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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

Date
March 17, 2025
Author
cc: Jeffrey S. Marks
Form
UPLOAD
Company
Turn Therapeutics Inc.

Letter

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:

March 17, 2025

Bradley Burnam Chief Executive Officer Global Health Solutions, Inc. 250 N. Westlake Blvd. Westlake Village, CA 91362

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

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 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
</TEXT>
</DOCUMENT>