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OS Therapies Inc
Response Received
1 company response(s)
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OS Therapies Inc
Response Received
1 company response(s)
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OS Therapies Inc
Response Received
1 company response(s)
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OS Therapies Inc
Awaiting Response
0 company response(s)
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OS Therapies Inc
Response Received
4 company response(s)
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OS Therapies Inc
Response Received
4 company response(s)
High - file number match
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Company responded
2024-11-27
OS Therapies Inc
References: November 20, 2024
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Company responded
2025-01-31
OS Therapies Inc
Summary
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OS Therapies Inc
Response Received
12 company response(s)
High - file number match
Company responded
2024-06-07
OS Therapies Inc
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SEC wrote to company
2024-06-11
OS Therapies Inc
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Company responded
2024-06-13
OS Therapies Inc
References: June 11, 2024
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Company responded
2024-06-18
OS Therapies Inc
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Company responded
2024-06-18
OS Therapies Inc
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Company responded
2024-06-20
OS Therapies Inc
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Company responded
2024-06-20
OS Therapies Inc
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Company responded
2024-06-25
OS Therapies Inc
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Company responded
2024-06-25
OS Therapies Inc
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Company responded
2024-06-26
OS Therapies Inc
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Company responded
2024-06-26
OS Therapies Inc
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Company responded
2024-07-26
OS Therapies Inc
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Company responded
2024-07-26
OS Therapies Inc
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OS Therapies Inc
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2023-04-10
OS Therapies Inc
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Company responded
2023-04-13
OS Therapies Inc
References: April 10, 2023
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Company responded
2023-04-24
OS Therapies Inc
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2023-05-22
OS Therapies Inc
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2023-12-22
OS Therapies Inc
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2024-01-24
OS Therapies Inc
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2024-02-12
OS Therapies Inc
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2024-02-12
OS Therapies Inc
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OS Therapies Inc
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2023-03-27
OS Therapies Inc
Summary
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Company responded
2023-03-31
OS Therapies Inc
References: March 26, 2023
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OS Therapies Inc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-02-20
OS Therapies Inc
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-21 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-08-13 | SEC Comment Letter | OS Therapies Inc | DE | 333-289443 | Read Filing View |
| 2025-08-08 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-08-08 | SEC Comment Letter | OS Therapies Inc | DE | 333-289216 | Read Filing View |
| 2025-06-02 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-05-28 | SEC Comment Letter | OS Therapies Inc | DE | 333-287569 | Read Filing View |
| 2025-03-10 | SEC Comment Letter | OS Therapies Inc | DE | 005-94604 | Read Filing View |
| 2025-02-07 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-05 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-04 | SEC Comment Letter | OS Therapies Inc | DE | 333-284631 | Read Filing View |
| 2025-02-04 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-04 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-03 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-11-27 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-11-20 | SEC Comment Letter | OS Therapies Inc | DE | 333-283171 | Read Filing View |
| 2024-07-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-25 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-25 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-13 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-11 | SEC Comment Letter | OS Therapies Inc | DE | 333-279839 | Read Filing View |
| 2024-06-07 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-01-24 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-12-22 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-05-22 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-04-24 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-04-13 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-04-10 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| 2023-03-31 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-03-27 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| 2023-02-20 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | SEC Comment Letter | OS Therapies Inc | DE | 333-289443 | Read Filing View |
| 2025-08-08 | SEC Comment Letter | OS Therapies Inc | DE | 333-289216 | Read Filing View |
| 2025-05-28 | SEC Comment Letter | OS Therapies Inc | DE | 333-287569 | Read Filing View |
| 2025-03-10 | SEC Comment Letter | OS Therapies Inc | DE | 005-94604 | Read Filing View |
| 2025-02-04 | SEC Comment Letter | OS Therapies Inc | DE | 333-284631 | Read Filing View |
| 2024-11-20 | SEC Comment Letter | OS Therapies Inc | DE | 333-283171 | Read Filing View |
| 2024-06-11 | SEC Comment Letter | OS Therapies Inc | DE | 333-279839 | Read Filing View |
| 2023-04-10 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| 2023-03-27 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| 2023-02-20 | SEC Comment Letter | OS Therapies Inc | DE | 377-06476 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-21 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-06-02 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-07 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-05 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-04 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-02-04 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2025-01-03 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-11-27 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-25 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-25 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-13 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-06-07 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2024-01-24 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-12-22 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-05-22 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-04-24 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-04-13 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
| 2023-03-31 | Company Response | OS Therapies Inc | DE | N/A | Read Filing View |
2025-08-21 - CORRESP - OS Therapies Inc
CORRESP 1 filename1.htm EMAIL: SFeldman@olshanlaw.com DIRECT DIAL: 212.451.2234 August 21, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Doris Stacey Gama Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-3 (No. 333-289443) Ladies and Gentlemen: On behalf of OS Therapies Incorporated, a Delaware corporation (the "Company"), we enclose the Company's request for acceleration of the above-referenced Registration Statement to 4:30 p.m., Eastern time, on Monday, August 25, 2025, or as soon as practicable thereafter. Please advise the undersigned of the effectiveness of the Registration Statement. Very truly yours, /s/ Spencer G. Feldman Spencer G. Feldman cc: Paul A. Romness, MPH August 21, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Doris Stacey Gama Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-3 (No. 333-289443) Ladies and Gentlemen: OS Therapies Incorporated hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective at 4:30 p.m., Eastern time, on Monday, August 25, 2025, or as soon as practicable thereafter. Very truly yours, OS Therapies Incorporated By: /s/ Paul A. Romness Paul A. Romness President and Chief Executive Officer
2025-08-13 - UPLOAD - OS Therapies Inc File: 333-289443
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 13, 2025 Paul A. Romness Chief Executive Officer OS Therapies Incorporated 115 Pullman Crossing Road, Suite #103 Grasonville, MD21638 Re: OS Therapies Incorporated Registration Statement on Form S-3 Filed August 8, 2025 File No. 333-289443 Dear Paul A. Romness: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Doris Stacey Gama at 202-551-3188 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Dakota J. Forsyth, Esq. </TEXT> </DOCUMENT>
2025-08-08 - CORRESP - OS Therapies Inc
CORRESP 1 filename1.htm August 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Doris Stacey Gama Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-1 (No. 333-289216) Ladies and Gentlemen: On behalf of OS Therapies Incorporated, a Delaware corporation (the "Company"), we enclose the Company's request for acceleration of the above-referenced Registration Statement to 4:30 p.m., Eastern time, on Tuesday, August 12, 2025, or as soon as practicable thereafter. Please advise the undersigned of the effectiveness of the Registration Statement. Very truly yours, /s/ Spencer G. Feldman Spencer G. Feldman cc: Paul A. Romness, MPH August 8, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Doris Stacey Gama Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-1 (No. 333-289216) Ladies and Gentlemen: OS Therapies Incorporated hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective at 4:30 p.m., Eastern time, on Tuesday, August 12, 2025, or as soon as practicable thereafter. Very truly yours, OS Therapies Incorporated By: /s/ Paul A. Romness Paul A. Romness President and Chief Executive Officer
2025-08-08 - UPLOAD - OS Therapies Inc File: 333-289216
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 8, 2025 Paul A. Romness Chief Executive Officer OS Therapies Incorporated 115 Pullman Crossing Road, Suite #103 Grasonville, MD 21638 Re: OS Therapies Incorporated Registration Statement on Form S-1 Filed August 4, 2025 File No. 333-289216 Dear Paul A. Romness: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Doris Stacey Gama at 202-551-3188 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Dakota J. Forsyth, Esq. </TEXT> </DOCUMENT>
2025-06-02 - CORRESP - OS Therapies Inc
CORRESP 1 filename1.htm EMAIL: SFeldman@olshanlaw.com DIRECT DIAL: 212.451.2234 June 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Joshua Gorsky Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-1 (No. 333-287569) Ladies and Gentlemen: On behalf of OS Therapies Incorporated, a Delaware corporation (the "Company"), we enclose the Company's request for acceleration of the above-referenced Registration Statement to 4:30 p.m., Eastern time, on Friday, June 6, 2025, or as soon as practicable thereafter. Please advise the undersigned of the effectiveness of the Registration Statement. Very truly yours, /s/ Spencer G. Feldman Spencer G. Feldman cc: Paul A. Romness, MPH June 2, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn.: Joshua Gorsky Office of Life Sciences Re: OS Therapies Incorporated Registration Statement on Form S-1 (No. 333-287569) Ladies and Gentlemen: OS Therapies Incorporated hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective at 4:30 p.m., Eastern time, on Friday, June 6, 2025, or as soon as practicable thereafter. Very truly yours, OS Therapies Incorporated By: /s/ Paul A. Romness Paul A. Romness President and Chief Executive Officer
2025-05-28 - UPLOAD - OS Therapies Inc File: 333-287569
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 28, 2025 Paul A. Romness President and Chief Executive Officer OS Therapies Incorporated 115 Pullman Crossing Road, Suite #103 Grasonville, MD 21638 Re: OS Therapies Incorporated Registration Statement on Form S-1 Filed May 23, 2025 File No. 333-287569 Dear Paul A. Romness: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Dakota J. Forsyth, Esq. </TEXT> </DOCUMENT>
2025-03-10 - UPLOAD - OS Therapies Inc File: 005-94604
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 10, 2025 Shalom Auerbach Reporting Person OS Therapies Incorporated 15 Atlantic Avenue, Suite M2 Lynbrook, NY 11563 Re: OS Therapies Incorporated Shalom Auerbach Schedule 13D filed January 17, 2025 by Shalom Auerbach and Einodmil LLC File No. 005-94604 Dear Shalom Auerbach: We have conducted a limited review of the above-captioned filing and have the following comments. Please respond to this letter by amending the filing or by providing the requested information. If you do not believe our comments apply to your facts and circumstances or that an amendment is appropriate, please advise us why in a response letter. After reviewing any amendment to the filing and any information provided in response to these comments, we may have additional comments. Schedule 13D filed January 17, 2025 General 1. We note that the event reported as requiring the filing of the Schedule 13D was July 31, 2024. Rule 13d-1(a) of Regulation 13D-G requires the filing of a Schedule 13D within five business days after the date beneficial ownership of more than five percent of a class of equity securities specified in Rule 13d-1(i)(1) was acquired. Based on the July 31, 2024 event date, the Schedule 13D submitted on January 17, 2025 was not timely filed. Please advise us why the Schedule 13D was not filed within the required five business days after the date of the acquisition. Item 4, page 1 2. Please amend Item 4 of the Schedule 13D to state the purpose or purposes of the acquisition of securities of OS Therapies Incorporated. Refer to Item 4 of Schedule 13D. March 10, 2025 Page 2 Item 5, page 1 3. We note your disclosure that "[t]here were no transactions by the Reporting Persons in shares of Common Stock during the period commencing sixty (60) days prior to" August 2, 2024 and July 31, 2024. Please revise to provide the requisite disclosure with respect to all transactions in the securities between the deadline for timely filing the Schedule 13D and the actual filing of the Schedule 13D. In amending the Schedule 13D to include the required disclosures, please be advised that the Instruction to Item 5(c) requires the beneficial owner to "describe," at a minimum, the following: "(1) The identity of the person covered by Item 5(c) who effected the transaction; (2) the date of transaction; (3) the amount of securities involved; (4) the price per share or unit; and (5) where and how the transaction was effected." We remind you that the filing persons are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please direct any questions to Blake Grady at 202-551-8573 or Nicholas Panos at 202-551-3266. Sincerely, Division of Corporation Finance Office of Mergers & Acquisitions </TEXT> </DOCUMENT>
2025-02-07 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
February 7, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Tim Buchmiller
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statement to 4:30 p.m., Eastern time, on Thursday, February 13, 2025, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
February
7, 2025
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Tim Buchmiller
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective
at 4:30 p.m., Eastern time, on Thursday, February 13, 2025, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2025-02-05 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
February 5, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Tim Buchmiller
Office of Life Sciences
Re: Withdrawal of Acceleration Request
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated (the “Company”),
this letter will serve to withdraw the request for acceleration of the above-referenced Registration Statement filed as correspondence
via EDGAR on Tuesday, February 4, 2025.
The Company is no longer requesting that such Registration
Statement be declared effective at 4:30 p.m., Eastern Time, on Thursday, February 6, 2025, and we hereby formally withdraw our request
for acceleration of the effective date.
Thank you for your assistance.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc:
Paul A. Romness, MPH
February 5, 2025
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Tim Buchmiller
Office of Life Sciences
Re: Withdrawal of Acceleration Request
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
OS Therapies Incorporated hereby withdraws the
request for acceleration of the above-referenced Registration Statement filed as correspondence via EDGAR on Tuesday, February 4, 2025.
We are no longer requesting
that such Registration Statement be declared effective at 4:30 p.m., Eastern Time, on Thursday, February 6, 2025, and we hereby formally
withdraw our request for acceleration of the effective date.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2025-02-04 - UPLOAD - OS Therapies Inc File: 333-284631
February 4, 2025
Paul A. Romness, MPH
President and Chief Executive Officer
OS Therapies Incorporated
115 Pullman Crossing Road, Suite #103
Grasonville, Maryland 21638
Re:OS Therapies Incorporated
Registration Statement on Form S-1
Filed January 31, 2025
File No. 333-284631
Dear Paul A. Romness MPH:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Spencer G. Feldman, Esq.
2025-02-04 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
February 4, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Tim Buchmiller
Office of Life Sciences
Re:
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated, a Delaware corporation (the “Company”),
we enclose the Company’s request for acceleration of the above-referenced Registration Statement to 4:30 p.m., Eastern time, on
Thursday, February 6, 2025, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc:
Paul A. Romness, MPH
2025-02-04 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
February 4, 2025
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Tim Buchmiller
Office of Life Sciences
Re:
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-284631)
Ladies and Gentlemen:
OS Therapies Incorporated hereby requests that the effectiveness of the
above-referenced Registration Statement be accelerated so that it will become effective at 4:30 p.m., Eastern time, on Thursday, February
6, 2025, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2025-01-31 - CORRESP - OS Therapies Inc
CORRESP
1
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January 31, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: OS Therapies Inc.
Registration Statement on Form S-1 for
Registration of 10,834,044 Shares of Common Stock
Ladies and Gentlemen:
On behalf of OS Therapies Inc., a Delaware corporation,
we hereby submit in electronic format for filing with the U.S. Securities and Exchange Commission (the “Commission”), pursuant
to the Securities Act of 1933, as amended (the “Securities Act”), and Rule 101(a)(1)(i) of Regulation S-T, one complete copy
of the captioned Registration Statement on Form S-1 (the “Registration Statement”) for the registration of OS Therapies’
shares of common stock issuable upon conversion of its shares of Series A Senior
Convertible Preferred Stock and the exercise of warrants to purchase shares of common stock sold in a private placement under a
selling stockholders resale prospectus, and one complete copy of the exhibits listed in the Registration Statement as filed therewith.
OS Therapies wishes to bring to the Commission’s
attention that the information contained in the Registration Statement follows closely the information contained in the registration statement
on Form S-1 (File No. 333-283171), declared effective by the Commission on January 13, 2025. In addition to including 2024 executive compensation
data, the Registration Statement primarily reflects, among other revisions, the completion of OS Therapies’ December 2024-January
2025 private placement, as disclosed in OS Therapies’ Form 8-Ks filed on December 30, 2024 and January 3 and 14, 2025.
A wire transfer in payment of the applicable registration
fee has been previously sent.
Should any member of the Commission’s staff
have any questions concerning the enclosed materials or desire any further information or clarification in respect of the Registration
Statement or the offering, please do not hesitate to contact me (tel.: (212) 451-2234) or Dakota J. Forsyth of our office (tel.: (212)
451-2247), or Paul A. Romness, the Company’s Chief Executive Officer (tel.: (703) 541-9811).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Mr. Paul A. Romness, MPH
2025-01-10 - CORRESP - OS Therapies Inc
CORRESP
1
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EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
January 10, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Doris Stacey Gama, Esq., Attorney
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-283171)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statement to 4:00 p.m., Eastern time, on Monday, January 13, 2025, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
January 10, 2025
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Doris Stacey Gama, Esq., Attorney
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-283171)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective
at 4:00 p.m., Eastern time, on Monday, January 13, 2025, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2025-01-03 - CORRESP - OS Therapies Inc
CORRESP
1
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EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
January 3, 2025
VIA EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Doris Stacey Gama, Esq.
Division of Corporation Finance
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1
File No. 333-283171
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S. Securities and Exchange
Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended (the “Securities Act”), one complete
copy of Amendment No. 2 to the Registration Statement on Form S-1 (the “Amendment”), covering (i) up to a maximum of 5,597,015
shares of common stock, (ii) 165,746 shares of common stock issued as initial commitment shares and (ii) up to 450,000 shares of common
stock issuable as true-up shares. One complete copy of the exhibits listed in the Amendment is also filed therewith.
The primary purpose of the
Amendment filing is to include a description of the Company’s recent PIPE financing in December 2024.
The Company has a strong interest
in obtaining effectiveness of the Registration Statement during the week of January 6, 2025, and greatly appreciates the staff’s
efforts in accommodating this timing.
Should any member of the Commission’s
staff have any questions concerning the enclosed materials or desire any further information or clarification in respect of the Amendment, please do not hesitate to contact me (tel.: (212) 451-2234) or Paul A. Romness, the Company’s Chief Executive
Officer (tel.: (703) 541-9811).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
Enclosures
cc: Mr. Paul A. Romness
2024-11-27 - CORRESP - OS Therapies Inc
CORRESP
1
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EMAIL:
SFELDMAN@OLSHANLAW.COM
DIRECT
DIAL: 212.451.2234
November 27,
2024
VIA EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Doris Stacey Gama, Esq.
Division of Corporation Finance
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1
Filed November 12, 2024
File No. 333-283171
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S. Securities and Exchange
Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended (the “Securities Act”), one complete
copy of Amendment No. 1 to the Registration Statement on Form S-1 (the “Amendment”), covering (i) up to a maximum of 5,597,015
shares of common stock, (ii) 165,746 shares of common stock issued as initial commitment shares and (ii) up to 450,000 shares of common
stock issuable as true-up shares. One complete copy of the exhibits listed in the Amendment is also filed therewith.
The Amendment responds to
the comments received from the staff of the SEC in its comment letter, dated November 20, 2024, with respect to the Registration Statement
on Form S-1 filed on November 12, 2024.
Courtesy copies of this letter
and the Amendment, together with all exhibits, are being provided directly to the staff for its convenience (attention: Doris Stacey Gama,
Esq.) in the review of the foregoing documents.
To facilitate the staff’s
review, the SEC’s comments are reproduced before the Company’s responses thereto.
November 27, 2024
Page 2
Registration Statement on Form S-1
Cover Page
1. We note you are registering the resale of common stock to be issued
pursuant to the equity line financing with Square Gate Capital Master Fund LLC. Please specify the number of shares being registered under
the equity line financing and ensure that Square Gate Capital Master Fund LLC is also named as an underwriter throughout the filing, where
appropriate, including the Selling Stockholder and Plan of Distribution sections. Refer to Securities Act Sections Compliance and Disclosure
Interpretation Question 139.13 for guidance.
Response: In
response to the staff’s comment, the Company has revised the cover page to specify the number of shares being registered under the
equity line financing, and has made revisions where appropriate to name Square Gate Capital Master Fund LLC as an underwriter. Please
see pages 100 and 102.
2. We note your disclosure on page 102 that Regulation M “may
apply to sales of shares in the market and to the activities of the Selling Securityholder and its affiliates.” Please revise to
disclose how the provisions of Regulation M may prohibit the Selling Securityholder and any other distribution participants that are participating
in the distribution of your securities from:
● engaging in market making activities (e.g., placing bids or making purchases to stabilize the price of the ordinary shares) while
the equity line is in effect; and
● purchasing shares in the open market while the equity line is in effect.
Response: In
response to the staff’s comment, the Company has revised the disclosure to state that it has advised the selling securityholder
that the anti-manipulation rules of Regulation M may prohibit the selling securityholder from engaging in market making activities (e.g.,
placing bids or making purchases to stabilize the price of the ordinary shares) while the equity line is in effect and purchasing shares
in the open market while the equity line is in effect. Please see page 102.
Should any member of the Commission’s
staff have any questions concerning the enclosed materials or desire any further information or clarification in respect of the Registration
Statement or the offering, please do not hesitate to contact me (tel.: (212) 451-2234) or Paul A. Romness, the Company’s Chief Executive
Officer (tel.: (703) 541-9811).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
Enclosures
cc: Mr. Paul A. Romness
2024-11-20 - UPLOAD - OS Therapies Inc File: 333-283171
November 20, 2024
Paul A. Romness
Chief Executive Officer
OS Therapies Incorporated
115 Pullman Crossing Road, Suite #103
Grasonville, MD 21638
Re:OS Therapies Incorporated
Registration Statement on Form S-1
Filed November 12, 2024
File No. 333-283171
Dear Paul A. Romness:
We have conducted a limited review of 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.
Registration Statement on Form S-1
Cover Page
1.We note you are registering the resale of common stock to be issued pursuant to the
equity line financing with Square Gate Capital Master Fund LLC. Please specify the
number of shares being registered under the equity line financing and ensure that
Square Gate Capital Master Fund LLC is also named as an underwriter throughout the
filing, where appropriate, including the Selling Stockholder and Plan of Distribution
sections. Refer to Securities Act Sections Compliance and Disclosure Interpretation
Question 139.13 for guidance.
Plan of Distribution, page 101
We note your disclosure on page 102 that Regulation M “may apply to sales of shares
in the market and to the activities of the Selling Securityholder and its affiliates.” 2.
November 20, 2024
Page 2
Please revise to disclose how the provisions of Regulation M may prohibit the Selling
Securityholder and any other distribution participants that are participating in the
distribution of your securities from:
•engaging in market making activities (e.g., placing bids or making purchases to
stabilize the price of the ordinary shares) while the equity line is in effect; and
•purchasing shares in the open market while the equity line is in effect.
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 Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-
6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Spencer G. Feldman, Esq.
2024-07-26 - CORRESP - OS Therapies Inc
CORRESP
1
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July 26, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statement to 4:45 p.m., Eastern Time, on Tuesday, July 30, 2024, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
July 26, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective
at 4:45 p.m., Eastern Time, on Tuesday, July 30, 2024, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-07-26 - CORRESP - OS Therapies Inc
CORRESP
1
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VIA EDGAR
July 26, 2024
U.S. Securities and Exchange Commission Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Jimmy McNamara, Esq.
Re: OS Therapies Incorporated
Registration Statement on
Form S-1, as amended (File No. 333-279839)
Request for Acceleration of
Effectiveness
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), Brookline Capital Markets, a division of Arcadia Securities,
LLC, as the representative of the underwriters (the “Representative”), hereby joins in the request of OS Therapies Incorporated
(the “Registrant”), for the acceleration of the effective date of the Registrant’s Registration Statement on Form S-1,
as amended (File No. 333-279839) (the “Registration Statement”), so that the Registration Statement may be declared effective
at 4:45 p.m., Eastern Time, on July 30, 2024, or as soon thereafter as practicable. The undersigned, as the Representative, confirms that
it is aware of its obligations under the Securities Act.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities and Exchange Commission under the Securities Act, we distributed to each dealer, who is
reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus, dated June 13, 2024, as appears to be reasonable to secure adequate distribution of the Preliminary
Prospectus.
The undersigned confirms that
it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they
have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with
the above-referenced issue.
Very truly yours,
Brookline Capital Markets,
a division of Arcadia Securities, LLC
By:
/s/ Michael Fontaine
Name:
Michael Fontaine
Title:
Managing Partner
2024-06-26 - CORRESP - OS Therapies Inc
CORRESP
1
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June 26, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re: Withdrawal of Acceleration Request
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated (the “Company”),
this letter will serve to withdraw the request for acceleration of the above-referenced Registration Statement filed as correspondence
via EDGAR on Tuesday, June 25, 2024.
The Company is no longer requesting that such Registration
Statement be declared effective at 4:00 p.m., Eastern Time, on Wednesday, June 26, 2024, and we hereby formally withdraw our request for
acceleration of the effective date.
Thank you for your assistance.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
June 26, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re: Withdrawal of Acceleration Request
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
OS Therapies Incorporated hereby withdraws the
request for acceleration of the above-referenced Registration Statement filed as correspondence via EDGAR on Tuesday, June 25, 2024.
We are no longer requesting
that such Registration Statement be declared effective at 4:00 p.m., Eastern Time, on Wednesday, June 26, 2024, and we hereby formally
withdraw our request for acceleration of the effective date.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-06-26 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
June 26, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re:
OS Therapies Incorporated
Registration Statement on Form S-1 (File No. 333-279839)
Withdrawal of Prior Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence with the U.S.
Securities and Exchange Commission via EDGAR on June 25, 2024, in which we requested the acceleration of the effective date of the above-captioned
Registration Statement to 4:00 p.m. Eastern time, on Wednesday, June 26, 2024. We are no longer requesting that the Registration Statement
be declared effective at that date and time, and we hereby formally withdraw our prior request for acceleration of the effective date
of the above-captioned Registration Statement.
Very truly yours,
Brookline capital markets, a
division of arcadia securities, llc
By:
/s/ Michael Fontaine
Name:
Michael Fontaine
Title:
Managing Partner
cc: Marc Ross, Esq.
2024-06-25 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
June 25, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statement to 4:00 p.m., Eastern Time, on Wednesday, June 26, 2024, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
June 25, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective
at 4:00 p.m., Eastern Time, on Wednesday, June 26, 2024, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-06-25 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
VIA EDGAR
June 25, 2024
U.S. Securities and Exchange Commission Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Jimmy McNamara, Esq.
Re:
OS Therapies Incorporated
Registration Statement on Form S-1, as amended (File No. 333-279839)
Request for Acceleration of Effectiveness
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), Brookline Capital Markets, a division of Arcadia Securities,
LLC, as the representative of the underwriters (the “Representative”), hereby joins in the request of OS Therapies Incorporated
(the “Registrant”), for the acceleration of the effective date of the Registrant’s Registration Statement on Form S-1,
as amended (File No. 333-279839) (the “Registration Statement”), so that the Registration Statement may be declared effective
at 4:00 p.m., Eastern Time, on June 26, 2024, or as soon thereafter as practicable. The undersigned, as the Representative, confirms that
it is aware of its obligations under the Securities Act.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities and Exchange Commission under the Securities Act, we distributed to each dealer, who is
reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus, dated June 13, 2024, as appears to be reasonable to secure adequate distribution of the Preliminary
Prospectus.
The undersigned confirms that
it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they
have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with
the above-referenced issue.
Very truly yours,
Brookline Capital Markets,
a division of Arcadia Securities, LLC
By:
/s/ Michael Fontaine
Name:
Michael Fontaine
Title:
Managing Partner
2024-06-20 - CORRESP - OS Therapies Inc
CORRESP
1
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June 20, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy McNamara, Esq.
Office of Life Sciences
Re:
OS Therapies Incorporated
Registration Statement on Form S-1 (File No. 333-279839)
Withdrawal of Prior Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence with the U.S.
Securities and Exchange Commission via EDGAR on June 18, 2024, in which we requested the acceleration of the effective date of the above-captioned
Registration Statement to 4:00 p.m. Eastern time, on Thursday, June 20, 2024. We are no longer requesting that the Registration Statement
be declared effective at that date and time, and we hereby formally withdraw our prior request for acceleration of the effective date
of the above-captioned Registration Statement.
Very truly yours,
Brookline capital markets, a division of arcadia securities, llc
By:
/s/ Michael Fontaine
Name:
Michael Fontaine
Title:
Managing Partner
cc: Marc Ross, Esq.
2024-06-20 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
June 20, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated (the “Company”),
this letter will serve to withdraw the request for acceleration of the above-referenced Registration Statement filed as correspondence
via EDGAR on Tuesday, June 18, 2024.
The Company is no longer requesting that such Registration
Statement be declared effective at 4:00 p.m., Eastern Time, on Thursday, June 20, 2024, and we hereby formally withdraw our request for
acceleration of the effective date.
Thank you for your assistance.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
June 20, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: Withdrawal of Acceleration Request
OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
OS Therapies Incorporated hereby withdraws the
request for acceleration of the above-referenced Registration Statement filed as correspondence via EDGAR on Tuesday, June 18, 2024.
We are no longer requesting
that such Registration Statement be declared effective at 4:00 p.m., Eastern Time, on Thursday, June 20, 2024, and we hereby formally
withdraw our request for acceleration of the effective date.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-06-18 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
VIA EDGAR
June 18, 2024
U.S. Securities and Exchange Commission Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Jimmy McNamara, Esq.
Re:
OS Therapies Incorporated
Registration Statement on Form S-1, as amended (File No. 333-279839)
Request for Acceleration of Effectiveness
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), Brookline Capital Markets, a division of Arcadia Securities,
LLC, as the representative of the underwriters (the “Representative”), hereby join in the request of OS Therapies Incorporated
(the “Registrant”), for the acceleration of the effective date of the Registrant’s Registration Statement on Form S-1,
as amended (File No. 333-279839) (the “Registration Statement”), so that the Registration Statement may be declared effective
at 4:00 p.m., Eastern Time, on June 20, 2024, or as soon thereafter as practicable. The undersigned, as the Representative, confirms that
it is aware of its obligations under the Securities Act.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities and Exchange Commission under the Securities Act, we distributed to each dealer, who is
reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus, dated June 13, 2024, as appears to be reasonable to secure adequate distribution of the Preliminary
Prospectus.
The undersigned confirms that
it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they
have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with
the above-referenced issue.
Very truly yours,
Brookline Capital Markets,
a division of Arcadia Securities, LLC
By:
/s/ Michael Fontaine
Name:
Michael Fontaine
Title:
Managing Partner
2024-06-18 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
June 18, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statement to 4:00 p.m., Eastern Time, on Thursday, June 20, 2024, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statement.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Paul A. Romness, MPH
June 18, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-279839)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statement be accelerated so that it will become effective
at 4:00 p.m., Eastern Time, on Thursday, June 20, 2024, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-06-13 - CORRESP - OS Therapies Inc
CORRESP
1
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June
13, 2024
VIA
EDGAR
U.S.
Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
OS
Therapies Incorporated
Amendment No. 1 to Registration Statement on Form S-1
Filed June 7, 2024
File
No. 333-279839
Ladies
and Gentlemen:
On
behalf of OS Therapies Incorporated, a Delaware corporation (the “Company”), we are hereby filing with the U.S. Securities
and Exchange Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended, one complete copy of the Company’s
Amendment No. 2 to the Registration Statement on Form S-1 (the “Amendment”), relating to a proposed public offering of shares
of the Company’s common stock, including a copy of the exhibits listed in the Amendment as filed therewith.
The
Amendment reflects responsive changes to the SEC staff’s comment letter dated June 11, 2024, with respect to revising the financial
statements and accompanying footnotes to reflect the reverse stock split of the Company’s common stock effected on June 4, 2024,
by updating all share and per share amounts for all common stock related instruments. Set forth below are each of the staff’s comments
and the respective responses.
Amendment
No. 1 to Registration Statement on Form S-1
Index
to Financial Statements
Balance
Sheet, page F-2
1. Please
revise the presentation of your equity shares in the March 31, 2024 and December 31, 2023
financial statements and elsewhere in your filing to retrospectively restate the number of
shares to reflect the reverse split. Refer to the guidance in SAB Topic 4C and FASB ASC 505-10-S99-4.
Additionally, include disclosures where appropriate in the filing confirming that the reverse
stock split has been retrospectively applied for all periods presented.
Response:
In accordance with the guidance in SAB Topic 4C and FASB ASC 505-10-S99-4, the Company has revised the presentation of its equity shares
in the March 31, 2024 and December 31, 2023 financial statements and elsewhere in the filing to retrospectively restate the number of
shares to reflect the reverse split. Additionally, disclosure has been included in the filing confirming that the reverse stock split
has been retrospectively applied for all periods presented.
The
following language appears or has been added to pages 6, 11-12, 56, 98, 101, F-23 and F-46.
“On
June 4, 2024, we filed a certificate of amendment to our third amended and restated certificate of incorporation to effectuate a
1-for-2 reverse stock split of our outstanding shares of common stock, effective upon such filing. The par value and authorized
shares of our common stock were not adjusted as a result of the reverse stock split. No fractional shares were issued in connection with
the reverse stock split as all fractional shares were rounded up to the nearest whole share. All share and per share amounts have been
retroactively restated for all periods presented to reflect the reverse stock split.”
Notes
to the Financial Statements
Note
8 - Subsequent Events, page F-22
2. Please
provide disclosures about the reverse stock split, effected on June 4, 2024, in the subsequent
events note here and as a subsequent note in the notes to the audited financial statement
for the year-ended December 31, 2023.
Response:
As requested by the staff, disclosures have been added about the reverse stock split, effected on June 4, 2024, in the subsequent events
note on page F-23 and as a subsequent note in the notes to the audited financial statement for the year-ended December 31, 2023, on page
F-46. Please see the prior comment response for the complete reverse stock split disclosure.
Report
of Independent Registered Public Accounting Firm, page F-23
3. Please
have your independent auditor provide a revised audit report to include a dual date for the
reverse stock split effected on June 4, 2024 in accordance with PCAOB – Auditor Reporting,
at paragraph .05 of AS 3110, or explain why a revised audit report is not required.
Response:
In accordance with PCAOB – Auditor Reporting, at paragraph .05 of AS 3110, the Company’s independent auditor has provided
a revised audit report to include a dual date for the reverse stock split effected on June 4, 2024, on page F-23, as follows:
“/s/
MaloneBailey, LLP
www.malonebailey.com
We
have served as the Company’s auditor since 2020.
Houston,
Texas
May 13, 2024, except Note 9 which is dated June 13, 2024”
Additionally, as requested by the staff, we have removed in various places throughout the prospectus the word “assumed” that
appeared prior to the initial public offering price.
As
we have previously advised the staff, the Company and the lead underwriter would like to submit requests for acceleration of effectiveness
of the Company’s registration statement promptly in order to have the registration statement declared effective by the Commission
on or about Tuesday, June 18, 2024, or as soon thereafter as is practicable. The Company appreciates the staff’s review of the Amendment
with this expedited timing.
A
copy of the letter from FINRA clearing the underwriting compensation arrangements for the offering has been forwarded to you, and we believe
all other information has been previously provided to the staff.
Should
any member of the Commission’s staff have any questions concerning the enclosed materials or desire any further information or
clarification in respect of the Amendment, please do not hesitate to contact me (tel.: (212) 451-2234) or Paul A. Romness,
MPH, the Company’s Chief Executive Officer (tel.: (410) 297-7793).
2
Very
truly yours,
/s/
Spencer G. Feldman
Spencer
G. Feldman
Enclosures
cc:
Jimmy
McNamara, Esq., U.S. Securities and Exchange Commission
Mr.
Paul A. Romness, MPH
Mr. Christopher P. Acevedo
3
2024-06-11 - UPLOAD - OS Therapies Inc File: 333-279839
United States securities and exchange commission logo
June 11, 2024
Paul A. Romness
Chief Executive Officer
OS Therapies Incorporated
15825 Shady Grove Road, Suite 135
Rockville, Maryland 20850
Re:OS Therapies Incorporated
Amendment No. 1 to Registration Statement on Form S-1
Filed June 7, 2024
File No. 333-279839
Dear Paul A. Romness:
We have reviewed your amended 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.
Amendment No. 1 to Registration Statement on Form S-1
Index to Financial Statements
Balance Sheet, page F-2
1.Please revise the presentation of your equity shares in the March 31, 2024 and December
31, 2023 financial statements and elsewhere in your filing to retrospectively restate the
number of shares to reflect the reverse split. Refer to the guidance in SAB Topic 4C and
FASB ASC 505-10-S99-4. Additionally, include disclosures where appropriate in the
filing confirming that the reverse stock split has been retrospectively applied for all
periods presented
Notes to the Financial Statements
Note 8 - Subsequent Events, page F-22
2.Please provide disclosures about the reverse stock split, effected on June 4, 2024, in the
subsequent events note here and as a subsequent note in the notes to the audited financial
FirstName LastNamePaul A. Romness
Comapany NameOS Therapies Incorporated
June 11, 2024 Page 2
FirstName LastName
Paul A. Romness
OS Therapies Incorporated
June 11, 2024
Page 2
statement for the year-ended December 31, 2023.
Report of Independent Registered Public Accounting Firm, page F-23
3.Please have your independent auditor provide a revised audit report to include a dual date
for the reverse stock split effected on June 4, 2024 in accordance with PCAOB - Auditor
Reporting, at paragraph .05 of AS 3110, or explain why a revised audit report is not
required.
Please contact Christine Torney at 202-551-3652 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Spencer G. Feldman
2024-06-07 - CORRESP - OS Therapies Inc
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June
7, 2024
VIA
EDGAR
U.S.
Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
OS Therapies Incorporated
Amendment No. 1 to Registration Statement on Form S-1
File No. 333-279839
Ladies
and Gentlemen:
On
behalf of OS Therapies Incorporated, a Delaware corporation (the “Company”), we hereby submit through EDGAR for filing with
the U.S. Securities and Exchange Commission (the “Commission”), pursuant to the Securities Act of 1933, as amended, one complete
copy of the Company’s Amendment No. 1 to the Registration Statement on Form S-1 (the “Amendment”), relating to a proposed
public offering of shares of the Company’s common stock, including a copy of the exhibits listed in the Amendment as filed therewith.
We wish to inform the staff of the Commission that the principal changes reflected in the Amendment from the initial registration statement
filed with the Commission on May 30, 2024 (the “Initial Filing”) are (i) updated disclosure relating to the filing of a certificate
of amendment to the Company’s third amended and restated certificate of incorporation (the “Charter Amendment”) for
the 1-for-2 reverse stock split of the Company’s outstanding shares on June 4, 2024 and (ii) an updated Exhibit 3.2 for the Charter
Amendment.
The
Amendment does not reflect any changes in the securities to be offered or the terms of the offering. There were no outstanding comments
from the staff following the Initial Filing.
As
we have previously advised the staff, the Company and the lead underwriter would like to submit requests for acceleration of effectiveness
of the Company’s registration statement as soon as Monday, June 10, 2024 in order to have it declared effective by the Commission
on or about Thursday, June 13, 2024. The Company appreciates the staff’s review of the Amendment with this expedited timing.
Should
any member of the Commission’s staff have any questions concerning the enclosed materials or desire any further information or
clarification in respect of the New Registration Statement, please do not hesitate to contact me (tel.: (212) 451-2234) or Paul A. Romness,
MPH, the Company’s Chief Executive Officer (tel.: (410) 297-7793).
Very truly yours,
/s/ Spencer
G. Feldman
Spencer G. Feldman
Enclosures
cc: Jimmy
McNamara, Esq., U.S. Securities and Exchange Commission
Mr.
Paul A. Romness, MPH
Mr. Christopher P. Acevedo
2024-02-12 - CORRESP - OS Therapies Inc
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February 12, 2024
VIA EDGAR
Division of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, DC 20549
Attention: Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1
File No. 333-271034
Ladies and Gentlemen:
Pursuant to Rule 461 of
the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), the undersigned, for itself and
the other underwriters, hereby join in the request of OS Therapies Incorporated that the effective date of the above-referenced registration
statement be accelerated so as to permit it to become effective at 5:00 p.m., Eastern time, on Wednesday, February 14, 2024, or as soon
thereafter as practicable.
Pursuant to 460 under the
Act, we wish to advise you that the underwriters have distributed as many copies of the preliminary prospectus dated January 24, 2024
to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of such preliminary prospectus.
The undersigned advises
that it has complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Boustead Securities, LLC
By:
/s/ Keith Moore
Name:
Keith Moore
Title:
Chief Executive Officer
As representative of the underwriters
2024-02-12 - CORRESP - OS Therapies Inc
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February 12, 2024
VIA EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Joe McCann, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-271034)
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we enclose the Company’s request for acceleration of the above-referenced
Registration Statements to 5:00 p.m., Eastern time, on Wednesday, February 14, 2024, or as soon as practicable thereafter.
Please advise the undersigned
of the effectiveness of the Registration Statements.
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc: Jimmy McNamara, Esq.
Paul A. Romness, MPH
February 12, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Joe McCann, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Registration Statement on Form S-1 (No. 333-271034)
Ladies and Gentlemen:
OS Therapies Incorporated
hereby requests that the effectiveness of the above-referenced Registration Statements be accelerated so that they will become effective
at 5:00 p.m., Eastern time, on Wednesday, February 14, 2024, or as soon as practicable thereafter.
Very truly yours,
OS Therapies Incorporated
By:
/s/ Paul A. Romness
Paul A. Romness
President and Chief Executive Officer
2024-01-24 - CORRESP - OS Therapies Inc
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EMAIL: SFELDMAN@olshanlaw.com
DIRECT DIAL: 212.451.2234
January 24, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Division of Corporation Finance
Office of Life Sciences
Re:
OS Therapies Incorporated
Amendment No. 5 to Registration Statement on Form S-1
File No. 333-271034
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated, a Delaware
corporation (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S. Securities and Exchange
Commission, pursuant to the Securities Act of 1933, as amended, one complete copy of Amendment No. 5 to the Registration Statement on
Form S-1 (this “Amendment”) for the registration of shares of the Company’s common stock, including one complete copy
of the exhibits listed in this Amendment as filed therewith.
We wish to inform the staff of the SEC of the following
principal changes reflected in this Amendment from the previous amendment filed on December 22, 2023:
● the inclusion of EF Hutton LLC as an
underwriter on the front and back cover pages, as well as the allocation table under the “Underwriting” section, of the
prospectus; and
● updated disclosure relating to the
Company’s “Group F” private placement “bridge” financing transaction to include investments that
occurred in early January 2024, and the inclusion of the three investors, none of which are officers, directors or affiliates of the
Company, in such transaction as selling stockholders in the alternate prospectus.
This Amendment does not reflect any changes in
the securities to be offered or the terms of the offering. There were no outstanding comments from the staff following the Company’s
last amendment.
As we have previously advised the staff, the Company
and the underwriters have a strong interest in completing this offering during the week of February 5, 2024, and respectfully request
the staff to review this Amendment in order to accommodate this timing. The Company believes the NYSE American is in a position to approve
the Company’s application to list its common stock for trading on the NYSE American pending the filing of this Amendment.
Should any member of the SEC’s staff have
any questions concerning the enclosed materials or desire any further information or clarification in respect of this Amendment or the
offering, please do not hesitate to contact me (tel.: (212) 451-2234) or Dakota J. Forsyth of our office (tel.: (212) 451-2247), or Paul
A. Romness, the Company’s Chief Executive Officer (tel.: (703) 541-9811).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
Enclosures
cc:
Mr. Paul A. Romness
2023-12-22 - CORRESP - OS Therapies Inc
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EMAIL:
SFELDMAN@olshanlaw.com
DIRECT
DIAL: 212.451.2234
December 22, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn.:
Jimmy McNamara, Esq.
Division of Corporation Finance
Office of Life Sciences
Re: OS Therapies Incorporated
Amendment No. 4 to Registration Statement on Form S-1
File No. 333-271034
Ladies and Gentlemen:
On behalf of OS Therapies Incorporated, a
Delaware corporation (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S. Securities
and Exchange Commission, pursuant to the Securities Act of 1933, as amended, one complete copy of Amendment No. 4 to the
Registration Statement on Form S-1 (this “Amendment”) for the registration of shares of the Company’s common
stock, including one complete copy of the exhibits listed in Amendment No. 4 to the Registration Statement as filed therewith.
We wish to inform the staff of the SEC of the following
principal changes reflected in this Amendment from the previous amendment filed on May 22, 2023:
● the inclusion of the Company’s unaudited financial statements
as of and for the nine months ended September 30, 2023, and related financial data and MD&A disclosure;
● updated disclosure with regard to the full enrollment of patients
in the Company’s Phase IIb clinical trial;
● replacing in most instances the term “new drug application
(NDA)” with “biologics license application (BLA),” except where both terms are used together. The Company’s review
division at the FDA is the Center for Biologics Evaluation and Research; and
● description of the Company’s private placement “bridge”
financing transactions during the last three months, and the inclusion of the investors in such transactions as selling
stockholders in the alternate prospectus.
This Amendment does not reflect any
changes in the securities to be offered or the terms of the offering. There were no outstanding comments from the staff following
the Company’s last amendment.
As we have previously advised the staff, the Company
and the underwriters have a strong interest in completing this offering during the week of January 15, 2024, and respectfully request
the staff to review this Amendment in order to accommodate this timing. The Company believes the NYSE American is in a position to approve
the Company’s application to list its common stock for trading on the NYSE American pending the filing of this Amendment.
December 22, 2023
Page 2
Should any member of the SEC’s staff have
any questions concerning the enclosed materials or desire any further information or clarification in respect of Amendment No. 4 to the
Registration Statement or the offering, please do not hesitate to contact me (tel.: (212) 451-2234) or Dakota J. Forsyth of our office
(tel.: (212) 451-2247), or Paul A. Romness, the Company’s Chief Executive Officer (tel.: (703) 541-9811).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
Enclosures
cc: Mr. Paul A. Romness
2023-05-22 - CORRESP - OS Therapies Inc
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EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
May 22,
2023
VIA EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 3628
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Joe McCann, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Amendment No. 3 to the Registration Statement
on Form S-1 File No. 333-271034
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S.
Securities and Exchange Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended, one complete copy of the
Company’s Amendment No. 3 to the Registration Statement on Form S-1 (the “Registration Statement”), including one
complete copy of the exhibits listed as filed therewith.
The Registration Statement
includes unaudited interim financial statements, and related disclosure, for the three months ended March 31, 2023.
Courtesy copies of this letter
and the Registration Statement (as marked to reflect changes), together with all exhibits, are being provided by email directly to the
staff for its convenience (attention: Joe McCann, Esq.) in the review of the foregoing documents.
* * *
Based on conversations with
the underwriters, the Company and the lead underwriter would like to submit requests for acceleration of effectiveness of the Registration
Statement during the week of May 22, 2023 in order to meet the Company’s ultimate goal of having the Registration Statement declared
effective by the SEC before the end of May. The Company respectfully requests the staff’s review of the Registration Statement to
coincide with this timing.
The remainder of the exhibits
to the Registration Statement have been included in this filing, and the changes that were made to the Registration Statement, other than
the inclusion of the unaudited interim financial statements, and related disclosure, for the three months ended March 31, 2023, are minimal.
Accordingly, we believe that all information, including the exhibits to the Registration Statement, have been provided to the staff.
Kindly address any comments
or questions that you may have concerning this letter or the enclosed materials to Paul A. Romness, MPH, the Chief Executive Officer of
the Company (tel.: (703) 541-9811), or me (tel.: (212) 451-2234).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc:
Jimmy McNamara, Esq.
Paul A. Romness, MPH
Mr. Keith Moore
Cavas Pavri, Esq.
2023-04-24 - CORRESP - OS Therapies Inc
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EMAIL: SFeldman@olshanlaw.com
DIRECT DIAL: 212.451.2234
April 24,
2023
VIA EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 3628
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Joe McCann, Esq.
Office of Life Sciences
Re: OS Therapies Incorporated
Amendment No. 2 to the Registration Statement
on Form S-1 File No. 333-271034
Ladies and Gentlemen:
On behalf of OS Therapies
Incorporated, a Delaware corporation (the “Company”), we are hereby filing in electronic format through EDGAR with the U.S.
Securities and Exchange Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended, one complete copy of the
Company’s Amendment No. 2 to the Registration Statement on Form S-1 (the “Registration Statement”), including one
complete copy of the exhibits listed as filed therewith.
The Registration Statement responds
to the oral comments received from the staff of the SEC by telephone call with Joe McCann, Esq. with respect to the Company’s Amendment
No. 1 to the Registration Statement on Form S-1 (File No. 333-271034) filed by the Company with the SEC on April 13, 2023.
Courtesy copies of this letter
and the Registration Statement (as marked to reflect changes), together with all exhibits, are being provided by email directly to the
staff for its convenience (attention: Joe McCann, Esq.) in the review of the foregoing documents.
In response to the staff’s
oral comments, disclosure has been added on pages 64 and 73 to (i) explain that the amended and restated development, license and supply
agreement with Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.) (“Advaxis”) was subsequently amended in April 2021 to modify
the payment amounts for Milestones 2 and 3 in consideration for an advance payment by the Company to Advaxis and (ii) clarify that the
Company is required to pay to Advaxis a percentage in the high single digits to low double digits with respect to sublicense fees and
royalties under the terms of such amended agreement. A copy of the first amendment to the amended and restated development, license and
supply agreement with Advaxis is being filed as Exhibit 10.5.1 to the Registration Statement.
* * *
April 24, 2023
Page 2
Based on conversations with the
underwriters, the Company and the lead underwriter would like to submit requests for acceleration of effectiveness of the Registration
Statement during the early part of the week of April 24, 2023 in order to meet the Company’s schedule to have the Registration Statement
declared effective by the SEC after the market closes on Wednesday, April 26, 2023. The Company respectfully requests the staff’s
review of the Registration Statement to coincide with this timing.
The remainder of the exhibits to
the Registration Statement have been included in this filing, and we believe the changes that were made to the Registration Statement,
other than the additional disclosures in response to the staff’s oral comments, are minor. Accordingly, we believe that all information,
including the exhibits to the Registration Statement, have been provided to the staff.
Kindly address any comments
or questions that you may have concerning this letter or the enclosed materials to Paul A. Romness, MPH, the Chief Executive Officer of
the Company (tel.: (703) 541-9811), or me (tel.: (212) 451-2234).
Very truly yours,
/s/ Spencer G. Feldman
Spencer G. Feldman
cc:
Jimmy McNamara, Esq.
Paul A. Romness, MPH
Mr. Keith Moore
Cavas Pavri, Esq.
2023-04-13 - CORRESP - OS Therapies Inc
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EMAIL:
SFeldman@olshanlaw.com
DIRECT
DIAL: 212.451.2234
April 13, 2023
VIA
EDGAR AND ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 3628
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy
McNamara, Esq.
Office
of Life Sciences
Re: OS
Therapies Incorporated
Registration Statement on Form S-1
Filed March 31, 2023
File No. 333-271034
Ladies
and Gentlemen:
On
behalf of OS Therapies Incorporated, a Delaware corporation (the “Company”), we are hereby filing in electronic format through
EDGAR with the U.S. Securities and Exchange Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended, one
complete copy of the Company’s Amendment No. 1 to the Registration Statement on Form S-1 (the “Registration Statement”),
including one complete copy of the exhibits listed as filed therewith.
The
Registration Statement responds to the comments received from the staff of the SEC in its comment letter dated April 10, 2023 with respect
to the Company’s Registration Statement on Form S-1 (File No. 333-271034) filed by the Company with the SEC on March 31, 2023,
as discussed below.
Courtesy
copies of this letter and the Registration Statement (as marked to reflect changes), together with all exhibits, are being provided by
email directly to the staff for its convenience (attention: Jimmy McNamara) in the review of the foregoing documents.
To
facilitate the staff’s review, the SEC’s comments are reproduced before each of the Company’s responses thereto. All
page numbers referred to in the responses to the staff’s comments correspond to the page numbers of the Registration
Statement.
Registration
Statement on Form S-1
Phase
1B Clinical Trial, page 3
1. We
note your revised disclosure on page 69 in response to Comment 5. Please revise the disclosure
on page 3 to highlight that no objective tumor response (complete or partial) was observed
in the trial.
Response:
As requested by the staff, disclosure has been added on page 3 to highlight that no objective tumor responses (complete or partial) were
observed in the Phase Ib trial.
*
* *
April 13, 2023
Page 2
The
Company respectfully requests the staff’s review of the Registration Statement to coincide with this timing in order to meet the
Company’s ultimate goal of an April 2023 initial public offering.
Based on conversations with
the underwriters, the Company and the lead underwriter would like to submit requests for acceleration of the effectiveness of the Registration
Statement during the early part of the week of April 24, 2023, or as soon thereafter as is practicable. As pricing information is included
in this filing, the Company does not expect to rely on Rule 430A. The request of the lead underwriter will include the representation
from the underwriters with respect to compliance with Rule 15c2-8. A copy of the no objections letter from FINRA clearing the underwriting
compensation arrangements for the offering will be forwarded to you immediately upon its receipt.
As requested by the staff,
we have confidentially submitted through Kiteworks, the SEC’s secure file transfer tool, an unredacted copy (marked to show where
the Company redacted information in its public filing) of the license agreement filed as Exhibit 10.5 to the Registration Statement. The
remainder of the exhibits to the Registration Statement have been included in this filing, and no other substantive changes were made to
the Registration Statement, other than the additional disclosure in response to the staff’s comment above. Accordingly, we believe
that all information, including the exhibits to the Registration Statement, have been provided to the staff.
Kindly
address any comments or questions that you may have concerning this letter or the enclosed materials to Paul A. Romness, MPH, the Chief
Executive Officer of the Company (tel.: (703) 541-9811), or me (tel.: (212) 451-2234).
Very
truly yours,
/s/
Spencer G. Feldman
Spencer
G. Feldman
cc: Joe
McCann, Esq.
Paul
A. Romness, MPH
Mr.
Keith Moore
Cavas
Pavri, Esq.
2023-04-10 - UPLOAD - OS Therapies Inc File: 377-06476
United States securities and exchange commission logo
April 10, 2023
Paul A. Romness, MPH
President and Chief Executive Officer
OS Therapies Incorporated
15825 Shady Grove Road, Suite 135
Rockville, Maryland 20850
Re:OS Therapies Incorporated
Registration Statement on Form S-1
Filed March 31, 2023
File No. 333-271034
Dear Paul A. Romness:
We have reviewed your registration statement and have the following comment. In this
comment, we may ask you to provide us with information so we may better understand your
disclosure.
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 these comments, we may have additional comments.
Registration Statement on Form S-1
Phase 1B Clinical Trial, page 3
1.We note your revised disclosure on page 69 in response to Comment 5. Please revise the
disclosure on page 3 to highlight that no objective tumor response (complete or partial)
was observed in the trial.
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
April 10, 2023 Page 2
FirstName LastName
Paul A. Romness, MPH
OS Therapies Incorporated
April 10, 2023
Page 2
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.
You may contact Christine Torney at 202-551-3652 or Lynn Dicker at 202-551-3616 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Spencer G. Feldman
2023-03-31 - CORRESP - OS Therapies Inc
CORRESP
1
filename1.htm
EMAIL:
SFeldman@olshanlaw.com
DIRECT
DIAL: 212.451.2234
March
31, 2023
VIA
EDGAR AND ELECTRONIC MAIL
U.S.
Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 3628
100 F Street, N.E.
Washington, D.C. 20549
Attn.: Jimmy
McNamara, Esq.
Office
of Life Sciences
Re: OS
Therapies Inc
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted March 14, 2023
CIK No. 0001795091
Ladies
and Gentlemen:
On
behalf of OS Therapies Incorporated, a Delaware corporation (the “Company”), we are hereby filing in electronic format through
EDGAR with the U.S. Securities and Exchange Commission (the “SEC”), pursuant to the Securities Act of 1933, as amended, one
complete copy of the Company’s Registration Statement on Form S-1 (the “Registration Statement”), for the registration
of shares of the Company’s common stock, including one complete copy of the exhibits listed as filed therewith.
The
Registration Statement responds to the comments received from the staff of the SEC in its comment letter dated March 26, 2023 with respect
to the Company’s Amendment No. 2 to Draft Registration Statement on Form S-1 (CIK No. 0001795091) submitted confidentially
to the Division of Corporation Finance by the Company on March 14, 2023, as discussed below.
Courtesy
copies of this letter and the Registration Statement (as marked to reflect changes), together with all exhibits, are being provided by
email directly to the staff for its convenience (attention: Jimmy McNamara) in the review of the foregoing documents.
To
facilitate the staff’s review, the SEC’s comments are reproduced before each of the Company’s responses thereto. All
page numbers referred to in the responses to the staff’s comments correspond to the page numbers of the Registration
Statement.
Amendment
No. 2 to Draft Registration Statement on Form S-1
Cover
Page
1. We
note your response to prior comment 1 and reissue. To the extent that a preliminary prospectus
will be circulated, please disclose on the IPO coverpage a bona fide estimate of the price
range and clarify, as applicable, whether $5.00 represents the mid-point of the price range.
For guidance, refer to Instruction 1(A) to Item 501(b)(3) of Regulation S-K and Compliance
Disclosure Interpretations, Securities Act Forms, Q. 34.04. Alternatively, please tell us
whether you are establishing $5.00 as the actual offering price. If so, your disclosure should
clarify this point rather than referencing an “expected” offering price.
Response:
As noted by the staff, the Company has established $5.00 as the actual offering price per share. Words such as “expected”
and “assumed” as to the offering price have been removed from the Registration Statement.
March 31, 2023
Page 2
Prospectus
Summary
Our
Pipeline of Product Candidates, page 1
2. We
refer to prior comment 9 and reissue in part. Please revise the Pipeline table to remove
the OST-HER-2 Canine Osteosarcoma candidate. In this regard, the Summary pipeline table should
highlight the most significant aspects of your offering, and your disclosures indicate that
you have not conducted any work developing a treatment for canines and that you do not have
plans to commercialize OST-HER-2 for this purpose.
Response:
As requested by the staff, the Company has removed the OST-HER2 canine osteosarcoma candidate from the pipeline table on pages 2 and
68. Additional disclosure on pages 2 and 68 under the pipeline table explains that OST-HER2 is a product candidate for veterinary
use in canines. OST-HER2 holds a conditional license granted by the U.S. Department of Agriculture for treatment of dogs diagnosed
with osteosarcoma that are one year of age or older. Accordingly, as part of the Company’s growth strategies following this
offering, the Company intends to consider potentially out-licensing OST-HER2 to animal health companies for such use in accordance
with applicable regulations. See “Our OS-Focused Clinical Trials and Studies – Preclinical Animal Study” on page 3
and “Our Growth Strategies” on page 5.
3. Please
revise the first column of your pipeline table on pg. 2 and on page 68 so that OST-HER2 and
Folate Receptor Targeted TDC are listed once and not twice in that column.
Response:
As requested by the staff, the first column of the Company’s oncology pipeline table has been revised so that OST-HER2 and Folate
Receptor Targeted TDC are listed once and not twice in that column. See pages 2 and 68.
4. We
note your revised disclosures in response to prior comment 7. To the extent that you highlight
the USDA conditional license on page 1, please revise to clarify whether you hold the conditional
license or whether it is held by the previous licensee of Advaxis. Explain whether the conditional
license permits full commercialization or rather allows administration of the drug in the
context of veterinary drug trials. Also, revise the Business section to include a discussion
of drug development and regulation in the veterinary space and provide specific information
concerning the conditional license including its scope and conditions.
Response:
In response to the staff’s comment, disclosure has been added under “Our OS-Focused Clinical Trials and Studies – Preclinical
Animal Study” on page 4 to (i) clarify that the Company holds the conditional license previously granted to the previous licensee
of ADXS-HER2 because the Company is the current licensee of ADXS-HER2 constructs, our OST-HER2 product candidate, and (ii) explain that
the conditional license allows commercialization but limits the use of OST-HER2 to treat dogs, one year of age and older, diagnosed with
osteosarcoma. Additionally, disclosure has been added to the Business section under “Government Regulation – Animal Health
Products” on page 78 that discusses drug development and regulation in the veterinary space and conditional licensing related to
animal health products.
Business
Our
OS-Focused Clinical Trials and Studies, page 68
5. We
note your revised disclosure concerning the completed Phase Ib clinical trial in response
to prior comments 16 and 17. Please further revise to present the Phase 1b endpoints, the
trial results, and your conclusions with respect to the primary and secondary endpoints/outcome
measures. In this regard, investors should be able to assess how the drug candidate performed
relative to the established endpoints, including whether the reported results were or were
not statistically significant, and also assess your conclusion that “the data presented
from the Phase Ib trial demonstrated that ADXS31-164 was well tolerated.”
Response:
In response to the staff’s comment, disclosure has been added under “Our OS-Focused Clinical Trials and Studies – Phase
Ib Clinical Trial” on page 69 explaining that the results of the Phase Ib trial were primarily intended to describe the safety
and tolerability of ADXS-HER2 (also known as ADXS31-164) and were not intended to contribute to the evaluation of the effectiveness of
ADXS-HER2 for the treatment of patients with a history of HER2 expressing tumors. Overall, the data presented from this Phase Ib trial
demonstrated that ADXS-HER2 IV infusion at the dose of 1×109 CFU appeared to be well tolerated in 12 subjects treated
and evaluable with no evidence of dose-limiting toxicities. No objective responses were observed in this late stage, heavily pre-treated
patient cohort. Accordingly, the recommended Phase II dose of ADXS-HER2 was determined to be 1x109 CFU as it was well tolerated
based on the trial.
March 31, 2023
Page 3
6. We
refer to prior comment 18 and note your revised disclosures concerning your on-going Phase
IIb clinical trial. With a view to disclosure, please tell us whether your present plan calls
for announcement of preliminary or topline data prior to the expected trial completion date
in 2024 and whether any CTCAE Grade 5 (death) treatment emergent results have been observed
to date.
Response:
In response to the staff’s comment, the Company has no present plans for the announcement of preliminary or topline data prior
to the expected trial completion date in 2024 of its ongoing Phase IIb clinical trial. Announcement of any data prior to trial completion
is at the discretion of the independent lead principal investigator of the trial, in consultation with the Data Safety and Monitoring
Committee, which is responsible for monitoring the trial’s progress and ensuring that participant safety is maintained. Further,
no CTCAE Grade 5 (death) treatment emergent results have been observed to date.
Business
Preclinical
development, page 70
7. We
note your response to Comment 16 and your disclosure that the OST31-164 product candidate
for “other solid tumor indications” is currently in preclinical development and
may not require additional preclinical development. Please revise to clarify whether these
disclosures apply to breast, esophageal and/or lung cancers.
Responses:
As requested by the staff, the Company has clarified its disclosure with respect to OST-HER2 (also known as OST31-164) to include that
it applies to breast, esophageal and/or lung cancers. See page 70.
Business
Our
Scientific Collaborations, page 71
8. We
note your response to Comment 19 and re-issue in part. Please describe with specificity the
“aspects of the intellectual property” owned by the University of Pennsylvania.
Response:
As requested by the staff, disclosure has been added under “Our Scientific Collaborations – Scientific Collaborators”
on page 72 describing with specificity that OST-HER2’s compositions and methods of use are covered by three granted U.S. utility
patents and one granted Japanese patent owned by the University of Pennsylvania.
Business
Our
Intellectual Property, page 74
9. We
note your response to Comment 20 and re-issue in part. Please provide the type of patent
(e.g., composition of matter) for the OST-TDC product candidate that is covered by five granted
U.S. patents and two granted foreign patents. Please also specify the jurisdictions for the
two granted foreign patterns.
Response:
As requested by the staff, the Company has included additional information explaining that the OST-TDC product candidate is covered by
five granted U.S. utility patents, one granted Australian patent and one granted Japanese patent. Of these granted patents, one U.S.
utility patent, the Japanese patent and the Australian patent are for methods of use of silicon based drug conjugates, and the other
four U.S. utility patents are for silanol based therapeutic payloads. See pages 36 and 74.
General
10. We
refer to prior comment 24 and the cover art graphics included in the prospectus. Please revise
the text at the bottom to clarify that OST-TDC is in pre-clinical development.
Response:
As requested by the staff, the text at the bottom of the inside front cover page art graphics has been revised to add that the OST-TDC
platform is in pre-clinical development.
*
* *
March 31, 2023
Page 4
The
Company respectfully requests the staff’s review of the Registration Statement to coincide with this timing in order to meet the
Company’s ultimate goal of an April 2023 initial public offering.
Kindly
address any comments or questions that you may have concerning this letter or the enclosed materials to Paul A. Romness, MPH, the Chief
Executive Officer of the Company (tel.: (703) 541-9811), or me (tel.: (212) 451-2234).
Very truly
yours,
/s/
Spencer G. Feldman
Spencer G. Feldman
cc:
Joe McCann, Esq.
Paul A. Romness, MPH
Mr. Keith Moore
Cavas Pavri, Esq.
2023-03-27 - UPLOAD - OS Therapies Inc File: 377-06476
United States securities and exchange commission logo
March 26, 2023
Paul A. Romness, MPH
President and Chief Executive Officer
OS Therapies Incorporated
15825 Shady Grove Road, Suite 135
Rockville, Maryland 20850
Re:OS Therapies Incorporated
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted March 14, 2023
CIK No. 0001795091
Dear Paul A. Romness:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement on Form S-1
Cover Page
1.We note your response to prior comment 1 and reissue. To the extent that a
preliminary prospectus will be circulated, please disclose on the IPO coverpage a bona
fide estimate of the price range and clarify, as applicable, whether $5.00 represents the
mid-point of the price range. For guidance, refer to Instruction 1(A) to Item 501(b)(3) of
Regulation S-K and Compliance Disclosure Interpretations, Securities Act Forms, Q.
134.04. Alternatively, please tell us whether you are establishing $5.00 as the actual
offering price. If so, your disclosure should clarify this point rather than referencing
an "expected" offering price.
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
March 26, 2023 Page 2
FirstName LastName
Paul A. Romness, MPH
OS Therapies Incorporated
March 26, 2023
Page 2
Prospectus Summary
Our Pipeline of Product Candidates, page 1
2.We refer to prior comment 9 and reissue in part. Please revise the Pipeline table to
remove the OST-HER-2 Canine Osteosarcoma candidate. In this regard, the Summary
pipeline table should highlight the most significant aspects of your offering, and your
disclosures indicate that you have not conducted any work developing a treatment for
canines and that you do not have plans to commercialize OST-HER-2 for this purpose.
3.Please revise the first column of your pipeline table on pg. 2 and on page 68 so that OST-
HER2 and Folate Receptor Targeted TDC are listed once and not twice in that column.
4.We note your revised disclosures in response to prior comment 7. To the extent that you
highlight the UDSA conditional license on page 1, please revise to clarify whether you
hold the conditional license or whether it is held by the previous licensee of Advaxis.
Explain whether the conditional license permits full commercialization or rather allows
administration of the drug in the context of veterinary drug trials. Also, revise the
Business section to include a discussion of drug development and regulation in the
veterinary space and provide specific information concerning the conditional license
including its scope and conditions.
Business
Our OS-Focused Clinical Trials and Studies, page 68
5.We note your revised disclosure concerning the completed Phase Ib clinical trial in
response to prior comments 16 and 17. Please further revise to present the Phase 1b
endpoints, the trial results, and your conclusions with respect to the primary and
secondary endpoints/outcome measures. In this regard, investors should be able to assess
how the drug candidate performed relative to the established endpoints, including whether
the reported results were or were not statistically significant, and also assess
your conclusion that "the data presented from the Phase Ib trial demonstrated that
ADXS31-164 was well tolerated."
6.We refer to prior comment 18 and note your revised disclosures concerning your on-going
Phase IIb clinical trial. With a view to disclosure, please tell us whether your present plan
calls for announcement of preliminary or topline data prior to the expected trial
completion date in 2024 and whether any CTCAE Grade 5 (death) treatment emergent
results have been observed to date.
Business
Preclinical development, page 70
7.We note your response to Comment 16 and your disclosure that the OST31-164 product
candidate for “other solid tumor indications” is currently in preclinical development and
may not require additional preclinical development. Please revise to clarify whether these
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
March 26, 2023 Page 3
FirstName LastName
Paul A. Romness, MPH
OS Therapies Incorporated
March 26, 2023
Page 3
disclosures apply to breast, esophageal and/or lung cancers.
Business
Our Scientific Collaborations, page 71
8.We note your response to Comment 19 and re-issue in part. Please describe with
specificity the "aspects of the intellectual property" owned by the University of
Pennsylvania.
Business
Our Intellectual Property, page 74
9.We note your response to Comment 20 and re-issue in part. Please provide the type of
patent (e.g., composition of matter) for the OST-TDC product candidate that is covered by
five granted U.S. patents and two granted foreign patents. Please also specify the
jurisdictions for the two granted foreign patterns.
General
10.We refer to prior comment 24 and the cover art graphics included in the prospectus.
Please revise the text at the bottom to clarify that OST-TDC is in pre-clinical
development.
You may contact Christine Torney at (202) 551-3652 or Lynn Dicker at (202) 551- 3616
if you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at (202) 551-7349 or Joe McCann at (202) 551- 6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Spencer G. Feldman
2023-02-20 - UPLOAD - OS Therapies Inc File: 377-06476
United States securities and exchange commission logo
February 19, 2023
Paul A. Romness, MPH
President and Chief Executive Officer
OS Therapies Incorporated
15825 Shady Grove Road, Suite 135
Rockville, Maryland 20850
Re:OS Therapies Inc
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted January 20, 2023
CIK No. 0001795091
Dear Paul A. Romness:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Cover page
1.We note your reference to an expected price. Please confirm that in a future amendment
you will disclose the actual price to the public or, as applicable, include a bona fide
estimate of the price range.
2.Please revise the second paragraph of the Public Offering Prospectus cover page to
disclose the conversion price applicable to the convertible promissory notes. Please also
revise the cover page of the Resale Prospectus, where appropriate, to include this same
information.
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
February 19, 2023 Page 2
FirstName LastName
Paul A. Romness, MPH
OS Therapies Incorporated
February 19, 2023
Page 2
3.With reference to page Alt-4 of the Resale Prospectus, please revise the cover of the
Public Offering Prospectus to highlight that the selling stockholders have represented to
you that they will not offer or sell shares prior to the closing of the primary offering. Also,
revise the third paragraph of the cover page to the Resale Prospectus so that it is consistent
with the representations disclosed on page Alt-4. In this regard, the Resale Prospectus
cover page appears to indicate that the selling stockholders could commence offers and
sales prior to the IPO closing.
About This Prospectus, page ii
4.Please tell us the authority on which you rely to qualify your disclosure by reference to
actual documents as you do in the second paragraph on this page.
Prospectus Summary, page 1
5.Please revise to disclose industry terms at first use. As examples and without limitation,
we refer to the following terms:
•Tunable,
•Antibody drug conjugate,
•Minimal residual disease, and
•exatecan-silanols.
6.We note your disclosure that the ADC technology is "(y)our proprietary" technology.
Please tell us, and revise your disclosure on page 61, to clarify whether the BlinkBio
license is an exclusive license without restrictions as to fields of use.
7.We refer to your disclosure on page 2 concerning the canine Osteosarcoma "Phase 1"
trial. Please tell us your basis for presenting this veterinary trial as a "Phase I" trial. Cite
to relevant USDA or other applicable regulatory guidance. Additionally, please revise to
clarify that this trial constitutes preclinical work as it relates to your development of
OST31-164 to treat Osteosarcoma in humans.
8.We note your disclosure on Page 2 and elsewhere that OST31-164 was awarded rare
pediatric disease designation, fast track designation, and orphan drug status which “may
allow for a speedier review process.” Please revise your disclosure to clarify that such
designations do not convey any advantage in, or shorten the duration of, the regulatory
review or approval process. In this regard, we note your risk factor disclosure on page 18
that a Fast Track Designation by the FDA may not actually lead to a faster development or
regulatory review or approval process.
9.In reference to your Pipeline table on page 2, please address the following:
•Please revise to remove the OST-HER-2 Canine Osteosarcoma candidate from the
table. In this regard, your prospectus does not describe any plans to commercialize a
veterinary product candidate.
•The bar for OST-HER-2 (Human Osteosarcoma) extends to the end of the Phase II
column, which suggests that that you have completed this phase. Shorten this bar to
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
February 19, 2023 Page 3
FirstName LastNamePaul A. Romness, MPH
OS Therapies Incorporated
February 19, 2023
Page 3
reflect that you are still conducting a Phase IIb clinical trial.
•Please tell us whether any preclinical work must be conducted prior to submission of
IND applications for the third, fourth and fifth candidates reflected in the table. If so,
then revise to shorten the bar for each such candidate.
•Delete the “Novel TDC Programs” for which you have not identified any indication.
10.We refer to your disclosure on page 1 highlighting that your OST-TDC platform can
"carry various types of payloads, and features tunable pH sensitive silicone linkers."
Given your disclosure on page 2 indicating that the OST-TDC platform remains in
preclinical development, it appears premature for you to make these performance claims.
Please revise or advise.
Summary Financial Data, page 10
11.It appears that some of the numbers in the Statement of Operations Data are presented in
thousands while others, for example, net loss available to common shareholders, are
presented as whole numbers. Please revise to present all items with the Statement of
Operations Data on the same basis.
In light of the large population of patients with Osteosarcoma who reside in foreign countries...,
page 23
12.Please revise the first sentence of the risk factor to clarify whether you are addressing
incidence or prevalence. In light of the global figure you present, please revise the risk
factor heading which references a "large" patient population. Please note that we would
not object to a reference to a "larger" patient population.
Paul A. Romness, MPH, and our other executive officers, directors and their affiliates will
continue to exercise significant influence..., page 43
13.We note that the other executive officers and directors, excluding Paul A. Romness,
beneficially own approximately 5% of your outstanding shares. Please reconcile this
disclosure with the beneficial ownership table on page 87, which provides an estimate of
approximately 8%, or otherwise advise.
Cautionary Note..., page 47
14.Please revise to remove references Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 given that these provisions do not
apply in the context of initial public offerings.
Use of Proceeds, page 48
15.We refer to the final sentence of the third paragraph and note that your disclosure on page
64 indicates that you plan to finish the Phase IIb trial in late 2024. With a view to revised
disclosure here and elsewhere, please tell us whether you plan to conduct a Phase III trial
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
February 19, 2023 Page 4
FirstName LastNamePaul A. Romness, MPH
OS Therapies Incorporated
February 19, 2023
Page 4
and, if applicable, the expected duration and costs of such a trial. Also, tell us the
timeframe necessary for preparing and submitting an NDA.
Pipeline of Our Product Candidates, page 64
16.Your Business section does not describe the preclinical work that has been conducted to
date for any of the candidates highlighted in your Oncology Pipeline table. Please revise
to present the results of all material preclinical work so that investors can understand why
you are pursuing these candidates. In particular, please provide detailed disclosure
concerning the OST31-164 canine study that you prominently highlight in the Summary.
In this regards, it is unclear what basis there is to claim “significant improvements” in
overall survival and metastatic disease progression. To the extent that you have not
conducted preclinical work to date for a given candidate, please clarify this status.
17.Please revise the Business section and Summary, where appropriate, to clarify whether
you, Advaxis or another party conducted Phase 1 and/or Phase IIa clinical trials for
OST31-164 in humans. If so, please revise the Business section to provide a detailed
description of the trial or trials, including trial protocols, the number of patients, primary
and secondary endpoints, and any serious adverse effects reported. Disclose who
conducted the trials, where they were conducted, and when.
18.With respect to the ongoing OST31-164 Phase IIb trial, please revise to present the trial
protocols, including the number of patients as well as primary and secondary endpoints.
Disclose where the trial is conducted. In terms of status, disclose whether enrollment
remains ongoing.
Our Scientific Collaborators, page 67
19.We note your disclosure regarding the use of proprietary technology developed at the
University of Pennsylvania under the guidance of Robert G. Petit, your Chief Scientific
& Medical Officer. Please clarify the rights and ownership of this proprietary technology,
including any rights or ownership of the University of Pennsylvania.
Our Intellectual Property, page 69
20.We note your disclosure here and elsewhere regarding “numerous” pending foreign
applications for OST31-164 and OST-TDC. Please specify the number of pending foreign
patent applications, the types of patents (e.g., composition of matter, method, or use), the
applicable jurisdictions, and dates of expiration for each application.
Management
Executive Officers, page 77
21.We note your disclosure that Christopher P. Acevedo is a part time employee. We also
note your disclosure on page 85 that you are contemplating entering into a consulting
agreement with him to continue as your Chief Financial Officer for no specified term.
FirstName LastNamePaul A. Romness, MPH
Comapany NameOS Therapies Incorporated
February 19, 2023 Page 5
FirstName LastName
Paul A. Romness, MPH
OS Therapies Incorporated
February 19, 2023
Page 5
Please revise to include risk factor disclosure concerning Mr. Acevedo's part-time status
and the number of hours of service hours per month he is expected to provide. Please also
revise throughout the prospectus to clarify whether Mr. Avecedo is an Interim Chief
Financial Officer. In this regard, we note that Mr. Avecedo is disclosed as your Chief
Financial Officer in the prospectus summary, but is identified as an Interim Chief
Financial Officer on page 77.
Executive Compensation, page 84
22.Please file the employment agreements for Paul A. Romness, Christopher P. Acevedo,
Robert G. Petit, and Jutta Wanner as exhibits pursuant to Item 601(b)(10) of Regulation S-
K. In this regard, we note your disclosure on page 40 that you have entered into
employment letter agreements with your executive officers.
General
23.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
24.Please provide us with a copy of your cover graphics. For guidance, please refer to
Compliance Disclosure Interpretations, Securities Act Forms, Question 101.02.
You may contact Christine Torney at (202) 551-3652 or Lynn Dicker at (202) 551-
3616 if you have questions regarding comments on the financial statements and related
matters. Please contact Jimmy McNamara at (202) 551-7349 or Joe McCann at (202) 551-
6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Spencer G. Feldman