What changed in this filing

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Item 1. Business

2024-04-01 compared with 2023-03-31 · 441 added, 490 removed, 891 unchanged (51% of the section changed)

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

1, the “Merger Agreement”), by and among MyMD Pharmaceuticals, Inc., a New Jersey corporation previously known as Akers

Biosciences, Inc.

(the “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,

(“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, Inc.

and its subsidiaries.

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

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.

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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,

MYMD-1 is a clinical stage

small molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited to) 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”)

Supera-CBD 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.

rights to Supera-CBD TM were previously owned by Supera and were acquired by MyMD Florida immediately prior to the closing

of the Merger.

rights to Supera-CBD TM were previously owned by Supera and were acquired by MyMD Florida (as defined below) immediately

prior to the closing of the Merger (as defined below) that occurred in 2021.

Background and Corporate History

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

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).

On 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, 2022, MyMD had 500,000,000 shares of authorized Common Stock, of which approximately 39,470,009 shares were outstanding

and 14,202,928 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 warrants.

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

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” or “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 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 closing;

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.

Asset Purchase Agreement

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).

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

quarter of 2022.

The last patient visit took place on June 6, 2023.

The clinical safety report is currently under development.

Additionally, MyMD is working with Charles River Laboratories to conduct

a study titled “A 13 Week Electroencephalogram Safety Study of MYMD-1 by Oral Gavage Administration in Beagle Dog.” Dosing

began on December 19, 2023.

Merger and Corporate Transactions

April 16, 2021, pursuant to an Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (as subsequently amended, the

“Merger Agreement”), by and among the Company, previously known as Akers Biosciences, Inc., XYZ Merger Sub, Inc., 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”).

The Merger consideration

included potential milestone payments to the pre-Merger MyMD Florida stockholders (the “Milestone Payments”) payable in shares

of the Company’s Common Stock upon the achievement of certain market capitalization milestone events during the 36-month period

immediately following the closing of the Merger.

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

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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.

Supera is a Florida corporation that was

incorporated in September 2018 by Mr.

Williams and The Starwood Trust in order to develop and commercialize Supera-CBD.

In December 2018,

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

As partial 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).

and Disposition of Cystron

Company acquired 100% of the membership interests of Cystron pursuant to a Membership Interest Purchase Agreement, dated March 23, 2020

(as amended by Amendment No.

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.

(“Premas”) 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

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 from Premas.

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”).

is pursuing the development of the COVID-19 vaccine candidate.

MyMD has evaluated 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.

As partial 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.

Company previously owned, through its subsidiary Cystron Biotech, LLC (“Cystron”), an exclusive license from Premas Biotech

(“Premas”) with respect to Premas’ vaccine platform for the development of a vaccine against COVID-19 and

other coronavirus infections.

On 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 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.

Oravax is pursuing the development of the COVID-19 vaccine candidate.

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.

In addition, MyMD currently has the right to designate a member of the board of directors of Oravax, pursuant

Joshua Silverman, our Chairman of the Board, has been designated to serve as a director of Oravax.

Status of MyMD Florida

On April 8, 2022, the MyMD

Florida subsidiary was dissolved and merged into the New Jersey corporation MyMD Pharmaceuticals, Inc.

pursuant to an Agreement and Plan

of Merger dated April 8, 2022.

MyMD has evaluated 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.

In addition, 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.

of MyMD Florida

April 8, 2022, the MyMD Florida subsidiary was dissolved and merged into the New Jersey corporation MyMD Pharmaceuticals, Inc.

to an Agreement and Plan of Merger dated April 8, 2022.

Reincorporation

On March 4, 2024, the Reincorporation

was effected, and the Company changed its state of incorporation from New Jersey to Delaware.

is developing two platform drugs targeting numerous disease indications.

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Below are MyMD’s key clinical strategies:

Phase 2 clinical trial in sarcopenia (i.e., age-related muscle loss) in the second quarter of 2023;

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

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

Completed Phase 2 clinical trial in sarcopenia (i.e., age-related muscle

loss) in the second quarter of 2023;

In the process of completing the Clinical Safety Report (CSR);

Advance MYMD-1 into Phase 2 clinical trials for rheumatoid arthritis

and Hashimoto’s Thyroiditis;

Execute 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;

Identify and validate additional

novel targets and utilize translational platforms to develop a pipeline of product candidates for aging and other autoimmune disease;

Maintain broad commercial

rights to MyMD’s product candidates;

Continue to strengthen

and expand MyMD’s intellectual property portfolio.

MYMD-1 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.

By 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 completed a Phase 2 clinical trial for sarcopenia (age-related muscle loss) and is planning a Phase 2 clinical trial for

rheumatoid arthritis.

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.

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.

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

IL-16 and IL-17.

IL-16 and IL-17a.

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

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Targets Autoimmune Diseases

is designed to regulate the immunometabolic system and intended for development as a potential treatment for certain autoimmune

diseases, including (but not limited to) multiple sclerosis, diabetes, rheumatoid arthritis, and/or inflammatory bowel disease.

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

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.

In response to an often-unknown trigger, the immune system starts producing antibodies

that attack the body’s own cells instead of fighting infections.

is designed to regulate the immunometabolic system and intended for development as a potential treatment for certain autoimmune diseases,

including (but not limited to) multiple sclerosis, diabetes, rheumatoid arthritis, and/or 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.

immune system defends the body against disease and infection.

If the immune system malfunctions, it can mistakenly attack healthy cells,

tissues, and organs.

In response 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

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several cytokine more effectively than Humira, Enbrel and Remicade.

believe MYMD-1 is distinguishable from currently marketed TNF-α blockers because it 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.

Based on our belief regarding the selectivity of MYMD-1 in blocking TNF-α, therefore, we

intend to explore the extent to which MYMD-1 may be a safer alternative to treat infectious, inflammatory, and autoimmune

conditions, as well as its potential to ameliorate immune mediated depression in such illnesses.

believe MYMD-1 is distinguishable from currently marketed TNF-α blockers because it 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.

our belief regarding the selectivity of MYMD-1 in blocking TNF-α, therefore, we intend to explore the extent to which MYMD-1 may

be a safer alternative to treat infectious, inflammatory, and autoimmune conditions, as well as its potential to ameliorate immune mediated

depression in such illnesses.

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

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

We believe the

results of this study show MYMD-1’s ability to suppress 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.

We believe the results

of this study show MYMD-1’s ability to suppress 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.

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.

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is associated with a loss of tight regulation of the immune system.

This leads to increased inflammatory activity in the body,

including increased circulating levels of TNF-α.

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.

TNF-α is a multifunctional pro-inflammatory

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

pre-clinical, proof of concept in vivo study in aging and longevity confirmed our belief regarding MYMD-1’s potential

therapeutic effect on inflamm-aging and other age-related disorders, which we intend to explore further in clinical trials, pending our submission,

and the corresponding acceptance, of the requisite regulatory and other relevant submissions.

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.

TNF-α is 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 our belief regarding MYMD-1’s potential therapeutic effect on inflamm-aging and other age-related disorders, which we

intend to explore further in clinical trials, pending our submission, and the corresponding acceptance, of the requisite regulatory and

other relevant submissions.

Palmer Eye Institute Collaboration

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Palmer has included pre-clinical and clinical investigations.

In July 2022 we entered into a Material

Transfer Agreement with Bascom Palmer.

In July 2022 we entered into a Material Transfer Agreement with Bascom

Our collaboration was announced in a press release and in an article in Ophthalmology Times .

Bascom Palmer confirmed in August 2022 that it had received a quantity of our MYMD-1 product candidate and MYMD provided a material

safety datasheet and certification of analysis.

In August 2022, Bascom Palmer researchers conducted a preliminary introductory study

of TON in mice.

Investigators ran a crush injury of the mice’s optic nerves with and without MYMD-1.

The study drug was given

once per day via oral gavage at a dosage of 30 mg/kg of body weight.

The mice were treated for five days, untreated for two

days, and then sacrificed, and their TNF-α levels were measured.

Data from this study is pending.

We intend to plan additional

pre-clinical studies.

addition to the pre-clinical study described above, we are collaborating with Bascom Palmer to plan future a clinical study.

August 2022, Bascom Palmer researchers executed a confidentiality and non-disclosure agreement and Bascom Palmer produced a draft

protocol synopsis entitled, Assessment of the Anti-Inflammatory Effects of MYMD-1 in Non-Infectious Anterior Uveitis:

Controlled, Double Blind Clinical Study.

Bascom Palmer confirmed in

August 2022 that it had received a quantity of our MYMD-1 product candidate and MYMD provided a material safety datasheet and certification

In August 2022, Bascom Palmer researchers conducted a preliminary introductory study of TON in mice.

Investigators ran a

crush injury of the mice’s optic nerves with and without MYMD-1.

The study drug was given once per day via oral gavage at a dosage

of 30 mg/kg of body weight.

The mice were treated for five days, untreated for two days, and then sacrificed, and their TNF-α levels

were measured.

The crush injury raised levels of TNF-α.

After being dosed with MYMD, TNF-α levels were brought down in crush injury compared to controls, but the decrease did not meet

statistical significance (p=0.095).

Likely cause of the result not reaching p<0.05 may be attributed to rebound (e.g.

would have gone up when MYMD-1 stopped;

daily dosing may need to me adjusted, crush injury may have been too severe for the medication,

and/or possible contribution of ketamine which is an anti-inflammatory.

Additional studies are not planned for now.

In addition to the pre-clinical study described above, we collaborated

with Bascom Palmer to plan a clinical study.

In August 2022, Bascom Palmer researchers executed a confidentiality and non-disclosure agreement

and Bascom Palmer produced a draft protocol synopsis entitled, Assessment of the Anti-Inflammatory Effects of MYMD-1 in Non-Infectious

Anterior Uveitis:

A Randomized Controlled, Double Blind Clinical Study.

This program is not active.

Commercialization Targets

MYMD-1 is being developed to address serious and debilitating autoimmune and inflammatory diseases, including sarcopenia,

frailty resulting from aging process, and rheumatoid arthritis (RA).

is being developed to address serious and debilitating autoimmune and inflammatory diseases, including sarcopenia, frailty resulting

from aging process, and rheumatoid arthritis (RA).

According to the U.S.

Census Bureau, in 2020, there were approximately

54 million U.S.

Census Bureau, in 2020, there were approximately 54 million

residents over 65 years of age, representing 16% of the U.S.

This figure is expected to increase to nearly

22% by the year 2040.

1 The Arthritis Foundation

estimates that approximately 1.5 million people in the U.S.

This figure is expected to increase to nearly 22% by the

1 The Arthritis Foundation estimates that approximately 1.5 million people in the U.S.

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 anecdotally 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

Supera-CBD is being developed

to treat conditions with which CBD is often anecdotally 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.

Department of Health and Human Services.

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May 2021 Page 3.

The Arthritis Foundation.

Arthritis Foundation.

Rheumatoid Arthritis:

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

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

treating opioid addiction.

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

opioid addiction.

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

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US reportedly reached $5.3 billion in 2021, 15% growth over 2020 sales, and are projected to reach $16 billion by 2026.

MyMD believes that if Supera-CBD is approved by the FDA, it may have competitive advantages over currently marketed CBD products that

have not been approved by FDA as drug products, as approved drugs must undergo rigorous premarket study and generate results sufficient

to support a finding that they are safe and effective for their intended use(s) and remain subject to ongoing FDA postmarket regulation,

believes that if Supera-CBD is approved by the FDA, it may have competitive advantages over currently marketed CBD products that have

not been approved by FDA as drug products, as approved drugs must undergo rigorous premarket study and generate results sufficient to

support a finding that they are safe and effective for their intended use(s) and remain subject to ongoing FDA postmarket regulation,

which provides additional assurances relating to quality, consistency and safety.

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year 2019 were approximately $296 million.

MYMD believes that, by utilizing synthetic, rather than naturally derived, CBD in Supera-CBD

may mitigate a number of obstacles generally associated with growing and processing an active drug ingredient produced from naturally

grown plant extracts.

On March 2, 2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific

review and determined that it would not Supera-CBD a controlled substance or listed chemical under the Controlled Substances Act (CSA)

and its governing regulations.

We believe that this decision will expedite future research involving Supera-CBD by relieving us or our

research partners from having to comply with regulations relating to controlled substances.

MYMD believes that, by utilizing synthetic, rather than naturally derived, CBD

in Supera-CBD may mitigate a number of obstacles generally associated with growing and processing an active drug ingredient produced

from naturally grown plant extracts.

March 2, 2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific review and determined that

it would not Supera-CBD a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

We believe that this decision will expedite future research involving Supera-CBD by relieving us or our research partners from having

to comply with regulations relating to controlled substances.

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 the commercial MYMD-1, if successfully developed and granted the requisite FDA

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, which cannot be guaranteed.

MyMD intends to build such capabilities

in North America prior to launch the commercial MYMD-1, if successfully developed and granted the requisite FDA approval.

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, which cannot be guaranteed.

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

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specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions.

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).

The total TNF-α market collectively

represented approximately $41 billion in global sales in 2022.

4 All of these existing TNF-α blocking drugs require

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

Our management believes patients and providers would view

the fact that MYMD-1 can be administered orally as a significant advantage.

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).

The total TNF-α market collectively represented approximately $41 billion in global

sales in 2022.

4 All of these existing TNF-α blocking drugs require injection, whereas MYMD-1 is being developed to be

orally bioavailable.

Our management believes patients and providers would view the fact that MYMD-1 can be administered orally as a significant

currently marketed TNF-α blockers, MYMD-1 is designed to selectively block TNF-α production related to adaptive immunity

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(iii) addiction treatments;

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

and (iv) methods of increasing hair growth.

of the date of this document, MyMD has 16 issued U.S.

patents, four pending U.S.

patents, three pending U.S.

patent applications, 64 issued foreign patents, and

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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.

before a new drug can be marketed, considerable data demonstrating its quality, safety, and efficacy in connection with the target

indication(s) for use must be obtained, organized into a format specific for each regulatory authority, submitted for review and

approved by the regulatory authority.

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 in connection with the target indication(s) for use

must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory

Approval Process

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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 on human

subjects 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.

Satisfaction of FDA pre-market approval requirements are inherently uncertain,

expensive, and it 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

typically requires pre-clinical laboratory

and animal tests, the submission to the FDA of an IND, which must become effective before clinical testing on human subjects 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.

Satisfaction of FDA pre-market approval requirements are inherently uncertain, expensive, and it 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.

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

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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

user fee, currently exceeding $4 million for fiscal year 2024 and $3.2 million for fiscal year

2023 (for applications containing clinical data), which increased from $3.1

million for fiscal year 2022.

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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.

fees, currently $393,933 for fiscal year 2023 for each prescription product and $416,734

for fiscal year 2024.

for each prescription product.

The FDA adjusts the user fees on an annual basis,

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the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

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 of COVID-19;

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.

of Clinical Trial Information

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under accelerated regulations are subject to prior review by the FDA.

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 of COVID-19;

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

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to scrutiny under these laws.

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.

Violations 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 it.

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.

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 a violation.

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.

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.

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.

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.

Violations 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 it.

The 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.

The 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.

HIPAA 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 a violation.

HIPAA, as amended by the Health Information Technology for Economic and

Clinical Health Act (“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.

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.

In addition, certain state and local laws require the registration of pharmaceutical sales representatives.

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.

In addition, certain

state and local laws require the registration of pharmaceutical sales representatives.

and foreign laws also govern the privacy and security of health information in some circumstances.

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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

In the U.S., California 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

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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.

A majority of other states have already proposed or enacted

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 amended 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 and enacted 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.

state and federal laws and regulations also require entities to implement “reasonable” or “adequate” security

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could impact the reimbursement

for prescribed drugs and pharmaceuticals, including any products hat we may commercialize or promote in the future.

for prescribed drugs and pharmaceuticals, including any products that 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.

for the products we may commercialize or promote in the future 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.

medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S.

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what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

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 1, 2024.

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.

5376) passed 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.

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 1, 2024.

And, in July 2021, the Biden administration

released an executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription

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, on August 16, 2022, President Biden signed into law the Inflation

Reduction Act of 2022, 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 requiring on drug manufacturers to pay rebates if they increase drug prices “faster than inflation.” 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.

is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the

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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 used.

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.

Accordingly, 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.

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.

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.

Accordingly, decisions

regarding the extent of coverage and amount of reimbursement to be provided for any of MyMD’s product 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.

Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with

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authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

of December 31, 2022, MyMD had nine full-time employees and no part-time employees.

of December 31, 2023, MyMD had six full-time employees and no part-time employees.

MyMD has not experienced any work stoppages.

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given placebo.

are focused on closing out our pivotal Phase 2 aging and sarcopenia study.

Final efficacy data from the Phase 2 study is expected in

the second quarter of 2023.

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.

company intends to submit an IND to the FDA in the second quarter 2023 for the indication of Rheumatoid Arthritis.

This will be followed

by a Phase 2 clinical trial with patients with Rheumatoid Arthritis.

In October 2020 we completed several

in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting MYMD-1 with Humira, Enbrel and Remicade.

MyMD in collaboration with its CRO is in the final stages of preparing the end of Phase II, “A double-blind, randomized, Phase 2

study to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in the treatment of participants aged 65 years or older

with chronic inflammation associated with sarcopenia/frailty” for submission to the FDA.

The submission is planned for the beginning

of the second quarter of 2024.

Exploratory analysis indicates the biomarker sTNFR1 is the most sensitive biomarker for Sarcopenia patients

aged 65-75 years old.

A phase II study for rheumatoid arthritis, “A double-blind, randomized, placebo-controlled multicenter Phase II proof-of-concept

study to evaluate the efficacy, safety, biological activity, and pharmacokinetics of MYMD-1™ added to methotrexate in patients with

moderate-to-severe active rheumatoid arthritis” IND application was reviewed and approved by the FDA to begin clinical trials on

August 9, 2023.

On November 17, 2023 an Annual Report was submitted to the FDA.

October 2020 we completed several in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting MYMD-1 with Humira,

Enbrel and Remicade.

Product Candidate

are currently completing enrollment in the fourth and final cohort of patients in the Phase 2 Aging and Sarcopenia Study (“A Double-Blind,

completed enrollment in the fourth and final cohort of patients in the Phase 2 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 2 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 2 clinical trial on November 1, 2021.

obtained IRB approval on November 16, 2021 which permitted us to start enrollment and dosing qualified participants.

To date, the trial has dosed 80% of its goal sample size of 40 subjects.

The primary objects of the study are to

a) Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD-1 ® versus placebo and b) To

evaluate the PK of oral doses of MYMD-1 ® capsules.

will be accomplished by analyzing the effect on serum levels of sTNFR1, IL-6, and TNF-α over 28 days of treatment as well as

plasma concentrations and urine and parameters of MYMD-1 ®, respectively.

To qualify for the clinical trial, subjects’

biomarkers during the screening period must be within the following Criteria:

IL-6 ≥ 2.5pg/mL;

and/or sTNFR-1 ≥ 1500pg/mL

date, we have randomized and dosed 30/40 subjects across Cohorts 1 (n=10;

600mg), 2 (n=10;

750mg), 3 (n=10;

900mg) and 4 (n=pending;

As mentioned above, MyMD is preparing the submission to the FDA in the beginning of the second quarter of 2024.

analysis indicates the biomarker sTNFR1 is the most sensitive biomarker for Sarcopenia patients aged 65-75 years old.

PK analysis indicates

that PK/PD strategy is consistent at measurements of biomarkers 2-4 hours post-dose.

There were no serious adverse events reported, no

subject dropout’s secondary to an adverse event.

Additionally, there were no clinically significant cardiovascular, ECG issues,

or neurotoxicity issues with any patients during the study.

for Autoimmune Diseases

Dog Study – completed on December 20, 2021:

10-month Dog Study –

completed on December 20, 2021:

A 39-Week Toxicity and Toxicokinetic Study of MYMD-1 by Oral Gavage in Beagle Dogs.

Rat Study – completed on December 17, 2021:

6-month Rat Study –

completed on December 17, 2021:

A 26-Week Toxicity and Toxicokinetic Study of MYMD-1 by Oral Gavage in Rats.

Mouse Study – Completed May 2020 with results pending:

A Preliminary Introductory Traumatic

Optic Neuropathy (TON) in a Mouse study

produced guidance on dosing levels and overall safety in the human studies.

5-Day Mouse Study –

Completed May 2020 with results pending:

A Preliminary Introductory Traumatic Optic Neuropathy (TON) in a Mouse study

Studies produced guidance

on dosing levels and overall safety in the human studies.

MyMD in collaboration with Charles River Laboratories

completed “A 90-Day Oral Gavage Electroencephalogram Safety Study of A Test Item In The Beagle Dog”.

Dosing began on

December 19, 2023, and ended around March 20, 2024.

All animals completed the study and there were no treatment related adverse

events reported.

Bascom Palmer in collaboration with MyMD completed a study “MyMD in Traumatic Optic Neuropathy (TON) in a Rat Pilot Study

Vehicle versus TNFalpha”.

The crush injury raised levels of TNF-α.

After being dosed with MYMD-1, TNF-α levels were

brought down in crush injury compared to controls, but the decrease did not meet statistical significance (p=0.095).

Likely cause of the

result not reaching p<0.05 may be attributed to rebound (e.g.

TNF-α levels would have gone up when MYMD-1 stopped;

may need to me adjusted, The initial data was promising and will guide a longer study in the future.

scientific journal article on MYMD-1 was published in The Journals of Gerontology in August 2022.

This manuscript supports our continued

efforts to conduct a second Phase 2 Trial for Rheumatoid Arthritis in 2023 and additional autoimmune diseases that we may pursue.

Additionally, “MyMD-1 Improves Health Span and Prolongs Life Span in Old Mice:

A Noninferiority Study to Rapamycin” by Johns

Hopkins Medical School.

This journal article 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 further supporting

our transition to Rheumatoid Arthritis.

This manuscript supports our

continued efforts to conduct a second Phase 2 Trial for Rheumatoid Arthritis, which was approved for clinical trials in August 2023, and additional autoimmune diseases that we may pursue.

Additionally, “MyMD-1 Improves Health Span and Prolongs Life Span in

A Noninferiority Study to Rapamycin” by Johns Hopkins Medical School.

This journal article 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 further supporting our transition to Rheumatoid Arthritis.

November 2022, MyMD published “A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study

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journal article details the results from the Phase 1 clinical trial.

Later, an abstract was accepted for presentation at the British Society of Immunology, Liverpool, UK in December 2022.

“Pharmacology

and clinical profile of MYMD-1 ® (isomyosamine), an oral, selective, next-generation, TNF- α inhibitor that crosses

the blood brain barrier” authored by Jenna Brager, Ronald Christopher, Adam Kaplin, and Chris Chapman.

an abstract was accepted for presentation at the British Society of Immunology, Liverpool, UK in December 2022.

“Pharmacology and

clinical profile of MYMD-1 ® (isomyosamine), an oral, selective, next-generation, TNF- α inhibitor that crosses the

blood brain barrier” authored by Jenna Brager, Ronald Christopher, Adam Kaplin, and Chris Chapman.

in to the 2023, an abstract was accepted for presentation at the Society of Toxicology to be presented in March 2023, entitled, “A

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and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis” authored by Chris Chapman and Sonia Edaye.

All publications and abstracts support

the continued development of MYMD-1 ® across various indications.

An abstract for submission of

the Phase II study to the Journal of Immunology or similar upon final development of the clinical safety report.

MyMD with its

partner Frontage Laboratories plans to submit an abstract to the 39 th Japanese Society for the Study of Xenobiotics

(JSSX) and 26 th North American Meeting of International Society for the Study of Xenobiotics (ISSX) in Honolulu, Hawaii;

September 15-18, 2024.

Identification of the Major Circulating Norcotinine and Elucidation of the Mechanism of Clearance of MYMD-1

Role of Aldehyde Oxidase and CYP2A6.

publications and abstracts support the continued development of MYMD-1 ® across various indications.

for Hashimoto’s Thyroiditis

February 18, 2022, 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 1 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.

dose group, there was a decrease in TNF-α levels found in MYMD-1 treated subjects, but no change in the levels in subjects

On February 18, 2022, we

submitted an Annual Update to the FDA for the previously opened Hashimoto’s Thyroiditis IND.

Another Annual Report was submitted to the FDA on November 22.

Phase 11 study for Hashimoto’s Thyroiditis is open for protocol

development and submission to the FDA.

In April 2021, the FDA

gave clearance for a Phase 1 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.

Analyses 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.

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 1 clinical trial was submitted to the FDA on September 14, 2021 as part of the Annual IND update for Hashimoto’s

Thyroiditis IND.

The data from the Phase

1 clinical trial was submitted to the FDA on September 14, 2021 as part of the Annual IND update for Hashimoto’s Thyroiditis

The FDA responded by providing guidance on moving forward with Phase 2 clinical trials.

data was also included in a new commercial IND to the FDA on September 22, 2021.

This 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.

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in subjects given placebo.

plan to manage our pivotal Phase 2 aging and sarcopenia study.

Final efficacy data from the Phase 2 study is expected in the second quarter

Final efficacy data from the Phase 2 study is expected in 2024.

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.

company intends to submit an IND to the FDA in the second quarter 2023 for the indication Rheumatoid Arthritis.

MyMD Pharmaceuticals,

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

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property for MYMD-1 in the United States and abroad.

Patent Issued March 26, 2024:

US Application 17/851,862:

Method of Treating Diseases of the Visual System.

Product Candidate

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company presented data referencing Super-CBD at the 4 th Annual International Cannabinoid Summit on September 9, 2021.

2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific review and determined that it would

not Supera-CBD a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

believe that this decision will expedite future research involving Supera-CBD by relieving us or our research partners from having to

comply with regulations relating to controlled substances.

March 2, 2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific review and determined that

it would not Supera-CBD a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

We believe that this decision will expedite future research involving Supera-CBD by relieving us or our research partners from having

to comply with regulations relating to controlled substances.

plan to continue our preclinical program starting genotoxicity studies in Europe.

Those studies include:

profiling and Ames test (initiation December 21, 2021;

Metabolic profiling and

Ames test (initiation December 21, 2021;

completion January 20, 2022) and

Micronucleus test (initiation December 21, 2021;

Micronucleus test (initiation

December 21, 2021;

completion February 20, 2022).

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CBD Acute Pain and Inflammation begins has been funded for 2022

2022 and 2023.

National Institutes of Health is planning to work on a grant for Supera-CBD in Epilepsy for the third quarter 2023.

manufacturing, we expect to continue providing GMP Supera-CBD materials for the preclinical toxicity programs.

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analysis to provide GMP materials for long term toxicity and Human trials.

example of continued efforts include the JHM Research is conducting a study with MYMD-1 and L/R-Supera-CBD for Depression and

Plus Maze and Fear Conditioning

response study.

open field and Y maze study.

LPS induced depression.

example of continued efforts include the JHM Research is conducting a study with MYMD-1 and L/R-Supera-CBD for Depression and Anxiety.

Forced Swim Test

Tail suspension

Elevated Plus Maze and

Fear Conditioning

Dose response study.

Supera-CBD open field and

Y maze study.

MYMD-1 LPS induced depression.

website address is www.mymd.com .

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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