What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2021-03-01 compared with 2020-03-25 · 727 added, 482 removed, 8 unchanged (99% of the section changed)

were incorporated in 1989 in the state of New Jersey.

Our principal executive offices are located at 201 Grove Road, Thorofare,

New Jersey USA 08086 and our telephone number is (856) 848-8698.

Our corporate website address is www.akersbio.com.

March 23, 2020, we entered into a Membership Interest Purchase Agreement (the “MIPA”) with the members of Cystron

Biotech, LLC (individually, each a “Seller,”

and collectively, the “Sellers”), pursuant to which the Company

will acquire 100% of the membership interests (the “Membership Interests”) of Cystron Biotech, LLC (“Cystron”).

Cystron is a party to license agreement with Premas Biotech PVT Ltd (“Premas) whereby Premas granted Cystron, amongst other

things, an exclusive license with respect to Premas’

vaccine platform for the development of a vaccine against COVID-19

and other corona virus infections.

also develop, manufacture, and supply rapid, point-of-care screening and testing products designed to bring health-related

information directly to the patient or clinician in a timely and cost-efficient manner.

We believe that we have advanced the science

of diagnostics through the development of several proprietary platform technologies.

Our current product offerings focus on delivering

diagnostic assistance in a variety of healthcare fields/specialties, including diagnostic rapid manual point-of-care tests for

the detection of allergic reactions to Heparin and for on- and off-the-job alcohol safety initiatives.

While we continue to

sell our rapid, point-of-care screening and testing products, as of December 31, 2019, we eliminated our sales force and we are

also experiencing a production backlog for some our diagnostic products as further described below.

We are exploring ways to revitalize

our screening and testing products business, but, for the time being, we also intend to focus our efforts on the business of Cystron

and our exploration of strategic alternatives in the cannabinoid space announced in November 2019 and as further described below.

were incorporated in 1989 in the state of New Jersey under the name “A.R.C.

Enterprises, Inc,”

which was changed to

“Akers Research Corporation”

on September 28, 1990 and “Akers Laboratories, Inc.”

on February 24, 1996.

Pursuant to the Amended and Restated Certificate of Incorporation filed on March 26, 2002, the corporation’s name was changed

to “Akers Biosciences, Inc.”

were historically a developer of rapid health information technologies.

On March 23, 2020, we entered into that certain membership

interest purchase agreement (the “Original MIPA”

and, as subsequently amended by Amendment No, 1 on May 14, 2020,

the “MIPA”) with the members of Cystron (the “Cystron Sellers”), pursuant to which we acquired 100% of

the membership interests of Cystron (the “Cystron Membership Interests”).

Cystron was incorporated on March 10, 2020

and is a party to a license agreement with Premas whereby Premas granted Cystron, among other things, an exclusive license with

respect to Premas’

genetically engineered yeast (S.

cerevisiae)-based vaccine platform, D-Crypt™, for the development

of a vaccine against COVID-19 and other coronavirus infections.

Since our entry into the MIPA, we have been primarily focused

on the rapid development and manufacturing of a COVID-19 vaccine candidate (the “COVID-19 Vaccine Candidate”), in

collaboration with Premas.

November 11, 2020, we entered into the Merger Agreement, pursuant to which, among other things, subject to the satisfaction or

waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into MYMD, with MYMD being the surviving

corporation and becoming a wholly owned subsidiary of the Company (the “Merger”).

The Merger is intended to qualify

for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code

of 1986, as amended (the “Code”).

In addition, in connection with the execution of the Merger Agreement, Akers agreed

to advance a bridge loan of up to $3,000,000 to MYMD pursuant to a secured promissory note (the “Note”).

Upon completion

of the merger, the combined company is expected to be renamed MyMD Pharmaceuticals, Inc.

to the Merger Agreement, upon the effectiveness of the Merger, (i) holders of outstanding shares of MYMD common stock (“

MYMD stockholders”) will be entitled to receive (x) the number of shares of Akers common stock equal to an exchange ratio

as described in the Merger Agreement (the “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 aggregate

cash proceeds received by Akers from the exercise of any options to purchase shares of MYMD common stock assumed by Akers upon

closing of the merger prior to the second-year anniversary of the closing of the merger (the “Option Exercise Period”),

such payment (the “Additional Consideration”) 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 payments (“Milestone Shares”) of up to the number of shares

of Akers common stock issued to MYMD stockholders at closing of the Merger (“Milestone Payments”) payable upon achievement

of certain market capitalization milestone events during the 36-month period immediately following the closing of the merger (the

“Milestone Period”);

and (ii) each outstanding option to purchase MYMD common stock granted under the Second Amendment

to Amended & Restated 2016 Stock Incentive Plan with an effective date of July 1, 2019, as established and maintained by MYMD

(and, as amended and restated from time to time, 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 the 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.

the exercise in full of the outstanding pre-funded warrants to purchase 1,040,540 shares of our common stock (“Pre-Funded

Warrants”) issued in connection with the private placement between Akers and certain institutional and accredited investors

that closed on November 17, 2020 (the “Private Placement”) and the exercise in full of additional pre-funded warrants

to purchase 932,432 shares of common stock issued certain investors in February 2021 upon cancellation of shares of common stock

purchased in 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 restricted stock units (“RSUs”)

immediately prior to the Merger will own approximately 20% of the equity of the combined company.

to the Merger Agreement, on January 15, 2020, we and MYMD filed an initial Registration Statement on Form S-4 (Registration No.

333-252181) (together with the joint proxy and consent solicitation/prospectus included therein, the “S-4 Registration Statement”)

describing the Merger and other related matters.

Consummation of the Merger is conditioned upon, among other things, approval

of the Merger by the stockholders of Akers (including (i) approval, for purposes of complying with Nasdaq Listing rule 5635(a),

the issuance of shares of Akers common stock to MYMD stockholders and other parties in connection with the Merger, the Merger

Agreement, and the transactions contemplated thereby or in connection therewith (the “Share Issuance Proposal”), (ii)

approval of an amendment to the amended and restated certificate of incorporation of the combined company, which will be in effect

at the effective time of the merger (the “A&R Charter”) to effect a reverse stock split, if applicable, at a reverse

stock split ratio mutually agreed by the Company and MYMD and within the range approved by our stockholders immediately prior

to the Effective Time (as defined in the Merger Agreement), which range shall be sufficient to cause the price of our common

stock on the Nasdaq Capital Market following the reverse stock split and the Effective Time to be no less than $5.00 per share

with respect to the issued and outstanding common stock of the combined company immediately following the merger (the “Reverse

Stock Split Proposal”), and (iii) approval of the amended and restated certificate of incorporation of Akers which will

be in effect upon consummation of the Merger (the “A&R Charter Proposal”), among others), approval of the Merger

by the stockholders of MYMD, the continued listing of Akers’

common stock on The Nasdaq Capital Market after the Merger

and satisfaction of a minimum cash threshold by Akers.

In addition, the Merger Agreement requires that MYMD consummate the purchase

of substantially all of the assets and certain liabilities of Supera Pharmaceuticals, Inc., a Florida corporation (“Supera”)

pursuant to an Asset Purchase Agreement pursuant to which MYMD agreed to acquire from Supera, immediately prior to the completion

of the Merger, substantially all of its assets (the “Supera Purchase”).

After closing of the Merger, the operations

of MYMD’s business will comprise substantially all of the combined company’s operations.

There 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.

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

and COVID-19 Pandemic

December 2019, SARS-CoV-2 was reported to have surfaced in Wuhan, China, and on March 12, 2020, the World Health Organization

(“WHO”) declared the global outbreak of COVID-19, the disease caused by SARS-CoV-2, to be a pandemic.

to contain and mitigate the spread of COVID-19, many countries, including the United States, Canada, China, and India, have imposed

unprecedented restrictions on travel, quarantines, and other public health safety measures.

According to the WHO situation report,

dated as of February 16, 2021, approximately 108.2 million cases were reported globally and 2.4 million of

these were deadly, making the development of effective vaccines to prevent this disease a major global priority.

Multiple vaccine

candidates against SARS-CoV-2 are under development, and in December 2020, certain large, multinational pharmaceutical companies

were granted authorizations for emergency use by the FDA.

Widespread distribution of the currently-available vaccines has begun

pursuant to Operation Warp Speed, a partnership among components of the U.S.

Department of Health and Human Services, the Centers

for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority,

and the Department of Defense, as well as certain private firms and other federal agencies.

The treatments for COVID-19, including

symptomatic and supportive therapies, among other things, continue to be updated on a rolling basis by healthcare authorities

and agencies.

of the COVID-19 Pandemic on Our Business

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

These include but are not limited to the duration of the COVID-19 pandemic, new information which may emerge concerning the severity

of the COVID-19 pandemic, and any additional preventative and protective actions that regulators, or our board of directors or

management, may determine are needed.

We do 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 have implemented work-from-home policies for many of our employees and temporarily

modified 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 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.

addition, while the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict,

it has significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future

negatively affect our liquidity.

A recession or market correction resulting from the continuation of the COVID-19 pandemic could

materially affect our business and the value of our common stock.

Vaccine Development

have partnered with Premas on the development of the COVID-19 Vaccine Candidate as we seek to advance such candidate through the

regulatory process, both with the U.S.

Food and Drug Administration (“FDA”) and the office of the drug controller

Premas is primarily responsible for the development of the COVID-19 Vaccine Candidate through proof of concept and is

entitled to receive milestone payments upon achievement of certain development milestones through proof of concept.

Premas’

D-Crypt platform has been developed to express proteins that are difficult to clone, express and manufacture and are a key component

in vaccine development.

Premas has identified three major structural proteins of SARS-CoV-2 as antigens for potential vaccine

candidates for COVID-19:

spike protein or S protein, envelope protein or E protein, and membrane protein or M protein.

2020, Premas used its D-Crypt platform to recombinantly express all three of such antigens, which we considered a significant

milestone for development of a triple antigen vaccine.

We believe including a combination of all three antigens will provide advantages

against the likelihood of protein mutation, in which case a single-protein vaccine can be rendered non-efficacious, and therefore,

enhance efficacy of our vaccine candidates.

We believe the D-Crypt provides us advantages in vaccine production and manufacturing,

as the technology platform is highly scalable with a robust process, which we expect will ultimately result in significant cost

savings compared to other similar vaccine platforms.

Based on genetically engineered baker’s yeast S.

cerevisiae, the platform

is highly scalable into commercial production quantities and has been previously utilized for the production of multiple human

and animal health vaccines candidates during its 10-year development track record.

Yeast has a large endoplasmic reticulum, or

(“ER”), which is a desirable attribute for expressing membrane protein.

In complex cells, ER is where the protein

The larger the surface, the more membrane protein that can attach to the ER inside the cell.

Yeast is also generally

believed to be easily manipulated and allow for results to be gathered quickly.

Yeast multiplies faster than mammalian cells and

is cheaper to work with than mammalian systems, which are much more complex and slower to grow comparatively.

Yeast has received

“Generally Recommended as Safe”

status from the FDA.

of May 14, 2020, Premas successfully completed its vaccine prototype and obtained transmission electron microscopic (“TEM”)

images of the recombinant virus like particle (“VLP”) assembled in yeast.

A manufacturing protocol has also been established

and large-scale production studies have been initiated for our COVID-19 Vaccine Candidate.

Though the prototype is complete, the

COVID-19 Vaccine Candidate is still in early stages of development, and, accordingly, must undergo pre-clinical testing and all

phases of clinical trials before we can submit a marketing application (in this case, a Biologics License Application, or “BLA”)

The BLA must be approved by the FDA before any biological product, including vaccines, may be lawfully marketed in

the United States.

We believe the most pivotal, yet difficult, stage in our anticipated development of the contemplated COVID-19

Vaccine Candidate is the requisite conduct of extensive clinical trials to demonstrate the safety and efficacy of our COVID-19

Vaccine Candidate.

Additionally, after we complete the necessary pre-clinical testing, but before we may begin any clinical studies

in the United States, we must submit an Investigational New Drug (“IND”) application to the FDA, as this is required

before any clinical studies may be conducted in the United States.

In some cases, clinical studies may be conducted in other countries;

however, the FDA may not accept data from foreign clinical studies in connection with a BLA (or other marketing application) submission.

July 2020, animal studies for our COVID-19 Vaccine Candidate were initiated in India.

In addition, we announced that Premas has

successfully completed the manufacturing process for the VLP vaccine candidate.

On August 27, 2020, we announced with Premas positive

proof of concept results from the animal studies conducted during a four-week test of the COVID-19 Vaccine Candidate in mice.

The test had two primary endpoints, safety and immune responses, both of which were met.

The study consisted of 50 mice, divided

into 10 cohorts dosed with 5, 10 and 20 micrograms of the COVID-19 Vaccine Candidate.

The COVID-19 Vaccine Candidate was generally

well tolerated and safe at all doses, with no adverse events reported.

The COVID-19 Vaccine Candidate was safe even at higher

doses and generated a robust immune response against the three SARS-Cov2 antigens, S, E, and M.

The COVID-19 Vaccine Candidate

elicited neutralizing antibody titers levels in all the dose cohorts starting from 5 microgram to 20 microgram dose regimens.

After three doses in mice, all the groups’

cohorts showed binding antibody levels similar to convalescent patients’

Clinical testing is expensive, time consuming, and uncertain as to outcome.

We cannot guarantee that any clinical trials

will be conducted as planned or completed in a timely manner, if at all.

Failures in connection with one or more clinical trials

can occur at any stage of testing.

owns, and has exclusively licensed rights to us to, two provisional Indian patent applications filed in January and March 2020.

The scope of these Indian provisional patent applications is directed, respectively, to (i) a platform for the expression of difficult

to express proteins (“DTE-Ps”), which might provide coverage for a method of making the to-be-developed vaccine;

(ii) an expression platform for SARS-CoV-2-like virus proteins, methods relevant thereto, and a relevant vaccine.

If non-provisional

patent rights are pursued claiming priority to each of these two provisional applications, any resulting patent rights that issue

might not expire until approximately January 20, 2041 and March 4, 2041, if all annuities and maintenance fees are timely paid.

The expiration dates may be extendable beyond these dates depending on the jurisdiction and the vaccine development process.

we do not own the patents or patent applications that we license, we may need to rely upon Premas to properly prosecute and maintain

those patent applications and prevent infringement of those patents.

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

companies as well as academic and research institutions pursing 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.

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 COVID-19

vaccine as soon as possible, including large, multinational pharmaceutical companies such as AstraZeneca, GlaxoSmithKline, Johnson

& Johnson, Moderna, Pfizer, and Sanofi.

In December 2020, the FDA issued 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

have vaccine candidates that are currently at a more advanced stage of development than our COVID-19 Vaccine Candidate and 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 be approved to be marketed.

Should 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 the

commercial or clinical advantage over competitors’

products that we believe we currently possess.

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

and License Agreements

March 23, 2020, we acquired Cystron pursuant to the MIPA.

consideration for the Membership Interests, we will deliver to the Sellers:

(1) that number of newly issued shares of our common

stock equal to 19.9% of the issued and outstanding shares of our common stock and pre-funded warrants as of the date of the MIPA,

but, to the extent that the issuance of the our common stock would result in any Seller owning in excess of 4.9% of our outstanding

common stock, then, at such Seller’s election, such Seller may receive “common stock equivalent”

preferred shares

with a customary 4.9% blocker (with such common stock and preferred stock collectively referred to as “Common Stock Consideration”),

and (2) $1,000,000 in cash.

As consideration for the Cystron Membership Interests, we delivered

to the Cystron Sellers:

(1) that number of newly issued shares of our common stock equal to 19.9% of the issued and outstanding

shares of our common stock and pre-funded warrants as of the date of the MIPA, but, to the extent that the issuance of our common

stock would have resulted in any Seller owning in excess of 4.9% of our outstanding common stock, then, at such Seller’s

election, such Seller received “common stock equivalent”

preferred shares with a customary 4.9% blocker (with such

common stock and preferred stock collectively referred to as “Common Stock Consideration”), and (2) $1,000,000 in

On March 24, 2020, we paid $1,000,000 to the Cystron Sellers and delivered 411,403 shares of common stock and 211,353 shares

of Series D Convertible Preferred Stock with a customary 4.9% blocker, with an aggregate fair market value of $1,233,057.

Additionally,

we shall (A) make an initial payment to the Sellers of up to $1,000,000 upon our receipt of cumulative gross proceeds from the

consummation of an initial equity offering after the date of the MIPA of $8,000,000, and (B) pay to Sellers an amount in cash

equal to 10% of the gross proceeds in excess of $8,000,000 raised from future equity offerings after the date of the MIPA until

the Sellers have received an aggregate additional cash consideration equal to $10,000,000.

Upon the achievement of certain milestones,

including the completion of a Phase 2 study for a COVID-19 vaccine that meets its primary endpoints, Sellers will be entitled

to receive an additional 750,000 shares of our common stock or, in the event we are unable to obtain stockholder approval for

the issuance of such shares, 750,000 shares of non-voting preferred stock that are valued following the achievement of such milestones

and shall bear a 10% annual dividend (the “Milestone Shares”).

Sellers will also be entitled to contingent payments

from us of up to $20,750,000 upon the achievement of certain milestones, including the approval of a new drug application by the

Food and Drug Administration (“FDA”).

shall also make quarterly royalty payments to Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination product

by the Company (the “COVID-19 Vaccine”) for a period of five (5) years following the first commercial sale of the

COVID-19 Vaccine;

provided, that such payment shall be reduced to 3% for any net sales of the COVID-19 Vaccine above $500 million.

addition, Sellers shall be entitled to receive 12.5% of the transaction value, as defined in the MIPA, of any change of control

transaction, as defined in the MIPA, that occurs prior to the fifth (5th) anniversary of the closing date of the MIPA, provided

that the Company is still developing the COVID-19 Vaccine at that time.

Following the consummation of any change of control transaction,

the Sellers shall not be entitled to any payments as described above under the MIPA.

we are required to (A) make an initial payment to the Cystron Sellers of up to $1,000,000 upon its receipt of cumulative gross

proceeds from the consummation of an initial equity offering after the date of the MIPA of $8,000,000, and (B) pay to the Cystron

Sellers an amount in cash equal to 10% of the gross proceeds in excess of $8,000,000 raised from future equity offerings after

the date of the MIPA until the Cystron Sellers have received an aggregate additional cash consideration equal to $10,000,000 (collectively,

the “Equity Offering Payments”).

On May 14, 2020, we entered into an Amendment No.

1 to the MIPA with the Cystron

Sellers, which provided that any Equity Offering Payments in respect of an equity offering that is consummated prior to September

23, 2020, shall be accrued, but shall not be due and payable until September 24, 2020.

The other provisions of the MIPA remained

unmodified and in full force and effect.

Upon the achievement of certain milestones, including the completion of a Phase 2 study

for a COVID-19 Vaccine Candidate that meets its primary endpoints, the Cystron Sellers are entitled to receive an additional 750,000

shares of our common stock or, in the event we are unable to obtain stockholder approval for the issuance of such shares, 750,000

shares of non-voting preferred stock that are valued following the achievement of such milestones and shall bear a 10% annual

dividend (the “Cystron Milestone Shares”).

At the 2020 annual meeting of our stockholders, held on August 27, 2020,

pursuant to Nasdaq listing rule 5635(a), our stockholders approved of the issuance of Common Stock Consideration (as defined in

the MIPA) and the potential future issuance of Cystron Milestone Shares in excess of 20% of our common stock outstanding prior

to the closing of the Cystron acquisition.

Pursuant to the

MIPA, the Company shall make contingent payments for the achievement of certain development and commercial milestones as follows;

(i) $250,000 upon the dosing of the first patient in a Phase I Clinical Trial, (ii) $500,000 upon the dosing of the first patient

in a Phase II Clinical Trial, (iii) $5,000,000 upon the dosing of the first patient in a Phase III Clinical Trial, and (iv) $15,000,000

upon approval by the FDA of the NDA for the COVID-19 vaccine.

to the Original MIPA, upon our consummation of the registered direct equity offering closed on April 8, 2020, we paid the Cystron

Sellers $250,000 on April 20, 2020 (the “April Payment”).

On April 30, 2020, Premas, one of the Cystron Sellers, returned

to us $83,334, representing their portion of the $250,000 amount paid to the Cystron Sellers on April 20, 2020.

Premas advised

us that these funds were returned temporarily for Premas to meet certain regulatory requirements in India.

We recorded liabilities

of $892,500 (the “May Payment”) and $684,790 (the “August Payment”) to the Cystron Sellers upon the consummation

of the registered direct equity offerings that closed on May 18, 2020 and August 13, 2020, respectively.

These funds (including

funds of $299,074 representing Premas’

portion of the cash purchase price and $83,334 representing Premas’

of the April Payment temporarily returned to us in April 2020) due the sellers under the MIPA were disbursed on September 25,

On October 13, 2020, Premas returned $908,117 representing Premas’

portion of the initial cash component for the purchase

of Cystron and Premas’

portion of the April Payment, May Payment and August Payment under the MIPA.

is working with the Reserve Bank of India to comply with regulations related to its ownership in a foreign entity and its ability

to receive funds for the sale of that entity.

The Company believes that (i) Premas will be successful in its efforts to resolve

such regulatory matters with the Reserve Bank of India, (ii) the Company will disburse the amounts due to Premas under the MIPA,

and (iii) the Company maintains a 100% membership interest in Cystron.

the consummation of the Private Placement, the Company paid

$1,204,525 of the proceeds from the Private Placement to three of the four former members of Cystron and recorded a liability

of $602,172 to the fourth former member of Cystron pursuant to the MIPA.

shall also make quarterly royalty payments to the Cystron Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination

product by us for a period of five (5) years following the first commercial sale of the COVID-19 vaccine;

provided, that such

payment shall be reduced to 3% for any net sales of the COVID-19 vaccine above $500 million.

addition, the Cystron Sellers shall be entitled to receive 12.5% of the transaction value, as defined in the MIPA, of any change

of control transaction, as defined in the MIPA, that occurs prior to the fifth (5th) anniversary of the closing date of the MIPA,

provided that we are still developing the COVID-19 Vaccine Candidate at that time.

Following the consummation of any change of

control transaction, the Cystron Sellers shall not be entitled to any payments as described above under the MIPA.

March 23, 2020, as an inducement to enter into the MIPA, and as one of the conditions to the consummation of the transactions

contemplated by the MIPA, the Sellers entered into a shareholder voting agreement with the Company (the “Support Agreement”),

pursuant to which each Seller agreed to vote their shares of our common stock or preferred stock in favor of each matter proposed

and recommended for approval by our management at every meeting of the stockholders and on any action or approval by written consent

of the stockholders.

contemplated by the MIPA, the Cystron Sellers entered into a shareholder voting agreement with us, pursuant to which each Cystron

Seller agreed to vote their shares of our common stock or preferred stock in favor of each matter proposed and recommended for

approval by our management at every meeting of the stockholders and on any action or approval by written consent of the stockholders.

Rights Agreement

induce the Sellers to enter into the MIPA, on March 23, 2020, we entered into a registration rights agreement (the “Registration

Rights Agreement”) with the Sellers, pursuant to which we shall by the 30th day following the closing of the transactions

contemplated by the MIPA, file with the United States Securities and Exchange Commission (the “SEC”) an initial Registration

Statement on Form S-3 (if such form is available for use by the Company at such time) or, otherwise, on Form S-1, covering all

of the shares of our common stock issued, or underlying the preferred stock issued, at closing under the MIPA and to subsequently

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

(“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 vaccine against

COVID-19 and other corona virus infections.

induce the Cystron Sellers to enter into the MIPA, on March 23, 2020, we entered into a registration rights agreement with the

Cystron Sellers, pursuant to which we filed with the SEC a Registration Statement on Form S-3, as amended, covering resale of

the Common Stock Consideration, which was declared effective on June 12, 2020.

We also agreed to subsequently register Cystron

Milestone Shares, if such securities are issued in the future.

is a party to the 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.

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 vaccine against COVID-19 and other coronavirus

the achievement of certain developmental milestones by Cystron, Cystron shall pay to Premas a total of up to $2,000,000.

D Convertible Preferred Stock

March 24, 2020, we filed the Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred

Stock (the “Certificate of Designation”) with the Secretary of State of the State of New Jersey.

Pursuant to the Certificate

of Designation, in the event of the Company’s liquidation or winding up of its affairs, the holders of our Series D Convertible

Preferred Stock (the “Preferred Stock”) will be entitled to receive the same amount that a holder of our common stock

would receive if the Preferred Stock were fully converted (disregarding for such purposes any conversion limitations set forth

in the Certificate of Designation) to common stock which amounts shall be paid pari passu with all holders of the Company’s

common stock.

Each share of Preferred Stock has a stated value equal to $0.01 (the “Stated Value”), subject to increase

as set forth in Section 7 of the Certificate of Designation.

holder of Preferred Stock is entitled at any time to convert any whole or partial number of shares of Preferred Stock into shares

of our common stock determined by dividing the Stated Value of the Preferred Stock being converted by the conversion price of

$0.01 per share.

holder of Preferred Stock will be prohibited from converting Preferred Stock into shares of our common stock if, as a result of

such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of our common

stock then issued and outstanding (with such ownership restriction referred to as the “Beneficial Ownership Limitation”).

However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any

increase in such percentage shall not be effective until 61 days after such notice to us.

to the Beneficial Ownership Limitation, on any matter presented to our stockholders for their action or consideration at any meeting

of our stockholders (or by written consent of stockholders in lieu of a meeting), each holder of Preferred Stock will be entitled

to cast the number of votes equal to the number of whole shares of our common stock into which the shares of Preferred Stock beneficially

owned by such holder are convertible as of the record date for determining stockholders entitled to vote on or consent to such

matter (taking into account all Preferred Stock beneficially owned by such holder).

Except as otherwise required by law or by

the other provisions of our certificate of incorporation, the holders of Preferred Stock will vote together with the holders of

our common stock and any other class or series of stock entitled to vote thereon as a single class.

holder of Preferred Stock shall be entitled to receive dividends as and when paid to the holders of our common stock on an as-converted

Backlog of PIFA®

Heparin/PF4 and PIFA®

We are currently experiencing

a production backlog of our PIFA®

Heparin/PF4 and PIFA®

Pluss/PF4 rapid assays.

While we believe that we will be able

to remedy the production backlog, we cannot be certain what impact this backlog will have on our business and it may have an adverse

effect on our 2020 revenues and results of operation.

of Strategic Alternatives

November 7, 2018, we announced that our board of directors had initiated a process to evaluate strategic alternatives to maximize

shareholder value.

The Company will continue its strategic alternatives review and has identified the hemp and minor cannabinoid

sectors as potential opportunities that could benefit from our core competencies.

The Company continues 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

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

The 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.

Current Products

are commercialing our Particle Immuno-Filtration Assay (PIFA®)

Technology platform.

technology is a patented immunoassay method which rapidly and accurately detects target antigens

or antibodies.

It is the technology platform utilized in the Company’s core commercialized products, the PIFA®

and PIFA®

Pluss/PF4 rapid assays, which test for an allergic reaction to Heparin.

These products account for the significant

majority of the Company’s current revenues.

portfolio also includes the manufacture and sale of BreathScan Alcohol Detectors (based on the Company’s Micro Particle

Catalyzed (MPC) Biosensor technology platform).

In September 2019, we determined that it was no longer economically appropriate

to offer our Tri- Cholesterol products (which was based on the Company’s Rapid Enzymatic Assay (REA™) technology platform).

Furthermore, we determined that it was not economically appropriate to further develop or pursue approval of the PIFA PLUSS Chlamydia

Rapid Assay device.

As of December 31, 2019, the Company’s marketed products consist of its PIFA®

Heparin/PF4, PIFA

PF4 and BreathScan Alcohol Detector families of products.

of Akers’

rapid, single-use tests are performed in vitro (outside the body) and are designed to enhance patient well-being

and reduce the cost of healthcare.

Our current product offerings focus on delivering diagnostic assistance in a variety of healthcare

fields/specialties, including diagnostic rapid manual point-of-care tests for the detection of allergic reactions to Heparin and

for on- and off-the-job alcohol safety initiatives.

believes that low-cost, single-use testing not only saves time and money, but allows for more frequent, near-patient testing which

may save lives.

We believe that our FDA-cleared rapid diagnostic tests help facilitate targeted diagnoses and real-time treatment.

We also believe that our rapid diagnostic tests surpass most other current diagnostic products with their flexibility, speed,

ease-of-use, readability, low cost and accuracy.

In minutes, detection of a medical condition can be performed on single-patient

specimens without sacrificing accuracy.

believe the use of rapid tests, which can be performed at the point-of-care when and where the patient is being consulted, can

result in immediate diagnostic decisions and subsequent treatment regimens and is an important development in the practice of

Point-of-care testing addresses today’s challenges in the healthcare industry, such as:

pressures/efficiency of healthcare delivery;

for easy to use, accurate at-home tests for individuals to monitor their personal health and wellness

strategy for the medical device business is to leverage where possible our distributor relationships, while exploring strategies

for further reducing our costs.

has developed and currently maintains strategic relationships with established companies in the clinical laboratory market.

Testing Platform Technologies

ImmunoFiltration Assay (PIFA ®

technology is an accurate, rapid, immunoassay ( a procedure for detecting or measuring specific proteins or

other substances through their properties as antigens or antibodies ) method based on the selective filtration of dyed microparticles

coated with antigen or antibody.

The microparticles are combined with a test sample (whole blood or serum) within a self-contained

If a patient tests positive for the antibody or antigen, a binding event will occur and the dyed microparticles will be

trapped by a filter within the device.

As a result, the test window will be void of any color.

Conversely, if the patient tests

negative, the dyed microparticles will flow freely into the test window.

Specific to the PIFA Heparin tests, we have two international

patents and one US patent granted in force.

Biosensor Technology

MicroParticle

Catalyzed Biosensor (“MPC Biosensor”) Technology permits the rapid identification of medical conditions through biomarkers

in exhaled breath.

MPC Biosensor-based products contain microparticles that change color to indicate a positive test result.

microparticles are coated with agents that both decrease the time to result and exhibit a more defined color change when appropriate.

MPC Biosensor-based products are packaged in small, disposable cartridges through which test subjects can easily blow for several

Sample Preparation Technology

Blood Cell Separation Technology

Rapid Blood Cell Separation (“Separator”) Technology, labeled under the brand name seraSTAT ®

accelerates the rate at which a test result is obtained as the often-required sample preparation step is abbreviated drastically.

Conventional methods of blood cell separation are labor-intensive and time-consuming, typically involving blood collection and

laboratory personnel, as well as electrically-powered centrifuges and other specialized equipment.

The disposable Separator device

requires only a small-volume blood sample obtained through a venous blood draw.

Akers has obtained the appropriate US FDA regulatory

clearances for seraSTAT ®

as a stand-alone device and the technology is currently integrated into PIFA PLUSS PF4

The seraSTAT ®

Rapid Blood Cell Separation Technology is currently protected by two U.S.

patents and three

international patents.

Product Portfolio

is positioned as a provider of rapid diagnostic solutions.

present, Akers’

commercialized product portfolio incorporates the three aforementioned proprietary platform testing and

sample preparation technologies:

, MPC Biosensor and Rapid Blood Cell Separation Technology.

following table sets forth our marketed products, identifies the appropriate “prescription use”

or “OTC”

designation and the required clearance that has been obtained.

marketed products include:

Marketed/Pipe

Obtained/Needed

breath alcohol detector

Heparin/PF4 & PIFA PLUSS ®

tests for Heparin/PF4 antibodies to detect an allergy to the widely used blood thinner, Heparin

Blood Cell Separator, marketed under the brand name seraSTAT ®

, further accelerates the rate at which a test

result is obtained as the often-required sample preparation step is abbreviated drastically.

core products marketed under the PIFA ®

platform are the PIFA ®

Heparin/PF4 Rapid Assay, and the

PIFA PLUSS ®

Heparin/PF4 Rapid Assay and PIFA PLUSS ®

PF4 remain the only FDA-cleared rapid manual assays that

quickly determine if a patient being treated with the blood thinner Heparin may be developing a drug allergy.

This clinical syndrome,

referred to as Heparin-Induced Thrombocytopenia (“HIT”), reverses the Heparin’s intended therapeutic effect

and transforms it into a clotting agent.

Patients with HIT are at risk of developing limb- and life-threatening complications,

so the timely test result provided by Akers’

Heparin/PF4 devices is paramount to effective clinical decision making.

largest at-risk populations are patients undergoing major cardiac or orthopedic surgical procedures.

It is estimated that up to

50% of cardiac surgery patients develop HIT-antibodies.

Given the size of the aging baby boomer market segment and the prevalence

of cardiac disease, surgeries within this category is expected to increase, as would the potential demand for our convenient,

Heparin/PF4 Rapid Assay improves the standard of care in HIT-testing with its result delivered in less than

five minutes after the patient sample has been prepared.

Traditional methods required the use of expensive equipment, specialized

laboratory personnel and hours of technician time to complete the 20+ assay test procedure in-house.

Clinicians were subjected

to a 24-to-72 hour turnaround time if the HIT-antibody determination was outsourced to a reference laboratory.

Especially in the

latter scenario, the patient information obtained is retrospective in nature as the HIT-antibody result cannot be factored into

time-sensitive diagnostic and treatment decisions.

have also introduced PIFA PLUSS ®

hospitals to further improve the rate at which healthcare professionals

can obtain a HIT-antibody result.

This PIFA ®

line extension merges the ease-of-use of the PIFA testing platform

with Akers’

recently patented Rapid Blood Cell Separation Technology, marketed under the brand name seraSTAT ®

The marriage of these two technologies condenses the sample preparation and analysis procedures as the precise micro-volume of

a seraSTAT ®

-prepared patient specimen is delivered directly into the PIFA ®

cassette for immediate

This eliminates an additional one-hour of sample processing time and the need for healthcare personnel to have access

to a centrifuge to separate the liquid fraction of blood from the cellular fraction.

As a result, HIT-testing can be initiated

and completed at or near the point-of-care, especially in emergency and critical care departments where time-efficient diagnostic

results can drastically improve patient outcomes.

the appropriate regulatory clearances have been obtained in the United States for these products, we do not anticipate needing

to fund additional clinical trials to facilitate product marketing domestically.

In addition, the current technical file that

has been assembled for seraSTAT ®

and PIFA PLUSS PF4 ®

will also be used to support Akers’

CE-marking self-certification process for potential sales in the EU;

the PIFA Heparin/PF4 Rapid Assay is already CE-marked.

Biosensor Technology

Alcohol Products

originated the disposable breath alcohol detector category and was the first single-use breathalyzer to obtain

the FDA 510(k) clearance in 2006 for Over-the-Counter use required to facilitate sales to U.S.

CE certification is

not required to market the product in the EU because BreathScan ®

results are not used to diagnose any medical

Our breath alcohol detector technology was granted an Australian Standard certification trademark, which cleared the

commercial pathway for product sales in Australia, New Zealand, and South Africa.

disposable breath alcohol detectors are available in versions designed to detect .02%, .04%, .05% and .08% blood alcohol concentrations

(“BACs”) and provide users with a test result in two minutes.

If the crystals in the interior of the device change

from yellow to aqua, the user has tested positive for the specific alcohol level.

Should the crystals remain yellow, the result

Preparation Technology

Blood Cell Separation Technology

addition to our testing platforms, Akers’

patented Rapid Blood Cell Separation (“Separator”) Technology, marketed

under the brand name seraSTAT ®

, which further accelerates the rate at which a test result is obtained as the

often-required sample preparation step is abbreviated drastically.

Conventional methods of blood cell separation are labor-intensive

and time-consuming, typically involving blood collection and laboratory personnel, as well as electrically-powered centrifuges

and other specialized equipment.

required micro-volume specimen of serum or plasma is immediately extracted and introduced into a rapid assay device for real-time

The savings afforded by the Separator device can be measured in time and cost given its quick turn-around-time and straightforward,

easy-to-master procedure.

seraSTAT ®

is integrated into PIFA PLUSS PF4 devices.

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, new 510(k) clearances or PMA

approvals were 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.

The seraSTAT ®

Cell Separation Technologies is currently protected by two United States patents (7,896,167;

8,097,171) and one international

patent (JP 4,885,134).

of Akers include other companies developing and marketing rapid, point-of-care diagnostic devices and companies with dedicated

laboratory instruments and/or automated test systems.

We face intense competition from companies with dominant market positions

within the in vitro diagnostic testing market such as Abbott, ACON Laboratories, Inc., Immucor, Inc., OraSure Technologies,

Inc., and Quidel Corporation.

believe the primary criteria for determining competitiveness within the rapid point-of-care sector are cost, ease-of-use, speed,

readability, accuracy and flexibility.

said, our competitors have significantly greater financial, technical, marketing and other resources than we have and may be better

to new technologies or technical standards;

resources to the development, production, promotion, support and sale of products;

other companies to gain new technologies or products that may displace our product lines;

to changing customer requirements and expectations;

market and sell products;

a broad range of competitive products at lower prices.

principal competitors are able to leverage their broader product portfolios and dominant market positions in some segments by,

for example, bundling their products into specially priced packages that create strong financial incentives for their customers

to purchase their products.

These practices may negate savings customers would gain from buying select products from Akers and

may deter such customers from buying Akers’

We expect competition in the markets in which we participate to continue

to increase as existing competitors improve or expand their product offerings.

We Generate Revenue

revenue comes from selling rapid, screening and testing products, largely through our distributor networks.

Most of our assays

are used in the clinical laboratory to ultimately help healthcare professionals to diagnose a medical condition or complication

that may require treatment.

Other products can be sold over-the-counter, to the general public, to help assess an individual’s

status as it relates to his/her blood alcohol level.

Current Markets

our test for the heparin drug allergy, the testing market largely resides within the clinical hospital laboratories of medical

markets for alcohol breathalyzers are reached through a network of large and small distributors.

These markets include industrial

safety, education, social responsibility and retail.

pharmaceutical and biotechnology companies are seeking to develop vaccines and other treatments for COVID-19.

Several of them

are large, multi-national pharmaceutical companies with significantly more resources than us.

Manufacturing

and Suppliers

are a vertically integrated manufacturer, producing substantially all of our devices in-house.

The vast majority of our products

start out as high quality, medical grade polymers and exit our facilities as fully manufactured and packaged medical devices.

As a result, we have a short supply line between our raw materials and finished goods which gives us greater control over our

product quality.

The downside of our in-house manufacturing is the requirements for facilities, personnel, and equipment.

approach also requires mid-to-long-term planning and the ability to predict future needs.

Many of our processes are unique to

us, but our flexible manufacturing capabilities and unused current capacity generally translate into relatively short production

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.

device manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable

requirements and specifications.

The quality systems for FDA-regulated products are known as current good manufacturing practices

(“cGMP’s”).

cGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f)

of the Federal Food, Drug, and Cosmetic Act.

We work closely with our suppliers to ensure continuity of supply while maintaining

high quality and reliability.

From time to time, we are required to source and requalify raw materials from new suppliers, when

an existing supplier discontinues a product.

We have from time to time we have experienced short-term difficulties in locating

and obtaining the materials necessary to fulfill our production requirements.

February 2, 2018, our quality management system was certified as compliant with the International Standards Organization’s

(“ISO”) 13485:2016 requirements for the design, manufacture and distribution of medical devices including in vitro

diagnostic products.

distribute our products through direct and indirect channels of distribution.

We have indirect distribution channels in the U.S.

with, among others, Cardinal Health 200, Inc.

(“Cardinal Health”) and Fisher Healthcare, a Division of Thermo Fisher

Scientific Inc.

(“Fisher Healthcare”) for our PIFA Heparin/PF4 assays.

The relationships with Cardinal Health and

Fisher Healthcare provide us with access to most U.S.

PIFA Heparin/PF4 assays are also sold direct to certain hospitals and buying groups.

respect to our breath alcohol product, Akers has focused its commercial attention within the on-the-job safety/human resources

Access was and currently is largely achieved through designated BreathScan ®

distributors and limited arrangements

in which we serve in an OEM capacity.

rely on a combination of patent, trademark and trade secret laws in the U.S.

and other jurisdictions to protect our proprietary

platform technologies and our brands.

We also rely on confidentiality procedures and agreements with key employees and distribution/business

partners where appropriate, and contractual provisions to achieve the same.

We do not pursue patent protection where the possibility

for meaningful enforcement is limited.

Akers logo is a registered trademark in the U.S.

Other registered trademarks/service marks include:

BreathScan ®

, PIFA PLUSS ®

, seraSTAT ®

following table summarizes the U.S.

and international utility patents that currently protect Akers intellectual property for actually

marketed products:

PIFA PLUSS ®

of separating fluid fraction from whole blood

rapid blood cell separator also integrated into PIFA PLUSS ®

PF4 and PIFA PLUSS ®

separator and method of separating fluid fraction from whole blood

rapid blood cell separator also integrated into PIFA PLUSS ®

PF4 and PIFA PLUSS ®

rapid blood cell separator also integrated into PIFA PLUSS ®

PF4 and PIFA PLUSS ®

rapid blood cell separator also integrated into PIFA PLUSS ®

PF4 and PIFA PLUSS ®

Infectious Diseases Rapid Assays

for detecting heparin platelet factor 4 antibodies

Heparin/PF4 Rapid Assay;

PIFA PLUSS ®

and kits for detecting heparin/platelet factor 4 antibodies

Heparin/PF4 Rapid Assay;

PIFA PLUSS ®

and kits for detecting heparin platelet factor 4 antibodies

Heparin/PF4 Rapid Assay;

PIFA PLUSS ®

Circumstances

outside our control could pose a threat to our intellectual property.

For example, effective intellectual property protection

may not be available in every country in which our products are distributed.

Also, the efforts we have taken to protect our proprietary

rights may not be sufficient or effective.

Any significant impairment of our intellectual property rights is costly and time consuming.

Any increase in unauthorized use of our intellectual property could make it more expensive to do business and harm our operating

PIFA Heparin/PF4 Rapid Assay is CE-marked for sale in the EU for professional use.

The CE-mark must be affixed to a product that

is intended, by the manufacturer, to be used for a medical purpose.

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

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

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

and the requirements may differ.

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

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

Some of our current

products that require CE Markings have them and it is anticipated that additional and future products may require them as well.

As of the date of this filing, the Company has received CE marks for its commercialized products/product components:

PIFA Heparin/PF4

Rapid Assay and Heparin/PF4 Serum Panels.

must also comply with numerous federal, state and local laws relating to matters such as healthcare fraud and abuse, anti-kickback,

false claims, HIPAA, environmental protection, safe working conditions, manufacturing practices, fire hazard control and, among

other things, the generation, handling, transportation and disposal of hazardous substances.

Reimbursement

care providers, including hospitals, that purchase our products generally rely on third-party payors, including the Medicare and

Medicaid programs, and private payors, such as indemnity insurers and managed care plans, to cover and reimburse all or part of

the cost of the products and the procedures in which they are used.

As a result, demand for our products is dependent in part

on the coverage and reimbursement policies of these payors.

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.

general, Medicare will cover a medical product or procedure when the product or procedure is reasonable and necessary for the

diagnosis or treatment of an illness or injury.

Even if the medical product or procedure is considered medically necessary and

coverage is available, Medicare may place restrictions on the circumstances where it provides coverage.

For 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.

markets 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.

16, 2020, we paid Premas $500,000 for the achievement of the first two development milestones.

On May 18, 2020, we paid

Premas $500,000 for the achievement of the third development milestone.

On July 7, 2020, we agreed with Premas that the fourth

milestone under the License Agreement had been satisfied.

Due to the achievement of this milestone on July 7, 2020, Premas was

paid $1,000,000 on August 4, 2020.

have exclusive rights in-licensed from Premas (as discussed above) to certain know-how and two provisional Indian patent applications

filed in January and March 2020.

The following table summarizes the two provisional Indian patent applications.

for the expression of difficult to express proteins (DTE-Ps)

a nonprovisional application is filed within one year of the provisional application, any resulting patent would expire on

January 20, 2041.

platform for SARS-Co-V-like virus proteins, methods relevant thereto, and relevant vaccine

a nonprovisional application is filed within one year of the provisional application, any resulting patent would expire on

March 4, 2041.

we do not own the patent applications that we in-license, we may need to rely upon Premas to properly prosecute and maintain those

and additional related patent applications, and to prevent infringement of any resulting patents.

have two U.S.

registered trademarks for “Akers Bio.”

Regulation and Product Approval

state, and local government authorities in the United States and in other countries extensively regulate, among other things,

the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion,

advertising, distribution, post-approval monitoring and reporting, marketing and export and import of biological and pharmaceutical

products such as those we are developing.

Our prospective vaccine candidate(s) must be approved by the FDA before they may be

legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in

foreign countries.

Generally, our activities in other countries will be subject to regulation that is similar in nature and scope

as that imposed in the United States.

The process for obtaining regulatory marketing approvals and the subsequent compliance with

appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial

Product Development Process

the United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug, and Cosmetic Act (“FD&C

Act”), the Public Health Service Act (“PHSA”), and their respective implementing regulations.

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 require the expenditure

of substantial time and financial resources.

Failure to comply with the applicable U.S.

requirements at any time during the product

development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.

sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold,

warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or

distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

agency or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a drug

or biological product may be marketed in the United States generally involves the following:

of nonclinical laboratory tests and animal studies according to FDA’s Good Laboratory Practices (“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 may begin;

of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good

clinical practice, 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 nonclinical 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 Good Manufacturing Practices (“cGMPs”), to 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 licensure, of the BLA.

testing any biological vaccine candidate in humans, the vaccine candidate enters the pre-clinical testing stage.

tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation,

as well as animal studies to assess the potential safety and activity of the vaccine candidate.

The conduct of the pre-clinical

tests must comply with federal regulations and requirements including GLPs.

The clinical trial sponsor must submit the results

of the pre-clinical tests, together with manufacturing information, analytical data, any available clinical data or literature

and a proposed clinical protocol, to the FDA as part of the IND.

Some pre-clinical testing may continue even after the IND is

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions

regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.

In such a case,

the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

The FDA may also impose

clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by

Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or

that, once begun, issues will not arise that suspend or terminate such trials.

trials involve the administration of the biological product candidate to healthy volunteers or patients under the supervision

of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.

Clinical trials are

conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection

and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical

trial will be stopped if certain adverse events should occur.

Each protocol and any amendments to the protocol must be submitted

to the FDA as part of the IND.

Clinical trials must be conducted and monitored in accordance with the FDA’s regulations

composing the Good Clinical Practice (“GCP”) requirements, including the requirement that all research subjects provide

informed consent.

Further, each clinical trial must be reviewed and approved by an independent institutional review board, (“IRB”),

at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting the welfare

and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials

are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the form and content of the informed

consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial

until completed.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

The biological product is initially introduced into healthy human subjects and tested for safety.

In the case of some products

for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to

healthy volunteers, the initial human testing is often conducted in subjects having the specific disease.

The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks,

to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal

dosage and dosing schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient

population at geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk

to benefit ratio of the product and provide an adequate basis for product labeling.

Post-approval

clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These clinical

trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly

for long-term safety follow-up.

all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities,

clinical data, and clinical trial investigators.

Annual progress reports detailing the results of the clinical trials must be

submitted to the FDA.

Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected

adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant

risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed

in the protocol or investigator brochure.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor

determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening

suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

Phase 1, Phase

2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the sponsor

or its data safety monitoring board may suspend or terminate a clinical trial at any time on various grounds, including a finding

that the research subjects are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval

of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements

or if the biological product has been associated with unexpected serious harm to subjects.

with clinical trials, companies usually complete additional studies and must also develop additional information about the physical

characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities

in accordance with cGMP requirements.

To help reduce the risk of the introduction of adventitious agents with use of biological

products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other

criteria, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological

Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate

that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

Review and Approval Processes

the completion of clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing

of the biological product.

The BLA must include results of product development, laboratory and animal studies, human trials, information

on the manufacture and composition of the product, proposed labeling and other relevant information.

The FDA may grant deferrals

for submission of data, or full or partial waivers.

The testing and approval processes require substantial time and effort and

there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on

a timely basis, if at all.

the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee.

The FDA adjusts the PDUFA user fees on an annual basis.

PDUFA also imposes an annual program fee for biological products.

waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application

filed by a small business.

60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete

before the agency accepts it for filing.

The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable

at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional

The resubmitted application also is subject to review before the FDA accepts it for filing.

Once the submission is

accepted for filing, the FDA begins an in-depth substantive review of the BLA.

The FDA reviews the BLA to determine, among other

things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile,

and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety,

strength, quality, potency and purity.

The FDA may refer applications for novel biological products or biological products that

present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other

experts, for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making

During the biological product approval process, the FDA also will determine whether a REMS, is necessary to assure

the safe use of the biological product.

If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS.

The FDA will not approve a BLA without a REMS, if required.

approving a BLA, the FDA will inspect the facilities at which the product is manufactured.

The FDA will not approve the product

unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to

assure consistent production of the product within required specifications.

Additionally, before approving a BLA, the FDA will

typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements

and GCP requirements.

To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort

in the areas of training, record keeping, production, and quality control.

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 are not always conclusive and the FDA may interpret data differently

than we interpret the same data.

If the agency decides not to approve the BLA in its present form, the FDA will issue a complete

response letter that describes all of the specific deficiencies in the BLA identified by the FDA.

The deficiencies identified

may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials.

Additionally,

the complete response letter may include recommended actions that the applicant might take to place the application in a condition

for approval.

If a complete response letter is issued, the applicant may either resubmit the BLA, seeing all of the deficiencies

identified in the letter, or withdraw the application.

a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications

for use may otherwise be limited, which could restrict the commercial value of the product.

the FDA may require that certain contraindications, warnings or precautions be included in the product labeling.

The FDA may impose

restrictions and conditions on product distribution, prescription, or dispensation in the form of a risk management plan, or otherwise

limit the scope of any approval.

In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase

4 clinical trials, designed to further assess a biological product’s safety and effectiveness, and testing and surveillance

programs to monitor the safety of approved products that have been commercialized.

addition, under the Pediatric Research Equity Act, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness

of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for

each pediatric subpopulation for which the product is safe and effective.

The FDA may grant deferrals for submission of data or

full or partial waivers.

Post-Approval

products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping

requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information,

product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include,

among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations

that are not described in the product’s approved uses, known as “off-label”

use, limitations on industry-sponsored

scientific and educational activities, and requirements for promotional activities involving the internet.

Although physicians

may prescribe legally available products for off-label uses, if the physicians deem to be appropriate in their professional medical

judgment, manufacturers may not market or promote such off-label uses.

addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after

approval to ensure the long-term stability of the product.

cGMP regulations require among other things, quality control and quality

assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct

any deviations from cGMP.

Manufacturers and other entities involved in the manufacture and distribution of approved products are

required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections

by the FDA and certain state agencies for compliance with cGMP and other laws.

Accordingly, manufacturers must continue to expend

time, money, and effort in the area of production and quality control to maintain cGMP compliance.

Discovery of problems with

a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including, among

other things, recall or withdrawal of the product from the market.

In addition, changes to the manufacturing process are strictly

regulated, and depending on the significance of the change, may require prior FDA approval before being implemented.

of changes to the approved product, such as adding new indications and claims, are also subject to further FDA review and approval.

of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences,

including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising

or communications with doctors, and civil or criminal penalties, among others.

Newly discovered or developed safety or effectiveness

data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications,

and also may require the implementation of other risk management measures.

Also, new government requirements, including those

resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory

approval of our prospective vaccine candidate(s).

Healthcare Laws and Compliance Requirements

the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition

to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services (“CMS”), other divisions

Department of Health and Human Services (“HHS”), for instance the Office of Inspector General, the U.S.

Department of Justice, or (“DOJ”), and individual U.S.

Attorney offices within the DOJ, and state and local governments.

For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of

the Social Security Act, the false claims laws, the physician payment transparency laws, the privacy and security provisions of

the federal Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology

for Economic and Clinical Health or “HITECH”

Act, and similar state laws, each as amended.

federal Anti-Kickback Statute (“AKS”) prohibits, among other things, any person or entity, from knowingly and willfully

offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to

induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable

under Medicare, Medicaid or other federal healthcare programs.

The term remuneration has been interpreted broadly to include anything

The AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers,

purchasers, and formulary managers on the other.

There are a number of statutory exceptions and regulatory safe harbors protecting

some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly and practices that involve remuneration

that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not

qualify for an exception or safe harbor.

Our practices may not in all cases meet all of the criteria for protection under a statutory

exception or regulatory safe harbor.

Failure to meet all of the requirements of a particular applicable statutory exception or

regulatory safe harbor, however, does not make the conduct per se illegal under the AKS.

Instead, the legality of the arrangement

will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.

Additionally,

the intent standard under the AKS was amended by the Affordable Care Act (“ACA”) to a stricter standard, such that

a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed

In addition, the ACA codified case law that a claim including items or services resulting from a violation of the

AKS constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or (“FCA”), as discussed

civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have

presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or

service that was not provided as claimed or is false or fraudulent.

federal FCA prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false

claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false

record or statement material to a false or fraudulent claim to the federal government.

As a result of a modification made by the

Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand”

for money or property presented

Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws

for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the

Other companies have been prosecuted for causing false claims to be submitted because of the companies’

of the product for unapproved, and thus non-reimbursable, uses.

created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud

or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under

the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,

concealing or covering up by trick, scheme or device, 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.

Similar to the AKS, a person

or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a

many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and

other state programs, or, in several states, apply regardless of the payor.

may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our

HIPAA, as amended by the HITECH Act, imposes requirements relating to the privacy, security and transmission of individually

identifiable health information.

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.

In addition, state laws govern the privacy and security of health

information in specified circumstances, many of which differ from each other in significant ways, thus complicating compliance

Additionally,

the federal Physician Payment Sunshine Act of 2010 (“PPSA”) under the ACA, and its implementing regulations, require

that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid

or the Children’s Health Insurance Program, with certain exceptions, to report information related to certain payments or

other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request

of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment

interests held by physicians and their immediate family members.

Failure to submit timely, accurately, and completely the required

information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million

per year for “knowing failures”.

Certain states also mandate implementation of compliance programs, impose restrictions

on pharmaceutical manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other

remuneration to healthcare providers and entities.

order to distribute products commercially, we must also comply with state laws that require the registration of manufacturers

and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors

who ship products into the state even if such manufacturers or distributors have no place of business within the state.

also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution,

including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as

it moves through the distribution chain.

Several states have enacted legislation requiring pharmaceutical and biotechnology companies

to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing,

pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies

and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies

for use in sales and marketing, and to prohibit certain other sales and marketing practices.

All of our activities are potentially

subject to federal and state consumer protection and unfair competition laws.

our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental

regulations that apply to us, we may be subject to penalties, including without limitation, civil, criminal and/or administrative

penalties, damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions,

private “qui tam”

actions brought by individual whistleblowers in the name of the government, or refusal to allow

us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and

future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate

our business and our results of operations.

Healthcare Reform

anticipate that current and future U.S.

legislative healthcare reforms may result in additional downward pressure on the price

that we receive for any approved product, if covered, and could seriously harm our business.

Any reduction in reimbursement from

Medicare and other government programs may result in a similar reduction in payments from private payors.

The implementation of

cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability

or commercialize our prospective vaccine candidate(s).

In addition, it is possible that there will be further legislation or regulation

that could harm our business, financial condition and results of operations.

website address is www.akersbio.com .

1 unchanged sentence

by reference the contents of the website into this Annual Report on Form 10-K.

The SEC maintains an Internet website

( http://www.sec.gov ) that contains reports, proxy and information statements and other information regarding issuers

that file electronically with the SEC.

currently employ 12 full-time equivalent employees, contractors or consultants, which include five in general and administrative,

three in regulatory compliance and four in direct and indirect manufacturing.

None of our employees are represented by a labor

union or are a party to a collective bargaining agreement.

We believe that we have good relations with our employees.

The SEC maintains an Internet website ( http://www.sec.gov )

that contains reports, proxy and information statements and other information regarding issuers that file electronically with

currently employ four (4) full-time equivalent employees, contractors or consultants, all in general and administrative.

None of our employees are represented by a labor union or are a party to a collective bargaining agreement.

We believe that we

have good relations with our employees.

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 1. Business