What changed in this filing

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Item 1A. Risk Factors

2025-04-11 compared with 2024-04-01 · 617 added, 664 removed, 1326 unchanged (49% of the section changed)

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Related to our Business

Our financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order to continue as a going concern.

The market price of our

Common Stock may be subject to significant fluctuations and volatility, and the stockholders of the Company may be unable to resell

their shares at a profit and may incur losses.

We may issue additional

equity securities in the future, which may result in dilution to existing investors.

The concentration of the

capital stock ownership with insiders of the Company will likely limit the ability of our stockholders to influence

financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order

to continue as a going concern.

market price of our Common Stock may be subject to significant fluctuations and volatility, and the stockholders of the Company may

be unable to resell their shares at a profit and may incur losses.

may issue additional equity securities in the future, which may result in dilution to existing investors.

concentration of the capital stock ownership with insiders of the Company will likely limit the ability of our stockholders to influence

corporate matters.

We may not be able to adequately

protect or enforce our intellectual property rights, which could harm our competitive position.

An active trading market

for our Common Stock may not be sustained.

Our business and operations

would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security or those of third-party

may not be able to adequately protect or enforce our intellectual property rights, which could harm our competitive position.

active trading market for our Common Stock may not be sustained.

business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security

or those of third-party providers.

Related to our Product Development and Regulatory Approval

If we are unable to develop,

obtain regulatory approval for and commercialize MYMD-1, Supera-CBD, or other future product candidates, or if we experience significant

delays in doing so, our business will be materially harmed.

Success in pre-clinical

studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained in later

clinical trials, including our Phase 2 clinical trial for MYMD-1, which may delay or prevent obtaining regulatory approval.

if we complete the necessary pre-clinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory

approval to commercialize a product candidate and the approval may be for a narrower indication than we seek.

Public health crises, such as the COVID-19 pandemic, could have a material

adverse impact the execution of our planned clinical trials.

Any product candidate for

which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing

restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements

or if it experiences unanticipated problems with our product candidates, when and if any of them are approved.

Our development program

for Supera-CBD, a synthetic analog of CBD, is uncertain and may not yield commercial results and is subject to significant regulatory

we are unable to develop, obtain regulatory approval for and commercialize Isomyosamine, Supera-CBD, or other future product candidates,

or if we experience significant delays in doing so, our business will be materially harmed.

in pre-clinical studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained

in later clinical trials, including our Phase 2 clinical trial for Isomyosamine, which may delay or prevent obtaining regulatory approval.

if we complete the necessary pre-clinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval

to commercialize a product candidate and the approval may be for a narrower indication than we seek.

Potential future public

health crises could have a material adverse impact the execution of our planned clinical trials.

product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and

could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply

with regulatory requirements or if it experiences unanticipated problems with our product candidates, when and if any of them are

development program for Supera-CBD, a synthetic analog of CBD, is uncertain and may not yield commercial results and is subject to

significant regulatory risks.

Related to Commercialization and Manufacturing

The commercial success

of our product candidates, including MYMD-1 and Supera-CBD, will depend upon their degree of market acceptance by providers, patients,

patient advocacy groups, third-party payors, and the general medical community.

The pricing, insurance

coverage, and reimbursement status of newly approved products is uncertain.

Failure to obtain or maintain adequate coverage and reimbursement

for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product

If third parties on which

we depend to conduct our planned pre-clinical studies or clinical trials, do not perform as contractually required, fail to satisfy

regulatory or legal requirements or miss expected deadlines, our development program could be delayed with adverse effects on our

business, financial condition, results of operations and prospects.

We face significant competition

in an environment of rapid pharmacological change and it is possible that our competitors may achieve regulatory approval before

us or develop therapies that are more advanced or effective than ours, which may harm our business, financial condition and our ability

to successfully market or commercialize MYMD-1, Supera-CBD and our other product candidates.

The manufacture of drugs

is complex, and our third-party manufacturers may encounter difficulties in production.

If any of our third-party manufacturers encounter

such difficulties, our ability to provide supply of MYMD-1, Supera-CBD or our other product candidates for clinical trials, our ability

to obtain marketing approval, or our ability to provide supply of our product candidates for patients, if approved, could be delayed

commercial success of our product candidates, including Isomyosamine and Supera-CBD, will depend upon their degree of market acceptance

by providers, patients, patient advocacy groups, third-party payors, and the general medical community.

pricing, insurance coverage, and reimbursement status of newly approved products is uncertain.

Failure to obtain or maintain adequate

coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease

our ability to generate product revenue.

third parties on which we depend to conduct our planned pre-clinical studies or clinical trials, do not perform as contractually

required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with

adverse effects on our business, financial condition, results of operations and prospects.

face significant competition in an environment of rapid pharmacological change and it is possible that our competitors may achieve

regulatory approval before us or develop therapies that are more advanced or effective than ours, which may harm our business, financial

condition and our ability to successfully market or commercialize Isomyosamine, Supera-CBD and our other product candidates.

manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production.

If any of our third-party

manufacturers encounter such difficulties, our ability to provide supply of Isomyosamine, Supera-CBD or our other product candidates for

clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients,

if approved, could be delayed or stopped.

Related to Government Regulation

Enacted and future legislation

may increase the difficulty and cost for us to commercialize and obtain marketing approval of our product candidates and may affect

the prices we may set.

The FDA’s ability

to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire

and retain key personnel, statutory, regulatory and policy changes and global health concerns.

Our operations and relationships

with future customers, providers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare

laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, contractual damages, reputational

harm and diminished profits and future earnings.

and future legislation may increase the difficulty and cost for us to commercialize and obtain marketing approval of our product

candidates and may affect the prices we may set.

FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels,

ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns.

operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback,

fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil

penalties, contractual damages, reputational harm and diminished profits and future earnings.

Related to Our Intellectual Property

Our success depends in

part on our ability to obtain, maintain and protect our intellectual property.

It is difficult and costly to protect our proprietary

rights and technology, and we may not be able to ensure their adequate protection.

Our potential strategy

of obtaining rights to key technologies through in-licenses may not be successful.

Changes in patent law in

success depends in part on our ability to obtain, maintain and protect our intellectual property.

It is difficult and costly to protect

our proprietary rights and technology, and we may not be able to ensure their adequate protection.

potential strategy of obtaining rights to key technologies through in-licenses may not be successful.

in patent law in the U.S.

and in non-U.S.

jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our

product candidates.

Related to Our Series F Convertible Preferred Stock

Our Series F Convertible

Preferred Stock (the “Series F Preferred Stock”) provides for the payment of dividends in cash or in shares of our Common

If we pay such dividends in shares of Common Stock, it may result in dilution to existing investors.

Holders of our Series F Preferred Stock are entitled to certain payments

under the Certificate of Designation that may be paid in cash or in shares of Common Stock depending on the circumstances.

these payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments in Common

Stock, it may result in substantial dilution to the holders of our Common Stock.

The certificate of designation

for the Series F Preferred Stock and the warrants issued concurrently contain anti-dilution provisions that may result in the reduction

of the conversion price of the Series F Preferred Stock or the exercise price of such warrants in the future.

These features may

result in an indeterminate number of shares of Common Stock being issued upon conversion of the Series F Preferred Stock or exercise

of the warrants.

jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect our product candidates.

Related to Our Preferred Stock

Series F Convertible Preferred Stock (the “Series F Preferred Stock”) and Series F-1 Convertible Preferred Stock

(“Series F-1 Preferred Stock”) provides for the payment of dividends in cash or in shares of our Common Stock.

such dividends in shares of Common Stock, it may result in dilution to existing investors.

of our Series F Preferred Stock, Series F-1 Preferred Stock and Series G Convertible Preferred Stock (“Series

G Preferred Stock”) are entitled to certain payments under the Certificate of Designation that may be paid in cash or

in shares of Common Stock depending on the circumstances.

If we make these payments in cash, it may require the expenditure of a

substantial portion of our cash resources.

If we make these payments in Common Stock, it may result in substantial dilution to the

holders of our Common Stock.

certificate of designation for the Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the

Series F Preferred Stock or the exercise price of such warrants in the future.

These features may result in an indeterminate number

of shares of Common Stock being issued upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock or exercise of the warrants.

addition, we face other business, financial, operational and legal risks and uncertainties set forth under “Risk Factors”

in Item 1A of this Annual Report on Form 10-K.

Risks Related to our Business

Our financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order to continue as a going concern.

In its report dated April 1, 2024, Morison Cogen LLP, our independent

registered public accounting firm, expressed substantial doubt about our ability to continue as a going concern as we have suffered recurring

losses from operations and have insufficient liquidity to fund our future operations.

If we are unable to improve our liquidity position,

we may not be able to continue as a going concern.

The accompanying consolidated financial statements do not include any adjustments that

might result if we are unable to continue as a going concern and, therefore, be required to realize our assets and discharge our liabilities

other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portion of their investment.

As of December 31, 2023, we had approximately $2.7 million of cash.

In order to have sufficient cash to fund our operations in the

future, we will need to raise additional equity or debt capital and cannot provide any assurance that we will be successful in doing so.

If are unable to raise sufficient capital to fund our operations, we may need to delay, reduce or eliminate certain research and development

programs or other operations, sell some or all of our assets or merge with another entity.

We expect that we will need to raise additional

funding before we can expect to become profitable from any potential future sales of our product candidates.

This additional financing

may not be available on acceptable terms or at all.

Failure to obtain this necessary capital when needed may force us to delay, limit

or terminate our product development efforts or other operations.

We will require substantial future

capital in order to complete planned and future pre-clinical and clinical development for MYMD-1 and Supera-CBD and potentially commercialize

these product candidates.

We expect increased spending levels in connection with our clinical trials of our product candidates.

if we obtain marketing approval for any of our product candidates, we expect to incur significant expenses related to commercial launch,

product sales, medical affairs, regulatory, marketing, manufacturing and distribution.

Furthermore, we expect to incur additional costs

associated with operating as a public company.

Accordingly, we will need to obtain substantial additional funding in connection with our

continuing operations before any commercial revenue may occur.

Any additional capital raised

through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages and could also result

in a decrease in the market value of our equity securities.

The terms of any securities issued

by us in future capital transactions may be more favorable to new investors, and may include preferences, superior voting rights and the

issuance of warrants or other derivative securities, which may have a further dilutive effect on the holders of any of our securities

then outstanding.

In addition, we may incur substantial

costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities law compliance

fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash expenses in connection with certain

securities we issue, such as convertible notes and warrants, which may adversely impact our financial condition.

Additional capital might not be

available when we need it and our actual cash requirements might be greater than anticipated.

If we require additional capital at a time

when investment in its industry or in the marketplace in general is limited, we might not be able to raise funding on favorable terms,

If we are not able to obtain financing when needed or on terms favorable to us, we may need to delay, reduce or eliminate certain

research and development programs or other operations, sell some or all of our assets or merge with another entity.

The market price of our Common Stock has been and may continue to be

subject to significant fluctuations and volatility, and the stockholders of the Company may be unable to resell their shares at a profit

and may incur losses.

The market price of our Common Stock has been and could continue to

be subject to significant fluctuation following.

Market prices for securities of life sciences and biopharmaceutical companies in particular

have historically been volatile and have shown extreme price and volume fluctuations that have often been unrelated or disproportionate

to the operating performance of those companies.

Broad market and industry factors, as well as general economic, political and market

conditions such as recessions or interest rate changes, may seriously affect the market price of our Common Stock, regardless of the actual

operating performance of the combined company.

Some of the factors that may cause the market price of our Common Stock to fluctuate include:

the announcement of new

products, new developments, services or technological innovations by us or our competitors;

actual or anticipated quarterly

increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or prospects;

announcements relating

to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or other events

by the us or our competitors;

conditions or trends in

the life sciences and biopharmaceutical industries;

changes in the economic

performance or market valuations of other life sciences and biopharmaceutical companies;

general market conditions

or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition;

sale of our Common Stock

by stockholders, including executives and directors;

volatility and limitations

in trading volumes of our Common Stock;

volatility in the market

prices and trading volumes of the life sciences and biopharmaceutical stocks;

our ability to finance

our business;

ability to secure resources

and the necessary personnel to pursue our plans;

failure to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, future issuances of securities, sales or distributions of large blocks of Common Stock by stockholders;

our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

analyst research reports,

recommendations and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigation

related to intellectual properties, proprietary rights, and contractual obligations;

investigations by regulators

into our operations or those of our competitors;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

Related to our Business

financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order to

continue as a going concern.

its report dated April 1, 2024, Morison Cogen LLP, our independent registered public accounting firm, expressed substantial doubt about

our ability to continue as a going concern as we have suffered recurring losses from operations and have insufficient liquidity to fund

our future operations.

If we are unable to improve our liquidity position, we may not be able to continue as a going concern.

The accompanying

consolidated financial statements do not include any adjustments that might result if we are unable to continue as a going concern and,

therefore, be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause

investors to suffer the loss of all or a substantial portion of their investment.

As of December 31, 2024, we had approximately $8.5

million of cash and marketable securities.

In order to have sufficient cash to fund our operations in the future, we will need to raise

additional equity or debt capital and cannot provide any assurance that we will be successful in doing so.

If are unable to raise sufficient

capital to fund our operations, we may need to delay, reduce or eliminate certain research and development programs or other operations,

sell some or all of our assets or merge with another entity.

expect that we will need to raise additional funding before we can expect to become profitable from any potential future sales of our

product candidates.

This additional financing may not be available on acceptable terms or at all.

Failure to obtain this necessary capital

when needed may force us to delay, limit or terminate our product development efforts or other operations.

will require substantial future capital in order to complete planned and future pre-clinical and clinical development for Isomyosamine and

Supera-CBD and potentially commercialize these product candidates.

We expect increased spending levels in connection with our clinical

trials of our product candidates.

In addition, if we obtain marketing approval for any of our product candidates, we expect to incur

significant expenses related to commercial launch, product sales, medical affairs, regulatory, marketing, manufacturing and distribution.

Furthermore, we expect to incur additional costs associated with operating as a public company.

Accordingly, we will need to obtain substantial

additional funding in connection with our continuing operations before any commercial revenue may occur.

additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages

and could also result in a decrease in the market value of our equity securities.

terms of any securities issued by us in future capital transactions may be more favorable to new investors, and may include preferences,

superior voting rights and the issuance of warrants or other derivative securities, which may have a further dilutive effect on the holders

of any of our securities then outstanding.

addition, we may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting

fees, securities law compliance fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash

expenses in connection with certain securities we issue, such as convertible notes and warrants, which may adversely impact our financial

capital might not be available when we need it and our actual cash requirements might be greater than anticipated.

If we require additional

capital at a time when investment in its industry or in the marketplace in general is limited, we might not be able to raise funding

on favorable terms, if at all.

If we are not able to obtain financing when needed or on terms favorable to us, we may need to delay,

reduce or eliminate certain research and development programs or other operations, sell some or all of our assets or merge with another

market price of our Common Stock has been and may continue to be subject to significant fluctuations and volatility, and the stockholders

of the Company may be unable to resell their shares at a profit and may incur losses.

market price of our Common Stock has been and could continue to be subject to significant fluctuation following.

Market prices for securities

of life sciences and biopharmaceutical companies in particular have historically been volatile and have shown extreme price and volume

fluctuations that have often been unrelated or disproportionate to the operating performance of those companies.

Broad market and industry

factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect

the market price of our Common Stock, regardless of the actual operating performance of the combined company.

Some of the factors that

may cause the market price of our Common Stock to fluctuate include:

announcement of new products, new developments, services or technological innovations by us or our competitors;

or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or

announcements

relating to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or

other events by the us or our competitors;

or trends in the life sciences and biopharmaceutical industries;

in the economic performance or market valuations of other life sciences and biopharmaceutical companies;

market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition;

of our Common Stock by stockholders, including executives and directors;

and limitations in trading volumes of our Common Stock;

in the market prices and trading volumes of the life sciences and biopharmaceutical stocks;

ability to finance our business;

to secure resources and the necessary personnel to pursue our plans;

to meet external expectations or management guidance;

in our capital structure or dividend policy, future issuances of securities, sales or distributions of large blocks of Common Stock

by stockholders;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

research reports, recommendations and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigation related to intellectual properties, proprietary rights, and contractual obligations;

investigations

by regulators into our operations or those of our competitors;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

the past, following periods of volatility in the overall market and the market prices of particular companies’ securities, securities

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litigation or any amounts paid to settle any such actual or threatened litigation could require that we make significant payments.

Moreover, pandemics, inflation, war and other macroeconomic and geopolitical factors have resulted in significant financial market

volatility and uncertainty in recent years.

A continuation or worsening of the levels of market disruption and volatility seen in the

recent past could have an adverse effect on our ability to access capital, on our business, results of operations and financial condition,

and on the market price of our Common Stock.

pandemics, inflation, war and other macroeconomic and geopolitical factors have resulted in significant financial market volatility and

uncertainty in recent years.

A continuation or worsening of the levels of market disruption and volatility seen in the recent past could

have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on the market

price of our Common Stock.

have a history of operating losses, and we may not achieve or sustain profitability.

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for the foreseeable future.

If we fails to obtain additional funding to conduct our planned research and development efforts, we could

If we fail to obtain additional funding to conduct our planned research and development efforts, we could

be forced to delay, reduce or eliminate our product development programs or commercial development efforts.

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We have not obtained regulatory approvals for any of our product candidates and we have funded our operations to date through

proceeds from private placements of Common Stock and a line of credit from an affiliate of MyMD’s founder.

proceeds from private placements of Common Stock and a line of credit from an affiliate of TNF’s founder.

have incurred net losses in each year since our inception.

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for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2023, we had an accumulated

deficit of $101,977,067.

Substantially all our operating losses have resulted from costs incurred in connection with our research

and development programs and from general and administrative costs associated with our operations.

We expect to continue to incur

significant expenses and operating losses over the next several years and for the foreseeable future as we intend to continue to

conduct research and development, clinical testing, regulatory compliance activities, manufacturing activities, and, if any of our

product candidates is approved, sales and marketing activities that, together with anticipated general and administrative expenses,

will likely result in the company incurring significant losses for the foreseeable future.

Our prior losses, combined with expected

future losses, have had and will continue to have an adverse effect on our shareholders’ equity and working

As of December 31, 2024, we had an accumulated deficit of $129,080,851.

Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and

from general and administrative costs associated with our operations.

We expect to continue to incur significant expenses and operating

losses over the next several years and for the foreseeable future as we intend to continue to conduct research and development, clinical

testing, regulatory compliance activities, manufacturing activities, and, if any of our product candidates is approved, sales and marketing

activities that, together with anticipated general and administrative expenses, will likely result in the company incurring significant

losses for the foreseeable future.

Our prior losses, combined with expected future losses, have had and will continue to have an adverse

effect on our shareholders’ equity and working capital.

limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.

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and no assurances can be given about our future performance.

stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they experienced in connection with the

we are unable to realize the full strategic and financial benefits currently anticipated from the Merger, our stockholders will have

experienced substantial dilution of their ownership interests in their respective pre-Merger companies without receiving any commensurate

benefit, or only while receiving part of the commensurate benefit to the extent the combined organization is able to realize only part

of the strategic and financial benefits anticipated at the time of the Merger.

Furthermore, if we fail to realize the intended benefits

of the Merger, the market price of our Common Stock could decline to the extent that the market price reflects those benefits.

the Merger and the Contribution Transaction were consummated, the business operations, strategies and focus of the Company

fundamentally changed, and these changes may not result in an improvement in the value of our Common Stock.

the Merger, our primary products are MyMD Florida’s therapeutic platforms:

MYMD-1, a clinical-stage immunometabolic regulator and

Supera-CBD, a pre-clinical stage patented synthetic CBD analog.

We expect to incur losses as we develop our product candidates, and our

product candidates, may never get approved by the FDA or, even if approved for marketing, may not be profitable.

The failure to successfully

develop product candidates will significantly diminish the anticipated benefits of the Merger and have a material adverse effect on our

There is no assurance that our business operations, strategies or focus will be successful, which could depress the value of

our Common Stock.

Contribution Transaction poses risks for our ongoing operations, including, among others:

consummation of the Contribution Transaction, if Oravax is not successful in developing the COVID-19 Vaccine Candidate, we may not

realize any value out of its ownership of Oravax shares;

and expenses associated with any undisclosed or potential liabilities.

a result of the foregoing, we may be unable to realize the full strategic and financial benefits originally anticipated from the Contribution

Transaction, and we cannot assure you that the Contribution Transaction will be accretive in the near term or at all.

Furthermore, if

we fail to realize the intended benefits of the Contribution Transaction, the market price of our Common Stock could decline to the extent

that the market price reflects those benefits.

concentration of the capital stock ownership with insiders of the Company will likely limit the ability of our stockholders to influence

corporate matters.

The executive officers, directors, five percent or greater stockholders,

and the respective affiliated entities of the Company, in the aggregate, beneficially owned more than 10% of the Company’s outstanding

of the date of this Annual Report on Form 10-K, the executive officers, directors, five percent or greater stockholders, and the

respective affiliated entities of the Company, in the aggregate, beneficially owned more than 10% of the Company’s outstanding

Common Stock.

As a result, these stockholders, acting together, had, and continue to have, control over matters that require approval

by our stockholders, including the election of directors and approval of significant corporate transactions.

Corporate actions might be

taken even if other stockholders oppose them.

This concentration of ownership might also have the effect of delaying or preventing a corporate

transaction that other stockholders may view as beneficial.

As a result, these stockholders, acting together, had, and continue to have, control over matters that require

approval by our stockholders, including the election of directors and approval of significant corporate transactions.

actions might be taken even if other stockholders oppose them.

This concentration of ownership might also have the effect of

delaying or preventing a corporate transaction that other stockholders may view as beneficial.

stockholders could attempt to influence changes within the Company, which could adversely affect our operations, financial condition

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These actions could adversely affect our operations, financial condition, and the value of our Common Stock.

largest stockholder maintains the ability to significantly influence all matters submitted to our stockholders for approval.

of April 4, 2025, our largest stockholder, PharmaCyte Biotech, Inc.

(“Pharmacyte”) beneficially owns approximately 88.64% of the

issued and outstanding Common Stock of the Company.

As a result, if Pharmacyte may be able to significantly influence all matters submitted

to the Company’s stockholders for approval, as well as the Company’s management and affairs.

For example, Pharmacyte could

significantly influence the election of directors or the approval of any merger, consolidation or sale of all or substantially all of

the Company’s assets.

This concentration of voting power could delay or prevent an acquisition of the Company on terms that other

must attract and retain highly skilled employees to succeed.

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at the management level, it could adversely affect our ability to execute our business plan, harm our results of operations and increase

our capabilities to successfully commercialize MYMD-1, Supera-CBD and our other product candidates.

our capabilities to successfully commercialize Isomyosamine, Supera-CBD and our other product candidates.

The competition for qualified personnel

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in commercializing their products than us, their success could adversely affect our competitive position and harm our business prospects

and may also lead to the diversion of funding away from us and toward other companies.

and may also lead to the diversion of funding away from us and towards other companies.

we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur

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viruses or other malware to our information systems.

Between August and October 2021, we experienced a cybersecurity incident.

On July 20, 2023, we experienced a cybersecurity incident.

A third-party

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regard to our Supera-CBD product candidate, we must conduct pre-clinical testing and prepare and submit an IND to the FDA.

to both our MYMD-1 and Supera-CBD product candidates, we must conduct all phases of clinical studies, which will likely take several

to both our Isomyosamine and Supera-CBD product candidates, we must conduct all phases of clinical studies, which will likely take several

years and substantial expenses to complete, before we can submit an application for marketing approval to the FDA, and we may be required

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complete such clinical development in a timely manner or at all or that we will obtain or maintain regulatory approval for either product

FDA – IND review

is conducted and feedback is delivered within 30 days of receipt of the initial application.

At the time, changes to the study protocol

may be requested in order to proceed with the proposed Phase 2 clinical trial.

Institutional Review Board

(IRB) – If the FDA requests changes to the protocol included in the initial application, an amendment must be submitted to

the IRB for an additional review.

This review may include changes to the protocol, informed consent form, surveys, and other assessments

planned over the course of the clinical trial.

COVID-19 – Clinical

sites must follow specific COVID-19 guidelines.

Clinical trial activity must adhere to those guidelines which may change over the

course of the study.

For example, the protocol may need to be revised to accommodate for in-home visits (if necessary) to maximize

patient and research staff safety.

Site Initiation Visit (SIV)

– Site initiation visits are scheduled around principal investigator (PI) availability.

Due to changing clinic schedules, SIVs

may need to be rescheduled to accommodate various PI demands.

Central Lab – Central

labs are responsible for creating all the kits (supplies) required for patient visits.

Kits are created to execute all aspects of

screening through study completion.

Kits are developed based on specifications from core labs and third-party vendors (as applicable).

– IND review is conducted and feedback is delivered within 30 days of receipt of the initial application.

At the time, changes

to the study protocol may be requested in order to proceed with the proposed Phase 2 clinical trial.

Institutional

Review Board (IRB) – If the FDA requests changes to the protocol included in the initial application, an amendment must be

submitted to the IRB for an additional review.

This review may include changes to the protocol, informed consent form, surveys, and

other assessments planned over the course of the clinical trial.

– Clinical sites must follow specific COVID-19 guidelines.

Clinical trial activity must adhere to those guidelines which may

change over the course of the study.

For example, the protocol may need to be revised to accommodate for in-home visits (if necessary)

to maximize patient and research staff safety.

Initiation Visit (SIV) – Site initiation visits are scheduled around principal investigator (PI) availability.

Due to changing

clinic schedules, SIVs may need to be rescheduled to accommodate various PI demands.

Lab – Central labs are responsible for creating all the kits (supplies) required for patient visits.

Kits are created to execute

all aspects of screening through study completion.

Kits are developed based on specifications from core labs and third-party vendors

(as applicable).

All shipping and storing requirements need to be clearly articulated and lab manuals provided to make the kits.

The central lab is

also responsible for building a database to store all the lab results.

Electronic Database –

The overall database used for the study must be built around the schedule of assessments planned for each patient over the course

of the clinical trial.

The central lab is also responsible for building a database to store all the lab results.

Database – The overall database used for the study must be built around the schedule of assessments planned for each patient

over the course of the clinical trial.

This includes every assessment and data element collected.

The complexity of the Phase 2 trial also requires

development and testing of drug randomization across treatment groups to ensure blinding is maintained.

The complexity of the Phase 2 trial

also requires development and testing of drug randomization across treatment groups to ensure blinding is maintained.

Thorough user-acceptability

testing (UAT) is required and is time-intensive.

CoreRx – To maintain

adequate blinding across treatment groups, new labels were created and applied to the active drug and placebo bottles.

and manufacturing need to work together to ensure capsules were not only filled appropriately, but also labelled correctly to ensure

the electronic database and randomization schemes maintain alignment over the course of the study.

– To maintain adequate blinding across treatment groups, new labels were created and applied to the active drug and placebo

Logistics and manufacturing need to work together to ensure capsules were not only filled appropriately, but also labelled

correctly to ensure the electronic database and randomization schemes maintain alignment over the course of the study.

drug development is a lengthy, expensive, and inherently uncertain process, and we may experience delays in completing, or ultimately

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to Supera-CBD, we are still in the pre-clinical stage, and we are in relatively early clinical stages with regard to certain indications

for which MyMD-1 is being developed and in pre-clinical stages for others.

for which Isomyosamine is being developed and in pre-clinical stages for others.

Clinical trials are expensive, difficult to design and implement,

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for any given indication, if ever.

completing the requisite preclinical testing, IND submission, internal review board (“IRB”) review, and any other

applicable early-development obligations, sponsors must conduct extensive clinical trials to demonstrate the safety and efficacy of

the product candidates.

We have completed such early-stage preclinical testing and IND-submission for some, but not all, indications

for which MyMD-1 is being developed and are currently working towards completion of such pre-IND activities for Supera-CBD.

the results of our pre-clinical testing and clinical trials are favorable, we expect our product candidates to remain in clinical

development for several years before they may be considered for regulatory approval, and clinical development of either or both

candidates for one or more targeted indications may take significantly longer to complete and may never be successful.

connection with one or more clinical trials can occur at any stage of testing.

completing the requisite preclinical testing, IND submission, internal review board (“IRB”) review, and any other applicable

early-development obligations, sponsors must conduct extensive clinical trials to demonstrate the safety and efficacy of the product

We have completed such early-stage preclinical testing and IND-submission for some, but not all, indications for which Isomyosamine

is being developed and are currently working towards completion of such pre-IND activities for Supera-CBD.

Even if the results of our

pre-clinical testing and clinical trials are favorable, we expect our product candidates to remain in clinical development for several

years before they may be considered for regulatory approval, and clinical development of either or both candidates for one or more targeted

indications may take significantly longer to complete and may never be successful.

Failures in connection with one or more clinical trials

can occur at any stage of testing.

that may prevent successful or timely completion of clinical development include:

delays in reaching a consensus

with regulatory authorities on trial design;

delays in reaching agreement

on acceptable terms with prospective contract research organization (“CRO”) and clinical trial sites;

delays in opening clinical

trial sites or obtaining required IRB or independent ethics committee approval at each clinical trial site;

actual or perceived lack

of effectiveness of any product candidate during clinical trials;

discovery of serious or

unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including

those which cause confounding changes to the levels of other concomitant medications;

slower than expected rates

of subject recruitment and enrollment rates in clinical trials;

difficulty in retaining

subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse side effects

from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

delays or inability in

manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;

inadequacy of or changes

in its manufacturing process or product candidate formulation;

delays in obtaining regulatory

authorization s, such as INDs and any others that must be obtained, maintained, and/or satisfied to commence a clinical trial, including

“clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before

or after a trial is commenced;

changes in applicable regulatory

policies and regulation, including changes to requirements imposed on the extent, nature or timing of studies;

delays or failure in reaching

agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

uncertainty regarding proper

delay or failure to supply

product for use in clinical trials which conforms to regulatory specification;

unfavorable results from

ongoing pre-clinical studies and clinical trials;

failure of its CROs, or

other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable

Our failure, or the failure

of any individuals, entities, or organizations involved in one or more aspects of our clinical development activities, to comply

with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials;

scheduling conflicts with

participating clinicians and clinical institutions;

failure to design appropriate

clinical trial protocols;

regulatory concerns and

additional difficulties associated with cannabinoid products, generally;

insufficient data to support

regulatory approval;

inability or unwillingness

of medical investigators to follow its clinical protocols;

difficulty in maintaining

contact with patients during or after treatment, which may result in incomplete data.

any of the clinical trials of any of our current or future therapeutic candidates do not produce favorable results or are found to have

been conducted in violation of the FDA’s or other regulatory body’s standards governing such studies, our ability to request

and obtain regulatory approval for the therapeutic candidate may be adversely impacted, which could have a material adverse effect on

our reputation, business, financial condition or results of operations.

we are unable to develop, obtain regulatory approval for and commercialize MYMD-1, Supera-CBD or other future product candidates, or

in reaching a consensus with regulatory authorities on trial design;

in reaching agreement on acceptable terms with prospective contract research organization (“CRO”) and clinical trial

in opening clinical trial sites or obtaining required IRB or independent ethics committee approval at each clinical trial site;

or perceived lack of effectiveness of any product candidate during clinical trials;

of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions,

including those which cause confounding changes to the levels of other concomitant medications;

than expected rates of subject recruitment and enrollment rates in clinical trials;

in retaining subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse

side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing

of or changes in its manufacturing process or product candidate formulation;

in obtaining regulatory authorization s, such as INDs and any others that must be obtained, maintained, and/or satisfied to commence

a clinical trial, the imposition of “clinical holds” or delays requiring suspension or termination of a trial by a regulatory

agency, such as the FDA, before or after a trial is commenced;

in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature or timing of studies;

or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

regarding proper dosing;

or failure to supply products for use in clinical trials which conforms to regulatory specification , or otherwise do not comply with required manufacturing obligations, such as cGMPs;

results from ongoing pre-clinical studies and clinical trials;

of its CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely

or acceptable manner;

failure, or the failure of any individuals, entities, or organizations involved in one or more aspects of our clinical development

activities, to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials;

conflicts with participating clinicians and clinical institutions;

to design appropriate clinical trial protocols;

concerns and additional difficulties associated with cannabinoid products, generally;

data to support regulatory approval;

or unwillingness of medical investigators to follow its clinical protocols;

in maintaining contact with patients during or after treatment, which may result in incomplete data.

the result of any of the clinical trials for any of our current or future therapeutic candidates do not produce sufficiently

favorable results or are found to have been conducted in violation of the FDA’s or other regulatory body’s standards

governing such studies, our ability to request and obtain regulatory approval for the therapeutic candidate may be adversely

impacted, which could have a material adverse effect on our reputation, business, financial condition or results of

we are unable to develop, obtain regulatory approval for and commercialize Isomyosamine, Supera-CBD or other future product candidates, or

if we experience significant delays in doing so, our business will be materially harmed.

have invested a substantial amount of effort and financial resources in MYMD-1 and Supera-CBD.

have invested a substantial amount of effort and financial resources in Isomyosamine and Supera-CBD.

We plan to initiate Phase 2 clinical trials

for treatment of diabetes, rheumatoid arthritis, aging and multiple sclerosis with MYMD-1 and IND-enabling pre-clinical studies of Supera-CBD

for treatment of diabetes, rheumatoid arthritis, aging and multiple sclerosis with Isomyosamine and IND-enabling pre-clinical studies of Supera-CBD

to enable submission of an Investigational New Drug (“IND”) application for a Phase 1 in healthy volunteers followed by clinical

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our products would not be able to move through the regulatory approval process.

ability to generate product revenue will depend heavily on the successful development and eventual commercialization of MYMD-1, Supera-CBD

ability to generate product revenue will depend heavily on the successful development and eventual commercialization of Isomyosamine, Supera-CBD

and our other product candidates, which may never occur.

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organization, substantial investment and significant marketing efforts before we generate any revenue from product sales.

Isomyosamine and

Supera-CBD and our other product candidates must be authorized for marketing by the FDA and certain other foreign regulatory agencies

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or requirements imposed by or agreed to with applicable regulatory authorities;

factors surrounding the approval process, such as government shutdowns, political instability or global pandemics such as the outbreak

of the novel strain of coronavirus, COVID-19.

factors surrounding the approval process, such as government shutdowns, political instability or global pandemics.

we do not succeed in one or more of these factors in a timely manner or at all, we could experience significant delays or an inability

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are often time-consuming, labor-intensive and expensive to execute.

We have not previously had the resources to effectively implement

We have previously and not had the resources to effectively implement

such clinical programs within our clinical development activities and may not be able to do so in the future.

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in pre-clinical studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained

in later clinical trials, including our Phase 2 clinical trial for MYMD-1, which may delay or prevent obtaining regulatory approval.

in later clinical trials, including our Phase 2 clinical trial for Isomyosamine, which may delay or prevent obtaining regulatory approval.

development is expensive and can take many years to complete, and its outcome is inherently uncertain.

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statistical results.

Even if we believe the data collected from clinical trials of our product candidates are promising, these data may

Even if we believe the data collected from clinical trials of our product candidates are promising, this data may

not be sufficient to support approval by the FDA or foreign regulatory authorities.

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in different ways.

Accordingly, the FDA or foreign regulatory authorities could interpret these data in different ways from us or our

Accordingly, the FDA or foreign regulatory authorities could interpret this data in different ways from us or our

partners, which could delay, limit or prevent regulatory approval.

If our study data do not consistently or sufficiently demonstrate

the safety or efficacy of any of our product candidates, including MYMD-1 and Supera-CBD, to the satisfaction of the FDA or foreign regulatory

the safety or efficacy of any of our product candidates, including Isomyosamine and Supera-CBD, to the satisfaction of the FDA or foreign regulatory

authorities, then the regulatory approvals for such product candidates could be significantly delayed as we work to meet approval requirements,

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to commercialize a product candidate and the approval may be for a narrower indication than we seek.

to commercialization in the United States, MYMD-1, Supera-CBD and our other product candidates must be approved by the FDA pursuant to

to commercialization in the United States, Isomyosamine, Supera-CBD and our other product candidates must be approved by the FDA pursuant to

an NDA for their respective target indication(s).

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us from commercializing the product candidate.

We have not received approval to market MYMD-1, Supera-CBD or any of our other product

We have not received approval to market Isomyosamine, Supera-CBD or any of our other product

candidates from regulatory authorities in any jurisdiction.

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could delay, limit or prevent marketing approval of a product candidate.

of MYMD-1, Supera-CBD or our other product candidates may be delayed or refused for many reasons, including:

of Isomyosamine, Supera-CBD or our other product candidates may be delayed or refused for many reasons, including:

FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

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if our product candidates meet their pre-specified safety and efficacy endpoints in clinical trials, the regulatory authorities may not

complete their review processes in a timely manner and may not consider such the clinical trial results sufficient to grant, or we may

complete their review processes in a timely manner and may not consider such clinical trial results sufficient to grant, or we may

not be able to obtain regulatory approval.

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These requirements include submissions of safety and other post-marketing

information and reports, registration and listing requirements, requirements relating to manufacturing, including current Good Manufacturing

Practices (“cGMPs”), quality control, quality assurance and corresponding maintenance of records and documents, including

information and reports, registration and listing requirements, requirements relating to manufacturing, including cGMPs, quality control, quality assurance and corresponding maintenance of records and documents, including

periodic inspections by the FDA and other regulatory authorities and requirements regarding the distribution of samples to providers

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the often-difficult-to-ascertain line into “promotion,” which is not defined by regulation but is generally interpreted broadly

Accordingly, if FDA finds any of our communications regarding MyMD-1 or Supera-CBD to be promotional, we may be subject to a

Accordingly, if FDA finds any of our communications regarding Isomyosamine or Supera-CBD to be promotional, we may be subject to a

wide range of enforcement actions, and our candidates’ prospects for regulatory approval may be adversely affected.

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failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the

market and sell MYMD-1, Supera-CBD or our other product candidates in other jurisdictions, we must obtain separate marketing approvals

market and sell Isomyosamine, Supera-CBD or our other product candidates in other jurisdictions, we must obtain separate marketing approvals

and comply with numerous and varying regulatory requirements.

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saleable products, or that the market will accept or respond positively to products based on Supera-CBD.

Further, the success of our prospective Supera-CBD candidate, if any, is subject to a number of constantly-evolving

state and federal laws, regulations, and enforcement policies pertaining to the use of CBD.

Regulation of CBD .

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Regulation of CBD.

Individual states and local jurisdictions have also established controlled substance laws and regulations, which may differ

States have also developed CBD-specific laws and regulations that govern a wide range of CBD-related activities,

from cultivation to processing to marketing.

There is substantial variation among states’ CBD laws, and we will have to devote

substantial time, expenses, and resources toward compliance, and such laws are also subject to ongoing evolution and, thus, must be actively

We or our business partners may be required to obtain separate state or country registrations, permits or licenses in order

to be able to develop produce, sell, store and transport cannabinoids.

Individual states and local jurisdictions have also established controlled substance laws and regulations, which

may differ from U.S.

States have also developed CBD-specific laws and regulations that govern a wide range of CBD-related

activities, from cultivation to processing to marketing.

There is substantial variation among states’ CBD laws, and we will have

to devote substantial time, expenses, and resources toward compliance, and such laws are also subject to ongoing evolution and, thus,

must be actively monitored.

We or our business partners may be required to obtain separate state or country registrations, permits or

licenses in order to be able to develop produce, sell, store and transport cannabinoids.

is Complex and Costly .

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In certain circumstances, violations could lead to criminal proceedings.

Additionally, to the extent we are able to successfully commercialize any of our currently contemplated CBD products,

including Supera-CBD, the presence of CBD as an active or inactive ingredient may give rise to heightened regulatory scrutiny and greater

risk of consumer litigation, either of which could further restrict the permissible scope of our marketing claims about such products

or our ability to sell them in the U.S.

Because synthetic CBD products may be regulated as controlled substances in the U.S., to conduct clinical trials in the U.S.,

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Related to Commercialization and Manufacturing

commercial success of our product candidates, including MYMD-1 and Supera-CBD, will depend upon their degree of market acceptance by

commercial success of our product candidates, including Isomyosamine and Supera-CBD, will depend upon their degree of market acceptance by

providers, patients, patient advocacy groups, third-party payors and the general medical community.

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product revenue and may not become profitable.

The degree of market acceptance of MYMD-1, Supera-CBD and our other product candidates,

The degree of market acceptance of Isomyosamine, Supera-CBD and our other product candidates,

if approved for commercial sale, will depend on several factors, including:

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expect that coverage and reimbursement by third-party payors will be essential for most patients to be able to afford these treatments.

Accordingly, sales of MYMD-1, Supera-CBD and our other product candidates will depend substantially, both domestically and internationally,

Accordingly, sales of Isomyosamine, Supera-CBD and our other product candidates will depend substantially, both domestically and internationally,

on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar

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is significant uncertainty related to the insurance coverage and reimbursement of newly approved products.

In the U.S., third-party payors,

including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent

to which new drugs will be covered and reimbursed.

The Medicare program covers certain individuals aged 65 or older, disabled or suffering

from end-stage renal disease.

The Medicaid program, which varies from state to state, covers certain individuals and families who have

limited financial means.

The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental

payors develop their coverage and reimbursement policies for drugs.

One payor’s determination to provide coverage for a drug product,

however, does not assure that other payors will also provide coverage for the drug product.

Further, a payor’s decision to provide

coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

In the U.S., third-party

payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining

the extent to which new drugs will be covered and reimbursed.

The Medicare program covers certain individuals aged 65 or older,

disabled or suffering from end-stage renal disease.

The Medicaid program, which varies from state to state, covers certain

individuals and families who have limited financial means.

The Medicare and Medicaid programs increasingly are used as models for

how third-party private payors and other governmental payors develop their coverage and reimbursement policies for drugs.

payor’s determination to provide coverage for a drug product, however, does not assure that other payors will also provide

coverage for the drug product.

Further, a payor’s decision to provide coverage for a drug product does not imply that an

adequate reimbursement rate will be approved.

addition to government and private payors, professional organizations such as the American Medical Association (“AMA”), can

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approval before us or develop therapies that are more advanced or effective than ours, which may harm our business, financial condition

and our ability to successfully market or commercialize MYMD-1, Supera-CBD and our other product candidates.

and our ability to successfully market or commercialize Isomyosamine, Supera-CBD and our other product candidates.

biotechnology and pharmaceutical industries are characterized by rapidly changing technologies, competition and a strong emphasis on

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If any of our third-party

manufacturers encounter such difficulties, our ability to provide supply of MYMD-1, Supera-CBD or our other product candidates for clinical

manufacturers encounter such difficulties, our ability to provide supply of Isomyosamine, Supera-CBD or our other product candidates for clinical

trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients, if approved,

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could be adversely affected if healthcare reform measures substantially change the market for medical care or healthcare coverage in

March 23, 2010, President Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the “ACA”)

and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L.

111-152), collectively commonly

referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new rules regarding health insurance,

the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other

healthcare policy reforms.

Through the law-making process, substantial changes have been and continue to be made to the current system

for paying for healthcare in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage

and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs,

and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies).

This legislation was one

of the most comprehensive and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed

the way healthcare is financed by both governmental and private insurers.

This legislation has impacted the scope of healthcare insurance

and incentives for consumers and insurance companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed

to encourage providers to find cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the cost

of providing care.

This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention

to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in products

we may commercialize or promote in the future being chosen less frequently or the pricing being substantially lowered.

At this stage,

it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

March 23, 2010, former President Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the

“ACA”) and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L.

collectively commonly referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new

rules regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to

Medicare and Medicaid patients, and other healthcare policy reforms.

Through the law-making process, substantial changes have been

and continue to be made to the current system for paying for healthcare in the U.S., including changes made to extend medical

benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or

conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on

pharmaceutical and medical device companies).

This legislation was one of the most comprehensive and significant reforms ever

experienced by the U.S.

in the healthcare industry and has significantly changed the way healthcare is financed by both governmental

and private insurers.

This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance

companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find

cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the cost of providing care.

environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing

negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in products we may

commercialize or promote in the future being chosen less frequently or the pricing being substantially lowered.

At this stage, it is

difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare,

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could impact the reimbursement

for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization

partners are currently developing or those that we may commercialize or promote in the future.

If reimbursement for the products we currently

commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or

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

If reimbursement for any product we may commercialize or promote is substantially reduced or

otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material

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Cost of care could be reduced further by decreasing the level of reimbursement for medical

services or products (including our any product we may commercialize or promote in the future), or by restricting coverage (and, thereby,

services or products (including any product we may commercialize or promote in the future), or by restricting coverage (and, thereby,

utilization) of medical services or products.

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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.

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

President Trump also issued an executive

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

For example, on

January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health

insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021.

The executive

order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare,

including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that

create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

On the legislative front, the

American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug

rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source

drugs, beginning January 1, 2024.

And, in July 2021, the Biden administration released an executive order entitled, “Promoting

Competition in the American Economy,” with multiple provisions aimed at prescription drugs.

In response, on September 9, 2021,

HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and

sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take

to advance these principles.

And, in August 2022, the Inflation Reduction Act (“IRA”) was signed into law, which will, among

other things, allow U.S.

Department of Health and Human Services (“HHS”) to negotiate the selling price of certain drugs

and biologics that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D,

although only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected

by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

The negotiated prices, which will

first become effective in 2026, will be capped at a statutory ceiling price.

Beginning in October 2023, the IRA will also penalize drug

manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation.

The IRA permits

the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Manufacturers

that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

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.

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

eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single

source drugs and innovator multiple source drugs, beginning January 1, 2024.

And, in July 2021, the Biden administration released an

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

prescription drugs.

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

Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that

Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

And, in August 2022, the

Inflation Reduction Act (“IRA”) was signed into law, which will, among other things, allow U.S.

Department of Health and

Human Services (“HHS”) to negotiate the selling price of certain drugs and biologics that the Centers for Medicare &

Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although only high-expenditure single-source

drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS for negotiation, with the

negotiated price taking effect two years after the selection year.

The negotiated prices, which will first become effective in 2026,

will be capped at a statutory ceiling price.

Beginning in October 2023, the IRA also began penalizing drug manufacturers that

increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation.

The IRA permits the Secretary of

HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Manufacturers that fail

to comply with the IRA may be subject to various penalties, including civil monetary penalties.

The IRA also extends enhanced

subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

Additionally, in December, 2023, the Biden Administration announced further related initiatives under the IRA to

lower prescription costs and increase competition with help from HHS, the DOJ, and the FTC.

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

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.

Furthermore, we cannot asses 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

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restrictions, partial suspension or total shutdown of production;

MyMD’s requests for a 510(k) clearance of new products;

a 510(k) clearance already granted;

approval of a marketing application;

failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect on our financial condition

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pharmaceutical industry.

Recently, the U.S.

Office of Management and Budget issued a memo that instructed agencies, including the FDA, to

implement reductions in the workforce.

If such reductions result in staffing cuts at the FDA, there may be delays in the review and approval

of drug candidates, which may delay our ability to market any current or future drug candidates.

operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback, fraud

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HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

We, or the covered entities we engage with, could be subject to a wide

range of penalties and sanctions under HIPAA, including criminal penalties if the individually identifiable health information maintained

by a covered entity is disclosed in a manner that is not authorized or permitted by HIPAA.

Failure to comply with applicable HIPAA requirements

or other current and future privacy laws and regulations could result in governmental enforcement actions (including the imposition of

significant penalties), criminal and civil liability, and/or adverse publicity that negatively affects our business.

We, or the covered entities we engage

with, could be subject to a wide range of penalties and sanctions under HIPAA, including criminal penalties if the individually identifiable

health information maintained by a covered entity is disclosed in a manner that is not authorized or permitted by HIPAA.

Failure to comply

with applicable HIPAA requirements or other current and future privacy laws and regulations could result in governmental enforcement

actions (including the imposition of significant penalties), criminal and civil liability, and/or adverse publicity that negatively affects

our business.

we rely on our internal and third-party provided information technology systems and applications to support our operations and to maintain

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actors, and our systems and the information maintained within those systems remain potentially vulnerable to data security incidents.

On July 20, 2023, we experienced a cybersecurity incident.

A third-party forensic technology company’s investigation confirmed that

we were a victim of wire fraud due to a compromised electronic mail account.

As of the date of this filing, we have identified losses

totaling $78,198 related to this incident, net of amounts recovered.

Following the incident, we have taken measures to enhance our electronic

mail security and have modified our internal procedures to ensure the authenticity of payment instructions and we continue to evaluate

additional measures for improving cybersecurity.

Despite these prophylactic measures, the risk of such cyber-attacks against us or our

third-party providers and business partners remains a serious issue.

Cybersecurity incidents are pervasive, and the risks of cybercrime

are complex and continue to evolve.

of the above-described cyber or other security-related incidents may trigger notification obligations to affected individuals and government

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commercial success will depend in large part on obtaining and maintaining patent, trademark, trade secret and other intellectual property

protection of our proprietary technologies and product candidates, which include MYMD-1, Supera-CBD and the other product candidates

protection of our proprietary technologies and product candidates, which include Isomyosamine, Supera-CBD and the other product candidates

we have in development, their respective components, formulations, combination therapies, methods used to manufacture them and methods

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may also be able to develop similar technology independently or design around the patents to which we have rights.

Currently, MyMD has 16 issued U.S.

patents, 63 foreign patents, three

patent applications, 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.

Although we expect to obtain additional

patents and in-licenses in the future, there is no guarantee that we will be able to successfully obtain such patents or in-licenses in

a timely manner or at all.

Further, any of our rights to existing patents, and any future patents issued to us, may be challenged, invalidated

or circumvented.

As such, any rights granted under these patents may not provide us with meaningful protection.

Even if foreign patents

are granted, effective enforcement in foreign countries may not be available.

If our patents or rights to patents do not adequately protect

our technology or processes, competitors may be able to offer products similar to our products.

TNF has 18 issued U.S.

patents, 69 issued foreign patents, one pending U.S.

patent applications, and five foreign patent applications

pending in such jurisdictions as Canada, China, Israel, and Japan, which if issued are expected to expire between 2036 and 2041.

we expect to obtain additional patents and in-licenses in the future, there is no guarantee that we will be able to successfully obtain

such patents or in-licenses in a timely manner or at all.

Further, any of our rights to existing patents, and any future patents issued

to us, may be challenged, invalidated or circumvented.

As such, any rights granted under these patents may not provide us with meaningful

Even if foreign patents are granted, effective enforcement in foreign countries may not be available.

If our patents or rights

to patents do not adequately protect our technology or processes, competitors may be able to offer products similar to our products.

potential strategy of obtaining rights to key technologies through in-licenses may not be successful.

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patent applications remain confidential in the U.S.

Patent and Trademark Office (the “USPTO”), for the entire time prior to issuance

Patent applications filed in countries outside of the United States are not typically published until at least 18 months

from their first filing date.

Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries.

We cannot be certain that we or our licensors were the first to invent, or the first to file, patent applications covering our products.

We also may not know if our competitors filed patent applications for technology covered by our pending applications or if we were the

first to invent the technology that is the subject of our patent applications.

Competitors may have filed patent applications or received

patents and may obtain additional patents and proprietary rights that block or compete with our patents.

Patent and Trademark Office (the “USPTO”), for the entire time prior

to issuance as a U.S.

Patent applications filed in countries outside of the United States are not typically published until at

least 18 months from their first filing date.

Similarly, publication of discoveries in scientific or patent literature often lags

behind actual discoveries.

We cannot be certain that we or our licensors were the first to invent, or the first to file, patent applications

covering our products.

We also may not know if our competitors filed patent applications for technology covered by our pending applications

or if we were the first to invent the technology that is the subject of our patent applications.

Competitors may have filed patent applications

or received patents and may obtain additional patents and proprietary rights that block or compete with our patents.

there may be third-party patents of which we are currently unaware with claims to materials, formulations, methods of manufacture or

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by one of our primary competitors.

If we are unable to obtain a necessary license to a third-party patent on commercially reasonable

If we are unable to obtain a necessary license for a third-party patent on commercially reasonable

terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could significantly harm our

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and prospects could be materially harmed.

Related to Our Series F Preferred Stock

of our Series F Preferred Stock are entitled to certain payments under the Certificate of Designation that may be paid in cash or in

shares of Common Stock depending on the circumstances.

If we make these payments in cash, it may require the expenditure of a substantial

portion of our cash resources.

If we make these payments in Common Stock, it may result in substantial dilution to the holders of our

Common Stock.

the Certificate of Designations (the “Certificate of Designation”) of our Series F Convertible Preferred Stock

(“Series F Preferred Stock”), we are required to redeem the shares of Series F Preferred Stock in 12 equal monthly

installments, commencing on July 1, 2023.

Holders of our Series F Preferred Stock are also entitled to receive dividends, payable in

arrears monthly, and dividends payable on installment dates shall be paid as part of the applicable installment amount.

amounts are payable, at the company’s election, in shares of Common Stock or, subject to certain limitations, in cash.

Installment amounts paid in cash must be paid in the amount of 105% of the applicable payment amount due.

For an installment amounts

paid in shares of Common Stock, the number of shares of Common Stock shall be calculated by dividing the applicable payment amount

due by the “installment conversion price.” The installment conversion price shall be equal to the lower of (i) the

Conversion Price (as defined in the Certificate of Designation) in effect as of the applicable payment date and (ii) the greater of

(A) 80% of the average of the three lowest closing prices of our Common Stock during the thirty trading day period immediately prior

to the date the payment is due or (B) $6.60 (subject to adjustment for stock splits, stock dividends, stock combinations,

recapitalizations or other similar events) or, in any case, such lower amount as permitted, from time to time, by the Nasdaq Stock

Our ability to make payments due to the holders of our Series F Preferred

Stock using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designation.

If we are unable to make installment payments in shares of Common

Stock, we may be forced to make such payments in cash.

If we do not have sufficient cash resources to make these payments, we may need

to raise additional equity or debt capital, and we cannot provide any assurance that we will be successful in doing so.

If are unable

to raise sufficient capital to meet our payment obligations, we may need to delay, reduce or eliminate certain research and development

programs or other operations, sell some or all of our assets or merge with another entity.

Our ability to make payments due to the holders of our Series F Preferred

Stock using cash is also limited by the amount of cash we have on hand at the time such payments are due as well as certain provisions

of the Delaware General Corporation Law (the “DGCL”).

Further, we intend to make the installment payments due to holders of

Series F Preferred Stock in the form of Common Stock to the extent allowed under the Certificate of Designation and applicable law in

order to preserve our cash resources.

The issuance of shares of Common Stock to the holders of our Series F Preferred Stock with increase

the number of shares of Common Stock outstanding and could result in substantial dilution to the existing holders of our Common Stock.

Certificate of Designation for the Series F Preferred Stock and the warrants issued concurrently therewith contain anti-dilution provisions

that may result in the reduction of the conversion price of the Series F Preferred Stock or the exercise price of such warrants in the

These features may increase the number of shares of Common Stock being issuable upon conversion of the Series F Preferred Stock

or upon the exercise of the warrants.

Certificate of Designation and the warrants issued concurrently with the Series F Preferred Stock (the “February 2023 Warrants”)

contain anti-dilution provisions, which provisions require the lowering of the applicable conversion price or exercise, as then in effect,

to the purchase price of equity or equity-linked securities issued in subsequent offerings.

If in the future, while any of our Series

F Preferred Stock or February 2023 Warrants are outstanding, we issue securities for a consideration per share of Common Stock (the “New

Issuance Price”) that is less than the Conversion Price of our Series F Preferred Stock or the exercise price of the February 2023

Warrants, as then in effect, we will be required, subject to certain limitations and adjustments as provided in the Certificate of Designation

or the February 2023 Warrants, to reduce the Conversion Price or the exercise price to be equal to the New Issuance Price, which will

result in a greater number of shares of Common Stock being issuable upon conversion or exercise, as applicable, which in turn will increase

the dilutive effect of such conversion or exercise on existing holders of our Common Stock.

It is possible that we will not have a sufficient

number of shares available to satisfy the conversion of the Series F Preferred Stock or the exercise of the February 2023 Warrants if

we enter into a future transaction that reduces the applicable Conversion Price or exercise price.

If we do not have a sufficient number

of available shares for any Series F Preferred Stock conversions or February 2023 Warrant exercises, we may need to seek shareholder

approval to increase the number of authorized shares of our Common Stock, which may not be possible and will be time consuming and expensive.

The potential for such additional issuances may depress the price of our Common Stock regardless of our business performance and may

make it difficult for us to raise additional equity capital while any of our Series F Preferred Stock or February 2023 Warrants are outstanding.

the February 2023 Securities Purchase Agreement we are subject to certain restrictive covenants that may make it difficult to procure

additional financing.

Securities Purchase Agreement pursuant to which we issued the Series F Preferred Stock (“February 2023 SPA”) contains the

following restrictive covenants:

(i) until all of the February 2023 Warrants are exercised, we agreed not to enter into any variable

rate transactions;

(ii) for approximately ten months after the execution of the February 2023 SPA, we agreed not to issue or sell any

equity security or convertible security, subject to certain exceptions;

and (iii) we agreed to offer to the investors party to the February

2023 SPA, until the later of no Series F Preferred Shares being outstanding and the maturity date of the Series F Preferred Shares, the

opportunity to participate in any subsequent securities offerings by us.

If we require additional funding while these restrictive covenants

remain in effect, we may be unable to effect a financing transaction while remaining in compliance with the terms of the February 2023

SPA, or we may be forced to seek a waiver from the investors party to the February 2023 SPA.

Related to Our Preferred Stock

Holders of our Series F Preferred

Stock, Series F-1 Preferred Stock and Series G Preferred Stock are entitled to certain payments under the applicable Certificate of Designations

that may be paid in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending on the circumstances.

If we make these payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments

in Common Stock, it may result in substantial dilution to the holders of our Common Stock.

the Series F Certificate of Designations and Series F-1 Certificate of Designations, we are required to redeem the shares of the shares

of the Series F Preferred Stock and Series F-1 Preferred Stock in equal monthly installments commencing July 1, 2023, and December 1,

2024, respectively.

Such holders are also entitled to receive dividends, payable in arrears monthly, and dividends payable on installment

dates shall be paid as part of the applicable installment amount.

Installment amounts are payable, at the Company’s election, in

shares of Common Stock or, subject to certain limitations, in cash.

Installment amounts paid in cash must be paid in the amount of 105%

of the applicable payment amount due.

ability to make payments due to the holders of our Series F Preferred Stock and Series F-1 Preferred Stock using shares of Common Stock

is subject to certain limitations set forth in the applicable Certificate of Designations.

If we are unable to make installment payments

in shares of Common Stock, we may be forced to make such payments in cash.

Additionally, the holders of the Series G Preferred Stock

are entitled to dividends of 10% per annum, compounded monthly, which are payable in arrears monthly, at the holder’s sole discretion,

in cash, or “in kind” in the form of additional Series G Preferred Stock, or a combination thereof.

If we do not have sufficient

cash resources to make these payments, we may need to raise additional equity or debt capital, and we cannot provide any assurance that

we will be successful in doing so.

If are unable to raise sufficient capital to meet our payment obligations, we may need to delay, reduce

or eliminate certain research and development programs or other operations, sell some or all of our assets or merge with another entity.

ability to make payments due to the holders of our Series F Preferred Stock, Series G Preferred Stock, Series F-1 Preferred Stock using

cash is also limited by the amount of cash we have on hand at the time such payments are due as well as certain provisions of the Delaware

General Corporation Law (the “DGCL”).

Further, we intend to make the installment payments due to holders of Series F Preferred

Stock and Series F-1 Preferred Stock in the form of Common Stock to the extent allowed under the applicable Certificate of Designation

and applicable law in order to preserve our cash resources.

The issuance of shares of Common Stock to the holders of our Series F Preferred

Stock and Series F-1 Preferred Stock with increase the number of shares of Common Stock outstanding and could result in substantial dilution

to the existing holders of our Common Stock.

Certificate of Designations for the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable

preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock

being issuable upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock or upon the exercise

of the warrants.

Series F Certificate of Designations, Series F-1 Certificate of Designations and Series G Certificate of Designations and the warrants

issued concurrently therewith, contain anti-dilution provisions, which provisions require the lowering of the applicable conversion price

or exercise, as then in effect, to the purchase price of equity or equity-linked securities issued in subsequent offerings.

future, while any of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock, Series F Warrants, Series F-1

Warrants or Series G Warrants are outstanding, we issue securities for a consideration per share of Common Stock (the “New Issuance

Price”) that is less than the applicable conversion price of our preferred stock or the exercise price of the Series F Warrants,

Series F-1 Warrants or Series G Warrants, as then in effect, we will be required, subject to certain limitations and adjustments as provided

in the applicable Certificate of Designations or the applicable warrants, to reduce the conversion price or the exercise price to be

equal to the New Issuance Price, which will result in a greater number of shares of Common Stock being issuable upon conversion or exercise,

as applicable, which in turn will increase the dilutive effect of such conversion or exercise on existing holders of our Common Stock.

It is possible that we will not have a sufficient number of shares available to satisfy the conversion of the Series F Preferred Stock,

Series F-1 Preferred Stock or Series G Preferred Stock or the exercise of the Series F Warrants, Series F-1 Warrants or Series G Warrants

if we enter into a future transaction that reduces the applicable conversion price or exercise price.

If we do not have a sufficient

number of available shares for any such conversions or any such warrant exercises, we may need to seek stockholder approval to increase

the number of authorized shares of our Common Stock, which may not be possible and will be time-consuming and expensive.

The potential

for such additional issuances may depress the price of our Common Stock regardless of our business performance and may make it difficult

for us to raise additional equity capital while any of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock

or Series F Warrants, Series F-1 Warrants or Series G Warrants are outstanding.

the February 2023 SPA, the Series F-1 Purchase Agreement and Series G Purchase Agreement we are subject to certain restrictive covenants

that may make it difficult to procure additional financing.

February 2023 SPA, pursuant to which we issued the Series F Preferred Stock, contains, among others, the following restrictive covenants:

(i) until all of the Series F Warrants are exercised, we agreed not to enter into any variable rate transactions;

and (ii) until the

later of no shares of Series F Preferred Stock being outstanding and the maturity date of the Series F Preferred Stock, the opportunity

to participate in any subsequent securities offerings by us.

The Series F-1 Purchase Agreement, pursuant to which we issued the Series

F-1 Preferred Stock, contains, among others, the following restrictive covenants:

(i) until all of the Series F-1 Warrants are exercised,

we agreed not to enter into any variable rate transactions;

and (ii) until the later of no shares of Series F-1 Preferred Stock being

outstanding and the maturity date, the opportunity to participate in any subsequent securities offerings by us.

The Series G Purchase

Agreement, pursuant to which we issued the Series G Preferred Stock, contains, among others, the following restrictive covenants:

until all of the Series G Warrants are exercised, we agreed not to enter into any variable rate transactions;

and (ii) until the later

of no shares of Series G Preferred Stock being outstanding and the second anniversary of the Series G Closing Date, the opportunity to

participate in any subsequent securities offerings by us.

we require additional funding while these restrictive covenants remain in effect, we may be unable to effect a financing transaction

while remaining in compliance with the terms of the February 2023 SPA or Purchase Agreements, or we may be forced to seek a waiver from

the investors party to the February 2023 SPA and Purchase Agreements.

or availability for sale of a substantial number of shares of our Common Stock may cause the price of our Common Stock to decline.

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it more difficult for us to raise funds through future offerings of Common Stock or other securities.

Our stockholders and the holders

of our options and warrants may sell substantial amounts of our Common Stock in the public market.

In addition, we may be required to

issue shares of Common Stock to the holders of our Series F Preferred Stock upon conversion of shares of our Series F Preferred Stock

and the payment of the dividends thereunder in Common Stock as a result of the full ratchet anti-dilution price protection in the Certificate

of Designation if the effective Common Stock purchase price in a subsequent offering is less than the then current Series F Preferred

Stock conversion price, which in turn will increase the number of shares of Common Stock available for sale.

See “Risk Factors—Risks

Related to Our Series F Preferred Stock—The Certificate of Designation for the Series F Preferred Stock and the warrants issued

concurrently contain anti-dilution provisions that may result in the reduction of the conversion price of the Series F Preferred Stock

or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock being issuable

upon conversion of the Series F Preferred Stock or upon the exercise of the warrants.”

Our stockholders and the

holders of our options and warrants may sell substantial amounts of our Common Stock in the public market.

In addition, we may be

required to issue shares of Common Stock to the holders of our Series F Preferred Stock, Series F-1 Preferred Stock or Series G

Preferred Stock upon conversion of such shares of our Series F Preferred Stock and the payment of the dividends thereunder in Common

Stock as a result of the full ratchet anti-dilution price protection in the Certificate of Designation if the effective Common Stock

purchase price in a subsequent offering is less than the then current conversion price, which in turn will

increase the number of shares of Common Stock available for sale.

See “Risk Factors—Risks Related to Our Series F Preferred Stock—

The Certificate of Designations for the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable

preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock

being issuable upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock or upon the exercise

of the warrants.”

addition, the fact that our stockholders can sell substantial amounts of our Common Stock in the public market, whether or not sales

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It is also more expensive for us to obtain director and officer liability insurance.

If we fail to comply with the continued listing

requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access

the capital markets could be negatively impacted.

Our common stock is currently

listed for trading on The Nasdaq Capital Market.

We must satisfy Nasdaq’s continued listing requirements, including, among other

things, a minimum stockholders’ equity of $2.5 million and a minimum closing bid price of $1.00 per share or risk delisting,

which would have a material adverse effect on our business.

A delisting of our common stock from The Nasdaq Capital Market could materially

reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock.

delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may

result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

As previously disclosed, on October

11, 2023, we received a written notice (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market

indicating that for the last 30 consecutive business days, the bid price for our Common Stock had closed below the minimum $1.00 per share

requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

The letter also indicated that the Company will be provided with a compliance period until April 8, 2024 (the “Compliance Period”),

in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

Effective as of 4:05 p.m.

Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of one-for-thirty.

Simultaneously

with the Reverse Stock Split, number of shares of our common stock authorized for issuance was reduced from 500,000,000 shares to 16,666,666

shares, and our authorized capital stock was reduced from 550,000,000 shares to 66,666,666 shares.

Our common stock continued to be traded

on the Nasdaq Capital Market under the symbol MyMD and began trading on a split-adjusted basis at market open on February 15, 2024.

March 4, 2024, we were notified by Nasdaq that we had regained compliance with all Nasdaq listing requirements and the matter was closed.

There is no assurance that we

will maintain compliance with such minimum listing requirements.

If our common stock were delisted from Nasdaq, trading of our common

stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market

maintained by OTC Markets Group Inc.

An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking

to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty

in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other

In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny stock,” which impose

additional disclosure requirements on broker-dealers.

The regulations relating to penny stocks, coupled with the typically higher cost

per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the

price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock.

delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may

result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the

value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations,

including our ability to attract and retain qualified employees and to raise capital.

we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price

of our common stock and our ability to access the capital markets could be negatively impacted.

common stock is currently listed for trading on The Nasdaq Capital Market.

We must satisfy Nasdaq’s continued listing requirements,

including, among other things, a minimum stockholders’ equity of $2.5 million and a minimum closing bid price of $1.00 per

share or risk delisting, which would have a material adverse effect on our business.

A delisting of our common stock from The Nasdaq

Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price

of our common stock.

In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable

to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business

development opportunities.

previously disclosed, on March 17, 2025, we received a written notice (the “Notice”) from the Listing Qualifications Department

of the Nasdaq Stock Market indicating that for the last 30 consecutive business days, the bid price for our Common Stock had closed below

the minimum $1.00 per share requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum

Bid Price Requirement”).

The letter also indicated that the Company will be provided with a compliance period until September 15, 2025

(the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

as of 4:05 p.m.

Eastern Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of one-for-thirty.

Simultaneously with the Reverse Stock Split, number of shares of our common stock authorized for issuance was reduced from 500,000,000

shares to 16,666,666 shares, and our authorized capital stock was reduced from 550,000,000 shares to 66,666,666 shares.

Our common stock

continued to be traded on the Nasdaq Capital Market under the symbol TNF and began trading on a split-adjusted basis at market open on

February 15, 2024.

On March 4, 2024, we were notified by Nasdaq that we had regained compliance with all Nasdaq listing requirements

and the matter was closed.

is no assurance that we will maintain compliance with such minimum listing requirements.

If our common stock were delisted from Nasdaq,

trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the

OTCQB or the Pink Market maintained by OTC Markets Group Inc.

An investor would likely find it less convenient to sell, or to obtain

accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell

our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed

on a national exchange or other reasons.

In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny

stock,” which impose additional disclosure requirements on broker-dealers.

The regulations relating to penny stocks, coupled with

the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing

a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade

in our common stock.

In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable

to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business

development opportunities.

For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of

our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition

and results of operations, including our ability to attract and retain qualified employees and to raise capital.

may issue additional equity securities in the future, which may result in dilution to existing investors.

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or warrants to purchase shares of capital stock may result in dilution to our stockholders upon any such exercise or conversion.

of our outstanding shares of Common Stock are, and any shares of our Common Stock that may be issued in the future in respect of potential milestone payments, will be,

freely tradable without restrictions or further registration under the Securities Act of 1933, as amended (the “Securities Act”),

except for shares subject to lock-up agreements, and any shares held by affiliates, as defined in Rule 144 under the Securities Act.

Rule 144 defines an affiliate as a person who directly, or indirectly through one or more intermediaries, controls, or is controlled

by, or is under common control with, the Company and would include persons such as our directors and executive officers and large shareholders.

In turn, resales, or the perception by the market that a substantial number of resales could occur, could have the effect of depressing

the market price of our Common Stock.

addition, we may be required to issue an indeterminate number of shares of Common Stock to the holders of our Series F Preferred Stock

and the February 2023 Warrants upon the conversion or exercise of either, as applicable.

See “Risk Factors—Risks Related

to Our Series F Preferred Stock— Holders of our Series F Preferred Stock are entitled to certain payments under the Certificate

of Designation that may be paid in cash or in shares of Common Stock depending on the circumstances.

If we make these payments in cash,

it may require the expenditure of a substantial portion of our cash resources.

If we make these payments in Common Stock, it may result

in substantial dilution to the holders of our Common Stock.” and “Risk Factors—Risks Related to Our Series F Preferred

Stock—The Certificate of Designation for the Series F Preferred Stock and the warrants issued concurrently contain anti-dilution

provisions that may result in the reduction of the conversion price of the Series F Preferred Stock or the exercise price of such warrants

in the future.

These features may increase the number of shares of Common Stock issuable upon conversion of the Series F Preferred Stock

or upon the exercise of the warrants.”

In addition, we may be required to issue an indeterminate number of shares

of Common Stock to the holders of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock and related warrants

upon the conversion or exercise of either, as applicable.

See “Risk Factors—Risks Related to Our Preferred Stock— Holders

of our Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock are entitled to certain payments under the applicable

Certificate of Designations that may be paid in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending

on the circumstances.

If we make these payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments in Common Stock, it may result in substantial dilution to the holders of our Common Stock..” and “Risk

Factors—Risks Related to Our Preferred Stock—The Certificate of Designations for the Series F Preferred Stock, Series F-1

Preferred Stock and Series G Preferred Stock and the warrants issued concurrently therewith contain anti-dilution provisions that may

result in the reduction of the conversion price of the applicable preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock being issuable upon conversion of the Series F Preferred Stock, Series

F-1 Preferred Stock and Series G Preferred Stock or upon the exercise of the warrants.”

do not anticipate paying cash dividends on our Common Stock and, accordingly, stockholders must rely on stock appreciation for any return

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have never declared or paid cash dividends on our Common Stock and do not expect to do so in the foreseeable future.

So long as any shares

of Series F Preferred Stock are outstanding, as they are at this time, we are not able to declare or pay any cash dividend or distribution

on any of our capital stock (other than as required by the Certificate of Designation) without the prior written consent of the Required

Holders (as defined in the Certificate of Designation).

The declaration of dividends is further subject to the discretion of our board

of directors and limitations under applicable law, and will depend on various factors, including our operating results, financial condition,

future prospects and any other factors deemed relevant our board of directors.

So long as any

shares of Series F Preferred Stock, Series F-1 Preferred Stock or Series G Preferred Stock are outstanding, as they are at this

time, we are not able to declare or pay any cash dividend or distribution on any of our capital stock (other than as required by the

respective Certificate of Designations) without the prior written consent of the Required Holders (as defined in the respective

Certificate of Designations).

The declaration of dividends is further subject to the discretion of our board of directors and

limitations under applicable law, and will depend on various factors, including our operating results, financial condition, future

prospects and any other factors deemed relevant our board of directors.

You should not rely on an investment in us if you require

dividend income from your investment in us.

The success of your investment will likely depend entirely upon any future appreciation of

the market price of our Common Stock, which is uncertain and unpredictable.

There is no guarantee that our Common Stock will appreciate

The success of your investment will likely depend entirely upon any future appreciation

of the market price of our Common Stock, which is uncertain and unpredictable.

There is no guarantee that our Common Stock will

appreciate in value.

securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our

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the authorized number of directors to be changed only by resolution of our board of directors;

our board of directors to issue, without stockholder approval, preferred stock, the rights

of which will be determined at the discretion of the board of directors and that, if issued,

could operate as a “poison pill” to dilute the stock ownership of a potential

our board of directors to issue, without stockholder approval, preferred stock, the rights of which will be determined at the discretion

of the board of directors and that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential

hostile acquirer to prevent an acquisition that our board of directors does not approve;

advance notice requirements for stockholder nominations to our board of directors or for

stockholder proposals that can be acted on at stockholder meetings;

advance notice requirements for stockholder nominations to our board of directors or for stockholder proposals that can be acted

on at stockholder meetings;

who may call a stockholder meeting.

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have been subject to a number of securities litigations, and we may be subject to similar or other litigation in the future.

have been subject to a number of litigations as described elsewhere in this Annual Report on Form 10-K and in Note 8 to our

consolidated financial statements.

In connection with certain of these litigations, we have entered into settlements of claims for

significant monetary damages.

We may also be subject to judgements or enter into additional settlements of claims for significant

monetary damages for the securities litigations that we have yet to enter into settlement agreements.

Defending against the current

litigations is or can be time-consuming, expensive and cause diversion of our management’s attention.

have been subject to a number of litigations as described elsewhere in this Annual Report on Form 10-K and in Note 8 to our consolidated

financial statements.

In connection with certain of these litigations, we have entered into settlements of claims for significant monetary

We may also be subject to judgements or enter into additional settlements of claims for significant monetary damages for the

securities litigations that we have yet to enter into settlement agreements.

Defending against the current litigations is or can be time-consuming,

expensive and cause diversion of our management’s attention.

that have experienced volatility in the market price of their stock have frequently been the objects of securities class action litigation.

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

What changed 10-K

Item 1A. Risk Factors