What changed in this filing

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Item 1A. Risk Factors

2024-04-01 compared with 2023-03-31 · 643 added, 695 removed, 1347 unchanged (50% of the section changed)

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Annual Report on Form 10-K and our other filings with the SEC before making investment decisions regarding our Common Stock.

Related to the Company Following the Merger

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

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 following the Merger will likely limit the ability of our

stockholders to influence corporate matters.

sale or availability for sale of a substantial number of shares of our Common Stock after expiration of the lock-up period could

adversely affect the market price of such shares.

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.

intended benefits of the Contribution Transaction may not be realized.

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 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

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

Related to our Product Development and Regulatory Approval

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.

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

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

COVID-19 pandemic, or similar 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.

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

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 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 MYMD-1, 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 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 or stopped.

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

Related to Government Regulation

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.

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.

Related to Our Intellectual Property

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.

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

and in non-U.S.

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

to protect our product candidates.

Risks Related to Our Series F Convertible

Preferred Stock

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 Stock.

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.

If we do not receive approval

from our stockholders, we will be unable to pay dividends due to the holders of our Series F Preferred Stock in shares of Common

Stock and we will be required to pay such dividends in cash, which may force us to divert cash from other uses.

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

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of the warrants.

In 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

Related to the Company Following the Merger

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

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.

market price of our Common Stock after the Merger 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.

to April 2021, there was no public market for the combined Company’s Common Stock.

The market price of our Common Stock

following the Merger has begun and could continue to be subject to significant fluctuation following the Merger.

The pre-Merger

business of the Company differs from its post-Merger business in important respects and, accordingly, the results of operations of

the combined Company and the market price of the combined Company’s Common Stock following the Merger may be affected by

factors different from those affecting the results of operations of the Company prior to the Merger.

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.

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

reacting negatively to the effect on our business and prospects from the Merger;

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.

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.

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.

the COVID-19 pandemic, 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.

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.

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

We anticipates that we will continue to incur losses

We anticipate that we will continue to incur losses

for the foreseeable future.

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have incurred net losses in each year since our inception.

We incurred net losses of $15,197,336 and $29,889,045 for the years ended

December 31, 2022 and 2021, respectively.

As of December 31, 2022, we had an accumulated deficit of $93,758,904.

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

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.

We incurred net losses attributable to shareholders of $8,218,163 and

$15,197,336 for the years ended December 31, 2023 and 2022, 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

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.

the Merger was 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.

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:

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our Common Stock.

concentration of the capital stock ownership with insiders of the Company after the Merger will likely limit the ability of our stockholders

to influence corporate matters.

the Supera Purchase and the Merger, 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.

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

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

stockholders may view as beneficial.

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

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.

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.

sale or availability for sale of a substantial number of shares of our Common Stock after expiration of the lock-up period could adversely

affect the market price of such shares.

of a substantial number of shares of our Common Stock in the public market after expiration of the lock-up period and other legal

restrictions on resale, or the perception that these sales could occur, could adversely affect the market price of such shares and

could materially impair our ability to raise capital through equity offerings in the future.

Upon completion of the Merger and the

transactions contemplated in the Merger Agreement, the Company issued 28,553,307 post reverse stock split shares of Company Common

Stock to the former stakeholders of pre-Merger MyMD Florida at the Exchange Ratio.

Shares that were issued to pre-Merger MyMD

Florida stockholders as merger consideration could be resold in the public market immediately without restriction, unless such

stockholder was subject to a lock-up or other restriction on resale.

All of the previous executive officers, directors and principal

stockholders of pre-Merger MyMD Florida, and all of our directors who continued to serve on the Board of Directors of the combined

Company after the Merger, were subject to lock-up agreements pursuant to which such stockholders agreed, except in limited

circumstances, not to transfer, grant an option with respect to, sell, exchange, pledge or otherwise dispose of, or encumber, any

shares of Company capital stock for 180 days following the effective time of the Merger;

such lock-up agreements have now expired,

so the shares of our Common Stock (excluding securities underlying options and warrants) held by our directors, executive officers

and principal stockholders may now be sold, subject to volume limitations under Rule 144 under the Securities Act and various

vesting agreements.

We are unable to predict what effect, if any, market sales of securities held by our significant stockholders,

directors or officers or the availability of these securities for future sale will have on the market price of our Common Stock in

also assumed approximately 4,188,315 shares of Common Stock subject to outstanding options to purchase pre-Merger MyMD Florida Common Stock.

We registered all of the shares of Common Stock issuable upon exercise of outstanding options to purchase MyMD Florida Common Stock, and therefore upon the exercise of any options or other equity incentives we may grant in the future, for public resale under

the Securities Act.

Accordingly, these shares will be able to be freely sold in the public market upon issuance as permitted by any applicable

vesting requirements, subject to the lock-up agreements described above.

Anti-takeover

provisions under New Jersey corporate law may make it difficult for our stockholders to replace or remove our Board of Directors and

could deter or delay third parties from acquiring us, which may be beneficial to our stockholders.

are subject to the anti-takeover provisions of New Jersey law, including Section 14A-10A of the New Jersey Shareholders Protection Act.

These statutes prohibit an “interested stockholder” of the Company from effecting a business combination with us for a period

of five years unless our Board of Directors approved the combination or transaction or series of related transactions that caused such

person to become an interested stockholder prior to the stockholder becoming an interested stockholder or after the stockholder becomes

an interested stockholder if the subsequent business combination is approved by (i) our Board of Directors (or a committee thereof consisting

solely of persons independent from the interested stockholder), and (ii) the affirmative vote of a majority of the voting stock not beneficially

owned by such interested stockholder.

In addition, but not in limitation of the five-year restriction, we may not engage at any time

in a business combination with any interested stockholder the Company unless the combination is approved by our Board of Directors (or

a committee thereof consisting solely of persons independent from such interested stockholder) prior to the consummation of the business

combination, and the combination receives the approval of a majority of the voting stock of the Company not beneficially owned by the

interested stockholder if the transaction or series of related transactions which caused the interested stockholder to become an interested

stockholder was approved by the Board of Directors prior to the stockholder becoming an interested stockholder.

These provisions could

discourage a third party from making a takeover offer and could delay or prevent a change of control.

For purposes of Section 14A-10A

of the New Jersey Shareholders Protection Act, “interested stockholder” means, generally, any beneficial owner of 10% or

more of the voting power of the outstanding voting stock of the corporation and any affiliate or associate of the corporation who within

the prior five year period has at any time owned 10% or more of the voting power of the then outstanding stock of the corporation.

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 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.

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

must attract and retain highly skilled employees to succeed.

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

business may be materially adversely affected by the COVID-19 pandemic.

The global health crisis caused

by the COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic activity, which, despite vaccination

efforts, remains uncertain and cannot be predicted with confidence.

The ultimate impact of COVID-19, including its variants, cannot be

predicted at this time, and could depend on numerous factors, including vaccination rates among the population, the effectiveness of COVID-19

vaccines against future COVID-19 variants and the response by governmental bodies and regulators to any resurgences.

Given the ongoing

and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our business.

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

The effects of the orders and related adjustments in our business have delayed and may continue to delay our timelines, including those with respect to patient enrollment in clinical trials.

Moreover, the COVID-19 pandemic has had and may continue to have indeterminable

adverse effects on general commercial activity and the world economy, and our business and results of operations have been and may continue

to be adversely affected to the extent that COVID-19 or any other epidemic harms the global economy generally.

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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those of third-party providers.

the ordinary course of our business, we and our third-party providers rely

on electronic communications and information system to conduct our operations.

We and our third-party providers have been, and may continue

to be, targeted by parties using fraudulent e-mails and other communications in attempts to misappropriate bank accounting information,

passwords, or other personal information or to introduce viruses or other malware to our information systems.

Between August and October

2021, 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

$1,260,864 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.

Although we are making significant efforts to maintain the security and integrity of our information

systems and are exploring various measures to manage the risk of a security breach or disruption, there can be no assurance that our security

efforts and measures will be effective or that attempted security breaches or disruptions would not be successful or damaging.

the ordinary course of our business, we and our third-party providers rely on electronic communications and information system to conduct

our operations.

We and our third-party providers have been, and may continue to be, targeted by parties using fraudulent e-mails and

other communications in attempts to misappropriate bank accounting information, passwords, or other personal information or to introduce

viruses or other malware to our information systems.

Between August and October 2021, 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

As of the date of this filing, we have identified losses totaling $1,260,864 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.

Although we are making significant efforts to

maintain the security and integrity of our information systems and are exploring various measures to manage the risk of a security breach

or disruption, there can be no assurance that our security efforts and measures will be effective or that attempted security breaches

or disruptions would not be successful or damaging.

addition, we collect and store sensitive data, including intellectual property, research data, our proprietary business information and

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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 may include post-market or

“Phase 4” studies), which will likely take several years and substantial expenses to complete, before we can submit an application

for marketing approval to the FDA.

There is no guarantee that we will complete such clinical development in a timely manner or at all

or that we will obtain regulatory approval for either product candidate.

– 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).

to both our MYMD-1 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

to complete additional post-market or “Phase 4” studies after application or approval.

There is no guarantee that we will

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).

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.

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.

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.

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.

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

– 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.

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.

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

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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

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.

Even if the results of our

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.

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.

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

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, 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;

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

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.

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

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have invested a substantial amount of effort and financial resources in MYMD-1 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 to enable submission of an Investigational New Drug (“IND”) application for a Phase 1 in healthy

volunteers followed by clinical trials in epilepsy, addiction and anxiety disorders.

In order to conduct human clinical trials, we

are required obtain approval from Institutional Review Boards (“IRBs”) or Ethics committees.

IRBs are independent

committee organizations that operate in compliance with U.S.

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

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

trials in epilepsy, addiction and anxiety disorders.

In order to conduct human clinical trials, we are required obtain approval from

Institutional Review Boards (“IRBs”) or Ethics committees.

IRBs are independent committee organizations that operate in compliance

federal regulations (including, but not limited to 21 C.F.R.

and 56, and 45 C.F.R.

Part 46) in order to help protect the rights of research subjects under the federal Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”).

IRBs provide expertise in examining research for its ethical

implications, including research involving vulnerable populations, such as pediatrics, critically ill, and cognitively impaired

participants.

There is no guarantee that an IRB will approve our current product candidates for human clinical trials.

approval, the Company would not be able to perform clinical research on humans and our products would not be able to move through

the regulatory approval process.

Parts 50 and 56, and 45 C.F.R.

Part 46) in order to help protect

the rights of research subjects under the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

IRBs provide expertise in examining research for its ethical implications, including research involving vulnerable populations, such

as pediatrics, critically ill, and cognitively impaired participants.

There is no guarantee that an IRB will approve our current product

candidates for human clinical trials.

Without IRB approval, the Company would not be able to perform clinical research on humans and

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

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financial condition, results of operations and prospects.

health crises, such as the COVID-19 pandemic, could have a material adverse impact the execution of our planned clinical

Phase 2 clinical trial for MYMD-1 currently in progress has been and may continue to be affected by the pandemic.

Protocols put into place for COVID-19 have delayed and may continue to delay patient enrollment in our current and

planned clinical trials.

delays to our planned Phase 2 and Phase 3 clinical trials for MYMD-1 could impact the use and sufficiency of our existing cash reserves,

and we may be required to raise additional capital earlier than we had previously planned.

We may be unable to raise additional capital

if and when needed, which may result in further delays or suspension of our development plans.

infections and deaths related to COVID-19 have disrupted certain healthcare and healthcare regulatory systems globally.

effects from such disruptions and/or any similar issues in the future could divert healthcare resources away from, or materially

delay review by, the FDA and comparable foreign regulatory agencies.

There is substantial uncertainty in connection with the extent to which the pandemic may impact or disrupt development

plans and/or operations, generally, in the future.

Any elongation or de-prioritization of our clinical

trials or delay in regulatory review resulting from such disruptions could materially adversely affect the development and study of

our product candidates.

currently utilize third parties to, among other things, manufacture raw materials and our product candidates, components, parts, and

consumables, and to perform quality testing.

If either we or any third-party in the supply chain for materials used in the production

of its product candidates are adversely impacted by restrictions resulting from the COVID-19 pandemic, our supply chain may be disrupted,

limiting our ability to manufacture product candidates for our clinical trials.

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

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or otherwise promote the therapeutic candidate.

Sponsors must strike the often difficult balance of communicating sufficient information about its product candidates

to inform investors and engaging in valid scientific exchanges with the medical community without crossing the often-difficult-to-ascertain

line into “promotion,” which is not defined by regulation but is generally interpreted broadly by FDA.

Accordingly, if FDA finds any of our communications regarding MyMD-1 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

occurrence of any event or penalty described above could give rise to material reputational harm to our business and our current, and any future, product candidates

we may develop and may inhibit our ability to commercialize our product candidates and generate revenue

Sponsors must strike the often difficult balance of communicating sufficient information

about its product candidates to inform investors and engaging in valid scientific exchanges with the medical community without crossing

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

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

occurrence of any event or penalty described above could give rise to material reputational harm to our business and our current, and

any future, product candidates we may develop and may inhibit our ability to commercialize our product candidates and generate revenue

and could require us to expend significant time and resources in response.

The FDA’s and

other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit

or delay regulatory approval of our product candidates.

If we are slow or unable to adapt to changes in existing requirements or the

adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval

that we have obtained, and we may not achieve or sustain profitability.

The FDA’s and other regulatory authorities’ policies

may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or

if we are not able to maintain regulatory compliance, we may lose any marketing approval that we have obtained, and we may not achieve

or sustain profitability.

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

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candidate and our business prospects could decline.

development program for Supera-CBD, a synthetic analog of CBD, is in its infancy and subject to substantial uncertainty and may not

yield commercial results and is subject to significant regulatory risks.

We are only in the pre-clinical stage of development for Supera-CBD, which is essentially the earliest stage of a

candidate’s development process and must be followed by regulatory submissions (such as, an IND application and FDA’s acceptance

thereof), IRB approval, as well as the complex, onerous clinical-trial process (which must be conducted in accordance with FDA’s

IND regulations), and ultimately, NDA submission, the approval of which is not guaranteed.

can be no assurance that our development program for Supera-CBD, a synthetic analog of CBD, will be successful, or that any research

and development and product testing efforts will result in commercially saleable products, or that the market will accept or respond

positively to products based on Supera-CBD.

development program for Supera-CBD, a synthetic analog of CBD, is in its infancy and subject to substantial uncertainty and may not yield

commercial results and is subject to significant regulatory risks.

are only in the pre-clinical stage of development for Supera-CBD, which is essentially the earliest stage of a candidate’s development

process and must be followed by regulatory submissions (such as, an IND application and FDA’s acceptance thereof), IRB approval,

as well as the complex, onerous clinical-trial process (which must be conducted in accordance with FDA’s IND regulations), and

ultimately, NDA submission, the approval of which is not guaranteed.

There can be no assurance that our development program for Supera-CBD,

a synthetic analog of CBD, will be successful, or that any research and development and product testing efforts will result in commercially

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

Regulation of CBD .

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Regulation of CBD.

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

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,

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

This attention may result in our current

commercial products, products we may commercialize or promote in the future, and our therapeutic candidates, 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.

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

services or products (including our current commercial products, our development or commercialization partners or any product we may

commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby,

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

utilization) of medical services or products.

In either case, a reduction in the utilization of, or reimbursement for our current commercial

products, any product we may commercialize or promote, or any therapeutic candidate, or for which we receive marketing approval in the

future, could have a material adverse effect on our reputation, business, financial condition or results of operations.

In either case, a reduction in the utilization of, or reimbursement for any product which

we receive marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or

results of operations.

states and private entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue

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to advance these principles.

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

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

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.

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.

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.

The IRA also extends enhanced

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

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

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pharmaceutical industry.

in response to the COVID-19 pandemic, on March 10, 2020, the FDA announced its intention to postpone most foreign inspections of manufacturing

facilities and, subsequently, on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing

Regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to the COVID-19

Subsequently, on July 10, 2020 the FDA announced its intention to resume certain on-site inspections of domestic manufacturing

facilities subject to a risk-based prioritization system.

The FDA intends to use this risk-based assessment system to identify the categories

of regulatory activity that can occur within a given geographic area, ranging from mission critical inspections to resumption of all

regulatory activities.

Regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to

the COVID-19 pandemic.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory

authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability

of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse

effect on our business.

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

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and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

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

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

We could be subject to a wide range

of penalties and sanctions under HIPAA, including criminal penalties if we, our affiliates, or our agents knowingly obtain or disclose

individually identifiable health information maintained by a covered entity 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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technologies and processes, despite efforts by us to protect our proprietary technologies and processes.

While we hold rights in

several patents, there can be no assurances that any additional patents will be issued, or additional rights will be granted, to us.

Even if new patents are issued, the claims allowed may not be sufficiently broad to adequately protect our technology and processes.

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

MyMD has 16 issued U.S.

patents, 50 foreign patents, four pending U.S.

patent applications, and 15 foreign patent applications pending

in such jurisdictions as Australia, Canada, China, European Union, Israel, Japan and South Korea, which if issued are expected to expire

between 2036 and 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.

While we hold rights in several

patents, there can be no assurances that any additional patents will be issued, or additional rights will be granted, to us.

new patents are issued, the claims allowed may not be sufficiently broad to adequately protect our technology and processes.

Our competitors

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.

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

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could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities

analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common Stock.

analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common

of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially

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patent applications remain confidential in the U.S.

Patent and Trademark Office, or the USPTO, for the entire time prior to issuance

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

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

Therefore, there

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

for treatment related to the use or manufacture of our product candidates.

Because patent applications can take many years to issue,

there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe.

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

methods for treatment related to the use or manufacture of our product candidates.

Because patent applications can take many years to

issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe.

In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

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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.

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.

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) the lower of (x) $0.4014 and

(y) 20% of the “Minimum Price” (as defined in Rule 5635 of the Rules of the Nasdaq Stock Market) on the date of the Stockholder

Approval (as defined below) (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 Market.

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, including a limit on the number of shares that may be issued until the time, if any, that

our stockholders have approved the issuance of more than 19.9% of our outstanding shares of Common Stock in accordance with the rules

of the Nasdaq Stock Market (the “Stockholder Approval”).

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

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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 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 New Jersey Business Corporations Act.

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 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.

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.

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.

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

we do not receive approval from our stockholders, we will be unable to pay amounts due to the holders of our Series F Preferred

Stock in shares of Common Stock and we will be required to pay such amounts in cash, which may force us to divert cash from other uses.

the February 2023 SPA, we are required to hold a meeting of our stockholders to seek approval under Nasdaq Listing Rule 5635(d) for the

sale, issuance or potential issuance by us of our Common Stock (or securities convertible into or exercisable for our Common Stock) in

excess of 7,894,001 shares, which is 20% of the shares of Common Stock outstanding immediately prior to the execution of the February 2023

Certain stockholders, who beneficially held approximately 44% of our outstanding Common Stock as of the date of the February 2023

SPA, are party to a voting agreement pursuant to which, among other things, each such stockholder agreed, solely in their capacity as

a stockholder, to vote all of their shares of Common Stock in favor of the approval, and if an insufficient number of our remaining stockholders

vote in favor of the proposal we will be unable to issue shares of Common Stock in order to pay amounts due under the Certificate of

Designation to holders of our Series F Preferred Stock in shares of Common Stock.

If we are unable to pay such amounts when due

in shares of Common Stock, we will have to satisfy our payment obligations by means of cash payments.

If we do not have sufficient cash

resources to make these payments, 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.

(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.

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

Sales of a significant number

of shares of our Common Stock in the public market could harm the market prices of our Common Stock and make 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.

of a significant number of shares of our Common Stock in the public market could harm the market prices of our Common Stock and make

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

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

If an active market for our Common Stock is not sustained, it may be difficult for investors to sell their shares either without depressing the market price for the shares

intended benefits of the Contribution Transaction may not be realized.

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.

If an active market for our Common

Stock is not sustained, it may be difficult for investors to sell their shares either without depressing the market price for the shares

are subject to various internal control reporting requirements under the Sarbanes-Oxley Act.

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at all times in the future be able to report that our internal controls over financial reporting are effective.

a public company, we are required to comply with Section 404 (“Section 404”) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

In any given year, we cannot be certain as to the time of completion

of our internal control evaluation, testing and remediation actions or of their impact on our operations.

Upon completion of this

process, we may identify control deficiencies of varying degrees of severity under applicable SEC and Public Company Accounting

Oversight Board (U.S.) rules and regulations.

Our management, including our principal executive officer and principal financial officer, does not expect that our internal controls and disclosure controls will prevent all errors and all fraud.

control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives

of the control system are met.

In addition, the design of a control system must reflect the fact that there are resource constraints

and the benefit of controls must be relative to their costs.

Because of the inherent limitations in all control systems, no

evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, in our company have

been detected.

a public company, we are required to comply with Section 404 (“Section 404”) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley

In any given year, we cannot be certain as to the time of completion of our internal control evaluation, testing and remediation

actions or of their impact on our operations.

Upon completion of this process, we may identify control deficiencies of varying degrees

of severity under applicable SEC and Public Company Accounting Oversight Board (U.S.) rules and regulations.

Our management, including

our principal executive officer and principal financial officer, does not expect that our internal controls and disclosure controls will

prevent all errors and all fraud.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute,

assurance that the objectives of the control system are met.

In addition, the design of a control system must reflect the fact that there

are resource constraints and the benefit of controls must be relative to their costs.

Because of the inherent limitations in all control

systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, in our company

have been detected.

These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns

can occur because of simple errors or mistakes.

Further, controls can be circumvented by individual acts of some persons, by

collusion of two or more persons, or by management override of the controls.

The design of any system of controls is also based in

part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in

achieving our stated goals under all potential future conditions.

Over time, a control may be inadequate because of changes in

conditions, such as growth of the company or increased transaction volume, or the degree of compliance with the policies or

procedures may deteriorate.

Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud

may occur and not be detected.

Further, controls can be circumvented by individual acts of some persons, by collusion

of two or more persons, or by management override of the controls.

The design of any system of controls is also based in part upon certain

assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated

goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as growth

of the company or increased transaction volume, or the degree of compliance with the policies or procedures may deteriorate.

of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

addition, as a public company, we are required to report, among other things, control deficiencies that constitute material weaknesses

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

failure to meet the continued listing requirements of Nasdaq could result in a delisting of our Common Stock.

delisting could adversely affect the market liquidity of our Common Stock and the market price of our Common Stock could

Common Stock is listed on The Nasdaq Capital Market.

In order to maintain our listing, we must meet minimum financial and other requirements,

including requirements for a minimum amount of capital and a minimum price per share.

We cannot assure you that we will continue to meet

the continued listing requirements in the future.

Nasdaq delists our Common Stock from trading on its exchange, due to failure to meet its continued listing requirements, and we are not

able to list our Common Stock on another national securities exchange, we expect our securities could be quoted on an over-the-counter

If this were to occur, we could face significant material adverse consequences, including:

limited availability of market quotations for our Common Stock;

liquidity for our Common Stock;

determination that our Common Stock is a “penny stock” which will require brokers trading in our Common Stock to adhere

to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our Common Stock;

limited amount of news and analyst coverage;

decreased ability to issue additional securities or obtain additional financing in the future.

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.

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 Milestone Shares of our Common Stock that may be issued in the future, will be,

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”),

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the market price of our Common Stock.

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 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.”

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.”

do not anticipate paying cash dividends on our Common Stock and, accordingly, stockholders must rely on stock appreciation for any return

on their investment.

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.

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.

is no guarantee that our Common Stock will appreciate in value.

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.

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

securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our

11 unchanged sentences

cause our stock price to decline.

Anti-takeover

provisions of our certificate of incorporation, our bylaws and Delaware law could make an acquisition of us, which may be beneficial

to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our board

and management.

provisions of our certificate of incorporation and bylaws could discourage, delay or prevent a merger, acquisition or other change of

control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.

Furthermore, these provisions could prevent or frustrate attempts by our stockholders to replace or remove members of our board of directors.

These provisions also could limit the price that investors might be willing to pay in the future for our securities, thereby depressing

the market price of our securities.

Stockholders who wish to participate in these transactions may not have the opportunity to do so.

These provisions, among other things:

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

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;

who may call a stockholder meeting.

addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law that may, unless certain criteria

are met, prohibit large stockholders, in particular those owning 15% or more of the voting rights on our common stock, from merging or

combining with us for a prescribed period of time.

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 these “Risk Factors” and in Note 9 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.

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.

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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to cover any eventual liability.

are subject to various internal control reporting requirements under the Sarbanes-Oxley Act.

We can provide no assurance that we will

at all times in the future be able to report that our internal controls over financial reporting are effective.

a public company, we are required to comply with Section 404.

In any given year, we cannot be certain as to the time of completion

of our internal control evaluation, testing and remediation actions or of their impact on our operations.

Upon completion of this

process, we may identify control deficiencies of varying degrees of severity under applicable SEC and Public Company Accounting

Oversight Board (United States) rules and regulations.

Our management, including our principal executive officer and principal financial

officer, does not expect that our internal controls and disclosure controls will prevent all errors and all fraud.

A control system,

no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control

system are met.

In addition, the design of a control system must reflect the fact that there are resource constraints and the

benefit of controls must be relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of

controls can provide absolute assurance that all control issues and instances of fraud, if any, in us have been detected.

inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of

simple errors or mistakes.

Further, controls can be circumvented by individual acts of some persons, by collusion of two or more

persons, or by management override of the controls.

The design of any system of controls is also based in part upon certain

assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our

stated goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as

growth of the company or increased transaction volume, or the degree of compliance with the policies or procedures may deteriorate.

Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be

addition, as a public company, we are required to report, among other things, control deficiencies that constitute material weaknesses

or changes in internal controls that, or that are reasonably likely to, materially affect internal controls over financial reporting.

A “material weakness” is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such

that there is a reasonable possibility that a material misstatement of our annual consolidated financial statements will not be prevented

or detected on a timely basis.

If we fail to comply with the requirements of Section 404 or if we report a material weakness, we might

be subject to regulatory sanction and investors may lose confidence in our consolidated financial statements, which may be inaccurate

if we fail to remedy such material weakness.

incur increased costs and demands on management as a result of compliance with laws and regulations applicable to public companies, which

could harm our operating results.

a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company, including costs

associated with public company reporting requirements.

In addition, the Sarbanes-Oxley Act and the Dodd-Frank Act, as well as rules implemented

by the SEC and Nasdaq, impose a number of requirements on public companies, including with respect to corporate governance practices.

Our management and other personnel need to devote a substantial amount of time to these compliance and disclosure obligations.

compliance with these rules and regulations has increased our legal, accounting and financial compliance costs and has made some activities

more time-consuming and costly.

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

Unresolved Staff Comments.

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