What changed in this filing

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Item 1A. Risk Factors

2021-03-01 compared with 2020-03-25 · 1160 added, 919 removed, 275 unchanged (88% of the section changed)

investment in our securities is speculative 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 and the

other information and documents we file with the SEC.

The occurrence of any of the following risks could have a material and adverse

effect on our business, reputation, financial condition, results of operations and future growth prospects, as well as our ability

to accomplish our strategic objectives.

As a result, the trading price of our common stock could decline and you could lose all

or part of your investment.

Additional risks and uncertainties not presently known to us or that we currently deem immaterial

may also impair our business operations and stock price.

Related to Our Acquisition

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

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”

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 Sellers, pursuant to which we will acquire the Membership Interests of Cystron.

Cystron is a party to the Initial License Agreement with Premas.

As a condition to the Company’s 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 a COVID-19 vaccine or combination product by the Company (the “COVID-19 Vaccine”).

Our ability to realize the anticipated benefits of the acquisition will depend, to a large extent, on our ability to produce a

vaccine that successfully treats coronavirus (“COVID-19”).

The development of the COVID-19 Vaccine is in very early

stages and there is no assurance that we will be able to produce an effective vaccine.

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

could adversely affect our business, financial condition and results of operations.

In addition, we expect to incur significant

expenses related to the acquisition.

These expenses include, but are not limited to, the Common Stock Consideration, a cash consideration

of $1.0 million, related contingent fees, legal fees and other related fees and expenses.

Many of these expenses will be payable

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

in the event that we fail to develop 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, we may:

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’

2 unchanged sentences

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

addition, the process of integrating Cystron may create operating difficulties and expenditures and pose numerous additional risks

to our operations, including:

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

of the COVID-19 Vaccine;

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

8 unchanged sentences

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

is dependent on technologies that is 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-license intellectual

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

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.

2 unchanged sentences

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.

The foregoing could result in a material adverse

effect on our business or results of operations.

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

1 unchanged sentence

If Premas is unable

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

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

in the drug discovery and development business.

will face intense competition.

believe that many other pharmaceutical and biotechnologies are working on vaccines and treatments for COVID—19.

them are large, multi-national pharmaceutical companies with significantly greater resources than Cystron.

If one of these other

companies develops an effective vaccine or treatment for COVID-19 before Cystron, then even if Cystron successfully develops a

vaccine it may never gain market acceptance.

Related to Our Business

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.

Our net losses for

the years ended December 31, 2019 and 2018 were $3,888,249 and $10,849,034, respectively.

Our accumulated deficit at December

31, 2019 was $119,583,130.

Our strategy for the medical device business is to leverage where possible our distributor relationships,

while exploring strategies for further reducing our costs.

Overall, we are working to reduce our cash burn in order to have sufficient

cash funds available to execute on a transaction which would result from our pursuit of strategic alternatives.

There can be no

assurance of success in reducing our loss, becoming profitable, or having sufficient cash to complete a strategic alternative

pursuit of the COVID-19 Vaccine 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 global outbreak of COVID-19, we are pursuing the rapid development of the COVID-19 Vaccine.

Our development of

the vaccine is in early stages, and we may be unable to produce a vaccine that successfully treats the virus in a timely manner,

Additionally, our ability to develop an effective vaccine depends on the success of our 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 outbreak is effectively contained or the risk of coronavirus infection

is diminished or eliminated before we can successfully develop and manufacture the COVID-19 Vaccine, we may be unable to successfully

generate revenue from the manufacturing of the COVID-19 Vaccine.

We are also committing financial resources and personnel to the

development of the COVID-19 Vaccine which may cause delays in or otherwise negatively impact our other business operations, despite

uncertainties surrounding the longevity and extent of coronavirus 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 our vaccine, if developed, may not be partially or fully effective.

the biotechnology market is highly competitive, is subject to rapid technological change and is significantly affected by existing

rival drugs and medical procedures, new product introductions and the market activities of other participants.

Pharmaceutical

and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations

may pursue the research and development of a vaccine to treat COVID-19.

Our competitors may develop products more rapidly or more

effectively than us.

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.

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

including for use by the U.S.

the event that the preclinical and clinical trials for the COVID-19 Vaccine 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 U.S.

government mechanisms such as an Expanded Access Program or an Emergency Use Authorization program.

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

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 our vaccine platform and technology.

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 successfully through the preclinical and clinical development process.

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

on many factors, including the following:

completion of preclinical studies and clinical trials;

achievement of the objectives of planned preclinical studies and clinical trials;

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.

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.

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.

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.

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,

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;

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

COVID-19 Vaccine 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 we receive regulatory approval from

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

If we are 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, which would materially and adversely affect our business, financial condition and results of operations.

to our dependence on a limited number of customers and the loss of any such customer would have a material adverse effect on our

operating results and prospects.

of December 31, 2019, we had two principal U.S.

Cardinal Health, Inc.

(“Cardinal Health”) and Fisher

Healthcare (“Fisher”).

Each has the non-exclusive right to distribute PIFA Heparin/PF4 Rapid Assays within

For the year ended December 31, 2019, Cardinal Health and Fisher accounted for approximately 79% of our product revenue.

of our dependence on a limited number of key customers, the loss of a major customer (or loss of a key program with a major customer),

or any significant reduction in orders by a major customer or termination of any of their distribution agreements would materially

affect our business, our results of operations and our financial condition.

We expect that sales to relatively few customers will

continue to account for a significant percentage of our net sales for the foreseeable future, however there can be no assurance

that any of these customers or any of our other customers will continue to utilize our products or our services at current levels.

to our dependence on a limited number of customers, we are subject to a concentration of credit risk.

of December 31, 2019, five customers accounted for 83% of trade receivables net of customer credits and allowance for doubtful

accounts, as compared to December 31, 2018, where two customers accounted for 99% of such trade receivables.

In the case of insolvency

by one of our significant customers, a trade receivable with respect to that customer might not be collectible, might not be fully

collectible, or might be collectible over longer than normal terms, each of which could adversely affect our financial position.

business would suffer if we were unable to acquire adequate sources of supply.

use a diverse and broad range of raw materials in the manufacturing of our products.

We purchase all of our raw materials and

select items, such as packaging, from external suppliers.

In addition, we purchase some supplies from single sources for reasons

of proprietary know-how, quality assurance, sole source availability, or due to regulatory qualification requirements and disruption

of these sources could have, at a minimum, a temporary adverse effect on shipments and the financial results of our company.

work closely with our suppliers to ensure continuity of supply while maintaining high quality and reliability.

Any prolonged inability

to obtain certain materials or components could have an adverse effect on our financial condition or results of operations and

could result in damage to our relationships with our customers and, accordingly, adversely affect our business.

expect to require additional capital in the future in order to pursue strategic alternative transactions.

If we do not obtain

any such additional financing, it may be difficult to effectively realize our long-term strategic goals and objectives.

execute our long-term business strategy, we expect to require additional financing and in connection therewith to issue

additional equity securities in public or private offerings.

If we cannot secure this additional funding when such funds are required,

we may 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.

we may not be able to maintain or obtain necessary regulatory clearances for some of our products, we may not generate revenue

in the amounts we expect, or in the amounts necessary to continue our business.

of our existing products are subject to regulation in the U.S.

by the FDA and/or other domestic and international governmental,

public health agencies, regulatory bodies or non-governmental organizations.

In particular, we are subject to strict governmental

controls on the development, manufacture, labeling, distribution and marketing of our products and may not be able to maintain

the necessary regulatory clearances for some of our products.

process of obtaining required approvals or clearances for a potential new product varies according to the nature of and uses for

a specific product.

These processes can involve lengthy and detailed laboratory testing, human clinical trials, sampling activities,

and other costly, time-consuming procedures.

The submission of an application to a regulatory authority does not guarantee that

the authority will grant an approval or clearance for the product.

Each authority may impose its own requirements and can delay

or refuse to grant approval or clearance, even though a product has been approved in another country.

time taken to obtain approval or clearance varies depending on the nature of the application and may result in the passage of

a significant period of time from the date of submission of the application.

Delays in the approval or clearance processes increase

the risk that we will not succeed in introducing or selling the subject products, and we may be required to abandon a proposed

product after devoting substantial time and resources to its development.

in domestic and foreign government regulations could increase our costs and could require us to undergo additional trials or procedures,

or could make it impractical or impossible for us to market our products for certain uses, in certain markets, or at all.

in government regulations may adversely affect our financial condition and results of operations because we may have to incur

additional expenses if we are required to change or implement new testing, manufacturing and control procedures.

If we are required

to devote resources to develop such new procedures, we may not have sufficient resources to devote to research and development,

marketing, or other activities that are critical to our business.

are subject to ongoing regulation by various government agencies, and, if we are unable to comply with such regulations, our products

could be subject to restrictions or withdrawal from the market and/or we could be subject to a wide-range of enforcement actions,

any of which would materially affect our business .

the United States, medical devices, including in vitro diagnostics, are subject to extensive regulation by FDA under the

Federal Food, Drug, and Cosmetic (“FD&C”) Act and its implementing regulations, along with other federal and state

statutes and regulations.

To be lawfully marketed in the United States, medical devices must generally receive 510(k) clearance

or premarket approval (“PMA”) from the FDA.

All of our currently commercial devices have received 510(k) clearance.

the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply.

These include:

compliance with

the Quality System Regulation (“QSR”), which requires manufacturers to follow elaborate design, testing, control,

documentation and other quality assurance procedures during the manufacturing process;

labeling regulations;

the FDA’s general

prohibition against promoting products for unapproved or “off-label”

the reports of Corrections and Removals

regulation, which requires manufacturers to report recalls and field actions to the FDA if initiated to reduce a risk of health

posed by the device or to remedy a violation of the FD&C Act;

and the Medical Device Reporting (“MDR”) regulation,

which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury

or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to reoccur.

Manufacturers

are also required to register and list their devices with the FDA, based on which the FDA will conduct inspections to ensure continued

compliance with applicable regulatory requirements.

FDA has broad post-market and regulatory and enforcement powers.

Failure to comply with the applicable U.S.

medical device regulatory

requirements could result in, among other things, warning letters;

consent decrees;

civil penalties;

replacements or refunds;

recalls, corrections or seizures of products;

total or partial suspension of production;

the FDA’s

refusal to grant future premarket clearances or approvals;

withdrawals or suspensions of current product applications;

Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some people with brain related

disorders from using our products and adversely affect our reputation and the perceived accuracy and safety of our products.

any of these events were to occur, they could have a material adverse effect on our business, financial condition and results

of operations.

Additionally,

medical device manufacturer, we must operate our production facility in accordance with the QSR requirements established

by the FDA under the FD&C Act.

The QSR requires a quality system for the design, manufacture, packaging, labeling, storage,

installation and servicing of marketed devices, and it includes extensive requirements with respect to quality management and

organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls,

packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and recordkeeping.

As such, we have implemented a quality system that is intended to comply with applicable regulations.

Our manufacturing plant

is subject to periodic inspections by the FDA, and at last inspection, the facility was found to be in substantial compliance

with current good manufacturing practice (“cGMP”) requirements.

cGMP requirements could change and negatively impact

our ability to manufacture our products without modifications to our operating procedures or changes to our equipment or human

resource allocations which may materially affect our business.

If the FDA believes that our manufacturing practices are not compliant

with applicable QSR requirements, it can shut down our manufacturing operations, require recall of our products, refuse to approve

new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil

and criminal penalties against us or our officers or other employees.

we fail to obtain regulatory approval in foreign jurisdictions, then we cannot market our products in those jurisdictions.

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

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and the requirements may differ.

Companies are now required to obtain a CE Mark, which shows conformance with the requirements

of applicable European Conformity directives, prior to the sale of some medical devices within the European Union.

current products that require CE Markings have them.

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 sell our products in such jurisdictions, thereby reducing the potential revenue from the sale of our products.

may be unable to market our products outside the United States if our products cannot meet certain requirements of the Federal

Food, Drug and Cosmetic Act requirements for exporting medical devices.

medical device that is legally marketed in the U.S.

may be exported anywhere in the world without prior FDA notification or approval.

Medical devices that are not FDA-cleared for marketing legally in the U.S.

may be exported under section 801(e)(1) of the FD&C

Act, provided that they are intended for export only, they are class I or class II devices, and they are:

accordance with the specifications of the foreign purchaser;

in conflict with the laws of the country to which they are intended for export;

on the outside of the shipping package that they are intended for export;

sold or distributed in the U.S.

cannot guarantee that certain current and future products will meet all of the aforementioned specifications for export which

could adversely impact our ability to market our products outside the U.S.

Modifications

to our devices may require additional FDA clearance or approval, which could force us to cease marketing and/or recall the modified

device until we obtain new approvals.

a device receives a 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would

constitute a major change in its intended use, requires a new 510(k) clearance or could require a Premarket approval (“PMA”).

The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any decision.

FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance, the agency may retroactively require the

manufacturer to seek 510(k) clearance or PMA.

The FDA also can require the manufacturer to cease marketing and/or recall the modified

devices until 510(k) clearance or PMA approval is obtained, among other enforcement actions.

We have modified one of our prescription

use, 510(k)-cleared devices, specifically the PIFA Heparin/PF4 Rapid Assay, to include our seraSTAT device.

However, we determined

that, in our view, based on FDA guidance as to when to submit a 510(k) notification for changes to a cleared device, a new 510(k)

clearance was not required.

We cannot assure you that the FDA would agree with any of our decisions not to seek 510(k) clearance

or PMA approval.

If the FDA requires us to seek 510(k) clearance or PMA approval for any modification, we also may be required

to cease marketing and/or recall the modified device until we obtain a new 510(k) clearance or PMA approval, which could harm

our operating results and require us to redesign the product.

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.

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

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restrictions, partial suspension or total shutdown of production;

our requests for a 510(k) clearance of new products;

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

a 510(k) clearance already granted;

FDA also has the authority to request repair, replacement or refund of the cost of any medical device manufactured or distributed

Our 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.

marketed products may be used by physicians for indications that are not cleared by the FDA.

If the FDA finds that we promoted

one or more of our products for off-label use(s), we may be subject to civil or criminal penalties.

the FD&C Act and other laws, we are prohibited from promoting our products for “off-label”

This means that

we may not make claims about the use of any of our marketed medical device products outside of their cleared indications, and

that our website, advertising promotional materials and training methods may not promote or encourage any unapproved uses.

we may not provide information to physicians or patients that promote off-label uses, except in limited circumstances.

the FDA determine that we have engaged in the promotion of any of our device products for off-label uses, the FDA could bring

a wide range of enforcement actions against us and/or our executives.

In addition, failure to follow FDA rules and guidelines

relating to promotion and advertising can result in, among other things, the FDA’s refusal to approve or clear products,

the withdrawal of an approved product from the market, product recalls, fines, disgorgement of profits, operating restrictions,

injunctions or criminal prosecutions.

Any of these adverse regulatory actions could result in substantial costs and could significantly

and adversely impact our reputation and divert management’s attention and resources, which could have a material adverse

effect on our business.

addition to potential FDA enforcement, the Department of Justice, as well as state attorneys general, may work with the FDA or

on their own to bring enforcement action against us and/or our executives in connection with any off-label promotion of our products.

Such action may include civil and criminal penalties, including significant fines, among other serious consequences.

are successful in resolving such matters without incurring penalties, responding to investigations or prosecutions will likely

result in substantial costs and could significantly and adversely impact our reputation and divert management’s attention

and resources, which could have a material adverse effect on our business, operating results, financial condition, and ability

to finance our operations.

In addition, the off-label use of our products may increase the risk of injury to patients, and, in

turn, the risk of product liability claims.

Product liability claims are expensive to defend and could divert our management’s

attention and result in substantial damage awards against us.

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

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

We have not had the resources to effectively implement

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

In addition, if

a protocol is initiated, the results of which may ultimately not support the anticipated positioning and benefit proposition for

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.

we fail to establish, maintain and expand relationships with distributors, sales of our products would decline.

do not control the efforts of our distributors and our distributors are not prohibited from selling competing products.

to sell our products depends largely on our relationships with such distributors.

Accordingly, we are subject to the risk that

they may not commit the financial and other resources to market and sell our products to our level of expectation, they may experience

financial hardship or they may otherwise terminate our relationship on short notice.

clinical laboratory marketplace,

many of our existing and potential customers purchase our products through our two national distributors, Cardinal Health and

Fisher Health.

In addition, we rely on our distribution network to negotiate pricing arrangements and contracts with Group Purchasing

Organizations and their affiliated hospitals and other members.

For the year ended December 31, 2019, two customers generated

48 % and 31 %, or 79 % in the aggregate, of our revenue.

For the year ended December 31, 2018, two customers generated 57%, and

14%, or 71% in the aggregate, of our revenue.

In the future, if we are unable to maintain existing relationships, our competitive

position would likely suffer and our business would be harmed.

business is vulnerable to the availability of raw materials, our ability to forecast customer demand and our ability to manage

production capacity.

ability to meet customer demand depends, in part, on our production capacity and on obtaining supplies, a number of which can

only be obtained from a single supplier or a limited number of suppliers.

A reduction or disruption in our production capacity

or our supplies could delay products and fulfillment of orders and otherwise negatively impact our business.

must accurately predict both the demand for our products and the lead times required to obtain the necessary components and materials.

If we overestimate demand, we may experience underutilized capacity and excess inventory levels.

If we underestimate demand, we

may miss delivery deadlines and sales opportunities and incur additional costs for labor overtime, equipment overuse and logistical

complexities.

Additionally, our production capacity could be affected by manufacturing problems.

Difficulties in the production

process could reduce yields or interrupt production, and, as a result, we may not be able to deliver products on time or in a

cost-effective, competitive manner.

Our failure to adequately manage our capacity could have a material adverse effect on our

business, financial condition and results of operations.

ability to meet customer demand also depends on our ability to obtain timely and adequate delivery of materials, parts and components

from our suppliers.

We generally do not maintain contracts with any of our key suppliers.

From time to time, suppliers may extend

lead times, limit the amounts supplied to us or increase prices due to capacity constraints or other factors.

Supply disruptions

may also occur due to shortages in critical materials.

In addition, a number of our raw materials are obtained from a single supplier.

Many of our suppliers must undertake a time-consuming qualification process before we can incorporate their raw materials into

our production process.

If we are unable to obtain materials from a qualified supplier, it can take up to a year to qualify a

new supplier, assuming an alternative source of supply is available.

A reduction or interruption in supplies or a significant

increase in the price of one or more supplies could have a material adverse effect on our business, financial condition and results

of operations.

of our finished goods, including our PIFA products and control materials related to PIFA Heparin/PF4 assays, are temperature-sensitive.

packaging and time in transit are critical to the stability of some of our clinical laboratory products when they are en route

to our distributors or end users.

If certain specialized packaging materials cannot be obtained, and/or if our contracted common

carriers, or those of our distributors, cannot meet product-specific delivery requirements, our products may not perform as intended

and may lead to requests for product replacement.

If such issues become widespread, it could hurt our reputation and we

could potentially lose customers which would adversely affect our business.

given the issue of temperature sensitivity, time in transit may limit our ability to service potential markets outside of the

for those products, especially those with geographies that do not allow for shipment and customs clearance within four business

This could adversely affect our potential to generate revenue for some products on an international level.

of third-party payors, cost reduction pressures among our customers and restrictive reimbursement practices may adversely affect

ability to negotiate favorable contracts with non-governmental payors, including managed-care plans or Group Purchasing Organizations

(“GPOs”), even if facilitated by our distributors, may significantly affect revenue and operating results.

Our customers

continue to face cost reduction pressures that may cause them to curtail their use of, or reimbursement for some of our products,

to negotiate reduced prices or other concessions or to delay payment.

Furthermore, the increasing leverage of organized buying

groups among non-governmental payors may reduce market prices for our products and services, thereby reducing our profitability.

Reductions in price increases or the amounts received from current customers or lower pricing for our products to new customers

could have a material adverse effect on the financial position, cash flows and results of operations.

to obtain medical reimbursement for our products, as well as a changing regulatory and reimbursement environment, may impact our

healthcare regulatory environment may change in a way that restricts our ability to market our products due to medical coverage

or reimbursement limits.

Sales of our diagnostic tests will depend in part on the extent to which the costs of such tests are

covered by health maintenance, managed care, and similar healthcare management organizations, or reimbursed by government health

payor administration authorities, private health coverage insurers and other third-party payors.

These healthcare payors are increasingly

challenging the prices charged for medical products and services.

The containment of healthcare costs has become a priority of

federal and state governments.

Accordingly, our products may not be considered to be cost effective, and reimbursement may not

be available or sufficient to allow us to sell our products on a competitive basis.

Legislation and regulations affecting reimbursement

for our products may change at any time and in ways that are difficult to predict and these changes may have an adverse effect

the federal agency responsible for administering the Medicare program, along with its contractors establishes coverage and reimbursement

policies for the Medicare program.

In addition, private payors often follow the coverage and reimbursement policies of Medicare.

We cannot assure you that government or private third-party payors will cover and reimburse the procedures using our products

in whole or in part in the future or that payment rates will be adequate.

some of our products, our success in non-U.S.

markets may depend upon the availability of coverage and reimbursement from the

third-party payors through which health care providers are paid in those markets.

Health care payment systems in non-U.S.

vary significantly by country, and include single-payor, government managed systems as well as systems in which private payors

and government-managed systems exist, side-by-side.

For some of our products, our ability to achieve market acceptance or significant

sales volume in international markets may be dependent on the availability of reimbursement for our products under health care

payment systems in such markets.

There can be no assurance that reimbursement for our products will be obtained or that such reimbursement

will be adequate.

may experience delays in any phase of the preclinical or clinical development of a product, including during its research and

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:

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clinical investigators do not perform the studies in accordance with the anticipated schedule or consistent with the study

protocol and good clinical practices or other third-party organizations do not perform data collection and analysis in a timely

or accurate manner;

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 sanction;

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 preclinical or clinical studies;

the pre-clinical or clinical studies;

in governmental regulations or administrative actions;

interim results of the preclinical or clinical study, if any, are inconclusive or negative;

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 preclinical and clinical studies that we are required to conduct to gain regulatory approval are delayed or unsuccessful,

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.

Preclinical studies and clinical trials are expensive

and difficult to design and implement and any delays or prolongment in our preclinical and clinical studies will require additional

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 the Company.

anticipate that we will rely completely on third parties to manufacture certain preclinical 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 preclinical and

clinical drug supplies for use in the conduct of our clinical studies, and we lack the resources and the capability to manufacture

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.

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business in a number of ways, including:

may not be able to initiate or continue preclinical and clinical trials of products that are under development;

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 our collaborators;

may lose the cooperation of its collaborators;

products could be the subject of inspections by regulatory authorities;

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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 preclinical and/or clinical trial materials, which could cause delays in the FDA

third-party manufacturers to manufacture our pre-clinical and/or clinical trial materials, which could cause delays in the FDA

approval process.

Further, should our 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

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.

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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 preclinical studies and clinical trials and perform other tasks for us.

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,

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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 preclinical and clinical programs.

We expect to continue to rely

on these parties for execution of our preclinical studies and clinical trials, and we control only certain aspects of their activities.

Nevertheless, we maintain responsibility for ensuring that each of our clinical trials and preclinical 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

Good Clinical Practices or cGCP, and current Good Laboratory Practices, or cGLP, 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, preclinical 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 preclinical studies and clinical trials may be deemed unreliable

and the FDA or comparable foreign authorities may require us to perform additional preclinical 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 CRO to comply with these regulations

may require us to repeat clinical trials, which would delay the development and regulatory approval processes.

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,

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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 preclinical and clinical programs.

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 cGCP 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.

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

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As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

COVID-19 Vaccine that we develop in the future will be subject to extensive governmental regulations relating to development,

clinical trials, manufacturing and commercialization.

preclinical studies, clinical trials and extensive regulatory approval processes are required to be successfully completed in

the United States and in many foreign jurisdictions before a new product may be offered and sold in any of these countries or

Satisfaction of these and other regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated

the United States, the products that we intend to develop and market are regulated by the FDA under its drug development and review

The time required to obtain FDA and other approvals for any product that we develop in the future is inherently unpredictable.

Before such products can be marketed, we must obtain clearance from the FDA first through submission of an investigational new

drug (“IND”), then through successful completion of human testing under three phases of clinical trials and finally

through submission of a new drug application (“NDA”).

Even after successful completion of clinical testing, there

is a risk that the FDA may request further information from us, disagree with our findings or otherwise undertake a lengthy review

of our NDA submission.

can be no assurance that the FDA will grant a license for any NDA that we may submit.

It is possible that none of the products

that we develop in the future will obtain the appropriate regulatory approvals necessary for us to commence the offer and sale

of such products.

Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to

generate revenues from a particular prospective product.

we decide to market any drug that we develop in jurisdictions in addition to the United States, we may incur the same costs or

more in satisfying foreign regulatory requirements governing the conduct of preclinical and clinical trials, manufacturing and

marketing and commercialization of any product that we develop in the future.

Approval by the FDA by itself does not assure approval

by regulatory authorities outside the United States.

Each of these foreign regulatory approval processes includes all of the risks

associated with the FDA approval process, as well as risks attributable to having to satisfy local regulations within each of

these foreign jurisdictions.

Our inability to obtain regulatory approval outside the United States may adversely compromise our

business prospects

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

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.

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.

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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 on our business, financial condition, results

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 officer of the management team.

rely on the key executive officers of the management team.

are dependent on our management team to execute against our business plan.

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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 our normal operations and activities, including making or selling our products or product candidates.

in its normal operations and activities, including making or selling our products or product candidates.

These lawsuits are costly

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or if any such information was independently developed by a competitor, our competitive position could be harmed.

marketing, sale, and use of our PIFA products and any other devices we currently manufacture or may manufacture in the future

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 effect on our business.

success depends on the market’s confidence that we can continue to provide reliable, high-quality diagnostic tests.

that our customers 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 manner.

a result, the failure of our tests or services to perform as expected could impair our reputation and the public image of our

tests and services, and we may be subject to legal claims arising from any defects or errors.

marketing, sale, and 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

our marketing and promotional activities or as part of 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.

our PIFA products are highly accurate, they are not 100% accurate and may generate erroneous results that could cause patient

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.

On July 25, 2019, we received a product-liability petition, alleging that multiple false-negative PIFA Heparin/PF4 Rapid Assay

results caused a patient’s treating hospital to delay the appropriate diagnosis by several days, which, the petition argues,

was a substantial contributing factor in the ultimate amputation of the patient’s left leg.

We are contesting this action

vigorously and believe our product liability insurance will be adequate to cover any costs incurred in connection with this matter.

However, we cannot guarantee that our insurance will fully protect us from the financial impact of defending against product liability

claims or any judgments, fines, or settlement costs arising out of any such claims.

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.

Additionally, any

product liability or professional liability lawsuit could harm our reputation, result in a cessation of our services or cause

our partners to terminate our agreements with them, any of which could adversely impact our results of operations.

under the FDA’s MDR regulations, we are required to report to the FDA any incident in which our 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.

For example, once brought to our attention, we reported the injury described

above in connection with alleged false-negative PIFA Heparin/PF4 Rapid Assay results.

Repeated product malfunctions may result

in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture

our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating

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.

currently manufacture our products at a single location.

Any disruption at this facility could adversely affect our business and

results of operations.

currently manufacture all our products at our manufacturing plant.

If our manufacturing plant were damaged or destroyed, or otherwise

subject to disruption, it would require substantial lead-time to replace or rebuild the facility for the manufacture of our products.

In such event, we would be forced to rely entirely on third-party contract manufacturers for an indefinite period of time.

do not currently have established relationships with any back-up manufacturers.

Even if we are able to establish a relationship

with a third-party manufacturer, there is no assurance that such manufacturer will be able to meet our needs from a technical,

timing, or cost effective manner.

are currently subject to a number of securities litigations and we may be subject to similar or other litigation in the future.

are currently subject to a number of litigations as described in the “Legal Proceedings”

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.

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 the 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 our eventual liability.

face substantial competition from other companies and our operating results may suffer if we fail to compete effectively.

among providers of rapid, point-of-care screening and testing products is intense and subject to rapid technological change and

evolving industry requirements and standards.

We compete with many companies that have greater financial, product development,

sales and marketing resources and experience than we do.

Furthermore, new product development and technological change characterize

the areas in which we compete.

Our present or future products could be rendered obsolete or uneconomical as a result of technological

advances by one or more of our present or future competitors.

We must continue to develop and commercialize new products and technologies

to remain competitive in the diagnostic testing industry.

We believe that we compete primarily on the basis of our single-use

Customer and clinical support, and data that demonstrate both improvement in a patient’s quality of life and a

product’s cost-effectiveness are additional aspects of competition.

are aware of other rapid, point-of-care screening and diagnostic testing products in the U.S., Canada, and Europe.

Specifically,

Abbott, ACON Laboratories, Inc., Immucor, Inc., OraSure Technologies, Inc., and Quidel Corporation are companies that develop

rapid, point-of-care screening and diagnostic testing products and currently maintain dominant market positions within the diagnostic

testing market.

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.

receive payments directly from or bill directly to Medicare, Medicaid or other national or third-party payers for our current

product, U.S.

federal and state healthcare laws and regulations pertaining to fraud or abuse are and will be applicable to our

We are subject to healthcare fraud and abuse regulation by the U.S.

federal government and the states in which we conduct

our business.

laws that may affect our ability to operate include the federal healthcare program anti-kickback statute, 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 programs.

This statute applies to arrangements between pharmaceutical

manufacturers and prescribers, purchasers and formulary managers.

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.

Health Insurance Portability and Accountability Act of 1996 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.

The 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 recent trend of increased federal and state regulation of payments made to physicians.

The ACA, through

the Physician Payment Sunshine Act of 2010, 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”

to 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.

security breaches may disrupt our operations and adversely affect our operating results.

network security and data recovery measures and those of third parties with which we contract, may not be adequate to protect

against computer viruses, cyber-attacks, breaches, and similar disruptions from unauthorized tampering with our computer systems.

The misappropriation, theft, sabotage or any other type of security breach with respect to any of our proprietary and confidential

information that is electronically stored, including patient data, could cause interruptions in our operations, could result in

a material disruption of our business operations and could expose us to third-party legal claims.

Furthermore, we could be required

to make substantial expenditures of resources to remedy the cause of cyber-attacks or break-ins.

This disruption could have a

material adverse impact on our business, operating results and financial condition.

business processes personal medical information.

The use of this information is critical to our operations and innovation.

and evolving regulations could bring increased scrutiny of our data management in the future.

Any cyber-attacks or other failure

to protect critical and sensitive systems and information could damage our reputation, prompt litigation or lead to regulatory

sanctions, all of which could materially affect our financial condition and results of operation.

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

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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 of the U.S.

Sarbanes-Oxley Act of 2002 (“Section 404”).

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

actions or of their impact on our operations.

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

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

Our management,

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

controls will prevent all errors and all fraud.

A control system, no matter how well conceived and operated, can provide only

reasonable, not absolute, assurance that the objectives of the control system are met.

In addition, the design of a control system

must reflect the fact that there are resource constraints and the benefit of controls must be relative to their costs.

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

The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events,

and there can be no assurance that any design will succeed in achieving our stated goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as growth of the company or increased transaction

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

Because of inherent limitations in a cost-effective

control system, misstatements due to error or fraud may occur and not be detected.

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

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.

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

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costs associated with public company reporting requirements.

In addition, the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Act

of 2010, as well as rules implemented by the SEC and the Nasdaq Stock Market, 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.

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.

business may be materially adversely affected by the recent coronavirus (COVID-19) outbreak.

outbreak of the COVID-19 could disrupt our operations due to absenteeism by infected or ill members of management or other employees,

or absenteeism by members of management and other employees who elect not to come to work due to the illness affecting others

in our office or laboratory facilities, or due to quarantines.

COVID-19 illness could also impact members of our Board of Directors

resulting in absenteeism from meetings of the directors or committees of directors, and making it more difficult to convene the

quorums of the full Board of Directors or its committees needed to conduct meetings for the management of our affairs.

could be disrupted if the manufacturers or suppliers of our products experience absenteeism due to illness of their employees

or due to local quarantines.

Absenteeism due to coronavirus illness could also impact companies that the suppliers use to ship

products to us.

We cannot presently predict the extent to which the virus may impact our operations.

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.

While 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 Pursuit of Strategic Alternatives

may opportunistically review strategic transactions and there can be no assurance that that any such strategic transaction we

may purse will result in additional value for our stockholders.

November 2018, we announced that our Board of Directors had initiated a process to evaluate strategic alternatives to maximize

shareholder value.

The Company sought to explore how to leverage its 30 years of operational history in its medical device business,

where its current products have FDA clearance, its current operations practice Good Manufacturing Processes (cGMP), its medical

device facility is certified under ISO 13485 –

2016 and the facility carries an Analytical Lab Certification for Schedules

2, 3, 4 and 5 controlled substances issued by the U.S.

Drug Enforcement Administration (DEA) and the State of New Jersey.

Company intends to pursue opportunities in the extraction, testing, purification and formulation of safe cannabinoids within the

hemp industry, including pathways to consumer products with a focus on minor cannabinoids.

To 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 will depend on, among

other things, 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.

we acquire a new business, or retain individuals with expertise in a new industry to pursue a strategic alternative, we will have

a limited operating history in such new industry, specifically the cannabis industry, and may not succeed.

will have a limited operating history within the cannabis industry and may not succeed.

We will be subject to all risks inherent

in a developing business enterprise.

The likelihood of our continued viability must be considered in light of the problems, expenses,

difficulties, complications, and delays frequently encountered in connection with manufacturing specialty products and the competitive

and regulatory environment in which we operate.

For example, the cannabis industry is a new industry that, as a whole, may not

succeed, particularly if the Federal government changes course and decides to prosecute those dealing in cannabis under Federal

If that happens, there may not be an adequate market for our products.

As a new industry, there are not established players

on whose business models we can follow or build upon.

Similarly, there is limited information about comparable companies available

for potential investors to review in making a decision about whether to invest in our company.

Furthermore, as the industrial

hemp industry is a new market, it is ripe for technological advancements that could limit or eliminate the need for our products.

Furthermore, unanticipated expenses, problems, and technical difficulties may occur and they may result in material delays in

the operation of our business, in particular with respect to our new products.

We may not be able to successfully address these

risks and uncertainties or successfully implement our operating strategies.

If we fail to do so, such failure could materially

harm our business to the point of having to cease operations and could impair the value of our common stock to the point investors

may lose their entire investment.

we acquire a business in the cannabis industry or otherwise pursues a strategic alternative, we would face additional unique and

evolving risks.

legislative development beneficial to the cannabis industry is not guaranteed

we acquire a business in the cannabis industry or otherwise pursues a strategic alternative, the success of such business would

depend on the continued development of the cannabis industry and the activity of commercial business and government regulatory

agencies within the industry.

The continued development of the cannabis industry is dependent upon continued legislative and regulatory

authorization of cannabis at the state level and a continued laissez-faire approach by federal enforcement agencies.

of factors could slow or halt progress in this area.

Further regulatory progress beneficial to the industry cannot be assured.

While there may be ample public support for legislative action, numerous factors impact the legislative and regulatory process,

including election results, scientific findings or general public events.

Any one of these factors could slow or halt progressive

legislation relating to cannabis and the current tolerance for the use of cannabis by consumers, which could adversely affect

the business we may acquire or pursue.

These changes may require us, should we acquire a business or otherwise pursues a strategic

alternative in the cannabis industry, to incur substantial costs associated with legal and compliance fees and ultimately require

us to alter our business plan.

Furthermore, violations of these laws, or alleged violations, could disrupt our business and result

in a material adverse effect on our operations.

In addition, we cannot predict the nature of any future laws, regulations, interpretations

or applications, and it is possible that regulations may be enacted in the future that will be directly applicable to the business

we may acquire or pursue.

cannabis industry could face strong opposition from other industries

believe that established businesses in other industries may have a strong economic interest in opposing the development of the

cannabis industry.

Cannabis may be seen by companies in other industries as an attractive alternative to their products, including

recreational marijuana as an alternative to alcohol, and medical marijuana as an alternative to various commercial pharmaceuticals.

Many industries that could view the emerging cannabis industry as an economic threat are well established, with vast economic

and federal and state lobbying resources.

It is possible that companies within these industries could use their resources to attempt

to slow or reverse legislation legalizing cannabis.

Any inroads these companies make in halting or impeding legislative initiatives

that would be beneficial to the cannabis industry could have a detrimental impact on our potential business.

legality of marijuana could be reversed in one or more states

is a substantial amount of change occurring in the U.S.

regarding the use of medical and recreational marijuana products.

federal law prohibits the sale and distribution of cannabis products not approved or authorized by the FDA, at least 30 jurisdictions

and the District of Columbia have enacted state laws to enable possession and use of marijuana in some form for medical purposes,

and at least ten jurisdictions for recreational purposes.

However, notwithstanding the permissive regulatory environment in some

states, marijuana continues to be classified as a Schedule I controlled substance under the federal Controlled Substances Act

and, thus, engaging in commercial activities involving such products violates federal law.

Further, the voters or legislatures

of states in which marijuana has already been legalized could potentially repeal applicable laws which permit the operation of

both medical and retail marijuana businesses.

These actions might force our potential business to cease operations in one or more

states entirely.

regulations could limit access to banking services

the use of marijuana is illegal under federal law, there is a compelling argument that banks cannot lawfully accept for deposit

funds from businesses involved with marijuana.

Consequently, businesses involved in the cannabis industry often have trouble finding

a bank willing to accept their business.

The inability to open bank accounts may make it difficult for our potential business

to operate and our reliance on cash could result in a heightened risk of theft.

Additionally, some courts have denied marijuana-related

businesses bankruptcy protection, thus, making it very difficult for lenders to recoup their investments, which may limit the

willingness of banks to lend to us.

the United States, many marijuana-related businesses are subject to a lack of adequate insurance coverage.

In addition, many insurance

companies may deny claims for any loss relating to marijuana or marijuana-related operations based on their illegality under federal

law, noting that a contract for an illegal transaction is unenforceable.

Thus, if we acquire a business or otherwise pursues a

strategic alternative in the cannabis industry, we may have a difficult time obtaining certain insurances that are desired to

operate our business, which may expose us to additional risks and financial liabilities.

Related to our Common Stock and our Company Generally

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.

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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

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of management’s attention and resources, which could adversely affect our business, operating results and financial condition.

failure to meet the continued listing requirements of The NASDAQ Capital Market 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.

common stock is listed on NASDAQ.

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.

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.

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

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such discount.

In addition, 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

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

our common stock is listed on the NASDAQ, the market for our shares has demonstrated varying levels of trading activity.

has been limited trading of our common stock in the U.S since we began trading on NASDAQ in January 2014.

Furthermore, the current

level of trading may not be sustained in the future.

The lack of an active market for our common stock may impair investors’

ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable, may reduce the fair

market value of their shares and may impair our ability to raise capital to continue to fund operations by selling shares and

may impair our ability to acquire additional intellectual property assets by using our shares as consideration.

do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any

return on their investment.

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.

have never declared or paid cash dividends on our common stock and do not expect to do so in the foreseeable future.

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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 by our Board

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 our company if you require dividend income from your investment in our company.

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.

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.

There is no guarantee that our common stock will appreciate in value.

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by our stockholders of a substantial number of shares of our common stock in the public market could occur in the future.

sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could

reduce the market price of our common stock.

may issue additional series of preferred stock that rank senior or equally to the Series C Preferred Stock as to dividend payments

and liquidation preference.

our certificate of incorporation nor the Certificate of Designation for the Series C Preferred Stock prohibits us from issuing

additional series of preferred stock that would rank senior or equally to the Series C Preferred Stock as to dividend payments

and liquidation preference.

Our certificate of incorporation provides that we have the authority to issue up to 50,000,000 shares

of preferred stock, no shares of which are outstanding prior to this offering.

The issuances of other series of preferred stock

could have the effect of reducing the amounts available to the Series C Preferred Stock in the event of our liquidation, winding-up

or dissolution.

It may also reduce cash dividend payments on the Series C Preferred Stock if we do not have sufficient funds to

pay dividends on all Series C Preferred Stock outstanding and outstanding parity preferred stock.

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

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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 our company 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.

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

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

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’

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.

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