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Item 1. Business

2023-03-31 compared with 2022-03-31 · 1072 added, 1056 removed, 309 unchanged (87% of the section changed)

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,

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.

prior to the Merger.

For more information

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

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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, 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.

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.

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

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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.

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 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 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 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.

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.

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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

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

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

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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.

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.

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

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.

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.

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

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.

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”)

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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.

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.

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.

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.

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 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;

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;

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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;

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 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.

and (3) COVID-19 associated

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

An Immunometabolic Regulator

Inflammation,

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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.

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.

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

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 micromoles.

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

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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.

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.

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

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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).

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.

market for TNF-α blockers was estimated at $41.6 billion in 2020 and is projected to reach $45.5 billion by 2027.

in 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.

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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)

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.

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.

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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.

in vivo 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

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

Effects of 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).

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)

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.

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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.

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.

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).

MYMD-1 decreases the incidence and severity of autoimmune thyroiditis in NOD.H-2h4 mice, as assessed by H&E histopathology.

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:

10 M, 6 F) or did not contain (16 mice:

10 M, 6 F) MYMD-1

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.

(A and B) Thyroiditis severity and incidence assessed

by histopathology in the regular water group.

(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).

(H) 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

Targets Inflamm-Aging and Related Disorders

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.

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.

Palmer Eye Institute Collaboration

July 12, 2022, we announced a new collaboration with Bascom Palmer Eye Institute of Miami, Florida (“Bascom Palmer”) to collaborate

on a pre-clinical study using MYMD-1 as a potential treatment for traumatic optic neuropathy (TON).

To date, our collaboration with Bascom

Palmer has included pre-clinical and clinical investigations.

In July 2022 we entered into a Material

Transfer Agreement with Bascom Palmer.

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.

Commercialization Targets

MYMD-1 is being developed

to address multiple autoimmune diseases and inflamm-aging.

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).

According to the U.S.

Census Bureau, in 2020, there were approximately

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.

54 million U.S.

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.

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

Department of Health and Human Services.

2020 Profile of Older Americans.

May 2021 Page 3.

The Arthritis Foundation.

Rheumatoid Arthritis:

Causes, Symptoms, Treatments and More.

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.

In the 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.

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

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

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.

MyMD conducted an in vitro MAO

inhibition study.

MyMD conducted an in vitro MAO inhibition

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,

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.

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

Early-Stage Plans for Development and Potential Commercialization Targets

is in early-stage development for pain, anxiety, and sleep disorders.

There are currently a number of over-the-counter CBD products marketed

with unapproved therapeutic claims relating to these conditions, among other conditions.

While there are a substantial number of such

products on the market that have not been subject to regulatory enforcement action, the FDA has consistently reiterated, in guidance

and warning letters against a number of the companies marketing such CBD products for such uses, that CBD products may not be lawfully

marketed for therapeutic uses in the United States without first-obtaining FDA approval via the NDA process.

CBD product sales in the

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,

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

there is one FDA-approved drug with plant-derived CBD as an active ingredient.

FDA subsequently approved three other cannabinoid-containing

drugs, two of which utilize synthetic cannabinoids analogous or similar to THC as the active ingredient and the other, a combination

of synthetic CBD and THC.

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.

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.

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.

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.

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.

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.

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.

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.

US Hemp CBD Market To Hit $5.3B In Sales In 2021.

https://www.thebusinessresearchcompany.com/report/tnf-alpha-inhibitor-global-market-report

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

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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

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 treatments;

(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.

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

patents, four pending U.S.

patent applications, 50 issued foreign patents, and

15 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.

26 unchanged sentences

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.

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.

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.

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:

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 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

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.

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

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.

(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;

(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.

patients and subsequent protocol amendments must be submitted to the FDA as

part of the IND.

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.

The study 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.

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.

trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

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.

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.

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.

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.

The FDA adjusts the user fees on an annual basis,

and the fees typically increase annually.

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

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.

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.

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.

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

The FDA has committed to reviewing resubmissions in two to six months depending on the type of information included.

such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

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.

2 unchanged sentences

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.

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

A 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.

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.

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

of clinical trials of FDA regulated products, including drugs, are required to register and disclose certain clinical trial information

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.

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.

Development and Review Programs

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.

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,

MyMD 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.

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.

The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information

and the sponsor must pay applicable user fees.

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.

Therapy Designation

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.

may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development

providing timely advice to the product sponsor regarding development and approval;

involving more senior staff in the review

assigning a cross-disciplinary project lead for the review team;

and taking other steps to design the clinical trials in an

efficient manner.

Review Designation

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.

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.

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

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.

7 unchanged sentences

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

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.

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.

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 new drug.

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.

Regulatory Matters

Manufacturing,

sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in

in addition 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.

Healthcare Laws

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 below.

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.

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.

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.

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.

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.

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

16 unchanged sentences

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.

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

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.

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.

and Future Healthcare Reform Legislation

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 reforms.

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.

This 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

At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on

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.

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.

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 savings.

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.

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.

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.

Supreme Court held that the legislation improperly required the states to expand their Medicaid

programs to cover more individuals.

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 programs.

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.

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.

financial impact of U.S.

healthcare reform legislation over the next few years will depend on a number of factors, including the policies

5 unchanged sentences

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.

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

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,

On 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.

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.

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.

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.

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.

and Distribution in the United States

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.

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;

Manufacturing,

sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws.

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.

failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action.

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.

in regulations, statutes or the interpretation of existing regulations could impact MyMD’s business in the future by requiring,

(i) changes to MyMD’s manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall or discontinuation

of MyMD’s products;

(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.

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.

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 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.

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.

Budget Reconciliation Act of 1990.

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.

While 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.

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.

a drug product to receive federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S.

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

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

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.

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

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

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.

18 unchanged sentences

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.

of December 31, 2022, MyMD had nine 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

of 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 2023

November 2022, the company published data from the Phase 1 dosing study for MYMD-1 as a treatment for aging.

There was a statistically

significant decrease in TNF-α levels (p-value <0.05) found in one MYMD-1 treated cohort, but no change in the levels in subjects

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.

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”).

are currently completing 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

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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.

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 II clinical trial on November 1, 2021.

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

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;

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.

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

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.

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.

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.

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.

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

to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects” Authors:

Jenna Brager, Chris Chapman, Leonard Dunn, and Adam Kaplin in Drug Research.

This became available in print in February 28, 2023.

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.

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

Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNFa, MYMD-1 (Isomyosamine), Significantly Reduced the Inflammation

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.

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;

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

2 unchanged sentences

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.

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

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 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.

5 unchanged sentences

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.

a Metabolite Identification and Quantitation of MYMD-1 in Rat, Dog, and Human Plasma Samples:

Metabolites in Safety Testing (MIST) was

completed in October 2022.

MYMD-1 was extensively metabolized, and was detected at low levels (<5%) in human plasma.

November 2022, the company published 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.

significant decrease in TNF-α levels (p-value <0.05) found in one MYMD-1 treated subjects cohort, but no change in the levels

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

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

11 unchanged sentences

for this pilot Phase 2 study in the fourth quarter 2024.

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.

5 unchanged sentences

provide GMP product other that capsules for long-term human trials.

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.

We will continue to prosecute patents to protect intellectual

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

Product Candidate

4 unchanged sentences

Addiction and Other Disorders,” covering the Super-CBD product candidate and its pharmaceutical formulations.

During 2021 and 2022

corresponding foreign patents were awarded in Australia, Canada, Europe, Israel, and South Korea, and patents are pending in China and

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 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.

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

1 unchanged sentence

profiling and Ames test (initiation December 21, 2021;

completion January 20, 2022) Micronucleus

test (initiation December 21, 2021;

completion January 20, 2022) and

Micronucleus test (initiation December 21, 2021;

completion February 20,

1 unchanged sentence

CBD Acute Pain and Inflammation begins has been funded for

2022 and 2023.

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

2 unchanged sentences

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.

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

2 unchanged sentences

LPS induced depression.

Available information

website address is www.mymd.com .

4 unchanged sentences

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