SecProbe.io

September 3, 2013

Via E -mail
Thomas A. Nicolette
Chief Executive Officer, President and Director
Akers Biosciences, Inc.
201 Grove Road
Thorofare, New Jersey 08086

Re: Akers Biosciences, Inc.
Registration Statement on Form S -1
Filed August 7, 2013
  File No. 333 -190456

Dear Mr. Nicolette :

We have reviewed your registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do  not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Summary
Genera l

1. Please note that when you file a pre -effective amendment containing pricing -related
information, we may have additional comments.   As you are likely aware, you must file
this amendment prior to circulating the prospectus.   Please note that when you file  a pre -
effective amendment that includes your price range, it must be bona fide.   We interpret
this to mean that your range may not exceed $2 if you price up to $10 and 20% if you
price above $10.

2. Please confirm that the images included in your registration statement are all of the
graphic, visual or photographic information  you will be including.  If you intend to use
any additional images, please provide us proofs of such materials .  Please note t hat we
may have comments regarding this material.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 2

 3. Please revise your prospectus to remove your statement on page 1 that you have not
independently verified market and industry data from third -party sources and prepared by
management.  It is not appropriat e to directly or indirectly disclaim liability for
information in the registration statement.

4. Please include in this part of your disclosure a brief description of your platform
technologies, as well as both your marketed products and your pipeline produc ts.

5. Please revise your disclosure to provide a summary of the material risks concerning your
company and your proposed offering, including but not necessarily limited to the
following:

 Your history of operating losses, including your large accumulated d eficit, and
your inability to date to achieve profitability;

 Your reliance on a small number of customers for the vast majority of your
revenues;

 Your need for additional capital to support your operations and the possibility that
you may not be able to obtain such capital;

 Your limited marketing resources and sales capabilities and your resulting
dependence on distributors; and

 The disproportionate share ownership by your directors, executive officers and
affiliates and the lack of influence your share holders will have over corporate
affairs.

Market Overview, page 3

6. Please identify your products that have received FDA clearance for over -the-counter use
and your other products that do not fall within the oversight of regulatory authorities in
this sec tion and elsewhere, as necessary, throughout your registration statement.

Risk Factors
Risks Related to the Company and Our Business
“We have a history of operating losses and we cannot guarantee that we can ever achieve
sustained profitability,” page 7

7. In this risk factor, you state that your net loss for the six months ended June 30, 2013 was
$200,962, which is also reflected in your financial statements.   However, y our summary
financial data on page 6 indicates  that your net loss during this period was over $3.6
million.  Please reconcile this discrepancy.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 3

 “Due to our dependence on a limited number of customers and the loss of any such customer
would have a material adverse effect…,” page 7

8. Please indicate whether you have entered into any agreement with Cardinal Health or
Fisher Healthcare with respect to the distribution of your PIFA Heparin/PF4 Rapid
Assays.  If so, please describe the material terms of any such agreement and file the
agreement as an exhibit to your registration statement or provide an analysis as to why
your business is not substantially dependent on any such agreement.

“If we fail to obtain regulatory approval in foreign jurisdictions…,” page 10

9. Please identify the specific foreign jurisdictions in which you plan to market your
products.

“We may be unable to market our products outside the United States if our products cannot meet
certain requirements of the Federal Food, Drug and Cosmetic Act requirements for exporting
medical devices,” page 10

10. The final two paragraphs in this risk factor relate to  meeting certain regulatory
requirements outside of the Federal Food, Drug and Cosmetic Act.  Please include  these
two paragraphs under a separate r isk factor heading discussing risks stemming from a
failure to meet the regulatory requirements in foreign markets.  You should also list here
and wherever else appropriate the six products for which you have received CE marks.

“Clinical trials that may b e required to support regulatory submissions in the United States and in
international markets are expensive . . .,” page 11

11. Please include in this risk factor the amount that you estimate you will spend on R&D
over the next fiscal year.

“The results of  our clinical trials may not support either further clinical development of the
commercialization of our product candidates,” page 12

12. Please explain in this risk factor that each medical device marketed in the United States
must receive a 510(k) clearance  from the Food and Drug Administration.

“Modification to our devices may require additional FDA approval which could force us to cease
marketing and/or recall the modified device until we obtain new approvals,” page 12

13. Please briefly explain the term “PMA approval” in this risk factor.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 4

 “We may not have sufficient resources to effectively introduce and market our products, which
could materially harm our operating results,” page 13

14. The last two sentences of this ris k factor appear to have been included in error. Please
revise your risk factor accordingly.

15. Please consider combining this risk factor with the final risk factor on this page as both
risk factors appear to relate to the same issue.  Also, in relation to your limited sales
capabilities, please revise your risk factor to note that you reduced your  account
executive sales force  by 40% during the six month period ended June 30, 2013, discuss
the reasons for this decision, and highlight any resulting impact on  your sales efforts.

“We may incur substantial costs as a result of litigation or other proceedings relating to patent or
other intellectual property rights . . .,” page 19

16. Please include in this risk factor examples of such litigation that has been filed against
you or any of your founders, executive officers, and/or directors, if any.

“We may be subject to claims that our employees have wrongfully used or disclosed allege d
trade secrets of their former employees,” page 20

17. Please include in this risk factor examples of such claims made against your employees,
if any.

“If we deliver products with defects, we may be subject to product recalls or negative
publicity…,”page 21

18. Please disclose the amount of product liability insurance you have obtained.

“There can be no assurance that our shares will be listed on the NASDAQ Capital Market . . .,”
page 23

19. Please note in this risk factor that you may not yet qualify for listing  on NASDAQ and
that you will need to take certain measures to do so, including effecting a reverse split of
your common shares.

“We will incur significant costs as a result of being a publicly traded company . . .,” page 27

20. Please include in this risk factor, to the extent practicable, an estimate of the annual costs
associated with being a public company.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 5

 “A sale of a substantial number of shares of the common stock …,” page 27

21. Please revise your risk factor heading to note that investors in the offering may
experience immediate dilution of their ownership following completion of the offering.

Dilution, page 30

22. You state on page 70 that the holder of the preferred stock has agr eed to convert such
shares into 50,000,000 shares of common stock immediately prior to the consummation
of this offering.  Please revise the presentation to separately disclose the effect of the
conversion of preferred stock to common stock.

Management’s Discussion and Analysis of Financial Condition and Results of Operations, page
32

23. Please describe the equity financing you have relie d upon over the last two years.

General and Administrative Expenses, page 34

24. Please disclose why you wrote -off the long -term note receivable of $151,569 from
ChubeWorkx in June 2012. In addition, you state on page F -14 that accounts receivable
of $1,041,388 was due from ChubeWorkx at June 30, 2013. Please clarify why you
believe that amount is collectible.

25. Please explain why you recorded bad debt expense of only $9,047 in 2012, given bad
debt expense of $1,650,185 in 2011. Revise your disclosure accordingly.

Research and Development Expenses, page 34

26. Please provide a breakdown of research and development expense by major project for
each period presented.

Other Income and Expenses, page 35

27. Please explain how you determined the $99,710 gain on the transaction, involving the
sale of (en) 10 in exchan ge for the expansion of the ChubeWorkx marketing rights and its
commitment to purchase 80 million shares of your common stock.  Revise your
disclosure accordingly.

28. Please explain how you determined the $91,286 gain on the demutualization of your
insurer. Revise your disclosure accordingly.

29. Please explain your accounting treatment for the re -acquisition of technology from Pulse
and the forgiveness of its obligations to you, as disclosed on page F -28, and quantify the
related impact on your operating result s for 2011. Revise your disclosure accordingly.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 6

 Critical Accounting Policies, page 38

30. We note that you  have elected to use the extended transition period for complying with
new or revised accounting standards under Section 102(b)(1) of the JOBS Act.  Pl ease
include a statement in your critical accounting policy disclosures  which explains that this
election allows you to delay the adoption of new or revised accounting standards that
have different effective dates for public and private companies until tho se standards apply
to private companies.  Please  also state that your financial statements may not be
comparable to companies that comply with public company effective dates.

Revenue Recognition, page 39

31. Please disclose in the notes to the financial st atements your accounting policy for
estimates of items that reduce gross revenue such as product returns, chargebacks,
customer rebates and other discounts and allowances. In addition, please provide us
proposed disclosure to address the following:

 Natur e and amount of each accrual at the balance sheet date ;

 The factors that you consider in estimating each accrual such as historical return
of products, levels of inventory in the distribution channel, etc. ;

 To the extent that information you consider in  the preceding bullet is quantifiable,
disclose both quantitative and qualitative information and to what extent
information is from external sources (e.g., end -customer prescription demand,
third -party market research data comparing wholesaler inventory l evels to end -
customer demand). For example, in discussing your estimate of product that may
be returned, consider disclosing and discussing, preferably by product and in
tabular format, the total amount of product (in sales dollars) that could be
potential ly be return ed as of the balance sheet date;

 Include a roll forward of the liability for each estimate for each period presented
showing the following:

o Beginning balance,
o Current provision related to sales made in current period,
o Current provision related to sales made in prior periods,
o Actual returns or credits in current period related to sales made in
current period,
o Actual returns or credits in current period related to sales made in
prior periods, and
o Ending balance ; and

 In your discussion of results of operations for the period to period revenue
comparisons, discuss the amount of and reason for fluctuations for each type of

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 7

 reduction of gross revenue (i.e. product returns, chargebacks, customer rebates
and other discount s and allowances) including the effect that changes in your
estimates of these items had on your revenues and operations.

Business
Product Portfolio, page 43

32. Please indicate which of your marketed or pipeline products, if any, are required or are
expected to require clinical trials to support your 510(K) submission. Please provide
disclosure that describes these trials , if applicable .

33. Please indicate whethe r the products marketed under the PIFA platform have received
FDA 510(k) approval. If any have not, please describe the exemption you relied upon.

Distribution, page 48

34. Please amend your disclosure to identify  the material terms of your License and Sup ply
Agreement with Chubeworkx Guernsey Limited, including the following:

 continuing obligations of both parties under the agreement ;

 payment obligations (including applicable any royalties  to be paid on product
sales);

 duration of the agreement; and,

 any termination provisions.

In addition, we note that you filed an amendment to your License and Supply Agreement
with Chubeworkx as Exhibit 10. 4 to the registration statement but that you have not filed
the original agreement between the parties.  Please amend your registration statement to
also include your original agreement with Chubeworkx as an exhibit.

Intellectual Property, page 49

35. In this disclosure, please list all of your material patents, the products to which they
relate, their expiration dates, and their jurisdictions. Please also consider indicating the
type of protection you have under each patent, e.g. composition of matter,  use or process.

Principal Stockholders, page 67

36. Please include footnote disclosure indicating the individual(s) who have voting and/or
investment power over the common shares held by Chubeworkx Guernsey Limited and
Legal & General Group plc.

Thomas A. Nicolette
Akers Biosciences, Inc.
Septembe r 3, 2013
Page 8

Shares Eligible for Future Sale
Lock -Up Arrangements, page 72

37. Please file a copy of the form lock -agreement as an exhibit to your registration statement.
If it is to be filed as an exhibit to your underwriting agreement, please confirm this for us.

Financial S tatements
General

38. Please revise to disclose all related party transactions on the face of the financial
statements and/or notes, as required by Rule 4 -08(k) of Regulation S -X and ASC 850 -10-
50.

Condensed Consolidated Financial Statements for the Six Mont hs Ended June 30, 2013 and 2012
Notes to Condensed Consolidated Financial Statements
Note 4 -Note Receivable, page F -9

39. Please clarify here and on page F -26 that this note was repaid in cash and that it was from
a related party.

Note 11 -Share -Based Payment s, page F -10

40. You disclose on page 61 that 7,000,000 warrants were cancelled in 2013.  Please revise to
cl