Loaded from persisted store.
Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
Turn Therapeutics Inc.
Response Received
2 company response(s)
High - file number match
↓
Company responded
2025-09-16
Turn Therapeutics Inc.
References: September 11, 2025
↓
Turn Therapeutics Inc.
Response Received
1 company response(s)
Medium - date proximity
↓
Company responded
2025-09-24
Turn Therapeutics Inc.
References: September 23, 2025
Turn Therapeutics Inc.
Response Received
1 company response(s)
Medium - date proximity
↓
Company responded
2025-08-29
Turn Therapeutics Inc.
References: August 14, 2025
Turn Therapeutics Inc.
Response Received
4 company response(s)
High - file number match
↓
Company responded
2025-03-06
Turn Therapeutics Inc.
References: February 27, 2025
↓
Company responded
2025-03-18
Turn Therapeutics Inc.
References: March 17, 2025
↓
Company responded
2025-03-25
Turn Therapeutics Inc.
References: March 24, 2025
↓
Turn Therapeutics Inc.
Awaiting Response
0 company response(s)
High
Turn Therapeutics Inc.
Awaiting Response
0 company response(s)
High
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-26 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-09-24 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-09-23 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-09-16 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-09-11 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-08-29 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-08-14 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-03-27 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-25 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| 2025-03-18 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-17 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| 2025-03-06 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-02-27 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-23 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-09-11 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-08-14 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 377-08130 | Read Filing View |
| 2025-03-24 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| 2025-03-17 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| 2025-02-27 | SEC Comment Letter | Turn Therapeutics Inc. | DE | 024-12562 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-26 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-09-24 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-09-16 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-08-29 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-27 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-25 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-18 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
| 2025-03-06 | Company Response | Turn Therapeutics Inc. | DE | N/A | Read Filing View |
2025-09-26 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm September 26, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Sasha Parikh Joe McCann Alan Campbell Re: Global Health Solutions, Inc. Registration Statement on Form S-1 File No. 333-289972 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Global Health Solutions, Inc., dba Turn Therapeutics (the " Company ") hereby requests that the effective date for the Company's Registration Statement on Form S-1 (File No. 333-289972) (the " Registration Statement ") be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on September 30, 2025 or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Davis Polk & Wardwell LLP, by calling Stephen Byeff at (212) 450-4715. Sincerely, Global Health Solutions, Inc. By: /s/ Bradley Burnam Name: Bradley Burnam Title: Chief Executive Officer
2025-09-24 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm +1 212 450 4000 davispolk.com Davis Polk & Wardwell llp 450 Lexington Avenue New York, NY 10017 September 24, 2025 Re: Global Health Solutions, Inc. Registration Statement on Form S-1 CIK No. 0002023016 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Sasha Parikh Joe McCann Alan Campbell Ladies and Gentlemen: On behalf of our client, Global Health Solutions, Inc., dba Turn Therapeutics (the " Company " or " Turn "), this letter sets forth the Company's responses to the comments provided by the staff (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ") relating to the Company's Registration Statement on Form S-1 filed on September 16, 2025 (the " Registration Statement ") contained in the Staff's letter dated September 23, 2025 (the " Comment Letter "). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is publicly filing an amended Registration Statement on Form S-1 (the " Amended Registration Statement ") together with this response letter. The Amended Registration Statement also contains certain additional updates and revisions. For the convenience of the Staff, each comment from the Comment Letter is restated in italics prior to the response to such comment. All references to page numbers and captions (other than those in the Staff's comments) correspond to pages and captions in the Amended Registration Statement. Amendment No. 2 to Registration Statement on Form S-1 Description of Capital Stock Common Stock, page 105 1. You disclose that in connection with the effectiveness of the registration statement and before the completion of the offering, a 2-for-1 forward stock split of your common stock will be effected. Please confirm whether it will be effected prior to effectiveness of your registration statement. If so, please revise your financial statements to reflect the forward stock split in accordance with ASC 260-10-55-12 and SAB Topic 4:C. and have your auditor dual date the report for the impact of the split. Response : The Company advises the Staff that the 2-for-1 forward stock split of its common stock will be effected after the effectiveness of the Amended Registration Statement. In response to the Staff's comment, the Company has revised the disclosure throughout the Amended Registration Statement. Division of Corporation Finance U.S. Securities and Exchange Commission Please do not hesitate to contact me at (212) 450-4715 or stephen.byeff@davispolk.com or Michael Kaplan at (212) 450-4111 or michael.kaplan@davispolk.com if you have any questions regarding the foregoing or if we can provide any additional information. Very truly yours, /s/ Stephen A. Byeff cc: Bradley Burnam Global Health Solutions, Inc. 2
2025-09-23 - UPLOAD - Turn Therapeutics Inc. File: 377-08130
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 23, 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 Registration Statement on Form S-1 Filed September 16, 2025 File No. 333-289972 Dear Bradley Burnam: We have reviewed your amended registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our 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 registration statement and the information you provide in response to this letter, we may have additional comments. Amendment No. 1 to Registration Statement on Form S-1 Description of Capital Stock Common Stock, page 105 1. You disclose that in connection with the effectiveness of the registration statement and before the completion of the offering, a 2-for-1 forward stock split of your common stock will be effected. Please confirm whether it will be effected prior to effectiveness of your registration statement. If so, please revise your financial statements to reflect the forward stock split in accordance with ASC 260-10-55-12 and SAB Topic 4:C. and have your auditor dual date the report for the impact of the split. 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 September 23, 2025 Page 2 matters. Please contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Stephen A. Byeff </TEXT> </DOCUMENT>
2025-09-16 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm +1 212 450 4000 davispolk.com Davis Polk & Wardwell llp 450 Lexington Avenue New York, NY 10017 September 16, 2025 Re: Global Health Solutions, Inc. Registration Statement on Form S-1 CIK No. 0002023016 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Sasha Parikh Lauren Sprague Hamill Alan Campbell Ladies and Gentlemen: On behalf of our client, Global Health Solutions, Inc., dba Turn Therapeutics (the " Company " or " Turn "), this letter sets forth the Company's responses to the comments provided by the staff (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ") relating to the Company's Registration Statement on Form S-1 filed on September 2, 2025 (the " Registration Statement ") contained in the Staff's letter dated September 11, 2025 (the " Comment Letter "). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is publicly filing an amended Registration Statement on Form S-1 (the " Amended Registration Statement ") together with this response letter. The Amended Registration Statement also contains certain additional updates and revisions. For the convenience of the Staff, each comment from the Comment Letter is restated in italics prior to the response to such comment. All references to page numbers and captions (other than those in the Staff's comments) correspond to pages and captions in the Amended Registration Statement. Registration Statement on Form S-1 Competitive Strengths, page 7 1. Please revise the text beneath the "Intellectual Property Protecting Core Technology and Product Candidates" heading to briefly summarize your revised risk factor disclosure on page 37 indicating that it is possible that a patent with overlapping claims with respect to the Hexagen formula could issue to a third party and to briefly discuss potential consequences. Please similarly revise the "Intellectual Property" subsection of your Business section to discuss this possibility and to disclose the type of patent that could be issued, as well as the subject matter covered by the pending patent application. Also discuss the reason(s), if any, that the U.S. Court of Appeals provided in support of its decision resulting in Mr. Selner's retention of the patent application . Response : In response to the Staff's comment, the Company has revised the disclosure on pages 7, 8 and 76 of the Amended Registration Statement. Division of Corporation Finance U.S. Securities and Exchange Commission Management's Discussion and Analysis of Financial Condition and Results of Operations Results Six Months ended June 30, 2025 Compared to Six Months ended June 30, 2024, page 65 2. Please revise your disclosure to break out research and development expenses incurred in the periods presented between the clinical trial program related to Hexagen's purported eczema effects and your vaccine candidate . Response : In response to the Staff's comment, the Company has revised the disclosure on page 63 of the Amended Registration Statement. Sale Price History of Our Capital Stock, page 119 3. We note your response to prior comment 11. We further note that your disclosure indicates that you have offered shares pursuant to Regulation A, Regulation D and Regulation CF within the prior two fiscal years. Please revise to disclose the transaction history of your common stock in fiscal 2023, fiscal 2024 and applicable interim periods in fiscal 2025. In your revisions, please disclose the number of shares sold and the applicable share price . Response : In response to the Staff's comment, the Company has revised the disclosure on page 119 of the Amended Registration Statement. Please do not hesitate to contact me at (212) 450-4715 or stephen.byeff@davispolk.com or Michael Kaplan at (212) 450-4111 or michael.kaplan@davispolk.com if you have any questions regarding the foregoing or if we can provide any additional information. Very truly yours, /s/ Stephen A. Byeff cc: Bradley Burnam Global Health Solutions, Inc. September 16, 2025 2
2025-09-11 - UPLOAD - Turn Therapeutics Inc. File: 377-08130
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 11, 2025 Bradley Burnam Chief Executive Officer Global Health Solutions, Inc 250 N. Westlake Blvd. Westlake Village, CA 91362 Re: Global Health Solutions, Inc Registration Statement on Form S-1 Filed September 2, 2025 File No. 333-289972 Dear Bradley Burnam: We have reviewed your registration statement and have the following comments. Please respond to this letter by amending your registration 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 registration 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 August 14, 2025 letter. Registration Statement on Form S-1 Competitive Strengths, page 7 1. Please revise the text beneath the "Intellectual Property Protecting Core Technology and Product Candidates" heading to briefly summarize your revised risk factor disclosure on page 37 indicating that it is possible that a patent with overlapping claims with respect to the Hexagen formula could issue to a third party and to briefly discuss potential consequences. Please similarly revise the "Intellectual Property" subsection of your Business section to discuss this possibility and to disclose the type of patent that could be issued, as well as the subject matter covered by the pending patent application. Also discuss the reason(s), if any, that the U.S. Court of Appeals provided in support of its decision resulting in Mr. Selner's retention of the patent application. September 11, 2025 Page 2 Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Six Months ended June 30, 2025 Compared to Six Months ended June 30, 2024, page 65 2. Please revise your disclosure to break out research and development expenses incurred in the periods presented between the clinical trial program related to Hexagen s purported eczema effects and your vaccine candidate. Sale Price History of Our Capital Stock, page 119 3. We note your response to prior comment 11. We further note that your disclosure indicates that you have offered shares pursuant to Regulation A, Regulation D and Regulation CF within the prior two fiscal years. Please revise to disclose the transaction history of your common stock in fiscal 2023, fiscal 2024 and applicable interim periods in fiscal 2025. In your revisions, please disclose the number of shares sold and the applicable share price. 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. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. 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 Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Stephen A. Byeff </TEXT> </DOCUMENT>
2025-08-29 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm +1 212 450 4000 davispolk.com Davis Polk & Wardwell llp 450 Lexington Avenue New York, NY 10017 August 29, 2025 Re: Global Health Solutions, Inc. Draft Registration Statement on Form S-1 CIK No. 0002023016 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Sasha Parikh Lauren Sprague Hamill Alan Campbell Ladies and Gentlemen: On behalf of our client, Global Health Solutions, Inc., dba Turn Therapeutics (the " Company " or " Turn "), this letter sets forth the Company's responses to the comments provided by the staff (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ") relating to the Company's Amendment No. 1 to Draft Registration Statement on Form S-1 submitted on July 30, 2025 (the " Draft Registration Statement ") contained in the Staff's letter dated August 14, 2025 (the " Comment Letter "). In response to the comments set forth in the Comment Letter, the Company has revised the Draft Registration Statement and is publicly filing a further revised Registration Statement on Form S-1 (the " Amended Registration Statement ") together with this response letter. The Amended Registration Statement also contains certain additional updates and revisions. For the convenience of the Staff, each comment from the Comment Letter is restated in italics prior to the response to such comment. All references to page numbers and captions (other than those in the Staff's comments) correspond to pages and captions in the Amended Registration Statement. Amendment No. 1 to Draft Registration Statement on Form S-1 Overview, page 2 1. We note that the first two paragraphs both highlight three FDA medical device clearances and their extensive use in humans. To the extent that you highlight these clearances and this history in the first two paragraphs, please revise to explain that these products are not presently on the market and/or that you are not currently generating revenues from these devices. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 2, 61 and 72 of the Amended Registration Statement. Core Products and Programs, page 4 2. We note your revisions in response to prior comment 7. Please further revise disclosures concerning the first three medical devices to disclose the year of FDA clearance and to include the drug/program names that you utilize on pages 10-11 ( e.g ., XEAL (K183681)). Disclose that the fourth medical device presented is out-licensed to MiMedx. For the GX-03 eczema drug candidate, please revise to indicate that the referenced human trials are Phase 2-equivalent. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 4 and 74 of the Amended Registration Statement. Division of Corporation Finance U.S. Securities and Exchange Commission GX-03 Development Roadmap: Eczema & Onychomycosis, page 5 3. We note your response to prior comment 9. As presented, the graphic appears to indicate that the Pivotal Phase 3 trials will start and end in Q4 2026. Please revise or advise. Also, revise to remove the NDA Submissions row given its speculative nature. Response : In response to the Staff's comment, the Company respectfully advises the Staff that it has revised the roadmap graphic on pages 5 and 75 of the Amended Registration Statement to clarify the start and end dates of the Pivotal Phase 3 trials and to remove the NDA Submissions row. Immunomodulatory Activity Without the Cost and Risks of Biologics, page 7 4. Please revise to explain the term "cytokine modulation" and clarify whether this was demonstrated in pre-clinical work or in humans. Also, revise the Business section to present support for this claim or tell us where such support is presented. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 7-8 and 77 of the Amended Registration Statement to explain the term "cytokine modulation" and to clarify that GX-03 (Hexagen) has demonstrated cytokine modulation in pre-clinical studies but not yet in human trials. The Company respectfully advises the Staff that support for this claim appears in the July 27, 2024, Altogen Labs study report titled "In vivo pretreatment Staphylococcus aureus dermal toxicity study" (Study R# XTN025491), pages 10-27, which includes detailed statistical analyses and raw protein quantification data. The Company has summarized the findings from the study on pages 10 and 79 of the Amended Registration Statement. Clinical Products, page 10 5. With reference to prior comment 16, please revise your disclosure to identify the two FDA-cleared products that you have packaged for out-licensing. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 11 and 80-81 of the Amended Registration Statement to identify the two FDA-cleared products that the Company has packaged for out-licensing as K171191 (medical device indicated to manage the symptoms of irritant, radiation, and atopic dermatitis) and K183681 (Xeal Antimicrobial). 6. We note your disclosure on page 8 that you have historically licensed cleared medical device technologies-including wound dressings and antimicrobial platforms-to commercial partners. As applicable, please revise the disclosures on pages 10-11 to indicate whether any of the three FDA-cleared medical devices were out-licensed in the past. If so, please revise the Business section, or elsewhere as applicable, to identify each licensee and the date of each commercial partnership. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 11 and 80-81 of the Amended Registration Statement to clarify that K171191, K183681 and K160872 have not been out-licensed in the past. August 29, 2025 2 Division of Corporation Finance U.S. Securities and Exchange Commission If we are unable to obtain, maintain and enforce patent protection for our current products..., page 35 7. We note your response to prior comment 25. Based on the inventions at issue, please revise the disclosure on page 37 to indicate whether any future licensing demands likely would pertain to one or all of your product candidates. Response : In response to the Staff's comment, the Company has revised the disclosure on page 38 of the Amended Registration Statement. Liquidity and Capital Resources, page 63 8. With reference to your Development Roadmap on page 5, please revise your Liquidity and Capital Resources discussion and/or Business section disclosures to indicate how much funding you will require over the next twelve months as well as the amount needed to complete your planned pivotal Phase 3 trials for eczema and onychomycosis. Also explain your material funding needs in 2025 and 2026 for any other products candidates that you may be developing during this timeframe. Response : In response to the Staff's comment, the Company has revised the disclosure on page 67 of the Amended Registration Statement. Business, page 69 9. We note your revisions in response to prior comment 3. Please revise the Business section, where appropriate, to present a detailed summary of the " Diaper Dermatitis " and " Treatment of Phytophotodermatitis with Topical Antimicrobial: A Case Report " case studies. Identify the providers and indicate when the case studies were performed. Disclose whether the providers are or were affiliated with you and whether you provided compensation for their efforts. Provide similar disclosures with respect to the "A Novel Approach to Polymicrobial Nail Infection" case study and include the patient results so it is clear how these results "suggested efficacy ranging from 70- 85%." Response : In response to the Staff's comment, the Company has revised the disclosure on pages 2-3, 61-62 and 72-73 of the Amended Registration Statement. Share Purchase Agreement, page 93 10. Your disclosure on page 94 indicates that you have contractual obligations under the agreement to file a resale registration statement concurrently with the filing of the registration statement covering this Direct Listing. With reference to Compliance Disclosure Interpretations, Securities Act Sections, Q. 139.13, please note that you would not be eligible to file a registration statement covering the equity line transaction until such time as there is an existing market for the securities. Accordingly, please advise us concerning your plans for registration of the equity line arrangement. Response : As discussed with the Staff, the Company understands that the resale registration statement for its equity line facility can be submitted or filed with the Staff prior to the listing of its common stock, but acknowledges that its stock must be listed and the other conditions set forth in Compliance Disclosure Interpretations, Securities Act Sections, Q. 139.13 must be satisfied prior to such resale registration statement being declared effective. The Company refers the Staff to pages 23 and 109-110. Sale Price History of Our Capital Stock, page 111 11. We note your revised disclosure in response to prior comment 30. Please revise to provide the disclosure specified in Regulation S-K, Item 201(a)(3) or explain why it is not applicable. Response : As disclosed on page 50, there is no established public trading market. In addition, the Company's stock is not quoted and there has been no history of over-the-counter or other trading of the Company's stock. The Company respectfully advises the Staff that there are no bid quotations to be provided in response to the requirements of SK 201(a)(iii). August 29, 2025 3 Division of Corporation Finance U.S. Securities and Exchange Commission Notes to Consolidated Financial Statements 9. Licensing Agreements, page F-21 12. We note your response to prior comment 31. Please revise your disclosure to clarify the specific development and commercialization performance obligations. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 63, F-14 and F-39 of the Amended Registration Statement. General 13. Given Clear Street LLC's dual role as your financial advisor and a Registered Stockholder and the financial advisor's role under Nasdaq direct listing rules, please consider whether it is necessary to include a discussion of any material risk factors relating to potential conflicts of interest. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 24, 119 and 120 of the Amended Registration Statement addressing potential conflicts of interest involving Clear Street. 14. We note the disclosure on your cover page that "the Registered Stockholders will [not] be involved in Nasdaq's price-setting mechanism, including any decision to delay or proceed with trading, nor will . . . they control or influence the Advisor in carrying out its role as a financial adviser." Please revise this and any other similar statements for consistency given Clear Street LLC's current dual role as your financial advisor and a Registered Stockholder. Response : In response to the Staff's comment, the Company has revised the disclosure on pages 24, 119 and 120 of the Amended Registration Statement. 15. Please confirm that Clear Street LLC will not serve as the issuer's valuation agent for purposes of the Nasdaq direct listing rules. Response : The Company confirms that Clear Street LLC will not serve as the issuer's valuation agent for purposes of the Nasdaq direct listing rules. Please do not hesitate to contact me at (212) 450-4715 or stephen.byeff@davispolk.com or Michael Kaplan at (212) 450-4111 or michael.kaplan@davispolk.com if you have any questions regarding the foregoing or if we can provide any additional information. Very truly yours, /s/ Stephen A. Byeff cc: Bradley Burnam Global Health Solutions, Inc. August 29, 2025 4
2025-08-14 - UPLOAD - Turn Therapeutics Inc. File: 377-08130
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 14, 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 Draft Registration Statement on Form S-1 Submitted July 30, 2025 CIK No. 0002023016 Dear Bradley Burnam: We have reviewed your amended draft registration statement and have the following comments. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement and non-public draft submissions on EDGAR. 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 the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our July 17, 2025 letter. Amendment No. 1 to Draft Registration Statement on Form S-1 Overview, page 2 1. We note that the first two paragraphs both highlight three FDA medical device clearances and their extensive use in humans. To the extent that you highlight these clearances and this history in the first two paragraphs, please revise to explain that these products are not presently on the market and/or that you are not currently generating revenues from these devices. August 14, 2025 Page 2 Core Products and Programs, page 4 2. We note your revisions in response to prior comment 7. Please further revise disclosures concerning the first three medical devices to disclose the year of FDA clearance and to include the drug/program names that you utilize on pages 10-11 (e.g., XEAL (K183681)). Disclose that the fourth medical device presented is out-licensed to MiMedx. For the GX-03 eczema drug candidate, please revise to indicate that the referenced human trials are Phase 2-equivalent. GX-03 Development Roadmap: Eczema & Onychomycosis, page 5 3. We note your response to prior comment 9. As presented, the graphic appears to indicate that the Pivotal Phase 3 trials will start and end in Q4 2026. Please revise or advise. Also, revise to remove the NDA Submissions row given its speculative nature. Immunomodulatory Activity Without the Cost and Risks of Biologics, page 7 4. Please revise to explain the term cytokine modulation and clarify whether this was demonstrated in pre-clinical work or in humans. Also, revise the Business section to present support for this claim or tell us where such support is presented. Clinical Products, page 10 5. With reference to prior comment 16, please revise your disclosure to identify the two FDA-cleared products that you have packaged for out-licensing. 6. We note your disclosure on page 8 that you have historically licensed cleared medical device technologies including wound dressings and antimicrobial platforms to commercial partners. As applicable, please revise the disclosures on pages 10-11 to indicate whether any of the three FDA-cleared medical devices were out-licensed in the past. If so, please revise the Business section, or elsewhere as applicable, to identify each licensee and the date of each commercial partnership. If we are unable to obtain, maintain and enforce patent protection for our current products..., page 35 7. We note your response to prior comment 25. Based on the inventions at issue, please revise the disclosure on page 37 to indicate whether any future licensing demands likely would pertain to one or all of your product candidates. Liquidity and Capital Resources, page 63 8. With reference to your Development Roadmap on page 5, please revise your Liquidity and Capital Resources discussion and/or Business section disclosures to indicate how much funding you will require over the next twelve months as well as the amount needed to complete your planned pivotal Phase 3 trials for eczema and onychomycosis. Also explain your material funding needs in 2025 and 2026 for any other products candidates that you may be developing during this timeframe. August 14, 2025 Page 3 Business, page 69 9. We note your revisions in response to prior comment 3. Please revise the Business section, where appropriate, to present a detailed summary of the "Diaper Dermatitis and Treatment of Phytophotodermatitis with Topical Antimicrobial: A Case Report case studies. Identify the providers and indicate when the case studies were performed. Disclose whether the providers are or were affiliated with you and whether you provided compensation for their efforts. Provide similar disclosures with respect to the A Novel Approach to Polymicrobial Nail Infection case study and include the patient results so it is clear how these results suggested efficacy ranging from 70- 85%. Share Purchase Agreement, page 93 10. Your disclosure on page 94 indicates that you have contractual obligations under the agreement to file a resale registration statement concurrently with the filing of the registration statement covering this Direct Listing. With reference to Compliance Disclosure Interpretations, Securities Act Sections, Q. 139.13, please note that you would not be eligible to file a registration statement covering the equity line transaction until such time as there is an existing market for the securities. Accordingly, please advise us concerning your plans for registration of the equity line arrangement. Sale Price History of Our Capital Stock, page 111 11. We note your revised disclosure in response to prior comment 30. Please revise to provide the disclosure specified in Regulation S-K, Item 201(a)(3) or explain why it is not applicable. Notes to Consolidated Financial Statements 9. Licensing Agreements, page F-21 12. We note your response to prior comment 31. Please revise your disclosure to clarify the specific development and commercialization performance obligations. General 13. Given Clear Street LLC s dual role as your financial advisor and a Registered Stockholder and the financial advisor s role under Nasdaq direct listing rules, please consider whether it is necessary to include a discussion of any material risk factors relating to potential conflicts of interest. 14. We note the disclosure on your cover page that the Registered Stockholders will [not] be involved in Nasdaq's price-setting mechanism, including any decision to delay or proceed with trading, nor will . . . they control or influence the Advisor in carrying out its role as a financial adviser. Please revise this and any other similar statements for consistency given Clear Street LLC s current dual role as your financial advisor and a Registered Stockholder. 15. Please confirm that Clear Street LLC will not serve as the issuer s valuation agent for purposes of the Nasdaq direct listing rules. August 14, 2025 Page 4 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 Joe McCann at 202-551- 6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Stephen A. Byeff </TEXT> </DOCUMENT>
2025-03-27 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm Jeffrey S. Marks, Esq. 9 Chatelaine Newport Coast, California 92657 (949) 887-8877 March 27, 2025 Via Edgar Securities and Exchange Commission 100 F. Street, NE Washington, D.C. 20549-7410 Attn: Lauren Sprague Hamill Re: Global Health Solutions, Inc. Offering Statement on Form 1-A/A File No. 024-12562 Dear Ms. Hamil: On behalf of our client, Global Health Solutions, Inc. (the " Company "), we hereby request qualification of the above-referenced offering statement at 4 p.m., Eastern Time, on March 31, 2025. 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
2025-03-25 - CORRESP - Turn Therapeutics Inc.
CORRESP 1 filename1.htm Jeffrey S. Marks, Esq. 9 Chatelaine Newport Coast, California 92657 (949) 887-8877 March 25, 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, as amended. 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 March 24, 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 Our Business Introduction, page 19 1. Comment : We note your response to prior comment 5 and revised disclosures on page 19. Please further revise to: · state whether it is expected that Flex will be classified as a Class I, II or III medical device; and · clarify the meaning of the following statement: "We expect its completion before the end of 2025." Explain when you expect all required testing to be completed, when you expect a de novo submission to the FDA and the estimated length of the FDA review period. Response : We have revised the disclosure in accordance with the Staff's comments. MiMedx Agreement, page 21 2. Comment : We note your response to prior comment 6 and revised disclosures, and we reissue in part. Please further revise page 21 to disclose: · the aggregate amounts of any milestone payments to which you may become entitled under the MiMedx Agreement, including but not limited to product- launch-based milestone payments and certain progressive aggregate sales-based milestone payments; and · term and termination provisions. Response : We have revised the disclosure in accordance with the Staff's comments. 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
2025-03-24 - UPLOAD - Turn Therapeutics Inc. File: 024-12562
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 24, 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. 2 to Offering Statement on Form 1-A Filed March 18, 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 March 17, 2025 letter. Offering Statement on Form 1-A Our Business Introduction, page 19 1. We note your response to prior comment 5 and revised disclosures on page 19. Please further revise to: state whether it is expected that Flex will be classified as a Class I, II or III medical device; and clarify the meaning of the following statement: "We expect its completion before the end of 2025." Explain when you expect all required testing to be completed, when you expect a de novo submission to the FDA and the estimated length of the FDA review period. March 24, 2025 Page 2 MiMedx Agreement, page 21 2. We note your response to prior comment 6 and revised disclosures, and we reissue in part. Please further revise page 21 to disclose: the aggregate amounts of any milestone payments to which you may become entitled under the MiMedx Agreement, including but not limited to product- launch-based milestone payments and certain progressive aggregate sales-based milestone payments; and term and termination provisions. 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>
2025-03-18 - CORRESP - Turn Therapeutics Inc.
CORRESP
1
filename1.htm
Jeffrey S. Marks, Esq.
9 Chatelaine
Newport Coast, California 92657
(949) 887-8877
March 18, 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, as amended. 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
March 17, 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.
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. Comment : 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 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
Use of Proceeds, page 18
2. Comment : 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
3. Comment : 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
Our Business, page 19
4. Comment : 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).
Response : We have revised our disclosure in accordance with the Staff's
comments.
5. Comment : 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
6. Comment : 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
Government Regulation, page 21
7. Comment : 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.
Response : We have revised our disclosure in accordance with the Staff's
comments.
Notes to Consolidated Financial Statements (Unaudited)
5. Licensing Agreements, page F-9
8. Comment : 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 reference on page 20. Include
a similar footnote in your notes to the audited financial statements.
Response : We have revised our disclosure in accordance with the Staff's
comments.
Exhibits
9. Comment : Please obtain and file an updated consent from your independent auditor.
Response : We have revised our disclosure in accordance with the Staff's
comments.
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,
/s/ Jeffrey S. Marks
Jeffrey S. Marks
2025-03-17 - UPLOAD - Turn Therapeutics Inc. File: 024-12562
<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>
2025-03-06 - CORRESP - Turn Therapeutics Inc.
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
2025-02-27 - UPLOAD - Turn Therapeutics Inc. File: 024-12562
February 27, 2025
Bradley Burnam
Chief Executive Officer
Global Health Solutions, Inc.
250 N. Westlake Blvd.
Westlake Village, CA 91362
Re:Global Health Solutions, Inc.
Offering Statement on Form 1-A
Filed January 31, 2025
File No. 024-12562
Dear Bradley Burnam:
We have reviewed your 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.
Offering Statement on Form 1-A
Summary
The Company, page 1
1.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.
Use of Proceeds, page 18
2.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.
February 27, 2025
Page 2
Our Business, page 19
3.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.
Hexagen, page 20
4.Please revise to briefly explain the 510(k) clearance process and to disclose when
Hexagen received its 510(k) clearances.
5.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.
6.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.
Thermostable Intranasal Vaccine, page 20
7.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.
Government Regulation, page 21
8.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.
Intellectual Property, page 21
9.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.
February 27, 2025
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operation
Results of Operations, page 22
10.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.
Directors and Executive Officers, page 23
11.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.
Liquidity and Capital Resources, page 23
12.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.
13.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.
Plan of Operations, page 23
14.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.
Compensation, page 24
15.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.
Signatures, page 29
16.Please revise your signature page to include the signatures of your principal financial
officer and principal accounting officer.
February 27, 2025
Page 4
Consolidated Financial Statements (Unaudited), page F-6
17.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.
2. Summary of Significant Accounting Policies, page F-7
18.Please revise to disclose your research and development expense policy. Refer to ASC
730-10-50-1.
12. Subsequent Events, page F-12
19.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.
We will consider qualifying your offering statement at your request. If a participant in
your offering is required to clear its compensation arrangements with FINRA, please have
FINRA advise us that it has no objections to the compensation arrangements prior to
qualification.
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. We also remind you that, following qualification of your Form 1-A,
Rule 257 of Regulation A requires you to file periodic and current reports, including a Form
1-K which will be due within 120 calendar days after the end of the fiscal year covered by the
report.
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 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