U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): July 7, 2020

 

AKERS BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

New Jersey   001-36268   22-2983783
(State or other jurisdiction of   (Commission   (I.R.S. Employer
incorporation or organization)   File Number)   Identification Number)

 

201 Grove Road

Thorofare, New Jersey USA 08086

(Address of principal executive offices, including zip code)

 

(856) 848-8698

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Company under any of the following provisions:

 

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, no par value   AKER   The NASDAQ Capital Market

 

 

 
 

 

Item 8.01 Other Events.

 

On July 7, 2020, Akers Biosciences, Inc. (the “Company”) issued a press release announcing with its partner, Premas Biotech PVT Ltd., the initiation of animal studies for its SARS-CoV-2 vaccine candidate in India. Concurrently with the initiation of this trial, the Company also announced that it will cease shipping its PIFA Heparin / Platelet Factor 4 Rapid Assay products and will no longer focus on the development, manufacture, and supply of rapid, point of care screening and testing products. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No. 		  Description
99.1   Press release, dated July 7, 2020

 

 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  AKERS BIOSCIENCES, INC.
   
Dated: July 8, 2020 /s/ Christopher C. Schreiber
  Christopher C. Schreiber
  Executive Chairman of the Board of Directors and Director

 

 

 

 

Exhibit 99.1 

 

Akers Biosciences and Premas Biotech Announce Initiation of Animal Studies

 

Company intends to cease focus on screening and testing products business

 

Thorofare, New Jersey, July 7, 2020/ -- Akers Biosciences, Inc. (the “Company”) (NASDAQ: AKER), a developer of rapid health information technologies, today announced with its partner, Premas Biotech, the initiation of animal studies for its SARS-CoV-2 vaccine candidate in India. Premas has successfully completed the manufacturing process for the VLP (virus like particle) vaccine candidate, including three antigens from SARS-CoV-2. The 4-week test is expected to be placebo controlled, blinded, and randomized, in mice. The test will first seek to evaluate safety in the rodent model and secondly examine immune response dose titration. Premas plans to administer the test across different dose amounts, including amounts that would be applicable to humans.

 

Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, commented, “We are excited that we have been able to manufacture and characterize the VLP containing three main proteins from the SARS-CoV-2 virus. We are now moving ahead for this animal study using mice to analyze safety and immunogenicity of the candidate. We believe it will be first case of a three antigen VLP being dosed in an animal for SARS CoV-2.”

 

Premas is also currently engaged in communications with regulatory authorities in both India and the United States. Data from this study is expected in approximately six weeks.

 

Concurrently with the initiation of this trial, Akers has determined that it will cease shipping its PIFA Heparin / Platelet Factor 4 Rapid Assay products and will no longer focus on the development, manufacture, and supply of rapid, point of care screening and testing products.

 

Christopher Schreiber, Executive Chairman of Akers, stated, “The initiation of animal studies is an important milestone for us with our partner, Premas. Concurrently with the initiation of this trial, the board of Akers believed it would be in the best interest of stockholders to cease Akers’ screening and testing products line of business and to focus its resources on other strategic priorities that are currently being evaluated.”

 

About Premas Biotech

 

Premas Biotech develops novel & transformational technologies and partners with global biopharmaceutical companies to build and develop novel biotherapeutic & vaccine candidates. Premas’ key focus areas are infectious diseases, cancer, metabolic disorders and inflammation. Besides D-CryptTM the difficult to express proteins expression platform, Premas’ leading technologies include Axtex-4D™: an ex-vivo tissueoid generation platform and C-Qwence™: a fully human naive India based scFv antibody library. Further information is available on the Company’s website: www.premasbiotech.com

 

Contact email: contact@premasbiotech.com

 

About Akers Biosciences Inc.

 

Akers Biosciences is pursuing the development of a recently acquired license to a coronavirus vaccine candidate.  Akers has also previously announced that that it had identified the hemp and minor cannabinoid sectors as promising adjacent opportunities that could benefit from Akers’ existing facility and its core competencies.  

 

Additional information on the company and its products can be found at www.akersbio.com.

 

 
 

 

Forward Looking Statements

 

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements of historical fact, and may be identified by words such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that”, “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, market and other conditions, changes in the market acceptance of the company’s products and services; challenges we may face in identifying, acquiring and operating new business opportunities; the outcome of litigation or other proceedings to which the company is subject or which it may become subject to in the future; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the company operates; the company’s relationships with its key customers; adverse conditions in the industries in which the company’s customers operate; the company’s ability to retain and attract senior management and other key employees; the company’s ability to quickly and effectively respond to new technological developments; the company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the company’s proprietary rights; the company’s ability to achieve the expected benefits and costs of the transactions related to the acquisition of Cystron Biotech, LLC, including, the timing of, and the company’s ability to, obtain and maintain regulatory approvals for clinical trials of the company’s vaccine product candidate, the timing and results of the company’s planned clinical trials for its vaccine product candidate, the amount of funds the company requires for its vaccine product candidate, and the company’s ability to maintain its license with Premas Biotech PVT Ltd; and the impact of the recent COVID-19 outbreak on the company’s results of operations, business plan and the global economy. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the company’s filings with the SEC, including its annual report on Form 10-K filed with the Securities and Exchange Commission, as may be supplemented or amended by the company’s Quarterly Reports on Form 10-Q. The company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Contact:

 

Investor Relations: Hayden IR

 

Brett Mass, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com

www.haydenir.com