Summary of Consolidated Financial Statements
for the First Six Months of Fiscal Year Ending December 31, 2024
[Japanese GAAP]
August 1 2024
Company Name

SymBio Pharmaceuticals Limited

Listing: Tokyo Stock Exchange

Securities Code4582

URL: https://www.symbiopharma.com/

Representative

Representative Director,
President and Chief Executive Officer

Fuminori Yoshida

Contact Person

Corporate Officer and Chief Financial Officer Shigetaka Natsukuri

Scheduled Date to File Quarterly August 2, 2024
ReportTEL +81-3-5472-1125

Date of Dividend
Payment (plan)

Supplementary materials for the quarterly financial statements:

Yes ・ No

Holding of quarterly earnings performance review:

Yes ・ No–

(Amounts of less than one million yen are rounded down.)
1. Business Results for the First Six Months of FY 2024 (January 1, 2024 to June 30, 2024)(1) Consolidated Operating Results (cumulative)(Percentages indicate year-on-year changes.)
Net Sales
Q2 FY 2024
Q2 FY 2023

Operating Profit

Millions of yen

%

1,284
3,178

(Note) Comprehensive income:(59.6)(34.8)

Millions of yen%(1,528)(80)

million yen
million yen(1,719)(49)

Q2 FY 2024
Q2 FY 2023

Earnings per ShareProfit attributable toowners of parent

Ordinary Profit
Millions of yen––(1,481)
66%

Millions of yen–(95.4)(1,541)
(79)

[－%]
[– %]

Diluted Earnings per Share
Yen

Yen

Q21 FY 2024
(34.75)–Q2 FY 2023
(2.02)–(Note) Diluted earnings per share is not stated due to recording of a net loss per share, despite the potential dilution of shares.
(2) Consolidated Financial Position
Total Assets
Millions of yen

Q2 FY 2024 (as of June 30, 2024)
FY 2023 (as of December 31, 2023)(Reference) Shareholders’ equity:

Net Assets

Equity Ratio

Millions of yen

7,241
8,170

%

6,447
7,209

Q2 FY 2024 (as of June 31, 2024)
FY 2023 (as of December 31, 2023)

85.0
84.9

6,156 million yen
6,932 million yen

2. Dividends
Annual Dividend per ShareFY 2023
FY 2024
FY 2024 (Forecast)

1st Quarter
Yen

–
–

2nd Quarter
Yen

3rd Quarter
Yen

Fiscal Year End
Yen

0.00

0.00

0.00

–

0.00

0.00

0.00

–

(Note) Revision of dividend forecasts most recently announced: Yes ・ No

Full Year
Yen

%

–
–

3. Earnings Forecast for FY 2024 (January 1, 2024 to December 31, 2024)
Operating Profit(Loss)Net Sales
Full Year

Millions of yen

2,623% Millions of yen(53.1)

Ordinary Profit(Loss)% Millions of yen(3,702)(Percentages indicate year-on-year changes.)
Profit (Loss)
Earnings (Loss) per
attributable toShareowners of parent–(3,524)% Millions of yen–(3,628)%–Yen(84.15)(Note) Revision of earnings forecasts most recently announced: Yes ・ No
Notes:(1) Changes in significant subsidiaries during the period:(Transfer of specified subsidiary accompanying a change in the scope of consolidation)
New: None
Removed: None

Yes ・ No

(2) Application of special accounting treatment in preparing the quarterly financial statements: Yes ・ No
(3) Changes in accounting policies, changes in accounting estimates and restatements after error corrections(a) Changes in accounting policies due to revision of accounting standards:

Yes ・ No(b) Changes in accounting policies due to other reasons:Yes ・ No(c) Changes in accounting estimates:

Yes ・ No(d) Restatements after error corrections:

Yes ・ No

(4) Number of issued shares (common stock)(i) Total number of issued shares at the end of
the period (including treasury shares)

Q2 FY 2024

45,908,581 shares

FY 2023

42,278,081 shares(ii) Total number of treasury shares at the endof the period

Q2 FY 2024

89,484 shares

FY 2023

87,720 shares

Q2 FY 2024

44,358,869 shares(iii) Average number of shares during theperiod (cumulative)

Q2FY 2023

39,606,729 shares* Summary of the quarterly financial statements is not subject to quarterly reviews by certified public accountants or accounting
corporations.
* Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including earnings forecasts, are based on the information currently available to theCompany and assumptions determined by the Company to be reasonable. Actual results may differ substantially from these
forecasts due to various factors. Regarding the assumptions on which the Company’s earnings forecasts are based and their usage,
please refer to “1. Qualitative Information on Quarterly Financial Results (3) Explanation of consolidated earnings forecast andother forward-looking information” on Page 4 of the Appendix.

Appendix
Index
1. Qualitative Information on Quarterly Financial Results ........................................................................................................................ 2(1) Business results ................................................................................................................................................................................ 2(2) Summary of financial position ......................................................................................................................................................... 4(3) Explanation of consolidated earnings forecasts and other forward-looking information ................................................................. 4
2. Quarterly Consolidated Financial Statements and Primary Notes ......................................................................................................... 5(1) Quarterly consolidated balance sheet ............................................................................................................................................... 5(2) Quarterly consolidated statement of income and consolidated statement of comprehensive income ............................................... 7
Quarterly consolidated statement of income for the first six months of FY 2024 ............................................................................ 7
Quarterly consolidated statement of comprehensive income for the first six months of FY 2024 ................................................... 8(3) Consolidated statements of cash flows ............................................................................................................................................. 9(4) Notes to consolidated financial statements ..................................................................................................................................... 10(Notes to going concern assumptions)............................................................................................................................................ 10( Notes in case of significant changes to shareholders’ equity) ...................................................................................................... 10( Significant subsequent events) ..................................................................................................................................................... 10―1―

1. Qualitative Information on Quarterly Financial Results(1) Business results

Progress of business of the Company and subsidiary (“the Group”) for the first six months of the fiscal year under review is asfollows.
(i) Business results for the period under review
Currently, TREAKISYM® 100mg/4mL ready-to-dilute liquid formulation (TREAKISYM® RTD) is approved for rapid injection(RI) administration. RI shortens the infusion time from 60 to 10 minutes, benefitting both patients and healthcare providers.
Compared to freeze-dried formulations, TREAKISYM® RTD eliminates the need for manual reconstitution and significantly reduces
preparation time. RI administration has the further benefit of reduced infusion volume (from 250 ml to 50 ml), meaning a lower
volume of saline solution is used.
As of the end of June 2024, more than 90% of medical institutions had converted to RI administration.
Regarding sales activities, market share erosion due to generic products is gradually continuing. On the other hand, the negative
impact on prescriptions of bendamustine due to concerns about prolonged or severe

infection during or after bendamustine

treatment has been gradually easing. Reflecting these factors the situation is progressing according to plan against the earnings
forecast, net sales were 1,284,426 thousand yen (a reduction of 59.6% year on year).
Selling, general and administrative expenses totaled 2,715,755 thousand yen (up 7.6% year on year). This amount includes
research and development expenses of 1,531,833 thousand yen (up 27.2% year on year).
As a result, operating loss was 1,719,487 thousand yen (versus an operating loss of 49,731 thousand yen for the same period in
FY 2023) and ordinary loss was 1,481,369 thousand yen (versus an ordinary profit 66,941 thousand yen for the same period in FY2023). Loss attributable to owners of parent amounted to 1,541,241 thousand yen (versus a loss attributable to owners of parent of
79,850 thousand yen for the same period in FY 2023).
In February 2022, generic bendamustine products from four companies were approved for manufacturing and two of theseproducts started to be sold in Japan within the year. Given the potential infringement of the patents related to TREAKISYM® inJapan which are exclusively licensed to the Company from Eagle Pharmaceuticals, Inc (head office: New Jersey, U.S.; hereinafter“Eagle”), the Company in coordination with Eagle notified four generic makers of potential patent infringement and, in December
2022, commenced litigation against the makers of the generic products, Towa Pharmaceutical Co., Ltd. (head office: Osaka) and
Pfizer Japan Inc. (head office: Tokyo), seeking an injunction against the manufacture and sale of the products and compensation fordamages arising from the infringement. This proceedings in both cases are ongoing. As of August 2024, other three companies weremarketing generic drugs.
Segment information has been omitted as the Group operates within a single segment, which includes the research anddevelopment, manufacturing, and marketing of pharmaceutical drugs and other related activities.
(ii) Research and development activities
During the first six months of FY 2024, we conducted the following research and development activities.
(a) Antiviral drug: SyB V-1901 (intravenous formulation) (generic name: brincidofovir [BCV])
Post-transplant infectious disease area
With a view to global expansion, the Group is developing brincidofovir (SyB V-1901, hereinafter "IV BCV" and "Oral BCV",
respectively), an antiviral drug in-licensed from Chimerix, Inc. with their broad activity against double-stranded DNA viruses(dsDNA viruses). The Group is conducting joint research with leading research facilities in Japan and overseas. Global clinical
trials will be considered and implemented based on the scientific findings of the research.
The Group is prioritizing the global development of BCV IV, focusing on the treatment of adenovirus infection in
immunocompromised patients, such as those who have had hematopoietic stem cell transplantation or organ transplantation. In
March 2021, the group submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA)
to initiate a Phase II a clinical trial for the treatment of adenovirus infection and infectious diseases, primarily in pediatric patients(including adults). in immunocompromised patients with adenovirus (AdV) infection
In April 2021, the program was granted Fast Track designation by the FDA, and in May 2023, this study established human POC
for BCV. Positive data demonstrating the efficacy of the study was presented orally at the 65th Annual Meeting of the American
Society of Hematology in December 2023, and subsequent oral presentations were given at other major conferences, including the2024 U.S. Tandem Meetings in February 2024, and the 50th Annual Meeting of the European Society for Blood and Marrow―2―Transplantation (EBMT) in April 2024. Additionally, a patent for the use of BCV for the treatment of adenovirus infection andinfectious diseases based on these results was granted and registered in Japan in January 2024.
The Phase II a clinical trial in the U.S. for patients with cytomegalovirus infection after hematopoietic stem cell transplantation
started in May 2024, with the first patient enrolled in June 2024, and the trial is ongoing.
The Group submitted clinical trial notifications for a Phase II study of IV BCV in patients with BK virus (BKV) infection after
kidney transplantation to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and the Therapeutic Goods
Administration (TGA) of Australia, in May and August 2022. The investigational drug was administered to the first subject inDecember 2022. Although the trial was planned to be completed in 2025, due to enrollment delays, we will discuss modifications
to the protocol will researchers.
Among dsDNA viruses, polyomaviruses are known to cause serious diseases through their infection. As existing antiviral drugs
show little efficacy, a high medical need exists for the development of an effective treatment. In November 2022, the Group enteredinto Material Transfer Agreement with Penn State College of Medicine whereby the Group will provide BCV for use in a nonclinical study to verify the antiviral activity of BCV in a mouse model of polyomavirus infection. In July 2024, the first report ofthe study's findings was published in the journal mBio with new findings.
Hematology and Oncology
In addition to its strong antiviral effect, BCV also is expected to have an antitumor effect, and the Group is exploring BCV’spotential in indications such as EBV-positive lymphoma, refractory brain tumors, and other cancers, through research collaborations
with the National Cancer Centre Singapore (NCCS) and the University of California San Francisco (UCSF) Brain Tumor Center.
In December 2022, the results of collaborative research with NCCS on the therapeutic efficacy of BCV in the treatment of NK/Tcell lymphoma, for which no effective treatment is currently available, were poster presented at the 64th American Society of
Hematology (ASH) Annual Meeting in New Orleans. Additionally, in June 2023, the results of its research collaboration with
NCCS on BCV were presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
In April 2024, the anti-tumor effect of brincidofovir on B-cell lymphoma was presented orally at the AACR Annual Meeting 2024,
held in San Diego, California.

In addition, a poster presentation on the anti-tumor effect of BCV on peripheral T-cell lymphoma(PTCL) was made at the European Hematology Association (EHA 2024 Hybrid Congress) held in Madrid, Spain, in June 2024
Other Areas
The Group is also investigating the use of BCV to treat multiple sclerosis, an intractable disease that has recently been shown to
be associated with Epstein-Barr virus (EBV). In August 2022, the Company entered into a collaboration agreement with the
National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH), for thetransfer of materials to evaluate the antiviral effect of BCV in EBV. In March 2023, the Company entered into a Cooperative
Research and Development Agreement (CRADA) for BCV with NINDS for research to verify the efficacy of BCV as an anti-viraltherapeutic for EBV in the treatment of multiple sclerosis, and to obtain necessary data with a view to future clinical trials. In
October 2023

, the results of the research were presented at the 9th Joint ECTRIMS-ACTRIMS Meeting in Milan, Italy. In

April 2023, the Company entered into a CRADA with the National Institute of Allergy and Infectious Diseases (NIAID), part of
NIH in the U.S., to investigate the efficacy of BCV in the treatment of EBV associated lymphoproliferative diseases.
Some dsDNA viruses, such as herpes simplex virus type 1 (HSV1) and varicella zoster virus (VZV), are directed against cranial
nerve tissues. Recent research has advanced on the involvement of the reactivation of those viruses in various serious diseases of
the nervous system, including Alzheimer's disease. In December 2022, the Group entered into a Sponsored Research Agreementwith Tufts University to conduct research to evaluate the efficacy of BCV in a HSV infection model using a 3D (three-dimensional)
brain model developed by Tufts University.
In September 2022, Chimerix announced the close of the sale of its brincidofovir business to Emergent BioSolutions(headquartered in Maryland, USA). The sale does not affect our exclusive worldwide license of the rights for development,
manufacturing, and marketing of BCV in all indications except orthopox diseases.
In March 2024, the group established a subsidiary, SymBio Pharma Ireland Limited (Dublin, Ireland), after which orphan drug
designations for the prevention of adenovirus and cytomegalovirus infections in immunocompromised patients were transferred tothe subsidiary from Emergent BioSolutions Ltd.
(b)Anticancer agents: SyB L-1701 (RTD formulation), and SyB L-1702 (RI administration) (generic name: bendamustinehydrochloride or bendamustine hydrochloride hydrate, trade name: TREAKISYM®)―3―

The Group continues to actively conduct further research on TREAKISYM®, such as ongoing joint research with the Universityof Tokyo and Kyoto University, to explore new potential uses and development of the drug.
(c) Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)Rigosertib is in-licensed from Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S.), .The Group is collaborating with
the University of Tokyo to conduct research to identify new potential indications or applications for the drug either alone or in
combination with other existing drugs (including TREAKISYM®).
In April 2024, Onconova Therapeutics and Trawsfynydd Therapeutics, Inc. merged to form Traws Pharma, Inc. (head office:Pennsylvania, U.S.).
(iii) Business outside JapanIn April 2024, the Group appointed John Houghton as CEO and President of SymBio Pharma USA, Inc., to further strengthen theGroup’s global development structure and make SymBio Pharma USA, Inc. the driving force for our international clinical trials as
we move forward with our global development plan for IV BCV, further accelerate development in Europe, the U.S., Japan, and the
U.K., and develop activities to achieve commercialization.
(iv) Licensing of new drug candidates
As a biopharmaceutical company with profitability and growth potential, the Group will promote the global development of BCV,an antiviral drug introduced in 2019, and will continue to evaluate promising new drug candidates .Through these efforts, the Groupaims to create medium-to long-term business value.

(2) Summary of financial position
Total consolidated assets at the end of the second quarter of the current fiscal year stood at 7,241,090 thousand yen. Current assets
totaled 7,196,297 thousand yen, mainly consisting of cash and deposits of 6,358,711 thousand yen, accounts receivable of 463,912
thousand yen, and merchandise and finished goods of 87,543 thousand yen. Noncurrent assets totaled 44,793 thousand yen is leasehold
and guarantee deposits.
Total liabilities were 793,102 thousand yen. Current liabilities totaled 789,078 thousand yen, mainly consisting of 649,195 thousand
yen in accounts payable-other. Non-current liabilities were 4,024 thousand yen, for retirement benefits accounted.
Total net assets totaled 6,447,988 thousand yen. This includes 18,328,911 thousand yen in capital stock, 18,303,783 thousand yen
in capital surplus, and 291,484 thousand yen in share acquisition rights.
As a result, the equity ratio was 85.0%.

(3) Explanation of consolidated earnings forecasts and other forward-looking information
There are no changes to the forecast for the fiscal year ending December 31, 2024 at this time.

―4―2. Quarterly Consolidated Financial Statements and Primary Notes(1) Quarterly consolidated balance sheet(Unit: thousands of yen)
FY 2023(as of December 31, 2023)

Q2 FY 2024
(as of June 30, 2024)

AssetsCurrent assets
Cash and deposits
Accounts receivable–trade
Merchandise and finished goods
Prepaid expenses
Other
Total current assets

6,517,007
913,094

6,358,711
463,912

231,650
119,271

87,543
147,367

301,504

138,762

8,082,526

7,196,297

Non-current assets
Investments and other assets
Leasehold and guarantee deposits

87,71644,793

Total investments and other assets

87,71687,71644,793

8,170,243

7,241,090

853,825

649,195

18,474
16,784

98,048

Total non-current assets
Total assets

44,793Liabilities
Current liabilities
Accounts payable
Income taxes payable
Provision for office transfer
Other67,540－41,835

Total current liabilities

956,625

789,078

Non-current liabilities
Liabilities for retirement benefits
Total non-current liabilities
Total liabilities

―5―

3,709

4,024

3,709
960,334

4,024
793,102

(Unit: thousands of yen)
FY 2023(as of December 31, 2023)

Q2 FY 2024
(as of June 30, 2024)

Net assets
Shareholders’ equity
Share capital

17,952,692
17,927,584

18,328,911
18,303,783(28,852,303)(89,122)(30,393,161)(89,473)

6,938,849

6,150,060

Foreign currency translation adjustment(5,985)

6,444

Total accumulated other comprehensive income(5,985)

6,444

Capital surplus
Retained earnings
Treasury shares
Total shareholders’ equity
Accumulated other comprehensive income

Share acquisition rights
Total net assets
Total liabilities and net assets―6―

277,044

291,484

7,209,909

6,447,988

8,170,243

7,241,090

(2) Quarterly consolidated statement of income and consolidated statement of comprehensive income
Quarterly consolidated statement of income for the first six months of FY 2024
Q2 FY 2023
(from January 1, 2023
to June 30, 2023)
Net sales
Cost of sales(Unit: thousands of yen)
Q2 FY 2024
(from January 1, 2024
to June 30, 2024)
1,284,426
288,158

Gross profit

3,178,665
705,552
2,473,112

Selling, general and administrative expenses

2,522,844

2,715,755(49,731)(1,719,487)

149

13,420Other

130,604
776

249,132
615

Total non-operating income

131,529

263,168
7,410

Share issuance costs

7,964
977

17,640Loss on disposal of fixed assets

5,915

－

Total non-operating expenses

Operating loss

996,267

Non-operating income
Interest income
Foreign exchange gains

Non-operating expenses
Commission expenses

14,85725,050Ordinary profit (loss)

66,941(1,481,369)

Extraordinary income
Gain on reversal of share acquisition rights

96,891

12,21696,891

12,216–56,956–
163,833

56,956(1,526,109)

Total extraordinary income
Extraordinary loss
Impairment loss
Total extraordinary loss
Profit (loss) before income taxes
Income taxes - current
Income taxes - deferred

81,925

15,231

161,757－

Total income taxes

243,683

15,231

Loss(79,850)(1,541,341)

Loss attributable to non-controlling interests–(79,850)(1,541,341)

Loss attributable to owners of parent―7―–

Quarterly consolidated statement of comprehensive income for the first six months of FY 2024

Loss
Accumulated other comprehensive income(79,850)(Unit: thousands of yen)
Q2 FY 2024
(from January 1, 2024
To June 30, 2024)(1,541,341)

Foreign currency translation adjustment(1,129)12,913

Total other comprehensive income(1,129)12.913(80,979)(1,528,427)(80,979)(1,528,427)––

Q2 FY 2023
(from January 1, 2023
to June 30, 2023)

Comprehensive income
Comprehensive income attributable toComprehensive income attributable to owners of parent
Comprehensive income attributable to non-controllinginterests―8―

(3) Quarterly consolidated statement of cash flows(Unit: thousands of yen)
Q2 FY 2024
(from January 1, 2024
to June 30, 2024)

Q2 FY 2023
(from January 1, 2023
to June 30, 2023)
Cash flows from operating activities
Loss before income taxes

163,833(1,526,109)

Depreciation
Amortization of guarantee deposits

48,389669––

Impairment loss
Share-based payment expenses
Increase (decrease) in provision for retirement
benefits
Increase (decrease) in provision for productchangeover
Increase (decrease) in provision for office transfer
expenses
Interest income
Foreign exchange losses (gains)–
47,95056,95650,213320

315(16,331)––(16,784)(149)(167,115)(13,420)(215,270)

7,964
977

7,410
17,640Gain on reversal of share acquisition rights
Loss on retirement of non-current assets(96,891)5,915(12,216)–

Decrease (increase) in trade receivables
Decrease (increase) in inventories

990,905
28,873449,181
144,106

6,656(50,429)

Commission expenses
Share issuance costs

Decrease (increase) in prepaid expenses
Increase/decrease in consumption taxes
payable/consumption taxes refund receivable
Increase (decrease) in trade payables
Increase (decrease) in accounts payable–other(186,611)(25,227)(46,633)(612,160)(217,063)

Decrease (increase) in other current assets
Increase (decrease) in other current liabilities(71,937)(32,716)

151,044
19,195

Subtotal

71,909(1,180,456)

Interest and dividends received
Commitment fees paid

149
(5,712)

25,117(23,953)

Income taxes refund(paid)(289,481)

44,668Net cash provided by (used in) operating activities(223,135)(1,134,626)–(8,787)(6,450)(143,898)(9,356)-–42.923(150,349)

24,778

236

30

(907)

(5,142)
728,850

(638)
21

(379)
8

(1,287)723,367

168,244

228,184

Cash flows from investing activities
Purchase of property, plant and equipment
Purchase of intangible assets
Payments of leasehold and guarantee deposits
Proceeds from refund of leasehold and guarantee
deposits
Net cash provided by (used in) investing activities
Cash flows from financing activities
Proceeds from issuance of shares resulting fromexercise of share acquisition rights
Payments for issuance of shares
Proceeds from issuance of shares
Purchase of treasury shares
Proceeds from disposal of treasury shares
Net cash provided by (used in) financing activities
Effect of exchange rate change on cash and cash
equivalents
Net increase (decrease) in cash and cash equivalents(206,527)(158,295)

Cash and cash equivalents at beginning of period

6,282,554

6,517,007

Cash and cash equivalents at end of period

6,076,026

6,358,711―9―

(4) Notes to quarterly consolidated financial statements(Notes to going concern assumptions)None to be reported.
(Notes in case of significant changes to shareholders’ equity)
In the first six months of FY 2024, the Company issued new shares due to the exercise of some of share acquisition rights pertaining
to the 41rd, 49rd, 53rd and 55th warrants. As a result, share capital increased by 11,794 thousand yen and capital surplus increased by
11,794 thousand yen. The total value of treasury shares increased 379 thousand yen as a result of share repurchases and decreasedby 28 thousand yen as a result of the disposal. In addition, the Company received payment for the third-party allotment of new sharesfrom EVO FUND on February 7, March 18, and April 19,2024, increasing capital stock by 364,425 yen and capital surplus by
364,425 thousand yen.
As a result, as of June 30, 2024, consolidated share capital was 18,328,911 thousand yen, capital surplus was 18,303,783 thousand
yen, and the total value of treasury shares was 89,473 thousand yen.
(Significant subsequent events)
None to be reported.

―10―