What changed in this filing

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Item 1. Business

2025-04-11 compared with 2024-04-01 · 542 added, 595 removed, 737 unchanged (61% of the section changed)

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

MyMD is focused on developing and commercializing

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

MYMD-1 is a clinical stage

small molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited to) rheumatoid arthritis, and inflammatory bowel disease.

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

frailty and sarcopenia.

MYMD-1 works by regulating the release of numerous pro-inflammatory cytokines, such as TNF-α, interleukin

6 (“IL-6”) and interleukin 17 (“IL-17”)

Supera-CBD is a synthetic

analog of CBD being developed to treat various conditions, including, but not limited to, epilepsy, pain and anxiety/depression,

TNF is focused on developing and commercializing

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

Isomyosamine is a clinical stage small

molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited to) sarcopenia, frailty, adverse

effects of drugs used to treat diabetes and obesity, rheumatoid arthritis, and inflammatory bowel disease.

The first indication for which

Isomyosamine is being developed is to treat age-related frailty and sarcopenia.

Isomyosamine 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 (as defined below) immediately

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

rights to Supera-CBD TM were previously owned by Supera Pharmaceuticals, Inc.

(“Supera”) and were acquired by MyMD

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

Background and Corporate History

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

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

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

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

Williams, Sr.

The company’s

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

Williams is settlor/grantor.

During the period from November 2014

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

an entity affiliated with Mr.

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

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

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

During the period 2016 through October of 2020, MyMD’s principal

business activities consisted of the execution and completion of in vitro assays, in vivo pre-clinical animal studies, and

genotoxicity and toxicology studies relating to MYMD-1 (as further described below).

On June 25, 2019, MyMD commenced a Phase 1 trial

in healthy volunteers for pharmacokinetics and tolerability studies, and in December of 2019 MyMD filed an IND for MYMD-1 for treatment

of Hashimoto thyroiditis.

The Phase 1 trial was completed on January 30, 2020, after which MyMD commenced preparation of a Phase 2 clinical

trial for MYMD-1 The company has also commenced a Phase 2 clinical trial for patients with sarcopenia, with dosing begin in the first

quarter of 2022.

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

The clinical safety report is currently under development.

Additionally, MyMD is working with Charles River Laboratories to conduct

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

began on December 19, 2023.

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

Williams is the

settlor/grantor.

During the period from November 2014 through November 2016, TNF was primarily focused on drug discovery and

establishing its patent position through SRQ Patent Holdings, an entity affiliated with Mr.

In November 2016, SRQ Patent

Holdings assigned to the Company all the patent rights and other intellectual property relating to Isomyosamine pursuant to an

agreement under which the Company granted to SRQ Patent Holdings a royalty based on product sales and other revenue arising from the

assigned intellectual property (as further described below).

the period 2016 through October of 2020, the Company’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 Isomyosamine (as

further described below).

On June 25, 2019, the Company commenced a Phase 1 trial in healthy volunteers for pharmacokinetics and tolerability

studies, and in December of 2019, the Company filed an IND for Isomyosamine for treatment of Hashimoto thyroiditis.

The Phase 1 trial was completed

on January 30, 2020, after which the Company commenced preparation of a Phase 2 clinical trial for Isomyosamine.

The Company has also commenced

a Phase 2 clinical trial for patients with sarcopenia, with dosing that began in the first quarter of 2022.

The last patient visit took

place on June 6, 2023.

Additionally, the Company together with h Charles River Laboratories has conducted a study titled “A 13 Week

Electroencephalogram Safety Study of MYMD-1 by Oral Gavage Administration in Beagle Dog.” Analysis and reporting were completed

in December 2024 and the results have been favorably received by the FDA.

Merger and Corporate Transactions

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

immediately following the closing of the Merger.

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

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

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

As partial consideration for such assignment, Supera has granted to SRQ Patent Holdings II, LLC a royalty with respect to product

sales and other consideration arising from the assigned intellectual property.

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

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

other coronavirus infections.

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

Agreement”) by and among the Company, Cystron, Oravax Medical, Inc.

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

therein, Premas, the Company caused Cystron to contribute substantially all of the assets associated with its business of developing

and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax.

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

MyMD’s interest in Oravax consists of 13% of Oravax’s outstanding shares of capital stock and the rights to a 2.5% royalty

on all future net sales.

MyMD has evaluated several options with respect to its interest in Oravax, including a potential distribution

of Oravax shares to the MyMD shareholders.

immediately following the closing of the Merger (the “Milestone Period”).

On April 16, 2024, the Milestone Period expired and accordingly, the pre-Merger

MyMD Florida stockholders are no longer entitled to any potential Milestone Payments pursuant to the Merger Agreement.

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

Supera, pursuant to which, MyMD Florida agreed to acquire from Supera substantially all of the assets (including all rights to

Supera-CBD) and certain obligations of Supera in consideration of the issuance of an aggregate of 13,096,640 shares of MyMD Florida

Common Stock to Supera.

As partial consideration for such an assignment, Supera granted to SRQ Patent Holdings II, LLC a royalty

with respect to product sales and other consideration arising from the assigned intellectual property.

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

Biotech PVT Ltd.

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

COVID-19 and other coronavirus infections.

On April 16, 2021, pursuant to a Contribution and Assignment Agreement, dated March 18,

2021 (the “Contribution Agreement”) by and among the Company, Cystron, Oravax Medical, Inc.

(“Oravax”) and,

for the limited purpose set forth therein, Premas, the Company caused Cystron to contribute substantially all of the assets

associated with its business of developing and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax (the “Contribution Transaction”).

pursuing the development of the COVID-19 vaccine candidate.

The Company’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.

The Company has evaluated several

options with respect to its interest in Oravax, including a potential distribution of Oravax shares to the Company’s

stockholders.

This would make Oravax a publicly held company.

In addition, MyMD currently has the right

to designate a member of the board of directors of Oravax, pursuant to which Mr.

Joshua Silverman, our Chairman of the Board, has been

designated to serve as a director of Oravax.

of MyMD Florida

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

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

Reincorporation

On March 4, 2024, the Reincorporation

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

is developing two platform drugs targeting numerous disease indications.

Below is MyMD’s development pipeline:

In addition, TNF 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.

Reincorporation and Name Change

July 22, 2024, the Company changed its name from MyMD Pharmaceuticals, Inc.

to TNF Pharmaceuticals, Inc.

by filing a certificate of amendment

to its certificate of incorporation with the Secretary of State of Delaware.

In addition, effective before the open of market trading

on July 24, 2024, the Company’s common stock, par value $0.001 per share (“Common Stock”) ceased trading under the

ticker symbol “MYMD” and began trading on the Nasdaq Stock Market under the ticker symbol “TNFA.”

the Company’s annual meeting of stockholders held on July 31, 2023, the stockholders approved a plan to merge the Company with

and into a newly formed wholly owned subsidiary, MyMD Pharmaceuticals, Inc., a Delaware corporation (“MyMD Delaware”), with

MyMD Delaware being the surviving corporation, for the purpose of changing the Company’s state of incorporation from New Jersey

to Delaware (the “Reincorporation”).

The Reincorporation was effected as of March 4, 2024.

In connection with the Reincorporation

to Delaware, the par value of the Company’s Common Stock and preferred stock was changed to $0.001 per share.

Delaware is deemed to be the successor issuer of MyMD New Jersey under Rule 12g-3 of the Securities Exchange Act of 1934, as amended.

Reincorporation did not result in any change in the Company’s name, business, management, fiscal year, accounting, location of

the principal executive offices, assets or liabilities.

Holders of shares of the Company’s Common

Stock did not have to exchange their existing MyMD New Jersey stock certificates for MyMD Delaware stock certificates.

of the Effective Date of the Reincorporation, the rights of the Company’s stockholders are governed by the Delaware General Corporation

Law, the MyMD Delaware Certificate of Incorporation and the Bylaws of MyMD Delaware.

TNF is developing two platform drugs targeting numerous disease indications.

Below is TNF’s development pipeline:

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

therapeutic targets.

Below are MyMD’s key clinical strategies:

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

loss) in the second quarter of 2023;

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

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

and Hashimoto’s Thyroiditis;

Execute on IND-enabling

studies of Supera-CBD to enable submission of an IND for a Phase 1 clinical trial in healthy volunteers followed by Phase 2 clinical

trials in epilepsy, addiction and anxiety disorders;

Identify and validate additional

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

Maintain broad commercial

rights to MyMD’s product candidates;

Continue to strengthen

and expand MyMD’s intellectual property portfolio.

MYMD-1 is a clinical stage drug that targets the immune system by inhibiting

the release of pro-inflammatory cytokines, such as TNF-α.

Cytokines are a broad category of molecules involved in immune system

coordination.

Immunometabolic regulation is the system of regulating the immune system and its pro-inflammatory cytokines in order to

prevent and treat autoimmune diseases and age-related illnesses.

By affecting the initial triggers that drive autoimmunity, MYMD-1 targets

the underlying cause of these diseases rather than just their symptoms.

Based on MYMD-1’s Phase 1 clinical trial, completed in January

2020, MyMD has completed a Phase 2 clinical trial for sarcopenia (age-related muscle loss) and is planning a Phase 2 clinical trial for

rheumatoid arthritis.

MyMD has an active IND with the Endocrinology Division at the FDA for other autoimmune diseases.

Studies have been

completed on the mechanisms of action and efficacy of MYMD-1 in several pre-clinical models of autoimmune diseases (i.e., experimental

autoimmune encephalomyelitis (“EAE”) that models multiple sclerosis and autoimmune thyroiditis), and these studies have been

published in peer reviewed journals.

MyMD plans to pursue these indications.

An Immunometabolic Regulator

Inflammation,

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

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

However, elevated

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

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

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

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

TNF-α, without preventing normal immune cell function.

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

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

Examples of currently approved immunometabolic regulating

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

transplants and being studied in aging).

is a novel immunometabolic regulator that has demonstrated in vitro and in vivo ability to regulate the release of multiple

cytokines from immune cells, including TNF-α.

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

sclerosis, diabetes, inflammatory bowel disease, rheumatoid arthritis, and aging.

Below are TNF’s key clinical strategies:

a 28-day Phase 2 clinical trial in sarcopenia (i.e., age-related muscle loss) in the second quarter of 2023, which showed safety and tolerability of Isomyosamine at clinically effective

Initiated a 90-day Phase 2 clinical trial in sarcopenia to evaluate improvement

in clinical outcomes in older sarcopenic patients who have sustained a hip or femur fracture;

Advance Isomyosamine into Phase 2 clinical trials for rheumatoid arthritis

and deleterious effects of drugs (GLP-1 agonists) used in patients with Type II diabetes to assist in weight loss;

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 TNF’s product candidates;

to strengthen and expand TNF’s intellectual property portfolio.

Isomyosamine is a clinical stage

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

Cytokines are a broad

category of molecules involved in immune system coordination(“Immunometabolic regulation”).

By affecting the initial triggers

that drive autoimmunity, Isomyosamine targets the underlying cause of these diseases rather than just their symptoms.

TNF has completed

a 28-day Phase 2 clinical trial for sarcopenia (age-related muscle loss) that showed safety and tolerability at clinically meaningful

doses, without dose-limiting side effects or immunosuppression.

TNF has initiated a Phase 2b clinical trial to evaluate clinical outcome

improvements in sarcopenic patients who have sustained a hip or femur fracture.

TNF 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 Isomyosamine 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.

TNF plans to pursue these indications.

Isomyosamine :

inhibitor without immunosuppressive liability

Inflammation, activated through

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

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

However, elevated levels of pro-inflammatory

cytokines, including TNF-α, can lead to prolonged, chronic inflammation, which is closely linked to autoimmune diseases (such as

multiple sclerosis, diabetes, rheumatoid arthritis) and aging (i.e., inflamm-aging) as well as cardiovascular disease and cancers, all

of which may result in reduced health span (the period of life spent in good health).

The goal of Isomyosamine is to

target immune cells that overproduce pro-inflammatory cytokines, such as TNF-α, without preventing normal immune cell function.

TNF-α is a cytokine that is released by immune cells that plays a key role in acute and chronic inflammation, autoimmune diseases

Isomyosamine is a novel small

molecule orally available “immunometabolic” regulator that has demonstrated in vitro and in vivo activity to

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

Isomyosamine is being developed to treat chronic

inflammatory diseases, with the initial priority of complications of sarcopenia and frailty, which together affect more than 1,000,000

patients in the US.

Regulates Multiple Cytokines

conducted an in vitro study to demonstrate that MYMD-1 regulates a broad range of cytokines, including TNF-α, interferon gamma

conducted an in vitro study to demonstrate that Isomyosamine 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

to play key roles in the development and maintenance of autoimmune diseases, Isomyosamine 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,

Isomyosamine modulates the release of a broad spectrum of cytokines.

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

IL-16 and IL-17a.

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

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

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

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

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

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

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

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

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

Cytokines were measured

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

(A and B) MYMD-1 significantly decreased serum

(A and B) Isomyosamine significantly decreased serum

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

(C and D) MYMD-1 showed a modest

(C and D) Isomyosamine showed a modest

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

Results are from three independent experiments.

The results are from three independent experiments.

Statistical comparisons were made

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

MYMD-1 is also

Isomyosamine is also

being developed to treat age-related illnesses such as frailty and sarcopenia.

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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.

Isomyosamine 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

in vitro study involving human blood cells analyzed the cytokine inhibitory effects of Isomyosamine together with leading approved TNF-α

blockers (monoclonal antibodies).

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

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

Comparison of inhibitory effect of Isomyosamine with other TNF-α blockers.

Isomyosamine exhibits a dose-dependent reduction in release of

several cytokine more effectively than Humira, Enbrel and Remicade.

believe MYMD-1 is distinguishable from currently marketed TNF-α blockers because it selectively blocks TNF-α production related

believe Isomyosamine 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

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

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

our belief regarding the selectivity of Isomyosamine in blocking TNF-α, therefore, we intend to explore the extent to which Isomyosamine 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)

Study of Isomyosamine 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.

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.

in vivo studies of the therapeutic efficacy of Isomyosamine in the animal model for multiple sclerosis, known as EAE, indicate that

Isomyosamine 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 Isomyosamine suppresses the influx of CD4+ T cells into the brain.

Effects of Isomyosamine on the influx of T cells into the CNS early in EAE.

To assess the effects of Isomyosamine on the infiltration of T cells

into the CNS, mice were immunized and treated with either vehicle control or 25 mg/mouse/day Isomyosamine.

Ten to 14 days later, mice were

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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.

of this study show Isomyosamine’s ability to suppress TNF-α production by CD-4+ T cells in a dose dependent manner.

Additionally,

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

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

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

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

studies have demonstrated that Isomyosamine ameliorated autoimmune thyroiditis in the thyroiditis mouse model.

Isomyosamine 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.

3 F) drank water that contained Isomyosamine (185 mg/l), and 16 mice (10 M, 6 F) drank water without it.

In the iodinated water group, the

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

10 M, 6 F) MYMD-1

10 M, 6 F) Isomyosamine

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

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(D) A representative thyroid from a mouse in the regular water group treated with MYMD-1, showing thyroid follicle preservation

(D) A representative thyroid from a mouse in the regular water group treated with Isomyosamine, showing thyroid follicle preservation

and an overall normal glandular size (severity score of 0).

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(H) A representative thyroid from a mouse in the iodine plus

MYMD-1 group (severity score of 2).

Isomyosamine group (severity score of 2).

Results represent the summary of 10 independent experiments, each analyzing 4 to 6 mice, for a total

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A multi-year pre-clinical, proof of concept in vivo study in aging and longevity

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

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

other relevant submissions.

Palmer Eye Institute Collaboration

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

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

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

Investigators ran a

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

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

of 30 mg/kg of body weight.

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

were measured.

The crush injury raised levels of TNF-α.

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

statistical significance (p=0.095).

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

would have gone up when MYMD-1 stopped;

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

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

Additional studies are not planned for now.

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

with Bascom Palmer to plan a clinical study.

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

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

Anterior Uveitis:

A Randomized Controlled, Double Blind Clinical Study.

This program is not active.

confirmed our belief regarding Isomyosamine’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.

Commercialization Targets

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May 2021 Page 3.

Arthritis Foundation.

The Arthritis Foundation.

Rheumatoid Arthritis:

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

MyMD conducted an in vitro binding

TNF conducted an in vitro binding

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

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

MyMD conducted an in vitro MAO inhibition

TNF conducted an in vitro MAO inhibition study.

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

In this study, Supera-CBD far

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

Drugs that inhibit MAOs have been commercially used for decades

to treat depression, and more recent studies have suggested MAO-B inhibiting drugs might have a role to play in treating cognitive decline

In 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

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.

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 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

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.

3 TNF 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 post market regulation, which provides additional assurances relating to quality, consistency and

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

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year 2019 were approximately $296 million.

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

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

from naturally grown plant extracts.

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

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

grown plant extracts.

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

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to comply with regulations relating to controlled substances.

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

and Marketing

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

MyMD intends to build such capabilities

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

North America, MyMD may rely on licensing, co-sale and co-promotion agreements with strategic partners for commercialization of its products.

If MyMD builds a commercial infrastructure to support marketing in North America, such commercial infrastructure could be expected to

TNF intends to build such capabilities

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

North America, TNF may rely on licensing, co-sale and co-promotion agreements with strategic partners for commercialization of its products.

If TNF 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.

To develop the appropriate commercial infrastructure internally, TNF would have to invest financial and management resources, some of

which would have to be deployed prior to any confirmation that Isomyosamine 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

Any product candidates that TNF 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,

While TNF believes that its drug candidates, development experience and scientific knowledge may provide

it with certain competitive advantages, TNF 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.

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sales in 2022.

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

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

orally bioavailable.

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

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

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

currently marketed TNF-α blockers, Isomyosamine 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

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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

TNF thus believes that, if Isomyosamine

is approved for marketing, the potential selectivity of Isomyosamine 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.

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

of MyMD’s business.

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

develop and maintain MyMD’s proprietary position.

patent portfolio includes protection for MYMD’s lead product candidates, MYMD-1 and Supera-CBD.

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

and foreign patents

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

of TNF’s business.

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

and maintain TNF’s proprietary position.

patent portfolio includes protection for TNF’s lead product candidates, Isomyosamine and Supera-CBD.

Currently, there are multiple patent

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and (iv) methods of increasing hair growth.

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

patents, three pending U.S.

patent applications, 64 issued foreign patents, and

10 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 2041.

As of the date of this

document, TNF has 18 issued U.S.

patents, one pending U.S.

patent application, 69 issued foreign patents, and 5 foreign patent applications

pending in such jurisdictions as Canada, China, Israel, and Japan which, if issued, are expected

to expire between 2036 and 2041.

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

In most countries

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

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

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

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

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

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

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

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

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

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

and Royalty Agreements

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

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

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

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

covered by the intellectual property that was assigned to MyMD.

covered by the intellectual property that was assigned to TNF.

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

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Approval Process

the U.S., pharmaceutical products are subject to extensive regulation under the FD&C Act and the FDA’s implementing regulations

the U.S., pharmaceutical products are subject to extensive regulation under the Food, Drug & Cosmetic Act (“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,

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Clinical trials involve

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

the administration of the new investigational 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

(ii) in compliance with Good Clinical Practices (“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;

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and ethics committee for approval.

The IRB will also monitor the clinical trial until completed.

The IRB will also monitor the clinical trial until it is completed.

An IRB may also require the clinical

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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 $4 million for fiscal year 2024 and $3.2 million for fiscal year

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

million for fiscal year 2022.

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

for fiscal year 2024.

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 $4.3 million for fiscal year 2025 and

$4 million for fiscal year 2024 (for applications containing clinical data), which increased from $3.2 million for fiscal year 2023.

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 $416,734 for fiscal

year 2024 for each prescription product and $403,889 for fiscal year 2025.

for each prescription product.

The FDA adjusts the user fees on an annual basis,

and the fees typically increase annually.

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.

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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.

they comply with Current Good Manufacturing Practice (“cGMP”) requirements.

The FDA will not approve the product unless it determines that the manufacturing processes and facilities

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priority review designation.

MyMD has not applied for expedited approval under any of these pathways to-date but intends to explore the

TNF 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

that FDA will grant any of TNF’s products candidates the expedited designation(s) for which it is submitted, if any, or that TNF

will secure any of the applicable benefits associated with any of any expedited designations that may be granted to its current or future

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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

The Company currently relies on third parties to produce clinical quantities of its drug candidates under development in accordance with applicable

GCPs and Good Laboratory Practices (“GLPs”), and expects to continue to rely, on third parties to produce clinical and commercial quantities of the Company’s products

that are approved for marketing in the United States, if any, in accordance with cGMP regulations.

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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

in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of the U.S.

Department of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer

Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection

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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.

TNF may obtain marketing approval.

TNF’s current and future arrangements with third-party payors, healthcare providers and physicians

may expose TNF to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial

arrangements and relationships through which TNF markets, sells and distributes any drugs for which the Company 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

The Company’s business operations,

including its research, marketing, and activities relating to the reporting of wholesale or estimated retail prices for TNF’s products,

the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party

reimbursement for TNF’s products, and the sale and marketing of TNF’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.

Violations of this law are punishable by imprisonment, criminal

fines, administrative civil money penalties and exclusion from participation in federal healthcare programs.

In addition, a person

or entity does not need to have actual knowledge of the statute or specific intent to violate it.

The federal civil and criminal

false claims laws, including the FCA, which can be enforced through civil whistleblower or qui tam actions, which impose penalties

against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented

false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment

of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government.

The government may deem

manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing

or coding information to customers or promoting a product off-label.

Claims that include items or services resulting from a violation

of the AKS are false or fraudulent claims for purposes of the FCA.

The federal anti-inducement

law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer

of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary

that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or

services reimbursable by a federal or state governmental program.

HIPAA imposes criminal

and civil liability for knowingly and willfully executing a scheme, or attempting to execute a scheme, to defraud any healthcare

benefit program, including private payors, or falsifying, concealing or covering up a material fact or making any materially false

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

Similar to the AKS, a person

or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate

it in order to have committed a violation.

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

Clinical Health Act (“HITECH”),

and their respective implementing regulations, imposes, among other things, specified requirements on covered entities and their

business associates relating to the privacy and security of individually identifiable health information including mandatory contractual

terms and required implementation of technical safeguards of such information.

HITECH also created new tiers of civil monetary penalties,

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

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

fees and costs associated with pursuing federal civil actions.

The PPSA, enacted as part

of the ACA, imposed new annual reporting requirements for certain manufacturers of drugs, devices, biologics, and medical supplies

for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, for certain payments and

“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors)

and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

January 1, 2022, these reporting obligations extend to include transfers of value made during the previous year to certain non-physician

providers such as physician assistants and nurse practitioners.

Analogous state and foreign

fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply

regardless of payor.

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 federal False Claims Act (“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.

The Health Insurance Portability and Accountability Act (“HIPAA”)

imposes criminal and civil liability for knowingly and willfully executing a scheme, or attempting to execute a scheme, to defraud

any healthcare benefit program, including private payors, or falsifying, concealing or covering up a material fact or making any

materially false statements in connection with the delivery of or payment for healthcare benefits, items or services.

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 the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective

implementing regulations, imposes, among other things, specified requirements on covered entities and their business associates relating

to the privacy and security of individually identifiable health information including mandatory contractual terms and required implementation

of technical safeguards of such information.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil

and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions

for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated

with pursuing federal civil actions.

federal Physician Payment Sunshine Act of 2021 (“PPSA”), enacted as part of the Patient Protection and Affordable Care Act (“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.

Some state laws

require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant

federal government compliance guidance, require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers, and restrict marketing practices or require disclosure of marketing expenditures.

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

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

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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

focus on privacy may result in amendments or changes to these laws in ways that may have an impact on TNF’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 enacted the CCPA, which

creates new individual privacy rights for California consumers (generally defined as any resident of California, including employees

and other business relations) and places increased privacy and security obligations on entities handling personal information of consumers

or households.

The CCPA also greatly extends the obligations of entities that process personal information to include information not

traditionally viewed as personal information and regulated by laws, such as Internet Protocol (IP) addresses, unique identifiers for

individuals, and information in online cookies and other online technologies.

A majority of other states have already proposed or enacted

laws similar to the CCPA, each differing in scope of the personal information covered and the rights of individuals.

Furthermore, the

CCPA has already been amended with the passage of California’s Proposition 24 (the California Privacy Rights Act, “CPRA”),

which adds additional rights and obligations.

While the CCPA and CPRA currently provide relatively broad exclusions for protected health

information regulated by HIPAA and clinical trials and a limited exception for consumer and business to business information, some of

the proposed and enacted laws in other states may not contain the same exceptions.

Furthermore, there have been a number of competing

proposals for federal laws, some of which propose to not preempt other state laws.

The uncertainty surrounding proposed new and changes

to existing privacy laws may lead to operational challenges for MYMD to comply with multiple, potentially conflicting, privacy and cybersecurity

laws related to the collection and use of personal information in each jurisdiction.

increased attention on privacy in the United States may also impact TNF’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.

U.S., California enacted the CCPA, which creates new individual privacy rights for California consumers (generally defined as any

resident of California, including employees and other business relations) and places increased privacy and security obligations on

entities handling personal information of consumers or households.

The CCPA also greatly extends the obligations of entities that

process personal information to include information not traditionally viewed as personal information and regulated by laws, such as

Internet Protocol (IP) addresses, unique identifiers for individuals, and information in online cookies and other online

technologies.

A majority of other states have already proposed or enacted laws similar to the CCPA, each differing in scope of the

personal information covered and the rights of individuals.

Furthermore, the CCPA has already been amended with the passage of

California’s Proposition 24 (the California Privacy Rights Act, “CPRA”), which adds additional rights and

While the CCPA and CPRA currently provide relatively broad exclusions for protected health information regulated by

HIPAA and clinical trials and a limited exception for consumer and business to business information, some of the proposed and

enacted laws in other states may not contain the same exceptions.

Furthermore, there have been a number of competing proposals for

federal laws, some of which propose to not preempt other state laws.

The uncertainty surrounding new proposed and changes to

existing privacy laws may lead to operational challenges for TNF to comply with multiple, potentially conflicting, privacy and

cybersecurity laws related to the collection and use of personal information in each jurisdiction.

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

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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

This may result in potential liability if a regulator finds that TNF’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.

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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.

It is possible that governmental authorities will conclude that TNF’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 TNF’s operations are found to be in violation of any of these laws or any other related governmental regulations

that may apply to it, TNF 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 TNF 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 TNF’s operations.

If any of the physicians or other healthcare providers

or entities with whom TNF 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

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to litigate various aspects of the legislation.

On July 26, 2012, the U.S.

In June 2012, the U.S.

Supreme Court generally upheld the provisions of the ACA at

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policies are often revised or interpreted in ways that may significantly affect our business and our products.

his time in office, former President Trump supported the repeal of all or portions of the ACA.

the first administration, President Trump supported the repeal of all or portions of the ACA.

President Trump also issued an executive

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

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

Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

on January 28, 2021, former 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

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and

rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that

include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through

Medicaid or the ACA.

On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in

relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer

price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024.

And, in July 2021, the Biden administration

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

In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines

principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential

administrative actions HHS can take to advance these principles.

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

Reduction Act of 2022, which aims to lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices for

certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been on the market for a certain number

of years and requiring on drug manufacturers to pay rebates if they increase drug prices “faster than inflation.” In the coming

years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical

companies and the success of our product candidates.

At the state level, legislatures have increasingly passed legislation and implemented

regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts,

restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage

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, on August 16,

2022, former President Biden signed into law the Inflation Reduction Act of 2022, which aims to lower prescription drug pricing by,

among other things, allowing Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and

Part B after the drugs have been on the market for a certain number of years and requiring on drug manufacturers to pay rebates if

they increase drug prices “faster than inflation.” 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.

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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.

Furthermore, we cannot assess the impact that President

Trump’s second term will have on healthcare programs and regulations or the pharmaceutical industry in general.

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

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

TNF’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.

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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;

Any action against TNF for violation of these laws, even if TNF is successful in defending against it, could cause TNF to incur significant

legal expenses and divert TNF’s management’s attention from the operation of its business.

Prohibitions or restrictions on

sales or withdrawal of future products marketed by TNF could materially affect its business in an adverse way.

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

(i) changes to TNF’s manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall

or discontinuation of MyMD’s products;

or discontinuation of TNF’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 implemented, they

could adversely affect the operation of TNF’s business.

Reimbursement

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

of any of TNF’s product candidates that are approved for marketing in the United States or any other products TNF may commercialize

in the future, as applicable, will depend, in part, on the extent to which TNF’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

that those third-party payors provide for MyMD’s products.

Patients and providers are unlikely to use MyMD’s products unless

coverage is provided and reimbursement is adequate to cover a significant portion of the cost of MyMD’s products.

no uniform policy of coverage and reimbursement for drugs or biological products exists, and one payor’s determination to provide

that those third-party payors provide for TNF’s products.

Patients and providers are unlikely to use TNF’s products unless

coverage is provided and reimbursement is adequate to cover a significant portion of the cost of TNF’s products.

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 product candidates, if approved,

will be made on a payor-by-payor basis.

As a result, the coverage determination process may be a time-consuming and costly process that

will require MyMD to provide scientific and clinical support for the use of MyMD’s products to each payor separately, with no assurance

regarding the extent of coverage and amount of reimbursement to be provided for any of TNF’s product candidates, if approved, will

be made on a payor-by-payor basis.

As a result, the coverage determination process may be a time-consuming and costly process that will

require TNF to provide scientific and clinical support for the use of TNF’s products to each payor separately, with no assurance

that coverage and adequate reimbursement will be obtained.

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Government payment for some of the costs

of prescription drugs may increase demand for products for which MyMD receives marketing approval.

of prescription drugs may increase demand for products for which TNF 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.

TNF’s products covered by a Part D prescription drug plan likely will be lower than the prices TNF might otherwise obtain.

while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment

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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

hospitals who might purchase TNF’s products in the future and affect the rates TNF 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

noted above, the marketability of any products for which TNF 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.

has increased and TNF expects it will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and

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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

products for which TNF receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the

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.

in Medicare and other healthcare funding and otherwise affect the prices TNF may obtain for any of its product candidates for which TNF

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.

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on the market.

In some countries, MyMD may be required to conduct a clinical study or other studies that compare the cost-effectiveness

of any of MyMD’s product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval.

In some countries, TNF may be required to conduct a clinical study or other studies that compare the cost-effectiveness

of any of TNF’s product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow

favorable reimbursement and pricing arrangements for any of MyMD’s products.

favorable reimbursement and pricing arrangements for any of TNF’s products.

Historically, products launched in the EU do not follow

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

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

MyMD has not experienced any work stoppages.

of MyMD’s employees are represented by a labor union or covered by collective bargaining agreements, and MyMD considers its relationship

of December 31, 2024, TNF had two full-time employees and no part-time employees.

TNF has not experienced any work stoppages.

TNF’s employees are represented by a labor union or covered by collective bargaining agreements, and TNF considers its relationship

with its employees to be good.

Plans for 2024

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

Clinical Studies

In October 2020 we completed several

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

November 2022, the company published data from the Phase 1 dosing study for Isomyosamine 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

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

given placebo.

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

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

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

The submission is planned for the beginning

of the second quarter of 2024.

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

aged 65-75 years old.

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

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

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

August 9, 2023.

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

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

Enbrel and Remicade.

Product Candidate

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

Placebo-controlled, Randomized Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD-1 in The Treatment of Participants

Aged 65 Years or Older with Chronic Inflammation Associated with Sarcopenia/Frailty”).

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

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

PK analysis indicates

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

There were no serious adverse events reported, no

subject dropout’s secondary to an adverse event.

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

or neurotoxicity issues with any patients during the study.

TNF is preparing a Phase 2 study protocol, “Double blind placebo-controlled

parallel group study of safety and efficacy of Isomyosamine in treating sarcopenia after hip or femoral fracture in gerontological population”

for submission to the FDA.

This study will expand upon the prior 28-day dosing study and will evaluate functional improvements in subjects

after Isomyosamine dosing of up to 90 days.

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

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

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

on August 9, 2023.

October 2020 we completed several in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting Isomyosamine

with Humira, Enbrel and Remicade.

for Autoimmune Diseases

10-month Dog Study –

completed on December 20, 2021:

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

6-month Rat Study –

completed on December 17, 2021:

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

5-Day Mouse Study –

Completed May 2020 with results pending:

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

Studies produced guidance

on dosing levels and overall safety in the human studies.

MyMD in collaboration with Charles River Laboratories

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

Dosing began on

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

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

events reported.

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

Vehicle versus TNFalpha”.

Dog Study – completed on December 20, 2021:

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

Rat Study – completed on December 17, 2021:

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

Mouse Study – Completed May 2020 with results pending:

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

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

in collaboration with Charles River Laboratories completed “A 90-Day Oral Gavage Electroencephalogram Safety Study of A Test

Item In The Beagle Dog”.

Dosing began on December 19, 2023, and ended around March 20, 2024.

All animals completed the study

and there was no treatment related adverse events reported.

A final study report was provided to FDA in December 2024.

Palmer in collaboration with TNF completed a study “TNF in Traumatic Optic Neuropathy (TON) in a Rat Pilot Study Vehicle versus

The crush injury raised levels of TNF-α.

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

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

Likely cause of the

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

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

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

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

This manuscript supports our

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

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

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

This journal article details a 12-month mouse

trial studying aging and longevity with MYMD-1.

We also completed several in vitro studies from human primary cell-based BioMap

systems at Eurofins contrasting MYMD-1 versus Rapamycin further supporting our transition to Rheumatoid Arthritis.

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

After being dosed with Isomyosamine, TNF-α levels were brought down

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

Likely cause of the result

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

TNF-α levels would have gone up when Isomyosamine stopped;

may need to me adjusted.

The initial data was promising and will guide a longer study in the future.

scientific journal article on Isomyosamine 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, which was approved for clinical trials in August 2023, and additional

autoimmune diseases that we may pursue.

Additionally, “MYMD-1 Improves Health Span and Prolongs Life Span in 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 Isomyosamine.

We also completed several in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting Isomyosamine versus

Rapamycin further supporting our transition to Rheumatoid Arthritis.

November 2022, TNF 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.

This became available in print on February 28, 2023.

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

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“Pharmacology and

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

clinical profile of MYMD-1 ® , 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

In 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, Significantly Reduced the Inflammation

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

An abstract for submission of

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

MyMD with its

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

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

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

September 15-18, 2024.

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

Role of Aldehyde Oxidase and CYP2A6.

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

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

of Aldehyde Oxidase and CYP2A6.

On December 7, 2024, TNF presented

at The Society on Sarcopenia, Cachexia, & Wasting Disorders (SCWD) 17 th International Conference in Washington, D.C.

of the presentation was, “Isomyosamine for the Treatment of Sarcopenia in Elderly Population.”

publications and abstracts support the continued development of Isomyosamine ® across various indications.

for Hashimoto’s Thyroiditis

On February 18, 2022, we

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

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

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

development and submission to the FDA.

In April 2021, the FDA

gave clearance for a Phase 1 dosing study in normal healthy volunteers;

Institutional Review Board (IRB) approval was obtained on

April 4, 2021.

The clinical trial was conducted by The Clinical Research of West Florida Phase 1 unit with a closeout visit taking

place on November 22, 2021.

Analyses of laboratory

parameters, vital sign, ECG, and physical findings did not reveal any clinically relevant effect of MYMD-1.

In one dose group, there

was a decrease in TNF-α levels found in MYMD-1 treated subjects, but no change in the levels in subjects given placebo.

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

February 18, 2022, we submitted an Annual Report to the FDA for the previously opened Hashimoto’s Thyroiditis IND.

Annual Report was submitted to the FDA on November 22.

April 2021, the FDA gave clearance for a Phase 1 dosing study in normal healthy volunteers;

Institutional Review Board (IRB) approval

was obtained on April 4, 2021.

The clinical trial was conducted by The Clinical Research of West Florida Phase 1 unit with a closeout

visit taking place on November 22, 2021.

of laboratory parameters, vital sign, ECG, and physical findings did not reveal any clinically relevant effect of Isomyosamine.

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

given placebo.

The data from the Phase

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

In one dose group, there was a decrease in TNF-α levels found in Isomyosamine 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.

This data was also included

in a new commercial IND to the FDA on September 22, 2021.

company completed CYP in vitro studies which concluded that clinical drug-drug interactions are not expected with MYMD-1.

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

Company completed CYP in vitro studies which concluded that clinical drug-drug interactions are not expected with Isomyosamine.

CYP induction

is the most commonly studied form of induction in drug metabolism and is required by regulatory authorities.

had MYMD-1 synthesized in August 2021 to [14C] MYMD-1 radiolabeled product for Mass Balance, Pharmacokinetic, and Metabolism.

of the rat study results demonstrated that MYMD-1 was metabolized extensively throughout the tissues, crosses the blood brain barrier,

had Isomyosamine synthesized in August 2021 to [14C] Isomyosamine radiolabeled product for Mass Balance, Pharmacokinetic, and Metabolism.

of the rat study results demonstrated that Isomyosamine was metabolized extensively throughout the tissues, crosses the blood brain barrier,

was cleared in the urine and feces, and there were no nitrosated metabolite biological samples detected.

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

in subjects given placebo.

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

We anticipate that we will review the safety and efficacy of this study and present the mandatory end of Phase 2 data to the FDA.

July 27, 2021, Eurofins showed Commonality in a Comparative Study with FDA-Approved Anti-Inflammatory and Anti-Autoimmune Drugs Used

for Arthritis, Colitis and Dermatitis.

On October 26, 2021, our President and Chief Medical Officer, Chris Chapman, M.D., was named Honoree

of the year by the Arthritis Foundation.

August 5, 2021, our lead product candidate MYMD-1 was shown to suppress cytokines, which are the major cause of death in COVID-19 patients,

in a human cell study.

The company plans to consult with the FDA on this indication for post COVID-19 immune mediated depression in the

second quarter 2024.

During this time, MyMD Pharmaceuticals, Inc.

also expects to seek additional FDA guidance on depression in MS patients

under an Orphan Drug Designation (ODD).

have an active IND to start a Phase 2 study for the indication Hashimoto’s Thyroiditis, and plan to present the FDA with a protocol

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

intend to begin long-term reproductive toxicity studies in the fourth quarter 2022.

These will include study of Fertility and Early Embryonic

Development to Implantation in Mice, and study for Effects on Embryo Fetal Development in Mice and Rabbits with a toxicokinetic evaluation.

These studies will continue to support long-term dosing in humans.

manufacturing, we will continue to provide GMP MYMD-1 capsules for Phase 2 clinical trials.

Metabolite Identification

and Quantitation of Isomyosamine in Rat, Dog, and Human Plasma Samples:

Metabolites in Safety Testing (MIST) was completed in October 2022.

Isomyosamine 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 Isomyosamine as a treatment for aging.

August 5, 2021, our lead product candidate Isomyosamine was shown to suppress cytokines, which are the major cause of death in COVID-19

patients, in a human cell study.

TNF may also seek additional FDA guidance on depression in MS patients under an Orphan Drug Designation

On October 3, 2023, Charles River

Laboratories provided a final report titled, “A Dose Range-Finding Embryo-fetal Development Study of MYMD-1 by Oral (Gavage) in

Rats.” The results of this study found that there were no drug-related fetal malformations or variations at any of the evaluated

We have an active IND to start

a Phase 2 study for the indication Hashimoto’s Thyroiditis.

manufacturing, we will continue to provide GMP Isomyosamine capsules for Phase 2 clinical trials.

We plan to continue analytical analysis to

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

have received domestic patent protection for Isomyosamine, 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.

property for Isomyosamine in the United States and abroad.

Patent Issued March 26, 2024:

US Application 17/851,862:

Method of Treating Diseases of the Visual System.

Method of Treating Diseases

of the Visual System.

Product Candidate

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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.

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

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

governing regulations.

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

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

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

Those studies include:

Metabolic profiling and

Ames test (initiation December 21, 2021;

completion January 20, 2022) and

Micronucleus test (initiation

December 21, 2021;

profiling and Ames test (initiation December 21, 2021;

completion January 20, 2022);

test (initiation December 21, 2021;

completion February 20, 2022).

study of Behavioral Biology at Johns Hopkins University Supera-CBD vs.

CBD Acute Pain and Inflammation begins has been funded for 2022

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

1 unchanged sentence

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

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

Forced Swim Test

Tail suspension

Elevated Plus Maze and

Fear Conditioning

Dose response study.

Supera-CBD open field and

Y maze study.

MYMD-1 LPS induced depression.

website address is www.mymd.com .

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

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

The SEC maintains an Internet website ( www.sec.gov ) that contains

reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.

example of our continued efforts include:

the JHM Research, which is conducting a study with Isomyosamine and L/R-Supera-CBD

for Depression and Anxiety;

Plus Maze and Fear Conditioning;

response study;

open field and Y maze study;

LPS induced depression.

Plans for 2025

plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025.

will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier

Phase 2 clinical study.

October 19 2024, the Company announced that it has entered into a collaborative agreement with Renova Health for a planned trial of its

TNF-alpha (TNF-α) inhibitor drug Isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty.

The fully funded study is

expected to evaluate TNF-α levels in patients receiving GLP-1 agonist Wegovy or Ozempic who show signals for increased inflammation

associated with sarcopenia.

website address is www.tnfpharma.com .

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

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

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

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

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business