October 9, 2018
Nicholas DeVito
Chief Executive Officer
Marizyme, Inc.
2295 Towne Lake Parkway
Suite 116-290
Woodstock, GA 30189
Re: Marizyme, Inc.
Registration Statement on Form 10-12G
Filed September 12, 2018
File No. 000-53223
Dear Mr. DeVito:
We have reviewed your filing 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 these comments within ten business days by providing
the requested
information or advise us as soon as possible when you will respond. If you do
not believe our
comments apply to your facts and circumstances, please tell us why in your
response.
After reviewing your response and any amendment you may file in response
to these
comments, we may have additional comments.
Form 10-12G
Item 1. Business
Overview, page 4
1. Throughout the filing you reference your "product candidates" and
"pipeline products."
Please disclose here what your product candidates are and their current
stages of clinical
or preclinical trials. If you do not have any current product candidates,
please remove all
references to current "product candidates" and "pipeline products."
2. Please include a detailed plan of operations for the next twelve months.
In the discussion
of each of your planned activities, include specific information
regarding each material
event or step; material contingencies such as raising additional funds;
the timeline and
Nicholas DeVito
FirstName LastNameNicholas DeVito
Marizyme, Inc.
Comapany 2018
October 9, NameMarizyme, Inc.
October 9, 2018 Page 2
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FirstName LastName
associated costs accompanying each proposed step; and discuss the
material assumptions
underlying your business plan which you reference in Liquidity &
Capital Resources.
3. We note your references to "Krillase technology" here and in other
sections of the
registration statement. Please provide more details on what this
technology is, the status
of any requiredapprovals by the FDA or other foreign country
regulators, and any patents
or licenses related to this technology. In addition, please provide
disclosure
regarding ProteomeX, MB101 and MB102 referenced on your website at
www.marizyme.com.
4. We note your last risk factor on page 19. Please disclose your
third-party manufacturers
and their locations.
5. It appears that you have conducted clinical trials in the United
States. If so, please
provide the description of the clinical trials conducted, including
the number of trial
participants, endpoints, serious adverse events and adverse events
encountered during the
clinical trials and any other material information about the trials
that you conducted or are
currently conducting.
Intellectual Property, page 5
6. We note your disclosure that you acquired patents and patent
applications in
biotechnology. Please disclose what specific product, product groups
or technologies the
patents relate to, whether you own or license the patents, patent
expiration dates, the type
of patent application (such as composition of matter, use or process),
and what
jurisdictions the patents apply to.
Risk Factors
Our future product candidates may exhibit undesirable side effects, page 11
7. Please remove the statement that your "product candidates have
demonstrated an
acceptable safety profile."
Stockholders may have difficulty reselling their shares, page 32
8. Please update this risk factor. For example, you state that "[if you]
fail to be restored to
the OTCQB by April 30, 2014 or to remain current in [your] annual and
quarterly periodic
reports with the SEC...."
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Operating Expenses, page 37
9. Please expand your disclosure to identify and quantify the specific
factors that led to the
change in operating expenses, general expenses, other income and other
expense. Ensure
the disclosure explains the nature of and quantifies each type of
other income and other
Nicholas DeVito
FirstName LastNameNicholas DeVito
Marizyme, Inc.
Comapany 2018
October 9, NameMarizyme, Inc.
October 9, 2018 Page 3
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expense.
Critical Accounting Policies and Estimates
Recent Accounting Pronouncements, page 41
10. Please update your disclosure in this section as the current
disclosure is outdated. Please
clarify whether there are any pronouncements that you expect to adopt
in future periods
and the impact that the adoption of the standard is expected to have
on your financial
statements, if material.
Item 3. Properties, page 41
11. Please disclose the terms material leases of properties used to
conduct your business.
Refer to Item 102 of Regulation S-K.
Item 4. Security Ownership of Certain Beneficial Owners and Management, page 41
12. Please revise the table to reflect the acquisition of ACB Holding AB
in exchange for
16.98 million shares, including disclosure of all additional five
percent or greater
beneficial owners as a result of the acquisition.
Item 6. Executive Compensation
Summary Compensation Table, page 43
13. We note your disclosure on page F-12 that you paid management fees to
officers in 2016.
Please revise your summary compensation table to disclose all
compensation paid to your
named executive officers.
Report of Independent Registered Public Accounting Firm, page F-1
14. Please have your auditor revise their report to comply with PCAOB
Auditing Standard
3101. Also, ensure the type size is legible.
15. You disclose on page F-7 that all subsidiaries of the company were
sold effective
December 31, 2016. Please explain why your auditor has included a
paragraph in their
report that the financial statements as of and for the years ended
December 31, 2017 and
2016 do not include any of the accounts of your subsidiaries or
companies over which you
exercise significant influence. Audit reports that express a qualified
or "except for"
opinion due to a departure from GAAP do not meet the requirements of
Regulation S-X
Article 2.
Statements of Operations, page F-4
16. In future filings, please present your per share information only to
the nearest cent so as
not to imply more precision than exists.
Nicholas DeVito
FirstName LastNameNicholas DeVito
Marizyme, Inc.
Comapany 2018
October 9, NameMarizyme, Inc.
Page 4
October 9, 2018 Page 4
FirstName LastName
Statements of Cash Flows, page F-5
17. Expand Management's Discussion and Analysis to explain how operating
activities
provided cash in 2016 and 2017 when you reported net losses. Explain
to us why the
$928,659 Notes/Loans Receivable and the $715,418 and $(745,125)
Related Party
Transactions are classified as operating activities, rather than
investing or financing
activities, or revise the statement as necessary.
18. Net cash provided (used) by operating activities and Net cash provided
(used) by investing
activities for 2016 do not agree to the amounts reported in Form
10-K/A. Please revise to
report consistent amounts.
Note 2 Accounting Policies
Recent Accounting Pronouncements, page F-11
19. Please revise the disclosure in the last sentence as the financial
statements do not reflect
six years.
Note 8. Assets and Liabilities Held for Sale, page F-13
20. Please disclose the percentage ownership in GROUP and indicate how you
account for
your investment. Also, tell us what the fair value of your investment
is at June 30, 2018
and why no impairment is required.
General
21. Please be advised that your registration statement will automatically
become effective 60
days after filing. Upon effectiveness, you will become subject to the
reporting
requirements of the Securities Exchange Act of 1934. In addition, we
will continue to
review your filing until all of our comments have been addressed. If
the review process
has not been completed before that date, and you are not required to
register pursuant to
Section 12(g) of the Exchange Act, you should consider withdrawing the
registration
statement to prevent it from becoming effective and file it again at
such time as you are
able to respond to any remaining issues or comments.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Nicholas DeVito
Marizyme, Inc.
October 9, 2018
Page 5
You may contact Vanessa Robertson at (202) 551-3649 or Lisa Vanjoske at
(202) 551-
3614 if you have questions regarding comments on the financial statements and
related
matters. Please contact Tonya K. Aldave at (202) 551-3601 or J. Nolan
McWilliams at (202)
551-3217 with any other questions.
Sincerely,
FirstName LastNameNicholas DeVito
Division of
Corporation Finance
Comapany NameMarizyme, Inc.
Office of Healthcare &
Insurance
October 9, 2018 Page 5
cc: Philip Magri, Esq.
FirstName LastName