, severance, risk insurances (e.g., life, or work
    disability insurance), payments for social security payments and tax gross-up payments, vacation, medical insurance and benefits,
    convalescence or recreation pay and other benefits and perquisites consistent with our policies.
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|(3) | Amount represents
    fees for board service.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|(4) | Amounts reported
    in this column refer to the cash bonuses provided by us with respect to 2018, which have been provided for in our financial
    statements for the year ended December 31, 2018 (including if such bonuses were paid in 2019). They exclude bonuses paid in
    2018 which were provided for in the Company’s financial statements for previous years.                                                                                                                                                                                                                                                                
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|(5) | The value of options
    is the expense recorded in our financial statements for the period ended December 31, 2018 with respect to all options granted
    to such person. Assumptions and key variables used in the calculation of such amounts are discussed in Note 12 of our financial
    statements.                                                                                                                                                                                                                                                                                                                                
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|(6) | Amount represents cost of use of company car.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              



Each director other
than our Chief Executive Officer and Avraham Sartani, is entitled to the payment of annual fee of NIS 48,721 (approximately $12,671),
and payment of NIS 3,256 (approximately $847) per meeting for participating in meetings of the board and committees of the board.
The annual fee shall not exceed the annual fee of an expert external director set forth in the Companies Regulations (Rules regarding
Compensation and Expenses of External Directors) 5760-2000 as adjusted by the Companies Regulations (Relief for Public Companies
with Shares Listed for Trading on a Stock Market Outside of Israel), 5760-2000. The compensation awarded for participating in
resolutions that are adopted without an actual convening (i.e., unanimous written resolutions) and for participating through telephone
meetings will be reduced as follows: (1) for resolutions that will be adopted without an actual convening, the participation compensation
will be reduced by 50%; and (2) for participation through telephone meetings, the participation compensation will be reduced by
40%. The participation compensation and the annual fee is inclusive of all expenses incurred by our directors in connection with
their participation in a meeting held at our offices or with regard to resolutions resolved by written consent or teleconference.
Avraham Sartani is entitled to a fee of $1,000 per meeting. In addition, our directors (other than our Chief Executive Officer
and external directors) are entitled to reimbursement for expenses related to their participation at meetings taking place not
at our offices and outside their respective residency area.



Employment and Consulting Agreements



We have entered into
employment or consulting agreements with our directors, senior management and key service providers. All of these agreements contain
customary provisions regarding noncompetition, confidentiality of information and assignment of proprietary information and inventions.
However, the enforceability of the noncompetition provisions may be limited under applicable law.





93


Table of Contents




The following are
summary descriptions of certain agreements to which we are a party. The descriptions provided below do not purport to be complete
and are qualified in their entirety by the complete agreements, which are attached as exhibits to this Annual Report on Form 20-F.



Service Management
Agreement with F.D. Consulting: On June 27, 2002, we entered into a Service Management Agreement with F.D. Consulting, a company
partially owned by Pnina Fishman, pursuant to which Dr. Fishman began serving as our Chief Scientific Officer and later became
our Chief Executive Officer and is a member of our Board of Directors and continues to be retained through this agreement. F.D.
Consulting’s current gross monthly fee is NIS 108,360 which is linked to the Israeli CPI and fluctuates accordingly. Dr.
Fishman, through F.D. Consulting, is also entitled to reimbursement for reasonable out-of-pocket expenses and use of a company
automobile and mobile phone.



The term of F.D. Consulting’s
service management agreement is indefinite, unless earlier terminated for cause by us or without cause by either party, subject
to three months’ advanced notice.



Dr. Fishman is also
entitled to receive options exercisable into our ordinary shares from time to time. As of March 21, 2019, we have granted
her options to purchase an aggregate of 744,443 ordinary shares, of which (i) 241,613 were exercised into ordinary shares, (ii)
options to purchase 195,630 ordinary shares expired, (iii) 2,680,000 options to purchase 107,200 ordinary shares have an exercise
price of NIS 0.644 per option, are fully vested and expire on January 13, 2021, and (iii) 200,000 options to purchase 200,000
ordinary shares have an exercise price of NIS 3.573 per ordinary share, vesting on a quarterly basis over three years commencing
October 22, 2015, and expire on October 22, 2025.



On January 7, 2019,
our compensation committee and board of directors approved the grant, subject to shareholder approval which was obtained on March
11, 2019, to Dr. Fishman of 400,000 options to purchase 400,000 ordinary shares of the Company. The options will be issued under
the following terms: (i) the exercise price per each such option shall be an exercise price equal to the average price of our
ordinary shares on the Tel Aviv Stock Exchange in the 30 trading days before the issuance; and (ii) such options shall vest on
a quarterly basis over four years such that 25,000 options shall vest at the end of each calendar quarter and that the options
shall be granted in accordance with our 2013 Share Option Plan.



Employment and
Non-Competition Agreement with Motti Farbstein: On September 1, 2003 we entered into an employment and non-competition agreement
with Motti Farbstein pursuant to which Mr. Farbstein began serving as our Director of Clinical Operations and Administrative Affairs
on September 1, 2003 and is currently serving as our Chief Operating and Financial Officer. Mr. Farbstein’s current gross
monthly salary is NIS 52,000. Mr. Farbstein is entitled to an allocation to a manager’s insurance policy equivalent to an
amount up to 13-1/3% of his gross monthly salary, up to 2-1/2% of his gross monthly salary for disability insurance and 7-1/2%
of his gross monthly salary for a study fund. The foregoing amounts are paid by us. Five percent of his gross monthly salary is
deducted for the manager’s insurance policy and 2-1/2% is deducted for the study fund. Mr. Farbstein is also entitled to
reimbursement for reasonable out-of-pocket expenses, including travel expenses, and use of a company automobile and mobile phone.



The term of Mr. Farbstein’s
employment and non-competition agreement is indefinite, unless earlier terminated for just cause by either party, upon the death,
disability or retirement age, or without cause by either party, subject to 60 days’ advanced notice.



Mr. Farbstein is also
entitled to receive options exercisable into our ordinary shares from time to time. As of March 21, 2019, we have granted
him options to purchase an aggregate of 514,195 ordinary shares, of which (i) options to purchase ordinary shares were exercised
into 1,133 ordinary shares, (ii) options to purchase 35, 062 ordinary shares, (iii) 100,000 options are exercisable into 4,000
ordinary shares at an exercise price of NIS 0.385 per option, are fully vested, and expire on May 2, 2022, (iv) 100,000 options
are exercisable into 4,000 ordinary shares at an exercise price of NIS 0.326 per option are fully vested, and expire on March
20, 2023, (v) 10,000 options to purchase 10,000 ordinary shares at an exercise price of NIS 8.1205 per option, vesting on a quarterly
basis over four years commencing March 19, 2015, and expire on March 18, 2025, (vi) 60,000 options to purchase 60,000 ordinary
shares at an exercise price of NIS 4.317 per option, vesting on a quarterly basis over four years commencing February 18, 2016
and expire on February 18, 2026, (vii) 250,000 options to purchase 250,000 ordinary shares at an exercise price of NIS 2.513 per
option, vesting on a quarterly basis over four years commencing December 28, 2017 and expire on December 28, 2027, and (viii)
150,000 options to purchase 150,000 ordinary shares at an exercise price of NIS 2.344 per option, vesting on a quarterly basis
over four years commencing January 7, 2019 and expire on January 7, 2029.





94


Table of Contents




Consulting Agreement
with BioStrategics: On September 27, 2005, we entered into a consulting agreement with BioStrategics through its President,
Michael Silverman pursuant to which Dr. Silverman began serving as our Medical Director. Dr. Silverman has extensive experience
in clinical development acquired through his involvement in clinical development in large pharmaceutical and small biopharmaceutical
companies. He was involved in international clinical research, market-oriented strategic planning, and the challenges of managing
research and development portfolios in various capacities at Sterling Winthrop Research Institute and subsequently at Sandoz Research
Institute.



BioStrategics’
current fee is $400 per hour with a maximum daily fee of $2,600. In addition, BioStrategics is entitled to reimbursement for reasonable
pre-approved expenses. The term of the consulting agreement is currently on a year-to-year basis, unless earlier terminated by
either party upon 30 days’ prior written notice or immediately by either party if such termination is for cause.



Master Services
Agreement with Accellient Partners: On May 10, 2010, we entered into a Master Services Agreement with Accellient Partners,
a company owned by William Kerns, who currently serves as our current Vice President of Drug Development. Dr. Kerns has over 20
years of experience in Pharmaceutical Research and Development at SmithKline Beecham and Eisai Pharmaceuticals. As a Senior Executive
he has participated in the development of drugs for over 100 Phase I studies and 13 NDA’s and/or Marketing Authorization
Applications. Dr. Kerns has chaired a FDA committee on biomarkers and he is an expert in preclinical development and regulatory
strategy.



According to the agreement,
consulting services are provided by Accellient Partners’ personnel in accordance with individual work orders that are executed
from time to time. Each individual work order defines the scope of work to be provided and sets forth the fees to be paid to Accellient
Partners.



Beginning on May 10,
2012, the term of the master services agreement is on a month-to-month basis, unless terminated by us upon 30 days’ prior
written notice, by us at any time if Accellient Partners commits a breach and fails to cure, or by Accellient Partners upon 30
days’ prior written notice if we commit a breach and fail to cure.



Reinhold Cohn and
Partners: Reinhold Cohn and Partners, an Israeli partnership, of which Ilan Cohn, Ph.D. is a partner provides intellectual
property services to us in the ordinary course of business.



C. Board Practices



General



According to the Israeli
Companies Law, the management of our business is vested in our Board of Directors. Our Board of Directors may exercise all powers
and may take all actions that are not specifically granted to our shareholders. Our executive officers are responsible for our
day-to-day management and have individual responsibilities established by our Board of Directors. Executive officers are appointed
by and serve at the discretion of our Board of Directors, subject to any applicable employment agreements we have entered into
with the executive officers. See “Item 6. Directors, Senior Management and Employees—B. Compensation—Employment
and Consulting Agreements.”



Election of Directors and Terms
of Office



Our Board of Directors
currently consists of six members. Other than our two external directors, our directors are elected by an ordinary resolution
at the annual general meeting of our shareholders. The nomination of our directors is proposed by the Board of Directors. Our
board has the authority to add additional directors up to the maximum number of 12 directors allowed under our Articles. Such
directors appointed by the board serve until the next annual general meeting of the shareholders. Unless they resign before the
end of their term or are removed in accordance with our Amended and Restated Articles of Association, all of our directors, other
than our external directors, will serve as directors until our next annual general meeting of shareholders. On December 10, 2018,
at an annual general meeting of our shareholders, Pnina Fishman, Ilan Cohn, Abraham Sartani, and Guy Regev were re-elected to
serve as directors for a term expiring at our next annual general meeting of shareholders and until his or her respective successor
is duly elected. On August 1, 2017, at an annual general meeting of our shareholders Yaacov Goldman was elected to serve as one
of our external directors for a three-year term ending July 31, 2020. On December 27, 2017, at a special meeting of our shareholders,
Israel Shamay was elected to serve for a three-year term ending December 26, 2020 as one of our external directors. Israel Shamay
may be re-elected for another three-year term. On May 30, 2013, Ilan Cohn was appointed as Chairman of the Board.





95


Table of Contents




None of our directors
or senior management has any family relationship with any other director or senior management except that Sari Fishman is the
daughter of Pnina Fishman. None of our directors have service contracts that provide for benefits upon termination of his or her
directorship with us, other than the payment of salary due, accrued and unpaid as of and through the date of termination. See
“Item 6. Directors, Senior Management and Employees—B. Compensation—Employment and Consulting Agreements.”



Chairman of the
Board. Under the Israeli Companies Law, without shareholder approval, a person cannot hold the role of both chairman of the
board of directors and chief executive officer of a company. Furthermore, a person who is directly or indirectly subordinate to
a chief executive officer of a company may not serve as the chairman of the board of directors of that company and the chairman
of the board of directors may not otherwise serve in any other capacity in a company or in a subsidiary of that company other
than as the chairman of the board of directors of such a subsidiary.



The Israeli Companies
Law provides that an Israeli company may, under certain circumstances, exculpate an office holder from liability with respect
to a breach of his duty of care toward the company if appropriate provisions allowing such exculpation are included in its articles
of association. Our Amended and Restated Articles of Association permit us to maintain directors’ and officers’ liability
insurance and to indemnify our directors and officers for actions performed on behalf of us, subject to specified limitations.
We maintain a directors and officers insurance policy which covers the liability of our directors and officers as allowed under
the Israeli Companies Law.



The term office holder
is defined in the Israeli Companies Law as a director, general manager, chief business manager, deputy general manager, vice general
manager, executive vice president, vice president, any other manager directly subordinate to the general manager or any other
person assuming the responsibilities of any of the foregoing positions, without regard to such person’s title.



External and Independent Directors



Under
the Israeli Companies Law, the boards of directors of companies whose shares are publicly traded, either within or outside of
Israel, are required to include at least two members who qualify as external directors.



External
directors must be elected by a majority vote of the shares present and voting at a shareholders meeting, provided that either:



| | ● | the
    majority of the shares that are voted at the meeting, including at least a majority of the shares held by non-controlling
    shareholders who do not have a personal interest in the election of the external director (other than a personal interest
    not deriving from a relationship with a controlling shareholder) who voted at the meeting, excluding abstentions, vote in
    favor of the election of the external director; or
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the
    total number of shares held by non-controlling, disinterested shareholders (as described in the preceding bullet point) that
    are voted against the election of the external director does not exceed 2% of the aggregate voting rights in the company.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





96


Table of Contents




The
term controlling shareholder is defined in the Israeli Companies Law as a shareholder with the ability to direct the activities
of the Company, other than by virtue of being an office holder, but there is a presumption that a shareholder holding 25% of the
shares of the Company is regarded as a controlling shareholder. A person may not serve as an external director of a company if
(i) such person is a relative of a controlling shareholder of a company or (ii) at the date of such person’s appointment
or within the prior two years, such person, such person’s relative, partner, employer or any entity under such person’s
control or anyone to whom such person is subordinate, whether directly or indirectly, has or had any affiliation with (a) the
company, (b) the controlling shareholder at the time of such person’s appointment or (c) any entity that is either controlled
by the company or under common control with the company at the time of such appointment or during the prior two years. If a company
does not have a controlling shareholder or a shareholder who holds company shares entitling him to vote at least 25% of the votes
in a shareholders meeting, then a person may not serve as an external director if, such person or such person’s relative,
partner, employer or any entity under such person’s control, has or had, on or within the two years preceding the date of
the person’s appointment to serve as an external director, any affiliation with the chairman of our board of directors,
chief executive officer, a substantial shareholder who holds at least 5% of the issued and outstanding shares of the company or
voting rights which entitle him to vote at least 5% of the votes in a shareholders meeting, or the chief financial officer of
the company.



The
term affiliation includes:



| | ● | an employment relationship;
| | - | ---------------------------



| | ● | a business or professional
    relationship even if not maintained on a regular basis (excluding insignificant relationships);
| | - | ------------------------------------------------------------------------------------------------------------------------------



| | ● | control; and
| | - | ------------



| | ● | service as an office
    holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such
    director was appointed as a director of the private company in order to serve as an external director following the public
    offering.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The
term relative is defined as a spouse, sibling, parent, grandparent or descendant; a spouse’s sibling, parent or descendant;
and the spouse of each of the foregoing persons.



In
addition, no person may serve as an external director if that person’s professional activities create, or may create, a
conflict of interest with that person’s responsibilities as a director or otherwise interfere with that person’s ability
to serve as an external director or if the person is an employee of the Israel Securities Authority, or the ISA, or of the TASE.
Furthermore, a person may not continue to serve as an external director if he or she received direct or indirect compensation
from the company for his or her role as a director. This prohibition does not apply to compensation paid or given in accordance
with regulations promulgated under the Israeli Companies Law or amounts paid pursuant to indemnification and/or exculpation contracts
or commitments and insurance coverage. If, at the time an external director is appointed, all current members of the board of
directors not otherwise affiliated with the company are of the same gender, then that external director must be of the other gender.
In addition, a director of a company may not be elected as an external director of another company if, at that time, a director
of the other company is acting as an external director of the first company.



Following
the termination of an external director’s service on a board of directors, such former external director and his or her
spouse and children may not be provided with a direct or indirect benefit by the company, its controlling shareholder or any entity
under its controlling shareholder’s control. This includes engagement to serve as an executive officer or director of the
company or a company controlled by its controlling shareholder, or employment by, or providing services to, any such company for
consideration, either directly or indirectly, including through a corporation controlled by the former external director, for
a period of two years (and for a period of one year with respect to relatives of the former external director).





97


Table of Contents




The Israeli Companies
Law provides that an external director must meet certain professional qualifications or have financial and accounting expertise
and that at least one external director must have financial and accounting expertise. However, if at least one of our other directors
(i) meets the independence requirements of the Securities Exchange Act of 1934, as amended, (ii) meets the standards of the NYSE
American rules for membership on the audit committee and (iii) has financial and accounting expertise as defined in the Israeli
Companies Law and applicable regulations, then neither of our external directors is required to possess financial and accounting
expertise as long as both possess other requisite professional qualifications. Our Board of Directors is required to determine
whether a director possesses financial and accounting expertise by examining whether, due to the director’s education, experience
and qualifications, the director is highly proficient and knowledgeable with regard to business-accounting issues and financial
statements, to the extent that the director is able to engage in a discussion concerning the presentation of financial information
in our financial statements, among others. The regulations define a director with the requisite professional qualifications as
a director who satisfies one of the following requirements: (i) the director holds an academic degree in either economics, business
administration, accounting, law or public administration; (ii) the director either holds an academic degree in any other field
or has completed another form of higher education in our primary field of business or in an area which is relevant to the office
of an external director; or (iii) the director has at least five years of experience serving in any one of the following, or at
least five years of cumulative experience serving in two or more of the following capacities: (a) a senior business management
position in a corporation with a substantial scope of business; (b) a senior position in our primary field of business; or (c)
a senior position in public administration. Yaacov Goldman, who is one of our external directors, meets the required qualifications
and has financial and accounting expertise as required by the Israeli Companies Law, while Guy Regev, an independent director,
also meets the required qualifications and has financial and accounting expertise as required by the Israeli Companies Law.



The Israeli Companies
Law defines an independent director as a director who complies with the following and was appointed as such in accordance with
Chapter 1 of Part 56 of the Israeli Companies Law: (1) the director complies with the qualification to serve as an external director
as set out in Sections 240 (b)-(f) of the Israeli Companies Law and the audit committee has approved such compliance; and (2)
the director has not served as a director of the company for more than nine consecutive years (which, for such purpose, does not
include breaks in such service for periods of less than two year).



If an external directorship
becomes vacant and there are less than two external directors on the board of directors at the time, then the board of directors
is required under the Israeli Companies Law to call a shareholders’ meeting as soon as possible to appoint a replacement
external director.



Each committee of
the board of directors that is authorized to exercise the powers of the board of directors must include at least one external
director, except that the audit committee and compensation committee must each include all external directors then serving on
the board of directors. Under the Israeli Companies Law, external directors of a company are prohibited from receiving, directly
or indirectly, any compensation for their services as external directors, other than compensation and reimbursement of expenses
pursuant to applicable regulations promulgated under the Israeli Companies Law. Compensation of an external director is determined
prior to his or her appointment and may not be changed during his or her term subject to certain exceptions.



Israel Shamay and
Yaacov Goldman serve as external directors on our Board of Directors pursuant to the provisions of the Israeli Companies Law.
They both serve on our audit committee and our compensation committee. Our Board of Directors has determined that Yaacov Goldman
possesses accounting and financial expertise, and that both of our external directors possess the requisite professional qualifications.
In addition to our external directors, Guy Regev and Abraham Sartani serve as independent directors on our Board of Directors.
Guy Regev also serves on our audit committee and our compensation committee.



Audit Committee



The Israeli Companies
Law requires public companies to appoint an audit committee. The responsibilities of the audit committee include identifying irregularities
in the management of our business and approving related party transactions as required by law. An audit committee must consist
of at least three directors, including all of its external directors and a majority of independent directors. The chairman of
the board of directors, any director employed by or otherwise providing services to the company, and a controlling shareholder
or any relative of a controlling shareholder, may not be a member of the audit committee. An audit committee may not approve an
action or a transaction with a controlling shareholder, or with an office holder, unless at the time of approval two external
directors are serving as members of the audit committee and at least one of the external directors was present at the meeting
in which an approval was granted.





98


Table of Contents




Our audit committee
is currently comprised of three independent non-executive directors. The audit committee is chaired by Yaacov Goldman, who serves
as the audit committee financial expert, with Israel Shamay and Guy Regev as members. Our audit committee meets at least four
times a year and monitors the adequacy of our internal controls, accounting policies and financial reporting. It regularly reviews
the results of the ongoing risk self-assessment process, which we undertake, and our interim and annual reports prior to their
submission for approval by the full Board of Directors. The audit committee oversees the activities of the internal auditor, sets
its annual tasks and goals and reviews its reports. The audit committee reviews the objectivity and independence of the external
auditors and also considers the scope of their work and fees.



Our audit committee
provides assistance to our Board of Directors in fulfilling its legal and fiduciary obligations in matters involving our accounting,
auditing, financial reporting, internal control and legal compliance functions by pre-approving the services performed by our
independent accountants and reviewing their reports regarding our accounting practices and systems of internal control over financial
reporting. Our audit committee also oversees the audit efforts of our independent accountants and takes those actions that it
deems necessary to satisfy itself that the accountants are independent of management.



Under the Israeli Companies
Law, our audit committee is responsible for (i) determining whether there are deficiencies in the business management practices
of our company, including in consultation with our internal auditor or the independent auditor, and making recommendations to the
Board of Directors to improve such practices and amend such deficiencies, (ii) determining whether certain related party transactions
(including transactions in which an office holder has a personal interest) should be deemed as material or extraordinary, and to
approve such transactions (which may be approved according to certain criteria set out by our audit committee on an annual basis)
(see “—Approval of Related Party Transactions under the Israeli Companies Law”); (iii) establishing procedures
to be followed in respect of related party transactions with a controlling shareholder (where such are not extraordinary transactions),
which may include, where applicable, the establishment of a competitive process for such transaction, under the supervision of
the audit committee, or individual, or other committee or body selected by the audit committee, in accordance with criteria determined
by the audit committee; (iv) determining procedures for approving certain related party transactions with a controlling shareholder,
which having been determined by the audit committee not to be extraordinary transactions, were also determined by the audit committee
not to be negligible transactions; (v) approving the working plan of the internal auditor, to examine such working plan before
its submission to the Board and proposing amendments thereto, (vi) examining our internal controls and internal auditor’s
performance, including whether the internal auditor has sufficient resources and tools to dispose of its responsibilities, (vii)
examining the scope of our auditor’s work and compensation and submitting a recommendation with respect thereto to our Board
of Directors or shareholders, depending on which of them is considering the appointment of our auditor, and (viii) establishing
procedures for the handling of employees’ complaints as to the management of our business and the protection to be provided
to such employees.



We have adopted a
written charter for our audit committee, setting forth its responsibilities as outlined by the regulations of the SEC. In addition,
our audit committee has adopted procedures for the receipt, retention and treatment of complaints we may receive regarding accounting,
internal accounting controls or auditing matters and the submission by our employees of concerns regarding questionable accounting
or auditing matters. In addition, SEC rules mandate that the audit committee of a listed issuer consist of at least three members,
all of whom must be independent, as such term is defined by rules and regulations promulgated by the SEC. We are in compliance
with the independence requirements of the SEC rules.



Any person who is
not eligible to serve on the audit committee is further restricted from participating in its meetings and votes, unless the chairman
of the audit committee determines that such person’s presence is necessary in order to present a certain matter; provided,
however, that company employees who are not controlling shareholders or relatives of such shareholders may be present in the meetings,
but not for actual voting, and likewise, company counsel and secretary who are not controlling shareholders or relatives of such
shareholders may be present in the meetings and for actual voting if such presence is requested by the audit committee.



In addition to the
above, all such committee’s members must apply with the following requirements:



| | ● | All members shall
    be members of the board of directors of the company.
| | - | --------------------------------------------------------------------------



| | ● | At least one of
    the committee’s members shall have financial and accounting expertise and the rest of the committee’s members
    must have the ability to read and understand financial statements.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Our company, through
our audit committee, is in full compliance with the above requirements.





99


Table of Contents




Financial Statement Examination
Committee



Under
the Israeli Companies Law, the board of directors of a public company must appoint a financial statement examination committee,
which consists of members with accounting and financial expertise or the ability to read and understand financial statements.
According to a resolution of our Board of Directors, the audit committee has been assigned the responsibilities and duties of
a financial statements examination committee, as permitted under relevant regulations promulgated under the Israeli Companies
Law. From time to time as necessary and required to approve our financial statements, the audit committee holds separate meetings,
prior to the scheduled meetings of the entire Board of Directors regarding financial statement approval. The function of a financial
statements examination committee is to discuss and provide recommendations to its board of directors (including the report of
any deficiency found) with respect to the following issues: (i) estimations and assessments made in connection with the preparation
of financial statements; (ii) internal controls related to the financial statements; (iii) completeness and propriety of the disclosure
in the financial statements; (iv) the accounting policies adopted and the accounting treatments implemented in material matters
of the company; and (v) value evaluations, including the assumptions and assessments on which evaluations are based and the supporting
data in the financial statements. Our independent auditors and our internal auditors are invited to attend all meetings of audit
committee when it is acting in the role of the financial statements examination committee.



Compensation Committee



Amendment
no. 20 to the Israeli Companies Law was published on November 12, 2012 and became effective on December 12, 2012, or
Amendment no. 20. In general, Amendment no. 20 requires public companies to appoint a compensation committee and to adopt a
compensation policy with respect to its officers, or the Compensation Policy. In addition, Amendment no. 20 addresses the
corporate approval process required for a public company’s engagement with its officers (with specific reference to a
director, a non-director officer, a chief executive officer and controlling shareholders and their relatives who are employed
by the company).



The compensation committee
shall be nominated by the board of directors and be comprised of its members. The compensation committee must consist of at least
three members. All of the external directors must serve on the compensation committee and constitute a majority of its members.
The remaining members of the compensation committee must be directors who qualify to serve as members of the audit committee (including
the fact that they are independent) and their compensation should be identical to the compensation paid to the external directors
of the company.



Similar to the rules
that apply to the audit committee, the compensation committee may not include the chairman of the board, or any director employed
by the Company, by a controlling shareholder or by any entity controlled by a controlling shareholder, or any director providing
services to the company, to a controlling shareholder or to any entity controlled by a controlling shareholder on a regular basis,
or any director whose primary income is dependent on a controlling shareholder, and may not include a controlling shareholder
or any of its relatives. Individuals who are not permitted to be compensation committee members may not participate in the committee’s
meetings other than to present a particular issue; provided, however, that an employee that is not a controlling shareholder or
relative may participate in the committee’s discussions, but not in any vote, and our legal counsel and corporate secretary
may participate in the committee’s discussions and votes if requested by the committee.



The roles of the compensation
committee are, among others, to: (i) recommend to the board of directors the Compensation Policy for office holders and recommend
to the board once every three years the extension of a Compensation Policy that had been approved for a period of more than three
years; (ii) recommend to the directors any update of the Compensation Policy, from time to time, and examine its implementation;
(iii) decide whether to approve the terms of office and of employment of office holders that require approval of the compensation
committee; and (iv) decide, in certain circumstances, whether to exempt the approval of terms of office of a chief executive officer
from the requirement of shareholder approval.





100


Table of Contents




The Compensation Policy
requires the approval of the general meeting of shareholders with a “Special Majority”, which requires a majority
of the shareholders of the company who are not either a controlling shareholder or an “interested party” in the proposed
resolution, or that shareholders holding less than 2% of the voting power in the company voted against the proposed resolution
at such meeting. However, under special circumstances, the board of directors may approve the compensation policy without shareholder
approval, if the compensation committee and thereafter the board of directors decided, based on substantiated reasons after they
have reviewed the Compensation Policy again, that the Compensation Policy is in the best interest of the company. The Compensation
Policy is required to be brought before the shareholders of the Company once every three years for approval.



Under the Israeli
Companies Law, our Compensation Policy must generally serve as the basis for corporate approvals with respect to the financial
terms of employment or engagement of office holders, including exemption, insurance, indemnification or any monetary payment or
obligation of payment in respect of employment or engagement. The Compensation Policy must relate to certain factors, including
advancement of the company’s objective, the company’s business plan and its long term strategy, and creation of appropriate
incentives for office holders. It must also consider, among other things, the company’s risk management, size and nature
of its operations. The Compensation Policy must furthermore consider the following additional factors:



| | ● | The knowledge, skills,
    expertise, and accomplishments of the relevant office holder;
| | - | ----------------------------------------------------------------------------------------



| | ● | The office holder’s
    roles and responsibilities and prior compensation agreements with him or her;
| | - | -----------------------------------------------------------------------------------------------------



| | ● | The relationship
    between the terms offered and the average compensation of the other employees of the company, including those employed through
    manpower companies;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The impact of disparities
    in salary upon work relationships in the company;
| | - | -------------------------------------------------------------------------------



| | ● | The possibility
    of reducing variable compensation at the discretion of the board of directors;
| | - | --------------------------------------------------------------------------------------------------



| | ● | The possibility
    of setting a limit on the exercise value of non-cash variable equity-based compensation; and
| | - | ----------------------------------------------------------------------------------------------------------------



| | ●                                                                       | As to severance
    compensation, the period of service of the office holder, the terms of his or her compensation during such service period,
    the company’s performance during that period of service, the person’s contributions towards the company’s
    achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the
    company.
| | ----------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |                                                                         |                                                                                                                                                                                                                                                                                                                                                                                                        
| | The Compensation Policy must also
    include the following principles:



| | ● | the link between
    variable compensation and the long term performance and measurable criteria;
| | - | -------------------------------------------------------------------------------------------------



| | ● | the relationship
    between variable and fixed compensation, and the ceiling for the value of variable compensation;
| | - | ---------------------------------------------------------------------------------------------------------------------



| | ● | the conditions under
    which an office holder would be required to repay compensation paid to him or her if it was later shown that the data upon
    which such compensation was based was inaccurate and was required to be restated in the company’s financial statements;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the minimum holding
    or vesting period for variable, equity-based compensation; and
| | - | --------------------------------------------------------------------------------------



| | ● | maximum limits for
    severance compensation.
| | - | ----------------------------------------------



The Compensation Policy
was approved by the general meeting of shareholders on January 19, 2017 after discussions and recommendation of the compensation
committee and approval by the Board of Directors. Moreover, the approval of the compensation committee is required in order to
approve terms of office and/or employment of office holders.





101


Table of Contents




Yaacov Goldman is
the chairman of our compensation committee. Israel Shamay and Guy Regev serve as the other members of our compensation committee.



Under Amendment no.
27 to the Israeli Companies Law, which became effective as of February 17, 2016, the audit committee of an Israeli public company
which has been established and conducts itself also in accordance with provisions governing the composition of the compensation
committee as set forth in the Israeli Companies Law, may act in lieu of a compensation committee with respect to the responsibilities
of a compensation committee which are set forth in the Israeli Companies Law.



Approval of Related Party Transactions
under the Israeli Companies Law



Fiduciary
duties of the office holders



The
Israeli Companies Law imposes a duty of care and a duty of loyalty on all office holders of a company. The duty of care of an
office holder is based on the duty of care set forth in connection with the tort of negligence under the Israeli Torts Ordinance
(New Version) 5728-1968. This duty of care requires an office holder to act with the degree of proficiency with which a reasonable
office holder in the same position would have acted under the same circumstances. The duty of care includes a duty to use reasonable
means, in light of the circumstances, to obtain:



| | ● | information on the
    advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
| | - | ----------------------------------------------------------------------------------------------------------------------------------------



| | ● | all other important information pertaining to
    these action.
| | - | ---------------------------------------------------------------



The
duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes the duty to:



| | ● | refrain from any
    act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties
    or personal affairs;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | refrain from any
    activity that is competitive with the business of the company;
| | - | -----------------------------------------------------------------------------------



| | ● | refrain from exploiting
    any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others;
    and
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | disclose to the
    company any information or documents relating to our affairs which the office holder received as a result of his or her position
    as an office holder.
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------



We
may approve an act performed in breach of the duty of loyalty of an office holder provided that the office holder acted in good
faith, the act or its approval does not harm the company, and the office holder discloses his or her personal interest, as described
below.



Disclosure
of personal interests of an office holder and approval of acts and transactions



The
Israeli Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may
have and all related material information or documents relating to any existing or proposed transaction by the company. An interested
office holder’s disclosure must be made promptly and in any event no later than the first meeting of the board of directors
at which the transaction is considered. An office holder is not obligated to disclose such information if the personal interest
of the office holder derives solely from the personal interest of his or her relative in a transaction that is not considered
as an extraordinary transaction.



The
term personal interest is defined under the Israeli Companies Law to include the personal interest of a person in an action or
in the business of a company, including the personal interest of such person’s relative or the interest of any corporation
in which the person is an interested party, but excluding a personal interest stemming solely from the fact of holding shares
in the company. A personal interest furthermore includes the personal interest of a person for whom the office holder holds a
voting proxy or the interest of the office holder with respect to his or her vote on behalf of the shareholder for whom he or
she holds a proxy even if such shareholder itself has no personal interest in the approval of the matter. An office holder is
not, however, obliged to disclose a personal interest if it derives solely from the personal interest of his or her relative in
a transaction that is not considered an extraordinary transaction.





102


Table of Contents




Under
the Israeli Companies Law, an extraordinary transaction which requires approval is defined as any of the following:



| | ● | a transaction other
    than in the ordinary course of business;
| | - | ----------------------------------------------------------------



| | ● | a transaction that
    is not on market terms; or
| | - | -------------------------------------------------



| | ● | a transaction that
    may have a material impact on our profitability, assets or liabilities.
| | - | ----------------------------------------------------------------------------------------------



Under
the Israeli Companies Law, once an office holder has complied with the disclosure requirement described above, a company may approve
a transaction between the company and the office holder or a third party in which the office holder has a personal interest, or
approve an action by the office holder that would otherwise be deemed a breach of duty of loyalty. However, a company may not
approve a transaction or action that is adverse to our interest or that is not performed by the office holder in good faith.



Under
the Israeli Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder,
a transaction with a third party in which the office holder has a personal interest, and an action of an office holder that would
otherwise be deemed a breach of duty of loyalty requires approval by the board of directors. Our Amended and Restated Articles
of Association do not provide otherwise. If the transaction or action considered is (i) an extraordinary transaction, (ii) an
action of an office holder that would otherwise be deemed a breach of duty of loyalty and may have a material impact on a company’s
profitability, assets or liabilities, (iii) an undertaking to indemnify or insure an office holder who is not a director, or (iv)
for matters considered an undertaking concerning the terms of compensation of an office holder who is not a director, including,
an undertaking to indemnify or insure such office holder, then approval by the audit committee is required prior to approval by
the board of directors. Arrangements regarding the compensation, indemnification or insurance of a director require the approval
of the audit committee, board of directors and shareholders, in that order.



A
director who has a personal interest in a matter that is considered at a meeting of the board of directors or the audit committee
may generally not be present at the meeting or vote on the matter, unless a majority of the directors or members of the audit
committee have a personal interest in the matter or the chairman of the audit committee or board of directors, as applicable,
determines that he or she should be present to present the transaction that is subject to approval. If a majority of the directors
have a personal interest in the matter, such matter would also require approval of the shareholders of the company.



Disclosure
of personal interests of a controlling shareholder and approval of transactions



Under
the Israeli Companies Law and a recent amendment thereto, the disclosure requirements that apply to an office holder also apply
to a controlling shareholder of a public company. See “— Audit Committee” for a definition of controlling shareholder.
Extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, including
a private placement in which a controlling shareholder has a personal interest, as well as transactions for the provision of services
whether directly or indirectly by a controlling shareholder or his or her relative, or a company such controlling shareholder
controls, and transactions concerning the terms of engagement of a controlling shareholder or a controlling shareholder’s
relative, whether as an office holder or an employee, require the approval of the audit committee, the board of directors and
a majority of the shares voted by the shareholders of the company participating and voting on the matter in a shareholders’
meeting. In addition, such shareholder approval must fulfill one of the following requirements:



| | ● | at least a majority
    of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be
    voted in favor of approving the transaction, excluding abstentions; or
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                             
| | ● | the shares voted
    by shareholders who have no personal interest in the transaction who vote against the transaction represent no more than 2%
    of the voting rights in the company.                                   





103


Table of Contents




To
the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval is
required once every three years, unless the audit committee determines that the duration of the transaction is reasonable given
the circumstances related thereto.



Duties
of shareholders



Under
the Israeli Companies Law, a shareholder has a duty to refrain from abusing its power in the company and to act in good faith
and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders, including,
among other things, voting at general meetings of shareholders on the following matters:



| | ● | an amendment to
    the articles of association;
| | - | ------------------------------------------------
| |   |                                                 
| | ● | an increase in our
    authorized share capital;



| | ● | a merger;
| | - | ---------



| | ● | an increase in our
    authorized share capital; and
| | - | ----------------------------------------------------



| | ● | the approval of
    related party transactions and acts of office holders that require shareholder approval.
| | - | ------------------------------------------------------------------------------------------------------------



A
shareholder also has a general duty to refrain from discriminating against other shareholders.



The
remedies generally available upon a breach of contract will also apply to a breach of the above mentioned duties, and in the event
of discrimination against other shareholders, additional remedies are available to the injured shareholder.



In addition, any controlling
shareholder, any shareholder that knows that its vote can determine the outcome of a shareholder vote and any shareholder that,
under a company’s articles of association, has the power to appoint or prevent the appointment of an office holder, or has
another power with respect to a company, is under a duty to act with fairness towards the company. The Israeli Companies Law does
not describe the substance of this duty except to state that the remedies generally available upon a breach of contract will also
apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position in the company into account.



Exculpation, Insurance and Indemnification of Directors
and Officers



Under the Israeli
Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company
may exculpate an office holder in advance from liability to us, in whole or in part, for damages caused to us as a result of a
breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our Amended
and Restated Articles of Association include such a provision. We may not exculpate in advance a director from liability arising
out of a prohibited dividend or distribution to shareholders.



Under the Israeli
Companies Law and the Israeli Securities Law, a company may indemnify, or undertake in advance to indemnify, an office holder,
provided its articles of association include a provision authorizing such indemnification, for the following liabilities and expenses
imposed on an office holder or incurred by office holder due to acts performed by him or her as an office holder:



| | ● | Financial liability
    incurred by or imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s
    award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided
    in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen
    based on our activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by
    the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen
    events and amount or criteria;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





104


Table of Contents




| | ● | Reasonable litigation
    expenses, including attorneys’ fees, incurred by the office holder as a result of an investigation or proceeding instituted
    against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment
    was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability
    was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or,
    if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal
    intent or as a monetary sanction;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Reasonable litigation
    expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against
    him or her by us, on our behalf, or by a third party, or in connection with criminal proceedings in which the office holder
    was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent; and
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Expenses, including
    reasonable litigation expenses and legal fees, incurred by an office holder in relation to an administrative proceeding instituted
    against such office holder, or certain compensation payments required to be made to an injured party, pursuant to certain
    provisions of the Israeli Securities Law.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Under the Israeli
Companies Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her
as an office holder if and to the extent provided in the Company’s articles of association:



| | ● | a breach of the
    duty of loyalty to us, provided that the office holder acted in good faith and had a reasonable basis to believe that the
    act would not harm us;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | a breach of duty
    of care to us or to a third party; and
| | - | -----------------------------------------------------------



| | ● | a financial liability
    imposed on the office holder in favor of a third party.
| | - | ---------------------------------------------------------------------------------



Subject to the provisions
of the Israeli Companies Law and the Israeli Securities Law, we may also enter into a contract to insure an office holder, in
respect of expenses, including reasonable litigation expenses and legal fees, incurred by an office holder in relation to an administrative
proceeding instituted against such office holder or payment required to be made to an injured party, pursuant to certain provisions
of the Israeli Securities Law.



Nevertheless, under
the Israeli Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:



| | ● | a breach of fiduciary
    duty, except for indemnification and insurance for a breach of the duty of loyalty to us in the event office holder acted
    in good faith and had a reasonable basis to believe that the act would not prejudice us;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | a breach of duty
    of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | an act or omission
    committed with intent to derive unlawful personal benefit; or
| | - | ------------------------------------------------------------------------------------



| | ● | a fine, monetary
    sanction, penalty or forfeit levied against the office holder.
| | - | -----------------------------------------------------------------------------------



Under the Israeli
Companies Law, exculpation, indemnification and insurance of office holders require the approval of the compensation committee,
board of directors and, in certain circumstances, the shareholders. Our Amended and Restated Articles of Association permit us
to exculpate, indemnify and insure our office holders to the fullest extent permitted by the Israeli Companies Law.





105


Table of Contents




Approval of Compensation to Our
Officers



The Israeli Companies
Law prescribes that compensation to officers must be approved by a company’s Board of Directors after obtaining the approval
of the compensation committee.



As detailed above,
our compensation committee consists of three independent directors: Israel Shamay, Yaacov Goldman and Guy Regev. The responsibilities
of the compensation committee are to set our overall policy on executive remuneration and to decide the specific remuneration,
benefits and terms of employment for directors, officers and the Chief Executive Officer.



The objectives of
the compensation committee’s policies are that such individuals should receive compensation which is appropriate given their
performance, level of responsibility and experience. Compensation packages should also allow us to attract and retain executives
of the necessary caliber while, at the same time, motivating them to achieve the highest level of corporate performance in line
with the best interests of shareholders. In order to determine the elements and level of remuneration appropriate to each executive
director, the compensation committee reviews surveys on executive pay, obtains external professional advice and considers individual
performance.



Internal Auditor



Under the Israeli
Companies Law, the board of directors must appoint an internal auditor, nominated by the audit committee. The role of the internal
auditor is to examine, among other matters, whether our actions comply with the law and orderly business procedure. Under the
Israeli Companies Law, an internal auditor may not be:



| | ● | a person (or a relative
    of a person) who holds more than 5% of our ordinary shares;
| | - | ---------------------------------------------------------------------------------------



| | ● | a person (or a relative
    of a person) who has the power to appoint a director or the general manager of the company;
| | - | -----------------------------------------------------------------------------------------------------------------------



| | ● | an executive officer
    or director of the company (or a relative thereof); or
| | - | -------------------------------------------------------------------------------



| | ● | a member of our
    independent accounting firm, or anyone on his or her behalf.
| | - | --------------------------------------------------------------------------------



We comply with the
requirement of the Israeli Companies Law relating to internal auditors. Our internal auditors examine whether our various activities
comply with the law and orderly business procedure. Our current internal auditor is Deloitte.



D. Employees.



As of December 31,
2018, we had seven employees, three of whom were employed in management and administration, three of whom were employed in research
and development and one of whom was employed in business development. All of these employees were located in Israel.



While none of our
employees are party to any collective bargaining agreements, certain provisions of the collective bargaining agreements between
the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’
Associations) are applicable to our employees by order of the Israel Ministry of Labor. These provisions primarily concern the
length of the workday, minimum daily wages for professional workers, pension fund benefits for all employees, insurance for work-related
accidents, procedures for dismissing employees, determination of severance pay and other conditions of employment. We generally
provide our employees with benefits and working conditions beyond the required minimums. We have never experienced any employment-related
work stoppages and believe our relationship with our employees is good.





106


Table of Contents




E.
Share Ownership.



The following table
sets forth information regarding the beneficial ownership of our outstanding ordinary shares as of March 21, 2019 by the members
of our senior management and board of directors individually and as a group. The beneficial ownership of ordinary shares is based
on the 44,875,482 ordinary shares outstanding as of March 21, 2019 and is determined in accordance with the rules of the SEC and
generally includes any ordinary shares over which a person exercises sole or shared voting or investment power. For purposes of
the table below, we deem shares subject to options or warrants that are currently exercisable or exercisable within 60 days of
March 21, 2019, to be outstanding and to be beneficially owned by the person holding the options or warrants for the purposes
of computing the percentage ownership of that person but we do not treat them as outstanding for the purpose of computing the
percentage ownership of any other person.



|Name of Beneficial Owner                               |  | Number of Ordinary Shares |           |     | Percentage of Class* | 
|------------------------------------------------------ |  | ------------------------- | --------- | --- | -------------------- | 
|                                                       |  |                           |           |     |                      | 
|Senior Management and Directors                        |  |                           |           |     |                      | 
|Ilan Cohn, Ph.D.                                       |  |                           | 151,567   | (1) |                      | 
|Pnina Fishman, Ph.D.                                   |  |                           | 595,633   | (2) |                      | 
|Motti Farbstein                                        |  |                           | 155,507   | (3) |                      | 
|Sari Fishman, Ph.D.                                    |  |                           | 144,875   | (4) |                      | 
|Guy Regev                                              |  |                           | 52,240    | (5) |                      | 
|Abraham Sartani, M.D.                                  |  |                           | 22,000    | (6) |                      | 
|Israel Shamay                                          |  |                           | 18,000    | (7) |                      | 
|Yaacov Goldman                                         |  |                           | 18,000    | (7) |                      | 
|Senior Management and Directors as a group (8 persons) |  |                           | 1,157,822 |     |                      | 
|Holders of more than 5% of our voting securities       |  |                           |           |     |                      | 
|Meitav Dash Investments Ltd.                           |  |                           | 2,990,321 | (8) |                      | 
|Anson Investments Master Fund LP                       |  |                           | 4,476,192 | (9) |                      | 



|*   | Denotes less than 1%                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
|--- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
|(1) | Represents
    (i) 133,567 ordinary shares, and (ii) 18,000 options to purchase 18,000 ordinary shares at an exercise price of NIS 2.926 per
    option and expire on November 8, 2027. Excludes 30,000 options to purchase 30,000 ordinary shares that vest in more than 60
    days from March 21, 2019.                                                                                                                                                                                                                                                                                         
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
|(2) | Represents
    (i) 263,433 ordinary shares, (ii) 2,680,000 options to purchase 107,200 ordinary shares at an exercise price of NIS 0.644
    per option and expiring on January 13, 2021, (iii) 200,000 options to purchase 200,000 ordinary shares at an exercise price
    of NIS 3.573 per option and expire on October 22, 2025 and (iv) 25,000 options to purchase 25,000 ordinary shares at an exercise
    price of NIS 2.344 per option and expire on January 7, 2029. Excludes 375,000 options to purchase 375,000 ordinary shares
    that vest in more than 60 days from March 21, 2019.



|(3) | Represents
    (i) 1,257 ordinary shares, (ii) 200,000 options to purchase 8,000 ordinary shares, of which (1) 100,000 are exercisable into
    4,000 ordinary shares at an exercise price of NIS 0.385 per option and expire on May 2, 2022, and (2) 100,000 are exercisable
    into 4,000 ordinary shares at an exercise price of NIS 0.326 per option and expire on March 20, 2023, (iii) 10,000 options
    to purchase 10,000 ordinary shares at an exercise price of NIS 8.1205 per option and expire on March 18, 2025, (iv) 48,750
    options to purchase 48,750 ordinary shares at an exercise price of NIS 4.317 per option and expire on February 18, 2026, (v)
    78,125 options to purchase 78,125 ordinary shares at an exercise price of NIS 2.513 per option and expire on December 28,
    2027 and (vi) 9,375 options to purchase 9,375 ordinary shares at an exercise price of NIS 2.344 per option and expire on January
    7, 2029. Excludes 323,750 options to purchase 323,750 ordinary shares that vest in more than 60 days from March 21, 2019.                                                                                                               
|--- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
|(4) | Represents
    (i) 200,000 options to purchase 8,000 ordinary shares, of which (1) 100,000 are exercisable into 4,000 ordinary shares at
    an exercise price of NIS 0.385 per option and expire on May 2, 2022, and (2) 100,000 are exercisable into 4,000 ordinary shares
    at an exercise price of NIS 0.326 per option and expire on March 20, 2023, and (ii) 10,000 options to purchase 10,000 ordinary
    shares at an exercise price of NIS 8.1205 per option and expire on March 18, 2025, (iii) 32,500 options to purchase 32,500
    ordinary shares at an exercise price of NIS 4.317 per option and expire on February 18, 2026, (iv) 40,000 options to purchase
    40,000 ordinary shares at an exercise price of NIS 3.662 per option and expire on March 30, 2027, (v) 46,875 options to purchase
    46,875 ordinary shares at an exercise price of NIS 2.513 per option and expire on December 30, 2027, and (vi) 7,500 options
    to purchase 7,500 ordinary shares at an exercise price of NIS 2.344 per option and expire on January 7, 2029. Excludes 263,125
    options to purchase 263,125 ordinary shares that vest in more than 60 days from March 21, 2019.





107


Table of Contents




|(5) | Represents
    (i) 24,240 ordinary shares, (ii) 250,000 options are exercisable into 10,000 ordinary shares at an exercise price of NIS 0.60
    per option and expire on May 2, 2023, (iii) 18,000 options are exercisable into 18,000 ordinary shares at an exercise price
    of NIS 2.926 per option and expire on December 28, 2027. Excludes 30,000 options to purchase 30,000 ordinary shares that vest
    in more than 60 days from March 21, 2019.
|--- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



|(6) | Represents
    (i) 100,000 options to purchase 4,000 ordinary shares at an exercise price of NIS 0.60 per option and expire on August 14,
    2022, and (ii) 18,000 options to purchase 18,000 ordinary shares at an exercise price of NIS 2.926 per option and expire on
    November 8, 2027. Excludes 30,000 options to purchase 30,000 ordinary shares that vest in more than 60 days from March 21,
    2019.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
|--- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|(7) | Represents
    18,000 options to purchase 18,000 ordinary shares at an exercise price of NIS 2.926 per option and expire on November 8, 2027.
    Excludes 30,000 options to purchase 30,000 ordinary shares that vest in more than 60 days from March 21, 2019.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|(8) | Based on information contained in a Schedule 13G/A
    filed with the SEC on March 19, 2019 jointly by Meitav Dash Investments Ltd. (“Meitav Investments”) and Meitav
    Dash Provident Funds Ltd. and Tachlit Indices Mutual Fund Management Ltd. (“Meitav Funds”) The ordinary shares
    are beneficially owned by various direct or indirect, majority or wholly-owned subsidiaries of Meitav Investments (the “Subsidiaries”).
    Meitav Investments, Meitav Funds and the Subsidiaries disclaim any beneficial ownership of the ordinary shares referred to
    herein in excess of their actual pecuniary interest therein and each of Meitav Investments, Meitav Funds and the Subsidiaries
    disclaim beneficial ownership of any such ordinary shares.                                                                                                                                                                                                                                                                                
|    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|(9) | Based
    on information contained in a Schedule 13G filed with the SEC on February 4, 2019 jointly by Anson Funds Management LP (d/b/a
    Anson Group), or AFM, Anson Management GP LLC, or AM, Bruce R. Winson, the principal of AFM and AM, Anson Advisors Inc. (d/b/a
    Anson Funds), or AA, Amin Nathoo, a director of AA, and Moez Kassam, a director of AA. AMF and AA serve as co-investment advisors
    to a private fund, or the Fund, and may direct the vote and disposition of the 4,476,192 ordinary shares represented by ADSs
    held by the Fund. As the general partner of AFM, AM may direct the vote and disposition of the 4,476,192 ordinary shares represented
    by ADSs held by the Fund. As the principal of AFM and AM, Mr. Winson may direct the vote and disposition of the 4,476,192
    ordinary shares represented by ADSs held by the Fund. As directors of AA, Mr. Nathoo and Mr. Kassam may each direct the vote
    and disposition of the 4,476,192 ordinary shares represented by ADSs held by the Fund.



To our knowledge the
significant changes in the percentage of ownership held by our major shareholders reported in our Annual Reports on Form 20-F
during the past three have been (i) the decrease in 2016 below 5%, the increase above 5% in 2018 and the later decrease below
5% in the percentage ownership held by Sabby Management, LLC, (ii) the increase in 2018 above 5%, the later decrease below 5%
and the increase above 5% in 2019 in the percentage ownership held by Anson, and (iii) the increase in 2019 above 5% in the percentage
ownership held by Meitav Dash.



The Bank of New York
Mellon, or BNY, is the holder of record for our ADR program, pursuant to which each ADS represents 2 ordinary shares. As of March
21, 2019, BNY held 29,554,441 ordinary shares representing approximately 66% of the outstanding ordinary shares at that date. Certain
of these ordinary shares were held by brokers or other nominees. As a result, the number of holders of record or registered holders
in the United States is not representative of the number of beneficial holders or of the residence of beneficial holders.





108


Table of Contents




Share Option Plans



We maintain the following
share option plans for our and our subsidiary’s employees, directors and consultants. In addition to the discussion below,
see Note 12b of our consolidated financial statements, included elsewhere in this Annual Report on Form 20-F.



Our Board of Directors
administers our share option plans and has the authority to designate all terms of the options granted under our plans including
the grantees, exercise prices, grant dates, vesting schedules and expiration dates, which may be no more than ten years after
the grant date. Options may not be granted with an exercise price of less than the fair market value of our ordinary shares on
the date of grant, unless otherwise determined by our Board of Directors.



As of December 31,
2018, options to purchase an aggregate of 2,177,400 ordinary shares, par value NIS 0.25, are outstanding pursuant to the 2003
and 2013 share option plans.



2003 Share Option Plan



Under the 2003 Plan
we granted options during the period between 2003 and 2013, at exercise prices between NIS 0.25 and NIS 31.175 per ordinary share,
par value NIS 0.25. Options to purchase up to 1,132,514 ordinary shares, par value NIS 0.25, were available to be granted under
the 2003 Plan. As of December 31, 2018, 3,810,000 options to purchase 125,400 ordinary shares were outstanding. Options granted
to Israeli employees were in accordance with section 102 of the Income Tax Ordinance, 1961, or the Tax Ordinance, under the capital
gains option set forth in section 102(b)(2) of the Tax Ordinance. The options are non-transferable.



The option term is
for a period of ten years from the grant date. The options were granted for no consideration. The options vest over a four or
two year period. As of March 21, 2019, 152,400 options to purchase 152,400 ordinary shares, par value NIS 0.25, were fully vested.



2013 Share Option Plan



Under the 2013 Plan
we granted options at exercise prices between NIS 3.573 and NIS 12 per ordinary share, par value NIS 0.25. Options to purchase
up to 2,500,000 ordinary shares, par value NIS 0.25, were available to be granted under the 2013 Plan. As of December 31, 2018,
2,025,000 options to purchase 2,025,000 ordinary shares were outstanding. Options granted to Israeli employees were in accordance
with the Tax Ordinance under the capital gains option set forth in section 102(b)(2) of the Tax Ordinance. The options are non-transferable.



The option term is
for a period of ten years from the grant date. The options were granted for no consideration. The options vest over a four year
period. As of March 21, 2019, options to purchase 729,129 ordinary shares, par value NIS 0.25, were fully vested.



ITEM 7. Major Shareholders and Related
Party Transactions



A.
Major Shareholders.



Except as set forth
in “Item 6. Directors, Senior Management and Employees—E. Share Ownership,” to the best of our knowledge, no
other person who we know beneficially owns 5.0% or more of the Company’s ordinary shares outstanding as of March 21, 2019.
None of our shareholders has different voting rights from other shareholders. Other than as described herein, to the best of our
knowledge, we are not owned or controlled, directly or indirectly, by another corporation, by any foreign government or by any
natural person or legal persons, severally or jointly, and we are not aware of any arrangement that may, at a subsequent date,
result in a change of control of our Company.



B.
Related Party Transactions.



The following is a
description of the transactions with related parties to which we, or our subsidiaries, are party, and which were in effect since
January 1, 2016. The descriptions provided below are summaries of the terms of such agreements, do not purport to be complete
and are qualified in their entirety by the complete agreements.





109


Table of Contents




We believe that we
have executed all of our transactions with related parties on terms no less favorable to us than those we could have obtained
from unaffiliated third parties. We are required by Israeli law to ensure that all future transactions between us and our officers,
directors and principal shareholders and their affiliates are approved by a majority of our Board of Directors, including a majority
of the independent and disinterested members of our Board of Directors, and that they are on terms no less favorable to us than
those that we could obtain from unaffiliated third parties.



OphthaliX Merger Agreement



On May 21, 2017, our
now former subsidiary, OphthaliX and a wholly-owned private Israeli subsidiary of OphthaliX, Bufiduck Ltd., or Merger Sub, and
Wize Pharma Ltd., an Israeli company formerly listed on the Tel Aviv Stock Exchange, or Wize Israel, entered into an Agreement
and Plan of Merger, or the Merger Agreement. On October 31, 2017, OphthaliX entered into an amendment to the Merger Agreement
with Merger Sub and Wize Israel extending the Expiration Date (as defined in the Merger Agreement) to November 30, 2017.



Concurrently with
the execution of the Merger Agreement and as contemplated therein, we entered into a Voting and Undertaking Agreement with OphthaliX
and Wize Israel, or the Voting Agreement, pursuant to which we agreed to vote our shares of OphthaliX held by us in favor of approving
the matters on the agenda of the annual general meeting and against any actions that could adversely affect the consummation of
the Merger. In addition, the Voting Agreement placed certain restrictions on the transfer of the shares of OphthaliX held by us
and we agreed to indemnify Wize Israel and OphthaliX with respect to certain liabilities of OphthaliX occurring in the period
up to the closing of the Merger but excluding certain liabilities in respect of any legal proceedings arising out of or related
to the transactions contemplated by the Merger Agreement.



On November 16, 2017,
OphthaliX (which has been renamed “Wize Pharma, Inc.”) completed its transaction with Wize Israel in accordance with
the terms of the Merger Agreement pursuant to which Merger Sub merged with and into Wize Israel, with Wize Israel surviving as
a wholly owned subsidiary of the Company, or the Merger. In connection with the Merger and under the terms of the Merger Agreement,
at the effective time of the Merger, each ordinary share of Wize Israel that was issued and outstanding was automatically cancelled
and converted into 4.1445791236989 shares of common stock of OphthaliX. As a result, an aggregate of 93,971,259 shares of common
stock of OphthaliX were issued to former Wize Israel shareholders. The pre-Merger stockholders of OphthaliX retained an aggregate
of 10,441,251 shares of the common stock of OphthaliX. Consequently, our ownership of OphthaliX, which consisted of 8,563,254
shares of common stock, was reduced from approximately 82% immediately prior to the Merger to approximately 8% immediately after
the Merger.



Immediately prior
to the effective time of the Merger, OphthaliX sold on an “as is” basis to us all the ordinary shares of Eye-Fite
in exchange for the irrevocable cancellation and waiver of all indebtedness owed by the OphthaliX and Eye-Fite to us, including
approximately $5 million of deferred payments owed by OphthaliX and Eye-Fite to us and, as part of the purchase of Eye-Fite, we
also assumed certain accrued milestone payments in the amount of $175,000 under a license agreement previously entered into with
NIH. In addition, that certain exclusive license between us and OphthaliX and a related services agreement were terminated pursuant
to a Termination of License Agreement and a Termination of Services Agreement that was entered into in connection with the closing
of the Merger. Immediately following the Merger, OphthaliX continued to hold 446,827 of our ordinary shares.



The foregoing share
amounts of OphthaliX do not give effect to a 1-for-24 reverse stock split of OphthaliX that took effect, subsequent to the completion
of the Merger, on March 5, 2018.



Employment and Consulting Agreements



We have or have had
employment, consulting or related agreements with each member of our senior management. See “Item 6. Directors, Senior Management
and Employees—Compensation”.



We employ Zivit Harpaz
as Director of Regulatory and Clinical Operations. For fiscal years 2018, 2017 and 2016, Ms. Harpaz received salary, bonus and
benefits totaling approximately NIS 589,000, NIS 532,000, and NIS 522,000, respectively, and during fiscal years 2019, 2017 and
2016 we awarded to Ms. Harpaz options to purchase 70,000, 125,000, and 30,000 ordinary shares, respectively. Ms. Harpaz is the
daughter of Pnina Fishman.





110


Table of Contents




Options



We have granted options
to purchase our ordinary shares to certain of our senior management and directors. See “Item 6. B.—Compensation”
and “Item 6. Directors, Senior Management and Employees—Share Ownership”. We describe our option plans under
“Item 6. Directors, Senior Management and Employees—Share Ownership”.



Indemnification Agreements



Our Amended and Restated
Articles of Association permit us to exculpate, indemnify and insure our directors and officeholders to the fullest extent permitted
by the Israeli Companies Law. We have obtained directors’ and officers’ insurance for each of our officers and directors
and have entered into indemnification agreements with all of our current officers and directors.



C.
Interests of Experts and Counsel.



Not applicable.



ITEM 8. Financial Information



A.
Consolidated Financial Statements and Other Financial Information



See “Item 18.
Financial Statements” for a list of all financial statements filed as part of this Annual Report on Form 20-F.



Legal Matters



We are not involved
in any legal or arbitration proceedings that may have or have had in the recent past, significant effects on our financial position
or profitability.



On June 29, 2015,
we received a lawsuit, filed with the District Court of Tel-Aviv, requesting recognition of this lawsuit as a class action. The
lawsuit named the Company, its Chief Executive Officer and directors as defendants. The lawsuit alleges, among other things, that
we misled the public with regard to disclosures concerning the efficacy of our drug candidate, Piclidenoson. The claimant alleges
that he suffered personal damages of over NIS 73,000, while also claiming that our shareholders suffered damages of approximately
NIS 125 million. On March 31, 2016, we filed a response to the lawsuit. On March 1, 2017, a hearing was held in the District Court
on whether to certify the lawsuit as a class action. A final hearing on the certification was held on May 17, 2017. On July 18,
2017, the District Court of Tel-Aviv issued a ruling in which it denied the request to recognize the lawsuit as a class action
and awarded us an amount of NIS 50,000 to pay our expenses in relation to such law suit. The claimant filed a petition with the
Supreme Court appealing the District Court decision. On January 28, 2018, the Supreme Court issued a notice of procedures to be
complied with by the relevant parties leading up to a formal hearing scheduled for December 5, 2018. On December 5, 2018, the
Supreme Court dismissed the appeal and as part of a compromise by the claimant not to pursue the appeal, the Supreme Court ordered
us to return the aforementioned expenses to the claimant. Accordingly, this lawsuit has been finally dismissed and is no longer
pending against us.



Dividend Policy



We have never declared
or paid cash dividends to our shareholders. Currently we do not intend to pay cash dividends. We intend to reinvest any earnings
in developing and expanding our business. Any future determination relating to our dividend policy will be at the discretion of
our Board of Directors and will depend on a number of factors, including future earnings, our financial condition, operating results,
contractual restrictions, capital requirements, business prospects, applicable Israeli Companies Law and other factors our Board
of Directors may deem relevant.





111


Table of Contents




B.
Significant Changes



See “Note 19:-
Subsequent Events” to our consolidated financial statements included in this Annual Report beginning on page F-1 for a discussion
of significant events that have occurred since December 31, 2018.



ITEM 9. The Offer and Listing



A.
Offer and Listing Details



Ordinary Shares



Our ordinary shares
have been trading on the TASE under the symbol “CFBI” since October 2005.



ADSs



On October 2, 2012,
our ADSs began trading OTC in the United States under the symbol “CANFY” and on November 19, 2013, our ADSs began
trading on the NYSE American under the symbol “CANF.” One ADS represents two ordinary shares. See “Item 12.
Description of Securities Other Than Equity Securities—D. American Depositary Shares” for a description of the rights
attaching to our ADSs. See “Item 12. Description of Securities Other Than Equity Securities—D. American Depositary
Shares” for a description of the rights attaching to our ADSs.



B.
Plan of Distribution.



Not applicable.



C.
Markets.



See “—Offer
and Listing Details” above.



D.
Selling Shareholders.



Not applicable.



E.
Dilution.



Not applicable.



F.
Expenses of the Issue.



Not applicable.



ITEM 10. Additional Information



A.
Share Capital.



Not applicable.



B.
Memorandum and Articles of Association.



Our number with the
Israeli Registrar of Companies is 512022153. Our purpose is set forth in Section 3 of our Articles of Association and includes
every lawful purpose.



Our ordinary shares
that are fully paid for are issued in registered form and may be freely transferred under our Amended and Restated Articles of
Association, unless the transfer is restricted or prohibited by applicable law or the rules of a stock exchange on which the shares
are traded. The ownership or voting of our ordinary shares by non-residents of Israel is not restricted in any way by our Amended
and Restated Articles of Association or the laws of the State of Israel, except for ownership by nationals of some countries that
are, or have been, in a state of war with Israel.





112


Table of Contents




Pursuant to the Israeli
Companies Law and our Amended and Restated Articles of Association, our board of directors may exercise all powers and take all
actions that are not required under law or under our Amended and Restated Articles of Association to be exercised or taken by
our shareholders, including the power to borrow money for company purposes.



Our Amended and Restated
Articles of Association enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the
Israeli Companies Law and must be approved by a resolution duly passed by our shareholders at a general or special meeting by
voting on such change in the capital. In addition, transactions that have the effect of reducing capital, such as the declaration
and payment of dividends in the absence of sufficient retained earnings and profits and an issuance of shares for less than their
nominal value, require a resolution of our board of directors and court approval.



Dividends



We may declare a
dividend to be paid to the holders of our ordinary shares in proportion to their respective shareholdings. Under the Israeli Companies
Law, dividend distributions are determined by the board of directors and do not require the approval of the shareholders of a
company unless such company’s articles of association provide otherwise. Our Amended and Restated Articles of Association
do not require shareholder approval of a dividend distribution and provide that dividend distributions may be determined by our
board of directors.



Pursuant to the Israeli
Companies Law, we may only distribute dividends from our profits accrued over the previous two years, as defined in the Israeli
Companies Law, according to our then last reviewed or audited financial reports, or we may distribute dividends with court approval.
In each case, we are only permitted to pay a dividend if there is no reasonable concern that payment of the dividend will prevent
us from satisfying our existing and foreseeable obligations as they become due.



Election of Directors



Our ordinary shares
do not have cumulative voting rights in the election of directors. As a result, the holders of a majority of the voting power
represented at a shareholders meeting have the power to elect all of our directors, subject to the special approval requirements
for external directors described under “Item 6. Directors, Senior Management and Employees—C. Board Practices —
External Directors”.



Pursuant to our Amended
and Restated Articles of Association, other than the external directors, for whom special election requirements apply under the
Israeli Companies Law, our directors are elected at a general or special meeting of our shareholders and serve on the board of
directors until the end of the next general meeting or they are removed by the majority of our shareholders at a general or special
meeting of our shareholders or upon the occurrence of certain events, in accordance with the Israeli Companies Law and our Amended
and Restated Articles of Association. In addition, our Amended and Restated Articles of Association allow our board of directors
to appoint directors to fill vacancies on the board of directors to serve until the next general meeting or special meeting, or
earlier if required by our Amended and Restated Articles of Association or applicable law. We have held elections for each of
our non-external directors at each annual meeting of our shareholders since our initial public offering in Israel. External directors
are elected for an initial term of three years and may be removed from office pursuant to the terms of the Israeli Companies Law.



See “Item 6.
Directors, Senior Management and Employees—C. Board Practices—External Directors.”



Shareholder Meetings



Under Israeli Companies
Law, we are required to hold an annual general meeting of our shareholders once every calendar year that must be no later than
15 months after the date of the previous annual general meeting. All meetings other than the annual general meeting of shareholders
are referred to as special meetings. Our board of directors may call special meetings whenever it sees fit, at such time and place,
within or outside of Israel, as it may determine. In addition, the Israeli Companies Law and our Amended and Restated Articles
of Association provide that our board of directors is required to convene a special meeting upon the written request of (i) any
two of our directors or one quarter of our board of directors or (ii) one or more shareholders holding, in the aggregate, either
(1) 5% of our outstanding shares and 1% of our outstanding voting power or (2) 5% of our outstanding voting power.





113


Table of Contents




Subject to the provisions
of the Israeli Companies Law and the regulations promulgated thereunder, shareholders entitled to participate and vote at general
meetings are the shareholders of record on a date to be decided by the board of directors, which may be between four and forty
days prior to the date of the meeting. Furthermore, the Israeli Companies Law and our Amended and Restated Articles of Association
require that resolutions regarding the following matters must be passed at a general meeting of our shareholders:



| | ● | amendments
                                         to our Amended and Restated Articles of Association;
| | - | --------------------------------------------------------------------------------------------------------



| | ● | appointment
                                         or termination of our auditors;
| | - | ------------------------------------------------------------------------------------



| | ● | appointment
                                         of directors and appointment and dismissal of external directors;
| | - | ----------------------------------------------------------------------------------------------------------------------



| | ● | approval
                                         of acts and transactions requiring general meeting approval pursuant to the Israeli Companies
                                         Law;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | director
                                         compensation, indemnification and change of the principal executive officer;
| | - | ------------------------------------------------------------------------------------------------------------------------------



| | ● | increases
                                         or reductions of our authorized share capital;
| | - | -------------------------------------------------------------------------------------------------



| | ● | a merger;
                                         and
| | - | ------------------------------------------------------



| | ● | the exercise
                                         of our Board of Director’s powers by a general meeting, if our board of directors
                                         is unable to exercise its powers and the exercise of any of its powers is required for
                                         our proper management.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The Israeli Companies
Law requires that a notice of any annual or special shareholders meeting be provided at least 21 days prior to the meeting and
if the agenda of the meeting includes the appointment or removal of directors, the approval of transactions with office holders
or interested or related parties, or an approval of a merger, notice must be provided at least 35 days prior to the meeting.



The Israeli Companies
Law does not allow shareholders of publicly traded companies to approve corporate matters by written consent. Consequently, our
Amended and Restated Articles of Association does not allow shareholders to approve corporate matters by written consent.



Pursuant to our Amended
and Restated Articles of Association, holders of our ordinary shares have one vote for each ordinary share held on all matters
submitted to a vote before the shareholders at a general meeting.



Quorum



The quorum required
for our general meetings of shareholders consists of at least two shareholders present in person, by proxy or written ballot who
hold or represent between them at least 25% of the total outstanding voting rights.



A meeting adjourned
for lack of a quorum is adjourned to the same day in the following week at the same time and place or on a later date if so specified
in the summons or notice of the meeting. At the reconvened meeting, any number of our shareholders present in person or by proxy
shall constitute a lawful quorum.



Resolutions



Our Amended and Restated
Articles of Association provide that all resolutions of our shareholders require a simple majority vote, unless otherwise required
by applicable law.





114


Table of Contents




Israeli law provides
that a shareholder of a public company may vote in a meeting and in a class meeting by means of a written ballot in which the
shareholder indicates how he or she votes on resolutions relating to the following matters:



| | ● | an appointment
                                         or removal of directors;
| | - | --------------------------------------------------------------------------------



| | ● | an approval
                                         of transactions with office holders or interested or related parties;
| | - | --------------------------------------------------------------------------------------------------------------------------



| | ● | an approval
                                         of a merger or any other matter in respect of which there is a provision in the articles
                                         of association providing that decisions of the general meeting may also be passed by
                                         written ballot;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | authorizing
                                         the chairman of the board of directors or his relative to act as our chief executive
                                         officer or act with such authority; or authorize our chief executive officer or his relative
                                         to act as the chairman of the board of directors or act with such authority; and
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | other matters
                                         which may be prescribed by Israel’s Minister of Justice.
| | - | ---------------------------------------------------------------------------------------------------------------



The provision allowing
the vote by written ballot does not apply where the voting power of the controlling shareholder is sufficient to determine the
vote. Our Amended and Restated Articles of Association provide that our board of directors may prevent voting by means of a written
ballot and this determination is required to be stated in the notice convening the general meeting.



The Israeli Companies
Law provides that a shareholder, in exercising his or her rights and performing his or her obligations toward the company and
its other shareholders, must act in good faith and in a customary manner, and avoid abusing his or her power. This is required
when voting at general meetings on matters such as changes to the articles of association, increasing our registered capital,
mergers and approval of related party transactions. A shareholder also has a general duty to refrain from depriving any other
shareholder of its rights as a shareholder. In addition, any controlling shareholder, any shareholder who knows that its vote
can determine the outcome of a shareholder vote and any shareholder who, under such company’s articles of association, can
appoint or prevent the appointment of an office holder, is required to act with fairness towards the company. The Israeli Companies
Law does not describe the substance of this duty except to state that the remedies generally available upon a breach of contract
will also apply to a breach of the duty to act with fairness, and, to the best of our knowledge, there is no binding case law
that addresses this subject directly.



Under the Israeli
Companies Law, unless provided otherwise in a company’s articles of association, a resolution at a shareholders meeting
requires approval by a simple majority of the voting rights represented at the meeting, in person, by proxy or written ballot,
and voting on the resolution. A resolution for the voluntary winding up of the company requires the approval of holders of 75%
of the voting rights represented at the meeting, in person, by proxy or by written ballot and voting on the resolution.



In the event of our
liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of our ordinary shares
in proportion to their shareholdings. This right, as well as the right to receive dividends, may be affected by the grant of preferential
dividend or distribution rights to the holders of a class of shares with preferential rights that may be authorized in the future.



Access to Corporate Records



Under the Israeli
Companies Law, all shareholders of a company generally have the right to review minutes of our general meetings, its shareholders
register and principal shareholders register, articles of association, financial statements and any document it is required by
law to file publicly with the Israeli Companies Registrar and the Israel Securities Authority. Any of our shareholders may request
access to review any document in our possession that relates to any action or transaction with a related party, interested party
or office holder that requires shareholder approval under the Israeli Companies Law. We may deny a request to review a document
if we determine that the request was not made in good faith, that the document contains a commercial secret or a patent or that
the document’s disclosure may otherwise prejudice our interests.





115


Table of Contents




Acquisitions under Israeli Law



Full Tender
Offer



A person wishing to
acquire shares of a public Israeli company and who would as a result hold over 90% of the target company’s issued and outstanding
share capital is required by the Israeli Companies Law to make a tender offer to all of our shareholders for the purchase of all
of the issued and outstanding shares of the company. A person wishing to acquire shares of a public Israeli company and who would
as a result hold over 90% of the issued and outstanding share capital of a certain class of shares is required to make a tender
offer to all of the shareholders who hold shares of the same class for the purchase of all of the issued and outstanding shares
of the same class. If the shareholders who do not accept the offer hold less than 5% of the issued and outstanding share capital
of the company or of the applicable class, all of the shares that the acquirer offered to purchase will be transferred to the
acquirer by operation of law (provided that a majority of the offerees that do not have a personal interest in such tender offer
shall have approved the tender offer except that if the total votes to reject the tender offer represent less than 2% of the company’s
issued and outstanding share capital, in the aggregate, approval by a majority of the offerees that do not have a personal interest
in such tender offer is not required to complete the tender offer). However, a shareholder that had its shares so transferred
may petition the court within six months from the date of acceptance of the full tender offer, whether or not such shareholder
agreed to the tender or not, to determine whether the tender offer was for less than fair value and whether the fair value should
be paid as determined by the court unless the acquirer stipulated in the tender offer that a shareholder that accepts the offer
may not seek appraisal rights. If the shareholders who did not accept the tender offer hold 5% or more of the issued and outstanding
share capital of the company or of the applicable class, the acquirer may not acquire shares of the company that will increase
its holdings to more than 90% of our issued and outstanding share capital or of the applicable class from shareholders who accepted
the tender offer.



Special Tender
Offer



The Israeli Companies
Law provides that an acquisition of shares of a public Israeli company must be made by means of a special tender offer if as a
result of the acquisition the purchaser would become a holder of 25% or more of the voting rights in the company, unless one of
the exemptions in the Israeli Companies Law is met. This rule does not apply if there is already another holder of at least 25%
of the voting rights in the company. Similarly, the Israeli Companies Law provides that an acquisition of shares in a public company
must be made by means of a tender offer if as a result of the acquisition the purchaser would become a holder of 45% or more of
the voting rights in the company, if there is no other shareholder of the company who holds 45% or more of the voting rights in
the company, unless one of the exemptions in the Israeli Companies Law is met.



A special tender offer
must be extended to all shareholders of a company but the offeror is not required to purchase shares representing more than 5%
of the voting power attached to our outstanding shares, regardless of how many shares are tendered by shareholders. A special
tender offer may be consummated only if (i) at least 5% of the voting power attached to our outstanding shares will be acquired
by the offeror and (ii) the number of shares tendered in the offer exceeds the number of shares whose holders objected to the
offer.



If a special tender
offer is accepted, then the purchaser or any person or entity controlling it or under common control with the purchaser or such
controlling person or entity may not make a subsequent tender offer for the purchase of shares of the target company and may not
enter into a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such
person or entity undertook to effect such an offer or merger in the initial special tender offer.



Merger



The Israeli Companies
Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described
under the Israeli Companies Law are met, a majority of each party’s shares voted on the proposed merger at a shareholders’
meeting called with at least 35 days’ prior notice.





116


Table of Contents




For purposes of the
shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares represented
at the shareholders meeting that are held by parties other than the other party to the merger, or by any person who holds 25%
or more of the outstanding shares or the right to appoint 25% or more of the directors of the other party, vote against the merger.
If the transaction would have been approved but for the separate approval of each class or the exclusion of the votes of certain
shareholders as provided above, a court may still approve the merger upon the request of holders of at least 25% of the voting
rights of a company, if the court holds that the merger is fair and reasonable, taking into account the value of the parties to
the merger and the consideration offered to the shareholders.



Upon the request of
a creditor of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists
a reasonable concern that, as a result of the merger, the surviving company will be unable to satisfy the obligations of any of
the parties to the merger, and may further give instructions to secure the rights of creditors.



In addition, a merger
may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed by
each party with the Israeli Registrar of Companies and 30 days have passed from the date the merger was approved by the shareholders
of each party.



Antitakeover
Measures



The Israeli Companies
Law allows us to create and issue shares having rights different from those attached to our ordinary shares, including shares
providing certain preferred rights, distributions or other matters and shares having preemptive rights. As of the date of this
Annual Report on Form 20-F, we do not have any authorized or issued shares other than our ordinary shares. In the future, if we
do create and issue a class of shares other than ordinary shares, such class of shares, depending on the specific rights that
may be attached to them, may delay or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium
over the market value of their ordinary shares. The authorization of a new class of shares will require an amendment to our Amended
and Restated Articles of Association which requires the prior approval of the holders of a majority of our shares at a general
meeting. In addition, the rules and regulations of the TASE also limit the terms permitted with respect to a new class of shares
and prohibit any such new class of shares from having voting rights. Shareholders voting in such meeting will be subject to the
restrictions provided in the Israeli Companies Law as described above.



Borrowing Powers



Under the Israeli
Companies Law and our Amended and Restated Articles of Association, our board of directors may exercise all powers and take all
actions that are not required under law or under our amended and restated articles of association to be exercised or taken by
our shareholders or other corporate bodies, including the power to borrow money for company purposes.



Changes in Capital



Our Amended and Restated
Articles of Association enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the
Israeli Companies Law and must be approved by a resolution duly passed by our shareholders at a general meeting by voting on such
change in the capital. In addition, transactions that have the effect of reducing capital, such as the declaration and payment
of dividends in the absence of sufficient retained earnings or profits and, in certain circumstances, an issuance of shares for
less than their nominal value, require the approval of both our board of directors and an Israeli court.



C.
Material Contracts.



The following are
summary descriptions of certain material agreements to which we are a party. The descriptions provided below do not purport to
be complete and are qualified in their entirety by the complete agreements, which may be attached as exhibits to this Annual Report
on Form 20-F.



License Agreements



See “Item 4.
Information on the Company—B. Business Overview—Out-Licensing and Distribution Agreements”.





117


Table of Contents




OphthaliX Merger Agreement



See “Item 7.
Major Shareholders and Related Party Transactions—B. Related Party Transactions”.



Employment and Consulting Agreements



See “Item 6.
Directors, Senior Management and Employees—B. Compensation—Employment and Consulting Agreements”.



D.
Exchange Controls



There are no Israeli
government laws, decrees or regulations that restrict or that affect our export or import of capital or the remittance of dividends,
interest or other payments to non-resident holders of our securities, including the availability of cash and cash equivalents
for use by us and our wholly-owned subsidiaries, except or otherwise as set forth under “Item 10. Additional Information—E.
Taxation.”



E.
Taxation



Certain Israeli Tax Considerations



The following is a
summary of the material Israeli tax laws applicable to us. This section also contains a discussion of material Israeli tax consequences
concerning the ownership and disposition of our ordinary shares. This summary does not discuss all the aspects of Israeli tax
law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some types of
investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of Israel or traders
in securities who are subject to special tax regimes not covered in this discussion. Because certain parts of this discussion
are based on new tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure
you that the appropriate tax authorities or the courts will accept the views expressed in this discussion. The discussion does
not cover all possible tax consequences.



You are urged to
consult your own tax advisor as to the Israeli and other tax consequences of the purchase, ownership and disposition of our ADSs,
including, in particular, the effect of any non-Israeli, state or local taxes.



General Corporate Tax Structure in Israel



Israeli companies
are generally subject to corporate tax, which has decreased in recent years, from a rate of 26.5% in 2014 and 2015 to 25% in 2016
and to 24% in 2017 to 23% for 2018 and 2019. However, the effective corporate tax rate payable by a company that derives income
from an Approved Enterprise, a Privileged Enterprise or a Preferred Enterprise (as discussed below) may be considerably less.
Capital gains generated by an Israeli company are generally subject to tax at the corporate tax rate.



In 2006, transfer
pricing regulations came into force, following the introduction of Section 85A of the Israeli Tax Ordinance under Amendment 132.
The transfer pricing rules require that cross-border transactions between related parties be carried out implementing an arms’
length principle based on a transfer pricing study and reported and taxed accordingly.



Pre-Ruling from the Israeli Income Tax Authorities



In connection with
the spin-off, we received a pre-ruling decision from the Israeli Income Tax Authority which confirms: (i) that the grant of the
license to Eye-Fite is not liable for tax pursuant to the provisions of section 104a to the Income Tax Ordinance (New Version),
1961, or the Ordinance; (ii) that OphthaliX is considered the receiving company pursuant to section 103c(7)(b) to the Ordinance;
(iii) that the sale of Eye-Fite shares to OphthaliX as consideration for OphthaliX shares does not create liability for tax pursuant
to the provisions of section 103t to the Ordinance, or change in structure; and (iv) the date for the change in structure was
determined. According to the tax pre-ruling, the date of change in structure shall also be the date of exchange of shares with
respect to the spin-off and notification to the tax assessor. We and Eye-Fite presented to the tax assessor and the merger and
spin-off department of the tax assessor the forms required by the Ordinance and the regulations thereunder. The tax pre-ruling
further provides that the grant of a license to Eye-Fite as consideration for the issuance of Eye-Fite shares to us does not create
liability for tax pursuant to the provisions of section 104a to the Ordinance.





118


Table of Contents




According to the pre-ruling,
we must not sell more than 10% of our common stock holdings in OphthaliX issued in connection with the change in structure for
at least two years from the date of the change (i.e., November 21, 2011), OphthaliX must not sell more than 10% of its ordinary
share holdings in Eye-Fite received in connection with the change in structure for at least two years from the date of the change
and Eye-Fite must retain the assets received from us in connection with the change in structure for at least two years from the
date of the change.



The shares of Eye-Fite
which were transferred to OphthaliX in connection with the change in structure will be held in escrow. The sale of these shares
will be deemed as a sale by an Israeli company and will be taxed accordingly. The trustee will withhold tax at the source.



The shares of OphthaliX
which were transferred to us in connection with the change in structure will be held in escrow. The sale of these shares will
be deemed as a sale by an Israeli company and will be taxed accordingly. The trustee will withhold tax at the source.



Any dividend distributed
by Eye-Fite to OphthaliX will be taxed in Israel in accordance with paragraph 125(b)5 of the Israeli Tax Ordinance.



A description of the
terms of the pre-ruling is also included in the notes to the financial statements.



Tax Benefits and Grants for Research and Development



Israeli tax law allows,
under certain conditions, a tax deduction for research and development expenditures, including capital expenditures, for the year
in which they are incurred. These expenses must relate to scientific research and development projects and must be approved by
the Office of the Chief Scientist, or the OCS, of the relevant Israeli government ministry, determined by the field of research.
Furthermore, the research and development must be for the promotion of the company and carried out by or on behalf of the company
seeking such tax deduction. The amount of such deductible expenses is reduced by the sum of any funds received through government
grants for the funding of the scientific research and development projects. No deduction under these research and development
deduction rules is allowed if such deduction is related to an expense invested in an asset depreciable under the general depreciation
rules of the Tax Ordinance. Expenditures not so approved are deductible in equal amounts over three years.



On a yearly basis,
we evaluate the applicability of the above tax deduction for research and development expenditures and, based on our evaluation,
determine whether to apply to the OCS for approval of a tax deduction. There can be no assurance that any application for a tax
deduction will be accepted.



Taxation of our Shareholders



Capital Gains Taxes
Applicable to Non-Israeli Resident Shareholders. Shareholders that are not Israeli residents are generally exempt from Israeli
capital gains tax on any gains derived from the sale, exchange or disposition of our ordinary shares, provided that such shareholders
did not acquire their shares prior to our initial public offering on the TASE and such gains were not derived from a permanent
establishment or business activity of such shareholders in Israel. However, non-Israeli corporations will not be entitled to the
foregoing exemptions if an Israeli resident (i) has a controlling interest of 25% or more in such non-Israeli corporation or (ii)
is the beneficiary of or is entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly
or indirectly.





119


Table of Contents




In addition, under
the U.S.-Israel Income Tax Treaty, 1995, or the U.S.-Israel Tax Treaty, the sale, exchange or disposition of our ordinary shares
by a shareholder who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) holding the shares as a capital asset is
exempt from Israeli capital gains tax unless either (i) the shareholder holds, directly or indirectly, shares representing 10%
or more of our voting capital during any part of the 12-month period preceding such sale, exchange or disposition or (ii) the
capital gains arising from such sale are attributable to a permanent establishment of the shareholder located in Israel. In either
case, the sale, exchange or disposition of the shares would be subject to Israeli tax, to the extent applicable; however, under
the U.S.-Israel Tax Treaty, the U.S. resident would be permitted to claim a credit for the tax against the U.S. federal income
tax imposed with respect to the sale, exchange or disposition, subject to the limitations in U.S. laws applicable to foreign tax
credits. The U.S.-Israel Tax Treaty does not relate to U.S. state or local taxes.



Shareholders may be
required to demonstrate that they are exempt from tax on their capital gains in order to avoid withholding at source at the time
of sale.



Taxation of Non-Israeli
Shareholders on Receipt of Dividends. Non-residents of Israel are generally subject to Israeli income tax on the receipt of
dividends paid on our ordinary shares at the rate of 20%, which tax will be withheld at the source, unless a different rate is
provided in a tax treaty between Israel and the shareholder’s country of residence. With respect to a person who is a “substantial
shareholder” at the time receiving the dividend or on any date in the 12 months preceding such date, the applicable tax
rate is 25%. A “substantial shareholder” is generally a person who alone, or together with his relative or another
person who collaborates with him on a permanent basis, holds, directly or indirectly, at least 10% of any of the “means
of control” of the corporation. “Means of control” generally include the right to vote, receive profits, nominate
a director or an officer, receive assets upon liquidation, or order someone who holds any of the aforesaid rights how to act,
and all regardless of the source of such right. Under the U.S.-Israel Tax Treaty, the maximum rate of tax withheld in Israel on
dividends paid to a holder of our ordinary shares who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) is 25%.
However, generally, the maximum rate of withholding tax on dividends that are paid to a U.S. corporation holding 10% or more of
our outstanding voting capital throughout the tax year in which the dividend is distributed as well as the previous tax year is
12.5%.



A non-resident of
Israel who receives dividends from which tax was withheld is generally exempt from the duty to file returns in Israel in respect
of such income, provided such income was not derived from a business conducted in Israel by the taxpayer, and the taxpayer has
no other taxable sources of income in Israel.



Taxation of Israeli Shareholders on Receipt of Dividends



Residents of Israel
are generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25%, which
tax will be withheld at the source. With respect to a person who is a “substantial shareholder” at the time of receiving
the dividend or on any date within the 12 months preceding such date, the applicable tax rate is 30%.



U.S. Federal Income Tax Consequences



The following is a
general summary of certain material U.S. federal income tax consequences relating to the purchase, ownership and disposition of
our ordinary shares and ADSs by U.S. Holders (as defined below) that hold such ordinary shares or ADSs as capital assets (generally,
property held for investment). This summary is based on the Internal Revenue Code of 1986, as amended, or the Code, the regulations
of the U.S. Department of the Treasury issued pursuant to the Code, or the Treasury Regulations, administrative and judicial interpretations
thereof, and the U.S.-Israel Income Tax Treaty, all as in effect on the date hereof and all of which are subject to change, possibly
with retroactive effect, or to different interpretation. No ruling has been sought from the Internal Revenue Service, or IRS,
with respect to any United States federal income tax consequences described below, and there can be no assurance that the IRS
or a court will not take a contrary position. This summary does not address all of the tax considerations that may be relevant
to specific U.S. Holders in light of their particular circumstances or to U.S. Holders subject to special treatment under U.S.
federal income tax law, such as (1) a bank, life insurance company, regulated investment company, or other financial institution
or “financial services entity”; (2) a broker or dealer in securities or foreign currency; (3) a person who acquired
our ordinary shares or ADSs in connection with employment or other performance of services; (4) a U.S. Holder that is subject
to the U.S. alternative minimum tax; (5) a U.S. Holder that holds our ordinary shares or ADSs as a hedge or as part of a hedging,
straddle, conversion or constructive sale transaction or other risk-reduction transaction for U.S. federal income tax purposes;
(6) a tax-exempt entity; (7) real estate investment trusts; (8) a U.S. Holder that expatriates out of the United States or a former
long-term resident of the United States; or (9) a U.S. Holder having a functional currency other than the U.S. dollar. This discussion
does not address the U.S. federal income tax treatment of a U.S. Holder that owns, directly or constructively, at any time, ordinary
shares or ADSs representing 10% or more of our voting power or value. Additionally, this summary does not address any U.S. state
or local or non-U.S. tax considerations or any U.S. federal estate, gift or alternative minimum tax considerations or any U.S.
federal tax consequences other than U.S. federal income tax consequences.





120


Table of Contents




As used in this summary,
the term “U.S. Holder” means a beneficial owner of our ordinary shares or ADSs that is, for U.S. federal income tax
purposes, (i) an individual citizen or resident of the United States, (ii) a corporation, or other entity taxable as a corporation
for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state thereof, or the
District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its source or (iv)
a trust with respect to which a court within the United States is able to exercise primary supervision over its administration
and one or more U.S. persons have the authority to control all of its substantial decisions, or that has a valid election in effect
under applicable Treasury Regulations to be treated as a “United States person.”



If an entity or arrangement
treated as a partnership for U.S. federal income tax purposes holds our ordinary shares or ADSs, the tax treatment of such partnership
and each partner thereof will generally depend upon the status and activities of the partnership and such partner. A holder that
is treated as a partnership for U.S. federal income tax purposes should consult its own tax advisor regarding the U.S. federal
income tax considerations applicable to it and its partners of the purchase, ownership and disposition of its ordinary shares
or ADSs.



This summary is
not intended to be, and should not be considered to be, legal or tax advice. Prospective investors should be aware that this summary
does not address the tax consequences to investors who are not U.S. Holders, except to the limited extent discussed below. Prospective
investors should consult their own tax advisors as to the particular tax considerations applicable to them relating to the purchase,
ownership and disposition of their ordinary shares or ADSs, including the applicability of U.S. federal, state and local tax laws
and non-U.S. tax laws.



Taxation of U.S. Holders



The discussions under
“— Distributions” and under “— Sale, Exchange or Other Disposition of Ordinary Shares and ADSs”
below assumes that we will not be treated as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes.
Based on our analysis of our income, assets, and operations, we do not believe that we were a PFIC for 2018. Because the PFIC
determination is highly fact intensive, there can be no assurance that we will not be a PFIC for 2019 or for any other taxable
year. For a discussion of the rules that would apply if we are treated as a PFIC, see the discussion under “— Passive
Foreign Investment Company.”



Distributions.We
have no current plans to pay dividends. To the extent we pay any dividends, a U.S. Holder will be required to include in gross
income as a taxable dividend the amount of any distributions made on the ordinary shares or ADSs, including the amount of any
Israeli taxes withheld, to the extent that those distributions are paid out of our current or accumulated earnings and profits
as determined for U.S. federal income tax purposes. Any distributions in excess of our earnings and profits will be applied against
and will reduce the U.S. Holder’s tax basis in its shares or ADSs and to the extent they exceed that tax basis, will be
treated as gain from the sale or exchange of those shares or ADSs. If we were to pay dividends, we expect to pay such dividends
in NIS with respect to the shares and in U.S. dollars with respect to ADSs. A dividend paid in NIS, including the amount of any
Israeli taxes withheld, will be includible in a U.S. Holder’s income as a U.S. dollar amount calculated by reference to
the exchange rate in effect on the date such dividend is received, regardless of whether the payment is in fact converted into
U.S. dollars. If the dividend is converted to U.S. dollars on the date of receipt, a U.S. Holder generally will not recognize
a foreign currency gain or loss. However, if the U.S. Holder converts the NIS into U.S. dollars on a later date, the U.S. Holder
must include, in computing its income, any gain or loss resulting from any exchange rate fluctuations. The gain or loss will be
equal to the difference between (i) the U.S. dollar value of the amount included in income when the dividend was received and
(ii) the amount received on the conversion of the NIS into U.S. dollars. Such gain or loss will generally be ordinary income or
loss and United States source for U.S. foreign tax credit purposes. U.S. Holders should consult their own tax advisors regarding
the tax consequences to them if we pay dividends in NIS or any other non-U.S. currency.





121


Table of Contents




Subject to certain
significant conditions and limitations, including potential limitations under the U.S.-Israel Tax Treaty, any Israeli taxes paid
on or withheld from distributions from us and not refundable to a U.S. Holder may be credited against the investor’s U.S.
federal income tax liability or, alternatively, may be deducted from the investor’s taxable income. The election to credit
or deduct foreign taxes is made on a year-by-year basis and applies to all foreign taxes paid by a U.S. Holder or withheld from
a U.S. Holder that year. Dividends paid on the ordinary shares generally will constitute income from sources outside the United
States and be categorized as “passive category income” or, in the case of some U.S. Holders, as “general category
income” for U.S. foreign tax credit purposes.



Because the rules
governing foreign tax credits are complex, U.S. Holders should consult their own tax advisor regarding the availability of foreign
tax credits in their particular circumstances.



Dividends paid on
the ordinary shares and ADSs will not be eligible for the “dividends-received” deduction generally allowed to corporate
U.S. Holders with respect to dividends received from U.S. corporations.



Certain distributions
treated as dividends that are received by an individual U.S. Holder from “qualified foreign corporations” generally
qualify for a 20% tax rate so long as certain holding period and other requirements are met. A non-U.S. corporation (other than
a corporation that is treated as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally
will be considered to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive tax treaty
with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision
and which includes an exchange of information program, or (ii) with respect to any dividend it pays on stock (or ADSs in respect
of such stock) which is readily tradable on an established securities market in the United States. Dividends paid by us in a taxable
year in which we are not a PFIC and with respect to which we were not a PFIC in the preceding taxable year are expected to be
eligible for the 20% tax rate, although we can offer no assurances in this regard. However, any dividend paid by us in a taxable
year in which we are a PFIC or were a PFIC in the preceding taxable year will be subject to tax at regular ordinary income rates.
Because the PFIC determination is highly fact intensive, there can be no assurance that we will not be a PFIC in 2018 or in any
other taxable year. The additional 3.8% “net investment income tax” (described below) may apply to dividends received
by certain U.S. Holders who meet certain modified adjusted gross income thresholds.



Sale, Exchange
or Other Disposition of Ordinary Shares and ADSs. Subject to the discussion under “— Passive Foreign Investment
Company” below, a U.S. Holder generally will recognize capital gain or loss upon the sale, exchange or other taxable disposition
of our ordinary shares or ADSs in an amount equal to the difference between the amount realized on the sale, exchange or other
disposition and the U.S. Holder’s adjusted tax basis in such shares. This capital gain or loss will be long-term capital
gain or loss if the U.S. Holder’s holding period in our ordinary shares exceeds one year. Preferential tax rates for long-term
capital gain (currently, with a maximum rate of 20%) will apply to individual U.S. Holders. The deductibility of capital losses
is subject to limitations. The gain or loss will generally be income or loss from sources within the United States for U.S. foreign
tax credit purposes, subject to certain exceptions in U.S.-Israel Tax Treaty. The additional 3.8% “net investment income
tax” (described below) may apply to gains recognized upon the sale, exchange, or other taxable disposition of our ordinary
shares or ADSs by certain U.S. Holders who meet certain modified adjusted gross income thresholds.



U.S. Holders should
consult their own tax advisors regarding the U.S. federal income tax consequences of receiving currency other than U.S. dollars
upon the disposition of their ordinary shares or ADSs.



Passive Foreign Investment Company



In general, a corporation
organized outside the United States will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which
either (i) at least 75% of its gross income is “passive income” or (ii) on average at least 50% of its assets (by
value) produce passive income or are held for the production of passive income. Passive income for this purpose generally includes,
among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and from
the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of
the temporary investment of funds, including those raised in the public offering. Assets that produce or are held for the production
of passive income include cash, even if held as working capital or raised in a public offering, marketable securities and other
assets that may produce passive income. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the
income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into
account.





122


Table of Contents




Under the tests described
above, whether or not we are a PFIC will be determined annually based upon the composition of our income and the composition and
valuation of our assets, all of which are subject to change.



Based on our analysis
of our income, assets, and operations, we do not believe that we were a PFIC for 2018. Because the PFIC determination is highly
fact intensive, there can be no assurance that we will not be a PFIC in 2019 or in any other taxable year.



Default PFIC Rules.
If we are a PFIC for any tax year, a U.S. Holder who does not make a timely QEF election or a mark-to-market election, referred
to in this disclosure as a “Non-Electing U.S. Holder,” will be subject to special rules with respect to (i) any “excess
distribution” (generally, the portion of any distributions received by the Non-Electing U.S. Holder on the ordinary shares
or ADSs in a taxable year in excess of 125% of the average annual distributions received by the Non-Electing U.S. Holder in the
three preceding taxable years, or, if shorter, the Non-Electing U.S. Holder’s holding period for the ordinary shares or
ADSs), and (ii) any gain realized on the sale or other disposition of such ordinary shares or ADSs. Under these rules:



| | ● | the excess distribution
    or gain would be allocated ratably over the Non-Electing U.S. Holder’s holding period for such ordinary shares or ADSs;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | the amount allocated
    to the current taxable year and any year prior to us becoming a PFIC would be taxed as ordinary income; and
| | - | ------------------------------------------------------------------------------------------------------------------------------------



| | ● | the amount allocated
    to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of
    taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting
    tax attributable to each such other taxable year.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



If a Non-Electing
U.S. Holder who is an individual dies while owning our ordinary shares or ADSs, the Non-Electing U.S. Holder’s successor
would be ineligible to receive a step-up in tax basis of such ordinary shares or ADSs. Non-Electing U.S. Holders should consult
their tax advisors regarding the application of the “net investment income tax” (described below) to their specific
situation.



To the extent a distribution
on our ordinary shares or ADSs does not constitute an excess distribution to a Non-Electing U.S. Holder, such Non-Electing U.S.
Holder generally will be required to include the amount of such distribution in gross income as a dividend to the extent of our
current or accumulated earnings and profits (as determined for U.S. federal income tax purposes) that are not allocated to excess
distributions. The tax consequences of such distributions are discussed above under “— Taxation of U.S. Holders —
Distributions.” Each U.S. Holder is encouraged to consult its own tax advisor with respect to the appropriate U.S. federal
income tax treatment of any distribution on our ordinary shares.



If we are treated
as a PFIC for any taxable year during the holding period of a Non-Electing U.S. Holder, we will continue to be treated as a PFIC
for all succeeding years during which the Non-Electing U.S. Holder is treated as a direct or indirect Non-Electing U.S. Holder
even if we are not a PFIC for such years. A U.S. Holder is encouraged to consult its tax advisor with respect to any available
elections that may be applicable in such a situation, including the “deemed sale” election of Code Section 1298(b)(1)
(which will be taxed under the adverse tax rules described above).





123


Table of Contents




We may invest in the
equity of foreign corporations that are PFICs or may own subsidiaries that own PFICs. If we are classified as a PFIC, under attribution
rules U.S. Holders will be subject to the PFIC rules with respect to their indirect ownership interests in such PFICs, such that
a disposition of the shares of the PFIC or receipt by us of a distribution from the PFIC generally will be treated as a deemed
disposition of such shares or the deemed receipt of such distribution by the U.S. Holder, subject to taxation under the PFIC rules.
There can be no assurance that a U.S. Holder will be able to make a QEF election or a mark-to-market election with respect to
PFICs in which we invest. Each U.S. Holder is encouraged to consult its own tax advisor with respect to tax consequences of an
investment by us in a corporation that is a PFIC.



QEF Election.One
way in which certain of the adverse consequences of PFIC status can be mitigated is for a U.S. Holder to make a QEF election.
A U.S. Holder who makes a timely QEF election, referred to in this disclosure as an “Electing U.S. Holder,” with respect
to us must report for U.S. federal income tax purposes his pro rata share of our ordinary earnings and net capital gain, if any,
for our taxable year that ends with or within the taxable year of the Electing U.S. Holder. The “net capital gain”
of a PFIC is the excess, if any, of the PFIC’s net long-term capital gains over its net short-term capital losses. The amount
so included in income generally will be treated as ordinary income to the extent of such Electing U.S. Holder’s allocable
share of the PFIC’s ordinary earnings and as long-term capital gain to the extent of such Electing U.S. Holder’s allocable
share of the PFIC’s net capital gains. Such Electing U.S. Holder generally will be required to translate such income into
U.S. dollars based on the average exchange rate for the PFIC’s taxable year with respect to the PFIC’s functional
currency. Such income generally will be treated as income from sources outside the United States for U.S. foreign tax credit purposes.
Amounts previously included in income by such Electing U.S. Holder under the QEF rules generally will not be subject to tax when
they are distributed to such Electing U.S. Holder. The Electing U.S. Holder’s tax basis in our ordinary shares or ADSs generally
will increase by any amounts so included under the QEF rules and decrease by any amounts not included in income when distributed.



An Electing U.S. Holder
will be subject to U.S. federal income tax on such amounts for each taxable year in which we are a PFIC, regardless of whether
such amounts are actually distributed to such Electing U.S. Holder. However, an Electing U.S. Holder may, subject to certain limitations,
elect to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If an Electing U.S.
Holder is an individual, any such interest will be treated as non-deductible “personal interest.”



Any net operating
losses or net capital losses of a PFIC will not pass through to the Electing U.S. Holder and will not offset any ordinary earnings
or net capital gain of a PFIC recognized by Electing U.S. Holder in subsequent years.



So long as an Electing
U.S. Holder’s QEF election with respect to us is in effect with respect to the entire holding period for our ordinary shares
or ADSs, any gain or loss recognized by such Electing U.S. Holder on the sale, exchange or other disposition of such shares or
ADSs generally will be long-term capital gain or loss if such Electing U.S. Holder has held such shares or ADSs for more than
one year at the time of such sale, exchange or other disposition. Preferential tax rates for long-term capital gain (currently,
a maximum rate of 20%) will apply to individual U.S. Holders. The deductibility of capital losses is subject to limitations.



In general, a U.S.
Holder must make a QEF election on or before the due date for filing its income tax return for the first year to which the QEF
election is to apply. A U.S. Holder makes a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance
with the instructions thereto. Upon request, we will annually furnish U.S. Holders with information needed in order to complete
IRS Form 8621 (which form would be required to be filed with the IRS on an annual basis by the U.S. Holder) and to make and maintain
a valid QEF election for any year in which we or any of our subsidiaries that we control is a PFIC. There is no assurance, however,
that we will have timely knowledge of our status as a PFIC, or that the information that we provide will be adequate to allow
U.S. Holders to make a QEF election. A QEF election will not apply to any taxable year during which we are not a PFIC, but will
remain in effect with respect to any subsequent taxable year in which we become a PFIC. Each U.S. Holder should consult its own
tax advisor with respect to the advisability of, the tax consequences of, and the procedures for making a QEF election with respect
to us.





124


Table of Contents




Mark-to-Market
Election. Alternatively, if our ordinary shares or ADSs are treated as “marketable stock,” a U.S. Holder would
be allowed to make a “mark-to-market” election with respect to our ordinary shares or ADSs, provided the U.S. Holder
completes and files IRS Form 8621 in accordance with the relevant instructions and related Treasury Regulations. If that election
is made, the U.S. Holder generally would include as ordinary income in each taxable year the excess, if any, of the fair market
value of our ordinary shares or ADSs at the end of the taxable year over such holder’s adjusted tax basis in such shares
or ADSs. The U.S. Holder would also be permitted an ordinary loss in respect of the excess, if any, of the U.S. Holder’s
adjusted tax basis in our ordinary shares or ADSs over their fair market value at the end of the taxable year, but only to the
extent of the net amount previously included in income as a result of the mark-to-market election. A U.S. Holder’s tax basis
in our ordinary shares or ADSs would be adjusted to reflect any such income or loss amount. Gain realized on the sale, exchange
or other disposition of our ordinary shares or ADSs would be treated as ordinary income, and any loss realized on the sale, exchange
or other disposition of our ordinary shares or ADSs would be treated as ordinary loss to the extent that such loss does not exceed
the net mark-to-market gains previously included in income by the U.S. Holder, and any loss in excess of such amount will be treated
as capital loss. Amounts treated as ordinary income will not be eligible for the favorable tax rates applicable to qualified dividend
income or long-term capital gains.



Generally, stock will
be considered marketable stock if it is “regularly traded” on a “qualified exchange” within the meaning
of applicable Treasury Regulations. A class of stock is regularly traded on an exchange during any calendar year during which
such class of stock is traded, other than in de minimisquantities, on at least 15 days during each calendar
quarter. To be marketable stock, our ordinary shares and ADSs must be regularly traded on a qualifying exchange (i) in the United
States that is registered with the SEC or a national market system established pursuant to the Exchange Act or (ii) outside the
United States that is properly regulated and meets certain trading, listing, financial disclosure and other requirements. Our
ordinary shares should constitute “marketable stock” as long as they remain listed on the OTC and/or the NYSE American
and are regularly traded. Our ADSs will be listed on the OTC and/or the NYSE American. While we believe that our ADSs may be treated
as marketable stock for purposes of the PFIC rules so long as they are listed on the OTC and/or the NYSE American and are regularly
traded, the IRS has not provided a list of the exchanges that meet the foregoing requirements and thus no assurance can be provided
that our ADSs will be (or will remain) treated as marketable stock for purposes of the PFIC rules.



A mark-to-market election
will not apply to our ordinary shares or ADSs held by a U.S. Holder for any taxable year during which we are not a PFIC, but will
remain in effect with respect to any subsequent taxable year in which we become a PFIC. Such election will not apply to any PFIC
subsidiary that we own. Each U.S. Holder is encouraged to consult its own tax advisor with respect to the availability and tax
consequences of a mark-to-market election with respect to our ordinary shares and ADSs.



In addition, U.S.
Holders should consult their tax advisors regarding the IRS information reporting and filing obligations that may arise as a result
of the ownership of ordinary shares in a PFIC, including IRS Form 8621, Information Return by a Shareholder of a Passive Foreign
Investment Company or Qualified Electing Fund.



The U.S. federal
income tax rules relating to PFICs, QEF elections, and mark-to market elections are complex. U.S. Holders are urged to consult
their own tax advisors with respect to the purchase, ownership and disposition of our ordinary shares or ADSs, any elections available
with respect to such shares or ADSs and the IRS information reporting obligations with respect to the purchase, ownership and
disposition of our ordinary shares or ADSs.



Tax Consequences for Non-U.S. Holders
of Ordinary Shares or ADSs



Except as provided
below, an individual, corporation, estate or trust that is not a U.S. Holder, referred to below as a non-U.S. Holder, generally
will not be subject to U.S. federal income or withholding tax on the payment of dividends on, and the proceeds from the disposition
of, our ordinary shares or ADSs.



A non-U.S. Holder
may be subject to U.S. federal income tax on a dividend paid on our ordinary shares or ADSs or gain from the disposition of our
ordinary shares or ADSs if: (1) such item is effectively connected with the conduct by the non-U.S. Holder of a trade or business
in the United States and, if required by an applicable income tax treaty is attributable to a permanent establishment or fixed
place of business in the United States; or (2) in the case of a disposition of our ordinary shares or ADSs, the individual non-U.S.
Holder is present in the United States for 183 days or more in the taxable year of the disposition and other specified conditions
are met.



In general, non-U.S.
Holders will not be subject to backup withholding with respect to the payment of dividends on our ordinary shares or ADSs if payment
is made through a paying agent, or office of a foreign broker outside the United States. However, if payment is made in the United
States or by a U.S. related person, non-U.S. Holders may be subject to backup withholding, unless the non-U.S. Holder provides
an applicable IRS Form W-8 (or a substantially similar form) certifying its foreign status, or otherwise establishes an exemption.



The amount of any
backup withholding from a payment to a non-U.S. Holder will be allowed as a credit against such holder’s U.S. federal income
tax liability and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.



125


Table of Contents




Certain Reporting
Requirements



Certain U.S. Holders
are required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign Corporation, and certain U.S. Holders may
be required to file IRS Form 5471, Information Return of U.S. Persons With Respect to Certain Foreign Corporations, reporting
transfers of cash or other property to us and information relating to the U.S. Holder and us. Substantial penalties may be imposed
upon a U.S. Holder that fails to comply. See also the discussion regarding Form 8621, Information Return by a Shareholder of a
Passive Foreign Investment Company or Qualified Electing Fund, above.



In addition, certain
U.S. Holders must report information on IRS Form 8938, Statement of Specified Foreign Financial Assets, with respect to their
investments in certain “foreign financial assets,” which would include an investment in our ordinary shares, if the
aggregate value of all of those assets exceeds $50,000 on the last day of the taxable year (and in some circumstances, a higher
threshold). This reporting requirement applies to individuals and certain U.S. entities.



U.S. Holders who fail
to report required information could become subject to substantial penalties. U.S. Holders should consult their tax advisors regarding
the possible implications of these reporting requirements arising from their investment in our ordinary shares.



Backup Withholding Tax and Information Reporting Requirements



Generally, information
reporting requirements will apply to distributions on our ordinary shares or ADSs or proceeds on the disposition of our ordinary
shares or ADSs paid within the United States (and, in certain cases, outside the United States) to U.S. Holders other than certain
exempt recipients, such as corporations. Furthermore, backup withholding (currently at 24%) may apply to such amounts if the U.S.
Holder fails to (i) provide a correct taxpayer identification number, (ii) report interest and dividends required to be shown
on its U.S. federal income tax return, or (iii) make other appropriate certifications in the required manner. U.S. Holders who
are required to establish their exempt status generally must provide such certification on IRS Form W-9.



Backup withholding
is not an additional tax. Amounts withheld as backup withholding from a payment may be credited against a U.S. Holder’s
U.S. federal income tax liability and such U.S. Holder may obtain a refund of any excess amounts withheld by filing the appropriate
claim for refund with the IRS and furnishing any required information in a timely manner.



Tax on Net Investment
Income



Certain U.S. persons,
including individuals, estates and trusts are generally subject to an additional 3.8% Medicare tax. For individuals, the additional
Medicare tax applies to the lesser of (i) “net investment income” or (ii) the excess of “modified adjusted gross
income” over $200,000 ($250,000 if married and filing jointly or $125,000 if married and filing separately). “Net
investment income” generally equals the taxpayer’s gross investment income reduced by the deductions that are allocable
to such income. Investment income generally includes passive income such as interest, dividends, annuities, royalties, rents,
and capital gains. U.S. Holders are urged to consult their own tax advisors regarding the implications of the additional Medicare
tax resulting from their ownership and disposition of our shares or ADSs.



U.S. Holders
should consult their own tax advisors concerning the tax consequences relating to the purchase, ownership and disposition of our
ordinary shares or ADSs.





126


Table of Contents




F.
Dividends and Paying Agents.



Not applicable.



G.
Statements by Experts.



Not applicable.



H.
Documents on Display.



We are subject to the
information reporting requirements of the Exchange Act, applicable to foreign private issuers and under those requirements will
file reports with the SEC. The SEC maintains an Internet website that contains reports and other information regarding issuers
that file electronically with the SEC. You may read and copy this annual report, including the related exhibits and schedules,
and any document we file with the SEC at http://www.sec.gov.



As a foreign private
issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our
officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained
in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly and current
reports and financial statements with the SEC as frequently or as promptly as United States companies whose securities are registered
under the Exchange Act. However, we will file with the SEC, within 120 days after the end of each fiscal year, or such applicable
time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered
public accounting firm, and will submit to the SEC, on a Form 6-K, unaudited quarterly financial information.



In addition, because
our ordinary shares are traded on the TASE, we have filed Hebrew language periodic and immediate reports with, and furnish information
to, the TASE and the ISA, as required under Chapter Six of the Israel Securities Law. Copies of our filings with the ISA can be
retrieved electronically through the MAGNA distribution site of the ISA (www.magna.isa.gov.il) and the TASE website (www.maya.tase.co.il).



We maintain a corporate
website at www.canfite.com. Information contained on, or that can be accessed through, our website does not constitute
a part of this Annual Report on Form 20-F. We have included our website address in this Annual Report on Form 20-F solely as an
inactive textual reference.



I.
Subsidiary Information.



Not applicable.



ITEM 11. Quantitative and Qualitative Disclosures About
Market Risk



Market risk is the
risk of loss related to changes in market prices, including interest rates and foreign exchange rates, of financial instruments
that may adversely impact our consolidated financial position, results of operations or cash flows.



Interest Rate
Risk



We do not anticipate
undertaking any significant long-term borrowings. At present, our investments consist primarily of cash and cash equivalents.
We may invest in investment-grade marketable securities with maturities of up to three years, including commercial paper, money
market funds, and government/non-government debt securities. The primary objective of our investment activities is to preserve
principal while maximizing the income that we receive from our investments without significantly increasing risk and loss. Our
investments are exposed to market risk due to fluctuation in interest rates, which may affect our interest income and the fair
market value of our investments, if any. We manage this exposure by performing ongoing evaluations of our investments. Due to
the short-term maturities, if any, of our investments to date, their carrying value has always approximated their fair value.
If we decide to invest in investments other than cash and cash equivalents, it will be our policy to hold such investments to
maturity in order to limit our exposure to interest rate fluctuations.





127


Table of Contents




Foreign Currency
Exchange Risk



Our  foreign
currency exposures give rise to market risk associated with exchange rate movements of the U.S dollar, our functional and reporting
currency, mainly against the NIS and the euro. Although the U.S dollar  is our functional currency, a portion of our expenses
are denominated in both NIS and euro and currently all of our revenues are denominated in dollars. Our U.S. dollar and euro expenses
consist principally of payments made to sub-contractors and consultants for preclinical studies, clinical trials and other research
and development activities, Our NIS expenses consist principally of salary related payments. We anticipate that a sizable portion
of our expenses will continue to be denominated in currencies other than the NIS. If the U.S dollar fluctuates significantly against
either the NIS or the euro, it may have a negative impact on our results of operations. To date, fluctuations in the exchange
rates have not materially affected our results of operations or financial condition for the periods under review.



To date, we have not engaged in hedging
transactions. In the future, we may enter into currency hedging transactions to decrease the risk of financial exposure from fluctuations
in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material
adverse effects of such fluctuations.



ITEM 12. Description of Securities Other Than Equity Securities



A.
Debt Securities.



Not applicable.



B.
Warrants and Rights.



Not applicable.



C.
Other Securities.



Not applicable.



D.
American Depositary Shares



The Bank of
New York Mellon, as Depositary, will register and deliver American Depositary Shares, or ADSs. Each ADS will represent two (2)
ordinary shares (or a right to receive two (2) ordinary shares) deposited with the principal Tel Aviv office of Bank Hapoalim,
as custodian for the Depositary. Each ADS will also represent any other securities, cash or other property which may be held by
the Depositary. The Depositary’s corporate trust office at which the ADSs will be administered is located at 101 Barclay
Street, New York, New York 10286. The Bank of New York Mellon’s principal executive office is located at One Wall Street,
New York, New York 10286.



The form of the deposit
agreement for our ADSs and the form of American Depositary Receipt that represents an ADS have been incorporated by reference
as exhibits to this Annual Report on Form 20-F.





128


Table of Contents




Fees and Expenses



|Persons
    depositing or withdrawing shares or ADS holders must pay:                                                                                                                              |  | For:
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  | ----
|                                                                                                                                                                                                   |  |     
|$5.00
    (or less) per 100 ADSs (or portion of 100 ADSs)                                                                                                                                          |  | ●   
|                                                                                                                                                                                                   |  |     
|                                                                                                                                                                                                   |  | ●   
|                                                                                                                                                                                                   |  |     
|$.05 (or less) per ADS                                                                                                                                                                             |  | ●   
|                                                                                                                                                                                                   |  |     
|A fee equivalent
    to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance
    of ADSs                                  |  | ●   
|                                                                                                                                                                                                   |  |     
|$.05 (or less) per
    ADSs per calendar year                                                                                                                                                      |  | ●   
|                                                                                                                                                                                                   |  |     
|Registration or transfer fees                                                                                                                                                                      |  | ●   
|                                                                                                                                                                                                   |  |     
|Expenses of the Depositary                                                                                                                                                                         |  | ●   
|                                                                                                                                                                                                   |  |     
|                                                                                                                                                                                                   |  | ●   
|                                                                                                                                                                                                   |  |     
|Taxes and other
    governmental charges the Depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock
    transfer taxes, stamp duty or withholding taxes |  | ●   
|                                                                                                                                                                                                   |  |     
|Any charges incurred
    by the Depositary or its agents for servicing the deposited securities                                                                                                    |  | ●   



The Depositary collects
its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of
withdrawal or from intermediaries acting for them. The Depositary collects fees for making distributions to investors by deducting
those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The Depositary may
collect its annual fee for depositary services by deduction from cash distributions, by directly billing investors or by charging
the book-entry system accounts of participants acting for them. The Depositary may generally refuse to provide fee-attracting
services until its fees for those services are paid.



From time to time,
the Depositary may make payments to us to reimburse us for expenses and/or share revenue with us from the fees collected from
ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of the establishment
and maintenance of the ADS program. In performing its duties under the Deposit Agreement, the Depositary may use brokers, dealers
or other service providers that are affiliates of the Depositary and that may earn or share fees or commissions.





129


Table of Contents




PART II



ITEM 13. Defaults, Dividend Arrearages and Delinquencies



Not applicable.



ITEM 14. Material Modifications to the Rights of Security
Holders and Use of Proceeds



Not applicable.



ITEM 15. Controls and Procedures



Disclosure controls and procedures



Our management, including
our chief executive officer, or CEO, and our chief financial officer, or CFO, are responsible for establishing and maintaining
our disclosure controls and procedures (within the meaning of Rule 13a-15(e) of the Exchange Act). These controls and procedures
were designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act
is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and that such
information is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions
regarding required disclosure. We evaluated these disclosure controls and procedures under the supervision of our CEO and CFO
as of December 31, 2018. Based upon that evaluation, our management, including our CEO and CFO, concluded that our disclosure
controls and procedures as of December 31, 2018 were effective.



Management’s annual report on
internal control over financial reporting



Our
management, including our CEO, and our CFO, is  responsible for establishing and maintaining adequate internal control over
our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act of 1934, as amended. Our internal
control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. Internal control over financial reporting includes policies and procedures that:



| | ● | pertain
    to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;                                                                
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                           
| | ● | provide
    reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in
    accordance with generally accepted accounting principles;       
| |   |                                                                                                                                                                                                           
| | ● | provide
    reasonable assurance that receipts and expenditures are made only in accordance with authorizations of our management and
    board of directors (as appropriate); and                        
| |   |                                                                                                                                                                                                           
| | ● | provide
    reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets
    that could have a material effect on our financial statements.



Due to its inherent
limitations, internal controls over financial reporting may not prevent or detect misstatements. In addition, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.



Under the supervision
and with the participation of our management, including our CEO, and our CFO, we assessed the effectiveness of our internal control
over financial reporting as of December 31, 2018 based on the framework for Internal Control-Integrated Framework set forth by
The Committee of Sponsoring Organizations of the Treadway Commission (COSO) (2013).



Based on our assessment
and this framework, our management concluded that our internal control over financial reporting were effective as of December
31, 2018.



Attestation Report of Registered Public Accounting Firm



Not applicable.



Changes in internal control over financial
reporting



There were no changes
in our internal control over financial reporting, other than as described above, that occurred during the year ended December
31, 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.





130


Table of Contents




ITEM 16. [RESERVED]



ITEM 16A. Audit Committee Financial Expert



Our Board of Directors
has determined that Guy Regev and Yaacov Goldman are audit committee financial experts, as defined by applicable SEC regulations.
Messrs. Regev and Goldman qualified as an “independent director,” as that term is defined under NYSE American rules.



ITEM 16B. Code of Ethics



We have adopted a
code of ethics, referred to as a Code of Business Conduct, applicable to our directors, officers and all other employees. Our
code of ethics is publicly available on our website at www.canfite.com. If we make any amendment to the code of ethics
or grant any waivers, including any implicit waiver, from a provision of the code of ethics, which applies to our chief executive
officer, chief financial officer, chief accounting officer or controller, or persons performing similar functions, we will disclose
the nature of such amendment or waiver on our website.



ITEM 16C. Principal Accountant Fees and Services



The following table
sets forth, for each of the years indicated, the fees billed by our independent registered public accounting firm.



|                           |  | Year Ended
    December 31, |    
|-------------------------- |  | --------------------------- | ---
|                           |  | 2018                        |    
|Services Rendered          |  | (USD in thousands)          |    
|Audit (1)                  |  |                             | 115
|Audit related services (2) |  |                             | 9  
|Tax                        |  |                             | 14 
|All other fees             |  |                             | -  
|Total                      |  |                             | 138



|(1) | Audit
    fees consist of services that would normally be provided in connection with statutory and regulatory filings or engagements,
    including services that generally only the independent accountant can reasonably provide.                                                
|--- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                                                                                                                                                     
|(2) | Audit
    related services consist of services that were reasonably related to the performance of the audit or reviews of our financial
    statements and not included under “Audit Fees” above, including, principally, providing consents for registration
    statement filings.



Audit Committee Pre-Approval Policies
and Procedures



Our audit committee’s
specific responsibilities in carrying out its oversight of the quality and integrity of the accounting, auditing and reporting
practices of us include the approval of audit and non-audit services to be provided by the external auditor. The audit committee
approves in advance the particular services or categories of services to be provided to us during the following yearly period
and also sets forth a specific budget for such audit and non-audit services. Additional non-audit services may be pre-approved
by the audit committee.



ITEM 16D. Exemptions from the Listing Standards for Audit
Committees



Not applicable.



ITEM 16E. Purchases of Equity Securities by the Issuer and
Affiliated Purchasers



Not applicable.





131


Table of Contents




ITEM 16F. Change in Registrant’s Certifying Accountant



Not applicable.



ITEM 16G. Corporate Governance



We are a foreign private
issuer whose ordinary shares are listed on the NYSE American. As such, we are required to comply with U.S. federal securities
laws, including the Sarbanes-Oxley Act, and the NYSE American rules, including the NYSE American corporate governance requirements.
The NYSE American rules provide that foreign private issuers may follow home country practice in lieu of certain qualitative listing
requirements subject to certain exceptions and except to the extent that such exemptions would be contrary to U.S. federal securities
laws, so long as the foreign issuer discloses that it does not follow such listing requirement and describes the home country
practice followed in its reports filed with the SEC. Below is a concise summary of the significant ways in which our corporate
governance practices differ from the corporate governance requirements of NYSE American applicable to domestic U.S. listed companies:



| | ● | The
                                         NYSE American rules recommend that an issuer have a quorum requirement for shareholders
                                         meetings of at least one-third of the outstanding shares of the issuer’s common
                                         voting stock. We have chosen to follow home country practice with respect to the quorum
                                         requirements of our shareholders meeting and our adjourned shareholders meeting. Our
                                         Amended and Restated Articles of Association, as permitted under the Israeli Companies
                                         Law and Israeli practice, provide that the quorum requirements for a shareholders meeting
                                         are the presence of at least two shareholders who represent at least 25%of the outstanding
                                         shares of the issuer’s common voting stock, and in the event of an adjourned meeting,
                                         the presence of a minimum of two shareholders present in person.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | We
                                         have chosen to follow our home country practice in lieu of the requirements of the NYSE
                                         American rules relating to shareholder approval required prior to the issuance of securities
                                         (i) when a stock option or purchase plan is to be established or materially amended or
                                         other equity compensation arrangement made or materially amended, pursuant to which stock
                                         may be acquired by officers, directors, employees or consultants and (ii) in connection
                                         with a transaction, other than a public offering, involving the issuance or potential
                                         issuance by the Company of ordinary shares (or their equivalent) equal to 20% or more
                                         of the ordinary shares or 20% voting power outstanding before the issuance for or at
                                         a price less than the greater of book or market value of the shares. We follow the provisions
                                         of the Israeli Companies Law with regard to transactions with our affiliates, i.e., our
                                         controlling shareholder and our directors and officers, including private placement transactions.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



ITEM 16H. Mine Safety Disclosure



Not applicable.





132


Table of Contents




PART III



ITEM 17. Financial Statements



We have responded to Item 18 in lieu of
responding to this item.



ITEM 18. Financial Statements



Please refer to the financial statements
beginning on page F-1.



ITEM 19. Exhibits



Index to Exhibits



|Exhibit No. |  | Description                                                                                                                                                                                                     
|----------- |  | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|1.1         |  | Amended
    and Restated Articles of Association of Can-Fite BioPharma Ltd (13)                                                                                                                                 
|            |  |                                                                                                                                                                                                                 
|2.1         |  | Form
    of Amended and Restated Deposit Agreement, by and among Can-Fite BioPharma Ltd., The Bank of New York Mellon and the Owners
    and Holders of American Depositary Shares, dated September 11, 2013 (1)
|            |  |                                                                                                                                                                                                                 
|4.1         |  | Employment
    and Non-Competition Agreement with Motti Farbstein, dated June 10, 2003 (2)                                                                                                                      
|            |  |                                                                                                                                                                                                                 
|4.2         |  | Consulting
    Agreement with BioStrategics Consulting, Ltd, dated September 27, 2005 (2)                                                                                                                       
|            |  |                                                                                                                                                                                                                 
|4.3         |  | Service
    Management Agreement with F.D. Consulting International and Marketing Ltd., dated June 27, 2002 (2)                                                                                                 
|            |  |                                                                                                                                                                                                                 
|4.4         |  | Master
    Services Agreement with Accellient Partners, dated May 10, 2010 (2)                                                                                                                                  
|            |  |                                                                                                                                                                                                                 
|4.5         |  | License
    Agreement, by and between The University of Leiden and Can-Fite BioPharma Ltd., dated November 2, 2009 (2)                                                                                          
|            |  |                                                                                                                                                                                                                 
|4.6         |  | License
    Agreement, by and between Kwang Dong Pharmaceutical Co., Ltd. and Can-Fite BioPharma Ltd., dated December 14, 2008 (2)                                                                              
|            |  |                                                                                                                                                                                                                 
|4.7         |  | Can-Fite
    BioPharma Ltd. 2003 Israeli Share Option Plan (2)                                                                                                                                                  
|            |  |                                                                                                                                                                                                                 
|4.8         |  | Can-Fite
    BioPharma Ltd. 2013 Israeli Share Option Plan (3)                                                                                                                                                  
|            |  |                                                                                                                                                                                                                 
|4.9         |  | Compensation Policy of Can-Fite BioPharma Ltd. (7)                                                                                                                                                              
|            |  |                                                                                                                                                                                                                 
|4.10        |  | Form
    of Securities Purchase Agreement dated as of December 2, 2014 between Can-Fite BioPharma Ltd. and the investors listed therein (4)                                                                     
|            |  |                                                                                                                                                                                                                 
|4.11        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on December 8, 2014 (4)                                                                                                                                   
|            |  |                                                                                                                                                                                                                 
|4.12        |  | Letter
    Agreement between H.C. Wainwright & Co., LLC and Can-Fite BioPharma Ltd. dated December 2, 2014 (4)                                                                                                  
|            |  |                                                                                                                                                                                                                 
|4.13        |  | Distribution
    and Supply Agreement between Can-Fite BioPharma Ltd. and Cipher Pharmaceuticals Inc. dated as of March 20, 2015 (3)†                                                                           
|            |  |                                                                                                                                                                                                                 
|4.14        |  | Form
    of Securities Purchase Agreement dated as of September 19, 2015 between Can-Fite BioPharma Ltd. and the investors listed therein (5)                                                                   
|            |  |                                                                                                                                                                                                                 
|4.15        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on September 21, 2015 (5)                                                                                                                                 
|            |  |                                                                                                                                                                                                                 
|4.16        |  | Letter
    Agreement between H.C. Wainwright & Co., LLC and Can-Fite BioPharma Ltd. dated September 18, 2015 (5)                                                                                                
|            |  |                                                                                                                                                                                                                 
|4.17        |  | Form
    of Securities Purchase Agreement dated as of October 13, 2015 between Can-Fite BioPharma Ltd. and the investors listed therein (6)                                                                     
|            |  |                                                                                                                                                                                                                 
|4.18        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on October 15, 2015 (6)                                                                                                                                   





133


Table of Contents




|Exhibit No. |  | Description                                                                                                                                           
|----------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------
|4.19        |  | Letter
    Agreement between H.C. Wainwright & Co., LLC and Can-Fite BioPharma Ltd. dated October 13, 2015 (6)                                        
|            |  |                                                                                                                                                       
|4.20        |  | Distribution
    Agreement between Can-Fite BioPharma Ltd. and Chong Kun Dang Pharmaceutical Corp. dated as of October 25, 2016 (9)†                  
|            |  |                                                                                                                                                       
|4.21        |  | Form
    of Securities Purchase Agreement dated as of January 18, 2017 between Can-Fite BioPharma Ltd. and the investors listed therein
    (8)       
|            |  |                                                                                                                                                       
|4.22        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on January 18, 2017 (8)                                                                         
|            |  |                                                                                                                                                       
|4.23        |  | Letter
    Agreement between H.C. Wainwright & Co., LLC and Can-Fite BioPharma Ltd. dated January 18, 2017 87)                                        
|            |  |                                                                                                                                                       
|4.24        |  | Agreement
    and Plan of Merger, dated as of May 21, 2017, by and between OphthaliX, Inc., Bufiduck Ltd., and Wize Pharma Ltd. (10)                  
|            |  |                                                                                                                                                       
|4.25        |  | Voting
    and Undertaking Agreement, dated as of May 21, 2017, by and between OphthaliX, Inc., Wize Pharma Ltd., and Can-Fite BioPharma
    Ltd. (10)
|            |  |                                                                                                                                                       
|4.26        |  | Form
    of Stock Purchase Agreement (10)                                                                                                             
|            |  |                                                                                                                                                       
|4.27        |  | Form
    of Termination of License Agreement (10)                                                                                                     
|            |  |                                                                                                                                                       
|4.28        |  | Form
    of Termination of Services Agreement (10)                                                                                                    
|            |  |                                                                                                                                                       
|4.29        |  | Form
    of Securities Purchase Agreement dated as of March 9, 2018 between Can-Fite BioPharma Ltd. and the investors listed therein
    (11)         
|            |  |                                                                                                                                                       
|4.30        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on March 13, 2018 (11)                                                                          
|            |  |                                                                                                                                                       
|4.31        |  | Form
    of Securities Purchase Agreement dated as of January 18, 2019 between Can-Fite BioPharma Ltd. and the investor listed therein
    (12)       
|            |  |                                                                                                                                                       
|4.32        |  | Form
    of Warrant issued by Can-Fite BioPharma Ltd. on January 23, 2019 (12)                                                                        
|            |  |                                                                                                                                                       
|4.33        |  | Form
    of Placement Agent Warrant issued by Can-Fite BioPharma Ltd. on January 23, 2019 (13)                                                        
|            |  |                                                                                                                                                       
|8.1         |  | List
    of Subsidiaries of Can-Fite BioPharma Ltd. (14)                                                                                              
|            |  |                                                                                                                                                       
|12.1        |  | Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*                                                   
|            |  |                                                                                                                                                       
|12.2        |  | Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*                                                   





134


Table of Contents




|Exhibit No. |  | Description                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
|----------- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|13.1        |  | Certification by Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*                                                                                                                                                                                                                                                                                                                                          
|            |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
|13.2        |  | Certification by Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*                                                                                                                                                                                                                                                                                                                                          
|            |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
|15.1        |  | Consent of Independent Registered Public Accounting Firm.*                                                                                                                                                                                                                                                                                                                                                                                                                                  
|            |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
|101         |  | The
    following financial information from Can-Fite BioPharma Ltd.’s Annual Report on Form 20-F for the year ended December
    31, 2018, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Statements of Financial Position, (ii)
    Consolidated Statements of Comprehensive Loss, (iii) Consolidated Statements of Changes in Equity (Deficiency) (iv) the Consolidated
    Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements.*



|*    | Filed
    Herewith.                                                                                                                                                                                                                                                                                                                                                                  
|---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|†    | Certain
    confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it
    with [...]. This exhibit has been filed separately with the Commission without the redaction pursuant to a Confidential Treatment
    Request under Rule 24b-2 of the Securities Exchange Act of 1934 and Rule 406 of the Securities Act.
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(1)  | Incorporated
    herein by reference to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.                                                                                                                                                                                                                                                              
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(2)  | Incorporated
    herein by reference to Amendment No. 1 to the Draft Registration Statement on Form 20-F filed with the SEC on September 10,
    2013.                                                                                                                                                                                                                               
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(3)  | Incorporated
    herein by reference to Annual Report on Form 20-F filed with the SEC on March 27, 2015.                                                                                                                                                                                                                                                                             
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(4)  | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on December 4, 2014.                                                                                                                                                                                                                                                                       
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(5)  | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on September 22, 2015.                                                                                                                                                                                                                                                                     
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(6)  | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on October 15, 2015.                                                                                                                                                                                                                                                                       
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(7)  | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on December 7, 2016.                                                                                                                                                                                                                                                                       
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(8)  | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on January 20, 2017.                                                                                                                                                                                                                                                                       
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(9)  | Incorporated
    herein by reference to the Annual Report on Form 20- F filed with the SEC on March 30, 2017.                                                                                                                                                                                                                                                                        
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(10) | Incorporated
    herein by reference to the Current Report on Form 8-K filed by OphthaliX, Inc. with the SEC on May 22, 2017.                                                                                                                                                                                                                                                        
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(11) | Incorporated
    herein by reference to the Current Report on Form 6-K filed with the SEC on March 12, 2018.                                                                                                                                                                                                                                                                         
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(12) | Incorporated herein by reference to the Current Report on Form 6-K filed
    with the SEC on January 22, 2019.                                                                                                                                                                                                                                                                       
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(13) | Incorporated
    herein by reference to Registration Statement on Form F-1 filed with the SEC on February 15, 2019.                                                                                                                                                                                                                                                                  
|     |                                                                                                                                                                                                                                                                                                                                                                                      
|(14) | Incorporated
    herein by reference to Annual Report on Form 20-F filed with the SEC on March 28, 2018.                                                                                                                                                                                                                                                                             



135


Table of Contents




SIGNATURES



The Registrant
hereby certifies that it meets all of the requirements for filing on Form 20-F/A and that it has duly caused and authorized the
undersigned to sign this Annual Report on its behalf.



|                        | CAN-FITE
    BIOPHARMA LTD.
|----------------------- | ---------------------------
|                        |                            
|Date:
    April 2, 2019 | By:                        
|                        |                            
|                        |                            





136


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED FINANCIAL STATEMENTS



AS OF DECEMBER 31, 2018



INDEX



|                                                        | Page       
|------------------------------------------------------- | -----------
|                                                        |            
|Report of Independent Registered Public Accounting Firm | F-2        
|                                                        |            
|Consolidated Statements of Financial Position           | F-3 - F-4  
|                                                        |            
|Consolidated Statements of Comprehensive Loss           | F-5        
|                                                        |            
|Consolidated Statements of Changes in Equity            | F-6 - F-8  
|                                                        |            
|Consolidated Statements of Cash Flows                   | F-9 - F-10 
|                                                        |            
|Notes to Consolidated Financial Statements              | F-11 - F-46



- - - - - - - - - - -





F-1


Table of Contents




| | Kost Forer Gabbay & Kasierer
        144 Menachem Begin Road
        Tel-Aviv 6492102, Israel |  | Tel: +972-3-6232525
        Fax: +972-3-5622555
        ey.com
| | --------------------------------------------------------------------------------------------- |  | --------------------------------------------------------------



REPORT OF INDEPENDENT REGISTERED PUBLIC
ACOUNTING FIRM



To the Shareholders and Board of Directors
of



CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



Opinion on
the Financial Statements



We have audited
the accompanying consolidated financial position of Can-Fite Ltd and its subsidiaries (the “Company”) as of December
31, 2018 and 2017, and the related consolidated statements of other comprehensive loss, shareholders’ equity and cash flows
for each of the three years in the period ended December 31, 2018, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidation financial statements present fairly, in all material respects,
the consolidated financial position of the Company at December 31, 2018 and 2017, and the results of its operations and its cash
flows for each of the three years in the period ended December 31, 2018, in conformity with International Financial Reporting
Standards as issued by the International Accounting Standards Board.





Basis for Opinion



These financial statements
are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements
based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and
the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.



We conducted our
audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of
our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting.  Accordingly, we express no such
opinion.



Our audits included
performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and
significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe
that our audits provide a reasonable basis for our opinion.



/s/
Kost Forer Gabbay & Kasierer



KOST FORER GABBAY
& KASIERER

A Member of Ernst
& Young Global



We have served as the Company’s auditor
since at least 2001, but we are unable to determine the specific year.

Tel-Aviv, Israel

March 29, 2019



F-2


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per
share data)



|                                                |  |      |  | December 31, |      
|----------------------------------------------- |  | ---- |  | ------------ | -----
|                                                |  |      |  | 2018         |      
|                                                |  | Note |  | USD          |      
|                                                |  |      |  |              |      
|ASSETS                                          |  |      |  |              |      
|                                                |  |      |  |              |      
|CURRENT ASSETS:                                 |  |      |  |              |      
|Cash and cash equivalents                       |  |      |  | $            | 3,615
|Other accounts receivables and prepaid expenses |  | 5    |  |              | 4,015
|Short-term investment                           |  | 6    |  |              | 273  
|                                                |  |      |  |              |      
|Total current assets                            |  |      |  |              | 7,903
|                                                |  |      |  |              |      
|NON-CURRENT ASSETS:                             |  |      |  |              |      
|Lease deposit                                   |  |      |  |              | 2    
|long-term investment                            |  | 6    |  |              | -    
|Property, plant and equipment, net              |  | 7    |  |              | 47   
|                                                |  |      |  |              |      
|Total long-term assets                          |  |      |  |              | 49   
|                                                |  |      |  |              |      
|Total assets                                    |  |      |  | $            | 7,952



The accompanying notes are an integral
part of the consolidated financial statements.



F-3


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per
share data)



|                                                      |  |      |  | December 31, |         
|----------------------------------------------------- |  | ---- |  | ------------ | --------
|                                                      |  |      |  | 2018         |         
|                                                      |  | Note |  | USD          |         
|                                                      |  |      |  |              |         
|LIABILITIES AND SHAREHOLDERS’ EQUITY                  |  |      |  |              |         
|                                                      |  |      |  |              |         
|CURRENT LIABILITIES:                                  |  |      |  |              |         
|Trade payables                                        |  |      |  | $            | 1,071   
|Deferred revenues                                     |  | 10   |  |              | 926     
|Other accounts payable                                |  | 8    |  |              | 1,122   
|                                                      |  |      |  |              |         
|Total current liabilities                             |  |      |  |              | 3,119   
|                                                      |  |      |  |              |         
|NON-CURRENT LIABILITIES:                              |  |      |  |              |         
|Deferred revenues                                     |  | 10   |  |              | 1,818   
|                                                      |  |      |  |              |         
|Total Long-term liabilities                           |  |      |  |              | 1,818   
|                                                      |  |      |  |              |         
|CONTIGENT LIABILITIES AND COMMITMENTS                 |  | 10   |  |              |         
|                                                      |  |      |  |              |         
|EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: |  | 11   |  |              |         
|Share capital                                         |  |      |  |              | 2,635   
|Share premium                                         |  |      |  |              | 81,668  
|Capital reserve from share-based payment transactions |  |      |  |              | 5,800   
|Warrants exercisable into shares                      |  |      |  |              | 12,408  
|Accumulated other comprehensive income                |  |      |  |              | 1,127   
|Accumulated deficit                                   |  |      |  |              | (100,623
|                                                      |  |      |  |              |         
|Total equity                                          |  |      |  |              | 3,015   
|                                                      |  |      |  |              |         
|Total liabilities and equity                          |  |      |  | $            | 7,952   



The accompanying notes are an integral
part of the consolidated financial statements.



F-4


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS

In thousands (except for share and per
share data)



|                                                                                                           |  |      |  | Year ended 
December 31, |      
|---------------------------------------------------------------------------------------------------------- |  | ---- |  | ------------------------ | -----
|                                                                                                           |  |      |  | 2018                     |      
|                                                                                                           |  | Note |  | USD                      |      
|                                                                                                           |  |      |  |                          |      
|Revenues                                                                                                   |  | 10   |  | $                        | 3,820
|                                                                                                           |  |      |  |                          |      
|Research and development expenses                                                                          |  | 13   |  |                          | 6,075
|General and administrative expenses                                                                        |  | 14   |  |                          | 3,159
|                                                                                                           |  |      |  |                          |      
|Operating loss                                                                                             |  |      |  |                          | 5,414
|                                                                                                           |  |      |  |                          |      
|Other income                                                                                               |  | 1b   |  |                          | -    
|                                                                                                           |  |      |  |                          |      
|Financial expenses                                                                                         |  | 15   |  |                          | 1,204
|Financial income                                                                                           |  | 15   |  |                          | (51  
|                                                                                                           |  |      |  |                          |      
|Total Financial expense (income), net                                                                      |  |      |  |                          | 1,153
|                                                                                                           |  |      |  |                          |      
|Loss before taxes on income                                                                                |  |      |  |                          | 6,567
|Taxes on income                                                                                            |  | 17   |  |                          | 4    
|                                                                                                           |  |      |  |                          |      
|Net loss                                                                                                   |  |      |  |                          | 6,571
|                                                                                                           |  |      |  |                          |      
|Other comprehensive loss:                                                                                  |  |      |  |                          |      
|                                                                                                           |  |      |  |                          |      
|Amounts that will not be reclassified subsequently to profit or loss:                                      |  |      |  |                          |      
|                                                                                                           |  |      |  |                          |      
|Adjustment arising from translating financial statements from functional currency to presentation currency |  |      |  |                          | -    
|                                                                                                           |  |      |  |                          |      
|Total other comprehensive loss                                                                             |  |      |  |                          | -    
|                                                                                                           |  |      |  |                          |      
|Total comprehensive loss                                                                                   |  |      |  | $                        | 6,571
|                                                                                                           |  |      |  |                          |      
|Net loss Attributable to:                                                                                  |  |      |  |                          |      
|Equity holders of the Company                                                                              |  |      |  | $                        | 6,571
|Non-controlling interests                                                                                  |  |      |  |                          | -    
|                                                                                                           |  |      |  |                          |      
|                                                                                                           |  |      |  |                          | 6,571
|Total comprehensive loss attributable to:                                                                  |  |      |  |                          |      
|Equity holders of the Company                                                                              |  |      |  |                          | 6,571
|Non-controlling interests                                                                                  |  |      |  |                          | -    
|                                                                                                           |  |      |  |                          |      
|                                                                                                           |  |      |  | $                        | 6,571
|                                                                                                           |  |      |  |                          |      
|Net loss per share attributable to equity holders of the Company:                                          |  |      |  |                          |      
|Basic and diluted net loss per share                                                                       |  | 16   |  | $                        | 0.17 



The accompanying notes are an integral
part of the consolidated financial statements.



F-5


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY

In thousands (except for share and per
share data)



|                                                                                                           |  | Attributable to equity holders of the Company |       |  |               |   |        |                                                       | 
|---------------------------------------------------------------------------------------------------------- |  | --------------------------------------------- | ----- |  | ------------- | - | ------ | ----------------------------------------------------- | 
|                                                                                                           |  | Share capital                                 |       |  | Share premium |   |        | Capital reserve from share-based payment transactions | 
|                                                                                                           |  | USD                                           |      
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of January 1, 2016                                                                              |  | $                                             | 1,780 |  |               | $ | 79,864 |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Net loss                                                                                                   |  |                                               | -     |  |               |   | -      |                                                       | 
|Loss from defined benefit plans                                                                            |  |                                               | -     |  |               |   | -      |                                                       | 
|Adjustment arising from translating financial statements from functional currency to presentation currency |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Total comprehensive loss                                                                                   |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Share-based payments                                                                                       |  |                                               | 3     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of December 31, 2016                                                                            |  | $                                             | 1,783 |  |               | $ | 79,864 |                                                       | 



The accompanying notes are an integral
part of the consolidated financial statements.



F-6


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY

In thousands (except for share and per
share data)





|                                                                                                           |  | Attributable to equity holders of the Company |       |  |               |   |        |                                                       | 
|---------------------------------------------------------------------------------------------------------- |  | --------------------------------------------- | ----- |  | ------------- | - | ------ | ----------------------------------------------------- | 
|                                                                                                           |  | Share capital                                 |       |  | Share premium |   |        | Capital reserve from share-based payment transactions | 
|                                                                                                           |  | USD                                           |      
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of January 1, 2017                                                                              |  | $                                             | 1,783 |  |               | $ | 79,864 |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Net loss                                                                                                   |  |                                               | -     |  |               |   | -      |                                                       | 
|Adjustment arising from translating financial statements from functional currency to presentation currency |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Total comprehensive loss                                                                                   |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Issuance of share capital and warrants, net of issue expenses of USD 621                                   |  |                                               | 330   |  |               |   | 1,993  |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Issuance of share capital                                                                                  |  |                                               | 10    |  |               |   | 85     |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Proceeds from sale of subsidiary in previously consolidated subsidiaries                                   |  |                                               | -     |  |               |   | (838   | )                                                     | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Share-based payments                                                                                       |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                                           |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of December 31, 2017                                                                            |  | $                                             | 2,123 |  |               | $ | 81,104 |                                                       | 



The accompanying notes are an integral
part of the consolidated financial statements.



F-7


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY

In thousands (except for share and per
share data)





|                                                                                    |  | Attributable to equity holders of the Company |       |  |               |   |        |                                                       | 
|----------------------------------------------------------------------------------- |  | --------------------------------------------- | ----- |  | ------------- | - | ------ | ----------------------------------------------------- | 
|                                                                                    |  | Share capital                                 |       |  | Share premium |   |        | Capital reserve from share-based payment transactions | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of January 1, 2018                                                       |  | $                                             | 2,123 |  |               | $ | 81,104 |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Net loss                                                                            |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Cumulative effect of initial adoption of IFRS 15 as of January 1, 2018 (see Note 4) |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Issuance of share capital and warrants, net of issuance expenses of USD 613         |  |                                               | 482   |  |               |   | 312    |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Issuance of share capital                                                           |  |                                               | 30    |  |               |   | 252    |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Share-based payment                                                                 |  |                                               | -     |  |               |   | -      |                                                       | 
|                                                                                    |  |                                               |       |  |               |   |        |                                                       | 
|Balance as of December 31, 2018                                                     |  | $                                             | 2,635 |  |               | $ | 81,668 |                                                       | 





The accompanying notes are an integral
part of the consolidated financial statements.



F-8


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



CONSOLIDATED STATEMENTS
OF CASH FLOWS

In thousands (except for share and per
share data)



|                                                                         |  | Year ended 
December 31, |       
|------------------------------------------------------------------------ |  | ------------------------ | ------
|                                                                         |  | 2018                     |       
|                                                                         |  | USD                      |       
|                                                                         |  |                          |       
|Cash flows from operating activities:                                    |  |                          |       
|                                                                         |  |                          |       
|Net loss                                                                 |  | $                        | (6,571
|Adjustments to reconcile loss to net cash used:                          |  |                          |       
|                                                                         |  |                          |       
|Depreciation of property, plant and equipment                            |  |                          | 14    
|Share-based payment                                                      |  |                          | 535   
|Decrease in severance pay, net                                           |  |                          | -     
|Changes in fair value of warrants liability exercisable into shares      |  |                          | -     
|Changes in fair value of short-term investment (previously long-term)    |  |                          | 644   
|Gain from sale of investment in previously consolidated subsidiaries (a) |  |                          | -     
|Exchange differences on balances of cash and cash equivalents            |  |                          | 89    
|                                                                         |  |                          |       
|                                                                         |  |                          | 1,282 
|Working capital adjustments:                                             |  |                          |       
|                                                                         |  |                          |       
|Increase in accounts receivable, prepaid expenses and lease deposit      |  |                          | (853  
|Decrease in trade payable                                                |  |                          | 644   
|Increase (decrease) in deferred revenues                                 |  |                          | 1,218 
|Increase (decrease) in other accounts payable                            |  |                          | 125   
|                                                                         |  |                          |       
|                                                                         |  |                          | 1,134 
|                                                                         |  |                          |       
|Net cash used in operating activities                                    |  | $                        | (4,155



The accompanying notes are an integral
part of the consolidated financial statements.



F-9


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





CONSOLIDATED STATEMENTS
OF CASH FLOWS

In thousands (except for share and per
share data)



|                                                                              |  | Year ended 
December 31, |      
|----------------------------------------------------------------------------- |  | ------------------------ | -----
|                                                                              |  | 2018                     |      
|                                                                              |  | USD                      |      
|                                                                              |  |                          |      
|Cash flows from investing activities:                                         |  |                          |      
|                                                                              |  |                          |      
|Purchase of property, plant and equipment                                     |  | $                        | (33  
|Proceeds from sale of investments in previously consolidated subsidiaries (a) |  |                          | -    
|                                                                              |  |                          |      
|Net cash used in investing activities                                         |  |                          | (33  
|                                                                              |  |                          |      
|Cash flows from financing activities:                                         |  |                          |      
|                                                                              |  |                          |      
|Issuance of share capital and warrants, net of issuance expenses              |  |                          | 4,387
|                                                                              |  |                          |      
|Net cash provided by financing activities                                     |  |                          | 4,387
|                                                                              |  |                          |      
|Exchange differences on balances of cash and cash equivalents                 |  |                          | (89  
|                                                                              |  |                          |      
|Increase (decrease) in cash and cash equivalents                              |  |                          | 110  
|Cash and cash equivalents at the beginning of the year                        |  |                          | 3,505
|                                                                              |  |                          |      
|Cash and cash equivalents at the end of the year                              |  |                          | 3,615
|                                                                              |  |                          |      
|Supplemental disclosure of cash flow information:                             |  |                          |      
|                                                                              |  |                          |      
|Cash paid during the year for income taxes                                    |  |                          | 4    
|                                                                              |  |                          |      
|Cash received during the year for interest                                    |  | $                        | 51   





|                                                                               |  | Year ended 
December 31, |  
|------------------------------------------------------------------------------ |  | ------------------------ | -
|                                                                               |  | 2018                     |  
|                                                                               |  | USD                      |  
|                                                                               |  |                          |  
|(a)   Proceeds from sale of investments in previously consolidated subsidiary: |  |                          |  
|                                                                               |  |                          |  
|The subsidiaries’ assets and liabilities at date of sale:                      |  |                          |  
|                                                                               |  |                          |  
|Working capital (excluding cash and cash equivalents)                          |  | $                        | -
|Treasury shares deduction, net                                                 |  |                          | -
|Non-controlling interests                                                      |  |                          | -
|Gain (loss) from sale of subsidiaries                                          |  |                          | -
|Long term investments                                                          |  |                          | -
|                                                                               |  |                          |  
|                                                                               |  | $                        | -





| | *) | Represent an amount lower than USD 1.
| | -- | -------------------------------------



The accompanying notes are an integral
part of the consolidated financial statements.



F-10


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
1:-	GENERAL



| | a. | Company description:
| | -- | --------------------



Can-Fite
Biopharma Ltd. (the “Company”) was incorporated and started to operate in September 1994 as a private Israeli company.
Can-Fite is a clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products
for the treatment of autoimmune-inflammatory, oncological and sexual dysfunction indications. Its platform technology utilizes
the Gi protein associated A3AR as a therapeutic target. A3AR is highly expressed in inflammatory and cancer cells, and not significantly
expressed in normal cells, suggesting that the receptor could be a unique target for pharmacological intervention. The Company’s
pipeline of drug candidates are synthetic, highly specific agonists and allosteric modulators, or ligands or molecules that initiate
molecular events when binding with target proteins, targeting the A3AR.



The Company’s
ordinary shares have been publicly traded on the Tel-Aviv Stock Exchange since October 2005 under the symbol “CFBI” and
the Company’s American Depositary Shares (“ADSs”) began public trading on the over the counter market in the U.S. in
October 2012 and since November 2013 the Company’s ADSs have been publicly traded on the NYSE Americanunder the symbol “CANF”.



| | b. | The Company owned 82% of a U.S. based subsidiary, Ophthalix,
Inc. which developed the CF101 drug for treatment of ophthalmic indications under license from the Company. The license to develop
this drug was transferred from the Company to Ophthalix, Inc. in the context of an ophthalmic activity spinoff transaction. Ophthalix,
Inc. was traded in the over the counter market in the U.S. under the symbol “OPLI”.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



On May 21, 2017, OphthaliX
and a wholly-owned private Israeli subsidiary of OphthaliX, Bufiduck Ltd. (the “Merger Sub”), and Wize Pharma Ltd.
(“Wize”), an Israeli company formerly listed on the Tel Aviv Stock Exchange currently focused on the treatment of ophthalmic
disorders, including dry eye syndrome, entered into an Agreement and Plan of Merger (the “Merger Agreement”), providing for the
merger of the Merger Sub with and into Wize, with Wize becoming a wholly-owned subsidiary of OphthaliX and the surviving corporation
of the merger (the “Merger”). On November 16, 2017, the Merger was completed. As a result of the Merger, the Company’s
ownership of OphthaliX, immediately post-Merger, became approximately 8% of the outstanding shares of common stock. In addition,
immediately prior to the Merger, OphthaliX sold on an “as is” basis to the Company all the ordinary shares of Eyefite
in exchange for the irrevocable cancellation and waiver of all indebtedness owed by OphthaliX and Eyefite to the Company, including
approximately USD 5,000 of deferred payments owed by OphthaliX and Eyefite to the Company and, as part of the purchase of Eyefite,
the Company also assumed certain accrued milestone payments in the amount of USD 175 under a license agreement previously entered
into with the NIH. In addition, that certain exclusive license of Piclidenoson granted to OphthaliX by the Company and a related
services agreement was terminated. In connection with the Merger, OphthaliX was renamed Wize Pharma, Inc.



As a result of the Merger,
the Company recorded a capital gain of USD 769.



F-11


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
1:-	GENERAL (Cont.)



| | c. | During the year ended December 31, 2018, the Company
incurred net losses of USD 6,571 and it had negative cash flows from operating activities in the amount of USD 4,155.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Furthermore,
the Company intends to continue to finance its operating activities by raising capital and seeking collaborations with multinational
companies in the industry. There are no assurances that the Company will be successful in obtaining an adequate level of financing
needed for its long-term research and development activities.



If the Company will not have
sufficient liquidity resources, the Company may not be able to continue the development of all of its products or may be required
to implement a cost reduction and may be required to delay part of its development programs. The Company’s management and
board of directors are of the opinion that its current financial resources will be sufficient to continue the development of the
Company’s products for at least the next twelve months.



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES



| | a. | Definitions:
| | -- | ------------



In these
consolidated financial statements:



|The Company       | - | Can-Fite Biopharma Ltd.                                                                                                                 
|----------------- | - | ----------------------------------------------------------------------------------------------------------------------------------------
|                  |   |                                                                                                                                         
|The Group         | - | The Company and its subsidiary (as defined below)                                                                                       
|                  |   |                                                                                                                                         
|Subsidiaries      | - | Companies that are controlled by the Company (as defined in IAS 27 (2008)) and whose accounts are consolidated with those of the Company
|                  |   |                                                                                                                                         
|Wize Pharma, Inc. | - | Wize Pharma, Inc. (formerly OphthaliX Inc.)                                                                                             
|                  |   |                                                                                                                                         
|Eye-Fite          | - | Eye-Fite Ltd (Can-Fite’s wholly owned subsidiary)                                                                                       
|                  |   |                                                                                                                                         
|Related parties   | - | As defined in IAS 24                                                                                                                    
|                  |   |                                                                                                                                         
|NIS               | - | New Israeli Shekel                                                                                                                      
|                  |   |                                                                                                                                         
|USD               | - | U.S. dollar                                                                                                                             
|                  |   |                                                                                                                                         
|€                 | - | European Union Euro                                                                                                                     
|                  |   |                                                                                                                                         
|CAD               | - | Canadian dollar                                                                                                                         
|                  |   |                                                                                                                                         
|ADS               | - | American Depositary Share (“ADS”). Each ADS represents 2 ordinary shares of the Company                                                 



The following
accounting policies have been applied consistently in the financial statements for all periods presented, unless otherwise stated.





F-12


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | b. | Basis of presentation of the financial statements:
| | -- | --------------------------------------------------



These financial statements
have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International
Accounting Standards Board.



The Company’s financial statements
have been prepared on a cost basis, except for financial assets and liabilities (including warrants) which are presented at fair
value through statement of comprehensive loss.



The preparation of the financial
statements requires management to make critical accounting estimates as well as exercise judgment in the process of adopting significant
accounting policies. The matters which required the exercise of significant judgment and the use of estimates, which have a material
effect on amounts recognized in the financial statements, are specified in Note 3.



| | c. | Consolidated financial statements:
| | -- | ----------------------------------



The consolidated
financial statements comprise the financial statements of companies that are controlled by the Company (i.e., subsidiaries). Control
is achieved when the Company is exposed, or has the rights, to variable returns from its involvement with the investee and has
the ability to affect those returns through its power over the investee. The effect of potential voting rights that are exercisable
at the end of the reporting period is considered when assessing whether an entity has control. The consolidation of the financial
statements commences on the date on which control is obtained and ends when such control ceases.



The financial statements of
the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated financial statements are prepared
using uniform accounting policies by all companies in the Group. Significant intragroup balances and transactions and gains or
losses resulting from intragroup transactions are eliminated in full in the consolidated financial statements.



Non-controlling interests in
subsidiaries represent the non-controlling shareholders’ share of the total comprehensive loss of the subsidiaries and their share
of the net assets. The non-controlling interests are presented in equity separately from the equity attributable to the equity
holders of the Company. Losses are attributed to non-controlling interests even if they result in a negative balance of non-controlling
interests in the consolidated statement of financial position.



Upon the disposal of a subsidiary
resulting in loss of control, the Company:



| | - | derecognizes the subsidiary’s assets (including goodwill) and liabilities.
| | - | --------------------------------------------------------------------------

| | - | derecognizes the carrying amount of non-controlling interests.
| | - | --------------------------------------------------------------

| | - | derecognizes the adjustments arising from translating financial statements carried to equity.
| | - | ---------------------------------------------------------------------------------------------

| | - | recognizes the fair value of the consideration received.
| | - | --------------------------------------------------------

| | - | recognizes the fair value of any remaining investment.
| | - | ------------------------------------------------------





F-13


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | - | reclassifies the components previously recognized in other comprehensive income (loss) on the same
basis as would be required if the subsidiary had directly disposed of the related assets or liabilities.
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | - | recognizes any resulting difference (surplus or deficit) as gain or loss.
| | - | -------------------------------------------------------------------------



| | d. | Functional currency, presentation currency and foreign currency:
| | -- | ----------------------------------------------------------------



| | 1. | Functional currency and presentation currency:
| | -- | ----------------------------------------------



From the Company’s inception
through January 1, 2018, the Company’s functional and presentation currency was the NIS. Management conducted a review of
the functional currency of the Company and decided to change its functional and presentation currency to the USD from the NIS effective
January 1, 2018. These changes were based on an assessment by Company management that the USD is the primary currency of the economic
environment in which the Company operates.



In determining the appropriate
functional currency to be used, the Company followed the guidance in International Accounting Standard 21 - The Effects of Changes
in Foreign Exchange Rates (“IAS 21”), which states that factors relating to sales, costs and expenses, financing activities
and cash flows, as well as other potential factors, should be considered. In this regard, the Company is incurring and expects
to continue to incur a majority of its expenses in USD as a result of its expanded clinical trials including Phase 3 trials. These
changes, as well as the fact that the majority of the Company’s available funds are in USD, the Company’s principal
source of financing is the U.S. capital market, and all of the Company’s budgeting is conducted solely in U.S. dollars, led
to the decision to make the change in functional currency as of January 1, 2018, as indicated above.



At the date of change of functional
currency, the Company also changed the presentation currency of these financial statements to the USD. This change was retrospectively
implemented. In accordance with IAS 21, since the Company’s presentation currency was different than its functional currency, results
and financial position were translated using the following principles: (i) all assets and liabilities were translated using the
current exchange rates, (ii) equity accounts were translated using the historical rates, and (iii) income and expenses for each
statement of comprehensive income or separate income statement presented were translated at exchange rates at the dates of the
transactions.



The Company also implements
the guidance in IAS 21 regarding translating foreign currency financial statements of consolidated subsidiaries.





F-14


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | 2. | Transactions, assets and liabilities in foreign currency:
| | -- | ---------------------------------------------------------



Transactions denominated in
foreign currency are recorded upon initial recognition at the exchange rate at the date of the transaction.



After initial recognition, monetary
assets and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional
currency at the exchange rate at that date. Exchange rate differences are recognized in statement of comprehensive loss.



Non-monetary assets and liabilities
measured at cost in foreign currency are translated at the exchange rate at the date of the transaction.



Non-monetary assets and liabilities
denominated in foreign currency and measured at fair value are translated into the functional currency using the exchange rate
prevailing at the date when the fair value was determined.



| | e. | Cash equivalents:
| | -- | -----------------



Cash equivalents are considered
as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less
from the investment date.



| | f. | Account receivables and prepaid expenses:
| | -- | -----------------------------------------



Prepaid expenses
are composed mainly from active pharmaceutical ingredients and clinical trial drug-kits which are expensed based on the percentage
of completion method of the related clinical trials.



| | g. | Property, plant and equipment:
| | -- | ------------------------------



Property, plant and equipment
are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and excluding
day-to-day servicing expenses.



Depreciation is calculated
on a straight-line basis over the useful life of the assets at annual rates as follows:



|                                                |  | % |        | Mainly%
|----------------------------------------------- |  | - | ------ | -------
|                                                |  |   |        |        
|Laboratory equipment and Leasehold improvements |  |   | 10     |        
|                                                |  |   |        |        
|Computers, office furniture and equipment       |  |   | 6 - 33 |        



Leasehold improvements are
depreciated on a straight-line basis over the shorter of the lease term (including extension option held by the Company and intended
to be exercised) and the expected life of the improvement.



The useful life, depreciation
method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a
change in accounting estimates. Depreciation of an asset ceases at the earlier of the date that the asset is classified
as held for sale and the date that the asset is derecognized.



F-15


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | h. | Revenue recognition:
| | -- | --------------------



The Company
generates revenues from distribution agreements. Such revenues comprises of upfront license fees, milestone payments and potential
royalty payments.



The Company
identified four components in the agreements: (i) performing the research and development services through regulatory approval;
(ii) exclusive license to distribute the product; (iii) participation in joint steering committee; and, (iv) royalties resulting
from future sales of the product.



As described in Note 4 regarding
the initial adoption of IFRS 15, “Revenue from Contracts with Customers” (“the Standard”), the Company elected
to adopt the provisions of the Standard using the modified retrospective method with the application of certain practical expedients
and without restatement of comparative data.



The accounting policy for revenue
recognition applied until December 31, 2017, is as follows:



The Company
recognizes revenue in accordance with IAS 18, “Revenue” pursuant to which each required deliverable is evaluated to determine
whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the
customer. The arrangement’s consideration that is fixed or determinable is then allocated to each separate unit of accounting based
on the relative selling price of each deliverable which is based on the Estimated Selling Price (“ESP”).



Components
(i) – (iii) were analyzed as one unit of accounting. Consequently, revenue from these components is recorded based on the
term of the research and development services (which is the last deliverable in the arrangement).



Contingent
payments related to milestones were recognized immediately upon satisfaction of the milestone and contingent payments
related to royalties were recognized in the period that the related sales have occurred.



Revenues
from royalties will be recognized as they accrue in accordance with the terms of the relevant agreement.



The accounting policy for revenue
recognition applied commencing from January 1, 2018, is as follows:





Revenue recognition:



Revenue from contracts with customers
is recognized when the control over the goods or services is transferred to the customer. The transaction price is the amount of
the consideration that is expected to be received based on the contract terms, excluding amounts collected on behalf of third parties
(such as taxes).



Revenue from contracts with strategic
partners:



Revenue from contracts with strategic
partners are recognized over time as the Company satisfies the performance obligations. The Company usually accepts long-term upfront
payment from its strategic partners. Contract liabilities for those upfront payments are recognizes as revenue over time.





Variable consideration:



The Company evaluates the individual
contracts to determine the estimated variable consideration and related constraint.



Significant financing component:



The Company receives long-term
advances. The transaction price for such contracts is discounted, using the rate that would be reflected in a separate financing
transaction between the Company and its advances at contract inception, to take into consideration the significant financing component.
Contract liabilities due to the upfront payments are recognized as revenue when the Group performs under the contract. See also
Note 4.



F-16


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)





| | i. | Research and development expenditures:
| | -- | --------------------------------------



Research expenditures are recognized
in the statement of comprehensive loss when incurred.



| | j. | Impairment of non-financial assets:
| | -- | -----------------------------------



The Company evaluates the
need to record an impairment of the carrying amount of non financial assets whenever events or changes in circumstances
indicate that the carrying amount is not recoverable. If the carrying amount of property, plant and equipment exceeds their
recoverable amount, the property, plant and equipment are reduced to their recoverable amount. The recoverable amount is the
higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are
discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset
that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs.
Impairment losses are recognized in profit or loss. As of December 31, 2018 and 2017, no impairment indicators have been
identified.



| | k. | Financial instruments:
| | -- | ----------------------



As described in Note 4 regarding
the initial adoption of IFRS 9, “Financial Instruments” (“the Standard”), the Company elected to adopt the
provisions of the Standard retrospectively without restatement of comparative data.



The accounting policy for financial
instruments applied until December 31, 2017, is as follows:



| | 1. | Financial assets:
| | -- | -----------------



Financial assets within the
scope of IAS 39 are initially recognized at fair value plus directly attributable transaction costs, except for financial assets
measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss.



After initial recognition,
the accounting treatment of financial assets is based on their classification as follows:





| | a) | Financial assets at fair value through profit or loss:
| | -- | ------------------------------------------------------



This category includes financial
assets held for trading and financial assets designated upon initial recognition as at fair value through profit or loss.



| | b) | Receivables:
| | -- | ------------



Receivables are investments
with fixed or determinable payments that are not quoted in an active market. Short-term borrowings are measured based on their
terms, normally at face value.



| | c) | Available-for-sale financial assets:
| | -- | ------------------------------------



Available-for-sale financial
assets are (non-derivative) financial assets that are designated as available for sale or are not classified in any of the three
preceding categories. After initial recognition, available-for-sale financial assets are measured at fair value.



| | 2. | Financial liabilities:
| | -- | ----------------------



Financial liabilities are initially
recognized at fair value.





F-17


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



After initial recognition,
the accounting treatment of financial liabilities is based on their classification as follows:





| | a) | Financial liabilities at amortized cost:
| | -- | ----------------------------------------



After initial recognition, loans and other liabilities
are measured based on their terms at amortized cost less directly attributable transaction costs using the effective interest method.



| | 3. | Issue of a unit of securities:
| | -- | ------------------------------



The issue of a unit of securities
involves the allocation of the proceeds received (before issue expenses) to the components of the securities issued in the unit
based on the following order: financial derivatives and other financial instruments measured at fair value in each period. Then
fair value is determined for financial liabilities and compound instruments that are presented at amortized cost. The consideration
allocated to the equity instruments is determined as the residual value. The issuance costs are allocated to each component based
on the amounts allocated to each component in the unit.



| | 4. | Derecognition of financial instruments:
| | -- | ---------------------------------------



| | a) | Financial assets:
| | -- | -----------------



A financial asset is derecognized
when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights
to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to
a third party and has transferred substantially all the risks and rewards of the asset, or has neither transferred nor retained
substantially all the risks and rewards of the asset, but has transferred control of the asset.



If the Company transfers its
rights to receive cash flows from an asset and neither transfers nor retains substantially all the risks and rewards of the asset
nor transfers control of the asset, a new asset is recognized to the extent of the Company’s continuing involvement in the asset.
When continuing involvement takes the form of guaranteeing the transferred asset, the extent of the continuing involvement is the
lower of the original carrying amount of the asset and the maximum amount of consideration received that the Company could be required
to repay.



| | b) | Financial liabilities:
| | -- | ----------------------



A financial liability is derecognized
when it is extinguished, that is when the obligation is discharged, realized, cancelled or expires. A financial liability is extinguished
when the debtor (i.e., the Group) discharges the liability by paying in cash, other financial assets, goods or services or shares,
or is legally released from the liability.





F-18


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)





The accounting policy for financial
instruments applied commencing from January 1, 2018, is as follows:



| | 1. | Financial assets:
| | -- | -----------------



Financial assets are measured
upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial
assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded
in profit or loss.



The Company classifies and
measures debt instruments in the financial statements based on the following criteria:



| | - | The Company’s business model for managing financial assets;
and
| | - | ---------------------------------------------------------------



| | - | The contractual cash flow terms of the financial asset.
| | - | -------------------------------------------------------



Equity instruments and other
financial assets held for trading:



Investments in equity instruments
do not meet the above criteria and accordingly are measured at fair value through profit or loss.



Impairment of financial assets:



The Company reviews at the
end of each reporting period the provision for loss of financial debt instruments which are not measured at fair value through
profit or loss. The Company distinguishes between two types of provision for losses:



| | a. | Debt instruments whose credit quality has not significantly
deteriorated since their initial recognition date or whose credit risk is low—the provision for loss that will be recognized
in respect of this debt instrument will take into account expected credit losses within 12 months from the reporting date; or
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | b. | Debt instruments whose credit quality has significantly
deteriorated since their initial recognition date or whose credit risk is not low—the provision for loss that will be recognized
will take into account expected credit losses over the instrument’s remaining term.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The Company has financial assets
bearing short-term credit such as trade receivables in respect of which it is required to adopt the relief prescribed in the model
i.e., the Company will measure the provision for loss in an amount which is equivalent to the expected credit losses.



An impairment loss of debt
instruments measured at amortized cost is carried to profit or loss against a provision whereas an impairment loss of debt instruments
measured at fair value through other comprehensive income will be carried against a capital reserve and will not reduce the carrying
amount of the financial asset in the statement of financial position.



Derecognition of financial
assets:



A financial asset is derecognized
only when the following criteria are met:



| | a. | The contractual rights to the cash flows from the financial
asset expire; or
| | -- | ----------------------------------------------------------------------------



| | b. | The Company has transferred substantially all the risks
and rewards deriving from the contractual rights to receive cash flows from the financial asset or has neither transferred nor
retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | c. | The Company has retained its contractual rights to receive
cash flows from the financial asset but has assumed a contractual obligation to pay the cash flows in full without material delay
to a third party.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-19


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | 2. | Financial liabilities:
| | -- | ----------------------



Financial liabilities are initially
recognized at fair value less transaction costs that are directly attributable to the issue of the financial liability, excluding
financial liabilities measured at fair value through profit or loss whose transaction costs are carried to profit or loss.



After initial recognition,
the Company measures all financial liabilities at amortized cost.



Derecognition of financial
liabilities:



A
financial liability is derecognized only when it is extinguished, that is when the obligation is discharged, cancelled or
expires. A financial liability is extinguished when the debtor discharges the liability by paying in cash, other financial
assets, goods or services; or is legally released from the liability.



| | 3. | Issue of a unit of securities:
| | -- | ------------------------------



The issue of a unit of securities involves the allocation of the proceeds received (before issue expenses)
to the securities issued in the unit based on the following order: financial derivatives and other financial instruments measured
at fair value in each period. Then fair value is determined for financial liabilities that are measured at amortized cost. The
proceeds allocated to equity instruments are determined to be the residual amount. Issue costs are allocated to each component
pro rata to the amounts determined for each component in the unit.



| | l. | Fair value measurement:
| | -- | -----------------------



Fair value is the price that
would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date.



Fair value measurement is based
on the assumption that the transaction will take place in the asset’s or the liability’s principal market, or in the absence of
a principal market, in the most advantageous market.



The fair value of an asset
or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming
that market participants act in their economic best interest.



Fair value measurement of a
non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest
and best use or by selling it to another market participant that would use the asset in its highest and best use.



The Group uses valuation techniques
that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use
of relevant observable inputs and minimizing the use of unobservable inputs.



All assets and liabilities
measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on
the lowest level input that is significant to the entire fair value measurement. See also Note 9.



| | m. | Treasury shares:
| | -- | ----------------



Company shares held by OphthaliX
are recognized at cost, and as a deduction from equity. Any gain or loss arising from a purchase, sale, issuance or cancellation
of treasury shares is recognized directly in equity. As of December 31, 2018, the Company has no treasury shares. Please refer
to note 1.b.



| | n. | Provisions:
| | -- | -----------



A provision in accordance with
IAS 37 is recognized when the Group has a present obligation (legal or constructive) as a result of a past event, it is probable
that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can
be made of the amount of the obligation. If the Group expects part or all of the expense to be reimbursed to the Company, such
as in an insurance contract, the reimbursement is recognized as a separate asset only when it is virtually certain that it will
be received by the Company. The expense is recognized in the income statement net of the reimbursed amount.





F-20


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



Legal claims:



A provision for claims is recognized
when the Group has a present legal or constructive obligation as a result of a past event, it is more likely than not that an outflow
of resources embodying economic benefits will be required by the Group to settle the obligation and a reliable estimate can be
made of the amount of the obligation. No provisions pursuant to IAS 37 have been identified.



| | o. | Employee benefit liabilities:
| | -- | -----------------------------



The Company’s
liability for severance pay is pursuant to Section 14 of the Severance Compensation Act, 1963 (“Section 14”), pursuant
to which all the Company’s employees are included under Section 14, and are entitled only to monthly deposits, at a rate of 8.33%
of their monthly salary, made in the employee’s name with insurance companies. Under Israeli employment law, payments in accordance
with Section 14 release the Company from any future severance payments in respect of those employees. The fund is made available
to the employee at the time the employer-employee relationship is terminated, regardless of cause of termination. The severance
pay liabilities and deposits under Section 14 are not reflected in the consolidated balance sheets as the severance pay risks have
been irrevocably transferred to the severance funds.



| | p. | Share-based payment transactions:
| | -- | ---------------------------------



The Company’s employees and
other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions. The cost of
equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair
value is determined using the binomial option pricing model.



As for other service providers,
the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments.
In cases where the fair value of the goods or services received as consideration of equity instruments cannot be measured, they
are measured by reference to the fair value of the equity instruments granted using binomial option pricing model.



The cost of equity-settled
transactions is recognized in statement of comprehensive loss, together with a corresponding increase in equity, during the period
which the performance and/or service conditions are to be satisfied, ending on the date on which the relevant employees become
fully entitled to the award (the “Vesting Period”).



The cumulative expense recognized
for equity-settled transactions at the end of each reporting period until the vesting date reflects the extent to which the Vesting
Period has expired and the Group’s best estimate of the number of equity instruments that will ultimately vest.



F-21


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE 2:-	SIGNIFICANT ACCOUNTING POLICIES
(Cont.)



| | q. | Taxes on income:
| | -- | ----------------



As it is not likely that taxable
income will be generated in the foreseeable future, deferred tax assets due to accumulated losses is not recognized in the Group’s
financial statements.



| | r. | Loss per share:
| | -- | ---------------



Losses per share are calculated
by dividing the net loss attributable to equity holders of the Company by the weighted number of ordinary shares outstanding during
the period. Potential ordinary shares (warrants and unlisted options) are only included in the computation of diluted loss per
share when their conversion increases loss per share from continuing operations. Potential ordinary shares that are converted during
the period are included in diluted loss per share only until the conversion date and from that date in basic loss per share.



NOTE
3:-	SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL
STATEMENTS



In the process of applying the
significant accounting policies, the Group has made the following judgments which have the most significant effect on the amounts
recognized in the financial statements:



| | - | Estimates and assumptions:
| | - | --------------------------



The preparation
of the financial statements requires management to make estimates and assumptions that have an effect on the application of the
accounting policies and on the reported amounts of assets, liabilities and expenses. Changes in accounting estimates are reported
in the period of the changes in estimates.



The key assumptions
made in the financial statements concerning uncertainties at the end of the reporting period and the critical estimates computed
by the Group that may result in a material adjustment to the carrying amounts of assets and liabilities within the next financial
year are discussed below.



| | - | Determining the fair value of share-based payment transactions:
| | - | ---------------------------------------------------------------



The fair
value of share-based payment transactions is determined using an acceptable option-pricing model. The model includes data as to
the share price and exercise price, and assumptions regarding expected volatility, expected life, expected dividend and risk-free
interest rate.



| | - | Legal claims:
| | - | -------------



In estimating
the likelihood of outcome of legal claims filed against the Company and its subsidiaries, the companies rely on the opinion of their
legal counsel. These estimates are based on the legal counsel’s best professional judgment, taking into account the stage of proceedings
and legal precedents in respect of the different issues. Since the outcome of the claims will be determined in courts, the results
could differ from these estimates.



F-22


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
3:-	SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS (Cont.)



| | - | Deferred tax assets:
| | - | --------------------



Deferred
tax assets are recognized for unused carryforward tax losses and deductible temporary differences to the extent that it is probable
that taxable profit will be available against which the losses can be utilized. Significant management judgment is required to
determine the amount of deferred tax assets that can be recognized, based upon the timing and level of future taxable profits,
its source and the tax planning strategy.



NOTE
4:-	DISCLOSURE OF NEW IFRS IN THE PERIOD



| | a. | IFRS 15 – Revenues from contracts with customers:
| | -- | -------------------------------------------------



IFRS 15 supersedes IAS 11 Construction
Contracts, IAS 18 Revenue and related Interpretations and it applies to all revenue arising from contracts with customers, unless
those contracts are in the scope of other standards. The new standard replaces IAS 18, “Revenue”, IAS 11, “Construction
Contracts”, IFRIC 13, “Customer Loyalty Programs”, IFRIC 15, “Agreements for the Construction of Real Estate”,
IFRIC 18, “Transfers of Assets from Customers” and SIC-31, “Revenue - Barter Transactions Involving Advertising
Services”. The new standard establishes a five-step model to account for revenue arising from contracts with customers.

Step 1: Identify the contract
with a customer, including reference to contract combination and accounting for contract modifications.

Step 2: Identify
the separate performance obligations in the contract



Step 3: Determine
the transaction price, including reference to variable consideration, financing components that are significant to the contract,
non-cash consideration and any consideration payable to the customer.



Step 4: Allocate
the transaction price to the separate performance obligations on a relative stand-alone selling price basis using observable information,
if it is available, or using estimates and assessments.



Step 5: Recognize
revenue when a performance obligation is satisfied, either at a point in time or over time.



Under IFRS
15, revenue is recognized at an amount that reflects the consideration to which an entity expects to be entitled in exchange for
transferring goods or services to a customer. The standard requires entities to exercise judgment, taking into consideration all
of the relevant facts and circumstances when applying each step of the model to contracts with their customers. The standard also
specifies the accounting for the incremental costs of obtaining a contract and the costs directly related to fulfilling a contract.



Revenue from
contracts with customers is recognized when control of the goods or services are transferred to the customer at an amount that
reflects the consideration to which the Group expects to be entitled in exchange for those goods or services.



The new standard has been applied
for the first time in these financial statements. The Company elected to adopt the provisions of the new standard using the modified
retrospective method and elected to apply that method to all contracts that were not completed at the date of initial application
and without restatement of comparative data. The Company recognizes any difference between the previous carrying amount and the
carrying amount on the date of initial application of the new standard as an adjustment to the opening balance of retained earnings.



The effect of the initial application of the new
standard on the Company’s financial statements is as follows:



Advances payment - in certain
service contracts, the Company receives advances from before the services are rendered. Before the application of the provisions
of the new standard, the Company recognized revenue based on the consideration received and did not accrue interest on the advances.
According to the new standard, when long-term advances (exceeding one year) are received for a service which the Company is to
provide in the future, the Company accrues interest and recognizes finance expense on the advances over the expected period of
the contract, provided that the contract contains a significant financing component, as defined in the new standard. As the advances
are recognized in revenue, the Company also recognizes the accrued interest as part of revenue from services. As a result of the
application of the new standard, the finance expenses included in the Company’s financial statements are higher in the period
from the date of receipt of the advance and the date of performance of the service. Also, the revenue recognized on the date of
performance of the service is higher.



The table discloses IFRS 15 impact
as of January 1, 2018, as of December 31, 2018 and for the year then ended:







F-23


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
4:-	DISCLOSURE OF NEW IFRS IN THE PERIOD (Cont.)



|                                                     |  | As of January 1, 2018 |        
|---------------------------------------------------- |  | --------------------- | -------
|                                                     |  | As reported (IFRS 15) |        
|Current liabilities                                  |  |                       |        
|Deferred revenues                                    |  | $                     | 280    
|                                                     |  |                       |        
|Non - current liabilities                            |  |                       |        
|Deferred revenues                                    |  | $                     | 1,246  
|                                                     |  |                       |        
|Equity attributable to equity holders of the Company |  |                       |        
|Accumulated deficit                                  |  | $                     | (94,052



|                                                     |  | As of December 31, 2018 |        
|---------------------------------------------------- |  | ----------------------- | -------
|                                                     |  | As reported (IFRS 15)   |        
|Current liabilities                                  |  |                         |        
|Deferred revenues                                    |  | $                       | 926    
|                                                     |  |                         |        
|Non - current liabilities                            |  |                         |        
|Deferred revenues                                    |  | $                       | 1,818  
|                                                     |  |                         |        
|Equity attributable to equity holders of the Company |  |                         |        
|Accumulated deficit                                  |  | $                       | (94,052



|                                     |  | Year ended December 31, 2018 |       
|------------------------------------ |  | ---------------------------- | ------
|                                     |  | As reported (IFRS 15)        |       
|Revenues                             |  | $                            | 3,820 
|Operating expenses                   |  |                              | (9,234
|Operating loss                       |  |                              | (5,414
|Financial expense, net               |  |                              | (1,153
|Loss before taxes on income          |  | $                            | (6,567
|Taxes on income                      |  |                              | (4    
|Net loss                             |  |                              | (6,571
|                                     |  |                              | .     
|Basic and diluted net loss per share |  | $                            | 0.08  



In implementing IFRS 15, the Company considered
the following:



| | (1) | Variable consideration:
| | --- | -----------------------



Some contracts with customers provide a right of
return, trade discounts or volume rebates. Currently, the Company recognizes revenue from achieving milestones, net of returns
and allowances, trade discounts and volume rebates. If revenue cannot be reliably measured, the Company defers revenue recognition
until the uncertainty is resolved. Such provisions give rise to variable consideration under IFRS 15, which will be required to
be estimated at contract inception.





F-24


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS
SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
4:-	DISCLOSURE OF NEW IFRS IN THE PERIOD (Cont.)



IFRS 15 requires that the variable consideration
be estimated conservatively to prevent over-recognition of revenue.



The Company continues to assess individual contracts
to determine the estimated variable consideration and related constraint. There is no impact of IFRS 15 on the financial statements.



| | (2) | Significant financing component:
| | --- | --------------------------------



The Company receives long-term advances. The transaction
price for such contracts is discounted, using the rate that would be reflected in a separate financing transaction between the
Company and its advances at contract inception, to take into consideration the significant financing component. Contract liabilities
due to the upfront payments are recognized as revenue when the Group performs under the contract.



| | (3) | Satisfaction of performance obligation:
| | --- | ---------------------------------------



Revenue from contracts with strategic partners are
recognized over time as the Company satisfies the performance obligations. The Company usually accepts long-term upfront payment
from its strategic partners. Contract liabilities for those upfront payments and recognizes as revenue over time.



IFRS 9 - Financial
Instruments:



In July 2014, the IASB issued
the final and complete version of IFRS 9, “Financial Instruments”, which replaces IAS 39, “Financial Instruments:
Recognition and Measurement”. The new standard mainly focuses on the classification and measurement of financial assets and
it applies to all assets within the scope of IAS 39.



The new standard has been applied
for the first time in these financial statements retrospectively without restatement of comparative data.



The effect of the initial adoption
of the new standard on the Company’s financial statements is as follows:



Under IFRS 9, the classification of financial assets
at initial recognition depends on the financial asset’s contractual cash flow characteristics and the Group’s business
model for managing them. The following is the relevant accounting policy to financial instruments of the Company:



Financial assets are classified, at initial recognition,
as subsequently measured at amortized cost, fair value through other comprehensive income (OCI), and fair value through profit
or loss.



The adoption of IFRS 9 has
changed the Company’s accounting for impairment losses for financial assets by replacing IAS 39’s incurred loss approach
with a forward-looking expected credit loss (ECL) approach. IFRS 9 requires the Company to record an allowance for ECLs for all
loans and other debt financial assets not held at FVPL.



F-25


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS
SUBSIDIARIES





NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS

In thousands (except for share and per
share data)



NOTE
4:-	DISCLOSURE OF NEW IFRS IN THE PERIOD (Cont.)



ECLs are based
on the difference between the contractual cash flows due in accordance with the contract and all the cash flows that the Company
expects to receive. For other debt financial assets (i.e., debt securities at fair value through other comprehensive income),
the ECL is based on the 12-month ECL. The 12-month ECL is the portion of lifetime ECLs that result from default events on a financial
instrument that are possible within 12 months after the reporting date.



DISCLOSURE OF NEW STANDARDS IN THE PERIOD PRIOR
TO THEIR ADOPTION



IFRS 16, “Leases”:



In January 2016, the IASB issued
IFRS 16, “Leases”. According to the new Standard, a lease is a contract, or part of a contract, that conveys the right
to use an asset for a period of time in exchange for consideration.



The effects of the adoption of
the new standard are as follows:



| | ● | According to the new standard, lessees are required to recognize all leases in the statement of
financial position (excluding certain exceptions, see below). Lessees will recognize a liability for lease payments with a corresponding
right-of-use asset, similar to the accounting treatment for finance leases under the existing standard, IAS 17, “Leases”.
Lessees will also recognize interest expense and depreciation expense separately.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Variable lease payments that are not dependent on changes in the Consumer Price Index (“CPI”)
or interest rates, but are based on performance or use are recognized as an expense by the lessees as incurred and recognized as
income by the lessors as earned.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | In the event of change in variable lease payments that are CPI-linked, lessees are required to
remeasure the lease liability and record the effect of the remeasurement as an adjustment to the carrying amount of the right-of-use
asset.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The accounting treatment by lessors remains substantially unchanged from the existing standard,
namely classification of a lease as a finance lease or an operating lease.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | The new standard includes two exceptions which allow lessees to account for leases based on the
existing accounting treatment for operating leases - leases for which the underlying asset is of low financial value and short-term
leases (up to one year).
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The new
standard is effective for annual periods beginning on or after January 1, 2019.



The new standard permits lessees
to use one of the following approaches:



1. Full retrospective approach
- according to this approach, a right-of-use asset and the corresponding liability will be presented in the statement of financial
position as if they had always been measured according to the provisions of the new standard. Accordingly, the effect of the adoption
of the new standard at the beginning of the earliest period presented will be recorded in equity. Also, the Company will restate
the comparative data in its financial statements. Under this approach, the balance of the liability as of the date of initial application
of the new standard will be calculated using the interest rate implicit in the lease, unless this rate cannot be easily determined
in which case the lessee’s incremental borrowing rate of interest on the commencement date of the lease will be used.



2. Modified retrospective approach
- this approach does not require restatement of comparative data. The balance of the liability as of the date of initial application
of the new standard will be calculated using the lessee’s incremental borrowing rate of interest on the date of initial application
of the new standard. As for the measurement of the right-of-use asset, the Company may choose, on a lease-by-lease basis, to apply
one of the two following alternatives:



| | ● | Recognize an asset in an amount equal to the lease liability, with certain adjustments.
| | - | ---------------------------------------------------------------------------------------



| | ● | Recognize an asset as if the new standard had always been applied.
| | - | ------------------------------------------------------------------



Any difference arising on the
date of first-time recorded in equity.



The Company believes,
based on an assessment of the impact of the adoption of the new standard, that its application is not expected to have a material
effect on the financial statements.





F-26


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
5:-	OTHER ACCOUNTS RECEIVABLE AND PREPAID EXPENSES



|                            |  | December 31, |      
|--------------------------- |  | ------------ | -----
|                            |  | 2018         |      
|                            |  | USD          |      
|                            |  |              |      
|Government authorities      |  | $            | 41   
|Prepaid expenses and others |  | $            | 3,974
|                            |  |              |      
|                            |  | $            | 4,015



NOTE
6:-	SHORT-TERM INVESTMENT



The Company holds 356,803 shares of Wize Pharma Inc. as of December 31, 2018 and December 31, 2017 which
as of such date represents 3.9% and 8.2% percent of Wize Pharma Inc’s outstanding shares, respectively. The shares are classified
as financial asset as designated at fair value through profit or loss. As of December 31, 2017, the investment was classified under
non-current assets.



NOTE
7:-	PROPERTY, PLANT AND EQUIPMENT, NET



Balance
as of December 31, 2018:



|                                      |  | Laboratory equipment |    |  | Computers, office
                                         furniture and equipment |   |     | Leasehold improvements |  |   | Total | 
|------------------------------------- |  | -------------------- | -- |  | ---------------------------------------------------------------------------------- | - | --- | ---------------------- |  | - | ----- | 
|                                      |  | USD                  |   
|Cost:                                 |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Balance at January 1, 2018            |  | $                    | 22 |  |                                                                                    | $ | 180 |                        |  | $ | 6     | 
|Purchases during the year             |  |                      | 17 |  |                                                                                    |   | 10  |                        |  |   | 6     | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Balance at December 31, 2018          |  |                      | 39 |  |                                                                                    |   | 190 |                        |  |   | 12    | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Accumulated depreciation:             |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Balance at January 1, 2018            |  |                      | 14 |  |                                                                                    |   | 161 |                        |  |   | 5     | 
|Depreciation during the year          |  |                      | 4  |  |                                                                                    |   | 9   |                        |  |   | 1     | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Balance at December 31, 2018          |  |                      | 18 |  |                                                                                    |   | 170 |                        |  |   | 6     | 
|                                      |  |                      |    |  |                                                                                    |   |     |                        |  |   |       | 
|Depreciated cost at December 31, 2018 |  | $                    | 21 |  |                                                                                    | $ | 20  |                        |  | $ | 6     | 



F-27


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
7:-	PROPERTY, PLANT AND EQUIPMENT, NET (Cont.)



Balance
as of December 31, 2017:



|                                          |  | Laboratory
    equipment |    |  | Computers, office
                                         furniture and equipment |   |     | Leasehold
                                         improvements |  |   | Total | 
|----------------------------------------- |  | ------------------------ | -- |  | ---------------------------------------------------------------------------------- | - | --- | --------------------------------------------------------------- |  | - | ----- | 
|                                          |  | USD                      |   
|Cost:                                     |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Balance
    at January 1, 2017            |  | $                        | 22 |  |                                                                                    | $ | 173 |                                                                 |  | $ | 6     | 
|Purchases
    during the year             |  |                          | -  |  |                                                                                    |   | 7   |                                                                 |  |   | -     | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Balance at
    December 31, 2017          |  |                          | 22 |  |                                                                                    |   | 180 |                                                                 |  |   | 6     | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Accumulated depreciation:                 |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Balance at
    January 1, 2017            |  |                          | 10 |  |                                                                                    |   | 146 |                                                                 |  |   | 5     | 
|Depreciation
    during the year          |  |                          | 4  |  |                                                                                    |   | 15  |                                                                 |  |   | *-)   | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Balance at
    December 31, 2017          |  |                          | 14 |  |                                                                                    |   | 161 |                                                                 |  |   | 5     | 
|                                          |  |                          |    |  |                                                                                    |   |     |                                                                 |  |   |       | 
|Depreciated
    cost at December 31, 2017 |  | $                        | 8  |  |                                                                                    | $ | 19  |                                                                 |  | $ | 1     | 



*)Represents an amount less than USD 1.



NOTE
8:-	OTHER ACCOUNTS PAYABLE



|                               |  | December 31, |      
|------------------------------ |  | ------------ | -----
|                               |  | 2018         |      
|                               |  | USD          |      
|                               |  |              |      
|Employees and payroll accruals |  | $            | 149  
|Accrued expenses               |  |              | 973  
|                               |  |              |      
|                               |  | $            | 1,122



NOTE
9:-	FINANCIAL INSTRUMENTS



| | a. | Financial
    assets:
| | -- | ---------------------



|                                                                                                               |  | December 31, |    
|-------------------------------------------------------------------------------------------------------------- |  | ------------ | ---
|                                                                                                               |  | 2018         |    
|                                                                                                               |  | USD          |    
|Financial assets at fair value through profit or
    loss (classified as Level 2 in the fair value hierarchy): |  |              |    
|                                                                                                               |  |              |    
|Short-term investment                                                                                          |  | $            | 273
|                                                                                                               |  |              |    
|Long-term investment                                                                                           |  | $            | -  





F-28


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
9:-	FINANCIAL INSTRUMENTS (Cont.)



| | b. | Financial
    liabilities, interest-bearing loans and borrowings:
| | -- | -----------------------------------------------------------------



|                                               |  | December 31, |      
|---------------------------------------------- |  | ------------ | -----
|                                               |  | 2018         |      
|                                               |  | USD          |      
|Other financial liabilities at amortized cost: |  |              |      
|                                               |  |              |      
|Trade payable                                  |  | $            | 1,071
|Other account payable                          |  |              | 1,122
|                                               |  |              |      
|                                               |  | $            | 2,193



| | c. | Financial
    risks factors:
| | -- | ----------------------------



The
Group’s activities expose it to foreign exchange risk. The Group’s comprehensive risk management plan focuses on activities that
reduce to a minimum any possible adverse effects on the Group’s financial performance.



The
Company’s management identifies and manages financial risks.



| | d. | Foreign
    exchange risk:
| | -- | --------------------------



The
Group is exposed to foreign exchange risk resulting from the exposure to different currencies, mainly the NIS. Foreign exchange
risk arises on recognized assets and liabilities that are denominated in a foreign currency other than the functional currency.



The
Group acts to reduce the foreign exchange risk by managing an adequate part of the available liquid sources in or linked to the
NIS.



Foreign currency sensitivity
analysis:



The following table demonstrates
the sensitivity test to a reasonably possible change of NIS exchange rates, with all other variables held constant. A 10% strengthening
of the NIS would have increased equity and the income statement by the amounts shown below. The Company’s exposure to foreign currency
changes for all other currencies is immaterial.



|              |  | December 31, 2018 |    |  | December 31, 2017 | 
|------------- |  | ----------------- | -- |  | ----------------- | 
|              |  |                   |    |  |                   | 
|Linked to NIS |  |                   | 32 |  |                   | 



| | e. | Fair
    value:
| | -- | ---------------



The
carrying amount of cash and cash equivalents, Short-term investments ,trade payables and other accounts payable approximate their
fair value.



Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy
prioritizes the inputs to valuation methodologies used to measure fair value:





F-29


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
9:-	FINANCIAL INSTRUMENTS (Cont.)



Level
1 -	Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets.



Level
2 -	Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets
and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active,
or other inputs that are observable or can be corroborated by observable market data.



Level
3 -	Valuations based on unobservable inputs reflecting assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment.



The
Company’s warrants exercisable into shares liability and the long term investment are classified as Level 1 in the fair value
hierarchy, and measured at fair value on a recurring basis.



Fair
value measurements using significant unobservable inputs (Level 1):



|                                                                 |  | USD |     
|---------------------------------------------------------------- |  | --- | ----
|                                                                 |  |     |     
|Balance at December 31, 2016                                     |  | $   | 564 
|                                                                 |  |     |     
|Changes in values of  warrants exercisable into shares liability |  |     | (564
|                                                                 |  |     |     
|Balance at December 31, 2017                                     |  |     | -   
|                                                                 |  |     |     
|Changes in values of  warrants exercisable into shares liability |  |     | -   
|                                                                 |  |     |     
|Balance at December 31, 2018                                     |  |     | -   



F-30


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
9:-	FINANCIAL INSTRUMENTS (Cont.)



Based
on the Group’s policy, the Group generally mitigates the currency risk arising from recognized assets and recognized liabilities
denominated in foreign currency other than the functional currency by maintaining part of the available liquid sources in deposits
in foreign currency. Accordingly, the main currency exposures presented in the sensitivity tables are for those deposits.



NOTE
10:-	CONTINGENT LIABILITIES AND COMMITMENTS



| | a. | Liabilities
    to pay royalties:
| | -- | ---------------------------------



| | 1. | According
    to the license agreement that the Company entered into with the NIH on January 29, 2003, the Company was committed to pay
    royalties until the expiration of the last patent licensed under the license agreement. The last patent under this agreement
    expired on June 29, 2015, and therefore except with respect to any amounts already accrued on the Company’s balance sheet,
    no future payments or royalties will be due.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Following the Merger, the Company accrued USD 425 in other accounts payable with respect to the NIH.



| | 2. | According
    to the patent license agreement that the Company entered into with Leiden University in the Netherlands on November 2, 2009,
    which is affiliated with the NIH, the Company was granted an exclusive license for the use of the patents of several compounds,
    including CF602 in certain territories.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The
Company is committed to pay royalties as follows:



| | a) | A
    one-time concession commission of € 25;
| | -- | ---------------------------------------------



| | b) | Annual
    royalties of € 10 until the clinical trials commence;
| | -- | ----------------------------------------------------------------



| | c) | 2%-3%
    of net sales (as defined in the agreement) received by the Company;
| | -- | -----------------------------------------------------------------------------



| | d) | Royalties
    in a total amount of up to € 850 based on certain progress milestones in the license stages of the products, which are
    the subject of the patent under the agreement, as follows: (i) € 50 upon initiation of Phase I studies; (ii) € 100
    upon initiation of Phase II studies; (iii) € 200 upon initiation of Phase III studies; and (iv) € 500 upon marketing
    approval by any regulatory authority.
| | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | e) | If
    the agreement is sublicensed to another company, the Company will provide Leiden University royalties at a rate of 10%. A
    merger, consolidation or any other change in ownership will not be viewed as an assignment of the agreement as discussed in
    this paragraph.
| | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



As
of December 31 2018, no accrual is recorded with respect to Leiden University.



F-31


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
10:-	CONTINGENT LIABILITIES AND COMMITMENTS (Cont.)



| | b. | Commitments
    and license agreements:
| | -- | ---------------------------------------



| | 1. | In
    March 2015, the Company signed a distribution agreement with Cipher. As part of the distribution agreement, Cipher will distribute
    Can-Fite’s lead drug candidate, Piclidenoson for the treatment of psoriasis and rheumatoid arthritis in the Canadian market
    upon receipt of regulatory approvals.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Under
the terms of the agreement, Cipher made an upfront payment of USD 1,292 (CAD 1,650) to the Company in March 2015. In addition,
the agreement provides that additional payments of up to CAD 2,000 will be received by the Company upon the achievement of certain
milestones plus royalty payments of 16.5% of net sales of Piclidenoson in Canada.



The
agreement further provides that the Company will deliver finished product to Cipher and that Cipher will reimburse the Company
for the cost of manufacturing. Furthermore, under the distribution agreement, the Company shall be responsible for conducting
product development activities including management of the clinical studies required in order to secure regulatory approvals,
and shall use commercially reasonable efforts in conducting such activities. In addition the Company agreed to form a
joint steering committee with Cipher which will oversee the progress of the clinical studies.



The
Company identified four components in the agreement: (i) performing the research and development services through regulatory approval;
(ii) an exclusive license to distribute the product in Canada; (iii) participation in joint steering committee; and,



(iv)
royalties resulting from future sales of the product. Components (i) – (iii) were analyzed as one unit of accounting. Consequently,
revenue from these components is recorded based on the term of the research and development services (which is the last deliverable
in the arrangement). The Company estimates these services will be spread over a period of 24 quarters. Component (iv) was not
accounted as part of the research and development services and will be recognized entirely upon the Company reaching the sales
stage. The useful life, depreciation method and residual value of a liability are reviewed at least each year-end.



| | 2. | In
    October 2016, the Company signed a distribution agreement with Chong Kun Dang Pharmaceuticals Corp. (“CKD”) for
    future sales in South Korea. As part of the distribution agreement, CKD will distribute Namodenoson for the treatment of
    liver cancer in the South Korean market upon receipt of regulatory approvals.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Under
the terms of the agreement, CKD made an upfront payment of USD 500 to the Company in December 2016 and in August 2017, the Company
received a second milestone payment in the amount of USD 500 from CKD, which has licensed the exclusive right to distribute Namodenoson
for the treatment of liver cancer in Korea upon receipt of regulatory approvals.



F-32


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
10:-	CONTINGENT LIABILITIES AND COMMITMENTS (Cont.)



In
addition, the agreement provides that additional payments of up to USD 2,500 will be received by the Company upon the achievement
of certain milestones.



The agreement further provides that the Company will deliver finished product to CKD and that CKD will
reimburse the Company for the cost of manufacturing for which the Company is entitled to a transfer price of the higher of the
manufacturing cost plus 10% or 23% of net sales of Namodenoson in South Korea.



The Company identified four
components in the agreement: (i) performing the research and development services through regulatory approval; (ii) an exclusive
license to distribute the product in South Korea;(iii) participation in a joint steering committee; and, (iv) royalties resulting
from future sales of the product. Components (i) – (iii) were analyzed as one unit of accounting. Consequently, revenue
from these components is recorded based on the term of the research and development services (which is the last deliverable in
the arrangement). The useful life, depreciation method and residual value of a liability are reviewed at least each year-end.



The
Company estimates these services will spread over a period of 24 quarters. Component (iv) was not accounted as part of the research
and development services and will be recognized entirely upon the Company reaching sales stage.



On February 25, 2019, the distribution agreement with CKD was amended (see Note 13).



| | 3. | On
    December 22, 2008, the Company signed an agreement regarding the provision of a license for Piclodenoson with a South Korean
    pharmaceutical company, Kwang Dong Pharmaceutical Co. Ltd. (the “KD”). According to the license agreement, the Company
    granted the KD a license to use, develop and market its Piclodenoson for treating only rheumatoid arthritis only in the Republic
    of Korea.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



As
of December 31, 2018, the Company estimates that such contingent payments are remote.



| | 4. | On
    January 8, 2018, the Company entered into a Distribution and Supply Agreement with Gebro Holding GmBH (“Gebro”),
    granting Gebro the exclusive right to distribute Piclidenoson in Spain, Switzerland, Liechtenstein and Austria for the treatment
    of psoriasis and rheumatoid arthritis.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Under the Distribution
and Supply Agreement, the Company is entitled to €1,500 upon execution of the agreement plus milestone payments upon
achieving certain clinical, launch and sales milestones, as follows: (i) €300 upon initiation of the ACRobat Phase III
clinical trial for the treatment of rheumatoid arthritis and €300 upon the initiation of the COMFORT Phase III clinical
trial for the treatment of psoriasis, (ii) between €750 and €1,600 following first delivery of commercial launch
quantities of Piclidenson for either the treatment of rheumatoid arthritis or psoriasis, and (iii) between €300 and up
to €4,025 upon meeting certain net sales. In addition, following regulatory approval, the Company shall be entitled to
future royalties on net sales of Piclidenoson in the territories and payment for the manufacturing
Piclidenoson. On January 25, 2018 the Company received a first payment of approximately USD 2,200 from Gebro and in
August 2018 received approximately USD 350 upon reaching the first milstone.



F-33


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
10:-	CONTINGENT LIABILITIES AND COMMITMENTS (Cont.)



| | 5. | On
    August 6, 2018, the Company entered into a License, Collaboration and Distribution Agreement with CMS Medical Venture
    Investment     Limited (“CMS Medical”) for the commercialization of Piclidenoson for the treatment of rheumatoid
    arthritis and     psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including
    Hong Kong, Macao and     Taiwan). Under the License, Collaboration and Distribution Agreement, the Company received USD
    2,000     upon execution of the     agreement and is entitled to additional milestone payments upon achieving certain
    regulatory and     sales milestones. In addition,     following regulatory approval, the Company shall be entitled to future
    double digit     royalties on net sales in the territories     and payment for the manufacturing of Piclidenoson and
    Namodenoson.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 6. | Lease
    commitments:
| | -- | ----------------------



The Company lease one
floor in one facility which expires on December 31, 2019. Lease payments are approximately USD 5 per month.



In
addition, the Company leases motor vehicles through operating leases. The lease is for a period ending April 2021.



Future
minimum lease commitments under non-cancelable operating leases as of December 31, 2018 are as follows:



|          |  | USD |   
|--------- |  | --- | --
|2019      |  | $   | 80
|2020-2021 |  |     | 10
|          |  | $   | 90



Motor lease expenses for the years ended December 31, 2017 and 2018 were approximately  USD 58 and
USD 56, respectively.



| | c. | Class
    action:
| | -- | -----------------



On
June 29, 2015 the Company received a lawsuit requesting recognition of the lawsuit as a class action, naming the Company, its
Chief Executive Officer and its directors as defendants. The lawsuit was filed with the District Court of Tel-Aviv.



The
lawsuit alleged, among other things, that the Company misled the public with regard to disclosures concerning the efficacy of
the Company’s drug candidate, Piclidenoson.



The claimant alleged that he suffered personal damages of over USD 20 (approximately NIS 73 based on the
exchange rate reported by the Bank of Israel on December 31, 2018), while also claiming that the shareholders of the Company suffered
damages of approximately USD 33,000 (approximately NIS 125,000 based on the exchange rate reported by the Bank of Israel on December
31, 2018). On July 18, 2017, the District Court of Tel-Aviv issued a ruling in which it denied the request to recognize the lawsuit
as a class action and awarded the Company an amount of USD 14 (approximately NIS 50 thousands based on the exchange rate reported
by the Bank of Israel on December 18, 2017) to pay the Company’s expenses in relation to such lawsuit.



F-34


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
10:-	CONTINGENT LIABILITIES AND COMMITMENTS (Cont.)



On
October 26, 2017, the claimant filed a petition with the Supreme Court appealing the District Court decision. On January 28, 2018,
the Supreme Court issued a notice of procedures to be complied with by the relevant parties leading up to a formal hearing scheduled
for December 5, 2018.



On December 5, 2018, the Supreme
Court dismissed the appeal and as part of a compromise by the claimant not to pursue the appeal, the Supreme Court ordered the
Company to return the aforementioned expenses to the claimant. Accordingly, this lawsuit has been finally dismissed and is no
longer pending against the Company.



NOTE
11:-	EQUITY



| | a. | Composition
    of share capital:
| | -- | ---------------------------------



|                                           |  | December 31, 2018 |            |  | December 31, 2017      | 
|------------------------------------------ |  | ----------------- | ---------- |  | ---------------------- | 
|                                           |  | Authorized        |            |  | Issued and outstanding | 
|                                           |  | Number of Shares  |           
|Ordinary shares of NIS 0.25 par value each |  |                   | 80,000,000 |  |                        | 



| | b. | On
    December 3, 2015, a special general meeting of shareholders of the Company approved, in accordance with the majority required,
    a proposal to increase the Company’s authorized share capital by NIS 10,000,000 such that following the increase, the authorized
    share capital shall equal NIS 20,000,000 divided into 80,000,000 ordinary shares, par value NIS 0.25 each, and to amend the
    Company’s articles of association accordingly.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | c. | Issued
    and outstanding capital:
| | -- | -----------------------------------





|                             |  | Number of shares |            |  | NIS par value | 
|---------------------------- |  | ---------------- | ---------- |  | ------------- | 
|                             |  |                  |            |  |               | 
|Balance at December 31, 2016 |  |                  | 28,156,728 |  |               | 
|                             |  |                  |            |  |               | 
|Issuance of share capital    |  |                  | 5,138,890  |  |               | 
|                             |  |                  |            |  |               | 
|Balance at December 31, 2017 |  |                  | 33,295,618 |  |               | 
|                             |  |                  |            |  |               | 
|Issuance of share capital    |  |                  | 7,103,672  |  |               | 
|                             |  |                  |            |  |               | 
|Balance at December 31, 2018 |  |                  | 40,399,290 |  |               | 



F-35


Table of Contents






CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
11:-	EQUITY (Cont.)



All
ordinary shares have equal rights for all intent and purposes and each ordinary share confers its holder:



| | 1. | The
    right to be invited and participate in all the Company’s general meetings, both annual and regular, and the right to one vote
    per ordinary share owned in all votes and in all Company’s general meeting participated.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2. | The
    right to receive dividends if and when declared and the right to receive bonus shares if and when distributed.
| | -- | ----------------------------------------------------------------------------------------------------------------------



| | 3. | The
    right to participate in the distribution of the Company’s assets upon liquidation.
| | -- | ------------------------------------------------------------------------------------------



| | d. | Issue
    of shares and warrants and changes in equity:
| | -- | -------------------------------------------------------



| | 1. | In
    September 2015, the Company completed a registered direct offering pursuant to which it sold an aggregate 2,068,966 ADSs representing
    4,137,932 ordinary shares. In addition, the Company issued unregistered warrants to purchase 1,034,483 ADSs representing 2,068,966
    ordinary shares. The offering (the “September 2015 Financing”) resulted in gross proceeds of USD 9,000. For further
    information regarding the warrants, please refer to Note 11.f.3.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



In
October 2015, the Company completed a registered direct offering pursuant to which it sold an aggregate 1,109,196 ADSs representing
2,218,392 ordinary shares. In addition, the Company issued unregistered warrants to purchase 443,678 ADSs representing 887,356
ordinary shares. The offering (the “October 2015 Financing”) resulted in gross proceeds of USD 4,825. For further information
regarding the warrants, please refer to Note 11.f.3.



As
part of the September 2015 Financing, the Company also issued placement agent warrants to purchase 103,448 ADSs representing 206,897
ordinary shares exercisable at USD 5.25 per ADS (equivalent to USD 2.625 per ordinary share), subject to certain adjustments,
for a period of five years. In addition, as part of the October 2015 Financing, the Company also issued placement agent warrants
to purchase 55,460 ADSs representing 110,920 ordinary shares exercisable at USD 5.25 per ADS (equivalent to USD 2.625 per ordinary
share), subject to certain adjustments, for a period of five years.



The
investor warrants and placement agent warrants may be exercised on a cashless basis if six months after issuance there is no effective
registration statement registering the ADSs underlying the warrants. The fair value of the placement agents warrants issued in
the September 2015 Financing and October 2015 Financing at the grant date were USD 317 and USD 143, respectively and were considered
as additional issuance costs.





F-36


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
11:-	EQUITY (Cont.)



The
cash issuance costs in relation to the September 2015 Financing and October 31, 2015 Financing were USD 789 and USD 525, respectively.



In
relation to the September 2015 Financing and October 2015 Financing, the Company first allocated the proceeds to the
warrants, and that due to the dollar exercise price terms and in accordance with IAS 39 the warrants are considered to be
a freestanding liability instrument that is measured at fair value at each reporting date, based on its fair value,
with changes in the fair values being recognized in the Company’s statement of comprehensive loss as financial income
or expense. The remaining proceeds were allocated to the shares and were recorded to equity. The issuance costs were
allocated between the warrants and the shares in proportion to the allocation of the proceeds.



The
portions of the issuance costs that were allocated to the warrants and to the ordinary share were recorded as financial expense
in the Company’s statement of comprehensive loss and to the additional paid in capital in the Company’s balance sheet, respectively.



| | 2. | In
    January 2017, the Company completed a registered direct offering with certain institutional and accredited investors, pursuant
    to which it sold an aggregate 2,500,000 ADSs representing 5,000,000 of its ordinary shares and warrants to purchase 1,250,000
    ADSs representing 2,500,000 of its ordinary shares for an aggregate purchase price of USD 5,000 (the “January 2017 Financing”).
    The warrants may be exercised after 6 months from the date of issuance for a period of five and a half years and have an exercise
    price of USD 2.25 per ADS (subject to certain adjustments). The Company also issued placement agent warrants to purchase 125,000
    ADSs representing 250,000 ordinary shares exercisable at USD 2.25 per ADS, subject to certain adjustments, for a period of
    five years. The investor warrants and placement agent warrants may be exercised on a cashless basis if six months after issuance
    there is no effective registration statement registering the ADSs underlying the warrants.
| | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The
issuance costs in relation to the January 2017 Financing was USD 621.



In relation to the January
2017 Financing, the Company first allocated the proceeds to the warrants, and that due to the dollar exercise price terms and
in accordance with IAS 39 the warrants are considered to be a freestanding liability instrument that is measured at fair value
at each reporting date, based on its fair value, with changes in the fair values being recognized in the Company’s statement
of comprehensive loss as financial income or expense. The remaining proceeds were allocated to the shares and were recorded to
equity. The issuance costs were allocated between the warrants and the shares in proportion to the allocation of the proceeds.



The
portions of the issuance costs that were allocated to the warrants and to the ordinary share were recorded as financial expense
in the Company’s statement of comprehensive loss and to the additional paid in capital in the Company’s balance sheet, respectively.



F-37


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
11:-	EQUITY (Cont.)



The
fair value of the warrants issued to the investors in the January 2017 Financing at the commitment date was USD 1,868. The fair
value of the placement agents warrants issued in the January 2017 Financing at the grant date were USD 188, and were considered
as additional issuance costs.



| | 3. | In
    December 2017, the Company issued 69,445 ADSs representing 138,890 of its ordinary shares to one of its service providers
    for its services.
| | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------



| | 4. | On
    March 13, 2018, the Company completed a registered direct offering with certain institutional investors, pursuant to which
    it sold an aggregate 3,333,336 ADSs representing 6,666,672 of its ordinary shares and warrants to purchase 2,500,002 ADSs
    representing 5,000,004 of its ordinary shares for an aggregate purchase price of USD 5,000. The warrants may be exercised
    after 6 months from the date of issuance for a period of five and a half years and have an exercise price of USD 2.00 per
    ADS (subject to certain adjustments). The Company also issued placement agent warrants to purchase 166,667 ADSs representing
    333,334 ordinary shares exercisable at USD 2.00 per ADS, subject to certain adjustments, for a period of five years.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 5. | On
    March 9, 2018, 982,344 and 98,234 warrants as part of a March 2014 financing grant expired.
| | -- | --------------------------------------------------------------------------------------------------



| | 6. | In
    May 2018, the Company issued 200,000 ADSs representing 400,000 ordinary shares to one of its service providers for its services.
| | -- | ---------------------------------------------------------------------------------------------------------------------------------------



| | 7. | In
    December 2018, the Company issued 18,500 ADSs representing 37,000 ordinary shares to one of its service providers for its
    services.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------



| | e. | Warrants
    classified as equity:
| | -- | ----------------------------------



| | 1. | On
    March 31, 2014, 9,907,500 registered warrants (Series 7) that were exercisable into 396,300 ordinary shares of the Company
    expired. Accordingly, the Company recorded an amount of USD 258 as share premium.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2. | As
    part of a March 2014 financing and December 2014 financing, the Company issued warrants. The warrants issued in the March
    2014 Financing may be exercised after 6 months from the date of issuance for a period of four years and have an exercise price
    of USD 6.43 per ADS (equivalent to USD 3.215 per ordinary share) (subject to certain adjustments). The warrants issued in
    the December 2014 financing may be exercised for a period of five years following issuance and have an exercise price of USD
    4.45 per ADS (equivalent to USD 2.225 per ordinary share) (subject to certain adjustments). The fair value of the warrants
    issued as part of the March 2014 financing as of commitment were USD 1,098. The fair value of the warrants issued as part
    of the December 2014 financing as of commitment were USD 1,535.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 3. | As
    mentioned in Note 11.d.1, the Company issued warrants as part of the September 2015 Financing and October 2015 Financing.
    These warrants may be exercised after 6 months from the date of issuance for a period of five and a half years and have an
    exercise price of USD 5.25 per ADS (equivalent to USD 2.625 per ordinary share) (subject to certain adjustments).
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-38


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
11:-	EQUITY (Cont.)



The
fair value of the warrants issued as part of the September 2015 Financing as of commitment was USD 3,167. The fair value of the
warrants issued as part of the October 2015 Financing as of commitment were USD 1,147.



| | 4. | As
    mentioned in Note 11.d.2 the Company issued warrants as part of the January 2017 Financing. The fair value of the warrants
    issued as part of the January 2017 Financing as of commitment date was USD 1,868.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 5. | As
    mentioned in Note 11.d.4 the Company issued warrants as part of the March 2018 Financing. The fair value of the warrants issued
    as part of the January 2018 Financing as of commitment date was USD 3,593.
| | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | f. | Warrants
    classified as liability:
| | -- | -------------------------------------



The Company had 39,042,000
registered warrants (Series 10) that were exercisable into 1,561,680 ordinary shares of the Company for NIS 9.85 per share.
The warrants were exercisable until October 31, 2017.



The
fair value of the warrants (Series 10), as of December 31, 2015 and 2016 was USD 240 and USD 146, respectively. Changes in fair
value of the warrants from commitment date to December 31, 2017 were recorded as financial income in the Company’s statement of
comprehensive loss.



The Company had 37,372,500
registered warrants (Series 11) that were exercisable into 1,494,900 ordinary shares of the Company for NIS 9.80 per share.
The warrants were exercisable until October 31, 2017.



The
fair value of the warrants (Series 11), as of December 31, 2015 and 2016 were USD 307 and USD 126, respectively. Changes in fair
value of the warrants from commitment date to December 31, 2017 were recorded as financial income in the Company’s statement of
comprehensive loss.



The Company had 1,470,000
registered warrants (Series 12) that were exercisable into 1,470,000 ordinary shares of the Company for NIS 15.29 per share.
The warrants were exercisable until October 31, 2017.



The
fair value of the warrants (Series 12), as of December 31, 2015 and 2016 was USD 303 and USD 291, respectively. Changes in fair
value of the warrants from commitment date to December 31, 2017 were recorded as financial income in the Company’s statement of
comprehensive loss.



As
described at Note 11.e.3, in September and October 2015 the Company issued warrants to purchase 2,275,863 and 998,276 of the Company’s
ordinary shares, respectively.



On
October 31, 2017 the registered warrants (Series 10,11,12) expired.



F-39


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
11:-	EQUITY (Cont.)



| | g. | Stock
    options:
| | -- | ------------------



On November 28, 2013, the
board of directors approved the adoption of the 2013 Share Option Plan (the “2013 Plan”). Under the 2013 Plan, the
Company may grant its officers, directors, employees and consultants, stock options, of the Company. Each stock option granted
shall be exercisable at such times and terms and conditions as the Board of Directors may specify in the applicable option agreement,
provided that no option will be granted with a term in excess of 10 years.



Upon the adoption of the
2013 Plan the Company reserved for issuance 2,500,000 shares of ordinary shares, NIS 0.25 par value each. As of December 31, 2018,
the Company had 1,215,000 shares available for future grant under the 2013 Plan.



NOTE
12:- SHARE-BASED PAYMENT TRANSACTIONS



| | a. | Expenses
    recognized in the financial statements:
| | -- | ----------------------------------------------------



|                                    |  | Year ended December 31, |    
|----------------------------------- |  | ----------------------- | ---
|                                    |  | 2018                    |    
|                                    |  | USD                     |    
|                                    |  |                         |    
|Research and development expenses   |  | $                       | 123
|General and administrative expenses |  |                         | 130
|                                    |  |                         |    
|                                    |  | $                       | 253



| | b. | Share-based
    payment transactions granted by the Company:
| | -- | ------------------------------------------------------------



| | 1. | In
    February 2016, the Company’s board of directors approved a grant of unlisted options exercisable into 160,000 of the Company’s
    ordinary shares to three of its employees and one senior officer for an exercise price of NIS 4.317 per shares (USD 1.15 per
    share based on the exchange rate reported by the Bank of Israel on December 31, 2018). The options vest on quarterly basis
    for a period of 4 years from the grant date.
| | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2. | In
    May 2016, the Company’s board of directors approved a grant of 74,000 shares of the Company to a service provider. Pursuant
    to the agreement with the service provider, and as partial consideration, the Company issued 37,000 ordinary shares and agreed
    to issue an additional 37,000 ordinary shares within 180 days, provided that the agreement was not terminated. During 2016
    the Company recorded an amount of USD 74 for share based payment expenses relating to this transaction.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-40


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
12:- SHARE-BASED PAYMENT TRANSACTIONS (Cont.)



| | 3. | On
    May 26, 2016 the Company’s board of directors approved a grant of 20,000 options exercisable into 20,000 ordinary shares of
    the Company to one of its advisers at an exercise price of 5.376 NIS per share (USD 1.43 per share based on December 31, 2018
    exchange rate). The options will vest on a quarterly basis for a period of 4 years from the grant date.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 4. | In
    March 2017, the Company’s board of directors approved a grant of unlisted options exercisable into 210,000 of the Company’s
    ordinary shares to three of its employees for an exercise price of NIS 3.662 per share (USD 0.97 per share based on December
    31, 2018 exchange rate). The options vest on a quarterly basis for a period of 48 months from the grant date.
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 5. | In
    May 2017, the Company’s board of directors approved a grant of unlisted options exercisable into 60,000 of the Company’s ordinary
    shares to an advisor for an exercise price of NIS 3.393 per share (USD 0.90 per share based on the exchange rate reported
    by the Bank of Israel on December 31, 2018). The options vest on a quarterly basis for a period of 48 months from the grant
    date.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 6. | In
    December 2017, the Company’s board of directors approved a grant of unlisted options exercisable into 460,000 and 240,000
    of the Company’s ordinary shares to the Company’s employees and directors, respectively, for an exercise price of NIS 2.513
    and NIS 2.926 per share, respectively (USD 0.67 and USD 0.78 per share, respectively, based on the exchange rate reported
    by the Bank of Israel on December 31, 2018). The options vest on a quarterly basis for a period of 48 months from the grant
    date.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | c. | Movement
    during the year:
| | -- | -----------------------------



The
following table lists the number of share options, their weighted average exercise prices and modification in option plans of
employees, directors and consultants for the periods indicated:



|                                 |  | Shares subject to options outstanding |          
|-------------------------------- |  | ------------------------------------- | ---------
|                                 |  | 2018                                  |          
|                                 |  | Number                                |          
|                                 |  |                                       |          
|Outstanding at beginning of year |  |                                       | 1,490,423
|Grants                           |  |                                       | -        
|Forfeited/expired                |  |                                       | (53,023  
|                                 |  |                                       |          
|Outstanding at end of year       |  |                                       | 1,437,400
|                                 |  |                                       |          
|Exercisable at end of year       |  |                                       | 736,155  



| | d. | The
    weighted average remaining contractual life for the shares subject to options outstanding as of December 31, 2018, 2017
    and 2016 was 7.64 years, 8.38 years and 8.86 years, respectively.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-41


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
12:- SHARE-BASED PAYMENT TRANSACTIONS (Cont.)



| | e. | The
    range of exercise prices for shares subject to options outstanding as of December 31, 2018, 2017 and 2016 was between
    USD 0.07 and USD 8.32.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------



| | f. | The
    fair value of the Company’s share options granted for the years ended December 31, 2016 and 2017 was estimated using the binomial
    option pricing model using the following assumptions:
| | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



|                                            |  | December 31, |             
|------------------------------------------- |  | ------------ | ------------
|Description                                 |  | 2017         |             
|                                            |  |              |             
|Risk-free interest rate                     |  |              | 1.89%-2.31% 
|Expected volatility                         |  |              | 74.4%-77.64%
|Dividend yield                              |  |              | 0           
|Contractual life                            |  |              | 10          
|Early Exercise Multiple (Suboptimal Factor) |  |              | 2.5         
|Exercise price                              |  |              | 0.72-0.98   



NOTE
13:-	RESEARCH AND DEVELOPMENT EXPENSES



|                                |  | Year ended December 31, |      
|------------------------------- |  | ----------------------- | -----
|                                |  | 2018                    |      
|                                |  | USD                     |      
|                                |  |                         |      
|Clinical and preclinical trials |  | $                       | 4,768
|Salary and related expenses     |  |                         | 909  
|Patents                         |  |                         | 229  
|Royalties                       |  |                         | 14   
|Laboratory materials            |  |                         | 73   
|Rent                            |  |                         | 51   
|Depreciation                    |  |                         | 3    
|Others                          |  |                         | 28   
|                                |  |                         |      
|                                |  | $                       | 6,075



NOTE
14:-	GENERAL AND ADMINISTRATIVE EXPENSES



|                                |  | Year ended December 31, |      
|------------------------------- |  | ----------------------- | -----
|                                |  | 2018                    |      
|                                |  | USD                     |      
|                                |  |                         |      
|Professional services           |  | $                       | 1,199
|Investors and public relations  |  |                         | 400  
|Salary and related expenses     |  |                         | 665  
|Directors’ fee                  |  |                         | 173  
|Rent                            |  |                         | 34   
|Travel                          |  |                         | 170  
|Insurance                       |  |                         | 282  
|Stock exchange fees             |  |                         | 58   
|Office and computer maintenance |  |                         | 82   
|Vehicle maintenance             |  |                         | 16   
|Depreciation                    |  |                         | 11   
|Others                          |  |                         | 69   
|                                |  |                         |      
|                                |  | $                       | 3,159





F-42


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
15:-	FINANCE INCOME



|                                                          |  | Year ended December 31, |      
|--------------------------------------------------------- |  | ----------------------- | -----
|                                                          |  | 2018                    |      
|                                                          |  | USD                     |      
|Finance expenses:                                         |  |                         |      
|                                                          |  |                         |      
|Bank commissions                                          |  | $                       | 18   
|Financial expenses from defined benefit plans             |  |                         |      
|Interest expenses from IFRS 15 implementation             |  |                         | 427  
|Net loss from exchange rate fluctuations                  |  |                         | 115  
|Other loss from  long-term investment revaluation         |  |                         | 644  
|                                                          |  |                         |      
|                                                          |  |                         | 1,204
|Finance income:                                           |  |                         |      
|                                                          |  |                         |      
|Interest income on bank deposits                          |  |                         | (51  
|Net change in fair value warrants exercisable into shares |  |                         | -    
|                                                          |  |                         |      
|                                                          |  |                         | (51  
|                                                          |  |                         |      
|                                                          |  | $                       | 1,153



NOTE
16:-	LOSS PER SHARE



| | a. | Details
    of the number of shares and loss used in the computation of loss per share:
| | -- | ---------------------------------------------------------------------------------------



|                                                                                      |  | Year ended December 31,   |           
|------------------------------------------------------------------------------------- |  | ------------------------- | ----------
|                                                                                      |  | 2018                      |           
|                                                                                      |  | Weighted number of shares |           
|                                                                                      |  | USD                       |           
|                                                                                      |  |                           |           
|Number of shares and loss used in the computation of basic and diluted loss per share |  |                           | 38,902,214



| | b. | To
    compute diluted loss per share for the year ended December 31, 2018, the total number of 1,437,400 shares subject to outstanding
    unlisted options have not been taken into account since they have anti-dilutive effect.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-43


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
17:-	TAXES ON INCOME



| | a. | Corporate
    tax rates:
| | -- | ------------------------



Israeli
taxation:



Corporate tax rate in Israel in 2018 was 23%, 2017 - 24% and in 2016 was 25%.



On
January 4, 2016, the Israeli Parliament’s Plenum approved by a second and third reading the Bill for Amending the Income Tax Ordinance
(No. 217) (Reduction of Corporate Tax Rate), 2015, which consists of the reduction of the corporate tax rate from 26.5% to 25%.



In
December 2016, the Israeli Parliament approved the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy
for the 2017 and 2018 Budget Years), 2016 which reduces the corporate income tax rate to 24% (instead of 25%) effective from January
1, 2017 and to 23% effective from January 1, 2018



The
Company estimates that the effect of the change in tax rates will have no impact on the financial statements.



| | b. | Final
    tax assessments:
| | -- | --------------------------



The
Company received final tax assessments through 2013.



The
related company, Eye-Fite, tax assessment through 2013 is considered as final.



| | c. | Net
    operating carryforward losses for tax purposes and other temporary differences:
| | -- | ---------------------------------------------------------------------------------------



As
of December 31, 2018 the Company and Eye-Fite had carryforward losses amounting to approximately USD 99,715 and Nil, respectively.



| | d. | Deferred
    taxes:
| | -- | -------------------



The
Company did not recognize deferred tax assets for carryforward losses and other temporary differences because their utilization
in the foreseeable future is not probable.



NOTE
18:-	TRANSACTIONS WITH RELATED PARTIES



| | a. | The
    related parties of the Company are associates, subsidiaries, directors and key management personnel of the Group, and a close
    member of the family of any of the persons mentioned above.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | b. | The
    Chairman of the Company’s board of directors is a senior partner in the patent firm which represents the Company in intellectual
    property and commercial matters (the “Service Provider”). The Service Provider charges the Company for services
    it renders on an hourly basis.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





F-44


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
18:-	TRANSACTIONS WITH RELATED PARTIES (Cont.)



| | c. | Composition
    of balances with related parties for the year ended December 31, 2018, and each of the three years then ended:
| | -- | ------------------------------------------------------------------------------------------------------------------------------



|                                                       |  | Year ended December 31, |    
|------------------------------------------------------ |  | ----------------------- | ---
|                                                       |  | 2018                    |    
|                                                       |  | USD                     |    
|                                                       |  |                         |    
|Management and consulting fees (including bonuses) (1) |  | $                       | 471
|                                                       |  |                         |    
|Other expenses and share-based payment (1)             |  | $                       | 50 
|                                                       |  |                         |    
|Patent expenses                                        |  | $                       | 229
|                                                       |  |                         |    
|Directors’ fee and share-based payment (2)             |  | $                       | 173
|                                                       |  |                         |    
|(1)	Number of related parties                          |  | $                       | 1  
|                                                       |  |                         |    
|(2)	Number of directors                                |  | $                       | 5  



| | d. | Eye-Fite
    License agreement and Services Agreement:
| | -- | ------------------------------------------------------



A
license agreement was entered into between the Company and Eye-Fite (the “Eye-Fite License Agreement”) according to
which the Company granted Eye-Fite a non-transferrable exclusive license for the use of the Company’s know-how solely in the field
of ophthalmic diseases for research, development, commercialization and marketing throughout the world.



In
addition to the Eye-Fite License Agreement, the Company, OpthhaliX and Eye-Fite entered into a services agreement (the “Services
Agreement”) pursuant to which the Company provided management services with respect to all pre-clinical and clinical research
studies, production and supply of the compounds related to the Eye-Fite License Agreement and payment for consultants that are
listed in the agreement for their involvement in the clinical trials and in all the activities leading up to, and including, the
commercialization of CF101 for ophthalmic indications.. The Company granted Eye-Fite an exclusive license to use these inventions
in the field of ophthalmic diseases around the world at no consideration. The Eye-Fite License and Service Agreement were terminated
during 2017 in connection with the Merger, please refer to note 1.b.





F-45


Table of Contents




CAN-FITE BIOPHARMA LTD. AND ITS SUBSIDIARIES



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS






In
thousands (except for share and per share data)



NOTE
19:-	SUBSEQUENT EVENTS



| | a. | On
January 18, 2019, the Company completed a registered direct offering with an institutional investor, pursuant to which it sold
an aggregate 2,238,096 ADSs representing 4,476,192 of its ordinary shares and warrants to purchase 2,238,096 ADSs representing
4,476,192 of its ordinary shares for an aggregate purchase price of USD 2,350. The warrants have an exercise price of $1.30 per
ADS, are immediately exercisable and expire five and one-half years from the issuance date.
| | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | b. | On
February 25, 2019, the Company’s Distribution Agreement with CKD was amended to expand the exclusive right to distribute
Namodenoson for the treatment of NASH in addition to liver cancer in South Korea. CKD has agreed to pay the Company up to an additional
USD 3,000 in upfront and milestone payments payable with respect to the NASH indication. The Company will also be entitled to
a transfer price for delivering finished product to CKD.                                                         
| | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
| | c. | On
March 11, 2019, a Special General Meeting of shareholders of the Company approved a grant of unlisted options exercisable into
400,000 of the Company’s ordinary shares to Company’s chief executive officer for an exercise price of NIS 2.344
per share (USD 0.67 per share based on the exchange rate reported by the Bank of Israel on December 31, 2018). The options vest
on a quarterly basis for a period of 48 months from the date of approval by the Company’s Board of Directors on January 7, 2019.





F-46