What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-03-31 compared with 2021-03-01 · 1363 added, 733 removed, 2 unchanged (100% of the section changed)

were incorporated in 1989 in the state of New Jersey under the name “A.R.C.

Enterprises, Inc,”

which was changed to

“Akers Research Corporation”

on September 28, 1990 and “Akers Laboratories, Inc.”

on February 24, 1996.

Pursuant to the Amended and Restated Certificate of Incorporation filed on March 26, 2002, the corporation’s name was changed

to “Akers Biosciences, Inc.”

were historically a developer of rapid health information technologies.

On March 23, 2020, we entered into that certain membership

interest purchase agreement (the “Original MIPA”

and, as subsequently amended by Amendment No, 1 on May 14, 2020,

the “MIPA”) with the members of Cystron (the “Cystron Sellers”), pursuant to which we acquired 100% of

the membership interests of Cystron (the “Cystron Membership Interests”).

Cystron was incorporated on March 10, 2020

and is a party to a license agreement with Premas whereby Premas granted Cystron, among other things, an exclusive license with

respect to Premas’

genetically engineered yeast (S.

cerevisiae)-based vaccine platform, D-Crypt™, for the development

of a vaccine against COVID-19 and other coronavirus infections.

Since our entry into the MIPA, we have been primarily focused

on the rapid development and manufacturing of a COVID-19 vaccine candidate (the “COVID-19 Vaccine Candidate”), in

collaboration with Premas.

November 11, 2020, we entered into the Merger Agreement, pursuant to which, among other things, subject to the satisfaction or

waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into MYMD, with MYMD being the surviving

corporation and becoming a wholly owned subsidiary of the Company (the “Merger”).

The Merger is intended to qualify

for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code

of 1986, as amended (the “Code”).

In addition, in connection with the execution of the Merger Agreement, Akers agreed

to advance a bridge loan of up to $3,000,000 to MYMD pursuant to a secured promissory note (the “Note”).

On April 16, 2021, pursuant

to the previously announced Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (the “Original Merger Agreement”),

as amended by Amendment No.

1 thereto, dated March 16, 2021 (the Original Merger Agreement, as amended by Amendment No.

1, the “Merger

Agreement”), by and among MyMD Pharmaceuticals, Inc., a New Jersey corporation previously known as Akers Biosciences, Inc.

“Company”), XYZ Merger Sub Inc., a Florida corporation and a wholly owned subsidiary of the Company (“Merger Sub”),

and MyMD Pharmaceuticals (Florida), Inc., a Florida corporation previously known as MyMD Pharmaceuticals, Inc.

(“MyMD Florida”),

Merger Sub was merged with and into MyMD Florida, with MyMD Florida continuing after the merger as the surviving entity and a wholly

owned subsidiary of the Company (the “Merger”).

In this Annual Report on Form 10-K, unless the context otherwise requires,

references to “we,” “us,” “our,” “our company” and “MyMD” refer to MyMD Pharmaceuticals,

and its subsidiaries.

References to “Akers” refer to Akers Biosciences, Inc.

prior to the Merger.

For more information

on the merger or the sale of assets, see “MyMD Background and Corporate History – Merger.”

is a clinical stage pharmaceutical company committed to extending healthy lifespan.

MyMD is focused on developing and commercializing

two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD:

is a clinical stage small molecule that regulates the immunometabolic system to treat autoimmune

disease, including (but not limited to) multiple sclerosis, diabetes, rheumatoid arthritis,

and inflammatory bowel disease.

MYMD-1 is being developed to treat age-related illnesses

such as frailty and sarcopenia.

MYMD-1 works by regulating the release of numerous pro-inflammatory

cytokines, such as TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”)

is a synthetic analog of CBD being developed to treat various conditions, including, but

not limited to, epilepsy, pain and anxiety/depression, through its effects on the CB2 receptor,

opioid receptors and monoamine oxidase enzyme (“MAO”) type B.

The rights to Supera-CBD TM were previously

owned by Supera and were acquired by MyMD Florida immediately prior to the closing of the Merger.

Background and Corporate History

was organized under the laws of the State of Florida in November 2014 for the purpose of developing and commercializing certain technology

and patent rights relating to MYMD-1 that were developed and/or held by the company’s founder, Jonnie R.

Williams, Sr.

The company’s

sole initial stockholder was The Starwood Trust, a trust for which Mr.

Williams is settlor/grantor.

During the period from November 2014

through November 2016, MyMD was primarily focused on drug discovery and establishing its patent position through SRQ Patent Holdings,

an entity affiliated with Mr.

In November 2016, SRQ Patent Holdings assigned to MyMD all of the patent rights and other intellectual

property relating to MYMD-1 pursuant to an agreement under which MyMD granted to SRQ Patent Holdings a royalty based on product sales

and other revenue arising from the assigned intellectual property (as further described below).

During the period 2016 through

October of 2020, MyMD’s principal business activities consisted of the execution and completion of in vitro assays, in

vivo pre-clinical animal studies, and genotoxicity and toxicology studies relating to MYMD-1 (as further described below).

June 25, 2019, MyMD commenced a Phase 1 trial in healthy volunteers for pharmacokinetics and tolerability studies, and in December

of 2019 MyMD filed an IND for MYMD-1 for treatment of Hashimoto thyroiditis.

The Phase 1 trial was completed on January 30, 2020, after

which MyMD commenced preparation of a Phase 2 clinical trial for MYMD-1 focused on the treatment of depression and inflammation in COVID-19

positive patients.

The company has also commenced a Phase 2 clinical trial for patients with sarcopenia, with dosing begin in the first

quarter of 2022.

of December 31, 2021, MyMD had 500,000,000 shares of authorized common stock, of which approximately 37,673,110 shares were outstanding

and 12,630,494 shares were reserved for issuance of common

stock upon the exercise of outstanding stock options, common stock warrants, restricted stock units and convertible preferred stock and

On April 16, 2021, pursuant

to the Merger Agreement, by and among the Company, Merger Sub and MyMD Florida, Merger Sub was merged with and into MyMD Florida, with

MyMD Florida continuing after the merger as the surviving entity and a wholly owned subsidiary of the Company.

At the effective time

of the Merger, without any action on the part of any stockholder, each issued and outstanding share of pre-Merger MyMD Florida’s

common stock, par value $0.001 per share (the “MyMD Florida Common Stock”), including shares underlying pre-Merger MyMD Florida’s

outstanding equity awards, was converted into the right to receive (x) 0.7718 shares (the “Exchange Ratio”) of the Company’s

common stock, no par value per share (the “Company Common Stock”), (y) an amount in cash, on a pro rata basis, equal to the

aggregate cash proceeds received by the Company from the exercise of any options to purchase shares of MyMD Florida Common Stock outstanding

at the effective time of the Merger assumed by the Company upon closing of the Merger prior to the second-year anniversary of the closing

of the Merger (the “Option Exercise Period”), such payment (the “Additional Consideration”), and (z) potential

milestone payments in shares of Company Common Stock up to the aggregate number of shares issued by the Company to pre-merger MyMD Florida

stockholders at the closing of the Merger payable upon the achievement of certain market capitalization milestone events during the 36-month

period immediately following the closing of the Merger.

Immediately following the effective time of the Merger, the Company effected

a 1-for-2 reverse stock split of the issued and outstanding Company Common Stock (the “Reverse Stock Split”).

Upon completion

of the merger, the combined company is expected to be renamed MyMD Pharmaceuticals, Inc.

to the Merger Agreement, upon the effectiveness of the Merger, (i) holders of outstanding shares of MYMD common stock (“

MYMD stockholders”) will be entitled to receive (x) the number of shares of Akers common stock equal to an exchange ratio

as described in the Merger Agreement (the “Exchange Ratio”) per share of MYMD common stock they hold, prior to giving

effect to the proposed reverse stock split discussed below, (y) an amount in cash, on a pro rata basis, equal to the aggregate

cash proceeds received by Akers from the exercise of any options to purchase shares of MYMD common stock assumed by Akers upon

closing of the merger prior to the second-year anniversary of the closing of the merger (the “Option Exercise Period”),

such payment (the “Additional Consideration”) to occur not later than 30 days after the last day of the Option Exercise

Period, up to the maximum amount of cash consideration that may be received by MYMD stockholders without affecting the intended

tax consequences of the merger, and (z) potential milestone payments (“Milestone Shares”) of up to the number of shares

of Akers common stock issued to MYMD stockholders at closing of the Merger (“Milestone Payments”) payable upon achievement

of certain market capitalization milestone events during the 36-month period immediately following the closing of the merger (the

“Milestone Period”);

and (ii) each outstanding option to purchase MYMD common stock granted under the Second Amendment

to Amended & Restated 2016 Stock Incentive Plan with an effective date of July 1, 2019, as established and maintained by MYMD

(and, as amended and restated from time to time, the “MyMD Incentive Plan”) that has not previously been exercised

prior to the closing of the Merger, whether or not vested, will be assumed by Akers subject to certain terms contained in the

Merger Agreement, and become an option to purchase a number of shares of the Akers common stock equal to the number of shares

of MYMD common stock underlying such option multiplied by the Exchange Ratio, which options to purchase MYMD common stock shall

be amended to expire on the second-year anniversary of the closing of the Merger, and the exercise price for each share of Akers

common stock underlying an assumed option to purchase MYMD common stock will be equal to the exercise price per share of the option

to purchase MYMD common stock in effect immediately prior to the completion of the merger divided by the Exchange Ratio.

the exercise in full of the outstanding pre-funded warrants to purchase 1,040,540 shares of our common stock (“Pre-Funded

Warrants”) issued in connection with the private placement between Akers and certain institutional and accredited investors

that closed on November 17, 2020 (the “Private Placement”) and the exercise in full of additional pre-funded warrants

to purchase 932,432 shares of common stock issued certain investors in February 2021 upon cancellation of shares of common stock

purchased in the Private Placement and including 9,979,664 shares of combined company common stock underlying options to purchase

shares of MYMD common stock to be assumed at the closing of the Merger, (i) MYMD stockholders and optionholders will own approximately

80% of the equity of the combined company;

and (ii) our current stockholders, holders of certain outstanding of our options and

warrants (excluding shares issuable upon exercise of options and warrants having an exercise price in excess of $1.72, prior to

giving effect to any such stock splits, combinations, reorganizations and the like with respect to the Akers common stock between

the announcement of the Merger and the closing of the Merger) and holders of our outstanding restricted stock units (“RSUs”)

immediately prior to the Merger will own approximately 20% of the equity of the combined company.

to the Merger Agreement, on January 15, 2020, we and MYMD filed an initial Registration Statement on Form S-4 (Registration No.

333-252181) (together with the joint proxy and consent solicitation/prospectus included therein, the “S-4 Registration Statement”)

describing the Merger and other related matters.

Consummation of the Merger is conditioned upon, among other things, approval

of the Merger by the stockholders of Akers (including (i) approval, for purposes of complying with Nasdaq Listing rule 5635(a),

the issuance of shares of Akers common stock to MYMD stockholders and other parties in connection with the Merger, the Merger

Agreement, and the transactions contemplated thereby or in connection therewith (the “Share Issuance Proposal”), (ii)

approval of an amendment to the amended and restated certificate of incorporation of the combined company, which will be in effect

at the effective time of the merger (the “A&R Charter”) to effect a reverse stock split, if applicable, at a reverse

stock split ratio mutually agreed by the Company and MYMD and within the range approved by our stockholders immediately prior

to the Effective Time (as defined in the Merger Agreement), which range shall be sufficient to cause the price of our common

stock on the Nasdaq Capital Market following the reverse stock split and the Effective Time to be no less than $5.00 per share

with respect to the issued and outstanding common stock of the combined company immediately following the merger (the “Reverse

Stock Split Proposal”), and (iii) approval of the amended and restated certificate of incorporation of Akers which will

be in effect upon consummation of the Merger (the “A&R Charter Proposal”), among others), approval of the Merger

by the stockholders of MYMD, the continued listing of Akers’

common stock on The Nasdaq Capital Market after the Merger

and satisfaction of a minimum cash threshold by Akers.

In addition, the Merger Agreement requires that MYMD consummate the purchase

of substantially all of the assets and certain liabilities of Supera Pharmaceuticals, Inc., a Florida corporation (“Supera”)

pursuant to an Asset Purchase Agreement pursuant to which MYMD agreed to acquire from Supera, immediately prior to the completion

of the Merger, substantially all of its assets (the “Supera Purchase”).

After closing of the Merger, the operations

of MYMD’s business will comprise substantially all of the combined company’s operations.

There is no assurance when

or if the Merger will be completed.

Any delay in completing the Merger may substantially reduce the potential benefits that we

expect to obtain from the Merger.

Furthermore, the intended benefits of the Merger may not be realized.

and COVID-19 Pandemic

December 2019, SARS-CoV-2 was reported to have surfaced in Wuhan, China, and on March 12, 2020, the World Health Organization

(“WHO”) declared the global outbreak of COVID-19, the disease caused by SARS-CoV-2, to be a pandemic.

to contain and mitigate the spread of COVID-19, many countries, including the United States, Canada, China, and India, have imposed

unprecedented restrictions on travel, quarantines, and other public health safety measures.

According to the WHO situation report,

dated as of February 16, 2021, approximately 108.2 million cases were reported globally and 2.4 million of

these were deadly, making the development of effective vaccines to prevent this disease a major global priority.

Multiple vaccine

candidates against SARS-CoV-2 are under development, and in December 2020, certain large, multinational pharmaceutical companies

were granted authorizations for emergency use by the FDA.

Widespread distribution of the currently-available vaccines has begun

pursuant to Operation Warp Speed, a partnership among components of the U.S.

Department of Health and Human Services, the Centers

for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority,

and the Department of Defense, as well as certain private firms and other federal agencies.

The treatments for COVID-19, including

symptomatic and supportive therapies, among other things, continue to be updated on a rolling basis by healthcare authorities

and agencies.

of the COVID-19 Pandemic on Our Business

ultimate impact of the global COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to future developments.

These include but are not limited to the duration of the COVID-19 pandemic, new information which may emerge concerning the severity

of the COVID-19 pandemic, and any additional preventative and protective actions that regulators, or our board of directors or

management, may determine are needed.

We do not yet know the full extent of potential delays or impacts on our business, our vaccine

development efforts, healthcare systems or the global economy as a whole.

However, the effects are likely to have a material impact

on our operations, liquidity and capital resources, and we will continue to monitor the COVID-19 situation closely.

response to public health directives and orders, we have implemented work-from-home policies for many of our employees and temporarily

modified our operations to comply with applicable social distancing recommendations.

The effects of the orders and our related

adjustments in our business are likely to negatively impact productivity, disrupt our business and delay our timelines, the magnitude

of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct

our business in the ordinary course.

Similar health directives and orders are affecting third parties with whom we do business,

including Premas, whose operations are located in India.

Further, restrictions on our ability to travel, stay-at-home orders and

other similar restrictions on our business have limited our ability to support our operations.

and/or long-term disruptions in our operations will negatively impact our business, operating results and financial condition

in other ways, as well.

Specifically, we anticipate that the stress of COVID-19 on healthcare systems generally around the globe

will negatively impact regulatory authorities and the third parties that we and Premas may engage in connection with the development

and testing of our COVID-19 Vaccine Candidate.

addition, while the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict,

it has significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future

negatively affect our liquidity.

A recession or market correction resulting from the continuation of the COVID-19 pandemic could

materially affect our business and the value of our common stock.

Vaccine Development

have partnered with Premas on the development of the COVID-19 Vaccine Candidate as we seek to advance such candidate through the

regulatory process, both with the U.S.

Food and Drug Administration (“FDA”) and the office of the drug controller

Premas is primarily responsible for the development of the COVID-19 Vaccine Candidate through proof of concept and is

entitled to receive milestone payments upon achievement of certain development milestones through proof of concept.

Premas’

D-Crypt platform has been developed to express proteins that are difficult to clone, express and manufacture and are a key component

in vaccine development.

Premas has identified three major structural proteins of SARS-CoV-2 as antigens for potential vaccine

candidates for COVID-19:

spike protein or S protein, envelope protein or E protein, and membrane protein or M protein.

2020, Premas used its D-Crypt platform to recombinantly express all three of such antigens, which we considered a significant

milestone for development of a triple antigen vaccine.

We believe including a combination of all three antigens will provide advantages

against the likelihood of protein mutation, in which case a single-protein vaccine can be rendered non-efficacious, and therefore,

enhance efficacy of our vaccine candidates.

We believe the D-Crypt provides us advantages in vaccine production and manufacturing,

as the technology platform is highly scalable with a robust process, which we expect will ultimately result in significant cost

savings compared to other similar vaccine platforms.

Based on genetically engineered baker’s yeast S.

cerevisiae, the platform

is highly scalable into commercial production quantities and has been previously utilized for the production of multiple human

and animal health vaccines candidates during its 10-year development track record.

Yeast has a large endoplasmic reticulum, or

(“ER”), which is a desirable attribute for expressing membrane protein.

In complex cells, ER is where the protein

The larger the surface, the more membrane protein that can attach to the ER inside the cell.

Yeast is also generally

believed to be easily manipulated and allow for results to be gathered quickly.

Yeast multiplies faster than mammalian cells and

is cheaper to work with than mammalian systems, which are much more complex and slower to grow comparatively.

Yeast has received

“Generally Recommended as Safe”

status from the FDA.

of May 14, 2020, Premas successfully completed its vaccine prototype and obtained transmission electron microscopic (“TEM”)

images of the recombinant virus like particle (“VLP”) assembled in yeast.

A manufacturing protocol has also been established

and large-scale production studies have been initiated for our COVID-19 Vaccine Candidate.

Though the prototype is complete, the

COVID-19 Vaccine Candidate is still in early stages of development, and, accordingly, must undergo pre-clinical testing and all

phases of clinical trials before we can submit a marketing application (in this case, a Biologics License Application, or “BLA”)

The BLA must be approved by the FDA before any biological product, including vaccines, may be lawfully marketed in

the United States.

We believe the most pivotal, yet difficult, stage in our anticipated development of the contemplated COVID-19

Vaccine Candidate is the requisite conduct of extensive clinical trials to demonstrate the safety and efficacy of our COVID-19

Vaccine Candidate.

Additionally, after we complete the necessary pre-clinical testing, but before we may begin any clinical studies

in the United States, we must submit an Investigational New Drug (“IND”) application to the FDA, as this is required

before any clinical studies may be conducted in the United States.

In some cases, clinical studies may be conducted in other countries;

however, the FDA may not accept data from foreign clinical studies in connection with a BLA (or other marketing application) submission.

July 2020, animal studies for our COVID-19 Vaccine Candidate were initiated in India.

In addition, we announced that Premas has

successfully completed the manufacturing process for the VLP vaccine candidate.

On August 27, 2020, we announced with Premas positive

proof of concept results from the animal studies conducted during a four-week test of the COVID-19 Vaccine Candidate in mice.

The test had two primary endpoints, safety and immune responses, both of which were met.

The study consisted of 50 mice, divided

into 10 cohorts dosed with 5, 10 and 20 micrograms of the COVID-19 Vaccine Candidate.

The COVID-19 Vaccine Candidate was generally

well tolerated and safe at all doses, with no adverse events reported.

The COVID-19 Vaccine Candidate was safe even at higher

doses and generated a robust immune response against the three SARS-Cov2 antigens, S, E, and M.

The COVID-19 Vaccine Candidate

elicited neutralizing antibody titers levels in all the dose cohorts starting from 5 microgram to 20 microgram dose regimens.

After three doses in mice, all the groups’

cohorts showed binding antibody levels similar to convalescent patients’

Clinical testing is expensive, time consuming, and uncertain as to outcome.

We cannot guarantee that any clinical trials

will be conducted as planned or completed in a timely manner, if at all.

Failures in connection with one or more clinical trials

can occur at any stage of testing.

owns, and has exclusively licensed rights to us to, two provisional Indian patent applications filed in January and March 2020.

The scope of these Indian provisional patent applications is directed, respectively, to (i) a platform for the expression of difficult

to express proteins (“DTE-Ps”), which might provide coverage for a method of making the to-be-developed vaccine;

(ii) an expression platform for SARS-CoV-2-like virus proteins, methods relevant thereto, and a relevant vaccine.

If non-provisional

patent rights are pursued claiming priority to each of these two provisional applications, any resulting patent rights that issue

might not expire until approximately January 20, 2041 and March 4, 2041, if all annuities and maintenance fees are timely paid.

The expiration dates may be extendable beyond these dates depending on the jurisdiction and the vaccine development process.

we do not own the patents or patent applications that we license, we may need to rely upon Premas to properly prosecute and maintain

those patent applications and prevent infringement of those patents.

face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology

companies as well as academic and research institutions pursing research and development of technologies, drugs or other therapies

that would compete with our products or product candidates.

The pharmaceutical market is highly competitive, subject to rapid

technological change and significantly affected by existing rival drugs and medical procedures, new product introductions and

the market activities of other participants.

Our competitors may develop products more rapidly or more effectively than us.

our competitors are more successful in commercializing their products than us, their success could adversely affect our competitive

position and harm our business prospects.

Specifically,

the competitive landscape of potential COVID-19 vaccines and treatment therapies has been rapidly developing since the beginning

of the COVID-19 pandemic, with several hundreds of companies claiming to be investigating possible candidates and approximately

4,800 studies registered worldwide as investigating COVID-19 (source:

clinicaltrials.gov).

Given the global footprint and

the widespread media attention on the COVID-19 pandemic, there are efforts by public and private entities to develop a COVID-19

vaccine as soon as possible, including large, multinational pharmaceutical companies such as AstraZeneca, GlaxoSmithKline, Johnson

& Johnson, Moderna, Pfizer, and Sanofi.

In December 2020, the FDA issued emergency use authorizations for vaccines developed

by certain of these large, multinational pharmaceutical companies and it is possible that additional vaccines developed by such

large, multinational pharmaceutical companies may receive further approvals and authorizations in the near term.

Those other entities

have vaccine candidates that are currently at a more advanced stage of development than our COVID-19 Vaccine Candidate and may

develop COVID-19 vaccines that are more effective than any vaccine we may develop, may develop a COVID-19 vaccine that becomes

the standard of care, may develop a COVID-19 vaccine at a lower cost or earlier than we are able to jointly develop any COVID-19

vaccine, or may be more successful at commercializing a COVID-19 vaccine.

Many of these other organizations are much larger than

we are and have access to larger pools of capital, and as such, are able to fund and carry on larger research and development

Such other entities may have greater development capabilities than we do and have substantially greater experience

in undertaking nonclinical and clinical testing of vaccine candidates, obtaining regulatory approvals and manufacturing and marketing

pharmaceutical products.

Our competitors may also have greater name recognition and better access to customers.

In addition, based

on the competitive landscape, additional COVID-19 vaccines or therapeutics may continue be approved to be marketed.

Should another

party be successful in producing a more efficacious vaccine for COVID-19, such success could reduce the commercial opportunity

for our COVID-19 Vaccine Candidate and could have a material adverse effect on our business, financial condition, results of operations

and future prospects.

Moreover, if we experience delayed regulatory approvals or disputed clinical claims, we may not have the

commercial or clinical advantage over competitors’

products that we believe we currently possess.

The success or failure

of other entities, or perceived success or failure, may adversely impact our ability to obtain any future funding for our vaccine

development efforts or for us to ultimately commercialize and market any vaccine candidate, if approved.

In addition, we may not

be able to compete effectively if our product candidates do not satisfy government procurement requirements with respect to biodefense

and License Agreements

March 23, 2020, we acquired Cystron pursuant to the MIPA.

As consideration for the Cystron Membership Interests, we delivered

to the Cystron Sellers:

(1) that number of newly issued shares of our common stock equal to 19.9% of the issued and outstanding

shares of our common stock and pre-funded warrants as of the date of the MIPA, but, to the extent that the issuance of our common

stock would have resulted in any Seller owning in excess of 4.9% of our outstanding common stock, then, at such Seller’s

election, such Seller received “common stock equivalent”

preferred shares with a customary 4.9% blocker (with such

common stock and preferred stock collectively referred to as “Common Stock Consideration”), and (2) $1,000,000 in

On March 24, 2020, we paid $1,000,000 to the Cystron Sellers and delivered 411,403 shares of common stock and 211,353 shares

of Series D Convertible Preferred Stock with a customary 4.9% blocker, with an aggregate fair market value of $1,233,057.

Additionally,

we are required to (A) make an initial payment to the Cystron Sellers of up to $1,000,000 upon its receipt of cumulative gross

proceeds from the consummation of an initial equity offering after the date of the MIPA of $8,000,000, and (B) pay to the Cystron

Sellers an amount in cash equal to 10% of the gross proceeds in excess of $8,000,000 raised from future equity offerings after

the date of the MIPA until the Cystron Sellers have received an aggregate additional cash consideration equal to $10,000,000 (collectively,

the “Equity Offering Payments”).

On May 14, 2020, we entered into an Amendment No.

1 to the MIPA with the Cystron

Sellers, which provided that any Equity Offering Payments in respect of an equity offering that is consummated prior to September

23, 2020, shall be accrued, but shall not be due and payable until September 24, 2020.

The other provisions of the MIPA remained

unmodified and in full force and effect.

Upon the achievement of certain milestones, including the completion of a Phase 2 study

for a COVID-19 Vaccine Candidate that meets its primary endpoints, the Cystron Sellers are entitled to receive an additional 750,000

shares of our common stock or, in the event we are unable to obtain stockholder approval for the issuance of such shares, 750,000

shares of non-voting preferred stock that are valued following the achievement of such milestones and shall bear a 10% annual

dividend (the “Cystron Milestone Shares”).

At the 2020 annual meeting of our stockholders, held on August 27, 2020,

pursuant to Nasdaq listing rule 5635(a), our stockholders approved of the issuance of Common Stock Consideration (as defined in

the MIPA) and the potential future issuance of Cystron Milestone Shares in excess of 20% of our common stock outstanding prior

to the closing of the Cystron acquisition.

Pursuant to the

MIPA, the Company shall make contingent payments for the achievement of certain development and commercial milestones as follows;

(i) $250,000 upon the dosing of the first patient in a Phase I Clinical Trial, (ii) $500,000 upon the dosing of the first patient

in a Phase II Clinical Trial, (iii) $5,000,000 upon the dosing of the first patient in a Phase III Clinical Trial, and (iv) $15,000,000

upon approval by the FDA of the NDA for the COVID-19 vaccine.

to the Original MIPA, upon our consummation of the registered direct equity offering closed on April 8, 2020, we paid the Cystron

Sellers $250,000 on April 20, 2020 (the “April Payment”).

On April 30, 2020, Premas, one of the Cystron Sellers, returned

to us $83,334, representing their portion of the $250,000 amount paid to the Cystron Sellers on April 20, 2020.

Premas advised

us that these funds were returned temporarily for Premas to meet certain regulatory requirements in India.

We recorded liabilities

of $892,500 (the “May Payment”) and $684,790 (the “August Payment”) to the Cystron Sellers upon the consummation

of the registered direct equity offerings that closed on May 18, 2020 and August 13, 2020, respectively.

These funds (including

funds of $299,074 representing Premas’

portion of the cash purchase price and $83,334 representing Premas’

of the April Payment temporarily returned to us in April 2020) due the sellers under the MIPA were disbursed on September 25,

On October 13, 2020, Premas returned $908,117 representing Premas’

portion of the initial cash component for the purchase

of Cystron and Premas’

portion of the April Payment, May Payment and August Payment under the MIPA.

is working with the Reserve Bank of India to comply with regulations related to its ownership in a foreign entity and its ability

to receive funds for the sale of that entity.

The Company believes that (i) Premas will be successful in its efforts to resolve

such regulatory matters with the Reserve Bank of India, (ii) the Company will disburse the amounts due to Premas under the MIPA,

and (iii) the Company maintains a 100% membership interest in Cystron.

the consummation of the Private Placement, the Company paid

$1,204,525 of the proceeds from the Private Placement to three of the four former members of Cystron and recorded a liability

of $602,172 to the fourth former member of Cystron pursuant to the MIPA.

shall also make quarterly royalty payments to the Cystron Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination

product by us for a period of five (5) years following the first commercial sale of the COVID-19 vaccine;

provided, that such

payment shall be reduced to 3% for any net sales of the COVID-19 vaccine above $500 million.

addition, the Cystron Sellers shall be entitled to receive 12.5% of the transaction value, as defined in the MIPA, of any change

of control transaction, as defined in the MIPA, that occurs prior to the fifth (5th) anniversary of the closing date of the MIPA,

provided that we are still developing the COVID-19 Vaccine Candidate at that time.

Following the consummation of any change of

control transaction, the Cystron Sellers shall not be entitled to any payments as described above under the MIPA.

March 23, 2020, as an inducement to enter into the MIPA, and as one of the conditions to the consummation of the transactions

contemplated by the MIPA, the Cystron Sellers entered into a shareholder voting agreement with us, pursuant to which each Cystron

Seller agreed to vote their shares of our common stock or preferred stock in favor of each matter proposed and recommended for

approval by our management at every meeting of the stockholders and on any action or approval by written consent of the stockholders.

Rights Agreement

induce the Cystron Sellers to enter into the MIPA, on March 23, 2020, we entered into a registration rights agreement with the

Cystron Sellers, pursuant to which we filed with the SEC a Registration Statement on Form S-3, as amended, covering resale of

the Common Stock Consideration, which was declared effective on June 12, 2020.

We also agreed to subsequently register Cystron

Milestone Shares, if such securities are issued in the future.

is a party to the License Agreement with Premas.

As a condition to our entry into the MIPA, Cystron amended and restated the Initial

License Agreement on March 19, 2020.

Pursuant to the License Agreement, Premas granted Cystron, amongst other things, an exclusive

license with respect to Premas’

vaccine platform for the development of a vaccine against COVID-19 and other coronavirus

the achievement of certain developmental milestones by Cystron, Cystron shall pay to Premas a total of up to $2,000,000.

16, 2020, we paid Premas $500,000 for the achievement of the first two development milestones.

On May 18, 2020, we paid

Premas $500,000 for the achievement of the third development milestone.

On July 7, 2020, we agreed with Premas that the fourth

milestone under the License Agreement had been satisfied.

Due to the achievement of this milestone on July 7, 2020, Premas was

paid $1,000,000 on August 4, 2020.

have exclusive rights in-licensed from Premas (as discussed above) to certain know-how and two provisional Indian patent applications

filed in January and March 2020.

The following table summarizes the two provisional Indian patent applications.

for the expression of difficult to express proteins (DTE-Ps)

a nonprovisional application is filed within one year of the provisional application, any resulting patent would expire on

January 20, 2041.

platform for SARS-Co-V-like virus proteins, methods relevant thereto, and relevant vaccine

a nonprovisional application is filed within one year of the provisional application, any resulting patent would expire on

March 4, 2041.

we do not own the patent applications that we in-license, we may need to rely upon Premas to properly prosecute and maintain those

and additional related patent applications, and to prevent infringement of any resulting patents.

have two U.S.

registered trademarks for “Akers Bio.”

Regulation and Product Approval

state, and local government authorities in the United States and in other countries extensively regulate, among other things,

the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion,

advertising, distribution, post-approval monitoring and reporting, marketing and export and import of biological and pharmaceutical

products such as those we are developing.

Our prospective vaccine candidate(s) must be approved by the FDA before they may be

legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in

foreign countries.

Generally, our activities in other countries will be subject to regulation that is similar in nature and scope

as that imposed in the United States.

The process for obtaining regulatory marketing approvals and the subsequent compliance with

appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial

Product Development Process

the United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug, and Cosmetic Act (“FD&C

Act”), the Public Health Service Act (“PHSA”), and their respective implementing regulations.

are also subject to other federal, state, and local statutes and regulations.

The process of obtaining regulatory approvals and

the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure

of substantial time and financial resources.

Failure to comply with the applicable U.S.

requirements at any time during the product

development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.

sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold,

warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or

distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

agency or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a drug

or biological product may be marketed in the United States generally involves the following:

of nonclinical laboratory tests and animal studies according to FDA’s Good Laboratory Practices (“GLPs”),

and applicable requirements for the humane use of laboratory animals or other applicable regulations;

to the FDA of an IND which must become effective before human clinical trials may begin;

of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good

clinical practice, and any additional requirements for the protection of human research subjects and their health information,

to establish the safety and efficacy of the proposed biological product for its intended use;

to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and

potency of the product that is the subject of the BLA based on results of nonclinical testing and clinical trials;

completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess

compliance with current Good Manufacturing Practices (“cGMPs”), to assure that the facilities, methods and controls

are adequate to preserve the biological product’s identity, strength, quality and purity;

FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

review and approval, or licensure, of the BLA.

testing any biological vaccine candidate in humans, the vaccine candidate enters the pre-clinical testing stage.

tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation,

as well as animal studies to assess the potential safety and activity of the vaccine candidate.

The conduct of the pre-clinical

tests must comply with federal regulations and requirements including GLPs.

The clinical trial sponsor must submit the results

of the pre-clinical tests, together with manufacturing information, analytical data, any available clinical data or literature

and a proposed clinical protocol, to the FDA as part of the IND.

Some pre-clinical testing may continue even after the IND is

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions

regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.

In such a case,

the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

The FDA may also impose

clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by

Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or

that, once begun, issues will not arise that suspend or terminate such trials.

trials involve the administration of the biological product candidate to healthy volunteers or patients under the supervision

of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.

Clinical trials are

conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection

and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical

trial will be stopped if certain adverse events should occur.

Each protocol and any amendments to the protocol must be submitted

to the FDA as part of the IND.

Clinical trials must be conducted and monitored in accordance with the FDA’s regulations

composing the Good Clinical Practice (“GCP”) requirements, including the requirement that all research subjects provide

informed consent.

Further, each clinical trial must be reviewed and approved by an independent institutional review board, (“IRB”),

at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting the welfare

and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials

are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the form and content of the informed

consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial

until completed.

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

The biological product is initially introduced into healthy human subjects and tested for safety.

In the case of some products

for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to

healthy volunteers, the initial human testing is often conducted in subjects having the specific disease.

The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks,

to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal

dosage and dosing schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient

population at geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk

to benefit ratio of the product and provide an adequate basis for product labeling.

Post-approval

clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These clinical

trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly

for long-term safety follow-up.

all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities,

clinical data, and clinical trial investigators.

Annual progress reports detailing the results of the clinical trials must be

submitted to the FDA.

Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected

adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant

risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed

in the protocol or investigator brochure.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor

determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening

suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

Phase 1, Phase

2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the sponsor

or its data safety monitoring board may suspend or terminate a clinical trial at any time on various grounds, including a finding

that the research subjects are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval

of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements

or if the biological product has been associated with unexpected serious harm to subjects.

with clinical trials, companies usually complete additional studies and must also develop additional information about the physical

characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities

in accordance with cGMP requirements.

To help reduce the risk of the introduction of adventitious agents with use of biological

products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other

criteria, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological

Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate

that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

Review and Approval Processes

the completion of clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing

of the biological product.

The BLA must include results of product development, laboratory and animal studies, human trials, information

on the manufacture and composition of the product, proposed labeling and other relevant information.

The FDA may grant deferrals

for submission of data, or full or partial waivers.

The testing and approval processes require substantial time and effort and

there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on

a timely basis, if at all.

the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee.

The FDA adjusts the PDUFA user fees on an annual basis.

PDUFA also imposes an annual program fee for biological products.

waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application

filed by a small business.

60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete

before the agency accepts it for filing.

The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable

at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional

The resubmitted application also is subject to review before the FDA accepts it for filing.

Once the submission is

accepted for filing, the FDA begins an in-depth substantive review of the BLA.

The FDA reviews the BLA to determine, among other

things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile,

and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety,

strength, quality, potency and purity.

The FDA may refer applications for novel biological products or biological products that

present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other

experts, for review, evaluation, and a recommendation 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

During the biological product approval process, the FDA also will determine whether a REMS, is necessary to assure

the safe use of the biological product.

If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS.

The FDA will not approve a BLA without a REMS, if required.

approving a BLA, the FDA will inspect the facilities at which the product is manufactured.

The FDA will not approve the product

unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to

assure consistent production of the product within required specifications.

Additionally, before approving a BLA, the FDA will

typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements

and GCP requirements.

To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort

in the areas of training, record keeping, production, and quality control.

Notwithstanding

the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria

for approval and deny approval.

Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently

than we interpret the same data.

If the agency decides not to approve the BLA in its present form, the FDA will issue a complete

response letter that describes all of the specific deficiencies in the BLA identified by the FDA.

The deficiencies identified

may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials.

Additionally,

the complete response letter may include recommended actions that the applicant might take to place the application in a condition

for approval.

If a complete response letter is issued, the applicant may either resubmit the BLA, seeing all of the deficiencies

identified in the letter, or withdraw the application.

a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications

for use may otherwise be limited, which could restrict the commercial value of the product.

the FDA may require that certain contraindications, warnings or precautions be included in the product labeling.

The FDA may impose

restrictions and conditions on product distribution, prescription, or dispensation in the form of a risk management plan, or otherwise

limit the scope of any approval.

In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase

4 clinical trials, designed to further assess a biological product’s safety and effectiveness, and testing and surveillance

programs to monitor the safety of approved products that have been commercialized.

addition, under the Pediatric Research Equity Act, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness

of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for

each pediatric subpopulation for which the product is safe and effective.

The FDA may grant deferrals for submission of data or

full or partial waivers.

Post-Approval

products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping

requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information,

product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include,

among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations

that are not described in the product’s approved uses, known as “off-label”

use, limitations on industry-sponsored

scientific and educational activities, and requirements for promotional activities involving the internet.

Although physicians

may prescribe legally available products for off-label uses, if the physicians deem to be appropriate in their professional medical

judgment, manufacturers may not market or promote such off-label uses.

addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after

approval to ensure the long-term stability of the product.

cGMP regulations require among other things, quality control and quality

assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct

any deviations from cGMP.

Manufacturers and other entities involved in the manufacture and distribution of approved products 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 cGMP and other laws.

Accordingly, manufacturers must continue to expend

time, money, and effort in the area of production and quality control to maintain cGMP compliance.

Discovery of problems with

a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including, among

other things, recall or withdrawal of the product from the market.

In addition, changes to the manufacturing process are strictly

regulated, and depending on the significance of the change, may require prior FDA approval before being implemented.

of changes to the approved product, such as adding new indications and claims, are also subject to further FDA review and approval.

of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences,

including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising

or communications with doctors, and civil or criminal penalties, among others.

Newly discovered or developed safety or effectiveness

data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications,

and also may require the implementation of other risk management measures.

Also, new government requirements, including those

resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory

approval of our prospective vaccine candidate(s).

Healthcare Laws and Compliance Requirements

the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition

to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services (“CMS”), other divisions

Department of Health and Human Services (“HHS”), for instance the Office of Inspector General, the U.S.

Department of Justice, or (“DOJ”), and individual U.S.

Attorney offices within the DOJ, and state and local governments.

For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of

the Social Security Act, the false claims laws, the physician payment transparency laws, the privacy and security provisions of

the federal Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology

for Economic and Clinical Health or “HITECH”

Act, and similar state laws, each as amended.

federal Anti-Kickback Statute (“AKS”) prohibits, among other things, any person or entity, from knowingly and willfully

offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to

induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable

under Medicare, Medicaid or other federal healthcare programs.

The term remuneration has been interpreted broadly to include anything

The AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers,

purchasers, and formulary managers on the other.

There are a number of statutory exceptions and regulatory safe harbors protecting

some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly and practices that involve remuneration

that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not

qualify for an exception or safe harbor.

Our practices may not in all cases meet all of the criteria for protection under a statutory

exception or regulatory safe harbor.

Failure to meet all of the requirements of a particular applicable statutory exception or

regulatory safe harbor, however, does not make the conduct per se illegal under the AKS.

Instead, the legality of the arrangement

will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.

Additionally,

the intent standard under the AKS was amended by the Affordable Care Act (“ACA”) to a stricter standard, such that

a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed

In addition, the ACA codified case law that a claim including items or services resulting from a violation of the

AKS constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or (“FCA”), as discussed

civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have

presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or

service that was not provided as claimed or is false or fraudulent.

federal FCA prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false

claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false

record or statement material to a false or fraudulent claim to the federal government.

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

Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws

for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the

Other companies have been prosecuted for causing false claims to be submitted because of the companies’

of the product for unapproved, and thus non-reimbursable, uses.

created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud

or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under

the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,

concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent

statement in connection with the delivery of or payment for healthcare benefits, items or services.

Similar to the AKS, 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

many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and

other state programs, or, in several states, apply regardless of the payor.

may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our

HIPAA, as amended by the HITECH Act, imposes requirements relating to the privacy, security and transmission of individually

identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable

to business associates, independent contractors or agents of covered entities that receive or obtain protected health information

in connection with providing a service on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties,

amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general

new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’

fees and costs associated with pursuing federal civil actions.

In addition, state laws govern the privacy and security of health

information in specified circumstances, many of which differ from each other in significant ways, thus complicating compliance

of the Merger and the transactions contemplated in the Merger Agreement, (i) the former MyMD Florida equity holders owned approximately

77.05% of the outstanding equity of the Company on a fully diluted basis, assuming the exercise in full of the pre-funded warrants to

purchase 986,486 shares of Company Common stock and including 4,188,315 shares of Company Common Stock underlying options to purchase

shares of MyMD Florida Common Stock assumed by the company at closing and after adjustments based on the Company’s net cash at

and (ii) former Akers Biosciences, Inc.

stockholders owned approximately 22.95% of the outstanding equity of the Company.

Merger was treated as a reverse recapitalization effected by a share exchange for financial accounting and reporting purposes.

was being treated as the accounting acquirer, as its stockholders control the Company after the Merger, even though Akers Biosciences,

was the legal acquirer.

As a result, the assets and liabilities and the historical operations that are reflected in our consolidated

financial statements are those of MyMD Florida as if MyMD Florida had always been the reporting company.

All references to MyMD Florida shares of common stock, warrants and options have been presented

on a post-merger, post-reverse split basis.

Supera Asset Purchase Agreement

November 11, 2020, in connection with entering into the Merger Agreement, MyMD Florida entered into the Supera Asset Purchase Agreement

pursuant to which MyMD Florida agreed to acquire from Supera substantially all of the assets (including all rights to Supera-CBD) and

certain obligations of Supera in consideration of the issuance to Supera of an aggregate of 13,096,640 shares of MyMD Florida Common

Supera is owned principally by The Starwood Trust and is controlled by Mr.

is a Florida corporation that was incorporated in September 2018 by Mr.

Williams and The Starwood Trust in order to develop and commercialize

In December 2018, Mr.

Williams assigned his rights and intellectual property relating to Supera-CBD to Supera.

consideration for such assignment, Supera has granted to SRQ Patent Holdings II, LLC a royalty with respect to product sales and other

consideration arising from the assigned intellectual property (as further described below).

Acquisition and Disposition of Cystron

The Company acquired 100%

of the membership interests of Cystron pursuant to a Membership Interest Purchase Agreement, dated March 23, 2020 (as amended by Amendment

1 on May 14, 2020, the “MIPA”) from certain selling parties (the “Cystron Sellers”).

The acquisition of Cystron

was accounted for as a purchase of an asset.

Cystron is a party to a License and Development Agreement (as amended and restated on March

19, 2020, in connection with our entry into the MIPA, the “License Agreement”) with Premas Biotech PVT Ltd.

whereby Premas granted Cystron, amongst other things, an exclusive license with respect to Premas’ vaccine platform for the development

of a vaccine against COVID-19 and other coronavirus infections.

Cystron was incorporated on March 10, 2020.

Since its formation and through

the date of its acquisition by the Company, Cystron did not have any employees and its sole asset consisted of the exclusive license

On March 18, 2021, the Company

and the Cystron Sellers, which are also shareholders of Oravax, entered into a Termination and Release Agreement terminating the MIPA

effective upon consummation of the Contribution Agreement.

In addition, the Cystron Sellers agreed to waive any change of control payment

triggered under the MIPA as a result of the Merger.

April 16, 2021, pursuant to the Contribution and Assignment Agreement, dated March 18, 2021 (the “Contribution Agreement”)

by and among the Company, Cystron, Oravax Medical, Inc.

(“Oravax”) and, for the limited purpose set forth therein, Premas,

the parties consummated the transactions contemplated therein.

Pursuant to the Contribution Agreement, among other things, the Company

caused Cystron to contribute substantially all of the assets associated with its business of developing and manufacturing Cystron’s

COVID-19 vaccine candidate to Oravax (the “Contribution Transaction”).

Following the Contribution Transaction, Oravax is expected to pursue the

COVID-19 vaccine candidate.

MyMD is currently evaluating several options with respect to its interest in Oravax, including a potential

distribution of Oravax shares to the MyMD shareholders.

This would make Oravax a publicly held company.

MyMD’s interest in Oravax

consists of 13% of Oravax’s outstanding shares of capital stock and the rights to a 2.5% royalty on all future net sales.

MyMD currently has the right to designate a member of the board of directors of Oravax, pursuant to which Mr.

Joshua Silverman, our Chairman

of the Board, has been designated to serve as a director of Oravax.

is developing two platform drugs targeting numerous disease indications.

Below is MyMD’s development pipeline:

strategy is to focus on extending healthy life span through the development and commercialization of novel drug platforms based on well-defined

therapeutic targets.

Below are MyMD’s key clinical strategies:

Phase 2 clinical trial in sarcopenia (i.e., age-related muscle loss) in the second and third

quarters of 2022;

MYMD-1 into Phase 2 clinical trials for treatment of diabetes, rheumatoid arthritis, and

inflammatory bowel disease;

on IND-enabling studies of Supera-CBD to enable submission of an IND for a Phase 1 clinical

trial in healthy volunteers followed by Phase 2 clinical trials in epilepsy, addiction and

anxiety disorders;

and validate additional novel targets and utilize translational platforms to develop a pipeline

of product candidates for aging and other autoimmune disease;

broad commercial rights to MyMD’s product candidates;

to strengthen and expand MyMD’s intellectual property portfolio.

is a clinical stage drug that targets the immune system by inhibiting the release of pro-inflammatory cytokines, such as TNF-α.

Cytokines are a broad category of molecules involved in immune system coordination.

Immunometabolic regulation is the system of regulating

the immune system and its pro-inflammatory cytokines in order to prevent and treat autoimmune diseases and age-related illnesses.

affecting the initial triggers that drive autoimmunity, MYMD-1 targets the underlying cause of these diseases rather than just their symptoms.

Based on MYMD-1’s Phase 1 clinical trial, completed in January 2020, MyMD has commenced a Phase 2 clinical trial for sarcopenia

(age-related muscle loss) and is planning multiple Phase

2 clinical trials in autoimmune disease, including (1) multiple sclerosis, diabetes, inflammatory bowel disease and rheumatoid arthritis;

(2) inflammation related depression and anxiety;

and (3) COVID-19 associated depression.

MyMD has an active IND with the Endocrinology

Division at the FDA for other autoimmune diseases.

Studies have been completed on the mechanisms of action and efficacy of MYMD-1 in

several pre-clinical models of autoimmune diseases (i.e., experimental autoimmune encephalomyelitis (“EAE”) that models multiple

sclerosis and autoimmune thyroiditis), and these studies have been published in peer reviewed journals.

MyMD plans to pursue these indications.

Immunometabolic Regulator

Inflammation,

activated through the release of TNF-α and other cytokines, is the body’s normal physiological defense against infections

and pathogens, and under normal circumstances such inflammation quickly resolves once the intruder is neutralized.

However, elevated

levels of pro-inflammatory cytokines, including TNF-α, can lead to prolonged, chronic inflammation, which is closely linked to

autoimmune diseases (such as multiple sclerosis, diabetes, rheumatoid arthritis) and aging (i.e., inflamm-aging) as well as cardiovascular

disease and cancers, all of which may result in reduced health span (the period of life spent in good health).

goal of immunometabolic regulatory drugs such as MYMD-1 is to target immune cells that overproduce pro-inflammatory cytokines, such as

TNF-α, without preventing normal immune cell function.

TNF-α is a cytokine that is released by immune cells that plays a

key role in acute and chronic inflammation, autoimmune diseases and aging.

Examples of currently approved immunometabolic regulating

drugs include Dimethyl Fumarate (“DMF”) (approved for the treatment of multiple sclerosis) and Rapamycin (used in kidney

transplants and being studied in aging).

is a novel immunometabolic regulator that has demonstrated in vitro and in vivo ability to regulate

the release of multiple cytokines from immune cells, including TNF-α.

MYMD-1 is being developed to treat chronic inflammatory diseases,

such as multiple sclerosis, diabetes, inflammatory bowel disease, rheumatoid arthritis, and aging.

Regulates Multiple Cytokines

MyMD conducted an in

vitro study to demonstrate that MYMD-1 regulates a broad range of cytokines, including TNF-α, interferon gamma (INFγ)

and interleukins, including interleukin 2 (“IL-2”) and IL-17A.

By blocking these cytokines that have been shown to play key

roles in the development and maintenance of autoimmune diseases, MYMD-1 treats the causes---and not just the symptoms---of this class

of illnesses.

MYMD-1 modulates the release of a broad spectrum of cytokines.

additional in vitro study demonstrates that MYMD-1 has broad cytokine inhibiting activity including inhibition of

TNF-α, IL-16 and IL-17.

The study also suggested MYMD-1 has limited toxicity, even at high doses, and none up to 2,000

an in vivo study (NOD.H2 mouse model), MYMD-1 decreased serum levels of TNF-α and INFγ.

MYMD-1 decreases the serum levels TNF-α and IFN-g in NOD.H-2h4 mice.

NOD.H-2h4 mice were treated with either regular water or

iodinated water (500 mg/l of sodium iodide), and each group was treated or not treated with MYMD-1 (185 mg/l).

Cytokines were measured

at baseline and after 6 and 12 weeks of treatment using a multiplex magnetic bead array.

(A and B) MYMD-1 significantly decreased serum

TNF-α levels in the regular water group and tended to decrease it in the iodinated water group.

(C and D) MYMD-1 showed a modest

effect on serum IFN-g in the iodinated water group.

Results are from three independent experiments.

Statistical comparisons were made

by longitudinal data analysis with generalized estimating equations.

Targets Autoimmune Diseases

is designed to regulate the immunometabolic system to treat autoimmune diseases, including (but not limited to) multiple sclerosis,

diabetes, rheumatoid arthritis, and inflammatory bowel disease.

MYMD-1 is also being developed to treat age-related illnesses such

as frailty and sarcopenia.

Autoimmune diseases are a broad category of diseases that result from an overactive immune response,

where immunometabolic system dysregulation is believed to play an important role.

A healthy immune system defends the body against

disease and infection.

If the immune system malfunctions, it can mistakenly attack healthy cells, tissues, and organs.

to an often-unknown trigger, the immune system starts producing antibodies that attack the body’s own cells instead of

fighting infections.

produced primarily by specific white blood cells, belongs to a category of proteins called cytokines that act as chemical messengers

throughout the body to regulate many aspects of the immune system.

Other key cytokines include IL-6, IL-17A, interleukin 10 (“IL-10”)

and Interferon gamma (“INFγ”).

Cytokines are essential to mounting an inflammatory response.

However, chronic or excessive

production of cytokines has been implicated in a number of acute and chronic inflammatory diseases.

number of drugs target the immunometabolic system to treat autoimmune diseases, including DMF (approved for the treatment of multiple

sclerosis) and Rapamycin (being studied in aging, rheumatoid arthritis, and other autoimmune diseases).

Additional therapies for

autoimmune diseases include anti-inflammatory drugs and immunosuppressive agents including drugs that non-selectively inhibit or block

TNF-α (generally referred to as “TNF-α blocking drugs”).

Currently available TNF- α blocking

drugs must be injected or infused to work.

In some instances, the efficacy of a given dosage of TNF- α blockers

declines with repeated administration, and side effects can also be a concern.

These non-selective TNF- α blockers

can cause serious bacterial, fungal, and viral infections.

MYMD-1 is a selective, oral TNF- α

inhibitor that might provide a safer alternative to existing products on the market.

The global market for TNF- α

blockers was estimated at $41.6 billion in 2020 and is projected to reach $45.5 billion by 2027.

vitro study involving human blood cells analyzed the cytokine inhibitory effects of MYMD-1 together with leading approved

TNF-α blockers (monoclonal antibodies).

Comparison of inhibitory effect of MYMD-1 with other TNF-α blockers.

MYMD-1 exhibits a dose-dependent reduction in release of

several cytokine more effectively than Humira, Enbrel and Remicade.

currently marketed TNF-α blockers, MYMD-1 selectively blocks TNF-α production related to adaptive immunity (involved in

autoimmunity) but spares the role of this cytokine in innate immunity (which plays a primary protective role in fighting off

invading organisms).

Because of the crucial role that TNF-α plays in front line protection by the innate immune system (e.g.,

from bacterial, fungal, and viral infections), the indiscriminate blockade of TNF-α by TNF-α blocking agents can cause

serious and even fatal infections, which is one of the primary limiting factors in the use of this class of drugs.

The selectivity

of MYMD-1 in blocking TNF-α, therefore, might provide a much safer alternative to existing treatments for infectious, inflammatory,

and autoimmune conditions, as well as simultaneously resulting in amelioration of immune mediated depression in such

Pre-Clinical Study

of MYMD-1 in Multiple Sclerosis Study (EAE Mouse Model)

sclerosis is an autoimmune disease in which T cells lead an attack on oligodendrocytes and neurons.

Multiple sclerosis is the leading

neurological cause of disability in adults aged 30–50, and approximately one million people in the United States are affected with

this debilitating disease.

T cells are one of the major components of the adaptive immune system.

Their roles include directly killing

infected host cells, activating other immune cells, producing cytokines and regulating the immune response.

When naïve, undifferentiated

T cells become activated, they differentiate and acquire effector functions that can be delineated by the cytokines they secrete.

studies of the therapeutic efficacy of MYMD-1 in the animal model for multiple sclerosis, known as EAE, indicate that MYMD-1 modulates

autoreactive T cell activation in a dose-dependent manner, suppresses T cell activation and ameliorates the course of EAE.

mouse studies suggest that MYMD-1 suppresses the influx of CD4+ T cells into the brain.

MYMD-1 on the influx of T cells into the CNS early in EAE.

To assess the effects of MYMD-1 on the infiltration of T cells into the CNS,

mice were immunized and treated with either vehicle control or 25 mg/mouse/day MYMD-1.

Ten to 14 days later, mice were perfused and brains

collected for analysis.

Infiltration was determined by flow cytometry.

Analysis of Th1 and Th17 subsets are shown;

data compiled from

2 to 3 experiments, n > 3/group per experiment).

Student’s t-test was conducted for statistics.

MYMD-1 In Vivo Study

of Autoimmune Thyroiditis (NODH.2 Mouse Model)

or Hashimoto thyroiditis is an autoimmune disease characterized by lymphocytic infiltration of the thyroid gland.

It has been shown that

tobacco smoking has a protective effect against Hashimoto thyroiditis as tobacco smokers have a lower prevalence of thyroid autoantibodies

than non-smokers.

conducted an in vivo study of autoimmune thyroiditis in a spontaneous thyroiditis (NODH.2) mouse model.

suggested that MYMD-1 suppresses TNF-α production by CD-4+ T cells in a dose dependent manner.

Additionally, the study

reported that MYMD-1 statistically decreases the incidence and severity (p <0.001) of thyroiditis in this mouse model.

Pre-clinical studies have demonstrated that MYMD-1 ameliorated autoimmune thyroiditis in the thyroiditis mouse model.

MYMD-1 decreases the incidence and severity of autoimmune thyroiditis

in NOD.H-2h4 mice, as assessed by H&E histopathology.

At 8 weeks old, 58 NOD.H-2h4 mice were divided into regular water and iodinated

water groups.

In the regular water group, 10 mice (7 M, 3 F) drank water that contained MYMD-1 (185 mg/l), and 16 mice (10 M, 6 F) drank

water without it.

In the iodinated water group, the water was supplemented with 500 mg/l of sodium iodide and contained (16 mice:

6 F) or did not contain (16 mice:

10 M, 6 F) MYMD-1 (185 mg/l).

After 12 weeks of treatment, thyroids were removed and divided in half.

(A and B) Thyroiditis severity and incidence assessed by histopathology in the regular water group.

a mouse in the regular water group, showing a severity score of 2.

(D) A representative thyroid from a mouse in the regular water group

treated with MYMD-1, showing thyroid follicle preservation and an overall normal glandular size (severity score of 0).

(E and F) Thyroiditis

incidence and severity scores assessed by histopathology in the iodinated water group.

(G) A representative thyroid from a mouse in the

iodine group, showing marked lymphocytic infiltration, follicular enlargement, and architectural disruption (severity score of 4).

A representative thyroid from a mouse in the iodine plus MYMD-1 group (severity score of 2).

Results represent the summary of 10 independent

experiments, each analyzing 4 to 6 mice, for a total of 58 mice.

MYMD-1 Targets Inflamm-Aging

and Related Disorders

Aging is associated with a loss of tight regulation of the immune

This leads to increased inflammatory activity in the body, including increased circulating levels of TNF-α.

Chronic inflammation

is a hallmark of aging, referred to as inflamm-aging.

Inflamm-aging and chronic inflammation are closely linked to a number of disorders

such as obesity, insulin resistance/type 2 diabetes, cardiovascular diseases, and cancers, which can reduce health span.

a multifunctional pro-inflammatory cytokine which may play a part in the pathogenesis of certain age-related disorders such as atherosclerosis.

A multi-year pre-clinical, proof of concept in vivo study in aging and longevity confirmed and elucidated MYMD-1’s

potential therapeutic effect on inflamm-aging and other age-related disorders.

Commercialization Targets

MYMD-1 is being developed

to address multiple autoimmune diseases and inflamm-aging.

According to the U.S.

Census Bureau, in 2019, there were approximately 54

residents over 65 years of age.

Thirty-four million Americans have diabetes with approximately 90% of the cases as type

2 diabetes (Centers for Disease Control and Prevention).

Multiple sclerosis affects approximately one million Americans and approximately

2.5 million people worldwide.

In 2021 there were an estimated 1.3 million adults with rheumatoid arthritis.

Supera-CBD is a synthetic

small molecule that is an analog of naturally grown CBD derived from the Cannabis sativa plant.

Supera-CBD is being developed to treat

conditions with which CBD is often associated but for which no natural or synthetic CBD-containing drugs have been approved by the FDA,

such as pain, anxiety/depression and seizures from epilepsy.

While naturally grown CBD is a constituent of Cannabis sativa, Supera-CBD

is a synthetic analog of CBD, thus eliminating potential complications associated with the psychoactive effects of Tetrahydrocannabinol

(“THC”), which is also a constituent of the Cannabis sativa plant.

Studies have suggested that CBD may have broad therapeutic

properties, including the treatment of neuropsychiatric disorders.

Pharmacology and Therapeutic Profile

inhibits a number of important receptors, including the CB2 receptor and opioid receptors, and can also inhibit MAO enzymes.

immune system, one of the important functions of the CB2 receptor is in the regulation of cytokine release from immune cells.

Antagonists targeting the CB2 receptor have been proposed for the treatment or management of a range of painful conditions as well

as for treating several neurological diseases.

The Company conducted an in vitro binding assay study to analyze the CB2

inhibition of Supera-CBD together with that of CBD derived from naturally grown plants.

receptors are widely expressed in the brain, spinal cord, peripheral nerves and digestive tract.

MyMD conducted an in vitro binding

analysis of Supera-CBD with the three types of opioid receptors.

The profile suggests that Supera-CBD could play a role in treating opioid

are enzymes involved in the catabolism, or digestion, of certain neurotransmitters.

MyMD conducted an in vitro MAO

inhibition study.

In this study, Supera-CBD and commercial CBD were analyzed against positive and negative controls.

In this study,

Supera-CBD far exceeded CBD in dose-dependent inhibition of MAOs, particularly MAO-B.

Drugs that inhibit MAOs have been commercially

used for decades to treat depression, and more recent studies have suggested MAO-B inhibiting drugs might have a role to play in

treating cognitive decline in aging.

Commercialization Targets

is anticipated that initial commercialization efforts for Supera-CBD will focus on various existing CBD markets.

These target markets

are anticipated to include CBD sold as an FDA regulated and approved drug and CBD sold for a variety of conditions.

Currently, there is one FDA-approved drug based on CBD.

Epidiolex is being

commercialized by GW Pharmaceuticals, plc (“GWPH”) to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome

in patients two years of age and older.

The reported revenues from Epidiolex in fiscal year 2019 were approximately $296 million.

synthetic drug product, MYMD believes that Supera-CBD may mitigate a number of obstacles generally associated with growing and processing

an active drug ingredient produced from naturally grown plant extracts.

Additionally, there are currently a number of over-the-counter CBD products

marketed for pain, anxiety and sleep disorders.

The regulatory status of these types of CBD products is not clear, but the FDA has taken

the position that products containing CBD may not be lawfully marketed for such uses in the United States without first-obtaining FDA

approval via the NDA process.

However, these products are still marketed with various therapeutic claims, and the FDA has taken enforcement

action against a number of CBD companies based on the claims being made about their products.

CBD sales in the US reached

$4.6 billion in 2020 and have been projected to reach $15 billion by 2025.

MyMD believes that if Supera-CBD is approved by the FDA, it

may have competitive advantages over currently marketed CBD products purified from cannabis, including cost and consistency.

Additionally,

the federal Physician Payment Sunshine Act of 2010 (“PPSA”) under the ACA, and its implementing regulations, require

that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid

or the Children’s Health Insurance Program, with certain exceptions, to report information related to certain payments or

other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request

of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment

interests held by physicians and their immediate family members.

Failure to submit timely, accurately, and completely the required

information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million

per year for “knowing failures”.

Certain states also mandate implementation of compliance programs, impose restrictions

on pharmaceutical manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other

remuneration to healthcare providers and entities.

order to distribute products commercially, we must also comply with state laws that require the registration of manufacturers

and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors

who ship products into the state even if such manufacturers or distributors have no place of business within the state.

also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution,

including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as

it moves through the distribution chain.

Several states have enacted legislation requiring pharmaceutical and biotechnology companies

to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing,

pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies

and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies

for use in sales and marketing, and to prohibit certain other sales and marketing practices.

All of our activities are potentially

subject to federal and state consumer protection and unfair competition laws.

our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental

regulations that apply to us, we may be subject to penalties, including without limitation, civil, criminal and/or administrative

penalties, damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions,

private “qui tam”

actions brought by individual whistleblowers in the name of the government, or refusal to allow

us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and

future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate

our business and our results of operations.

Healthcare Reform

anticipate that current and future U.S.

legislative healthcare reforms may result in additional downward pressure on the price

that we receive for any approved product, if covered, and could seriously harm our business.

Any reduction in reimbursement from

Medicare and 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 prospective vaccine candidate(s).

In addition, it is possible that there will be further legislation or regulation

that could harm our business, financial condition and results of operations.

website address is www.akersbio.com .

We do not intend our website address to be an active link or to otherwise incorporate

by reference the contents of the website into this Annual Report on Form 10-K.

The SEC maintains an Internet website ( http://www.sec.gov )

that contains reports, proxy and information statements and other information regarding issuers that file electronically with

currently employ four (4) full-time equivalent employees, contractors or consultants, all in general and administrative.

None of our employees are represented by a labor union or are a party to a collective bargaining agreement.

We believe that we

have good relations with our employees.

we believe that Supera-CBD may also have competitive advantages over CBD products that have not been approved by FDA as drug products,

as approved drugs are subject to ongoing FDA regulation and must, accordingly, have documented manufacturing processes that comply with

applicable regulations, which provides assurances relating to, consistency and safety.

and Marketing

does not currently have sales and marketing infrastructure to support the launch of its products.

MyMD intends to build such capabilities

in North America prior to launch of MYMD-1.

Outside of North America, MyMD may rely on licensing, co-sale and co-promotion agreements

with strategic partners for commercialization of its products.

If MyMD builds a commercial infrastructure to support marketing in North

America, such commercial infrastructure could be expected to include a targeted sales force supported by sales management, internal sales

support, an internal marketing group and distribution support.

To develop the appropriate commercial infrastructure internally, MyMD

would have to invest financial and management resources, some of which would have to be deployed prior to any confirmation that MYMD-1

or Supera-CBD will be approved.

biotechnology and biopharmaceutical industries are characterized by rapid evolution of technologies, fierce competition and vigorous

defense of intellectual property.

Any product candidates that MyMD successfully develops and commercializes will have to compete

with existing and future new therapies.

While MyMD believes that its drug candidates, development experience and scientific

knowledge may provide it with certain competitive advantages, MyMD faces potential competition from many different sources,

including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies,

and public and private research institutions.

Existing therapies for autoimmune

diseases include anti-inflammatory drugs and immunosuppressive agents, including drugs that seek to selectively inhibit or block TNF-α

(generally referred to as “TNF-α blocking drugs”).

TNF-α blocking drugs are large molecules that are generally

injected or infused.

In some instances, the period of efficacy of a given dosage of TNF-α blockers can decline with repeated administration

and side effects can be a concern.

Leading TNF-α blocking drugs include Etanercept (Enbrel), Infliximab (Remicade), and Adalimumab

(Humira) which collectively represented approximately $29.3 billion in global sales in 2017.

All of these existing TNF-α blocking

drugs require injection, whereas MYMD-1 is being developed to be orally bioavailable.

Unlike currently marketed

TNF-α blockers, MYMD-1 is designed to selectively block TNF-α production related to adaptive immunity (involved in autoimmunity)

but to spare the role of this cytokine in innate immunity (which plays the primary initial role in fighting off invading organisms).

Because of the crucial role that TNF-α plays in front line protection by the innate immune system from bacterial, fungal, and viral

infections, the indiscriminate blockade of TNF-α by TNF-α blocking agents can cause serious and even fatal infections, which

is the primary limiting factor in the use of this class of drugs.

MyMD thus believes that, if MYMD-1 is approved for marketing, the potential

selectivity of MYMD-1 in blocking TNF-α might make it a preferrable alternative to some existing treatments for infectious, inflammatory,

and autoimmune conditions, as well as simultaneously resulting in amelioration of immune mediated depression in such illnesses if it

is also approved for such indication.

policy is to develop and maintain MyMD’s proprietary position by, among other methods, filing or in-licensing U.S.

patents and applications related to MyMD’s drug candidates and methods of treatment that are material to the development and implementation

of MyMD’s business.

MyMD also relies on trademarks, know-how, confidentiality agreements and invention assignment agreements to

develop and maintain MyMD’s proprietary position.

MyMD’s patent portfolio includes protection for MYMD’s lead

product candidates, MYMD-1 and Supera-CBD.

Currently, there are multiple patent families relating to (i) age reversal and treatments of

age-related disorders including sarcopenia;

(ii) reduction of TNF-α levels and treatments of autoimmune disorders;

(iii) addiction

(iv) methods of increasing hair growth and (v) plant nutrition.

As of the date of this document, MyMD has 15 issued U.S.

three pending U.S.

patent applications and 25 foreign patent applications pending in such jurisdictions as Australia, Canada, China, European

Union, Israel, Japan and South Korea, which, if issued, are expected to expire between 2036 and 2039.

term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.

In most countries

in which MyMD files, the patent term is 20 years from the date of filing of the first non-provisional application in which priority is

patent term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays

by the USPTO in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent.

the term of a patent that covers an FDA-approved drug may also be eligible for a patent term extension of up to five years under the

Hatch-Waxman Act, which is designed to compensate for the patent term lost during the FDA regulatory review process.

The length of the

patent term extension involves a complex calculation based on the length of time it takes for regulatory review.

A patent term extension

under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval

and only one patent applicable to an approved drug may be extended.

Moreover, a patent can only be extended once, and thus, if a single

patent is applicable to multiple products, it can only be extended based on one product.

Similar provisions are available in Europe and

certain other foreign jurisdictions to extend the term of a patent that covers an approved drug.

commercial success depends in part on its ability to obtain and maintain proprietary protection for MyMD’s product candidates,

as well as novel discoveries, core technologies, and know-how, as well as its ability to operate without infringing on the proprietary

rights of others and to prevent others from infringing its proprietary rights.

and Royalty Agreements

is a party to two Amended and Restated Confirmatory Patent Assignment and Royalty Agreements, both dated November 11, 2020, with SRQ

Patent Holdings and SRQ Patent Holdings II, under which MyMD (or its successor) will be obligated to pay to SRQ Patent Holdings or SRQ

Patent Holdings II (or its designees) certain royalties on product sales or other revenue received on products that incorporate or are

covered by the intellectual property that was assigned to MyMD.

The royalty is equal to 8% of the net sales price on product sales and,

without duplication, 8% of milestone revenue or sublicense compensation.

SRQ Patent Holdings and SRQ Patent Holdings II are affiliates

authorities in the U.S.

at the federal, state and local level and in other countries regulate, among other things, the research, development,

testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,

post-approval monitoring and reporting, marketing and export and import of drugs and biological products.

Generally, before a new drug

can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific

for each regulatory authority, submitted for review and approved by the regulatory authority.

Approval Process

In the U.S., pharmaceutical

products are subject to extensive regulation under the FD&C Act and the FDA’s implementing regulations and other federal and

state statutes and regulations governing, among other things, the research, development, testing, manufacture, storage, recordkeeping,

approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and import and export of

pharmaceutical products.

Failure to comply with applicable U.S.

requirements may subject a company to a variety enforcement actions and/or

administrative or judicial sanctions, including, but not limited to clinical holds, FDA refusal to approve NDA submissions and/or

revocation or limitation of existing NDAs for approved products, warning or untitled letters, product recalls, product seizures, total

or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

Pharmaceutical product development

for a new drug product or certain changes to an approved product in the U.S.

typically requires pre-clinical laboratory and animal tests,

the submission to the FDA of an IND, which must become effective before clinical testing may commence, and adequate and well-controlled

clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought.

of FDA pre-market approval requirements are inherently uncertain, expensive, and typically takes many years to generate sufficient data

to apply for approval, even when such approval is not ultimately granted, and the actual time required may vary substantially based upon

the type, complexity and novelty of the product or disease.

Pre-clinical tests include

laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential

safety and efficacy of the product.

The conduct of the pre-clinical tests must comply with federal regulations and requirements, including

good laboratory practices.

The results of pre-clinical testing are submitted to the FDA as part of an IND along with other information,

including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.

Long-term pre-clinical

tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

A 30-day waiting period

after the submission of each IND is required prior to the commencement of clinical testing in humans.

If the FDA has neither commented

on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical trials involve the administration

of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator.

Clinical trials

must be conducted:

(i) in compliance with federal regulations;

(ii) in compliance with GCP, an international standard meant to protect

the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors;

and (iii) under protocols

detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Each protocol involving testing on U.S.

patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.

The FDA may order the temporary,

or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either

is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients.

protocol and informed consent information for patients in clinical trials must also be submitted to an IRB and ethics committee for approval.

The IRB will also monitor the clinical trial until completed.

An IRB may also require the clinical trial at the site to be halted, either

temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions.

Additionally, some

clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety

monitoring board or committee.

This group provides authorization for whether a trial may move forward at designated checkpoints based

on access to certain data from the trial.

Clinical trials to support

NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

In Phase 1, the initial introduction

of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions,

side effects associated with increasing doses, and, if possible, early evidence of effectiveness.

Phase 2 usually involves trials in

a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage,

and to identify common adverse effects and safety risks.

If a drug demonstrates evidence of effectiveness and an acceptable safety profile

in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger

number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk

relationship of the drug and to provide adequate information for the labeling of the drug.

In most cases the FDA requires two adequate

and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug.

A single Phase 3 trial may be sufficient in rare

instances, including (1) where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive

finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious

outcome and confirmation of the result in a second trial would be practically or ethically impossible or (2) when in conjunction with

other confirmatory evidence.

The manufacturer of an investigational

drug in a Phase 2 or 3 clinical trial for a serious or life-threatening disease is required to make available, such as by posting on

its website, its policy on evaluating and responding to requests for expanded access.

After completion of the required

clinical testing, an NDA is prepared and submitted to the FDA.

FDA approval of the NDA is required before marketing of the product may

begin in the U.S.

The NDA must include the results of all pre-clinical, clinical and other testing and a compilation of data relating

to the product’s pharmacology, chemistry, manufacture and controls.

The cost of preparing and

submitting an NDA is substantial.

The submission of most NDAs is additionally subject to a substantial application user fee,

currently exceeding $3.1 million for fiscal year 2022 (for applications containing clinical data), which increased from $2.9 million

for fiscal year 2021.

Fee waivers or reductions are available in certain circumstances,

including a waiver of the application fee for the first application filed by a small business.

Additionally, no user fees are

assessed on NDAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The applicant

under an approved NDA is also subject to annual program fees, currently exceeding $369,413 for fiscal year 2022 for each prescription product.

adjusts the user fees on an annual basis, and the fees typically increase annually.

The FDA reviews each submitted

NDA before it determines whether to file it and may request additional information.

The FDA must make a decision on whether to file an

NDA within 60 days of receipt, and such decision could include a refusal to file by the FDA.

Once the submission is filed, the FDA begins

an in-depth review of the NDA.

The FDA has agreed to certain performance goals in the review of NDAs.

Most applications for standard

review drug products are reviewed within ten to twelve months; most applications for priority review drugs are reviewed in six to

eight months.

Priority review can be applied to drugs that the FDA determines may offer significant improvement in safety or effectiveness

compared to marketed products or where no adequate therapy exists.

The review process for both standard and priority review may be extended

by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information

already provided in the submission.

The FDA does not always meet its goal dates for standard and priority NDAs, and the review process

can be extended by FDA requests for additional information or clarification.

The FDA may also refer applications

for novel drug products, or drug products that present difficult questions of safety or efficacy, to an outside advisory committee—typically

a panel that includes clinicians and other experts—for review, evaluation and a recommendation as to whether the application should

be approved and under what conditions, if any.

The FDA is not bound by the recommendation of an advisory committee, but it generally

follows such recommendations.

Before approving an NDA, the

FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with

cGMP requirements.

The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance

with cGMP requirements and are adequate to assure consistent production of the product within required specifications.

The FDA also typically

inspects clinical trial sites to ensure compliance with GCP requirements and the integrity of the data supporting safety and efficacy.

After the FDA evaluates the NDA and the manufacturing facilities, it issues

either an approval letter or a complete response letter (“CRL”).

A CRL generally outlines the

deficiencies in the submission, which may be minor and more technical, or major and more substantive and, in the latter case may require

substantial additional testing or data to be eligible for substantive review by FDA upon resubmission, such as additional clinical data,

additional pivotal clinical trial(s), and/or other significant and time-consuming requirements related to clinical trials, pre-clinical

studies or manufacturing.

If a CRL is issued, the applicant may resubmit the NDA addressing all of the deficiencies identified in the

letter, withdraw the application, engage in formal dispute resolution or request an opportunity for a hearing.

The FDA has committed to

reviewing resubmissions in two to six months depending on the type of information included.

Even if such data and information are submitted,

the FDA may decide that the NDA does not satisfy the criteria for approval.

If the deficiencies

identified in the CRL are addressed to FDA’s satisfaction in a resubmission of the NDA (and FDA does not identify any other issues

that need to be corrected prior to approval or that, otherwise, cause the agency to determine that approval is not appropriate at the

given time), the FDA will issue an approval letter.

An approval letter authorizes commercial marketing of the drug with specific prescribing

information for specific indications.

In addition, under the Pediatric Research Equity Act of 2003 (“PREA”), as amended and

reauthorized, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the

drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric

subpopulation for which the product is safe and effective.

The FDA may, on its own initiative or at the request of the applicant, grant

deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers

from the pediatric data requirements.

As a condition of NDA

approval, the FDA may also require a REMS, to help ensure that the benefits of the drug outweigh the potential risks to patients.

REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use

ETASU can include, but are not limited to, special training or certification for prescribing or dispensing,

dispensing only under certain circumstances, special monitoring, and the use of patient registries.

The requirement for a REMS can

materially affect the potential market and profitability of the drug.

Moreover, product approval may require substantial

post-approval testing and surveillance to monitor the drug’s safety or efficacy.

Once granted, product approvals may be

withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.

Changes to some of the conditions

established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require

submission and FDA approval of an NDA supplement or, in some case, a new NDA, before the change can be implemented.

An NDA supplement

for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures

and actions in reviewing NDA supplements as it does in reviewing NDAs.

Further, as a result of the

COVID-19 pandemic, the extent and length of which is uncertain, MyMD will be required to develop and implement additional clinical study

policies and procedures designed to help protect study participants from the SARS-CoV-2 virus, which may include using telemedicine visits

and remote monitoring of patients and clinical sites.

MyMD will also need to ensure data from its clinical studies that may be disrupted

as a result of the pandemic is collected pursuant to the study protocol and is consistent with GCPs, with any material protocol deviation

reviewed and approved by the site IRB.

Patients who may miss scheduled appointments, any interruption in study drug supply, or other

consequence that may result in incomplete data being generated during a study as a result of the pandemic must be adequately documented

and justified.

For example, on March 18, 2020, the FDA issued guidance on conducting clinical trials during the pandemic, which describes

a number of considerations for sponsors of clinical trials impacted by the pandemic, including the requirement to include in the clinical

study report (or as a separate document) contingency measures implemented to manage the study, and any disruption of the study as a result

a list of all study participants affected by COVID-19-related study disruption by unique subject identifier and by investigational

site, and a description of how the individual’s participation was altered;

and analyses and corresponding discussions that address

the impact of implemented contingency measures (e.g., participant discontinuation from investigational product and/or study, alternative

procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study.

Disclosure of Clinical

Trial Information

Sponsors of clinical

trials of FDA regulated products, including drugs, are required to register and disclose certain clinical trial information to the U.S.

public by publishing such information on clinicaltrials.gov.

Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of

the clinical trial is then made public as part of the registration.

Sponsors are also obligated to discuss the results of their

clinical trials after completion.

Disclosure of the results of these trials can be delayed in certain circumstances for up to two

years after the date of completion of the trial.

Competitors may use this publicly available information to gain knowledge regarding

the progress of development programs.

Expedited Development

and Review Programs

The FDA is authorized to designate

certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening

disease or condition.

These programs are fast track designation, breakthrough therapy designation, and priority review designation.

has not applied for expedited approval under any of these pathways to-date but intends to explore the extent to which any of its current

or future product candidates may be eligible for one or more such pathways.

There is no guarantee that FDA will grant any of MyMD’s

products candidates the expedited designation(s) for which it is submitted, if any, or that MyMD will secure any of the applicable benefits

associated with any of any expedited designations that may be granted to its current or future product candidates, if applicable.

Fast-Track Designation

Fast track designation may

be granted for a product that is intended to treat a serious or life-threatening disease or condition for which pre-clinical or clinical

data demonstrate the potential to address unmet medical needs for the condition.

The sponsor of an investigational drug product may request

that the FDA designate the drug candidate for a specific indication as a fast-track drug concurrent with, or after, the submission of

the IND for the drug candidate.

The FDA must determine if the drug candidate qualifies for fast-track designation within 60 days of receipt

of the sponsor’s request.

For fast-track products, sponsors may have greater interactions with the FDA and the FDA may initiate

review of sections of a fast-track product’s NDA before the application is complete.

This rolling review is available if the FDA

determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast-track product may be effective.

must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable

At the time of NDA filing, the FDA will determine whether to grant priority review designation.

Additionally, fast track designation

may be withdrawn if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

Breakthrough Therapy Designation

In 2012, Congress enacted the

Food and Drug Administration Safety and Innovation Act, or FDASIA.

This law established a new regulatory scheme allowing for expedited

review of products designated as “breakthrough therapies.” A product may be designated as a breakthrough therapy if it is

intended, either alone or in combination with one or more other drugs, 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 FDA may take certain

actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process;

timely advice to the product sponsor regarding development and approval;

involving more senior staff in the review process;

a cross-disciplinary project lead for the review team;

and taking other steps to design the clinical trials in an efficient manner.

Priority Review Designation

The FDA may designate a product

for priority review if it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety

or effectiveness.

The FDA determines, on a case- by-case basis, whether the proposed drug represents a significant improvement when compared

with other available therapies.

Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of

a condition, elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance

that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation.

A priority designation

is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for

taking action on a marketing application from ten months to six months.

Accelerated Approval

Accelerated approval may be

granted for a product that is intended to treat a serious or life-threatening condition and that generally provides a meaningful therapeutic

advantage to patients over existing treatments.

A product eligible for accelerated approval may be approved on the basis of either 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.

The accelerated approval pathway is most often used in settings in which the course of a disease is long, and an extended period of time

is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint

occurs rapidly.

The accelerated approval pathway is contingent on a sponsor’s agreement to conduct additional post-approval confirmatory

studies to verify and describe the product’s clinical benefit.

These confirmatory trials must be completed with due diligence and,

in some cases, the FDA may require that the trial be designed, initiated, and/or fully enrolled prior to approval.

Failure to conduct

required post-approval studies, or to confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the product

from the market on an expedited basis.

All promotional materials for product candidates approved under accelerated regulations are subject

to prior review by the FDA.

Further, as a result of the

COVID-19 pandemic, the extent and length of which is uncertain, MyMD will be required to develop and implement additional clinical study

policies and procedures designed to help protect study participants from the SARS-CoV-2 virus, which may include using telemedicine visits

and remote monitoring of patients and clinical sites.

MyMD will also need to ensure data from its clinical studies that may be disrupted

as a result of the pandemic is collected pursuant to the study protocol and is consistent with GCPs, with any material protocol deviation

reviewed and approved by the site IRB.

Patients who may miss scheduled appointments, any interruption in study drug supply, or other

consequence that may result in incomplete data being generated during a study as a result of the pandemic must be adequately documented

and justified.

For example, on March 18, 2020, the FDA issued guidance on conducting clinical trials during the pandemic, which describes

a number of considerations for sponsors of clinical trials impacted by the pandemic, including the requirement to include in the clinical

study report (or as a separate document) contingency measures implemented to manage the study, and any disruption of the study as a result

a list of all study participants affected by COVID-19-related study disruption by unique subject identifier and by investigational

site, and a description of how the individual’s participation was altered;

and analyses and corresponding discussions that address

the impact of implemented contingency measures (e.g., participant discontinuation from investigational product and/or study, alternative

procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study.

Post-marketing Requirements

Following approval of a new

product, the manufacturer and the approved product are subject to continuing regulation by the FDA.

Drug manufacturers’ and/or

sponsors’ post-marketing FDA obligations, include, among other things, monitoring and record-keeping activities, reporting of adverse

experiences, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses

or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities,

and a number of other specific requirements for prescription-drug advertising.

Although physicians may prescribe legally available products

for off-label uses, manufacturers may not market or promote their approved drug products for off-label uses.

Product approvals may be

withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.

Newly discovered or developed

safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications,

and may also require the implementation of other risk management measures, including a REMS, or the conduct of post-marketing studies

to assess a newly discovered safety issue.

FDA regulations require that

drug products be manufactured in registered drug-manufacturing facilities and in accordance with cGMP regulations.

MYMD currently relies

on third parties to produce clinical quantities of its drug candidates under development in accordance with applicable GCPs and GLPs,

and expects to continue to rely, on third parties to produce clinical and commercial quantities of MYMD’s products that are approved

for marketing in the United States, if any, in accordance with cGMP regulations.

These manufacturers must comply with cGMP regulations

that require, among other things, quality control and quality assurance, the maintenance of records and documentation and the obligation

to investigate and correct any deviations from cGMP.

Accordingly, manufacturers must continue to expend time, money and effort in the

area of production and quality control to maintain cGMP compliance.

The discovery of violative conditions, including failure to conform

to cGMP regulations, could result in a wide range of enforcement actions against the manufacturer, including, but not limited to, recalls,

warning letters, “dear doctor” letters, civil lawsuits, fines, and criminal prosecution.

And the discovery of previously

unknown safety or efficacy problems with a product after approval may result in restrictions on, revocation of, or the addition of conditions

to the product’s approval, among other potential adverse actions.

In addition to the requirements

applicable to approved drug products, sponsors may also be subject to enforcement action in connection with any promotion of any investigational

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, may not represent in a promotional

context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote

or market the product.

Other Regulatory Matters

Manufacturing, sales, promotion

and other activities following product approval are also subject to regulation by numerous regulatory authorities in the U.S.

to the FDA, including the CMS, other divisions of the HHS, the DOJ, the Drug Enforcement Administration, the Consumer Product Safety

Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and

state and local governments and governmental agencies.

Other Healthcare Laws

Healthcare providers,

physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which MyMD

may obtain marketing approval.

MyMD’s current and future arrangements with third-party payors, healthcare providers and

physicians may expose MyMD to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the

business or financial arrangements and relationships through which MyMD markets, sells and distributes any drugs for which MYMD

obtains marketing approval.

In the U.S., these laws include, without limitation, state and federal anti-kickback, false claims,

physician transparency, and patient data privacy and security laws and regulations, including but not limited to those described

MYMD’s business operations, including its research, marketing, and activities relating to the reporting of wholesale or

estimated retail prices for MyMD’s products, the reporting of prices used to calculate Medicaid rebate information and other

information affecting federal, state and third-party reimbursement for MyMD’s products, and the sale and marketing of

MyMD’s product and any future product candidates, are subject to scrutiny under these laws.

● The AKS, makes it illegal

for any person, including a prescription drug manufacturer (or a party acting on its behalf),

to knowingly and willfully solicit, receive, offer or pay any remuneration, directly or indirectly,

overtly or covertly, in cash or in kind, that is intended to induce or reward referrals,

including the purchase, recommendation, order or prescription of a particular drug, for which

payment may be made under a federal healthcare program, such as Medicare or Medicaid.

of this law are punishable by imprisonment, criminal fines, administrative civil money penalties

and exclusion from participation in federal healthcare programs.

In addition, a person or

entity does not need to have actual knowledge of the statute or specific intent to violate

federal civil and criminal false claims laws, including the FCA, which can be enforced through

civil whistleblower or qui tam actions, which impose penalties against individuals or entities

(including manufacturers) for, among other things, knowingly presenting, or causing to be

presented false or fraudulent claims for payment by a federal healthcare program or making

a false statement or record material to payment of a false claim or avoiding, decreasing

or concealing an obligation to pay money to the federal government.

The government may deem

manufacturers to have “caused” the submission of false or fraudulent claims by,

for example, providing inaccurate billing or coding information to customers or promoting

a product off-label.

Claims that include items or services resulting from a violation of

the AKS are false or fraudulent claims for purposes of the FCA.

federal anti-inducement law, which prohibits, among other things, the offering or giving

of remuneration, which includes, without limitation, any transfer of items or services for

free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid

beneficiary that the person knows or should know is likely to influence the beneficiary’s

selection of a particular supplier of items or services reimbursable by a federal or state

governmental program.

imposes criminal and civil liability for knowingly and willfully executing a scheme, or attempting

to execute a scheme, to defraud any healthcare benefit program, including private payors,

or falsifying, concealing or covering up a material fact or making any materially false statements

in connection with the delivery of or payment for healthcare benefits, items or services.

Similar to the AKS, a person or entity does not need to have actual knowledge of the healthcare

fraud statute implemented under HIPAA or specific intent to violate it in order to have committed

● HIPAA, as amended

by HITECH, and their respective implementing regulations, imposes, among other things, specified requirements on covered entities and

their business associates relating to the privacy and security of individually identifiable health information including mandatory contractual

terms and required implementation of technical safeguards of such information.

HITECH also created new tiers of civil monetary penalties,

amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority

to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and

costs associated with pursuing federal civil actions.

● The PPSA, enacted as part of the ACA,

imposed new annual reporting requirements for certain manufacturers of drugs, devices, biologics,

and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s

Health Insurance Program, for certain payments and “transfers of value” provided

to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors)

and teaching hospitals, as well as ownership and investment interests held by physicians

and their immediate family members.

Effective January 1, 2022, these reporting obligations

extend to include transfers of value made during the previous year to certain non-physician

providers such as physician assistants and nurse practitioners.

● Analogous state and foreign fraud and

abuse laws and regulations, such as state anti-kickback and false claims laws, which may

be broader in scope and apply regardless of payor.

These laws are enforced by various state

agencies and through private actions.

Some state laws require pharmaceutical companies to

comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant

federal government compliance guidance, require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers,

and restrict marketing practices or require disclosure of marketing expenditures.

certain state and local laws require the registration of pharmaceutical sales representatives.

State and foreign laws also

govern the privacy and security of health information in some circumstances.

These data privacy and security laws may differ from each

other in significant ways and often are not pre-empted by HIPAA, which may complicate compliance efforts.

Furthermore, most states in

the United States have enacted laws regulating the confidentiality and security of medical information and increased public focus on

privacy may result in amendments or changes to these laws in ways that may have an impact on MyMD’s business activities related

to the collection and use of health-related information.

The increased attention on

privacy in the United States may also impact MyMD’s business activities for the processing of personal information not otherwise

governed by HIPAA.

The EU General Data Protection Regulation (“GDPR”) imposes significant privacy and cybersecurity requirements

related to the handling of all types of personal information, with heightened requirements on sensitive personal information, such as

health information.

The GDPR imposes significant limitations on the use of this personal information and grants individuals in the EU

certain rights associated with the collection and use of personal information.

In the U.S., California recently enacted the CCPA, which

creates new individual privacy rights for California consumers (generally defined as any resident of California, including employees

and other business relations) and places increased privacy and security obligations on entities handling personal information of consumers

or households.

The CCPA also greatly extends the obligations of entities that process personal information to include information not

traditionally viewed as personal information and regulated by laws, such as Internet Protocol (IP) addresses, unique identifiers for

individuals, and information in online cookies and other online technologies.

A majority of other states have already proposed laws similar

to the CCPA, each differing in scope of the personal information covered and the rights of individuals.

Furthermore, the CCPA has already

been replaced with the passage of California’s Proposition 24 (the California Privacy Rights Act, “CPRA”), which adds

additional rights and obligations.

While the CCPA and CPRA currently provide relatively broad exclusions for protected health information

regulated by HIPAA and clinical trials and a limited exception for consumer and business to business information, some of the proposed

laws in other states may not contain the same exceptions.

Furthermore, there have been a number of competing proposals for federal laws,

some of which propose to not preempt other state laws.

The uncertainty surrounding proposed new and changes to existing privacy laws

may lead to operational challenges for MYMD to comply with multiple, potentially conflicting, privacy and cybersecurity laws related

to the collection and use of personal information in each jurisdiction.

Various state and federal laws

and regulations also require entities to implement “reasonable” or “adequate” security measures to protect personal

information, but generally do not provide any specific sets of security measures that would be considered compliant to avoid liability.

Instead, different regulators have adopted inconsistent and evolving standards based on the regulator’s view of what is appropriate

given the nature and scope of the personal information and the processing performed, resulting in unclear obligations.

This may result

in potential liability if a regulator finds that MYMD’s security practices do not meet or exceed the types of security measures

that the regulator believes to be adequate or reasonable under the circumstances.

The scope and enforcement of

each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially considering the

lack of applicable precedent and regulations.

Federal and state enforcement bodies have continued to increase their scrutiny of interactions

between healthcare companies and healthcare providers, which has led to investigations, prosecutions, convictions and settlements in

the healthcare industry.

It is possible that governmental authorities will conclude that MyMD’s business practices do not comply

with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If MyMD’s operations are found to be in violation of any of these laws or any other related governmental regulations that may apply

to it, MyMD may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion

of drugs from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, additional oversight and reporting

obligations if MyMD becomes subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance

with these laws and the curtailment or restructuring of MyMD’s operations.

If any of the physicians or other healthcare providers

or entities with whom MyMD expects to do business is found to be not in compliance with applicable laws, they may be subject to similar

actions, penalties and sanctions.

Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible

investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from its business.

Current and Future Healthcare

Reform Legislation

On March 23, 2010,

President Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the “ACA”) and on March 30,

2010, he signed the “Health Care and Education Reconciliation Act” (P.L.

111-152), collectively commonly referred to as the

“Healthcare Reform Law.” The Healthcare Reform Law included a number of new rules regarding health insurance, the provision

of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy

Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare

in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce

healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional

taxes, fees, and rebate obligations on pharmaceutical and medical device companies).

This legislation was one of the most comprehensive

and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed the way healthcare is financed

by both governmental and private insurers.

This legislation has impacted the scope of healthcare insurance and incentives for consumers

and insurance companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers

to find cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the cost of providing care.

environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing

negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in our product candidates,

to the extent approved for commercialization in the future, being chosen less frequently or the pricing being substantially lowered.

this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

These structural changes

could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and

the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination

of both, as well as other changes.

Restructuring the coverage of medical care in the U.S.

could impact the reimbursement for prescribed

drugs and pharmaceuticals, including any products hat we may commercialize or promote in the future.

If reimbursement for the products

we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially

reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could

have a material adverse effect on our reputation, business, financial condition or results of operations.

Extending medical benefits

to those who currently lack coverage will likely result in substantial costs to the U.S.

federal government, which may force significant

additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be sought through cost

While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of

preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased

enforcement activities.

Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products

or by restricting coverage (and, thereby, utilization) of medical services or products.

In either case, a reduction in the utilization

of, or reimbursement for any product we may commercialize or promote in the future, could have a material adverse effect on our reputation,

business, financial condition or results of operations.

Several states and private

entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue to litigate various

aspects of the legislation.

On July 26, 2012, the U.S.

Supreme Court generally upheld the provisions of the ACA at issue as constitutional.

However, the U.S.

Supreme Court held that the legislation improperly required the states to expand their Medicaid programs to cover more

As a result, states have a choice as to whether they will expand the number of individuals covered by their respective state

Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving and coverage measures

to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution of Medicaid-managed care

The manner in which these cost-saving and coverage measures are implemented could have a material adverse effect on our reputation,

business, financial condition or results of operations.

Further, the healthcare regulatory

environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify, limit, replace,

or repeal the ACA and judicial challenges have continued.

We cannot predict the impact on our business of future legislative and

legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations.

The financial

impact of U.S.

healthcare reform legislation over the next few years will depend on a number of factors, including the policies

reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation.

to time, legislation is drafted, introduced and passed in the U.S.

Congress that could significantly change the statutory provisions

governing coverage, reimbursement, and marketing of pharmaceutical products.

In addition, third-party payor coverage and reimbursement

policies are often revised or interpreted in ways that may significantly affect our business and our products.

During his time in office,

former President Trump supported the repeal of all or portions of the ACA.

President Trump also issued an executive order in which he

stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive departments

and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to the maximum

extent permitted by law.

Congress has enacted legislation that repeals certain portions of the ACA, including but not limited to the

Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual

mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other

things, repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth

in Medicare spending).

Additionally, in December 2018,

a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore, invalid.

appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court

to reassess whether and how such holding affects the validity of the rest of the ACA.

The Fifth Circuit’s decision on the individual

mandate was appealed to the U.S.

Supreme Court.

On June 17, 2021, the Supreme Court held that the plaintiffs (comprised of the state

of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality of the ACA’s

individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to dismiss the case.

As a result, the ACA will remain in-effect in its current form for the foreseeable future;

however, we cannot predict what additional

challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

The Biden administration also

introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

For example, on January 28, 2021, President

Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through

the ACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021.

The executive order also instructed

certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among

others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary

barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

On the legislative front, the American Rescue

Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently

set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, beginning January

And, in July 2021, the Biden administration released an executive order entitled, “Promoting Competition in the American

Economy,” with multiple provisions aimed at prescription drugs.

In response, on September 9, 2021, HHS released a “Comprehensive

Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative

policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

And, in November

2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back Better Act (H.R.

by the House of Representatives on November 19, 2021, which aims to lower prescription drug pricing by, among other things, allowing

Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been

on the market for a certain number of years and imposing tax penalties on drug manufacturers that refuse to negotiate pricing with Medicare

or increase drug prices “faster than inflation.” If enacted, this bill could have a substantial impact on our business.

In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly

impact pharmaceutical companies and the success of our product candidates.

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, designed to encourage importation from other countries and bulk purchasing.

There is uncertainty as to

what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the United States or the

effect of any future legislation or regulation.

Furthermore, we cannot predict what actions the Biden administration will implement in

connection with the Health Reform Law.

However, it is possible that such initiatives could have an adverse effect on our ability to obtain

approval and/or successfully commercialize products in the United States in the future.

For example, any changes that reduce, or impede

the ability to obtain, reimbursement for our product candidates approved for commercialization in the United States, if any, or any other

drug products we may commercialize in the future or that reduce medical procedure volumes could adversely affect our operations and/or

future business plans.

Packaging and Distribution

in the United States

If MyMD’s product

candidates that are approved for commercialization in the United States, if any, are made available to authorized users of the Federal

Supply Schedule of the General Services Administration, additional laws and requirements may apply.

In relevant part, products must meet

applicable child-resistant packaging requirements under the U.S.

Poison Prevention Packaging Act.

Manufacturing, sales, promotion and

other activities also are potentially subject to federal and state consumer protection and unfair competition laws.

The distribution of pharmaceutical

products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements

intended to prevent the unauthorized sale of pharmaceutical products.

The failure to comply with

any of these laws or regulatory requirements subjects firms to possible legal or regulatory action.

Depending on the circumstances, failure

to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, exclusion from

federal healthcare programs, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal

of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts.

Any action against MyMD

for violation of these laws, even if MyMD is successful in defending against it, could cause MyMD to incur significant legal expenses

and divert MyMD’s management’s attention from the operation of its business.

Prohibitions or restrictions on sales or withdrawal

of future products marketed by MyMD could materially affect its business in an adverse way.

Changes in regulations, statutes

or the interpretation of existing regulations could impact MyMD’s business in the future by requiring, for example:

to MyMD’s manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall or discontinuation

of MyMD’s products;

or (iv) additional record-keeping requirements.

If any such changes were to be imposed, they could adversely

affect the operation of MyMD’s business.

Reimbursement

Sales of any of MyMD’s product candidates that are approved for marketing in the United States or any other products

MyMD may commercialize in the future, as applicable,

will depend, in part, on the extent to which MyMD’s products, if approved, will be covered by third-party payors, such as government

health programs, commercial insurers and managed healthcare organizations, as well as the level of reimbursement such that those third-party

payors provide for MyMD’s products.

Patients and providers are unlikely to use MyMD’s products unless coverage is provided

and reimbursement is adequate to cover a significant portion of the cost of MyMD’s products in which MyMD’s products are

In the U.S., no uniform policy of coverage and reimbursement for drugs or biological products exists, and one payor’s determination

to provide coverage and adequate reimbursement for a product does not assure that other payors will make a similar determination.

decisions regarding the extent of coverage and amount of reimbursement to be provided for any of MyMD’s products candidates, if

approved, will be made on a payor-by-payor basis.

As a result, the coverage determination process may be a time-consuming and costly

process that will require MyMD to provide scientific and clinical support for the use of MyMD’s products to each payor separately,

with no assurance that coverage and adequate reimbursement will be obtained.

The Medicaid Drug Rebate Program

requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the HHS as a

condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients.

The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability

by raising the minimum basic Medicaid rebate on most branded prescription drugs and adding a new rebate calculation for “line extensions”

(i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded products, creating a new method

by which rebates owed by pharmaceutical manufacturers are calculated for drugs that are inhaled, infused, instilled, implanted or injected,

as well as potentially impacting their rebate liability by modifying the statutory definition of average manufacturer’s price (“AMP”).

The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates

on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug benefits.

Pricing and rebate

programs must also comply with the Medicaid rebate requirements of the U.S.

Omnibus Budget Reconciliation Act of 1990.

The Medicare Prescription Drug

Improvement and Modernization Act of 2003 (“MMA”) established the Medicare Part D program to provide a voluntary prescription

drug benefit to Medicare beneficiaries.

Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private

entities that provide coverage of outpatient prescription drugs.

Unlike Medicare Part A and B, Part D coverage is not standardized.

all Medicare drug plans must give at least a standard level of coverage set by Medicare, Part D prescription drug plan sponsors are not

required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will

cover and at what tier or level.

However, Part D prescription drug formularies must include drugs within each therapeutic category and

class of covered Part D drugs, though not necessarily all the drugs in each category or class.

Any formulary used by a Part D prescription

drug plan must be developed and reviewed by a pharmacy and therapeutic committee.

Government payment for some of the costs of prescription

drugs may increase demand for products for which MyMD receives marketing approval.

However, any negotiated prices for MyMD’s products

covered by a Part D prescription drug plan likely will be lower than the prices MyMD might otherwise obtain.

Moreover, while the MMA

applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations

in setting their own payment rates.

Any reduction in payment that results from the MMA may result in a similar reduction in payments

from non-governmental payors.

For a drug product to receive

federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S.

government agencies, the manufacturer

must extend discounts to entities eligible to participate in the 340B drug pricing program.

The required 340B discount on a given product

is calculated based on the AMP, and Medicaid rebate amounts reported by the manufacturer.

As of 2010, the ACA expanded the types of entities

eligible to receive discounted 340B pricing, although, under the current state of the law, with the exception of children’s hospitals,

these newly eligible entities will not be eligible to receive discounted 340B pricing on orphan drugs.

In addition, as 340B drug pricing

is determined based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula and AMP definition described above

could cause the required 340B discount to increase.

The 340B program imposes ceilings on prices that drug manufacturers can charge for

medications sold to certain health care facilities.

It is unclear how this decision could affect covered hospitals who might purchase

MyMD’s products in the future and affect the rates MyMD may charge such facilities for its approved products.

In addition, legislation

may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating

manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

As noted above, the marketability

of any products for which MyMD receives regulatory approval for commercial sale may suffer if the government and other third-party payors

fail to provide adequate coverage and reimbursement.

An increasing emphasis on cost containment measures in the U.S.

has increased and

MyMD expects it will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and third-party reimbursement rates

may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products for which MyMD receives

regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

These laws, and future state and federal healthcare reform measures

may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise

affect the prices MyMD may obtain for any of its product candidates for which MyMD may obtain regulatory approval or the frequency with

which any such product candidate is prescribed or used.

addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements

governing drug pricing and reimbursement vary widely from country to country.

For example, the EU 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.

Reference pricing used by various EU Member States and parallel distribution, or arbitrage

between low-priced and high-priced Member States, can further reduce prices.

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.

In some countries, MyMD may be required to conduct a clinical study or other studies that compare the cost-effectiveness

of any of MyMD’s product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow

favorable reimbursement and pricing arrangements for any of MyMD’s products.

Historically, products launched in the EU do not follow

price structures of the U.S.

and, generally, prices tend to be significantly lower.

Publication of discounts by third-party payors or

authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

of December 31, 2021, MyMD had 9 full-time employees and no part-time employees.

MyMD has not experienced any work stoppages.

MyMD’s employees are represented by a labor union or covered by collective bargaining agreements, and MyMD considers its relationship

with its employees to be good.

Plans for 2022

Product Candidate

are currently enrolling patients in the Phase II Aging and Sarcopenia Study (“A Double-Blind, Placebo-controlled, Randomized Study

to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD-1 in The Treatment of Participants Aged 65 Years or Older with

Chronic Inflammation Associated with Sarcopenia/Frailty”).

completed a Phase 1 Dosing Study (“A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to

Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose of MYMD-1 Capsules in Healthy Male and Female Adult Subjects”).

Investigational New Drug (IND) application for Aging and Sarcopenia was accepted by FDA.

IND was submitted to support a Phase II study focused on Aging and Sarcopenia in adults 65 years and older.

The FDA reviewed the

IND with its corresponding protocol and allowed the company to proceed to a Phase II clinical trial on November 1, 2021.

obtained IRB approval on November 16, 2021 which permitted us to start enrollment and dosing qualifying participants.

for Autoimmune Diseases

Dog Study – completed on December 20, 2021:

A 39-Week Toxicity and Toxicokinetic Study of MYMD-1 by Oral Gavage

in Beagle Dogs.

There were no treatment related gross pathology findings at Autopsy.

Rat Study – completed on December 17, 2021:

A 26-Week Toxicity and Toxicokinetic Study of MYMD-1 by Oral Gavage

There were no treatment related gross pathology findings at Autopsy.

produced guidance on dosing levels and overall safety in the human studies.

have received domestic patent protection for MYMD-1, including its use in methods of extending lifespan and treating arthritis,

autoimmune diseases, and inflammatory and age-related disorders including sarcopenia.

will continue to prosecute patents to protect intellectual property in the United States and abroad.

scientific manuscript on MYMD-1 is under review:

improves health span and prolongs lifespan in old mice and modulates aging-relevant biomarkers in vitro:

A comparison to rapamycin

and metformin.” Author:

Johns Hopkins Medical School.

manuscript details a 12-month mouse trial studying aging and longevity with MYMD-1.

We also completed several in vitro studies from

human primary cell-based BioMap systems at Eurofins contrasting MYMD-1 versus Rapamycin.

for Hashimoto’s Thyroiditis

July 26, 2021, we submitted an Annual Update to the FDA for the previously opened Hashimoto’s

Thyroiditis IND.

April 2021, the FDA gave clearance for a Phase I dosing study in normal healthy volunteers;

Institutional Review Board (IRB) approval

was obtained on April 4, 2021.

The clinical trial was conducted by The Clinical Research of West Florida Phase 1 unit with a closeout

visit taking place on November 22, 2021.

of laboratory parameters, vital sign, ECG, and physical findings did not reveal any clinically

relevant effect of MYMD-1.

In one dose group, there was a decrease in TNF-α levels

found in MYMD-1 treated subjects, but no change in the levels in subjects given placebo.

In one dose group, there was a decrease in TNF-α levels found in MYMD-1 treated subjects,

but no change in the levels in subjects given placebo.

data from the Phase I clinical trial was submitted to the FDA on September 14, 2021 as part

of the Annual IND update for Hashimoto’s Thyroiditis IND.

The FDA responded by providing

guidance on moving forward with Phase II clinical trials.

data was also included in a new commercial IND to the FDA on September 22, 2021.

company completed CYP in vitro studies which concluded that clinical drug-drug interactions are not expected with MYMD-1.

CYP induction

is the most commonly studied form of induction in drug metabolism and is required by regulatory authorities.

had MYMD-1 synthesized in August 2021 to [14C] MYMD-1 radiolabeled product for Mass Balance, Pharmacokinetic, and Metabolism.

of the rat study results demonstrated that MYMD-1 was metabolized extensively throughout the tissues, crosses the blood brain barrier,

was cleared in the urine and feces, and there were no nitrosated metabolite biological samples detected.

company plans to publish data from the Phase 1 dosing study for MYMD-1 as a treatment for aging.

There was a statistically

significant decrease in TNF-alpha levels (p-value <0.05) found in one MYMD-1 treated subjects cohort, but no change in the levels in

subjects given placebo.

We plan to manage our pivotal

Phase 2 aging and sarcopenia study.

Final efficacy data from the phase 2 study is expected in the fourth quarter 2022.

We anticipate

that we will review the safety and efficacy of this study and present the mandatory end of phase 2 data to the FDA.

The company intends to submit

an IND to the FDA in the third quarter 2022 for the indication Rheumatoid Arthritis.

MyMD Pharmaceuticals, Inc.

completed several in

vitro studies from human primary cell-based BioMap systems at Eurofins contrasting MYMD-1 to Humira, Enbrel and Remicade.

July 27, 2021, Eurofins showed Commonality in a Comparative Study with FDA-Approved Anti-Inflammatory and Anti-Autoimmune Drugs Used

for Arthritis, Colitis and Dermatitis.

On October 26, 2021, our President and Chief Medical Officer, Chris Chapman, M.D., was named Honoree

of the year by the Arthritis Foundation.

August 5, 2021, our lead product candidate MYMD-1 was shown to suppress cytokines, which are the major cause of death in COVID-19 patients,

in a human cell study.

The company plans to consult with the FDA on this indication for post COVID-19 immune mediated depression in the

second quarter 2022.

During this time, MyMD Pharmaceuticals, Inc.

also expects to seek additional FDA guidance on depression in MS patients

under an Orphan Drug Designation (ODD).

have an active IND to start a Phase 2 study for the indication Hashimoto’s Thyroiditis, and plan to present the FDA with a protocol

for this pilot phase 2 study in the fourth quarter 2022.

company expects to commence a [14C] MYMD-1 radiolabeled study in four healthy male volunteers in the fourth quarter 2022.

intend to begin long-term reproductive toxicity studies in the fourth quarter 2022.

These will include study of Fertility and Early Embryonic

Development to Implantation in Mice, and study for Effects on Embryo Fetal Development in Mice and Rabbits with a toxicokinetic evaluation.

These studies will continue to support long-term dosing in humans.

manufacturing, we will continue to provide GMP MYMD-1 capsules for Phase 2 clinical trials.

We plan to continue analytical analysis to

provide GMP product other that capsules for long-term human trials.

Product Candidate

from Eurofins studies involving human primary cell-based BioMap system demonstrated that Supera-CBD delivers an extremely potent therapeutic

benefit of 8,000 times that of plant-derived CBD at activating CB2 receptors, permitting its delivery at a very low non-toxic dose.

August 10, 2021 the company was awarded U.S.

Patent 11,085,047 B2, titled “Synthetic Cannabinoid Compounds for Treatment of Substance

Addiction and Other Disorders,” covering the Super-CBD product candidate and its pharmaceutical formulations.

Hopkins Medicine researchers presented Supera-CBD data at the 3 rd annual Neuroimmunology Drug Development Summit on April

company presented data referencing Super-CBD at the 4th Annual International Cannabinoid Summit on September 9, 2021.

plan to continue our preclinical program starting genotoxicity studies in Europe.

Those studies include:

profiling and Ames test (initiation December 21, 2021;

completion January 20, 2022) Micronucleus

test (initiation December 21, 2021;

completion February 20, 2022)

study of Behavioral Biology at Johns Hopkins University Supera-CBD vs.

CBD Acute Pain and Inflammation begins has been funded for 2022.

National Institutes of Health is planning to work on a grant for Supera-CBD in Epilepsy for the third quarter

manufacturing, we expect to continue providing GMP Supera-CBD materials for the preclinical toxicity programs.

We plan to continue analytical

analysis to provide GMP materials for long term toxicity and Human trials.

Research is conducting a study with MYMD-1 and L/R-Supera-CBD for Depression and Anxiety.

Plus Maze and Fear Conditioning

response study.

open field and Y maze study.

LPS induced depression.

Available information

website address is www.mymd.com .

We do not intend our website address to be an active link or to otherwise incorporate by reference

the contents of the website into this Annual Report on Form 10-K.

The SEC maintains an Internet website ( www.sec.gov ) that contains

reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business