0001493152-20-010671.txt : 20200714 0001493152-20-010671.hdr.sgml : 20200714 20200605164328 ACCESSION NUMBER: 0001493152-20-010671 CONFORMED SUBMISSION TYPE: CORRESP PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200605 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Akers Biosciences, Inc. CENTRAL INDEX KEY: 0001321834 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: CORRESP BUSINESS ADDRESS: STREET 1: 201 GROVE RD CITY: THOROFARE STATE: NJ ZIP: 08086 BUSINESS PHONE: 856-848-8698 MAIL ADDRESS: STREET 1: 201 GROVE RD CITY: THOROFARE STATE: NJ ZIP: 08086 FORMER COMPANY: FORMER CONFORMED NAME: Akers Biosciences Inc DATE OF NAME CHANGE: 20050325 CORRESP 1 filename1.htm

 

 

June 5, 2020

 

VIA EDGAR

 

Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attention: Mr. Alan Campbell
Ms. Celeste Murphy

 

Re: Akers Biosciences, Inc.
  Registration Statement on Form S-3
  Filed May 22, 2020
  File No. 333-238631

 

Ladies and Gentlemen:

 

On behalf of Akers Biosiences, Inc. (the “Company” or “Akers”), we are writing to respond to the comments set forth in the comment letter of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”), dated June 2, 2020 (the “Comment Letter”), to Christopher Schreiber, Executive Chairman of the Company, relating to the above referenced Registration Statement on Form S-3 (the “Registration Statement”). In connection with this response to the Comment Letter, the Company is contemporaneously filing via EDGAR an amendment to the Registration Statement (“Amendment No. 1”), responding to the Staff’s comments in the Comment Letter and updating the Registration Statement.

 

The following are the Company’s responses to the Comment Letter. For your convenience, the Staff’s comments contained in the Comment Letter have been restated below in their entirety in bold type, with the Company’s corresponding responses set forth immediately under such comments, including, where applicable, a cross-reference to the location of changes made in Amendment No.1 in response to the Staff’s comment. All page references in the responses set forth below refer to page numbers in Amendment No. 1. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in Amendment No. 1.

 

Registration Statement on Form S-3 filed May 22, 2020

 

Prospectus Summary, Overview, Page 2

 

  1. We note your disclosure that Premas Biotech PVT Ltd, your partner company, has successfully completed its COVID-19 vaccine prototype. Please update your disclosure to clarify the current clinical or pre-clinical stage of development of the vaccine product candidate and the jurisdiction. Make clear the possibility that the FDA may not accept clinical trials performed in other jurisdictions and may require additional testing. Please also balance your disclosure by stating that you will need to submit an IND to the FDA and complete all phases of clinical trials before you can apply to receive marketing approval for this product candidate.

 

Response:

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company has updated the disclosure under the heading “Overview” on page 2 of the prospectus contained in Amendment No. 1 and added additional risk factors on pages 4 through 6 of the prospectus contained in Amendment No.1 in response to the Staff’s comment.

 

   
 

 

U.S. Securities and Exchange Commission

June 5, 2020

Page 2

 

  2. If true, please also clarify that Premas has responsibility to develop the product candidate through proof of concept.

 

Response:

 

The Company hereby clarifies that Premas has responsibility to develop the vaccine candidate through proof of concept and has made the requested clarifying revisions under the heading “Overview” on page 2 of the prospectus contained in Amendment No. 1.

 

  3. Please disclose the scope, jurisdiction and expiry date for each of the patents that are related to the COVID-19 vaccine product candidate. To the extent that neither you nor Premas have any patents related to the COVID-19 product candidate, please disclose.

 

Response:

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company has added the requested disclosure under the heading “Overview” on page 2 of the prospectus contained in Amendment No. 1 to disclose the scope, jurisdiction and expiry date for each of the patents that are related to the COVID-19 vaccine product candidate.

 

* * *

 

Please direct any questions or comments concerning this response to the undersigned at (212) 659-4974.

 

  Very truly yours,
   
 

Rick A. Werner, Esq.

   
cc: Christopher C. Schreiber, Akers Biosciences, Inc.  

 

   

 

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