What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-31 · 734 added, 614 removed, 1308 unchanged (51% of the section changed)

Risk Factors.

investment in our Common Stock involves a high degree of risk.

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operating results and stock price.

The following discussion of risk factors contains

forward-looking statements.

These risk factors may be important to understanding other statements in this Form 10-K.

The following information

should be read in conjunction with our consolidated financial statements and related notes thereto and with Item 7, “Management’s

Discussion and Analysis of Financial Condition and Results of Operations ” included elsewhere in this Annual Report on Form

Risk Factor Summary

following discussion of risk factors contains forward-looking statements.

These risk factors may be important to understanding other

statements in this Form 10-K.

The following information should be read in conjunction with our consolidated financial statements and

related notes thereto and with Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations ”

included elsewhere in this Annual Report on Form 10-K.

Factor Summary

is a summary of the principal factors that make an investment in our Common Stock speculative or risky.

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be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this

Annual Report on Form 10-K and our other filings with

the SEC before making investment decisions regarding our common stock.

Risks Related to the Company Following the

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

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or those of third-party providers.

Risks Related to our Product Development and Regulatory

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,

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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.

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

significant regulatory risks.

Related to Commercialization and Manufacturing

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to protect our product candidates.

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 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.

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.

The certificate of designation

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

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

These features may

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

of the warrants.

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 will experience in connection with

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

strategic and financial benefits currently anticipated from 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 may be subject to significant fluctuations and volatility, and the stockholders of

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 the combined Company’s

common stock could 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 particularly 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

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;

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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 has resulted in significant financial market volatility and uncertainty in recent months.

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

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

We have incurred net losses in each year since our inception.

net losses of $29,890,308 and $9,810,157 for the years ended December 31, 2021 and 2020, respectively.

As of December 31, 2021, we had

an accumulated deficit of $78,885,164.

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

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

We expect to continue

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

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

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

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

Our prior losses, combined with expected future

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

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.

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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not result in an improvement in the value of our Common Stock.

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

MYMD-1, a clinical-stage immunometabolic regulator and Supera-CBD, a pre-clinical stage patented synthetic CBD analog.

We expect to incur losses as we develop our product candidates, and our product candidates, may never get approved by the FDA or even

if approved for marketing, may not be profitable.

The failure to successfully develop product candidates will significantly diminish the

anticipated benefits of the Merger and have a material adverse effect on our business.

There is no assurance that our business operations,

strategies or focus will be successful, which could depress the value of our common stock.

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

MYMD-1, a clinical-stage immunometabolic regulator and

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

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

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

The failure to successfully

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

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

our Common Stock.

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

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entities of the Company, in the aggregate, beneficially owned more than 10% of the Company’s outstanding Common Stock.

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.

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.

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

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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

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 have 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 the future.

also assumed approximately 4,188,315 shares of common stock subject to outstanding options to purchase pre-Merger MyMD Florida common

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

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.

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

December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China and has reached multiple other

countries, resulting in government-imposed quarantines, travel restrictions and other public health safety measures, including in

the United States and India.

On March 12, 2020, the WHO declared COVID-19 to be a global pandemic.

The various precautionary

measures taken by many governmental authorities around the world in order to limit the spread of COVID-19 have had and may continue

to have an adverse effect on the global markets and global economy.

Such government-imposed precautionary measures may have been

relaxed in certain countries or states, but there is no assurance that more strict measures will not be put in place again due to a

resurgence in COVID-19 cases.

The ultimate impact of the global COVID-19 pandemic or a similar health

epidemic is highly uncertain and subject to change.

We do not yet know the full extent of potential delays or impacts on our business,

healthcare systems or the global economy as a whole.

However, the effects have had and will likely continue to have a material impact

on our operations, liquidity and capital resources, and we will continue to monitor the COVID-19 situation closely.

In response to public health directives and orders, we implemented and

have continued to maintain work-from-home policies for many of our employees and the temporary modification of our operations to comply

with applicable social distancing recommendations.

The effects of the orders and our related adjustments in our business are likely to

negatively impact productivity, disrupt our business and delay our timelines, the magnitude of which will depend, in part, on the length

and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

Similar health directives

and orders are affecting third parties with whom we do business.

Further, restrictions on our ability to travel, stay-at-home orders and

other similar restrictions on our business have limited, and may continue to limit, our ability to support our operations.

and/or long-term disruptions in our operations will negatively impact our business, operating results and financial condition in other

ways as well.

Specifically, we anticipate that the stress of COVID-19 on healthcare systems generally around the globe will negatively

impact regulatory authorities and the third parties that we may engage in connection with the development and testing of our product

anticipated economic consequences of the COVID-19 pandemic have adversely impacted financial markets, resulting in high share price volatility,

reduced market liquidity, and substantial declines in the market prices of the shares of most publicly traded companies, including MyMD.

Volatile or declining markets for equities could adversely affect our ability to raise capital when needed through the sale of shares

of common stock or other equity securities.

Should these market conditions persist when we need to raise capital, and if we are able

to sell shares of our common stock under then prevailing market conditions, we might have to accept lower prices for our shares and issue

a larger number of shares than might have been the case under better market conditions, resulting in significant dilution of the interests

of our shareholders.

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

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 $1,265,306 related to this

Our management continues to investigate the incident together with our bank’s fraud department and law enforcement

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.

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.

In addition, we collect and store sensitive data, including intellectual

property, research data, our proprietary business information and that of our suppliers, technical information about our products, clinical

trial plans and employee records.

Similarly, our third-party providers possess certain of our sensitive data and confidential information.

The secure maintenance of this information is critical to our operations and business strategy.

Despite the implementation of security

measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses,

malware, ransomware, cyber fraud, natural disasters, terrorism, war, telecommunication and electrical failures, cyberattacks or cyberintrusions

over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.

The risk of a security breach or disruption, particularly through cyberattacks or cyberintrusions, including by computer hackers, foreign

governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions

from around the world have increased.

Any such breach could compromise our networks and the information stored there could be accessed,

publicly disclosed, encrypted, lost or stolen.

Any such access, inappropriate disclosure of confidential or proprietary information or

other loss of information, including our data being breached at third-party providers, could result in legal claims or proceedings, liability

or financial loss under laws that protect the privacy of personal information, disruption of our operations or our product development

programs and damage to our reputation, which could adversely affect our business.

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.

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

that of our suppliers, technical information about our products, clinical trial plans and employee records.

Similarly, our third-party

providers possess certain of our sensitive data and confidential information.

The secure maintenance of this information is critical

to our operations and business strategy.

Despite the implementation of security measures, our internal computer systems, and those of

third parties on which we rely, are vulnerable to damage from computer viruses, malware, ransomware, cyber fraud, natural disasters,

terrorism, war, telecommunication and electrical failures, cyberattacks or cyberintrusions over the Internet, attachments to emails,

persons inside our organization, or persons with access to systems inside our organization.

The risk of a security breach or disruption,

particularly through cyberattacks or cyberintrusions, including by computer hackers, foreign governments, and cyber terrorists, has generally

increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

breach could compromise our networks and the information stored there could be accessed, publicly disclosed, encrypted, lost or stolen.

Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including our data

being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws that protect

the privacy of personal information, disruption of our operations or our product development programs and damage to our reputation, which

could adversely affect our business.

Related to our Product Development and Regulatory Approval

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At the time, changes

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

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

Institutional

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This includes every assessment and data element collected.

The complexity of the Phase II

The complexity of the Phase 2

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

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

We 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 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.

independent committee organizations that operate in compliance with U.S.

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.

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

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.

Our ability to generate product

revenue will depend heavily on the successful development and eventual commercialization of MYMD-1, Supera-CBD and our other product

candidates, which may never occur.

We currently generate no revenue from sales of any product and we may never be able to develop or

commercialize a marketable product.

Each of our programs and product candidates will require further clinical

and/or pre-clinical development, regulatory approval in multiple jurisdictions, obtaining pre-clinical, clinical and commercial manufacturing

supply, capacity and expertise, building of a commercial organization, substantial investment and significant marketing efforts before

we generate any revenue from product sales.

MYMD-1 and Supera-CBD and our other product candidates must be authorized for marketing by

the FDA and certain other foreign regulatory agencies before we may commercialize any of our product candidates.

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.

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

and our other product candidates, which may never occur.

We currently generate no revenue from sales of any product and we may never

be able to develop or commercialize a marketable product.

of our programs and product candidates will require further clinical and/or pre-clinical development, regulatory approval in multiple

jurisdictions, obtaining pre-clinical, clinical and commercial manufacturing supply, capacity and expertise, building of a commercial

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

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

before we may commercialize any of our product candidates.

success of our product candidates depends on multiple factors, including:

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in a way that leads to NDA submission and approval of any product candidate we are developing.

Many companies in the pharmaceutical industry have suffered significant

setbacks in late-stage clinical trials after achieving positive results in early-stage development, and there is a high failure rate for

product candidates proceeding through clinical trials.

In addition, different methodologies, assumptions and applications we utilize to

assess particular safety or efficacy parameters may yield different statistical results.

Even if we believe the data collected from clinical

trials of our product candidates are promising, these data may not be sufficient to support approval by the FDA or foreign regulatory

Pre-clinical and clinical data can be interpreted in different ways.

Accordingly, the FDA or foreign regulatory authorities

could interpret these data in different ways from us or our partners, which could delay, limit or prevent regulatory approval.

study data do not consistently or sufficiently demonstrate the safety or efficacy of any of our product candidates, including MYMD-1 and

Supera-CBD, to the satisfaction of the FDA or foreign regulatory authorities, then the regulatory approvals for such product candidates

could be significantly delayed as we work to meet approval requirements, or, if we are not able to meet these requirements, such approvals

could be withheld or withdrawn.

companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical trials after achieving positive results

in early-stage development, and there is a high failure rate for product candidates proceeding through clinical trials.

different methodologies, assumptions and applications we utilize to assess particular safety or efficacy parameters may yield different

statistical results.

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

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

Pre-clinical and clinical data can be interpreted

in different ways.

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

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

If our study data do not consistently or sufficiently demonstrate

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

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

or, if we are not able to meet these requirements, such approvals could be withheld or withdrawn.

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.

Prior to commercialization in the United States, MYMD-1, Supera-CBD and

our other product candidates must be approved by the FDA pursuant to an NDA for their respective target indication(s).

The process of

obtaining marketing approvals, both in the U.S.

and abroad, is expensive and takes many years, if approval is obtained at all, and can

vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.

to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate.

We have not received

approval to market MYMD-1, Supera-CBD or any of our other product candidates from regulatory authorities in any jurisdiction.

limited experience in submitting and supporting the applications necessary to gain marketing approvals, and, in the event regulatory authorities

indicate that we may submit such applications, we may be unable to do so as quickly and efficiently as desired.

Securing marketing approval

requires the submission of extensive pre-clinical and clinical data and supporting information to regulatory authorities for each therapeutic

indication to establish the product candidate’s safety and efficacy.

Securing marketing approval also requires the submission of

information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities.

product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects,

toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

authorities have substantial discretion in the approval process and may refuse to accept or file any application or may decide that our

data is insufficient for approval and require additional pre-clinical, clinical or other studies.

In addition, varying interpretations

of the data obtained from pre-clinical and clinical testing could delay, limit or prevent marketing approval of a product candidate.

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

an NDA for their respective target indication(s).

The process of obtaining marketing approvals, both in the U.S.

and abroad, is expensive

and takes many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type,

complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate will prevent

us from commercializing the product candidate.

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

candidates from regulatory authorities in any jurisdiction.

We have limited experience in submitting and supporting the applications

necessary to gain marketing approvals, and, in the event regulatory authorities indicate that we may submit such applications, we may

be unable to do so as quickly and efficiently as desired.

Securing marketing approval requires the submission of extensive pre-clinical

and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s

safety and efficacy.

Securing marketing approval also requires the submission of information about the product manufacturing process

to, and inspection of manufacturing facilities by, the regulatory authorities.

Our product candidates may not be effective, may be only

moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude

our obtaining marketing approval or prevent or limit commercial use.

Regulatory authorities have substantial discretion in the approval

process and may refuse to accept or file any application or may decide that our data is insufficient for approval and require additional

pre-clinical, clinical or other studies.

In addition, varying interpretations of the data obtained from pre-clinical and clinical testing

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

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

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financial condition, results of operations and prospects.

COVID-19 pandemic, or similar public health crises, could have a material adverse impact the execution of our planned clinical trials.

Our Phase 2 clinical trial for MYMD-1 currently in progress has been and

may continue to be affected by the pandemic.

Initial studies indicate that MYMD-1 may have potential therapeutic effects on treatment

MyMD may not be successful in demonstrating the efficacy of this treatment before another, more effective drug enters the

Furthermore, site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials,

study monitoring and data analysis for our planned clinical trials may be delayed due to changes in hospital or university policies, federal,

state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic.

Additionally,

some participants and clinical investigators may not be able to comply with clinical trial protocols.

For example, quarantines or other

travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt

healthcare services, and we may be unable to conduct our planned clinical trials.

If the global effort to control the spread of COVID-19

and treat COVID-19 patients continues on the current trajectory for an extended period of time, we risk a delay in activating sites and

enrolling subjects as previously projected.

Any such 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

We may be unable to raise additional capital if and when needed, which may result in further delays or suspension of our development

We completed a dosing study in Tampa in 2021 that took four and a

half months because of COVID-19.

The facility could only dose four subjects a week instead of the planned eight subjects per week.

this study would have been completed in two months.

That has delayed reporting of our results and the final report we needed to provide

for an IND to the FDA for the next pivotal study.

infections and deaths related to COVID-19 are disrupting certain healthcare and healthcare regulatory systems globally.

Such disruptions

could divert healthcare resources away from, or materially delay review by, the FDA and comparable foreign regulatory agencies.

unknown how long these disruptions could continue, were they to occur.

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

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

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

ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet know

the full extent of potential delays or impacts on our business, our planned clinical trials, healthcare systems or the global economy.

However, these effects could have a material adverse impact on our business, financial condition and results of operations.

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.

If FDA finds any of our communications regarding MyMD-1 or Supera-CBD to be promotional,

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

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

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

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candidate and our business prospects could decline.

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.

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

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The market for cannabinoids is heavily regulated.

Synthetic cannabinoids

may be viewed as qualifying as controlled substances under the federal Controlled Substances Act of 1970 (CSA) and may be subject to a

high degree of regulation including, among other things, certain registration, licensing, manufacturing, security, record keeping, reporting,

import, export, inspection by DEA clinical and non-clinical studies, insurance and other requirements administered by the U.S.

Drug Enforcement

Administration (DEA) and/or the FDA.

Synthetic cannabinoids may be viewed as qualifying as controlled

substances under the federal Controlled Substances Act of 1970 (CSA) and may be subject to a high degree of regulation including, among

other things, certain registration, licensing, manufacturing, security, record keeping, reporting, import, export, inspection by DEA

clinical and non-clinical studies, insurance and other requirements administered by the U.S.

Drug Enforcement Administration (DEA) and/or

Regulation of CBD.

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we could lose clinical trial sites.

Negative public perception of cannabis-related

businesses, misconceptions about the nature of our business or Supera-MD, and regulatory uncertainties relating to the legality of cannabinoids

could each have a material adverse effect on our business, financial condition, and results of operations.

public perception of cannabis-related businesses, misconceptions about the nature of our business or Supera-MD, and regulatory uncertainties

relating to the legality of cannabinoids could each have a material adverse effect on our business, financial condition, and results

of operations.

believe the cannabinoid industry is highly dependent upon consumer perception regarding the safety, efficacy, quality, and legality of

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we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry

out their contractual duties, satisfy legal and regulatory requirements for the conduct of pre-clinical studies or clinical trials

or meet expected deadlines, our clinical development programs could be delayed and otherwise adversely affected.

In all events, we are

responsible for ensuring that each of our pre-clinical studies and clinical trials is conducted in accordance with the general investigational

plan and protocols for the trial, as well as in accordance with GLP, GCPs and other applicable laws, regulations and standards.

out their contractual duties, satisfy legal and regulatory requirements for the conduct of pre-clinical studies or clinical trials or

meet expected deadlines, our clinical development programs could be delayed and otherwise adversely affected.

In all events, we are responsible

for ensuring that each of our pre-clinical studies and clinical trials is conducted in accordance with the general investigational plan

and protocols for the trial, as well as in accordance with GLP, GCPs and other applicable laws, regulations and standards.

on third parties that we do not control does not relieve us of these responsibilities and requirements.

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Related to Government Regulation

We could be adversely affected if

healthcare reform measures substantially change the market for medical care or healthcare coverage in the U.S.

On March 23, 2010, President

Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the “ACA”) and on March 30,

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

111-152), collectively commonly referred to as the

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

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

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

in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce

healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional

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

This legislation was one of the most comprehensive

and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed the way healthcare is financed

by both governmental and private insurers.

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

and insurance companies, among others.

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

to find cost savings in their clinical operations.

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

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

negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in our 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.

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

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

111-148) (the “ACA”)

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

111-152), collectively commonly

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

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

healthcare policy reforms.

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

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

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

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

This legislation was one

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

in the healthcare industry and has significantly changed

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

This legislation has impacted the scope of healthcare insurance

and incentives for consumers and insurance companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed

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

Pharmaceuticals represent a significant portion of the cost

of providing care.

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

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

This attention may result in 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.

These structural changes could

entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State

Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both,

as well as other changes.

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

Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or

some combination of both, as well as other changes.

Restructuring the coverage of medical care in the U.S.

could impact the reimbursement for prescribed drugs

and pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently

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

If reimbursement for the products we currently commercialize

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

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

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

Extending medical benefits

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

federal government, which may force significant

additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be sought through cost

While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of

preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased

enforcement activities.

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

(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, utilization) of medical services

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

could impact the reimbursement

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

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

If reimbursement for the products we currently

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

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

adverse effect on our reputation, business, financial condition or results of operations.

Several states and private

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

aspects of the legislation.

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

federal government, which may

force significant additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be

sought through cost savings.

While some of these savings may come from realizing greater efficiencies in delivering care, improving the

effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost

of care and increased enforcement activities.

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

services or products (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,

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.

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

to litigate various aspects of the legislation.

On July 26, 2012, the U.S.

Supreme Court generally upheld the provisions of the ACA at issue as constitutional.

Supreme Court generally upheld the provisions of the ACA at

issue as constitutional.

However, the U.S.

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

As a result, states have a choice as to whether they will expand the number of individuals covered by their respective state

Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving and coverage measures

to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution of Medicaid-managed care

The manner in which these cost-saving and coverage measures are implemented could have a material adverse effect on our reputation,

business, financial condition or results of operations.

Further, the healthcare regulatory

environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify, limit, replace,

or repeal the ACA and judicial challenges have continued.

We cannot predict the impact on our business of future legislative and

legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations.

The financial

impact of U.S.

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

programs to cover more individuals.

As a result, states have a choice as to whether they will expand the number of individuals covered

by their respective state Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving

and coverage measures to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution

of Medicaid-managed care programs.

The manner in which these cost-saving and coverage measures are implemented could have a material

adverse effect on our reputation, business, financial condition or results of operations.

the healthcare regulatory environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify,

limit, replace, or repeal the ACA and judicial challenges have continued.

We cannot predict the impact on our business of future legislative

and legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations.

financial impact of U.S.

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

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

During his time in office,

former President Trump supported the repeal of all or portions of the ACA.

President Trump also issued an executive order in which he

stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive departments

and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to the maximum

extent permitted by law.

Congress has enacted legislation that repeals certain portions of the ACA, including but not limited to the

Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual

mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other

things, repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth

in Medicare spending).

Additionally, in December 2018,

a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore, invalid.

appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court

to reassess whether and how such holding affects the validity of the rest of the ACA.

The Fifth Circuit’s decision on the individual

mandate was appealed to the U.S.

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

President Trump also issued an executive

order in which he stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive

departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to

the maximum extent permitted by law.

Congress has enacted legislation that repeals certain portions of the ACA, including but not limited

to the Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual

mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things,

repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth in Medicare

Additionally,

in December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore,

On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the

lower court to reassess whether and how such holding affects the validity of the rest of the ACA.

The Fifth Circuit’s decision

on the individual mandate was appealed to the U.S.

Supreme Court.

On June 17, 2021, the Supreme Court held that the plaintiffs (comprised of the state

of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality of the ACA’s

individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to dismiss the case.

On June 17, 2021, the Supreme Court held that the plaintiffs (comprised

of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality

of the ACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court

to dismiss the case.

As a result, the ACA will remain in-effect in its current form for the foreseeable future;

however, we cannot predict what additional

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

Biden administration also introduced various measures in 2021 focusing on healthcare and

drug pricing, in particular.

For example, on January 28, 2021, President Biden issued an

executive order that initiated a special enrollment period for purposes of obtaining health

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

open through August 15, 2021.

The executive order also instructed certain governmental agencies

to review and reconsider their existing policies and rules that limit access to healthcare,

including among others, reexamining Medicaid demonstration projects and waiver programs that

include work requirements and policies that create unnecessary barriers to obtaining access

to health insurance coverage through Medicaid or the ACA.

On the legislative front, the American

Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates

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

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

however, we cannot predict

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

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

For example, on

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

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

The executive

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

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

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

On the legislative front, the

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

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

drugs, beginning January 1, 2024.

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

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

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

High Drug Prices” that outlines principles for drug pricing reform and sets out a variety

of potential legislative policies that Congress could pursue as well as potential administrative

actions HHS can take to advance these principles.

And, in November 2021, President Biden

announced the “Prescription Drug Pricing Plan” as part of the Build Back Better

5376) passed by the House of Representatives on November 19, 2021, which aims to

lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices

for certain high-cost prescription drugs covered under Medicare Part D and Part B after the

drugs have been on the market for a certain number of years and imposing tax penalties on

drug manufacturers that refuse to negotiate pricing with Medicare or increase drug prices

“faster than inflation.” If enacted, this bill could have a substantial

impact on our business.

In the coming years, additional legislative and regulatory changes

could be made to governmental health programs that could significantly impact pharmaceutical

companies and the success of our product candidates.

At the state level, legislatures have

increasingly passed legislation and implemented regulations designed to control pharmaceutical

and biological product pricing, including price or patient reimbursement constraints, discounts,

restrictions on certain product access and marketing cost disclosure and transparency measures,

and, in some cases, designed to encourage importation from other countries and bulk purchasing.

There is uncertainty as to

what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S.

or the effect of

any future legislation or regulation.

Furthermore, we cannot predict what actions the Biden administration will implement in connection

with the Health Reform Law.

However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval

and/or successfully commercialize products in the U.S.

in the future.

For example, any changes that reduce, or impede the ability to

obtain, reimbursement for any products we may commercialize in the future, if applicable.

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

In response, on September 9, 2021,

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

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

to advance these principles.

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

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.

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

or the effect of any future legislation or regulation.

Furthermore, we cannot predict what actions the Biden administration will

implement in connection with the Health Reform Law.

However, it is possible that such initiatives could have an adverse effect on our

ability to obtain approval and/or successfully commercialize products in the U.S.

in the future, as applicable.

are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

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are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

If the FDA finds

that we have failed to comply, with one or more applicable requirements the agency can institute a wide variety of enforcement

actions, ranging from a public warning letter to more severe sanctions such as:

If the FDA finds that

we have failed to comply, with one or more applicable requirements the agency can institute a wide variety of enforcement actions, ranging

from a public warning letter to more severe sanctions such as:

injunctions and civil penalties;

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strengthen our information security posture, or respond to cyber threats and incidents.

Risks Related to

Our Intellectual Property

Our success largely

depends 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.

Related to Our Intellectual Property

success largely depends 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.

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

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It is possible that competitors or other unauthorized third parties may obtain, copy, use or disclose proprietary

technologies and processes, despite efforts by the us to protect our proprietary technologies and processes.

technologies and processes, despite efforts by us to protect our proprietary technologies and processes.

While we hold rights in

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

Currently, MyMD Florida has 15 issued U.S.

patents, eight foreign patents,

three pending U.S.

patent applications, one pending international application, and 23 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.

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.

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

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from third parties on acceptable terms or at all.

For example, our agreements with certain of our third-party research partners

provide that improvements developed in the course of our relationship with a given partner may be owned solely by either us or our third-party

research partner, or jointly between us and the third party.

If we determine that exclusive rights to such improvements owned solely by

a research partner or other third party with whom we collaborate are necessary to commercialize our drug candidates or maintain our competitive

advantage, we may need to obtain an exclusive license from such third party in order to use the improvements and

continue developing, manufacturing or marketing our drug candidates.

We may not be able to obtain such a license on an exclusive basis,

on commercially reasonable terms, or at all, which could prevent us from commercializing our drug candidates or allow our competitors

or others the opportunity to access technology that is important to our business.

We also may need the cooperation of any co-owners of

our intellectual property in order to enforce such intellectual property against third parties, and such cooperation may not be provided

example, our agreements with certain of our third-party research partners provide that improvements developed in the course of our relationship

with a given partner may be owned solely by either us or our third-party research partner, or jointly between us and the third party.

If we determine that exclusive rights to such improvements owned solely by a research partner or other third party with whom we collaborate

are necessary to commercialize our drug candidates or maintain our competitive advantage, we may need to obtain an exclusive license

from such third party in order to use the improvements and continue developing, manufacturing or marketing our drug candidates.

not be able to obtain such a license on an exclusive basis, on commercially reasonable terms, or at all, which could prevent us from

commercializing our drug candidates or allow our competitors or others the opportunity to access technology that is important to our

We also may need the cooperation of any co-owners of our intellectual property in order to enforce such intellectual property

against third parties, and such cooperation may not be provided to us.

addition, the in-licensing and acquisition of these technologies is a highly competitive area, and a number of more established companies

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pay treble damages plus the patent owner’s attorneys’ fees;

a court prohibiting us from developing, manufacturing, marketing, selling

or importing our product candidates, or from using our proprietary technologies, unless the third-party licenses its product rights or

proprietary technology to us, which it is not required to do in the U.S.

and certain other countries, on commercially reasonable terms

court prohibiting us from developing, manufacturing, marketing, selling or importing our product candidates, or from using our proprietary

technologies, unless the third-party licenses its product rights or proprietary technology to us, which it is not required to do

and certain other countries, on commercially reasonable terms or at all;

a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant

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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

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

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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that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof.

may not have identified all patents, published applications or published literature that affect our business by blocking our ability

to commercialize our products, by preventing the patentability of one or more aspects of our products to us or our licensors, or by covering

the same or similar technologies that may affect our ability to market our products.

For example, we (or the licensor of a product to

us) may not have conducted a patent clearance search sufficient to identify potentially obstructing third party patent rights.

patent applications in the United States are maintained in confidence for up to 18 months after their filing.

In some cases, however,

patent applications remain confidential in the U.S.

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

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

from their first filing date.

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

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

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

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

Competitors may have filed patent applications or received

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

Therefore, there

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

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and unsuccessful and could result in a finding that such patents are unenforceable or invalid.

Competitors may infringe our patents or the patents of our licensors.

counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid, is unenforceable or may refuse

to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

may infringe our patents or the patents of our licensors.

To counter infringement or unauthorized use, we may be required to file infringement

claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that one or more of

our patents is not valid, is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that

our patents do not cover the technology in question.

patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous

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issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and

defending intellectual property rights in foreign jurisdictions.

The legal and political systems of certain countries, particularly certain

developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly

those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing

of competing products against third parties in violation of our proprietary rights generally.

The initiation of proceedings by third parties

to challenge the scope or validity of our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts

and attention from other aspects of our business.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial

costs and divert our efforts and attention from other aspects of our business, could be impossible or impractical due to sanctions or

trade disputes between countries, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications

at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate

and the damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual

property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we

develop or license.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

legal and political systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents,

trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make

it difficult for us to stop the infringement of our patents or marketing of competing products against third parties in violation of

our proprietary rights generally.

The initiation of proceedings by third parties to challenge the scope or validity of our patent rights

in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other

aspects of our business, could be impossible or impractical due to sanctions or trade disputes between countries, could put our patents

at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties

to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may

not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate

to obtain a significant commercial advantage from the intellectual property that we develop or license.

and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements

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and inherently uncertain.

Past or future patent reform legislation could increase the uncertainties

and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

For example, in

March 2013, under the Leahy-Smith America Invents Act (“America Invents Act”), the U.S.

moved from a “first to invent”

to a “first-inventor-to-file” patent system.

Under our “first-inventor-to-file” system, assuming the other requirements

for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless

of whether another inventor had made the invention earlier.

The America Invents Act includes a number of other significant changes to

patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a new post-grant

review system.

The effects of these changes continue to evolve as the USPTO continues to promulgate new regulations and procedures in

connection with the America Invents Act and many of the substantive changes to patent law, including the “first-inventor-to-file”

provisions, only became effective in March 2013.

In addition, the courts have yet to address many of these provisions and the applicability

of the act and new regulations on the specific patents discussed in this filing have not been determined and would need to be reviewed.

Moreover, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our

patent applications and the enforcement or defense of our issued patents.

or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications

and the enforcement or defense of our issued patents.

For example, in March 2013, under the Leahy-Smith America Invents Act (“America

Invents Act”), the U.S.

moved from a “first to invent” to a “first-inventor-to-file” patent system.

our “first-inventor-to-file” system, assuming the other requirements for patentability are met, the first inventor to file

a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention

The America Invents Act includes a number of other significant changes to U.S.

patent law, including provisions that affect

the way patent applications are prosecuted, redefine prior art and establish a new post-grant review system.

The effects of these changes

continue to evolve as the USPTO continues to promulgate new regulations and procedures in connection with the America Invents Act and

many of the substantive changes to patent law, including the “first-inventor-to-file” provisions, only became effective in

In addition, the courts have yet to address many of these provisions and the applicability of the act and new regulations

on the specific patents discussed in this filing have not been determined and would need to be reviewed.

Moreover, the America Invents

Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the

enforcement or defense of our issued patents.

cases by the U.S.

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and prospects could be materially harmed.

Related to Our Series F Preferred Stock

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

shares of Common Stock depending on the circumstances.

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

portion of our cash resources.

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

Common Stock.

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

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

on July 1, 2023.

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

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

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”).

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

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

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

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

If are unable

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

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

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.

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.

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.

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.”

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

have occurred or are occurring, could make it more difficult for us to raise additional financing through the sale of equity or equity-related

securities in the future at a time and price that we deem reasonable or appropriate, or at all.

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

listing of our common stock on The Nasdaq Capital Market does not assure that a meaningful, consistent and liquid trading market exists.

listing of our Common Stock on The Nasdaq Capital Market (“Nasdaq”) does not assure that a meaningful, consistent and liquid

trading market exists.

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 or at all.

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.

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.

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 chief executive officer and chief 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

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.

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.

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.

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

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

The delisting could adversely

affect the market liquidity of our common stock and the market price of our common stock could decrease.

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.

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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

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.

We may issue additional equity securities

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

To the extent we raise additional

capital by issuing equity securities, our stockholders may experience substantial dilution.

The combined Company may, from time to time,

sell additional equity securities in one or more transactions at prices and in a manner it determines.

If we sell additional equity securities,

existing stockholders may be materially diluted.

In addition, new investors could gain rights superior to existing stockholders, such

as liquidation and other preferences.

In addition, the number of shares available for future grant under our equity compensation plans

may be increased in the future.

In addition, the exercise or conversion of outstanding options or warrants to purchase shares of capital

stock may result in dilution to our stockholders upon any such exercise or conversion.

All 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, freely tradable without

restrictions or further registration under the Securities Act of 1933, as amended (the “Securities Act”), except for shares

subject to lock-up agreements, and any shares held by affiliates, as defined in Rule 144 under the Securities Act.

Rule 144 defines an

affiliate as a person who directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common

control with, the Company and would include persons such as our directors and executive officers and large shareholders.

In turn, resales,

or the perception by the market that a substantial number of resales could occur, could have the effect of depressing the market price

of our common stock.

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

the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.

Company may, from time to time, sell additional equity securities in one or more transactions at prices and in a manner it determines.

If we sell additional equity securities, existing stockholders may be materially diluted.

In addition, new investors could gain rights

superior to existing stockholders, such as liquidation and other preferences.

In addition, the number of shares available for future

grant under our equity compensation plans may be increased in the future.

In addition, the exercise or conversion of outstanding options

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,

freely tradable without restrictions or further registration under the Securities Act of 1933, as amended (the “Securities Act”),

except for shares subject to lock-up agreements, and any shares held by affiliates, as defined in Rule 144 under the Securities Act.

Rule 144 defines an affiliate as a person who directly, or indirectly through one or more intermediaries, controls, or is controlled

by, or is under common control with, the Company and would include persons such as our directors and executive officers and large shareholders.

In turn, resales, or the perception by the market that a substantial number of resales could occur, could have the effect of depressing

the market price of our Common Stock.

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.”

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.

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 subject to the discretion of our board of directors and limitations under applicable law, and will depend on various

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 in value.

If securities analysts do not publish

research or reports about our business, or if they publish negative evaluations, the price of our common stock could decline.

The trading market for our

common stock relies in part on the availability of research and reports that third-party industry or financial analysts publish about

There are many large, publicly traded companies active in the life sciences and biopharmaceutical industries, which may mean it will

be less likely that we receive widespread analyst coverage.

Furthermore, if one or more of the analysts who do cover the Company (if

any) downgrades our stock, our stock price would likely decline.

If one or more of these analysts cease coverage of the Company, we could

lose visibility in the market, which in turn could cause our stock price to decline.

Additionally, if securities analysts publish negative

evaluations of competitors in the life sciences and biopharmaceutical industries, the comparative effect could cause our stock price

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.

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

Common Stock could decline.

trading market for our Common Stock relies in part on the availability of research and reports that third-party industry or financial

analysts publish about us.

There are many large, publicly traded companies active in the life sciences and biopharmaceutical industries,

which may mean it will be less likely that we receive widespread analyst coverage.

Furthermore, if one or more of the analysts who do

cover the Company (if any) downgrades our stock, our stock price would likely decline.

If one or more of these analysts cease coverage

of the Company, we could lose visibility in the market, which in turn could cause our stock price to decline.

Additionally, if securities

analysts publish negative evaluations of competitors in the life sciences and biopharmaceutical industries, the comparative effect could

cause our stock price to decline.

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 damages.

We may also be subject to judgements or enter into additional settlements of claims for significant monetary

damages for the securities litigations that we have yet to enter into settlement agreements.

Defending against the current litigations

is or can be time-consuming, expensive and cause diversion of our management’s attention.

have been subject to a number of litigations as described elsewhere in 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.

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.

We 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.

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 chief executive officer and chief 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

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.

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.

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

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if we fail to remedy such material weakness.

We 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.

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

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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