UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

Washington,
D.C. 20549



FORM
10-K



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



For
the fiscal year ended October 31, 2022



or



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



Commission
File No. 000-17378



VITRO
BIOPHARMA, INC.

(Exact
name of Registrant as specified in its charter)



|Nevada                                                                     |  | 84-1012042                                         
|-------------------------------------------------------------------------- |  | ---------------------------------------------------
|(State
    or other jurisdiction of
    incorporation
    or organization) |  | (I.R.S.
    employer
    identification
    number)
|                                                                           |  |                                                    
|3200
    Cherry Creek Drive South, Suite 720
    Denver,
    Colorado      |  | 80209                                              
|(Address of principal executive
    offices)                               |  | (Zip code)                                         



(855)
848-7627

(Registrant’s
telephone number, including area code)



Securities
registered pursuant to Section 12(b) of the Act: None



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



Common
Stock, par value $0.001 per share



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



Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. 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 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 every Interactive Data File required to be submitted 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 such files). Yes ☐  No ☒



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



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



If
an emerging growth company, 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 13(a) of the Exchange Act. ☐



Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐



Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒



The
Company is unable to calculate the aggregate market value for its Common Stock, as there is presently no market for the Common Stock
and there was no market and no quotations as of the last business day of the Company’s most recently completed second fiscal quarter.



As
of January 27, 2023, there were outstanding 115,160,180 shares of the registrant’s Common Stock, $0.001 par value.



DOCUMENTS
INCORPORATED BY REFERENCE



None.




















TABLE
OF CONTENTS



|PART I                                                                                                               |    
|-------------------------------------------------------------------------------------------------------------------- | ---
|ITEM 1. BUSINESS.                                                                                                    | 1  
|ITEM 1A. RISK FACTORS                                                                                                | 49 
|ITEM 1B. UNRESOLVED STAFF COMMENTS                                                                                   | 92 
|ITEM 2. PROPERTIES                                                                                                   | 92 
|ITEM 3. LEGAL PROCEEDINGS                                                                                            | 92 
|ITEM 4. MINE SAFETY DISCLOSURES                                                                                      | 92 
|PART II                                                                                                              |    
|ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | 93 
|ITEM 6. [RESERVED]                                                                                                   | 93 
|ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS                        | 94 
|ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK                                                  | 101
|ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA                                                                  | 101
|ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE                         | 101
|ITEM 9A. CONTROLS AND PROCEDURES                                                                                     | 101
|ITEM 9B. OTHER INFORMATION                                                                                           | 102
|ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS                                         | 102
|PART III                                                                                                             |    
|ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.                                                     | 103
|ITEM 11. EXECUTIVE COMPENSATION.                                                                                     | 106
|ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.             | 115
|ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE                                   | 116
|ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES                                                                      | 121
|PART IV                                                                                                              |    
|ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES                                                                   | 122
|ITEM 16. FORM 10-K SUMMARY                                                                                           | 124
|SIGNATURES                                                                                                           | 125













SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS



This
Annual Report on Form 10-K (this “Report”) contains forward-looking statements that can involve substantial risks and uncertainties.
All statements other than statements of historical facts contained in this Report, including statements regarding our future results
of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future
revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products
and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties
and other important factors that may cause our actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking statements.



In
some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain
these words. Forward-looking statements contained in this Report include, but are not limited to, statements about:



| | ● | the ability of our clinical
    trials to demonstrate safety and efficacy of our product candidates, and other positive results;                                                                                                                   
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                    
| | ● | the timing of commencement
    and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials;                                                                               
| |   |                                                                                                                                                                                                                                                    
| | ● | our expectations with regard
    to the results of our clinical studies, preclinical studies and research and development programs, including the timing for enrollment
    and the timing and availability of data from such studies;             
| |   |                                                                                                                                                                                                                                                    
| | ● | the size of the market
    opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;                                                                                
| |   |                                                                                                                                                                                                                                                    
| | ● | our expectations with regard
    to the timing of submission of an amended request for ODD (as defined below) and the eligibility of PTHS (as defined below) or any
    other indications to qualify for ODD or any other regulatory incentives;   
| |   |                                                                                                                                                                                                                                                    
| | ● | our expectations with respect
    to entry into clinical trial agreements and other agreements with contract research organizations (“CROs”), potential
    collaborators and clinical trial sites for our preclinical studies and clinical trials;
| |   |                                                                                                                                                                                                                                                    
| | ● | our ability to acquire,
    discover, develop and advance product candidates into, and successfully complete, clinical trials;                                                                                                                     
| |   |                                                                                                                                                                                                                                                    
| | ● | developments and projections
    relating to our competitors and our industry and the success of competing therapies that are or may become available;                                                                                             
| |   |                                                                                                                                                                                                                                                    
| | ● | the beneficial characteristics,
    safety, efficacy and therapeutic effects of our product candidates;                                                                                                                                            
| |   |                                                                                                                                                                                                                                                    
| | ● | our ability to obtain and
    maintain regulatory approval of our product candidates;                                                                                                                                                              
| |   |                                                                                                                                                                                                                                                    
| | ● | our plans relating to the
    further development and commercialization of our product candidates, including additional disease states or indications we may pursue;                                                                               
| |   |                                                                                                                                                                                                                                                    
| | ● | our expectations regarding
    future sales of our other products, including MSC-Gro (as defined below), and future revenues from our agreement with European Wellness;                                                                            











| | ● | the potential effects of
    public health crises, such as the COVID-19 pandemic, on our preclinical and clinical programs and business;                                                                                      
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                               
| | ● | existing regulations and
    regulatory developments in the United States and other jurisdictions;                                                                                                                            
| |   |                                                                                                                                                                                                                               
| | ● | our plans and ability to
    obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to
    avoid infringing the intellectual property rights of others;
| |   |                                                                                                                                                                                                                               
| | ● | our ability to effectively
    manage our growth, including the need to hire additional personnel and our ability to attract, recruit and retain such personnel,
    and maintain our culture;                                



| | ● | our ability to fund the
    acquisition of fully automated closed system bioprocessing and other equipment and for the development of a new current Good Manufacturing
    Practices (“cGMP”) compliant manufacturing facility we expect to lease;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                   
| | ● | our estimates regarding
    expenses, future revenue, capital requirements and needs for additional financing;                                                                                                                                    
| |   |                                                                                                                                                                                                                                                   
| | ● | our plans and ability to
    obtain funding for our operations, including funding necessary to develop, manufacture and commercialize our product candidates,
    and to continue as a going concern;                                             
| |   |                                                                                                                                                                                                                                                   
| | ● | the performance of our
    third-party suppliers, CROs and manufacturers;                                                                                                                                                                         
| |   |                                                                                                                                                                                                                                                   
| | ● | our financial performance;
    and                                                                                                                                                                                                                
| |   |                                                                                                                                                                                                                                                   
| | ● | the period over which we
    estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements.                                                                                            



We
have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which
we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and
these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only
as of the date of this Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk
Factors” and elsewhere in this Report. Because forward-looking statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events.
The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ
materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update
or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.



In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable
basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have
conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain
and you are cautioned not to unduly rely upon these statements.



REFERENCES



Unless
the context indicates otherwise, (i) the terms “Vitro,” the “Company,” “we,” “us” and
“our” refer to Vitro Biopharma, Inc., and its consolidated subsidiaries; (ii) “Securities Act” refers to the
Securities Act of 1933, as amended; and (iii) “Exchange Act” refers to the Securities Exchange Act of 1934, as amended. This
Report also may include trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade
names included in this Report are the property of their respective owners.













PART
I



Item 1. Business



Overview



We
are an innovative biotechnology company targeting autoimmune diseases and inflammatory disorders, with an ancillary focus in the research
services and cosmeceutical fields. With respect to our regenerative medicine business, we are developing novel cellular therapeutic candidates
intended to address significant unmet medical needs. In the United States, we are authorized to conduct two clinical trials under two
U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) applications to assess the safety
and efficacy of AlloRx Stem Cell therapy in Pitt Hopkins syndrome (“PTHS”) and post-acute sequelae to SARs-CoV-2 (“PASC”),
or long COVID (“Long COVID”), and expect to commence those trials sometime in 2023 pending receipt of sufficient working
capital. We generate revenue from our other technologies through a number of other activities, including providing research services
and through the sale of our stem cell products as well as cosmeceuticals through InfiniVive MD, LLC (“InfiniVive MD”), our
wholly-owned subsidiary, which helps to alleviate our capital expenses.



Our
lead investigational product candidate is our cell-based therapy product (“AlloRx Stem Cell therapy”), which is based on
our proprietary AlloRx® stem cells (“AlloRx Stem Cells”) that are derived from culture-expanded mesenchymal stem cells
(“MSCs”) sourced from the Wharton’s jelly of umbilical cords donated by healthy volunteers following childbirth. During
our manufacturing process, we utilize our proprietary specialty culture media, MSC-GroTM (“MSC-Gro”), to support the
growth and expansion of MSCs from umbilical cords to create AlloRx Stem Cells. MSC-Gro has been developed by us over 20 years of research
and development. We have also developed other cell culture processes that are applied during our manufacturing process, which, together
with MSC-Gro, we believe confers additional benefits to AlloRx Stem Cells and generates increased adenosine triphosphate (“ATP”)
expression (an energy molecule), viability, immunosuppression measurement and yield.



We
believe that AlloRx Stem Cell therapy makes a compelling product candidate to further evaluate in clinical trials for the potential treatment
of inflammatory and autoimmune disorders. Through clinical trials in the United States, we intend to explore the potential of AlloRx
Stem Cell therapy to reduce inflammation, stimulate tissue repair and balance immune system response, among other things. In addition
to inflammatory disorders, we intend to evaluate the potential of AlloRx Stem Cell therapy to combat immune dysregulation in patients
affected by autoimmune disorders based on results from our pre-clinical research described below, including the observed ability of MSCs
to secrete concentrations of certain immunomodulatory substances, including indoleamine 2,3-dioxygenase (“IDO”). We also
believe AlloRx Stem Cell therapy is an attractive option to further evaluate in the potential treatment of various neurodegenerative
diseases.



We
are currently focused on the treatment of inflammatory and autoimmune disorders, which represent a significant burden to society and
the healthcare systems. There are over 80 recognized autoimmune disorders, which are caused by an acute or chronic imbalance in the immune
system where the immune system recognizes proteins of the body as foreign and elicits a specific immune response that leads to the immune
system improperly attacking certain bodily tissues, cells or organs (for example, in MS (as defined below), the immune system recognizes
myelin basic protein as foreign). Some inflammatory and autoimmune conditions are caused by genetic or environmental factors, or a combination
of both, while others may be caused from complications associated with other diseases or trauma or the treatment of other diseases or
trauma. In general, inflammatory and autoimmune disorders share certain biological characteristics, in that the immune system imbalance
results from the improper activation of certain immune cells that can lead to extensive tissue damage and destruction and cause pain
and loss of function. Inflammatory and autoimmune disorders represent major areas of unmet clinical needs, as well as substantial commercial
opportunities.



Our
Science



The
starting raw material source for AlloRx Stem Cells is the Wharton’s jelly of donated umbilical cords (“UCs”). Based
on extensive pre-clinical studies and research conducted by us and third-parties, as further described below (see “—AlloRx
Stem Cell therapy for Various Indications: a Scientific Approach”), we believe UC-derived MSCs like AlloRx Stem Cells may have
advantages compared to MSCs derived from other starting raw material sources, such as MSCs derived from bone-marrow (“BM-MSCs”),
adipose/fat (“AD-MSCs”), and placenta (“P-MSCs”). In our extensive pre-clinical, in vitro studies described
below, we analyzed various biological characteristics of AlloRx Stem Cells (UC-derived MSCs) in head-to-head comparisons to AD-MSCs,
BM-MSCs, and P-MSCs, including:





- 1 -







Growth
rate. Because MSCs must be expanded in vitro prior to use in a clinical setting, we believe that the growth and expansion
characteristics of MSCs in vitro are an important consideration. In a pre-clinical, in vitro study, we analyzed MSCs’
growth in cell cultures in head-to-head comparisons and observed that AlloRx Stem Cells (UC-derived MSCs) doubled in size in vitroafter only 25 hours, as compared to longer doubling times of 35 hours, 40 hours and 53 hours for AD-MSCs, P-MSCs and BM-MSCs, respectively,
indicating an increased growth rate of AlloRx Stem Cells as compared to these other MSCs. Pre-clinical studies conducted by third parties
using other UC-derived MSCs also support our observations described above. In a pre-clinical, in vitro study conducted by Jin-Hee
Kim, et al. (the “Kim Study”) analyzing the immunological characteristics of UC-derived MSCs in a head-to-head comparison
to AD-MSCs and MSCs derived from periodontal ligaments (“PL-MSCs”), it was observed that UC-derived MSCs doubled in size
in vitroafter only 32.1 hours, whereas PL-MSCs doubled after 42.7 hours and AD-MSCs doubled after 56.4 hours (Jin-Hee Kim et
al, “Comparison of Immunological Characteristics of Mesenchymal Stem Cells from the Periodontal Ligament, Umbilical Cord, and Adipose
Tissue,” Volume 2018 Hindawi Stem Cells International, 1-12, 1 April 2018).



Immunomodulatory
potency by quantification of γ-IFN-induced IDO activity: In a pre-clinical, in vitro study, we analyzed the immunomodulatory
potency of AlloRx Stem Cells (UC-derived MSCs) in a head-to-head comparison to AD-MSCs, BM-MSCs, and P-MSCs by measuring the activity
of γ-IFN-induced IDO, as quantified by the conversion of tryptophan to kynurenine. IDO, an immunomodulatory substance secreted
by MSCs, initiates the conversion of tryptophan to kynurenine, and kynurenine expression plays a critical role in regulating the body’s
immune response. As illustrated in the chart below, we observed a significant difference in γ-IFN-induced IDO activity in AlloRx
Stem Cells (UC-derived MSCs) as compared to AD-MSCs, BM-MSCs, and P-MSCs. Maximal IDO activity at 10 ng/ml γ-IFN was approximately
two-fold greater in AlloRx Stem Cells versus the MSCs derived from other sources. We believe these results indicate UC-derived MSCs like
AlloRx Stem Cells may have greater immunomodulatory cellular potency by quantification of γ-IFN-induced IDO activity, as compared
to AD-MSCs, P-MSCs, and BM-MSCs.







Immunomodulatory
potency of AlloRx Stem Cells (UC-derived MSCs), AD-MSCs, P-MSCs and BM-MSCs by the γ-IFN induced IDO activity assay is shown above.



Pre-clinical
studies conducted by third parties using other UC-derived MSCs support our observations described above, as the Kim Study also observed
the following concentrations of two other immunomodulatory substances secreted by MSCs, TGF-ꞵ1 and hepatocyte growth factor (“HGF”),
48 hours after γ-IFN activation in UC-derived MSCs as compared to AD-MSCs and PL-MSCs:



|Immunomodulatory
    Substance |  | UC-derived
    MSCs |  | AD-MSCs   |  | PL-MSCs  
|------------------------------ |  | ------------------- |  | --------- |  | ---------
|TGF-ꞵ1                         |  | 4.5 ng/ml           |  | 3.5 ng/ml |  | 3.5 ng/ml
|HGF                            |  | 325 pg/ml           |  | 190 pg/ml |  | 100 pg/ml





- 2 -







Cellular
ATP expression (an energy molecule): In a pre-clinical, in vitro study, we performed a quantitative assessment
of mitochondrial function by measuring ATP expression of AlloRx Stem Cells (UC-derived MSCs) in a head-to-head comparison to AD-MSCs,
BM-MSCs, and P-MSCs. As illustrated in the chart below, AlloRx Stem Cells (UC-derived MSCs) showed a significant difference in cellular
ATP-content. ATP expression is a measure of cellular energy, as ATP is the primary molecule that stores and transfers energy in a cell
and powers metabolic processes within the body. Due to the fact that mitochondria produce most ATP within the body, we believe these
results indicate the potential for increased mitochondrial functionality of UC-derived MSCs like AlloRx Stem Cells as compared to AD-MSCs,
P-MSCs, and BM-MSCs.







In
the chart above, cellular ATP is shown as a function of cells per well. Cellular potency is measured by the slope of this relation.



Cell
migration in response to Substance P: In a pre-clinical, in vitro study, we analyzed the migration of AlloRx Stem Cells
in a head-to-head comparison to AD-MSCs, BM-MSCs, and P-MSCs, in response to exposure to Substance P. Substance P is a peptide that presents
itself when an injury occurs, thus simulating an environment of injury. As illustrated in the chart below, AlloRx Stem Cells (UC-derived
MSCs) showed a significant difference in cell migration in response to Substance P, as AlloRx Stem Cells (UC-derived MSCs) showed greatest
closure at 50 pg/mL Substance P (~40% closure), while AD-MSC, P-MSC, and BM-MSC had a closure between 5-15% all within a 72-hour period.
Due to the fact that Substance P is a peptide that presents itself in response to an injury, we believe that UC-derived MSCs’ ability
to migrate to Substance P reaction at a faster rate may be indicative of an ability to more quickly migrate to the source of injury within
the body as compared to AD-MSCs, P-MSCs, and BM-MSCs.





- 3 -











Comparison
of migration into cell-free regions. Migration was measured by percent closure of the occluded plate region and is plotted as a function
of time following exposure to 50 pg/ml Substance P.



In
addition, UC-derived MSCs are also the youngest stem cells and are therefore generally free from issues related to age (such as mutations),
and prior medical conditions that come with the use of BM-MSCs and AD-MSCs. In addition, unlike BM-MSCs or AD-MSCs, UC-derived MSCs involve
a non-invasive collection process, are sourced and collected after childbirth, and may provide significant economies of scale in the
manufacturing process, as further described below. We believe these factors taken together may provide us with a competitive and financial
advantage compared to other cell therapies currently in development that are derived from BM-MSCs, AD-MSCs, or P-MSCs.



Our
Pipeline



Our
five core development programs are illustrated in the pipeline chart below:







- 4 -







Core
Development Programs



Our
pipeline includes five core development programs. In the United States, we are authorized to conduct two clinical trials under two FDA
IND applications to assess the safety and efficacy of AlloRx Stem Cell therapy in the following clinical trials and indications:



| | ● | Phase 1/2a clinical
    trial of PTHS, which is a rare neurogenetic disorder primarily affecting children that is characterized by global developmental
    delays including significant language delays, intellectual disability, debilitating breath holding, neuro-irritability, autistic
    features, disordered sleep, and significant behavioral concerns. Per the Pitt Hopkins Research Foundation, PTHS impacts between 1
    in 34,000 and 1 in 41,000 individuals according to some estimates. Although the exact incidence of PTHS is unknown, we believe it
    would meet the prevalence requirements for an Orphan Drug Designation (“ODD”) from the FDA if the other designation requirements
    are met, although any determination as to whether PTHS qualifies as a “rare disease or condition” will be made by FDA,
    as further described below.                                      
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
| | ● | Phase 1/2a clinical
    trial of PASC, or Long COVID, a newly recognized condition following the onset of the COVID-19 pandemic, which is characterized
    by persistent and prolonged symptoms or long-term complications four weeks or more after first being infected with the SARs-CoV-2
    virus. Long COVID results from COVID-19 infection and produces prolonged symptoms of fatigue, cognitive impairment and various additional
    symptoms that can be debilitating. According to the Centers for Disease Control and Prevention (“CDC”), a recent study
    found that approximately two-thirds of respondents who had tested positive for COVID-19 experienced long-term symptoms often associated
    with SARs-CoV-2 infection. Given the emerging nature of COVID-19 and new virus variants resulting from mutations, we believe the
    incidence of Long COVID will continue to increase.



We
intend to initiate our FDA cleared clinical trials for PTHS and Long COVID sometime in 2023 pending the receipt of sufficient
capital through future debt or equity financings and institutional review board (“IRB”) approval of clinical trial
agreements with contemplated collaborators and clinical trial sites. In addition, we are also currently focused on our pre-clinical
development programs for multiple sclerosis (“MS”), Lupus/systemic lupus erythematosus (“Lupus (SLE)”) and
Alzheimer’s disease. We plan to submit two additional IND applications to FDA to initiate Phase 1/2a clinical trials to assess
the safety and efficacy of AlloRx Stem Cell therapy in adults with Lupus (SLE) sometime in 2023 and in adults with MS in late 2023 or early 2024,
which will be subject to FDA clearance prior to the initiation of any clinical trials for these indications. We are also advancing
and actively pursuing preclinical research and development activities of AlloRx Stem Cell therapy for the potential treatment of
Alzheimer’s disease with the goal of progressing towards a potential IND filing for this indication in the future.



Other
Pre-Clinical Development Programs



In
addition to our core development programs, we are also evaluating the potential for AlloRx Stem Cell therapy in the treatment of a broad
range of other indications. We believe that we can leverage clinical safety and tolerability data from our core development programs
to support our development efforts in other indications, saving substantial research and development time and resources compared to traditional
drug development, where each program is separately developed. To achieve this goal, we are also advancing preclinical research and development
activities in the following additional indications: Amyotrophic Lateral Sclerosis (“ALS”), also known as Lou Gehrig’s
disease; Parkinson’s disease; and traumatic brain injury. Our ultimate mission is to advance AlloRx Stem Cell therapy into pivotal
registration studies for each of these indications, with the goal of achieving regulatory approvals, subsequent commercialization, and
broad use by the healthcare community.



AlloRx
Stem Cell therapy is currently in the early stage of development and will require substantial time, resources, manufacturing scale-up,
establishment of a cGMP manufacturing facility that would comply with FDA requirements to support a biologics license application (“BLA”),
and regulatory approval prior to potential commercialization in the United States. For a discussion of certain risks related to our development
programs, see “Risk Factors” herein.





- 5 -







MSC-GroTM



Our
“clinical grade” formulation of MSC-Gro, our proprietary specialty culture media, is sold by us to a single customer in Australia
that utilizes MSC-Gro to manufacture its stem cell therapy product candidate currently being investigated for the potential treatment
of osteoarthritis; this customer is planning to commence a pivotal Phase 3 clinical trial in Australia in late 2023 and, upon a successful
outcome, expects that its stem cell therapy product candidate would be eligible to obtain regulatory approval for commercialization in
Australia in 2026. If this customer’s stem cell therapy product candidate is ultimately approved for commercialization in Australia,
we expect to benefit from the increased sales of MSC-Gro to this particular customer as it scales up manufacturing to meet commercial
demand.



Our
Business Model



While
our primary business strategy is to become a leading regenerative medicine and cellular therapy company through the development and commercialization
of AlloRx Stem Cell therapy, we currently generate revenue from our proprietary technologies through a variety of sources:



| | ● | In addition to selling
    our clinical grade formulation of MSC-Gro to a single customer in Australia, as further described above, we sell multiple variations
    of our “research grade” formulation of MSC-Gro, along with a variety of other stem cell products and technologies developed
    by us, directly to leading biopharmaceutical institutions, university research labs, clinics, investigators and sponsors. These products
    include native MSCs, several lines of Cancer-Associated Fibroblasts (“CAFs”) and native fibroblasts that are used by
    these institutions for stem cell research and the development of advanced immunotherapy of cancer.                                                                                                                                                                                                                                                                                                                                                                                                                    
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
| | ● | We supply AlloRx Stem Cells
    to certain foreign clinics and medical centers that use AlloRx Stem Cells to conduct open-label, patient-sponsored clinical studies
    for the potential treatment of a wide variety of indications, including osteoarthritis, MS, Lupus (SLE), chronic obstructive pulmonary
    disease (“COPD”), ALS, and Alzheimer’s disease, in other countries. In addition to generating revenue from these
    supply arrangements, we leverage safety, tolerability and dosing data, along with certain other anecdotal data and information, generated
    by these foreign clinical studies to support our internal research and development activities and for the efficient and informed
    internal development of our AlloRx Stem Cell therapy development programs. Continued distribution of AlloRx Stem Cells to these foreign
    third-party clinics and medical centers pursuant to these supply arrangements will continue to be an important business objective
    of ours.                                                                           
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
| | ● | We have a drug discovery
    and development contract to develop novel biologic products with European Wellness Biomedical Group (“European Wellness”),
    a multinational company based in Europe, and its U.S. subsidiary, Bio Peptides LLC (“BioPep”). The goal of this agreement
    is to discover, develop and commercialize biological products with application to regenerative medicine. We are working with BioPep
    to establish manufacturing and regulatory support aimed at gaining FDA approval for specific products derived from AlloEx Exosomes
    (as defined below) that could potentially be used for treatment of various conditions, including aesthetic dermatology and skin revitalization.
    AlloEx Exosomes® (“AlloEx Exosomes”) are a derivative of AlloRx Stem Cells that are developed and manufactured by
    us. AlloEx Exosomes are derived from cultured AlloRx Stem Cells at the latter part of their growth curve by our proprietary cell
    culture process. In the United States, AlloEx Exosomes are regulated by the FDA as a biological product.
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
| | ● | Through InfiniVive MD,
    our wholly-owned subsidiary, we develop and sell topical cosmetic conditioned media and exosome-containing serums, which are manufactured
    using AlloRx Stem Cells and its derivatives, to plastic surgeons, cosmetic surgeons, aestheticians and consumers in the United States
    and internationally. These products are designed to moisturize and hydrate the skin to reduce the appearance of aging, including
    lines and wrinkles, and we believe the inclusion of AlloRx Stem Cells and its derivatives may promote healthy looking skin and the
    appearance of rejuvenation.                                                                                                                                                                                                                                                                                                                                                                                                                                                                      





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International
Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies



As
discussed above, we supply AlloRx Stem Cells to numerous foreign third-party clinics and medical centers. We currently have supply arrangements
with numerous third-party clinics and medical centers in foreign locations, including:



| | ● | The Medical Surgical Associates
    Center, in collaboration with The Foundation for Orthopaedics and Regenerative Medicine, a collection of stem cell treatment clinics
    located in St. John’s, Antigua and Barbuda; and
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                             
| | ● | DVC Stem, a stem cell treatment
    clinic located in the Cayman Islands, owned and operated by Da Vinci Wellness Center.                                                                                                   



These
and other foreign third-party clinics and medical centers are currently using, or intend to use, AlloRx Stem Cells to conduct open-label,
patient-sponsored clinical studies for the potential treatment of a wide variety of indications, including MS, ALS, Alzheimer’s
disease, Parkinson’s disease, multiple system atrophy (“MSA”), Lupus (SLE), COPD/asthma, chronic kidney disease (“CKD”),
and diabetes. Eligible individuals with certain specified indications and who meet eligibility requirements may receive AlloRx Stem Cells
at their own expense at these third-party clinics and medical centers with which we supply AlloRx Stem Cells. The primary purpose of
these clinical studies is for the open-label treatment of the respective indication; accordingly, there is no randomized control group
for patients treated in these foreign clinical studies. For foreign clinical studies that are conducted using AlloRx Stem Cells, the
third-party clinics and medical centers are responsible for the administration of AlloRx Stem Cells to these individuals as well as their
care and follow-up. They are also responsible for compliance with all applicable regulations. These third-party clinics and medical centers
receive formal letters from the Ministry of Health (or other comparable agency) of these countries and/or approval from an IRB (or other
comparable ethics review committee) prior to the commencement of these studies.



We
leverage safety, tolerability and dosing data, along with certain other anecdotal data and information, generated by these foreign clinical
studies to support our internal research and development activities and for the efficient and informed internal development of our AlloRx
Stem Cell therapy development programs. These clinical studies have enabled us to gain additional prior human experience using AlloRx
Stem Cells, and the resulting data has enabled us to better understand the tolerability profile of AlloRx Stem Cells, as well as allowing
us to cost effectively explore where AlloRx Stem Cell therapy may have relevance and efficacy and how it may be utilized to advance treatment
over current standards of care. AlloRx Stem Cells are not licensed for commercial sale in these countries and is considered an investigational
therapeutic. Our supply arrangements with foreign third-party clinics and medical centers are typically not governed by any written supply,
clinical trial, or data sharing agreements. For additional information and a discussion of certain risks related to our supply arrangements
with these foreign third-party clinics, see “—International Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party
Conducted Clinical Studies” below and “Risk Factors” herein.



Our
Strategy



Our
primary business strategy is to become a leading regenerative medicine company through the development and commercialization of novel
cell therapy products for unmet medical needs, with an emphasis on autoimmune disorders and inflammatory disease indications. Key elements
of our business strategy are as follows:



| | ● | Advance AlloRx Stem
    Cell therapy through clinical development to registration and commercialization in the United States for PTHS, Long COVID, and other
    indications in our core development programs. We are focused on initiating and executing Phase 1/2a clinical trials in the
    United States for PTHS and Long COVID in accordance with FDA-authorized INDs, with intentions of advancing into Phase 2b and Phase
    3 pivotal registration studies for these indications as efficiently as possible. We also intend to further pursue an ODD for PTHS,
    as further described below. We are also currently focused on our pre-clinical development programs for MS, Lupus (SLE) and Alzheimer’s
    disease.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



- 7 -







| | ● | Initiate and conduct
    clinical development in an effort to establish clinical proof-of-concept and biological activity for AlloRx Stem Cell therapy and
    continue to deepen our understanding of therapeutic mechanisms of action. We intend to initiate Phase 1/2a clinical trials
    in PTHS and Long COVID in accordance with FDA-authorized INDs with the intent to establish safety, tolerability and efficacy proof-of-concept
    and evidence of biological activity in these indications. We seek to initiate and conduct well-designed Phase 1/2a clinical studies
    for AlloRx Stem Cell therapy for PTHS, Long COVID and potentially other indications in our pipeline in hopes of establishing a solid
    foundation for later-stage clinical trials, development and partnering activity, and expansion into complementary indications. We
    are committed to a rigorous clinical approach, which we believe will help us advance our programs efficiently, providing high quality,
    transparent communications and regulatory submissions with FDA. In addition, we hope to continue to refine our understanding of AlloRx
    Stem Cell therapy’s activities and mechanisms of action to prepare the foundation for product enhancements and expansion into
    additional treatment opportunities.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Explore new potential
    treatment opportunities by leveraging prior human experience derived from our supply arrangements with foreign medical centers and
    our results from other programs. We are committed to efficiently exploring potential clinical indications where AlloRx Stem
    Cell therapy may achieve a superior profile to the current standards of care and where we believe we can effectively address significant
    unmet medical needs. In pursuit of this goal:
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | ● | We
are working to enter into clinical trial agreements with research and clinical institutions and clinical trial sites across the United
States for our Phase 1/2a trials for PTHS and Long COVID, although we have not yet entered into any clinical trial agreement(s) for these
contemplated Phase 1/2a clinical trials at this time. We do not expect that any future collaborations pursuant to one or more clinical
trial agreements will involve the type of collaborative arrangements in which we would share the risks and rewards of any such clinical
trials or otherwise with the third-party clinical institution. We have also established supply arrangements with certain foreign third-party
clinics and medical centers, including with The Medical Surgical Associates Center and other institutions. Through these supply arrangements
and our own internal research and development activities, we are evaluating AlloRx Stem Cell therapy in numerous open-label, patient
sponsored foreign clinical studies and preclinical studies that reflect various types of disorders/indications, including Parkinson’s
disease and traumatic brain injury. These supply arrangements have enabled us to cost effectively explore where AlloRx Stem Cell therapy
may have relevance and how it may be utilized to advance treatment over current standards of care. We use safety, tolerability and dosing
data, along with certain other anecdotal data and information, generated by these third parties for our research and development activities,
including for the efficient and informed internal development of AlloRx Stem Cell therapy. For additional information regarding our supply
arrangements with foreign third-party clinics and medical centers, including a description of the material terms of such supply arrangements,
see “—International Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies”
below.
| |  | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |  |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
| |  | ● | We
intend to leverage clinical safety, tolerability and efficacy data from our core development programs, especially from our development
program for PTHS, a rare neurogenetic disorder that features autistic traits, to support our research and development activities in a
wide variety of other areas such as ASD, saving substantial development time and resources compared to traditional drug development where
each program is separately developed. For example, if the results from our Phase 1/2a clinical trial for PTHS are successful to establish
the safety and tolerability of AlloRx Stem Cell therapy, we intend to request FDA authorization to advance AlloRx Stem Cell therapy directly
into Phase 2b/3 clinical trials potentially for cerebral palsy, Crohn’s disease, Parkinson’s disease, Epilepsy and autism,
which are indications that are symptomatically similar to PTHS. For additional information, see “—Our Core Development
Programs.”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         





- 8 -







| | ● | Expand our scalable
    manufacturing platform and refine our manufacturing processes. We currently lease and operate a manufacturing facility in
    Golden, Colorado that is designated as cGMP compliant and Clinical Laboratory Improvement Amendment (“CLIA”) certified,
    with a quality management system (“QMS”) that is globally recognized as ISO 9001:2015 and ISO 13485:2016 certified. We
    manufacture AlloRx Stem Cells and certain other of our stem cell products and technologies, including CAFs and native fibroblasts,
    at this manufacturing facility. We currently have the capacity to manufacture 300 AlloRx Stem Cell therapy treatments per month.
    We have also recently completed equipping an additional facility to expand the production of AlloRx Stem Cells for international
    clinics. We are also planning a separate cGMP manufacturing facility that, if completed, will be used exclusively for the manufacture
    of AlloRx Stem Cells. We plan to use highly scalable, fully automated closed system bioprocessing in the new cGMP biomanufacturing
    facility. We intend to use a portion of the net proceeds from any future debt or equity financings, together with our existing cash
    and any additional funds received upon the exercise for cash of our outstanding common stock purchase warrants, if and when exercised
    at the election of the warrant holders, to fund the acquisition of fully automated closed system bioprocessing and other equipment
    and for the development of this new cGMP compliant manufacturing facility we expect to lease. We believe that this separate facility
    will be necessary to comply with all FDA requirements to support a BLA and related inspections for the manufacture of AlloRx Stem
    Cell therapy, given that AlloRx Stem Cell therapy is a product intended for parenteral use in humans. Subject to available capital
    resources, we expect to commence development of the new cGMP biomanufacturing facility in 2024, which is estimated to cost approximately
    $1.0 to $3.0 million depending on the amount of anticipated production increase. We believe that the use of fully automated closed
    system bioprocessing in a new cGMP biomanufacturing facility would allow us to fully capitalize on the potential biological advantages
    of UC-derived MSCs. Leveraging the potential biological advantages of UC-derived MSCs and the increased technological and manufacturing
    capabilities in a new cGMP biomanufacturing facility once completed, we believe that the number of AlloRx Stem Cell therapy treatments
    that we may be able to manufacture from just one umbilical cord may increase exponentially from current levels, and we believe these
    economies of scale will provide us with a competitive and financial advantage if we expand our scalable manufacturing platform in
    the future.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Continue to generate
    value by commercializing our existing products and technologies to support internal development efforts for AlloRx Stem Cell therapy.
    We intend to continue to broaden our commercial access for AlloRx Stem Cells and our other proprietary stem cell products and technologies.
    Unlike many of our competitors that do not generate revenue, we currently generate value from our proprietary products and technologies
    through a number of distinct revenue-generating activities. For example, we sell and distribute our proprietary research products,
    including MSCs, CAFs, native fibroblasts, and other cell culture products and technologies, which have been developed by us, to support
    stem cell and cancer research by leading institutions, clinics, investigators and sponsors. We also generate revenue through our
    agreement with European Wellness and BioPep for the development of novel biologic products. In addition, we generate revenue from
    the sale of AlloRx Stem Cells to certain foreign clinics and medical centers, as well as from the sale of our InfiniVive MD cosmetic
    products. These arrangements generate revenue and provide us with working capital that we use to execute on our primary business
    strategy of becoming a leading regenerative medicine company through the development and commercialization of our novel cellular
    therapies. We believe that this strategy will help us to develop a portfolio of high-quality product development opportunities, enhance
    our commercialization capabilities and increase our ability to generate value from our proprietary technologies, as well as potentially
    limiting our reliance on external financing going forward.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Pursue additional
    collaboration arrangements and out-licensing opportunities. We intend to be opportunistic and consider pursuing co-development,
    out-licensing, commercialization or other supply or collaboration agreements for the purpose of commercializing AlloRx Stem Cell
    therapy, AlloRx Stem Cells and our other products and product candidates, both domestically and internationally. We currently have
    a drug discovery and development contract to develop novel biologic products with European Wellness and BioPep.
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
| | ● | Seek non-dilutive
    funding and grant awards to support our clinical research and product candidate development. We intend to continue to seek
    non-dilutive funding and grant awards to support our clinical research and product candidate development. These funding awards are
    non-dilutive, may further limit our reliance on external financing, and would allow us to collaborate with state and federal partners
    in pursuing safe and effective therapeutics for disorders that have few, if any, available approved treatments.





- 9 -







Our
Core Development Programs



Our
pipeline includes five core development programs, including our expected lead development program for the treatment of PTHS. In the United
States, we are authorized to conduct two clinical trials under two FDA cleared INDs for the purpose of evaluating the safety and efficacy
of AlloRx Stem Cell therapy in PTHS and Long COVID. We intend to initiate these clinical trials sometime in 2023 pending the receipt
of sufficient capital through future debt or equity financings and requisite third-party approval of clinical trial agreements or other
agreements with contemplated collaborators and clinical trial sites. In the future, we may engage one or more third-party CROs to assist
us in, among other things, identifying trial sites for these contemplated clinical trials and in conducting and managing these clinical
trials on our behalf. In January 2023, we engaged a consulting firm, Solstice Life Sciences (“Solstice”), to provide certain
advisory services related to the clinical trial process for our contemplated Phase 1/2a clinical trials for PTHS and Long COVID. We expect
that Solstice will assist us in, among other things, identifying, managing and overseeing one or more CROs and/or clinical trial sites
that may conduct our Phase 1/2a clinical trials on our behalf. For additional information regarding the Solstice Agreement, see “—Consulting
Services Agreement with Solstice Life Sciences” below.



We
are also currently focused on our pre-clinical development programs for MS, Lupus (SLE) and Alzheimer’s disease. We plan to
submit two additional IND applications to FDA to initiate Phase 1/2a clinical trials to assess the safety and efficacy of AlloRx
Stem Cell therapy in adults with Lupus (SLE) sometime in 2023 and in adults with MS in late 2023 or early 2024, which will be subject to FDA
clearance prior to the initiation of any clinical trials for these indications. We are also advancing and actively pursuing
preclinical research and development activities of AlloRx Stem Cell therapy for the potential treatment of Alzheimer’s disease
with the goal of progressing towards a potential IND filing for this indication in the future.



Set
forth below is additional information regarding our core development programs:



Pitt-Hopkins
Syndrome



Under
FDA IND #27853, which became effective on November 4, 2021, we are authorized to conduct a randomized, double-blind, placebo-controlled
Phase 1/2a trial to evaluate the safety and efficacy of AlloRx Stem Cell therapy in children with PTHS. We intend to enter into a clinical
trial agreement with one or more medical institutions or clinical trial sites to conduct this trial. The trial stipulates enrolling up
to 30 patients, with enrollment expected to commence sometime in 2023 pending the receipt of sufficient capital and requisite third-party
approval of clinical trial agreements or other agreements with contemplated collaborators and clinical trial sites. Once fully enrolled,
we expect this trial to last for approximately 12 to 24 months.



Description
of PTHS and Medical Need.PTHS is a rare neurogenetic disorder that features autistic traits. PTHS results from genetic mutations/deletions
of a key brain development gene, TCF4 (transcription factor 4) that controls neurogenesis. Affected children have distinctive facial
features and experience moderate to severe intellectual disability, feeding difficulties, delays in reaching developmental milestones,
impaired ability to speak, and can have recurrent seizures, poor sleep, autistic features, maladaptive behaviors, and breathing pattern
abnormalities (reported from age 7 months to 7 years old). Gastrointestinal problems are common. Given that there are currently no pharmaceutical
treatments available for PTHS and that current options are focused on management of symptoms, a successful cell therapy could be expected
to significantly improve quality of life for those suffering from the condition.





- 10 -







Summary
of Potential Mechanism of Action and Treatment Opportunity. We intend to conduct clinical trials in the United States and additional
pre-clinical research in hopes of continuing to refine our understanding of AlloRx Stem Cell therapy’s activities and mechanisms
of action. We believe there may be numerous potential biological mechanisms that underly MSC therapy. We believe that UC-derived MSCs
may have the potential to mediate a variety of intercellular communication pathways, creating cellular processes that may have the potential
to result in anti-inflammatory effects, immunomodulation, and anti-apoptotic effects. Our beliefs are based on our pre-clinical studies
and research, as supplemented by the findings of the Ryu Study (as defined and described below), the Kim Study and the Chen Study (as
defined and described below), among others. In connection with PTHS, we intend to evaluate the potential of AlloRx Stem Cell therapy
to cross the blood-brain barrier, which may be compromised in PTHS and other neurodegenerative diseases, and enter the brain through
intravenous infusion. Our working hypothesis is that the mechanism of action in PTHS may involve both cellular and gene therapy, the
former from mechanisms described below and the latter from the presence of cells that express functional TCF-4 gene products.



Potential
for Orphan Drug Designation and Exclusivity.Because PTHS is a rare indication, affecting between 1 in 34,000 and 1 in 41,000
individuals according to some estimates, we believe that this indication would meet the prevalence requirements for an ODD from FDA if
the other designation requirements are met. A sponsor may request an ODD any time before the marketing application for the product for
the rare disease or condition is submitted. In August 2021, we submitted an initial request for ODD for this indication to FDA’s
Office of Orphan Products Development. In November 2021, FDA indicated that it was unable to grant our initial ODD request but indicated
that we may submit an amendment to our initial request containing additional information, specifically outcome data from our Phase 1/2a
clinical trial for PTHS under FDA IND #27853. We intend to submit an amendment to our request for ODD once additional information becomes
available to us, including initial clinical data from the first cohort of patients treated in our Phase 1/2a trial for PTHS, as supplemented
thereafter with additional clinical data as it becomes available. FDA has not yet made a determination as to whether PTHS qualifies as
a “rare disease or condition,” and we expect such determination will be made on the basis of the facts and circumstances
as of the date the amendment to our request for ODD is submitted. If the ODD is granted, then AlloRx Stem Cell therapy may be eligible
for a period of orphan drug exclusivity (“ODE”) for seven years for this indication, except in limited circumstances. We
may also have the opportunity to pursue one of the FDA’s expedited review programs for the use of AlloRx Stem Cell therapy in PTHS.
As of the date of this Report, we have not sought expedited review from the FDA as clinical trial outcome data is not yet available.
For additional information regarding an ODD, ODE and the FDA’s expedited review programs, including other associated benefits,
see “—Government Regulation and Biologic Drug Approval” herein.



Next
Steps.We intend to enter into clinical trial agreements with one or more medical institutions or clinical trial sites to conduct
this trial. Once we have executed a clinical trial agreement, we intend to enroll patients as quickly as possible and complete the protocol
authorized by FDA in IND #27853. As further described above, we intend to further pursue an ODD once additional information becomes available
to us, including initial clinical data from our Phase 1/2a trial, before seeking marketing authorization. We intend to begin providing
initial clinical data to FDA once it becomes available following treatment of the first cohort of patients in the trial, with supplemental
clinical data to be provided to FDA thereafter as it becomes available. We also intend to leverage data from our Phase 1/2a clinical
trial to support the advancement of our clinical programs for other indications. For example, if the results from our Phase 1/2a clinical
trial are successful to establish the safety and tolerability of AlloRx Stem Cell therapy, we intend to request FDA approval to advance
AlloRx Stem Cell therapy directly into Phase 2b/3 clinical trials potentially for cerebral palsy, Crohn’s disease, Epilepsy and
autism, which are indications that are symptomatically similar to PTHS. We also believe the dosage and treatment regimen for these indications
will be consistent with PTHS given the patient population.



Long
COVID/PASC.



On
April 1, 2021, IND #20503 became effective pursuant to which we received authorization to conduct a multicenter, randomized,
double-blind, placebo-controlled Phase 1/2a trial to evaluate the safety and efficacy of AlloRx Stem Cell therapy for the treatment
of ARDS due to COVID-19 in adults. Acute Respiratory Distress Syndrome (“ARDS”) is a serious immunological and
inflammatory condition characterized by widespread inflammation in the lungs that can be triggered by COVID-19 and represents a
major cause of morbidity and mortality in patients that have been hospitalized and are in critical care settings. Since April 2021
however, COVID-19 vaccination and booster rates have continued to increase across the United States and the standard of care for the
treatment of hospitalized patients with ARDS due to COVID-19 has continued to develop, including from the emergence of new
therapeutics and treatments that have been authorized by FDA under EUA. After analyzing these trends, we have shifted our focus and
clinical development efforts from the treatment of hospitalized patients with ARDS due to COVID-19 to the treatment of patients with
Long COVID on an outpatient basis.





- 11 -







In
October 2021, we submitted an amendment to request an extension of IND #20503 from FDA to expand the clinical protocol and treated indication
of ARDS secondary to COVID-19 infection to include Long COVID, which is now effective. Accordingly, we are authorized to conduct a multicenter,
randomized, double-blind, placebo-controlled Phase 1/2a trial under IND #20503 to evaluate the safety and efficacy of AlloRx Stem Cell
therapy for the treatment of Long COVID in adults. The trial stipulates enrolling 30 patients, with enrollment expected to commence sometime
in 2023 pending receipt of sufficient capital and requisite third-party approval of clinical trial agreements or other agreements with
contemplated collaborators and clinical trial sites. Once fully enrolled, we expect the trial to last for approximately six to nine months.



Description
of Long COVID and Medical Need.Long COVID is a serious condition characterized by persistent and prolonged symptoms or long-term
complications four weeks or more after first being infected with the SARs-CoV-2 virus. Some individuals suffering from Long COVID may
experience lingering symptoms, such as difficulty breathing or shortness of breath, cough, fatigue, post-exertional malaise, or chest
pain, while others experience more serious long-lasting effects, such as organ damage or multisystem inflammatory syndrome, a condition
in which organs and tissues become severely inflamed, following the onset of COVID-19 infection. Individuals suffering from severe Long
COVID may also experience lasting health effects such as long-term breathing problems, stroke, chronic kidney impairment, and heart complications.
According to the CDC, a recent study found that approximately two-thirds of respondents who had tested positive for COVID-19 experienced
long-term symptoms often associated with SARs-CoV-2 infection. Currently there are no FDA-approved treatments for Long COVID. There is
a great unmet need for novel approaches towards the effective management and potential treatment of Long COVID, and we believe AlloRx
Stem Cell therapy represents a promising approach.



Summary
of Potential Mechanism of Action and Treatment Opportunity.We believe that the immunomodulatory properties of UC-derived MSCs,
including their ability to secrete concentrations of certain immunomodulatory substances, including IDO, may support the potential clinical
use of UC-derived MSCs to combat the immune dysregulation and improve the prognosis in Long COVID patients. Our pre-clinical studies
are further described below under “—AlloRx Stem Cell therapy for Various Indications: a Scientific Approach”.



Next
Steps.We intend to engage a third-party CRO to assist us in, among other things, identifying trial sites for this clinical trial
and expect to rely on any such CRO and clinical study sites to conduct and manage this clinical trial on our behalf. Prior to commencing
this trial, we will need to reach agreement on acceptable terms with prospective CROs and enter into one or more clinical trial agreements
with medical institutions or clinical trial sites to conduct this trial. Afterwards, we intend to enroll patients as quickly as possible
and complete the expanded clinical protocol for Long COVID authorized by FDA in IND #20503. If the results from our ongoing Phase 1/2a
clinical trial for Long COVID are successful to establish the safety, tolerability and/or efficacy of AlloRx Stem Cell therapy, our goal,
subject to FDA review, is to advance AlloRx Stem Cell therapy directly into a larger Phase 2b/3 clinical trial for Long COVID. We also
intend to leverage data from our Phase 1/2a clinical trial or any such future Phase 2b/3 clinical trial for Long COVID to support the
advancement of our clinical programs for other indications.



Lupus
(SLE)



In
2023, we plan to submit an IND application to FDA to initiate a Phase 1/2a clinical trial to assess the safety and efficacy of AlloRx
Stem Cell therapy in adults with Lupus (SLE), which will be subject to FDA review and clearance prior to the initiation of any clinical
trials for this indication. The commencement of any Phase 1/2a clinical trial will depend on, among other things, the timing of FDA review
and authorization.





- 12 -







Description
of Lupus (SLE) and Medical Need.Lupus (SLE) is a chronic autoimmune disease involving many systems in the human body, including
joints, kidneys, the central nervous system, heart, the hematological system and others. The biologic basis of the disease is a dysfunction
of the immune system, leading to production of self (auto) antibodies, attacking healthy organs and causing damage that can be irreversible.
Lupus (SLE) is the most prominent type of lupus and affects over 70% of lupus patients. Lupus (SLE) is a chronic autoimmune disease characterized
by inflammation of the connective tissue which can be life threatening due to damage caused to the central nervous system and major bodily
organs. There is currently no known cure for Lupus (SLE). Only one new treatment for Lupus (SLE), Benlysta, has been approved by the
FDA in the last 50 years. According to research estimates of the Lupus Foundation of America, at least 1.5 million Americans have lupus
(more than 5 million worldwide) with more than 16,000 new cases diagnosed each year in the United States.



Summary
of Potential Mechanism of Action and Treatment Opportunity.The etiology of Lupus (SLE) may involve disfunction of MSC autophagy
(cellular uptake of extracellular materials), which we believe may support the potential of UC-derived MSCs like AlloRx Stem Cells for
the treatment of Lupus (SLE). Pre-clinical research, including the Chen Study described below, supports the role of MSC autophagy resulting
in the reduction of auto-antigens as being especially relevant to Lupus (SLE). In a pre-clinical, in vitro study of 32 Lupus (SLE)
patients conducted by Jinyun Chen evaluating the link between autophagy and apoptosis of activated T cells from Lupus (SLE) patients
and the regulation of UC-derived MSCs on T cell autophagy (the “Chen Study”), it was observed that activated autophagy increased
apoptosis of T cells in Lupus (SLE) patients. To evaluate the autophagic activity of T cells, the Chen Study measured the level of autophagic
LC3-IIB utilizing flow cytometry. The basal autophagic activity in Lupus (SLE) patients, as compared to healthy control subjects, was
6.69 ± 0.23 versus 4.31 ± 0.13, p < 0.0001 for CD3+T cells; 5.25 ± 0.22 versus 3.58 ± 0.07, p= 0.0001 for CD4+T cells; 7.52 ± 0.26 versus 5.01 ± 0.09, p < 0.0001 for CD8+T cells, respectively. After
stimulation with anti-CD3/CD28, the autophagic activity in T Cells in Lupus (SLE) patients as compared to healthy controls was 48.07
± 1.51 versus 37.00 ± 1.00, p = 0.0077 for CD3+T cells; 50.38 ± 3.02 versus 33.20 ± 2.30, p
= 0.0213 for CD4+T cells; 51.64 ± 1.10 versus 41.20 ± 5.20, p = 0.0254 for CD8+T cells, respectively. In addition
to elevated autophagy following stimulation with anti-CD3/CD28, the Chen Study also observed increased apoptosis of T cells from Lupus
(SLE) patients following stimulation and further observed that apoptosis was positively associated with autophagy (r = 0.570,
p < 0.0001 for CD4+T cells; r = 0.508, p = 0.0001 for CD8+T cells).



To
analyze whether UC-derived MSCs could regulate T cell autophagy, peripheral blood mononuclear cells (PBMCs) from Lupus (SLE) patients
were cultured with or without UC-derived MSCs in vitro for 3 days with anti-CD3/CD28 stimulation. In comparison to PBMCs cultured
without UC-derived MSCs, PBMCs cultured with UC-derived MSCs had a significant decrease in T cell autophagy (30.70 ± 1.76 versus
51.37 ± 7.07, p = 0.0469 for CD3+T cells; 22.47 ± 2.41 versus 58.78 ± 4.68,  p <
0.0001 for CD4+T cells; 27.16 ± 1.87 versus 67.00 ± 6.32,  p < 0.0001 for CD8+T cells) and a significant
decrease in apoptosis (24.31% ± 9.47% versus 50.10% ± 6.33%,  p = 0.0432 for CD3+T cells; 22.20% ±
2.60% versus 51.93% ± 1.77%,  p = 0.0003 for CD4+T cells; 23.25% ± 2.43% versus 55.87% ± 4.63%,  p= 0.0011 for CD8+T cells). To further understand these results, the Chen Study also analyzed mitochondrial content of cells utilizing
Mitotracker Deep Red (MDR) staining, in which it was observed that UC-derived MSCs transferred mitochondria to activate T cells. This
data suggests that UC-derived MSCs may have the potential to regulate autophagy, and therefore decrease apoptosis, via mitochondrial
transfer (Jinyun Chen et al, “Umbilical Cord-Derived Mesenchymal Stem Cells Suppress Autophagy of T Cells in Patients with Systemic
Lupus Erythematosus via Transfer of Mitochondria,” Volume 2016 Stem Cells Int., 7 Dec. 2016).



Multiple
Sclerosis (MS)



In
late 2023 or early 2024, we plan to submit an IND application to FDA to initiate a Phase 1/2a clinical trial to assess the safety and efficacy of
AlloRx Stem Cell therapy in adults with MS, which will be subject to FDA review and clearance prior to the initiation of any
clinical trials for this indication. The commencement of any Phase 1/2a clinical trial will depend on, among other things, the
timing of FDA review and authorization.



Description
of MS and Medical Need.MS is a chronic inflammatory, demyelinating and neurodegenerative disorder of the central nervous system.
The initial diagnosis of MS is frequently characterized by episodes of neurological disturbances followed with residual deficits or full
recovery (relapsing-remitting MS) and in a minority by a slow accumulation of disability from the onset (primary progressive MS). MS
affects almost one million patients in the United States and over two and a half million people worldwide. MS results in decreased quality
of life, with cognitive deficiencies reported in 40-70% of patients and 30% of patients requiring caregiving which often comes from their
families, according to the National Multiple Sclerosis Society. Very few treatment options for progressive MS exist.





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Summary
of Potential Mechanism of Action and Treatment Opportunity.We believe that the lack of safe and effective therapies in MS and
the ability of UC-derived MSCs to secrete concentrations of certain immunomodulatory substances, including IDO, and other substances
that may have the potential to suppress pro-inflammatory Th17 cells that underly MS makes AlloRx Stem Cell therapy an attractive treatment
option to evaluate in MS. We also believe that other potential mechanisms of action may be relevant to MS, including the potential of
UC-derived MSCs to potentially promote neuronal repair and remyelination. In addition, as observed by the Chen Study, in the context
of Lupus (SLE) treatments, UC-derived MSCs may have the potential to decrease apoptosis (cell death), making UC-derived MSCs like AlloRx
Stem Cell therapy an attractive option to further evaluate in the potential treatment of MS.



Alzheimer’s
Disease



We
are advancing and actively pursuing preclinical research and development activities of AlloRx Stem Cell therapy for the potential treatment
of Alzheimer’s disease with the goal of progressing towards a potential IND filing for this indication in the future. In this regard,
we continue to supply AlloRx Stem Cells to foreign third-party clinics and medical centers for use in foreign clinical studies of Alzheimer’s
disease being conducted by these clinics and medical centers at the patients’ own expense, thereby expanding the sample population
to gain additional prior human experience with subjects affected by Alzheimer’s disease. We intend to provide all relevant human
experience data to FDA in connection with any future IND application submitted by us to FDA seeking authorization to commence clinical
trials of Alzheimer’s disease in humans in the United States. For additional information, see “—International Supply
Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies” below. Further, as further described below,
numerous preclinical studies have been conducted by third parties investigating the potential relevancy of MSCs in the treatment of Alzheimer’s
disease.



Description
of Alzheimer’s disease and Medical Need. Alzheimer’s disease is a progressive and chronic neurodegenerative disease
characterized by memory and cognitive deterioration beyond normal aging that becomes severe enough to interfere with daily tasks. It
is the most common form of dementia. Alzheimer’s disease is characterized by the loss of neurons and synapses in the cerebral cortex
and certain subcortical regions. Different mechanisms have been implicated in the underlying cause of the cognitive and functional impairments
observed in Alzheimer’s disease including disfunction of stem cells within the brain. Degeneration of the cholinergic nervous system
has been shown to be closely linked to the impairment of cognitive functions. Also, neurodegeneration caused by a complex interplay among
abnormal tau and beta-amyloid proteins and several other factors is thought to play a major role in the pathogenesis of Alzheimer’s
disease. However, neurodegeneration in Alzheimer’s disease appears to be a multi-factorial event, in which various genetics as
well as environmental risk factors may play a role sequentially and/or in parallel.



According
to the Alzheimer’s Association, Alzheimer’s disease currently affects over six million people in the United States. Worldwide,
the disease is estimated to afflict as many as 24 million people, and the patient population in the United States is expected to grow
to approximately 13 million people in the United States by 2050. While medications that provide a modest improvement in Alzheimer’s
disease symptoms are available, there are no therapies currently approved to address the underlying pathology of and slow the inexorable
progression of the disease, with the exception of Biogen’s aducanumab, which was approved by the FDA in June 2021, and Eisai’s
Leqembi (lecanemab-irmb), which was approved by FDA in January 2023 via the Accelerated Approval pathway.



Summary
of Potential Mechanism of Action and Treatment Opportunity.We intend to evaluate AlloRx Stem Cell therapy in the potential treatment
of Alzheimer’s disease, including its potential relevance in reducing Alzheimer’s disease-associated brain inflammation,
improving the function of blood vessels in the brain and reducing brain damage due to Alzheimer’s disease progression, and are
focusing our preclinical research and development efforts of AlloRx Stem Cell therapy accordingly. As observed by the Chen Study in the
context of Lupus (SLE) treatments, UC-derived MSCs may have the potential to decrease apoptosis (cell death), which we believe makes
UC-derived MSCs like AlloRx Stem Cell therapy an attractive option to further evaluate in the potential treatment of Alzheimer’s
disease.





- 14 -







For
a discussion of certain risks related to our contemplated clinical trials and various factors that may affect our ability to initiate
or complete such clinical trials on a timely basis or at all, including potential enrollment issues, unacceptable adverse events, and
inspections by FDA or IRBs of clinical trial sites, see “Item 1A. Risk Factors” herein.



Our
Products



MSC-Gro



MSC-Gro
is our proprietary specialty culture media that has been developed by us over 20 years of research and development with multiple formulations:



| | ● | Research grade formulation:We have developed a variety of research grade formulations of MSC-Gro, which are marketed and sold mainly to research institutions,
    clinics and investigators. These institutions use MSC-Gro to support cellular immunotherapy development for cancer and also support
    stem cell research. We have low serum, serum-free and CAF-specific formulations. We have recently hired a full-time marketer of these
    products with extensive experience in the marketing and sales of related products. We sell these products directly and through select
    distributors.                                                                                                                                                                                                                                                                                                                                                     
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
| | ● | Clinical grade formulation:Our clinical grade formulation of MSC-Gro is used by us for the manufacture of AlloRx Stem Cells. As discussed above, we
    also sell our clinical grade formulation to a single customer in Australia that utilizes MSC-Gro to manufacture its stem cell therapy
    product candidate currently being investigated for the potential treatment of osteoarthritis; this customer is planning to commence
    a pivotal Phase 3 clinical trial in Australia in late 2023 and, upon a successful outcome, expects that its stem cell therapy product
    candidate would be eligible to obtain regulatory approval for commercialization in Australia in 2026. If this customer’s stem
    cell therapy product candidate is ultimately approved for commercialization in Australia, we expect to benefit from the increased
    sales of MSC-Gro to this particular customer as it scales up manufacturing to meet commercial demand.



Cancer-Associated
Fibroblasts



We
sell CAFs and native fibroblasts developed by us directly to leading institutions, clinics, investigators and sponsors, including major
biotechnology/biopharmaceutical firms and several universities. These institutions use CAFs and native fibroblasts for advanced cancer
research, especially for the development of immunotherapy for the treatment of solid tumors.



Cosmetic
Conditioned Media and Exosome-Containing Serums



Through
InfiniVive MD, our wholly-owned subsidiary that we acquired in August 2021, we develop, manufacture and sell topical conditioned media
and exosome-containing serums. Our InfiniVive MD cosmetic products use our exosome-containing conditioned medium derived from AlloRx
Stem Cells as the main active ingredient. Accordingly, InfiniVive MD cosmetic products contain exosomes for use topically by certified
plastic surgeons, cosmetic surgeons, and aestheticians, or consumers, including:



| | ● | InfiniVive MD’s
    Exosome Serum. This cosmetic product contains conditioned media derived from AlloRx Stem Cells containing various secreted
    products including proteins, RNA and exosomes. InfiniVive MD’s Exosome Serum is marketed and sold by us exclusively to certified
    plastic surgeons, cosmetic surgeons, aestheticians and other medical professionals. InfiniVive MD’s Exosome Serum is intended
    to be applied topically by these medical professionals. Exosomes, which are extracellular vesicular nanostructures containing proteins,
    mRNA, and other substances, are involved in cellular communication, regulation of immune function, and tissue regeneration, among
    other things. We currently sell InfiniVive MD’s Exosome Serum throughout the United States and internationally.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





- 15 -







InfiniVive
MD’s Exosome Serum is intended to be applied only by medical professionals on a non-invasive and topical basis only. On this basis,
InfiniVive MD’s Exosome Serum has been marketed and sold in the United States with product labels and instructions regarding the
proper administration in accordance with FDA regulations. FDA regulations require, among other things, that InfiniVive MD’s Exosome
Serums be applied topically by certified physicians and aestheticians and any off-label uses, including administration by injection,
is strictly prohibited. From June 2022 to July 2022, we voluntarily suspended sales of InfiniVive MD’s Exosome Serum in the United
States in order to conduct an investigation into the administration of this product by medical professionals that have purchased this
product directly from us or via distribution from other medical professionals. The purpose of this investigation was to, among other
things, ensure that this product has not been used “off-label” by medical professionals that have purchased our product,
including by injection into patients in the United States in violation of FDA regulations, and that products delivered by us have included
the necessary labeling and instructions for proper administration. After careful investigation and consultation with regulatory advisors,
we determined to resume sales of InfiniVive MD’s Exosome Serum, with additional precautionary measures, including receipt of medical
provider questionnaires. This voluntarily suspension of sales of InfiniVive MD’s Exosome Serum in the United States did not have
a material impact on our operating results for fiscal year 2022.



| | ● | InfiniVive MD’s
    Daily Serum. This cosmetic product is a conditioned media and exosome-based cosmetic serum derived from AlloRx Stem Cells.
    InfiniVive MD’s Daily Serum is currently marketed and sold by us exclusively to plastic surgeons, cosmetic surgeons, aestheticians
    and other medical professionals.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Our
statements herein regarding our InfiniVive MD topical cosmetic and exosome-containing serums have not been reviewed or approved by the
FDA. For a discussion of certain risks and governmental regulation related to these products, see “Item 1A. Risk Factors”
herein and “—Government Regulation and Biologic Drug Approval—U.S. Regulation of Wellness Products” below.



On
November 20, 2022, we entered into a Supply Agreement with Dr. Jack Zamora, our former Chief Executive Officer, pursuant to which we
agreed to provide InfiniVive MD Exosome Serum and InfiniVive MD Daily Serum to Dr. Zamora at his request. The provision of InfiniVive MD
products under the Supply Agreement is subject to certain minimum and maximum quantity limitations. For additional information regarding
the Supply Agreement, see “Item 13. Certain Relationships and Related Transactions, and Director Independence.”



Dietary
Supplements and Nutraceuticals



Through
Fitore, Inc. (“Fitore”), our wholly-owned subsidiary that we acquired in August 2021, we sell dietary supplements, nutraceuticals
and health products, many of which are based on our stem cell research. These products are designed to induce certain benefits by activating
the body’s own stem cells and transplanted stem cells. These nutraceutical products are marketed and sold online. We are currently
selling Fitore products solely from remaining inventory and do not anticipate manufacturing any additional products in the foreseeable
future or at all. For a discussion of certain risk relating to the manufacture of dietary supplements, nutraceuticals and other health
products, see “Risk Factors— Risks Related to the Dietary and Nutritional Supplements Industry and Fitore Products.”



AlloEx
Exosomes®



We
have also developed AlloEx Exosomes, which are a derivative of AlloRx Stem Cells. In the United States, AlloEx Exosomes are regulated
by the FDA as a biological product. AlloEx Exosomes are manufactured by us and are derived from cultured AlloRx Stem Cells at the latter
part of their growth curve by our proprietary cell culture process. AlloEx Exosomes are currently being used by us as the starting biological
material in our effort to identify, and ultimately seek FDA approval for, a key investigational product candidate in our agreement with
European Wellness. For additional information regarding our agreement with European Wellness and AlloEx Exosomes, see “—Joint
Operating Agreement with European Wellness” below.





- 16 -







Preliminary
Tolerability Data for AlloRx Stem Cells



As
of December 31, 2022, over 327 subjects have received treatment with AlloRx Stem Cells via peripheral intravenous infusion or direct
injection for potential treatment of a wide variety of indications, including ARDS due to COVID-19, Long COVID, MS, ALS, Lupus, MSA, Alzheimer’s disease, CKD, COPD, diabetes and age-related conditions. To date,
there have been no serious adverse events reported that were considered related to AlloRx Stem Cells.



Preliminary
Tolerability Data from Compassionate Use in the United States



Sixteen
patients in the United States have been treated with AlloRx Stem Cells by third-party physicians or our former partners pursuant to emergency
single use eIND authorization (“eIND authorization”) that was granted from the FDA (often referred to as compassionate use)
for the treatment of patients with immediately life-threatening conditions or serious diseases, including ARDS due to COVID-19, anaphylaxis
secondary to COVID monoclonal antibodies and ALS.Of the sixteen patients treated with AlloRx Stem Cells pursuant to eIND authorization
in the United States, seven patients died from causes determined to be related to COVID-19 but did not experience any serious adverse
events that were considered related to the treatment itself, in each case as determined by the treating physician. In general, while
we have received certain preliminary and/or anecdotal data and information from third-party physicians and partners following treatment
by them with AlloRx Stem Cells pursuant to emergency single use eIND authorization, we typically have not received final objective data
or information related to final end results.



Set
forth below is additional information related to the treatment of patients with AlloRx Stem Cells pursuant to eIND authorization in the
United States, including the name and location of the hospital, the identity of the treating physician and the number of patients treated
for various indications. In connection with these treatments, there were no serious adverse events reported that were considered related
to AlloRx Stem Cells:



|Hospital                             |  | Location        |  | Treating
    Physician    |  | Patients
    Treated (#) |  | Indication(s)                                     
|------------------------------------ |  | --------------- |  | ------------------------- |  | ------------------------ |  | --------------------------------------------------
|Hackensack Medical Center            |  | Hackensack, NJ  |  | Dr. Keith Rose            |  | 2                        |  | Critical COVID - ARDS                             
|Orlando Health                       |  | Orlando, FL     |  | Dr. Nimish Nemani         |  | 1                        |  | Critical COVID - ARDS                             
|Tri City Medical Center              |  | Oceanside, CA   |  | Dr. Navneet Boduu         |  | 5                        |  | Critical COVID - ARDS                             
|UC Anschutz                          |  | Denver, CO      |  | Dr. Susan Boakle          |  | 1                        |  | Anaphylaxis Due to COVID
    monoclonal antibodies
|Thorek Memorial Hospital             |  | Glenview, IL    |  | Dr. Chad Padromos         |  | 1                        |  | ALS                                               
|NY Community Hospital                |  | Brooklyn, NY    |  | Dr. Prabhat Soni; Giostar |  | 1                        |  | Critical COVID - ARDS                             
|Providence Alaska Medical
    Center |  | Anchorage, AK   |  | Dr. Mike Schwalbe         |  | 1                        |  | Critical COVID - ARDS                             
|LA Downtown Medical Center           |  | Los Angeles, CA |  | Dr. Prabhat Soni; Giostar |  | 4                        |  | Critical COVID - ARDS                             



Compassionate
use is intended to provide access to investigational medicines for patients with serious or life-threatening conditions who have limited
available treatment options. Under applicable FDA rules, a patient cannot receive a compassionate use drug unless FDA has issued an individual
patient eIND authorization, which the attending physician requested and received from FDA prior to each individual patient treatment.
There is no randomized control group for patients treated under individual patient eIND authorization. For additional information regarding
compassionate use using AlloRx Stem Cells, and data derived therefrom, see “Item 1A. Risk Factors” herein.





- 17 -







Preliminary
Tolerability Data from Foreign Clinical Studies



Over
311 subjects have also been treated with AlloRx Stem Cells in foreign clinical studies being conducted by third parties. For a more
complete description of our collaborative arrangements with certain foreign third-party clinics and medical centers and the
open-label, patient-sponsored clinical studies being conducted by such foreign third-party clinics and medical centers, see
“—International Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies”
below. As further described below, for all clinical studies that are conducted by foreign third-party clinics using AlloRx Stem
Cells, we receive safety and tolerability data, including data relating to any occurrence of any serious adverse events, from such
third-party clinics and medical centers, but they are ultimately responsible for the administration of AlloRx Stem Cells to
individuals as well as their care and follow-up. In addition to receipt of safety and tolerability data, we also receive other
preliminary and/or anecdotal data and information from time to time, but final end results generated from these open-label clinical
studies conducted by foreign third-party clinics are unknown by us, and final objective data is not provided to us by these foreign
third-party clinics and medical centers. While certain anecdotal data is used by us to cost-effectively explore where AlloRx Stem
Cell therapy may have relevance, we intend to initiate and conduct clinical trials in the United States with the goal of proving
efficacy and achieving regulatory approvals for AlloRx Stem Cell therapy, each of which is in the sole authority of the
FDA.



Set
forth below is additional information related to the treatment of subjects with AlloRx Stem Cells in open-label, patient-sponsored clinical
studies conducted by foreign third-party clinics and medical centers, including the name and location of the third-party clinic, the
identity of the lead investigator and the number of subjects treated for various indications. In connection with these treatments, there
were no serious adverse events reported that were considered related to AlloRx Stem Cells:



|Clinic
    Name                   |  | Location                                  |  | Investigator        |  | Subjects
    Treated (#) |  | Indications                                               
|--------------------------------- |  | ----------------------------------------- |  | ------------------- |  | ------------------------ |  | ----------------------------------------------------------
|Medical & Surgical
    Associates |  | St. John, Antigua                         |  | Dr. Chad Padromos   |  | Total: 109               |  |                                                           
|                                  |  |                                           |  |                     |  | 62                       |  | Anti-inflammatory                                         
|                                  |  |                                           |  |                     |  | 30                       |  | Osteoarthritis                                            
|                                  |  |                                           |  |                     |  | 3                        |  | Diabetes                                                  
|                                  |  |                                           |  |                     |  | 2                        |  | Parkinson’s disease                                       
|                                  |  |                                           |  |                     |  | 3                        |  | Chronic Kidney Disease                                    
|                                  |  |                                           |  |                     |  | 3                        |  | Autism                                                    
|                                  |  |                                           |  |                     |  | 6                        |  | 1 patient treated for each of various other indications(a)
|Medical & Surgical
    Associates |  | St. John, Antigua                         |  | Dr. Joey Johns      |  | Total: 17                |  | COVID - ARDS                                              
|DVCStem                           |  | Seven Mile Beach, Grand
    Cayman Island |  | Dr. Lou Kona        |  | Total: 175               |  |                                                           
|                                  |  |                                           |  |                     |  | 80                       |  | Anti-inflammatory                                         
|                                  |  |                                           |  |                     |  | 43                       |  | Multiple Sclerosis                                        
|                                  |  |                                           |  |                     |  | 3                        |  | Diabetes                                                  
|                                  |  |                                           |  |                     |  | 3                        |  | Fibromyalgia                                              
|                                  |  |                                           |  |                     |  | 5                        |  | Crohn’s disease                                           
|                                  |  |                                           |  |                     |  | 11                       |  | ALS                                                       
|                                  |  |                                           |  |                     |  | 4                        |  | Lyme disease                                              
|                                  |  |                                           |  |                     |  | 2                        |  | Muscular Dystrophy                                        
|                                  |  |                                           |  |                     |  | 3                        |  | Alzheimer’s disease                                       
|                                  |  |                                           |  |                     |  | 6                        |  | Parkinson’s disease                                       
|                                  |  |                                           |  |                     |  | 2                        |  | RA                                                        
|                                  |  |                                           |  |                     |  | 13                       |  | 1 patient treated for each of various other indications(b)
|Matamata Medical Center           |  | Matamata, New Zealand                     |  | Dr. Bruce Pitchford |  | Total: 8                 |  |                                                           
|                                  |  |                                           |  |                     |  | 3                        |  | MSA-p                                                     
|                                  |  |                                           |  |                     |  | 2                        |  | ALS                                                       
|                                  |  |                                           |  |                     |  | 3                        |  | Familial
    Tremor, Menigitis, MSA-c                     
|PRMedica                          |  | Cabo San Lucas, Mexico                    |  | Dr. Victor Ocegueda |  | Total: 2                 |  |                                                           
|                                  |  |                                           |  |                     |  | 1                        |  | Spinal Cord                                               
|                                  |  |                                           |  |                     |  | 1                        |  | Long COVID                                                





- 18 -







| | (a) | 1 patient treated for each
    of various other indications, including: MS, RA, UC, Alzheimer’s, ED and Polymyalgia Rheumatica (a type of RA).                                                                                              
| | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | (b) | 1 patient treated for each
    of various other indications, including: Long COVID, Stroke, Spinal Cord, Kidney Disease, UC, OA, COPD, Inclusion Body Myositis,
    Asbestosis, Asthma, MCA Stoke and Complex regional pain syndrome (CRPS).



Relevance
of Preliminary Tolerability Data



We
consider the preliminary tolerability data generated from the prior human experience described above to be relevant to our business for
a variety of reasons, including:



| | ● | Our IND applications submitted
    to FDA in which we sought, and ultimately received, FDA authorization to conduct Phase 1/2a clinical trials in PTHS and Long COVID
    were required to include, among other things, a comprehensive summary of all prior human experience with the product candidate. Accordingly,
    prior human experience data for AlloRx Stem Cells, including data collected in foreign clinical studies conducted by third parties,
    was previously provided by us to FDA at the time we submitted such IND applications, including comprehensive information relating
    to the subject and treating physician, safety and tolerability data, and whether any serious adverse events were reported. We expect
    to provide additional preliminary tolerability data to FDA in any regulatory submissions that may be submitted by us in the future.
    Accordingly, this preliminary tolerability data has enabled us to provide high quality, transparent communications and regulatory
    submissions with FDA.
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | This extensive prior human
    experience with our product candidate is a factor that goes into authorization from FDA to proceed with Phase 1/2a clinical trials
    to evaluate both the safety and efficacy of AlloRx Stem Cell therapy. Accordingly, we believe preliminary tolerability data has saved
    us substantial research and development time and resources.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
| | ● | Our
    continued supply of AlloRx Stem Cells for use in foreign clinical studies is also relevant for our continued study of the safety and
    tolerability effects of AlloRx Stem Cells while also exploring other potential indications where AlloRx Stem Cells may have
    relevance. Accordingly, we also use this preliminary tolerability data for our research and development activities, including for
    the efficient and informed internal development of our product candidates like AlloRx Stem Cell therapy. Therefore, we intend to
    continue to gain additional prior human data for additional indications for AlloRx Stem Cells, including in foreign clinical studies
    conducted by third parties. Accordingly, we believe this preliminary tolerability data is relevant given its use by us in the
    efficient and informed internal development of our product candidates.                                                                                                                                        



Recent
Acquisitions



InfiniVive
MD



Effective
August 1, 2021, we acquired all of the outstanding equity interests of InfiniVive MD from Dr. Jack Zamora, our former Chief Executive
Officer, pursuant to an Agreement and Plan of Exchange. We issued 23,000,000 shares of our common stock to Dr. Zamora valued at $0.19
per share in the exchange transaction, which resulted in InfiniVive MD becoming a wholly-owned subsidiary of our company. The shares
issued to Dr. Zamora are subject to restrictions on transfer. At the time of the acquisition, Dr. Zamora was Chief Executive Officer
and a director of our company.





- 19 -







Prior
to the acquisition, InfiniVive MD was a customer of our company.



Fitore



Also
effective August 1, 2021, we acquired all of the issued and outstanding stock of Fitore, making that entity a wholly-owned subsidiary
of our company. That acquisition was completed pursuant to the terms of an Agreement and Plan of Merger (the “Merger Agreement”)
and resulted in the issuance of an aggregate of 4,000,000 shares of our common stock valued at $0.19 per share, six Series A Convertible
Preferred Share Units (“Series A Units”), with each Series A Unit consisting of 2,000 shares of Series A Preferred Stock,
a Class A Warrant to purchase up to 100,000 shares of our common stock at an exercise price of $0.50 per share and a Class B Warrant
to purchase up to 100,000 shares of our common stock at an exercise price of $1.00 per share, and 5% Convertible Promissory Notes in
the aggregate principal amount of $1 million. The notes are payable three years from the effective date of the acquisition and are convertible
into our common stock at a conversion price of $1.00 per share. All of the securities issued in connection with the acquisition are subject
to restrictions on transfer.



Our
Chief Financial Officer, Nathan Haas, was a significant stockholder of Fitore at the time of the acquisition and in that capacity received
800,000 shares of our common stock, 1.2 Series A Units and a 5% Convertible Promissory Note in the principal amount of $200,000. Our
former Chief Executive Officer, Dr. Jack Zamora, was also a significant stockholder of Fitore at the time of the acquisition and in that
capacity received 1,200,000 shares of our common stock valued at $0.19 per share, 1.8 Series A Units and a 5% Convertible Promissory
Note in the principal amount of $300,000.



Our
Regenerative Medicine Business: AlloRx Stem Cell therapy



AlloRx
Stem Cell therapy for Various Indications: a Scientific Approach



In
a pre-clinical animal study by Hak-Hyun Ryu, et al, evaluating the effects of MSCs on spinal cord injuries in dogs (the “Ryu
Study”), the following benefits were observed in animals receiving UC-derived MSCs as compared to the control group receiving no
MSCs (Hak-Hyun Ryu et al, “Comparison of Mesenchymal Stem Cells Derived from Fat, Bone Marrow, Wharton’s Jelly, and
Umbilical Cord Blood for Treating Spinal Cord Injuries in Dogs,” 74(12) J. Vet. Med. Sci., 1617-1630, 9 August 2012):



Increased
locomotion of hind limbs (as measured by Olby scores). To objectively measure functional recovery after spinal injury, the Ryu
Study utilized the Olby score (0-14). Prior to the spinal injury, all of the dogs in the Ryu Study had an Olby score of 14 points, which
is indicative of normal pelvic limb gait. Eight weeks following treatment with MSCs, the MSC-treated dogs had Olby scores of 5 or 6 points,
which indicates purposeful hind limb motion. By comparison, the control dogs not treated with MSCs had Olby scores of 3 points after
eight weeks, which indicates possible minimal nonweight-bearing protraction of the pelvic limb in only one joint.



Lower
levels of proinflammatory cytokines. The Ryu Study measured the concentration of certain proinflammatory cytokines, including
COX-2 and IL-6, in the animals eight weeks after transplantation of UC-derived MSCs. The average concentration of COX-2 in the control
group and the group treated with UC-derived MSCs was 55 ng/ml and 30 ng/ml, respectively. The average concentration of IL-6 in the control
group and the group treated with UC-derived MSCs was 39 ng/ml and 24 ng/ml, respectively.



Increased
expressions of neural proteins. The Ryu Study analyzed the expressions of neural proteins including class III beta-tubulin (Tuj1),
neurofilament (NF160) and neuronal nuclei (NeuN), and galactosylceramidase (GALC) using Western blot analysis. After eight weeks, as
compared to the untreated control group, dogs treated with UC-derived MSCs had 28% increased expression of Tuj1, 30% increased expression
of NF160, 10% increased expression of NeuN and 11% increased expression of GALC. The increased expressions of these proteins are indicative
of increased neuroprotective effects.





- 20 -







Potential
Mechanisms of Action of AlloRx Stem Cell therapy



We
intend to conduct clinical trials in the United States and additional pre-clinical research in hopes of continuing to refine our understanding
of AlloRx Stem Cell therapy’s activities and mechanisms of action. Based on the findings described above and our own extensive
pre-clinical research, among others, we intend to further evaluate the potential of AlloRx Stem Cell therapy to treat multiple facets
of various indications through potentially multiple mechanisms of actions that may include the following:



| | ● | Reduction of inflammation.We believe AlloRx Stem Cell therapy may have the potential to reduce inflammation (i) through activation of anti-inflammatory
    biochemical and cellular pathways, including potentially reducing destructive pro-inflammatory cytokines that may negatively impact
    the brain, muscles, bones, and joints, and (ii) by converting certain harmful pro-inflammatory macrophages, called M1 macrophages
    (a type of white blood cell that is vital to the immune system) to certain anti-inflammatory macrophages, called M2 macrophages.
    These potential mechanisms of action are illustrated in the diagram below.
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------







| | ● | Modulate immune function.We believe that AlloRx Stem Cell therapy may have the potential to improve immune system function, such as by potentially regulating
    a variety of immune cells mediating the cellular immune system including T-cells, T-helper cells, TREG cells and dendritic cells.
    Immunomodulation typically involves immunosuppression, which support the potential use of UC-derived MSCs in treating autoimmune
    diseases.                                                                    
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | ● | Restore blood flow.We believe AlloRx Stem Cell therapy may have the potential to restore blood flow due to injury or stroke through a process
    called angiogenesis and to induce formation of endothelial cells that restore blood flow to tissues and improve overall functioning
    of the blood vessels. We intend to evaluate the potential of AlloRx Stem Cell therapy to improve blood supply to the muscles, bones,
    and organs, including the brain, and thereby improve nutrient supply and waste removal.
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | ● | Activate intrinsic
    repair and regenerative mechanisms.We believe AlloRx Stem Cell therapy may have the potential to induce regenerative and
    repair pathways to promote cellular recovery from damage and restore homeostasis.                                                                                                                                                                                                                                                                                     



Potential
biological advantages of UC-Derived MSCs



The
starting raw material source for AlloRx Stem Cells is the Wharton’s jelly of donated UCs. Based on extensive pre-clinical
studies and research conducted by us and third parties, as further described below, we believe UC-derived MSCs like AlloRx Stem
Cells may have advantages compared to MSCs derived from other starting raw material sources, such as BM-MSCs, AD-MSCs, and
P-MSCs.



UC-derived
MSCs are the youngest adult stem cells and are therefore generally free from issues related to age (such as mutations), and prior medical
conditions that come with the use of BM-MSCs and AD-MSCs. In addition, unlike BM-MSCs, AD-MSCs, UC-derived MSCs involve a non-invasive
collection process, are sourced and collected after childbirth, and may provide significant economies of scale in the manufacturing process,
as further described below. We believe these factors taken together may provide us with a competitive and financial advantage compared
to other cell therapies currently in development that are derived from BM-MSCs, AD-MSCs or P-MSCs.





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In
addition, in our extensive pre-clinical, in vitro studies described below, we analyzed various biological characteristics of AlloRx
Stem Cells (UC-derived MSCs) in head-to-head comparisons to AD-MSCs, BM-MSCs, and P-MSCs, including:



Growth
Rate



Because
MSCs must be expanded in vitro prior to use in a clinical setting, we believe that the growth and expansion characteristics of
MSCs in vitro are an important consideration. In a pre-clinical, in vitro study, we analyzed MSCs’ growth in cell
cultures in head-to-head comparisons and observed that AlloRx Stem Cells (UC-derived MSCs) doubled in size in vitro after only
25 hours, as compared to longer doubling times of 35 hours, 40 hours and 53 hours for AD-MSCs, P-MSCs and BM-MSCs, respectively, indicating
an increased growth rate of AlloRx Stem Cells as compared to these other MSCs. Pre-clinical studies conducted by third parties using
other UC-derived MSCs also support our observations described above. In the Kim Study, which analyzed the immunological characteristics
of UC-derived MSCs in a head-to-head comparison to AD-MSCs and PL-MSCs, it was observed that UC-derived MSCs doubled in size in vitroafter only 32.1 hours, whereas PL-MSCs doubled after 42.7 hours and AD-MSCs doubled after 56.4 hours.



Immunomodulatory
Potency Measures



In
a pre-clinical, in vitro study, we analyzed the immunomodulatory potency of AlloRx Stem Cells (UC-derived MSCs) in a head-to-head
comparison to AD-MSCs, BM-MSCs, and P-MSCs. To compare immunomodulatory properties of MSCs from these sources, the activation of IDO
by exposure to γ-IFN was determined on an equivalent cellular basis (see graph below). The γ-IFN-induced IDO activity was
quantified by the conversion of tryptophan to kynurenine. IDO, an immunomodulatory substance secreted by MSCs, initiates the conversion
of tryptophan to kynurenine, and kynurenine expression plays a critical role in regulating the body’s immune response. Maximal
IDO activity at 10 ng/ml γ-IFN was approximately two-fold greater in AlloRx Stem Cells versus the MSCs derived from other sources.
There was a significant difference in γ-IFN-induced IDO activity between the AD-MSCs, BM-MSCs, and P-MSCs compared to AlloRx Stem
Cells (UC- derived MSCs) with a p-value<0.005 by one-way ANOVA analysis of variance for significance of slope difference. We believe
these results indicate UC-derived MSCs like AlloRx Stem Cells may have greater immunomodulatory cellular potency by quantification of
γ-IFN-induced IDO activity, as compared to AD-MSCs, P-MSCs, and BM-MSCs.







Immunomodulatory
potency of UC- derived MSCs, AD-MSCs, P-MSCs and BM -MSCs by the γ-IFN induced IDO activity assay is shown above.





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Pre-clinical
studies conducted by third parties using other UC-derived MSCs support our observations described above, as the Kim Study also observed
the following concentrations of two other immunomodulatory substances secreted by MSCs, TGF-ꞵ1 and hepatocyte growth factor (“HGF”),
48 hours after γ-IFN activation in UC-derived MSCs as compared to AD-MSCs and PL-MSCs:



|Immunomodulatory
    Substance |  | UC-derived
    MSCs |  | AD-MSCs   |  | PL-MSCs  
|------------------------------ |  | ------------------- |  | --------- |  | ---------
|TGF-ꞵ1                         |  | 4.5 ng/ml           |  | 3.5 ng/ml |  | 3.5 ng/ml
|HGF                            |  | 325 pg/ml           |  | 190 pg/ml |  | 100 pg/ml



Cellular
ATP Expression



In
a pre-clinical, in vitro study, we performed a quantitative assessment of mitochondrial function by measuring ATP expression of
AlloRx Stem Cells (UC-derived MSCs) in a head-to-head comparison to AD-MSCs, BM-MSCs, and P-MSCs. As illustrated in the chart below,
AlloRx Stem Cells (UC-derived MSCs) showed a significant difference in cellular ATP-content. ATP expression is a measure of cellular
energy, as ATP is the primary molecule that stores and transfers energy in a cell and powers metabolic processes within the body. Due
to the fact that mitochondria produce most ATP within the body, we believe these results indicate the potential for increased mitochondrial
functionality of UC-derived MSCs like AlloRx Stem Cells as compared to AD-MSCs, P-MSCs, and BM-MSCs.







In
the chart above, cellular ATP is shown as a function of cells per well. Cellular potency is measured by the slope of this relation.



Cell
Migration



In
a pre-clinical, in vitro study, we analyzed the migration of AlloRx Stem Cells (UC-derived MSCs) in a head-to-head comparison
to AD-MSCs, BM-MSCs, and P-MSCs, in response to exposure to Substance P. Substance P is a peptide that presents itself when an injury
occurs, thus simulating an environment of injury. As illustrated in the chart below, AlloRx Stem Cells (UC-derived MSCs) showed a significant
difference in cell migration in response to Substance P, as AlloRx Stem Cells (UC-derived MSCs) showed greatest closure at 50 pg/mL Substance
P (~40% closure), while AD-MSC, P-MSC, and BM-MSC had a closure between 5-15% all within a 72-hour period. These results were seen in
several replicates (n=4). Due to the fact that Substance P is a peptide that presents itself in response to an injury, we believe that
UC-derived MSCs’ ability to migrate to Substance P reaction at a faster rate may be indicative of an ability to more quickly migrate
to the source of injury within the body as compared to AD-MSCs, P-MSCs, and BM-MSCs.





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Comparison
of migration into cell-free regions. Migration was measured by percent closure of the occluded plate region and is plotted as a function
of time following exposure to 50 pg/ml Substance P.



Proliferation
Capacity



In
a pre-clinical, in vitro study, we also analyzed the proliferation capacity of AlloRx Stem Cells (UC-derived MSCs) in a head-to-head
comparison to AD-MSCs, BM-MSCs, and P-MSCs, by quantifying cellular redox activity by a well-validated resazurin-based fluorometric assay.
As illustrated in the chart below, we observed that AlloRx Stem Cells (UC-derived MSCs) had a maximum effect of fetal bovine serum (“FBS”)
at 6%, while no saturation was seen in the other cell lines, indicating greater cell proliferation capacity in AlloRx Stem Cells as compared
to AD-MSCs, BM-MSCs, and P-MSCs.







In
the chart above, the relative fluorescent difference at day 1 and 3 using Presto Blue as shown as a function of FBS content in a serum-free
medium.





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Key
Features and Potential Benefits of AlloRx Stem Cell therapy



The
key features of AlloRx Stem Cell therapy offer potential benefits as a possible therapeutic, including the following:



| | ● | “Off-the-Shelf”
    and scalable product.AlloRx Stem Cell therapy is intended to be an “off-the-shelf” commercialized product that
    is stored frozen and available for on-demand use. AlloRx Stem Cells are allogeneic cells derived from the youngest known adult stem
    cells as opposed to autologous MSCs derived from adipose tissue, bone marrow, etc. Since these cells are non-immunogenic and do not
    transfer DNA to the recipient, they do not require tissue extraction as do autologous MSCs. As of December 31, 2022, AlloRx Stem
    Cells have been administered in over 327 individuals without eliciting a rejection or allergic response from the recipient. We believe
    this is because umbilical cord-derived MSCs are non-immunogenic meaning that they do not illicit an immune response based on previous
    independent research by third parties, and thus AlloRx Stem Cell therapy does not require tissue-type matching. Each lot of AlloRx
    Stem Cell therapy is derived from the Wharton’s jelly of donated umbilical cords, where young MSCs are present. AlloRx Stem
    Cells are then culture-expanded in vitrousing MSC-Gro, our proprietary specialty culture media, to produce more MSCs with
    potentially increased potency and viability as compared to MSCs prepared using stromal vascular fraction (“SVF”). We
    currently have the capacity to manufacture 300 AlloRx Stem Cell therapy treatments per month. We are currently planning a separate
    cGMP manufacturing facility that, if completed, will be used exclusively for the manufacture of AlloRx Stem Cells. We plan to use
    highly scalable, fully automated closed system bioprocessing in the new cGMP biomanufacturing facility. We believe that the use of
    fully automated closed system bioprocessing in a new cGMP biomanufacturing facility would allow us to fully capitalize on the potential
    biological advantages of UC-derived MSCs. Leveraging the potential biological advantages of UC-derived MSCs and the increased technological
    and manufacturing capabilities in a new cGMP biomanufacturing facility, we believe that the number of AlloRx Stem Cell therapy treatments
    that we may be able to manufacture from just one umbilical cord could increase exponentially from current levels. We believe that
    these economies of scale may provide us with a significant competitive and financial advantage compared to other cell therapies currently
    in development that are derived from BM-MSCs, AD-MSCs or P-MSCs. This also provides significant advantages over autologous cell therapy
    interventions, which involve removing cells from an individual through an operative procedure, and then reintroducing the cells back
    into the same person, sometimes after weeks of culture expansion. Accordingly, autologous approaches lack economies of scale since
    they serve only a single patient. In foreign clinical studies conducted by third-parties thus far, AlloRx Stem Cells have been administered
    through intravenous infusion in under one hour on an outpatient basis, or via direct tissue injection, depending upon the indication.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | Potential biological
    advantages of UC-derived MSCs.The starting raw material source for AlloRx Stem Cells is the Wharton’s jelly of donated
    umbilical cords. As further described above (see “AlloRx Stem Cell therapy for Various Indications: a Scientific Approach
    —Potential Biological advantages of UC-Derived MSCs”), we believe that UC-derived MSCs have a number of potential
    biological advantages compared to MSCs sourced from other raw materials. The sourcing and manufacturing of AlloRx Stem Cells are
    designed to capitalize on the potential biological advantages of MSCs sourced from umbilical cords.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
| | ● | Consistent manufacturing.Manufacturing of AlloRx Stem Cells is performed by us at the manufacturing facility we lease in Golden, Colorado. The manufacturing
    facility is cGMP compliant and CLIA certified, with a QMS that is globally recognized as ISO 9001:2015 and ISO 13485:2016 certified.
    AlloRx Stem Cells are sourced from the Wharton’s jelly of umbilical cords. All donated umbilical cords are received directly
    from tissue banks registered with The American Association of Tissue Banks (“AATB”). Prior to accepting donated umbilical
    cords, strict screening and evaluation of the donor’s medical and social history is performed. Prior to processing, the umbilical
    cords undergo additional rigorous testing, screening and monitoring, including third-party in vitro testing for the absence
    of a wide variety of common viral infections in donors by FDA-approved assays for a wide variety of infections, including hepatitis
    A, B and C, COVID-19, and HIV-1/HIV-2. Throughout the production process, the cells are analyzed according to pre-established criteria
    to ensure that a consistent, well-characterized product candidate is produced in accordance with the Chemistry, Manufacturing and
    Controls (“CMC”) section of our INDs. We are planning to lease a separate cGMP manufacturing facility that, if completed,
    will be used exclusively for the manufacture of AlloRx Stem Cells. We believe that this separate facility will be necessary to comply
    with all FDA requirements to support a BLA for the manufacture of AlloRx Stem Cells, given that it is a product intended for parenteral
    use in humans. Subject to available capital resources, we expect to commence development of the new cGMP biomanufacturing facility
    in 2024.
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
| | ● | Preliminary Tolerability
    Data. As of December 31, 2022, over 327 subjects have received treatment with our AlloRx Stem Cells, primarily in foreign
    clinical studies conducted by third parties, and no serious adverse events have been reported that were considered related to the
    product candidate. In foreign clinical studies using AlloRx Stem Cells, we have observed that intra-articular injections for musculoskeletal
    conditions can produce transient pain, which can be treated by analgesics and typically subsides within 24 to 48 hours.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  





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Other
Pre-Clinical Development Programs: AlloRx Stem Cell therapy for Potential Treatment of Other Indications



In
addition to our core development programs, we are also evaluating the potential of AlloRx Stem Cell therapy for the treatment of a broad
range of other indications, with a focus on autoimmune diseases and inflammatory disorders. We believe that we can leverage clinical
safety data from our core development programs, including for PTHS and Long COVID, and preclinical studies to support research and development
efforts in other areas, saving substantial development time and resources compared to traditional drug development where each program
is separately developed. Accordingly, we are advancing preclinical research and development work in the indications described below.



Inflammatory
and Autoimmune Disorders In General



We
are currently focused on the treatment of autoimmune diseases and inflammatory disorders. There are over 80 recognized autoimmune disorders,
which are caused by an acute or chronic imbalance in the immune system where the immune system recognizes proteins of the body as foreign
and elicits a specific immune response that leads to the immune system improperly attacking certain bodily tissues, cells or organs (for
example, in MS, the immune system recognizes myelin basic protein as foreign). Some inflammatory and autoimmune conditions are caused
by genetic or environmental factors, or a combination of both, while others may be caused from complications associated with other diseases
or trauma or the treatment of other diseases or trauma. In general, inflammatory and autoimmune disorders share certain biological characteristics,
in that the immune system imbalance results from the improper activation of certain immune cells that can lead to extensive tissue damage
and destruction and cause pain and loss of function. Inflammatory and autoimmune disorders represent major areas of unmet clinical needs,
as well as substantial commercial opportunities.



ALS



Description
and Medical Need



ALS,
often referred to as “Lou Gehrig’s disease,” is a progressive neurodegenerative disease caused by selective death of
motor nerve cells in the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout
the body. The progressive degeneration of the motor neurons in ALS patients lead to progressive weakness, respiratory failure and eventually,
death.



Worldwide,
the prevalence of ALS is approximately 5 to 7 per 100,000 individuals. According to Johns Hopkins Medicine, it is estimated that as many
as 30,000 Americans have the disease at any given time. Treatment decisions are typically determined by the patient’s symptoms,
preferences and the stage of the disease. Approved disease modifying medications include Riluzole, which has been approved by FDA to
treat ALS.



Next
Steps



We
intend to investigate AlloRx Stem Cells in an animal model of ALS to test various cohorts including AlloRx Stem Cells alone or in combination
with neural stem cells (“NSCs”), NSCs alone and another cohort where TDP-43, a recently discovered neuromuscular protein
that may underly motor neuron death, is inactivated. We intend to seek grant funding to conduct these studies. We plan to continue to
supply AlloRx Stem Cells to foreign third-party clinics and medical centers for use in foreign clinical studies of ALS that are being
conducted, or that will be conducted, by these clinics and medical centers at the patients’ own expense, thereby expanding the
sample population to gain additional prior human experience. For additional information, see “—International Supply Arrangements
for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies” below.





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Parkinson’s
Disease



Description
and Medical Need



Parkinson’s
disease is a chronic, progressive neurodegenerative disorder in which dopamine-producing neurons residing in the Substantia Nigra region
of the brain undergo degeneration and eventually die, resulting in progressive impairment in movement and gait and other non-motor symptoms.
The cause of the disease is presently unknown. Parkinson’s disease is the second-most common neurodegenerative disorder. Most people
are over the age of 50 when they are first diagnosed.



According
to the Parkinson’s Foundation, over 10 million people worldwide suffer from Parkinson’s disease, of whom about 1 million
are in the United States. Treatment of Parkinson’s disease primarily comprises symptomatic treatment through dopamine replacement,
either directly (Levodopa), with dopamine mimetics or by inhibition of its breakdown. These treatments focus on treating the symptoms
of the disease and are not a cure for Parkinson’s disease. Parkinson’s disease is also treated by Deep Brain Stimulation
(“DBS”), which consists of implanting electrodes deep into the brain to provide permanent electrical stimulation to specific
areas of the brain and to cause a delay in the activity in those areas. Similar to drug therapy, DBS focuses on treating the symptoms
of Parkinson’s disease and does not provide a cure.



Next
Steps



There
is a great unmet need for novel approaches towards the effective management and potential treatment of Parkinson’s disease and
we believe AlloRx Stem Cell therapy may represent a promising approach especially when deployed by methods that could allow access
of these cells to the brain. We plan to continue to supply AlloRx Stem Cells to foreign third-party clinics and medical centers for
use in foreign clinical studies of Parkinson’s disease being conducted by these clinics and medical centers at the
patients’ own expense, thereby expanding the sample population to gain additional prior human experience. For additional
information, see “—International Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical
Studies” below.



Traumatic
Brain Injury



Description
and Medical Need



Traumatic
brain injury, or TBI, typically occurs when a sudden force impacts the head, resulting in damage and functional impairment of the brain.
Injuries range in severity, from mild, characterized by a brief change in mental status or consciousness, to severe, involving an extended
period of unconsciousness or amnesia. Mild TBI accounts for 70 to 80% of all reported TBIs, but the prevalence may be even higher, as
many cases often do not receive medical attention. Symptoms of mild TBI may include headaches, fatigue, depression, irritability and
impaired cognitive function and may persist for many years, negatively affecting quality of life. In addition, mild TBI can lead to increased
risk of affective mood disorders such as major depressive disorder, post-traumatic stress disorder and other psychiatric and nonpsychiatric
disorders.



In
the United States, the CDC estimates 1.7 million people sustain a TBI annually. Nearly 3.2 to 5.3 million people in the United States
live with TBI-related disabilities, and 15% to 30% of patients being treated for TBI continue to exhibit prolonged neurocognitive dysfunctions.
To date, there are no pharmacological treatments approved for mild TBI, and there are limited assets in development. Patients with mild
TBI are often told to avoid mentally strenuous activities to allow their brains to rest.





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Next
Steps



We
believe that AlloRx Stem Cell therapy may have the potential to reduce the extent of damage caused by a TBI and promote accelerated healing
of the blood-brain barrier. We plan to first perform pre-clinical studies of animal models comparing AlloRx Stem Cells to their secreted
products containing exosomes and we plan to seek future grant support for these studies. We plan to supply AlloRx Stem Cells to foreign
third-party clinics and medical centers for use in foreign clinical studies of TBI that are being conducted, or that will be conducted,
by these clinics and medical centers at the patients’ own expense, thereby expanding the sample population to gain additional prior
human experience. For additional information, see “—International Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party
Conducted Clinical Studies” below.



International
Supply Arrangements for AlloRx Stem Cells; Foreign Third-Party Conducted Clinical Studies



In
addition to our development programs in the United States, we supply AlloRx Stem Cells to certain foreign third-party clinics and medical
centers. Internationally, AlloRx Stem Cells are being supplied for use in clinical studies in the following countries:



| | ● | St. John’s,
    Antigua and Barbuda: The Medical Surgical Associates Center, in collaboration with The Foundation for Orthopaedics and Regenerative
    Medicine, is expected to conduct over 25 clinical studies for a wide variety of indications, including: stroke, Parkinson’s
    disease, osteoporosis, lupus, osteoarthritis, cerebral palsy, COPD/asthma, MS, autism, and diabetes. These clinical studies are currently
    recruiting patients for enrollment. The PI for these clinical studies, Dr. Chadwick Prodromos, owns 4 Series A Units of the Company.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | ● | Cayman Islands:
    Ongoing clinical studies being conducted by DVC Stem for a wide variety of indications, including Crohn’s disease, osteoarthritis,
    meniscus tears, Alzheimer’s disease, and Parkinson’s disease.                                                                                                                                                                                                                                                                                                                                                  



Eligible
individuals with certain specified indications and who meet eligibility requirements may receive AlloRx Stem Cells at their own expense
at these third-party clinics and medical centers and others with which we may supply AlloRx Stem Cells in the future. The primary purpose
of these clinical trials is for the open-label treatment of the respective indication; accordingly, there is no randomized control group
for patients treated in these foreign clinical studies. For foreign clinical studies that are conducted using AlloRx Stem Cells, the
third-party clinics and medical centers are responsible for the administration of AlloRx Stem Cells to these individuals as well as their
care and follow-up. They are also responsible for compliance with all applicable regulations. These third-party clinics or medical centers
receive formal letters from the Ministry of Health (or other comparable agency) of these countries and/or IRB approval (or other comparable
ethical review committee approval) prior to the commencement of these clinical studies.



We
leverage safety, tolerability and dosing data, along with certain other anecdotal data and information, generated by these foreign clinical
studies to support our internal research and development activities and for the efficient and informed internal development of our AlloRx
Stem Cell therapy development programs. These clinical studies have enabled us to gain additional prior human experience using AlloRx
Stem Cells, and the resulting data has enabled us to better understand the tolerability profile of AlloRx Stem Cells, as well as allowing
us to cost-effectively explore where AlloRx Stem Cell therapy may have relevance and efficacy and how it may be utilized to advance treatment
over current standards of care. AlloRx Stem Cells are not licensed for commercial sale in these countries and are considered an investigational
therapeutic.



Participation
in these foreign clinical studies has been adversely impacted by the COVID-19 pandemic, including due to travel restrictions imposed
by various countries. While many of these travel restrictions have now been lifted, participation in these clinical trials remains lower
than anticipated, due in part to pandemic-related effects on international travel.





- 28 -







Material
Terms of Supply Arrangements



Our
supply arrangements with third-party clinics and medical centers are typically not governed by any written supply, clinical trial, or
data sharing agreements. However, prior to the sale of AlloRx Stem Cells to these foreign clinics and medical centers, we require that
each foreign third-party clinic and medical center first provide us with proof of review and approval or favorable opinion of an IRB
or another independent ethics committee and compliance with any local government regulations. Each foreign third-party clinic must also
provide us with the name of the administrator of the study and his or her qualifications to conduct the study. Finally, each foreign
third-party clinic must agree to provide us with the safety, tolerability and dosing data from the use of AlloRx Stem Cells in the study,
including any serious adverse events or adverse events, in compliance with HIPPA requirements. In return, we agree to supply the clinic
with AlloRx Stem Cells at an agreed price per vial of AlloRx Stem Cells. We derive revenues from our sale of AlloRx Stem Cells pursuant
to these supply arrangements, and these arrangements do not involve the type of collaborative arrangements in which we share the risks
and rewards of any clinical trials or otherwise with these foreign third-party medical centers.



Generally,
under these supply arrangements, these foreign third-party clinics must issue purchase orders for AlloRx Stem Cells. Although these purchase
orders stipulate key terms including order quantity, price, payment terms, and delivery instructions, these arrangements do not have
any minimum purchase requirements. In addition, pursuant to our informal supply arrangement with DVC Stem located in the Cayman Islands,
we will not supply any other third-party clinic located in the Cayman Islands with AlloRx Stem Cells for so long as DVC Stem continues
to purchase AlloRx Stem Cells from us. For a discussion of certain risks related to our supply arrangements with these foreign clinics,
including that a substantial portion of our sales are completed on a purchase order basis without any written supply, clinical trial
or data sharing agreements, see “Item 1A. Risk Factors” herein.



Memorandum
of Understanding with Dr. Zamora



On
November 20, 2022, we entered into a Memorandum of Understanding with Dr. Zamora (the “MOU”) in order to support clinical
research for AlloRx Stem Cells. Under the MOU, we agreed to provide AlloRx Stem Cells at a specified price to international clinical
research facilities or other clinics with which Dr. Zamora may become affiliated, provided that certain regulatory conditions are satisfied,
including proof of satisfaction of applicable United States and local legal requirements. The MOU will be effective for a period of five
years, unless earlier terminated or replaced by mutual written agreement between Dr. Zamora and the Company. See “Item 13. Certain
Relationships and Related Transactions, and Director Independence” for additional information.



Joint
Operating Agreement with European Wellness



On
August 6, 2021, we entered into a Joint Operating Agreement (the “JOA”) with European Wellness and BioPep, its research and
development subsidiary, under which we agreed to provide research and development services on identified targets. We were unable to identify
a key target product to submit for FDA IND authorization using European Wellness’s existing mito-organelle peptides as the starting
biological material as contemplated by the JOA. As a result, on April 28, 2022, we entered into an amendment (the “Amendment”)
to the JOA (as amended, the “European Wellness Agreement”).



Pursuant
to the European Wellness Agreement, we are now obligated to use our best efforts to identify a key investigational product candidate,
using AlloEx Exosomes as the starting biological material, that can be submitted by European Wellness for FDA IND authorization. AlloEx
Exosomes, and any investigational product candidate identified and developed under the agreement with European Wellness, are or will
be regulated by the FDA as a biological product. We are currently in the early stage of identification and potential development of any
key investigational product candidate, and are working with third-party service providers to support this process, which will require
substantial time, resources and regulatory approval prior to potential commercialization in the United States



The
European Wellness Agreement also requires us to use our best efforts, in collaboration with a third-party service provider to be identified
by us, to develop an FDA-validated immunoassay and potency assay of any target product. It is contemplated that any pre-clinical studies
will be carried out by a third-party service provider, with our support and oversight. In addition, we agreed to manage the production
of any target research products and to quantify biological activity for preclinical and clinical testing to support an FDA IND filing,
all of which will be carried out by third-party service providers identified by us, at third-party manufacturing facilities.





- 29 -







We
are additionally required, pursuant to the European Wellness Agreement, to oversee the development by a third-party service provider
of a recombinant cell line, to be delivered to European Wellness, for certain manufacturing.



With
the ultimate goal of supporting BioPep in becoming a cGMP manufacturer in the US, we are also obligated to help develop a biomanufacturing
infrastructure to support BLA-compliant operations and to develop a certified Quality Management System for BioPep to support FDA approval
of target products. For any INDs to be submitted by us or European Wellness covering products developed under the European Wellness Agreement,
we are obligated to provide the “Chemistry, Manufacturing, and Controls” section in support of the full IND application.



The
Amendment further contemplates the potential identification and development of a veterinary product by a third-party using rabbit-sourced
umbilical-cord derived MSCs. It is contemplated that development of this veterinary product in collaboration with European Wellness will
begin once the key investigational product using AlloEx Exosomes is completed. We and European Wellness are obligated to use our best
efforts to negotiate the terms of this arrangement at such time.



If
any products developed pursuant to the European Wellness Agreement are ultimately approved for commercialization, the European Wellness
Agreement contemplates that such products will be commercialized and distributed by European Wellness and/or BioPep. However, the European
Wellness Agreement also contemplates that certain post-development rights and obligations of us and European Wellness, such as potential
licensing rights to us and shared ownership over intellectual property developed pursuant to the agreement, will be negotiated with European
Wellness at a later date. The European Wellness Agreement further contemplates that the parties may enter into negotiations to potentially
engage Vitro as a CMO to carry out product manufacturing on behalf of European Wellness and BioPep. At this time, the European Wellness
Agreement does not provide us any licensing rights, royalty rights or ownership over the products developed.



Upon
signing the Joint Operating Agreement in August 2021, European Wellness paid us an initial fee of $500,000, which was recognized as revenue
during the first quarter of 2022 when the associated performance milestones had been achieved. In connection with the Amendment, European
Wellness also paid us an additional lump-sum payment of $250,000 in May 2022, which has been recorded as deferred revenue and will be
recognized as revenue upon achievement of certain other milestones. Future milestones may include identifying an Active Pharmaceutical
Ingredient (API) for product development within AlloEx Exosomes, development of an FDA-validated immunoassay and qualify third-party
vendors for ISO certification, development of a downstream manufacturing method and handle equipment procurement, development and scaling
of a manicuring system with the goal of commercial scale and potential future IND filings. We also receive quarterly payments of $25,000
for providing research and development management services. In total, we may be eligible to receive additional estimated payments up
to $5.6 million from European Wellness upon the achievement of certain developmental and regulatory milestones as set forth in the European
Wellness Agreement, which we expect will result in more than $500,000 profit to us after deducting estimated expenses. Except for the
payment to us by European Wellness of an additional lump-sum payment of $250,000 upon signing the Amendment, the financial terms of the
amended Joint Operating Agreement remain unchanged.



By
its terms, the European Wellness Agreement will terminate July 31, 2023. We or European Wellness may terminate the European Wellness
Agreement in its entirety without cause at any time by providing 30-days prior written notice. In addition, we or European Wellness may
terminate the European Wellness Agreement immediately under certain circumstances, including without limitation, if either party defaults
with respect to its obligations under the agreement and does not cure such default within 30 days after receiving notice of such default.



Consulting
Services Agreement with Solstice Life Sciences



On
January 24, 2023, we entered into a services agreement with Solstice pursuant to which Solstice will provide an array of advisory services
related to the development and commercialization of our product candidates (the “Solstice Agreement”). With respect to our
lead development program for AlloRx Stem Cell therapy, pursuant to the Solstice Agreement, Solstice will assist us in reviewing various
regulatory submissions and provide guidance on study protocols and development plans. Solstice will also provide certain advisory services
related to the clinical trial process for our contemplated Phase 1/2a clinical trials for PTHS and Long COVID, as further discussed above.





- 30 -







Solstice
has also agreed to assist us in advancing our development program for AlloEx Exosomes. In this capacity, Solstice will assist us in analyzing
certain data and research related to AlloEx Exosomes and in the design and implementation of a development and marketing plan for AlloEx
Exosomes for potential various applications, as well as to further support and manage any potential clinical trial process for AlloEx
Exosomes, including the identification of clinical trial site(s), the engagement of a principal investigator and the negotiation of a
CTA for any contemplated trial.



The
Solstice Agreement has an initial term of six months and may be terminated earlier by the Company without cause upon 30 days’ written
notice to Solstice or immediately by either party under certain circumstances, including without limitation, if either party defaults
with respect to its obligations under the agreement and does not cure such default within 30 days after receiving notice of such default.



Manufacturing



The
manufacture and delivery of cell therapy products to patients involves complex, integrated processes. Commercial success in this area
requires manufacturing processes that are reliable, scalable, and economical. We have and will continue to devote significant resources
to process development and manufacturing scale-up to optimize process robustness and success rates in developing AlloRx Stem Cells, AlloRx
Stem Cell therapy, AlloEx Exosomes and other potential product candidates, as well as to reduce per-unit manufacturing costs and enable
us to quickly achieve regional and global scale production upon regulatory approval for AlloRx Stem Cell therapy or any additional product
candidates.



We
currently operate a manufacturing facility in Golden, Colorado that is cGMP compliant and CLIA certified, with a QMS that is globally
recognized as ISO 9001:2015 and ISO 13485:2016 certified. We manufacture AlloRx Stem Cells and certain other of our products and technologies,
including CAFs, at this manufacturing facility. In addition, we are also planning a separate cGMP manufacturing facility that, if completed,
will be used exclusively for the manufacture of AlloRx Stem Cells. We intend to use a portion of the net proceeds from any future debt
or equity financing, together with our existing cash and any additional funds received upon the exercise for cash of our outstanding
warrants, if and when exercised at the election of the warrant holders, to fund the acquisition of fully automated closed system bioprocessing
and other equipment needed for the development of a new cGMP compliant manufacturing facility which we expect to lease. We believe that
this separate facility will be necessary to comply with all FDA requirements to support a BLA for the manufacture of AlloRx Stem Cell
therapy, given that it is a product intended for parenteral use in humans. Subject to available capital resources, we expect to commence
development of the new cGMP biomanufacturing facility in 2024. We plan to use highly scalable, fully automated closed system bioprocessing
in the new cGMP biomanufacturing facility.



AlloRx
Stem Cells and AlloRx Stem Cell therapy



The
sourcing and manufacturing of AlloRx Stem Cells are designed to capitalize on the potential biological advantages of MSCs sourced from
umbilical cords. We currently have the capacity to manufacture 300 AlloRx Stem Cell therapy treatments per month. We believe that the
use of fully automated closed system bioprocessing in a new cGMP biomanufacturing facility would allow us to fully capitalize on the
potential biological advantages of UC-derived MSCs. Leveraging the potential biological advantages of UC-derived MSCs and the increased
technological and manufacturing capabilities in a new cGMP biomanufacturing facility, we believe that the number of AlloRx Stem Cell
therapy treatments that we may be able to manufacture from just one umbilical cord may increase exponentially from current levels.



The
manufacturing facility that we lease went online in 2007 and consists of 2000 square feet of R&D space, with approximately 250 square
feet of cleanroom and 1000 square feet of warehouse and Quality Control space. The cleanroom area is used exclusively for processing
of human cellular and tissue products for use in clinical trials, research and development, and sale to third parties as discussed above.





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During
our proprietary manufacturing process, we utilize our proprietary specialty culture media, MSC-Gro, to support the growth and expansion
of MSCs from umbilical cords to create AlloRx Stem Cells. We believe that MSC-Gro provides us with additional significant competitive
advantages given its potential ability to produce more MSCs with potentially increased potency and viability as compared to MSCs prepared
through SVF. In an in vitrostudy comparing SVF and expanded MSCs using MSC-Gro, we observed that MSCs expanded using MSC-Gro
had (i) increased γ-IFN-induced IDO activity, suggesting greater immunomodulatory potency, (ii) increased cellular ATP-content,
suggesting the potential for increased mitochondrial functionality, and (iii) greater cell counts and viability, as compared to SVF-prepared
MSCs.



After
expansion using MSC-Gro, AlloRx Stem Cells are then formulated, packaged and stored frozen (cryopreserved) until shortly before use.Our manufacturing process for AlloRx Stem Cell therapy has been reviewed and authorized by the FDA under CMC as part of our IND applications.



All
umbilical cords are donated by healthy adult females following childbirth and are received directly from tissue banks registered with
the AATB. Prior to accepting donated umbilical cords, strict screening of the donor’s medical and social history is evaluated.
The donor also consents with the AATB accredited facility, and serology and virology are performed prior to processing. Throughout the
production process, the cells are analyzed according to pre-established criteria to ensure that a consistent, well-characterized product
candidate is produced. Due to the significant number of AlloRx Stem Cell therapy treatments that can be manufactured from just one umbilical
cord, we currently believe that we have an adequate number of umbilical cords on hand to meet our current and anticipated manufacturing
needs. We anticipate obtaining any additional umbilical cords that may be needed from tissue banks registered with the AATB. Because
umbilical cords are sourced from medical waste that is discarded after childbirth, we believe that there is an adequate supply of umbilical
cords that can be sourced from these registered tissue banks on an as needed basis. If these registered tissue banks were to no longer
provide umbilical cords to us, alternate suppliers would be needed; otherwise, this could impact our ability to produce AlloRx Stem Cells
in the future. Our cell banks used in production of AlloRx Stem Cells also undergo substantial safety testing, including in-vitrocell-based assay tests, in-vivo testing in animal models as well as extensive viral pathogen and bacterial assays to assure
absence of adventitious agents according to FDA guidelines.



InfiniVive
MD Cosmetic and Exosomes Serums



At
the manufacturing facility that we lease in Golden, Colorado, we manufacture all our products sold through InfiniVive MD, including InfiniVive
MD’s Exosome Serum and InfiniVive MD’s Daily Serum.



Fitore
Dietary Supplements and Nutraceuticals



We
are currently selling Fitore products solely from remaining inventory and do not anticipate manufacturing any additional products in
the foreseeable future or at all. For a discussion of certain risk relating to the manufacture of dietary supplements, nutraceuticals
and other health products, see “Item 1A. Risk Factors— Risks Related to the Dietary and Nutritional Supplements Industry
and Fitore Products.”



Commercialization



We
currently have limited sales, marketing and product distribution infrastructure relating to sales of our MSC-Gro and other stem cell
products, InfiniVive MD cosmetic treatments, and Fitore dietary supplements and nutraceuticals. In order to commercialize any of our
biologic or drug product candidates, including AlloRx Stem Cell therapy, if approved by FDA for commercial sale, we will need to develop
a more robust sales and marketing organization with technical expertise and supporting distribution capabilities for the biologic or
drug product candidates or collaborate with third parties that have sales and marketing experience.



As
we move AlloRx Stem Cell therapy or any additional product candidates through development toward regulatory approval, we will evaluate
several options for each product candidate’s commercialization strategy. These options include further building an internal sales
force, entering into a joint marketing collaboration with another pharmaceutical or biotechnology company, or out-licensing any future
approved product to another pharmaceutical or biotechnology company.





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Competition



We
compete in an industry characterized by rapidly advancing technologies, intense competition, a changing regulatory and legislative landscape
and a strong emphasis on the benefits of intellectual property protection and regulatory exclusivities. The field of regenerative medicine,
which includes gene therapies, cell therapies (such as AlloRx Stem Cell therapy), and tissue-engineered products, is broadly defined
as “products intended to repair, replace or regenerate organs, tissues, cells, genes, and metabolic processes in the body,”
per the Alliance for Regenerative Medicine, an international advocacy organization. Regenerative medicine companies number over 1,000
worldwide as of the first half of 2020.



In
many of the indications in our development programs, we face competition from both cellular therapy companies, and pharmaceutical/biotechnology
companies. The following table is a general list of cellular therapy companies that we believe could be considered our primary competition
on the basis that these companies are developers of living cell-based therapies, albeit for different indications in some cases.



|Name                             |  | Corporate
    Headquarters |  | Clinical
    stage pipeline indication(s)                    
|-------------------------------- |  | -------------------------- |  | -------------------------------------------------------------
|Athersys,
    Inc.               |  | U.S.                       |  | Ischemic
    stroke; ARDS; GvHD; Acute Myocardial Infarction 
|BrainStorm
    Cell Therapeutics |  | U.S.                       |  | ALS;
    MS                                                  
|Celularity
    Inc.              |  | U.S.                       |  | AML;
    GBM                                                 
|Corestem                         |  | South
    Korea            |  | ALS
    (Commercial in South Korea); Lupus (SLE)             
|Coya
    Therapeutics, Inc.      |  | U.S.                       |  | ALS                                                          
|Fate
    Therapeutics, Inc.      |  | U.S.                       |  | AML;
    BCL                                                 
|Healios
    K.K.                 |  | Japan                      |  | Ischemic
    stroke; ARDS                                    
|Longeveron
    Inc.              |  | U.S.                       |  | AD;
    Metabolic Syndrome; ARDS; Aging frailty              
|Medipost                         |  | South
    Korea            |  | Osteoarthritis
    (commercial); BPD; AD                     
|Mesoblast
    Ltd.               |  | Australia                  |  | Heart
    failure, low back pain, GvHD; ARDS; Crohn’s disease
|Pluristem
    Therapeutics, Inc. |  | Israel                     |  | CLI;
    ARDS; ARS; GvHD                                     
|SanBio
    Co., Ltd.             |  | Japan                      |  | Ischemic
    stroke; Traumatic brain injury                  
|Stemedica
    Cell Technologies  |  | U.S.                       |  | Ischemic
    stroke; heart failure; AD                       



ARDS
= Acute Respiratory Distress Syndrome; GvHD = Graft versus host disease; ALS = Amyotrophic lateral sclerosis; MS = Multiple sclerosis;
BPD = Bronchopulmonary dysplasia; CLI = Critical limb ischemia; CMD = coronary microvascular disease; ARS = Acute radiation syndrome;
AML = Acute Myeloid Leukemia; GBM = Glioblastoma multiforme; BCL = B-cell lymphoma.



Many
of our potential competitors have substantially greater scientific, research, and product development capabilities, as well as greater
financial, marketing, sales and human resources capabilities than we do. In addition, many specialized biotechnology firms have formed
collaborations with large, established companies to support the research, development, and commercialization of products that may be
competitive with ours.



Competition
in Long COVID



Currently,
there are no FDA-approved treatments for Long COVID. Several companies currently have ongoing Long COVID development programs or may
be in active discussions to expand their current development programs to the potential treatment of Long COVID, including:



| | ● | Axcella Health Inc.,
    headquartered in the United States.                
| | - | ----------------------------------------------------------------------------
| |   |                                                                             
| | ● | GlaxoSmithKline plc,
    headquartered in England.                          
| |   |                                                                             
| | ● | Tonix Pharmaceuticals
    Holding Corp., headquartered in the United States.
| |   |                                                                             
| | ● | Vir Biotechnology, Inc.,
    headquartered in the United States.            





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Competition
in Pitt-Hopkins Syndrome



Currently,
there are no FDA-approved treatments for PTHS. Several companies currently have ongoing PTHS development programs, including:



| | ● | Neuren Pharmaceuticals
    Ltd., headquartered in Australia, received FDA approval in March 2022 to conduct a Phase 2 trial of its product candidate in
    PTHS.
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------



Intellectual
Property



Generation
and protection of intellectual property, including patents, trade secrets, trademarks, proprietary technology, proprietary manufacturing
techniques, and know-how, is of critical importance in our field and in biotechnology generally. We rely on a combination of trade secrets,
patent filings and other intellectual property protections in an effort to protect our product candidates as well as related methods
of use. We will be able to protect our product candidates and methods of use from unauthorized use by third parties only to the extent
that our technology is effectively and diligently maintained as trade secrets or where applicable, covered by valid and enforceable patents.
Our commercial success may also depend on whether we can defend our patents against third-party challenges and on operating without infringing
on the intellectual property rights of others.



We
have filed patent applications related to stem cell-based compositions and therapeutic uses. The patent applications are directed to
compositions and therapeutic uses of allogeneic MSCs to (a) treat Long COVID; (b) treat PTHS having multiple complications; (c) treat
MS; (d) treat ALS; (e) treat lupus; as well as other inflammatory and autoimmune conditions; and (f) for use in combination therapies
for treatment of various conditions. Claims in the patent applications, if allowed, could protect aspects of our product-related compositions
as well as the use of our product-related compositions. Our pending patent applications include provisional applications. Provisional
applications are converted to non-provisional and/or foreign applications but these conversion applications may not result in a patent.
Further, if patents do issue, these patents may not provide exclusivity for our products and methods of use.



We
have no U.S. patents and have a single patent registered in the Bahamas. We currently have eight pending applications with additional
applications in preparation. The eight pending patent applications include three provisional applications, three U.S. non-provisional
applications, one foreign application, and two international applications (a PCT which serves as a placeholder for many foreign countries
that are members).



We
expect to file additional patent applications in support of our currently targeted indications, as well as potentially new processes
and manufacturing-related inventions. These expected additional patent applications may be related to existing patent applications or
may create new patent families.



Patent
searches have been performed and we are aware of U.S. and foreign patents held by third parties that cover similar or related compositions
and therapeutic treatment regimens. We are also aware of clinical trials in progress or completed covering similar or related compositions
and therapeutic treatment regimens as the ones we are seeking.



Successful
enforcement of any patent is not guaranteed. In addition, biotechnology patents are subject to additional uncertainty and enforcement
involves complex legal and factual questions. Further, patents may not preclude third party companies or entities from developing similar
or therapeutically equivalent MSC products and uses that do not infringe our patents. In addition, changes in patent laws, rules, or
regulations or in their interpretations by the courts may materially diminish the value of our intellectual property or narrow the scope
of our patent protection, which could have a material adverse effect on our business and financial condition.





- 34 -







Company
Intellectual Property Related to Patent Filings



Stem
Cell Line for Treatment of Various Medical Conditions. The pending claims in this patent application family are currently directed
to compositions of MSC cells and therapeutic uses. Indications to be treated disclosed in this application include, but are not limited
to, MS, autism spectrum disorders, memory loss, impaired cognitive function, traumatic brain injury (TBI), Lupus (SLE), ALS, GvHD, diabetes,
and other disorders characterized by inflammation. In this patent family, we own one registered patent in the Bahamas, one pending U.S.
patent application filed as a continuation and one pending application in Great Britain. If issued and maintained, patents arising from
these applications are projected to expire in 2037.



Immune
Modulation by MSCs. Claims in this family of patent applications are directed to treating side effects of subject having ARDS-related
symptoms due to infective agents such as pneumonia related to COVID-19 infections. This patent application family has one pending U.S.
patent application and one international placeholder application (PCT). If issued and maintained, patents arising from these applications
are projected to expire in 2042.



Treatment
of Medical Conditions by Stem Cell Transplants and Stem Cell Activation. Claims in this family of patent applications are
directed to our technology for treatment of a variety of medical conditions using MSCs such as our AlloRx Stem Cells® with distinctions
from native umbilical cord MSCs. This patent family has one pending U.S. patent application and one international placeholder application
(PCT). If issued and maintained, patents arising from these applications are projected to expire in 2042.



Treatment
of Multiple Sclerosis using Pre-treated Human MSCs. Claims in this patent family relate to treating MS. This patent family
has one provisional application. If a patent is issued and maintained, patents arising from this application are projected to expire
in 2043.



Treatment
of Pitt Hopkins Disease using Pre-treated Human MSCs. Claims in this patent family relate to treating PTHS and related side
effects. This patent family has one provisional application. If a patent is issued and maintained, patents arising from this application
are projected to expire in 2043.



Treatment
of Post-Acute Sequalae of SARs-CoV-2 Infection (Long COVID) using Pre-treated Human MSCs.Claims in this patent family relate to
treating side effects of Long COVID. This patent family has one provisional application. If a patent is issued and maintained, patents
arising from this application are projected to expire in 2043.



Trade
Secrets



We
also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position. We seek to
protect our proprietary information with respect to our employees and collaborators by obtaining executed agreements requiring protection
of our trade secrets and assignment of patents to us.



We
have a proprietary process for producing MSCs that is believed to reliably produce more MSC product than other known processes in a shorter
period. This process is not patented and is protected by trade secret. Trade Secrets are only beneficial as long as the trade secret
can be protected, which in turn requires certain internal record keeping and security measures. Further, third parties are not precluded
from practicing such trade secret methods developed on their own because there is no right to prevent others from this innovation. Our
MSCs are cultured using our state-of-the-art scalable process for manufacturing in high volume quality allogeneic MSCs referred to as
our proprietary AlloRx Stem Cells®. Our technology can generate enough cells of use for multiple therapeutic treatments
giving this process significant economies of scale and cost advantage. These current processes of manufacture and scale-up are protected
by trade secrets.



Using
our MSC technology, we have developed and own a commercially-available media for growing and expanding cells such as stem cells referred
to as MSC-Gro. This stem cell growth media is protected by trade secret. It is possible that a competitor will create a comparable or
the same cell growth media as MSC-Gro and/or independently discover our proprietary MSC expansion techniques for our AlloRx Stem Cells®and this could adversely affect our company.



Trade
secrets are difficult to protect and enforce and therefore provide us with only limited protection. Trade secrets must be protected within
the company and those employees and former employees of our company with knowledge of our trade secrets must not share with a third party
while employees of the company and any time thereafter. It is difficult to ensure that our trade secrets will be kept secret and not
shared with a third party, for example, a third-party competitor. For this and more comprehensive risks related to our intellectual property,
please see “Item 1A. Risk Factors—Risks Related to Intellectual Property.”





- 35 -







Trademarks



We
also have applied for and been awarded certain trademarks. These trademarks include MSC-GroTM, AlloRx Stem Cells®,
AlloEX Exosomes®, STEMulize®, now marketed as StemulifeTM, Science for Life®and “Vitro
Biopharma.” We intend to maintain and protect our trademarks from unauthorized use.



Government
Regulation and Biologic Drug Approval



Government
authorities in the United States, at the federal, state and local level, and other countries, extensively regulate, among other things,
the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising,
distribution, marketing and export and import of products such as those we are selling and developing. Because we are developing novel
cell therapy product candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely
clear and may change. Even with respect to more established products that fit into the categories of gene therapies or cell therapies,
the regulatory landscape is still developing. Regulatory requirements governing gene therapy products and cell therapy products have
changed frequently and will likely continue to change in the future. We believe that the FDA will regulate AlloRx Stem Cell therapy as
a biologic drug (i.e., a biologic) through the BLA process under the jurisdiction of the Office of Tissues and Advanced Therapies within
the Center for Biologics Evaluation and Research (“CBER”). The Office of Tissues and Advanced Therapies was established to
consolidate the review of gene therapy and related products, and the Cellular, Tissue and Gene Therapy Advisory Committee to advise CBER
on its review. We will work with FDA to confirm that a BLA is the most appropriate pathway and that CBER will be the FDA center responsible
for review and licensure (i.e., approval). For future product candidates, we will also confirm the appropriate approval pathway (i.e.,
BLA or new drug application (“NDA”)) and the appropriate FDA center with regulatory oversight (i.e., CBER or CDER).



U.S.
Biologic Drug Development Process



In
the United States, biologic drugs (“biologics”) are regulated under two statutes: The Public Health Service Act (“PHS
Act”) and the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and their implementing regulations. However, submission
and approval of only one application—typically either a BLA or an NDA—is required prior to marketing. The FDA has also issued
numerous “Guidance Documents” and other materials that address specific aspects of biologic development for particular types
of product candidates (e.g., cells, tissues, gene therapies, or vaccines). Substantial time and financial resources are required
to obtain regulatory approvals and subsequently comply with appropriate federal, state, and local statutes and regulations. Failure to
comply with the applicable U.S. requirements at any time during the biologic development, approval, or post-approval processes may subject
an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications,
withdrawal of an approval, imposition of a clinical hold on ongoing clinical trials, issuance of warning or untitled letters, product
recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts,
restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect
on us.



The
process required by the FDA before a biologic may be marketed in the United States generally involves the following steps:



| | ● | completion of preclinical
    laboratory tests, animal studies and formulation studies in accordance with FDA’s current good laboratory practice requirements
    and other applicable regulations;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                    
| | ● | submission to the FDA of
    an IND, which must become effective before human clinical trials may begin;                                                                                           
| |   |                                                                                                                                                                                                    
| | ● | approval by an independent
    IRB at each clinical site (or by one “commercial IRB”) before each trial may be initiated;                                                                          



- 36 -







| | ● | performance of adequate
    and well-controlled human clinical trials in accordance with cGCP requirements to establish the safety, purity, and potency (i.e.,
    efficacy) of the proposed biologic for its intended use;                                                                                                                                                                                            
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                        
| | ● | submission to the FDA of
    a BLA after completion of all clinical trials;                                                                                                                                                                                                                                                                                                                                            
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                        
| | ● | satisfactory outcome of
    an FDA advisory committee review, if applicable;                                                                                                                                                                                                                                                                                                                                           
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                        
| | ● | satisfactory completion
    of an FDA inspection of the manufacturing facility or facilities at which the biologic is produced to assess compliance with cGMP
    requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength,
    quality and purity, and FDA inspection of selected clinical investigation sites to assess compliance with cGCPs; and
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                        
| | ● | FDA review and approval
    of the BLA to permit commercial marketing of the product for particular indications for use in the United States.                                                                                                                                                                                                                                                                          



The
specific preclinical studies and clinical testing that is required for a BLA varies widely depending upon the specific type of product
candidate under development. Prior to beginning a human clinical trial with either a biologic or drug product candidate in the United
States, we must submit an IND to the FDA and that IND must become effective. The focus of an IND submission is the general investigational
plan and protocol for the proposed clinical study. The IND also includes results of animal and in vitro studies assessing the
toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; CMC information; and any available human
data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin.
The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety
concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold, and the IND sponsor
and the FDA must resolve any outstanding concerns or questions before the clinical hold is lifted and the clinical trial can begin. Submission
of an IND therefore may or may not result in FDA authorization to begin a clinical trial.



Clinical
trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
accordance with cGCPs, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the
parameters for monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made
for each successive clinical trial conducted during product development. Other submissions to an IND include protocol amendments, information
amendments, IND safety reports and annual reports. Furthermore, an independent IRB for each clinical trial site (or a “commercial
IRB” that acts as the IRB at one or more of the clinical trial sites) must review and approve the protocol and informed consent
form before the clinical trial may begin. The IRB also monitors the clinical trial until completed.



Regulatory
authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects
are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some clinical trials also
include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring
board (“DSMB”). A DSMB authorizes whether or not a study may move forward at designated check points based on access to certain
data from the trial. The DSMB may halt the clinical trial if it determines there is an unacceptable safety risk for subjects or on other
grounds, such as no demonstration of efficacy. Related reporting requirements for the sponsor, clinical investigator, and/or IRB also
include IND safety reports and updating clinical trial results in public registries (e.g., ClinicalTrials.gov).





- 37 -







Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:



| | ● | Phase 1:
    The product candidate is initially introduced into healthy human subjects. These clinical trials are designed to test the safety,
    dosage tolerance, absorption, metabolism, distribution, excretion, side effects, and, if possible, early evidence of effectiveness.
    In the case of some products for severe or life-threatening diseases when the product may be too inherently toxic to ethically administer
    it to healthy volunteers, the initial human testing is often conducted in individuals who have the targeted disease or condition
    instead of healthy subjects.
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | ● | Phase 2:
    The product candidate is administered to a limited population of individuals who have the specified disease or condition to continue
    to evaluate safety, as well as preliminary efficacy, optimal dosages and dosing schedule, possible adverse side effects and safety
    risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase
    3 (i.e., pivotal) clinical trials.                                                                                                                                     
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
| | ● | Phase 3:Generally,
    the largest in size, Phase 3 clinical trials are generally conducted at multiple geographically dispersed clinical trial sites. The
    product candidate is administered to an expanded population of individuals who have the specified disease or condition to further
    evaluate dosage, provide statistically significant evidence of clinical efficacy and gain additional safety data. These clinical
    trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for
    product approval.       



Concurrent
with clinical trials, sponsors usually complete additional animal studies. Sponsors must also develop information about the chemical
and physical characteristics of the biologic and finalize a process for manufacturing the product in commercial quantities in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate,
and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final biologic.
In addition, the sponsor must develop and test appropriate packaging, and must conduct stability studies to demonstrate that the product
candidate does not undergo unacceptable deterioration over its shelf life. Before approval of a BLA, FDA evaluates the establishment
by an on-site inspection to ensure the facilities and controls used for the manufacture, processing, packaging, and testing of the drug
are adequate to ensure and preserve its identity, strength, quality, and purity.



During
the development of a new biologic, sponsors are given opportunities to meet with the FDA. These meetings typically occur before the submission
of an IND (i.e., pre-IND meeting), at the end of Phase 2 (i.e., EOP2 meeting), and before a BLA is submitted (i.e.,
pre-BLA meeting). Meetings at other times may be requested. These meetings provide an opportunity for the sponsor to share information
about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase
of development. Sponsors typically use EOP2 meetings to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical
trials that they believe will support approval of the new biologic.



U.S.
Review and Approval Process for Biologic Drugs



Assuming
successful completion of all required testing in accordance with the applicable statutory and regulatory requirements, the sponsor submits
a BLA to the FDA. A BLA contains the results of product development, preclinical and other non-clinical studies and clinical trials,
descriptions of the manufacturing process, analytical testing, proposed labeling and other relevant information. The submission of a
BLA is subject to the payment of a substantial application fee under the Prescription Drug User Fee Amendments (“PDUFA”).
PDUFA fees apply to both drugs and biologics. Sponsors may seek a waiver of these fees in certain limited circumstances, including a
waiver of the application fee for the first BLA or NDA submitted by a small business. Product candidates with an ODD are not subject
to the BLA application fee unless the product application also includes a non-orphan indication.



The
FDA reviews a BLA to determine, among other things, whether a biologic is safe, pure, and potent (i.e., effective) for its intended
use and whether its manufacturing is GMP-compliant to assure the product’s identity, strength, quality and purity. Under PDUFA,
the FDA has a goal date of ten months from the date of “filing” to review and act on the submission. However, the time between
submission and filing can add an additional two months as FDA conducts a preliminary review to ensure that the BLA is sufficiently complete
to permit substantive review. Formal FDA review of the BLA does not begin until FDA has accepted it for filing. The FDA may refer an
application in some cases to an advisory committee for its independent review. An advisory committee is a panel of independent experts,
including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation to FDA as to whether the application
should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers
such recommendations carefully when making decisions.





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Before
approving a BLA, the FDA will typically inspect the locations where the product is manufactured. The FDA will not approve an application
unless it determines that the manufacturing processes and facilities are in compliance with GMPs and are adequate to assure consistent
production of the product within required specifications. An important part of a BLA is a lot release protocol that the sponsor will
use to test each lot of product made after BLA approval, as well as the FDA’s own test plan that will be used for confirmatory
testing of each post-approval product lot that is made before it is released to the public. If the FDA determines that the data and information
in the application, including about the manufacturing process or manufacturing facilities, are not acceptable, then the FDA will outline
the deficiencies and often will request additional testing or information. Notwithstanding the submission of any requested additional
information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.



After
the FDA evaluates a BLA, it will either issue an approval letter or a Complete Response Letter (“CRL”). The approval letter
authorizes commercial marketing of the biologic with approved prescribing information for specific approved indications. On the other
hand, a CRL indicates that the review cycle of the application is complete but the BLA cannot be approved in its present form. A CRL
usually describes the specific deficiencies identified by the FDA and describes the actions the sponsor must take to correct those deficiencies.
A sponsor that receives a CRL must resubmit the BLA after addressing the deficiencies or withdraw the application. Even if such additional
data and information are submitted to address the deficiencies, the FDA may decide that the data and information in the resubmitted BLA
do not satisfy the approval criteria.



Following
marketing approval, a sponsor may need to fulfill certain post-marketing requirements (“PMRs”) or post-marketing commitments
(“PMCs”). For example, post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing
approval. These trials are used to gain additional experience from the treatment of patients for the intended therapeutic indication.
The trials may be agreed upon prior to approval, or the FDA may require them if new safety issues emerge. Following approval, a sponsor
may also need to conduct a pediatric study that was temporarily deferred during the initial product development process. Under the Pediatric
Research Equity Act (“PREA”), a sponsor must conduct pediatric clinical trials for most new drugs or biologics, for a new
active ingredient, new indication, new dosage form, new dosing regimen or new route of administration. The required assessment must evaluate
the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and
administration for each pediatric subpopulation for which the product is safe and effective. PREA studies must be included in the application
unless the sponsor has received a deferral or waiver.



A
risk evaluation and mitigation strategy (“REMS”) may also be an important component of a BLA approval that requires sponsor
post-marketing regulatory efforts. A REMS is a safety strategy to manage a known or potential serious risk associated with a drug or
biologic and to enable patients to have continued access to such medicines by managing their safe use. A REMS may include medication
guides, physician communication plans, or elements to assure safe use (ETASU) such as restricted distribution methods, patient registries,
and other risk minimization tools.



Once
approved, the FDA may withdraw the product approval if compliance with PMRs, PMCs, or a REMS program is not maintained or if problems
occur after the product reaches the marketplace. The FDA may also request that a product be recalled for an identified safety issue.
In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies
may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.



FDA
Expedited Review Programs for Serious Conditions



Under
various statutory and regulatory authorities, the FDA has authority to review and approve certain drugs and biologic drugs on an expedited
basis if they are intended to treat a serious condition and meet other requirements. These expedited programs are discussed below.





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RMAT
Designation



In
2017, the FDA established a new designation, known as the regenerative medicine advanced therapy (again, “RMAT”) designation,
as part of its implementation of the 21st Century Cures Act. If they meet the appropriate criteria, regenerative medicine therapies to
treat, modify, reverse, or cure serious conditions may be eligible for RMAT designation as well as FDA’s other expedited programs
(i.e., fast track, breakthrough therapy, or priority review designations or accelerated approval). As with other biological products,
regenerative medicine therapies receiving RMAT designation must meet the same standards for approval, including demonstrating the product’s
safety and effectiveness. As described in Section 3033 of the 21st Century Cures Act, an investigational product is eligible
for RMAT designation if:



| | ● | It is a regenerative medicine
    therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination
    product using such therapies or products (except for those regulated solely under Section 361 of the PHS Act and 21 C.F.R. Part 1271);
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | ● | It is intended to treat,
    modify, reverse, or cure a serious or life-threatening disease or condition; and                            
| | - | -----------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                          
| | ● | Preliminary clinical evidence
    indicates that the drug has the potential to address unmet medical needs for such disease or condition.



Advantages
of the RMAT designation include all the benefits of the fast track and breakthrough designations, including early interactions with the
FDA to discuss the use of any potential surrogate or intermediate endpoints to support an accelerated approval. However, unlike a breakthrough
designation, the RMAT designation does not require evidence to indicate that the drug may offer a substantial improvement over available
therapies. A request for an RMAT designation can be included in a new IND, or submitted as an amendment to an existing IND. As with other
expedited programs, the FDA can withdraw an RMAT designation that has been granted if the designation criteria are no longer met.



Accelerated
Approval



In
addition, a product may be eligible for accelerated approval. Drug products intended to treat serious or life-threatening diseases or
conditions may be eligible for accelerated approval upon a determination that the product has an effect on a surrogate endpoint that
is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity
or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking
into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition
of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing
clinical trials. In addition, the FDA currently requires pre-approval of promotional materials as a condition for accelerated approval,
which could adversely impact the timing of the commercial launch of the product.



Fast-Track
Designation



The
fast-track designation is intended to expedite or facilitate the process for reviewing new drug and biologic drug products that meet
certain criteria. Specifically, products are eligible for this designation if they are intended to treat a serious or life-threatening
disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. With regard to a fast-track
product, the FDA may review sections of the marketing applications on a rolling basis before the complete application is submitted if
the sponsor provides a schedule for the submission of the application sections, the FDA agrees to accept sections of the application
and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section.



Priority
Review Designation



A
product is eligible for priority review designation if it has the potential to provide a safe and effective therapy where no satisfactory
alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products.
The FDA will attempt to direct additional resources to the evaluation of an application for a priority review-designated product in an
effort to facilitate the review. The FDA endeavors to review applications with priority review designations within six months of the
filing date as compared to the standard ten months for review.





- 40 -







Breakthrough
Therapy Designation



The
Food and Drug Administration Safety and Innovation Act established a category of products referred to as “breakthrough therapies”
that may be eligible to receive breakthrough therapy designation. A sponsor may seek FDA designation of a product candidate as a “breakthrough
therapy” if the product is intended, alone or in combination with one or more other products, to treat a serious or life-threatening
disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
The designation includes all of the features of a fast-track designation, as well as more intensive FDA interaction and guidance. The
breakthrough therapy designation is a distinct status from both accelerated approval and priority review designation, which can also
be granted to the same drug if relevant criteria are met. If a product is designated as breakthrough therapy, the FDA will work to expedite
the development and review of that product.



A
drug or biologic drug that is subject to one or more of these expedited programs may be reviewed and approved more quickly than other
non-expedited program products; however, the standard for approval (i.e., safety and effectiveness) does not change. Even if a
product candidate qualifies for one or more of these programs, the FDA may later decide that it no longer meets the conditions of the
expedited program and the expedited program status may be removed. We may explore one or more of these opportunities for our product
candidates as appropriate.



Marketing
Exclusivity



In
the case of biologic drugs, several types of marketing exclusivity may apply:



| | ● | Reference product exclusivity;          
| | - | ----------------------------------------
| |   |                                         
| | ● | ODD and orphan drug exclusivity;
    and
| |   |                                         
| | ● | Pediatric exclusivity.                  



Reference
Product Exclusivity



We
believe that FDA will regulate AlloRx Stem Cell therapy as a new biologic and require submission and approval of a BLA under the PHS
Act. The PHS Act includes a framework for determining when a biologic is a “reference product” and therefore eligible for
marketing exclusivity. The reference product is the single biologic against which a biosimilar (a product that is highly similar to and
has no clinically meaningful differences from the reference product) or an interchangeable biosimilar (a product that is both biosimilar
to, and will produce the same clinical result as, the reference product) is evaluated.



FDA
must determine the date of “first licensure” (i.e., approval) of a biologic which will, in turn, determine whether
that biologic qualifies as a reference product that will be eligible for statutory exclusivity (and when such exclusivity will expire).
Typically (but not always) the date of approval is the date of first licensure. Once that date of first licensure is determined for a
reference product, then FDA will not approve a biosimilar or interchangeable biosimilar until the date that is 12 years after the date
on which the reference product was first approved. However, FDA may receive an application for a biosimilar or interchangeable biosimilar
four years after the date on which the reference product was first approved. These 12- and four-year terms are each extended by six months
if the product has been awarded six-month pediatric exclusivity.



Legal
uncertainties remain about FDA’s application of the date of first licensure and statutory exclusivity provisions to cell therapy
products. At the appropriate time, we intend to provide information to FDA so that FDA can determine the date of first licensure of AlloRx
Stem Cell therapy (or any other product candidate that will be regulated as a biologic) which will, in turn, set the date from which
statutory exclusivity will begin to run. However, FDA may not make an immediate decision about the date of first licensure at the time
it approves a new biologic. Furthermore, there is currently no precedent showing how FDA will apply this statutory framework to a cell
therapy product. The law in this area is evolving and will likely continue to evolve.





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Orphan
Drug Designation and Exclusivity



To
encourage the pharmaceutical and biotechnology industries to develop drugs and biologics to treat diseases or conditions that affect
relatively few patients in the U.S., Congress enacted the Orphan Drug Act in 1983. As amended, under this act the FDA may grant an ODD
for a drug or biologic drug being developed to treat a “rare disease or condition,” defined as affecting less than 200,000
persons in the U.S. or affecting more than 200,000 persons in the U.S. but for which there is no reasonable expectation that development
costs will be recovered from U.S. sales of the product. A request for ODD must be submitted to the FDA before a marketing application
is submitted (i.e., BLA or NDA), but there is no assurance that FDA will award an ODD if requested. If awarded, information about
the ODD will be made public on FDA’s website.



An
ODD does not change the regulatory review standards of safety and effectiveness and does not shorten the length of the FDA review or
approval process. However, there are a number of potential benefits if a drug or biologic with an ODD is eventually approved. If an investigational
product with an ODD subsequently receives the first FDA approval for the disease or condition for which it has such designation, then
the approved product is entitled to orphan drug exclusivity (again, “ODE”). Having ODE means that the FDA may not approve
any other applications to market the same drug or biologic for the same use or indication for seven years, except in limited circumstances
(including but not limited to demonstrating clinical superiority of a new product vs. the product with ODE because of greater safety,
greater effectiveness, or making a major contribution to patient care; or an FDA finding that the sponsor of the product with ODE cannot
assure that sufficient quantities of the product will be available for patients). Even if an investigational product has an ODD, there
is no guarantee that FDA will award ODE upon approval.



Competitors
may receive approval of either a different product for the same use or indication, or the same product for a different use or indication.
Approved drugs and biologics can also be used by physicians off-label, which is within the scope of their practice of medicine. Accordingly,
receiving ODE is not an absolute protection against potentially competing products. Moreover, an ODE awarded to another sponsor could
block FDA approval of one of our product candidates for seven years. The law involving ODDs and ODEs, including FDA’s interpretation
of “same drug,” is continuing to evolve through litigation, as well as changes to FDA regulations and policies.



In
addition to the potential award of seven-year ODE upon product approval, the benefits of an ODD also include eligibility for certain
research tax credits and a waiver of the marketing application fee. An application for a prescription product with an ODD is not subject
to an application fee unless the application also includes an indication for a non-rare disease or condition as well. For fiscal year
2021, the application fee for a new drug or biologic requiring clinical studies was $2,875,842.



Pediatric
Exclusivity



Pediatric
exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional
six months of marketing exclusivity attached to another period of exclusivity (e.g., ODE) if a sponsor conducts clinical trials
in children in response to a written request from the FDA. The issuance of a written request does not require the sponsor to undertake
the described clinical trials.



Post-Approval
Requirements



Any
products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,
among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and
distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new
indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for
any marketed products. Drug and biologic drug manufacturers and their subcontractors are required to register their establishments with
the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance
with cGMPs, which therefore imposes certain procedural and documentation requirements on us and our third-party manufacturers. Changes
to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval
before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting
requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend
time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory
compliance.





- 42 -







The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:



| | ● | restrictions on the marketing
    or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
| | - | -----------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                          
| | ● | fines, warning letters,
    or untitled letters;                                                                                         



| | ● | clinical holds on clinical
    studies;                                                                                                                                               
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                       
| | ● | refusal of the FDA to approve
    pending applications or supplements to approved applications, or suspension or revocation of product approvals;                                     
| |   |                                                                                                                                                                                       
| | ● | product seizure or detention,
    or refusal to permit the import or export of products;                                                                                              
| |   |                                                                                                                                                                                       
| | ● | consent decrees, corporate
    integrity agreements, debarment or exclusion from federal healthcare programs;                                                                         
| |   |                                                                                                                                                                                       
| | ● | mandated modification of
    promotional materials and labeling and the issuance of corrective information;                                                                           
| |   |                                                                                                                                                                                       
| | ● | the issuance of safety
    alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information
    about the product; or
| |   |                                                                                                                                                                                       
| | ● | injunctions or the imposition
    of civil or criminal penalties.                                                                                                                     



The
FDA closely regulates the marketing, labeling, advertising and promotion of approved products. A company can make only those claims that
were approved by the FDA in the application for marketing approval and in accordance with the provisions of the approved labeling. The
FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with
these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil
and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for
uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians
may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the
behavior of physicians in their choice of approved treatments, as the practice of medicine is outside the scope of FDA’s authority.
The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products. The federal government
has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies
from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees
or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful and
not misleading information that is otherwise consistent with a product’s FDA-approved labeling.





- 43 -







U.S.
Regulation of Wellness Products



Products
that promote health and wellness, including cosmetics, dietary supplements, and other personal care products, are regulated by various
federal, state, and local agencies, including but not limited to the following: (i) the FDA; (ii) the Federal Trade Commission (FTC);
and (iii) various state regulatory bodies. Similar to biologic drug products, the FDA in the course of enforcing the FFDCA may subject
a company to various sanctions for violating FDA regulations or provisions of the FFDCA, including requiring or requesting recalls, issuing
warning letters, seeking to impose civil money penalties, and seizing products that the agency believes are non-compliant. The FTC, in
addition to FDA, regulates the advertising of dietary supplements, cosmetics, and other health-related products to ensure that any advertising
is truthful and not misleading, and that an advertiser maintains adequate substantiation for all product claims. FTC enforcement actions
may result in consent decrees, cease and deist orders, judicial injunctions, and the payment of fines with respect to advertising claims
that are found to be unsubstantiated.



Dietary
Supplements



The
Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the FFDCA to establish a new framework governing the composition,
safety, labeling, manufacturing, and marketing of dietary supplements. Generally, under DSHEA, dietary ingredients (i.e., vitamins;
minerals; herb or other botanical; amino acids; or dietary substances for use by humans to supplement the diet) that were marketed in
the United States prior to October 15, 1994 as a dietary supplement may be used in dietary supplements without notifying FDA. “New”
dietary ingredients (i.e., dietary ingredients that were not marketed in the United States before October 15, 1994) must be the subject
of a new dietary ingredient notification submitted to the FDA unless the ingredient has been “present in the food supply as an
article used for food” without being “chemically altered.” A new dietary ingredient notification must provide the FDA
evidence of a “history of use or other evidence of safety” establishing that use of the dietary ingredient “will reasonably
be expected to be safe.” A new dietary ingredient notification must be submitted to FDA at least 75 days before the initial marketing.
The FDA may determine that a new dietary ingredient notification does not provide an adequate basis to conclude that a dietary ingredient
is reasonably expected to be safe. In addition, manufacturers of dietary supplements must ensure that ingredients in their products that
are not defined as dietary ingredients comply with all requirements applicable to conventional foods. For example, fillers and other
constituents of the product must be approved as food additives or must be deemed generally recognized as safe for the conditions of use
in order to be sold.



The
FDA generally prohibits the marketing of a dietary supplement with any “disease claim,” including claims that the product
is intended to treat, cure, mitigate, or prevent disease or other health-related conditions or correlating use of the product with a
decreased risk of disease, unless the claim constitutes a “health claim” that is authorized by the FDA. The FTC has imposed
stringent, claim-specific substantiation standards on certain dietary supplement manufacturers, to settle charges that they deceptively
advertised their supplements’ efficacy. However, “statements of nutritional support,” including so-called “structure/function
claims,” are permitted to be included in labeling for dietary supplements. Such statements may describe how a particular dietary
ingredient affects the structure, function, or general well-being of the body, or mechanism of action by which a dietary ingredient may
affect the structure, function, or well-being of the body, but such statements may not state that a dietary supplement will reduce the
risk or incidence of a disease unless such claim has been reviewed and approved by the FDA. A company that uses a statement of nutritional
support in labeling must possess evidence substantiating that the statement is truthful and not misleading. Such statements must be submitted
to the FDA no later than thirty days after first marketing the product with the certification that they possess the necessary evidence
and must be accompanied by an FDA mandated label disclaimer that “This statement has not been evaluated by the FDA. This product
is not intended to diagnose, treat, cure or prevent any disease.”



The
FDA has published detailed current Good Manufacturing Practice (cGMP), regulations that govern the manufacturing, packaging, labeling
and holding operations of dietary supplement manufacturers. The cGMP regulations, among other things, impose significant recordkeeping
requirements on manufacturers and require dietary supplements to be of appropriate potency, purity and identity. The cGMP requirements
are in effect for all dietary supplement manufacturers, and the FDA conducts inspections of dietary supplement manufacturers pursuant
to these requirements.



The
FSMA, expands the reach and regulatory powers of the FDA with respect to the production and importation of food, including dietary supplements.
The expanded reach and regulatory powers include the FDA’s ability to order mandatory recalls, administratively detain domestic
products, and require certification of compliance with domestic requirements for imported foods associated with safety issues. FMSA also
gave FDA the authority to administratively revoke manufacturing facility registrations, effectively enjoining manufacturing of dietary
ingredients and dietary supplements without judicial process.





- 44 -







Cosmetics
and Personal Care Products



Personal
care products are subject to various laws and regulations that set forth among other things whether a product can be marketed as a “cosmetic”
or requires further approval or regulation as an over-the-counter (OTC) drug. In the United States, the regulation of cosmetic content
and labeling is under the primary jurisdiction of FDA with advertising, labeling claims, and marketing also regulated by FTC. Cosmetic
products are not subject to pre-market approval by FDA, but their ingredients and their label and labeling content are regulated by FDA,
and it is the burden of those who sell cosmetics to ensure that they are safe for use as directed and not adulterated or misbranded.
The labeling of cosmetic products is subject to the requirements of the FFDCA, the Fair Packaging and Labeling Act, and other FDA regulations.



The
FFDCA defines cosmetic products by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to the human body ... for cleansing, beatifying, promoting attractiveness, or altering the appearance.”
Among the products included in this definition are skin moisturizers, serums, perfumes, lipsticks, eye and facial makeup preparations,
as well as material intended for use as a component of a cosmetic product. A product may be considered a drug if it is intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the
body (“structure/function claims”). A product’s intended use can be inferred from marketing or product claims. Structure/function
claims are generally prohibited for cosmetic products as are disease prevention and treatment claims. The FDA prohibits certain ingredients
from being included in cosmetic products. It is possible that cosmetic product ingredients now commonly in use that are the product of
certain scientific advancements or production processes may be restricted or prohibited in the future as more is learned about such ingredients.



In
recent years, the FDA has issued warning letters to many cosmetic companies alleging improper structure/function claims regarding their
cosmetic products, including, for example, product claims regarding gene activity, cellular rejuvenation, and rebuilding collagen. Cosmetic
companies confront difficulty in determining whether a claim would be considered by the FDA to be an improper structure/function claim.
Given this difficulty, there is a risk that we could receive a warning letter, be required to modify our product claims, or take other
actions to satisfy the FDA if the FDA determines any of our marketing materials contain improper structure/function claims for our cosmetic
products.



Other
Healthcare Laws



Pharmaceutical
manufacturers are subject to additional healthcare regulation and enforcement by the U.S. federal government and authorities in the states
and foreign jurisdictions in which they conduct their business. Such laws include, without limitation, U.S. federal anti-kickback and
other fraud and abuse, false claims, consumer fraud, pricing reporting, data privacy and security, and transparency laws and regulations
as well as similar foreign laws in the jurisdictions in which companies conduct their business outside the U.S. Similar state and local
laws and regulations may also restrict business practices in the pharmaceutical industry, which may apply to business practices, including
but not limited to, research, pricing, discounting, promotion, sales commission, incentive program, distribution, sales and marketing,
and other arrangements and with respect to claims involving healthcare items or services reimbursed by non-governmental third-party payors,
including private insurers, or by patients themselves; state laws that require pharmaceutical companies to implement compliance programs,
comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the
federal government; or that otherwise restrict payments that may be made to healthcare providers and other potential referral sources;
state laws requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports, and/or make periodic
public disclosures on sales, marketing, pricing, clinical trials, and other activities; state laws and regulations that prohibit certain
marketing-related activities, including provision of gifts, meals, or other items to certain healthcare providers, restrict the ability
of manufacturers to offer co-pay support to patients for certain prescription drugs, and/or require drug manufacturers to file reports
relating to pricing and marketing information; state laws that require disclosures to state agencies and/or commercial purchasers with
respect to certain price increases that exceed certain specified thresholds; state and local laws which require tracking and reporting
of gifts, compensation, and other remuneration and items of value provided to physicians, other healthcare providers and entities; state
and local laws that require the registration of pharmaceutical sales representatives; and state and local laws governing 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. Violation of any of such laws or any other governmental regulations that apply
may result in significant civil, criminal, and administrative penalties, damages, fines, disgorgement, reputational harm, additional
reporting obligations and oversight, including if we become subject to a corporate integrity agreement or other agreement to resolve
allegations of non-compliance with these laws, the curtailment or restructuring of operations, exclusion from participation in governmental
healthcare programs, such as Medicare and Medicaid, and individual imprisonment.





- 45 -







Coverage
and Reimbursement



Sales
of any pharmaceutical product depend, in part, on the extent to which the product will be covered by third-party payors, such as federal,
state and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and, if covered, their level
of reimbursement for the product. Significant uncertainty exists as to the coverage and reimbursement status of any newly approved product.
Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. One third-party
payor’s decision regarding coverage and reimbursement for a particular product does not ensure that other payors will also provide
coverage and reimbursement for the product. As a result, the coverage determination process can require manufactures to provide scientific
and clinical support for the use of a product to each payor separately and can be time-consuming, with no assurance that coverage and
adequate reimbursement will be applied consistently or obtained in the first instance. For products administered under the supervision
of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated
with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used
may not be available, which may impact physician utilization. In addition, companion diagnostic tests require coverage and reimbursement
separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products. Similar challenges
to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics.



In
addition, third-party payors are increasingly reducing reimbursements for pharmaceutical products and services. The U.S. government and
state legislatures have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement
and requirements for substitution of generic products. Third-party payors are increasingly challenging the prices charged, examining
the medical necessity and reviewing the cost effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy.
Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls
and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party
payor not to cover a product could reduce utilization of the product.



In
international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted
price ceilings on specific products and therapies. For example, the European Union provides options for its member states to restrict
the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of
medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system
of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Pharmaceutical products
may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products and may
also compete with imported foreign products. Furthermore, there is no assurance that a product will be considered medically reasonable
and necessary for a specific indication, will be considered cost-effective by third-party payors, that an adequate level of reimbursement
will be established even if coverage is available or that the third-party payors’ reimbursement policies will not adversely affect
the ability for manufacturers to sell products profitably.





- 46 -







Healthcare
Reform



In
the United States and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative
and regulatory changes to the healthcare system. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health
Care and Education Reconciliation Act (collectively, the “ACA”) was signed into law, which substantially changed the way
healthcare is financed by both governmental and private insurers and delivered in the United States. By way of example, the ACA increased
the minimum level of Medicaid rebates payable by manufacturers of most innovator brand name drugs from 15.1% to 23.1%; required collection
of rebates for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers
or importers who sell certain “branded prescription drugs” and biologic agents to specified federal government programs,
implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs
that are inhaled, infused, instilled, implanted, or injected; expanded eligibility criteria for Medicaid programs; created a new Patient-Centered
Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding
for such research; established the Medicare Part D coverage gap discount program that, as a condition for the manufacturers outpatient
drugs to be covered under Medicare Part D, requires manufacturers to provide a now 70% point-of-sale-discount off the negotiated price
of applicable brand drugs to eligible beneficiaries during their coverage gap period; required reporting of certain financial arrangements
between manufacturers of drugs, biologics, devices, and medical supplies and physicians and teaching hospitals under the Physician Payments
Sunshine Act; and established a Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services (“CMS”)
to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug
spending.



Since
its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional
challenges and amendments to the ACA in the future. While Congress has not passed comprehensive repeal legislation, legislation affecting
the implementation of the ACA has passed. For example, in 2017, Congress enacted the Tax Act, which eliminated, effective January 1,
2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage
for all or part of a year, which is commonly referred to as the “individual mandate.” On June 17, 2021, the U.S. Supreme
Court dismissed a judicial challenge to the ACA brought by several states arguing that the ACA’s individual mandate, without the
shared responsibility payment, was unconstitutional and could not be severed from the ACA. The Supreme Court’s ruling did not specifically
address the states’ constitutionality arguments. In addition, the Further Consolidated Appropriations Act of 2020, signed into
law December 20, 2019, permanently eliminated, effective January 1, 2020, the ACA-mandated “Cadillac” tax on certain high-cost
employer-sponsored health coverage and the excise tax on non-exempt medical devices and, effective January 1, 2021, also eliminates the
annual fee imposed on certain health insurance providers based on market share.



Other
legislative changes have been proposed and adopted since the ACA was enacted, including aggregate reductions of Medicare payments to
providers of 2% per fiscal year and reduced payments to several types of Medicare providers, which will remain in effect into fiscal
year 2031 — except for the period from May 1, 2020 through March 31, 2022, during which Congress temporarily suspended the sequester
due to the COVID-19 pandemic, and except for the period from April 1, 2022 through June 30, 2022, during which Congress reduced the sequester
from 2% to 1% — absent additional congressional action. Moreover, there has recently been heightened governmental scrutiny over
the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed
and enacted legislation designed, among other things, to bring more transparency to product pricing, review the relationship between
pricing and manufacturer patient programs and reform government program reimbursement methodologies for pharmaceutical products. While
several proposed reform measures will require Congress to pass legislation to become effective, Congress and the Biden administration
have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs. The Biden administration
has taken several recent executive actions that signal changes in policy from the prior administration. For example, on July 9, 2021,
President Biden signed an executive order to promote competition in the U.S. economy that included several initiatives addressing prescription
drugs. Among other provisions, the executive order directed the Secretary of HHS to issue a report to the White House that includes a
plan to, among other things, reduce prices for prescription drugs, including prices paid by the federal government for such drugs. In
response to the Executive Order, on September 9, 2021, HHS issued a Comprehensive Plan for Addressing High Drug Prices that identified
potential legislative policies and administrative tools that Congress and the agency can pursue in order to make drug prices more affordable
and equitable, improve and promote competition throughout the prescription drug industry, and foster scientific innovation. In addition,
individual states in the United States have also become increasingly active in passing laws and implementing regulations designed to
control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product
access, marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries
and bulk purchasing. Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing
systems and publication of discounts and list prices. Implementation of cost containment measures or other healthcare reforms that affect
the pricing and/or availability of drug products may impact our ability to generate revenue, attain or maintain profitability, or commercialize
products for which we may receive regulatory approval in the future. We expect that additional state and federal healthcare reform measures
will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products
and services, which could result in reduced demand for our drug candidates or additional pricing pressures.





- 47 -







Further,
on May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, or the Right to
Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational
new product candidates that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain
circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the
FDA expanded access program. There is no obligation for a drug manufacturer to make its products available to eligible patients as a
result of the Right to Try Act.



Employees



As
of January 23, 2023, we had 11 full-time employees, 2 part time employees, 2 full-time consultants, and 6 part-time consultants. Among
those, 2 have M.D. or Ph.D. degrees. Of these full-time employees and consultants, 8 are engaged in research and development activities.
None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship
with our employees to be good.



Corporate
History



We
were incorporated under the laws of the State of Nevada on March 31, 1986 under the name Imperial Management, Inc. On December 17, 1986,
we merged with Labtek, Inc., a Colorado corporation, and the name of the company was changed to Labtek, Inc. The name of the Company
was thereafter changed to Vitro Diagnostics, Inc. on February 6, 1987. From November 1990 to July 31, 2000, we were engaged in the development,
manufacture and distribution of purified human antigens and the development of diagnostic products and related technologies. In August
2000, we sold the assets used in the manufacture and sale of purified antigens for diagnostic applications, following which we focused
on developing therapeutic products, our stem cell technology, our patent portfolio and proprietary technology and cell lines for applications
in autoimmune disorders and inflammatory disease processes and stem cell research. On February 3, 2021, our name was changed to Vitro
Biopharma, Inc. and in August 2021, we completed the acquisitions of InfiniVive MD and Fitore. On July 6, 2022, Christopher Furman joined
our Board of Directors (“Board” or “Board of Directors”) and become our Chief Executive Officer.



Available
Information



Electronic
copies of the materials we file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K, and proxy statements, are available to the public at the web site maintained by the SEC at http://www.sec.gov.



We
also maintain a website at www.vitrobiopharma.com, at which you may access these materials free of charge as soon as reasonably practicable
after they are electronically filed with or furnished to the SEC. Our website and the information contained therein or connected thereto
shall not be deemed to be incorporated into this Report. We have included our website address as an inactive textual reference only.





- 48 -







Item 1A. Risk Factors



Summary
of Risk Factors



Our
business and operations are subject to a number of risks, which you should be aware of prior to making a decision to invest in our common
stock. Listed below is a summary of these risks, which are discussed more fully immediately following this summary.



Risks
Related To Our Financial Condition



| | ● | There is substantial doubt
    about our ability to continue as a going concern, and if we are unable to continue, you may lose your entire investment;                                                                     
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | We have incurred substantial
    losses in recent years and may never be profitable;                                                                                                                                        
| | ● | A significant portion of
    our revenue is concentrated on a few large customers;                                                                                                                                          
| | ● | The use of our product
    candidates and our other products or any future products in individuals may expose us to product liability claims, and we may not
    be able to obtain adequate product liability insurance; and
| | ● | In order to successfully
    implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth.                                                         



Risks
Related To Our Business



| | ● | We are heavily dependent
    on the successful development and commercialization of AlloRx Stem Cell therapy, and we may not be able to successfully develop and
    commercialize the product candidate and obtain the necessary regulatory approvals;                                                                   
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | If the potential of our
    product candidates, particularly AlloRx Stem Cell therapy, to treat various diseases and conditions is not realized, the value of
    our technology and development programs could be significantly reduced;                                                                                 
| | ● | We have never commercialized
    a biologic or drug product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize
    any products on our own or together with suitable collaborators;                                                                             
| | ● | We have a limited operating
    history with our current business model, which may make it difficult for you to evaluate our current business and predict our future
    success and viability;                                                                                                                           
| | ● | Our product development
    programs are based on novel technologies and are inherently risky;                                                                                                                                                                                                                            
| | ● | The lack of any existing
    FDA-approved allogeneic, cell-based therapies for Long COVID, PTHS, Lupus (SLE), MS or Alzheimer’s disease could complicate
    and delay FDA approval of AlloRx Stem Cell therapy for these indications;                                                                                    
| | ● | If we are not able to recruit
    and retain additional qualified management and scientific personnel, we may fail in obtaining financing, pursuing collaborations
    or developing our technologies and product candidates;                                                                                             
| | ● | Our collaborations we intend
    to enter into with one or more medical institutions to help us develop our product candidates and commercialize our products may
    never materialize, and our ability to commercialize such products may be impaired or delayed if collaborations are unsuccessful;                    
| | ● | Our business could be harmed
    if the third-party healthcare professionals on whom we rely to administer AlloRx Stem Cell therapy and AlloRx Stem Cells to patients
    administer these incorrectly or fail to follow our instructions or recommendations;                                                             
| | ● | We may be unable to develop
    a new manufacturing facility on a timely basis or at all;                                                                                                                                                                                                                                 
| | ● | Interim, “topline”
    and preliminary data from our clinical trials that we announce or publish may change as more data become available and are subject
    to audit and verification procedures that could result in material changes in the final data;                                                               
| | ● | We may expend our limited
    resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates or indications
    that may be more profitable or for which there is a greater likelihood of success;                                                                   
| | ● | Our competitors may develop
    similar or comparable treatments for the target indications of our product candidates that are approved more quickly, marketed more
    successfully or are demonstrated to be safer or more effective than our product candidates, and we may not compete successfully with
    them; and
| | ● | Our product candidates
    are derived from human UCs and therefore have the potential for disease transmission and are susceptible to ethical and other concerns
    surrounding the use of stem cell therapy or human tissue.                                                                                           





- 49 -







Risks
Related To Intellectual Property



| | ● | If our intellectual property
    does not adequately protect our products and uses, others could compete against us more directly, which could harm our business and
    have a material adverse effect on our business, financial condition, and results of operations;                                                                                                                                                   
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | If we fail to obtain assignment
    of rights of our intellectual property from all inventors, we may not own or exclusively own our intellectual property, which could
    adversely affect our ability to protect our product and have a materially effect on our business;                                                                                                                                              
| | ● | Our commercial success
    depends in part on our avoiding infringement of the patents and proprietary rights of third parties and if one or more third parties
    were to assert that we infringe their patents or are otherwise employing their proprietary technology without authorization, it could
    impair our ability to commercialize our product candidates and otherwise significantly harm our business; and
| | ● | If we do not obtain patent
    term extension for our product candidates and/or methods of their use, our business may be materially harmed.                                                                                                                                                                                                                                                                               



Risks
Related To Regulatory Approval And Other Government Regulations



| | ● | We cannot market and sell
    our product candidates in the United States or in other countries if we fail to obtain the necessary regulatory approvals;                                                                                    
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | If we are not able to conduct
    our clinical trials properly and on schedule, marketing approval by FDA and other regulatory authorities may be delayed or denied;                                                                        
| | ● | Final marketing approval
    of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of
    which could adversely affect our ability to generate operating revenues;
| | ● | Producing and marketing
    an approved drug or other medical product is subject to significant and costly post-approval regulation;                                                                                                        
| | ● | We and any of our future
    development partners will be required to report to regulatory authorities if any of our approved products cause or contribute to
    adverse medical events;                                                   
| | ● | We may not ultimately qualify
    for or benefit from orphan drug exclusivity, breakthrough therapy designation, fast track designation, or priority review; and                                                                            
| | ● | The FDA and other regulatory
    agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.                                                                                                            



Risks
Related To Our Subsidiaries



| | ● | The cosmetics industry
    is highly competitive, and InfiniVive MD’s Daily Serum may be unable to compete effectively;                                                                        
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | InfiniVive MD products
    may fail to achieve the broad degree of physician adoption and use or consumer demand necessary for commercial success;                                             
| | ● | FDA and FTC may enforce
    against our cosmetic products if they do not accept our advertising and marketing or if those products are used beyond the intended
    uses that we authorize; and
| | ● | Adulterated or misbranded
    products appearing on the market under the Fitore brand may subject us to costs or liabilities or damage our reputation and brand.                               



Additional
Risks Related To Our Supply Arrangements With Third-Party Foreign Medical Centers



| | ● | FDA could prohibit us from
    exporting products for use in compassionate use programs or clinical studies in foreign jurisdictions;                                                                                                                                       
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | FDA, FTC, and other regulatory
    agencies actively enforce against medical tourism companies and medical providers advertising to patients in the United States if
    the claims or procedures are not substantiated or in compliance with the local countries’ laws; and
| | ● | The FDA and other comparable
    foreign regulatory authorities may not accept data from trials or studies conducted in locations outside of their jurisdiction.                                                                                                            





- 50 -







Risks
Related To Ownership Of Our Common Stock



| | ● | Our principal
    stockholders and management, including our former Chief Executive Officer in particular, own a significant percentage of our stock
    and will be able to exert significant control over matters subject to stockholder approval;                                                                                      
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | ● | There currently exists
    no public trading market for our common stock and you may not be able to sell your shares of common stock if an active trading market
    does not develop;                                                                                                                                                    
| | ● | Management identified a
    material weakness in our internal control over financial reporting that caused us to restate our financial statements for the three
    and nine months ended July 31, 2022, and there is no assurance that we will be able to accurately report our financial results or
    prevent fraud in the future; and
| | ● | Provisions in our articles
    of incorporation and bylaws might discourage, delay or prevent a change in control of our company or changes in our management and,
    therefore, depress the market price of our common stock.                                                                                                           



Investing
in shares of our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, together
with all of the other information contained in this Report, including our financial statements and related notes included elsewhere in
this Report, before making an investment decision. The risks described below are not the only ones facing us. The occurrence of any of
the following risks, or of additional risks and uncertainties not presently known to us or that we currently believe to be immaterial,
could materially and adversely affect our business, financial condition, reputation, or results of operations. In such case, if a market
for our stock should develop, the trading price of shares of our common stock could decline, and you may lose all or part of your investment.



Risks
Related To Our Financial Condition



As
described in the report of our auditors for the fiscal years ended October 31, 2022 and 2021 and the notes to our consolidated financial
statements, there is substantial doubt about our ability to continue as a going concern, and if we are unable to continue, you may lose
your entire investment.



The
uncertainty about our ability to continue in operation is based on our continuing losses from operation, limited revenue and limited
working capital, among other things which existed as of the fiscal years ended October 31, 2022 and October 31, 2021. As of October 31,
2022, we had a cash balance of $0.7 million, working capital of $0.4 million and an accumulated deficit of $22.7 million. Included in
the accumulated deficit are losses of $6.9 and $4.5 million for the fiscal years ended October 31, 2022 and October 31, 2021, respectively.
Given all these facts, we are dependent on improving operations and the sale of debt or equity to continue as a going concern. The financial
statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary
should we be unable to continue as a going concern.



Our
ability to continue as a going concern depends on receipt of additional funds through debt or equity financing and our operations. In
the event we are unable to obtain such funding, we may have to delay, reduce or eliminate certain of our planned operations, including
some of our research and development and/or clinical trials, reduce overall overhead expense, or divest assets. This in turn may have
an adverse effect on our ability to realize the value of our assets. If we are unable to continue as a going concern, you may lose all
or part of your investment.



We
have limited revenue and cash flow and are dependent on improving operations, along with receipt of additional working capital, to fund
continued development and implementation of our business plan, and our failure to obtain this capital may cause the partial or total
loss of your investment.



As
of October 31, 2022, our ongoing cash flow is inadequate to implement our business plan. In the recent past, we have relied on equity
and debt financing to supplement operations to provide necessary cash flow and will depend on the receipt of funds through additional
debt or equity financings for the foreseeable future. Since significant amounts of capital are required for companies to pursue clinical
trials in pursuit of FDA approval, we are dependent on improving our cash flow and revenue, as well as receipt of additional working
capital, to fund continued development and implementation of our business plan. In addition to funds required for research and the development
of our product candidates, we will require capital to pay our administrative expenses, including salaries and rent. Any future equity
financing may be at prices or on terms that are disadvantageous to existing stockholders. We may not be able to obtain additional capital
at all and may be forced to curtail or cease our operations. We will continue to rely on equity or debt financing and limited revenue
to finance operations until such time, if ever, that we generate sufficient cash flow. The inability to obtain necessary financing may
adversely impact our ability to develop our product candidates and to expand our business operations.





- 51 -







We
have incurred substantial losses in recent years and may never be profitable.



During
the fiscal years ended October 31, 2022 and 2021, we have incurred losses of approximately $6.9 million and $4.5 million, respectively.
In the future, our ability to become profitable will depend on our ability to commercialize one or more of our product candidates, expand
sales of our subsidiaries and generate revenue sufficient to cover our costs and expenses. As we advance the preclinical and clinical
development of our programs, we expect to continue to incur significant expenses and operating losses, for which we do not have sufficient
offsetting revenue. We expect that our sales, research and development and general and administrative costs will increase in connection
with conducting additional preclinical studies and clinical trials for our current and future programs and product candidates, contracting
with CROs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and
administrative support for our operations. There is no assurance that we will ever be profitable.



The
acquisitions of our two subsidiaries were only recently completed and we may not successfully grow those businesses to be profitable
and contribute to our cash flow. We expect that sales of Fitore products in the future will be limited.



The
acquisition of both InfiniVive MD and Fitore were completed effective August 1, 2021. Accordingly, we have had only a limited time to
become familiar with the businesses and determine whether and how we can grow the businesses. Neither entity is profitable on a stand-alone
basis and each contributed to our net loss in 2021. We recently terminated the chief executive officer and all other employees of Fitore;
consequently, we expect that sales of Fitore products in the future will be limited. Our ability to grow the business of InfiniVive MD
is dependent on our ability to improve marketing and sales to the point that revenue will be sufficient to offset operating expenses
of that entity. If we are unable to grow this business, our operations will consume our working capital sooner than we expect, and, if
we are successful in listing on an exchange or other public trading market, our stock price may suffer.



A
significant portion of our revenue is concentrated on a few large customers. If we lose one or more of them, our results of operations
may be adversely impacted.



Our
revenue is currently concentrated in two of our domestic customers, Dr. Jack Zamora, our former Chief Executive Officer, and European
Wellness. The sales to Dr. Zamora accounted for approximately 1% and 28% of our sales in fiscal year 2022 and fiscal year 2021, respectively.
In addition to the product revenue noted above, we recognized $600,000 in consulting revenue from European Wellness in fiscal 2022. The
loss of all or a part of our revenue from one or both of these customers could have a material adverse effect on our revenues until an
alternative channel partner could be developed.



Servicing
our debt may require a significant amount of cash. We may not have sufficient cash flow from our business to pay our indebtedness.



As
of October 31, 2022, we have outstanding approximately $2 million in indebtedness to our Chief Science Officer on account of past-due
compensation and accrued interest, and approximately $0.5 million to a former officer on account of the acquisition of Fitore. These
obligations mature in 2024 and 2025, respectively. Our ability to make scheduled payments of the principal of, to pay interest on or
to refinance our indebtedness, depends on our future performance and receipt of additional capital, which is subject to economic, financial,
competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to
service our debt and make necessary capital expenditures. Repayment of these obligations, even if we are able to obtain the requisite
capital, would decrease the funds available to further our business plan. In addition, any of our future debt agreements may contain
restrictive covenants that may prohibit us from adopting any of these alternatives. Our failure to comply with these covenants could
result in an event of default which, if not cured or waived, could result in the acceleration of our debt.





- 52 -







Our
ability to recognize the benefits of deferred tax assets is dependent on future cash flows and taxable income.



We
recognize deferred tax assets when the tax benefit is considered to be more likely than not of being realized; otherwise, a valuation
allowance is applied against deferred tax assets. Assessing the recoverability of deferred tax assets requires management to make significant
estimates related to expectations of future taxable income. Estimates of future taxable income are based on forecasted cash flows from
operations and the application of existing tax laws in each jurisdiction. To the extent that future cash flows and taxable income differ
significantly from estimates, our ability to realize the deferred tax assets could be impacted. Additionally, future changes in tax laws
could limit our ability to obtain the future tax benefits represented by our deferred tax assets. As of October 31, 2022, our net deferred
tax assets were $3.7 million. We have recorded a full valuation allowance against this asset.



The
use of our product candidates and our other products, including AlloRx Stem Cells, InfiniVive MD products, MSC-Gro, CAFs and our other
products, or any future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate
product liability insurance.



Because
of the nature of our products, including our product candidates like AlloRx Stem Cell therapy as well as our AlloRx Stem Cells, InfiniVive
MD products, MSC-Gro, CAFs and our other products, we face an inherent risk of product liability claims. None of our product candidates
or other products have been widely used over an extended period of time, and our safety data is therefore limited. We derive the raw
materials for our product candidates from human donor sources, the manufacturing process is complex, and the handling requirements are
specific, all of which increase the likelihood of quality failures and subsequent product liability claims. In addition, we supply AlloRx
Stem Cells to certain foreign clinics pursuant to purchase orders issued by our customers, which are likely to be favorable to those
customers. We generally do not enter into long-term purchase agreements with our customers that obligate them to purchase our products
or protect us from product liability claims made by the patients such customers treat using AlloRx Stem Cells. We will need to increase
our insurance coverage if and when we receive approval for and begin commercializing our product candidates. We may not be able to obtain
or maintain product liability insurance on acceptable terms with adequate coverage or at all. If we are unable to obtain insurance, or
if claims against us substantially exceed our coverage, then our business could be adversely impacted. Whether or not we are ultimately
successful in any product liability litigation, such litigation either before or after product approval and marketing could consume substantial
amounts of our financial and managerial resources and could result in, among other things:



| | ● | significant awards against
    us;                                                                                 
| | - | -------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                    
| | ● | substantial litigation
    costs;                                                                                  
| |   |                                                                                                                    
| | ● | recall of products or termination
    of clinical trials;                                                          
| |   |                                                                                                                    
| | ● | FDA withdrawal of marketing
    approval of products or suspension or revocation of an IND for a product candidate;
| |   |                                                                                                                    
| | ● | injury to our reputation;                                                                                          
| |   |                                                                                                                    
| | ● | withdrawal of clinical
    trial participants;                                                                     
| |   |                                                                                                                    
| | ● | withdrawal of clinical
    trial sites or investigators; or                                                        
| |   |                                                                                                                    
| | ● | adverse regulatory action.                                                                                         



Any
of these results could have a material adverse effect on our business, financial condition, and results of operations.





- 53 -







In
order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in
managing this growth.



As
of January 23, 2023, we had 11 full-time employees, 2 part time employees, 2 full-time consultants, and 6 part-time consultants. Of these
full-time employees and consultants, 8 are engaged in research and development activities. In order to successfully implement our development
and commercialization plans and strategies, and as we transition into operating as a public company, we expect to need additional managerial,
operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members
of management, including:



| | ● | identifying, recruiting,
    integrating, maintaining and motivating additional employees;                                                                                                                                                                                                                                                                              
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                         
| | ● | managing our internal development
    efforts effectively, including preclinical and clinical studies and investigations, as well as FDA and other comparable foreign regulatory
    agencies’ review process for any current or future product candidates, while complying with any contractual obligations to
    contractors and other third parties we may have; and
| |   |                                                                                                                                                                                                                                                                                                                                                                         
| | ● | improving our operational,
    financial and management controls, reporting systems and procedures.                                                                                                                                                                                                                                                                     



Our
future financial performance and our ability to successfully develop and, if approved, commercialize, any current or future product candidates
will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate
amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.



We
currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors
and consultants to provide certain services, including key aspects of clinical development and manufacturing. We cannot assure you that
the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed,
or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality
or accuracy of the services provided by third party service providers is compromised for any reason, our clinical trials may be extended,
delayed or terminated, and we may not be able to obtain marketing approval of our current and future product candidates or otherwise
advance our business. We cannot assure you that we will be able to manage our existing third-party service providers or find other competent
outside contractors and consultants on economically reasonable terms, or at all.



If
we are not able to effectively expand our organization by hiring new employees and/or engaging additional third-party service providers,
we may not be able to successfully implement the tasks necessary to further develop and commercialize our current and future product
candidates and, accordingly, may not achieve our research, development and commercialization goals.



We
have in the past and may in the future enter into transactions that give rise to conflicts of interest with our affiliates and related
parties and such transactions may harm our business and financial condition if they are not structured in our best interest.



Every
transaction that the Company enters into with affiliates is subject to an inherent conflict of interest. As further described below (see
“Item 13. Certain Relationships and Related-Party Transactions, and Director Independence”), effective August 2021,
we acquired InfiniVive MD, a company that at the time was solely owned by Dr. Zamora, and Fitore, a company that at the time was partially
owned by Dr. Zamora. At the time of these transactions, Dr. Zamora was serving as our Chief Executive Officer and was member of our Board
of Directors; he was also a stockholder of our company. Our Board of Directors was aware of the interests of Dr. Zamora in each transaction
and insisted that he recuse himself from any Board deliberations or votes with regard to each of these transactions in order to address
these inherent conflicts of interest between our interests and those of Dr. Zamora. As a result of these and other efforts, our Board
of Directors believes that these transactions were negotiated at arms’ length and these transactions were consummated on terms
as favorable to us as they could have been if obtained from non-affiliated persons. In addition, each of these transactions was approved
by all of the disinterested members of our Board of Directors. While an effort has been made, and will continue to be made, to engage
in transactions and enter into agreements with affiliated persons and other related parties on terms as favorable to us as they could
have been if obtained from non-affiliated persons, there will always be an inherent conflict of interest between our interests and those
of our affiliates and related parties if they have any interest adverse to those of our company. The Company may be adversely impacted
if any related party agreement or transaction has been made, or is made in the future, on unfavorable terms.





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Risks
Related to our Business



We
are heavily dependent on the successful development and commercialization of AlloRx Stem Cell therapy, and if we encounter delays or
difficulties in the development of this product candidate, we may not generate sufficient revenue to continue our business operations
and our business could be harmed.



AlloRx
Stem Cell therapy is currently in the early stage of development and will require substantial time, resources, research and development,
and regulatory approval prior to potential commercialization in the United States. To generate sales revenue from our product candidates,
we must conduct extensive preclinical studies and clinical trials to demonstrate that our product candidates are safe and effective and
we must obtain required regulatory approvals. We will need to devote significant additional research and development, financial resources,
and personnel to develop commercially viable products. It is likely to take several years to obtain the required regulatory approvals
for our product candidates, or we may never gain the necessary approvals.



Many
companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive
results in preclinical development or early-stage clinical trials, and we cannot be certain that we will not face similar setbacks. Significant
adverse effects caused by, or other unexpected properties of, any product candidates that we may choose to develop could cause us, an
IRB or regulatory authority to interrupt, delay or halt clinical trials of one or more of such product candidates and could result in
a more restrictive label or the delay or denial of marketing approval by the FDA or comparable non-U.S. regulatory authorities. If any
product candidate that we may choose to develop is associated with significant adverse effects or other unexpected properties, we may
need to abandon development or limit development of that product candidate to certain uses or subpopulations in which those undesirable
characteristics would be expected to be less prevalent, less severe or more tolerable from a risk-benefit perspective. Moreover, preclinical
and clinical data is often susceptible to varying interpretations and analyses, and many companies that believed their product candidates
performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval.
If we fail to produce positive results in clinical trials of our product candidates, the development timeline and regulatory approval
and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be negatively
impacted. If we fail to obtain such approvals, we may not generate sufficient revenues to continue our business operations.



Even
if we obtain regulatory approval of a product, that approval may be subject to limitations on the indicated uses for which it may be
marketed. Even after granting regulatory approval, the FDA and regulatory agencies in other countries continue to review and inspect
marketed products, manufacturers, and manufacturing facilities, which may create additional regulatory burdens. Later discovery of previously
unknown problems with a product, manufacturer, or facility may result in restrictions on the product or manufacturer, including a withdrawal
of the product from the market or a withdrawal of the approved application by the FDA. Furthermore, FDA may require post-approval studies
or other commitments from us, and failure to comply with or meet those commitments could result in withdrawal of the approved application
by FDA. Regulatory agencies may also establish additional regulations, policies, or guidance that could prevent or delay regulatory approval
of our product candidates.



As
a result, our business could be materially harmed if we encounter difficulties in the development of this product candidate, such as:



| | ● | delays in the design, enrollment,
    implementation or completion of required preclinical studies and clinical trials;                                                                 
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                         
| | ● | an inability to follow
    our current development strategy for obtaining regulatory approval from regulatory authorities because of changes in the regulatory
    approval process; and
| |   |                                                                                                                                                                                         
| | ● | less than desired or complete
    lack of efficacy or safety in preclinical studies or clinical trials.                                                                                 





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If
any of the above were to occur, this could significantly and adversely affect the development and commercialization of our AlloRx Stem
Cell therapy or other products and could have a material adverse effect on our business, financial condition, and results of operations.



If
the potential of our product candidates, particularly AlloRx Stem Cell therapy, to treat various diseases and conditions is not realized,
the value of our technology and our development programs could be significantly reduced.



We
are currently planning Phase 1/2a clinical trials with the intent to establish safety, tolerability and efficacy proof-of-concept and/or
evidence of biological activity of AlloRx Stem Cell therapy in various indications. We have not yet proven in clinical trials that AlloRx
Stem Cell therapy will be a safe and effective treatment for any disease or condition. This product candidate is susceptible to various
risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy, or other
characteristics that may prevent or limit its marketing approval or commercial use. We have not yet completed all of the testing necessary
to allow us to make a determination that serious unintended consequences will not occur. If the potential of this product candidate to
treat diseases or conditions is not realized, the value of our technology and our development programs could be significantly reduced.
Because our product candidates are based on MSCs, any negative developments regarding the therapeutic potential or side effects of our
MSCs, or to scientific and medical knowledge about MSCs in general, could have a material adverse effect on our business, financial condition,
results of operations, and prospects.



We
have never commercialized a biologic or drug product candidate before and may lack the necessary expertise, personnel and resources to
successfully commercialize any products if we attain an EUA or other regulatory approval for commercialization of AlloRx Stem Cell therapy
or any other product candidates.



We
have never commercialized a biologic or drug product candidate, and we currently have no sales force, marketing or distribution capabilities
for such a product. To achieve commercial success for our biologic or drug product candidates, which we may license to others, we may
rely on the assistance and guidance of those collaborators who will provide sales and marketing support as well as logistic and distribution
services. For product candidates for which we retain commercialization rights, we will have to develop our own sales, marketing and supply
organization or outsource these activities to a third party.



Factors
that may affect our ability to commercialize any future approved products on our own include recruiting and retaining adequate numbers
of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our products
and other unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing
organization will be expensive and time-consuming and could delay the launch of our future approved products. We may not be able to build
an effective sales and marketing organization. If we are unable to build our own distribution and marketing capabilities or find suitable
partners for the commercialization of our future approved products, we may not generate revenues from them or be able to reach or sustain
profitability.



We
have a limited operating history with our current business model, which may make it difficult for you to evaluate our current business
and predict our future success and viability.



We
are an early-stage clinical development company with a limited operating history with our current business model upon which you can evaluate
our business and prospects. Prior to 2020, our historical operations were limited to research and development and limited sales of research-related
products. In 2020, we began the transition to become a clinical stage biotechnology company focused primarily in the field of regenerative
medicine. Since 2020, we have devoted substantially all of our resources and efforts to reorganizing and staffing our company, business
planning, expanding our research and development capabilities, expanding our manufacturing facility, raising capital, evaluating and
completing acquisitions, developing product candidates, pursuing related intellectual property rights and organizing clinical trials
of AlloRx Stem Cell therapy.





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Our
limited operating history developing clinical-stage product candidates may make it more difficult for us to succeed or for investors
to evaluate our business and prospects. In addition, as an early-stage development company, we have limited experience in development
activities, including conducting clinical trials, or seeking and obtaining regulatory approvals, even though certain of our executives
have had relevant experience at other companies. We will also need to transition from a company with a research focus to a company capable
of conducting clinical trials and, if successful, supporting commercial activities beyond our current InfiniVive MD and Fitore products.
Such a transition will involve substantial additional capital requirements to launch and market a product and significant adjustment
to personnel, compared to a development company. In addition, we have not yet demonstrated an ability to successfully overcome many of
the risks and uncertainties frequently encountered by companies in the biopharmaceutical area. To execute our business plan, we will
need to successfully:



| | ● | execute our product candidate
    development activities, including successfully completing our clinical trial programs;                            
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                     
| | ● | obtain required regulatory
    approvals or authorizations for the development and commercialization of our product candidates;                     
| |   |                                                                                                                                                     
| | ● | manage our costs and expenses
    related to clinical trials, regulatory approvals, manufacturing and commercialization;                            
| |   |                                                                                                                                                     
| | ● | secure substantial additional
    funding;                                                                                                          
| |   |                                                                                                                                                     
| | ● | develop and maintain successful
    strategic relationships;                                                                                        
| |   |                                                                                                                                                     
| | ● | maintain a strong intellectual
    property portfolio;                                                                                              
| |   |                                                                                                                                                     
| | ● | build and maintain appropriate
    clinical, sales, manufacturing, distribution, and marketing capabilities on our own or through third parties; and
| |   |                                                                                                                                                     
| | ● | gain market acceptance
    and favorable reimbursement status for our product candidates.                                                           



If
we are unsuccessful in accomplishing these objectives, we may not be able to develop product candidates, raise capital or expand our
business, or continue our operations.



Our
product development programs are based on novel technologies and are inherently risky.



We
are subject to the risks of failure inherent in the development of product candidates based on new technologies. The novel nature of
our product candidates creates significant challenges in regard to product development and optimization, manufacturing, government regulation,
third-party reimbursement, and market acceptance. For example, although the FDA has approved several autologous (i.e., taken from, and
given to, the same individual) cell therapy products, the FDA has not approved any allogeneic (i.e., taken from one individual and given
to a different person) cell therapy products, and the FDA has relatively limited experience with regulating these kinds of therapies,
and its regulations and policies are still evolving. As a result, the pathway to regulatory approval for our current and future product
candidates may accordingly be more complex and lengthier.



Additionally,
stem cells that are taken from one person and transplanted into a different individual may pose additional risks. For example, stem cells
that are not autologous but are instead allogeneic are subject to donor-to-donor variability, which can make standardization more difficult.
As a result of these factors, the development and commercialization pathway for our therapies may be more complex, lengthier, and subject
to increased uncertainty, as compared to the pathway for new conventional (i.e., new chemical entity) drugs.



There
are no FDA-approved allogeneic, cell-based therapies for Long COVID, PTHS, Lupus (SLE), MS, Alzheimer’s disease, or many other
indications targeted by AlloRx Stem Cell therapy, our lead investigational product candidate. This could complicate and delay FDA approval
of our product candidate for these indications.



Although
FDA has approved several autologous cell therapy products, there are no allogeneic cell-based or stem cell therapies currently approved
for the treatment of Long COVID, PTHS, Lupus (SLE), MS or Alzheimer’s disease. To obtain FDA approval for any indication for the
disease states we are studying, we will have to demonstrate, among other things, that our product candidates are safe and effective for
that indication in the target population. The results of our clinical trials must be statistically significant, meaning that there must
be sufficient data to indicate that it is unlikely the outcome occurred by chance. The FDA will also require us to demonstrate an appropriate
dose (i.e., number of cells) and dosing interval for our product candidates, and to identify and define treatment responders, which may
require additional clinical trials. As a result, the clinical endpoints, the criteria to measure the intended results of treatment, and
the correct dosing for our cell-based therapeutic approaches for these indications may be difficult to determine. These challenges may
prevent us from developing and commercializing products on a timely or profitable basis, or at all.





- 57 -







Our
product candidates represent new classes of therapy that the marketplace may not understand or accept.



Even
if we successfully develop and obtain regulatory approval for our product candidates, the market may not understand or accept them. We
are developing product candidates that represent novel treatment approaches and will compete with a number of more conventional products
and therapies manufactured and marketed by others, including major pharmaceutical companies. The degree of market acceptance of any of
our developed and potential products will depend on a number of factors, including:



| | ● | the clinical safety and
    effectiveness of our products and their perceived advantage over alternative treatment methods;                                                                                                    
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                
| | ● | our ability to demonstrate
    that our cell-based products can have a clinically significant effect, initially for Long COVID, PTHS and other disease states, for
    which we may seek marketing approval;                   
| |   |                                                                                                                                                                                                                                
| | ● | our ability to separate
    ourselves from the ethical controversies associated with cell product candidates derived from human embryonic or fetal tissue;                                                                     
| |   |                                                                                                                                                                                                                                
| | ● | ethical controversies that
    may arise regarding the use of stem cells or human tissue of any kind, including adult stem cells, adult bone marrow, adult cardiac
    stem cells, and other adult tissues derived from donors;
| |   |                                                                                                                                                                                                                                
| | ● | adverse events involving
    our product candidates or candidates of others that are cell based;                                                                                                                               
| |   |                                                                                                                                                                                                                                
| | ● | our ability to supply a
    sufficient amount of our products to meet regular and repeated demand in order to develop a core group of medical professionals familiar
    with and committed to the use of our products; and    
| |   |                                                                                                                                                                                                                                
| | ● | the cost of our products
    and the reimbursement policies of government and third-party payors.                                                                                                                              



If
the health care community does not accept our product candidates or future approved products for any of the foregoing reasons, or for
any other reason, it could affect our sales or have a material adverse effect on our business, financial condition, results of operations,
and prospects.



If
we are not able to recruit and retain additional qualified management and scientific personnel, we may fail in obtaining financing, pursuing
collaborations or developing our technologies and product candidates.



Our
future success depends to a significant extent on the skills, experience, and efforts of the principal members of our scientific and
management personnel. These members include Christopher Furman, our Chief Executive Officer, Dr. James Musick, our Chief Science Officer,
and Dr. Caroline Mosessian, our Chief Regulatory Officer, among others. The loss of any or all of these individuals could harm our business
and might significantly delay or prevent the achievement of research, development or business objectives. Competition for regulatory,
clinical manufacturing and management personnel in the pharmaceutical industry is intense. We may be unable to recruit or retain personnel
with sufficient management skills in the area of cell therapeutics or attract or integrate other qualified management and scientific
personnel in the future.





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We
may, in the future, enter into arrangements with third-party collaborators to help us develop our product candidates and commercialize
our products, and our ability to commercialize such products may be impaired or delayed if collaborations are unsuccessful.



We
expect to enter into clinical trial agreements with third-party investigators and research and clinical institutions across the United
States to conduct our clinical trials in the United States, including our Phase 1/2a trials for PTHS and Long COVID, although we have
not yet entered into any clinical trial agreement(s) for these contemplated Phase 1/2a clinical trials at this time. We may be unable
to enter into these clinical trial agreements or related agreements on a timely basis or at all, which are contingent on approvals required
to be obtained from the clinical institutions and clinical trial sites. We do not expect that any future collaborations pursuant to one
or more clinical trial agreements will involve the type of collaborative arrangements in which we would share the risks and rewards of
any such clinical trials or otherwise with the third-party clinical institution.



We
are dependent upon the success of any future collaborators in performing their responsibilities in connection with the relevant collaboration.
If we fail to maintain these collaborative relationships for any reason, we would need to perform the activities that we currently anticipate
would be performed by our collaborators on our own at our sole expense. This could substantially increase our capital needs, and we may
not have the capability or financial capacity to undertake these activities on our own, or we may not be able to find other collaborators
on acceptable terms, or at all. This may limit the programs we are able to pursue and result in significant delays in the development,
sale, and manufacture of our product candidates and products, and may have a material adverse effect on our business, financial condition,
and results of operations.



Our
dependence upon potential future collaborations exposes us to a number of risks, including that our collaborators (i) may fail to cooperate
or perform their contractual obligations, including financial obligations, (ii) may choose to undertake differing business strategies
or pursue alternative technologies, or (iii) may take an opposing view regarding ownership of clinical trial results or intellectual
property. Due to these factors and other possible events, we could suffer delays in the research, development, or commercialization of
our product candidates and future products or we may become involved in litigation or arbitration, which could be time-consuming and
expensive. We additionally may be compelled to split revenue with our collaborators, which could have a material adverse effect on our
business, financial condition, and results of operations.



We
rely on third-party healthcare professionals to administer AlloRx Stem Cell therapy and AlloRx Stem Cells to patients, and our business
could be harmed if these third parties administer these incorrectly or fail to follow our instructions or recommendations.



We
rely, or will rely in the future, on the expertise of third-party physicians, nurses and other associated medical personnel to administer,
as the case may be, AlloRx Stem Cell therapy and AlloRx Stem Cells in clinical trials in the United States and as part of compassionate
use treatments authorized by FDA, as well as in foreign third-party conducted clinical studies. If these medical personnel are not properly
trained to administer, or do not properly administer, AlloRx Stem Cell therapy and AlloRx Stem Cells, the therapeutic effect of AlloRx
Stem Cell therapy and AlloRx Stem Cells may be reduced or the patient may suffer injury.



In
addition, we freeze our AlloRx Stem Cells prior to shipping and distribution to third parties, which requires third-party medical personnel
to be trained on proper methodology for proper storage, quality control and deployment procedures for all AlloRx Stem Cells received
from us. If these or other processes are not performed correctly, the cells may become damaged and/or the patient may suffer injury.
While we intend to provide training materials and other resources to these third-party medical personnel, the storage, quality control
and deployment procedures, including the thawing and subsequent peripheral intravenous infusion or direct injection, of AlloRx Stem Cell
therapy and AlloRx Stem Cells will occur outside our supervision and may not be performed or administered properly. If, due to a third-party
error, people believe that AlloRx Stem Cells are ineffective or harmful, the desire to use AlloRx Stem Cells may decline, which would
negatively impact our business, reputation and prospects. We may also face significant liability even though we may not be responsible
for the actions of these third parties.





- 59 -







Our
business would be adversely affected if our relationships with third-party healthcare professionals on which we rely were disrupted.



Our
contractual relationships with our network of healthcare professionals which provide for consulting and other services may implicate
certain state laws in the United States that generally prohibit non-physician entities from practicing medicine, exercising control over
physicians or engaging in certain practices such as fee-splitting with physicians. Although we believe that we have structured our arrangements
to ensure that the healthcare professionals maintain exclusive authority regarding the delivery of medical care when deemed clinically
appropriate, there can be no assurance that these laws will be interpreted in a manner consistent with our practices or that other laws
or regulations will not be enacted in the future that could have a material and adverse effect on our business, financial condition and
results of operations. Regulatory authorities, state medical boards of medicine, state attorneys general and other parties, including
our affiliated healthcare professionals, may assert that we are engaged in the prohibited corporate practice of medicine, or that our
arrangements with our network of healthcare professionals constitute unlawful fee-splitting. If a state’s prohibition on the corporate
practice of medicine or fee-splitting law is interpreted in a manner that is inconsistent with our practices, we would be required to
restructure or terminate our relationship with our healthcare professionals to bring our activities into compliance with such laws. A
determination of non-compliance, or the termination of or failure to successfully restructure these relationships could result in disciplinary
action, penalties, damages, fines, and a loss of revenue, any of which could have a material and adverse effect on our business, financial
condition and results of operations. State corporate practice of medicine doctrines and fee-splitting prohibitions also often impose
penalties on healthcare professionals for aiding the corporate practice of medicine, which could discourage physicians and other healthcare
professionals from participating in our network of providers.



We
may be unable to develop a new manufacturing facility on a timely basis or at all, which may impact our ability to capitalize on the
potential biological advantages of UC-derived MSCs, to comply with all FDA requirements to support a BLA, or to commercialize any future
approved products following any regulatory approval.



As
we proceed with our clinical trial efforts and in advance of any commercialization, we must be able to demonstrate to the FDA that we
can manufacture our product candidates with consistent characteristics. While we currently manufacture our product candidates in our
own facility, scaling up the manufacturing process would require us to develop a larger facility, which would require significant time
and capital investments to conform to applicable manufacturing standards.



We
are planning a new, separate manufacturing facility that, if completed, will be used exclusively for the manufacture of AlloRx Stem Cell
therapy and AlloRx Stem Cells. We believe that this separate facility will be necessary to comply with all FDA requirements to support
a BLA and related inspections for the manufacture of AlloRx Stem Cell therapy, given that AlloRx Stem Cell therapy is a product intended
for parenteral use in humans. We plan to use highly scalable, fully automated closed system bioprocessing in the new cGMP biomanufacturing
facility, which we believe is necessary for us to fully capitalize on the potential biological advantages of UC-derived MSCs.



We
expect to commence development of the new manufacturing facility in 2024 but may be unable to commence or complete development on a timely
basis, or at all. Developing a new manufacturing facility, which we expect will contain fully automated closed system bioprocessing equipment,
and recruiting necessary additional personnel will be expensive and time-consuming, and we may not be able to raise sufficient funds
to develop such facility and to buy such equipment. In addition, although we intend to use a portion of any net proceeds from future
debt or equity financings, together with our existing cash and any additional funds received upon the exercise for cash of our outstanding
warrants, for the acquisition of fully automated closed system bioprocessing and other equipment and for the development of a new biomanufacturing
facility, receipt of any funds from warrant holders will only occur in the event that warrant holders elect to exercise their warrants.
We cannot predict if or when the warrants will be exercised, and it is possible that the warrants may expire and never be exercised.
Accordingly, we are unable to control the timing or amount of receipt of such funds or to determine when or if we will receive such funds,
which may impact our ability to fund the development of a new manufacturing facility on a timely basis or at all.



In
addition, the development of a new manufacturing facility may require additional regulatory approvals. If we are unable to develop a
new manufacturing facility in compliance with regulatory requirements or to hire additional necessary manufacturing personnel, we may
encounter delays or additional costs in achieving our research, development and commercialization objectives, which could materially
damage our business and financial prospects. In addition, our ability to complete any ongoing clinical trials may be negatively affected.





- 60 -







We
may be dependent on third parties for the manufacture or distribution of any product candidates, and any problems experienced by these
third parties could result in a delay or interruption in the supply of our product candidate in our clinical trials and any future approved
products.



If
we are unable to develop a new manufacturing facility, we may need to outsource manufacturing on a large scale for AlloRx Stem Cells
and AlloRx Stem Cell therapy, which would cause us to be materially dependent on these suppliers for supply of components of consistent
quality. Reliance on third-party manufacturers entails risks such as the failure of the third party to follow regulatory guidelines,
possible breach of the manufacturing agreement, and possible termination or non-renewal of that agreement. Our ability to complete any
ongoing clinical trials may be negatively affected in the event that we are forced to seek and validate a replacement source for any
of these critical components. If we are not able to obtain adequate supplies of these items of consistent quality from our third-party
suppliers, it will also be more difficult to manufacture commercial quantities of our product candidates that are approved for commercial
sale.



In
addition, if one or more of our product candidates is approved for commercial sale, we intend to rely on third parties for their distribution.
Proper shipping and distribution require compliance with specific storage and shipment procedures (e.g., prevention of damage to shipping
materials and prevention of temperature excursions during shipment). Failure to comply with such procedures will necessitate return and
replacement, potentially resulting in additional cost and causing us to fail to meet supply requirements.



Changes
in the manufacturing process or procedure, including a change in the location where the product is manufactured or a change of a third-party
manufacturer, may require prior FDA review and approval of the manufacturing process and procedures in accordance with the FDA’s
cGMPs. Any new facility is subject to a pre-approval inspection by the FDA and would again require us to demonstrate product comparability
to the FDA. We would also need to verify, such as through a manufacturing comparability study, that any new manufacturing process would
produce our product candidate according to the specifications previously submitted to the FDA, and there are comparable foreign requirements.
The delays associated with the verification of a new third-party manufacturer, or a new facility built by us, could negatively affect
our ability to develop product candidates or commercialize our products in a timely manner or within budget. This review may be costly
and time consuming and could delay or prevent the launch of a product.



We
will be reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform in an unsatisfactory
manner, it may harm our business.



We
currently do not have the ability to independently conduct nonclinical studies that comply with Good Laboratory Practice (“GLP”)
requirements. We intend to rely substantially on CROs and clinical study sites to ensure the proper and timely conduct of our clinical
studies, and we have limited influence over their actual performance.



We
rely upon CROs to monitor and manage data for our clinical programs, as well as for the execution of nonclinical studies. We control
only certain aspects of our CROs’ activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on the CROs does not relieve
us of our regulatory responsibilities.



We
and our CROs are required to comply with current GLP andCurrent
Good Clinical Practice (“cGCP”) regulations and guidelines enforced by the FDA and
are also required by the competent authorities of the member states of the European Economic Area and comparable foreign regulatory authorities
to comply with the International Council for Harmonization guidelines for any of our product candidates that are in nonclinical and clinical
development, respectively. The regulatory authorities enforce cGCP regulations through periodic inspections of clinical study sponsors,
CROs, and clinical study sites. Although we rely on CROs to conduct our GLP-compliant nonclinical studies and cGCP-compliant clinical
studies, we remain responsible for ensuring that each of our nonclinical studies and clinical studies is conducted in accordance with
our investigational plan and protocol and applicable laws and regulations, and our reliance on the CROs does not relieve us of our regulatory
responsibilities. If we, our CROs or clinical study sites fail to comply with cGCP requirements, the clinical data generated in our clinical
studies may be deemed unreliable and the FDA or comparable foreign regulatory authorities may reject our marketing applications or require
us to perform additional clinical studies before approving our marketing applications. Accordingly, if we or our CROs fail to comply
with these regulations or other applicable laws, regulations or standards, or fail to recruit a sufficient number of subjects, we may
be required to repeat clinical studies, which would delay the relevant regulatory approval process. Failure by our CROs to properly execute
study protocols in accordance with applicable law could also create product liability and healthcare regulatory risks for us as the sponsor
of those studies.





- 61 -







While
we have agreements governing their activities, our CROs are not our employees, and we do not control whether or not they devote sufficient
time and resources to our future clinical and nonclinical programs. These CROs may also have relationships with other commercial entities,
including our competitors, for whom they may also be conducting clinical studies, or other drug development activities which could harm
our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs,
which may reduce our trade secret and intellectual property protection and allow our potential competitors to access and exploit our
proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines
or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our (or their own) clinical
protocols or regulatory requirements or for any other reasons, our clinical studies may be extended, delayed or terminated, and we may
not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop. As a result, our
financial results and the commercial prospects for any product candidate that we develop could be harmed, our costs could increase, and
our ability to generate revenue could be delayed.



In
addition, we and our CROs are subject to various data privacy laws in the U.S., Europe, and elsewhere that are often uncertain, contradictory,
and evolving. It is possible that these data privacy laws may be interpreted and applied inconsistent with our or our CROs’ practices.
If so, this could result in government-imposed fines or orders requiring that we or our CROs change our practices, which could adversely
affect our business.



If
our relationships with these CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially
reasonable terms or in a timely manner. Switching or adding additional CROs involves substantial cost and requires management time and
focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially
impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there
can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have an
adverse impact on our business, financial condition, and prospects.



Favorable
results from compassionate use treatment or initial interim results from a clinical trial do not ensure that later clinical trials will
be successful and success in early-stage clinical trials does not ensure success in later-stage clinical trials.



AlloRx
Stem Cells have been administered as part of compassionate use treatments, which permit the administration of the AlloRx Stem Cells outside
of clinical trials. No assurance can be given that any positive results are attributable to the AlloRx Stem Cells, or that administration
of AlloRx Stem Cells to other patients will have positive results. Compassionate use is a term that is used to refer to the use of an
investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition
who has no comparable or satisfactory alternative treatment options. Regulators often allow compassionate use on a case-by-case basis
for an individual patient or for defined groups of patients with similar treatment needs.



There
is no assurance that we will obtain regulatory approval for AlloRx Stem Cells. We will only obtain regulatory approval to commercialize
a product candidate if we can demonstrate to the satisfaction of the FDA or other applicable regulatory authorities, in well-designed
and conducted clinical trials, that the product candidate is safe and effective and that the product candidate, including the cell production
methodology, otherwise meets the appropriate standards required for approval. Clinical trials can be lengthy, complex and extremely expensive
processes with uncertain results. A failure of one or more clinical trials may occur at any stage of testing.



Success
in pre-clinical and early clinical trials does not ensure that later clinical trials will be successful, and initial results from a clinical
trial do not necessarily predict final results. While results from treating patients through compassionate use have in certain cases
been successful, we cannot be assured that further trials will ultimately be successful. Results of further clinical trials may be disappointing.





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Even
if pre-clinical and early-stage clinical trials are successful, we may need to conduct additional clinical trials for product candidates
with patients receiving the drug for longer periods before we are able to seek approvals to market and sell these product candidates
from the FDA and regulatory authorities outside the United States. Even if we are able to obtain approval for our product candidates
through an accelerated approval review program, we may still be required to conduct clinical trials after such an approval. If we are
not successful in commercializing any of our lead product candidates, or are significantly delayed in doing so, our business will be
materially harmed.



In
addition, adverse events involving our product candidates or candidates of others that are cell based, either in compassionate use treatments,
third-party foreign clinical trials or studies or otherwise, could negatively impact future clinical trials and the approval process
for AlloRx Stem Cells. Any such adverse event would affect our ability to commercialize and sell AlloRx Stem Cells.



Interim,
“topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more
data become available and are subject to audit and verification procedures that could result in material changes in the final data.



From
time to time, we may publicly disclose preliminary or topline data from our preclinical studies and clinical trials, which is based on
a preliminary analysis of then-available data. These results and related findings and conclusions are based on assumptions, estimations,
calculations and conclusions, and are subject to change following the generation of additional data or a more comprehensive review of
the data related to the particular study or trial. As a result, the topline or preliminary results that we report may differ from future
results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received
and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially
different from the preliminary data we previously published. As a result, topline and preliminary data should be viewed with caution
until the final data are available.



From
time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data from clinical trials that
we may complete are subject to the risk that one or more of the clinical outcomes may materially change as subject enrollment continues
and more subject data become available or as subjects from our clinical trials continue other treatments for their disease. Adverse differences
between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data
by us or by our competitors could result in volatility in the price of our common stock.



Further,
others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses
or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability
or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose
to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others
may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.



If
the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities,
disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which
could have a material adverse effect on our business, financial condition, and results of operations.



We
may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates
or indications that may be more profitable or for which there is a greater likelihood of success.



Because
we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific
indications. As a result, we may forego or delay pursuit of opportunities with other therapeutic platforms or product candidates or for
other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions
may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future
research and development programs, therapeutic platforms and product candidates for specific indications may not yield any commercially
viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may
relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which
it would have been more advantageous for us to retain sole development and commercialization rights.





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If
our competitors develop similar or comparable treatments for the target indications of our product candidates that are approved more
quickly, marketed more successfully or are demonstrated to be safer or more effective than our product candidates, or if FDA approves
biosimilar competitors to our products post-approval, our commercial opportunity will be reduced or eliminated.



We
compete in an industry characterized by rapidly advancing technologies, intense competition, a changing regulatory and legislative landscape
and a strong emphasis on the benefits of intellectual property protection and regulatory exclusivities. Our competitors include other
biotechnology companies, pharmaceutical companies, academic institutions, government agencies and other private and public research organizations.
AlloRx Stem Cell therapy or any future product candidates, if successfully developed and approved, may compete with established therapies
and with new treatments that may be introduced by our competitors. We believe that competitors are actively developing competing products
to our product candidates, and in some cases, such as with autism spectrum disorders, there may be tens or hundreds of companies seeking
to commercialize therapeutics.



Many
of our competitors and potential competitors have substantially greater scientific, research, and product development capabilities, as
well as greater financial, marketing, sales and human resources capabilities than we do. In addition, many specialized biotechnology
firms have formed collaborations with large, established companies to support the research, development and commercialization of products
that may be competitive with ours. Accordingly, our competitors may be more successful with respect to their products than we may be
in developing, commercializing, and achieving widespread market acceptance for our products. If a competitor obtains approval for an
orphan drug that is the same drug or the same biologic as one of our candidates before we do, we will be blocked from obtaining FDA approval
for seven years from the date of the competitor’s product, unless we can establish that our product is clinically superior to the
previously-approved competitor’s product or we can meet another exception, such as by showing that the competitor has failed to
provide an adequate supply of its product to patients after approval. In addition, our competitors’ products may be more effective
or more effectively marketed and sold than any treatment we may commercialize and may render our product candidates obsolete or non-competitive
before we can recover the expenses related to developing and supporting the commercialization of any of our product candidates. Developments
by competitors may render our product candidates obsolete or noncompetitive. After one of our product candidates is approved, FDA may
also approve a generic version with the same dosage form, safety, strength, route of administration, quality, performance characteristics
and intended use as our product. These generic equivalents would be less costly to bring to market and could generally be offered at
lower prices, thereby limiting our ability to gain or retain market share.



The
acquisition or licensing of pharmaceutical products is also very competitive, and a number of more established companies, which have
acknowledged strategies to in-license or acquire products, may have competitive advantages as may other emerging companies taking similar
or different approaches to product acquisitions. The more established companies may have a competitive advantage over us due to their
size, cash flows, institutional experience and historical corporate reputation.



MSCs
are biological entities obtained from living humans that can pose risks to the recipient. Any claims relating to improper handling, storage
or disposal of these materials could be time consuming and costly. We may incur significant costs to comply with current or future environmental,
health and safety laws and regulations.



MSC
therapies require many manufacturing steps. Cells must be harvested from donor tissue, isolated, and expanded in cell culture to produce
a sufficient number of cells for use. Each step carries risks of contamination by other cells, microbes, or adventitious agents. The
transfer of cells into a recipient can also carry risks and complications associated with the procedure itself, and a recipient may reject
the transplanted cells. Any failure by us to adequately mitigate such risks and complications could have a material adverse effect on
our reputation or our ability to market our products, which could have a material adverse effect on our business, financial condition,
results of operations, and prospects.





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We
and our suppliers and other collaborators are subject to federal, state and local regulations governing the use, manufacture, storage,
handling and disposal of materials and waste products. Even if we and these suppliers and collaborators comply with the standards prescribed
by law and regulation, the risk of accidental contamination or injury from biological materials cannot be completely eliminated. In the
event of an accident, we could be held liable for any damages that result, and any liability could exceed the limits or fall outside
the coverage of any insurance we may obtain and exceed our financial resources. We may not be able to maintain insurance on acceptable
terms, or at all.



We
are also subject to numerous environmental, health and safety laws and regulations. We may incur substantial costs in order to comply
with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair
our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial
fines, penalties or other sanctions.



Our
product candidates are derived from human UCs and therefore have the potential for disease transmission.



The
utilization of donated umbilical cords creates the potential for transmission of cancer and communicable disease, including but not limited
to human immunodeficiency virus (HIV), viral hepatitis A, B and C, COVID-19, syphilis, Creutzfeldt-Jakob disease, and other viral, fungal,
or bacterial pathogens. Although we and our suppliers are required to comply with federal and state regulations intended to prevent communicable
disease transmission, we or our suppliers may fail to comply with such regulations. Further, even with compliance, our products might
nevertheless be viewed by the public as being associated with transmission of disease, and a clinical trial subject or patient who contracts
an infectious disease might assert that the use of our product candidate or products resulted in disease transmission, even if the individual
became infected through another source.



Any
actual or alleged transmission of communicable disease could result in clinical trial subject or patient claims, litigation, distraction
of management’s attention, potentially increased expenses, and adverse regulatory authority action. Further, any failure in screening,
whether by us or other manufacturers of similar products, could adversely affect our reputation, the support we receive from the medical
community, and overall demand for our products. As a result, such actions or claims, whether or not directed at us, could have a material
adverse effect on our reputation with our customers and our ability to market our products, which could have a material adverse effect
on our business, financial condition, results of operations, and prospects.



Ethical
and other concerns surrounding the use of stem cell therapy or human tissue may negatively affect public perception of us or our products
or product candidates or may negatively affect regulatory approval of our products or product candidates, thereby reducing demand for
our products.



The
commercial success of our product candidates will depend in part on general public acceptance of the use of MSC therapy for the prevention
or treatment of human diseases. The use of embryonic cells and fetal tissue for research and MSC therapy has been the subject of substantial
national and international debate regarding related ethical, legal, and social issues. In the U.S., for example, until March 2009, federal
government funding of embryonic stem cell research was limited to specifically identified cell lines and was not otherwise available.
We do not use embryonic stem cells or fetal tissue, but the public may not be able to, or may fail to, differentiate our use of adult
MSCs from the use of embryonic stem cells or fetal tissue by others, especially considering our use of donor umbilical cords. This could
result in a negative perception of our company or our products or product candidates, thereby reducing demand, which could have a material
adverse effect on our business, financial condition, results of operations, and prospects.



We
may obtain MSCs from umbilical cords donated by healthy adult female donors from non-profit organizations that collect and process tissue
donations. Umbilical cord donors receive payment, but ethical concerns have been raised by some about the use of donated human tissue
in a for-profit setting, as we are doing. Future adverse events in the field of stem cell therapy, changes in public policy, or changes
to the FDA’s regulatory approval framework for these products could also result in greater governmental regulation of our product
candidates or products, and potential regulatory delays relating to their testing or approval.





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The
successful commercialization of our current or future product candidates will depend on obtaining reimbursement from government and third-party
payors.



If
we successfully develop and obtain necessary regulatory approvals, we intend to sell our product candidates in the United States and
outside of the United States where the regulatory environment allows us to expand such products. In the United States and any other jurisdictions
in which we may market our product, the market for any pharmaceutical product is affected by the availability of reimbursement from government
and third-party payors, such as government health administration authorities, private health insurers, health maintenance organizations,
and pharmacy benefit management companies. MSC therapies may be expensive compared with conventional pharmaceuticals, due to the higher
cost and complexity associated with the research, development, and production of product candidates, the small size and large geographic
diversity of the target patient population for some indications, and the complexity associated with the distribution of signaling cell
therapies which require special handling, storage, and shipment procedures and protocols. This, in turn, may make it more difficult for
us to obtain adequate reimbursement from government and third-party payors, particularly if we cannot demonstrate a favorable cost-benefit
relationship. Government and third-party payors may also deny coverage or offer inadequate levels of reimbursement for our potential
products if they determine that the product has not received appropriate clearances from the FDA or other government regulators or is
experimental, unnecessary or inappropriate.



In
some other countries where we may seek to market our products, such as The Commonwealth of the Bahamas, Antigua and The Grand Cayman
Islands, the pricing of prescription pharmaceutical products and services and the level of government reimbursement are subject to governmental
control. In these countries, pricing negotiations with governmental authorities can take six to twelve months or longer after the receipt
of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we or our potential future collaborators
may be required to conduct one or more clinical trials that compare the cost effectiveness of our product candidates or products to other
available therapies. Conducting one or more additional clinical trials would be expensive and could result in delays in commercialization
of our product candidates.



Managing
and reducing health care costs has been a general concern of federal and state governments in the United States and various foreign governments.
Although we do not believe that any recently enacted or presently proposed legislation in any jurisdictions in which we currently operate
should impact our business based on our current model, we might be subject to future regulations or other cost-control initiatives that
materially restrict the price we would receive for our products. In addition, government and third-party payors are increasingly challenging
the price and cost-effectiveness of medical products and services, and many limit reimbursements for newly approved health care products.
In particular, government and third-party payors may limit the indications for which they will reimburse patients who use any products
that we may develop. Cost control initiatives could decrease the price for products that we may develop, which could result in lower
product revenues to us.



A
variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.



We
plan to seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject
to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:



| | ● | differing regulatory requirements
    and reimbursement regimes in foreign countries;                                                                                              
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                    
| | ● | unexpected changes in tariffs,
    trade barriers, price and exchange controls and other regulatory requirements;                                                                  
| |   |                                                                                                                                                                                    
| | ● | economic weakness, including
    inflation, or political instability in particular foreign economies and markets;                                                                  
| |   |                                                                                                                                                                                    
| | ● | compliance with tax, employment,
    immigration and labor laws for employees living or traveling abroad;                                                                          
| |   |                                                                                                                                                                                    
| | ● | foreign taxes, including
    withholding of payroll taxes;                                                                                                                         
| |   |                                                                                                                                                                                    
| | ● | foreign currency fluctuations,
    which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another
    country;



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| | ● | difficulties staffing and
    managing foreign operations;                                                                                                                                                                
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                           
| | ● | workforce uncertainty in
    countries where labor unrest is more common than in the United States;                                                                                                                       
| |   |                                                                                                                                                                                                                           
| | ● | potential liability under
    foreign regulations;                                                                                                                                                                        
| |   |                                                                                                                                                                                                                           
| | ● | challenges enforcing our
    contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual
    property rights to the same extent as the United States;
| |   |                                                                                                                                                                                                                           
| | ● | production shortages resulting
    from any events affecting raw material supply or manufacturing capabilities abroad; and                                                                                                
| |   |                                                                                                                                                                                                                           
| | ● | business interruptions
    resulting from geo-political actions, including war and terrorism.                                                                                                                             



These
and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable
operations.



Risks
Related To Intellectual Property



If
our intellectual property does not adequately protect our products and uses, others could compete against us more directly, which could
harm our business and have a material adverse effect on our business, financial condition, and results of operations.



Our
success depends, in large part, on our ability to obtain and maintain intellectual property protection for product candidates, process
candidates and manufacturing/scale-up processes. Patent positions for biotechnology companies are generally uncertain, involve complex
legal and factual questions, and can be subject to litigation.



We
have no U.S. patents and we may never be awarded one. Our portfolio contains several patent applications, including provisional applications.
Provisional applications may be converted to non-provisional and/or foreign applications, but these applications may not result in a
patent. If patents do not issue, we may not have exclusivity for our products and methods of use.



The
claims of U.S. and foreign patent applications and patents may not confer significant commercial protection against competing products
and may not preclude entry by third parties into the marketplace. Furthermore, to the extent that we own patent rights covering our business,
third parties may challenge or design around those patents; for example, by asserting that the patents are invalid or arguing that the
patent claims should be narrowly construed, and thereby avoid infringement actions. Further, the laws of foreign countries may not protect
intellectual property rights to the same extent as laws of the United States.



Our
patent applications on MSC technologies include claims directed to MSC-containing compositions and therapeutic uses. The MSC technology
area is subject to competition and as a result, third parties may challenge the validity of any patents to facilitate entry into the
market. Patents might not contain claims that are sufficiently broad to prevent others from practicing our technologies or from competing
with us with their own MSC technologies in the fields of interest to us. Consequently, competitors may independently develop competing
products that do not infringe any patents or do not violate other intellectual property rights.



Obtaining
and enforcing patents in the biopharmaceutical industry requires a high level of technological and legal complexity. Therefore, obtaining
and enforcing patents is costly, time-consuming and as a result unpredictable.



Pending
patent applications may not issue or may issue with substantially narrower claims than currently pending claims. These narrower claims
may not confer protection of our products.



Because
of the extensive time required for development, testing, and regulatory review of a potential product, it is possible that a patent may
expire or remain in force for a short period following commercialization, thereby limiting the period of exclusivity. To the extent our
product candidates may not be protected, third parties are not precluded from making using, or selling a competing product or method.





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Additionally,
the background technologies used in some development of our therapeutics and treatments may be known by third parties. This could allow
for third parties to compete using the same prior technologies.



If
we fail to obtain assignment of rights of our intellectual property from all inventors, we may not own or exclusively own our intellectual
property, and this could adversely affect our ability to protect our product and have a materially effect on our business.



Control
over patented technology requires us to obtain formal assignment of patents and patent applications from all inventors. If inventor assignments
are not received or not received in a timely manner, we may not exclusively own the rights in the patents or patent applications.



While
we believe that each inventor on each patent application or patent has already assigned the intellectual property rights by obligation
of employment with us or, if it has not yet been formally assigned, is under an obligation to be assigned to us, if such is not the case,
our business, financial condition, results of operations, and prospects could be adversely affected. Further, we have certain rights
of assignment by employee inventors regarding patents and we have been assigned some of the patents and patent applications by certain
parties, while some of assignments are still outstanding. As such there is a risk that the inventors may refuse to assign the intellectual
property. In addition, an inventor may have rights in the intellectual property being pursued by us. Under U.S. patent law, each co-inventor
where there is no assignment or agreement (e.g., percent ownership or assignment requirement), has joint and several ownership
of the whole application or patent regardless of individual contribution. In the absence of any agreement to the contrary, each of the
joint owners or inventors without assignment of a patent may make, use, offer to sell, or sell the patented invention within the United
States, or import the patented invention into the United States, without the consent of and without accounting to the other owners. In
certain instances, negotiation and/or litigation may be required to compel the execution of those documents where assignment obligation
can be verified.



If
we are unable to protect the confidentiality of our proprietary information, trade secrets, and know-how, our competitive position could
be impaired and our business, financial condition, results of operations, and prospects could be adversely affected.



Some
aspects of our technology, especially regarding MSC expansion, manufacturing, and storage processes, are unpatented. This confidential
information is protected by trade secret. These trade secrets are valuable to us and maintaining the secrecy of our processes is important
to the success of our business. Trade secrets remain valid and enforceable without regard to limitations such as term restrictions that
are imposed on patents. Trade secrets are not enforceable against a third party that innovates these processes independently. To date,
our trade secrets and know-how are protected by confidentiality and/or employment agreements. These agreements, however, may not provide
us with adequate protection against improper use or disclosure of confidential information, and these agreements may be breached. A breach
of confidentiality could affect our competitive position. In addition, in some situations, these agreements may conflict with, or be
subject to, the rights of third parties with whom our employees, consultants, collaborators, or advisors have previous employment or
consulting relationships. Also, others may independently develop substantially equivalent proprietary information and techniques, or
otherwise gain access to our trade secrets or other proprietary information.



Adequate
remedies may not exist in the event of unauthorized use or disclosure of confidential information. The disclosure of trade secrets or
other proprietary information could impair our competitive position and could have a material adverse effect on our business, financial
condition, results of operations, and prospects.



Third-party
claims of patent infringement may prevent or delay our product development efforts.



There
is a risk of litigation involving patents and other intellectual property rights. Numerous U.S. and foreign patents, and pending patent
applications, are owned by third parties in the fields in which we are developing product candidates. There is a risk that our product
and formulation candidates, methods of making product candidates, and methods of using our product candidates may give rise to claims
of infringement by third parties. Third parties may assert that we infringe their patents or are otherwise employing their proprietary
technology without authorization. If our MSCs are approved by the FDA to treat our targeted indications, third parties may seek to enforce
their patents by filing a patent infringement lawsuit.





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Additionally,
there may be third-party patents of which we are currently unaware with claims related to the use or manufacture of our product or therapeutic
use candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may
later result in patents that our product or therapeutic use candidates may infringe. Some of these patent applications may not yet be
available for public review because they are not yet publicly available. If any third-party patents were held by a court of competent
jurisdiction to cover our targeted therapeutic uses, formulations or dosing regimens, or any final product itself, the holders of any
such patents may be able to block our ability to commercialize targeted processes and compositions unless we are able to obtain a license
regarding the applicable patents, or until such patents expire or they are finally determined to be held not infringed, unpatentable,
invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our
formulations, processes for manufacture or methods of use or dosing regimens, including combination therapy or patient selection criteria,
the holders of any such patent may be able to block our ability to develop and commercialize the product candidate and/or our methods
of use unless we obtain a license or until such patent expires or is finally determined to be held not infringed, unpatentable, invalid
or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to
obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product
candidates may be impaired or delayed, which could in turn significantly harm our business.



Parties
making claims against us may seek and obtain injunctive or other equitable relief, which, if granted would block our ability to further
develop and commercialize our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation
expense and would be a substantial diversion of Company resources from our business. In the event of a successful claim of infringement,
we may have to pay substantial damages, obtain one or more licenses from third parties, pay royalties or redesign accused products and/or
methods, which may be impossible or require substantial time and monetary expenditure.



Furthermore,
even in the absence of litigation, we may need to obtain licenses from third parties to advance research or allow commercialization of
product candidates and in certain cases, to avoid litigation. We may fail to obtain any of these licenses at a reasonable cost or on
reasonable terms, if at all. In that event, we would be unable to further develop and commercialize product candidates, which could harm
our business significantly.



We
may become involved in lawsuits to protect or enforce our patents which could be expensive and time consuming.



Litigation
may be necessary to enforce patent rights to protect trade secrets or know-how; or to defend the scope and validity of patent rights.
Litigation, opposition, or other patent office proceedings in the U.S. and foreign jurisdictions, as applicable, could result in substantial
additional costs and diversion of management focus. If we are ultimately unable to protect our intellectual property, we may be subject
to competition which will potentially impact profitably. Competitors may infringe our patents. As a result, we may be required to file
infringement claims against one or more competitors to protect our intellectual property rights, which can be expensive and time-consuming.
In addition, in an infringement proceeding, a court may decide that a patent is invalid or unenforceable, thus preventing enjoinment
of a third party or may refuse to enjoin the other party from using the technology at issue. An adverse determination of any litigation
or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly. Litigation or other
patent office proceedings may fail and, even if successful, may result in substantial costs and distraction to management. We may not
be able, alone or with our collaborators, to prevent misappropriation of our proprietary rights, particularly in countries where the
local laws may not protect or enforce such rights as fully as in the U.S.



Furthermore,
though we would seek protective orders where appropriate, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could be compromised. Disclosure of confidential
information during this type of litigation could cause harm to our business.





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Intellectual
property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.



During
the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as
results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard
these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished.
Accordingly, the value of our company may decline. These declines could be significant. Such announcements could also harm our reputation
or the market for future products, which could have a material adverse effect on our current business, current financial condition, and
prospects.



Biotechnology
is a well-capitalized area, and as a result, we may not be able to keep up with other well-capitalized companies in the market.



Biotechnology
and biotechnological inventions are heavily capitalized and very competitive. The biotechnology industry is subject to significant and
rapid technological change. Accordingly, our success may depend, in part, on our ability to respond quickly to such change through the
development and introduction of new products or revised treatment regimens. Our ability to compete successfully against currently existing
and future alternatives to our product candidates and systems and competitors who compete directly with us in the biotechnology industry
may depend, in part, on our ability to attract and retain skilled personnel, develop superior products, be competitively priced, obtain
patent or regulatory approvals as well as being early entrants to the market and to manufacture, market, and sell our products, independently
or through collaborations. If we are unable to keep up with these changes and competition, our business could be significantly affected.



If
our product candidates are approved by the FDA, then potential competitors could seek to use a publicly available stem-cell products
to compete with our products for the same therapeutic uses, taking advantage of an abbreviated approval pathway as interchangeable with
our product candidates. If we are unable prevent entry of these products into our targeted market, our business could be significantly
affected.



Patent
reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our issued patents.



Laws
change and these changes in laws could have an impact on our business. U.S. patent laws that govern filing, prosecution and patentable
subject matter are constantly in flux. These laws can include provisions that affect the way patent applications are filed, the way in
which patent applications are prosecuted and may also affect patent litigation. New laws confirmed by lower courts and new procedures
available through USPTO proceedings may also affect our ability to obtain patents and to prevent our claims from being narrowly construed
or invalidated. The availability of these processes to third parties could increase the uncertainties and costs surrounding the prosecution
of our patent applications and the enforcement or defense of our patents, all of which could have a material adverse effect on our business,
financial condition, results of operations, and prospects.



Depending
on decisions by the U.S. Congress, the U.S. federal courts, the USPTO, or similar authorities in foreign jurisdictions, the laws and
regulations governing patents could change in unpredictable ways that would weaken our ability to obtain patents or to enforce our patents
we might obtain in the future.



Patent
terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.



Patents
have a limited lifespan. In the United States, if a patent remains in good standing, the natural expiration of a patent is 20 years from
its earliest U.S. non-provisional filing date. Various extensions may be available, but the term of a patent, and the protection it affords,
are limited. In addition, patent life can be reduced if it is found that patented claims have overlapping subject matter of a related
co-owned patent and a terminal disclaimer is filed, reducing the life of the subject patent to less than 20 years. Even if patents directed
to our product candidates are obtained, once the patent term has expired, we may be open to competition from competitive products. As
a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical
to ours.





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If
we do not obtain patent term extension for our product candidates and/or methods of their use, our business may be materially harmed.



Depending
upon the timing, duration, and specifics of any applicable FDA marketing approval of our product candidates and our methods of use, one
or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration
Act of 1984, or the Hatch-Waxman Amendments, or the Biologics Price Competition and Innovation Act of 2009. These laws permit a patent
restoration or extension of term as compensation for patent term lost during product development and the FDA regulatory review process.
These extensions are limited to a single patent being extended per FDA-approved product. A patent term extension cannot extend the remaining
term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product,
a method for using it or a method for manufacturing it may be extended.



Patent
term extension may also be available in certain foreign countries upon regulatory approval of our product candidates and/or therapeutic
uses of these product candidates. However, we may not be granted an extension. If we are unable to obtain patent term extension or restoration
or the term of any such extension is less than applied for, our business could be affected. In addition, competitors may obtain approval
of competing products at the same time or following our patent expiration, and our revenue could be reduced, possibly materially. Further,
if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical
data and launch their product earlier than might otherwise be the case.



We
may not be able to protect our intellectual property rights throughout the world.



We
may not have patents in every jurisdiction in which we sell, thus creating competition that could impact our profitability. Although
we have pending patent applications in the U.S. and certain other countries, filing, prosecuting, and defending patents in all countries
throughout the world would be prohibitively expensive. Due to local laws and other causes, our intellectual property rights in some countries
outside the U.S. can be less robust than those in the U.S. In addition, the laws of some foreign countries do not protect intellectual
property rights to the same extent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from
practicing our inventions in all countries outside the U.S. whether we have filed an application in that country or not. In addition,
we may not be able to prevent third parties from selling or importing products made using our inventions in and into the U.S. or other
jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own
products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not
as strong as that in the U.S. These products may compete with our product candidates and/or therapeutic uses, and this could have adverse
effects on our business.



Further,
it is costly and time-consuming to assert infringement of intellectual property rights against a competitor in a foreign country. Besides
cost and time, many companies have encountered significant problems in protecting and defending intellectual property rights in foreign
jurisdictions. Some legal systems in foreign countries do not favor the enforcement of patents and other intellectual property protection,
which could make it difficult for us to stop the infringement of our intellectual property or stop marketing of competing products in
violation of proprietary rights. As noted above, proceedings to enforce patent rights in foreign jurisdictions could result in substantial
costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or
interpreted narrowly and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate,
and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, efforts to protect and enforce our
intellectual property rights in foreign jurisdictions may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop.



Many
countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition,
many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent
owner may have limited remedies, which could materially diminish the value of such patents. If we are forced to grant a license to third
parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition,
results of operations and prospects may be adversely affected in that country and overall.





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Maintenance
of patents and patent applications is expensive and loss of patent rights by non-payment of required fees could impact the company. We
rely on our outside legal counsel to assist with these matters by sending reminders, as well as, on third parties to pay these fees when
due.



Additionally,
the USPTO and various foreign patent offices require compliance with procedural, documentary, fee payment and other similar provisions
during the patent application process and once a patent is issued or granted. We employ reputable law firms and other professionals to
help us comply, and if needed for an inadvertent lapse many of these deadlines can be extended and a lapse in payment cured by applying
a late fee or by other means in accordance with rules applicable to the particular jurisdiction. However, there are situations in which
noncompliance and/or non-payment can result in abandonment or lapse of the patent or patent application without chance of reinstatement,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, it could have a
material adverse effect on our business, financial condition, and commercial operations.



Risks
Related To Regulatory Approval And Other Government Regulations



If
we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA and other regulatory authorities may
be delayed or denied.



The
commencement and completion of our clinical trials may be delayed or terminated for many reasons, including, but not limited to, if:



| | ● | the FDA does not grant
    INDs to test the product candidates in humans;                                                                                                                                                                                                                                                                          
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | the FDA does not grant,
    or suspends, permission to proceed and places the trial on clinical hold;                                                                                                                                                                                                                                              
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | we are not able to identify
    sufficient clinical trial sites and/or clinical trial investigators to begin or complete a trial;                                                                                                                                                                                                                  
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | subjects do not enroll
    in our trials at the rate we expect;                                                                                                                                                                                                                                                                                    
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | subjects experience an
    unacceptable rate or severity of adverse side effects;                                                                                                                                                                                                                                                                  
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | third-party clinical investigators
    do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, cGCP and regulatory
    requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner, or maintain data
    security and integrity;        
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | the FDA does not agree
    with our interpretation of data obtained from preclinical and nonclinical animal testing and clinical trials, even though the data
    can be interpreted in different ways;                                                                                                                                            
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | inspections by the FDA
    or IRBs of clinical trial sites at research institutions participating in our clinical trials find regulatory violations that require
    us to undertake corrective action, suspend, or terminate one or more sites, or prohibit us from using some or all of the data in
    support of our marketing applications; or
| |   |                                                                                                                                                                                                                                                                                                                                                    
| | ● | one or more IRBs or DSMBs
    (as defined below) suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws
    its approval of the trial.                                                                                                                                             



Our
development costs will increase if we have material delays in our clinical trials, or if we are required to modify, suspend, terminate,
or repeat a clinical trial. If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed
or denied by the FDA.





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Producing
and marketing an approved drug or other medical product is subject to significant and costly post-approval regulation.



Even
if approved for commercial sale, we may be required to conduct Phase 4 clinical trials or comply with other post-marketing requirements
for the products. Even if we obtain approval of a product, we can only market the product for the approved indications. After granting
marketing approval, the FDA and regulatory agencies in other countries continue to review and inspect marketed products, manufacturers,
and manufacturing facilities, creating additional regulatory burdens. Later discovery of previously unknown problems with a product,
manufacturer, or facility may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.
Further, regulatory agencies may establish different or additional regulations that could impact the post-marketing status of our products.



If
we inadvertently violate the guidelines pertaining to promotion and advertising of our clinical candidates or approved products, we may
be subject to disciplinary action by the FDA’s Office of Prescription Drug Promotion (“OPDP”) or other regulatory bodies.



The
FDA’s Office of Prescription Drug Promotion, or OPDP, is responsible for reviewing prescription drug advertising and promotional
labeling to ensure that the information contained in these materials is not false or misleading. There are specific disclosure requirements
and the applicable regulations mandate that advertisements cannot be false or misleading or omit material facts about the product. Prescription
drug promotional materials must present a fair balance between the drug’s effectiveness and the risks associated with its use.
Most warning letters from OPDP cite inadequate disclosure of risk information.



OPDP
prioritizes its actions based on the degree of risk to the public health, and often focuses on newly introduced drugs and those associated
with significant health risks. There are two types of letters that OPDP typically sends to companies that violate its drug advertising
and promotional guidelines: notice of violation letters, or untitled letters, and warning letters. In the case of an untitled letter,
OPDP typically alerts the drug company of the violation and issues a directive to refrain from future violations but does not typically
demand other corrective action. A warning letter is typically issued in cases that are more serious or where the company is a repeat
offender. Although we have not received any such letters from OPDP, we may inadvertently violate OPDP’s guidelines in the future
and be subject to a OPDP untitled letter or warning letter, which may have a negative impact on our business. Similarly, we and our collaborators
may inadvertently violate the guidelines of the foreign equivalent of the FDA’s OPDP.



We
and any of our future development partners will be required to report to regulatory authorities if any of our approved products cause
or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.



If
we and any future development partners are successful in commercializing our products, FDA and foreign regulatory authorities would require
that we and any future development partners report certain information about adverse medical events if those products may have caused
or contributed to those adverse events. The timing of our obligation to report would be triggered by the date we become aware of the
adverse event as well as the nature of the event. We and any future development partners may fail to report adverse events we become
aware of within the prescribed timeframe. We and any future development partners may also fail to appreciate that we have become aware
of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected
or removed in time from the use of our products. If we and any future development partners fail to comply with our reporting obligations,
FDA or a foreign regulatory authority could take action against us including criminal prosecution, the imposition of civil monetary penalties,
seizure of our products, or delay in approval or clearance of future products.



Our
business could target benefits from various regulatory incentives, such as orphan drug exclusivity, breakthrough therapy designation,
fast track designation, and priority review, but we may not ultimately qualify for or benefit from these incentives.



We
may seek various regulatory incentives, such as orphan drug exclusivity, breakthrough therapy designation, fast track designation, accelerated
approval, priority review and Priority Review Vouchers (“PRVs”), where available, that provide for certain periods of exclusivity,
expedited review and/or other benefits, and we may also seek similar designations elsewhere in the world. Often, regulatory agencies
have broad discretion in determining whether products qualify for such regulatory incentives and benefits. We cannot guarantee that we
will be able to receive orphan drug status from FDA or equivalent regulatory designations elsewhere. We also cannot guarantee that we
will obtain breakthrough therapy or fast track designation, which may provide certain potential benefits such as more frequent meetings
with FDA to discuss the development plan, intensive guidance on an efficient drug development program, and potential eligibility for
rolling review or priority review. Legislative developments in the U.S., including proposed legislation that would restrict eligibility
for PRVs, may affect our ability to qualify for these programs in the future.





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Even
if we are successful in obtaining beneficial regulatory designations by FDA or other regulatory agency for our product candidates, such
designations may not lead to faster development or regulatory review or approval and does not increase the likelihood that our product
candidates will receive marketing approval. We may not be able to obtain or maintain such designations for our product candidates, and
our competitors may obtain these designations for their product candidates, which could impact our ability to develop and commercialize
our product candidates or compete with such competitors, which would adversely impact our business, financial condition or results of
operations.



Obtaining
and maintaining regulatory approval of a product in one jurisdiction does not mean that we will be successful in obtaining or maintaining
regulatory approval in other jurisdictions.



Obtaining
and maintaining regulatory approval of a product in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory
approval in any other jurisdiction. For example, even if the FDA grants marketing approval of a product, comparable regulatory authorities
in foreign jurisdictions must also approve the manufacturing, marketing and promotion and reimbursement of the product in those countries.
However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval
process in others. Moreover, product types or regulatory classifications, as well as approval procedures vary among jurisdictions and
can involve requirements and administrative review periods different from those in the United States, including different or additional
preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities
in other jurisdictions. In many jurisdictions outside the United States, a product must be approved for reimbursement before it can be
approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.



Obtaining
foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant
delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we or any
future collaborator fails to comply with the regulatory requirements in international markets or fails to receive applicable marketing
approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.



The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.



If
any of our product candidates are approved and we are found to have improperly promoted off-label uses of those products, we may become
subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about
prescription products, such as our product candidates, if approved. In particular, an approved product may not be promoted for uses that
are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If we receive marketing
approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the
approved label, which is within their purview as part of their practice of medicine. If we are found to have promoted such off-label
uses, however, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines
against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.
The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct
is changed or curtailed. The FDA may also issue a public warning letter or untitled letter to the company. If we cannot successfully
manage the promotion of our future approved products, we could become subject to significant liability, which would materially adversely
affect our business and financial condition.





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The
FDA and other comparable foreign regulatory authorities may not accept data from trials or studies conducted in locations outside of
their jurisdiction.



We
currently supply AlloRx Stem Cells to numerous foreign third-party clinics and medical centers. Such foreign third-party clinics and
medical centers are currently using, or intend to use, AlloRx Stem Cells to conduct clinical studies for the potential treatment of a
wide variety of indications, and we may choose to conduct international clinical trials or studies in the future. The primary purpose
of these clinical studies is for the open-label treatment of the respective indication; accordingly, there is no randomized control group
for patients treated in these foreign clinical studies.



The
acceptance of study data by the FDA, or other comparable foreign regulatory authority from clinical trials or studies conducted outside
of their respective jurisdictions may be subject to certain conditions. In cases where data from foreign clinical trials or studies are
intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the
basis of foreign data alone unless (1) the data are applicable to the United States population and United States medical practice; (2)
the trials are performed by clinical investigators of recognized competence and pursuant to cGCP requirements; and (3) the FDA is able
to validate the data through an on-site inspection or other appropriate means. The FDA may accept the use of some foreign data to support
a marketing approval if the clinical trial meets certain requirements. Additionally, the FDA’s clinical trial requirements, including
the adequacy of the subject population studied and statistical powering, must be met. Furthermore, such foreign trials or studies would
be subject to the applicable local laws of the foreign jurisdictions where the trials or studies are conducted, including from our ongoing
and planned pre-clinical studies of AlloRx Stem Cells, for which we plan to enroll cohorts outside the United States. There can be no
assurance that the FDA or any applicable foreign regulatory authority will accept data from trials or studies conducted outside of its
respective jurisdiction. Moreover, since the foreign third-party conducted clinical studies using AlloRx Stem Cells are neither placebo-controlled
nor blinded, the FDA may be less likely to accept such data. If the FDA, or any applicable foreign regulatory authority does not accept
such data, it may result in the need for additional studies, which would be costly and time-consuming and delay aspects of our business
plan, and which may result in our product candidates not receiving approval for commercialization in the applicable jurisdiction.



In
addition, foreign clinical studies conducted by The Foundation for Orthopaedics and Regenerative Medicine in St. John’s, Antigua
and Barbuda using AlloRx Stem Cells are run by Chadwick Prodromos, M.D., who holds Series A Convertible Preferred Share Units, with each
Preferred Unit consisting of 2,000 shares of Series A Preferred Stock, a Class A Warrant to purchase up to 100,000 shares of our common
stock at an exercise price of $0.50 per share and a Class B Warrant to purchase up to 100,000 shares of our common stock at an exercise
price of $1.00 per share (“Series A Units”). As part of future drug approval applications to the FDA, we must disclose certain
financial interests of investigators who participated in any of the clinical studies being submitted in support of approval or must certify
to the absence of such financial interests. The FDA evaluates the information contained in such disclosures to determine whether disclosed
interests may have an impact on the reliability of a study. If the FDA determines that financial interests of any clinical investigator,
including that of Dr. Prodromos, raise serious questions of data integrity, the FDA can institute a data audit, request that we submit
further data analyses, conduct additional independent studies to confirm the results of the questioned study, or refuse to use the data
from the questioned study as a basis for approval. A finding by the FDA that a financial relationship of an investigator raises serious
questions of data integrity could delay or otherwise adversely affect approval of our products.



We
may attempt to secure approval from the FDA or comparable foreign regulatory authorities through an expedited review program, and if
we are unable to do so, then we could face increased expense to obtain, and delays in the receipt of, necessary marketing approvals.



We
may in the future seek approval for one or more of our product candidates under one of the FDA’s expedited review programs for
serious conditions. These programs are available to sponsors of therapies that address an unmet medical need to treat a serious condition.
The qualifying criteria and requirements vary for each expedited program. Prior to seeking review under one of these expedited programs
for any of our product candidates, we intend to seek feedback from the FDA and will otherwise evaluate our ability to seek and receive
marketing approval through an expedited review program.



In
August 2021, we submitted an initial request for ODD for PTHS to FDA’s Office of Orphan Products Development. In November 2021,
FDA indicated that it was unable to grant our initial ODD request but indicated that we may submit an amendment to our initial request
containing additional information, specifically outcome data from our Phase 1/2a clinical trial for PTHS. FDA has not yet made a determination
as to whether PTHS qualifies as a “rare disease or condition,” and we expect such determination will be made on the basis
of the facts and circumstances if and when the amendment to our request for ODD is submitted.





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There
can be no assurances that, after our evaluation of the FDA’s feedback and other factors, we will decide to pursue one or more of
these expedited review programs. Similarly, there can be no assurance that after subsequent FDA feedback we will continue to pursue one
or more of these expedited programs, even if we initially decide to do so. Furthermore, FDA could decide not to grant our request to
use one or more of the expedited review programs for a product candidate, even if the FDA’s initial feedback is that the product
candidate would qualify for such program(s). Moreover, FDA can decide to stop reviewing a product candidate under one or more of these
expedited review programs if, for example, the conditions that warranted expedited review no longer apply to that product candidate.



Some
of these expedited programs (e.g., accelerated approval) also require post-marketing clinical trials to be completed and, if any such
required trial fails, the FDA could withdraw the approval of the product. If one of our product candidates does not qualify for any expedited
review program, then this could result in a longer time period to approval and commercialization of such product candidate, could increase
the cost of development of such product candidate, and could harm our competitive position in the marketplace.



Our
research and development activities could be affected or delayed due to possible restrictions on animal testing.



Certain
laws and regulations require us to test our product candidates on animals before initiating clinical trials involving humans. Animal
testing activities have been the subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals
have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities
through protests and other means. To the extent the activities of these groups are successful, or if the laws and regulations regarding
animal testing otherwise change, our research and development activities may be interrupted, delayed or become more expensive.



We
may face difficulties from changes to current statutes or regulations and future legislation or regulations, both in the U.S. as well
as in other foreign jurisdictions where we may be operating.



Existing
statutes or regulations may be revised and additional legislation or regulations may be codified that could prevent, limit, delay or
otherwise adversely affect regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or
unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain
regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.



For
example, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010,
or collectively the ACA, substantially changed the way healthcare is financed by both the government and private insurers, and significantly
impacts the U.S. pharmaceutical industry. Some of the provisions of the ACA have yet to be implemented, and there have been judicial
and Congressional challenges and attempts to repeal or replace certain aspects of the ACA. While Congress has not passed comprehensive
repeal legislation, legislation affecting the implementation of the ACA have passed. On December 22, 2017, President Trump signed into
law federal tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”), which includes a provision
eliminating, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail
to maintain qualifying health coverage for all or part of a year, which is commonly referred to as the “individual mandate”.
In addition, the Further Consolidated Appropriations Act of 2020, signed into law December 20, 2019, permanently eliminates, effective
January 1, 2020, the ACA-mandated “Cadillac” tax on certain high-cost employer-sponsored health coverage and the excise tax
on non-exempt medical devices and, effective January 1, 2021, also eliminates the annual fee imposed on certain health insurance providers
based on market share. The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the ACA, effective January 1, 2019,
to increase from 50% to 70% the point-of-sale discount that pharmaceutical manufacturers participating in the Medicare Coverage Gap Discount
Program must provide to eligible Medicare Part D beneficiaries during the coverage gap phase of the Part D benefit, commonly referred
to as the “donut hole,” and to reduce standard beneficiary cost sharing in the coverage gap from 30% to 25% in most Medicare
Part D plans. In December 2018, the Centers for Medicare & Medicaid Services, or CMS, published a new final rule permitting further
collections and payments to and from certain ACA-qualified health plans and health insurance issuers under the ACA risk adjustment program
in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On December
14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate”
was repealed by Congress as part of the Tax Act. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit ruled
that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining
provisions of the ACA are invalid as well. On June 17, 2021, the U.S. Supreme Court dismissed this challenge without specifically ruling
on the constitutionality of the ACA.





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In
addition, other legislative changes have been proposed and adopted in the United States that could impact our future business and operations,
including those that may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse
effect on customers for our product candidates, if approved, and accordingly, our business, financial condition, and results of operations.



Moreover,
there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drug products. While several proposed reform measures will require additional Congress
to pass legislation to become effective, Congress and the Biden administration have each indicated that they will continue to seek new
legislative and/or administrative measures to control drug costs. The Biden administration has taken several recent executive actions
that signal changes in policy from the prior administration. For example, on July 9, 2021, President Biden signed an executive order
(the “Executive Order”) to promote competition in the U.S. economy that included several initiatives addressing prescription
drugs. Among other provisions, the Executive Order directed the Secretary of Health and Human Services (“HHS”) to issue a
report to the White House that includes a plan to, among other things, reduce prices for prescription drugs, including prices paid by
the federal government for such drugs. In response to the Executive Order, on September 9, 2021, HHS issued a Comprehensive Plan for
Addressing High Drug Prices that identified potential legislative policies and administrative tools that Congress and the agency can
pursue in order to make drug prices more affordable and equitable, improve and promote competition throughout the prescription drug industry,
and foster scientific innovation. At the state level, legislatures have increasingly passed legislation and implemented regulations designed
to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions
on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, mechanisms designed to encourage
importation from other countries and bulk purchasing.



We
expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from
Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product
candidates.



Legislative
and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for biotechnology
products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations
will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition,
increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as
subject us to more stringent product labeling and post-marketing testing and other requirements.





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Our
relationships with healthcare providers, clinical investigators, CROs and third-party payors in connection with our current and future
business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government
price reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions,
civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and
diminished profits and future earnings.



Healthcare
providers and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtain
future marketing approval. Our current and future arrangements with healthcare providers, clinical investigators, CROs, third-party payors
and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business
or financial arrangements and relationships through which we market, sell and distribute our products for which we obtain marketing approval.
Restrictions under applicable federal and state healthcare laws and regulations include, without limitation, the following:



| | ● | the federal Anti-Kickback
    Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing
    remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual
    for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program,
    such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or
    specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including
    items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for
    purposes of the civil False Claims Act. The Anti-Kickback Statute applies to arrangements between pharmaceutical manufacturers on
    the one hand and individuals, such as prescribers, patients, purchasers, and formulary managers on the other hand, including, for
    example, consulting/speaking arrangements, discount and rebate offers, grants, charitable contributions, and patient support offerings,
    among others. A conviction for violation of the Anti-Kickback Statute can result in criminal fines and/or imprisonment and requires
    exclusion from participation in federal health care programs. Exclusion may also be imposed if the government determines that an
    entity has committed acts that are prohibited by the Anti-Kickback Statute. Although there are a number of statutory exceptions and
    regulatory safe harbors to the federal Anti-Kickback Statute that protect certain common industry practices from prosecution, the
    exceptions and safe harbors are narrowly drawn, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy
    all elements of an available exception or safe harbor. The Anti-Kickback Statute safe harbors have been the subject of recent regulatory
    reforms. As a general matter, however, any changes to the safe harbors may impact our future contractual and other arrangements with
    pharmacy benefit managers, group purchasing organizations, third-party payors, wholesalers and distributors, healthcare providers
    and prescribers, and other entities, as well as our future pricing strategies;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | the federal false claims
    laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam
    actions, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal
    government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation
    to pay money to the federal government. FCA liability is potentially significant in the healthcare industry because the statute provides
    for treble damages and mandatory penalties of $11,803 to $23,607 per false claim or statement for penalties assessed after December
    13, 2021, with respect to violations occurring after November 2, 2015. In addition, the 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 False Claims Act. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any
    request or demand” for money or property presented to the U.S. government. Manufacturers can be held liable under the False
    Claims Act even when they do not submit claims directly to government payers if they are deemed to “cause” the submission
    of false or fraudulent claims. Criminal prosecution is also possible under the federal criminal False Claims Act, which is similar
    to the federal civil False Claims Act and imposes criminal liability for making or presenting a false, fictitious or fraudulent claim
    to the federal government;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              



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| | ● | the federal Health Insurance
    Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, knowingly and willfully executing or attempting
    to execute a scheme or artifice to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses,
    representations, or promises, any of the money or property owned by, or under the custody or control of any health care benefit program
    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. Criminal statutes enacted as part of HIPAA also make it a crime to knowingly and willfully falsify, conceal or cover
    up a material fact, make any materially false, fictitious or fraudulent statements or representations, or make or use any materially
    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 certain 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; (4) failing to report and return a known overpayment; or
    (5) offering or transferring remuneration to any Medicare or Medicaid beneficiary that the offeror or transferor knows or should
    know is likely to influence such individual to order or receive from a particular provider, practitioner or supplier any item or
    service for which payment may be made, in whole or in part, under Medicare or Medicaid;
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
| | ● | the federal Physician Payments
    Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available
    under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to track and annually report
    to CMS (for public disclosure) information regarding certain payments and other transfers of value to covered recipients. The term
    covered recipients includes U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist
    assistants, certified nurse anesthetists, certified nurse midwives, and teaching hospitals, as well as information regarding certain
    ownership and investment interests held by physicians and their immediate family members; and                                                                                                                                                                                                                                                             
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
| | ● | analogous state and foreign
    laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing or other arrangements and
    claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        



Some
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 and may require drug manufacturers to report information related to
certain payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Some state laws
require pharmaceutical companies to report information on the pricing of certain drug products. State and foreign laws also 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. For instance, the collection and use of health data in the European
Union is governed by the General Data Protection Regulation (the “GDPR”), which extends the geographical scope of European
Union data protection law to non-European Union entities under certain conditions, tightens existing European Union data protection principles,
creates new obligations for companies and new rights for individuals. Failure to comply with the GDPR may result in substantial fines
and other administrative penalties. In addition, on June 28, 2018, the State of California enacted the California Consumer Privacy Act,
or CCPA, which took effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers and increases the
privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations,
as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our
compliance costs and potential liability, and similar laws have been passed or proposed in other states and proposed at the federal level.





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Efforts
to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations
will involve on-going substantial costs. It is possible that governmental authorities will conclude that our business practices may not
comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may
be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual
imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight
and reporting obligations, temporary or permanent debarment, contractual damages, reputational harm, diminished profits and future earnings
and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time-consuming and may require
significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be
brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom
we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative
sanctions, including exclusions from government funded healthcare programs.



Risks
Related To The Cosmetic Product Industry And InfiniVive MD Products



A
recall or suspension of sale of our InfiniVive MD products, or the discovery of serious safety issues with our products or the incorrect
application of such products by medical professionals to which we sell such products, could have a significant negative impact on us.



The
FDA and equivalent foreign regulatory authorities have the authority to require the recall or suspension, either temporarily or permanently,
of commercialized products in the event of material deficiencies or defects in quality systems, product design or manufacture or in the
event that a product poses an unacceptable risk to health. Regulatory authorities have broad discretion to require the recall or suspension
of a product or to require that manufacturers alert customers of safety risks and may do so even in circumstances where we do not believe
our product poses an unacceptable risk to health. Recalls, suspensions or other notices relating to any products that we distribute would
divert managerial and financial resources, and have an adverse effect on our reputation, financial condition and operating results.



In
addition, regulatory authorities may require us to, or we may voluntarily, suspend sales of a product if we become aware that the medical
professionals to which we sell our products have not followed our instructions for application. For example, InfiniVive MD’s Exosome
Serum contains conditioned media derived from AlloRx Stem Cells containing various secreted products including proteins, RNA and exosomes
and must be applied topically by a professional. When such product is marketed and sold by us to plastic surgeons, cosmetic surgeons
and aestheticians throughout the United States and internationally, we include instructions specifying that such product must be applied
topically by these medical professionals. Administration outside of those specific directions could result in us running afoul of FDA
rules and regulations.



InfiniVive
MD products may fail to achieve the broad degree of physician adoption and use or consumer demand necessary for commercial success.



InfiniVive
MD products, which are used solely in a clinical setting, may fail to gain sufficient market acceptance by physicians, consumers and
others in the medical aesthetics community. The commercial success of these products and any future products will depend significantly
on the broad adoption and use of the resulting product by physicians for the treatment of aesthetic indications that we may seek to pursue.
We are aware that other companies are seeking to develop alternative products and treatments, any of which could impact the demand for
our InfiniVive MD products.



The
degree and rate of physician adoption of our exosome serums and any future products depend on a number of factors, including the cost,
profitability to our customers, consumer demand, characteristics and effectiveness of the product. Our success will also depend our ability
to create compelling marketing programs and ability to overcome any biases physicians or consumers may have toward the use, safety and
efficacy of existing products over our InfiniVive MD products. Moreover, our competitors may offer more compelling marketing or discounting
programs than we are able to offer, including by bundling multiple aesthetic products to provide
a more comprehensive offering than we can. We can provide no assurance that health professionals will continue to recommend our products
at their current levels, or at all. Additionally, we may be unable to continue to grow our network of health professionals and therefore
may not continue to achieve revenue growth through this channel.





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With
respect to consumer demand, treatment with InfiniVive MD products is an elective procedure, the cost of which must be borne by the consumer,
and we do not expect costs related to the treatment to be reimbursable through any third-party payor, such as Medicaid, Medicare or commercial
insurance. The decision by a consumer to undergo treatment with InfiniVive MD products for aesthetic indications may be influenced by
a number of factors, including the cost, efficacy, safety, perception, marketing programs for, and physician recommendations of InfiniVive
MD products versus competitive products or procedures. Moreover, consumer demand may fluctuate over time as a result of consumer sentiment
about the benefits and risks of aesthetic procedures generally and InfiniVive MD products in particular, changes in demographics and
social trends, and general consumer confidence and consumer discretionary spending, which may be impacted by the COVID-19 outbreak, economic
and political conditions.



If
our InfiniVive MD products or any future product candidates fail to achieve the broad degree of physician adoption necessary for commercial
success or the requisite consumer demand, our operating results and financial condition will be adversely affected, which may delay,
prevent or limit our ability to generate revenue and continue our business.



FDA
and FTC may undertake enforcement action against our cosmetic products if they do not accept our advertising and marketing or if those
products are used beyond the intended uses that we authorize.



If
our products are marketed outside of their intended use, for example if they are advertised for the treatment, diagnosis, cure, prevention,
or mitigation of a disease, then regulatory agencies may issue a warning letter or further investigate our marketing practices to ensure
we are complying with advertising and promotional rules that apply to the product category.



If
we fail to develop and maintain our InfiniVive MD brand, our business could suffer.



We
believe that InfiniVive MD is a brand that has contributed to the success of our business since it was acquired by us in 2021, and we
believe our continued success depends on our ability to maintain and grow the value of our InfiniVive MD brand. Maintaining, promoting
and positioning our brand and reputation will depend on, among other factors, the success of our product offerings, product safety, quality
assurance, marketing and merchandising efforts, our continued focus on delivering well-designed and effective products to our consumers
and our ability to provide a consistent, high-quality consumer experience. Any negative publicity, regardless of its accuracy, could
have an adverse effect on our business. Brand value is based on perceptions of subjective qualities, and any incident that erodes the
loyalty of our consumers, suppliers or manufacturers, including changes to our products or packaging, adverse publicity or a governmental
investigation, litigation or regulatory enforcement action, could significantly reduce the value of our brands and adversely affect our
business, financial condition, results of operations and prospects.



Our
InfiniVive MD brand and reputation may be diminished due to real or perceived quality, safety, efficacy or environmental impact issues
with its products, which could have an adverse effect on our business, financial condition, results of operations and prospects.



Any
loss of confidence on the part of consumers in our InfiniVive MD products or the ingredients used in our products, whether related to
product contamination or product safety or quality failures, actual or perceived, environmental impacts, or inclusion of prohibited ingredients,
or ingredients that are perceived to be “toxic”, or any societal apprehension about the use of stem cells in consumer products,
could tarnish the image of our brand and could cause consumers to choose other products. Allegations of contamination or other adverse
effects on product safety or efficacy or suitability for use by a particular consumer or on the environment, even if untrue, may require
us to expend significant time and resources responding to such allegations and could, from time to time, result in a recall of a product
from any or all of the markets in which the affected product was distributed. Any such issues or recalls could negatively affect our
ability to achieve or maintain profitability and brand image.



We
also have no control over our InfiniVive MD products once purchased by consumers. For example, consumers may store or use our InfiniVive
MD products under conditions and for periods of time inconsistent with approved directions for use or the listed expiration date or required
warnings or other governmental guidelines on our labels, which may adversely affect the quality and safety of our products.





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If
our InfiniVive MD products are found to be, or perceived to be, defective or unsafe, or if they otherwise fail to meet our consumers’
expectations, our relationships with consumers could suffer, the appeal of our brands could be diminished, we may need to recall some
of our InfiniVive MD products and/or become subject to regulatory action, and we could lose sales or market share or become subject to
boycotts or liability claims. In addition, safety or other defects in our competitors’ products could reduce consumer demand for
our own products if consumers view them to be similar. Any such adverse effect could be exacerbated by our market positioning as a purveyor
of cosmetic products and may significantly reduce our brand’s value. Issues regarding the safety, efficacy, quality or environmental
impact of any of our products, regardless of the cause, may have an adverse effect on our brand, reputation and operating results. Negative
publicity about us, our brand or our InfiniVive MD products could seriously damage our brand and reputation. Any loss of confidence on
the part of consumers in the quality, safety, efficacy or environmental suitability of our products would be difficult and costly to
overcome, even if such concerns were based on inaccurate or misleading information. If we do not maintain the favorable perception of
our InfiniVive MD brand, our business, financial condition, results of operations and prospects could be adversely affected.



The
cosmetics industry is highly competitive, and if InfiniVive MD’s products are unable to compete effectively our results will suffer.



InfiniVive
MD faces vigorous competition from companies throughout the world, including large multinational consumer products companies that have
many cosmetics brands under ownership and standalone cosmetics brands. Competition in the cosmetics industry is based on the introduction
of new products, pricing of products, quality of products and packaging, brand awareness, perceived value and quality, innovation, in-store
presence and visibility, promotional activities, advertising, editorials, e-commerce and other activities. Any future direct to consumer
products that we may develop, must compete with a high volume of new product introductions and existing products by diverse companies
across several different distribution channels.



Many
multinational consumer companies have greater financial, technical, or marketing resources, longer operating histories, greater brand
recognition or larger customer bases than we do and may be able to respond more effectively to changing business and economic conditions
than we can. Our competitors may attempt to gain market share by offering products at prices at or below the prices at which our InfiniVive
MD products are typically offered, including through the use of large percentage discounts and “buy one and get one free”
offers. Competitive pricing may require us to reduce our prices, which would decrease our profitability or result in lost sales. Our
competitors, many of whom have greater resources than we do, may be better able to withstand these price reductions and lost sales.



Risks
Related To The Dietary And Nutritional Supplements Industry And Fitore Products



Adulterated
or misbranded products appearing on the market under the Fitore brand may subject us to costs or liabilities or damage our reputation
and brand.



Adulterated
or misbranded supplements sold under our Fitore brand in the future could contain harmful or unlawful ingredients or may not perform
as intended. In the future, we could become involved in investigations with the FDA or other federal and state agencies as a result of
adulterated or misbranded supplements. We may incur costs or liabilities resulting from an investigation or become involved in product
liability litigation resulting from adulterated or misbranded supplements. Even if there is no customer harm, adulterated or misbranded
products that do not perform as intended could damage our reputation and brand and lead to a loss of customer sales as a result.





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We
and our suppliers are subject to numerous laws and regulations that apply to the manufacture, sale and marketing of products that promote
health and wellness, including cosmetics, dietary supplements, and other personal care products, and compliance with these laws and regulations,
as they currently exist or as modified in the future, may increase our costs, limit or eliminate our ability to sell certain products,
subject us or our suppliers to the risk of enforcement action, or otherwise adversely affect our business, results of operations and
financial condition.



As
a distributor of products that promote health and wellness, including cosmetics, dietary supplements, and other personal care products,
we are subject to numerous health and safety laws and regulations. Our third-party manufacturers for Fitore products are also subject
to such laws and regulations. These laws and regulations apply to many aspects of our business, including the manufacturing, packaging,
labeling, distribution, advertising, sale, quality and safety of products we sell, as well as the health and safety of our team members
and the protection of the environment. We are subject to regulation by various government agencies, including the FDA, the FTC, as well
as various state and local agencies. For example, certain of our products are subject to numerous and extensive laws and regulations
governing the type of claims we can make regarding our products, the product constituents that can be used to manufacture our products,
and whether our product constituents or the products themselves require pre-market review or pre-market notification. Outside the United
States, our activities and products are also subject to numerous similar statutes and regulations. Many of these laws and regulations
involve a high level of subjectivity, are inherently fact-based and subject to interpretation, and vary significantly from market to
market.



Dietary
supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a statute which is administered by the
FDA which amended the FFDCA. DSHEA expressly permits supplements to bear statements describing how a product affects the structure, function
or general well-being of the body. However, no statement may expressly or implicitly represent that a supplement will diagnose, cure,
mitigate, treat or prevent a disease. DSHEA has not been materially amended since it was enacted in 1994 but the newly constituted U.S.
Congress or executive branch could decide to revisit whether changes are necessary to modernize this legislation.



Our
dietary supplement products are required to be manufactured in compliance with current cGMP requirements. As a result, the third-party
manufacturing facilities used by us or any of our current or future suppliers must be compliant with cGMPs. These manufacturing facilities
are subject to ongoing periodic unannounced inspections by the FDA and corresponding state and international authorities for compliance
with cGMPs and similar regulatory requirements. If we or our manufacturers cannot successfully manufacture material that conforms to
our specifications and the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, our products may
be deemed noncompliant, and we could face sanctions being imposed on us, including fines, injunctions, civil penalties, delays, operating
restrictions, interruptions in supply, recalls, withdrawals, issuance of safety alerts and criminal prosecutions, any of which could
have a material adverse impact on our business, financial condition, results of operations and prospects. Finally, we also could experience
manufacturing delays if our contractors give greater priority to the manufacture and supply of other products over our products or otherwise
do not satisfactorily perform according to the terms of their agreements with us.



The
FDA has broad authority to enforce the provisions of the FFDCA applicable to the safety, labeling, manufacturing and promotion of dietary
supplements, including powers to issue a public warning letter to a company, publicize information about illegal products, institute
an administrative detention, request or order a recall of illegal products from the market and request the Department of Justice to initiate
a seizure action, an injunction action or a criminal prosecution in the U.S. courts. Pursuant to the Food Safety Modernization Act (“FSMA”),
the FDA also has the power to refuse the import of dietary supplement from a foreign supplier that is not appropriately verified as in
compliance with all FDA laws and regulations. Moreover, the FDA has the authority to administratively suspend the registration of any
facility producing dietary supplements, deemed to present a reasonable probability of causing serious adverse health consequences.



In
connection with the marketing and advertisement of certain of the products we sell, we could be the target of claims relating to false
or deceptive advertising, including under the auspices of the FTC and the consumer protection statutes of some states. Furthermore, in
recent years, the FDA has been aggressive in enforcing its regulations with respect to nutrient content claims, unauthorized “health
claims,” which are defined as claims that characterize the relationship between a food or food ingredient and a disease or health
condition, and other claims that impermissibly suggest therapeutic benefits for certain products including dietary supplements. These
events could interrupt the marketing and sales of our products, severely damage our brand reputation and public image, increase the cost
of our products, result in product recalls, market withdrawals or litigation and impede our ability to deliver our products, any of which
could result in a material adverse effect on our business, financial condition and results of operations.



As
is common in the dietary supplements industry, we rely on our suppliers to ensure that the Fitore products that they manufacture for
us comply with all applicable regulatory and legislative requirements. However, there is no assurance that our suppliers comply with
such requirements and any claims of non-compliance could significantly damage our reputation and consumer confidence in our products.





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We
cannot predict the nature of future laws, regulations, interpretations or applications, or determine what effect either additional government
regulations or administrative orders, when and if promulgated, or disparate federal, state and local regulatory schemes would have on
our business in the future. They could, however, increase our costs or require the reformulation of certain products to meet new standards,
the recall or discontinuance of certain products not able to be reformulated, additional recordkeeping, expanded documentation of the
properties of certain products, expanded or different labeling or scientific substantiation. Another example is that the FDA could require
the production of efficacy data for nutritional supplements. Any or all of such requirements could have a material adverse effect on
our business, financial condition and results or operation.



If
Fitore’s products cause undesirable side effects, our business may suffer.



Although
many of the ingredients in Fitore’s current products are vitamins, minerals and other substances for which there is a long history
of human consumption, they also contain innovative ingredients or combinations of ingredients. Although we believe all of such products
and the combinations of ingredients in them will not result in adverse events when taken as directed, the products could have certain
undesirable side effects if not taken as directed or if taken by a consumer that has certain medical conditions. In addition, such products
may not have the effect intended if they are not taken in accordance with certain instructions, which include certain dietary restrictions.
Furthermore, there can be no assurance that any of the products, even when used as directed, will have the effects intended or will not
have harmful side effects in an unforeseen way or affect populations differently. If any of our Fitore products or products we develop
or commercialize in the future are shown to be harmful or generate negative publicity from perceived harmful effects, our business, financial
condition, results of operations and prospects would be harmed significantly.



Additional
Risks Related To Our Supply Arrangements With Third-Party Foreign Medical Centers



FDA
could prohibit us from exporting products for use in compassionate use programs or clinical studies in foreign jurisdictions.



Currently,
we are exporting products for use in clinical studies for indications that are not subject to an FDA-authorized IND. In order to export
the drug legally, we must comply with FDA regulations including 21 C.F.R. Part 312.110 and 21 C.F.R. Part 312.120. These FDA regulations
require us to provide written certification to FDA regarding the countries that we plan to export the drug to and certify that the drug,
among other things, complies with the foreign countries’ laws and that our clinical studies are in compliance with FDA’s
regulations for foreign clinical studies that are not conducted under an IND. If FDA determines that we have not provided the proper
written certification prior to export, or that our clinical studies are not in compliance with FDA rules, FDA can prohibit us from exporting
the product. This could impact our revenue from our patient-sponsored studies as well as our ability to receive approval for use of AlloRx
in the United States.



FDA,
FTC, and other regulatory agencies actively enforce against medical tourism companies and medical providers advertising to patients in
the United States if the claims or procedures are not substantiated or in compliance with the local countries’ laws.



If
one of our medical tourism partners does not take care to properly substantiate their claims or properly contextualize their claims made
about their services, FTC can take enforcement action, sometimes in conjunction with foreign governments, against companies offering
medical treatments in foreign countries. Enforcement can be in the form of civil money penalties or prohibitions from exporting the product
to these jurisdictions.





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A
substantial portion of our sales of AlloRx Stem Cells for use in foreign clinical studies are completed on a purchase order basis without
any written agreements. Such customers may issue fewer or smaller purchase orders than we expect under our current arrangements, which
could negatively impact our revenues. In addition, although these purchase orders are generally not cancelable, such customers may decide
to delay or cancel orders, which could also negatively impact our revenues.



Generally,
under our arrangements with foreign third-party clinics and medical centers, customers must issue purchase orders for AlloRx Stem Cells.
Although these purchase orders stipulate key terms including order quantity, price, payment terms, and delivery instructions, these arrangements
are typically not governed by any written agreement and have no minimum purchase requirements. In addition, although orders covered by
firm purchase orders are generally not cancelable, customers may decide to delay or cancel orders, and we may have difficulty enforcing
the provisions of the purchase order. In the event that customers with whom we supply AlloRx Stem Cells, including foreign third-party
clinics and medical centers, issue fewer or smaller purchase orders than we expect, or we experience any delays or cancellations in orders
(due to current distress in the global economy caused by the COVID-19 pandemic or otherwise), our revenues could decline substantially.
Any such decline could result in us incurring net losses, increasing our accumulated deficit and needing to raise additional capital
to fund our operations.



Risks
Related to Ownership of our Common Stock



Our
principal stockholder and management, including our former Chief Executive Officer in particular, own a significant percentage of our
stock and will be able to exert significant control over matters subject to stockholder approval.



Our
executive officers and directors currently beneficially own approximately 60.8% of our voting stock. Our former Chief Executive Officer
and former Chair of the Board of Directors beneficially owns approximately 31% of our voting stock. This concentration of control creates
a number of risks. This group of stockholders will have the ability to exert significant influence over us through this ownership position.
These stockholders may be able to exert significant influence over all matters requiring stockholder approval, including with respect
to elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets or other major corporate
transaction, and our stockholders may find it difficult to replace members of management should our stockholders disagree with the manner
in which the Company is operated. Furthermore, this concentration of ownership may prevent or discourage unsolicited acquisition proposals
or offers for our common stock that you may feel are in your best interest as one of our stockholders. The interests of this group of
stockholders may not always coincide with your interests or the interests of other stockholders and they may act in a manner that advances
their best interests and not necessarily those of other stockholders.



The
price of our stock may be volatile, and you could lose all or part of your investment.



The
trading price of our common stock , if we are successful in listing on an exchange or other public trading market, is likely to be highly
volatile and subject to wide fluctuations in response to various factors, some of which we cannot control. The stock market in general,
and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of these companies.



Broad
market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Report, these factors include:



| | ● | the timing and results
    of preclinical studies and clinical trials of our product candidates or those of our competitors;
| | - | ----------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                             
| | ● | the success of competitive
    products or announcements by potential competitors of their product development efforts;     
| |   |                                                                                                                             
| | ● | regulatory actions with
    respect to our or our competitors’ product candidates or products;                              
| |   |                                                                                                                             
| | ● | actual or anticipated changes
    in our growth rate relative to our competitors;                                           
| |   |                                                                                                                             
| | ● | regulatory or legal developments
    in the United States and other countries;                                              
| |   |                                                                                                                             
| | ● | developments or disputes
    concerning patent applications, issued patents or other proprietary rights;                    
| |   |                                                                                                                             
| | ● | the recruitment or departure
    of key personnel;                                                                          



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| | ● | announcements by us or
    our competitors of significant acquisitions, strategic collaborations, joint ventures, or capital commitments;
| | - | -----------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                          
| | ● | actual or anticipated changes
    in estimates as to financial results, development timelines or recommendations by securities analysts; 
| |   |                                                                                                                                          
| | ● | fluctuations in the valuation
    of companies perceived by investors to be comparable to us;                                            
| |   |                                                                                                                                          
| | ● | market conditions in the
    pharmaceutical and biotechnology sector;                                                                    
| |   |                                                                                                                                          
| | ● | changes in the structure
    of healthcare payment systems;                                                                              
| |   |                                                                                                                                          
| | ● | share price and volume
    fluctuations attributable to inconsistent trading volume levels of our shares;                                
| |   |                                                                                                                                          
| | ● | announcement or expectation
    of financing efforts;                                                                                    
| |   |                                                                                                                                          
| | ● | sales of our common stock
    by us, our insiders or our other stockholders;                                                             
| |   |                                                                                                                                          
| | ● | expiration of market stand-off
    or lock-up agreements; and                                                                            
| |   |                                                                                                                                          
| | ● | general economic, industry
    and market conditions.                                                                                    



The
realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors”
section, could have a dramatic and adverse impact on the market price of our common stock.



There
currently exists no public trading market for our common stock and you will not be able to sell your shares of common stock if an active
trading market does not develop.



There
is currently no public market for our common stock, and no assurance that a public trading market will ever develop. There is no assurance
that our efforts to complete a public offering and obtain listing of our common stock on a national securities exchange will be successful.
Without an active public trading market, you may not be able to sell your shares without considerable delay, if at all. If a market does
develop, the price for our common stock may be highly volatile and may bear no relationship to our actual financial condition or results
of operations. Unless our common stock is listed on a national securities exchange, many brokerage firms may not be willing to sell our
common stock on your behalf. Trading in our common stock may also be subject to “penny stock” rules applicable to lower priced
securities that are not traded on an exchange.



If
securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding
us, our business or our market, our stock price and trading volume could decline.



Any
trading market for our common stock, if we are successful in listing on an exchange or other public trading market, may be influenced
by the research and reports that securities or industry analysts publish about us, our business or our market. We do not currently have
and may never obtain research coverage by securities or industry analysts. If no or few securities or industry analysts commence coverage
of us, our stock price would be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts
who cover us issue adverse or misleading research or reports regarding us, our business model, our intellectual property, our stock performance
or our market, or if our operating results fail to meet the expectations of analysts, our stock price would likely decline. If one or
more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets,
which in turn could cause our stock price or trading volume to decline.





- 86 -







Our
quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each
of which may cause our stock price to fluctuate or decline.



We
expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous
factors, including:



| | ● | variations in the level
    of expense related to the ongoing development of our product candidates or future development programs;                                                                                                               
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                   
| | ● | results of clinical trials,
    or the addition or termination of clinical trials or funding support by us or potential future partners;                                                                                                          
| |   |                                                                                                                                                                                                                                                   
| | ● | our execution of any collaboration,
    licensing or similar arrangements, and the timing of payments we may make or receive under potential future arrangements or the termination
    or modification of any such potential future arrangements;
| |   |                                                                                                                                                                                                                                                   
| | ● | any intellectual property
    infringement, misappropriation or violation lawsuit or opposition, interference or cancellation proceeding in which we may become
    involved;                                                                     
| |   |                                                                                                                                                                                                                                                   
| | ● | additions and departures
    of key personnel;                                                                                                                                                                                                    
| |   |                                                                                                                                                                                                                                                   
| | ● | strategic decisions by
    us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business
    strategy;                                                                       
| |   |                                                                                                                                                                                                                                                   
| | ● | if any of our product candidates
    receives regulatory approval, the terms of such approval and market acceptance and demand for such approved products;                                                                                        
| |   |                                                                                                                                                                                                                                                   
| | ● | regulatory developments
    affecting our product candidates or future products, or those of our competitors; and                                                                                                                                 
| |   |                                                                                                                                                                                                                                                   
| | ● | changes in general market
    and economic conditions.                                                                                                                                                                                            



If
our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock, if we
are successful in listing on an exchange or other public trading market, could decline substantially. Furthermore, any quarterly fluctuations
in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons
of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.



As
a result of the restatement of our financial statements for the three and nine months ended July 31, 2022, our management believes that
our internal control over financial reporting was not effective as of October 31, 2022 due to a material weakness related to our accounting
for revenue and related expenses.If we
are unable to remediate this material weakness and otherwise implement and maintain an effective system of internal control over financial
reporting, we may not be able to timely and accurately report our financial results or prevent fraud in the future. As a result, stockholders
could lose confidence in our financial and other public reporting, which would harm our business and, if we are successful in listing
on an exchange or other public trading market, the trading price of our common stock.



As
previously disclosed, subsequent to the fiscal year ended October 31, 2022, we restated our consolidated financial statements for
the three and nine month periods ended July 31, 2022, included in our Registration Statement on Form 10, as amended (the “Form 10”), due to errors
relating to a service contract with a customer that impacted the recognition of revenue and related expenses. Specifically, in
consultation with our financial consultants, we determined that we had improperly recognized revenue from our JOA with European
Wellness and BioPep, as further described in “Item 1. Business”, that should have been deferred. That error
resulted in the overstatement of consulting revenue by $200,000 and related expenses in the amount of $177,147 in the consolidated
statements of operations for the three and nine month periods ended July 31, 2022 and the understatement of deferred revenue in the
consolidated balance sheets as of July 31, 2022 in the amount of $200,000. As a result of these errors, management determined that
it was appropriate to restate the consolidated financial statements included in the Form 10.



In
addition, as a result of the errors discussed above, our management determined that our internal control over financial reporting was
not effective as of October 31, 2022 due to a material weakness related to our accounting for revenue and related expenses.





- 87 -







Effective
internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure
controls and procedures, are designed to prevent fraud. Any failure to design, and implement required new or improved controls, or difficulties
encountered in their implementation, could limit our ability to prevent or detect a misstatement of our accounts or disclosures that
could result in a material misstatement of our annual or interim financial statements and cause us to fail to meet our reporting obligations.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent
registered public accounting firm, may reveal additional deficiencies in our internal controls over financial reporting that are deemed
to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas
for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial
information, which could have a negative effect on the trading price of our stock. The requirements of being a public company may strain
our resources, result in more litigation and divert management’s attention.



We
are subject to certain reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer
Protection Act, or the Dodd-Frank Act, and other applicable securities rules and regulations. Complying with these rules and regulations
results in legal and financial compliance costs, makes some activities more difficult, time consuming or costly and increases demand
on our systems and resources, including management. In order to maintain and, if required, improve our disclosure controls and procedures
and internal control over financial reporting to meet this standard, significant resources and management oversight will be required.
As a result, management’s attention may be diverted from other business concerns, which could adversely affect our business and
operating results. We may also need to hire additional employees or engage outside consultants to comply with these requirements, which
will increase our costs and expenses.



We
can give no assurance that ourremedial measures will
be sufficient to address the material weakness related to our accounting for revenue and related expenses discussed above or that any
additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain
adequate internal control over financial reporting or circumvention of these controls. In addition, even if we are successful in strengthening
our controls and procedures in the future, those controls and procedures may not be adequate to prevent or identify irregularities or
errors or to facilitate the fair presentation of our financial statements.



We
have previously failed to timely file certain periodic reports with the SEC and as a result, the SEC revoked the registration of our
common stock in 2020. Our failure to timely file required reports in the future poses significant risks to trading in our common stock
and could materially and adversely affect our financial condition and results of operations.



In
the past, we have not been able to, and may continue to be unable to produce timely financial statements, and file these financial statements
as part of a periodic report in a timely manner with the SEC. We have failed to timely file with the SEC all requisite periodic reports
beginning with the period ending October 31, 2015. Consequently, we were not compliant with the periodic reporting requirements under
the Exchange Act beginning with the period ending October 31, 2015.



On
September 29, 2020, the SEC instituted public administrative proceedings to determine whether to revoke or suspend registration, for
a period not exceeding twelve months, the registration of each class of our securities for failure to make required periodic filings
with the SEC. On October 8, 2020, the SEC revoked the registration of our common stock pursuant to Section 12(j) of the Exchange Act
for failure to comply with Section 13(a) of the Exchange Act and Rules 13a-1 and 13a-13 thereunder by failing to make required periodic
filings with the SEC.



We
cannot guarantee that in the future our reporting will always be timely. Our failure to timely file future periodic reports with the
SEC could subject us to enforcement action by the SEC and stockholder lawsuits and could, if we are successful in listing on NYSE American
or other public trading market, eventually result in the delisting of our common stock from the NYSE American, or other public trading
market, regulatory sanctions from the SEC, and/or the breach of covenants in our credit facilities or of any preferred equity or debt
securities we may issue in the future, any of which could have a material adverse impact on our operations and your investment in our
common stock, and our ability to register with the SEC public offerings of our securities for our benefit or the benefit of our security
holders. Additionally, our failure to file our past periodic reports and future periodic reports has resulted in and could result in
investors not receiving adequate information regarding the Company with which to make investment decisions. As a result, investors may
not have access to current or timely financial information about our Company.





- 88 -







The
sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.



A
substantial portion of our outstanding common stock is freely tradeable under relevant provisions of securities laws. It is likely that
market sales of large amounts of common stock (or the potential for those sales even if they do not actually occur) could cause the market
price of our common stock to decline, if a trading market is ever established, which may make it difficult to sell our common stock in
the future at a time and price which we deem reasonable or appropriate and may also cause you to lose all or a part of your investment.



We
may be subject to securities litigation, which is expensive and could divert management attention.



The
market price of our common stock may be volatile and, in the past, companies that have experienced volatility in the market price of
their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities
litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which
could seriously harm our business.



We
do not currently intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will
depend on appreciation of the value of our common stock.



We
have never declared or paid any cash dividends on our equity securities. We currently anticipate that we will retain future earnings,
if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for
the foreseeable future. In addition, debt instruments to which we may be party in the future may limit our ability to pay dividends.
Any return to stockholders will therefore be limited to any appreciation in the value of our common stock, which is not certain.



Provisions
in our articles of incorporation and bylaws and Nevada law might discourage, delay or prevent a change in control of our company or changes
in our management and, therefore, depress the market price of our common stock, if we are successful in listing our common stock on an
exchange or other public trading market.



Our
second amended and restated articles of incorporation and bylaws, as amended, contain provisions that could depress the market price
of our common stock, if we our successful in listing our common stock on an exchange or other public trading market, by acting to discourage,
delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous.
These provisions, among other things:



| | ● | permit the number of directors
    to be increased or decreased by action of the majority of the board;                   
| | - | --------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                           
| | ● | authorize the Board of
    Directors to issue all or any part of our common stock, without action by the stockholders; and
| |   |                                                                                                                           
| | ● | prohibit cumulative voting.                                                                                               



In
addition, certain provisions of Nevada law could also delay or make more difficult a merger, tender offer or proxy contest involving
our company, including Sections 78.411 through 78.444 of the Nevada Revised Statutes, which prohibit a Nevada corporation from engaging
in any business combination with any “interested stockholder” (as defined in the statute) for a period of two years after
the date that the person first became an interested stockholder unless certain conditions are met.



Any
provision of our articles of incorporation, bylaws or Nevada law that has the effect of delaying or preventing a change in control could
limit the opportunity for our stockholders to receive a premium for their shares of our common stock and could also affect the price
that some investors are willing to pay for our common stock.





- 89 -







General
Risk Factors



The
ongoing coronavirus pandemic has caused interruptions or delays of our business plan. Delays caused by the coronavirus pandemic and other
healthcare emergencies may have a significant adverse effect on our business, including the manufacturing, clinical trial and other business
activities performed by us or third parties with whom we conduct business.



In
December 2019, a strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China, and on March 12, 2020, the World Health
Organization declared COVID-19 to be a pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries, including
the United States, Canada and China, have imposed unprecedented restrictions on travel, quarantines and other public health safety measures.
The extent to which the pandemic or any other healthcare crisis may impact our business will depend on future developments, which are
highly uncertain and cannot be predicted, but the development of clinical supply materials could be delayed and enrollment of patients
in our studies may be delayed or suspended, as hospitals and clinics in areas where we are conducting trials shift resources to cope
with the COVID-19 pandemic and may limit access or close clinical facilities due to the COVID-19 pandemic. Additionally, if our trial
participants are unable to travel to our clinical study sites as a result of quarantines or other restrictions resulting from the COVID-19
pandemic, we may experience higher drop-out rates or delays in our clinical studies including obtaining data and patient reported outcomes
in a timely manner. We have manufacturers and collaboration partners located in foreign jurisdictions, and travel restrictions have limited,
and may continue to limit, our ability to visit their locations in person and conduct on-site inspections.



In
addition, our future clinical trials may be affected by the COVID-19 pandemic and any related travel restrictions. Clinical trial progression,
dosing, patient enrollment and related activities may be delayed due to concerns among patients about participating in clinical trials
during a pandemic, and reporting of some clinical data may be incomplete or delayed if patients who enroll in our clinical trials are
unable to fully participate in all necessary measurement protocols as a result of any hospital resource prioritization, patient participation
concerns or other factors associated with the COVID-19 pandemic. Federal, state, and local guidelines for reopening in the United States
and other countries may negatively impact our ability to enroll patients in any of our clinical programs. Some patients may have difficulty
following certain aspects of clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.



We
cannot predict the ultimate impact of the COVID-19 pandemic as consequences of such an event are highly uncertain and subject to change,
at times on a daily or weekly basis. We do not yet know the full extent of potential delays or impacts on our clinical studies or on
our business as a whole; however, the COVID-19 pandemic may materially disrupt or delay our business operations, further divert the attention
and efforts of the medical community to coping with COVID-19, disrupt the marketplace in which we operate, and/or have a material adverse
effect on our operations. Moreover, the various precautionary measures taken by many governmental authorities around the world in order
to limit the spread of COVID-19 has had and may continue to have an adverse effect on the global markets and global economy generally,
including on the availability and pricing of employees, resources, materials, manufacturing and delivery efforts and other aspects of
the global economy. There have been business closures and a substantial reduction in economic activity in countries that have had significant
outbreaks of COVID-19. Significant uncertainty remains as to the potential impact of the COVID-19 pandemic on the global economy as a
whole. It is currently not possible to predict how long the pandemic will last or the time that it will take for economic activity to
return to prior levels. The COVID-19 pandemic could materially disrupt our business and operations, interrupt our sources of supply,
hamper our ability to raise additional funds or sell our common stock, continue to slow down the overall economy or curtail consumer
spending.



The
spread of an infectious disease, including COVID-19, may also result in the inability of our suppliers to deliver components or raw materials
on a timely basis. Such events may result in a period of business and manufacturing disruption, and in reduced operations, any of which
could materially affect our business, financial condition and results of operations. The extent to which the coronavirus impacts our
business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may
emerge concerning the severity of COVID-19 and the actions to contain the coronavirus or treat its impact, among others.





- 90 -







Our
internal computer systems, or those of any of our CROs, manufacturers, other contractors, consultants, collaborators or potential future
collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction
of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant
liabilities, harm to our brand and material disruption of our operations.



Despite
the implementation of security measures, our internal computer systems and those of our current and any future CROs and other contractors,
consultants, collaborators and third-party service providers, are vulnerable to damage from computer viruses, cybersecurity threats,
unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failure. If such an event were to occur and
cause interruptions in our operations or result in the unauthorized acquisition of or access to personally identifiable information or
individually identifiable health information (violating certain privacy laws such as HIPAA, Health Information Technology for Economic
and Clinical Health Act and GDPR), it could result in a material disruption of our drug discovery and development programs and our business
operations, whether due to a loss of our trade secrets or other similar disruptions. Some of the federal, state and foreign government
requirements include obligations of companies to notify individuals of security breaches involving particular personally identifiable
information, which could result from breaches experienced by us or by our vendors, contractors, or organizations with which we have formed
strategic relationships. Notifications and follow-up actions related to a security breach could impact our reputation, cause us to incur
significant costs, including legal expenses and remediation costs. For example, the loss of clinical trial data from completed or future
clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce
the lost data. We also rely on third parties to manufacture our product candidates, and similar events relating to their computer systems
could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss
of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation
and governmental investigations, the further development and commercialization of our product candidates could be delayed, and we could
be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacy and security
laws.



Our
insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption, failure or security
breach. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our
insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of
its merit, could be costly and divert management attention.



Our
business activities may be subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, and similar anti-bribery and anti-corruption
laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and
regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability
if we violate them.



Due
to our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations in
each jurisdiction in which we operate or plan to operate. Our business activities are subject to the FCPA and similar anti-bribery or
anti-corruption laws, regulations or rules of other countries in which we operate. The FCPA generally prohibits companies and their employees
and third-party intermediaries from offering, promising, giving or authorizing the provision of anything of value, either directly or
indirectly, to a non-U.S. government official in order to influence official action or otherwise obtain or retain business. The FCPA
also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation
and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves
significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, hospitals
owned and operated by the government, and doctors and other hospital employees would be considered foreign officials under the FCPA.
Recently the Securities and Exchange Commission (SEC) and Department of Justice (DOJ) have increased their FCPA enforcement activities
with respect to biotechnology and pharmaceutical companies. There is no certainty that all of our employees, agents or contractors, or
those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these
laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers or our employees, disgorgement,
and other sanctions and remedial measures, and prohibitions on the conduct of our business. Any such violations could include prohibitions
on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international
activities, our ability to attract and retain employees and our business, prospects, operating results and financial condition.



In
addition, our products and technology are subject to U.S. and foreign export controls, trade sanctions and import laws and regulations
including requirements to obtain licensure to properly operate in the local these territories. Governmental regulation of the import
or export of our products and technology, or our failure to obtain any required import or export authorization for our products, when
applicable, could harm our international sales and adversely affect our revenue. Compliance with applicable regulatory requirements regarding
the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent
the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the shipment
of certain products and services to countries, governments, and persons targeted by U.S. sanctions. If we fail to comply with export
and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain export privileges.
Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope of existing regulations,
or in the countries, persons, or products targeted by such regulations, could result in decreased use of our products by, or in our decreased
ability to export our products to existing or potential customers with international operations. Any decreased use of our products or
limitation on our ability to export or sell access to our products would likely adversely affect our business.





- 91 -







Item
1B. Unresolved Staff Comments



Not
applicable.



Item
2. Properties



We
lease three separate office or laboratory facilities for our business and operations. Our executive offices are located in the Cherry
Creek neighborhood of Denver, where we occupy approximately 2,226 square feet of office space under a sublease until July 31, 2023 at
a rate of $6,700 per month. Our manufacturing and administrative offices and facilities are currently located at 4621 Technology Drive,
Golden Colorado, where we lease approximately 3,100 square feet under a 10-year lease commencing July 1, 2020 and which provides us with
several options to renew upon expiration for additional 5-year terms. The lease is with an affiliate of our Chief Science Officer. The
rent is $5,645 per month plus taxes, insurance and utilities. We also lease approximately 850 square feet of laboratory space in Ft.
Collins, Colorado, where we intend to manufacture AlloRx Stem Cells for distribution to foreign clinics. The monthly rent at that space
is $5,200 for one year commencing May 1, 2022.



While
we believe these premises are suitable for our current needs, we are also planning to lease a separate cGMP manufacturing facility that,
if and when completed, will be used exclusively for the manufacture of AlloRx Stem Cells in order to meet potential future commercial
demand for AlloRx Stem Cell therapy. In connection with the development of a new cGMP manufacturing facility, we intend to lease a facility
and purchase highly scalable, fully automated closed system bioprocessing equipment, subject to available capital resources. For additional
information, see “Item 1. Business—Manufacturing” above.



Item
3. Legal Proceedings



From
time to time, we may become involved in litigation relating to claims arising out of our operations in the normal course of business.
No legal proceedings, government actions, administrative actions, investigations, or claims are currently pending against us or our officers
and directors in which we are adverse. The results of any future litigation cannot be predicted with certainty, and regardless of the
outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and
other factors.



Item
4. Mine Safety Disclosures



None.





- 92 -







PART
II



Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities



Market
Information



Our
securities are not currently listed on any exchange or over-the-counter market, and there is no established public trading market for
any class of our securities.



Holders



As
of January 23, 2023, we had 115,160,180 shares of common stock outstanding, held of record by approximately 3,200 stockholders. There
were no shares of preferred stock outstanding.



Dividends



Subject
to preferences that may be applicable to any then outstanding preferred stock, holders of our common stock are entitled to receive dividends
as may be declared from time to time by our Board of Directors out of legally available funds. However, we have never paid cash dividends
on any of our capital stock and we currently intend to retain our future earnings, if any, to fund the development and growth of our
business. We do not intend to pay cash dividends to holders of our common stock in the foreseeable future.



Recent
Sales of Unregistered Securities



Except
as otherwise disclosed in a Current Report on Form 8-K, the following sets forth information regarding all unregistered securities sold
during the period covered by this Report.



On
February 22, 2022, a note holder converted $3,000,000 in principal and $712,500 of accrued interest related to the Senior Secured Convertible Promissory Note into 3,712,500 shares of the Common Stock of the Company at $1 per share. This conversion was completed pursuant to the exemption
from registration contained in Section 3(a)(9) of the Securities Act.



On
March 1, 2022, the Company issued 350,000 stock purchase options to an
employee and a consultant to the Company. The options are exercisable at $0.50 per share. Those options vest as follows: 60,000 vested
at the date of grant and 48,333 vest on each anniversary date until fully vested. The options are exercisable for a period of ten years.
The options were issued pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506(b)
promulgated
thereunder.



On
March 31, 2022, the holders of 136,059 shares of our Series A Convertible Preferred Stock converted those shares, along with accrued
dividends payable thereon, into an aggregate of 14,806,028 shares of our Common Stock. These conversions were completed pursuant to the
exemption from registration contained in Section 3(a)(9) of the Securities Act.



On
April 15, 2022, $320,000 in principal and $11,266 in accrued interest related to the 2021 Series Convertible Notes was converted into
331,265 shares of the Common Stock of the Company at $1 per share. These conversions were completed pursuant to the exemption from registration
contained in Section 3(a)(9) of the Securities Act.



On
May 31, 2022, we issued two convertible promissory notes to two accredited investors in the aggregate principal amount of $200,000 which
accrue interest at a rate of 5.0% per annum. These notes were issued pursuant to the exemption from registration contained in Section
4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.



In
each transaction in which we relied on Section 4(a)(2) of the Securities Act and/or Rule 506(b) promulgated thereunder, we did not engage
in any general solicitation or advertising and we offered the securities to a limited number of persons with whom we had pre-existing
relationships. We exercised reasonable care to ensure that the purchasers of securities were not underwriters within the meaning of the
Securities Act, including making reasonable inquiry prior to accepting any subscription, making written disclosure regarding the restricted
nature of the securities and placing a legend on the certificates representing the shares. In each case, the offerees were provided with
a subscription agreement detailing the restrictions on transfer of the shares and eliciting their investment intent. Further, stop transfer
restrictions were placed with our transfer agent and a restrictive legend was placed on the certificate in connection with these offerings.
In addition, sales in the transactions exempt under Rule 506(b) were made exclusively to what the Company reasonably believed were accredited
investors as defined in Rule 501 of the Securities Act. The recipients of securities in each of these transactions acquired the securities
for investment only and not with a view to or for sale in connection with any distribution thereof. No underwriters were involved in
the above transactions.



Item
6. [Reserved]





- 93 -











Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations



You
should read the following discussion and analysis of our financial condition and results of operations together with our consolidated
financial statements and the related notes included elsewhere in this Report. This discussion and analysis and other parts of this Report
contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial
performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations
for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by
these forward-looking statements as a result of several factors, including those set forth in the section titled “Item 1A. Risk
Factors.” See also the section titled “Special Note Regarding Forward-Looking Statements.”



Overview



We
are an innovative biotechnology company targeting autoimmune diseases and inflammatory disorders, with an ancillary focus in the research
services and cosmeceutical fields. With respect to our regenerative medicine business, we are developing novel cellular therapeutic candidates
intended to address significant unmet medical needs. In the United States, we are authorized to conduct two clinical trials under two
FDA IND applications to assess the safety and efficacy of AlloRx Stem Cell therapy in PTHS and Long COVID, and expect to commence those
trials sometime in 2023 pending receipt of sufficient working capital. We generate revenue from our other technologies through a number
of other activities, including providing research services and through the sale of our stem cell products as well as cosmeceuticals through
InfiniVive MD, our wholly-owned subsidiary, which helps to alleviate our capital expenses.



For
additional details regarding our business, see the discussion under “Business” in Item 1 of Part I of this Report,
which is incorporated by reference into this Part II, Item 7 of this Report.



Components
of Operating Results



Revenue



We
generate revenue primarily from our proprietary products and technologies, including through supplying AlloRx Stem Cells, CAFs, native
fibroblasts and other stem cell products and technologies developed by us. We also generate consulting revenue from our JOA with European
Wellness. In addition, our acquisitions of InfiniVive MD and Fitore provide us revenue through sales of topical cosmetic conditioned
media and exosomes serums through InfiniVive MD and sales of dietary supplements, nutraceuticals and health products through Fitore.
For a discussion of certain risk relating to the manufacture of dietary supplements, nutraceuticals and other health products, see “Item
1A. Risk Factors— Risks Related to the Dietary and Nutritional Supplements Industry and Fitore Products.”



Selling,
General and Administrative Expenses



Selling,
General and Administrative (“SG&A”) expenses consist of salaries and other related costs, legal fees relating to corporate
matters, other professional fees for accounting, auditing, tax and consulting services, insurance costs, travel expenses, and facility-related
expenses.



We
expect that our SG&A expenses will increase in the future as we increase our headcount to support increased research and development
activities relating to our clinical programs. We also expect to incur increased SG&A expenses associated with being a public company,
including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with stock exchange
and SEC requirements, director and officer insurance costs, and investor and public relations costs.



Research
and Development Expenses



All
our research and development expenses to date have been incurred in connection with the discovery and development of our research products
and product candidates. We expect our research and development expenses to increase significantly for the foreseeable future when we
enter clinical trials and advance an increased number of our product candidates through pre-clinical and clinical development, including
the conduct of our planned clinical trials.



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Research
and development expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation, external
research and development expenses incurred under arrangements with third parties, laboratory supplies, costs to acquire and license technologies
aligned with our goal of translating engineered cells to medicines, facility and other allocated expenses, including rent, depreciation,
and allocated overhead costs, and other research and development expenses. Where appropriate, we will allocate our third-party research
and development expenses on a program-by-program basis.



The
successful development of product candidates is highly uncertain and subject to numerous risks and uncertainties. For a discussion of
certain risks related to the development of product candidates and costs of clinical trials, see “Item 1A. Risk Factors”
herein.



Accordingly,
at this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product
candidates and to obtain regulatory approval for one or more of these product candidates.



Other
Income and Expenses



Other
income/expense consisted of interest expense on our outstanding debt.



Going
Concern



Our
consolidated financial statements contained in this Report have been prepared assuming that we will continue as a going concern,
which contemplates the continuity of operations, realization of assets, and liquidation of liabilities in the normal course of
business. As reflected in our consolidated financial statements, we have an accumulated deficit as of October 31, 2022 of $22.7
million. We incurred net losses of $6.9 million and $4.5 million and used cash in operating activities of $2.2 million and $1.0
million for the years ended October 31, 2022 and 2021, respectively. We had limited working capital as of October 31, 2022. These
factors raise substantial doubt about our ability to continue as a going concern.



We
have commenced the execution of our long-range business plan and efforts to generate additional revenue; however, our current cash position
may not be sufficient to support our daily operations for the next 12 months. Our ability to continue as a going concern is dependent
upon our ability to further implement our business plan and generate additional revenue and our ability to raise additional funds through
debt or equity financings.



The
consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts
or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.



Results
of Operations for the year ended October 31, 2022 compared to the year ended October 31, 2021



The
following discussion analyzes our operating results for the fiscal year ended October 31, 2022, which we refer to as “Fiscal 2022,”
and compares those results to results for the fiscal year ended October 31, 2021, which we refer to as “Fiscal 2021. The discussion
below also analyzes our liquidity and capital resources as of October 31, 2022 and material changes in those resources since the end
of Fiscal 2021. We suggest that you read the following information in conjunction with our audited consolidated financial statements
for the two years ended October 31, 2022 contained elsewhere in this Report.



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Comparison
of the Years Ended October 31, 2022 and 2021



The
following table summarizes our operating results for Fiscal 2022 and 2021:



|                                                            |  | Year Ended October 31, |           
|----------------------------------------------------------- |  | ---------------------- | ----------
|                                                            |  | 2022                   |           
|                                                            |  |                        |           
|Product sales                                               |  | $                      | 2,662,793 
|Product sales, related parties                              |  |                        | 30,500    
|Consulting revenue                                          |  |                        | 600,000   
|Total revenue                                               |  |                        | 3,293,293 
|Less: Cost of goods sold                                    |  |                        | (586,884  
|Gross profit                                                |  |                        | 2,706,409 
|General and administrative expenses                         |  |                        | (7,602,945
|Research and development                                    |  |                        | (155,630  
|Impairment expense                                          |  |                        | (914,091  
|Interest expense                                            |  |                        | (198,450  
|Loss on conversion of senior secured note payable           |  |                        | (695,342  
|Net Loss                                                    |  | $                      | (6,860,049
|Deemed dividend on convertible preferred stock              |  |                        | (793,175  
|Cumulative convertible preferred stock dividend requirement |  |                        | (111,333  
|Net Loss to Common Stockholders                             |  | $                      | (7,764,557



Net
Loss



We
recorded a net loss of $6,860,049 in Fiscal 2022, an increase of $2,338,386 from Fiscal 2021, or 52%. The increased loss in Fiscal 2022
was due to the significant increases in general and administrative expenses in Fiscal 2022, as discussed further below. However, the
impairment expense arising from the write-off of a portion of the goodwill recorded in connection with our investment in Fitore and the
loss on conversion of senior secured notes payable during Fiscal 2022 were more than offset by a 151% increase in our total revenue during
Fiscal 2022. Interest expense also decreased in Fiscal 2022 due to the conversion during Fiscal 2021 of convertible notes payable. We
expect to continue reporting losses until such time, if ever, we can improve the operation of our newly acquired subsidiaries and/or
commercialize one or more of our product candidates and generate sales sufficient to offset our operating costs and expenses and interest
expenses.



Net
Loss to Common Stockholders



In
connection with the sale of the Series A Convertible Preferred Stock in Fiscal 2020 and 2021, we determined that there was an embedded
conversion feature associated with the value of the beneficial conversion feature. The initial embedded conversion feature was initially
determined to be $930,577. For the year ended October 31, 2022, the accretion of this embedded conversion feature was $793,175 and has
been recorded as a deemed dividend. Including the deemed dividend on the Series A Convertible Preferred Stock for the year ended October
31, 2022 and the cumulative dividend on that Preferred Stock, the net loss to common stockholders was $7,764,557, or $0.07 per share.



Product
Sales



Total
revenue in Fiscal 2022 increased by $1,982,347, or 151%, from Fiscal 2021. Our revenue is generated by sales of research products, sales
of AlloRx Stem Cells to foreign third-party clinics and medical centers, consulting revenue and sales from our subsidiaries, InfiniVive
MD and Fitore.



During
Fiscal 2022 and Fiscal 2021, research and development product sales were $1,072,312 and $857,648, respectively, an increase in Fiscal
2022 of $214,664 or 25%. The increase was primarily attributable to hiring a full-time marketer of these products on October 4, 2021.
Sales of AlloRx Stem Cells to foreign third-party clinics for the year ended October 31, 2022 and October 31, 2021 were $1,174,456 and
$180,856 respectively, an increase of $993,600 or 549%. These increases were due to an increase in pricing, greater research interest
and acceptance of our products. In addition to the foregoing, the lingering effects of the COVID pandemic adversely affected sales in
Fiscal 2021.



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For
Fiscal 2022 and Fiscal 2021, InfiniVive MD revenue amounted to $236,788 and $139,070, respectively. Fiscal 2021 revenues were lower
than Fiscal 2022 because sales were only recorded for three months in Fiscal 2021 since the acquisition of InfiniVive MD was
completed effective August 2021. For Fiscal 2022 and Fiscal 2021, Fitore product revenue amounted to $209,737 and $81,550,
respectively. Fiscal 2021 revenues were lower than Fiscal 2022 for the same reason as InfiniVive MD.



We
expect AlloRx Stem Cell sales internationally to increase significantly over the next year as these products expand into additional foreign
third-party clinics and medical centers and our current foreign third-party clinics and medical center customers increase their total
monthly patients. We terminated the chief executive officer and all other employees of Fitore in June 2022; consequently, we expect that
sales of Fitore products in the future will be limited.



Product
Sales – Related Parties



Product
sales to related parties are sales to the medical practice of Dr. Zamora, our former Chief Executive Officer. Such sales decreased during
Fiscal 2022 by $332,300, or 92%, compared to Fiscal 2021.



Consulting
Revenue



During
Fiscal 2022, our consulting revenue was derived from our contract with European Wellness under which we have agreed to assist in the
discovery, development and commercialization of biological products related to regenerative medicine. During Fiscal 2022, we recognized
$600,000 in revenue as we completed two milestones under the contract. We developed and deployed a quality management system for that
entity and delivered a manual for the aforementioned system in order to position European Wellness for FDA authorization as a U.S.-based
cGMP manufacturer for products being studied for potential IND authorization. In addition to the revenue that was recognized, we recorded
deferred revenue of $650,000 related to those services. That deferred revenue will be recognized if and when related milestones under
the contract are achieved. See Notes to our Consolidated Financial Statements for additional information on the future milestones that
may allow us to recognize that deferred revenue.



There
was no revenue recognized for this agreement during Fiscal 2021 and $500,000 in revenue was deferred. During Fiscal 2021, the
Company recognized $51,822 in consulting revenue from Fitore, unrelated to the European Wellness agreement. No Fitore consulting
revenue was recorded during Fiscal 2022.



Cost
of Goods Sold



Our
cost of goods sold during Fiscal 2022 totaled $586,884 compared to $351,307 during Fiscal 2021, an increase of $235,577 or 67%, resulting
in gross profit of $2,706,409 and $959,639 for Fiscal 2022 and 2021, respectively. The gross profit percentages for Fiscal 2022 and Fiscal
2021 were 82% and 73%, respectively. The increase in gross profit in Fiscal 2022 was primarily attributable to $600,000 in consulting
revenue recognized in Fiscal 2022, with $51,822 in similar revenue recorded in Fiscal 2021. Also contributing to the increase in gross
profit was an increase in revenue, as discussed above under “-Product Sales.”



Selling,
General and Administrative Expenses



SG&A
expenses increased from $4,957,908 in Fiscal 2021 to $7,602,945 in Fiscal 2022. This increase of $2,645,037 was due to an increase in
share-based compensation of $156,980 (a non-cash expense), an increase of $122,945 in amortization expense (non-cash), an increase in
salary and benefits expense of $1,195,591 as we hired additional executive officers and staff to pursue our business plan, an increase
in legal fees of $551,961, an increase in professional and stockholder relations fees of $218,622 related to financial statement audits
and other corporate purposes, a $86,026 increase in sales and marketing expenses related to one of the subsidiaries, a $118,017 increase
in European Wellness project costs and an increase in insurance costs of $139,425 for directors and officers liability coverage.



Research
and Development



Research
and development expenses for Fiscal 2022 and Fiscal 2021 were $155,630 and $118,479, respectively. The increase of $37,151 in Fiscal
2022 was attributable to additional efforts to identify possible additional indications for the study of AlloRx Stem Cell therapy and
to prepare AlloRx Stem Cell therapy for future clinical trials which have been authorized by the FDA. We spent $139,122 and $41,768 with
third party research laboratories in Fiscal 2022 and Fiscal 2021, respectively, which laboratories perform rigorous testing, screening,
and monitoring on our product candidate to verify the absence of viral infections and $16,508 and $76,711, respectively, in the implementation
of a data capture platform.



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Impairment
Expense



During
the third fiscal quarter of 2022, we recorded an impairment expense of $914,091 related to the carrying value of the goodwill associated
with the acquisition of Fitore on August 1, 2021. The evaluation of the goodwill as of July 31, 2022 was performed following the termination
of the chief executive officer and all other employees of Fitore. While the termination of the chief executive officer and employees
of Fitore did not constitute the discontinuation of Fitore’s operations, it was considered by management to be a material change
in circumstance so as to warrant an evaluation of the goodwill.



Interest
Expense



Interest
expense for Fiscal 2022 was $198,450, a decrease of $206,465 from the interest expense for Fiscal 2021 of $404,915. This decrease in
interest expense is related to conversion of debt instruments to equity. During late Fiscal 2021, we were able to convert approximately
$0.9 million in debt into common stock and in February 2022, we converted $3.0 million in debt into common stock. The interest expense
related to the remaining debt on our balance sheet of approximately $2.7 million is expected to be all non-cash interest expense.



Loss
on Conversion of Senior Secured Note Payable



During
Fiscal 2022, we incurred a one-time loss of $695,342 due to the early conversion of the Senior Convertible Note Payable. Interest of
$695,342 from the date of the note conversion to the note’s stated maturity date was converted to equity and was recorded as a
loss on conversion of the note. The remaining principal amount and accrued interest on the note itself were converted to common stock
at the same conversion rate.



Liquidity
and Capital Resources



Overview



Since
our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses as we advance
the preclinical and clinical development of our programs. We expect that our sales, research and development, and general and administrative
costs will increase in connection with conducting additional preclinical studies and clinical trials for our current and future programs
and product candidates, expanding our intellectual property portfolio, and providing general and administrative support for our operations.
As a result, we will need additional capital to fund our operations for the next twelve months and beyond, which we hope to obtain from
additional equity or debt financings, collaborations, licensing arrangements, or other sources.



Historically,
we have relied on sales of our equity securities, borrowings from independent third parties and advances and/or borrowings from related
parties to address our working capital needs, and that was true in Fiscal 2021. In Fiscal 2022, our need for additional capital became
more acute, as we accelerated the pace of the execution of our business plan, began reporting under rules of the SEC and prepared for
a public offering of our securities.



We
currently have no credit facility or other committed sources of capital. Debt financing and preferred equity financing, if available,
may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, collaboration
agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable
rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be
favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay,
limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market products or
product candidates that we would otherwise prefer to develop and market ourselves.



-98-









In
order to meet our operational goals, we will need to obtain additional capital, which we will likely obtain through a variety of means,
including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from
strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, the
ownership interest of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect
the rights of our stockholders. Such financing may result in dilution to stockholders, imposition of debt covenants, increased fixed
payment obligations or other restrictions that may affect our business. If we raise additional funds through up-front payments or milestone
payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates,
or grant licenses on terms that are not favorable to us. 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.



Working
Capital



As
of October 31, 2022, we had working capital of $0.4 million, comprised of
current assets of $2.9 million and current liabilities of $2.5 million. The working capital at year-end Fiscal 2022 decreased $2.8 million
from year-end Fiscal 2021. Current liabilities, consisting primarily of deferred revenue, accrued liabilities, lease obligations and a
line of credit, increased by approximately $1.1 million as of October 31, 2022, compared to October 31, 2021. Cash was reduced from $3.6
million as of October 31, 2021 to $0.7 million at October 31, 2022 as cash was used during Fiscal 2022 for operations and preparation
for a proposed public offering of our securities.



As
a result of our limited working capital position as of October 31, 2022, we continue to rely on cash from outside sources to meet our
liquidity requirements. Our need for liquidity and capital in the next 12 months include:



| | ● | advancing
    the clinical development of AlloRx Stem Cell therapy for the treatment of several indications;                                                                                                                                                                                                       
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | pursuing
    the preclinical and clinical development of other current and future research programs and product
    candidates;                                                                                                                                                                                    
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | in-license
    or acquire the rights to other products, product candidates or technologies;                                                                                                                                                                                                                        
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | maintain,
    expand and protect our intellectual property portfolio;                                                                                                                                                                                                                                              
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | hire
                                                                              additional personnel in research, manufacturing and regulatory and clinical development as well as management personnel;                                                                                                        
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | seek
    regulatory approval for any product candidates that successfully complete clinical development;                                                                                                                                                                                                           
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | expand
    our manufacturing capabilities;                                                                                                                                                                                                                                                                         
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | expand
                                                                              our operational, financial and management systems and increase personnel, including personnel to support our operations as a public
                                                                              company; and
| |   |                                                                                                                                                                                                                                                                                                                    
| | ● | pay
    our other administrative expenses.                                                                                                                                                                                                                                                                         



As
reported in a Form 8-K filed on January 17, 2023, our working capital increased slightly subsequent to the end of the fiscal year. On
January 6, 2023, we sold an aggregate of $405,000 of 8% convertible promissory notes and common stock purchase warrants for aggregate
proceeds of $405,000. The convertible notes are payable solely in shares of our common stock, mature five years from the date of issuance,
and are immediately due in connection with a change in control or completion of a “Qualified Financing,” as defined in the
purchase and sale agreement. Please see the Notes to our consolidated financial statements contained in this report for additional information
on the terms and conditions of the convertible notes and warrants. We expect to use the proceeds from the sale of the securities for
working capital and general corporate purposes.



-99-









We
have filed a registration statement on Form S-1 with the SEC to register our securities for sale in a proposed underwritten public offering.
If that offering is successful, we intend to use the proceeds to initiate and conduct one or more clinical trials of our AlloRx Stem
Cell therapy, for preclinical activities for other possible treatments with AlloRx, and for working capital and other general corporate
purposes. If we are successful in completing a public offering of our securities, including our common stock, and obtaining a market
for that stock, we may realize additional capital through the exercise of outstanding common stock purchase warrants. However, that will
depend on the warrants being “in the money,” in addition to  having a market for our stock. We may also endeavor to raise
additional capital through the sale of equity or debt in one or more non-public offerings. We do not anticipate commencing any clinical
trials of our AlloRx Stem Cell therapy pending receipt of substantial additional capital, estimated to be $4 million to $6 million to commence our contemplated
Phase 1/2a clinical trials for PTHS and Long COVID, depending on whether we commence one or both trials.



Our
working capital needs beyond the next 12 months include ongoing general and administrative expenses and research and development expenses,
the latter of which are expected to increase if and when we commence one or more of our planned clinical trials. Our long-term capital
requirements also include the cost of building a planned new cGMP biomanufacturing facility in 2024, which is estimated to cost approximately
$1.0 to $3.0 million depending on the amount of anticipated production increase, available capital and manufacturing demands at that
time.



Cash
Flows



The
following table summarizes our cash flows for Fiscal 2022 and 2021:



|                                                    |  | Year Ended October 31, |           
|--------------------------------------------------- |  | ---------------------- | ----------
|                                                    |  | 2022                   |           
|                                                    |  |                        |           
|Net Cash Used in Operating Activities               |  | $                      | (2,216,620
|Net Cash Provided by (Used in) Investing Activities |  |                        | (310,113  
|Net Cash provided by (Used in) Financing Activities |  |                        | (1,108,712
|Beginning Cash Balance                              |  |                        | 4,376,983 
|Ending Cash Balance                                 |  | $                      | 741,538   



Operating
Activities



Net
cash used in operating activities during Fiscal 2022 was $2,216,620, compared to $998,187 during Fiscal 2021, representing an increase
in use of $1,218,433. This increase is primarily attributable to the increased net loss during Fiscal 2022, partially offset by non-cash
adjustments used to reconcile the net loss, such as $2,197,597 in stock-based compensation, an impairment expense, the loss on conversion
of the Senior Secured Note Payable and changes in the operating assets and liabilities, including $150,000 in deferred revenue.



Investing
Activities



Cash
used by investing activities during Fiscal 2022 was $310,113 compared to cash provided by investing activities during Fiscal 2021 of
$337,014, representing an increase in cash used of $647,127. This change is primarily attributable to cash acquired through the acquisitions
of Fitore and InfiniVive MD in August of 2021 of approximately $370,000, creating positive cash flow from investing activities in Fiscal
2021. During Fiscal 2022 and Fiscal 2021, we invested approximately $310,000 and $25,000, respectively, in the acquisition of property
and equipment.



Financing
Activities



Cash
used in financing activities during Fiscal 2022 was $1,108,712, while cash provided by financing activities during Fiscal 2021 was $4,740,944.
During Fiscal 2022, we issued $200,000 in convertible notes payable, made capital lease principal payments of $75,698, paid off a revolving
loan of $58,596 and paid $1,174,418 in deferred offering costs related to the proposed public offering. During Fiscal 2021, we raised
approximately $4.8 million from the sale of Series A Units and a Convertible Promissory Note, resulting in a substantial increase in
cash generated from financing activities in that year and made capital lease principal payments of $48,626.





Critical
Accounting Estimates



Management’s
discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements,
which have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). The
preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets
and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the
reported revenue generated, and expenses incurred during the reporting periods. Our estimates are based on our historical experience
and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may
differ from these estimates under different assumptions or conditions and any such differences may be material. We have determined
that we have no critical accounting estimates material to our consolidated financial position, results of operations or cash
flow related to our consolidated financial statements included in this Report.



-100-









Item
7A. Quantitative and Qualitative Disclosures about Market Risk



We
are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required
under this item.



Item
8. Financial Statements and Supplementary Data



Our
Consolidated Financial Statements and The Report of Independent Registered Public Accounting Firm required by this item are included
in this Report on pages F-1 through F-29 and are incorporated herein by reference.



ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE



There
have been no disagreements with our Independent Registered Public Accounting Firm on any matter of accounting principles or financial
disclosures.



ITEM
9A. CONTROLS AND PROCEDURES



Evaluation
on Disclosure Controls and Procedures



Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed by our
Company is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that
such information is collected and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate,
to allow timely decisions regarding required disclosure. Our Chief Executive Officer and Chief Financial Officer are responsible for
establishing and maintaining disclosure controls and procedures for our Company. In designing and evaluating our disclosure controls
and procedures, management recognizes that no matter how well conceived and operated, disclosure controls and procedures can provide
only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.



Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness
of our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the
period covered by this Report (the “Evaluation Date”). Based upon that evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that, as of the Evaluation Date, our disclosure controls and procedures were not effective, at the reasonable
assurance level, to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act
(i) is recorded, processed, summarized and reported, within the time periods specified in the SEC rules and forms and (ii) is accumulated
and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely
decisions regarding required disclosure.



As
previously disclosed, following the fiscal year ended October 31, 2022, management identified a material weakness in our internal
controls with respect to revenue recognition in the third quarter of fiscal 2022. Specifically, we improperly recognized revenue in
accordance with the terms of a Joint Operating Agreement that was entered into in August 2021. Following a review of our revenue
recognition policy and in discussion with our consultants, we concluded that the milestones for recognition of $200,000 of revenue
and the related general and administrative expenses under that agreement were not met, that revenue had been improperly recognized,
and that such revenue and the related expenses should have been deferred. This weakness resulted in the restatement of our financial
statements for the three and nine months ended July 31, 2022 included in the Form 10. For additional information, see “Item 1A. Risk Factors” herein.



Subsequent
to the fourth quarter of fiscal 2022, management has taken steps to remediate the weakness discovered during that quarter.



-101-









Management’s
report on internal control over financial reporting



This
annual report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation
report of the company’s registered public accounting firm due to a transition period established by rules of the Securities and
Exchange Commission for newly public companies.



Changes
In Internal Control Over Financial Reporting



There
were no changes in our internal control over financial reporting that occurred during the quarter ended October 31, 2022 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting. However, see the discussion above
under Evaluation of Disclosure Controls and Procedures for a description of changes in our internal control over financial reporting
initiated subsequent to the quarter ended October 31, 2022.



ITEM
9B. OTHER INFORMATION



None.



ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS



Not
applicable.



-102-







PART
III



ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE



Executive
Officers, Directors, and Significant Employees



The
following table sets forth information regarding our executive officers, directors, and significant employees as of January 23, 2023:



|Name                   |  | Age |  | Positions
    with the Company        
|---------------------- |  | --- |  | --------------------------------------
|Christopher
    Furman |  | 53  |  | Chief
    Executive Officer, Director 
|Nathan
    Haas        |  | 25  |  | Chief
    Financial Officer           
|James
    R. Musick    |  | 75  |  | Chief
    Science Officer, Director   
|Caroline
    Mosessian |  | 58  |  | Chief
    Regulatory Officer, Director
|Tiana
    States       |  | 33  |  | Chief
    Manufacturing Officer       
|John
    Packs         |  | 67  |  | Chair
    of the Board                



Each
of our directors is serving a term which expires at the next annual meeting of stockholders and until his or her successor is elected
and qualifies or until such individual resigns or is removed. The officers serve at the will of the Board of Directors. There
are no arrangements or understandings with major stockholders, customers, suppliers or others pursuant to which any of our executive
management or our directors were selected.



Executive
Officers and Directors



Christopher
M. Furman



Mr.
Furman was appointed as our Chief Executive Officer and a member of the Board on July 6, 2022. From December 2021 until joining our company,
Mr. Furman was Managing Director at Virtus Investment Partners. He previously founded and served as a Managing Partner at Forum Capital
Advisors, LLC, an asset management firm, from March 2018 until January 2021 and as Managing Director at ArrowMark Partners, an asset
management firm, from September 2016 to March 2018. Prior to that, he served as the Managing Director at Janus Capital Group Inc., a
publicly traded investment management company. Mr. Furman holds a Bachelor of Arts in Political Science from the University of Pittsburgh.



We
believe Mr. Furman is qualified to serve as a member of our Board of Directors because of his leadership experience in various executive
roles, particularly his experience in publicly traded companies and capital markets.



Nathan
Haas



Mr.
Haas has served as our Chief Financial Officer since October 1, 2021 and previously served as our Vice President of Finance from August
1, 2021. From August 2020, Mr. Haas co-founded and served as the Chief Financial Officer of Fitore, and from October 2020 he also
served as the Chief Financial Officer of Infinivive MD, until both companies were acquired by us on August 1, 2021. Prior to that,
Mr. Haas held positions at Brightedge as an associate from February 2020 to March 2020, where he was responsible for conducting analysis
to identify revenue growth opportunities, at Bank of New York Mellon as a Global Client Management Analyst from May 2019 to September
2019, where he provided enterprise-wide relationship management, and at TandaPay, a crypto insurance platform, as a Managing Director
from January 2019 to May 2019, where he was responsible for implementing a go-to market strategy of the first fully peer-to-peer insurance
platform built on the Ethereum blockchain. Earlier in his career, Mr. Haas was a member of the development and transactions team at UDR,
Inc., a multi-family REIT, as a Development Analyst from May 2018 to September 2018 and served as a Financial Representative at Northwestern
Mutual, a financial planning firm, from May 2017 to May 2018. Mr. Haas holds a Bachelor of Arts from Miami University.



-103-









James
R. Musick, Ph.D



Dr.
Musick, one of our founders, currently serves as our Chief Science Officer, a position he has held since April 2018, and as our CLIA
Laboratory Director, a position he has held since April 2021. Dr. Musick has also served as a member of our Board of Directors since
September 1989. Over the past three decades, Dr. Musick has held various executive positions with the Company, including Chair of the
Board from March 2005 to November 2020, President and Chief Executive Officer from August 1999 to November 2020, and Chief Financial
Officer from September 1999 to April 2018. Dr. Musick began his career at our Company as a Production Supervisor from April 1988 to May
1992 and occupied roles of increasing responsibility thereafter, including Chief Operating Officer. Dr. Musick holds a Bachelor of Arts
and a Doctor of Philosophy in Biological Sciences from Northwestern University. In addition, Dr. Musick completed a program on Managing
New Product Development at Northwestern University’s Kellogg School of Management.



We
believe that Dr. Musick is qualified to serve as a member of our Board of Directors because of his extensive experience in various leadership
roles and in the development of biopharmaceutical products at our Company, as well as the continuity that he brings to our Board of Directors
as one of our founders.



Caroline
Mosessian, PhD., DRSc.



Dr.
Mosessian has served as our Chief Regulatory Officer since October 2021 and as a member of our Board of Directors since February 2021,
including serving as Chair of our Board of Directors from May 2022 until January 19, 2023. She currently devotes approximately 85% of
her working time on company affairs. She previously served as our Director of Regulatory Affairs from January 2021 until October 2021.
Dr. Mosessian also currently serves as an adjunct Clinical Associate Professor at the University of Southern California, a position she
has held since August 2000. She also currently sits on the IRB of Common Spirit Health, a nonprofit health system, and provides clinical,
research and ethical advice on numerous clinical trial research projects. Dr. Mosessian also currently serves as the Principal/Founder
of Innovative Strategies & Solutions, Inc., a management consulting firm in life sciences and healthcare industries, a position she
has held since January 2015. Dr. Mosessian holds a Master of Science and a Doctor of Philosophy in Regulatory & Quality Management
Systems as well as a Master of Science and a Doctor of Philosophy in Healthcare Management and Health Economics, all from the University
of Southern California.



We
believe Dr. Mosessian is qualified to serve on our Board of Directors because of her expansive knowledge in regulatory science and strategies
in quality management and her vast experience with domestic and international regulatory bodies, including the FDA, EMA, and Health Canada,
providing human research protection and clinical trial design for drug discovery and developments.



John
Packs



Mr.
Packs was appointed as the Chair of our Board on January 19, 2023 and has served as a member of the Board since August 2022. Mr. Packs
retired from American International Group (AIG) in July 2021, where he was employed beginning in August 2001. While at AIG, Mr. Packs
served in various capacities including Senior Investment Officer-VALIC Funds at AIG Retirement Services from 2001 to July 2021, where
he oversaw $32 billion in assets, and Senior Vice President-Product and Research at SunAmerica Asset Management from September 2009 to
July 2021. Prior to that, Mr. Packs served as Senior Vice President-Investment Research at American General Financial Group from March
2000 until its acquisition by AIG in 2001. Prior to that Mr. Packs was a principal at Cypress Holding Company, an asset management company
and a consultant at Allmerica Financial. Previously he was co-founder of College America Corporation, focused on college savings and
educational tools. Mr. Packs served as a legislative aide specializing in foreign and defense policy in the U.S. Senate from May 1979-
December 1984. Mr. Packs holds a Bachelor of Arts in economics from Tufts University and an MBA from Columbia University.



We
believe that Mr. Pack’s previous experience as a fiduciary, including work in legal and regulatory affairs, and his work with various
regulatory agencies, makes him qualified to serve as a director of our Company.



-104-









Significant
Employees



Tiana
States



Ms.
States has served as our Chief Manufacturing Officer since December 2020. She has served in various capacities at the Company since December
2013. From April 2018 until December 2020, she served as our Chief Operating Officer. During her role as COO, Ms. States helped create
and validate research and development products, development of nutraceuticals to support stem cell health, and move into a quality management
system certified by ISO 9001:2015 and ISO 13485:2016. She established operations into cGMP compliance and diagnostics to CLIA certified.
From August 2011 to May 2012, she performed academic cancer research at Colorado State University and governmental genetic research from
USDA-ARS to help achieve overall high-quality regulations. Ms. States is an inventor and has contributed to six patent pending technologies
assigned to our company. She is in the process of expanding current technologies and developing multiple other technologies for our company.



Family
Relationships



There
are no family relationships among any of our current executive officers or directors.



Executive
Committee



We
currently have one standing committee of the Board of Directors, the executive committee. Our executive committee, comprised of Christopher
Furman, Caroline Mosessian and James Musick, supports our Board of Directors in the performance of its duties and responsibilities between
its regularly scheduled meetings. Subject to such limitations as the Board of Directors or applicable law may from time to time impose,
the executive committee has and may exercise all powers and authority of the Board, except that the executive committee does not have
power or authority to, among other things:



| | ● | amend
    the Company’s articles of incorporation or bylaws;
| | - | ------------------------------------------------------------
| |   |                                                             
| | ● | fill
    vacancies on the Board of Directors;               
| |   |                                                             
| | ● | adopt
    an agreement or plan of merger or consolidation;  
| |   |                                                             
| | ● | declare
    a dividend; or                                  
| |   |                                                             
| | ● | authorize
    the issuance of stock.                        



Audit
Committee Financial Expert



Our
Board of Directors does not currently maintain an audit committee. Nor does our Board have an “audit committee financial expert,”
as defined by SEC rule. Due to difficulty in attracting independent directors to our Board with our present capitalization, we do not
deem it feasible to have an audit committee financial expert at this time.



Our
Board of Directors expects to appoint additional independent directors in connection with our anticipated future public offering and
anticipated listing on a national securities exchange and at that time, create an audit committee and identify and appoint independent
directors to such committee, including an audit committee financial expert.



Compensation
Committee Interlocks and Insider Participation



None
of our executive officers has served as a member of a compensation committee (or if no committee performs that function, the Board of
Directors) of any other entity that has an executive officer serving as a member of our Board of Directors.





Code
of Ethics



Our
Board has adopted a Code of Conduct and Ethics which is applicable to all of the Company’s directors and officers, including our
principal executive officer and principal financial officer.



A
copy of the Company’s Code of Conduct Ethics may be obtained free of charge by making the request to the Company in writing or
on the Company’s website at https://www.vitrobiopharma.com/pages/corporate-governance.



-105-







Item
11. Executive Compensation



This
section discusses the material components of the executive compensation program for our named executive officers (NEOs) who are named
in the subsection titled “—Summary Compensation Table.” In fiscal year 2022, our NEOs and their positions were as follows:



| | ● | Christopher
    Furman, Chief Executive Officer;     
| | - | -----------------------------------------------------
| |   |                                                      
| | ● | Nathan
    Haas, Chief Financial Officer;            
| |   |                                                      
| | ● | Caroline
    Mosessian, Chief Regulatory Officer; and
| |   |                                                      
| | ● | Jack
    Zamora, former Chief Executive Officer.     



Christopher
Furman began serving as our Chief Executive Officer on July 6, 2022. Dr. Zamora ceased serving as our Chief Executive Officer on May
4, 2022.



This
discussion may contain forward-looking statements that are based on our current plans, considerations, expectations and determinations
regarding future compensation programs.



Summary
Compensation Table



The
following table sets forth information concerning the compensation awarded to or earned by our NEOs during the two fiscal years ended
October 31, 2022 and 2021:



SUMMARY
COMPENSATION TABLE



|Name and Principal Position    |  | Year |      |  | Salary ($)(1) |  |         | Bonus ($) |  |  | Stock Awards ($) |     |  | Option Awards ($) (2),(3) |   |     | Non- Equity Incentive Plan Compensation ($) |  |           | All Other Compensation ($) |  |  | Total ($) |    
|------------------------------ |  | ---- | ---- |  | ------------- |  | ------- | --------- |  |  | ---------------- | --- |  | ------------------------- | - | --- | ------------------------------------------- |  | --------- | -------------------------- |  |  | --------- | ---
|Christopher Furman(4)          |  |      | 2022 |  |               |  | 129,231 |           |  |  | —                |     |  |                           | — |     |                                             |  | 4,957,603 |                            |  |  | 400,000   | (5)
|Chief Executive Officer        |  |      | 2021 |  |               |  | —       |           |  |  | —                |     |  |                           | — |     |                                             |  | —         |                            |  |  | —         |    
|                               |  |      |      |  |               |  |         |           |  |  |                  |     |  |                           |   |     |                                             |  |           |                            |  |  |           |    
|Nathan Haas(6)                 |  |      | 2022 |  |               |  | 177,356 |           |  |  | 175,000          | (5) |  |                           | — |     |                                             |  | —         |                            |  |  | —         |    
|Chief Financial Officer        |  |      | 2021 |  |               |  | 37,500  |           |  |  | 23,250           |     |  |                           | — |     |                                             |  | 282,595   |                            |  |  | —         |    
|                               |  |      |      |  |               |  |         |           |  |  |                  |     |  |                           |   |     |                                             |  |           |                            |  |  |           |    
|Caroline Mosessian             |  |      | 2022 |  |               |  | —       |           |  |  | 5,000            | (5) |  |                           | — |     |                                             |  | —         |                            |  |  | —         |    
|Chief Regulatory Officer       |  |      | 2021 |  |               |  | —       |           |  |  | 5,000            |     |  |                           | — |     |                                             |  | 384,896   |                            |  |  | —         |    
|                               |  |      |      |  |               |  |         |           |  |  |                  |     |  |                           |   |     |                                             |  |           |                            |  |  |           |    
|Jack Zamora (8)                |  |      | 2022 |  |               |  | 204,674 |           |  |  | —                |     |  |                           | — |     |                                             |  | —         |                            |  |  | —         |    
|Former Chief Executive Officer |  |      | 2021 |  |               |  | 44,967  |           |  |  | 46,197           |     |  |                           | — | (9) |                                             |  | 1,974,601 |                            |  |  | —         |    



(1) Salary amounts represent actual amounts paid to or earned during the applicable year. See “— Narrative to the Summary Compensation Table—Annual Base Salary” below.



(2) The amounts shown represent the grant date fair values of option awards granted
in 2022 and 2021 as computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) Topic
718. See Note 8 to our consolidated financial statements included elsewhere in this Report under the caption “—Stock-Based
Compensation” for a discussion of the assumptions used in the calculation of these amounts.





-106-









(3) Includes the grant date fair values of both vested and, if any, unvested options.



(4) Mr. Furman has served as our Chief Executive Officer since July 6, 2022.



(5) Includes a cash bonus determined for fiscal year 2022 performance, but to be paid in 2023.



(6) Mr. Haas has served as our Chief Financial Officer since October 1, 2021. Prior to that, he served as our Vice President of Finance from August 1, 2021. The amounts included in the summary compensation table include compensation Mr. Haas received in both roles.



(7) Includes consulting fees paid to or earned by Dr. Mosessian, through her consulting firm, Innovative Strategies & Solutions, Inc., for her services to the Company during the applicable year.



(8) Dr. Zamora served as our Chief Executive Officer until May 4, 2022.



(9) Excludes 23,000,000 shares issued to Dr. Zamora in connection with the acquisition of InfiniVive MD on August 1, 2021.



Narrative
to Summary Compensation Table



2022
Salaries



The
named executive officers receive a base salary to compensate them for services rendered to our company. The base salary payable to each
named executive officer is intended to provide a fixed component of compensation reflecting the executive’s skill set, experience,
role and responsibilities.



Pursuant
to the terms of Mr. Furman’s employment agreement dated July 6, 2022 (the “Furman Agreement”), Mr. Furman is paid an
annual base salary of $400,000.



Pursuant
to the terms of Mr. Haas’s employment agreement dated October 1, 2021 (the “Haas Agreement”), Mr. Haas is paid an annual
base salary of $175,000.



Pursuant
to the terms of Dr. Mosessian’s consulting agreement dated October 1, 2021 (the “Mosessian Agreement”), Dr. Mosessian,
through her consulting firm, Innovative Strategies & Solutions Inc., is paid annual consulting fees of $249,996.



Pursuant
to the terms of Dr. Zamora’s employment agreement dated December 1, 2020 (the “Zamora Agreement”), Dr. Zamora was paid
an annual base salary based on two components: (i) quarterly Gross Revenues multiplied by five (5%) percent plus (ii) the quarterly average
daily amount of cash on hand multiplied by five (5%) percent, subject to a $500,000 annual cap. “Gross Revenues” is defined
to mean all revenue of any kind which accrues or is owed to the Company during each fiscal year and is derived from any source.



2022
Bonuses



Mr.
Furman



The
Furman Agreement provides that Mr. Furman may receive an annual performance bonus of up to 100% of his base salary upon the achievement
of individual and/or Company performance objectives to be established each year by the Board and Mr. Furman. In the event individual
or Company performance objectives are exceeded in any given year, Mr. Furman is also eligible to receive a discretionary stretch bonus.
For the fiscal year ended October 31, 2022, the Company determined that he was entitled to a bonus of $400,000 based on the achievement
of individual and Company objectives since he was appointed as Chief Executive Officer.



-107-









Mr.
Haas



The
Haas Agreement provides for an annual bonus pursuant to which Mr. Haas may receive a discretionary annual performance bonus of up to
100% of his base salary, as well as a stretch bonus on account of extraordinary success in capital formation, merger and acquisition
activities and/or furthering the Company’s other business objectives, as determined by the Company’s Chief Executive Officer
and the Compensation Committee (the “Haas Annual Bonus”). For the fiscal year ended October 31, 2022, the Company determined
that Mr. Haas was entitled to a bonus of $175,000.



Dr.
Mosessian



For
the fiscal year ended October 31, 2022, the Board determined that Dr. Mosessian was entitled to a discretionary cash bonus of $5,000.



Equity
Compensation



We
have granted stock options to our employees, including our named executive officers, in order to attract and retain them, as well as
to align their interests with the interests of our stockholders. Below is a summary of the stock options granted to our named executive
officers during fiscal years 2021 and 2022.



Mr.
Furman



On
July 6, 2022, we granted 5,000,000 stock options to Mr. Furman, with an exercise price of $0.50 per share, in connection with his appointment
as Chief Executive Officer of the Company. These options became immediately exercisable as to 1,000,000 shares and the remainder will
vest in four equal annual installments, with accelerated vesting in the event of a change of control. The options are exercisable for
10 years from the grant date.



Mr.
Haas



On
August 1, 2021, we granted 1,000,000 stock options to Mr. Haas in connection with his employment agreement to serve as Vice President
of Finance of the Company. The options are exercisable at $0.50 per share, vest 20% on each anniversary of the date of grant and are
exercisable for 10 years.



On
October 1, 2021, we granted an additional 500,000 stock options to Mr. Haas in connection with his appointment as the Chief Financial
Officer. These options are exercisable at $0.50 per share, vest 20% on each anniversary of the date of grant and are exercisable for
10 years.



Dr.
Mosessian



On
February 1, 2021, we granted 500,000 stock options to Dr. Mosessian in connection with her consulting agreement to serve as Director
of Regulatory Affairs of the Company. The options are exercisable at $0.50 per share, vest 20% on December 31stof each year,
beginning on December 31, 2021, and are exercisable for a period of 10 years.



On
October 1, 2021, we granted 1,000,000 stock options to Dr. Mosessian in connection with her appointment as Chief Regulatory Officer of
the Company. These options became immediately exercisable as to 500,000 shares and vest as to 125,000 shares on each of October 1, 2022
and October 1, 2023 and 250,000 shares on October 1, 2024. The options are exercisable at $0.50 per share and are exercisable for a period
of 10 years.



No
options were exercised by any of our named executive officers during the fiscal years ended October 31, 2021 or 2022.



Other
Elements of Compensation



Employee
Benefits and Perquisites



Health
and Welfare Plans and Perquisites.All of our current named executive officers are eligible to participate in our employee benefit
plans, including our medical, dental, vision, disability and life insurance plans, in each case on the same basis as all of our other
employees. We generally do not provide perquisites or personal benefits to our named executive officers.



-108-









No
Tax Gross-Ups



Other
than a gross-up payment with respect to any parachute payments, as defined in Section 280G of the Internal Revenue Code of 1986, as amended
(the “Code”), paid to each of Mr. Haas, and Drs. Zamora and Musick pursuant to Section 4999 of the Code, we do not make gross-up
payments to cover our named executive officers’ personal income taxes that may pertain to any of the compensation or perquisites
paid or provided by our company.



Equity
Incentive Plan



We
have adopted the 2022 Omnibus Incentive Compensation Plan (the “2022 Plan”) in order to facilitate the grant of cash and
equity incentives to directors, employees (including our named executive officers) and consultants of our company and certain of its
affiliates and to enable us to obtain and retain services of these individuals, which is essential to our long-term success. For additional
information about the 2022 Plan, please see the section titled “Equity Incentive Plans” below.



Outstanding
Equity Awards at Fiscal Year End



The
following table sets forth information concerning the number of shares of common stock underlying outstanding equity incentive awards
for each NEO as of October 31, 2022:



|                   |  | Option Awards |     |  |                                                                     | Stock Awards | 
|------------------ |  | ------------- | --- |  | ------------------------------------------------------------------- | ------------ | 
|Name               |  | Grant Date    |     |  | Number of Securities Underlying Unexercised Options Exercisable (#) |              | 
|Christopher Furman |  | 07/06/2022    | (1) |  | 1,000,000                                                           |              | 
|Nathan Haas        |  | 08/01/2021    | (2) |  | 200,000                                                             |              | 
|                   |  | 10/01/2021    | (2) |  | 100,000                                                             |              | 
|Caroline Mosessian |  | 02/01/2021    | (3) |  | 100,000                                                             |              | 
|                   |  | 10/01/2021    | (4) |  | 625,000                                                             |              | 
|Jack Zamora        |  | 04/09/2020    |     |  | 666,000                                                             |              | 
|                   |  | 12/01/2020    |     |  | 1,000,000                                                           |              | 



(1)On the date of grant, 20% of the options vested immediately, and the remaining options vest ratably over four years on each annual
anniversary of the grant date.



(2)These options vest ratably over five years on each annual anniversary of the grant date.



(3)These options vest ratably over five years on December 31st of each year, beginning with December 31, 2021.



(4)On the date of grant, 50% of the options vested immediately, and the remaining options vested or will vest on each annual anniversary
of the grant date as follows: (i) 125,000 shares on October 1, 2022, (ii) 125,000 shares on October 1, 2023 and (iii) 250,000 shares
on October 1, 2024.



Executive
Compensation Arrangements



Below
is a description of the material terms of each employment contract, agreement, plan or arrangement that provides for the employment of
and payments to our NEOs and other executive officers (including such payments to be made at, following or in connection with the resignation,
retirement or other termination of such officer, or following a change in control).



-109-









Christopher
Furman



We
entered into the Furman Agreement effective July 6, 2022. Pursuant to the Furman Agreement, Mr. Furman is entitled to a base salary of
$400,000 per year. He will also be eligible to receive an annual bonus based on his performance as evaluated by our Board based on objective
factors to be established by the parties, with the target for such bonus being established at 100% of his base salary but which bonus
may exceed such target. In addition, as provided in the Furman Agreement, we have awarded Mr. Furman an option to purchase up to 5,000,000
shares of our common stock, of which 1,000,000 vested upon the date of grant and the remainder will vest in four equal annual installments
over a four-year period beginning on the first-year anniversary of the date of grant so long as he remains employed by or otherwise continues
providing services to our Company. The exercise price for each share of common stock underlying the option is $0.50 per share.



Under
the terms of the Furman Agreement, Mr. Furman’s employment may be terminated at any time. If he is terminated with “Cause”,
as defined in the Furman Agreement and summarized below, we would be obligated to pay him his accrued salary and accrued and unused vacation
and reimbursable expenses and continue his benefits to the date of termination. If he is terminated without Cause or resigns with “Good
Reason”, as defined in the Furman Agreement and summarized below, we would be obligated to pay him the sum of (A) one year’s
base salary at the then-applicable rate plus (B) an amount equal to the average of his annual bonus, if any, for the two years immediately
preceding the date of termination plus (C) any stretch bonus determined by the Board to be earned by Mr. Furman prior to his termination
(collectively, the “Severance Amount”). The Severance Amount would be payable in a lump sum. For purposes of the Furman Agreement,
“Cause” shall mean (1) a material breach by CEO of the agreement; (2) failure by CEO to perform in any manner CEO’s
material duties under the agreement after being given notice of such failure, along with an explanation of such failure of performance;
(3) conviction of CEO of a felony, crime of moral turpitude, or another crime that has had an adverse, negative impact on our Company’s
reputation or business (or a plea of guilty or nolo contendere thereto); (4) CEO securing any personal monetary profit not fully disclosed
to and approved by the Board in connection with any transaction CEO entered into on behalf of our Company; (5) gross negligence, willful
misconduct, or conduct which constitutes a breach of any fiduciary duty or duty of loyalty owed to our Company by CEO; or (6) material
violation of any lawful Company policy, procedure, rule, regulation or Company directive. A resignation shall be deemed to be for “Good
Reason” if (1) Mr. Furman’s title, authority, position, duties or responsibilities are materially diminished; (2) his base
salary or annual bonus opportunity is materially diminished (other than a reduction of his base salary as part of a salary reduction
plan applicable to all executive officers in a similar manner); (3) we change in any material way the geographic location at which Mr.
Furman must perform services or reside; or (4) we commit a material breach of the Agreement.



Finally,
the Furman Agreement contains a non-compete arrangement pursuant to which Mr. Furman has agreed not to compete with us anywhere in the
United States for a period of 12-months following termination of his employment for any reason.



Nathan
Haas



We
entered into the Haas Agreement on October 1, 2021 for a five (5) year term which expires October 1, 2026 and will automatically be extended
for one (1) year terms thereafter, unless otherwise terminated or not renewed pursuant to the terms of the Haas Agreement.



The
Haas Agreement provides for an annual bonus pursuant to which Mr. Haas may receive the Haas Annual Bonus. In connection with the execution
of the Haas Agreement, Mr. Haas was granted stock options to purchase up to 500,000 shares of the Company’s common stock at an
exercise price of $0.50 per share (the “Haas Initial Options”). The Haas Initial Options vest ratably over five (5) years
with the vesting period having commenced October 1, 2021. The Haas Initial Options shall be exercisable for a period of 10 years. The
Haas Initial Options will vest immediately upon a Change of Control.



Mr.
Haas may also receive a one-time discretionary bonus (the “One-Time Bonus”) as determined by the Chief Executive Officer
and the Company’s Board of Directors upon the Company’s successful fundraising and/or mergers and acquisitions activities,
or Mr. Haas’s contributions to the furtherance of the Company’s objectives.



-110-









If
we terminate Mr. Haas’s employment with us without cause (as defined in the Haas Agreement) or Mr. Haas elects not to renew his
then current term for good reason (as defined in the Haas Agreement), including a Change in Control, he will receive the following payments
and benefits: (i) a payment in the amount of two (2) times his then-current annual base salary and any accrued vacation pursuant to the
terms of the Haas Agreement; (ii) reimbursement any outstanding expenses owed at the end of the term of his employment (iii) an amount
equal to two (2) times the average of the Haas Annual Bonus for the two (2) fiscal years preceding his termination, and (iv) the One-Time
Bonus as determined by the Company’s Chief Executive Officer. In addition, any outstanding options granted to Mr. Haas will vest
immediately and will be exercisable for the remaining term of such options.



Caroline
Mosessian



We
entered into the Mosessian Agreement, through her consulting firm, Innovative Strategies & Solutions, Inc., on October 1, 2021. The
Mosessian Agreement terminates on October 1, 2024 (the “Termination Date”), unless earlier terminated.



The
Mosessian Agreement provides for annual consulting fees of $249,996. In connection with the execution of the Mosessian Agreement, on
October 1, 2021, Dr. Mosessian was granted stock options to purchase up to 1,000,000 shares of the Company’s common stock at an
exercise price of $0.50 per share, of which 500,000 vested immediately, 125,000 vest on the first anniversary, 125,000 vest on the second
anniversary, and 250,000 vest on the 3rd anniversary of the grant date. These options are exercisable for a period of ten
years.



Upon
a Change of Control or any termination of the Mosessian Agreement prior to the Termination Date, Dr. Mosessian will be entitled to payment
of her annual base compensation for the remainder of the term thereunder and all outstanding unvested options will vest immediately and
will be exercisable for the remaining term of such options.



James
Musick



We
entered into an employment agreement with Dr. Musick on December 1, 2020 (the “Musick Agreement”) for a five (5) year term
which expires December 1, 2025 and will automatically be extended for one (1) year terms thereafter, unless otherwise terminated or not
renewed pursuant to the terms of the Musick Agreement.



The
Musick Agreement provides for an annual bonus pursuant to which Dr. Musick may receive the Musick Annual Bonus. In connection with the
execution of the Musick Agreement, Dr. Musick was granted stock options to purchase up to 1,000,000 shares of the Company’s common
stock at an exercise price of $0.50 per share (the “Musick Initial Options”). The Musick Initial Options vest ratably over
five (5) years with the vesting period having commenced December 1, 2020. The Musick Initial Options shall be exercisable for a period
of 10 years. The Musick Initial Options will vest immediately upon a Change of Control.



Dr.
Musick may also receive the One-Time Bonus as determined by the Chief Executive Officer and the Company’s Board of Directors on
account of extraordinary success in furtherance of the Company’s business objectives.



If
we terminate Dr. Musick’s employment with us without cause (as defined in the Musick Agreement) or Dr. Musick elects not to renew
his then current term for good reason (as defined in the Musick Agreement), including a Change in Control, he will receive the following
payments and benefits: (i) a payment in the amount of two (2) times his then-current annual base salary and any accrued vacation pursuant
to the terms of the Musick Agreement; (ii) reimbursement any outstanding expenses owed at the end of the term of his employment (iii)
an amount equal to two (2) times the average of the Musick Annual Bonus for the two (2) fiscal years preceding his termination, and (iv)
the One-Time Bonus as determined by the Company’s Chief Executive Officer. In addition, any outstanding options granted to Dr.
Musick will vest immediately and will be exercisable for the remaining term of such options.



Tiana
States



We
entered into an executive employment agreement with Tiana States on December 8, 2020 (the “States Agreement”) pursuant to
which she serves as our Chief Manufacturing Officer. The States Agreement is for a five (5) year term which expires December 8, 2025
and will automatically be extended for one (1) year terms thereafter, unless otherwise terminated or not renewed pursuant to the terms
of the States Agreement.



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The
States Agreement provides for an initial annual salary of $125,000, which has been increased to $200,000 by verbal agreement. The States
Agreement also provides Ms. States the opportunity to receive an annual bonus up to 50% of her base salary, as determined by the Company’s
Chief Executive Officer, as well as a stretch bonus as determined by the Chief Executive Officer and the Company’s Board of Directors
on account of extraordinary success in furtherance of the Company’s business objectives.



In
connection with the execution of the States Agreement, Ms. States was granted stock options to purchase up to 1,000,000 shares of the
Company’s common stock at an exercise price of $0.50 per share (the “States Initial Options”). The States Initial Options
vest ratably over five (5) years with the vesting period having commenced December 8, 2020 and will vest immediately upon a Change of
Control. The States Initial Options shall be exercisable for a period of 10 years.



If
we terminate Ms. States’ employment with us without cause (as defined in the States Agreement) or Ms. States resigns for good reason
(as defined in the States Agreement), including a Change of Control, she will receive the following payments and benefits: (i) a payment
in the amount of two (2) times her then-current annual base salary and any accrued vacation; (ii) an amount equal to two (2) times the
average of the Ms. States’ annual bonus for the two (2) fiscal years preceding her termination, and (iii) the stretch bonus, if
any, as determined by the Company’s Chief Executive Officer. In addition, any outstanding options granted to Ms. States will vest
immediately and will be exercisable for the remaining term of such options.



Jack
Zamora



Dr.
Zamora ceased serving as the Chief Executive Officer of the Company on May 4, 2022. Prior to the termination of Dr. Zamora’s employment
without cause, we previously entered into the Zamora Agreement on December 1, 2020 for a five (5) year term which was to expire on December
1, 2025 (the “Initial Term”).



Under
the Zamora Agreement, Dr. Zamora was paid an annual base salary based on two components: (i) quarterly Gross Revenues multiplied by five
(5%) percent plus (ii) the quarterly average daily amount of cash on hand multiplied by five (5%) percent, subject to a $500,000 annual
cap. “Gross Revenues” is defined to mean all revenue of any kind which accrues or is owed to the Company during each fiscal
year and is derived from any source. The Zamora Agreement also provided for the Zamora Annual Bonus. In connection with the execution
of the Zamora Agreement, Dr. Zamora was granted stock options to purchase up to 5,000,000 shares of the Company’s common stock
at an exercise price of $0.50 per share (the “Zamora Initial Options”). As mentioned above, only 1,000,000 of these options
vested prior to the time that Dr. Zamora was removed as the Chief Executive Officer. Dr. Zamora was also entitled to receive a one-time
bonus (the “Transaction Bonus”) if the Company consummated any of the following (each a “Transaction”):



| | ● | sale
    or other disposition of the Company’s equity securities representing more than 50% of then outstanding voting securities to
    any person who is not an affiliate of the Company;                                                     
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                 
| | ● | a
    merger, consolidation or other reorganization of the Company;                                                                                                                                                                             
| |   |                                                                                                                                                                                                                                                 
| | ● | direct
    or indirect sale, transfer, conveyance or other disposition, in one or more related transactions, of all or substantially all of
    the properties or assets of the Company to any person who is not an affiliate of the Company; or
| |   |                                                                                                                                                                                                                                                 
| | ● | any
    other transaction, the intent of which may reasonably and equitably be construed to effect a substantially equivalent to any of the
    aforementioned.                                                                                 



The
Transaction Bonus would be equal to (i) 2.5% of the value of the Transaction if the value is more than $500 million and up to $1.0 billion
or (ii) 5.0% of the value of the Transaction if the value is more than $1.0 billion, provided that the Transaction is consummated during
the Initial Term. A Transaction’s value shall equal the total proceeds and other consideration received by us and/or our stockholders,
or total proceeds and other consideration paid by us, in each case, including cash, securities or notes, whether in lump sum or installments.
The Transaction Bonus would be payable in either cash or securities of our company, or a combination thereof, depending on the nature
of the Transaction. If the Transaction Bonus is paid in shares of our common stock, it will be valued at the 20-day VWAP as quoted on
principal trading market of our common stock.



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After
the end of fiscal year 2022, in connection with the termination of Dr. Zamora’s employment, we entered into a mutual release and
settlement agreement (the “Settlement Agreement”) with Dr. Zamora on November 20, 2022 (the “Effective Date”).
Pursuant to the Settlement Agreement, the parties confirmed that Dr. Zamora’s termination was “without cause” and Dr.
Zamora resigned as a director of the Company, effective on the Effective Date. As part of the Settlement Agreement, Dr. Zamora acknowledged
that he had been paid all amounts owed to him by us under the Zamora Agreement and that his unvested options would be terminated.



Potential
Payments and Benefits upon Termination or Change in Control



The
Employment Agreements with each of Messrs. Furman and Haas and Dr. Mosessian provide for severance benefits as described above under
“— Executive Compensation Arrangements.”



Director
Compensation



Directors
who also serves as employees of the Company do not receive additional compensation for their service as a director of the Company. The
following table contains information concerning the compensation of our non-employee directors in 2022:



|Name       |  | Fees Earned or Paid in Cash ($) |        |     | Stock Awards ($) |  |   | Option Awards ($) |  |  | All Other Compensation ($) |  |  | Total ($) |  
|---------- |  | ------------------------------- | ------ | --- | ---------------- |  | - | ----------------- |  |  | -------------------------- |  |  | --------- | -
|John Packs |  |                                 | 15,000 | (1) |                  |  | — |                   |  |  | —                          |  |  |           | —
|           |  |                                 |        |     |                  |  |   |                   |  |  |                            |  |  |           |  





(1) Mr. Packs earned $15,000 in fees for his services during fiscal year 2022, although such amounts will not be paid until 2023.



Incentive
Compensation Plans



The
following summarizes the material terms of the 2022 Plan, which will be the long-term incentive compensation plans in which our directors
and named executive officers are eligible to participate.



2022
Plan



Our
Board adopted the 2022 Plan on February 7, 2022 and it was subsequently approved by a majority of our Common Stockholders on June 29,
2022. The 2022 Plan was amended by our Board in July 2022 to increase the number of shares reserved for issuance under the Plan from
4,000,000 shares to 9,000,000 shares of common stock (the “2022 Plan Amendment”). Pursuant to the terms of the 2022 Plan,
stockholder approval of the 2022 Plan Amendment was not required. The principal purpose of the 2022 Plan is to attract, retain and motivate
selected employees, consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus
awards. The material terms of the 2022 Plan, as amended by the 2022 Plan Amendment, are summarized below:



Number
of Shares. 9,000,000 shares of common stock have been reserved for issuance under the 2022 Plan, of which 3,650,000 shares of
common stock remain available for issuance.



Duration
of the 2022 Plan. The 2022 Plan will remain in effect until February 7, 2032, unless terminated earlier by the Board.



Administration.The 2022 Plan will be administered by the Board or a committee appointed by the Board. Generally, it is expected that the compensation
committee will administer the 2022 Plan. The compensation committee is comprised entirely of independent directors. The compensation
committee may delegate its authority under the 2022 Plan, subject to certain limitations.



-113-









Eligibility.Awards may be granted to employees of the Company, its subsidiaries and affiliates, directors of the Company, and consultants
or advisers who provide bona fide services to the Company, its subsidiaries and affiliates, as an independent contractor and who qualifies
as a consultant or advisor under Instruction A.1.(a)(1) of Form S-8 under the Securities Act. The compensation committee will decide
who should receive awards and what kind of awards they should receive. The 2022 Plan does not limit the number of employees and affiliates
who may receive awards.



Clawback.The Company may require employees to reimburse any previously paid compensation provided under the 2022 Plan or an award agreement
in accordance with any recoupment policy that may be adopted in the future.



Types
of Awards. The compensation committee may grant the following types of awards under the 2022 Plan: stock options (including non-qualified
stock options and incentive stock options), stock appreciation rights, restricted stock, stock awards, restricted stock units, performance
shares, performance units, cash-based awards and substitute awards. A maximum of 4,000,000 incentive stock options may be issued under
the Plan.



Adjustments.In the event of material changes in the outstanding number of shares of common stock or in the capital structure of the Company
by reason of a stock split, stock or extraordinary dividend, a reverse stock split, or an extraordinary corporate transaction, such as
any recapitalization, merger, consolidation, combination, exchange of shares or the like, separation, including a spin-off, or other
distribution of stock or property of the Company, any reorganization or any partial or complete liquidation of the Company, the compensation
committee shall make an appropriate adjustment in the number and class of shares that are authorized under the 2022 Plan, and in the
number, class of and/or price of shares subject to outstanding awards granted under the 2022 Plan, as may be determined to be equitable
by the compensation committee, in its sole discretion, subject to certain limitations and requirements as set forth in the 2022 Plan,
to prevent dilution or enlargement of rights.



Change
in Control. Generally, in the event of a change in control of the Company, as defined in the 2022 Plan, unless otherwise specified
in the award agreement, accelerated vesting for awards will only occur if: (i) the awards are not continued or assumed (e.g., the awards
are not equitably converted or substituted for awards of a successor entity) in connection with the change in control; or (ii) the participant
has a qualifying termination of his or her service relationship (as defined in the award agreement) within two years following the date
of the change in control. Unless otherwise specified in the award agreement, in the event that the awards are not so continued or assumed
in connection with the change in control or in the event of a qualifying termination of his or her service relationship within two years
following the date of the change in control, then upon such change in control or such qualifying termination (as the case may be): (1)
all outstanding options and stock appreciation rights will become immediately exercisable in full during their remaining term; (2) any
restriction periods and restrictions imposed on non-performance based restricted stock awards will lapse; (3) all outstanding awards
of performance-based restricted stock, performance units and performance shares will be paid out assuming achievement of all relevant
target performance goals; (4) all restricted stock units will vest and be paid; and (5) all outstanding cash-based awards shall be accelerated
as of the effective date of the change in control (and, in the case of performance-based cash-based awards, based on an assumed achievement
of all relevant target performance goals), and be paid.



The
compensation committee’s policies relating to vesting of awards in the event of a change in control are implemented in the award
agreements approved by it from time to time.



Principles.The 2022 Plan contains several provisions intended to make sure that awards under the 2022 Plan comply with established principles
of good corporate governance. These provisions include:



| | ● | No
    Discounted Stock Options or Stock Appreciation Rights. Except for certain substitute awards, stock options and stock appreciation
    rights may not be granted with an exercise price of less than the fair market value of the common stock on the date the stock option
    or stock appreciation right is granted. This restriction may not be changed without stockholder approval.                                                                                                         
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | No
    Stock Option or Stock Appreciation Rights Repricings. Stock options and stock appreciation rights may not be repriced absent
    stockholder approval. This provision applies to both direct repricings—lowering the exercise price of an outstanding stock
    option or stock appreciation right—and indirect repricings—canceling an outstanding stock option or stock appreciation
    right and granting a replacement stock option or stock appreciation right with a lower exercise price.
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         

-114-









| | ● | No
    Cash Buyouts of Underwater Stock Options or Stock Appreciation Rights. The 2022 Plan does not permit cash buyouts of underwater
    stock options or stock appreciation rights without stockholder approval.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | No
    Liberal Share Recycling.The 2022 Plan permits share recycling only if an award expires or is terminated, surrendered or canceled
    without having been fully exercised or is forfeited in whole or in part. The 2022 Plan expressly prohibits recycling shares in specified
    circumstances, including: shares tendered to the Company by a participant to pay the exercise price of stock options; shares forfeited
    to satisfy tax withholding obligations; shares that were subject to a stock-settled stock appreciation right granted under the 2022
    Plan that were not issued upon the exercise of such stock appreciation right; and shares repurchased by the Company on the open market
    using the proceeds from the exercise of an award.
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | No
    Unvested Dividends or Dividend Units.The 2022 Plan prohibits the Company from paying dividends or dividend units on unvested
    awards.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | Cap
    on Director Compensation: The total compensation paid to a single non-employee director in any calendar year, including the cash
    compensation and cash value of all equity awards granted to such director in such year, cannot exceed $1,000,000.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | No
    Evergreen Provision. The 2022 Plan does not contain an “evergreen provision”—there is no automatic provision
    to replenish the shares of common stock authorized for issuance under the 2022 Plan.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
| |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
| | ● | No
    reload options. The 2022 Plan does not provide for the issuance of stock options or stock appreciation rights which, upon exercise,
    automatically entitle a participant to a new stock option or stock appreciation right.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   



Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters



The
following table sets forth information regarding beneficial ownership of our common stock as of January 23, 2023 by:



| | ● | each
    person whom we know to beneficially own more than 5% of our common stock;
| | - | ----------------------------------------------------------------------------------
| |   |                                                                                   
| | ● | each
    of our directors;                                                        
| |   |                                                                                   
| | ● | each
    of our named executive officers; and                                     
| |   |                                                                                   
| | ● | all
    directors and executive officers as a group.                              



In
accordance with the rules of the SEC, beneficial ownership includes voting or investment power with respect to securities and includes
the shares issuable pursuant to stock options and warrants that are exercisable within 60 days of January 23, 2023. Shares issuable pursuant
to stock options and warrants are deemed outstanding for computing the percentage of the person holding such options but are not outstanding
for computing the percentage of any other person.



We
have based our calculation of the percentage of beneficial ownership on 115,160,180 shares of our common stock outstanding as of January
23, 2023.



Unless
otherwise indicated, the address for each listed stockholder is: c/o Vitro Biopharma, Inc., 3200 Cherry Creek Drive South, Suite 720,
Denver, Colorado 80209. To our knowledge, except as indicated in the footnotes to this table and pursuant to applicable community property
laws, the persons named in the table have sole voting and investment power with respect to all shares of common stock.



|Name
    of Beneficial Owner                                                                                          |  | Number
                                            of Shares Beneficially Owned (#) |            |        | Percentage
                                            of Shares Beneficially Owned (%) | 
|--------------------------------------------------------------------------------------------------------------------- |  | ----------------------------------------------------------------------------------- | ---------- | ------ | --------------------------------------------------------------------------------------- | 
|Named
    Executive Officers and Directors:                                                                           |  |                                                                                     |            |        |                                                                                         | 
|                                                                                                                      |  |                                                                                     |            |        |                                                                                         | 
|Christopher
    Furman                                                                                                |  |                                                                                     | 35,177,462 | (1)(2) |                                                                                         | 
|Nathan Haas                                                                                                           |  |                                                                                     | 3,221,299  | (3)    |                                                                                         | 
|Jack Zamora
                                    36 Steele Street
                                    Denver, CO 80206 |  |                                                                                     | 37,049,318 | (4)    |                                                                                         | 
|James Musick                                                                                                          |  |                                                                                     | 32,724,982 | (5)(6) |                                                                                         | 
|Caroline Mosessian                                                                                                    |  |                                                                                     | 825,000    | (7)    |                                                                                         | 
|John Packs                                                                                                            |  |                                                                                     | 0          |        |                                                                                         | 
|All executive officers
    and directors as a group (5 persons)                                                       |  |                                                                                     | 74,820,599 | (8)    |                                                                                         | 
|                                                                                                                      |  |                                                                                     |            |        |                                                                                         | 
|All
    Other Greater than 5% Owners:                                                                                 |  |                                                                                     |            |        |                                                                                         | 
|James R. Musick Trust(9)                                                                                              |  |                                                                                     | 22,727,635 |        |                                                                                         | 
|John Evans                                                                                                            |  |                                                                                     | 6,780,740  | (10)   |                                                                                         | 





*
Less than 1%.



(1)Includes
1,000,000 shares issuable upon exercise of options which are exercisable within 60 days of January 23, 2023.



(2)Includes
34,177,462 shares over which the reporting person shares voting power by virtue of a proxy granted by Jack Zamora pursuant to a
Standstill Agreement dated November 20, 2022 between the Company and Dr. Zamora.



(3)Includes
1,040,000 shares issuable upon exercise of warrants and 300,000 shares that are issuable upon exercise of options, all of which are exercisable
within 60 days of January 23, 2023.





-115-







(4) Includes
1,666,000 shares issuable upon exercise of options and 1,205,856 shares issuable upon exercise of outstanding warrants, all of which
is are exercisable within 60 days of January 23, 2023. Pursuant to a Standstill Agreement between the reporting person and the Company dated November 20, 2022, the reporting
person granted an irrevocable proxy to 34,177,462 of these shares to Christopher Furman under certain conditions. See the Schedule 13D
filed by Mr. Furman with the SEC on December 2, 2022 for additional information.



(5) Includes 4,700,000 shares issuable upon exercise of options that are exercisable within 60 days of January 23, 2023. Also includes 2,956,849 shares owned by the reporting person’s spouse.



(6) Includes 22,727,635 shares held in The James R. Musick Trust, a grantor trust. Dr. James Musick has sole voting and investment control of the shares held in The James R. Musick Trust.



(7) Includes 825,000 issuable upon exercise of options that are exercisable within 60 days of January 23, 2023.



(8) Includes 1,040,000 shares issuable upon exercise of outstanding warrants and 6,825,000 shares
underlying options, all of which are exercisable within 60 days of January 23, 2023.



(9) Dr. James Musick, a director and our Chief Science Officer, has sole voting and investment control of the shares held in The James R. Musick Trust.



(10) Includes (i) 1,260,740 shares held by the reporting person’s spouse, of which he disclaims beneficial ownership, (ii) 300,000 shares held by the reporting person’s adult children, and (iii) 3,400,000 shares issuable upon exercise of options that are exercisable within 60 days of January 23, 2023.



Equity
Compensation Plan Information



The
following table sets forth information concerning equity compensation granted to various consultants and employees of the Company pursuant
to individual compensation arrangements as of October 31, 2022:



|Plan Category                                              |  | Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) |            |  | Weighted-average exercise price of outstanding options, warrants and rights (b) |   |      | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) | 
|---------------------------------------------------------- |  | ----------------------------------------------------------------------------------------------- | ---------- |  | ------------------------------------------------------------------------------- | - | ---- | ----------------------------------------------------------------------------------------------------------------------------------------------- | 
|Equity compensation plans approved by security holders     |  |                                                                                                 | 350,000    |  |                                                                                 |   | 0.50 |                                                                                                                                                 | 
|Equity compensation plans not approved by security holders |  |                                                                                                 | 28,876,000 |  |                                                                                 | $ | 0.32 |                                                                                                                                                 | 
|Total                                                      |  |                                                                                                 | 29,226,000 |  |                                                                                 |   | 0.32 |                                                                                                                                                 | 



Information
regarding the individual compensation arrangements pursuant to which outstanding options were granted to employees prior to October 31,
2022 is contained above under the section titled “Executive and Director Compensation.” In addition, the Company granted
175,000 options each to an employee and a consultant on March 1, 2022 as part compensation for their services to the Company.



Item
13. Certain Relationships and Related Transactions, and Director Independence



The
following information summarizes transactions since November 1, 2020 and any currently proposed transactions, to which we were or are
to be a participant, in which (i) the amount involved exceeded or will exceed the lesser of (a) $120,000 or (b) 1% of the average of
our total assets at year end for the last two completed fiscal years; and (ii) any of our directors, executive officers, persons who
were directors or executive officers at the time of such transaction or holders of more than 5% of our common stock, or any affiliate
or member of the immediate family of the foregoing persons, had or will have a direct or indirect material interest, other than compensation
and other arrangements that are described under the section titled “Executive and Director Compensation” above.



-116-









We
believe the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below
were comparable to terms available or the amounts that we would pay or receive, as applicable, in arm’s-length transactions.



Promissory
Notes



On
November 1, 2020, we issued promissory notes (the “Promissory Notes”) to our Chief Science Officer and Director, in the aggregate
principal amount of (i) $1,221,958 which accrues interest at a rate of 4.0% per annum and (ii) $767,288 which accrues interest at a rate
of 6.0% per annum. The Promissory Notes, which were issued to the CSO in exchange for accrued compensation and interest on such accrued
compensation and mature on December 31, 2025; provided, however, if certain conditions precedent have not been satisfied, the
Promissory Notes will be automatically extended to the date which is 60 days after the satisfaction of such conditions precedent. As
of October 31, 2022, approximately $2.0 million in aggregate principal amount was outstanding under the Promissory Notes. From November
1, 2018 through October 31, 2022, we accrued $189,832 in interest payments under the Promissory Notes.



10%
Senior Secured Convertible Notes



In
October 2021, our former Chief Executive Officer converted his holdings of our 10% senior secured convertible notes , into shares of
our Common Stock as follows:



|Investor Name |  | Date of Issuance |           |  | Principal Amount |   |         | Accrued Interest |  |  | Maturity Date |  | Conversion Date |  | Share Received Upon Conversion | 
|------------- |  | ---------------- | --------- |  | ---------------- | - | ------- | ---------------- |  |  | ------------- |  | --------------- |  | ------------------------------ | 
|Jack Zamora   |  |                  | 6/15/2018 |  |                  | $ | 150,000 |                  |  |  |               |  | 12/31/2021      |  | 10/10/2021                     | 
|Jack Zamora   |  |                  | 7/27/2018 |  |                  | $ | 100,000 |                  |  |  |               |  | 12/31/2021      |  | 10/10/2021                     | 
|Jack Zamora   |  |                  | 7/29/2019 |  |                  | $ | 70,000  |                  |  |  |               |  | 12/31/2021      |  | 10/10/2021                     | 



Series
A Units



Between
November 2020 and October 2021, we sold approximately 36.3 Series A Units for cash proceeds in the aggregate amount of approximately
$1,815,000 million. Each Series A Unit consisted of (i) 2,000 shares of Series A Convertible Preferred Stock, (ii) a Class A Warrant,
exercisable for up to three (3) years from the issuance date, to purchase up to 100,000 shares of our common stock at an exercise price
of $0.50 per share and (iii) a Class B Warrant, exercisable for up to five (5) years from the issuance date, to purchase up to 100,000
shares of our common stock at an exercise price of $1.00 per share. Our former CEO received approximately 1.73 Series A Units in October
2021 upon the conversion of advances payable to the former CEO in the amount of $86,464. Also, in October 2021, our Chief Financial Officer
was issued four (4) Series A Units upon cancellation of a 5% Convertible Note (as defined below) in the aggregate principal amount of
$0.2 million issued in August 2021 in connection with the Fitore Acquisition as described below.



Fitore
Merger



Effective
August 2021, we acquired Fitore (the “Fitore Acquisition”) for consideration consisting of six of our Series A Units, our
convertible notes in the aggregate principal amount of $1,000,000 which accrue interest at a rate of 5% per annum (the “5% Convertible
Notes”) and an aggregate of 4,000,000 shares of our common stock. Prior to, and up to the time of closing of, the acquisition,
Dr. Zamora was our Chief Executive Officer, a member of our Board of Directors and the owner of less than 1% of our outstanding common
stock and the owner of 30% of the outstanding stock of Fitore. Our Board of Directors was aware of the interest of Dr. Zamora in the
transaction and he recused himself from any Board deliberations or votes with regard to the proposed acquisition in order to address
the inherent conflicts of interest between our interests and those of Dr. Zamora. For a discussion of certain risks related to these
inherent conflicts of interest, see “Risk Factors” herein.



-117-









Each
Series A Unit issued in connection with the Fitore Acquisition consisted of (i) 2,000 shares of Series A Convertible Preferred Stock,
(ii) a Class A Warrant, exercisable for up to three (3) years from the issuance date, to purchase 100,000 shares of our common stock
at an exercise price of $0.50 per share and (iii) a Class B Warrant, exercisable for up to five (5) years from the issuance date, to
purchase 100,000 shares of our common stock at an exercise price of $1.00 per share.



We
issued 5% Convertible Notes in the aggregate principal amount of $1 million in connection with the Fitore Acquisition. The 5% Convertible
Notes are convertible at the option of the holder at any time and are subject to mandatory conversion if (i) there exists a public market
for the our common stock, (ii) the closing price of the common stock in the principal trading market has been $3.00 per share or higher
for the preceding twenty (20) trading days, and the average daily trading volume during such 20 day period is at least 15,000 shares
and (iii) either (A) there is an effective registration statement registering for resale the shares issuable upon conversion or (B) the
shares issuable upon conversion are eligible to be resold by non-affiliates of the Company without restriction under Rule 144 under the
Securities Act.



As
of November 3, 2022, $480,000 in aggregate principal amount was outstanding under a single remaining 5% Convertible Note issued in connection
with the Fitore Acquisition. From August 2021 through October 31, 2022, we accrued $29,904 in interest payments under the remaining 5%
Convertible Note. From August 1, 2021 through April 15, 2022, we converted $11,265 in accrued interest into shares of Common Stock upon
the conversion of two of the 5% Convertible Notes.



Pursuant
to the terms of the Agreement and Plan of Merger with Fitore (the “Fitore Merger Agreement”), we issued the following consideration
to our former Chief Executive Officer, who was a stockholder of Fitore, and our Chief Financial Officer, who was a stockholder and Chief
Financial Officer of Fitore:



Jack
Zamora, Former Chief Executive Officer



|Security              |  | Number of Securities/Aggregate Principal Amount |           |  | Maturity Date |           | Conversion/Cancellation Date
|--------------------- |  | ----------------------------------------------- | --------- |  | ------------- | --------- | ----------------------------
|Common Stock          |  |                                                 | 1,200,000 |  |               | N/A       |                             
|Preferred Stock Units |  |                                                 | 1.8       |  |               | N/A       |                             
|5% Convertible Note   |  | $                                               | 300,000   |  |               | 7/31/2024 |                             



Dr.
Zamora’s note was converted on April 15, 2022 into 310,561 shares of Common Stock, which included the conversion of accrued interest
of $10,561.



Nathan
Haas, Chief Financial Officer



|Security                       |  | Number of Securities/Aggregate Principal Amount |         |  | Maturity Date |           | Conversion/Cancellation Date
|------------------------------ |  | ----------------------------------------------- | ------- |  | ------------- | --------- | ----------------------------
|Common Stock                   |  |                                                 | 800,000 |  |               | N/A       |                             
|Preferred Stock Units          |  |                                                 | 1.2     |  |               | N/A       |                             
|5% Convertible Promissory Note |  | $                                               | 200,000 |  |               | 7/31/2024 |                             



We
canceled Mr. Haas’s note in October 2021 and he received four (4) Series A Units in connection with such cancellation. Each Series
A Unit consisted of (i) 2,000 shares of Series A Convertible Preferred Stock, (ii) a Class A Warrant, exercisable for up to three (3)
years from the issuance date, to purchase up to 100,000 shares of our common stock at an exercise price of $0.50 per share and (iii)
a Class B Warrant, exercisable for up to five (5) years from the issuance date, to purchase up to 100,000 shares of our common stock
at an exercise price of $1.00 per share.



Mr.
Haas also entered into a confidentiality and proprietary rights agreement with us pursuant to which he agreed to maintain the confidentiality
of certain information learned by him in the course of his employment with the Company. Pursuant to the terms of the Fitore Merger Agreement,
we also have certain customary indemnification obligations to Mr. Haas in the event of any losses or damages arising out of certain breaches
under the Fitore Merger Agreement.



-118-









Tanner
Haas, Immediate Family Member of our Chief Financial Officer



Tanner
Haas, who is Nathan Haas’s brother, was a stockholder and Chief Executive Officer of Fitore, received the following consideration
pursuant to the Fitore Merger Agreement:



|Security                       |  | Number of Securities/Aggregate Principal Amount |           |  | Maturity Date
|------------------------------ |  | ----------------------------------------------- | --------- |  | -------------
|Common Stock                   |  |                                                 | 1,920,000 |  |              
|Preferred Stock Units          |  |                                                 | 2.9       |  |              
|5% Convertible Promissory Note |  | $                                               | 480,000   |  |              



The
consideration issued to the related parties was on the same terms and conditions as the non-affiliated parties.



InfiniVive
MD Acquisition



Effective
August 2021, we also acquired InfiniVive MD, a company solely owned by Dr. Zamora. Pursuant to the Agreement and Plan of Exchange
(the “Exchange Agreement”) governing our acquisition of InfiniVive MD, Dr. Zamora exchanged 100% of his membership units
in InfiniVive MD for 23,000,000 shares of our common stock. As with the merger with Fitore, our Board of Directors was aware of his
interest in the transaction and Dr. Zamora recused himself from any Board deliberations related to the acquisition of InfiniVive MD
in order to address the inherent conflict which existed in him owning that entity and serving as our Chief Executive Officer, a
member of our Board of Directors and a stockholder of our company. Including the common stock that was issued in connection with the
merger of Fitore, Dr. Zamora owned 3.4% of the voting power of our common stock before the acquisition. For a discussion of certain
risks related to these inherent conflicts of interest, see “Item 1A. Risk Factors” herein.



Pursuant
to the terms of the Exchange Agreement, we also have certain customary indemnification obligations to Dr. Zamora in the event of any
losses or damages arising out of certain breaches under the Exchange Agreement.



Other
Transactions with Former Chief Executive Officer



Set
forth below are additional transactions that we have entered into with Dr. Jack Zamora, our former Chief Executive Officer and former
director. As of January 23, 2023, Dr. Zamora beneficially owned approximately 31% of our voting stock.



Release
and Settlement Agreement



On
November 20, 2022 (the “Settlement Effective Date”), we entered into a Mutual Release and Settlement Agreement with our former
Chief Executive Officer, Dr. Jack Zamora (the “Settlement Agreement”). Pursuant to the Settlement Agreement, Dr. Zamora’s
termination was confirmed as being “without cause” and Dr. Zamora resigned as a director of the Company, effective on the
Settlement Effective Date.



As
part of the Settlement Agreement, the parties agreed to confidentiality and non-disparagement restrictions, as well as a release of any
potential claims against each other. In addition, certain provisions of Dr. Zamora’s Employment Agreement that survive termination
of employment were modified to provide that Dr. Zamora shall not, for a period of one year from the Settlement Effective Date, “directly
or indirectly solicit any person who has been a customer or employee of the Company during the period of one (1) year prior to the Settlement
Effective Date.” The Settlement Agreement also provides for the termination of all previous supply agreements between the Company
and Dr. Zamora, effective immediately, with such previous agreements to be replaced by the Supply Agreement and the MOU described below.
In addition, Dr. Zamora acknowledged the forfeiture of certain of his stock purchase options.



-119-









Supply
Agreement



On
the Settlement Effective Date, in connection with the Settlement Agreement,
we entered into a Supply Agreement with Dr. Zamora (the “Supply Agreement”), pursuant to which we agreed to provide InfiniVive
MD Exosome Serum and InfiniVive Daily Serum (the “Cosmetic Products”) to Dr. Zamora at his request. The provision of the Cosmetic
Products under the Supply Agreement is subject to minimum and maximum quantity limitations. The Supply Agreement is effective for a period
of five years, unless earlier terminated. The Company or Dr. Zamora may terminate the Supply Agreement immediately in prescribed circumstances,
including if either party defaults with respect to its obligations under the Supply Agreement and, if the default is capable of being
cured, does not cure such default within 30 days after receiving notice of such default. If the Supply Agreement is deemed terminated
by Dr. Zamora for failure of the Company to supply the Cosmetic Products in accordance with its terms or by the Company without cause,
the Standstill Agreement would be deemed terminated and of no further force or effect. As of January 23, 2023, Dr. Zamora has purchased
approximately $15,750 of Cosmetic Products pursuant to the Supply
Agreement.



Memorandum
of Understanding



On
the Settlement Effective Date, in connection with the Settlement Agreement, we also entered into a Memorandum of Understanding with Dr.
Zamora (the “MOU”) in order to support clinical research for AlloRx. Under the MOU, the Company agreed to provide AlloRx
at a specified price to international clinical research facilities or other clinics with which Dr. Zamora may become affiliated, provided
that certain regulatory conditions are satisfied, including proof of satisfaction of applicable United States and local legal requirements.
The MOU will be effective for a period of five years, unless earlier terminated or replaced by mutual written agreement between Dr. Zamora
and the Company. The MOU may also be earlier terminated in the event any clinic or the Company materially breaches the terms and conditions
of the MOU. In the event the MOU is terminated by Dr. Zamora for failure of the Company to supply AlloRx in accordance with its terms
or by the Company without cause, the Standstill Agreement would be deemed terminated and of no further force or effect.



Revenues



Dr.
Zamora is also a significant customer of ours in his capacity as a practicing physician. For the years ended October 31, 2022 and 2021,
Dr. Zamora accounted for $30,500 and $362,800 in product sales, respectively.



Lease
with Spouse of Chief Science Officer



The
spouse of our Chief Science Officer, through entities she controls, leases office and lab space to our company. The rent is $5,645 per
month plus taxes, insurance and utilities. We believe that the rental rate charged to us under this lease are consistent with commercial
rental rates in the area.



Other
Transactions



We
have entered into employment agreements with our executive officers that, among other things, provide for certain compensatory and change
in control benefits, as well as severance benefits. For a description of these agreements with our named executive officers, see the
subsection titled “Executive and Director Compensation—Executive Compensation Arrangements.”



We
have also granted stock options to our executive officers and certain of our directors. For a description of these equity awards, see
the subsection titled “Executive and Director Compensation—Equity Compensation.”



-120-









Director
Independence



Our
Board of Directors currently consists of four members. Our Board of Directors has determined that only Mr. Packs qualifies as an independent
director in accordance with the NYSE American’s listing standards. Mr. Furman and Drs. Musick and Mosessian are not considered
independent by virtue of their positions as executive officers of the Company. Dr. Zamora, who served as a director throughout fiscal
year 2022 and until his resignation on November 20, 2022, was not considered independent as a result of his prior employment with the
Company. Under the NYSE American’s listing standards, the definition of independence includes a series of objective tests, such
as that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of
his or her family members has engaged in various types of business dealings with us. In addition, as required by the NYSE American’s
listing standards, our Board of Directors has made a subjective determination as to each independent director that no relationships exists
that, in the opinion of our Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities
of a director. In making these determinations, our Board of Directors reviewed and discussed information provided by the directors and
us with regard to each director’s relationships as they may relate to us and our management.



ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES



The
Board appointed MaloneBailey LLP (“MaloneBailey”) as our independent registered public accounting firm for the fiscal year
ended October 31, 2022, as well as for our fiscal year ending October 31, 2023.



Pre-Approval
Policies and Procedures



Our
Board of Directors does not presently have an Audit Committee. Notwithstanding this absence, it is our policy to pre-approve all audit
and other services rendered by our independent registered public accounting firm. The
independent auditors are required to periodically report to the Board of Directors regarding the extent of services provided by the independent
registered public accounting firm in accordance with such pre-approval.



During
the year ended October 31, 2022, the Board of Directors approved, in advance,
all audit and non-audit services to be provided by MaloneBailey. The Board of Directors has determined that the non-audit services rendered
by MaloneBailey during fiscal years 2022 and 2021 were compatible with maintaining the independence of the independent registered public
accounting firm.



Independent
Registered Certified Public Accounting Firm Fees and Services



The
following table sets forth a summary of the fees billed by MaloneBailey for professional services rendered for the fiscal years ended
October 31, 2022 and 2021:



|Fee Category          |  | Fiscal Year 2022 |         |  | Fiscal Year 2021 |  
|--------------------- |  | ---------------- | ------- |  | ---------------- | -
|Audit Fees(1)         |  | $                | 110,000 |  |                  | $
|Audit-Related Fees(2) |  |                  | 36,000  |  |                  |  
|Tax Fees              |  |                  | —       |  |                  |  
|All Other Fees(3)     |  |                  | —       |  |                  |  
|Total Fees            |  | $                | 146,000 |  |                  | $



(1)Audit fees consist of fees billed for professional services rendered for the audit of our Company’s financial statements
and review of our interim financial statements included in quarterly reports and services that are normally provided by our auditors
in connection with statutory and regulatory filings or engagements.



(2)Audit
related fees consist of fees billed for assurance and related services that are reasonably related to the performance of the audit
or review of our financial statements and are not reported under “Audit Fees”.





(3)All Other Fees consist of the aggregate fees billed in each of the last two fiscal years for the products and services provided
by our auditors, other than the products and services included in Audit Fees, Tax Fees, and Audit-Related Fees.



-121-







PART
IV



ITEM
15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES



|(a) | The
    following documents are filed as part of this Report:
|--- | -------------------------------------------------------------
|    |                                                              
|    | (1)                                                          
|    |                                                              
|    | (2)                                                          
|    |                                                              
|    | (3)                                                          
|    |                                                              
|(b) | Exhibits:                                                    



|Exhibit
    Number |  | Exhibit
    Description                                                                                                                                                                                                                                                                                      
|------------------ |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|2.1                |  | Agreement and Plan of Exchange, dated August 1, 2021, by and among InfiniVive MD, LLC, Jack Zamora, its Sole Member, and the Registrant (Incorporated by reference to Exhibit 2.1 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                               
|2.2                |  | Agreement and Plan of Merger, dated August 1, 2021, by and among Fitore, Inc., the Registrant, Vitro Acquisition Corp. No. 1 and the Fitore Stockholders named therein (Incorporated by reference to Exhibit 2.2 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)
|3.1                |  | Second Amended and Restated Articles of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                     
|3.2                |  | Bylaws (Incorporated by reference to Exhibit 3.3 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                                                
|3.3                |  | Amendment to the Bylaws (Incorporated by reference to Exhibit 3.4 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                               
|4.1                |  | Form of Common Stock Certificate (Incorporated by reference to Exhibit 4.2 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                      
|4.2                |  | Form of Stock Purchase Warrant A (Incorporated by reference to Exhibit 4.3 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                      
|4.3                |  | Form of Stock Purchase Warrant B (Incorporated by reference to Exhibit 4.4 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                      
|4.4*               |  | Form of Warrant to Purchase Stock                                                                                                                                                                                                                                                                            
|4.5*               |  | Description of Capital Stock                                                                                                                                                                                                                                                                                 
|10.1#              |  | 2022 Equity Incentive Plan (Incorporated by reference to Exhibit 10.2 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                                           
|10.2#              |  | Amendment to the 2022 Equity Incentive Plan (Incorporated by reference to Exhibit 10.3 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                                                                          
|10.3#              |  | Form of Incentive Stock Option Grant Notice and Stock Option Agreement under the 2022 Incentive Award Plan (Incorporated by reference to Exhibit 10.4 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                           



-122-







|10.4#  |  | Form of Non-Statutory Stock Option Grant Notice and Stock Option Agreement under the 2022 Incentive Award Plan (Incorporated by reference to Exhibit 10.5 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                  
|------ |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|10.5#  |  | Non-Statutory Stock Option Agreement, dated May 1, 2018, by and between the Registrant and James Musick (Incorporated by reference to Exhibit 10.7 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                         
|10.6#  |  | Non-Statutory Stock Option Agreement, dated May 1, 2018, by and between the Registrant and John R. Evans (Incorporated by reference to Exhibit 10.8 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                        
|10.7#  |  | Non-Statutory Stock Option Agreement, dated November 30, 2020, by and between the Registrant and John R. Evans (Incorporated by reference to Exhibit 10.9 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                  
|10.8#  |  | Non-Statutory Stock Option Agreement, dated November 30, 2020, by and between the Registrant and James R. Musick (Incorporated by reference to Exhibit 10.10 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)               
|10.9#  |  | Non-Statutory Stock Option Agreement, dated December 1, 2020, by and between the Registrant and Jack Zamora (Incorporated by reference to Exhibit 10.11 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                    
|10.10# |  | Non-Statutory Stock Option Agreement, dated April 9, 2020, by and between the Registrant and Jack Zamora (Incorporated by reference to Exhibit 10.12 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                       
|10.11# |  | Non-Statutory Stock Option Agreement, dated August 1, 2021, by and between the Registrant and Nathan Haas (Incorporated by reference to Exhibit 10.13 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                      
|10.12# |  | Non-Statutory Stock Option Agreement, dated October 1, 2021, by and between the Registrant and Caroline Mosessian (Incorporated by reference to Exhibit 10.14 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)              
|10.13# |  | Non-Statutory Stock Option Agreement, dated October 1, 2021, by and between the Registrant and John R. Evans (Incorporated by reference to Exhibit 10.15 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                   
|10.14# |  | Non-Statutory Stock Option Agreement, dated October 1, 2021, by and between the Registrant and Nathan Haas (Incorporated by reference to Exhibit 10.16 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                     
|10.15# |  | Non-Statutory Stock Option Agreement, dated February 1, 2021, by and between the Registrant and Caroline Mosessian (Incorporated by reference to Exhibit 10.17 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)             
|10.16# |  | Executive Employment Agreement, dated December 1, 2020, by and between the Registrant and James R. Musick (Incorporated by reference to Exhibit 10.18 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                      
|10.17# |  | Executive Employment Agreement, dated December 1, 2020, by and between the Registrant and Jack Zamora (Incorporated by reference to Exhibit 10.19 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                          
|10.18# |  | Executive Employment Agreement, dated October 1, 2021, by and between Nathan Haas and the Registrant (Incorporated by reference to Exhibit 10.20 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                           
|10.19# |  | Consultant Agreement, dated October 1, 2021, by and between the Registrant and Innovative Strategies & Solutions, Inc. (Incorporated by reference to Exhibit 10.21 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)         
|10.20# |  | Executive Employment Agreement, dated December 2, 2020, by and between the Registrant and Keith Burge (Incorporated by reference to Exhibit 10.22 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                          
|10.21# |  | Addendum to Employment Agreement (Separation Agreement), dated February 19, 2021, by and between the Registrant and Keith Burge (Incorporated by reference to Exhibit 10.23 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)



-123-







|10.22#  |  | Executive Employment Agreement, effective July 6, 2022, by and between the Registrant and Christopher Furman (Incorporated by reference to Exhibit 10.24 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                             
|------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|10.23#  |  | Executive Employment Agreement, dated November 30, 2020, by and between the Registrant and John Evans (Incorporated by reference to Exhibit 10.25 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                    
|10.24   |  | Lease Agreement, dated July 1, 2020, by and between Kokopelli Properties, LLC and the Registrant (Incorporated by reference to Exhibit 10.27 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                         
|10.25   |  | Subscription Agreement and 4% Unsecured Promissory Note Due December 31, 2025, dated November 1, 2020, by and between the Registrant and James Musick (Incorporated by reference to Exhibit 10.28 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                    
|10.26   |  | Subscription Agreement and 6% Unsecured Promissory Note Due December 31, 2025, dated November 1, 2020, by and between the Registrant and James Musick (Incorporated by reference to Exhibit 10.29 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                    
|10.27†  |  | Joint Operating Agreement, dated August 6, 2021, by and among European Wellness Biomedical Group, Bio Peptides LLC and the Registrant (Incorporated by reference to Exhibit 10.31 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                    
|10.28   |  | Amendment, dated April 28, 2022, to Joint Operating Agreement, dated August 6, 2021, by and among European Wellness Biomedical Group, Bio Peptides LLC and the Registrant (Incorporated by reference to Exhibit 10.32 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)
|10.29   |  | Note Purchase Agreement, dated May 31, 2022, by and between the Registrant and Bruce Peterson (Incorporated by reference to Exhibit 10.34 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                            
|10.30   |  | Convertible Promissory Note, dated May 31, 2022, issued by the Registrant to Bruce Peterson (Incorporated by reference to Exhibit 10.35 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                              
|10.31   |  | Note Purchase Agreement, dated May 31, 2022, by and between the Registrant and Kevin Melling (Incorporated by reference to Exhibit 10.36 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                             
|10.32   |  | Convertible Promissory Note, dated May 31, 2022, issued by the Registrant to Kevin Melling (Incorporated by reference to Exhibit 10.37 to the Company’s registration statement on Form S-1 filed with the SEC on September 9, 2022)                                                                               
|10.33#* |  | Mutual Release and Settlement Agreement, dated November 20, 2022, by and between the Registrant and Jack Zamora                                                                                                                                                                                                   
|10.34*  |  | Standstill Agreement, dated November 20, 2022, by and between the Registrant and Jack Zamora                                                                                                                                                                                                                      
|10.35*† |  | Supply Agreement, dated November 20, 2022, by and between the Registrant and Jack Zamora                                                                                                                                                                                                                          
|10.36*† |  | Memorandum of Understanding, dated November 20, 2022, by and between the Registrant and Jack Zamora                                                                                                                                                                                                               
|10.37*  |  | Form of 8% Convertible Promissory Note                                                                                                                                                                                                                                                                            
|10.38*  |  | Form of Convertible Note and Warrant Purchase Agreement                                                                                                                                                                                                                                                           
|21.1*   |  | List of subsidiaries                                                                                                                                                                                                                                                                                              
|31.1*   |  | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002                                                                                                                                                                                                                
|31.2*   |  | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002                                                                                                                                                                                                                
|32.1*+  |  | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002                                                                                                                                                                 
|32.2*+  |  | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002                                                                                                                                                                 



|# | Indicates
    management contract or compensatory plan.                                                                                                                                                                                                                                                                                                                                        
|- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|† | Certain
    portions of this document that constitute confidential information have been redacted in accordance with Regulation S-K, Item 601(b)(10).                                                                                                                                                                                                                                          
|* | Filed
    or furnished herewith                                                                                                                                                                                                                                                                                                                                                                
|+ | The
    certifications attached as Exhibits 32.1 and 32.2 that accompanies this Report are not deemed filed with the SEC and are not to be
    incorporated by reference into any filing of the Registrant under the Securities Act or the Exchange Act, whether made before or
    after the date of this Report, irrespective of any general incorporation language contained in such filing.



ITEM
16. FORM 10-K SUMMARY



None.



-124-







SIGNATURES



Pursuant
to the requirements of Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized on January 30, 2023.



| | VITRO
    BIOPHARMA, INC.
| | -------------------------
| |                          
| | By:                      
| | Name:                    
| | Title:                   



Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.



|Signature                  |  | Title                                                   |  | Date                
|-------------------------- |  | ------------------------------------------------------- |  | --------------------
|                           |  |                                                         |  |                     
|/s/
    Christopher Furman |  | Chief Executive Officer (Principal                      |  | January
    30, 2023
|Christopher
    Furman     |  | Executive
    Officer), Director                        |  |                     
|                           |  |                                                         |  |                     
|/s/
    Nathan Haas        |  | Chief Financial Officer (Principal                      |  | January
    30, 2023
|Nathan
    Haas            |  | Financial
    Officer and Principal Accounting Officer) |  |                     
|                           |  |                                                         |  |                     
|/s/
    James R. Musick    |  | Chief Science Officer, Director                         |  | January
    30, 2023
|James
    R. Musick        |  |                                                         |  |                     
|                           |  |                                                         |  |                     
|/s/
    Caroline Mosessian |  | Chief
    Regulatory Officer, Director                  |  | January
    30, 2023
|Caroline
    Mosessian     |  |                                                         |  |                     
|                           |  |                                                         |  |                     
|/s/
    John Packs         |  | Chair
    of the Board                                  |  | January
    30, 2023
|John
    Packs             |  |                                                         |  |                     



-125-







INDEX
TO FINANCIAL STATEMENTS



|                                                                                                            |  | Page
|----------------------------------------------------------------------------------------------------------- |  | ----
|VITRO BIOPHARMA, INC.                                                                                       |  |     
|                                                                                                            |  |     
|Audited Financial Statements                                                                                |  |     
|Years Ended October 31, 2022 and 2021                                                                       |  |     
|                                                                                                            |  |     
|Report
    of Independent Registered Public Accounting Firm (Firm ID 206)                                   |  | F-2 
|Consolidated Balance Sheets as of
    October 31, 2022 and 2021                                             |  | F-3 
|Consolidated Statements of Operations
    for the Years Ended October 31, 2022 and 2021                     |  | F-4 
|Consolidated Statement of Changes
    in Stockholders’ Equity for the Years Ended October 31, 2022 and 2021 |  | F-5 
|Consolidated Statements of Cash Flows
    for the Years Ended October 31, 2022 and 2021                     |  | F-6 
|Notes to Consolidated Financial Statements                                                                  |  | F-7 



F-1







REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM



To
the Shareholders and Board of Directors of

Vitro
Biopharma, Inc.



Opinion
on the Financial Statements



We
have audited the accompanying consolidated balance sheets of Vitro Biopharma, Inc. and its subsidiaries (collectively, the “Company”)
as of October 31, 2022 and 2021, and the related consolidated statements of operations, stockholders’ equity, and cash flows for
the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the
financial statements present fairly, in all material respects, the financial position of the Company as of October 31, 2022 and 2021,
and the results of their operations and their cash flows for the years then ended, in conformity with accounting principles generally
accepted in the United States of America.



Going
Concern Matter



The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
2 to the financial statements, the Company has suffered recurring losses from operations and negative cash flow from operations that
raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also
described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.



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.



Critical
Audit Matters



Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the Board of Directors and that: (1) relate to accounts or disclosures that are material to the financial statements
and (2) involved our especially challenging, subjective, or complex judgements. We determined that there are no critical audit matters.





|/s/ MaloneBailey, LLP                               | 
|--------------------------------------------------- | 
|www.malonebailey.com                                | 
|We have served as the Company’s auditor since 2020. | 
|Houston, Texas                                      | 
|January 30,
2023                                    | 



F-2







Vitro
BioPharma, Inc.

Consolidated
Balance Sheets



|                                                                                                                                                                             |  | October
    31, 2022 |             |   | October
    31, 2021 |  
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  | -------------------- | ----------- | - | -------------------- | -
|ASSETS                                                                                                                                                                       |  |                      |             |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Cash                                                                                                                                                                         |  | $                    | 741,538     |   |                      | $
|Restricted Cash                                                                                                                                                              |  |                      | –           |   |                      |  
|Accounts Receivable, Net                                                                                                                                                     |  |                      | 73,537      |   |                      |  
|Inventory                                                                                                                                                                    |  |                      | 280,138     |   |                      |  
|Prepaid Expense                                                                                                                                                              |  |                      | 140,759     |   |                      |  
|Prepaid project costs                                                                                                                                                        |  |                      | 217,747     |   |                      |  
|Deferred Offering Costs                                                                                                                                                      |  |                      | 1,482,422   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total Current Assets                                                                                                                                                         |  |                      | 2,936,141   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Goodwill                                                                                                                                                                     |  |                      | 3,608,949   |   |                      |  
|Intangible Assets, Net                                                                                                                                                       |  |                      | 1,377,401   |   |                      |  
|Property and Equipment, Net                                                                                                                                                  |  |                      | 351,940     |   |                      |  
|Patents, Net                                                                                                                                                                 |  |                      | 8,390       |   |                      |  
|Right of Use Asset – Operating Lease                                                                                                                                         |  |                      | 277,381     |   |                      |  
|Other Assets                                                                                                                                                                 |  |                      | 13,860      |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Assets                                                                                                                                                             |  | $                    | 8,574,062   |   |                      | $
|                                                                                                                                                                             |  |                      |             |   |                      |  
|LIABILITIES                                                                                                                                                                  |  |                      |             |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Accounts Payable                                                                                                                                                             |  | $                    | 604,606     |   |                      | $
|Deferred Revenue                                                                                                                                                             |  |                      | 650,000     |   |                      |  
|Revolving Line of Credit                                                                                                                                                     |  |                      | –           |   |                      |  
|Accrued Liabilities                                                                                                                                                          |  |                      | 939,523     |   |                      |  
|Accrued Liabilities – Related Party                                                                                                                                          |  |                      | 232,512     |   |                      |  
|Current Maturities of Capital Lease Obligations                                                                                                                              |  |                      | 62,979      |   |                      |  
|Current Maturities of
    Operating Lease Obligations                                                                                                                        |  |                      | 50,055      |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Current Liabilities                                                                                                                                                |  |                      | 2,539,675   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Capital Lease Obligations, Net of Current Portion                                                                                                                            |  |                      | 78,955      |   |                      |  
|Operating Lease Obligation, Net of Current
    Portion                                                                                                                       |  |                      | 227,326     |   |                      |  
|Unsecured 6% Note Payable – Related Party                                                                                                                                    |  |                      | 767,288     |   |                      |  
|Unsecured 4% Note Payable – Related Party                                                                                                                                    |  |                      | 1,221,958   |   |                      |  
|2021 Series Convertible Notes Payable –
    Related Party                                                                                                                    |  |                      | 480,000     |   |                      |  
|Senior Convertible Note Payable                                                                                                                                              |  |                      | –           |   |                      |  
|2022 Series Convertible Notes Payable                                                                                                                                        |  |                      | 200,000     |   |                      |  
|Long Term Accrued Interest Payable                                                                                                                                           |  |                      | 3,205       |   |                      |  
|Long Term Accrued Interest
    Payable – Related Party                                                                                                                       |  |                      | 219,815     |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Long-Term Liabilities                                                                                                                                              |  |                      | 3,198,547   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Liabilities                                                                                                                                                        |  |                      | 5,738,222   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|STOCKHOLDERS’
    EQUITY                                                                                                                                                     |  |                      |             |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Preferred Stock, 5,000,000 Shares Authorized,
    par value $0.001; Series A Convertible Preferred Stock, 250,000 Shares Authorized, 0 and 136,059 Outstanding, respectively |  |                      | –           |   |                      |  
|Common stock, 500,000,000 Shares Authorized,
    par value $0.001, 115,160,180 and 96,310,387 Outstanding, respectively                                                      |  |                      | 115,440     |   |                      |  
|Additional Paid in Capital                                                                                                                                                   |  |                      | 25,523,816  |   |                      |  
|Less Treasury Stock                                                                                                                                                          |  |                      | (84,000     | ) |                      |  
|Accumulated Deficit                                                                                                                                                          |  |                      | (22,719,416 | ) |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Stockholders’ Equity                                                                                                                                               |  |                      | 2,835,840   |   |                      |  
|                                                                                                                                                                             |  |                      |             |   |                      |  
|Total
    Liabilities and Stockholders’ Equity                                                                                                                               |  | $                    | 8,574,062   |   |                      | $



These
financial statements should be read in connection with the notes to consolidated financial statements.



F-3







Vitro
BioPharma, Inc.

Consolidated
Statements of Operations



|                                                                          |  | Year
                                            Ended October
                                            31, 2022 |             |   | Year
                                            Ended October
                                            31, 2021 |  
|------------------------------------------------------------------------- |  | ------------------------------------------------------------------------------------------------------------------- | ----------- | - | ------------------------------------------------------------------------------------------------------------------- | -
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Product Sales                                                             |  | $                                                                                                                   | 2,662,793   |   |                                                                                                                     | $
|Product Sales, Related Parties                                            |  |                                                                                                                     | 30,500      |   |                                                                                                                     |  
|Consulting Revenue                                                        |  |                                                                                                                     | 600,000     |   |                                                                                                                     |  
|Total Revenue                                                             |  |                                                                                                                     | 3,293,293   |   |                                                                                                                     |  
|Less Cost of Goods Sold                                                   |  |                                                                                                                     | (586,884    | ) |                                                                                                                     |  
|Gross Profit                                                              |  |                                                                                                                     | 2,706,409   |   |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Operating Costs and Expenses:                                             |  |                                                                                                                     |             |   |                                                                                                                     |  
|Selling, General and Administrative                                       |  |                                                                                                                     | 7,602,945   |   |                                                                                                                     |  
|Research and Development                                                  |  |                                                                                                                     | 155,630     |   |                                                                                                                     |  
|Impairment
    expense                                                    |  |                                                                                                                     | 914,091     |   |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Loss From Operations                                                      |  |                                                                                                                     | (5,966,257  | ) |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Other Expense:                                                            |  |                                                                                                                     |             |   |                                                                                                                     |  
|Interest Expense                                                          |  |                                                                                                                     | (198,450    | ) |                                                                                                                     |  
|Loss
    on Conversion of Senior Secured Note Payable                     |  |                                                                                                                     | (695,342    | ) |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Net Loss                                                                  |  |                                                                                                                     | (6,860,049  | ) |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Deemed Dividend on Series A Convertible Preferred
    Stock               |  |                                                                                                                     | (793,175    | ) |                                                                                                                     |  
|Cumulative Series A
    Convertible Preferred Stock Dividend Requirement  |  |                                                                                                                     | (111,333    | ) |                                                                                                                     |  
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Net Loss Available to
    Common Stockholders                             |  | $                                                                                                                   | (7,764,557  | ) |                                                                                                                     | $
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Net Loss per Common
    Share, Basic and Diluted                          |  | $                                                                                                                   | (0.07       | ) |                                                                                                                     | $
|                                                                          |  |                                                                                                                     |             |   |                                                                                                                     |  
|Shares Used in Computing
    Net Loss per Common Share, Basic and Diluted |  |                                                                                                                     | 107,724,768 |   |                                                                                                                     |  



These
financial statements should be read in connection with the notes to consolidated financial statements.



F-4







Vitro
BioPharma, Inc.

Consolidated
Statement of Changes in Stockholders’ Equity

For
the Years Ended October 31, 2022 and 2021





|                                                                       |  | Preferred
    Stock |          |   | Common
    Stock |   |      | Additional
                                                                                Paid
                                            in |  |  | Treasury      |  |  | Accumulated |         |  |       |  
|---------------------------------------------------------------------- |  | ------------------- | -------- | - | ---------------- | - | ---- | ---------------------------------------------------------------------------------------------------------------------------------------------- |  |  | ------------- |  |  | ----------- | ------- |  | ----- | -
|                                                                       |  | Shares              |          |   | Par
    Value    |   |      | Shares                                                                                                                                         |  |  | Par
    Value |  |  | Capital     |         |  | Stock |  
|                                                                       |  |                     |          |   |                  |   |      |                                                                                                                                                |  |  |               |  |  |             |         |  |       |  
|Balance at October
    31, 2020                                        |  |                     | 41,000   |   |                  |   | 41   |                                                                                                                                                |  |  | 46,130,200    |  |  |             | 46,410  |  |       |  
|                                                                       |  |                     |          |   |                  |   |      |                                                                                                                                                |  |  |               |  |  |             |         |  |       |  
|Sale of preferred stock                                                |  |                     | 71,600   |   |                  |   | 72   |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Common stock issued for services                                       |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | 75,000        |  |  |             | 75      |  |       |  
|Stock based compensation                                               |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Shares issued in connection
    with acquisition of subsidiaries       |  |                     | 12,000   |   |                  |   | 12   |                                                                                                                                                |  |  | 27,000,000    |  |  |             | 27,000  |  |       |  
|Conversion of notes payable
    and advances from related parties      |  |                     | 11,459   |   |                  |   | 11   |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Conversion of notes to common
    stock                                |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | 23,105,187    |  |  |             | 23,105  |  |       |  
|Beneficial conversion feature
    on convertible preferred stock       |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Deemed dividend on convertible
    preferred stock-                    |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Net
    loss                                                           |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|                                                                       |  |                     |          |   |                  |   |      |                                                                                                                                                |  |  |               |  |  |             |         |  |       |  
|Balance at October 31, 2021                                            |  |                     | 136,059  |   |                  |   | 136  |                                                                                                                                                |  |  | 96,310,387    |  |  |             | 96,590  |  |       |  
|                                                                       |  |                     |          |   |                  |   |      |                                                                                                                                                |  |  |               |  |  |             |         |  |       |  
|Common Stock issued in connection
    with note conversions            |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | 4,043,765     |  |  |             | 4,044   |  |       |  
|Common Stock issued in connection
    with preferred stock conversions |  |                     | (136,059 | ) |                  |   | (136 | )                                                                                                                                              |  |  | 14,806,028    |  |  |             | 14,806  |  |       |  
|Stock based compensation                                               |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Beneficial conversion feature
    on convertible preferred stock       |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Deemed dividend on convertible
    preferred stock                     |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|Net
    loss                                                           |  |                     | -        |   |                  |   | -    |                                                                                                                                                |  |  | -             |  |  |             | -       |  |       |  
|                                                                       |  |                     |          |   |                  |   |      |                                                                                                                                                |  |  |               |  |  |             |         |  |       |  
|Balance
    at October 31, 2022                                        |  |                     | -        |   |                  | $ | -    |                                                                                                                                                |  |  | 115,160,180   |  |  | $           | 115,440 |  |       | $



These
financial statements should be read in connection with the notes to consolidated financial statements.



F-5







Vitro
BioPharma, Inc.

Consolidated
Statements of Cash Flows



|                                                                                     |  | Year
                                            Ended October
                                            31, 2022 |            |   | Year
                                            Ended October
                                            31, 2021 |  
|------------------------------------------------------------------------------------ |  | ------------------------------------------------------------------------------------------------------------------- | ---------- | - | ------------------------------------------------------------------------------------------------------------------- | -
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Operating Activities                                                                 |  |                                                                                                                     |            |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Net Loss                                                                             |  | $                                                                                                                   | (6,860,049 | ) |                                                                                                                     | $
|Adjustment to Reconcile Net Loss:                                                    |  |                                                                                                                     |            |   |                                                                                                                     |  
|Loss on Conversion of Senior
    Secured Note Payable                                |  |                                                                                                                     | 695,342    |   |                                                                                                                     |  
|Depreciation Expense                                                                 |  |                                                                                                                     | 163,799    |   |                                                                                                                     |  
|Amortization Expense                                                                 |  |                                                                                                                     | 131,735    |   |                                                                                                                     |  
|Bad Debt Expense                                                                     |  |                                                                                                                     | 10,440     |   |                                                                                                                     |  
|Impairment Expense                                                                   |  |                                                                                                                     | 914,091    |   |                                                                                                                     |  
|Amortization of Operating
    Lease – ROU Asset                                      |  |                                                                                                                     | 55,616     |   |                                                                                                                     |  
|Accretion of Debt Discount                                                           |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Stock Based Compensation                                                             |  |                                                                                                                     | 2,197,597  |   |                                                                                                                     |  
|Issuance of shares for services                                                      |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Write-off of inventory                                                               |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Changes in Assets and Liabilities                                                    |  |                                                                                                                     |            |   |                                                                                                                     |  
|Accounts Receivable                                                                  |  |                                                                                                                     | 43,505     |   |                                                                                                                     |  
|Accounts Receivable, Related
    Parties                                             |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Inventory                                                                            |  |                                                                                                                     | (162,133   | ) |                                                                                                                     |  
|Prepaid Expenses                                                                     |  |                                                                                                                     | (126,781   | ) |                                                                                                                     |  
|Prepaid project costs                                                                |  |                                                                                                                     | (217,747   | ) |                                                                                                                     |  
|Accounts Payable                                                                     |  |                                                                                                                     | 237,068    |   |                                                                                                                     |  
|Accounts Payable, Related
    Parties                                                |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Deferred Revenue                                                                     |  |                                                                                                                     | 150,000    |   |                                                                                                                     |  
|Operating Lease Obligation                                                           |  |                                                                                                                     | (55,616    | ) |                                                                                                                     |  
|Accrued Liabilities                                                                  |  |                                                                                                                     | 417,341    |   |                                                                                                                     |  
|Accrued Liabilities –
    Related Party                                              |  |                                                                                                                     | 60,365     |   |                                                                                                                     |  
|Accrued Interest                                                                     |  |                                                                                                                     | 2,582      |   |                                                                                                                     |  
|Accrued Interest, Related
    Parties                                                |  |                                                                                                                     | 136,165    |   |                                                                                                                     |  
|Advances                                                                             |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Other
    assets                                                                     |  |                                                                                                                     | (9,940     | ) |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Net Cash Used in Operating
    Activities                                            |  |                                                                                                                     | (2,216,620 | ) |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Investing Activities                                                                 |  |                                                                                                                     |            |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Acquisition of Fitore                                                                |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Acquisition of InfiniVive                                                            |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Acquisition of Property
    and Equipment                                            |  |                                                                                                                     | (310,113   | ) |                                                                                                                     |  
|Patent
    Costs                                                                     |  |                                                                                                                     | –          |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Net Cash Provided by
    (Used in) Investing Activities                              |  |                                                                                                                     | (310,113   | ) |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Financing Activities                                                                 |  |                                                                                                                     |            |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Preferred Stock Issued
    For Cash                                                  |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Issuance of Senior Secured
    Convertible Note Payable                              |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Deferred Offering Costs                                                              |  |                                                                                                                     | (1,174,418 | ) |                                                                                                                     |  
|Issuance of 2022 Series
    Convertible Notes Payable                                |  |                                                                                                                     | 200,000    |   |                                                                                                                     |  
|Capital Lease Principal
    Payments                                                 |  |                                                                                                                     | (75,698    | ) |                                                                                                                     |  
|Payments
    on Revolving Line of Credit                                             |  |                                                                                                                     | (58,596    | ) |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Net Cash Provided by
    (Used in) Financing Activities                              |  |                                                                                                                     | (1,108,712 | ) |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Total Cash Provided (Used) During the Fiscal
    Period                              |  |                                                                                                                     | (3,635,445 | ) |                                                                                                                     |  
|Beginning Cash Balance                                                               |  |                                                                                                                     | 4,376,983  |   |                                                                                                                     |  
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Ending Cash Balance                                                                  |  | $                                                                                                                   | 741,538    |   |                                                                                                                     | $
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Cash Paid for Interest                                                               |  | $                                                                                                                   | 59,702     |   |                                                                                                                     | $
|Cash Paid for Income
    Taxes                                                       |  | $                                                                                                                   | -          |   |                                                                                                                     | $
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Supplemental Schedule of
    Non-Cash Financing Activities:                          |  |                                                                                                                     |            |   |                                                                                                                     |  
|Recognition of New Capital
    Leases                                                |  | $                                                                                                                   | 90,444     |   |                                                                                                                     | $
|Beneficial Conversion
    Feature and Deemed Dividend on Convertible Preferred Stock |  | $                                                                                                                   | 793,175    |   |                                                                                                                     | $
|Common Stock Issued
    for Conversion of Senior Note Payable                        |  | $                                                                                                                   | 3,712,500  |   |                                                                                                                     | $
|Common Stock Issued
    for Conversion of Related Party Note Payable                 |  | $                                                                                                                   | 331,266    |   |                                                                                                                     | $
|Deferred Offering Costs
    Recorded as Accounts Payable                             |  | $                                                                                                                   | 308,004    |   |                                                                                                                     | $
|Conversion of accrued
    payable to note payable                                    |  | $                                                                                                                   | -          |   |                                                                                                                     | $
|Common stock issued
    for conversion of note payable                               |  | $                                                                                                                   | -          |   |                                                                                                                     | $
|Preferred stock issued
    for conversion of convertible notes and advances          |  | $                                                                                                                   | -          |   |                                                                                                                     | $
|                                                                                     |  |                                                                                                                     |            |   |                                                                                                                     |  
|Cash and Cash Equivalents, end of year                                               |  | $                                                                                                                   | 741,538    |   |                                                                                                                     | $
|Restricted cash, end
    of year                                                     |  |                                                                                                                     | -          |   |                                                                                                                     |  
|Total Cash, Cash Equivalents
    and Restricted cash in the Statement of Cash Flows  |  | $                                                                                                                   | 741,538    |   |                                                                                                                     | $



These
financial statements should be read in connection with the notes to consolidated financial statements.



F-6







VITRO
BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



NOTE
1 – NATURE OF ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES



Nature
of Organization and Description of Business



Vitro
Biopharma, Inc. (the “Company”) was incorporated under the laws of the State of Nevada on March 31, 1986, under the name
Imperial Management, Inc. On December 17, 1986, the Company merged with Labtek, Inc., a Colorado corporation, with the Company being
the surviving entity and the name of the Company was changed to Labtek, Inc. The name was then changed to Vitro Diagnostics, Inc. on
February 6, 1987. From November of 1990 through July 31, 2000, the Company was engaged in the development, manufacturing, and distribution
of purified human antigens (“Diagnostics”) and related technologies. The Company also developed cell technology including
immortalization of certain cells, which allowed entry into other markets besides Diagnostics. In August 2000, the Company sold the Diagnostics
business, following which it focused on developing therapeutic products, its stem cell technology, patent portfolio and proprietary technology
and cell lines for applications in autoimmune disorders and inflammatory disease processes and stem cell research. On February 3, 2021,
the Company filed an amendment to the articles of incorporation with the Nevada Secretary of State, changing the name of the Company
to Vitro BioPharma, Inc.



Summary
of Significant Accounting Policies



Basis
of Presentation



The
accompanying consolidated financial statements are presented in U.S. dollars in conformity with accounting principles generally accepted
in the United States of America (“GAAP”).



Basis
of Consolidation



The
consolidated financial statements include the operations of the Company and its wholly owned subsidiaries, Fitore, Inc. (“Fitore”)
and InfiniVive MD, LLC (“InfiniVive”), both acquired effective August 1, 2021 (Note 4).



Cash
Equivalents



For
the purposes of the Statements of Cash Flows, the Company considers all highly liquid debt instruments purchased with an original maturity
of three months or less to be cash equivalents.



Restricted
Cash



Included
in the Consolidated Balance Sheets as of October 31, 2022 and October 31, 2021, is restricted cash of $0 and $750,000, respectively.
This amount was restricted to cover future interest expense payments on the senior convertible note through maturity. On February 22,
2022, the senior convertible note was converted to common stock and this restriction on cash was removed. (Note 7)



Concentration
of Credit Risk



Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the Federal depository insurance coverage limits. The Company has not experienced losses on these accounts
and management believes the Company is not exposed to significant risks on such accounts.



F-7







VITRO
BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Concentrations



During
the years ended October 31, 2022 and 2021, 1% and 28% respectively, of the Company’s total revenues were derived from sales to
an entity controlled by the Company’s former Chief Executive Officer and President, Dr. Jack Zamora (“Dr. Zamora”)
(Note 10 and Note 11). During the year ended October 31, 2022, another 17%, 15% and 14% of the Company’s total revenue was attributable
to product sales to three other customers. During the year ended October 31, 2021, another two customers accounted for 16% and 13% of
the Company’s revenues. Other than the revenues derived through sales to an entity controlled by Dr. Zamora and the additional
customers mentioned herein, no customer accounted for greater than 10% of the Company’s gross sales for the years ended October
31, 2022 and 2021. In addition to the product revenue concentrations noted above, the Company recognized $600,000 in consulting revenue
from a single client during the year ended October 31, 2022. This amount was 18% of the total revenue recognized for the period. The
company recognized $51,822 in consulting revenue, unrelated to the large customer in 2022, during the year ended October 31, 2022.



Financial
Instruments



The
fair value of the Company’s assets and liabilities, which qualify as financial instruments under Financial Accounting Standards
Board’s (“FASB”) Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,”
approximates the carrying amounts represented in the balance sheets.



Use
of Estimates



The
preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.



Revenue
Recognition



As
of January 1, 2018, the Company adopted Revenue from Contracts with Customers (Topic 606) (“ASC 606”). The new guidance sets
forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended
to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed in GAAP. The underlying
principle of the new standard is that a business or other organization will recognize revenue to depict the transfer of promised goods
or services to customers in an amount that reflects what it expects to receive in exchange for the goods or services. To determine the
appropriate amount of revenue to be recognized for arrangements that the Company determines are within the scope of ASC 606, the Company
performs the following steps: (i) identify the contract(s) with the customer, (ii) identify the performance obligations in the contract,
(iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize
revenue when (or as) each performance obligation is satisfied. The Company adopted the standard using the modified retrospective method
and the adoption did not have a material impact on the Company’s consolidated financial statements.



For
each performance obligation identified in accordance with ASC 606, the Company determines at contract inception whether it satisfies
the performance obligation over time (in accordance with paragraphs 606-10-25-27 through 25-29) or satisfies the performance obligation
at a point in time (in accordance with paragraph 606-10-25-30). If an entity does not satisfy a performance obligation over time, the
performance obligation is satisfied at a point in time.



Control
is considered transferred over time if any one of the following criteria is met:



| | ● | The
                                            customer simultaneously receives and consumes the benefits of the asset or service which
                                            the entity performs;                                                  
| | - | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |   |                                                                                                                                                                                                                                                            
| | ● | The
                                            entity’s performance creates or enhances an asset; or                                                                                                                                                      
| |   |                                                                                                                                                                                                                                                            
| | ● | The
                                            entity’s performance creates or enhances an asset that has no alternative use to the
                                            entity and the entity has the right to payment for work completed to date.



F-8







VITRO
BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



For
certain contracts to which the Company is party, it uses the recognition over time method to recognize revenue.



The
Company recognizes revenue when performance obligations with the customer are satisfied. Product sales occur once control is transferred
upon delivery to the customer at the time of the sale. Revenue is measured as the amount of consideration the Company expects to receive
in exchange for transferring goods and services. The Company’s revenue is primarily derived from the sources listed below:



Sale
of research and development product: Sales of research and development product include the sale of stem cell medium.



Sale
of therapeutic product:Includes cell culture media to be used in therapeutic treatment.



Shipping:Includes amounts charged to customers for shipping products.



Consulting
Revenue:The Company has agreed to assist another party to develop an FDA-approved biological product. Revenues are recognized
when certain contractual milestones are achieved.



Fitore
product sales online:Includes internet sales, via the Fitore Nutrition website, of dietary supplements called Stemulife,
Spectrum+, Easy Sleep and Thought Calmer.



InfiniVive
product sales:InfiniVive, via its website and call-in orders, sells exosomes and daily cosmetic serum.



Disaggregation
of revenue



The
following table summarizes the Company’s revenue for the reporting periods, disaggregated by product or service type:



|                                                     |  | Year
    Ended October 31, 2022 |           |  | Year
    Ended October 31, 2021 |  
|---------------------------------------------------- |  | ------------------------------- | --------- |  | ------------------------------- | -
|Revenues:                                            |  |                                 |           |  |                                 |  
|Research and
    development products                |  | $                               | 1,072,312 |  |                                 | $
|AlloRx Stem Cells to Foreign
    Third-Party Clinics |  |                                 | 1,174,456 |  |                                 |  
|Consulting revenue                                   |  |                                 | 600,000   |  |                                 |  
|InfiniVive products                                  |  |                                 | 236,788   |  |                                 |  
|Fitore products                                      |  |                                 | 209,737   |  |                                 |  
|                                                     |  |                                 |           |  |                                 |  
|Total                                                |  | $                               | 3,293,293 |  |                                 | $



Deferred
Revenue



The Company has recorded deferred revenue in connection with a Joint Operating Agreement (as subsequently amended, the “JOA”)
executed between the Company and European Wellness/BIO PEP USA (“BIO PEP”). Under the terms of this JOA, the Company is obligated
to use its best efforts to identify, develop and deliver various potential active pharmaceutical ingredients and to oversee the development
of a recombinant cell line by a third-party service provider. The Company was also engaged to establish a Quality Management System to
be utilized by BIO PEP in their pursuit of FDA authorizations. See “Joint Operating Agreement” below for additional information.



F-9









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
Company records as deferred revenue amounts for which the Company has been paid but for which it has not yet achieved and delivered related
milestones or when the level of effort required to complete performance obligations under an arrangement can be reasonably estimated
under the terms of the JOA. Deferred revenue is classified as current or long-term based on when management estimates the revenue will
be recognized. As of October 31, 2022, the Company has deferred $650,000 in revenue. The Company has recorded $217,747 in prepaid project
costs related to this deferred revenue in current assets. The amounts recorded as deferred revenue and prepaid project costs will be
recognized if and when the Company achieves and delivers the milestones under the terms of the JOA.



The
table below summarizes Deferred Revenues as of October 31, 2022:



|                 |  | October
    31, 2021 |         |  | Revenue
    Recognized |   |          | Revenue
    Deferred |  |   | October
    31, 2022 | 
|---------------- |  | -------------------- | ------- |  | ---------------------- | - | -------- | -------------------- |  | - | -------------------- | 
|Deferred Revenue |  | $                    | 500,000 |  |                        | $ | (500,000 | )                    |  | $ | 650,000              | 
|Total            |  | $                    | 500,000 |  |                        | $ | (500,000 | )                    |  | $ | 650,000              | 



During
the year ended October 31, 2022, the Company recognized $500,000 in previously deferred revenue, $100,000 in additional revenue and $218,017
in expenses related to the JOA. The expenses are included in the Selling, general and administrative line on the accompanying consolidated
statements of operations.



Accounts
Receivable



Accounts
receivable consists of amounts due from customers. The Company considers accounts more than 30 days old to be past due. The Company uses
the allowance method for recognizing bad debts. When an account is deemed uncollectible, it is written off against the allowance. The
Company generally does not require collateral for its accounts receivable. At October 31, 2022 and 2021, total accounts receivable amounted
to $73,537 and $127,482, respectively, net of allowances. The Company monitors accounts receivable for collectability and when doubt
as to the realization of amounts recorded arises, an allowance is recorded and/or accounts deemed to be uncollectible will be written
off. As of October 31, 2022 and 2021, the allowance for doubtful accounts was $2,500 and $7,000, respectively.



As
of October 31, 2022, two customers accounted for 28% and 10% of accounts receivable. As of October 31, 2021, 43% and 23%, of the Company’s
accounts receivable were attributable to sales to two customers. No other customer comprised more than 10% of the accounts receivable
balance as of October 31, 2022 or 2021.



Deferred
Offering Costs



The
Company defers, as other current assets, the direct incremental costs of raising capital through equity offerings, until such time as
the offering is completed or abandoned. At the time of the offering completion, the costs are charged against the capital raised. Should
the offering be terminated, deferred offering costs are charged to operations during the period in which the offering is terminated.



Property
and Equipment



Property,
equipment, and leasehold improvements are recorded at historical cost. The cost of property and equipment is depreciated over the estimated
useful lives, when placed in service (ranging from 3 -5 years), of the related assets utilizing the straight-line method of depreciation.
The cost of leasehold improvements is depreciated (amortized) over the lesser of the length of the related leases or the estimated useful
lives of the assets. Ordinary repairs and maintenance are expensed when incurred and major repairs are capitalized and expensed if they
benefit future periods.



F-10









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Intangible
Assets and Impairment



Intangible
assets that are subject to amortization are reviewed for potential impairment whenever events or circumstances indicate that carrying
amounts may not be recoverable. Assets not subject to amortization are tested for impairment at least annually.



The
Company periodically reviews its intangible assets for impairment whenever events or changes in circumstances indicate that the carrying
amount of the assets may not be fully recoverable. The Company recognizes an impairment loss when the sum of expected undiscounted future
cash flows is less that the carrying amount of the asset. The amount of impairment is measured as the difference between the asset’s
estimated fair value and its book value.



Goodwill



Goodwill
is the excess of acquisition cost over the fair value of the net assets of acquired businesses. The Company does not amortize goodwill
but assesses goodwill for impairment at least annually or when there has been a material change in circumstances, using the market approach.



Leases



In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update early as of November 1, 2018, using the modified retrospective transition method and prior periods have not been
restated. Upon implementation, the Company recognized an initial operating lease right-of-use asset of $80,171 and operating lease liability
of $80,171. In July 2020, a new office lease was executed, resulting in an initial operating lease right-of-use asset of $411,287 and
operating lease liability of $411,287. Due to the simplistic nature of the Company’s leases, no retained earnings adjustments were
required. The Company recorded amortization of the operating lease right-of-use asset of $55,616 and $61,796 for the years ended October
31, 2022 and 2021, respectively.



Basic
Loss Per Share



The
Company complies with accounting and disclosure requirements ASC Topic 260, “Earnings Per Share.” Basic net loss per share
is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding
during the period. Diluted net loss per share takes into consideration shares of common stock outstanding (computed under basic income
or loss per share) and potentially dilutive shares of common stock that are not anti-dilutive. For the years October 31, 2022 and 2021,
the following number of potentially dilutive shares have been excluded from diluted net loss since such inclusion would be anti-dilutive:



|                                                                                          |  | October
    31, 2022 |            |  | October
    31, 2021 | 
|----------------------------------------------------------------------------------------- |  | -------------------- | ---------- |  | -------------------- | 
|                                                                                          |  |                      |            |  |                      | 
|Stock options
    outstanding                                                             |  |                      | 29,226,000 |  |                      | 
|Shares to be issued in
    connection with convertible preferred shares                   |  |                      | -          |  |                      | 
|Shares to be issued in
    connection with exercise of warrants                           |  |                      | 13,605,856 |  |                      | 
|Shares to be issued upon conversion of convertible
    notes payable and accrued interest |  |                      | -          |  |                      | 
|2021 Series Convertible Notes Payable – Related Party                                     |  |                      | 480,000    |  |                      | 
|2022 Series Convertible Notes Payable                                                     |  |                      | 200,000    |  |                      | 
|Total                                                                                     |  |                      | 43,511,856 |  |                      | 



F-11









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Joint
Operating Agreement



On
August 6, 2021, the Company entered into a JOA with European Wellness and BioPep, its research and development subsidiary, under which
the Company agreed to provide research and development services on identified targets. The Company was unable to identify a key target
product to submit for FDA IND authorization using European Wellness’s existing mito-organelle peptides as the starting biological
material as contemplated by the JOA. As a result, on April 28, 2022, the Company entered into an amendment to the JOA (“Amendment”).



Under
the JOA, the Company is obligated to use its best efforts to identify a key investigational product candidate that can be submitted by
European Wellness for FDA IND authorization. The JOA also requires the Company to use its best efforts to develop an FDA-validated immunoassay
and potency assay of any target product. It is contemplated that any pre-clinical studies will be carried out by a third-party service
provider, with the Company’s support and oversight. In addition, the Company agreed to manage the production of any target research
products and to quantify biological activity for preclinical and clinical testing to support an FDA IND filing, all of which will be
carried out by third-party service providers identified by the Company at third-party manufacturing facilities.



With
the ultimate goal of supporting BioPep in becoming a cGMP manufacturer in the US, the Company is also obligated to help develop a biomanufacturing
infrastructure to support BLA-compliant operations and to develop a certified Quality Management System for BioPep to support FDA approval
of target products. For any INDs to be submitted to the FDA covering products developed under the JOA, the Company is obligated to provide
the “Chemistry, Manufacturing, and Controls” section in support of the application.



The
JOA further contemplates the potential identification and development of a veterinary product by a third-party using rabbit-sourced umbilical-cord
derived MSCs. It is contemplated that development of this veterinary product will begin once the key investigational product is completed.
The Company and European Wellness are obligated to use their best efforts to negotiate the terms of this arrangement at such time.



If
any products developed pursuant to the European Wellness Agreement are ultimately approved for commercialization, the JOA contemplates
that such products will be commercialized and distributed by European Wellness and/or BioPep. However, the JOA also contemplates that
certain post-development rights and obligations of the parties, such as potential licensing rights and shared ownership over intellectual
property developed pursuant to the agreement, will be negotiated at a later date. The JOA further contemplates that the parties may enter
into negotiations to potentially engage the Company as a CMO to carry out product manufacturing on behalf of European Wellness and BioPep.



By
its terms, the JOA will terminate on July 31, 2023. Either the Company or European Wellness may terminate the JOA sooner without cause
at any time by providing 30-days prior written notice. In addition, the Company or European Wellness may terminate the European Wellness
Agreement immediately under certain circumstances, including without limitation, if either party defaults with respect to its obligations
under the agreement and does not cure such default within 30 days after receiving notice of such default.



Upon
signing the JOA in August 2021, European Wellness paid the Company an initial fee of $500,000, which was recognized as revenue during
the first quarter of 2022 when the associated performance milestones had been achieved. Those milestones included the development and
deployment of a quality management system for European Wellness and the delivery of a manual describing the aforementioned quality management
system. In connection with the Amendment, European Wellness also paid an additional lump-sum payment of $250,000 in May 2022, which has
been recorded as deferred revenue and will be recognized as revenue if and when the associated milestones under the contract are reached.
The Company also receives quarterly payments of $25,000 for providing research and development management services. All expenses incurred
in connection with the JOA are classified as general and administrative expenses. In total, the Company may be eligible to receive additional
estimated payments up to $5.8 million from European Wellness, which is expected to result in a more than $500,000 profit to the Company
after deducting estimated expenses.



F-12









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Future
milestones may include estimated payments up to an additional $1,800,000 for research and development services identifying an Active
Pharmaceutical Ingredient (API) for product development within AlloEX, up to $1,200,000 to develop an FDA-validated immunoassay and qualify
third-party vendors for ISO certification, up to $600,000 to develop a downstream manufacturing method and handle equipment procurement,
up to $1,000,000 for the development and scaling of a manicuring system with the goal of commercial scale and up to $1,000,000 for potential
future IND filings.



The
Company provides BioPep with the expertise in scientific, quality, manufacturing methods, design developments and regulatory matters
to ensure full compliance with the U.S. regulations for drug development, manufacturing, and potential future commercialization of BioPep
product(s).



Expenses
incurred in connection with completed milestones for which the Company has recognized revenue are included as a component of selling
general and administrative expense in the statement of operations. Expenses incurred in connection with milestones which have yet to
be completed are recorded as deferred project costs on the balance sheet.



Income
Taxes



The
Company complies with the accounting and reporting requirements of ASC Topic 740, “Income Taxes,” which requires an
asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed
for differences between the financial statements and tax bases of assets and liabilities that will result in future taxable or deductible
amounts, based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income.
Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.



ASC
Topic 740 prescribes a recognition threshold and a measurement attribute for the financial statement’s recognition and measurement
of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not
to be sustained upon examination by taxing authorities.



On
December 22, 2017, the U.S. Tax Cuts and Jobs Act of 2017 (“Tax Reform”) was signed into law. As a result of Tax Reform,
the top U.S. statutory corporate tax rate was lowered from 35% to 21% effective January 1, 2018, among other changes. ASC Topic 740 requires
companies to recognize the effect of tax law changes in the period of enactment; therefore, the Company was required to revalue its deferred
tax assets and liabilities at the new rate.



Impairment
and Disposal of Long-Lived Assets



The
Company evaluates its long-lived assets for impairment when events or changes in circumstances indicate, in management’s judgment,
that the carrying value of such assets may not be recoverable. If such assets are considered impaired, the impairment to be recognized
is determined as the amount by which the carrying value exceeds the fair value of the assets.



The
Company periodically reviews the carrying amount of its long-lived assets for possible impairment. The Company recorded no asset impairment
charges during the years ended October 31, 2022, and 2021.



Inventory



Inventories,
consisting of raw materials and finished goods, are stated at the lower of cost (using the specific identification method) or market.
Inventories consisted of the following at the balance sheet dates:





|                    |  | October
    31, 2022 |         |  | October
    31, 2021 |  
|------------------- |  | -------------------- | ------- |  | -------------------- | -
|                    |  |                      |         |  |                      |  
|Raw materials       |  | $                    | 112,023 |  |                      | $
|Finished goods      |  |                      | 168,115 |  |                      |  
|Total
    inventory |  | $                    | 280,138 |  |                      | $



F-13









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
Company periodically reviews the value of items in inventory and provides write-downs or write-offs of inventory based on its assessment
of market conditions. During the years ended October 31, 2022 and 2021, the Company recorded impairment expense of $0 and $73,300, respectively.



Related
Party Transactions



The
Company follows ASC 850, “Related Party Disclosures”, for the identification of related parties and disclosure of
related party transactions (see Note 10).



Research
and Development



These
costs are expensed as incurred and are primarily comprised of costs for: salaries, overhead and occupancy, contract services and other
outside costs, quality assurance and analytical testing. As the Company’s operations include manufacturing and R&D, it reports
cost of goods sold, including estimates of labor, materials, and overhead allocations, to the production of specific products manufactured
for sale.



Stock
Based Compensation



The
Company accounts for expenses associated with shares issued for services using the fair value method following the guidance outlined
in Section 718-10 of the FASB ASC for disclosure about stock-based compensation. This section requires a public entity to measure the
cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant date fair value
of the award (with limited exceptions). That cost is recognized over the period during which the service is provided. No compensation
cost is recognized for equity instruments for which service is not provided or rendered.



Recent
Accounting Standards



The
Company periodically reviews new accounting standards that are issued and has not identified any new standards that it believes merit
further discussion or would have a significant impact on its financial statements.



NOTE
2 – GOING CONCERN



The
accompanying financial statements have been prepared in conformity with GAAP, which contemplate continuation of the Company as a going
concern. The Company has incurred net losses of approximately $6.9 million for the year ended October 31, 2022 and approximately $4.5
million for the year ended October 31, 2021. The Company had a working capital surplus of approximately $0.4 million as of October 31,
2022. However, the revenues of the Company do not provide adequate working capital for the Company to sustain its current and planned
business operations.



These
factors raise substantial doubt about the Company’s ability to continue as a going concern. In view of these matters, realization
of certain of the assets in the accompanying balance sheet is dependent upon continued operations of the Company, which in turn is dependent
upon the Company’s ability to meet its financial requirements, raise additional capital, and generate additional revenues and profit
from operations.



Management
plans to address the going concern include but are not limited to raising additional capital through an attempted public and/or private
offering of equity securities, as well potentially issuing additional debt instruments. The Company also has various initiatives underway
to increase revenue generation through diversified offerings of products and services related to its stem cell technology and analytical
capabilities. The goal of these initiatives is to achieve profitable operations as quickly as possible. Various strategic alliances that
are ongoing and under development are also critical aspects of management’s overall growth and development strategy. There is no
assurance that these initiatives will yield sufficient capital to maintain the Company’s operations. There is no assurance that
the ongoing capital raising efforts will be successful. Should management fail to successfully raise additional capital and/or fully
implement its strategic initiatives, it may be compelled to curtail part or all of its ongoing operations.



F-14









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might
be necessary should the Company be unable to continue as a going concern. The Company has historically financed its operations primarily
through various private placements of debt and equity securities.



NOTE
3 – PROPERTY AND EQUIPMENT



The
following is a summary of property and equipment, less accumulated depreciation at the balance sheet dates:



|                              |  | October
    31, 2022 |          |   | October
    31, 2021 |  
|----------------------------- |  | -------------------- | -------- | - | -------------------- | -
|                              |  |                      |          |   |                      |  
|Leasehold improvements        |  | $                    | 12,840   |   |                      | $
|Property and equipment        |  |                      | 925,427  |   |                      |  
|Total cost                    |  |                      | 938,267  |   |                      |  
|Less accumulated depreciation |  |                      | (586,327 | ) |                      |  
|Net property and equipment    |  | $                    | 351,940  |   |                      | $



Depreciation
expense for the years ended October 31, 2022 and 2021 was $163,799 and $88,516, respectively.



NOTE
4 – ACQUISITIONS



Fitore
Inc.



On
August 1, 2021, the Company, through a merger with a wholly owned subsidiary, acquired 100% of the stock of Fitore Inc., an unaffiliated
online marketing and sales company. The acquisition of Fitore provided the Company an additional revenue stream through the online sales
of nutritional supplements, as well as the online marketing expertise of the two majority selling shareholders, each of whom remained
with the Company after the acquisition, one as the Chief Executive Officer of Fitore and the other as the Chief Financial Officer of
the Company. The Chief Executive Officer of Fitore has since separated from that position.



The
former shareholders of Fitore received convertible promissory notes totaling $1,000,000, 4,000,000 shares of common stock of the Company
valued at approximately $0.19 per share and 6 Series A Convertible Preferred Units, with each Unit consisting of 2,000 shares of Series
A Convertible Preferred Stock, 1,000 Series A Warrants and 1,000 series B Warrants. The total consideration was valued at $2,042,999.
Total transaction costs related to the acquisition were approximately $24,800, which were recorded within the general and administrative
expenses line item for the year ended October 31, 2021.



The
assets acquired were recorded at their fair value. The purchase price excludes post acquisition compensation arrangements. The purchase
price was allocated among cash, inventory and readily identifiable intangible assets, along with Goodwill of approximately $1.4 million
(see further detail below), net of accrued payables and a revolving line of credit. Goodwill is primarily attributable to the synergies
that were expected to arise after the acquisition. Goodwill is not expected to be deductible for tax purposes. The acquisition was accounted
for using the acquisition method under ASC 805, Business Combinations, which requires the acquired assets to be recorded at fair
values as of the acquisition date of August 1, 2021. The following table summarizes the purchase price and final allocation of the fair
value of assets acquired:



|                                      |  | August
    1, 2021 |          
|------------------------------------- |  | ------------------ | ---------
|Allocation of purchase price          |  |                    |          
|Consideration given:                  |  |                    |          
|2021 Series
    Convertible Notes     |  | $                  | 1,000,000
|Common stock                          |  |                    | 742,999  
|Preferred
    stock and warrants      |  |                    | 300,000  
|Total
    consideration               |  | $                  | 2,042,999
|                                      |  |                    |          
|Allocation of purchase price          |  |                    |          
|Cash                                  |  | $                  | 291,783  
|Inventory                             |  |                    | 99,496   
|Goodwill                              |  |                    | 1,351,458
|Trademarks and trade names            |  |                    | 217,440  
|Know-how and unpatented technology    |  |                    | 112,020  
|Customer relationships                |  |                    | 59,019   
|Accrued expenses                      |  |                    | (29,221  
|Revolving line of credit              |  |                    | (58,996  
|Fair
    value of net assets acquired |  | $                  | 2,042,999



F-15









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



InfiniVive
MD, LLC.



On
August 1, 2021, the Company, through an exchange agreement, acquired 100% of the ownership interests of InfiniVive, an affiliated company
that sold stem cell serums, exosomes, and daily serums manufactured for InfiniVive by the Company. The Company believed that the acquisition
of InfiniVive would significantly expand the Company’s target market for sale of products through a network of clinics with which
InfiniVive has historically done business.



The
former member of InfiniVive, Dr. Zamora, received 23,000,000 shares of common stock of the Company valued at $4,272,245, or $0.19 per
share. Total transaction costs related to the acquisition were approximately $16,200, which were recorded within the general and administrative
expenses line item for the year ended October 31, 2021.



The
assets and liabilities acquired were recorded at their fair value. The purchase price excludes post acquisition compensation arrangements.
The purchase price was allocated among cash, accounts receivable and readily identifiable intangible assets along with Goodwill of approximately
$3.2 million net of accrued payables and accrued payables related party (see further detail below). Goodwill is primarily attributable
to the synergies that were expected to arise after the acquisition. Goodwill is not expected to be deductible for tax purposes.



The
acquisition was accounted for using the acquisition method under ASC 805, Business Combinations, which requires the acquired assets
to be recorded at fair values as of the acquisition date of August 1, 2021. The following table summarizes the purchase price and the
final allocation of the fair value of assets acquired.



|                                      |  | August
    1, 2021 |          
|------------------------------------- |  | ------------------ | ---------
|Allocation of purchase price          |  |                    |          
|Consideration given:                  |  |                    |          
|Common
    stock                      |  | $                  | 4,272,245
|Total
    consideration               |  | $                  | 4,272,245
|                                      |  |                    |          
|Allocation of purchase price          |  |                    |          
|Cash                                  |  | $                  | 78,234   
|Accounts receivable                   |  |                    | 5,536    
|Goodwill                              |  |                    | 3,171,582
|Trademarks and tradenames             |  |                    | 475,890  
|Patents and unpatented technology     |  |                    | 598,040  
|Customer relationships                |  |                    | 55,517   
|Accrued payables                      |  |                    | (17,982  
|Accrued payables –
    related party  |  |                    | (94,572  
|Fair
    value of net assets acquired |  | $                  | 4,272,245



F-16









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Pro-forma
results, unaudited



In
accordance with FASB Topic ASC 805, the following table presents the unaudited pro forma combined results of operations for the year
ended October 31, 2021, of the Company and its two new subsidiaries. The unaudited proforma results reflect significant pro forma adjustments
related to costs directly attributable to the acquisition and operating costs incurred as a result of the acquisition. The pro forma
results do not include any cost savings or other synergies that may result from the acquisitions or any estimated costs that have been
or will be incurred by the Company to integrate the acquired assets. The pro forma results are not necessarily indicative of what actually
would have occurred if the acquisition had been completed as of the beginning of the period, nor are they necessarily indicative of future
results:



|                          |  | October
                                            31, 2021 (Unaudited) |           
|------------------------- |  | ------------------------------------------------------------------------ | ----------
|                          |  |                                                                          |           
|Revenue                   |  | $                                                                        | 1,802,164 
|Net loss                  |  |                                                                          | (4,689,006
|Net loss per common share |  | $                                                                        | (0.09     



NOTE
5 – INTANGIBLE ASSETS



The
following table sets forth the carrying amounts of intangible assets and goodwill including accumulated amortization as of October 31,
2022:





|                                                |  | Remaining
    Useful Life |                                                                   |  | Cost |   |           | Accumulated
    Amortization |  |   | Net
    Carrying Value |  
|----------------------------------------------- |  | ------------------------- | ----------------------------------------------------------------- |  | ---- | - | --------- | ---------------------------- |  | - | ---------------------- | -
|Trademarks
    and tradenames                   |  |                           | 14
                                            years              |  |      | $ | 693,330   |                              |  | $ | (46,222                | )
|Patents,
    know-how and unpatented technology |  |                           | 14
                                            years              |  |      |   | 710,060   |                              |  |   | (47,337                | )
|Customer
    relationships                      |  |                           | 1.75
                                            years            |  |      |   | 114,536   |                              |  |   | (46,966                | )
|Total                                           |  |                           |                                                                   |  |      |   | 1,517,926 |                              |  |   | (140,525               | )
|                                                |  |                           |                                                                   |  |      |   |           |                              |  |   |                        |  
|                                                |  |                           | Remaining Useful
                                            Life |  |      |   | Cost      |                              |  |   | Impairment             |  
|Goodwill                                        |  |                           | Indefinite                                                        |  |      | $ | 4,523,040 |                              |  | $ | (914,091               | )



During
the fiscal years ended October 3, 2022 and 2021, the Company recorded amortization expense of $131,735 and $8,790, respectively.



During
the fiscal year ended October 31, 2022 and 2021, the Company recorded impairment expense of $914,091 and $0, respectively. Impairment
expenses recorded during 2022 related to the carrying value of the goodwill associated with the acquisition of Fitore on August 1, 2021.
(Note 4).



NOTE
6 – LEASE OBLIGATIONS



The
Company’s operating lease consists of a lease for office space. The Company’s finance lease activities consist of leases
for equipment. Leases with an initial term of 12 months or less are not recorded on the balance sheet. The office lease contains an option
to a renewal period of five years at then-current market rates. The equipment leases are non-renewable as the Company owns the equipment
at the end of the lease period, for a nominal amount.



F-17









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
following table shows the classification and location of the Company’s leases in the Consolidated Balance Sheets:



|Leases                      |  | Balance
    Sheet Location |                                                                                  |  | October
    31, 2022 |   |         | October
    31, 2021 | 
|--------------------------- |  | -------------------------- | -------------------------------------------------------------------------------- |  | -------------------- | - | ------- | -------------------- | 
|Assets                      |  |                            |                                                                                  |  |                      |   |         |                      | 
|Noncurrent:                 |  |                            |                                                                                  |  |                      |   |         |                      | 
|Operating                   |  |                            | Right-of-use
                                            asset – operating lease |  |                      | $ | 277,381 |                      | 
|Finance                     |  |                            | Property
                                            and equipment, net          |  |                      |   | 74,324  |                      | 
|Total Lease Assets          |  |                            |                                                                                  |  |                      | $ | 351,705 |                      | 
|                            |  |                            |                                                                                  |  |                      |   |         |                      | 
|Liabilities                 |  |                            |                                                                                  |  |                      |   |         |                      | 
|Current:                    |  |                            |                                                                                  |  |                      |   |         |                      | 
|Operating                   |  |                            | Operating
                                            lease liabilities          |  |                      | $ | 50,055  |                      | 
|Finance                     |  |                            | Finance
                                            lease liabilities            |  |                      |   | 62,979  |                      | 
|Noncurrent:                 |  |                            |                                                                                  |  |                      |   |         |                      | 
|Operating                   |  |                            | Operating
                                            lease liabilities          |  |                      |   | 227,326 |                      | 
|Finance                     |  |                            | Finance
                                            lease liabilities            |  |                      |   | 78,955  |                      | 
|Total
    Lease Liabilities |  |                            |                                                                                  |  |                      | $ | 419,315 |                      | 



The
following table shows the classification and location and the Company’s lease costs in the Consolidated Statements of Operations:



|                            |  | Statements
    of Operations |                                                                                |  | Years
    Ended October 31, |  
|--------------------------- |  | ---------------------------- | ------------------------------------------------------------------------------ |  | --------------------------- | -
|                            |  | Location                     |                                                                                |  | 2022                        |  
|Operating lease expense     |  |                              | General
                                            and administrative expense |  |                             | $
|Finance lease expense:      |  |                              |                                                                                |  |                             |  
|Interest on lease liability |  |                              | Interest
                                            expense                   |  |                             |  
|Total Lease expense         |  |                              |                                                                                |  |                             | $



Minimum
contractual obligations for the Company’s leases (undiscounted) as of October 31, 2022 were as follows:



|                      |  | Operating |          |   | Finance |  
|--------------------- |  | --------- | -------- | - | ------- | -
|Fiscal year 2023      |  | $         | 67,734   |   |         | $
|Fiscal year 2024      |  |           | 67,734   |   |         |  
|Fiscal year 2025      |  |           | 67,734   |   |         |  
|Fiscal year 2026      |  |           | 67,734   |   |         |  
|Fiscal year 2027      |  |           | 67,734   |   |         |  
|Thereafter            |  |           | 180,619  |   |         |  
|Total Lease Payments  |  | $         | 519,289  |   |         | $
|Less Imputed interest |  |           | (241,908 | ) |         |  
|Total lease liability |  | $         | 277,381  |   |         | $



The
following table shows the weighted average remaining lease term and the weighted average discount rate for the Company’s leases
as of the dates indicated:





|                                                     |  | October
    31, 2022 |       |   | October
    31, 2021 | 
|---------------------------------------------------- |  | -------------------- | ----- | - | -------------------- | 
|                                                     |  | Operating
    Leases |       |   | Finance
    Leases   | 
|Weighted-average
    remaining lease term (in years) |  |                      | 7.6   |   |                      | 
|Weighted-average discount
    rate (1)               |  |                      | 10.00 | % |                      | 



(1)The discount rate used for operating leases is based on the Company’s incremental borrowing rate at lease commencement and
may be adjusted if modification to lease terms or lease reassessments occur. The discount rate used for finance leases is based on the
rates implicit in the leases.



F-18









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
following table includes other quantitative information for the Company’s leases for the years indicated:



|                                                                       |  | Years
    Ended October 31, |        
|---------------------------------------------------------------------- |  | --------------------------- | -------
|                                                                       |  | 2022                        |        
|Cash paid for amounts included in measurement
    of lease liabilities |  |                             |        
|Cash payments for operating leases                                     |  | $                           | 145,710
|Cash payments for finance leases                                       |  |                             | 75,698 



NOTE
7 – DEBT



The
table below presents outstanding debt instruments as of October 31, 2022 and 2021:



|                                                  |  | October
    31, 2022 |           |  | October
    31, 2021 |  
|------------------------------------------------- |  | -------------------- | --------- |  | -------------------- | -
|Short
    Term                                    |  |                      |           |  |                      |  
|Revolving line
    of credit                      |  | $                    | -         |  |                      | $
|Total
    Short-Term Debt                         |  | $                    | -         |  |                      | $
|                                                  |  |                      |           |  |                      |  
|Long
    Term                                     |  |                      |           |  |                      |  
|Unsecured 6% note payable
    – related party     |  | $                    | 767,288   |  |                      | $
|Unsecured 4% note payable
    – related party     |  |                      | 1,221,958 |  |                      |  
|2021 Series convertible
    notes – related party |  |                      | 480,000   |  |                      |  
|2022 Series convertible
    notes                 |  |                      | 200,000   |  |                      |  
|Senior secured convertible
    note               |  |                      | -         |  |                      |  
|Total Long-Term Debt                              |  | $                    | 2,669,246 |  |                      | $



The
table below presents the future maturities of outstanding debt obligations as of October 31, 2022:



|Fiscal year 2023 |  | $ | -         | 
|---------------- |  | - | --------- | 
|Fiscal year 2024 |  |   | 480,000   | 
|Fiscal year 2025 |  |   | -         | 
|Fiscal year 2026 |  |   | 1,989,246 | 
|Fiscal year 2027 |  |   | 200,000   | 
|Total            |  | $ | 2,669,246 | 



Revolving
line of credit



The
Company, through its wholly owned subsidiary Fitore, maintained a $60,000 revolving line of credit. The line of matured on February 2,
2022 and was renewed for one year. Interest expense recorded in connection with the line of credit was $1,649 and $376 during the years
ended October 31, 2022 and 2021, respectively. On June 6, 2022, this line of credit was paid in full. As of October 31, 2022 and 2021,
borrowing on this line was $0 and $58,596.



Unsecured
6% Note Payable Related Party



On
October 31, 2020, the Company converted accrued and unpaid compensation in the amount of $767,288 payable to the Company’s Chief
Science Officer into an unsecured promissory note. The note bears simple interest at 6% per annum and is due and payable on December
31, 2025; provided, however, if certain conditions have not been satisfied at that time, the maturity date of the note will be extended
to the date that is 60 days after the satisfaction of those conditions. Interest expense on this note was $46,038 and $46,038 for the
years ended October 31, 2022 and 2021, respectively. Accrued interest on this note was $92,076 and $46,038 October 31, 2022 and 2021,
respectively.



F-19









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Unsecured
4% Note Payable - Related Party



On
October 31, 2020, the Company converted accrued and unpaid compensation and interest, in the amount of $1,221,958 payable to the Company’s
Chief Science Officer, into an unsecured promissory note. The note bears simple interest at 4% per annum and is due and payable on December
31, 2025; provided, however, if certain conditions have not been satisfied at that time, the maturity date of the note will be extended
to the date that is 60 days after the satisfaction of those conditions. Interest expense on this note was $48,878 and $48,878 for the
years ended October 31, 2022, and 2021, respectively. Accrued interest on this note was $97,756 and $48,878 as of October 31, 2022 and
2021, respectively.



2021
Series Convertible Notes - Related Party



On
August 1, 2021, in connection with the acquisition of Fitore (Note 4), the Company issued 2021 Series Unsecured Convertible Notes in
the amount of $1,000,000 to the four former shareholders of Fitore. The notes earned interest at 5%, and were set to mature on July 31,
2024 and were convertible into common stock, at the holder’s option, at $1.00 per share. On October 22, 2021, the holder of $200,000
of the convertible note converted the note into 8,000 shares of Series A Preferred Stock (Note 7).



On
April 15, 2022, the Company issued 310,561 Common Shares in connection with the conversion of $300,000 in principal together with $10,562
in accrued interest of a 2021 Series Note held by the then Chief Executive Officer of the Company, Dr. Jack Zamora. The Common Shares
were issued at $1.00 per share.



On
April 15, 2022, the Company issued 20,704 Common Shares in connection with the conversion of $20,000 in principal together with $704
in accrued interest of a 2021 Series Note. The Common Shares were issued at $1.00 per share.



The
remaining principal balance outstanding on the 2021 Series Convertible notes amounted to $480,000 and $800,000 as October 31, 2022 and
2021, respectively. During the years ended October 31, 2022 and 2021, the Company recorded $31,276 and $12,219, respectively, in interest
expense. As of October 31, 2022 and October 31, 2021, accrued, but unpaid, interest on these notes was $29,983 and $9,973, respectively.



Senior
Secured Convertible Note Payable



On
October 12, 2021, the Company borrowed $3,000,000 in connection with a Senior Secured Convertible Promissory Note. The note was set to
mature on October 12, 2026 and bore interest at 5%. The note allowed for borrowings up to $10,000,000. The note was secured by all the
assets of the Company and was eligible to be prepaid in whole or in part at any time prior to maturity. The note was convertible together
with accrued interest at $1.00 per share.



The
note contained both negative and positive covenants. Pursuant to an Escrow Agreement executed in connection with the note, 25% of the
proceeds of the note (“Escrow Amount”) were held in a restricted account. Pursuant to this provision, the Company recorded
restricted cash of $750,000 reflecting the restricted amount as of October 31, 2021.



On
February 22, 2022, this note, along with accrued interest of $17,158, was voluntarily converted into 3,712,500 shares of common stock
issued at $1.00 per share. In connection with the conversion, the Company recognized a loss of $695,342.



The
outstanding balance of the note was $0 and $3,000,000 as of October 31, 2022 and 2021, respectively. Accrued interest recorded as of
October 31, 2022 and 2021, amounted to $0 and $7,808 respectively. Interest expense was $46,849 and $7,808 for the years ended October
31, 2022 and 2021, respectively.



F-20









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



2022
Series Convertible Notes



During
June and July of 2022, the Company issued a total of $200,000 in 2022 Series Convertible notes to two unrelated parties. These notes
are unsecured, earn interest at a rate of 5% per annum and mature in June and July of 2027. The notes are payable solely in common stock
of the Company and convertible upon the closing of a Qualified Financing of at least $5,000,000, upon the closing of a change in control,
at the option of the holder of the notes or at maturity.

During the years ended October 31, 2022 and 2021, the Company recorded $3,205 and $0 in interest expense on these notes, respectively.
As of October 31, 2022 and 2021, the Company had accrued $3,205 and $0, respectively, in interest on these notes.



NOTE
8 – STOCKHOLDERS’ EQUITY



Preferred
Stock



The
Company has authorized 5,000,000 shares of $0.001 par value Preferred Stock, of which 250,000 were designated as Series A Convertible
Preferred Shares. As of October 31, 2022 and 2021, 0 and 136,059 shares of Series A Convertible Preferred Stock were issued and outstanding.



The
following is a summary of the rights and preferences of the Series A Convertible Preferred Stock.



Liquidation
preferences shall mean $25 per share, subordinate to the stated value of the outstanding shares of preferred stock ranking senior to
the Series A Convertible Preferred Stock and senior to the rights of the holders of common stock.



The
holders of the Series A Convertible Preferred Stock were entitled to cumulative dividends at the annual rate of 8% based on the Stated
Value per share, payable on the maturity date, which was five years from the date of issuance. Dividends are payable in the form of shares
of common stock valued at $0.25 per share.



The
number of shares of common stock into which the Series A Convertible Preferred A Stock were convertible is determined by dividing (A)
the sum of (i) the stated value of $25 per share, plus (ii) all accrued but unpaid dividends, by (B) the conversion price of $0.25 per
share. The Series A Convertible Preferred Shares was convertible at the discretion of the holder or automatically if the trading price
of the common stock into which the Series A Convertible Preferred Shares were convertible equaled or exceeded 200% of the conversion
price as in effect for ten or more consecutive trading days.



The
holders of the Series A Convertible Preferred Stock had the right to vote on any matters presented to the stockholders at any regular
or special meeting of the stockholders of the Company.



The
Series A Convertible Preferred Shares were issued as part of a unit, each unit containing 2,000 shares of Series A Convertible Preferred
Stock, a Class A Warrant to purchase up to 100,000 shares of Common Stock, exercisable for three years at an exercise price of $0.50
per share, and a Class B Warrant to purchase up to 100,000 shares of Common Stock, exercisable for five years at an exercise price of
$1.00 per share (see warrants as described further below).



Activity
for the year ended October 31, 2022



On
March 31, 2022, the holders of all 136,059 shares of outstanding Series A Convertible Preferred Stock converted those shares and all
accrued but unpaid dividends into 14,806,028 shares of Common Stock of the Company. As of October 31, 2022, there were no Series A Convertible
Preferred Shares outstanding.



F-21









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Activity
for the fiscal year ended October 31, 2021



During
the fiscal year ended October 31, 2021, the Company sold 71,600 Series A Convertible Preferred Shares for net proceeds of $1,790,000.
The shares were sold through a private placement of 35.8 units. Each unit was priced at $50,000 and consisted of 2,000 shares of Series
A Convertible Preferred Stock, a Class A Warrant to purchase up to 100,000 shares of Common Stock, exercisable for three years at an
exercise price of $0.50 per share, and a Class B Warrant to purchase up to 100,000 shares of Common Stock, exercisable for five years
at an exercise price of $1.00 per share (see warrants as described further below).



On
October 22, 2021, the Company issued 8,000 Preferred A Shares to a former stockholder of Fitore in exchange for the extinguishment of
a $200,000 note payable. The note had been issued in connection with the acquisition of Fitore (Note 4).



On
October 31, 2021, the Company issued 3,459 Preferred A Shares to the Chief Executive Officer of the Company in exchange for the forgiveness
of $86,464 of advances to the Company.



On
August 1, 2021, the Company issued 12,000 Series A Convertible Preferred Shares to four former stockholders as consideration for the
acquisition of Fitore (Note 4).



In
connection with the sale of the Series A Convertible Preferred Shares, the Company determined that there was an embedded conversion feature
associated with the preferred shares. The total intrinsic value of the beneficial conversion feature was determined to be approximately
$930,577. For the years ended October 31, 2022 and 2021, $793,175 and $110,938, respectively, was recorded as deemed dividends.



Dividend



The
holders of the Series A Convertible Preferred Shares were entitled to receive dividends at an annual rate of 8% based on the stated value
per share, payable when declared by the issuance of Company common stock at $0.25 per share. Dividends were cumulative from the date
of the final closing of the private placement, whether or not, in any dividend period or periods, the Company has assets legally available
for the payment of such dividends. Accumulations of dividends on shares of Series A Convertible Preferred Shares do not bear interest.
Dividends are payable upon declaration by the Board of Directors. All accrued but unpaid dividends were paid when the Preferred Stock
was converted.



Cumulative
dividends earned as of October 31, 2022 and 2021 are set forth in the table below:



|                            |  | Stockholders
    at Period End |     |   | Accumulated
    Dividends |  
|--------------------------- |  | ------------------------------ | --- | - | ------------------------- | -
|Balance at October 31, 2020 |  |                                | 11  |   |                           | $
|Issued                      |  |                                | 24  |   |                           |  
|Balance at October 31, 2021 |  |                                | 35  |   |                           |  
|Issued                      |  |                                | -   |   |                           |  
|Converted                   |  |                                | (35 | ) |                           |  
|Balance at October 31, 2022 |  |                                | -   |   |                           | $



Common
Stock



As
of October 31, 2022, the Company had authorized 500,000,000 shares of $0.001 par value common stock. As of October 31, 2022 and 2021,
115,160,180 and 96,310,387 shares were  issued and outstanding, respectively.



Activity
for the year ended October 31, 2022



On
February 22, 2022, the Company issued 3,712,500 shares at $1.00 in connection with the conversion of the Senior Secured Convertible Note
Payable in the amount of $3,000,000 along with accrued interest of $17,158 and $695,342 in unearned interest through the term of the
note. The Company recorded a loss of $695,342 in connection with the conversion of the note.



F-22









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



On
March 31, 2022, the Company issued 14,806,028 shares in connection with the conversion of 136,059 shares of Series A Convertible Preferred
Stock.



On
April 15, 2022, the Company issued 310,561 shares in connection with the conversion of $300,000 in principal together with $10,562 in
accrued interest of a 2021 Series Note held by the then Chief Executive Officer of the Company. The shares were issued at $1.00 per share.



On
April 15, 2022, the Company issued 20,704 shares in connection with the conversion of $20,000 in principal together with $704 in accrued
interest of a 2021 Series Note. The shares were issued at $1.00 per share.



Activity
during the year ended October 31, 2021



On
October 10, 2021, the Company issued 23,105,187 shares in connection with the conversion of $316,027 in principal and $110,035 in accrued
interest of the Company’s 10% Convertible Promissory Notes and $555,000 in principal and $174,197 accrued interest of the Company’s
10% Convertible Promissory Notes – Related Party. The shares were valued at $0.05 per share, the stated conversion rate contained
in the notes, and no gain or loss was recorded.



On
September 1, 2021, the Company issued 75,000 shares valued at $14,250 in connection with the execution of a release and settlement agreement.



On
August 1, 2021, the Company issued 27,000,000 shares in connection with the acquisitions of Fitore and Infinivive. (Note 4)



The
Company valued shares issued in connection with transactions occurring on August 1, 2021 and subsequent at $0.19 per share, based on
a valuation analysis performed in connection with ASC 805 (Note 4). Common share transactions occurring for the period November 1, 2020
through October 8, 2021 were valued at the then estimated market values of the respective shares issued.



Stock-Based
Compensation



Activity
for the year ended October 31, 2022



On
March 1, 2022, the Company issued 350,000 stock purchase options to an employee and a consultant to the Company. The options are exercisable
at $0.50 per share and vest as follows: 60,000 vested at the date of grant and 48,333 vest on each anniversary date so long as the individuals
continue providing service to the Company. The options are exercisable for a period of ten years.



On
July 6, 2022, the Company issued 5,000,000 stock purchase options to the newly appointed Chief Executive Officer of the Company. The
options are exercisable at $0.50 per share and vest as follows: 1,000,000 vested at the date of grant and 1,000,000 vest on each anniversary
date so long as the executive remains affiliated with the Company. The options are exercisable for a period of ten years.



Activity
for the year ended October 31, 2021



On
November 30, 2020, the Company issued 3,000,000 stock purchase options to officers of the Company. The options are exercisable at $0.50
per share and vest 20% on each anniversary date thereafter so long as the individuals remain affiliated with the Company. The options
are exercisable for a period of ten years.



On
November 30, 2020, the Company issued 1,000,000 stock purchase options to an officer of the Company. The options are exercisable at $0.50
per share and were to vest 20% on each anniversary date thereafter until fully vested. The options were exercisable for a period of ten
years. The officer was separated from the Company in February 2021. The Board of Directors of the Company approved the retention of the
options by the officer under the tenor of a consulting agreement, the remaining unvested portion of the options were vested immediately.



F-23







VITRO
BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



On
December 1, 2020, the Company issued 5,000,000 stock purchase options to the then Chief Executive Officer of the Company. The options
are exercisable at $0.50 per share. In connection with the executive’s separation from the Company (See Note 10), 4,000,000 of
these options were forfeited. The options are exercisable for a period of ten years.



On
February 1, 2021, the Company issued 500,000 stock purchase options to a then consultant to the Company. The options are exercisable
at $0.50 per share and vest 20% on each anniversary following the date of grant so long as the consultant remains affiliated with the
Company.



On
August 1, 2021, the Company issued 2,000,000 stock purchase options in connection with the execution of two employment agreements. The
options are exercisable at $0.50 per share and vest 20% on each anniversary following the date of grant so long as the individuals remain
affiliated with the Company. The options are exercisable for a period of ten years.



On
August 1, 2021, the Company issued 20,000 stock purchase options to an employee of the Company. The options are exercisable at $0.40
per share. These options vest 33% on each anniversary date from the date of grant so long as the individual remains affiliated with the
Company and are exercisable for ten years.



On
October 1, 2021, the Company issued 2,620,000 stock purchase options to employees and an officer of the Company. All of the foregoing
options vest 20% on each anniversary date of the date of grant so long as the individuals remain affiliated with the Company and are
exercisable at a price of $0.50 per share for a period of ten years.



On
October 1, 2021, the Company issued 1,000,000 options to a member of the Board of Directors of the Company The options are exercisable
at $0.50 per share. These options vest 500,000 on the date of grant, 125,000, 125,000 and 250,000 on each of the three successive anniversary
dates so long as the individual remains affiliated with the Company and are exercisable for ten years.



Also
on October 1, 2021, the Company issued 120,000 options to two consultants to the Company. The options are exercisable at $0.50 per share,
vest 30,000 on the date of grant and 30,000 on each anniversary of the date of grant and are exercisable for ten years.



Grants
during the years ended October 31, 2022 and 2021 are all considered to be non-qualified.



The
fair value of the options granted during the periods presented was estimated at the date of grant using the Black-Scholes option-pricing
model with the following assumptions:



|                               |  | October
    31, 2022 |            |   | October
    31, 2021 | 
|------------------------------ |  | -------------------- | ---------- | - | -------------------- | 
|Risk-free interest rate        |  |                      | 1.67%-2.99 |   |                      | 
|Dividend yield                 |  |                      | 0.00       |   |                      | 
|Volatility factor              |  |                      | 195%-198   | % |                      | 
|Weighted average expected life |  |                      | 10         |   |                      | 



F-24









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



The
table below presents option activity for the years ended October 31, 2022 and 2021:



|                            |  | Number
    of Shares |            |   | Weighted
    Average Exercise Price per Share |   |       | Weighted
    Average Remaining Contractual Life (in years) |  |  | Aggregate
                                            intrinsic value |  
|--------------------------- |  | -------------------- | ---------- | - | --------------------------------------------- | - | ----- | ---------------------------------------------------------- |  |  | --------------------------------------------------------------------- | -
|Balance at October 31, 2020 |  |                      | 12,970,000 |   |                                               | $ | 0.10  |                                                            |  |  | 6.85                                                                  |  
|Options exercised           |  |                      | -          |   |                                               |   | -     |                                                            |  |  | -                                                                     |  
|Options granted             |  |                      | 15,260,000 |   |                                               |   | 0.49  |                                                            |  |  | 7.97                                                                  |  
|Options expired             |  |                      | -          |   |                                               |   | -     |                                                            |  |  | -                                                                     |  
|Options forfeited           |  |                      | -          |   |                                               |   | -     |                                                            |  |  | -                                                                     |  
|Balance at October 31, 2021 |  |                      | 28,230,000 |   |                                               |   | 0.31  |                                                            |  |  | 7.56                                                                  |  
|                            |  |                      |            |   |                                               |   |       |                                                            |  |  |                                                                       |  
|Options exercised           |  |                      | -          |   |                                               |   | -     |                                                            |  |  | -                                                                     |  
|Options granted             |  |                      | 5,350,000  |   |                                               |   | 0.50  |                                                            |  |  | 9.91                                                                  |  
|Options expired             |  |                      | -          |   |                                               |   | -     |                                                            |  |  | -                                                                     |  
|Options forfeited           |  |                      | (4,354,000 | ) |                                               |   | (0.48 | )                                                          |  |  | (8.90                                                                 | )
|Balance at October 31, 2022 |  |                      | 29,226,000 |   |                                               | $ | 0.32  |                                                            |  |  | 7.64                                                                  |  



Stock
based compensation expense related to options for the years ended October 31, 2022 and 2021 amounted to $2,197,597 and $2,040,617, respectively.
As of October 31, 2022 and 2021, 18,101,327 and 12,330,000 options were exercisable, respectively. Unrecognized compensation expense
related to outstanding options amounted to $5,086,039 and $3,548,662 as of October 31, 2022 and 2021, respectively.



Warrants



During
the year ended October 31, 2022, the Company did not issue any warrants.



Activity
for the year ended October 31, 2021



In
connection with the issuances of Series A Preferred Stock Units during the year ended October 31, 2021, the Company issued Class A warrants
to purchase up to 4,572,929 shares of Common Stock and Class B warrants to purchase up to 4,572,929 shares of Common Stock. The series
A warrants are exercisable as of the date of grant at $0.50 cents per share for a period of three years from the date, of grant. The
Series B warrants are exercisable as of the date of grant at $1.00 per share for a period of five years.



A
summary of the Company’s common stock underlying the outstanding warrants as of October 31, 2022 is as follows:



|                                           |  | Underlying
    Number of Shares |            |  | Average
     Exercise Price |   |      | Weighted
    Average Life | 
|------------------------------------------ |  | ------------------------------- | ---------- |  | --------------------------- | - | ---- | ------------------------- | 
|Outstanding – October 31, 2020             |  |                                 | 4,100,000  |  |                             | $ | 0.75 |                           | 
|Warrants A – Granted during the period     |  |                                 | 4,752,928  |  |                             |   | 0.50 |                           | 
|Warrants B – Granted
    during the period |  |                                 | 4,752,928  |  |                             |   | 1.00 |                           | 
|Outstanding – October 31, 2021             |  |                                 | 13,605,856 |  |                             |   | 0.75 |                           | 
|Warrants A – Granted during the period     |  |                                 | -          |  |                             |   | -    |                           | 
|Warrants B – Granted
    during the period |  |                                 | -          |  |                             |   | -    |                           | 
|Outstanding – October 31, 2022             |  |                                 | 13,605,856 |  |                             | $ | 0.75 |                           | 



F-25









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



NOTE
9 – COMMITMENTS AND CONTINGENCIES



Employment
agreements



On
July 6, 2022, the Company hired Christopher Furman as its new Chief Executive Officer. Mr. Furman will receive an annual base salary
of $400,000 and an annual bonus of up to 100% of his base salary. In addition, Mr. Furman received 5,000,000 options to purchase common
stock at an exercise price of $0.50 per common share. On July 6, 2022, 1,000,000 of these options vested, with an additional 1,000,000
options vesting on July 6 in each of the next four years so long as Mr. Furman remains affiliated with the Company.



On
December 1, 2021, the Company and John Evans entered into a Consulting Agreement (“Evans Consulting Agreement”). Under the
terms of the Evans Consulting Agreement, Mr. Evans is to provide advisory services to the CEO and CFO of the Company. The term of the
Evans Consulting Agreement is for four years and initially compensates Mr. Evans in the amount of $200,000 per annum. This compensation
will be increased to $250,000 per annum at the time that the Company receives a financing of $10 million or more. In connection with
the execution of the Consulting Agreement, stock options granted to Mr. Evans in connection with the execution of his employment agreement
on November 30, 2020 shall continue to vest according to their initial terms.



On
December 8, 2020, the Company entered into a new employment agreement with Tiana States, Chief Manufacturing Officer (the “States
Agreement”). Pursuant to the terms of the States Agreement, the Company agreed to pay Mrs. States a base salary of $125,000, which
was subsequently increased to $200,000 per annum, for a term of five years. In addition, Mrs. States is eligible to receive an annual
bonus in the form of cash in the amount of up to 50% of her base salary in the discretion of the CEO and Board of Directors. The States
Agreement shall renew in one-year periods unless either Mrs. States or the Company gives notice that the agreement will not be renewed
with a 90-day notice.



On
December 1, 2020, the Company entered into a new employment agreement with James Musick, Chief Science Officer (the “Musick Agreement”).
Pursuant to the terms of the Musick Agreement, the Company agreed to pay Dr. Musick a base salary of $150,000 per annum for a term of
five years. In addition, Dr. Musick is eligible to receive an annual bonus in the form of cash in the amount of up to 100% of his base
salary at the discretion of the CEO and the Board of Directors. Following expiration of the initial five-year term, the Musick Agreement
renews in one-year periods unless either Dr. Musick or the Company gives notice that the agreement will not be renewed with a 90-day
notice. In the event of a change in control, termination of his employment by the Company without cause or termination by Dr. Musick
with good reason, the Company would be obligated to pay him certain severance payments.



On
December 1, 2020, the Company entered into a new employment agreement with Dr. Jack Zamora, Chief Executive Officer and President (“Zamora
Agreement”) with a term of five years. On November 20, 2022, the Company entered into a Mutual Release and Settlement Agreement
with Dr. Zamora relating to his separation from the Company (the “Settlement Agreement”). Among other things, the Settlement
Agreement provides that Dr. Zamora in not entitled to any additional compensation from the Company under the Zamora Agreement. See Note
10 for additional information relating to the Settlement Agreement.



On
October 1, 2021, the Company appointed Nathan Haas as the Chief Financial Officer and entered into an employment agreement with him.
Pursuant to the terms the Nathan Haas CFO Agreement, the Company agreed to pay Mr. Haas a base salary of $175,000 per annum for a term
of five years. In addition, Mr. Haas is eligible to receive an annual bonus in the form of cash in the amount of up to 100% of his base
salary payable at the discretion of the CEO and Board of Directors. Following the initial five-year term, the Nathan Haas Agreement would
renew in one-year periods unless either Mr. Haas or the Company gave notice that the agreement would not be renewed with a 90-day notice.



On
August 1, 2021, the Company entered into a new employment agreement (the “Tanner Haas Agreement”) with Tanner Haas, the chief
executive officer of Fitore. The Company agreed to pay Mr. Haas a base salary of $135,000 per annum for a term of five years. In addition,
Mr. Haas was eligible to receive an annual bonus in the form of cash in the amount of up to 100% of his base salary payable at the discretion
of the CEO and Board of Directors. The Tanner Haas Agreement was to renew in one-year periods unless either Mr. Haas or the Company gave
notice that the agreement would not be renewed with a 90-day notice. Effective June 30, 2022, Mr. Hass’ employment with Fitore
was terminated. He is entitled to severance of one year’s salary, to be paid over the ensuing 12 months.



F-26









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



NOTE
10 – RELATED PARTY TRANSACTIONS



Settlement
Agreement with Dr. Zamora



As
part of the Settlement Agreement dated November 20, 2022 (the “Effective Date”), the parties agreed to confidentiality and
non-disparagement restrictions, as well as a release of any potential claims against each other. In addition, certain provisions of Dr.
Zamora’s Employment Agreement that survive termination of employment were modified to provide that Dr. Zamora shall not, for a
period of one year from the Effective Date, “directly or indirectly solicit any person who has been a customer or employee of the
Company during the period of one (1) year prior to the Effective Date.” The Settlement Agreement also provides for the termination
of all previous supply agreements between the Company and Dr. Zamora, effective immediately, with such previous agreements to be replaced
by the Supply Agreement described below.



Standstill
Agreement



On
the Effective Date, in connection with the Settlement Agreement, the Company entered into a Standstill Agreement with Dr. Zamora (the
“Standstill Agreement”).



Supply
Agreement



On
the Effective Date, in connection with the Settlement Agreement, the Company entered into a Supply Agreement with Dr. Zamora (the “Supply
Agreement”), pursuant to which the Company agreed to provide InfiniVive MD Exosome Serum and InfiniVive Daily Serum (the “Cosmetic
Products”) to Dr. Zamora at his request. The provision of the Cosmetic Products under the Supply Agreement is subject to minimum
and maximum quantity limitations. The Supply Agreement is effective for a period of five years, unless earlier terminated. The Company
or Dr. Zamora may terminate the Supply Agreement immediately in prescribed circumstances, including if either party defaults with respect
to its obligations under the Supply Agreement and, if the default is capable of being cured, does not cure such default within 30 days
after receiving notice of such default. If the Supply Agreement is deemed terminated by Dr. Zamora for failure of the Company to supply
the Cosmetic Products in accordance with its terms or by the Company without cause, the Standstill Agreement would be deemed terminated
and of no further force or effect.



Memorandum
of Understanding



On
the Effective Date, in connection with the Settlement Agreement, the Company entered into a Memorandum of Understanding with Dr. Zamora
(the “MOU”) in order to support clinical research for the Company’s AlloRx® stem cells (“AlloRx”).
Under the MOU, the Company agreed to provide AlloRx at a specified price to international clinical research facilities or other clinics
with which Dr. Zamora may become affiliated, provided that certain regulatory conditions are satisfied, including proof of satisfaction
of applicable United States and local legal requirements. The MOU will be effective for a period of five years, unless earlier terminated
or replaced by mutual written agreement between Dr. Zamora and the Company. The MOU may also be earlier terminated in the event any clinic
or the Company materially breaches the terms and conditions of the MOU. In the event the MOU is terminated by Dr. Zamora for failure
of the Company to supply AlloRx in accordance with its terms or by the Company without cause, the Standstill Agreement would be deemed
terminated and of no further force or effect.



Accounts
Receivable and Revenues



Dr.
Zamora was also a significant customer of the Company in his capacity as a practicing physician. (See also Note 8 and Note 9 for more
information regarding this individual.) As of October 31, 2022 and 2021, Dr. Zamora owed the Company $0 and $0, respectively. During
the years ended October 31, 2022 and 2021, Dr. Zamora accounted for $30,500 and $362,800 in product sales, respectively. These sales
amounts were 1% and 29% of total product sales, respectively, for the years ended October 31, 2022 and 2021.



Accounts
Payable and Other Accrued Liabilities



The
spouse of the Company’s Chief Science Officer, through an entity she controls, leases office and lab space to the Company. As of
October 31, 2022 and 2021, the Company owes this entity $0 and $0, respectively, in past rent. The rental rates charged to the Company,
$5,645 per month, are consistent with commercial rental rates in the area.



As
of October 31, 2022 and 2021, the Company owed an entity controlled by Dr. Zamora $137,953 and $172,147, respectively, for goods and
services paid for on behalf of the Company by the related entity.



F-27









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



Amounts
due to Dr. Zamora were relieved in November 2022 as part of the Settlement Agreement as described elsewhere herein.



As
of October 31, 2022 and 2021, the Company owed the former CEO of Fitore $94,559 and $0, respectively, in severance pay and related
taxes.



Accrued
Compensation and Advances Payable



Through
October 31, 2020, the Company had recorded $1,221,958 in accrued compensation payable to the Chief Science Officer. Through October 31,
2020, the Company had recorded $767,288 in connection with interest accrued on the compensation payable and accrued bonuses due the Chief
Science Officer. These amounts were converted into unsecured convertible promissory notes on October 31, 2020. (See Note 7 for further
information.)



Convertible
Notes, Debt Discount and Accrued Interest



On
August 1, 2021, in connection with the acquisition of Fitore (Note 4), the Company issued 2021 Series Unsecured Convertible Notes in
the amount of $1,000,000 to the four former shareholders of Fitore. The notes earned interest at 5%, mature on July 31, 2024 and are
convertible, at the holder’s option, at $1.00 per common share. On October 22, 2021, the holder of $200,000 of the convertible
notes converted the note and accrued but unpaid interest into four Series A Preferred Stock units. On April 15, 2022, the holders of
$320,000 of the convertible notes converted the notes and accrued but unpaid interest into 331,266 shares of common stock. The remaining
principal balance outstanding on the 2021 Series Convertible notes amounted to $480,000 and $800,000 as of October 31, 2022 and 2021,
respectively. During the years ended October 31, 2022 and 2021, the Company recorded $31,276 and $12,219, respectively, in interest expense.
As of October 31, 2022 and 2021, accrued, but unpaid, interest on these notes was $29,983 and $9,973, respectively.



NOTE
11 – INCOME TAXES



The
Company accounts for income taxes in accordance with ASC 740, Income Taxes. Under the provisions of ASC 740, a deferred tax asset or
liability (net of a valuation allowance) is provided in the financial statements by applying the provisions of applicable laws to measure
the deferred tax consequences of temporary differences that will result in taxable or deductible amounts in future years as a result
of events recognized in the financial statements in the current or ensuing years.



The
Company has not recorded an income tax expense. The Company has a net operating loss and has provided a valuation allowance against net
deferred tax assets due to uncertainties regarding the Company’s ability to realize these assets.



Significant
components of the Company’s net deferred tax assets for federal and state income taxes at October 31, 2022 and 2021 consist of
the following:



|                                |  | Years
    Ended October 31, |           
|------------------------------- |  | --------------------------- | ----------
|                                |  | 2022                        |           
|                                |  |                             |           
|Net operating loss carryforward |  | $                           | 2,163,000 
|Stock compensation              |  |                             | 1,258,000 
|Basis of shares in subsidiary   |  |                             | 445,000   
|Capitalized intangible costs    |  |                             | (253,000  
|Accruals and reserves           |  |                             | 94,000    
|Deferred tax assets             |  |                             | 3,707,000 
|Valuation allowance             |  |                             | (3,707,000
|                                |  |                             |           
|Effective income tax
    asset  |  | $                           | –         



F-28









VITRO
                                            BIOPHARMA, INC.

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER
31, 2022 AND 2021



As
of October 31, 2022 and 2021, the Company has net operating loss carry forwards of approximately $8,465,000 and $4,581,000, respectively,
available to reduce future taxable income, if any, for both Federal and Colorado state income tax purposes. The net operating loss carry
forwards generated from tax years ending after December 31, 2017 will not expire. Net operating loss carry forwards generated from tax
years ending before January 1, 2018 expire after 20 years. Valuation allowances have been reserved, where necessary. The net valuation
allowance increased by $1,735,000 for the period ended October 31, 2022.



The
valuation allowance is evaluated at the end of each year, considering positive and negative evidence about whether the asset will be
realized. At that time, the allowance will either be increased or reduced; reduction could result in the complete elimination of the
allowance if positive evidence indicates that the value of the deferred tax asset is no longer impaired, and the allowance is no longer
required.



NOTE
12 – SUBSEQUENT EVENTS



On
January 6, 2023, the Company sold $405,000 of its 8% Convertible Promissory Notes (the “Notes”)
and common stock purchase warrants (“Warrants”)to five (5) investors. The sale and purchase were made through a Convertible
Note and Warrant Purchase Agreement (“Purchase Agreement”) entered into with each investor.



The
Notesbear interest at the rate of eight per cent per
year and are payable solely in shares of the Company’s common stock. The Notes may be converted at any time at the option of the
holder and are payable in full at the earliest of (i) the completion of a “Qualified Financing,” as defined below, (ii) a
change in control, (iii) in the event of default, or (iv) the maturity date, which is five years from the date of issuance. A Qualified
Financing is defined in the Purchase Agreement as any financing completed after the date of issuance of the Notes involving the sale
of the Company’s equity securities primarily for capital raising purposes resulting in gross proceeds to the Company of at least
$5 million. Upon completion of a Qualified Financing, each Convertible Note is convertible into the securities issued in such financing
(the “Qualified Financing Securities”) in an amount determined by dividing (i) the outstanding principal on the Note plus
all accrued interest by (ii) the lessor of (x) the “Discounted Qualified Financing Price” and (y) the “Capped Price.”
In the event of a change in control or default, voluntary conversion or upon maturity, each Note is convertible into that number of shares
of the Company’s common stock that equals (i) the outstanding principal amount of the Note plus any accrued but unpaid interest,
divided by (ii) the Capped Price.



The
Discounted Qualified Financing Price is defined as the per share price at which the shares of the Qualified Financing Securities are
sold in such Qualified Financing as determined for accounting purposes under GAAP, multiplied by 0.75. The Capped Price is the per share
price implied by a fully-diluted (on an as-converted to common stock basis), pre-money valuation of $200,000,000 for the Company.



Each
Warrant issued by the Company pursuant to the Purchase Agreement entitles the holder to purchase that number of fully paid and nonassessable
shares of the Company’s common stock determined (A) in the case following a Qualified Financing, by dividing (i) the sum of the
aggregate outstanding principal amount of the Convertible Note plus all accrued and unpaid interest thereon at the time of conversion
multiplied by .25, by (ii) the quotient of the Discounted Qualified Financing Price divided by .75, or (B) in connection with a Change
of Control, by dividing (i) the sum of the aggregate outstanding principal amount of the Convertible Note plus all accrued and unpaid
interest thereon at the time of the Note’s conversion, by (ii) the Capped Price, subject to adjustment as set forth in the Warrant.
In each case, the Warrants are exercisable at a price of $0.625 per share for a period of five years.



Participation
Rights. Each Note entitles the holder to purchase in a Qualified Financing an amount of Qualified Financing Securities (as defined
above) up to 200% of the aggregate principal amount of the Notes subscribed for by such holder in this Offering.





F-29