−Removed: Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.
+Added: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
common stock began trading on the NASDAQ Capital Market under the symbol “AKER”
on January 23, 2014.
−Removed: Prior to that,
−Removed: our common stock traded on the OTCQB of the OTC Markets Group Inc.
−Removed: under the same symbol.
−Removed: of March 20, 2020, there were approximately 698 holders of record of our common stock.
−Removed: This figure does not include
−Removed: shareholders whose certificates are held in the name of the broker-dealers of other nominees.
−Removed: (c) Dividends
−Removed: have never paid any cash dividends on our common shares, and we do not anticipate that we will pay any dividends with respect
−Removed: to those securities in the foreseeable future.
−Removed: Our current business plan is to retain any future earnings to finance the expansion
−Removed: and development of our business.
−Removed: (d) Securities
−Removed: Authorized for Issuance Under Equity Compensation Plans
−Removed: following table shows information with respect to this plan as of the fiscal year ended December 31, 2019.
−Removed: Compensation Plan Information
−Removed: of securities to be issued upon exercise of outstanding options, warrants and rights (a)
−Removed: Weighted-average
−Removed: price of outstanding options, warrants and rights (b)
−Removed: of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column
−Removed: compensation plans approved by security holders
−Removed: compensation plans not approved by security holders
−Removed: transfer agent is VStock Transfer LLC, 18 Lafayette Place, Woodmere, NY 11598.
−Removed: Sales of Unregistered Securities
−Removed: issued 1,667 blank shares of our Common Stock to Typenex Medical, LLC on December 3, 2019.
−Removed: The shares of Common Stock were issued
−Removed: to Typenex pursuant to an exemption from registration afford by Section 4(a)(2) of the Securities Act of 1933, as amended.
−Removed: for the foregoing, During the year ended December 31, 2019,
−Removed: we have not issued any securities which were not registered under the Securities Act and not previously disclosed in our Quarterly
−Removed: Reports on Form 10-Q or Current Reports on Form 8-K.
−Removed: (f) Purchases
−Removed: of Equity Securities by Issuer and Affiliated Purchasers
−Removed: the year ended December 31, 2019, we and to our knowledge our affiliated purchasers have not purchased any securities which were
−Removed: not previously disclosed in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
+Added: of February 26, 2020, there were approximately 755 holders of record of our common stock.
+Added: as described herein, we have never paid any cash or other dividends to our stockholders and we do not plan to declare or pay any
+Added: cash or other dividends in the foreseeable future.
+Added: On or around September 9, 2020, our Board declared a dividend of one preferred
+Added: share purchase right for each share of our common stock outstanding held by stockholders of record on September 21, 2020.
+Added: intend to retain earnings, if any, for use in the operation and expansion of our business.
+Added: Subject to the foregoing, the payment
+Added: of cash dividends in the future, if any, will be at the discretion of our Board and will depend on such factors as earning levels,
+Added: contractual restrictions, capital requirements, our overall financial condition and any other factors deemed relevant by the Board.
+Added: Sales of Securities
+Added: Purchases of Equity Securities
+Added: did not repurchase any of our equity securities during the fourth quarter of the fiscal year ended December 31, 2020.
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: following discussion of our plan of operation and results of operations should be read in conjunction with the financial statements
−Removed: and related notes to the financial statements included elsewhere in this Annual Report.
−Removed: This discussion contains forward-looking
−Removed: statements that relate to future events or our future financial performance.
−Removed: These statements involve known and unknown risks,
−Removed: uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially
−Removed: different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking
−Removed: These risks and other factors include, among others, those listed under “Cautionary Note Regarding Forward-Looking
+Added: information set forth below should be read in conjunction with our consolidated financial statements and related notes thereto
+Added: included elsewhere in this Annual Report on Form 10-K.
+Added: This discussion and analysis contains forward-looking statements based
+Added: on our current expectations, assumptions, estimates and projections.
+Added: These forward-looking statements involve risks and uncertainties.
+Added: Our actual results could differ materially from those indicated in these forward-looking statements as a result of certain factors,
+Added: including those discussed in Item 1 of this Annual Report on Form 10-K, entitled “Business,”
+Added: under “Forward-Looking
Statements”
−Removed: and “Risk Factors”
−Removed: and those included elsewhere in this Annual Report.
−Removed: develops, manufactures, and supplies rapid, point-of-care screening and testing products designed to bring health-related information
−Removed: directly to the patient or clinician in a timely and cost-efficient manner.
−Removed: Akers believes it has advanced the science of diagnostics
−Removed: through the development of several proprietary platform technologies.
−Removed: of Akers’
−Removed: rapid, single-use tests are performed in vitro (outside the body) and are designed to enhance patient well-being
−Removed: and reduce the cost of healthcare.
−Removed: Our current product offerings focus on delivering diagnostic assistance in a variety of healthcare
−Removed: fields/specialties, including diagnostic rapid manual point-of-care tests for the detection of allergic reactions to Heparin,
−Removed: for cholesterol screening and for on- and off-the-job alcohol safety initiatives.
−Removed: believes that low-cost, single-use testing not only saves time and money, but allows for more frequent, near-patient testing which
−Removed: may save lives.
−Removed: We believe that our FDA-cleared rapid diagnostic tests help facilitate targeted diagnoses and real-time treatment.
−Removed: March 23, 2020, we entered into a Membership Interest Purchase Agreement (the “MIPA”) with the members of Cystron
−Removed: Biotech, LLC (individually, each a “Seller,”
−Removed: and collectively, the “Sellers”), pursuant to which the Company
−Removed: will acquire 100% of the membership interests (the “Membership Interests”) of Cystron Biotech, LLC (“Cystron”).
−Removed: Cystron is a party to license agreement with Premas Biotech PVT Ltd (“Premas) whereby Premas granted Cystron, amongst other
−Removed: things, an exclusive license with respect to Premas’
−Removed: vaccine platform for the development of a vaccine against COVID-19
−Removed: and other corona virus infections.
−Removed: March 23, 2020, we acquired Cystron pursuant to the MIPA.
−Removed: consideration for the Membership Interests, we will deliver to the Sellers:
−Removed: (1) that number of newly issued shares of our common
−Removed: 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,
−Removed: 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
−Removed: common stock, then, at such Seller’s election, such Seller may receive “common stock equivalent”
−Removed: preferred shares
−Removed: with a customary 4.9% blocker (with such common stock and preferred stock collectively referred to as “Common Stock Consideration”),
−Removed: and (2) $1,000,000 in cash.
+Added: and Item 1A of this Annual Report on Form 10-K, entitled “Risk Factors.”
+Added: References in this discussion
+Added: and analysis to “us,”
+Added: “we,”
+Added: “our,”
+Added: or “the Company”
+Added: refer collectively to Akers
+Added: Biosciences, Inc.
+Added: financial statements are prepared in accordance with GAAP.
+Added: These accounting principles require us to make certain estimates, judgments
+Added: and assumptions.
+Added: We believe that the estimates, judgments and assumptions upon which we rely are reasonable based upon information
+Added: available to us at the time that these estimates, judgments and assumptions are made.
+Added: These estimates, judgments and assumptions
+Added: can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts
+Added: of revenues and expenses during the periods presented.
+Added: Our financial statements would be affected to the extent there are material
+Added: differences between these estimates and actual results.
+Added: In many cases, the accounting treatment of a particular transaction is
+Added: specifically dictated by GAAP and does not require management’s judgment in its application.
+Added: There are also areas in which
+Added: management’s judgment in selecting any available alternative would not produce a materially different result.
+Added: The following
+Added: discussion should be read in conjunction with our financial statements and notes thereto appearing elsewhere in this Annual Report
+Added: on Form 10-K.
+Added: were historically a developer of rapid health information technologies but since March 2020, have been primarily focused on the
+Added: development of a vaccine candidate against COVID-19.
+Added: In response to the global pandemic, we are pursuing rapid development and
+Added: manufacturing of our COVID-19 Vaccine Candidate, in collaboration with Premas.
+Added: November 11, 2020, we entered into the Merger Agreement, pursuant to which we will acquire MYMD as a wholly owned subsidiary.
+Added: Upon completion of the Merger, the combined company is expected to be renamed “MyMD Pharmaceuticals, Inc.”.
+Added: to the Merger Agreement, upon the effectiveness of the Merger, each share of MYMD common stock issued and outstanding immediately
+Added: prior to the Effective Time will convert into and become exchangeable for the number of pre-reverse stock split shares of our
+Added: common stock equal to the number of shares of MYMD common stock multiplied by the Exchange Ratio.
+Added: As a result of the issuance
+Added: of the merger consideration and the merger, MYMD stockholders will receive an aggregate of approximately 68,035,360 shares of
+Added: Akers common stock, without giving effect to the proposed reverse stock split contemplated by the Reverse Stock Split Proposal.
+Added: Additionally, MYMD stockholders will be entitled to receive (i) an amount in cash, on a pro rata basis, equal to the aggregate
+Added: cash proceeds received by Akers from the exercise of any options to purchase MYMD common stock assumed by Akers upon closing of
+Added: the merger during the Option Exercise Period, such payment to occur no later than 30 days after the last day of the Option Exercise
+Added: Period, and (ii) potential Milestone Payments of up to an aggregate of 68,035,360 Milestone Shares payable upon achievement of
+Added: certain market capitalization milestone events during the Milestone Period.
+Added: pursuant to the Merger Agreement, on January 15, 2020, we and MYMD filed the S-4 Registration Statement describing the Merger
+Added: and other related matters.
+Added: Consummation of the Merger is conditioned upon, among other things, approval of the Merger by the stockholders
+Added: of Akers (including (i) approval of the Share Issuance Proposal, (ii) approval of the Reverse Stock Split Proposal, and (iii)
+Added: approval of the A&R Charter Proposal, including, among other things, changing the name of the combined company to MyMD Pharmaceuticals,
+Added: Inc., among others), approval of the Merger by the stockholders of MYMD, the continued listing of Akers’
+Added: common stock on
+Added: The Nasdaq Capital Market after the Merger and satisfaction of a minimum cash threshold by Akers.
+Added: In addition, the Merger Agreement
+Added: requires that MYMD consummate the Supera Purchase.
+Added: After closing of the Merger, the operations of MYMD’s business will
+Added: comprise substantially all of the combined company’s operations.
+Added: There is no assurance when or if the Merger will be completed.
+Added: Any delay in completing the Merger may substantially reduce the potential benefits that we expect to obtain from the Merger.
+Added: the intended benefits of the Merger may not be realized.
+Added: and COVID-19 Pandemic
+Added: December 2019, SARS-CoV-2 was reported to have surfaced in Wuhan, China, and on March 12, 2020, the WHO declared the global outbreak
+Added: of COVID-19, the disease caused by SARS-CoV-2, to be a pandemic.
+Added: In an effort to contain and mitigate the spread of COVID-19,
+Added: many countries, including the United States, Canada, China, and India, have imposed unprecedented restrictions on travel, quarantines,
+Added: and other public health safety measures.
+Added: According to the WHO situation report, dated as of February 16, 2021, approximately
+Added: 108.2 million cases were reported globally and 2.4 million of these were deadly, making the development of effective
+Added: vaccines to prevent this disease a major global priority.
+Added: Multiple vaccine candidates against SARS-CoV-2 are under development,
+Added: and most recently, certain large, multinational pharmaceutical companies have been granted authorizations for emergency use by
+Added: however, widespread distribution of the vaccines remains limited, with the primary treatment being symptomatic and supportive
+Added: and Plan of Merger and Reorganization
+Added: November 11, 2020, the Company, Merger Sub, and MYMD, entered the Merger Agreement, pursuant to which, among other things, subject
+Added: to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into MYMD, with
+Added: MYMD being the surviving corporation and becoming a wholly owned subsidiary of the Company.
+Added: The Merger is intended to qualify
+Added: for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code
+Added: of 1986, as amended.
+Added: In addition, in connection with the execution of the Merger Agreement, Akers agreed to advance a bridge loan
+Added: of up to $3,000,000 to MYMD pursuant to the Note.
+Added: to the terms and conditions of the Merger Agreement, at the Effective Time (i) each outstanding share of MYMD common stock, will
+Added: be converted into the right to receive the number of shares of the Akers common stock equal to the Exchange Ratio;
+Added: and (ii) each
+Added: outstanding stock option of MYMD (collectively, “MYMD options”) that has not previously been exercised prior to the
+Added: Effective Time, whether or not vested, will be assumed by the Company subject to certain terms contained in the Merger Agreement
+Added: (including, but not limited to, the amendment of such stock option to extend the term of such stock option for a period expiring
+Added: on the second-year anniversary of the Effective Time).
+Added: In connection with the Merger, each holder of options is required to enter
+Added: into a Lock-Up Agreement/Leak-Out Agreement with respect to the shares of Akers common stock issued upon the exercise of such
+Added: Also, not later than 30 days after the second-year anniversary of the Effective Date, the Company will pay stockholders
+Added: of MYMD on a pro rata basis an amount in cash equal to the aggregate cash proceeds received by Akers from the exercise of any
+Added: MYMD options assumed by the Company prior to the second-year anniversary of the Effective Time;
+Added: provided, however, the amount
+Added: of such payment will not exceed the maximum amount of cash consideration that may be received by stockholders of MYMD without
+Added: affecting the intended tax consequences of the Merger.
Additionally,
−Removed: 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
−Removed: 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
−Removed: 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
−Removed: the Sellers have received an aggregate additional cash consideration equal to $10,000,000.
−Removed: Upon the achievement of certain milestones,
−Removed: including the completion of a Phase 2 study for a COVID-19 vaccine that meets its primary endpoints, Sellers will be entitled
−Removed: to receive an additional 750,000 shares of our common stock or, in the event we are unable to obtain stockholder approval for
−Removed: the issuance of such shares, 750,000 shares of non-voting preferred stock that are valued following the achievement of such milestones
−Removed: and shall bear a 10% annual dividend (the “Milestone Shares”).
−Removed: Sellers will also be entitled to contingent payments
−Removed: from us of up to $20,750,000 upon the achievement of certain milestones, including the approval of a new drug application by the
−Removed: Food and Drug Administration (“FDA”).
−Removed: shall also make quarterly royalty payments to Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination product
−Removed: by the Company (the “COVID-19 Vaccine”) for a period of five (5) years following the first commercial sale of the
−Removed: COVID-19 Vaccine;
−Removed: provided, that such payment shall be reduced to 3% for any net sales of the COVID-19 Vaccine above $500 million.
−Removed: addition, Sellers shall be entitled to receive 12.5% of the transaction value, as defined in the MIPA, of any change of control
−Removed: transaction, as defined in the MIPA, that occurs prior to the fifth (5th) anniversary of the closing date of the MIPA, provided
−Removed: that the Company is still developing the COVID-19 Vaccine at that time.
−Removed: Following the consummation of any change of control transaction,
−Removed: the Sellers shall not be entitled to any payments as described above under the MIPA.
−Removed: March 23, 2020, as an inducement to enter into the MIPA, and as one of the conditions to the consummation of the transactions
−Removed: contemplated by the MIPA, the Sellers entered into a shareholder voting agreement with the Company (the “Support Agreement”),
−Removed: pursuant to which each Seller agreed to vote their shares of our common stock or preferred stock in favor of each matter proposed
−Removed: and recommended for approval by our management at every meeting of the stockholders and on any action or approval by written consent
−Removed: of the stockholders.
−Removed: Rights Agreement
−Removed: induce the Sellers to enter into the MIPA, on March 23, 2020, we entered into a registration rights agreement (the “Registration
−Removed: Rights Agreement”) with the Sellers, pursuant to which we shall by the 30th day following the closing of the transactions
−Removed: contemplated by the MIPA, file with the United States Securities and Exchange Commission (the “SEC”) an initial Registration
−Removed: 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
−Removed: of the shares of our common stock issued, or underlying the preferred stock issued, at closing under the MIPA and to subsequently
−Removed: register the common stock issued or underlying the preferred stock issued at Milestone Shares.
−Removed: is a party to a License and Development Agreement (the “Initial License Agreement”) with Premas Biotech PVT Ltd.
−Removed: (“Premas”).
−Removed: As a condition to the Company’s entry into the MIPA, Cystron amended and restated the Initial License Agreement on March
−Removed: 19, 2020 (as amended and restated, the “License Agreement”).
−Removed: Pursuant to the License Agreement, Premas granted Cystron,
−Removed: amongst other things, an exclusive license with respect to Premas’
−Removed: vaccine platform for the development of a vaccine against
−Removed: COVID-19 and other corona virus infections.
−Removed: the achievement of certain developmental milestones by Cystron, Cystron shall pay to Premas a total of up to $2,000,000.
−Removed: D Convertible Preferred Stock
−Removed: March 24, 2020, we filed the Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred
−Removed: Stock (the “Certificate of Designation”) with the Secretary of State of the State of New Jersey.
−Removed: Pursuant to the Certificate
−Removed: of Designation, in the event of the Company’s liquidation or winding up of its affairs, the holders of our Series D Convertible
−Removed: Preferred Stock (the “Preferred Stock”) will be entitled to receive the same amount that a holder of our common stock
−Removed: would receive if the Preferred Stock were fully converted (disregarding for such purposes any conversion limitations set forth
−Removed: in the Certificate of Designation) to common stock which amounts shall be paid pari passu with all holders of the Company’s
−Removed: common stock.
−Removed: Each share of Preferred Stock has a stated value equal to $0.01 (the “Stated Value”), subject to increase
−Removed: as set forth in Section 7 of the Certificate of Designation.
−Removed: holder of Preferred Stock is entitled at any time to convert any whole or partial number of shares of Preferred Stock into shares
−Removed: of our common stock determined by dividing the Stated Value of the Preferred Stock being converted by the conversion price of
−Removed: $0.01 per share.
−Removed: holder of Preferred Stock will be prohibited from converting Preferred Stock into shares of our common stock if, as a result of
−Removed: such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of our common
−Removed: stock then issued and outstanding (with such ownership restriction referred to as the “Beneficial Ownership Limitation”).
−Removed: However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any
−Removed: increase in such percentage shall not be effective until 61 days after such notice to us.
−Removed: to the Beneficial Ownership Limitation, on any matter presented to our stockholders for their action or consideration at any meeting
−Removed: of our stockholders (or by written consent of stockholders in lieu of a meeting), each holder of Preferred Stock will be entitled
−Removed: 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
−Removed: owned by such holder are convertible as of the record date for determining stockholders entitled to vote on or consent to such
−Removed: matter (taking into account all Preferred Stock beneficially owned by such holder).
−Removed: Except as otherwise required by law or by
−Removed: the other provisions of our certificate of incorporation, the holders of Preferred Stock will vote together with the holders of
−Removed: our common stock and any other class or series of stock entitled to vote thereon as a single class.
−Removed: 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
−Removed: Backlog of PIFA®
−Removed: Heparin/PF4 and PIFA®
−Removed: of March 20, 2020, we are experiencing a production backlog of our PIFA®
−Removed: Heparin/PF4 and PIFA®
−Removed: Pluss/PF4 rapid assays.
−Removed: As a result, one of our distributors notified us that the distributor is informing its customers that the PIFA®
−Removed: and PIFA®
−Removed: Pluss/PF4 rapid assays are temporarily unavailable.
−Removed: While we believe that we will be able to remedy the production
−Removed: backlog in several weeks, we cannot be certain what impact this backlog will have on our business and it may have an adverse effect
−Removed: on our 2020 revenues and results of operation.
−Removed: Events, Management’s Plans and Basis of Presentation
−Removed: Board’s
−Removed: Evaluation of Strategic Alternatives
−Removed: November 7, 2018, we announced that our board of directors had initiated a process to evaluate strategic alternatives to maximize
−Removed: shareholder value.
−Removed: The Company continues to explore how to leverage its 30 years of operational history in its medical device
−Removed: business, where its current products have FDA clearance, its current operations practice Good Manufacturing Processes (cGMP),
−Removed: its medical device facility is certified under ISO 13485 –
−Removed: 2016 and the facility carries an Analytical Lab Certification
−Removed: for Schedules 2, 3, 4 and 5 controlled substances issued by the U.S.
−Removed: Drug Enforcement Administration (DEA) and the State of New
−Removed: The Company intends to pursue opportunities in the extraction, testing, purification and formulation of safe cannabinoids
−Removed: within the hemp industry, including pathways to consumer products with a focus on minor cannabinoids.
−Removed: to our pursuit of strategic alternatives, pursuant to an unsecured promissory note date July 4, 2019, on July 25, 2019 we advanced
−Removed: $100,000 to a company in the hemp related industry with which we had been considering a potential business transaction.
−Removed: with this party toward a potential transaction have been suspended.
−Removed: The unsecured promissory note became due on October 2, 2019
−Removed: and we are pursuing collection of the obligation.
−Removed: December 19, 2018, we announced our intent to delist from the AIM Market of the London Stock Exchange.
−Removed: We believed that due to
−Removed: the relatively low liquidity in our common stock, reaming listed on the AIM did not merit the ongoing costs and regulatory complexities
−Removed: associated with maintaining the AIM listing.
−Removed: On March 5, 2019, we held a special meeting of shareholders who then voted in favor
−Removed: of our delisting from the AIM Market.
−Removed: The delisting took effect on March 29, 2019.
−Removed: March 29, 2019, the Compensation Committee of the Board of Directors approved payments to the members of the Board of Directors,
−Removed: which were paid as follows (i) lump sum payment of $64,000 to each of Mr.
−Removed: Schreiber and Mr.
−Removed: White and a lump sum payment of $56,000
−Removed: Silverman, (ii) each of Mr.
−Removed: Schreiber, Mr.
−Removed: White and Mr.
−Removed: Silverman were granted 5,201 Restricted Stock Units (“RSUs”),
−Removed: which vested on January 1, 2020, and (iii) beginning April 2019, each serving director who is not also holding a position as an
−Removed: executive officer shall be paid $8,000 per month.
−Removed: The lump sum payments were paid during April 2019 and the monthly payments to
−Removed: directors have been paid each month.
−Removed: There was no other compensation for directors during the year ended December 31, 2019.
−Removed: to Articles of Incorporation or Bylaws;
−Removed: Change in Fiscal Year.
−Removed: filed two certificates of amendment (each a “Certificate of Amendment”, collectively, the “Certificates of Amendment”)
−Removed: to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of New Jersey, each to be effective
−Removed: as of November 25, 2019, to reduce our authorized common stock at a ratio of one-for-eight then effect a reverse stock split of
−Removed: our authorized and outstanding common stock at a ratio of one-for-twenty four.
−Removed: The reduction and the reverse stock split affected
−Removed: all stockholders uniformly and did not alter any stockholder’s percentage interest in our equity, except to the extent that
−Removed: the reverse stock split would have resulted in a stockholder owning a fractional share.
−Removed: Fractional shares have not been issued
−Removed: as a result of the reverse stock split;
−Removed: instead, the Board of Directors determined to effect an issuance of shares to holders
−Removed: that would otherwise have been entitled to a fractional share such that any fractional shares were rounded up to the nearest whole
−Removed: The Certificates of Amendment reduced the number of outstanding shares of our common stock to 521,676 and the number of
−Removed: shares of common stock we are authorized to issue to 2,604,167.
−Removed: On December 30, 2019, our shareholders approved an increase
−Removed: to 100,000,000 of the number of the authorized shares of our Common Stock.
−Removed: of Christopher C.
−Removed: Schreiber as Executive Chairman of the Board of Directors
−Removed: November 1, 2019, the Board of Directors appointed Christopher C.
−Removed: Schreiber, a current director of our company, as Executive Chairman
−Removed: of the Board of Directors of our company, effective immediately.
−Removed: Schreiber’s appointment as Executive Chairman
−Removed: of the Board of Directors, Mr.
−Removed: Schreiber is no longer “independent”
−Removed: within the meaning of the Nasdaq Stock Market
−Removed: Rules and under Rule 10A-3(b)(1)(i) of the Securities Exchange Act of 1934 and is no longer a “non-employee director”
−Removed: under Rule 16b-3 of the Securities Exchange Act of 1934.
−Removed: As such, on November 1, 2019, Mr.
−Removed: Schreiber resigned from our Audit Committee,
−Removed: Compensation Committee and Nominating and Corporate Governance Committee.
−Removed: In order to fill the vacancy occasioned by the resignation
−Removed: Schreiber as the Chairman of the Compensation Committee, Mr.
−Removed: Joshua Silverman, a current director and member of the Compensation
−Removed: Committee, was appointed as the Chairman of the Compensation Committee.
−Removed: Schroeder as a Director
−Removed: November 1, 2019, the Board of Directors appointed Robert C.
−Removed: Schroeder as a director and as a member of our Audit Committee, effective
−Removed: November 15, 2019, the Board of Directors approved a reverse stock split of our authorized and issued and outstanding common stock
−Removed: at a ratio of 1-for-24, effective on Monday, November 25, 2019 at 8:00 a.m.
−Removed: Trading on our common stock on a post-reverse stock
−Removed: split basis began at market open on November 25, 2019 (the “Reverse Stock Split”).
−Removed: No fractional shares have been
−Removed: issued in the Reverse Stock Split and the remaining fractions were rounded up to the next whole share.
−Removed: On November 22, 2019, the
−Removed: Board of Directors approved an amendment to the amended and restated certificate of incorporation to reduce the number of authorized
−Removed: shares of common stock, prior to the Reverse Stock Split, at a ratio of 1-for-8.
−Removed: connection with the Reverse Stock Split, all shares of our common stock subject to all outstanding equity awards and the exercise
−Removed: price of any such award (if applicable) have been reduced by the 1-for-24 ratio.
−Removed: The number of shares remaining available
−Removed: for issuance under the 2018 Akers Biosciences, Inc.
−Removed: Equity Incentive Plan were not reduced by the 1-for-24 ratio.
−Removed: December 4, 2019, we formed an advisory board (the “Advisory Board”) with expertise in the hemp and minor cannabinoid
−Removed: We will continue our strategic alternatives review and have identified the hemp and minor cannabinoid sectors
−Removed: as potential opportunities that could benefit from our core competencies.
−Removed: We are exploring how to leverage its 30 years of operational
−Removed: history in our medical device business, where our current products have U.S.
−Removed: Food and Drug Administration (FDA) clearance, our
−Removed: current operations practice Good Manufacturing Processes (cGMP), our medical device facility is certified under ISO 13485 –
−Removed: 2016 and the facility carries an Analytical Lab Certification for Schedules 2, 3, 4 and 5 controlled substances issued by the
−Removed: Drug Enforcement Administration (DEA) and the State of New Jersey.
−Removed: The Advisory Board will assist the Board of Directors
−Removed: in its strategic review including, potentially, the extraction, testing, purification and formulation of safe cannabinoids within
−Removed: the hemp industry.
−Removed: The Advisory Board may also explore a pathway to consumer products with a focus on minor cannabinoids.
+Added: under the terms of the Merger Agreement, the Company has agreed to pay contingent consideration to MYMD stockholders in the form
+Added: of Milestone Payments.
+Added: The Milestone Payments are payable in the dollar amounts set forth in the chart below upon the achievement
+Added: of the milestone events set forth opposite such dollar amount during the Milestone Period as follows:
+Added: capitalization of Akers for at least 10 trading days during any 20 consecutive trading day period during the Milestone Period
+Added: is equal to or greater than $500 million (the “
+Added: First Milestone Event ”).
+Added: every $250 million incremental increase in market capitalization of Akers after the First Milestone Event to the extent such
+Added: incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone
+Added: Period, up to a $1 billion market capitalization of Akers.
+Added: million per each incremental increase (it being understood, however, that, if such incremental increase results in market
+Added: capitalization equal to $1 billion, such $20 million payment in respect of such incremental increase shall be payable without
+Added: duplication of any amount payable in respect of a Second Milestone Event).
+Added: Capitalization of Akers for at least 10 trading days during any 20 consecutive trading day period is equal to or greater than
+Added: $1 billion (the “
+Added: Second Milestone Event ”).
+Added: every $1 billion incremental increase in market capitalization of Akers after the Second Milestone Event to the extent such
+Added: incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone
+Added: million per each incremental increase.
+Added: Milestone Payment will be payable in shares of common stock of Akers, with the number of Milestone Shares to be issued determined
+Added: by dividing the applicable Milestone Payment amount by the volume-weighted average price of a share of Akers’
+Added: during the 10 trading days immediately preceding the achievement of the milestone event;
+Added: provided, however, that in no event shall
+Added: the price of a share of Akers common stock used to determine the number of Milestone Shares to be issued be deemed to be less
+Added: than $5.00 per share (as adjusted for stock splits, stock dividends, reverse stock splits, and the like occurring after the closing
+Added: Notwithstanding
+Added: the above, the number of Milestone Shares payable by Akers shall not exceed the number of shares of Akers common stock to be issued
+Added: to MyMD stockholders at the Effective Time in connection with the Merger (as described in the following paragraph).
+Added: the exchange ratio formula in the Merger Agreement, and immediately upon the closing of the Merger, the former MYMD securityholders
+Added: are expected to own approximately 80% of the aggregate number of shares of Akers common stock issued and outstanding immediately
+Added: following the consummation of the Merger (the “Post-Closing Shares”), and the stockholders of the Company as of immediately
+Added: prior to the Merger are expected to own approximately 20% of the aggregate number of Post-Closing Shares.
+Added: prior to the Effective Time, the name of the Company will be changed from “Akers Biosciences, Inc.”
+Added: to “MyMD
+Added: Pharmaceuticals, Inc.”
+Added: At the Effective Time, the Merger Agreement contemplates that the board of directors of the Company
+Added: will consist of seven directors, with (i) Akers having the right to designate up to four members and (ii) MYMD having the right
+Added: to designate up to three members.
+Added: The officers of the Company immediately after the Effective Time will be elected by the board
+Added: of directors of Akers.
+Added: Merger Agreement contains customary representations, warranties and covenants made by the Company and MYMD, including covenants
+Added: relating to obtaining the requisite approvals of the stockholders of the Company and MYMD, indemnification of directors and officers,
+Added: and the Company’s and MYMD’s conduct of their respective businesses between the date of signing the Merger Agreement
+Added: and the closing of the Merger.
+Added: Consummation of the Merger is subject to certain closing conditions, including, among other things,
+Added: approval by the stockholders of Akers and MYMD.
+Added: Merger Agreement contains certain termination rights for both the Company and MYMD, including, among other things, (a) Akers may,
+Added: upon written notice, extend the originally scheduled End Date to May 15, 2021 (the “Extended Date”) so long as (i)
+Added: Akers and Merger Sub are not then in material breach of any provision of the Merger Agreement and (ii) within three calendar days
+Added: of the written request by MYMD, Akers makes an additional loan to MYMD of up to $600,000, which will have the same terms and conditions
+Added: of the Note (such additional note “Second Note”) and (b) Akers may, upon written notice, extend the Extended Date
+Added: to June 30, 2021, so long as (i) Akers and Merger Sub are not then in material breach of any provision of the Merger Agreement,
+Added: (ii) on the effective date of such extension, the loan amount evidenced by the Note and the Second Note may, at the sole option
+Added: of MYMD upon written notice to Akers, be converted into shares of MYMD common stock at a conversion price of $2.00 per share,
+Added: subject to certain adjustments and (iii) Akers will, at MYMD’s request, either (at the option of MYMD);
+Added: (A) subscribe for
+Added: 300,000 shares of MYMD common stock at a subscription price of $2.00 per share, subject to certain adjustments as set forth in
+Added: the Merger Agreement, or (B) make an additional loan to MYMD of up to $600,000, which will have the same terms and conditions
+Added: of the Note (the “Third Note,”
+Added: and all amounts outstanding under the Note, the Second Note and the Third Note, the
+Added: “Loan Amount”).
+Added: In addition, if Akers terminates the Merger Agreement under certain circumstances specified therein,
+Added: the Loan Amount, if any, at the sole discretion of MYMD, will be convertible into shares of common stock of MYMD at a conversion
+Added: price of $2.00 per share upon delivery of written notice by MYMD to Akers within 30 calendar days after the effective date of
+Added: termination of the Merger Agreement.
+Added: Merger Agreement also contemplates that the Company will seek approval from its stockholders to effect a reverse stock split,
+Added: if applicable, at a reverse stock split ratio mutually agreed to by the Company and MYMD and within the range approved by the
+Added: Company’s stockholders immediately prior to the Effective Time, which range shall be sufficient to cause the price of Akers
+Added: common stock on the Nasdaq Capital Market following such reverse stock split and the Effective Time to be no less than $5.00 per
+Added: In addition, under the Merger Agreement, Akers may, in its discretion, consummate a spin-off of all or a part of its pre-closing
+Added: assets and liabilities (the “Spin-Off”).
+Added: connection with the Merger, the Company will seek the approval of its stockholders of (a) the transactions contemplated in the
+Added: Merger Agreement, including the issuance of Akers common stock pursuant to the Merger and (b) the amendment of its certificate
+Added: of incorporation, including for purposes of (i) effectuating a reverse split of Akers common stock at a ratio to be determined
+Added: by a split ratio to be mutually agreed to by Akers and MYMD within the range approved by the Company’s stockholders immediately
+Added: prior to the Effective Time and on certain terms as specifically described herein, (ii) change Akers’
+Added: name to “MyMD
+Added: Pharmaceuticals, Inc.,”
+Added: and (c) to the extent necessary, the Spin-Off.
+Added: accordance with the terms of the Merger Agreement, (i) the officers and directors of Akers have each entered into a voting agreement
+Added: with MYMD (the “Akers Voting Agreements”), and (ii) the officers, directors and certain affiliated stockholders of
+Added: MYMD have each entered into a voting agreement with Akers (the “MYMD Voting Agreement s ,”
+Added: together with the
+Added: Akers Voting Agreements, the “Voting Agreements”).
+Added: The Voting Agreements place certain restrictions on the transfer
+Added: of the shares of Akers and MYMD held by the respective signatories thereto and include covenants as to the voting of such shares
+Added: in favor of approving the transactions contemplated by the Merger Agreement and against any actions that could adversely affect
+Added: the consummation of the Merger.
+Added: with the execution of the Merger Agreement or prior to the closing, the officers and directors of Akers, and the officers, directors
+Added: and certain stockholders of MYMD, each entered into lock-up/leak-out agreements (the “Lock-Up/Leak-Out Agreements”)
+Added: pursuant to which they have agreed, among other things, not to sell or dispose of (subject to certain exceptions specified therein)
+Added: any shares of Akers common stock which are or will be beneficially owned by them at the Effective Time or which are acquired thereafter,
+Added: with such shares being released from such restrictions 180 days after the Effective Time.
+Added: After the expiration of such initial
+Added: 180-day period, such stockholders will be subject to a 180-day leak-out period during which they may not sell shares in excess
+Added: of the amount permitted by the Rule 144 volume limitations (even if such stockholder is not currently subject to such provisions
+Added: of Rule 144), which leak-out period shall be extended for an additional 180 days for any shares of Akers common stock issued upon
+Added: the exercise of existing options or warrants.
+Added: Promissory Note
+Added: set forth above, in connection with the execution of the Merger Agreement, Akers will advance a bridge loan to MYMD in an amount
+Added: of up to $3,000,000 pursuant to the Note.
+Added: Advances under the Note will be made in accordance with MYMD’s cash needs pursuant
+Added: to a pre-agreed operating budget for MYMD.
+Added: The Note accrues interest on the outstanding principal amount at the rate of 5% per
+Added: annum and matures on the earliest of (i) April 15, 2022, (ii) upon demand of Akers in the event the Merger is consummated, or
+Added: (iii) the date on which MYMD’s obligations under the Note are accelerated in accordance with the terms of the Note.
+Added: forth above, in the event the Merger Agreement is terminated by MYMD upon a change in Akers’
+Added: board of directors’
+Added: recommendations
+Added: to the Akers stockholders in connection with the Merger Agreement and certain other circumstances specified in the Merger Agreement,
+Added: the principal amount of the Note, and all accrued and unpaid interest thereon, shall be converted into shares of MYMD common stock
+Added: at a conversion price of $2.00 per share.
+Added: MYMD may prepay the Note in whole or in part at any time or from time to time at its
+Added: sole discretion.
+Added: Under the terms of the Note, if, at any time after the termination or expiration of the Merger Agreement, MYMD
+Added: (i) incurs any debt other than Permitted Debt (as defined in the Note), (ii) issues any equity interests, or (iii) consummates
+Added: any Asset Sale or Recovery Event (each as defined in the Note) then, in each case, no later than two business days after MYMD
+Added: receives the net cash proceeds of such incurrence, issuance or other action, then MYMD shall be required to prepay an amount under
+Added: the Note equal to the net cash proceeds received, up to the total amount of the advances made under the Note at such time, including
+Added: all accrued and unpaid interest thereon, of the Note.
+Added: The payment and performance of all obligations under the Note are secured
+Added: by a first priority security interest in all of MYMD’s right, title and interest in and to its assets as collateral.
+Added: As of December 31,
+Added: 2020, the Company had advanced MYMD $1,200,000 under the Note, which is classified as Other Receivables on the Consolidated Balance
+Added: The Company advanced two additional draws of $600,000, or $1,200,000 cumulatively, on January 21, 2021 and February 25,
+Added: 2021 to MYMD under this secured promissory note.
+Added: with the Merger Agreement, on November 11, 2020, Akers entered into the Private Placement SPA with certain institutional and accredited
+Added: investors (the “SPA Purchasers”), pursuant to which Akers agreed to issue and sell to the SPA Purchasers (i) an aggregate
+Added: of 9,765,933 shares of Akers common stock, at an offering price of $1.85 per share or, at the election of each investor, Pre-Funded
+Added: Warrants, and (ii) for each share of Akers common stock (or for each Pre-Funded Warrant, as applicable) purchased in the Private
+Added: Placement, a common warrant (the “Investor Warrants”
+Added: and, together with the Pre-Funded Warrants, the “Warrants”)
+Added: to purchase one share of Akers common stock, for gross proceeds of approximately $18.1 million before the deduction of placement
+Added: agent fees and expenses and estimated offering expenses.
+Added: In addition, Akers also issued the Placement Agent a warrant to purchase
+Added: up to 390,368 shares of Akers common stock at an exercise price of $1.85 (the “Placement Agent Warrant”).
+Added: The Placement
+Added: Agent Warrant will be exercisable at any time and from time to time, in whole or in part, for a term of five and a half years.
+Added: The Private Placement closed on November 17, 2020, and Akers issued an aggregate of 8,725,393 shares of Akers common stock, Pre-Funded
+Added: Warrants to purchase 1,040,540 shares of Akers common stock, and Investor Warrants to purchase 9,765,933 shares of Akers common
+Added: In February 2021, an investor exchanged 932,432 shares of common stock purchased in the Private Placement into Pre-Funded
+Added: Warrants to purchase 932,432 shares of common stock.
+Added: the Private Placement SPA, Akers agreed not to (i) issue, enter into any agreement to issue or announce the issuance or proposed
+Added: issuance of, any shares of Akers common stock or any securities convertible into or exercisable or exchangeable for shares of
+Added: Akers common stock at an effective price less than the exercise price of the Investor Warrants or (ii) file any registration statement
+Added: or any amendment or supplement thereto, other than as contemplated under the Private Placement SPA, for a period of 90 days following
+Added: the later of (x) the date the Registration Statement (as defined below) is declared effective by the SEC and (y) the record date
+Added: for the Akers stockholder meeting called to approve the Merger.
+Added: In addition, Akers agreed not to effect or enter into an agreement
+Added: to effect any issuance of Akers common stock or common stock equivalents involving a variable rate transaction (as defined in
+Added: the Private Placement SPA) from the date of the Private Placement SPA until such time as no SPA Purchaser holds any of the Investor
+Added: Warrants, subject to certain exceptions (including the issuance of any of Akers common stock pursuant to the Merger Agreement).
+Added: Private Placement SPA provides that (i) within 10 days following the date that Akers first files a proxy statement with the SEC
+Added: in connection with the merger (including by means of a registration statement on Form S-4), Akers shall file a registration statement
+Added: (the “Registration Statement”) under the Securities Act of 1933, as amended (the “Securities Act”) for
+Added: the resale of all of the shares of Akers common stock issued in the private placement and the shares of Akers common stock issuable
+Added: upon exercise of the Warrants (the “Warrant Shares”) by the SPA Purchasers and (ii) Akers shall use commercially reasonable
+Added: efforts to cause such Registration Statement to be declared effective within 60 days of the filing thereof (or 90 days in the
+Added: event of a full review);
+Added: provided, however, that Akers shall not be required to register any shares of Akers common stock issued
+Added: in the private placement or Warrant Shares that are eligible for resale pursuant to Rule 144 under the Securities Act (assuming
+Added: cashless exercise of the Warrants).
+Added: currently intend to use the proceeds from the Private Placement in order to satisfy the closing conditions set forth in the
+Added: Merger Agreement that requires the Company to have a minimum parent net cash amount equal to $25 million, less
+Added: certain amounts advanced to MyMD, which shall also include any amounts to be used to payoff The Starwood Trust to repay in
+Added: full the Starwood Line of Credit at the closing of the Merger, and for general working capital purposes.
+Added: In addition, the
+Added: Company paid $1,204,525 of the proceeds from the Private Placement to three of the former members of Cystron and recorded a
+Added: liability of $602,172 to the fourth former member of Cystron pursuant to the MIPA.
+Added: addition, we paid a cash fee of $501,500 and issued warrants to purchase an aggregate of 255,135 shares of common stock to the
+Added: designees of H.C.
+Added: Wainwright & Co., LLC (“HCW”), pursuant to a side letter by and between Akers and HCW, dated
+Added: November 23, 2020, regarding certain tail fees provided in two engagement letters (one dated October 18, 2019 and the other dated
+Added: April 7, 2020) entered into in connection with prior offerings by and between Akers and HCW.
+Added: Such warrants issued were in the
+Added: same form as the Investor Warrants except that the HCW Warrants have an exercise price of $2.3125 per share.
+Added: Investor Warrants
+Added: Investor Warrant issued in the Private Placement has an initial exercise price equal to $2.06 per share of common stock.
+Added: Warrants are immediately exercisable and will terminate five and a half years following issuance.
+Added: The exercise price and number
+Added: of shares of Akers common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock
+Added: splits, reorganizations or similar events affecting Akers common stock and the exercise price.
+Added: at any time following the six-month anniversary of November 17, 2020, there is no effective registration statement registering,
+Added: or the prospectus contained therein is not available for the issuance of the shares underlying the Investor Warrants (the “Investor
+Added: Warrant Shares”) to the holder, then the Investor Warrants may also be exercised, in whole or in part, at such
+Added: time by means of a “cashless exercise”
+Added: in which the holder shall be entitled to receive a number of Investor
+Added: Warrant Shares according to a formula set forth in the Investor Warrants.
+Added: holder (together with its affiliates) may not exercise any portion of the Investor Warrant to the extent that the holder would
+Added: own more than 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the outstanding Akers common stock
+Added: immediately after exercise;
+Added: provided, however, that upon notice to Akers, the holder may increase or decrease the beneficial ownership
+Added: limitation, provided that in no event shall the beneficial ownership limitation exceed 9.99% and any increase in the beneficial
+Added: ownership limitation will not be effective until 61 days following notice of such increase from the holder to Akers.
+Added: the event of a fundamental transaction, as described in the Investor Warrants and generally including any reorganization, recapitalization
+Added: or reclassification of Akers common stock, the sale, transfer or other disposition of all or substantially all of Akers’
+Added: properties or assets, Akers’
+Added: consolidation or merger with or into another person, the acquisition of more than 50% of Akers
+Added: outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by Akers’
+Added: outstanding common stock, the holders of the Investor Warrants will be entitled to receive upon exercise of such warrants the
+Added: kind and amount of securities, cash or other property that the holders would have received had they exercised the Investor Warrants
+Added: immediately prior to such fundamental transaction.
+Added: The Merger shall not be deemed a fundamental transaction as defined in the
+Added: Investor Warrants.
+Added: Pre-Funded Warrants
+Added: the request of an investor, in lieu of Akers common stock, certain investors received Pre-Funded Warrants.
+Added: The Pre-Funded Warrants
+Added: are exercisable at any time immediately upon issuance and until such warrant is exercised in full.
+Added: The exercise price of the Pre-Funded
+Added: Warrants is $0.001 per share of Akers common stock, and, in lieu of making the cash payment otherwise contemplated to be
+Added: made to Akers upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such
+Added: exercise (either in whole or in part) the net number of shares of Akers common stock determined according to a formula set forth
+Added: in the Pre-Funded Warrants.
+Added: holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrants to the extent that the holder would
+Added: own more than 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the outstanding Akers common stock
+Added: immediately after exercise;
+Added: provided, however, that upon notice to Akers, the holder may increase or decrease the beneficial ownership
+Added: limitation, provided that in no event shall the beneficial ownership limitation exceed 9.99% and any increase in the beneficial
+Added: ownership limitation will not be effective until 61 days following notice of such increase from the holder to Akers.
+Added: and Support Agreement
+Added: November 11, 2020, Akers entered into a Lock-Up and Support Agreement (the “Support Agreement”) with substantially
+Added: all of the SPA Purchasers, pursuant to which, from the date of the Support Agreement until May 31, 2021, such SPA Purchasers agreed
+Added: to vote their respective shares of Akers common stock in favor of each matter proposed and recommended for approval by the Akers
+Added: board of directors or management at every shareholders’
+Added: Pursuant to the Support Agreement, such SPA Purchasers
+Added: also agreed to, until the earlier of (a) the termination of the Merger Agreement or (b) the date that the SPA Purchasers vote
+Added: their respective shares of Akers common stock in support of the merger and all matters related to the merger, will not, directly
+Added: or indirectly, without Akers’
+Added: prior written consent, transfer, assign or dispose of their rights to vote the shares of Akers
+Added: common stock issued in the private placement or otherwise take any act that could restrict or otherwise affect their legal power,
+Added: authority or right to vote all of their shares of Akers common stock issued in the private placement in the manner required by
+Added: the Support Agreement.
+Added: Securities LLC Engagement Letter
+Added: October 31, 2020, Akers entered into an engagement letter with Katalyst Securities LLC (the “Placement Agent”
+Added: or “Katalyst”),
+Added: pursuant to which the Placement Agent agreed to serve as the non-exclusive placement agent for Akers, on a reasonable best efforts
+Added: basis, in connection with the Private Placement.
+Added: Akers agreed to pay the Placement Agent an aggregate cash fee equal to 6.5% of
+Added: the gross proceeds received in the Private Placement and reimburse the Placement Agent’s expenses in the Private Placement
+Added: up to $25,000.
+Added: In addition, Akers agreed to grant to Katalyst the Placement Agent Warrant, which was issued upon closing of the
+Added: Private Placement.
+Added: The Placement Agent Warrant is exercisable at any time and from time to time, in whole or in part, following
+Added: the date of issuance and for a term of five and a half years.
+Added: of Operations
+Added: discussed in Note 3 and Note 6 of the Notes to the Consolidated Financial Statements, the results of operations presented below
+Added: exclude our screening and testing products business due to its classification as discontinued operations.
of Statements of Operations for the Fiscal Years Ended December 31, 2020 and 2019
−Removed: Company’s revenue for the year ended December 31, 2019
−Removed: totaled $1,577,033, a 5% decrease from the same period in 2018.
−Removed: The table below summarizes our revenue by product line for the
−Removed: years ended December 31, 2019 and 2018, as well as the percentage of change year-over-year:
−Removed: the Years Ended
−Removed: ImmunoFiltration Assay (“PIFA”)
−Removed: MicroParticle
−Removed: Catalyzed Biosensor (“MPC”)
−Removed: Enzymatic Assay (“REA”)
−Removed: from the Company’s PIFA products decreased 7% to $1,327,752 (2018:
−Removed: $1,422,361) during the year ended December 31, 2019,
−Removed: as compared to the same period of 2018.
−Removed: The decrease was attributable to both a decline in shipments of the PIFA products as well
−Removed: as increase in customer rebates.
−Removed: Company’s largest U.S.
−Removed: distribution partners are Cardinal
−Removed: Health and Thermo Fisher Scientific.
−Removed: Domestic net sales for the year ended December 31, 2019 for these two distributors accounted
−Removed: for $1,249,913 of the total PIFA related product revenue as compared to $1,104,533 for the same period of 2018.
−Removed: Company’s MPC product sales increased by 2% to $126,150 (2018:
−Removed: $123,941) during the year ended December 31, 2019.
−Removed: Company’s REA products generated $85,000 (2018:
−Removed: $68,750) during the year ended December 31, 2019, principally on account
−Removed: of a large order by a customer during the 2019 period.
−Removed: revenue, consisting primarily of shipping and handling charges, decreased to $38,131 (2018:
−Removed: $50,518) during the year ended December
−Removed: 31, 2019 due to a decline in orders shipped.
−Removed: Company’s gross profit percentage improved to 30% (2018:
−Removed: 8%), and the gross margin improved to $478,747 (2018:
−Removed: for the year ended December 31, 2019, principally due to our focus on a more narrowed and higher margin product lineup.
−Removed: improvements in gross margin were attributable to cost reductions, including reduced headcount .
−Removed: of sales for the year ended December 31, 2019 decreased to $1,098,286 (2018:
−Removed: $1,538,285) primarily as a result of decreases in
−Removed: manufacturing personnel costs ($286,187 (2018:
−Removed: $471,563)), inventory obsolescence ($336,349 (2018:
−Removed: $453,761)) and shipping expenses
−Removed: ($46,534 (2018:
+Added: previously disclosed, in light of the unfavorable factors persistent in our rapid, point-of-care screening and testing product
+Added: business and the progress the Company has made in its partnership with Premas, the Company conducted a strategic review of the
+Added: screening and testing products business.
+Added: Following such review, in early July 2020, the Company ceased the production and sale
+Added: of its rapid, point-of-care screening and testing products.
+Added: The Company will continue to provide support for these testing products
+Added: that remain in the market through their respective product expiration dates.
+Added: The Company had been experiencing declining sales
+Added: revenue and production backlogs for these products and, as it previously reported, had eliminated its sales force for such products.
+Added: The Company intends to devote its attention to its partnership with Premas for the development of its COVID-19 Vaccine Candidate
+Added: and transactions that the Company believes will increase shareholder value.
+Added: In connection with the ceasing production and sale
+Added: of its existing product line, on July 16, 2020, the Company decided to close the Thorofare Facility and exercised the early termination
+Added: option under the Thorofare Lease, which provided for a 150-day notice to terminate the lease.
+Added: Pursuant to the early termination
+Added: option, the Thorofare Lease matured on December 13, 2020.
+Added: The lease terminated on November 30, 2020, at the lessor’s
+Added: request, and the property was handed over to the property manager on November 30, 2020.
+Added: Company determined that the discontinuation of the production and distribution of the Company’s screening and testing products
+Added: constituted a strategic shift in the Company’s business and as a result the elimination of the product lines should be presented
+Added: as discontinued operations under FASB ASC 205-20 Presentation of Financial Statements, Discontinued Operations.
+Added: had no revenue from continuing operations during the years ended December 31, 2020 and December 31, 2019.
Administrative
Administrative
−Removed: expenses for the year ended December 31, 2019, totaled $3,728,514 which was a 34% decrease as compared to $5,666,018 for the year
+Added: expenses for the year ended December 31, 2020, totaled $4,299,062 which was a 27% increase as compared to $3,372,103 for the year
ended December 31, 2019.
2 unchanged sentences
the Years Ended
−Removed: Service Costs
−Removed: Market & Investor Relations Costs
−Removed: Administrative Costs
−Removed: Administrative Expense
−Removed: expenses decreased by 28% for the year ended December 31, 2019 as compared to the same period of 2018 on account of a reduction
−Removed: bonus expense, benefits, payroll service fees and auto allowances during 2019, as compared to December 31, 2018.
−Removed: service costs decreased 63% for the year ended December 31, 2019 as compared to the same period of 2018, principally on account
−Removed: of reduced legal fees ($699,118 (2018:
−Removed: $1,551,798)) and accounting and audit expenses ($51,381 (2018:
−Removed: The higher costs
−Removed: in 2018 were principally attributable to the investigation and restatement of the financial statements, and certain litigation
−Removed: defense costs.
+Added: Personnel Costs
+Added: Professional Service Costs
+Added: Stock Market & Investor Relations
+Added: Other Administrative
+Added: Total Administrative
+Added: expenses increased by 57% for the year ended December 31, 2020 as compared to the same period of 2019 on account of the addition
+Added: of an executive staff member.
+Added: service costs increased 115% for the year ended December 31, 2020 as compared to the same period of 2019, principally due to increased
+Added: accounting and audit, legal and general consulting fees.
market and investor fees decreased 37% for the year ended December 31, 2020.
−Removed: The decrease in these fees was principally associated
−Removed: with the costs savings generated by the withdrawal from the London Stock Exchange.
−Removed: administrative expenses increased by 10%, principally attributable to increased Director’s fees and expenses ($706,964 (2018:
−Removed: $409,910)), including the amortization of RSU awards, of ($362,005 (2018:
+Added: The decrease in these fees was principally due to
+Added: our delisting from the London Stock Exchange during the first half of 2019 and the avoidance of the costs associated with a presence
+Added: on the London Stock Exchange.
+Added: administrative expenses decreased by 5%, principally due to a decrease in bad debt expense, decreases in legal settlements,
+Added: license and permit fees and travel expenses which were offset by increases in board, building, business insurance and computer
and Marketing Expenses
−Removed: and marketing expenses for the year ended December 31, 2019 totaled $238,036 which was an 87% decrease compared to $1,782,315
−Removed: for the year ended December 31, 2018.
−Removed: table below summarizes our sales and marketing expenses for the years ended December 31 and 2018 as well as the percentage of
−Removed: change year-over-year:
−Removed: the Years Ended
−Removed: Service Costs
−Removed: and Outside Commission Costs
−Removed: Sales and Marketing Costs
−Removed: Sales and Marketing Expenses
−Removed: the first quarter of 2019, as part of our cost savings measures, we eliminated the personnel within the sales and marketing departments,
−Removed: including employees, consultants and third-party related representatives.
−Removed: expenses decreased by 93% for the year ended December 31, 2019 as compared to the same period of 2018 on account of the reduction
−Removed: in the sales and marketing headcount to zero as of December 31, 2019, as compared to four as of December 31, 2018.
−Removed: service costs decreased by 72% for year ended December 31, 2019, as compared to the same period of 2018 primarily on account of
−Removed: reductions in marketing and sales related consultants.
−Removed: and outside commission costs decreased by 76%, principally on account of ISR costs incurred for approximately two months in 2019
−Removed: as compared to twelve months in the 2018 period.
−Removed: An evaluation of the ISR program determined it to be ineffective and, as a result,
−Removed: all ISR’s agreements were terminated effective February 19, 2019.
−Removed: sales and marketing costs declined to $28,974 (2018:
−Removed: $225,896) principally due to the reductions in travel and entertainment for
−Removed: the sales and marketing personnel.
−Removed: Research and Development Expenses
−Removed: research and development expenses for the year ended December 31, 2019 totaled $276,788, which was a 74% decrease as compared
−Removed: to $1,063,253 for the year ended December 31, 2018.
−Removed: table below summarizes our compliance, research and development expenses for the years ended December 31, 2019 and 2018 as well
−Removed: as the percentage of change year-over-year:
−Removed: the Years Ended
−Removed: Service Costs
−Removed: Compliance, Research and Development Costs
−Removed: Compliance, Research and Development Expenses
−Removed: expenses decreased by 64% for the year ended December 31, 2019 as compared to the same period of 2018 due to a reduction in the
−Removed: headcount to three as of December 31, 2019, as compared to four as of December 31, 2018.
−Removed: These staff reductions eliminated the
−Removed: research & development functions, with the remaining personnel maintaining regulatory and quality assurance (compliance) functions.
−Removed: service costs, principally third-party engineering costs, declined by 90% for the year ended December 31, 2019, as compared to
−Removed: the same period of 2018, principally on account of the elimination of research & development activities.
−Removed: compliance, research and development costs declined by 94%, for the year ended December 31, 2019, as compared to the same period
−Removed: of 2018, principally on account of reduction in research and development activities, as discussed above.
−Removed: Settlement Expense
−Removed: settlement expenses for the year ended December 31, 2019, were $141,478 as compared to $1,505,000 for the year ended December
−Removed: settlement expenses for the year ended December 31, 2018 principally consisted of the settlement of the Pulse Litigation which
−Removed: resulted in a one-time charge of $930,000 and $500,000 in connection with the class action and derivative lawsuits.
−Removed: of Non-Current Assets
−Removed: of non-current assets for the year ended December 31, 2019 totaled $40,008, which was a 77% decrease as compared to $171,108 for
−Removed: the year ended December 31, 2018.
−Removed: The 2019 amount was less on account of impairment of intellectual property recorded in 2018,
−Removed: principally connected with the settlement of the Pulse Litigation.
+Added: and marketing expenses for the year ended December 31, 2020 totaled $22,963 which was an 8% decrease compared to $25,000 for the
+Added: year ended December 31, 2019.
+Added: and Development Expenses
+Added: and development expenses for the year ended December 31, 2020 totaled $7,963,678 as compared to $0 for the year ended December
+Added: 31, 2019, principally reflecting our current focus on the development of the COVID-19 Vaccine Candidate.
Income and Expense
−Removed: income, net of expense, for the year ended December 31, 2019 totaled $57,828 as compared to other expenses, net of income of $788,625
−Removed: for the year ended December 31, 2018.
+Added: income, net of expenses, for the year ended December 31, 2020 totaled $133,489 as compared to other income,
+Added: net of expenses of $90,808 for the year ended December 31, 2019.
table below summarizes our other income and expenses for the years ended December 31, 2020 and 2019 as well as the percentage
1 unchanged sentence
the Years Ended
−Removed: of Intangible Assets
−Removed: of Other Assets
on Disposal of Property and Equipment
Currency Transaction (Gain)/Loss
+Added: on FMV of Equity Investments
on Investments
1 unchanged sentence
Other (Income)/Expense
−Removed: of intangible assets, for the year ended December 31, 2019 totaled $32,980 as compared to $716,418 for the year ended December
−Removed: The 2018 amount included the impairment of intellectual property principally as a result of the settlement of the Pulse
−Removed: on disposal of property and equipment, for the year ended December 31, 2019 totaled $9,576 as compared to $156,493 for the year
−Removed: ended December 31, 2018.
−Removed: The 2018 amount included the write-off of computer equipment, computer software and production molds
−Removed: no longer in use by the Company.
+Added: investment gains increased to $54,100 for the year ended December 31, 2020 as compared to $0 for the same period in 2019.
+Added: increase was due to an increase in the fair market value of the equity investments.
+Added: loss on investments was $36,714 for the year ended December 31, 2020 as compared to a gain of $3,952 for the same period in 2019.
+Added: The decrease is principally due to the impact of the COVID-19 pandemic on the financial markets.
+Added: and dividend income increased to $119,052 for the year ended December 31, 2020 compared to $101,483 for the year ended December
+Added: The increase was principally due to the increase in funds available for investment.
of December 31, 2020, and 2019, the Company had Federal net operating loss carry forwards of approximately $100,615,000 and $79,678,000,
−Removed: respectively, expiring through the year ending December 31, 2039.
−Removed: As of December 31, 2019, and 2018, the Company had New Jersey
−Removed: state net operating loss carry forwards of approximately $28,855,000 and $29,700,000, respectively, expiring the year ending December
+Added: respectively, expiring through the year ending December 31, 2037 for net operating losses originating in tax years beginning
+Added: before January 1, 2018.
+Added: Net operating losses recorded in tax years beginning January 1, 2018 and after are allowed for an indefinite
+Added: carryforward period but limited to 80% of each subsequent year’s net income.
+Added: As of December 31, 2020, and 2019, the
+Added: Company had New Jersey state net operating loss carry forwards of approximately $7,548,000 and $28,855,000, respectively,
+Added: through the year ending December 31, 2040.
+Added: Section 382 of the Code, use of our NOLs will be limited if we experience a cumulative change in ownership of greater than 50%
+Added: in a moving three-year period.
+Added: We will experience an ownership change as a result of the Merger and therefore our ability to utilize
+Added: our NOLs and certain credit carryforwards remaining at the Effective Time will be limited.
+Added: The limitation will be determined by
+Added: the fair market value of our common stock outstanding prior to the ownership change, multiplied by the applicable federal rate.
+Added: It is expected that the Merger will impose a limitation on our NOLs.
+Added: The Company has recorded a full valuation allowance for its
+Added: deferred tax assets as of December 31, 2020 and 2019.
+Added: (See Note 9 to the Consolidated Financial Statements)
and Capital Resources
−Removed: of December 31, 2019, the Company’s cash on hand was $632,538 (which included restricted cash of $115,094
−Removed: and its marketable securities were $9,164,273.
−Removed: The Company has incurred net losses of $3,888,249 and $10,849,034
−Removed: for the years ended December 31, 2019 and 2018, respectfully.
−Removed: As of December 31, 2019, the Company had working capital of $8,781,049
−Removed: and a stockholder’s deficit of $119,583,130.
−Removed: During the year ended December 31, 2019, cash flows used in operating activities
−Removed: were $3,074,283, consisting primarily of a net loss of $3,888,249, which includes non-cash stock-based compensation charges
+Added: of December 31, 2020, the Company’s cash and cash equivalents on hand was $18,617,955 and its marketable securities
+Added: were $16,718,452.
+Added: The Company has incurred net losses of $17,580,609 and $3,888,249 for the years ended December
+Added: 31, 2020 and 2019, respectfully.
+Added: As of December 31, 2020, the Company had working capital of $34,579,466 and a stockholders’
+Added: deficit of $137,163,739.
+Added: During the year ended December 31, 2020, cash flows used in operating activities were $11,924,941,
+Added: consisting primarily of a net loss from ongoing operations of $12,152,214 and net loss from discontinued operations of
Since inception, the Company has met its liquidity requirements principally through the sale of its common stock
in public and private placements.
−Removed: December 9, 2019, the Company raised proceeds of $6,965,635 net of offering costs of $994,227 in connection with a registered
−Removed: offering of its common stock.
−Removed: our current cash resources will not be sufficient to fund the development of our COVID-19 Vaccine candidate through all of the
−Removed: required clinical trials to receive regulatory approval and commercialization.
−Removed: While we do not currently have an estimate of all
−Removed: of the costs that we will incur in the development of the COVID-19 Vaccine, we anticipate we will need to raise significant additional
−Removed: funds in order to continue the development of the our COVID-19 Vaccine candidate during the next 12-months.
−Removed: In addition, we could
−Removed: also have increased capital needs if we were to engage in a strategic transaction in the cannabinoid space.
−Removed: Company believes that its current financial resources as of the date of the issuance of these consolidated financial statements,
−Removed: are sufficient to fund its current twelve month operating budget, alleviating any substantial doubt raised by our historical operating
−Removed: results and satisfying our estimated liquidity needs for twelve months from the issuance of these consolidated financial statements.
−Removed: expenditures for the year ended December 31, 2019 were $0 (2018:
+Added: and commercialization of the Company’s COVID-19 Vaccine Candidate will require the Company to raise significant additional
+Added: funds as the project proceeds through clinical trials, the attainment of the required regulatory approvals and the commercialization
+Added: of the vaccine.
+Added: The timing of these events is difficult to estimate and are unlikely to be fully completed within the next twelve-months.
+Added: The Company evaluated
+Added: the current cash requirements for operations in conjunction with management’s strategic plan and believes that the Company’s
+Added: current financial resources as of the date of the issuance of these consolidated financial statements, are sufficient to fund
+Added: its current operating budget and contractual obligations as of December 31, 2020 as they fall due within the next twelve-month
+Added: period, alleviating any substantial doubt raised by the Company’s historical operating results and satisfying its estimated
+Added: liquidity needs for twelve months from the issuance of these consolidated financial statements.
+Added: expenditures for the years ended December 31, 2020 and December 31, 2019 were $0.
net cash consumed by operating activities totaled $11,924,941 during the year ended December 31, 2020.
Cash was consumed
−Removed: by the loss of $3,888,249 reduced by non-cash adjustments principally consisting of $3,353 for accrued interest on marketable
−Removed: securities, $74,064 for depreciation and amortization of non-current assets, $32,980 for impairment of intangible assets, $9,576
−Removed: for the loss on the disposal of fixed assets, $371,997 for charge for obsolescence, $105,325 for the allowance of doubtful accounts
−Removed: and other receivables and $400,174 for share based compensation.
−Removed: For the year ended December 31, 2019, within changes of assets
−Removed: and liabilities, cash provided consisted of a decrease in trade receivables of $128,120, a decrease in deposits and other receivables
−Removed: of $9,347, a decrease in inventories of $14,285, a decrease in prepaid expenses of $103,152 and a decrease in other assets of
−Removed: $9,280, off-set by a decrease in trade and other payables of $443,735.
+Added: by the net loss from continuing operations of $12,152,214 and a net loss from discontinued operations of $5,428,395 reduced by
+Added: non-cash adjustments principally consisting of $4,154,964 for stock-based compensation, $291,442 for impairment of prepaid royalties,
+Added: $152,822 for impairment of intangible assets and $197,723 for inventory adjustment for net realizable value.
+Added: For the year ended
+Added: December 31, 2020, within changes of assets and liabilities, cash was principally provided by an increase in trade and other
+Added: payables of $733,530 and decreases in trade receivables of 42,881 and prepaid expenses of $41,452.
net cash consumed by operating activities totaled $3,074,283 during the year ended December 31, 2019.
Cash was consumed
−Removed: by the loss of $10,849,034 reduced by non-cash adjustments principally consisting of impairment of intangible assets of $716,148,
−Removed: reserve for obsolete inventory of $279,029, $234,486 for depreciation and amortization of non-current assets, $156,835 for the
−Removed: allowance of doubtful accounts, $50,647 for share based compensation less $11,011 for accrued interest and dividends on marketable
−Removed: For the year ended December 31, 2019, within changes of assets and liabilities, cash provided consisted of a decrease
−Removed: in trade receivables of $631,510, a decrease in inventories of $83,316, an increase in trade and other payables of $188,462, off-set
−Removed: by an increase in prepaid expenses of $225,586.
−Removed: Company’s net cash provided by investing totaled $3,940,627, as compared to $359,685 during the years ended
+Added: by the net loss from continuing operations of $3,381,295 and a net loss from discontinued operations of $506,954 reduced by non-cash
+Added: adjustments principally consisting of $74,064 for depreciation and amortization of non-current assets, $32,980 for impairment
+Added: of intangible assets, $371,997 for charge for obsolescence inventory, $105,325 for the allowance of doubtful accounts and other
+Added: receivables and $400,174 for share-based compensation.
+Added: For the year ended December 31, 2019, within changes of assets and
+Added: liabilities, cash provided consisted principally of a decrease in trade receivables of $128,120, and a decrease in prepaid expenses
+Added: of $103,152 off-set by a decrease in trade and other payables of $443,735.
+Added: Company’s net cash used in investing totaled $8,757,469, as compared to $3,940,627 during the years ended
December 31, 2020 and 2019, respectively.
−Removed: Net cash provided by investing activities for the year ended December 31, 2019 consisted
−Removed: of proceeds from the sale of marketable securities of $2,857,960 and the sale of equipment of $6,250 offset by $6,704,837
−Removed: consumed by the purchase of marketable securities and $100,000 for the issuance of a short-term note receivable.
−Removed: During the year
−Removed: ended December 31, 2018, investing activities consisted of proceeds from the sale of marketable securities of $6,313,330 offset
−Removed: by $6,604,801 consumed by the purchase of marketable securities and $68,214 for capital expenditures.
+Added: Net cash used in investing activities for the year ended December 31, 2020 consisted
+Added: of proceeds from the sale of marketable securities of $2,314,374 offset by $9,871,843 consumed by the purchase of marketable
+Added: Net cash used in investing activities for the year ended December 31, 2019 consisted of proceeds from the sale of
+Added: marketable securities of $2,857,960 and the sale of equipment of $6,250 offset by $6,704,837 consumed by the purchase of
+Added: marketable securities and $100,000 for the issuance of a short-term note receivable.
Company’s net cash provided by financing activities in 2020 was $38,667,827 (2019:
1 unchanged sentence
the 2020 period consisted of $29,184,244 of net proceeds from the issuance of common shares, $1,743,503 of net proceeds for the
−Removed: issuance of prepaid equity forward contracts for the purchase of common shares and $58 of net proceeds for the exercise of prepaid
−Removed: equity forward contracts for common shares Net cash provided during the 2018 period consisted of $1,950,000 of net proceeds for
−Removed: the issuance of common shares and $7,155,200 for the exercise of warrants for common shares.
+Added: issuance of prepaid equity forward contracts for the purchase of common shares and $7,740,000 of net proceeds from the
+Added: exercise of warrants for common stock.
+Added: Net cash provided during the 2019 period consisted of $2,147,778 of net proceeds from issuance
+Added: of common stock and $4,817,857 of net proceeds from issuance of prepaid equity forward contracts for the purchase of common stock.
Accounting Policies
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America
−Removed: (US GAAP) requires management to make estimates and assumptions about future events that affect the amounts reported in the financial
−Removed: statements and accompanying notes.
+Added: (“US GAAP”) requires management to make estimates and assumptions about future events that affect the amounts reported
+Added: in the financial statements and accompanying notes.
Future events and their effects cannot be determined with absolute certainty.
−Removed: Therefore, the
−Removed: determination of estimates requires the exercise of judgment.
−Removed: Actual results inevitably will differ from those estimates, and
−Removed: such differences may be material to the financial statements.
−Removed: The most significant accounting estimates inherent in the preparation
−Removed: of our financial statements include estimates associated with revenue recognition, impairment analysis of intangibles and stock-based
−Removed: compensation.
+Added: Therefore, the determination of estimates requires the exercise of judgment.
+Added: Actual results inevitably will differ from those
+Added: estimates, and such differences may be material to the financial statements.
+Added: The most significant accounting estimates inherent
+Added: in the preparation of our financial statements include estimates associated with revenue recognition, impairment analysis of intangibles
+Added: and stock-based compensation.
financial position, results of operations and cash flows are impacted by the accounting policies we have adopted.
get a full understanding of our financial statements, one must have a clear understanding of the accounting policies employed.
−Removed: A summary of our critical accounting policies is presented within the footnotes in the consolidated financial statements presented
−Removed: with in the Annual Report.
−Removed: and Qualitative Disclosure About Market Risk
+Added: A summary of our critical accounting policies is presented within the notes to our consolidated financial statements appearing
+Added: elsewhere in this Annual Report on Form 10-K.
Sheet Arrangements
1 unchanged sentence
Quantitative and Qualitative Disclosures About Market Risk.
+Added: Financial Statements and Supplementary Data.
+Added: information required by this Item 8 is included at the end of this Annual Report on Form 10-K beginning on page F-1.
+Added: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
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.