SEC Comment Letter 0000000000-25-002905 to Turn Therapeutics Inc. (TTRX)
Turn Therapeutics Inc.
Date: March 17, 2025 · CIK: 0002023016 · Accession: 0000000000-25-002905
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File numbers found in text: 024-12562
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March 17, 2025
Bradley Burnam
Chief Executive Officer
Global Health Solutions, Inc.
250 N. Westlake Blvd.
Westlake Village, CA 91362
Re: Global Health Solutions, Inc.
Amendment No. 1 to Offering Statement on Form 1-A
Filed March 6, 2025
File No. 024-12562
Dear Bradley Burnam:
We have reviewed your amended offering statement and have the following
comments.
Please respond to this letter by amending your offering statement and
providing the
requested information. If you do not believe a comment applies 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 offering statement and the
information you
provide in response to this letter, we may have additional comments. Unless we
note
otherwise, any references to prior comments are to comments in our February 27,
2025 letter.
Amendment No. 1 to Offering Statement on Form 1-A
Risk Factors
Risks Related to The Pharmaceutical and Medical Device Business.
Our business is dependent on the successful development..., page 4
1. In light of your revised disclosure on page 24, please revise here and
throughout
where appropriate to clarify, if true, that you are not currently
conducting any human
clinical trials and that you have not yet submitted an IND for your
Hexagen drug
product candidates. By way of example and not limitation:
Revise your statement that you have "two developed
pharmaceutical/drug
candidates at the clinical stage of development" on page 4.
Revise the reference to "ongoing clinical trials" on page 7.
Revise page 20 to clarify that your clinical development of the
Hexagen formula
March 17, 2025
Page 2
as new drug will require an IND in order to commence clinical trials.
Similarly,
revise the "clinical stage" column of the table on page 20 to
indicate that the
Hexagen product candidates for Moderate-Severe Eczema and
for Onychomycosis are in the preclinical, IND-enabling stage.
Use of Proceeds, page 18
2. We note your response to prior comment 2, which we reissue in part. With
reference
to your going concern disclosure in your financial statements, please
disclose how
long you expect the proceeds from this offering to fund your operations
if you sell
100%, 75%, 50% or 25% of the total amount of shares offered.
3. We note you have added the following new footnote to the Use of Proceeds
table on
page 18: "(3) Does not include the full cost of the Phase 3 trial." In
this regard, please
revise to mark the table in the appropriate place(s) to identify the
corresponding
disclosure to which footnote 3 relates.
Our Business, page 19
4. We note your response to prior comment 4 which we reissue in part.
Please revise to
disclose when you received the following FDA 510(k) clearances:
K171191 (Hexagen as a medical device for the management of
eczematous skin
and the symptoms relating to eczema); and
K183681 ('Xeal' porous gauze combination product as a medical device
for use on
post-surgical wounds).
5. We note your response to prior comment 5 and revised disclosures and
re-issue in
part. Please revise to disclose whether, and if so when, you have
applied for FDA
clearance for Flex and the type of FDA medical device clearance you have
sought or
plan to seek.
6. We note your references to your agreement(s) with MiMedx. Please revise
to describe
the material terms of the MidMedx agreement(s) including the rights and
obligations
of the parties, term and termination provisions and payment terms,
including
applicable royalty rates or a range not to exceed 10 percentage points.
Government Regulation, page 21
7. We note your response to prior comment 8, which we reissue. Please
expand your
disclosure to briefly describe the FDA regulations and processes that
apply or may
apply to your development of each of medical device, drug and/or
biologic product
candidates. Your disclosure should describe the FDA review and approval
procedures
by material stage, as well as any material post-marketing requirements.
Notes to Consolidated Financial Statements (Unaudited)
5. Licensing Agreements, page F-9
8. Please clarify your revised disclosure in this note and in the Liquidity
and Capital
Resources section on page 24 to explain what the next milestone relates
to and the
specific performance obligations. Also expand your disclosure to
quantify the
development and sales-based milestones related to the license agreement
that you
March 17, 2025
Page 3
reference on page 20. Include a similar footnote in your notes to the
audited financial
statements.
Exhibits
9. Please obtain and file an updated consent from your independent auditor.
Please contact Vanessa Robertson at 202-551-3649 or Sasha Parikh at
202-551-3627
if you have questions regarding comments on the financial statements and
related
matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Alan Campbell
at 202-
551-4224 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Jeffrey S. Marks
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