The following discussion and analysis of our financial condition and results of
operations should be read together with the unaudited condensed financial
statements and related notes appearing elsewhere in this Quarterly Report on
Form 10-Q and the audited financial statements and related notes for the year
ended December 31, 2021 included in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission, or SEC. In addition to historical
information, this discussion and analysis contains forward-looking statements
that involve risks, uncertainties, and assumptions. Our actual results may
differ materially from those anticipated in these forward-looking statements as
a result of certain factors. We discuss factors that we believe could cause or
contribute to these differences below and elsewhere in this Quarterly Report on
Form 10-Q, including those factors set forth in the section entitled "Cautionary
Note Regarding Forward-Looking Statements and Industry Data" and in the section
entitled "Risk Factors" in Part II, Item 1A.



Overview



We are a biotech innovation company with a mission of prolonging life and
enhancing its quality by improving the health of the immune system. We are
developing biotechnologies specifically focused on improving the health of the
immune system through immune reprogramming and monitoring. Our immune
reprogramming technologies are currently at the pre-clinical stage and are
designed to retrain the immune system to induce tolerance with an objective of
addressing rejection of transplanted organs, autoimmune diseases, and allergies.
Our immune monitoring technologies are designed to provide a personalized
comprehensive profile of the immune system and we plan to utilize them in our
upcoming reprogramming clinical trials to monitor subjects' immune response
before, during and after drug administration.



Immune Reprogramming



The discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40
years ago has made possible life-saving organ transplantation procedures and
blocking of unwanted immune responses in autoimmune diseases. However, immune
suppression leads to significant undesirable side effects, such as increased
susceptibility to life-threatening infections and cancers, because it
indiscriminately and broadly suppresses immune function throughout the body.
While the use of these drugs has been justifiable because they prevent or delay
organ rejection, their use for treatment of autoimmune diseases and allergies
may not be acceptable because of the aforementioned side effects. Furthermore,
transplanted organs often ultimately fail despite the use of immune suppression,
and about 40% of transplanted organs survive no more than 5 years.

New, focused therapeutic approaches are needed that modulate only the small portion of immune cells that are involved in rejection of the transplanted organ, as this approach can be safer for patients than indiscriminate immune suppression. Such approaches are referred to as immune tolerance, and when therapeutically induced, may be safer for patients and potentially allow long-term survival of transplanted tissues and organs.





In the late 1990s, academic research on these approaches was conducted at the
Transplant Center in Loma Linda University ("LLU") in connection with a project
that secured initial grant funding from the U.S. Department of Defense. The
focus of that project was for skin grafting for burn victims. Twenty years of
research at LLU and an affiliated incubator led to a series of discoveries that
have been translated into a large patent portfolio of therapeutic approaches
that may be applied to the modulation of the immune system to induce tolerance
to self and transplanted organs.



We have an exclusive worldwide license for commercializing this nucleic
acid-based technology (which is currently at the pre-clinical stage), named
Apoptotic DNA Immunotherapy™ (ADI™) from LLU, which utilizes a novel approach
that mimics the way the body naturally induces tolerance to our own tissues
("therapeutically induced immune tolerance"). While immune suppression requires
continuous administration to prevent rejection of a transplanted organ,
induction of tolerance has the potential to retrain the immune system to accept
the organ for longer periods of time. Thus, ADI™ may allow patients to live with
transplanted organs with significantly reduced immune suppression. ADI™ is a
technology platform which we believe can be engineered to address a wide variety
of indications.



                                       22






We are developing ADI™ products for organ transplantation including skin
grafting, autoimmune diseases, and allergies, with the initial focus on skin
allografts and psoriasis, as we believe these indications will be most efficient
in providing safety and efficacy data in clinical trials. To submit a Biologics
License Application ("BLA") for a biopharmaceutical product, clinical safety and
efficacy must be demonstrated in a series of clinical studies conducted with
human subjects. For products in our class of drugs, the first-in-human trials
will be a combination of Phase I (safety/tolerability) and Phase II (efficacy)
in affected subjects. To obtain approval to initiate the Phase I/IIa studies, an
Investigational New Drug Application will be submitted to compile non-clinical
efficacy data as well as manufacturing and pre-clinical safety/toxicology data.
To date, we have conducted non-clinical studies in a stringent model of skin
transplantation using genetically mismatched donor and recipient animals
demonstrating a 3-fold increase in the survival of the skin graft in animals
that were tolerized with ADI™ compared to animals that receive immune
suppression alone. Prolongation of graft life was observed despite
discontinuation of immune suppression after the first 5 weeks. Additionally, in
an induced non-clinical model for psoriasis, ADI™ treatment resulted in a 69%
reduction in skin thickness and a 38% decrease in skin flaking (two clinical
parameters for assessment of psoriasis skin lesions). The Phase I/IIa studies in
psoriasis will evaluate the safety/tolerability of ADI™ in patients diagnosed
with psoriasis. Since the drug will be administered in subjects diagnosed with
psoriasis, effectiveness of the drug to improve psoriatic lesions will also be
evaluated. In another Phase I/IIa study, patients requiring skin allografts will
receive weekly intra-dermal injections of ADI™ in combination with standard
immune suppression to assess safety/tolerability and possibility of reducing
levels of immunosuppressive drugs as well as prolongation of graft life. Later
phase trials are planned after successful completion of these studies in
preparation for submission for a BLA to regulatory agencies.



Immune Monitoring



We believe that understanding the status of an individual's immune system is key
to developing and administering immunotherapies such as ADI™. We have secured an
exclusive worldwide license for commercializing a technology platform named
AditxtScore™, which provides a personalized comprehensive profile of the immune
system. It is intended to be informative for individual immune responses to
viruses, bacterial antigens, peptides, drugs, bone marrow and solid organ
transplants, and cancer. It has broad applicability to many other agents of
clinical interest impacting the immune system, including those not yet
identified such as future infectious agents.



AditxtScore™ is being designed to allow individuals to understand, manage and
monitor their immune profiles in order to be informed about attacks on or by
their immune system. We believe AditxtScore™ can also assist the medical
community in anticipating possible immune responses and reactions to viruses,
bacteria, allergens and transplanted organs. It can be useful in anticipating
attacks on the body by having the ability to determine its potential response
and for developing a plan to deal with an undesirable reaction by the immune
system. Its advantages include the ability to provide a simple, rapid, accurate,
high throughput, single platform assay that can be multiplexed to determine the
immune status with respect to several factors simultaneously, in 3-16 hours, as
well as detect antigen and antibody in a single test (i.e. infectious,
recovered, immune). In addition, it can determine and differentiate between
various types of cellular and humoral immune responses (T and B cells). It also
provides for simultaneous monitoring of cell activation and levels of cytokine
release (i.e., cytokine storms).



We plan to utilize AditxtScore™ in our upcoming clinical trials to monitor
subjects' immune response before, during and after ADI™ drug administration. We
are also evaluating plans to obtain FDA approval for AditxtScore™'s use as a
clinical assay and seeking to secure manufacturing, marketing and distribution
partnerships for application in the Infectious Diseases market, by end of 2020.
To obtain FDA approval to use AditxtScore™ as a clinical assay, we plan to
conduct validation studies comparing AditxtScore™ to other immunological tests
to demonstrate reproducibility of data and to demonstrate the sensitivity of the
assays for use in different indications (e.g., detection of antigens present in
infectious agents or antibodies against infectious agents). We believe that
these data will show AditxtScore™'s ability to multiplex in two ways using a
single assay: (i) evaluating the immune response to multiple antigens (from
different infectious agents) and (ii) measuring quantities of multiple
cytokines. Furthermore, we believe that the additional validation studies will
demonstrate AditxtScore™'s ability to measure the presence of several antibody
isotypes against several antigens in a single reaction. Our plan is to submit a
510(K) application to the FDA after successful completion of these studies. We
have engaged consultants for our communications and submissions to the FDA.
Beyond 2021, we plan to develop AditxtScore™ for applications in additional
markets such as Organ Rejection, Allergies, Drug/Vaccine Response, and Disease
Susceptibility.



                                       23






The initial application of the platform will be AditxtScore™ for COVID-19 which
has been designed to provide a more complete assessment of an individual's
infection and immunity status with respect to the SARS-CoV-2 virus. Infection
status will be determined by evaluating the presence or absence of the virus,
and immunity status by measuring levels of antibodies against viral antigens and
their ability to neutralize the virus. We will soon be expanding the panel to
measure other components of the immune response such as cellular immunity. In
early 2021, we established our AditxtScore™ Immune Monitoring Center in
Richmond, Virginia (the "Center"). The Center operates as a Clinical Laboratory
Improvement Amendments (CLIA) certified facility for the processing of our
AditxtScore™ for COVID-19 Lab Developed Test (LDT) for our prospective channel
partners, including labs and hospitals.

License Agreement with Loma Linda University


On March 8, 2018, we entered into an Assignment Agreement (the "Assignment
Agreement") with Sekris Biomedical, Inc. ("Sekris"). Sekris was a party to a
license agreement with LLU, entered and made effective on May 25, 2011, and
amended on June 24, 2011, July 16, 2012 and December 27, 2012 (the "Original
Agreement," and together with the Assignment Agreement, the "Sekris
Agreements"). Pursuant to the Assignment Agreement, Sekris transferred and
assigned all of its rights, obligations and liabilities under the Original
Agreement, of whatever kind or nature, to us. In exchange, on March 8, 2018, we
issued a warrant to Sekris to purchase up to 10,000 shares of our common stock
(the "Sekris Warrant"). The warrant was immediately exercisable and has an
exercise price of $200.00 per share. The expiration date of the warrant is March
8, 2023. On March 15, 2018, as amended on July 1, 2020, we entered into a LLU
License Agreement directly with Loma Linda University, which amends and restates
the Sekris Agreements.



Pursuant to the LLU License Agreement, we obtained the exclusive royalty-bearing
worldwide license in and to all intellectual property, including patents,
technical information, trade secrets, proprietary rights, technology, know-how,
data, formulas, drawings, and specifications, owned or controlled by LLU and/or
any of its affiliates (the "LLU Patent and Technology Rights") and related to
therapy for immune-mediated inflammatory diseases (the ADI™ technology). In
consideration for the LLU License Agreement, we issued 500 shares of common
stock to LLU.



Pursuant to the LLU License Agreement, we are required to pay an annual license
fee to LLU. Also, we paid LLU $455,000 in July 2020 for outstanding milestone
payments and license fees. We are also required to pay to LLU milestone payments
in connection with certain development milestones. Specifically, we are required
to make the following milestone payments to LLU: $175,000 on March 31, 2022;
$100,000 on March 31, 2024; $500,000 on March 31, 2026; and $500,000 on March
31, 2027. In lieu of the $175,000 milestone payment due on March 31, 2022, the
Company paid LLU an extension fee of $100,000. Upon payment of this extension
fee, an additional year will be added for the March 31, 2022 milestone.
Additionally, as consideration for prior expenses incurred by LLU to prosecute,
maintain and defend the LLU Patent and Technology Rights, we made the following
payments to LLU: $70,000 at the end of December 2018, and a final payment of
$60,000 at the end of March 2019. We are required to defend the LLU Patent and
Technology Rights during the term of the LLU License Agreement. Additionally, we
will owe royalty payments of (i) 1.5% of Net Product Sales (as such terms are
defined under the LLU License Agreement) and Net Service Sales on any Licensed
Products (defined as any finished pharmaceutical products which utilizes the LLU
Patent and Technology Rights in its development, manufacture or supply), and
(ii) 0.75% of Net Product Sales and Net Service Sales for Licensed Products and
Licensed Services (as such terms are defined under the LLU License Agreement)
not covered by a valid patent claim for technology rights and know-how for a
three (3) year period beyond the expiration of all valid patent claims. We also
are required to produce a written progress report to LLU, discussing our
development and commercialization efforts, within 45 days following the end of
each year. All intellectual property rights in and to LLU Patent and Technology
Rights shall remain with LLU (other than improvements developed by or on our
behalf).



The LLU License Agreement shall terminate on the last day that a patent granted
to us by LLU is valid and enforceable or the day that the last patent
application licensed to us is abandoned. The LLU License Agreement may be
terminated by mutual agreement or by us upon 90 days written notice to LLU. LLU
may terminate the LLU License Agreement in the event of (i) non-payments or late
payments of royalty, milestone and license maintenance fees not cured within 90
days after delivery of written notice by LLU, (ii) a breach of any non-payment
provision (including the provision that requires us to meet certain deadlines
for milestone events (each, a "Milestone Deadline")) not cured within 90 days
after delivery of written notice by LLU and (iii) LLU delivers notice to us of
three or more actual breaches of the LLU License Agreement by us in any 12-month
period. Additional Milestone Deadlines include: (i) the requirement to have
regulatory approval of an IND application to initiate first-in-human clinical
trials on or before March 31, 2022, which has been extended to March 31, 2023
due to payment of a $100,000 extension fee paid in March 2022, (ii) the
completion of first-in-human (phase I/II) clinical trials by March 31, 2024,
(iii) the completion of Phase III clinical trials by March 31, 2026 and (iv)
biologic licensing approval by the FDA by March 31, 2027.



                                       24

License Agreement with Leland Stanford Junior University ("Stanford")





On February 3, 2020, we entered into an exclusive license agreement (the
"February 2020 License Agreement") with Stanford regarding a patent concerning a
method for detection and measurement of specific cellular responses. Pursuant to
the February 2020 License Agreement, we received an exclusive worldwide license
to Stanford's patent regarding use, import, offer, and sale of Licensed Products
(as defined in the agreement). The license to the patented technology is
exclusive, including the right to sublicense, beginning on the effective date of
the agreement, and ending when the patent expires. Under the exclusivity
agreement, we acknowledged that Stanford had already granted a non-exclusive
license in the Nonexclusive Field of Use, under the Licensed Patents in the
Licensed Field of Use in the Licensed Territory (as those terms are defined in
the February 2020 License Agreement"). However, Stanford agreed to not grant
further licenses under the Licensed Patents in the Licensed Field of Use in the
Licensed Territory. On December 29, 2021, we entered into an amendment to the
February 2020 License Agreement which extended our exclusive right to license
the technology deployed in AditxtScoreTM and securing worldwide exclusivity in
all fields of use of the licensed technology.



We were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of
February 3, 2020. We also issued 375 shares of the Company's common stock to
Stanford. An annual licensing maintenance fee is payable by us on the first
anniversary of the February 2020 License Agreement in the amount of $40,000 for
2021 through 2024 and $60,000 starting in 2025 until the license expires upon
the expiration of the patent. The Company is required to pay and has paid
$25,000 for the issuances of certain patents. The Company will pay milestone
fees of $50,000 on the first commercial sales of a licensed product and $25,000
at the beginning of any clinical study for regulatory clearance of an in vitro
diagnostic product developed and a potential licensed product. The Company paid
a milestone fee for a clinical study for regulatory clearance of an in vitro
diagnostic product developed and a potential licensed product of $25,000 in
March of 2022. We are also required to: (i) provide a listing of the management
team or a schedule for the recruitment of key management positions by March 31,
2020 (which has been completed), (ii) provide a business plan covering projected
product development, markets and sales forecasts, manufacturing and operations,
and financial forecasts until at least $10,000,000 in revenue by June 30, 2020
(which has been completed), (iii) conduct validation studies by September 30,
2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA
by September 30, 2020 (which has been completed), (iv) submit a 510(k)
application to the FDA, Emergency Use Authorization ("EUA"), or a Laboratory
Developed Test ("LDT") by March 31, 2021 (which has been completed), (vi)
develop a prototype assay for human profiling by December 31, 2021 (which has
been completed), (vii) execute at least one partnership for use of the
technology for transplant, autoimmunity, or infectious disease purposes by March
31, 2022 (which has been completed) and (viii) will provide further development
and commercialization milestones for specific fields of use in writing by
December 31, 2022.



In addition to the annual license maintenance fees outlined above, we will pay
Stanford royalties on Net Sales (as such term is defined in the February 2020
License Agreement) during the of the term of the agreement as follows: 4% when
Net Sales are below or equal to $5 million annually or 6% when Net Sales are
above $5 million annually. The February 2020 License Agreement may be terminated
upon our election on at least 30 days advance notice to Stanford, or by Stanford
if we: (i) are delinquent on any report or payment; (ii) are not diligently
developing and commercializing Licensed Product; (iii) miss certain performance
milestones; (iv) are in breach of any provision of the February 2020 License
Agreement; or (v) provide any false report to Stanford. Should any events in the
preceding sentence occur, we have a thirty (30) day cure period to remedy such
violation.



Our Team




We have assembled a team of experts from a variety of scientific fields and
commercial backgrounds, with many years of collective experience that ranges
from founding startup biotech companies, to developing and marketing
biopharmaceutical products, to designing clinical trials, and to management of
private and public companies.



                                       25





Going Concern



We were incorporated on September 28, 2017 and have not generated significant
revenues to date. During the nine months ended September 30, 2022 we had a net
loss of $19,466,710 and cash of $9,244,876 as of September 30, 2022. The Company
will require significant additional capital to operate in the normal course of
business and fund clinical studies in the long-term. As a result of the January
2021 Securities Purchase Agreement, the August 2021 Offering, the October 2021
Offering, the December 2021 Offering, and September 2022 Offering we received
net proceeds of approximately $52,000,000 during the last twelve months. We
believe that the remaining funds on hand will not be sufficient to fund our
operations for the next 12 months and such creates substantial doubt about our
ability to continue as a going concern beyond one year.



Financial Results




We have a limited operating history. Therefore, there is limited historical
financial information upon which to base an evaluation of our performance. Our
prospects must be considered in light of the uncertainties, risks, expenses, and
difficulties frequently encountered by companies in their early stages of
operations. Our condensed financial statements as of September 30, 2022, show a
net loss of $19,466,710. We expect to incur additional net expenses over the
next several years as we continue to maintain and expand our existing
operations. The amount of future losses and when, if ever, we will achieve
profitability are uncertain.



Results of Operations

Results of operations for the three months ended September 30, 2022 and 2021





We generated revenue of $323,125 and $0 for the three months ended September 30,
2022 and 2021, respectively. Cost of sales for the three months ended September
30, 2022 and 2021 was $233,684 and $0, respectively.



During the three months ended September 30, 2022, we incurred a loss from
operations of $5,392,164. This is due to general and administrative expenses of
$3,919,618, which includes $461,492 in stock-based compensation, research and
development of $1,570,540, which includes $170,066 in stock-based compensation,
and sales and marketing expenses of negative $8,553, which includes $0 in
stock-based compensation. The $1,570,540 in research and development is mainly
comprised of $248,012 in consulting expenses, and $974,982 in compensation.



During the three months ended September 30, 2021, we incurred a loss from
operations of $6,073,145. This is due to general and administrative expenses of
$4,451,545, which includes $650,325 in stock-based compensation, research and
development of $1,471,544, which includes $248,989 in stock-based compensation,
and sales and marketing expenses of $150,056. The $1,471,544 in research and
development is comprised of $3,700 in licensing fees, $484,197 in product
development, $736,997 in compensation, and $246,650 in other research and
development expense.

The increase in expenses during the three months ended September 30, 2022 compared to the three months ended September 30, 2021 was due to the Company continuing to execute its business plan and incur costs of being a public company.

Results of operations for the nine months ended September 30, 2022 and 2021


We generated revenue of $748,119 and $0 for the nine months ended September 30,
2022 and 2021, respectively. Cost of sales for the nine months ended September
30, 2022 and 2021 was $596,613 and $0, respectively.



During the nine months ended September 30, 2022, we incurred a loss from
operations of $17,280,052. This is due to general and administrative expenses of
$12,332,728, which includes $1,288,829 in stock-based compensation, research and
development of $4,186,842, which includes $473,593 in stock-based compensation,
and sales and marketing expenses of $911,988, which includes $754,699 in
stock-based compensation. The $4,186,842 in research and development is mainly
comprised of $1,350,384 in consulting expenses, and $2,517,836 in compensation
offset by a one-time adjustment to research and development purchases. During
the quarter, the Company transitioned from purchasing certain inventory items to
internally manufacturing these items.



                                       26





During the nine months ended September 30, 2021, we incurred a loss from
operations of $17,941,184. This is due to general and administrative expenses of
$14,348,375, which includes $2,887,657 in stock-based compensation, research and
development of $3,340,247, which includes $248,989 in stock-based compensation,
and sales and marketing expenses of $252,562. The $3,340,247 in research and
development is comprised of $76,245 in licensing fees, $1,460,086 in product
development, $736,997 in compensation, and $1,066,919 in other research and
development expense.

The increase in expenses during the nine months ended September 30, 2022 compared to the nine months ended September 30 2021 was due to the Company continuing to execute its business plan and incur costs of being a public company.

Liquidity and Capital Resources


We have incurred substantial operating losses since inception and expect to
continue to incur significant operating losses for the foreseeable future and
may never become profitable. As of September 30, 2022, we had an accumulated
deficit of $86,828,138 We had working capital of $8,251,803 as of September 30,
2022. During the nine months ended September 30, 2022, we purchased $274,073 in
fixed assets, for which we made cash payments of $278,256. These fixed assets
were purchased to continue the buildout of our operations. Approximately
$215,000 of these purchased fixed assets were lab equipment, $54,000 was for
computers, and $5,000 was for office furniture.

Our condensed financial statements have been prepared assuming that we will continue as a going concern.





We have funded our operations from proceeds from the sale of equity and debt
securities. On July 2, 2020, we completed our IPO and raised approximately $9.5
million in net proceeds. At the time of the IPO, we believed that these funds
would be sufficient to fund our operations for the foreseeable future.



On September 10, 2020, we completed a follow-on public offering. In connection
therewith, we issued 48,000 units, or Follow-On Units, excluding the
underwriters' option to cover overallotments, at an offering price of $200.00
per Follow-On Unit, resulting in gross proceeds of approximately $9.6 million.



On January 25, 2021, the Company entered into a securities purchase agreement
with an institutional accredited investor (the "Investor") for the sale of a
$6,000,000 senior secured convertible note (the "Convertible Note"). The
Convertible Note had a term of 24 months, was originally convertible at a price
of $200.00 per share and was issued at an original issuance discount of
$1,000,000. On August 30, 2021, the Company entered into a defeasance and waiver
agreement with the Investor, pursuant to which the Noteholder has agreed in
exchange for (a) a cash payment by the Company to the Investor of $1.2 million
(the Cash Payment"), (b) a waiver, in part of the conversion price adjustment
provision such that the January 2021 Note shall be convertible into 96,050
shares of common stock (without giving effect to the conversion notice received
by the company form the Noteholder prior to the date hereof totaling (20,115
shares) (the "Shares"), and (c) a voluntary and permanent reduction by the
Company of the exercise price of the warrant to purchase 16,000 shares of the
common stock of the Company (the "January 2021 Warrant") to $126.50 per share.
As of September 30, 2022, the outstanding principle of the convertible note had
been converted to 96,050 shares of common stock.

On August 30, 2021, we completed a registered direct; offering and raised approximately $10.1 million in net proceeds.

On October 20, 2021, we completed an offering for net proceeds of $3.8 million. As part of this offering, we issued 56,667 shares of the Company's common stock





On December 6, 2021, we completed an offering for net proceeds of $16.0 million.
As part of this offering, we issued 164,929 units consisting of shares of the
Company's common stock and warrant to purchase shares of the Company's common
stock and 166,572 prefunded warrants. The warrant issued as part of the units
had an exercise price of $57.50 and the prefunded warrants had an exercise

price
of $0.001.



                                       27





On September 20, 2022, we completed a public offering for net proceeds of
$18.1 million (the "September 2022 Offering"). As part of the September 2022
Offering, we issued 1,224,333 of shares of the Company's common stock,
pre-funded warrants to purchase 2,109,000 shares of the Company's common stock
and warrants to purchase 3,333,333 shares of the Company's common stock . The
warrants had an exercise price of $6.00 and the pre-funded warrants had an
exercise price of $0.001.



We may need to raise significant additional capital to continue to fund our
operations and the clinical trials for our product candidates. We may seek to
sell common stock, preferred stock or convertible debt securities, enter into a
credit facility or another form of third-party funding or seek other debt
financing. In addition, we may seek to raise cash through collaborative
agreements or from government grants. The sale of equity and convertible debt
securities may result in dilution to our stockholders and certain of those
securities may have rights senior to those of our common shares. If we raise
additional funds through the issuance of preferred stock, convertible debt
securities, or other debt financing, these securities or other debt could
contain covenants that would restrict our operations. Any other third-party
funding arrangement could require us to relinquish valuable rights.



The source, timing, and availability of any future financing will depend
principally upon market conditions, and, more specifically, on the progress of
our clinical development program. Funding may not be available when needed, at
all, or on terms acceptable to us. Lack of necessary funds may require us to,
among other things, delay, scale back or eliminate expenses including some or
all our planned development, including our clinical trials. While we may need to
raise funds in the future, we believe the current cash reserves should be
sufficient to fund our operation for the foreseeable future. Because of these
factors, we believe that this creates doubt about our ability to continue as a
going concern.



Contractual Obligations



The following table shows our contractual obligations as of September 30, 2022:



                                                         Payment Due by Year
                           Total          2022           2023            2024           2025          2026
Lease                   $ 3,676,932     $ 301,074     $ 1,149,247     $ 1,034,084     $ 708,804     $ 483,723
Financed asset              252,221       140,709         111,512               -             -             -

Total contractual
obligations             $ 3,929,153     $ 441,783     $ 1,260,759     $

1,034,084     $ 708,804     $ 483,723

Critical Accounting Polices and Estimates





Our condensed financial statements are prepared in accordance with generally
accepted accounting principles in the United States. The preparation of our
condensed financial statements and related disclosures requires us to make
estimates, assumptions and judgments that affect the reported amount of assets,
liabilities, revenue, costs and expenses, and related disclosures. We believe
that our critical accounting policies described under the heading "Management's
Discussion and Analysis of Financial Condition and Plan of Operations-Critical
Accounting Policies" in our Prospectus, dated September 1, 2020, filed with the
SEC pursuant to Rule 424(b), are critical to fully understanding and evaluating
our financial condition and results of operations. The following involve the
most judgment and complexity:



  ? Research and development




  ? Stock-based compensation expense




  ? Fair value of common stock





Accordingly, we believe the policies set forth above are critical to fully
understanding and evaluating our financial condition and results of operations.
If actual results or events differ materially from the estimates, judgments and
assumptions used by us in applying these policies, our reported financial
condition and results of operations could be materially affected.

Off-Balance Sheet Arrangements


We did not have during the periods presented, and we do not currently have, any
off-balance sheet arrangements, as defined in the rules and regulations of

the
SEC.



                                       28





JOBS Act



On April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides
that an "emerging growth company" can take advantage of the extended transition
period provided in Section 7(a)(2)(B) of the Securities Act, for complying with
new or revised accounting standards. In other words, an "emerging growth
company" can delay the adoption of certain accounting standards until those
standards would otherwise apply to private companies.



When favorable, we have chosen to take advantage of the extended transition
periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise
apply to private companies provided under the JOBS Act.



We are in the process of evaluating the benefits of relying on other exemptions
and reduced reporting requirements provided by the JOBS Act. Subject to certain
conditions set forth in the JOBS Act, as an "emerging growth company," we intend
to rely on certain of these exemptions, including without limitation,
(i) providing an auditor's attestation report on our system of internal
controls over financial reporting pursuant to Section 404(b) of the
Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the Public Company Accounting Oversight Board ("PCAOB") regarding mandatory
audit firm rotation or a supplement to the auditor's report providing additional
information about the audit and the financial statements, known as the auditor
discussion and analysis. We will remain an "emerging growth company" until the
earliest of (i) the last day of the fiscal year in which we have total annual
gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year
following the fifth anniversary of the date of the completion of our IPO
(December 31, 2025); (iii) the date on which we have issued more than $1 billion
in nonconvertible debt during the previous three years; or (iv) the date on
which we are deemed to be a large accelerated filer under the rules of the SEC.

Recently Issued and Adopted Accounting Pronouncements

See Note 3 - Summary of Significant Accounting Policies to the accompanying condensed financial statements for a description of other accounting policies and recently issued accounting pronouncements.





Recent Developments

See Note 12 - Subsequent Event to the accompanying condensed financial statements for a description of material recent developments.

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