Correspondence 0001104659-25-021270 from Turn Therapeutics Inc. (TTRX)
Turn Therapeutics Inc.
Date: March 6, 2025 · CIK: 0002023016 · Accession: 0001104659-25-021270
AI Filing Summary & Sentiment
File numbers found in text: 024-12562
Referenced dates: February 27, 2025
Show Raw Text
CORRESP
1
filename1.htm
Jeffrey S. Marks, Esq.
9 Chatelaine
Newport Coast, California 92657
(949) 887-8877
March 6, 2025
Via Edgar
Securities and Exchange Commission
100 F. Street, NE
Washington, D.C. 20549-7410
Attn: Vanessa Robertson
Re:
Global Health Solutions, Inc.
Offering Statement on Form 1-A
Filed January 31, 2025
File No. 024-12562
Dear Ms. Robertson:
This letter is submitted on behalf of our client,
Global Health Solutions, Inc. (the “Company”), regarding the Company’s offering statement on Form 1-A,
filed January 31 2024. The following are the Company’s responses to the comments of the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”), specified in the Commission’s letter dated
February 27, 2025; referencing where appropriate, the revisions made in Amendment No. 1 to the Form 1-A which was filed
on or about the date of this letter. For your convenience, we have included each of your comments before each of the Company’s responses,
and they correspond to the headings and order of the paragraphs in your letter. References in this letter to “we,” “our”
or “us” mean the Company as the context may require.
Offering Statement on Form 1-A Summary
The Company, page 1
1. Comment: Please provide the basis for your statement that Hexagen "has over 200,000 human
applications." Please also clarify, if true, that your company has yet to recognize any revenues from its products.
Response: We have revised our disclosure to remove
the above-referenced statement.
Use of Proceeds, page
2. Comment: Please revise Use of Proceeds to disclose more specifically how proceeds from this offering
will be applied, identifying the specific products and/or indications relating to the allocations for "research & development"
and "marketing and sales." 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.
Response: We have revised our disclosure in accordance
with the Staff’s comments with respect to research and development expenses. The proceeds from this offering will be used for brand
building for the Company, and not for marketing and selling specific products.
Our Business, page 19
3. Comment: Please revise this section, where appropriate, to disclose whether any of your products
are currently sold commercially through partnerships or out-licensing arrangements. To the extent that Hexagen has received pre-market
clearances but is not currently available for commercial sale, please briefly describe the reasons why. Please also revise to briefly
describe your future business plan.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Hexagen, page 20
4. Comment: Please revise to briefly explain the 510(k) clearance process and to disclose when
Hexagen received its 510(k) clearances.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
5. Comment: We note your disclosure that your combination powder product utilizing Hexagen with
animal collagen, known as "Flex," is pending FDA clearance for use on advanced wounds and burns. Please revise to disclose the
type of FDA clearance you have sought for Flex and, to the extent known, when you expect to receive a decision from the FDA. Please also
describe the material terms of the license agreement and file the agreement as an exhibit or otherwise advise. Refer to Item 17(6) of
Part III of Form 1-A.
Response: We have revised our disclosure in accordance
with the Staff’s comments. The license agreement referred to in the disclosure was made in the ordinary course of business and entered
into more than two years before the filing.
6. Comment: We note that you reference "ongoing clinical trials" and "ongoing clinical
development efforts" on page 7, and on page 23 you state that during 2025, you plan to "complete phase 2 trials for
[y]our eczema indications." Please revise this section to clarify whether these trials will be evaluating Hexagen as a medical device
or as a pharmaceutical. Please also revise to disclose whether you have submitted INDs for your planned trials and whether you are currently
conducting any clinical trials. To the extent you are currently conducting clinical trials, please briefly describe the parameters of
each trial, including the jurisdiction of the trial and the indication being evaluated.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Thermostable Intranasal Vaccine, page 20
7. Comment: We note your disclosure that you have partnered with IAVI.org on a live intranasal vaccine
candidate. Please revise to identify the indication(s) to be targeted, and disclose the current clinical development status of this
vaccine candidate. Please also briefly describe the material terms of your partnership with IAVI and file the agreement as an exhibit.
Response: We have revised our disclosure in accordance
with the Staff’s comments. The license agreement referred to in the disclosure was made in the ordinary course of business and is
not material to the Company’s business.
Government Regulation, page 21
8. Comment: Please expand your disclosure to briefly describe the FDA regulations that apply or
may apply to your development of each of medical device, drug and/or biologic product candidates.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Intellectual Property, page 21
9. Comment: In relation to the company's material patents, please revise your intellectual property
disclosure to clearly describe on an individual or patent family basis whether such patent is owned or licensed, the product candidate
or technology to which such patent relates, the expiration year of each patent and the jurisdiction, including any foreign jurisdiction,
of each material pending or issued patent.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Management's Discussion and Analysis of Financial Condition and
Results of Operation Results of Operations, page 22
10. Comment: You disclose that the increase in research and development expenses during the 2024
Interim Period primarily resulted from a $65,900 payment to your R&D vendor for clinical trials. Please clarify in revised disclosure
which clinical trial(s) this payment was related to.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Directors and Executive Officers, page 23
11. Comment: Please revise the rightmost column of the table on page 23 to disclose the approximate
average number of hours per week or month that your Chief Medical Officer is anticipated to work. Refer to Item 10(a)(2) of Part II
of Form 1-A.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Liquidity and Capital Resources, page 23
12. Comment: You disclose in the notes to the financial statements that your cash and cash equivalents
are less than a year's worth of cash reserves as of June 30, 2024. Please expand your discussion here to include a description and
evaluation of your internal and external sources of liquidity (i.e. share purchase agreement with GEM, Crowdfunding Campaign) and include
a brief discussion of any material unused sources of liquidity. If you have identified a material deficiency in liquidity, indicate the
course of action that you have taken or propose to take to remedy the deficiency. Refer to Item 9(b) of Form 1-A.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
13. Comment: You noted that deferred revenue for the periods presented is attributable to a license
agreement for your FlexAM product. Please provide disclosure, where appropriate in the filing, of the material terms under the agreement.
In your disclosure, also address the amount of funds received for each period presented and to date, as well as your accounting treatment,
specifically when the deferred revenues will be recognized.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Plan of Operations, page 23
14. Comment: We note your disclosure on page 6 indicating that the regulatory process is lengthy,
expensive, and inherently uncertain. As such, please remove the statements in this section that you plan to submit for FDA drug registration
for eczema indications during 2027 and for the onychomycosis indication in 2028, as such statements appear to assume the successful completion
of clinical trials for these indications.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Compensation, page 24
15. Comment: In your next filing, please update your executive compensation table for the fiscal
year ended December 31, 2024. Refer to Item 11(a) of Part II of Form 1-A. Also, in a footnote or otherwise, please
disclose if your Chief Medical Officer is not compensated for his service in this capacity.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Signatures, page 29
16. Comment: Please revise your signature page to include the signatures of your principal financial
officer and principal accounting officer.
Response: We have revised our disclosure in accordance
with the Staff’s comments.
Consolidated Financial Statements (Unaudited), page F-6
17. Comment: Regarding your unaudited interim financial statements, please provide disclosure on
whether in the opinion of management all adjustments necessary to make the interim financial statements not misleading have been included.
Refer to Part F/S(b)(5)(iii) of Form 1-A.
Response: We have revised the notes to the financial
statements in accordance with the Staff’s comments. in accordance with the Staff’s comments.
Summary of Significant Accounting Policies, page F-7
18. Comment: Please revise to disclose your research and development expense policy. Refer to ASC
730-10-50-1.
Response: We have revised the notes to the financial
statements in accordance with the Staff’s comments.
Subsequent Events, page F-12
19. Comment: You noted that since July 2024, the Company granted 110,075 options under the 2024
Stock Option Plan. Please explain how you determined the fair value of the common stock underlying these issuances. In addition, tell
us the reasons for any significant differences between that fair value and the $11.26 offering price.
Response: We have revised the notes to our financial
statement to explain how we determined the fair market value of the common stock underlying these issuances. The difference between the
option price and the $11.26 offering price is based on management’s good faith determination of the value of the Company as of the
date hereof.
The changes reflected in this Amendment have been
made in response to the Staff’s comments and for the purpose of updating and revising certain other information. I hope this response
letter and the amendments to the above referenced filing adequately address the issues raised in your comment letter.
If you should require any additional information
or clarification, please do not hesitate to contact me at 949-887-8877.
Very truly yours,
/Jeffrey S. Marks/
Jeffrey S. Marks