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Item 1A. Risk Factors

2022-03-31 compared with 2021-03-01 · 1880 added, 1393 removed, 42 unchanged (99% of the section changed)

investment in our common stock involves a high degree of risk.

Before deciding whether to invest in our securities, you should

consider carefully the risks described below, together with other information in this Annual Report on Form 10-K and the other

information and documents we file with the SEC.

Our business, financial condition and operating results can be affected by a number

of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could,

directly, or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated

future, financial condition and operating results.

Any of these factors in whole or in part, could materially and adversely affect

our business, financial condition, operating results and stock price.

Factor Summary

Before deciding whether to invest in our securities, you should consider

carefully the risks described below, together with other information in this Annual Report on Form 10-K and the other information and

documents we file with the SEC.

Our business, financial condition and operating results can be affected by a number of factors, whether

currently known or unknown, including but not limited to those described below, any one or more of which could, directly, or indirectly,

cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition

and operating results.

Any of these factors in whole or in part, could materially and adversely affect our business, financial condition,

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

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

This summary does not

address all of the risks that we face.

Additional discussion of risks summarized in this risk factor summary, and other risks

that we face, can 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.

Related to the Proposed Merger

The ongoing COVID-19 pandemic may pose risks and could harm business and results of operations for us and the combined company

following the completion of the Merger.

There is no assurance when or if the Merger will be complete.

Any delay in completing the Merger may substantially reduce the

potential benefits that we expect to obtain from the Merger.

Furthermore, the intended benefits of the Merger may not be realized.

The issuance of shares of our common stock to MYMD stockholders in the Merger will substantially dilute the voting power of current

Akers stockholders.

Having a minority share position will reduce the influence that current stockholders have on the management

of the combined company.

The issuance, or expected issuance, of our common stock in connection with the Merger, including the Milestone Shares, could decrease

the market price of our common stock.

Because the lack of a public market for MYMD common stock makes it difficult to evaluate the fairness of the Merger, MYMD stockholders

may receive consideration in the Merger that is greater than or less than the fair market value of MYMD common stock.

Our directors and officers may have interests in the Merger that are different from, or in addition to, those of our stockholders

generally that may influence them to support or approve the Merger.

If the Merger is completed, MYMD executive officers and MYMD appointees to the combined company’s board of directors will

have the ability to significantly influence the combined company’s management and business affairs, as well as matters submitted

to the combined company’s board of directors or stockholders for approval, especially if they decide to act together with

the current MYMD stockholders.

The announcement and pendency of the Merger could have an adverse effect on our business, financial condition, results of operations

or business prospects.

During the pendency of the Merger, we may not be able to enter into a business combination with another party and will be subject

to contractual limitations on certain actions because of restrictions in the Merger Agreement.

Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals

that may be superior to the arrangements contemplated by the Merger Agreement.

The Exchange Ratio is not adjustable based on the market price of our common stock, so the merger consideration at the closing

may have a greater or lesser value than at the time the Merger Agreement was signed.

We are expected to incur substantial expenses related to the Merger.

Failure to complete the Merger could negatively affect the value of our common stock and our future business and financial results.

The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide

changes or other causes.

We may become involved in additional securities litigation or stockholder derivate litigation in connection with the Merger,

and this could divert the attention of our management and harm the combined company’s business, and insurance coverage may

not be sufficient to cover all related costs and damages.

The reverse stock split may not increase the combined company’s stock price over the long term.

The reverse stock split would have the effect of increasing the amount of common stock that the combined company is authorized

to issue without further approval by the combined company’s stockholders.

The reverse stock split may decrease the liquidity of our common stock and lead to a decrease in overall market capitalization

of the combined company.

Related to Our Business Prior to Consummation of the Merger

We have a history of operating losses and we cannot guarantee that we can ever achieve sustained profitability.

We may fail to realize the anticipated benefits related to our acquisition of Cystron and those benefits may take longer to realize

than expected.

Our pursuit of the COVID-19 Vaccine Candidate is at an early stage.

We have not previously tested our rapid response capability

and may be unable to produce a vaccine that successfully treats the virus in a timely manner, if at all.

We operate in a highly competitive industry.

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

With regard to our COVID-19 Vaccine Candidate, we must conduct pre-clinical testing, prepare and submit an IND to the FDA, and

conduct all phases of clinical studies (which may include postmarket or “Phase 4”

studies), which will likely take

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

there is no guarantee that we will complete such clinical development in a timely manner or at all or that our BLA will be approved,

if submitted.

We may be unable to advance the COVID-19 Vaccine Candidate successfully through the pre-clinical and clinical development process.

Governmental involvement may limit the commercial success of the COVID-19 Vaccine Candidate.

Even if we are able to commercialize our prospective or future product candidates, the products may not receive coverage or adequate

reimbursement from third-party payors in the United States or in other countries in which we seek to commercialize such products,

which could harm our business.

We expect to require additional capital in the future in order to develop the COVID-19 Vaccine Candidate.

If we do not obtain

any such additional financing, it may be difficult to complete development of the COVID-19 Vaccine Candidate or effectively realize

our long-term strategic goals and objectives.

Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common

The delisting could adversely affect the market liquidity of our common stock and the market price of our common stock

could decrease.

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

This summary does not address

all of the risks that we face.

Additional discussion of risks summarized in this risk factor summary, and other risks that we face, can

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

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

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

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

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

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

stockholders to influence corporate matters.

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

adversely affect the market price of such shares.

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

active trading market for our common stock may not be sustained.

intended benefits of the Contribution Transaction may not be realized.

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

or those of third-party providers.

Risks Related to our Product Development and Regulatory

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

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

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

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

if we complete the necessary pre-clinical studies and clinical trials, we cannot predict

when, or if, we will

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

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

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

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

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

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

to significant regulatory risks.

Related to Commercialization and Manufacturing

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

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

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

Failure to obtain or maintain adequate

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

our ability to generate product revenue.

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

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

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

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

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

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

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

If any of our third-party

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

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

if approved, could be delayed or stopped.

Related to Government Regulation

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

candidates and may affect the prices we may set.

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

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

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

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

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

Related to Our Intellectual Property

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

It is difficult and costly to protect

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

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

in patent law in the U.S.

and in non-U.S.

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

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.

Related to the Proposed Merger

ongoing COVID-19 pandemic may pose risks and could harm business and results of operations for each of Akers, MYMD, and the combined

company following the completion of the merger.

global outbreak of COVID-19 has resulted in, and is likely to continue to result in, substantial disruptions to markets and economies

around the world, including the United States.

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

businesses, or the business of MYMD, and the combined company following the completion of the Merger, and there is no guarantee

that our efforts, or the efforts of MYMD, and the combined company following the completion of the Merger to address the adverse

impacts of the COVID-19 pandemic will be effective.

The extent of such impact will depend on future developments, which are highly

uncertain and cannot be predicted, including the duration of the pandemic, continued travel restrictions, social distancing requirements,

and government mandates, among others.

poses a material risk to the business, financial condition and results of operations of both us and MYMD, and potentially could

create risks for the combined company following the completion of the merger, including:

delays or impacts on business operations, product candidate development efforts, healthcare systems or the global economy

on key employees, including operational management personnel and those charged with preparing, monitoring and evaluating the

companies’

financial reporting and internal controls;

or protracted volatility in the price of our common stock.

factors, together or in combination with other events or occurrences not yet known or anticipated, could adversely affect the

value of the merger consideration or could delay or prevent the completion of the Merger and the related transactions.

or MYMD is, unable to recover from a business disruption on a timely basis, the Merger and the combined company’s business

and financial conditions and results of operations following the completion of the Merger could be adversely affected.

may also be delayed and adversely affected by the COVID-19 pandemic and become more costly.

Each of Akers, MYMD, and the combined

company may also incur additional costs to remedy damages caused by such disruptions, which could adversely affect each of their

financial condition and results of operations.

is no assurance when or if the Merger will be completed.

Any delay in completing the Merger may substantially reduce the potential

benefits that we expect to obtain from the Merger.

of the Merger is subject to the satisfaction or waiver of a number of conditions, as set forth in the Merger Agreement, including

the approval by our stockholders, approval by Nasdaq of our application for the initial listing of our common stock to be issued

in connection with the Merger, and other customary closing conditions.

There can be no assurance that we and MYMD will be able

to satisfy the closing conditions or that closing conditions beyond our or MYMD’s control will be satisfied or waived.

the conditions are not satisfied or waived, the Merger may not occur or may not be completed within the expected timeframe, and

we may materially and adversely lose some or all of the potential benefits that we expect to achieve as a result of the Merger

and could result in additional transaction costs or other effects associated with uncertainty about the Merger.

In addition, pursuant

to the Merger Agreement, we may extend the originally scheduled End Date (defined in the Merger Agreement as April 15, 2021) to

a later date, but we will have to make additional loans to MYMD or purchase MYMD common stock for such extensions.

have incurred and expect to continue to incur significant expenses related to the Merger, such as legal and accounting fees, some

of which must be paid even if the Merger is not completed.

and MYMD can agree at any time to terminate the Merger Agreement, even if our stockholders and/or MYMD’s securityholders

have already adopted the Merger Agreement and thereby approved the Merger and the other transactions contemplated by the Merger

We and MYMD can also terminate the Merger Agreement under other specified circumstances.

addition, if the Merger Agreement is terminated and our board of directors determines to seek another business combination, we

may not be able to find a third party willing to provide equivalent or more attractive consideration than the consideration to

be provided in the Merger.

In such circumstances, our board of directors may elect to, among other things, divest all or a portion

of our business, or take the steps necessary to liquidate all of our business and assets, and in either such case, the consideration

that we receive may be less attractive than the consideration to be received by us pursuant to the Merger Agreement.

issuance of shares of our common stock to MYMD stockholders in the Merger will substantially dilute the voting power of our current

stockholders.

Having a minority share position will reduce the influence that current stockholders have on our management.

to the Merger Agreement, upon the effectiveness of the Merger, (i) (“

MYMD stockholders”) will be entitled to receive

(x) the number of shares of Akers common stock equal to Exchange Ratio per share of MYMD common stock they hold, prior to giving

effect to the proposed reverse stock split discussed below, (y) an amount in cash, on a pro rata basis, equal to the Additional

Consideration, such payment to occur not later than 30 days after the last day of the Option Exercise Period, up to the maximum

amount of cash consideration that may be received by MYMD stockholders without affecting the intended tax consequences of the

merger, and (z) potential Milestone Shares payable upon achievement of certain market capitalization milestone events during the

Milestone Period;

and (ii) each outstanding option to purchase MYMD common stock granted under the MyMD Incentive Plan that has

not previously been exercised prior to the closing of the Merger, whether or not vested, will be assumed by Akers subject to certain

terms contained in the Merger Agreement, and become an option to purchase a number of shares of Akers common stock equal to the

number of shares of MYMD common stock underlying such option multiplied by the Exchange Ratio, which options to purchase MYMD

common stock shall be amended to expire on the second-year anniversary of the closing of the Merger, and the exercise price for

each share of Akers common stock underlying an assumed option to purchase MYMD common stock will be equal to the exercise price

per share of the option to purchase MYMD common stock in effect immediately prior to the completion of the Merger divided by the

Exchange Ratio.

Assuming the exercise in full of the outstanding Pre-Funded Warrants issued in connection with the Private Placement

and including 9,979,664 shares of combined company common stock underlying options to purchase shares of MYMD common stock to

be assumed at the closing of the Merger, (i) MYMD stockholders and optionholders will own approximately 80% of the equity of the

combined company;

and (ii) our current stockholders, holders of certain outstanding of our options and warrants (excluding shares

issuable upon exercise of options and warrants having an exercise price in excess of $1.72, prior to giving effect to any such

stock splits, combinations, reorganizations and the like with respect to the Akers common stock between the announcement of the

Merger and the closing of the Merger) and holders of our outstanding RSUs immediately prior to the Merger will own approximately

20% of the equity of the combined company.

Accordingly, the issuance of the shares of Akers common stock to MYMD stockholders

in the Merger will significantly reduce the ownership stake and relative voting power of each share of Akers common stock held

by current Akers stockholders.

Consequently, following the Merger, the ability of our current stockholders to influence the management

of the combined company will be substantially reduced.

under the terms of the Merger Agreement, we agreed to pay Milestone Payments, payable in shares of Akers common stock to MYMD

stockholders upon the achievement of certain market capitalization milestone events during the Milestone Period, up to the number

of shares of Akers common stock issuable to the MYMD stockholders upon the closing of the Merger.

In the event that such milestone

events are achieved and Milestone Payments are made, our current stockholders will experience further reduction in relative voting

issuance, or expected issuance, of our common stock in connection with the Merger could decrease the market price of our common

connection with the Merger and as part of the merger consideration, we expect to issue shares of our common stock to MYMD stockholders.

The anticipated issuance of our common stock in the Merger may result in fluctuations in the market price of our common stock,

including a stock price decrease.

In addition, issuance of the milestone shares, if any applicable milestone is achieved, and

the perception in the market that the holders of a large number of shares of our common stock may intend to sell shares could

reduce the market price of our common stock.

intended benefits of the Merger may not be realized.

Merger poses risks for our ongoing operations, including, among others:

senior management’s attention may be diverted from the management of our current operations and development of the COVID-19

Vaccine Candidate;

and expenses associated with any undisclosed or potential liabilities;

difficulties may arise in integrating MYMD’s and Akers’

business in the combined company.

a result of the foregoing, the combined company may be unable to realize the full strategic and financial benefits currently anticipated

from the Merger, and we cannot assure you that the Merger will be accretive to us in the near term or at all.

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.

Our stockholders will have experienced substantial dilution of their ownership interests

in the Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the

combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

the lack of a public market for MYMD common stock makes it difficult to evaluate the fairness of the Merger, MYMD stockholders

may receive consideration in the Merger that is greater than or less than the fair market value of MYMD common stock.

outstanding common stock of MYMD is privately held and is not traded in any public market.

The lack of a public market makes it

extremely difficult to determine the fair market value of MYMD shares.

Since the percentages of Akers common stock to be issued

to MYMD stockholders was determined based on negotiations between the parties, it is possible that the value of Akers common stock

to be issued in connection with the Merger will be greater than the fair market value of MYMD shares.

Alternatively, it is possible

that the value of the shares of Akers common stock to be issued in connection with the Merger will be less than the fair market

value of MYMD shares.

directors and officers may have interests in the Merger that are different from, or in addition to, those of our stockholders

generally that may influence them to support or approve the Merger.

officers and directors may have interests in the Merger that are different from, or are in addition to, those of our stockholders

Effective upon the closing of the Merger, Christopher Schreiber, current President and Chief Executive Officer of Akers,

is expected to serve as an executive officer of the Supera line of business.

It is expected that four of the current directors

of Akers, Messrs.

Schreiber, Silverman, White and Schroeder, are to be appointed as directors of the combined company after the

completion of the Merger and will receive cash and equity compensation in consideration for such service.

The outstanding unvested

RSUs held by our current executive officers and directors will vest in connection with the Merger.

In addition, our directors

and executive officers also have certain rights to indemnification or to directors’

and officers’

liability insurance

that will survive the completion of the Merger.

These interests may have influenced our directors and executive officers to support

or recommend the proposals that will be presented to our stockholders.

the Merger is completed, MYMD executive officers and MYMD appointees to the combined company’s board of directors will have

the ability to significantly influence the combined company’s management and business affairs, as well as matters submitted

to the combined company’s board of directors or stockholders for approval, especially if they decide to act together with

the current MYMD stockholders.

completion of the merger, the former MYMD stockholders will own approximately 80% of the combined company on a partially diluted

basis, excluding the effect of warrants issued in the Private Placement.

If the Merger is completed, the combined company is expected

to be led by MYMD executive officers.

Furthermore, the combined company’s anticipated board of directors will consist of

seven members, three of which will be appointed by MYMD pursuant to the terms of the Merger Agreement.

As a result, such persons,

if they choose to act together, will have the ability to significantly influence the combined company’s management and business

affairs, as well as matters submitted to the combined company’s board of directors or stockholders for approval.

announcement and pendency of the Merger could have an adverse effect on our business, financial condition, results of operations

or business prospects.

announcement and pendency of the Merger could disrupt Akers’

businesses in the following ways, among others:

current and prospective employees could experience uncertainty about their future roles within the combined company, and this

uncertainty might adversely affect our ability to retain, recruit and motivate key personnel;

attention of our management may be directed towards the completion of the Merger and other transaction-related considerations

and may be diverted from the day-to-day business operations of the Company, and matters related to the Merger may require

commitments of time and resources that could otherwise have been devoted to other opportunities that might have been beneficial

prospective customers, suppliers, collaborators and other third parties with business relationships with Akers may decide

not to renew or may decide to seek to terminate, change or renegotiate their relationships with Akers as a result of the Merger,

whether pursuant to the terms of their existing agreements with Akers;

market price of Akers’

common stock may decline to the extent that the current market price reflects a market assumption

that the proposed Merger will be completed.

they occur, any of these matters could adversely affect our businesses of, or harm our financial condition, results of operations

or business prospects.

the pendency of the Merger, we may not be able to enter into a business combination with another party and will be subject to

contractual limitations on certain actions because of restrictions in the Merger Agreement.

in the Merger Agreement impede our ability to make dispositions or acquisitions or complete other transactions that are not in

the ordinary course of business pending completion of the Merger, other than the Supera Purchase, potential spin-off of all or

a portion of our assets prior to the consummation of the Merger, and certain permitted financings as set forth in the Merger Agreement.

As a result, if the Merger is not completed, we may be at a disadvantage to our competitors.

In addition, while the Merger Agreement

is in effect and subject to limited exceptions, we are prohibited from soliciting, initiating, encouraging or taking actions designed

to facilitate any inquiries or the making of any proposal or offer that could lead to entering into certain extraordinary transactions

with any third party, such as a sale of assets, an acquisition, a tender offer, a merger or other business combination outside

the ordinary course of business.

These restrictions may prevent us from pursuing otherwise attractive business opportunities or

other capital structure alternatives and making other changes to our business or executing certain of our business strategies

prior to the completion of the Merger, which could be favorable to our stockholders.

provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that

may be superior to the arrangements contemplated by the Merger Agreement.

terms of the Merger Agreement prohibit us from soliciting competing proposals or cooperating with persons making unsolicited takeover

proposals, except in limited circumstances if our board of directors determines in good faith, after consultation with its independent

financial advisor and outside counsel, that an unsolicited competing proposal constitutes, or would reasonably be expected to

result in, a superior competing proposal and that failure to take such action would be reasonably likely to result in a breach

of the fiduciary duties of our board of directors.

In the event that our board of directors withdraws or modifies its recommendation

for the Share Issuance Proposal based on such superior competing proposal, MYMD may terminate the Merger Agreement.

rights of MYMD stockholders who become Akers stockholders in the Merger and Akers stockholders following the merger will be governed

by the A&R Charter and the Akers Bylaws.

consummation of the Merger, outstanding shares of MYMD common stock will be converted into the right to receive shares of Akers

common stock.

MYMD stockholders who receive shares of Akers common stock in the merger will become Akers stockholders.

MYMD stockholders who become stockholders in Akers will be governed by Akers’

organizational documents and bylaws, rather

than being governed by MYMD’s organizational documents and bylaws.

Pursuant to the Merger Agreement, the Akers Charter will

be amended and restated, subject to Akers stockholders’

approval of the A&R Charter Proposal, immediately prior to the

Effective Time.

Exchange Ratio is not adjustable based on the market price of our common stock, so the merger consideration at the closing may

have a greater or lesser value than at the time the Merger Agreement was signed.

Merger Agreement has set the Exchange Ratio formula for the MYMD common stock, and the Exchange Ratio (as defined in the Merger

Agreement) is only adjustable upward or downward to reflect our and MYMD’s equity capitalization as of immediately prior

to the Effective Time.

Any changes in the market price of common stock before the completion of the Merger will not affect the

number of shares MYMD securityholders will be entitled to receive pursuant to the Merger Agreement.

Therefore, if before the completion

of the Merger, the market price of our common stock declines from the market price on the date of the Merger Agreement, then MYMD

securityholders could receive merger consideration with substantially lower value.

Similarly, if before the completion of the

merger, the market price of our common stock increases from the market price on the date of the Merger Agreement, then MYMD securityholders

could receive merger consideration with substantially more value for their shares of MYMD common stock than the parties had negotiated

for in the establishment of the Exchange Ratio.

In addition, the Exchange Ratio (as defined in the Merger Agreement) does not

reflect the potential issuance of the Milestone Shares upon the achievement of certain market capitalization milestone events.

the merger does not qualify as a reorganization under Section 368(a) of the Internal Revenue Code of 1986, as amended, or is otherwise

taxable to United States MYMD stockholders, then such holders may be required to pay United States federal income taxes.

United States federal income tax purposes, the Merger is intended to constitute a reorganization within the meaning of Section

368(a) of the Code.

If the Internal Revenue Service (the “IRS”) or a court determines that the Merger should not be

treated as a reorganization, a holder of MYMD common stock would recognize taxable gain or loss upon the exchange of MYMD common

stock for our common stock pursuant to the Merger Agreement.

are expected to incur substantial expenses related to the Merger.

have incurred, and expect to continue to incur, substantial expenses in connection with the Merger, as well as operating as a

public company.

We will incur significant fees and expenses relating to legal, accounting, financial advisory and other transaction

fees and costs associated with the merger.

Actual transaction costs may substantially exceed our estimates and may have an adverse

effect on the combined company’s financial condition and operating results.

to complete the Merger could negatively affect the value of our common stock and our future business and financial results.

the Merger is not completed, our ongoing businesses could be adversely affected and we will be subject to a variety of risks associated

with the failure to complete the Merger, including without limitation the following:

of management focus and resources from operational matters and other strategic opportunities while working to implement the

harm due to the adverse perception of any failure to successfully complete the Merger;

to pay certain costs relating to the Merger, such as legal, accounting, financial advisory, filing and printing fees.

the Merger is not completed, these risks could materially affect the market price of our common stock and our business and financial

results (including the cessation of our operations).

Merger is expected to result in a limitation on the combined company’s ability to utilize its net operating loss carryforward.

Section 382 of the Code, use of our net operating loss carryforwards (“NOLs”) will be limited if we experience a cumulative

change in ownership of greater than 50% in a moving three-year period.

At December 31, 2020, we had approximately $100,615,000

of operating loss carryforwards for federal and approximately $7,548,000 for New Jersey state tax purposes that may

be applied against future taxable income.

We will experience an ownership change as a result of the Merger and therefore our ability

to utilize our NOLs and certain credit carryforwards remaining at the Effective Time will be limited.

The limitation will be determined

by the fair market value of our common stock outstanding prior to the ownership change, multiplied by the applicable federal rate.

It is expected that the Merger will impose a limitation on our NOLs.

Limitations imposed on our ability to utilize NOLs could

cause United States federal and state income taxes to be paid earlier than would be paid if such limitations were not in effect

and could cause such NOLs to expire unused, in each case reducing or eliminating the benefit of such NOLs.

opinion received by our board of directors from Gemini Valuation Services (“GVS”) has not been, and is not expected

to be, updated to reflect changes in circumstances that may have occurred since the date of the opinion.

a board of directors meeting held on November 11, 2020, our financial advisor, GVS, rendered its opinion as to the fairness, from

a financial point of view, of the contribution made and consideration received by the holders of our common stock pursuant to

the Merger Agreement and rendered its oral opinion to our board of directors (which was subsequently confirmed in writing as of

November 11, 2020) that, as of the date of such opinion and subject to the various assumptions made, procedures followed, matters

considered and qualifications and limitations set forth in such opinion, the contribution made and consideration received by the

holders of our common stock pursuant to the Merger Agreement was fair to the holders of our common stock from a financial

point of view.

Such opinion was one of many factors considered by our board of directors in approving the Merger.

does not speak as of the time the Merger will be completed or any date other than the date of such opinion.

Subsequent changes

in our or MYMD’s operation and prospects, general market and economic conditions and other factors that may be beyond our

control, may significantly alter the value of Akers or MYMD or the prices of the shares of our common stock by the time the Merger

is to be completed.

The opinion does not address the fairness of the merger consideration from a financial point of view to us

at the time the Merger is to be completed, or as of any other date other than the date of such opinion, and the Merger Agreement

does not require that the opinion be updated, revised or reaffirmed prior to the closing of the Merger to reflect any changes

in circumstances between the date of the signing of the Merger Agreement and the completion of the Merger as a condition to closing

Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes

or other causes.

general, either party can refuse to complete the Merger if there is a material adverse effect (as defined in the Merger Agreement)

affecting the other party between November 11, 2020, the date of the Merger Agreement, and the closing of the Merger.

some types of changes do not permit either party to refuse to complete the merger, even if such changes would have a material

adverse effect on Akers or MYMD, as the case may be:

or events affecting the industries or industry sectors in which the parties operate generally;

or events generally affecting the U.S.

or global economy or capital markets as a whole;

respect to us, changes in the trading price or trading volume of our common stock;

flood, tornado, earthquake or other natural disaster, epidemic, plague, pandemic (including the COVID-19 pandemic) or other

public health event or any other force majeure event;

in GAAP or other applicable law or legal requirement;

caused by the announcement or pendency of the Merger;

caused by any action taken, or the failure to take any action that is expressly required by the Merger Agreement.

adverse changes occur but we must still complete the merger, the market price of our common stock may suffer.

may become involved in additional securities litigation or stockholder derivative litigation in connection with the merger,

and this could divert the attention of our management and harm the combined company’s business, and insurance coverage may

not be sufficient to cover all related costs and damages.

litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions,

such as the sale of a business division or announcement of a business combination transaction.

Between January 22, 2021 and

February 10, 2021, five alleged Akers stockholders filed separate actions in the state and federal courts of New York and New

Jersey against Akers and the members of its board of directors, respectively captioned as follows:

(i) Douglas McClain v.

Biosciences, Inc., et al., No.

650497/2021 (Sup.

(ii) Owen Murphy v.

Akers Biosciences, Inc., et al.

650545/2021 (Sup.

Sue Gee Cheng v.

Akers Biosciences, Inc., et al., No.

1:21-cv-01110 (S.D.N.Y.);

Akers Biosciences, Inc.

GLO-C-000006-21 (N.J.

and Alan Misenheimer

Akers Biosciences, Inc., et al.

1:21-cv-02310 (D.N.J.) (collectively, the “

MYMD Merger Complaints ”).

The McClain and Lui actions are styled as putative class actions brought on behalf of the plaintiff and other similarly

situated stockholders, while the Murphy, Cheng , and Misenheimer actions are brought solely on behalf of the individual

stockholders.

The MYMD Merger Complaints generally assert that Akers and its board of directors failed to disclose allegedly material

information in the joint proxy and consent solicitation statement/prospectus and seek an order enjoining or unwinding the consummation

of the Merger Agreement and awarding damages.

The defendants believe that the claims asserted in the MYMD Merger Complaints are

without merit and intend to appropriately defend themselves against them.

Accordingly, we do not expect that these claims will

have a material adverse effect on its financial condition or results of operations.

We may become involved in more of

this type of litigation in connection with the Merger, and the combined company may become involved in this type of litigation

in the future.

Litigation often is expensive and diverts management’s attention and resources, which could adversely affect

our business and the business of the combined company.

the Merger is consummated, the business operations, strategies and focus of the combined company will fundamentally change, and

these changes may not result in an improvement in the value of its common stock.

the consummation of the Merger, it is currently anticipated that the combined company would focus its resources on executing MYMD’s

current business plan.

In addition, prior to the consummation of the Merger, we may, in our discretion, consummate a spin-off

of all or a part of our legacy assets.

In the event we consummate such spin-off, the stockholders of Akers and MYMD will not participate

in the future prospects of such legacy assets.

the Merger, it is expected that the combined company’s primary products will be MYMD’s product candidates:

a clinical-stage immunometabolic regulator and Supera-1R, a pre-clinical stage patented synthetic cannabidiol derivative.

Consequently,

if the merger is consummated, an investment in our common stock will primarily represent an investment in the business operations,

strategies and focus of MYMD.

MYMD expects to incur losses as it develops its product candidates, and MYMD’s 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 the

business of the combined company.

There is no assurance that the combined company’s business operations, strategies or focus

will be successful following the Merger, and the Merger could depress the value of the combined company’s common stock.

reverse stock split may not increase the combined company’s stock price over the long term.

the Reverse Stock Split Proposal is approved, the combined company anticipates effecting a reverse stock split at a reverse

stock split ratio as mutually agreed to by Akers and MYMD, which range shall be sufficient to cause its stock price to be

at least $5.00 immediately following the Merger.

While it is expected that the reduction in the number of outstanding shares of

common stock will proportionally increase the market price of the combined company’s common stock upon effectiveness of

the reverse stock split, it cannot be assured that the reverse stock split will result in any sustained proportionate increase

in the market price of the combined company’s common stock, which is dependent upon many factors, including the business

and financial performance of the combined company, general market conditions, and prospects for future success, which are unrelated

to the number of shares of the combined company’s common stock outstanding.

Thus, while the stock price of the combined

company might meet the initial listing requirements for Nasdaq initially, it cannot be assured that it will continue to do so.

reverse stock split would have the effect of increasing the amount of common stock that the combined company is authorized to

issue without further approval by the combined company’s stockholders.

proposed A&R Charter for the combined company is anticipated to authorize the combined company to issue 500,000,000 shares

of common stock and does not anticipate reducing this amount in connection with the reverse stock split.

Except in certain instances,

as required by law or by the rules of the securities exchange that lists the combined company’s common stock, these additional

shares may be issued by the combined company without further vote of the combined company’s stockholders.

If the combined

company’s board of directors chooses to issue additional shares of the combined company’s common stock, such issuance

could have a dilutive effect on the equity, earnings and voting interests of the combined company’s stockholders.

reverse stock split may decrease the liquidity of our common stock.

our board of directors believes that the anticipated increase in the market price of our common stock could encourage interest

in our common stock and possibly promote greater liquidity for our stockholders, such liquidity could also be adversely affected

by the reduced number of shares outstanding after the reverse stock split.

The reduction in the number of outstanding shares may

lead to reduced trading and a smaller number of market makers for our common stock.

reverse stock split may lead to a decrease in overall market capitalization of the combined company.

the market price of our common stock decline after the reverse stock split, the percentage decline may be greater, due to the

smaller number of shares outstanding, than it would have been prior to the reverse stock split.

A reverse stock split is often

viewed negatively by the market and, consequently, can lead to a decrease in the overall market capitalization of the combined

If the per share market price does not increase in proportion to the reverse stock split ratio, then the value of the

combined company, as measured by its stock capitalization, will be reduced.

In some cases, the per-share stock price of companies

that have effected reverse stock splits subsequently declined back to pre-reverse split levels and, accordingly, it cannot be

assured that the total market value of our common stock will remain the same after the reverse stock split is effected, or that

the reverse stock split will not have an adverse effect on our stock price due to the reduced number of shares outstanding after

the reverse stock split.

Related to Our Business Prior to Consummation of the Merger

have a history of operating losses and we cannot guarantee that we can ever achieve sustained profitability.

have recorded a net loss attributable to common stockholders in most reporting periods since our inception.

We had a net loss

of $17,580,609 during the year ended December 31, 2020.

Our accumulated deficit at December 31, 2020 was $137,163,739.

of the unfavorable factors existing within our rapid, point-of-care screening and testing products business, we ceased the production

and sale of our screening testing products.

We are focusing on the development and manufacturing of the COVID-19 Vaccine Candidate,

or combination product candidate in partnership with Premas and expect to incur additional operating losses for the foreseeable

As part of our efforts to increase shareholder value, on November 11, 2020, Akers entered into the Merger Agreement with

MYMD, pursuant to which Merger Sub will merge with and into MYMD, with MYMD becoming our wholly owned subsidiary.

For risks related

to the merger, please see risk factors set forth under the heading “—

Risks Related to the Proposed Merger”

However, there can be no assurance of success in reducing our loss, becoming profitable, or having sufficient cash to

develop a COVID-19 Vaccine Candidate or to complete the consummation of the Merger.

may fail to realize the anticipated benefits of our acquisition of Cystron and those benefits may take longer to realize than

March 23, 2020, we entered into the MIPA with the Cystron Sellers, pursuant to which we acquired the Cystron Membership Interests.

Cystron is a party to a License and Development Agreement (the “Initial License Agreement”) with Premas.

As a condition

to our entry into the MIPA, Cystron amended and restated the Initial License Agreement on March 19, 2020 (as amended and restated,

the “License Agreement”).

Pursuant to the License Agreement, Premas granted Cystron, amongst other things, an exclusive

license with respect to Premas’

vaccine platform for the development of the COVID-19 Vaccine Candidate.

Our ability to realize

the anticipated benefits of the acquisition will depend, to a large extent, on our ability to produce an effective vaccine against

The development of the COVID-19 Vaccine Candidate is in very early stages and there is no assurance that we will be

able to produce an effective vaccine.

Moreover, we have the right to terminate the License Agreement on a country-by-country basis

for any reason or for no reason at any time upon sixty (60) days’

prior written notice to Premas, and may decide to cease

development of the COVID-19 Vaccine Candidate and terminate the License Agreement.

The failure to produce the COVID-19 Vaccine

Candidate or termination of the License Agreement could adversely affect our business, financial condition and results of operations.

In addition, we have incurred and expect to incur significant expenses related to the acquisition.

These expenses include, but

are not limited to, the Common Stock Consideration (as defined in the MIPA), a cash consideration of $1.0 million, related contingent

fees, legal fees and other related fees and expenses.

Many of these expenses have been paid or will be payable by us regardless

of our ability to successfully develop the COVID-19 Vaccine Candidate, and we will not be able to recover these expenses in the

event that we fail to develop the COVID-19 Vaccine Candidate.

pursuit of the COVID-19 Vaccine Candidate is at an early stage.

We have not previously tested our rapid response capability and

may be unable to produce a vaccine that successfully treats the virus in a timely manner, if at all.

response to the COVID-19 pandemic, we are pursuing the rapid development of the COVID-19 Vaccine Candidate.

Our development of

the COVID-19 Vaccine Candidate is in early stages, and we may be unable to produce the COVID-19 Vaccine Candidate.

Additionally,

our ability to develop an effective COVID-19 Vaccine Candidate depends on the success of its rapid response capability, which

we have not previously tested and which will need to be funded by third parties in order to enable us to have sufficient capacity

to respond to a global health challenge.

If the COVID-19 pandemic is effectively contained or the risk of COVID-19 infection is

diminished or eliminated before we can successfully develop and manufacture a COVID-19 Vaccine Candidate, including availabilities

of effective vaccines, we may be unable to successfully generate revenue from the manufacturing of the COVID-19 Vaccine Candidate.

We are also committing financial resources and personnel to the development of the COVID-19 Vaccine Candidate which may divert

resources from other transactions, despite uncertainties surrounding the longevity and extent of COVID-19 as a global health concern.

Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable

and could rapidly dissipate or against which the COVID-19 Vaccine Candidate, if developed, may not be partially or fully effective.

acquisition of Cystron could result in additional costs, integration or operating difficulties, dilution and other adverse consequences.

connection with the acquisition of the Cystron and in pursuit of developing the COVID-19 Vaccine Candidate, we may:

equity securities that may substantially dilute our stockholders’

percentage of ownership;

obligated to make milestone, royalty or other contingent or non-contingent payments;

debt or non-recurring and other charges, or assume liabilities.

addition, the process of integrating Cystron’s business may create operating difficulties and expenditures and pose numerous

additional risks to our operations, including:

to develop, manufacture or supply the COVID-19 Vaccine Candidate economically or successfully commercialize or achieve market

acceptance of the COVID-19 Vaccine Candidate;

to liabilities of Cystron, including known or unknown risks relating to the validity or enforceability of exclusivity rights

and generic competition;

effects on our operating results or financial condition, including due to expenditures or acquisition-related costs, costs

of commercialization or amortization or impairment costs for acquired goodwill and other intangible assets;

of relationships with key suppliers and manufacturers due to changes in management and ownership and difficulty in maintaining

existing agreements, licenses and other arrangements or rights on substantially similar terms as existed prior to the acquisition;

changes and market dynamics after the acquisition;

loss of key employees, particularly those of the acquired entity.

any of the above events (or more) occur, or if we cannot effectively manage or respond to such events following the acquisition,

they may have material adverse effect on our business, results of operations and financial condition.

is dependent on technologies that it has licensed, and Cystron may need to license in the future, and if Cystron fails to obtain

licenses it needs, or fails to comply with its payment obligations in the agreements under which Cystron in-licenses intellectual

property and other rights from third parties, Cystron could lose its ability to develop a COVID-19 Vaccine Candidate.

currently is dependent on a license from Premas for its key technologies.

Any failure to make the payments required by the License

Agreement may permit Premas to terminate the license.

If Cystron were to lose or otherwise be unable to maintain the license for

any reason, it would halt Cystron’s ability to develop a COVID-19 Vaccine Candidate.

The foregoing could result in a material

adverse effect on Akers’

business or results of operations.

addition, Cystron does not own the patents or patent applications that it licenses, and as such, Cystron may need to rely upon

Premas to properly prosecute and maintain those patent applications and prevent infringement of those patents.

If Premas is unable

to adequately protect the proprietary intellectual property Cystron licenses from legal challenges, or if Cystron is unable to

enforce such licensed intellectual property against infringement or alternative technologies, Akers will not be able to compete

effectively in the drug discovery and development business.

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

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

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

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

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

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

announcements

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

other events by the us or our competitors;

or trends in the life sciences and biopharmaceutical industries;

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

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

of our common stock by stockholders, including executives and directors;

and limitations in trading volumes of our common stock;

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

ability to finance our business;

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

to meet external expectations or management guidance;

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

by stockholders;

cash position;

announcements

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

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

and additions of key personnel;

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

investigations

by regulators into our operations or those of our competitors;

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

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

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

class action litigation has often been instituted against these companies.

Litigation of this type, if instituted against us, could result

in substantial costs and a diversion of management’s attention and resources of the Company.

Any adverse determination in any such

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.

A continuation or worsening

of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital,

on our business, results of operations and financial condition, and on the market price of our common stock.

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

We anticipates that we will continue to incur losses

for the foreseeable future.

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

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

are a clinical-stage pharmaceutical company with a limited operating history.

Pharmaceutical product development is a highly speculative

undertaking and involves a substantial degree of risk.

Our operations to date have been limited primarily to business planning, raising

capital and conducting research and development activities for our product candidates.

We have never generated any revenue from product

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

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

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.

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

predecessor, MyMD Florida, was formed in late 2014.

Our operations to date have been limited primarily to business planning, raising

capital and conducting research and development activities for our product candidates.

We have not yet demonstrated the ability to complete

clinical trials of our product candidates, obtain marketing approvals, manufacture a commercial scale product or conduct sales and marketing

activities necessary for successful commercialization.

Consequently, predictions about our future success or viability are speculative

and no assurances can be given about our future performance.

the Merger was consummated, the business operations, strategies and focus of the Company fundamentally changed, and these changes may

not result in an improvement in the value of our common stock.

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.

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

to influence corporate matters.

the Supera Purchase and the Merger, the executive officers, directors, five percent or greater stockholders, and the respective affiliated

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

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

including the election of directors and approval of significant corporate transactions.

Corporate actions might be taken even if other

stockholders oppose them.

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

that other stockholders may view as beneficial.

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

and the value of our common stock.

stockholders may from time to time seek to acquire a controlling stake in the Company, engage in proxy solicitations, advance stockholder

proposals or otherwise attempt to effect changes.

Campaigns by stockholders to effect changes at publicly traded companies are sometimes

led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special

dividends, stock repurchases or sales of assets or the entire company.

Responding to proxy contests and other actions by activist stockholders

can be costly and time-consuming and could disrupt our operations and divert the attention of our Board of Directors and senior management.

These actions could adversely affect our operations, financial condition, and the value of our common stock.

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

affect the market price of such shares.

of a substantial number of shares of our common stock in the public market after expiration of the lock-up period and other legal restrictions

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

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

Upon completion of the Merger and the transactions contemplated

in the Merger Agreement, the Company issued 28,553,307 post reverse stock split shares of Company Common Stock to the former stakeholders

of pre-Merger MyMD Florida at the Exchange Ratio.

Shares that were issued to pre-Merger MyMD Florida stockholders as merger consideration

could be resold in the public market immediately without restriction, unless such stockholder was subject to a lock-up or other restriction

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

the Securities Act.

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

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

Anti-takeover

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

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

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

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

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

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

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

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

owned by such interested stockholder.

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

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

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

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

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

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

These provisions could

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

For purposes of Section 14A-10A

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

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

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

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

product candidates.

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

Failure to obtain this necessary capital

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

will require substantial future capital in order to complete planned and future pre-clinical and clinical development for MYMD-1 and

Supera-CBD and potentially commercialize these product candidates.

We expect increased spending levels in connection with our clinical

trials of our product candidates.

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

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

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

Accordingly, we will need to obtain substantial

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

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

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

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

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

of any of our securities then outstanding.

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

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

We may also be required to recognize non-cash

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

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

If we require additional

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

on favorable terms, if at all.

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

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

must attract and retain highly skilled employees to succeed.

succeed, we must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel, and we face

significant competition for experienced personnel.

If we do not succeed in attracting and retaining qualified personnel, particularly

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

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

The competition for qualified personnel

in the biotechnology field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary

for the development of our business or to recruit suitable replacement personnel.

of the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different

risk profiles and a longer history in the industry than we do.

They also may provide more diverse opportunities and better chances for

career advancement.

Some of these characteristics may be more appealing to high-quality candidates than what we have to offer.

are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover and develop product

candidates and our business will be limited.

operate in a highly competitive industry.

face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology

companies as well as academic and research institutions pursuing research and development of technologies, drugs or other therapies

that would compete with our products or product candidates.

The pharmaceutical market is highly competitive, subject to rapid

technological change and significantly affected by existing rival drugs and medical procedures, new product introductions and

the market activities of other participants.

companies as well as academic and research institutions pursuing research and development of technologies, drugs or other therapies that

would compete with our products or product candidates.

The pharmaceutical market is highly competitive, subject to rapid technological

change and significantly affected by existing rival drugs and medical procedures, new product introductions and the market activities

of other participants.

Our competitors may develop products more rapidly or more effectively than us.

our competitors are more successful in commercializing their products than us, their success could adversely affect our competitive

position and harm our business prospects and may also lead to the diversion of funding away from us and toward other companies.

Specifically,

the competitive landscape of potential COVID-19 vaccines and treatment therapies has been rapidly developing since the beginning

of the COVID-19 pandemic, with several hundreds of companies claiming to be investigating possible candidates and approximately

4,800 studies registered worldwide as investigating COVID-19 ( source:

clinicaltrials.gov ).

Given the global footprint

and the widespread media attention on the COVID-19 pandemic, there are efforts by public and private entities to develop a vaccine

against SARS-CoV-2 as soon as possible, including large, multinational pharmaceutical companies such as AstraZeneca, GlaxoSmithKline,

Johnson & Johnson, Moderna, Pfizer, and Sanofi, with vaccine candidates that are currently at more advanced stage of development

than our COVID-19 Vaccine Candidate.

In December 2020, the FDA began to issue emergency use authorizations for vaccines developed

by certain of these large, multinational pharmaceutical companies and it is possible that additional vaccines developed by such

large, multinational pharmaceutical companies may receive further approvals and authorizations in the near term.

Those other entities

may develop COVID-19 vaccines that are more effective than any vaccine we may develop, may develop a COVID-19 vaccine that becomes

the standard of care, may develop a COVID-19 vaccine at a lower cost or earlier than we are able to jointly develop any COVID-19

vaccine, or may be more successful at commercializing a COVID-19 vaccine.

Many of these other organizations are much larger than

we are and have access to larger pools of capital, and as such, are able to fund and carry on larger research and development

Such other entities may have greater development capabilities than we do and have substantially greater experience

in undertaking nonclinical and clinical testing of vaccine candidates, obtaining regulatory approvals and manufacturing and marketing

pharmaceutical products.

Our competitors may also have greater name recognition and better access to customers.

In addition, based

on the competitive landscape, additional COVID-19 vaccines or therapeutics may continue to be approved to be marketed.

another party be successful in producing a more efficacious vaccine for COVID-19, such success could reduce the commercial opportunity

for our COVID-19 Vaccine Candidate and could have a material adverse effect on our business, financial condition, results of operations

and future prospects.

Moreover, if we experience delayed regulatory approvals or disputed clinical claims, we may not have a commercial

or clinical advantage over competitors’

products that we believe we currently possesses.

The success or failure of other

entities, or perceived success or failure, may adversely impact our ability to obtain any future funding for our vaccine development

efforts or for us to ultimately commercialize and market any vaccine candidate, if approved.

In addition, we may not be able to

compete effectively if our product candidates do not satisfy government procurement requirements with respect to biodefense products.

If our competitors are more successful

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

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

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 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.

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.

ultimate impact of the global COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change.

not yet know the full extent of potential delays or impacts on our business, our vaccine development efforts, healthcare systems

or the global economy as a whole.

However, the effects are likely to have a material impact on our operations, liquidity and capital

resources, and we will continue to monitor the COVID-19 situation closely.

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, including Premas, whose operations are located in India.

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 and Premas may engage in connection with the development

and testing of our COVID-19 Vaccine Candidate.

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 Akers.

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.

Related to Our Product Development

regard to our COVID-19 Vaccine Candidate, we must conduct pre-clinical testing, prepare and submit an IND to the FDA, and conduct

all phases of clinical studies (which may include postmarket or “Phase 4”

studies), which will likely take several

years and substantial expenses to complete, before we can submit an application for marketing approval to the FDA, and there is

no guarantee that we will complete such clinical development in a timely manner or at all or that our BLA will be approved, if

expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to our COVID-19 Vaccine

Accordingly, our business currently depends heavily on the successful development, FDA approval, and commercialization

of such candidate, which may never receive FDA approval or be successfully commercialized even if FDA approval is received.

research, testing, manufacturing, labeling, approval, sale, marketing, and distribution of the COVID-19 Vaccine Candidate are,

and will remain, subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries,

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.

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

costs that could harm our business.

are subject to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the

handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations will involve the use of hazardous materials,

including chemicals and biological materials.

Our operations also may produce hazardous waste products.

We generally anticipate contracting

with third parties for the disposal of these materials and wastes.

We will not be able to eliminate the risk of contamination or injury

from these materials.

In the event of contamination or injury resulting from any use by us of hazardous materials, we could be held liable

for any resulting damages, and any liability could exceed our resources.

We also could incur significant costs associated with civil

or criminal fines and penalties for failure to comply with such laws and regulations.

we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting

from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

addition, we may incur substantial costs in order to comply with current or future environmental, health, and safety laws and regulations.

These current or future laws and regulations may impair our research, development or production efforts.

Our failure to comply with these

laws and regulations also may result in substantial fines, penalties or other sanctions.

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

those of third-party providers.

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.

Related to our Product Development and Regulatory Approval

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

to both our MYMD-1 and Supera-CBD product candidates, we must conduct all phases of clinical studies (which may include post-market or

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

for marketing approval to the FDA.

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

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

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

At the time, changes

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

Institutional

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

submitted to the IRB for an additional review.

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

other assessments planned over the course of the clinical trial.

– Clinical sites must follow specific COVID-19 guidelines.

Clinical trial activity must adhere to those guidelines which may

change over the course of the study.

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

to maximize patient and research staff safety.

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

Due to changing

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

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

Kits are created to execute

all aspects of screening through study completion.

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

(as applicable).

We are not permitted to market our tablet vaccines in the United States until we receive FDA approval of our applicable

To date, we have not-yet begun any pre-clinical studies for the COVID-19 Vaccine Candidate, nor have we prepared or submitted

Accordingly, we have not submitted a BLA to the FDA or comparable applications to other regulatory authorities and do

not expect to be in a position to do so for the foreseeable future, as there are numerous developmental steps that must be completed

before we can prepare and submit a BLA.

the United States, the FDA regulates pharmaceutical and biological products (including vaccines and vaccine candidates, such as

the COVID-19 Vaccine Candidate currently in early stages of development) under the FD&C Act and the PHSA, as well as their

respective implementing regulations.

Such products and product candidates are also subject to other federal, state, and local

statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,

state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

required by the FDA before a drug or biological product may be marketed in the United States generally involves the following:

of pre-clinical laboratory tests and animal studies in accordance with FDA’s GLPs and applicable requirements for the

humane use of laboratory animals or other applicable regulations;

to the FDA of an IND, which must become effective before human clinical trials in the United States may begin;

of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, GCPs, and any additional

requirements for the protection of human research subjects and their health information, to establish the safety and efficacy

of the proposed biological product for its intended use;

to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and

potency of the product that is the subject of the BLA based on results of pre-clinical testing and clinical trials;

completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess

compliance with current cGMPs and assure that the facilities, methods and controls are adequate to preserve the biological

product’s identity, strength, quality and purity;

FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

review and approval, or denial, of the BLA.

Notwithstanding

the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria

for approval and deny approval.

Data obtained from clinical trials is not always conclusive and the FDA may interpret data differently

than we interpret the same data.

The COVID-19 Vaccine Candidate is in the earliest stages of clinical development and, therefore,

a long way from BLA submission.

We cannot predict with any certainty if or when we might submit a BLA for regulatory approval

for the COVID-19 Vaccine Candidate or whether any such BLA will be approved by the FDA.

Human clinical trials are very expensive

and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

For example, the

FDA may not agree with our proposed endpoints for any clinical trial we propose, which may delay the commencement of our clinical

The clinical trial process is also lengthy and requires substantial time and effort.

We estimate that the clinical trials

we need to conduct to be in a position to submit a BLA for the COVID-19 Vaccine Candidate will take several years to complete.

Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat

clinical trials.

Also, the results of early pre-clinical and clinical testing of the COVID-19 Vaccine Candidate may not be predictive

of the results of subsequent clinical trials.

A number of companies in the biopharmaceutical industry have suffered significant

setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in

earlier studies.

Moreover, pre-clinical and clinical data are often susceptible to multiple interpretations and analyses.

companies that have believed their vaccine candidates performed satisfactorily in pre-clinical studies and clinical trials have,

nonetheless, failed to obtain marketing approval of their products.

Success in pre-clinical testing and early clinical trials

does not ensure that later clinical trials, which involve many more subjects, will be successful, and the results of later clinical

trials may not replicate the results of prior clinical trials and pre-clinical testing.

Any failure or substantial delay in our

vaccine development plans may have a material adverse effect on our business.

may opt to conduct future clinical studies for the COVID-19 Vaccine Candidate outside the United States, which could heighten

the risk of delay and/or failure, as the FDA may not accept data from such studies in support of any BLA we may submit after completing

the applicable developmental and regulatory prerequisites, if ever.

are still in the earliest stages of development with respect to the COVID-19 Vaccine Candidate and may ultimately decide to conduct

pre-clinical and/or clinical studies in one or more countries outside the United States.

Although the FDA may accept data from

clinical trials conducted outside the United States that are not conducted under an IND, the FDA’s acceptance of such data

is subject to certain conditions.

For example, the clinical trial must be well designed and conducted and performed by qualified

investigators in accordance with ethical principles and all applicable FDA regulations.

The trial population must also adequately

represent the intended United States population, and the data must be applicable to the United States population and United States

medical practice in ways that the FDA deems clinically meaningful.

In general, the patient population for any clinical trials

conducted outside of the United States must be representative of the population for whom we intend to market the COVID-19 Vaccine

Candidate in the United States, if approved.

In addition, while these clinical trials are subject to the applicable local laws,

FDA acceptance of the data will be dependent upon its ability to verify the data and its determination that the trials also complied

with all applicable United States laws and regulations.

We cannot guarantee that the FDA will accept data from trials we conduct

outside of the United States, if any.

If the FDA does not accept the data from such clinical trials, it would likely result in

the need for additional trials and the completion of additional regulatory steps, which would be costly and time-consuming and

could delay or permanently halt our development of the COVID-19 Vaccine Candidate.

we are successful in producing the COVID-19 Vaccine Candidate, we may need to devote significant resources to our scale-up and

development including for use by the United States government.

the event that the pre-clinical and clinical trials for the COVID-19 Vaccine Candidate are perceived to be successful, we may

need to work toward the large scale technical development, manufacturing scale-up and larger scale deployment of this potential

vaccine through a variety of United States government mechanisms such as an Expanded Access Program or an Emergency Use Authorization

In this case, we may need to divert significant resources to this program, which would require diversion of resources

from our other businesses.

In addition, since the path to licensure of any vaccine against COVID-19 is unclear, if use of the

vaccine is mandated by the United States government, we may have a widely used vaccine in circulation in the United States or

another country prior to our full validation of the overall long term safety and efficacy profile of its vaccine platform and

Unexpected safety issues in these circumstances could lead to significant reputational damage for the Company going

forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for

significant additional financial resources.

may be unable to advance the COVID-19 Vaccine Candidate successfully through the pre-clinical and clinical development process.

ability to develop, obtain regulatory approval for, and ultimately commercialize, the COVID-19 Vaccine Candidate effectively will

depend on many factors, including the following:

completion of pre-clinical studies and clinical trials;

achievement of the objectives of planned pre-clinical studies and clinical trials;

of marketing approvals from the FDA and similar regulatory authorities outside the United States;

efficient and effective commercial manufacturing, supply and distribution arrangements;

sufficient market share and promoting acceptance of the product by patients, the medical community and third-party payors;

executing an effective pricing and reimbursement strategy;

a continued acceptable safety and adverse event profile following regulatory approval;

for, identifying, registering, maintaining, enforcing and defending intellectual property rights and claims.

COVID-19 Vaccine Candidate will require additional non-clinical and clinical development, regulatory review and approval, substantial

investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can be in a position

to generate any revenue from product sales.

We are not permitted to market or promote any vaccine before it receives regulatory

approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval.

unable to develop or receive marketing approval in a timely manner or at all, we could experience significant delays or an inability

to commercialize the COVID-19 Vaccine Candidate, which would materially and adversely affect our business, financial condition

and results of operations.

involvement may limit the commercial success of our COVID-19 Vaccine Candidate.

COVID-19 pandemic has been classified as a pandemic by public health authorities, and it is possible that one or more government

entities may take actions that directly or indirectly have the effect of abrogating some of our rights or opportunities.

government entities, including the United States government, are offering incentives, grants, and contracts to encourage additional

investment by commercial organizations into preventative and therapeutic agents against COVID-19, which may have the effect of

increasing the number of competitors and/or providing advantages to known competitors.

Accordingly, there can be no assurance

that we will be able to successfully establish a competitive market share, if any, for our COVID-19 Vaccine Candidate even if

we succeed in developing one.

we fail to obtain regulatory approval in foreign jurisdictions, then we cannot market our products, including the COVID-19 Vaccine

Candidate, in those jurisdictions.

foreign countries in which we market or may market our products have regulatory bodies and restrictions similar to those of the

International sales are subject to foreign government regulation, the requirements of which vary substantially from country

The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval

and the requirements may differ.

We may be required to conduct additional testing or to provide additional information, resulting

in additional expenses, to obtain necessary approvals.

If we fail to obtain approval in such foreign jurisdictions, we would not

be able to market our products, including the COVID-19 Vaccine Candidate, in such jurisdictions, thereby reducing the potential

revenue from the sale of our products.

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

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

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

over the course of the clinical trial.

This includes every assessment and data element collected.

The complexity of the Phase II

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

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

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

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

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

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

be unable to complete, the development and commercialization of our product candidates.

FDA must approve any new drug products before they can be marketed in the United States, and such approval is contingent upon the collection

of sufficient safety- and efficacy-data from preclinical and clinical studies.

We must complete preclinical development and conduct extensive

clinical trials to demonstrate the safety and efficacy of our product candidates for their respective targeted indications.

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

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

Clinical trials are expensive, difficult to design and implement,

and can take many years to complete, and their outcomes are inherently uncertain.

Failure can occur at any time during the clinical trial

Nonclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies have believed

their product candidates performed satisfactorily in nonclinical studies and clinical trials and, nonetheless, were denied marketing

approval for such candidates due to insufficient safety or efficacy data and/or other clinical-study deficiencies.

It is impossible to

predict whether we will be able to prove that either or both of our product candidates are safe and effective for any of the indications

for which they are, respectively, being developed and, accordingly, when they will be approved for commercialization in the United States

for any given indication, if ever.

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

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

We have completed such early-stage preclinical testing and IND-submission for some, but not all, indications for which MyMD-1

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

Even if the results of our

clinical trials are favorable, we expect our product candidates to remain in clinical development for several years before they may be

considered for regulatory approval, and clinical development of either or both candidates for one or more targeted indications may take

significantly longer to complete and may never be successful.

Failures in connection with one or more clinical trials can occur at any

stage of testing.

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

in reaching a consensus with regulatory authorities on trial design;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

regarding proper dosing;

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

results from ongoing pre-clinical studies and clinical trials;

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

or acceptable manner;

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

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

conflicts with participating clinicians and clinical institutions;

to design appropriate clinical trial protocols;

concerns and additional difficulties associated with cannabinoid products, generally;

data to support regulatory approval;

or unwillingness of medical investigators to follow its clinical protocols;

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

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

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

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

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

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

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.

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.

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

completion of pre-clinical studies, including those compliant with Good Laboratory Practices (“GLP”) or GLP toxicology

studies, biodistribution studies and minimum effective dose studies in animals, and successful enrollment and completion of clinical

trials compliant with current Good Clinical Practices (“GCPs”);

INDs and Clinical Trial Authorizations (“CTAs”) that allow commencement of our planned clinical trials or future clinical

trials for our product candidates in relevant territories;

from IRBs or Ethics committees to conduct human clinical trials;

and maintaining relationships with contract research organizations (“CROs”), and clinical sites for the clinical development

of our product candidates;

clearance of products arriving from foreign countries, needed to perform clinical trials, through U.S.

of arrangements with third-party contract manufacturing organizations (“CMOs”) for key materials used in our manufacturing

processes and to establish backup sources for clinical and large-scale commercial supply;

results from our clinical programs that are supportive of safety and efficacy and provide an acceptable risk-benefit profile for

our product candidates in the intended patient populations;

of regulatory approvals from applicable regulatory authorities, including those necessary for pricing and reimbursement of our product

establishment

and maintenance of patent and trade secret protection and regulatory exclusivity for our product candidates;

launch of our product candidates, if and when approved, whether alone or in collaboration with others;

of our product candidates, if and when approved, by patients, patient advocacy groups, third-party payors and the general medical

effective competition against other therapies available in the market;

establishment

and maintenance of adequate reimbursement from third-party payors for our product candidates;

ability to acquire or in-license additional product candidates;

maintenance, enforcement and defense of intellectual property rights and claims;

of a continued acceptable safety profile of our product candidates following approval, including meeting any post-marketing commitments

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

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

of the novel strain of coronavirus, COVID-19.

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

to successfully commercialize our product candidates, which would materially harm our business.

If we do not receive regulatory approvals

for our product candidates, we may not be able to continue our operations.

may not have the resources to conduct clinical protocols sufficient to yield data suitable for publication in peer-reviewed journals

and our inability to do so in the future could have an adverse effect on marketing our products effectively.

order for our products targeted for use by hospital laboratory professionals and healthcare providers to be widely adopted, we would

have to conduct clinical protocols that are designed to yield data suitable for publication in peer-reviewed journals.

These studies

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

We have not previously had the resources to effectively implement

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

In addition, if a protocol

is initiated, the results of such protocol may ultimately not support the anticipated positioning and benefit proposition for the product.

Either of these scenarios could hinder our ability to market our products, and revenue may decline.

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

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

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

Failure can occur at any time

during the clinical trial process.

Success in pre-clinical studies and early clinical trials may not be predictive of results in later-stage

clinical trials, and successful results from early or small clinical trials may not be replicated or show as favorable an outcome in

later-stage or larger clinical trials, even if successful.

We will be required to demonstrate through adequate and well-controlled clinical

trials that our product candidates are safe and effective for their intended uses before we can seek regulatory approvals for their commercial

The conduct of Phase 2 and Phase 3 trials, and the submission of a New Drug Application (“NDA”) is a complicated process.

We have not previously conducted any clinical trials, and have limited experience in preparing, submitting and supporting regulatory

Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials and other requirements

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.

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.

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

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

may be unable to demonstrate, to the satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates

are safe and effective for any of their proposed indications;

populations studied in clinical trials may not be sufficiently broad or representative to assure efficacy and safety in the populations

for which we seek approval;

results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory

authorities for approval;

may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;

data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other

comparable submission in foreign jurisdictions or to obtain regulatory approval in the U.S.

or elsewhere;

facilities of third-party manufacturers with which we contract or procure certain service or raw materials, may not be adequate to

support approval of our product candidates;

approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering

our clinical data insufficient for approval.

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

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

not be able to obtain regulatory approval.

Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends

non-approval or restrictions on approval.

In addition, we may experience delays or rejections based upon additional government regulation

from future legislation or administrative action, or changes in regulatory authority policy during the period of product development,

clinical trials and the review process.

authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations

in the form of narrow indications, warnings, contraindications or Risk Evaluation and Mitigation Strategies (“REMS”).

regulatory authorities may also grant approval subject to the performance of costly post-marketing clinical trials.

In addition, regulatory

authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates and adversely affect our business,

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

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

consumables, and to perform quality testing.

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

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

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

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

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

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

product candidates and the activities associated with their development and potential commercialization, including their testing, manufacturing,

recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by

the FDA and other U.S.

and international regulatory authorities.

These requirements include submissions of safety and other post-marketing

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

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

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

and recordkeeping.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced

inspections by the FDA and other regulatory authorities for compliance with cGMPs.

FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy

of any approved product.

addition, later discovery of previously unknown adverse events or other problems with our product candidates, manufacturers or manufacturing

processes, or failure to comply with regulatory requirements, may yield various results, including:

on such product candidates, manufacturers or manufacturing processes;

on the labeling or marketing of a product;

on product distribution or use;

to conduct post-marketing studies or clinical trials;

or untitled letters;

of any approved product from the market;

to approve pending applications or supplements to approved applications that we submit;

of product candidates;

restitution or disgorgement of profits or revenues;

or withdrawal of marketing approvals;

to permit the import or export of our product candidates;

or the imposition of civil or criminal penalties.

FDA also closely regulates the post-approval marketing and promotion of drugs to ensure that they are marketed in a manner consistent

with the provisions of the approved labeling.

The FDA imposes stringent restrictions on manufacturers’ communications regarding

use of their products.

For example, under applicable FDA marketing regulations, prescription drug promotions must be consistent with

and not contrary to approved labeling, present a “fair balance” between the product’s risks and benefits, be truthful

and not false or misleading, and be sufficiently substantiated with appropriate documentary evidence, among numerous other requirements.

If we promote our products that are approved for marketing in the United States, if any, in a manner inconsistent with FDA-approved labeling

or otherwise not in compliance with FDA regulations, we may be subject to enforcement action.

Violations of the Federal Food, Drug, and

Cosmetic Act (“FD&C Act”) relating to the promotion of prescription drugs may lead to investigation or prosecution by

the DOJ or other applicable agencies and could give rise to ancillary violations of federal and state healthcare fraud and abuse laws,

as well as state consumer protection laws and similar laws in international jurisdictions.

Additionally, our marketing activities relating

to any products we may commercialize in the United States in the future may also be subject to enforcement by the FTC and/or state attorneys

general, and we may face consumer class-action liability if our marketing practices are actually or allegedly misleading or deceptive.

addition to the requirements applicable to approved drug products, we may also be subject to enforcement action in connection with any

promotion of an investigational new drug.

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, may

not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation

or otherwise promote the therapeutic candidate.

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.

The FDA’s and

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

or delay regulatory approval of our product candidates.

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

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

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

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

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

and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional

The time and data required to obtain approval may differ substantially from that required to obtain FDA approval.

The regulatory

approval process outside the U.S.

generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries

outside the U.S., we must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that

Failure to obtain foreign regulatory approvals or non-compliance with foreign regulatory requirements could result in significant

delays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries.

we fail to comply with the regulatory requirements in international markets and receive applicable marketing approvals, our target market

will be reduced and our ability to realize the full market potential of our product candidates will be harmed and our business will be

adversely affected.

We may not obtain foreign regulatory approvals on a timely basis, if at all.

Our failure to obtain approval of any

of our product candidates by regulatory authorities in another country may significantly diminish the commercial prospects of that product

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.

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

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

positively to products based on Supera-CBD.

Regulation of CBD .

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.

Regulation of CBD.

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

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

from cultivation to processing to marketing.

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

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

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

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

is Complex and Costly .

Complying with laws and regulations relating to cannabinoids is evolving, complex and expensive, and may divert

management’s attention and resources from other aspects of our business.

Failure to maintain compliance with such laws and regulations

may result in regulatory action that could have a material adverse effect on our business, results of operations and financial condition.

The DEA, FDA or state agencies may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those

registrations.

In certain circumstances, violations could lead to criminal proceedings.

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

each of our research sites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will

allow those sites to handle and dispense products based on Supera-CBD and to obtain product from our manufacturer.

If the DEA delays

or denies the grant of a research registration to one or more research sites, the clinical trial could be significantly delayed, and

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.

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

cannabinoids, whether naturally derived or synthetic.

Consumer perception of cannabinoid products can be significantly influenced by

scientific research or findings, regulatory investigations, litigation, media attention, and other publicity regarding the consumption

of CBD products.

There can be no assurance that future scientific research, findings, regulatory proceedings, litigation, media attention,

or other research findings or publicity will be favorable to the CBD market or Supera-CBD, in particular.

Our dependence upon consumer

perceptions with regard to Supera-CBD, particularly once it is approved for commercialization, if ever, means that adverse scientific

research reports, findings, regulatory proceedings, litigation, media attention, or other publicity relating to cannabinoid products,

generally, or any particular cannabinoid products or derivatives, in particular, regardless of merit or accuracy, could have a material

adverse effect on our business, the development of, or ultimate commercial demand for (if applicable), Supera-CBD.

Such adverse publicity

or other negative media attention could arise even if the adverse effects reportedly associated with such products resulted from consumers’

failure to consume such products appropriately or as directed.

Any adverse publicity or other similar occurrences affecting consumer

perception may have a material adverse impact on our reputation, perception of Supera-CBD, and our ability to obtain the necessary regulatory

approvals for Supera-CBD and its prospective commercial viability.

Related to Commercialization and Manufacturing

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

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

with the requisite approvals from the FDA and other regulatory authorities internationally, the commercial success of our product candidates

will depend, in part, on the acceptance of providers, patients and third-party payors of our product candidates, as medically necessary,

cost-effective and safe.

Any product that we commercialize may not gain acceptance by providers, patients, patient advocacy groups, third-party

payors and the general medical community.

If these products do not achieve an adequate level of acceptance, we may not generate significant

product revenue and may not become profitable.

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

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

efficacy, durability and safety of such product candidates as demonstrated in clinical trials;

potential and perceived advantages of product candidates over alternative treatments;

cost of treatment relative to alternative treatments;

clinical indications for which the product candidate is approved by the FDA or the European Commission;

willingness of providers to prescribe new therapies;

willingness of the target patient population to try new therapies;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities, including any limitations or warnings contained

in a product’s approved labeling;

strength of marketing and distribution support;

timing of market introduction of competitive products;

quality of our relationships with patient advocacy groups;

concerning our product candidates or competing products and treatments;

third-party payor coverage and adequate reimbursement.

if a potential product displays a favorable efficacy and safety profile in pre-clinical studies and clinical trials, market acceptance

of the product will not be fully known until after it is launched.

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

Failure to obtain or maintain adequate

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

ability to generate product revenue.

we are unable to establish or sustain coverage and adequate reimbursement for our product candidates from third-party payors, the adoption

of those product candidates and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market

or sell those product candidates, if approved.

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

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

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

healthcare management organizations, or will be reimbursed by government authorities, private health coverage insurers and other third-party

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing

sufficient to realize a sufficient return on our investment.

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

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

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

to which new drugs will be covered and reimbursed.

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

from end-stage renal disease.

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

limited financial means.

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

payors develop their coverage and reimbursement policies for drugs.

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

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

Further, a payor’s decision to provide

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

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

influence decisions about coverage and reimbursement for new products by determining standards for care.

In addition, many private payors

contract with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and therefore reimbursement

for, certain products deemed to provide limited benefit to existing alternatives.

Such organizations may set guidelines that limit reimbursement

or utilization of our product candidates.

Even if favorable coverage and reimbursement status is attained for one or more product candidates

for which our collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented

in the future.

the U.S., international operations are generally subject to extensive governmental price controls and other market regulations, and we

believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to put pressure

on the pricing and usage of therapeutics such as our product candidates.

In many countries, particularly the countries of the European

Union, the prices of medical products are subject to varying price control mechanisms as part of national health systems.

In these countries,

pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness

of our product candidate to other available therapies.

In general, the prices of products under such systems are substantially lower

than in the U.S.

Other countries allow companies to fix their own prices for products but monitor and control company profits.

foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates.

Accordingly, in markets outside the U.S., the reimbursement for our product candidates may be reduced compared with the U.S.

be insufficient to generate commercially reasonable revenues and profits.

increasing efforts by governmental and third-party payors, in the U.S.

and internationally, to cap or reduce healthcare costs may cause

such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or

provide adequate payment for our product candidates.

We expect to experience pricing pressures in connection with the sale of any of

our product candidates due to the trend toward managed healthcare, the increasing influence of certain third-party payors, such as health

maintenance organizations, and additional legislative changes.

The downward pressure on healthcare costs in general, particularly prescription

drugs and surgical procedures and other treatments, has become very intense.

As a result, increasingly high barriers are being erected

to the entry of new products into the healthcare market.

Recently there have been instances in which third-party payors have refused

to reimburse treatments for patients for whom the treatment is indicated in the FDA-approved product labeling.

Even if we are successful

in obtaining FDA approvals to commercialize our product candidates, we cannot guarantee that we will be able to secure reimbursement

for all patients for whom treatment with our product candidates is indicated.

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

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

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

rely on third party CROs, CMOs, consultants and others to design, conduct, supervise and monitor key activities relating to, discovery,

manufacturing, pre-clinical studies and clinical trials of our product candidates, and we intend to do the same for future activities

relating to existing and future programs.

Because we rely on third parties and do not have the ability to conduct all required testing,

discovery, manufacturing, preclinical studies or clinical trials independently, we have less control over the timing, quality and other

aspects of discovery, manufacturing, pre-clinical studies and clinical trials than we would if we conducted them on our own.

These investigators,

CROs, CMOs and consultants are not our employees, and we have limited control over the amount of time and resources that they dedicate

to our programs.

These third parties may have contractual relationships with other entities, some of which may be our competitors, which

may draw time and resources from our programs.

The third parties we contract with might not be diligent or timely in conducting our discovery,

manufacturing, pre-clinical studies or clinical trials, resulting in discovery, manufacturing, pre-clinical studies or clinical trials

being delayed or unsuccessful, in whole or in part.

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.

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

The FDA and other regulatory

authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of these

third parties fails to comply with applicable GCPs, the clinical data generated in its clinical trials may be deemed unreliable and the

FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving its marketing

applications.

We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any

of our clinical trials have complied with GCPs.

In addition, our clinical trials must be conducted with product produced in accordance

Our failure to comply with these regulations may require us to repeat clinical trials, which could delay or prevent the receipt

of regulatory approvals.

Any such event could have an adverse effect on our business, financial condition, results of operations and

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

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

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

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

intellectual property.

We are aware of several companies focused on developing immunometabolic treatments in various indications as well

as several companies addressing other treatments for anti-aging, anxiety and depression.

We may also face competition from large and

specialty pharmaceutical and biotechnology companies, academic research institutions, government agencies and public and private research

institutions that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing

and commercialization.

companies are focused on developing treatments for immunometabolic dysregulation in treatment of autoimmune disorders.

of our potential competitors, alone or with their strategic partners, may have substantially greater financial, technical and other resources

than we do, such as larger research and development, clinical, marketing and manufacturing organizations.

Mergers and acquisitions in

the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors.

Our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop.

also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our products, which

could result in our competitors establishing a strong market position before we are able to enter the market, if ever.

Additionally,

new or advanced technologies developed by our competitors may render our current or future product candidates uneconomical or obsolete,

and we may not be successful in marketing our product candidates against competitors.

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

If any of our third-party

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

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

could be delayed or stopped.

intend to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, the drug substance and

finished product of any product candidate for which we are responsible for pre-clinical or clinical development.

Each supplier may require

licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

As part of any marketing

approval, a manufacturer and its processes are required to be qualified by the FDA prior to regulatory approval.

If supply from the approved

vendor is interrupted, there could be a significant disruption in commercial supply.

An alternative vendor would need to be qualified

through an NDA supplement which could result in further delay.

The FDA or other regulatory agencies outside of the U.S.

may also require

additional studies if a new supplier is relied upon for commercial production.

Switching vendors may involve substantial costs and is

likely to result in a delay in our desired clinical and commercial timelines.

process of manufacturing drugs is complex, highly regulated and subject to multiple risks.

Manufacturing drugs is highly susceptible

to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency

in yields, variability in product characteristics and difficulties in scaling the production process.

Even minor deviations from normal

manufacturing processes could result in reduced production yields, product defects and other supply disruptions.

If microbial, viral

or other contaminations are discovered at the facilities of our manufacturers, such facilities may need to be closed for an extended

period of time to investigate and remedy the contamination, which could delay clinical trials and adversely harm our business.

if the FDA determines that our CMOs are not in compliance with FDA laws and regulations, including those governing cGMPs, the FDA may

deny NDA approval until the deficiencies are corrected or we replace the manufacturer in our NDA with a manufacturer that is in compliance.

In addition, approved products and the facilities at which they are manufactured are required to maintain ongoing compliance with extensive

FDA requirements and the requirements of other similar agencies, including ensuring that quality control and manufacturing procedures

conform to cGMP requirements.

As such, our CMOs are subject to continual review and periodic inspections to assess compliance with cGMPs.

Furthermore, although we do not have day-to-day control over the operations of our CMOs, we are responsible for ensuring compliance with

applicable laws and regulations, including cGMPs.

addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,

cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing

practices, lot consistency and timely availability of raw materials.

Even if our collaborators obtain regulatory approval for any of

our product candidates, there is no assurance that manufacturers will be able to manufacture the approved product to specifications acceptable

to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch

of the product or to meet potential future demand.

If our manufacturers are unable to produce sufficient quantities for clinical trials

or for commercialization, commercialization efforts would be impaired, which would have an adverse effect on our business, financial

condition, results of operations and prospects.

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.

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.

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

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.

On July 26, 2012, the U.S.

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.

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

reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation.

to time, legislation is drafted, introduced and passed in the U.S.

Congress that could significantly change the statutory provisions

governing coverage, reimbursement, and marketing of pharmaceutical products.

In addition, third-party payor coverage and reimbursement

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.

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.

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,

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.

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

finds that we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially affect

our business operations.

If the FDA finds that

we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially affect our business operations.

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

finds that we have failed to comply, 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;

2 unchanged sentences

restrictions, partial suspension or total shutdown of production;

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

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

a 510(k) clearance already granted;

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

condition and results of operations.

if we are able to commercialize our prospective or future product candidates, the products may not receive coverage or adequate

reimbursement from third-party payors in the United States or in other countries in which we seek to commercialize such products,

which could harm our business.

ability to commercialize any product successfully will depend, in part, on the extent to which coverage and adequate reimbursement

for such products will be available from government health administration authorities, private health insurers, and other organizations.

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, determine

which medications they will cover and establish reimbursement levels.

A primary trend in the healthcare industry is cost containment.

authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from

list prices and are challenging the prices charged for medical products.

Third-party payors may also seek additional clinical

evidence, beyond the data required to obtain regulatory approval, demonstrating clinical benefits and value in specific patient

populations before covering our products for those patients.

We cannot be sure that coverage and adequate reimbursement will be

available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain regulatory approval.

reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any product

candidate for which we obtain regulatory approval.

may not have the resources to conduct clinical protocols sufficient to yield data suitable for publication in peer-reviewed journals

and our inability to do so in the future could have an adverse effect on marketing our products effectively.

order for our products targeted for use by hospital laboratory professionals and healthcare providers to be widely adopted, we

would have to conduct clinical protocols that are designed to yield data suitable for publication in peer-reviewed journals.

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

We have not previously had the resources to effectively

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

if a protocol is initiated, the results of such protocol may ultimately not support the anticipated positioning and benefit proposition

for the product.

Either of these scenarios could hinder our ability to market our products, and revenue may decline.

may experience delays in any phase of the pre-clinical or clinical development of a product, including during its research and

completion of any of these studies may be delayed or halted for numerous reasons, including, but not limited to, the following:

FDA or other regulatory authorities do not approve a clinical study protocol or place a clinical study on hold;

do not enroll in a clinical study or results from patients are not received at the expected rate;

discontinue participation in a clinical study prior to the scheduled endpoint at a higher than expected rate;

experience adverse events from a product we develop;

clinical investigators do not perform the studies in accordance with the anticipated schedule or consistent with the study

protocol and GCPs or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;

clinical investigators engage in activities that, even if not directly associated with our studies, result in their debarment,

loss of licensure, or other legal or regulatory sanctions;

inspections of manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend

the pre-clinical or clinical studies;

in governmental regulations or administrative actions;

interim results of the pre-clinical or clinical study, if any, are inconclusive or negative;

study design, although approved and completed, is inadequate to demonstrate effectiveness and safety.

the pre-clinical and clinical studies that we are required to conduct to gain regulatory approval are delayed or unsuccessful,

we may not be able to market any product that we develop in the future.

Pre-clinical studies and clinical trials are expensive

and difficult to design and implement and any delays or prolongment in our pre-clinical and clinical studies will require additional

There is no assurance that we will be able to acquire additional capital to support our studies.

The failure to obtain

additional capital would have a material adverse effect on our business, results of operations and financial condition.

anticipate that we will rely completely on third parties to manufacture certain pre-clinical and all clinical drug supplies.

business could be harmed if those third parties fail to provide us with sufficient quantities of drug product or fail to

do so at acceptable quality levels or prices.

do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture our pre-clinical

and clinical drug supplies for use in the conduct of our clinical studies, and we lack the resources and the capability to manufacture

any of our product candidates on a clinical or commercial scale.

In order to develop products, apply for regulatory approvals

and commercialize our products, we will need to develop, contract for, or otherwise arrange for access to the necessary manufacturing

capabilities.

We anticipate that we will rely on CMOs, or contract manufacturing organizations, and other third party contractors,

some of whom may have limited cGMP experience, to manufacture formulations and produce larger scale amounts of drug substance

and the drug product required for any clinical trials that we initiate.

manufacturing process for any vaccine candidate is subject to the FDA and foreign regulatory authority approval process, and we

will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an ongoing

In addition, if we receive the necessary regulatory approval for any product candidate, we also expect to rely on third

parties to produce materials required for commercial supply.

We may experience difficulty in obtaining adequate manufacturing

capacity for our needs.

Furthermore, it is our responsibility to ensure that all of our third-party contractors meet cGMP laws,

regulations and guidance.

Due to their failure to comply with applicable regulatory requirements, we may face fines and civil

penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product

These actions could have a material impact on the availability of products.

If we are unable to obtain or maintain contract

manufacturing for these product candidates, or to do so on commercially reasonable terms, we may not be able to successfully develop

and commercialize our products.

the extent that we enter into manufacturing arrangements with third parties, we will depend on these third parties to perform

their obligations in a timely manner and consistent with regulatory requirements, including those related to quality control and

quality assurance.

The failure of a third-party manufacturer to perform its obligations as expected could adversely affect our

business in a number of ways, including:

may not be able to initiate or continue pre-clinical and clinical trials of products that are under development;

may need to repeat pivotal clinical trials;

may be delayed in submitting regulatory applications, or receiving regulatory approvals, for our product candidates;

may lose the cooperation of its collaborators;

products could be the subject of inspections by regulatory authorities;

may be required to cease distribution or recall some or all batches of our products;

we may not be able to meet commercial demands for our products.

a third-party manufacturer with whom we contract fails to perform its obligations, we may be forced to seek out one or more other

third-party manufacturers to manufacture our pre-clinical and/or clinical trial materials, which could cause delays in the FDA

approval process.

Further, should the COVID-19 Vaccine Candidate be approved for marketing by the FDA, a change in a third-party

manufacturer could cause significant delays to meeting the demand of patients.

In some cases, the technical skills required to

manufacture our product may be unique to the original manufacturer and we may have difficulty transferring such skills to a back-up

or alternate manufacturer, or we may be unable to transfer such skills at all.

In addition, if we are required to change manufacturers

for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality

standards and with all applicable regulations and guidelines.

We will also be required to demonstrate that the newly manufactured

material is the same or similar to the previously manufactured material, or we may need to repeat clinical trials with the newly

manufactured material.

The delays associated with the verification of a new manufacturer could negatively affect our ability to

develop product candidates in a timely manner or within budget.

Furthermore, a manufacturer may possess technology related to

the manufacture of our product candidate that such manufacturer owns independently, which would increase our reliance on such

manufacturer or require us to obtain a license from such manufacturer in order to have another third party manufacture our products.

intend to rely on third parties to conduct our pre-clinical studies and clinical trials and perform other tasks for us.

third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements,

we may not be able to obtain regulatory approval for or commercialize our product candidates and our business, financial condition

and results of operations could be substantially harmed.

plan to rely upon third-party contract research organizations, or CROs, medical institutions, clinical investigators and contract

laboratories to monitor and manage data for our licensed ongoing pre-clinical and clinical programs.

We expect to continue to

rely on these parties for execution of our pre-clinical studies and clinical trials, and we control only certain aspects of their

Nevertheless, we maintain responsibility for ensuring that each of our clinical trials and pre-clinical studies is

conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on these third

parties does not relieve us of our regulatory responsibilities.

We and our CROs and other vendors are required to comply with

cGMP, current GCP, and current GLPs, which are a collection of laws and regulations enforced by the FDA or comparable foreign

authorities for all of our product candidates in clinical development.

Regulatory authorities enforce these regulations through

periodic inspections of manufacturing facilities, pre-clinical study and clinical trial sponsors, principal investigators, preclinical

study and clinical trial sites, and other contractors.

If we or any of our CROs or vendors fails to comply with applicable regulations,

the data generated in our pre-clinical studies and clinical trials may be deemed unreliable and the FDA or comparable foreign

authorities may require us to perform additional pre-clinical studies and clinical trials before approving our marketing applications.

We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our

clinical trials comply with GCP regulations.

In addition, our clinical trials must be conducted with products manufactured consistently

with cGMP regulations.

Failure by us or our third party CROs to comply with these regulations may require us to repeat clinical

trials, which would delay the development and regulatory approval processes.

any of our relationships with these third-party CROs, medical institutions, clinical investigators or contract laboratories terminate,

we may not be able to enter into arrangements with alternative CROs on commercially reasonable terms, or at all.

our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control

whether or not they devote sufficient time and resources to our ongoing pre-clinical and clinical programs.

If CROs do not successfully

carry out their contractual duties, or comply with current GCP laws, regulations and guidance, or obligations or meet expected

deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure

to adhere to our protocols, regulatory requirements, or for other reasons, our clinical trials may be extended, delayed or terminated

and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.

CROs may also generate

higher costs than anticipated.

As a result, our business, financial condition and results of operations and the commercial prospects

for our product candidates could be materially and adversely affected, our costs could increase, and our ability to generate revenue

could be delayed.

or adding additional CROs, medical institutions, clinical investigators or contract laboratories involves additional cost and

requires management time and focus.

In addition, there is a natural transition period when a new CRO commences work replacing

a previous CRO.

As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

We are opportunistically reviewing

strategic transactions and there can be no assurance that any such strategic transaction we pursue will result in additional

value for our stockholders.

As a result, the makeup of our lines of business may change.

are assessing alternate ways to generate value for shareholders, including reviewing opportunities that may lead to acquisitions,

dispositions, business combinations or other strategic transactions.

Strategies we may employ include seeking new or expanding

existing specialty market niches, expanding our presence, acquiring businesses complementary to existing strengths and continually

evaluating the performance and strategic fit of our existing business units.

As a result, the makeup of our lines of business

is subject to change.

For example, as previously disclosed, in light of the unfavorable factors persistent in our rapid, point-of-care

screening and testing product business and the progress we have made in its partnership with Premas, we conducted a strategic

review of the screening and testing products business.

Following such review, in early July 2020, we ceased the production and

sale of our rapid, point-of-care screening and testing products.

In connection with the discontinuation of its existing product

line, we decided to close the facility located in Thorofare, New Jersey (the “Thorofare Facility”), which previously

housed our manufacturing, operations and support personnel, and terminated the lease (the “Thorofare Lease”) on

November 30, 2020.

Furthermore, on November 11, 2020, we entered into the Merger Agreement with MYMD.

For risks related to

the Merger, please see risks set forth under the heading “—

Risks Related to the Proposed Merger”

there can be no assurance that our pursuit of such strategic alternatives will result in any transaction or other alternatives.

the extent we engage in other strategic transactions, the process may be time consuming and disruptive to our business operations

and, our business, financial condition and results of operations could be adversely affected.

We could incur substantial expenses

associated with evaluating and negotiating potential strategic alternatives.

Furthermore, our ability to effectively integrate

any future acquisitions or mergers will depend on, among other things, our ability to integrate businesses, the adequacy of our

implementation plans, the ability of our management to oversee and operate effectively the combined operations and our ability

to achieve desired operational efficiencies.

If we are unable to successfully integrate the operations of any businesses that

we may acquire in the future, our business, financial position, results of operations or cash flows could be adversely affected.

There can be no assurance that any potential transaction, if consummated, will provide greater value to our stockholders than

that reflected in the current price of our common stock.

we are unable to make acquisitions and investments, or successfully integrate them into our business, our business could be harmed.

part of our business strategy, we may acquire other companies or businesses.

However, we may not be able to find suitable acquisition

candidates, and we may not be able to complete acquisitions on favorable terms, if at all.

Acquisitions involve numerous risks,

any of which could harm our business and negatively affect our operating results, including:

in integrating the technologies, operations, existing contracts and personnel of an acquired company;

in supporting and transitioning clients and suppliers, if any, of an acquired company;

of financial and management resources from existing operations or alternative acquisition opportunities;

to realize the anticipated benefits or synergies of a transaction;

to identify all of the problems, liabilities or other shortcomings or challenges of an acquired company or technology, including

issues related to intellectual property, regulatory compliance practices, revenue recognition or other accounting practices,

or employee or client issues;

of entering new markets in which we have limited or no experience;

loss of key employees, clients, vendors and suppliers from either our current business or an acquired company’s business;

to generate sufficient revenue to offset acquisition costs;

costs or equity dilution associated with funding the acquisition;

write-offs or impairment charges relating to acquired businesses.

use of our PIFA products could result in serious injuries, product liability claims, regulatory enforcement action, and/or recalls

or market withdrawals, any of which would likely subject us to substantial costs and reputational harm and have a material adverse

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

and results of operations.

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

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

ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding

levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of

user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

In addition, government funding

of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid

and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved

by necessary government agencies, which would adversely affect our business.

For example, over the last several years, including for

35 days beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the

FDA, have had to furlough critical employees and stop critical activities.

ability of the FDA and other government agencies to properly administer their functions is highly dependent on the levels of government

funding and the ability to fill key leadership appointments, among various factors.

Delays in filling or replacing key positions could

significantly impact the ability of the FDA and other agencies to fulfill their functions and could greatly impact healthcare and the

pharmaceutical industry.

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

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

Regulatory authorities outside the U.S.

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

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

facilities subject to a risk-based prioritization system.

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

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

regulatory activities.

Regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to

the COVID-19 pandemic.

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

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

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

effect on our business.

July 2020, we ceased the production and sale of its rapid, point-of-care screening and testing products.

We will continue to provide

support for these testing products that remain in the market through their respective product expiration dates.

We believe that

the users of our PIFA products are likely to be particularly sensitive to test defects and errors, as the conditions that the

PIFA products are designed to identify may cause limb- and life-threatening complications if not accurately diagnosed in a timely

As a result, the failure of our tests or services to perform as expected could subject us to legal claims arising from

any defects or errors.

use of our PIFA products and our other products could lead to product liability (and other similar) claims against us if someone

were to allege that one of our tests failed to perform as it was designed or as claimed in our promotional materials, was performed

pursuant to incorrect or inadequate laboratory procedures, if we delivered incorrect or incomplete test results, or if someone

were to misinterpret test results.

In addition, we may be subject to liability for errors in, a misunderstanding of, or inappropriate

reliance upon, the information we provide, or for failure to provide such information, in connection with the results generated

by our products.

A product liability or professional liability claim could result in substantial damages and be costly and time-consuming

for us to defend.

PIFA products are not 100% accurate and may generate erroneous results that could cause patient harm.

For example, PIFA could

provide a so-called “false negative”

result upon which a patient or physician may rely to make a conclusion about

how to proceed with the patient’s treatment.

If the false negative causes, or exacerbates, a patient injury or condition,

the patient (and/or the patient’s family) may file a lawsuit against us based on product liability.

product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates,

cause our insurance coverage to be terminated or prevent us from securing insurance coverage in the future.

under the FDA’s Medical Device Regulations, we are required to report to the FDA any incident in which its product may have

caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur,

would likely cause or contribute to death or serious injury.

Repeated product malfunctions may result in a voluntary or involuntary

product recall, which could divert managerial and financial resources and have an adverse effect on our reputation, financial

condition and operating results.

adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications,

or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.

Any corrective action,

whether voluntary or involuntary, will require the dedication of our time and capital, distract management from operating our

business and may harm our reputation and financial results.

we market products or interact with health care practitioners in a manner that violates healthcare fraud or abuse laws, we may

be subject to civil or criminal penalties, including exclusion from participation in government healthcare programs.

we receive payments directly from or bill directly to Medicare, Medicaid or other national or third-party payers for its products,

United States federal and state healthcare laws and regulations pertaining to fraud or abuse will be applicable to our business.

We are subject to healthcare fraud and abuse regulation by the United States federal government and the states in which we conduct

our business.

laws that may affect our ability to operate include the AKS, which prohibits, among other things, knowingly and willfully offering,

paying, soliciting, or receiving remuneration to induce, or in return for, the purchase, lease or order, or arrangement for the

purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare

This statute applies to arrangements between pharmaceutical manufacturers and prescribers, purchasers and formulary

Although there are a number of statutory exceptions and regulatory safe harbors protecting certain common activities,

the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases

or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the

federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid.

Pharmaceutical companies

have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as providing free product

to customers with the expectation that the customers would bill federal programs for the product, reporting to pricing services

inflated average wholesale prices that were then used by federal programs to set reimbursement rates, engaging in off-label promotion

that caused claims to be submitted to Medicaid for non-covered off-label uses and submitting inflated best price information to

the Medicaid Drug Rebate Program.

also created prohibitions against healthcare fraud and false statements relating to healthcare matters.

The healthcare fraud statute

prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payers.

false statements statute immediately noted above prohibits knowingly and willfully falsifying, concealing or covering up a material

fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare

benefits, items or services.

addition, there has been a trend of increased federal and state regulation of payments made to physicians.

The ACA, through the

PPSA, imposed new requirements on manufacturers of drugs, devices, biologics and medical supplies for which payment is available

under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the

Centers for Medicare and Medicaid Services (“CMS”) information related to payments or other “transfers of value”

made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals,

and applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held

by physicians (as defined above) and their immediate family members and payments or other “transfers of value”

such physician owners and their immediate family members.

Manufacturers are required to report such data to the government by

the 90th calendar day of each year.

majority of states also have statutes or regulations similar to these federal laws, which apply to items and services reimbursed

under Medicaid and other state programs, or, in several states, apply regardless of the payer.

In addition, some states have laws

that require pharmaceutical companies to adopt comprehensive compliance programs.

For example, under California law, pharmaceutical

companies must comply with both the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers

and the PhRMA Code on Interactions with Healthcare Professionals, as amended.

Moreover, certain states mandate the tracking and

reporting of gifts, compensation and other remuneration paid by us to physicians and other healthcare providers.

compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely

Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur

significant legal expenses, cause reputational harm and divert our management’s attention from the operation of our business.

Moreover, achieving and sustaining compliance with applicable U.S.

federal and state laws may prove costly.

internal computer systems, or those of its third-party vendors, collaborators, or other contractors may be subject to various

federal and state confidentiality and privacy laws in the United States and abroad and could sustain system failures, security

breaches, or other disruptions, any of which could have a material adverse effect on our business.

international, national, federal, provincial and state laws, including state privacy laws (such as the California Consumer Privacy

Act), state security breach notification and information security laws, and federal and state consumer protection laws govern

the collection, use, and disclosure of personal information.

In addition, most healthcare providers who may, in the future, prescribe

and dispense our products in the United States and research institutions in the United States with whom we may collaborate in

the future are “covered entities”

subject to privacy and security requirements under HIPAA.

Among other things, HITECH

makes HIPAA’s privacy and security standards directly applicable to business associates, independent contractors, or agents

of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a

covered entity.

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

directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or

injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’

fees and costs associated with pursuing

federal civil actions.

We could be subject to a wide range of penalties and sanctions under HIPAA, including criminal penalties

if we, our affiliates, or our agents knowingly obtain or disclose individually identifiable health information maintained by a

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

Failure to comply with applicable HIPAA requirements

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

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

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

to maintain and process company information including personal information, confidential business information and proprietary

If these information technology systems are subject to cybersecurity attacks, or are otherwise compromised, due to

cyberattacks, human error or malfeasance, system errors or otherwise, it may adversely impact our business, disrupt our operations,

or lead to the loss, theft, destruction, corruption, or compromise of our information or that of our collaborators, study subjects,

or other third-party contractors, as applicable.

Such information technology or security events could also lead to legal liability,

regulatory investigations or enforcement actions, loss of business, negative media coverage, and reputational damage.

seek to protect our information technology systems from these types of incidents, the healthcare sector continues to see a high

frequency of cyberattacks and increasingly sophisticated threat actors, and our systems and the information maintained within

those systems remain potentially vulnerable to data security incidents.

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

and government agencies, legal claims or proceedings, and liability under foreign, federal, provincial and state laws that protect

the privacy and security of personal information.

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

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

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

providers and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which

we obtain marketing approval.

Our future arrangements with providers, third-party payors and customers will subject us to broadly applicable

fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships

through which we market, sell and distribute any product candidates for which we obtain marketing approval.

under applicable U.S.

federal and state healthcare laws and regulations include the following:

federal Anti-Kickback Statute (“AKS”) prohibits, among other things, persons and entities from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either

the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made

under federal healthcare programs such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the

AKS or specific intent to violate it in order to have committed a violation;

false claims laws, including the federal False Claims Act, imposes criminal and civil penalties, including through civil whistleblower

or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government,

claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money

to the federal government.

In addition, the government may assert that a claim including items or services resulting from a violation

of the AKS constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

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

to defraud any healthcare benefit program or making false statements relating to healthcare matters.

Similar to the AKS, a person

or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

federal Physician Payment Sunshine Act of 2010 (“PPSA”) requires applicable manufacturers of covered drugs, devices,

biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance

Program, with specific exceptions, to report payments and other transfers of value provided during the previous year to physicians,

as defined by such law, certain other healthcare providers starting in 2022 (for payments made in 2021), and teaching hospitals,

as well as certain ownership and investment interests held by such physicians and their immediate family, which includes annual data

collection and reporting obligations;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements

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

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

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

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

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

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

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

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with current

or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations

are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant

civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of product candidates from government-funded healthcare

programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings,

and the curtailment or restructuring of our operations.

If any of the physicians or other healthcare providers or entities with whom

we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative

sanctions, including exclusions from government-funded healthcare programs.

internal computer systems, or those of its third-party vendors, collaborators, or other contractors may be subject to various federal

and state confidentiality and privacy laws in the United States and abroad and could sustain system failures, security breaches, or other

disruptions, any of which could have a material adverse effect on our business.

international, national, federal, provincial and state laws, including state privacy laws (such as the California Consumer Privacy Act),

state security breach notification and information security laws, and federal and state consumer protection laws govern the collection,

use, and disclosure of personal information.

In addition, most healthcare providers who may, in the future, prescribe and dispense our

products in the United States and research institutions in the United States with whom we may collaborate in the future are “covered

entities” subject to privacy and security requirements under HIPAA.

Among other things, HITECH makes HIPAA’s privacy and

security standards directly applicable to business associates, independent contractors, or agents of covered entities that receive or

obtain protected health information in connection with providing a service on behalf of a covered entity.

HITECH also created four new

tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and

gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal

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

We could be subject to a wide range

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

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

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

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

negatively affects our business.

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

and process company information including personal information, confidential business information and proprietary information.

information technology systems are subject to cybersecurity attacks, or are otherwise compromised, due to cyberattacks, human error or

malfeasance, system errors or otherwise, it may adversely impact our business, disrupt our operations, or lead to the loss, theft, destruction,

corruption, or compromise of our information or that of our collaborators, study subjects, or other third-party contractors, as applicable.

Such information technology or security events could also lead to legal liability, regulatory investigations or enforcement actions,

loss of business, negative media coverage, and reputational damage.

While we seek to protect our information technology systems from

these types of incidents, the healthcare sector continues to see a high frequency of cyberattacks and increasingly sophisticated threat

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

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

agencies, legal claims or proceedings, and liability under foreign, federal, provincial and state laws that protect the privacy and security

of personal information.

Our proprietary and confidential information may also be accessed.

these events could cause our business to be materially harmed and our results of operations may be adversely impacted.

as cyber threats continue to evolve, and privacy and cybersecurity laws and regulations continue to develop, we may need to invest

additional resources to implement new compliance measures, strengthen our information security posture, or respond to cyber threats

and incidents.

may fail to retain qualified personnel.

have substantially reduced the number of our employees in order to reduce our costs.

Accordingly, retaining our remaining personnel

in the future will be critical to our success.

If we fail to retain and motivate these highly skilled personnel, we may be unable

to continue our operating activities, and this could have a material adverse effect or our business, financial condition, results

of operations and future prospects.

rely on the key executive officers of the management team.

are dependent on our management team to execute against our business plan.

Failure could result in delays in product development,

loss of customers and sales and diversion of management resources, which could adversely affect our operating results.

incurred with respect to monitoring, protecting, and defending our intellectual property rights could adversely affect our business.

and others may infringe on our intellectual property rights, or may allege that we have infringed on theirs.

Monitoring infringement

and misappropriation of intellectual property can be difficult and expensive, and we may not be able to detect infringement or

misappropriation of our proprietary rights.

may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property

rights and we may be unable to protect our rights to, or use of, our technology.

or all of our patent applications may not result in the issue of patents, or the claims of any issued patents may not afford meaningful

protection for our technologies or products.

In addition, patents issued to us or our licensors, if any, may be challenged and

subsequently narrowed, invalidated, found unenforceable or circumvented.

Patent litigation is widespread in the biotechnology

industry and could harm our business.

Litigation might be necessary to protect our patent position.

Patentability, invalidity,

freedom-to-operate or other opinions may be required to determine the scope and validity of third-party proprietary rights.

we choose to go to court to stop a third party from using the inventions protected by our patent, that third party would have

the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party.

lawsuits are expensive and we may not have the required resources to pursue such litigation or to protect our patent rights.

addition, there is a risk that the court will decide that our patents are not valid or that we cannot stop the other party from

using their inventions.

There is also the risk that, even if the validity of these patents is upheld, the court will find that

the third party’s activities do not infringe our rights in these patents.

a third party may claim that we are infringing the third party’s patent rights and may go to court to stop us from engaging

in its normal operations and activities, including making or selling our products or product candidates.

These lawsuits are costly

and could affect our results of operations and divert the attention of managerial and technical personnel.

There is a risk that

a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered

by the patents.

In addition, there is a risk that a court will order us to pay the other party’s treble damages or attorneys’

fees for having violated the other party’s patents.

The biotechnology industry has produced a proliferation of patents,

and it is not always clear to industry participants, including us, which patents cover various types of products or methods of

The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims

of the relevant patent and/or that the third-party patent claims are invalid, and we may not be able to do this.

Proving invalidity

in the United Sates is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity

enjoyed by issued patents.

addition, changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially

diminish the value of our intellectual property or narrow the scope of our patent protection.

Any one of these events could cause our business

to be materially harmed and our results of operations may be adversely impacted.

Finally, as cyber threats continue to evolve, and privacy

and cybersecurity laws and regulations continue to develop, we may need to invest additional resources to implement new compliance measures,

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.

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

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

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

of treatment, as well as successfully defending our patents and other intellectual property rights against third-party challenges.

ability to stop unauthorized third parties from making, using, selling, offering to sell, importing or otherwise commercializing our

product candidates is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover

these activities.

If we are unable to secure and maintain patent protection for any product or technology we develop, or if the scope

of the patent protection secured is not sufficiently broad, our competitors could develop and commercialize products and technology similar

or identical to ours, and our ability to commercialize any product candidates we may develop may be adversely affected.

patenting process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications

at a reasonable cost or in a timely manner.

In addition, we may not pursue or obtain patent protection in all relevant markets.

also possible that we will fail to identify patentable aspects of our research and development activities before it is too late to obtain

patent protection.

Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent

applications, or to maintain the patents, covering technology that we may license from or license to third parties and may be reliant

on our licensors or licensees to do so.

Our pending and future patent applications may not result in issued patents.

Even if patent applications

we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with adequate protection,

prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage.

that we hold or in-license may be challenged, narrowed, circumvented or invalidated by third parties.

Consequently, we do not know whether

any of our platform advances and product candidates will be protectable or remain protected by valid and enforceable patents.

our existing patents and any future patents we obtain may not provide an adequate scope of protection or otherwise may not be enforceable

to prevent others from using our technology or from developing competing products and technologies.

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

success and future revenue growth will depend, in part, on our ability to protect our intellectual property.

We will primarily rely on

patent, copyright, trademark and trade secret laws, as well as nondisclosure agreements and other methods, to protect our proprietary

technologies or processes.

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.

While we hold rights in

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

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

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

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.

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

future growth of our business may depend in part on our ability to in-license or otherwise acquire the rights to additional product candidates

and technologies.

We cannot assure that we will be able to in-license or acquire the rights to any product candidates or technologies

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

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

are also pursuing strategies to license or acquire product candidates or technologies that we may consider attractive.

These established

companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization

capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to license rights to us.

Furthermore, we may

be unable to identify suitable product candidates or technologies within our area of focus.

If we are unable to successfully obtain rights

to suitable product candidates or technologies, our business and prospects could be materially and adversely affected.

we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

addition to patent protection, we rely upon know-how and trade secret protection, as well as non-disclosure agreements and invention

assignment agreements with our employees, consultants and third-parties, to protect our confidential and proprietary information, especially

where we do not believe patent protection is appropriate or obtainable.

is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute

confidentiality agreements upon the commencement of employment or consulting relationships with us.

These agreements provide that all

confidential information concerning our business or financial affairs developed or made known to the individual or entity during the

course of the party’s relationship with us is to be kept confidential and not disclosed to third parties, except in certain specified

circumstances.

In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related

to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment

or proprietary information (or as otherwise permitted by applicable law), are our exclusive property.

In the case of consultants and

other third parties, the agreements provide that all inventions conceived in connection with the services provided are our exclusive

However, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to

our trade secrets or proprietary technology and processes.

We have also adopted policies and conduct training that provides guidance

on our expectations, and our advice for best practices, in protecting our trade secrets.

Despite these efforts, any of these parties

may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate

remedies for such breaches.

addition to contractual measures, we try to protect the confidential nature of our proprietary information through other appropriate

precautions, such as physical and technological security measures.

However, trade secrets and know-how can be difficult to protect.

measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access,

provide adequate protection for our proprietary information.

Our security measures may not prevent an employee or consultant from misappropriating

our trade secrets and providing them to a competitor, and any recourse we might take against this type of misconduct may not provide

an adequate remedy to protect our interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret

can be difficult, expensive, and time-consuming, and the outcome is unpredictable.

In addition, trade secrets may be independently developed

by others in a manner that could prevent us from receiving legal recourse.

If any of our confidential or proprietary information, such

as our trade secrets, were to be disclosed or misappropriated, such as through a data breach, or if any of that information was independently

developed by a competitor, our competitive position could be harmed.

Additionally, certain trade secret and proprietary information may

be required to be disclosed in submissions to regulatory authorities.

If such authorities do not maintain the confidential basis of such

information or disclose it as part of the basis of regulatory approval, our competitive position could be adversely affected.

may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

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Although we have no knowledge of any claims against

us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or

other proprietary information of their former employers.

us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary

information of their former employers.

Litigation may be necessary to defend against these claims.

are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

To date, none of our employees have been subject to such claims.

may be at risk that our former employees may wrongfully use or disclose our trade secrets.

addition to patent protection, we rely heavily upon know-how and trade secret protection, as well as non-disclosure agreements

and invention assignment agreements with our employees, consultants, and third parties, to protect our confidential and proprietary

information, especially where we do not believe patent protection is appropriate or obtainable.

In addition to contractual measures,

we try to protect the confidential nature of our proprietary information using physical and technological security measures.

measures may not, for example, in the case of misappropriation of a trade secret by an employee, former employee, consultant,

former consultant or third party with authorized access, provide adequate protection for our proprietary information.

measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor,

and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully.

Enforcing a claim

that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome

is unpredictable.

In addition, trade secrets may be independently developed by others in a manner that could prevent legal recourse

If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated,

or if any such information was independently developed by a competitor, our competitive position could be harmed.

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management.

To date, none of our employees

have been subject to such claims.

claims of intellectual property infringement may prevent, delay or otherwise interfere with our product discovery and development efforts.

commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary

technologies without infringing, misappropriating or otherwise violating the intellectual property or other proprietary rights of third

There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and

pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, inter partes

review, post grant review, and reexamination proceedings before the United States Patent and Trademark Office (“USPTO”) or

oppositions and other comparable proceedings in foreign jurisdictions.

We may be exposed to, or threatened with, future litigation by

third parties having patent or other intellectual property rights alleging that our product candidates and/or proprietary technologies

infringe, misappropriate or otherwise violate their intellectual property rights.

Numerous U.S.

and foreign issued patents and pending

patent applications that are owned by third parties exist in the fields in which we are developing our product candidates.

As the biotechnology

and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims

of infringement of the patent rights of others.

Moreover, it is not always clear to industry participants, including us, which patents

cover various types of drugs, products or their methods of use or manufacture.

Thus, because of the large number of patents issued and

patent applications filed in our field, third parties may allege they have patent rights encompassing our product candidates, technologies

a third party claims that we infringe, misappropriate or otherwise violate its intellectual property rights, we may face a number of

issues, including, but not limited to:

and other intellectual property claims that, regardless of merit, may be expensive and time-consuming to litigate and may divert

our management’s attention from our core business;

damages for infringement, which we may have to pay if a court decides that the product candidate or technology at issue infringes

on or violates the third party’s rights, and, if the court finds that the infringement was willful, we could be ordered to

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

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

cross-licenses to intellectual property rights for our product candidates;

requirement that we redesign our product candidates or processes so they do not infringe, which may not be possible or may require

substantial monetary expenditures and time;

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

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

greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material

adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect

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

parties may assert that we are employing their proprietary technology without authorization, including by enforcing its patents against

us by filing a patent infringement lawsuit against us.

In this regard, patents issued in the U.S.

by law enjoy a presumption of validity

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

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

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

Because patent applications can take many years to issue,

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

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

any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates,

or materials used in or formed during the manufacturing process, or any final product itself, the holders of those patents may be able

to block our ability to commercialize our product candidates unless we obtain a license under the applicable patents, or until those

patents were to expire or those patents are finally determined to be invalid or unenforceable.

Similarly, if any third-party patent were

held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including

combination therapy or patient selection methods, the holders of that patent may be able to block our ability to develop and commercialize

a product candidate unless we obtain a license or until such patent expires or is finally determined to be invalid or unenforceable.

In either case, a license may not be available on commercially reasonable terms, or at all, particularly if such patent is owned or controlled

by one of our primary competitors.

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

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

Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed

In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could

dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further

develop and commercialize our product candidates.

Defense of these claims, regardless of their merit, would involve substantial litigation

expense and would be a substantial diversion of employee time and resources from our business.

In the event of a successful claim of

infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement,

obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require

substantial time and monetary expenditure.

We cannot predict whether any license of this nature would be available at all or whether

it would be available on commercially reasonable terms.

Furthermore, even in the absence of litigation, we may need to obtain licenses

from third parties to advance our research or allow commercialization of our product candidates and we may fail to obtain any of these

licenses at a reasonable cost or on reasonable terms, if at all.

In that event, we would be unable to further develop and commercialize

our product candidates, which could significantly harm our business.

may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming

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.

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

grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before

administrative bodies in the U.S.

or abroad, even outside the context of litigation.

These types of mechanisms include re-examination,

post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions

(e.g., opposition proceedings).

These types of proceedings could result in revocation or amendment to our patents such that they no longer

cover our product candidates.

The outcome for any particular patent following legal assertions of invalidity and unenforceability is

unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which

we, our patent counsel and the patent examiner were unaware during prosecution.

If a defendant were to prevail on a legal assertion of

invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and

perhaps all, of the patent protection on our product candidates.

Defense of these types of claims, regardless of their merit, would involve

substantial litigation expense and would be a substantial diversion of employee resources from our business.

we may choose to challenge the patentability of claims in a third party’s U.S.

patent by requesting that the USPTO review the patent

claims in re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings

in foreign jurisdictions (e.g., opposition proceedings), or we may choose to challenge a third party’s patent in patent opposition

proceedings in the Canadian Intellectual Property Office (“CIPO”) the European Patent Office (“EPO”) or another

foreign patent office.

Even if successful, the costs of these opposition proceedings could be substantial, and may consume our time or

other resources.

If we fail to obtain a favorable result at the USPTO, CIPO, EPO or other patent office then we may be exposed to litigation

by a third party alleging that the patent may be infringed by our product candidates or proprietary technologies.

because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some

of our confidential information could be compromised by disclosure during this type of litigation.

In addition, there could be public

announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive

these results to be negative, that perception could have a substantial adverse effect on the price of our common stock.

Any of the foregoing

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

have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

currently have limited intellectual property rights outside the U.S.

Filing, prosecuting and defending patents on product candidates

in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside

can be less extensive than those in the U.S.

In addition, the laws of some foreign countries do not protect intellectual property

rights to the same extent as federal and state laws in the U.S.

For example, patents covering therapeutic methods of treating humans

are not available in many foreign countries.

Consequently, we may not be able to prevent third parties from practicing our inventions

in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S.

or other jurisdictions.

Competitors may use our technologies in jurisdictions where we do not have or have not obtained patent protection to develop their own

products and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement

is not as strong as that in the U.S.

These products may compete with our product candidates in jurisdictions where we do not have any

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.

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

imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime

of the patent.

The USPTO and various foreign patent agencies also require compliance with a number of procedural, documentary, fee payment

and other provisions during the patent application process and following the issuance of a patent.

While an inadvertent lapse can in

many cases be cured by payment of a late fee or by other means in accordance with the applicable laws and rules, there are situations

in which noncompliance can result in irrevocable abandonment or lapse of the patent or patent application, resulting in partial or complete

loss of patent rights in the relevant jurisdiction.

Noncompliance events that could result in abandonment or lapse of a patent or patent

application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees

and failure to properly legalize and submit formal documents.

Were a noncompliance event to occur, our competitors might be able to enter

the market, which would have a material adverse effect on our business financial condition, results of operations and prospects.

in patent law in the U.S.

and in non-U.S.

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

to protect our product candidates.

is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

and enforcing patents in the pharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming

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.

cases by the U.S.

Supreme Court have held that certain methods of treatment or diagnosis are not patent-eligible.

law regarding

patent-eligibility continues to evolve.

While we do not believe that any of our patents will be found invalid based on these changes

to US patent law, we cannot predict how future decisions by the courts, the U.S.

Congress or the USPTO may impact the value of our patents.

Any similar adverse changes in the patent laws of other jurisdictions could also have a material adverse effect on our business, financial

condition, results of operations and prospects.

terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

have a limited lifespan.

In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years

from its earliest U.S.

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection

it affords, is limited.

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open

to competition from competitive products, including generics.

Given the amount of time required for the development, testing and regulatory

review of new product candidates, patents protecting our product candidates might expire before or shortly after our or our partners

commercialize those candidates.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude

others from commercializing products similar or identical to ours.

we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.

upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, (the

“Hatch-Waxman Amendments”).

The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation

for patent term lost during clinical trials and the FDA regulatory review process.

A patent term extension cannot extend the remaining

term of a patent beyond a total of 14 years from the date of product approval, only one patent per product may be extended and only those

claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.

law concerning

patent term extensions and foreign equivalents continue to evolve.

Even if we were to seek a patent term extension, it may not be granted

because of, for example, the failure to exercise due diligence during the testing phase or regulatory review process, the failure to

apply within applicable deadlines, the failure to apply prior to expiration of relevant patents, or any other failure to satisfy applicable

requirements.

Moreover, the applicable time period of extension or the scope of patent protection afforded could be less than we request.

If we are unable to obtain patent term extension or term of any such extension is less than we request, our competitors may obtain approval

of competing products following our patent expiration sooner than expected, and our business, financial condition, results of operations

and prospects could be materially harmed.

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.

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.

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.

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 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 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

(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.

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

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

A “material weakness”

is a deficiency, or a combination of deficiencies, in internal control over financial reporting,

such that there is a reasonable possibility that a material misstatement of our annual consolidated financial statements will

not be prevented or detected on a timely basis.

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

weakness, we might be subject to regulatory sanction and investors may lose confidence in our consolidated financial statements,

which may be inaccurate if we fail to remedy such material weakness.

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

which could harm our operating results.

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

costs associated with public company reporting requirements.

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

as rules implemented by the SEC and Nasdaq, impose a number of requirements on public companies, including with respect to corporate

governance practices.

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

Moreover, compliance with these rules and regulations has increased our legal, accounting and financial compliance

costs and has made some activities more time-consuming and costly.

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

liability insurance.

Related to Our Financial Position and Need for Additional Capital

expect to require additional capital in the future in order to develop the COVID-19 Vaccine Candidate.

If we do not obtain any

such additional financing, it may be difficult to complete development of the COVID-19 Vaccine Candidate or effectively realize

our long-term strategic goals and objectives.

current cash resources will not be sufficient to fund the development of the COVID-19 Vaccine Candidate through all of the required

clinical trials to receive regulatory approval and commercialization.

While we do not currently have an estimate of all of the

costs that we will incur in the development of the COVID-19 Vaccine Candidate, we anticipate that we will need to raise significant

additional funds in order to continue the development of the COVID-19 Vaccine Candidate during the next 12-months.

secure this additional funding when such funds are required, we may fail to develop a COVID-19 Vaccine Candidate or be forced

to forego certain strategic opportunities.

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

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

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

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

the holders of any of our securities then outstanding.

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

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

We may also be required to

recognize non-cash expenses in connection with certain securities we issue, such as convertible notes and warrants, which may

adversely impact our financial condition.

market price for our common stock may be volatile, and your investment in our common stock could decline in value.

stock market in general has experienced extreme price and volume fluctuations.

The market prices of the securities of biotechnology

and specialty pharmaceutical companies, particularly companies like ours without product revenues and earnings, have been highly

volatile and may continue to be highly volatile in the future.

This volatility has often been unrelated to the operating performance

of particular companies.

The following factors, in addition to other risk factors described in this section, may have a significant

impact on the market price of our common stock:

announcements

of technological innovations or new products by us or our competitors;

of FDA approval or disapproval of our product candidates or other product-related actions;

involving our discovery efforts and clinical studies;

or disputes concerning patents or proprietary rights, including announcements of infringement, interference or other litigation

against us or our potential licensees;

announcements

concerning our competitors, or the biotechnology, pharmaceutical or drug delivery industry in general;

concerns as to the safety or efficacy of our products or our competitors’

in government regulation of the pharmaceutical or medical industry;

in the reimbursement policies of third party insurance companies or government agencies;

or anticipated fluctuations in our operating results;

in financial estimates or recommendations by securities analysts;

involving corporate collaborators, if any;

in accounting principles;

loss of any of our key scientific or management personnel.

the COVID-19 pandemic has resulted in significant financial market volatility and uncertainty in recent weeks.

A continuation

or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability

to access capital, on our business, results of operations and financial condition, and on the market price of our common stock.

the past, securities class action litigation has often been brought against companies that experience volatility in the market

price of their securities.

Whether or not meritorious, litigation brought against us could result in substantial costs and a diversion

of management’s attention and resources, which could adversely affect our business, operating results and financial condition.

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

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

or detected on a timely basis.

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

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

if we fail to remedy such material weakness.

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

could harm our operating results.

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

associated with public company reporting requirements.

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

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

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

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

more time-consuming and costly.

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

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.

The delisting could adversely

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

common stock is listed on The Nasdaq Capital Market.

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

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

We cannot assure you that

we will continue to meet the continued listing requirements in the future.

Nasdaq delists our common stock from trading on its exchange, due to failure to meet its continued listing requirements, and we

are not able to list our common stock on another national securities exchange, we expect our securities could be quoted on an

over-the-counter market.

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

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

We cannot assure you that we will continue to meet

the continued listing requirements in the future.

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

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

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

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liquidity for our common stock;

determination that our common stock is a “penny stock”

which will require brokers trading in our common stock

to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market

for our common stock;

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

limited amount of news and analyst coverage;

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

we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our

stock price may decline.

may from time to time issue additional shares of common stock at a discount from the current market price of our common stock.

As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at

such discount.

As opportunities present themselves, we may enter into financing or similar arrangements in the future, including

the issuance of debt securities, preferred stock or common stock.

If we issue common stock or securities convertible or exercisable

into common stock, our common stockholders would experience additional dilution and, as a result, our stock price may decline.

do not anticipate paying cash dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for

any return on their investment.

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.

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.

1 unchanged sentence

of dividends is 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.

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.

of your investment will likely depend entirely upon any future appreciation of the market price of our common stock, which is

uncertain and unpredictable.

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.

sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline,

even if our business is doing well.

by our stockholders of a substantial number of shares of our common stock in the public market could occur in the future.

to the Securities Purchase Agreement for the Private Placement (the “Private Placement SPA”), we are required to file

a registration statement for the resale of 9,765,933 shares of common stock issued at an offering price of $1.85 per share or,

at the election of each investor, Pre-Funded Warrants, and up to 9,765,933 shares of our common stock issuable upon exercise of

the Pre-Funded Warrants shortly after we file a proxy statement with the SEC in connection with the Merger.

Following their registration

and resale under a registration statement, such shares would become freely tradable.

Sales by our stockholders of a substantial

number or resales by the purchasers of such shares and shares issuable upon exercise of such warrants pursuant to a registration

statement, or the perception in the market that the holders of a large number of shares of common stock may or intend to sell

their shares, could reduce the market price of our common stock and make it more difficult for us to sell equity or equity-related

securities in the future at a time and at a price that we might otherwise desire.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or

if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.

trading market for our common stock will be influenced by the research and reports that industry or securities analysts may publish

about us, our business, our market or our competitors.

If any of the analysts who may cover us change their recommendation regarding

our stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would likely decline.

If any analyst who may cover us were to cease coverage of us or fail to regularly publish reports on us, we could lose visibility

in the financial markets, which in turn could cause our stock price or trading volume to decline.

are currently subject to a number of securities litigations, and we may be subject to similar or other litigation in

are currently subject to a number of litigations as described elsewhere in these “Risk Factors”

and in Note 10 to

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

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.

that have experienced volatility in the market price of their stock have frequently been the objects of securities class action

In connection with certain of these litigations, we have entered into settlements of claims for

significant monetary damages.

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

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

Defending against the current litigations

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

that have experienced volatility in the market price of their stock have frequently been the objects of securities class action litigation.

We may be the target of this type of litigation in the future.

Class action and derivative lawsuits could result in

substantial costs to us and cause a diversion of our management’s attention and resources, which could materially harm our

financial condition and results of operations.

respect to any litigation, our insurance may not reimburse us, or may not be sufficient to reimburse us, for the expenses or losses

we may suffer in contesting and concluding such lawsuit.

Substantial litigation costs, including the substantial self-insured

retention that we are required to satisfy before any insurance applies to a claim, unreimbursed legal fees or an adverse result

in any litigation may adversely impact our business, operating results or financial condition.

We believe that our directors’

and officers’

Class action and derivative lawsuits could result in substantial costs

to us and cause a diversion of our management’s attention and resources, which could materially harm our financial condition and

results of operations.

respect to any litigation, our insurance may not reimburse us, or may not be sufficient to reimburse us, for the expenses or losses we

may suffer in contesting and concluding such lawsuit.

Substantial litigation costs, including the substantial self-insured retention

that we are required to satisfy before any insurance applies to a claim, unreimbursed legal fees or an adverse result in any litigation

may adversely impact our business, operating results or financial condition.

We believe that our directors’ and officers’

liability insurance will cover our potential liability with respect to any securities class-action lawsuit;

however, the insurer has reserved its rights to contest the applicability of the insurance to such claims and the limits of the

insurance may be insufficient to cover any eventual liability.

however, the insurer has

reserved its rights to contest the applicability of the insurance to such claims and the limits of the insurance may be insufficient

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.

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.

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

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

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

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

or detected on a timely basis.

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

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

if we fail to remedy such material weakness.

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.

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

associated with public company reporting requirements.

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

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

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

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

more time-consuming and costly.

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

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