SEC Company Response from CARDAX, INC. (CIK 0001544238) — Jun 30, 2020
CARDAX, INC. (CIK 0001544238)
Date: June 30, 2020 · CIK: 0001544238 · Accession: 0001493152-20-012274
AI Filing Summary & Sentiment
File numbers found in text: 333-181719
Referenced dates: May 21, 2020
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Cardax,
Inc.
2800
Woodlawn Drive, Suite 129, Honolulu, HI 96822
telephone
808.457.1400 fax 808.237.5901
www.cardaxpharma.com
June
30, 2020
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
Washington,
DC 20549
Attention:
Mary Mast and Dan Gordon
Re:
CARDAX,
INC.
Form
10-K for the Fiscal Year Ended December 31, 2019
Filed
March 30, 2020
File
No. 333-181719
Ladies
and Gentlemen:
Cardax,
Inc. (the “Company”) is responding to comments by the staff (the “Staff”) of the United
States Securities and Exchange Commission (the “Commission”) to the Company’s Form 10-K for the Fiscal
Year Ended December 31, 2019 filed on March 30, 2020 (the “Annual Report”) that were provided on June 16, 2020
(the “Second Comment Letter”) following the Company’s correspondence on June 5, 2020 in response to the
Staff’s comments dated May 21, 2020 (the “First Comment Letter”).
For
convenience, the headings and numbered items of this letter correspond to the headings and numbered items contained in the Second
Comment Letter and each of the comments is restated in bold italics prior to the response. Any page number references
in the responses below refer to the page numbers in the Annual Report. Any capitalized terms in the responses below that are not
otherwise defined in this letter shall have the respective meanings ascribed to such terms in the Annual Report.
The
Company believes that the additional information provided herein in response to the Staff’s comments would not constitute
any material substantive disclosure by the Company if included in the Annual Report by amendment. Accordingly, the Company respectfully
requests that it be allowed to disclose such information in its future filings with the Commission, where applicable, as an alternative
to filing an amendment to the Annual Report to address the comments provided in the Second Comment Letter.
Item
9A. Controls and Procedures
Disclosure
Controls and Procedures, page 54
1.
Please
revise the proposed disclosure in response to comment 1, to provide a separate evaluation of your disclosure controls and
procedures pursuant to Item 307 of Regulation S-X along with a Management’s report on your internal controls over financial
reporting pursuant to Item 308 of Regulation S-K. In addition, please address the second part of comment 1 relating to how
the omission of these required disclosures impacts your conclusion with respect to the effectiveness of the disclosure controls
and procedures as of December 31, 2019.
United
States Securities and Exchange Commission
Division
of Corporation Finance
Page
2
RESPONSE:
The
Company acknowledges the Staff’s comment and agrees the disclosure could be clarified. The Company proposes to provide disclosure
in substantially the form below in its future filings with the Commission, where applicable. In addition, the Company believes
that the disclosure in the Annual Report was adequately presented in all material respects and the additional information provided
below would have no impact on our conclusion with respect to the effectiveness of the disclosure controls and procedures as of
December 31, 2019.
ITEM
9A. CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures
Our
management is responsible for establishing and maintaining adequate disclosure controls and procedures, as defined in Rule 15d-15(e)
under the Exchange Act. Our disclosure controls and procedures are designed to ensure that information we are required to disclose
in reports we file or submit under the Exchange Act is (a) recorded, processed, summarized, and reported, within the time periods
specified in the Commission’s rules and forms; and (b) accumulated and communicated to our management, including our Chief
Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Our management
evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure
controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our
disclosure controls and procedures were effective as of December 31, 2019.
Internal
Control over Financial Reporting
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule
15d-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles and includes those policies and procedures that (a) pertain to the maintenance of
records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets; (b) provide
reasonable assurance that our transactions are recorded as necessary to permit the preparation of financial statements in accordance
with generally accepted accounting principles and that our receipts and expenditures are being made only in accordance with authorizations
of our management and directors; and (c) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of our assets that could have a material effect on the financial statements. Our management evaluated,
with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our internal control over
financial reporting using the framework in Internal Control — Integrated Framework (2013) issued by the Committee
of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control
over financial reporting was effective as of December 31, 2019.
Changes
in Internal Control over Financial Reporting
Our
management evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, any change in our internal
control over financial reporting and identified no change during the quarter ended December 31, 2019, that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
United
States Securities and Exchange Commission
Division
of Corporation Finance
Page
3
Notes
to the Consolidated Financial Statements
Note
2- Summary of Significant Accounting Policies
Research
and development, page F-11
2.
We
acknowledge your representations in your response to comment number 2 that, for the years ended December 31, 2019 and 2018,
substantially all of the Company’s in-house scientific personnel’s time and services supported aspects of your
business not directly or indirectly related to research and development, and accordingly, the compensation of your in-house
personnel was included as part of salaries and wages. However, your proposed disclosure appears to indicate that your in-house
scientific personnel spend considerable time and services on research and development activities as defined in ASC 730-10-20
and ASC 730-10-25-2e. For each of the statements in your proposed disclosure below, please clarify in the proposed disclosure
that the time spent by your in-house scientific personnel is not material, as you appear to indicate in your response, or
revise your composition of research and development expense in your Statement of Operations in future filings.
●
“In
addition to directing or overseeing research and development activities, our inhouse scientific personnel...”
●
“our
in-house scientific personnel also support other aspects of our business, including ... as well as an analysis of available
information on astaxanthin, related compounds, competing products, applications, and industry trends, which helps to inform
management’s business planning and public disclosure assessments”
●
“has
also presented our in-house scientific personnel with the critical task of keeping up-to-date on all of the latest information
and interpreting and integrating the findings with our understanding of the mechanism of action and biological applications
of astaxanthin and related carotenoids”
RESPONSE:
The
Company acknowledges the Staff’s comment and agrees the disclosure could be clarified. The Company proposes to provide disclosure
in substantially the form below in its future filings with the Commission, where applicable.
Research
and Development
Our
research and development program utilizes contract research organizations, contract development and manufacturing organizations,
academic institutions, third-party collaborators, employees, and consultants, including scientific, medical, and regulatory professionals.
Contract organizations and other third parties provide us with access to significant research and development resources and infrastructure.
We anticipate that our research and development will be primarily conducted by contract organizations and other third parties
with direction and oversight by our in-house scientific personnel to the extent necessary.
In
addition to directing or overseeing research and development activities to the extent necessary, which did not constitute a material
amount of time during the years ended December 31, 2019 and 2018, our in-house scientific personnel support other aspects of our
business that do not directly or indirectly constitute research and development, including (a) general and administration, such
as presentations and due diligence related to fundraising or business development, as well as assessments that help inform our
management’s business planning and public disclosure assessments, and (b) sales and marketing, such as preparation and dissemination
of existing scientific information related to our products.
Our
research and development expenditures totaled $315,994 and $269,077 for the years ended December 31, 2019 and 2018, respectively.
These expenditures primarily reflect the cost of product development activities, including clinical trials.
United
States Securities and Exchange Commission
Division
of Corporation Finance
Page
4
Thank
you for your constructive comments. Please do not hesitate to contact the undersigned by email at dwatumull@cardaxpharma.com or
jrussell@cardaxpharma.com with any questions or further comments regarding the Annual Report or to discuss the above responses.
Very
truly yours,
/s/
David G. Watumull
/s/
John B. Russell
David G. Watumull
John B. Russell
Chief Executive Officer
Chief Financial Officer