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Shuttle Pharmaceuticals Holdings, Inc.
Response Received
2 company response(s)
Medium - date proximity
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Shuttle Pharmaceuticals Holdings, Inc.
Response Received
3 company response(s)
High - file number match
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Shuttle Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
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Shuttle Pharmaceuticals Holdings, Inc.
Response Received
2 company response(s)
High - file number match
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↓
Shuttle Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
↓
Shuttle Pharmaceuticals Holdings, Inc.
Response Received
3 company response(s)
High - file number match
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Shuttle Pharmaceuticals Holdings, Inc.
Response Received
3 company response(s)
High - file number match
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Company responded
2023-01-30
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-08-31
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2022-06-15
Shuttle Pharmaceuticals Holdings, Inc.
Summary
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↓
Company responded
2022-06-23
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
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Company responded
2022-07-12
Shuttle Pharmaceuticals Holdings, Inc.
Summary
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Company responded
2022-08-23
Shuttle Pharmaceuticals Holdings, Inc.
Summary
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Company responded
2022-08-25
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-08-23
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-06-29
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-05-16
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
↓
Company responded
2022-06-03
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Shuttle Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-03-18
Shuttle Pharmaceuticals Holdings, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-13 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-02-13 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-01-29 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-01-20 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-01-16 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-291628 | Read Filing View |
| 2025-12-29 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-12-15 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-291628 | Read Filing View |
| 2025-08-08 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-289231 | Read Filing View |
| 2025-03-06 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-03-06 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-02-19 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-284889 | Read Filing View |
| 2025-01-21 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-01-21 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-284286 | Read Filing View |
| 2024-10-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-18 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-04 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-282231 | Read Filing View |
| 2023-01-30 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-27 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-27 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-31 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-07-12 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-29 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-23 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-15 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-03 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-05-16 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-03-18 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-16 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-291628 | Read Filing View |
| 2025-12-15 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-291628 | Read Filing View |
| 2025-08-08 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-289231 | Read Filing View |
| 2025-02-19 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-284889 | Read Filing View |
| 2025-01-21 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-284286 | Read Filing View |
| 2024-10-04 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | 333-282231 | Read Filing View |
| 2023-01-27 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-31 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-29 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-15 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-05-16 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-03-18 | SEC Comment Letter | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-13 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-02-13 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-01-29 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-01-20 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-12-29 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-03-06 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-03-06 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2025-01-21 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-10-18 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-30 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-27 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-01-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-25 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-07-12 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-23 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2022-06-03 | Company Response | Shuttle Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
2026-02-13 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm E.F. Hutton & Co. 745 Fifth Avenue, 34th Floor & PH New York, NY 10151 February 13, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Shuttle Pharmaceuticals Holdings, Inc. Registration Statement on Form S-1 File No. 333-293363 REQUEST FOR ACCELERATION OF EFFECTIVENESS Requested Date: Tuesday, February 17, 2026 Requested Time: 4:30 p.m., Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the "Securities Act"), we, the undersigned, as the sole placement agent for the proposed public offering on a best-efforts basis of securities of Shuttle Pharmaceuticals Holdings, Inc. (the "Company"), hereby join the Company's request that the effective date of the above-referenced Registration Statement on Form S-1, as amended, be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on Tuesday, February 17, 2026, or as soon thereafter as possible. Pursuant to Rule 460 under the Securities Act, please be advised that we will distribute as many copies of the proposed form of preliminary prospectus as it 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 the requirements of Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended. Very truly yours, E.F. HUTTON & CO. By: /s/ Duncan B. Swanston Name: Duncan B. Swanston Title: Supervisory Principal
2026-02-13 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm Shuttle Pharmaceuticals Holdings, Inc. 401 Professional Drive, Suite 260 Gaithersburg, MD 20879 February 13, 2026 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Shuttle Pharmaceuticals Holdings, Inc. (CIK: 0001757499) Registration Statement No. 333-293363 on Form S-1 (the "Registration Statement") Ladies and Gentlemen: Shuttle Pharmaceuticals Holdings, Inc. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended, so that it may become effective on February 17, 2026, at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant respectfully requests that it be notified of such effectiveness by a telephone call to Aaron Schleicher, Esq. of Sullivan & Worcester LLP at (212) 660-3034 and that such effectiveness also be confirmed in writing. Very truly yours, Shuttle Pharmaceuticals Holdings, Inc. By: /s/ Christopher Cooper Name: Christopher Cooper Title: Interim Chief Executive Officer
2026-01-29 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm Shuttle Pharmaceuticals Holdings, Inc. 401 Professional Drive, Suite 260 Gaithersburg, MD 20879 January 29, 2026 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Shuttle Pharmaceuticals Holdings, Inc. (CIK: 0001757499) Registration Statement No. 333-291628 on Form S-1 (the "Registration Statement") Ladies and Gentlemen: Shuttle Pharmaceuticals Holdings, Inc. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended, so that it may become effective on January 30, 2026, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant respectfully requests that it be notified of such effectiveness by a telephone call to Aaron Schleicher, Esq. of Sullivan & Worcester LLP at (212) 660-3034 and that such effectiveness also be confirmed in writing. Very truly yours, Shuttle Pharmaceuticals Holdings, Inc. By: /s/ Christopher Cooper Name: Christopher Cooper Title: Interim Chief Executive Officer
2026-01-20 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Shuttle
Pharmaceuticals Holdings, Inc.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
January
20, 2026
Via
EDGAR
Alan
Campbell and Laura Crotty
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Securities
and Exchange Commission
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
December 11, 2025
File
No. 333-291628
Ladies
and Gentlemen:
This
correspondence responds to the letter, dated January 16, 2026, received from the staff of the Securities and Exchange Commission (the
" Staff ") regarding the above-mentioned Amendment No. 1 to the Registration Statement on Form S-1 filed on December
11, 2025 (" Amendment No. 1 ") by Shuttle Pharmaceuticals Holdings, Inc. (the " Company ", " we ",
" us " or " our ") and our response letter, dated December 29, 2025 (the "Response"). For
convenience, the Staff's comment is restated below in bold text, with the comment followed by our response.
General
1.
We
note your response to our prior comment. Please provide us with the following information:
●
Tell us how you will account for the acquisition.
Response:
The Company respectfully acknowledges the Staff's comment and confirms the Company will account for the acquisition as an asset
acquisition. The Company reached this conclusion considering that substantially all of the fair value of the gross assets acquired
is concentrated in the intellectual property comprising the Molecule.ai platform. Further, the Company considered whether the acquired
assets meet the definition of a "business" in accordance with ASC 805-10-55-4. That is, whether the Company acquired
inputs, processes and outputs. While the intellectual property assets meet the definition of inputs, the Company acquired no processes
nor did the Company acquire an organized workforce having the necessary skills and experience following rules and conventions capable
of being applied to inputs to create outputs. Therefore, the Company concluded that it did not acquire a business, and the acquisition
was an asset acquisition.
●
Your
disclosure says that you acquired substantially all of the assets and liabilities of Molecule.ai. Please confirm whether you acquired
the legal entity of Molecule.ai.
Response:
The Company acknowledges the Staff's comment and confirms that it did not acquire the legal entity of Molecule.ai.
●
Please confirm whether the software platform you acquired
was ready to use upon acquisition
Response:
The Company acknowledges the Staff's comment and confirms that, although the software platform did have "technical feasibility"
at the time of acquisition, it still required substantial development for the Company's intended purpose and, therefore, was
not ready for use upon purchase. Specifically, since the acquisition, the Company has developed, and expects to
continue to develop, new models that support more therapeutic development tasks such as drug-target interaction, and an agentic framework
that can automatically perform complex therapeutic development workflow. These developments are required to bring the product to
market.
●
Please describe any arrangements you have with Zhitian (Andy)
Zhang to provide post-acquisition services to your company
Response:
The Company acknowledges the Staff's comment and confirms that it has entered into a consulting agreement with Mr. Zhang, pursuant
to which he has agreed to provide services to the Company "for the continued development, maintenance and expansion of the
Molecule.ai [s]oftware." Specifically, these services include: (i) developing new features to the platform including drug-target
interactions and gene-disease negotiations, (ii) developing an autonomous AI agent for drug discovery, (iii) providing agentic AI-driven
iterative experiment design, (iv) making improvements on model accuracy, robustness, explainability and compliance with scientific
and regulatory standards, (v) routine monitoring and debugging services, and (vi) such other support services reasonably required
by the Company. The initial term of the agreement is 12 months, and automatically renews for successive 12-month periods unless earlier
terminated. In consideration for his services, the Company has agreed to pay a company wholly-owned by Mr. Zhang a sum of $12,000
per month in arrears.
●
Please provide an estimate of the additional development costs you expect to be incurred on the software
platform post-acquisition compared to the costs incurred prior to acquisition.
Response: The Company acknowledges the Staff's comment and currently estimates that it will incur an additional $185,000 in additional post-acquisition development costs for the activities further described in the preceding comment response and bring the product to market. Pre-acquisition development costs were de minimis, as relevant activity was substantially platform development by Mr. Zhang, for which no compensation was paid.
We
hope the foregoing has been responsive to your comments. If you have any questions or comments regarding the foregoing, please contact
Aaron Schleicher, Esq. at (212) 660-3034 or aschleicher@sullivanlaw.com.
Very
truly yours,
/s/
Christopher Cooper
Christopher
Cooper
Interim
Chief Executive Officer
Shuttle
Pharmaceuticals Holdings, Inc.
cc:
David
E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron
M. Schleicher, Esq., Sullivan & Worcester LLP
2026-01-16 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-291628
January 16, 2026
Christopher Cooper
Interim Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
401 Professional Drive, Suite 260
Gaithersburg, MD 20879
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Response dated December 29, 2025
File No. 333-291628
Dear Christopher Cooper:
We have reviewed your December 29, 2025 response to our comment letter and have
the following comment. If you do not believe our comment applies to your facts and
circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Response dated December 29, 2025
General
1.We note your response to our prior comment. Please provide us with the following
information:
•Tell us how you will account for the acquisition.
•Your disclosure says that you acquired substantially all of the assets and liabilities
of Molecule.ai. Please confirm whether you acquired the legal entity of
Molecule.ai.
•Please confirm whether the software platform you acquired was ready to use upon
acquisition.
•Please describe any arrangements you have with Zhitian (Andy) Zhang to provide
post-acquisition services to your company.
•Please provide an estimate of the additional development costs you expect to be
incurred on the software platform post-acquisition compared to the costs incurred
prior to acquisition.
January 16, 2026
Page 2
Please contact Alan Campbell at 202-551-4224 or Laura Crotty at 202-551-7614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Aaron M. Schleicher, Esq.
2025-12-29 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Shuttle
Pharmaceuticals Holdings, Inc.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
December
29, 2025
Via
EDGAR
Alan
Campbell and Laura Crotty
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Securities
and Exchange Commission
Washington,
D.C. 20549
Re:
Shuttle Pharmaceuticals Holdings, Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
December 11, 2025
File
No. 333-291628
Ladies
and Gentlemen:
This
correspondence responds to the letter, dated December 15, 2025, received from the staff of the Securities and Exchange Commission (the
" Staff ") regarding the above-mentioned Amendment No. 1 to the Registration Statement on Form S-1 filed on December
11, 2025 (" Amendment No. 1 ") by Shuttle Pharmaceuticals Holdings, Inc. (the " Company ", " we ",
" us " or " our "). For convenience, the Staff's comment is restated below in bold text, with
the comment followed by our response.
Amendment
No. 1 to Registration Statement on Form S-1
Cover
Page
1.
We
note your disclosure in your registration statement and in your Form 8-K filed November 26, 2025, incorporated by reference into
the registration statement, indicating that a wholly owned subsidiary of your company acquired substantially all of the assets and
liabilities of Molecule.ai and that you plan to discontinue clinical trials of your lead product candidate. We further note the consideration
payable by your company consisted of a one-time cash contribution of $3M, a first installment contribution equal to $3M, a second
installment contribution equal to $2M and two contingent contributions. Please revise to include acquired company financial statements
for Molecule.ai, including pro forma financial statements. Alternatively, please tell us why these financial statements are not required.
Refer to Rule 11-01(d) of Regulation S-X.
Response:
The Company acknowledges the Staff's comment and respectfully advises the Staff that we have concluded that no such financial
statements are required. In determining whether the acquisition of substantially all of the assets and liabilities of Molecule.ai should
be treated as an acquisition of a business, the Company considered the guidance in Rule 11-01(d) of Regulation S-X, which indicates that
the acquisition should be evaluated in light of the facts and circumstances involved and whether there is sufficient continuity of the
acquired entity's operations prior to and after the transactions such that disclosure of prior financial information is material
to an understanding of future operations. Among the facts and circumstances the Company considered were the following: (1) whether the
acquired assets and liabilities of Molecule.ai had any revenue-producing activity or other operations or (2) whether the acquired assets
and liabilities of Molecule.ai had any of the following attributes: (i) physical facilities, (ii) employee base, (iii) market distribution
system, (iv) sales force, (v) customer base, (vi) operating rights, (vii) production techniques or (viii) trade names.
Pursuant
to the Asset Purchase Agreement (the " Asset Purchase Agreement ") between the Company, 1563868 B.C. Ltd., a Canadian
limited corporation and the Company's wholly owned subsidiary, 1542770 BC Ltd., a Canadian limited corporation, and Zhitian (Andy)
Zhang (the " Consultant "), an individual residing in Vancouver, Canada, the Company acquired Molecule.ai's software
platform designed to accelerate drug discovery through AI powered molecular intelligence. Prior to the acquisition, the acquired software
did not have any revenue-producing activities, and no customer base existed. In addition, the Company did not assume any liabilities
pursuant to the Asset Purchase Agreement, nor did the Company acquire any physical facilities, employee base (other than the services
of a single consultant, as described in the Asset Purchase Agreement), market distribution system, sales force, operating rights, production
techniques or trade names. Accordingly, given the lack of operations associated with the acquired software, the Company affirms that
disclosure of prior financial information would not be material to an understanding of future operations. For this reason, historical
financial information of the acquired assets is not required.
We
hope the foregoing has been responsive to your comments. If you have any questions or comments regarding the foregoing, please contact
Aaron Schleicher, Esq. at (212) 660-3034 or aschleicher@sullivanlaw.com.
Very
truly yours,
/s/
Christopher Cooper
Christopher
Cooper
Interim
Chief Executive Officer and Chief Financial Officer
Shuttle
Pharmaceuticals Holdings, Inc.
cc:
David
E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron
M. Schleicher, Esq., Sullivan & Worcester LLP
2025-12-15 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-291628
December 15, 2025
Christopher Cooper
Interim Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
401 Professional Drive, Suite 260
Gaithersburg, MD 20879
Re:Shuttle Pharmaceuticals Holdings, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed December 11, 2025
File No. 333-291628
Dear Christopher Cooper:
We have conducted a limited review of your registration statement and have the
following comment.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
General
1.We note your disclosure in your registration statement and in your Form 8-K filed
November 26, 2025, incorporated by reference into the registration
statement, indicating that a wholly owned subsidiary of your company acquired
substantially all of the assets and liabilities of Molecule.ai and that you plan to
discontinue clinical trials of your lead product candidate. We further note the
consideration payable by your company consisted of a one-time cash contribution of
$3M, a first installment contribution equal to $3M, a second installment contribution
equal to $2M and two contingent contributions. Please revise to include acquired
company financial statements for Molecule.ai, including pro forma financial
statements. Alternatively, please tell us why these financial statements are not
required. Refer to Rule 11-01(d) of Regulation S-X.
December 15, 2025
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.
Please contact Alan Campbell at 202-551-4224 or Laura Crotty at 202-551-7614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Aaron M. Schleicher, Esq.
2025-08-08 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm SHUTTLE PHARMACEUTICALS HOLDINGS, INC. 401 Professional Drive, Suite 260 Gaithersburg, MD 20879 August 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Trade & Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Tyler Howes Re: Shuttle Pharmaceuticals Holdings, Inc. Registration Statement on Form S-1 Filed August 5, 2025 File No. 333-289231 Dear Mr. Howes, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the "Act"), Shuttle Pharmaceuticals Holdings, Inc. (the "Company") respectfully requests that the Securities and Exchange Commission accelerate the effectiveness of the above-referenced Registration Statement on Form S-1 (the "Registration Statement") and declare such Registration Statement effective at 4:30 p.m., Eastern Standard Time, on Monday, August 11, 2025, or as soon thereafter as practicable. It would be appreciated if, as soon as the Registration Statement is declared effective, you would so inform Jeff Cahlon, Esq. of Sichenzia Ross Ference Carmel at 212-930-9700. * * * * Very Truly Yours, Shuttle Pharmaceuticals Holdings, Inc. /s/ Christopher Cooper Christopher Cooper Chief Executive Officer cc: Jeff Cahlon, Esq.
2025-08-08 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-289231
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 8, 2025 Christopher Cooper Interim Chief Executive Officer Shuttle Pharmaceuticals Holdings, Inc. 401 Professional Drive, Suite 260 Gaithersburg, MD 20879 Re: Shuttle Pharmaceuticals Holdings, Inc. Registration Statement on Form S-1 Filed August 5, 2025 File No. 333-289231 Dear Christopher Cooper: 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 Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jeff Cahlon, Esq. </TEXT> </DOCUMENT>
2025-03-06 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
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WestPark
Capital, Inc.
1800
Century Park East, Suite 220
Los
Angeles, CA 90067
March
6, 2025
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
File
No. 333-284889
Acceleration
Request
Requested
Date:
Friday,
March 7, 2025
Requested
Time:
4:30
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities Act”), WestPark
Capital, Inc., as representative of the underwriters of the offering, hereby joins the request of Shuttle Pharmaceuticals Holdings, Inc.
that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it may become effective at
4:30 p.m., Eastern Time, on Friday, March 7, 2025, or as soon thereafter as practicable.
Pursuant
to Rule 60 of the General Rules and Regulations under the Securities Act, please be advised that there will be distributed to each underwriter
or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary
prospectus 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.
WESTPARK
CAPITAL, INC.
Very
truly yours,
By:
/s/
Jason Stern
Name:
Jason
Stern
Title:
Chief
Operating Officer
2025-03-06 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
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SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(240)
430-4212
March
6, 2025
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
File
No. 333-284889
Acceleration
Request
Requested
Date:
Friday,
March 7, 2025
Requested
Time:
4:30
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its registration statement on Form S-1 (File No. 333-284889) so that it may become
effective at 4:30 p.m. Eastern Time on Friday, March 7, 2025, or at such time as the Registrant may request by telephone to the staff
of the Securities and Exchange Commission. In addition, the Registrant hereby authorizes Megan J. Penick, Esq. of Dorsey & Whitney
LLP, counsel for the Registrant, to make such request on the Registrant’s behalf.
Very
truly yours,
Shuttle
Pharmaceuticals Holdings, Inc.
By:
/s/
Anatoly Dritschilo
Name:
Anatoly
Dritschilo
Title:
Chief
Executive Officer and
Chairman
of the Board of Directors
2025-02-19 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-284889
February 19, 2025
Anatoly Dritschilo, M.D.
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
401 Professional Drive, Suite 260
Gaithersburg, MD 20879
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed February 13, 2025
File No. 333-284889
Dear Anatoly Dritschilo M.D.:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick, Esq.
2025-01-21 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
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SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(240)
430-4212
January
21, 2025
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
File
No. 333-284286
Acceleration
Request
Requested
Date:
Thursday,
January 23, 2025
Requested
Time:
5:00
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its registration statement on Form S-1 (File No. 333-284286) so that it may become
effective at 5:00 p.m. Eastern Time on Thursday, January 23, 2025, or at such time as the Registrant may request by telephone to the
staff (the “Staff”) of the Securities and Exchange Commission. In addition, the Registrant hereby authorizes Megan J. Penick,
Esq. of Dorsey & Whitney LLP, counsel for the Registrant, to make such request on the Registrant’s behalf.
Very
truly yours,
Shuttle
Pharmaceuticals Holdings, Inc.
By:
/s/
Anatoly Dritschilo
Name:
Anatoly
Dritschilo
Title:
Chief
Executive Officer and
Chairman
of the Board of Directors
2025-01-21 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-284286
January 21, 2025
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
401 Professional Drive, Suite 260
Gaithersburg, MD 20879
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed January 15, 2025
File No. 333-284286
Dear Anatoly Dritschilo:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick, Esq.
2024-10-25 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
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SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(240)
430-4212
October
25, 2024
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-282231
Acceleration
Request
Requested
Date:
Tuesday,
October 29, 2024
Requested
Time:
5:00
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its registration statement on Form S-1 (File No. 333-282231) so that it may become
effective at 5:00 p.m. Eastern Time on Tuesday, October 29, 2024, or at such time as the Registrant may request by telephone to the staff
(the “Staff”) of the Securities and Exchange Commission. In addition, the Registrant hereby authorizes Megan J. Penick, Esq.
of Dorsey & Whitney LLP, counsel for the Registrant, to make such request on the Registrant’s behalf.
Very
truly yours,
Shuttle
Pharmaceuticals Holdings, Inc.
/s/
Anatoly Dritschilo
Name:
Anatoly
Dritschilo
Title:
Chief
Executive Officer and
Chairman
of the Board of Directors
2024-10-25 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
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A.G.P.
/ Alliance Global Partners
590
Madison Ave., 28th Floor
New
York, NY 10022
October
25, 2024
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1, as amended
File
No: 333-282231
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners
as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it
will become effective at 5:00pm Eastern Time on October 29, 2024 or as soon thereafter as practicable.
Very
truly yours,
A.G.P
/ Alliance Global Partners
By:
/s/
Thomas J. Higgins
Name:
Thomas
J. Higgins
Title:
Managing
Director
2024-10-18 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
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Shuttle
Pharmaceuticals Holdings, Inc.
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
October
18, 2024
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Ms. Jessica Dickerson
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
Filed
September 20, 2024
File
No. 333-282231
Ladies
and Gentlemen:
On
behalf of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company” or “Shuttle”),
we are hereby transmitting the Company’s response to the comment letter it received from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) on October 4, 2024, regarding the Registration
Statement on Form S-1, as filed with the Commission on September 20, 2024 (the “Registration Statement”).
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
response. Simultaneously with the transmission of this letter, the Company is submitting via EDGAR an Amendment No. 1 to the Registration
Statement, responding to the Staff’s comments and including certain other revisions and updates.
Registration
Statement on Form S-1
General
1.
Please revise your registration statement as appropriate to provide clear and consistent disclosure of the nature and amount of securities
being registered. In this regard, it appears that you are registering units, with each unit consisting of (i) a share of common stock
plus a common warrant or (ii) for security holders who would exceed 4.99% beneficial ownership, a pre-funded warrant plus a common warrant.
It further appears that, in addition to the units, you are registering the shares of common stock issuable upon exercise of the pre-funded
warrants and the common warrants. However, the foregoing is not clear in the heading at the top of your prospectus cover page and is
not addressed until the fourth paragraph of the prospectus cover page. Your revised disclosures, including the heading at the top of
your prospectus cover page, should prominently and clearly identify the types of securities, and the number of each type of security,
you are registering. Your revised disclosures should also clearly disclose the offering price per unit. Refer to Items 501(b)(2) and
(3) of Regulation S-K. In addition to your revisions on the prospectus cover page, please similarly revise your disclosures in “The
Offering,” “Description of Securities We are Offering,” and “Plan of Distribution” sections beginning on
pages 12, 95, and 97, respectively, as appropriate.
Response:
The Company respectfully advises the Staff that it has revised the registration statement to clarify the amount and type
of securities the Company is registering and offering thereunder to ensure the disclosure is consistent throughout the registration
statement. The Company further disclosed the offering price of each share of common stock, or pre-funded warrant, and warrant it
is offering on the cover page and throughout Amendment No. 1.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s filing of Amendment No. 1 to its Registration
Statement on Form S-1 with the Commission on October 18, 2024. Should you have any questions or concerns, kindly contact our counsel,
Megan J. Penick, Esq. of Dorsey & Whitney LLP by telephone at (212) 415-9200.
Sincerely,
/s/
Anatoly Dritschilo
Anatoly
Dritschilo, M.D.
Chief
Executive Officer
Shuttle
Pharmaceuticals Holdings, Inc.
2024-10-04 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc. File: 333-282231
October 4, 2024
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
401 Professional Drive, Suite 260
Gaithersburg, MD 20879
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed September 20, 2024
File No. 333-282231
Dear Anatoly Dritschilo:
We have conducted a limited review of your registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe 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
General
Please revise your registration statement as appropriate to provide clear and consistent
disclosure of the nature and amount of securities being registered. In this regard, it
appears that you are registering units, with each unit consisting of (i) a share of common
stock plus a common warrant or (ii) for security holders who would exceed 4.99%
beneficial ownership, a pre-funded warrant plus a common warrant. It further appears
that, in addition to the units, you are registering the shares of common stock issuable upon
exercise of the pre-funded warrants and the common warrants. However, the foregoing is
not clear in the heading at the top of your prospectus cover page and is not addressed until
the fourth paragraph of the prospectus cover page. Your revised disclosures, including the
heading at the top of your prospectus cover page, should prominently and clearly identify
the types of securities, and the number of each type of security, you are registering. Your
revised disclosures should also clearly disclose the offering price per unit. Refer to Items 1.
October 4, 2024
Page 2
501(b)(2) and (3) of Regulation S-K. In addition to your revisions on the prospectus cover
page, please similarly revise your disclosures in "The Offering," "Description of
Securities We are Offering," and "Plan of Distribution" sections beginning on pages 12,
95, and 97, respectively, as appropriate.
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 Jessica Dickerson at 202-551-8013 or Joshua Gorsky at 202-551-7836
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick, Esq.
2023-01-30 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
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January
30, 2023
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Daniel
Crawford
Re:
Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
File No. 333-269414
Acceleration
Request
Requested Date:
February 1, 2023
Requested Time:
9:00 AM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-269414), as amended (the “Registration
Statement”), so that it may become effective at 9:00 a.m. Eastern Daylight Time on Friday, February 1, 2023, or as soon as practicable
thereafter.
The
Registrant hereby acknowledges that:
(i)
should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare
the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;
(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and
(iii)
the Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
We
request that we be notified of such effectiveness by telephone call to our counsel, Megan J. Penick, of Michelman & Robinson, LLP,
at 646-320-4104.
Very truly yours,
SHUTTLE PHARMACEUTICALS
HOLDINGS, INC.
By:
/s/
Anatoly Dritschilo
Anatoly Dritschilo, M.D.
Chief Executive Officer
cc:
Megan J. Penick, Esq.,
Michelman & Robinson, LLP
2023-01-27 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
January
27, 2023
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Daniel
Crawford
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1 (File No. 333-269414)
Withdraw
of Acceleration Request
Dear
Mr. Crawford:
Reference
is made to our letter, filed as correspondence via EDGAR on January 25, 2023, in which the registrant, Shuttle Pharmaceuticals Holdings,
Inc., a Delaware corporation (the “Company”), requested the acceleration of the effective date of the above referenced
Registration Statement on Form S-1 (the “Registration Statement”) for 5 pm Eastern Time on Friday, January
27, 2023, or as soon thereafter as reasonably practicable (the “Effective Time”), in accordance with Rule 460 and
461 under the Securities Act of 1933, as amended.
The
Company is no longer requesting that such Registration Statement be declared effective at the Effective Time and we hereby formally withdraw
our request for acceleration of the effective date until further notice from the Company.
Very
truly yours,
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
By:
/s/
Anatoly Dritschilo
Anatoly
Dritschilo, M.D.
Chief
Executive Officer
cc: Megan J. Penick,
Esq.,
Michelman & Robinson,
LLP
2023-01-27 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
January 27, 2023
Anatoly Dritschilo, M.D.
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, Maryland 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed January 25, 2023
File No. 333-269414
Dear Anatoly Dritschilo:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan J. Penick, Esq.
2023-01-25 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
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January
25, 2023
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Conlon Danberg
Re:
Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
CIK No. 0001757499
File No. 333-269414
Acceleration
Request
Requested Date:
January 27, 2023
Requested Time:
5:00 PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-269414) (the “Registration
Statement”) so that it may become effective at 5:00 p.m. Eastern Daylight Time on Friday, January 27, 2023, or as soon as practicable
thereafter.
The
Registrant hereby acknowledges that:
(i)
should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare
the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;
(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and
(iii)
the Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
We
request that we be notified of such effectiveness by telephone call to our counsel, Megan J. Penick, of Michelman & Robinson,
LLP, at 212-659-2568.
Very truly yours,
SHUTTLE PHARMACEUTICALS HOLDINGS, INC.
By:
/s/ Anatoly Dritschilo
Anatoly Dritschilo, M.D.
Chief Executive Officer
cc:
Megan J. Penick, Esq.,
Michelman
& Robinson, LLP
2022-08-31 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
October 11, 2019
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Draft Registration Statement on Form S-1
Submitted September 16, 2019
CIK No. 0001757499
Dear Dr. Dritschilo:
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.
Draft Registration Statement on Form S-1
Cover Page
1.We note your statement in footnote (4) that this registration statement also covers under a
separate prospectus the resale of shares of common stock issuable upon conversion of
Series A Preferred Stock and issuable upon exercise of warrants. However, there does not
appear to be a separate prospectus relating to these shares. Please revise or advise. Please
also identify the selling stockholders and the number of shares being offered for resale by
each in the table on page 89.
2.On the prospectus cover page please state clearly that this is a minimum-maximum
offering, disclose any minimum purchase requirements, if applicable, and any
arrangements to place the funds in escrow, trust, or similar account. Refer to Item
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
October 11, 2019 Page 2
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
October 11, 2019
Page 2
501(b)(8)(ii)-(iii) of Regulation S-K. To the extent the offering will be a firm commitment
underwritten offering, please revise the cover page and throughout accordingly.
3.Please revise to clarify whether the selling shareholders intend to sell their shares at the
same price the company is selling shares.
Prospectus Summary, page 1
4.Please revise throughout to remove any inference regarding the safety and efficacy of
your product candidates. Given that the determination of a product's safety and efficacy
is solely within the FDA's authority and your product candidates have not yet
completed clinical trials, these inferences are not appropriate. We note by way of
example statements that "[t]hese data are interpreted as demonstrating safety for use of
IPdR in humans for efficacy testing in clinical trials in combination with RT" on page 3;
and disclosure regarding "[e]vidence of efficacy from Phase II clinical trials" on page 6.
5.Please revise the summary to disclose that your subsidiary, Shuttle Pharmaceuticals, Inc.,
conducted a min-max initial public offering in 2017 but did not meet the minimum and
therefore terminated the offering without selling any shares.
6.Given your early stage of development, please revise the second paragraph on page 3 to
remove any implication that you hope or expect to receive FDA approval by a particular
date.
Implications of Being an Emerging Growth Company, page 9
7.Please 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.
The Offering, page 11
8.Please explain the reference to your officers and directors relying on Rule 3a4-1 in
offering the shares on your behalf. This is inconsistent with the disclosure elsewhere that
you will engage an underwriter.
Use of Proceeds, page 41
9.We note your disclosure that you intend to use the proceeds of this offering to further the
development of your ropidoxuridine and doranidazole product candidates. Please specify
how far in the development of each of the listed clinical trials you expect to reach with the
proceeds of the offering. If any material amounts of other funds are necessary to
accomplish the specified purposes, state the amounts and sources of other funds needed
for each specified purpose and the sources. Refer to Instruction 3 to Item 504 of
Regulation S-K.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
October 11, 2019 Page 3
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
October 11, 2019
Page 3
Dilution, page 43
10.Please disclose dilution to current shareholders if 28%, 50%, 75% and 100% of the
offering is sold.
Business
DORANIDAZOLE, page 61
11.Please disclose the aggregate milestone payments and royalty rates (or royalty range) to be
paid under the Pola License Agreement.
Doranidazole, page 68
12.Based on the pipeline on page 51, it appears that doranidazole is currently in Phase I
clinical trials. However, the second table on page 68 shows the trial for doranidazole in
Phase 3 and states as follows: "1st Phase 3 study completed." Please revise for
consistency or advise.
Executive Compensation
Summary Compensation Table, page 87
13.Please revise the last column in the summary compensation table to reflect the total
amounts paid to your named executive officers.
Description of Capital Stock, page 92
14.We note that your forum selection provision in your certificate of incorporation identifies
the Court of Chancery of the State of Delaware as the exclusive forum for certain
litigation, including any “derivative action.” Please disclose whether this provision applies
to actions arising under the Securities Act or Exchange Act. In that regard, we note that
Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought
to enforce any duty or liability created by the Exchange Act or the rules and regulations
thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all suits brought to enforce any duty or liability created by the
Securities Act or the rules and regulations thereunder. If the provision applies to Securities
Act claims, please also revise your prospectus to state that there is uncertainty as to
whether a court would enforce such provision and that investors cannot waive compliance
with the federal securities laws and the rules and regulations thereunder. If this provision
does not apply to actions arising under the Securities Act or Exchange Act, please also
ensure that the exclusive forum provision in the governing documents states this clearly,
or tell us how you will inform investors in future filings that the provision does not apply
to any actions arising under the Securities Act or Exchange Act. Please also reconcile this
forum selection provision with the provision in your bylaws which designates the federal
district court for the District of Delaware if no state court in Delaware has jurisdiction.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
October 11, 2019 Page 4
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
October 11, 2019
Page 4
Underwriting, page 95
15.We note your disclosure on page 96 that the "underwriters agreed to purchase all of the
shares offered by this prospectus ... if any are purchased." We also note disclosure on
page 11 that this offering is "being conducted on a 'best efforts' basis." Please revise here
and throughout the prospectus for consistency or advise.
16.We note your references to the escrow agreement on page 11. Please describe the
material terms of the agreement. In addition, please clarify, if true, that to the extent the
offering is terminated without satisfying the minimum offering contingency, escrowed
funds will be promptly returned to investors.
Report of Independent Registered Public Accounting Firm, page F-2
17.While you provide 2017 and 2018 financial statements for Shuttle Pharmaceutical
Holdings, Inc., the audit report for Shuttle Pharmaceutical Holdings, Inc. only covers the
fiscal year ended December 31, 2018. Please provide an audit report for Shuttle
Pharmaceutical Holdings, Inc. that covers the fiscal year ended December 31, 2017.
Note 1 – Organization and Basis of Presentation
Basis of Presentation, page F-9
18.You state on pages F-8 and F-9 that the “company,” initially formed as Shuttle
Pharmaceuticals, LLC, became Shuttle Pharmaceuticals, Inc. in 2016, and changed its
name to Shuttle Pharmaceuticals Holdings, Inc. in 2018. On page 54, you state that
Shuttle Pharmaceuticals, LLP became Shuttle Pharmaceuticals, Inc. in 2017. You further
state that Shuttle Pharma Acquisition Corp. changed its name to Shuttle Pharmaceuticals
Holdings, Inc. after acquiring Shuttle Pharmaceuticals Inc., in 2018. Please resolve the
discrepancies between these disclosures and clearly describe the basis for the financial
statements that are presented.
Recapitalization, page F-9
19.Please revise to describe the purpose of the recapitalization involving the company and
Shuttle Pharma Acquisition Corp. and your accounting for the transaction. Tell us
whether this transaction involved entities under common control.
Note 3 – Summary of Significant Accounting Policies
Research and Development Expenses, page F-10
20.Please revise to describe the conditions for receiving contract awards resulting in negative
R&D expenses recognized in certain periods.
Fair Value of Financial Instruments, page F-12
21.You state on page F-17 that you issued 3,600,000 shares of common stock for cash of $36
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
October 11, 2019 Page 5
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
October 11, 2019
Page 5
or at $0.01 per share. Please tell us how you considered this issuance in your 2018
valuation of common stock at $10.26 per share.
Part II
Item 15. Recent Sales of Unregistered Securities, page II-1
22.We note your reference to "the following transactions" in this section, but there are no
transactions listed. Please revise.
Item 17. Undertakings, page II-2
23.Please revise the undertakings language in section 1(b) to match the language set forth in
Item 512(a)(1)(ii) of Regulation S-K. In addition, include the undertaking required by
Item 512(a)(6) of Regulation S-K or advise.
Signatures, page II-3
24.Please revise your signatures section to comply with Form S-1 requirements.
Exhibits
25.Please revise your exhibit list and file a list of your subsidiaries as an exhibit to your
registration statement. Refer to Item 601 of Regulation S-K. In addition, revise the
exhibit list to add the underwriting agreement referenced on page 95.
26.We note your references to strategic agreements with Brown University, University of
Virginia, George Washington University and Propagenix, Inc. If these agreements are
material, please file them as exhibits to your registration statement and describe their
material terms in the business section.
General
27.Please revise to include the dealer prospectus delivery obligation. Refer to Item 502(b) of
Regulation S-K.
You may contact Keira Nakada at (202) 51-3659 or Sharon Blume, Accounting Branch
Chief, at (202) 551-3474 if you have questions regarding comments on the financial statements
and related matters. Please contact Tonya K. Aldave at (202) 551-3601 or Justin Dobbie, Legal
Branch Chief, at (202) 551-3469 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.
2022-08-25 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
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August
25, 2022
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Jordan
Nimitz
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
File
No. 333-265429
Acceleration
Request
Requested
Date:
August
29, 2022
Requested
Time:
4:00
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Shuttle Pharmaceuticals Holdings, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-265429) (the “Registration
Statement”) so that it may become effective at 4:00 p.m. Eastern Daylight Time on Monday, August 29, 2022, or at such time
as the Registrant may request by telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”).
In addition, the Registrant hereby authorizes Megan J. Penick, Esq. of Michelman & Robinson, LLP, counsel for the Registrant, to
make such request on the Registrant’s behalf.
The
Registrant hereby acknowledges that:
(i)
should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does
not foreclose the Commission from taking any action with respect to the Registration Statement;
(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the
Registration Statement; and
(iii)
the Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration
Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Very truly yours,
SHUTTLE PHARMACEUTICALS HOLDINGS, INC.
By:
/s/
Anatoly Dritschilo
Anatoly
Dritschilo, M.D.
Chief
Executive Officer
cc:
Megan J. Penick, Esq.,
Michelman
& Robinson, LLP
2022-08-23 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
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Shuttle
Pharmaceuticals Holdings, Inc.
One
Research Court, Suite 450
Rockville,
MD 20850
August
23, 2022
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Ms. Jordan Nimitz
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Amendment
No. 3 to Registration Statement on Form S-1
Filed
on August 19, 2022
File
No. 333-265429
Ladies
and Gentlemen:
On
behalf of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company” or “Shuttle”),
we are hereby transmitting the Company’s response to the comment letter it received from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) on August 23, 2022, regarding the Amendment
No. 3 to the Registration Statement on Form S-1 (the “Registration Statement”), as filed with the Commission
on August 19, 2022 (the “2022 Filing”). Also, in addition to addressing the Staff’s comments in the Registration
Statement, we have modified the Registration Statement to adjust the pricing of the offering in the primary prospectus to $8.00 per unit,
for the sale of a total of 1,245,000 units, with each unit consisting of one share of common stock, par value $0.00001 per share, and
one warrant to purchase one share of common stock, at an exercise price of $0.01 per share.
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
response.
Amendment
No. 3 to Form S-1 Filed August 19, 2022
Pre-IPO
Bridge Financing, page 8
1.
Please provide an analysis supporting your conclusion that the August 2022 offering qualified for the 506(b) safe harbor. Your analysis
should address the fact that you had a registration statement on file at the time of the offering.
On August 1, 2022, as the Company
required additional bridge funds pending the closing of its initial public offering (“IPO”), for which a registration statement
was already on file with the SEC, Shuttle Pharmaceuticals closed on a private placement of $125,000 in units consisting of (1) a 10%
promissory note, payable within 12 months of the issuance date, and (2) warrants to purchase common stock, exercisable at $2.50 per share
or 50% of the IPO per share purchase price (the “August 2022 Private Placement”). The August 2022 Private Placement was conducted
pursuant to Rule 506(b) of the Securities Act of 1933, as amended (the “Securities Act”), as it was made to three accredited
investors, including two who were previously known by Boustead Securities, LLC, our placement agent (“Boustead”), and Joy
Dritschilo, the wife of Shuttle’s chairman and CEO and one of our major shareholders. Further, the August 2022 Private Placement
was conducted pursuant to the terms of a private placement memorandum, including a subscription agreement, which was provided
to all three accredited investors and pursuant to which each investor made the representation that they “received no representation
or warranty from the Company or any of its officers, directors, employees or agents in respect of [their] investment in the Company and
[they] have received no information (written or otherwise) from [those directors, employees or agents] relating to the Company or its
business other than as set forth in the Offering Documents.” [In such case “Offering Documents” was defined as those
documents set forth in the private placement memorandum distributed to each of the August 2022 Private Placement investors.] As such,
the Company in no way relied on its registration statement on Form S-1 as a means of solicitation of the investors and the terms of the
offering and the type of securities sold in the offering were different from those being sold in the IPO.
Rule
152(a) of the Securities Act provides a safe harbor from integration where “offers and sales will not be integrated if, based on
particular facts and circumstances, the issuer can establish that each offering either complies with the registration requirements of
the Act, or that an exemption from registration is available for the particular offering.” Further, Rule 152(a) states that “[i]n
making this determination … the issuer must have a reasonable belief, based on facts and circumstances, with respect to each purchaser
in the exempt offering prohibiting general solicitation, that the issuer (or any person acting on the issuer’s behalf) either:
(i) Did not solicit such purchaser through the use of general solicitation; or (ii) Established a substantive relationship with such
purchaser prior to the commencement of the exempt offering prohibiting general solicitation.”
Here,
the August 2022 Private Placement was made to three accredited investors who had substantive pre-existing relationships with either the
issuer or the placement agent. In addition, the August 2022 Private Placement was marketed using a separate private placement memorandum,
in accordance with Rule 506(b), and not using the Company’s filed registration statement on Form S-1. As such, neither the Company
nor Boustead solicited purchasers using general solicitation or relying on the registration statement filed with the SEC. As a result,
the Company is entitled to rely on the safe harbor provided by Rule 506(b), in accordance with the exception from integration provided
under Rule 152(a).
2.
Please expand your disclosure to include the exercise prices of the warrants issued to Boustead Securities in each transaction.
We
have updated the disclosure under the section entitled “Pre-IPO Bridge Financing” to include the exercise prices of the warrants
issued to Boustead Securities in each transaction.
Underwriting
Discount, page 92
3.
We note your statement that you completed a $125,000 unit private placement offering to three accredited investors on August 1, 2022,
but you state on page 94 that the offering was made to two investors. Please revise to address the inconsistency.
We
have revised the disclosure to indicate that the August 2022 Private Placement was made to three accredited investors.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s filing of Amendment No. 4 to its Registration
Statement on Form S-1 with the SEC on August 23, 2022. We respectfully request that you provide us with any additional comments on or
before August 24, 2022. Should you have any questions or concerns, kindly contact our counsel, Megan J. Penick, Esq. or Stephen Weiss,
Esq. of Michelman & Robinson, LLP, by telephone at (646) 320-4104 or (917) 797-0015, respectively.
Sincerely,
/s/ Anatoly
Dritschilo
Anatoly Dritschilo, M.D.
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
2022-08-23 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
August 23, 2022
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Amendment No. 3 to Registration Statement on Form S-1
Filed on August 19, 2022
File No. 333-265429
Dear Dr. Dritschilo:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 3 to Registration Statement on Form S-1 filed August 19, 2022
Pre-IPO Bridge Financing, page 8
1.Please provide an analysis supporting your conclusion that the August 2022 offering
qualified for the 506(b) safe harbor. Your analysis should address the fact that you had a
registration statement on file at the time of the offering.
2.Please expand your disclosure to include the exercise prices of the warrants issued to
Boustead Securities in each transaction.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
August 23, 2022 Page 2
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
August 23, 2022
Page 2
Underwriting Discount, page 92
3.We note your statement that you completed a $125,000 unit private placement offering to
three accredited investors on August 1, 2022, but you state on page 94 that the offering
was made to two investors. Please revise to address the inconsistency.
You may contact Tracie Mariner at 202-551-3744 or Kevin Kuhar at 202-551-3662 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jordan Nimitz at 202-551-5831 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.
2022-07-12 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
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Shuttle
Pharmaceuticals Holdings, Inc.
One
Research Court, Suite 450
Rockville,
MD 20850
July
12, 2022
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Ms. Jordan Nimitz
Re:
Shuttle Pharmaceuticals
Holdings, Inc.
Registration Statement
on Form S-1
Filed on June 3, 2022
File No. 333-265429
Ladies
and Gentlemen:
On
behalf of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company” or “Shuttle”),
we are hereby transmitting the Company’s response to the comment letter it received from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) on June 29, 2022, regarding the Registration
Statement on Form S-1 (the “Registration Statement”), as filed with the Commission on June 23, 2022.
Also, in addition to addressing the Staff’s comments in the Registration Statement, we have modified the Registration Statement
to include both a primary offering prospectus (through which we are seeking to register 2,500,000 shares of the Company’s
common stock) and a resale prospectus (through which we are seeking to register 1,250,000 shares of common stock held by certain selling
stockholders of the Company). Aside from changing the formatting to include the separate resale prospectus and removing the selling
stockholders from the primary prospectus, we have not made any other substantive modifications to the Registration Statement.
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
response.
Form
S-1 Filed June 23, 2022
Summary
Financial Information, page 12
1.
We note the revisions made in response to prior comment 2. Please also re-label your summary financial information for the year ended
December 31, 2021 as restated.
We
have re-labeled the summary financial information in the Company’s Amendment No. 2 to the Registration Statement. See page 12.
Exhibits
2.
Please have BF Borgers CPA PC provide an updated consent that is currently dated with the filing date of the next amendment. We note
that this date will be different than the audit opinion date.
We
have added an updated consent by BF Borgers CPA PC, dated July 12, 2022, to the Company’s Amendment No. 2 to the Registration
Statement.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s filing of Amendment No. 2 to its Registration
Statement on Form S-1 with the SEC on July 12, 2022. We respectfully request that you provide us with any additional comments on or
before July 15, 2022. Should you have any questions or concerns, kindly contact our counsel, Megan J. Penick, Esq. or Stephen Weiss,
Esq. of Michelman & Robinson, LLP, by telephone at (646) 320-4104 or (917) 797-0015, respectively.
Sincerely,
/s/
Anatoly Dritschilo
Anatoly
Dritschilo, M.D.
Chief
Executive Officer
Shuttle
Pharmaceuticals Holdings, Inc.
2022-06-29 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
June 29, 2022
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed on June 23, 2022
File No. 333-265429
Dear Dr. Dritschilo:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our June 15, 2022 letter.
Amendment No. 1 to Form S-1 filed June 23, 2022
Summary Financial Information, page 12
1.We note the revisions made in response to prior comment 2. Please also re-label your
summary financial information for the year ended December 31, 2021 as restated.
Exhibits
2.Please have BF Borgers CPA PC provide an updated consent that is currently dated with
the filing date of the next amendment. We note that this date will be different than the
audit opinion date.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
June 29, 2022 Page 2
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
June 29, 2022
Page 2
You may contact Tracie Mariner at 202-551-3744 or Kevin Kuhar at 202-551-3662 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jordan Nimitz at 202-551-5831 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.
2022-06-23 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Shuttle
Pharmaceuticals Holdings, Inc.
One
Research Court, Suite 450
Rockville,
MD 20850
June
23, 2022
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Ms. Jordan Nimitz
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-1
Filed
on June 3, 2022
File
No. 333-265429
Ladies
and Gentlemen:
On
behalf of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company” or “Shuttle”),
we are hereby transmitting the Company’s response to the comment letter it received from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) on June 15, 2022, regarding the Registration
Statement on Form S-1 (the “Registration Statement”), as filed confidentially to the Commission on June 3,
2022 (the “2022 Filing”).
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
response.
Form
S-1 Filed June 3, 2022
Market
Opportunity, Page 6
1.
We note your response to comment 5. Please remove the references to indications that you are not currently developing candidates to address.
If you have no current plans to develop candidates to treat such indications, they are not part of your current market opportunity.
Although
we intend to develop our drug candidates for treatment for all of the cited areas in the future, we have removed the areas that are not
currently being tested from page 6 of the registration statement.
Related
Party Transactions, page 84
2.
We note the revisions made to your financial statements in response to our prior comment 14. Tell us how you considered the guidance
in ASC 250-10-20 (definition in glossary) and ASC 250-10-45-22 to 45-24 as well as SAB Topic 1:M in concluding that the changes should
not be reported as an error in previously issued financial statements. Otherwise, revise to comply with that guidance by providing all
the information required by ASC 250-10-50-7, label the appropriate columns of the financial statements as “Restated” and
have your auditor revise its report to reference the restatement consistent with paragraph 18e. of PCAOB Auditing Standard 3101.
We
have revised the financial statements by relabeling the appropriate columns “Restated” and our auditor has revised its report
to reference the restatement consistent with paragraph 18e. of PCAOB Auditing Standard 3101.
Exhibits
3.
Please provide searchable copies of all of your exhibits. We refer you to Rules 301 and 304 of Regulation S-T.
We
have updated the exhibits to make all of the exhibits searchable.
4.
We note that the forum selection provision in your Amended and Restated Certificate of Incorporation identifies the Court of Chancery
of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose
in your Risk Factors whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note
that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for
federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations
thereunder. If the provision applies to Securities Act claims, please also revise your prospectus to state that there is uncertainty
as to whether a court would enforce such provision and that investors cannot waive compliance with the federal securities laws and the
rules and regulations thereunder. If this provision does not apply to actions arising under the Securities Act or Exchange Act, please
also ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors
in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act.
We
have amended Article VII, Section 7.2 of the Company’s Amended and Restated Certificate of Incorporation to specifically exclude
actions arising under the Securities Act or Exchange Act from the exclusive forum selection provision. Such certificate of amendment
to our Amended and Restated Certificate of Incorporation is filed as Exhibit 3.5 to the registration statement. In addition, we have
revised the registration statement to add in an additional risk factor at page 38.
5.
Please revise the legality opinion filed as Exhibit 5.1 to state that the shares will be legally issued, fully paid and non-assessable
when sold in accordance with the registration statement. Refer to Section II.B.2.h of Staff Legal Bulletin No. 19. Please note that Item
601 of Regulation S-K expressly provides for short form opinion with respect to a tax opinion, but does not provide for a short form
legal opinion.
Exhibit
5.1 has been updated to clearly state that the shares will be legally issued, fully paid and non-assessable when sold in accordance with
the registration statement.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s confidential filing of its Registration
Statement on Form S-1 with the SEC on June 3, 2022. We respectfully request that you provide us with any additional comments on or before
June 27, 2022. Should you have any questions or concerns, kindly contact our counsel, Megan J. Penick, Esq. or Stephen Weiss, Esq. of
Michelman & Robinson, LLP, by telephone at (646) 320-4104 or (917) 797-0015, respectively.
Sincerely,
/s/ Anatoly
Dritschilo
Anatoly
Dritschilo, M.D.
Chief
Executive Officer
Shuttle
Pharmaceuticals Holdings, Inc.
2022-06-15 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
June 15, 2022
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed on June 3, 2022
File No. 333-265429
Dear Dr. Dritschilo:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-1 Filed June 3, 2022
Market Opportunity, page 6
1.We note your response to comment 5. Please remove the references to indications that
you are not currently developing candidates to address. If you have no current plans to
develop candidates to treat such indications, they are not part of your current market
opportunity.
Related Party Transactions, page 84
2.We note the revisions made to your financial statements in response to our prior comment
14. Tell us how you considered the guidance in ASC 250-10-20 (definition in glossary)
and ASC 250-10-45-22 to 45-24 as well as SAB Topic 1:M in concluding that the changes
should not be reported as an error in previously issued financial statements. Otherwise,
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
June 15, 2022 Page 2
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
June 15, 2022
Page 2
revise to comply with that guidance by providing all the information required by ASC
250-10-50-7, label the appropriate columns of the financial statements as "Restated" and
have your auditor revise its report to reference the restatement consistent with paragraph
18e. of PCAOB Auditing Standard 3101.
Exhibits
3.Please provide searchable copies of all of your exhibits. We refer you to Rules 301 and
304 of Regulation S-T.
4.We note that the forum selection provision in your Amended and Restated Certificate of
Incorporation identifies the Court of Chancery of the State of Delaware as the exclusive
forum for certain litigation, including any “derivative action.” Please disclose in your Risk
Factors whether this provision applies to actions arising under the Securities Act or
Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder, and Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state courts over all suits
brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please also revise
your prospectus to state that there is uncertainty as to whether a court would enforce such
provision and that investors cannot waive compliance with the federal securities laws and
the rules and regulations thereunder. If this provision does not apply to actions arising
under the Securities Act or Exchange Act, please also ensure that the exclusive forum
provision in the governing documents states this clearly, or tell us how you will inform
investors in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
5.Please revise the legality opinion filed as Exhibit 5.1 to state that the shares will be legally
issued, fully paid and non-assessable when sold in accordance with the registration
statement. Refer to Section II.B.2.h of Staff Legal Bulletin No. 19. Please note that Item
601 of Regulation S-K expressly provides for short form opinion with respect to a tax
opinion, but does not provide for a short form legal opinion.
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 Tracie Mariner at 202-551-3744 or Kevin Kuhar at 202-551-3662 if
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
June 15, 2022 Page 3
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
June 15, 2022
Page 3
you have questions regarding comments on the financial statements and related matters. Please
contact Jordan Nimitz at 202-551-5831 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.
2022-06-03 - CORRESP - Shuttle Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Shuttle
Pharmaceuticals Holdings, Inc.
One
Research Court, Suite 450
Rockville,
MD 20850
June
3, 2022
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Ms. Jordan Nimitz
Re:
Shuttle
Pharmaceuticals Holdings, Inc.
Amendment
to the Draft Registration Statement on Form S-1
Submitted
April 26, 2022
CIK
No. 0001757499
Ladies
and Gentlemen:
On
behalf of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company” or “Shuttle”),
we are hereby transmitting the Company’s response to the comment letter it received from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) on May 16, 2022, regarding the Draft Registration
Statement on Form S-1 (the “Registration Statement”), as submitted confidentially to the Commission on April
26, 2022 (the “2022 Filing”).
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
responses.
Amendment
No. 1 to Draft Registration Statement Submitted April 26, 2022
Prospectus
Summary, page 1
1.
We
note your statements on pages 6 and 51 that you intend to “[c]apitalize on [y]our first mover advantage of having potentially
the first-in-class drug approved as a radiation sensitizer” and your disclosure that Cetuximab has been approved by the FDA
as a radiation sensitizer. Please remove your references to your first mover advantage, and potentially first in class product. In
addition to being overly speculative given your product candidates’ early stage of development, the statement appears to imply
that Ropidoxuridine has the potential to be the first radiation sensitizer. Additionally, delete your belief that Ropidoxuridine
has the capability to become a well tolerated sensitizer that could displace currently used drugs for radiation sensitization. The
statement is overly speculative and appears to assume that your candidate is more effective than other products.
We
have updated the disclosure to provide more information on Cetuximab and have removed all references to first-in-class or first mover
statements. See pages 6 and 51.
1
As
further explanation, Cetuximab is not a small molecule
radiation sensitizer. The following statement about Cetuximab offers insight on why Cetuximab is not used much and why an orally available
small molecule radiation sensitizer is desirable: Cetuximab is a recombinant monoclonal antibody that binds to epidermal growth factor
receptor (EGFR) and inhibits the binding of epidermal growth factor (EGF). Cetuximab is administered via intravenous infusion and is
used as monotherapy or in combination with other chemotherapies or radiation therapy. In clinical trials, cetuximab was associated with
serious and fatal infusion reactions, cardiopulmonary arrest or sudden death, and serious dermatologic toxicities, toxicities that have
limited enthusiasm for its use as a radiation sensitizer.
2.
We
note your revisions in response to our prior comment 6. Please delete your statement plans to rapidly develop Ropidoxuridine and
HDAC inhibitor (SP-2-225) and clearly state that it may be several years before you are able to file an application for an NDA with
the FDA. Similarly revise pages 48 and 51.
We
have updated the disclosure to delete the “rapidly develop” statement and have added a statement that it may take years to
file an NDA application.
3.
We
note your response to our prior comment 8 and reissue. It is inappropriate for you to state or imply that your product candidates
are effective or are likely to be found effective. You may present clinical trial end points and objective data results from your
clinical trials without concluding that the product candidate was effective or had an impact on the observed results. Please revise
or remove these and similar statements/inferences throughout your prospectus:
●
Any
statements that your research has “demonstrated”, “shown”, “suggests” a certain effect or safety,
such as , “these data are interpreted as demonstrating safety of IPdR with RT in humans”, and “[p]reclinical models
suggest that selective HDAC6 inhibitors may lead to effective therapy.”
●
Any
statements that imply or conclude that your products cause a certain effect, such as “Preliminary data using radiation therapy
in combination with IUdR suggests that the combination may offer delay and disease progression of up to 6 months” and “efficacy
. . . has been observed following treatment of sarcomas by the combination of IUdR and RT.”
●
Any
characteristics of clinical results or data as “favorable” or having “potential” for certain effects, such
as “we have data suggesting these drugs also have potential immune regulatory properties.”
We
have modified the suggestive or interpreted sentences throughout the registration statement to delete adjectives implying anticipated
or suggested favorable interpretation as summarized above. We have retained the data supported statements in the amended document.
4.
Please
revise the graphic at the bottom of page 2 to use a term other than “expected outcome,” such as trial endpoint. It currently
appears that you maybe predicting the outcome of the trial.
We
have edited the Overview of Radiation Sensitizer Development graphic to remove the expected outcome heading on page 2.
Market
Opportunity, page 6
5.
We
have reviewed your revisions in response to our prior comment 6. Please tell us how you arrived at the Estimated RT Cases estimates
and disclose any material assumptions and limitations associated with these estimates. Please also explain why you have presented
the market opportunity related to indications for which you are not currently developing target candidates, such as liver and esophageal
cancers.
Based
on the mechanism of action, Ropidoxuridine is metabolized to IUdR and IUdR is incorporated into DNA for radiation sensitization. Therefore,
growing cells in all cancers that undergo radiation therapy are candidates for radiation sensitization by Ropidoxuridine.
2
The
proportion of patients in each cancer type that present with RT indications is based on published data from the following publication:
Delaney G, Jacob S, Featherstone C, Barton M., “The role of radiotherapy in cancer treatment: estimating optimal utilization from
a review of evidence-based clinical guidelines,” Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.
The
number of cases by disease site for 2021 in the U.S. was estimated from data in the ACS Facts & Figures publication. The estimated
RT cases were determined by multiplying the number of cases by the fraction optimally receiving RT for each disease site. The Table legend
on page 6 has been amended to provide clarification. All listed disease sites disclosed in the registration statement offer
potential market opportunities for sensitization.
Our
Development Strategy, page 6
6.
We
note your response to our prior comment 12. Please clarify here that Temodar is a drug that has shown some activity in treating brain
tumors.
Adding
Temozolamide to RT improved survival of patients treated for glioblastoma by four months. Most clinicians see this as a small improvement.
van Genugten JA, Leffers P, Baumert BG, Tjon-A-Fat H, Twijnstra A. Effectiveness of temozolomide for primary glioblastoma multiforme
in routine clinical practice. J Neurooncol. 2010 Jan;96(2):249-57. doi: 10.1007/s11060-009-9956-7. Epub 2009 Jul 7. PMID: 19582373; PMCID:
PMC2808536.
We
have amended the sentence to note this four-month improved survival. See page 57.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 43
7.
We
note your response to prior comment 2. As previously requested, please expand your disclosure to include the costs incurred during
each period presented for each of your key research and development products/projects. If you do not track your research and development
costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project.
The Company has expanded on
costs by project, including a table detailing the breakdown of the costs per project, noting that the NIH funded projects are reimbursed
on a fixed price basis. Therefore, all research and development costs not reimbursed by the NIH are funded by the Company. See pages
44 and 45.
8.
Please
expand your disclosure, under this heading, to provide a qualitative and quantitative discussion and analysis of the changes in your
general and administrative expenses from the prior period in accordance with Item 303(b) of Regulation S-K.
We
have expanded the disclosures under Management’s Discussion and Analysis to include a paragraph addressing general and administrative
expenses, including a discussion of such changes from the prior period. See pages 44 and 45.
Business
Our Pipeline, page 49
3
9.
We
note your response to our prior comment 15. Since you are currently conducting a Phase 1b/2 trial it continues to appear that you have
not completed all required Phase 1 trials and therefore it is inappropriate to portray that you have completed Phase 1 testing. Please
revise your pipeline table accordingly. Alternatively, explain the basis for your belief that a Phase 1b/2 trial was not required for
development of Ropidoxuridine for brain tumors and sarcomas and that you could have relied on the phase 1 trial relating to advanced
GI cancers and proceeded to a Phase 2 trial.
Since
the Phase I clinical trial has been completed and published, and the maximum tolerated dose (MTD) has been established at 1200
mg per day for 28 days, the trial we are proposing here has been updated to properly refer to it as a Phase II clinical
trial. Referring to it as a Phase II clinical trial is appropriate considering we have completed the Phase I clinical trial. We
have incorporated this clarification of the terminology into the current document.
10.
We
note your revisions in response to our prior comment 17 and reissue. Given the limited amount of disclosure related to these programs,
please explain why these programs are sufficiently material to your business to warrant inclusion in your pipeline table. If they are
material, please expand your disclosure in your Business section to provide a more fulsome discussion of these, including:
●
the
nature, objective, and current status of each project, and the intended market for the products;
●
steps
necessary to complete each project, including a description of preclinical studies and clinical validation and what you must demonstrate
in order to receive FDA approval; and
●
the
extent and nature of additional resources that need to be obtained if current liquidity is not expected to be sufficient to complete
the development of each product candidate.
Please
also expand your “Government Regulation and Product Approval” to describe the applicable regulations related to these types
of products.
We
have removed the ancillary projects from the pipeline figure because the capital to be raised via this IPO is not intended or sufficient
to fund those projects. This IPO capital raise will not raise funds for the commercialization of the health disparities project or the
predictive biomarker project. Going forward, our plan is to continue our research on those projects solely through NIH funding.
As Shuttle Pharma has a proven record of success in competing for government funded contracts from the NIH SBIR program and intends
to apply for future, non-dilutive NIH SBIR phase IIb funding for these projects, we are disclosing these projects in the Registration
Statement.
Shuttle
Pharma is not seeking FDA approval of the prostate cancer cell cultures.
Shuttle
Pharma has completed the analytical validation of the candidate predictive biomarker and will seek NIH SBIR Phase IIb funding to perform
the clinical validation.
Radiation
Therapy, page 52
11.
You
indicate on page 52 and in your table on page 62 that Cetuximab is being used off label for its radiation sensitizing properties.
However, you indicate on pages 6 and 51 that it has been approved by the FDA as a radiation sensitizer. Please explain the discrepancy.
Cetuximab
is a recombinant monoclonal antibody that binds to epidermal growth factor receptor (EGFR) and inhibits the binding of epidermal growth
factor (EGF) to inhibit cell growth. It has FDA approval as a radiation sensitizer. We have corrected the errors on pages 52 and 62.
4
Principal
and Selling Stockholders, page 83
12.
Please
revise footnote 9 to clarify whether Steven Bayern has control over shares held by Bayern Capital and disclose Steven Bayern’s
role as a consultant for the company. See
Item
507 of Regulation S-K.
Steven
Bayern controls the shares held by Bayern Capital
and serves as a business development consultant to Shuttle Pharma. This ownership and control has been reflected in footnote 9 to the
principal and selling stockholders table.
Related
Party Transactions, page 83
13.
We
note your revisions in response to our prior comment 23. Please identify the “spouse of an officer of the Company” and
the officer in the June 21, 2021 transaction.
We
have identified the spouse as Mrs. Dritschilo and the officer of the company as Dr. Dritschilo.
14.
We
note your disclosure stating that, on September 22, 2021, Mrs. Dritschilo, who is one of your major shareholders, transferred 210,000
shares of Company common stock to Steven Bayern, who was performing certain consulting services for the Company. Please expand your disclosure
to clarify the reason the shares were transferred to Bayern, tell us how you accounted for this transaction in your financial statements,
and confirm that your financial statements reflect all the costs of doing business including all expenses paid by shareholders on behalf
of the Company. Refer to SAB Topic 1:B, SAB Topic 5:T and ASC 220-10-S99-4.
Mrs.
Dritschilo sold 210,000 shares (105,000 shares post-split) of Shuttle Pharma common stock to Mr. Bayern in a private transaction. As
Steve Bayern was serving as a consultant to the Company at the time of the transfer, however, we have included disclosure of the
issuance in the Company’s financial statements, even though the sale and transfer was a private transaction. We have updated the
financial statements to show a one-time transaction cost of $420,000 to account for the value of the consulting services and transfer
of shares valued at $4.00 per share. This update accounts for all the costs of doing business during this trial period leading up to
the 2022 monthly consulting fee agreement. See page 84.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s Registration Statement on Form S-1. We
respectfully request that you provide us with any additional comments on or before June 10, 2022. Should you have any questions
or concerns, kindly contact our counsel, Megan J. Penick, Esq. or Stephen Weiss, Esq. of Michelman & Robinson, LLP, by telephone
at (646) 320-4104 or (917) 797-0015, respectively.
Sincerely,
/s/
Anatoly Dritschilo
Anatoly Dritschilo, M.D.
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
5
2022-05-16 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
May 16, 2022
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Amendment to Draft Registration Statement on Form S-1
Submitted April 26, 2022
CIK No. 0001757499
Dear Dr. Dritschilo:
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 to Draft Registration Statement Submitted April 26, 2022
Prospectus Summary, page 1
1.We note your statements on pages 6 and 51 that you intend to "[c]apitalize on [y]our first
mover advantage of having potentially the first-in-class drug approved as a radiation
sensitizer" and your disclosure that Cetuximab has been approved by the FDA as a
radiation sensitizer. Please remove your references to your first mover advantage, and
potentially first in class product. In addition to being overly speculative given your
product candidates' early stage of development, the statement appears to imply that
Ropidoxuride has the potential to be the first radiation sensitizer. Additionally, delete your
belief that Ropidoxuride has the capability to become a well tolerated sensitizer that could
displace currently used drugs for radiation sensitization. The statement is overly
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
May 16, 2022 Page 2
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
May 16, 2022
Page 2
speculative and appears to assume that your candidate is more effective than other
products.
2.We note your revisions in response to our prior comment 6. Please delete your statement
plans to rapidly develop Ropidoxuridine and HDAC inhibitor (SP-2-225) and clearly state
that it may be several years before you are able to file an application for an NDA with the
FDA. Similarly revise pages 48 and 51.
3.We note your response to our prior comment 8 and reissue. It is inappropriate for you to
state or imply that your product candidates are effective or are likely to be found
effective. You may present clinical trial end points and objective data results from your
clinical trials without concluding that the product candidate was effective or had an impact
on the observed results. Please revise or remove these and similar statements/inferences
throughout your prospectus:
•Any statements that your research has "demonstrated", "shown", "suggests" a certain
effect or safety, such as , "these data are interpreted as demonstrating safety of IPdR
with RT in humans", and "[p]reclinical models suggest that selective HDAC6
inhibitors may lead to effective therapy."
•Any statements that imply or conclude that your products cause a certain effect, such
as "Preliminary data using radiation therapy in combination with IUdR suggests that
the combination may offer delay and disease progression of up to 6 months" and
"efficacy . . . has been observed following treatment of sarcomas by the combination
of IUdR and RT."
•Any characteristics of clinical results or data as "favorable" or having "potential" for
certain effects, such as "we have data suggesting these drugs also have potential
immune regulatory properties."
4.Please revise the graphic at the bottom of page 2 to use a term other than "expected
outcome," such as trial endpoint. It currently appears that you maybe predicting the
outcome of the trial.
Market Opportunity, page 6
5.We have reviewed your revisions in response to our prior comment 6. Please tell us how
you arrived at the Estimated RT Cases estimates and disclose any material assumptions
and limitations associated with these estimates. Please also explain why you have
presented the market opportunity related to indications for which you are not currently
developing target candidates, such as liver and esophageal cancers.
Our Development Strategy, page 6
6.We note your response to our prior comment 12. Please clarify here that Temodar is a
drug that has shown some activity in treating brain tumors.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
May 16, 2022 Page 3
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
May 16, 2022
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 43
7.We note your response to prior comment 2. As previously requested, please expand your
disclosure to include the costs incurred during each period presented for each of your key
research and development products/projects. If you do not track your research and
development costs by project, disclose that fact and explain why you do not maintain and
evaluate research and development costs by project.
8.Please expand your disclosure, under this heading, to provide a qualitative and
quantitative discussion and analysis of the changes in your general and administrative
expenses from the prior period in accordance with Item 303(b) of Regulation S-K.
Business
Our Pipeline, page 49
9.We note your response to our prior comment 15. Since you are currently conducting a
Phase 1b/2 trial it continues to appear that you have not completed all required Phase 1
trials and therefore it is inappropriate to portray that you have completed Phase 1 testing.
Please revise your pipeline table accordingly. Alternatively, explain the basis for your
belief that a Phase 1b/2 trial was not required for development of Ropidoxuridine for brain
tumors and sarcomas and that you could have relied on the phase 1 trial relating to
advanced GI cancers and proceeded to a Phase 2 trial.
10.We note your revisions in response to our prior comment 17 and reissue. Given the
limited amount of disclosure related to these programs, please explain why these programs
are sufficiently material to your business to warrant inclusion in your pipeline table. If
they are material, please expand your disclosure in your Business section to provide a
more fulsome discussion of these, including:
•the nature, objective, and current status of each project, and the intended market for
the products;
•steps necessary to complete each project, including a description of preclinical
studies and clinical validation and what you must demonstrate in order to receive
FDA approval; and
•the extent and nature of additional resources that need to be obtained if current
liquidity is not expected to be sufficient to complete the development of each product
candidate.
Please also expand your "Government Regulation and Product Approval" to describe the
applicable regulations related to these types of products.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
May 16, 2022 Page 4
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
May 16, 2022
Page 4
Radiation Therapy, page 52
11.You indicate on page 52 and in your table on page 62 that Cetuximab is being used off
label for its radiation sensitizing properties. However, you indicate on pages 6 and 51 that
it has been approved by the FDA as a radiation sensitizer. Please explain the discrepancy.
Principal and Selling Stockholders, page 83
12.Please revise footnote 9 to clarify whether Steven Bayern has control over shares held by
Bayern Capital and disclose Steven Bayern's role as a consultant for the company. See
Item 507 of Regulation S-K.
Related Party Transactions, page 83
13.We note your revisions in response to our prior comment 23. Please identify the "spouse
of an officer of the Company" and the officer in the June 21, 2021 transaction.
14.We note your disclosure stating that, on September 22, 2021, Mrs. Dritschilo, who is one
of your major shareholders, transferred 210,000 shares of Company common stock to
Steven Bayern, who was performing certain consulting services for the Company. Please
expand your disclosure to clarify the reason the shares were transferred to Bayern, tell us
how you accounted for this transaction in your financial statements, and confirm that your
financial statements reflect all the costs of doing business including all expenses paid by
shareholders on behalf of the Company. Refer to SAB Topic 1:B, SAB Topic 5:T and
ASC 220-10-S99-4.
You may contact Tracie Mariner at 202-551-3744 or Kevin Kuhar at 202-551-3662 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jordan Nimitz at 202-551-5831 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.
2022-03-18 - UPLOAD - Shuttle Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
March 18, 2022
Anatoly Dritschilo
Chief Executive Officer
Shuttle Pharmaceuticals Holdings, Inc.
One Research Court, Suite 450
Rockville, MD 20850
Re:Shuttle Pharmaceuticals Holdings, Inc.
Draft Registration Statement on Form S-1
Submitted September 16, 2019
CIK No. 0001757499
Dear Dr. Dritschilo:
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 Submitted February 11, 2022
Summary Financial Information, page 12
1.Please revise the financial information presented here to also include loss per share
calculations.
Research and Development-Net of contract expense reimbursements, page 44
2.Please revise to disclose the costs incurred during each period presented for each of your
key research and development products/projects. If you do not track your research and
development costs by project, please disclose that fact and explain why you do not
maintain and evaluate research and development costs by project. Provide other
quantitative or qualitative disclosure that provides more transparency as to the type of
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 2
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 2
research and development expenses incurred (i.e., by nature or type of expense) which
should reconcile to total research and development expense on the Consolidated
Statements of Operations.
Financial Statements
Note 2- Summary of Significant Accounting Policies
Fair Value of Finanicial Statements, page F-10
3.We note your disclosures stating, "In drawing its conclusions, management considered
various relevant factors, including the work of an independent third-party valuation firm
engaged to provide a valuation analysis as of June 30, 2019, which indicated a valuation
of $12.61 per common share. Management ultimately determined, and the valuation firm
concurred, that the Market Approach method was the most appropriate valuation
methodology under the circumstances." Please tell us your reliance on a third-party and
how you considered filing a written consent of this entity as an exhibit to your registration
statement. Refer to Rule 436 and Section 7 of the Securities Act and Question 141.02 of
the Compliance and Disclosure Interpretations on Securities Act Sections, which can be
found at https://www.sec.gov/corpfin/securities-actsections.
Note 8- Stockholders' Equity
Equity Incentive Plan, page F-17
4.We note your disclosure stating that your 2018 Equity Incentive Plan provides for equity
incentives to be granted to your employees, executive officers, or directors and to key
advisers and consultants, which may be in the form of stock options, restricted stock
awards, other stock based awards, or any combination of the foregoing. As it relates to
the 773,453 shares granted under your 2018 equity Incentive Plan, please expand your
disclosure to include all of the information required by ASC 718-10-50-2, as applicable to
you.
Amendment to Form S-1 filed February 11, 2022
Cover Page
5.We note your response to comment 1 indicating that you are not registering any shares for
resale. However, your registration statement references 500,000 shares being sold by your
selling shareholders. Please revise your fee table to include the shares being offered by
your selling shareholders and file the fee table as an exhibit to your registration statement.
Please see Item 601(b)(107) of Regulation SK. Additionally, we note your cover page
indicates your intention to offer securities on a delayed and continuous basis. Given that
you are conducting a firm commitment offering, please explain why you have indicated
that you are relying on Rule 415.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 3
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 3
Prospectus Summary, page 1
6.Please revise your summary to present a balanced view of your company and its current
stage of development by focusing on the most material aspects of your company,
eliminating the predictive assumptions and clearly stating that you have no FDA approved
products, disclosing that you are several years away from applying for a new drug
application, have never generated any product revenue and received an audit report that
raised substantial doubt about your ability to continue as a going concern. For example:
•Eliminate the description of your product candidates as "first-in-class." The
description applies to a product that has received FDA approval;
•Remove your statement that you intend to follow the FDA's fast-track development
program for developing Ropidoxuridine as it is not appropriate to assume the
required evidence of efficacy from trials that you have not yet conducted;
•Remove statements predicting positive results and future partnerships, such as
"Positive results from proof-of-concept studies will enable collaborative partnerships
with other pharmaceutical companies for Phase III clinical trials";
•Ensure that you discuss the risks and obstacles you face in developing your product
candidates with the same level of detail as you use to discuss the positive aspects of
your operations.
7.Move the detailed scientific explanations of the mechanism of action of your candidates
and discussions of clinical trial results to the Business section where the disclosure can be
placed in the proper context.
8.We have reviewed your revisions in response to our prior comment 4 and reissue. There
are still multiple numerous references to the safety and efficacy throughout your
disclosure. Efficacy and safety are determinations that are solely within the authority of
the FDA. You may present clinical trial end points and objective data resulting from trials
without concluding efficacy, and you may state that your product candidates are well
tolerated, if accurate. Please revise any statements referencing safety and efficacy
throughout your document, including but not limited to the following:
•on page 44, "The clinical development of Ropidoxuridine has shown drug safety,
bioavailability and a maximum tolerated dose has been established for use in Phase II
clinical trials."
•on page 48, "These results support the safety and potential efficacy in combination
with radiation and provide the foundation for design of Phase Ib/II clinical trials in
brain tumors and Phase II clinical trials in sarcomas or un-resectable pancreatic
cancers, with all three disease sites being eligible for orphan disease designations."
•on page 49, "suggesting that a combination of SP-1-303 with an immune checkpoint
blocker may enhance the therapeutic efficacy in hormone responsive breast cancer."
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 4
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 4
9.Please provide a textual discussion explaining the graphic appearing at the bottom of page
2. It appears to depict two product candidates and the potential disease indications you
intend to develop the candidates to address but it is not clear what the arrows are intended
to depict. Additionally, it does not indicate provide any indication of what remains to be
done to develop the product candidate.
10.Please revise your disclosure to clarify whether you have filed an IND for your Phase I
study of Extended Bio-availability Ropidoxurdine (IPdR/TPI) and, if accurate clarify
that SP-1-161 and SP-1-303 are in pre-clinical stages of development.
11.We note your statement on page 4 indicating that you "intend to perform clinical studies
to support the FDA's efficacy and safety findings (IND-enabling studies) for the -
IPdR/TPI combination..." Please explain your reference to the FDA's efficacy and safety
findings. If this is a reference to the approval to conduct a Phase I clinical trial, please
delete the reference to the FDA's efficacy and safety findings. The FDA continues to
assess safety and efficacy throughout the entire development process and it is not
appropriate to interpret FDA approval of your Phase I trial as an FDA finding related to
safety and/or efficacy.
Development Strategy, page 6
12.Please clarify the meaning of "CTEP," and "MTD" and explain the significance of
Temodar.
Market Opportunity, page 6
13.Please revise your table on page 6 to explain the significance of the asterisks and to
explain the the headers "RT Cases Annually" and "RT Cases (estimated)." Do the RT
Cases estimated relate to a different time period? What is the basis for the estimate?
Pre-IPO Bridge Financing, page 8
14.Please explain the timing of your plan to use funds from this offering to repay two
accredited investors, who will use such proceeds to exercise their warrants and sell their
shares in this offering. It appears that the shares they are planning to sell in this offering
will not be outstanding at the time of your offering.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 5
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 5
Business
Our Pipeline, page 48
15.We note that your table indicates you have completed Phase I in your development of
Ropidoxuridine. However, the description of your product candidate indicates that your
Phase I clinical trial results provide the foundation for the design of Phase Ib/II clinical
trials. Your pipeline table should depict when an entire phase of development has been
completed, as opposed to one of multiple trials in a phase of development. Please tell us
why you believe it is appropriate to indicate that you have completed Phase I testing when
you are planning to conduct a Phase Ib/II trial.
16.Please revise your table to clarify which product candidates Class II HDAC6 Selective,
Class I - ER+ Targeting and Dual Functional Pan HDAC are and identify the indications
you are seeking to treat with your candidates.
17.Please expand your business section to explain the Cell Lines and Cell Products and
Patient Metabolite testing kit.
18.We note your description of Ropidoxuridine discloses the results of fourteen of the
eighteen participants in the study, please revise to describe the results of the other four
participants.
Our Product Candidates, page 60
19.We note your disclosure indicates you have received an SBIR contract from NIH to fund a
Phase I trial with Brown University to determine the maximum tolerated dose in patients
with advanced gastrointestinal cancers. This disclosure appears to related to the Phase I
trial that has been completed. Please revise to update your disclsoure.
Strategic Agreements, page 60
20.The significance of the identified strategic agreements is unclear. Please revise to your
descriptions to provide additional information. For example:
•With respect to the agreement with Georgetown, we note that Georgetown acted as a
subcontractor for the work you conducted pursuant to two SBIR contracts. Please
clarify whether the intellectual property you have the option to license is related to
those subcontract agreements, including whether the intellectual property was
developed by Georgetown in the course of conducting such work or if Georgetown
University used it's own previously developed intellectual property in performing the
subcontracted work. If you develop candidates related to the African-American
prostate cancer health disparities project or the metabolomic biomarker project, is
such development dependent on intellectual property owned by Georgetown
University?
•With respect to the material transfer agreement with Georgetown University, please
clarify whether your HDAC inhibitor platform technology is dependent on this
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 6
FirstName LastNameAnatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 6
agreement. If so, please describe the material terms of this agreement, including
payment terms as well as your rights and obligations under the agreement.
21.Please describe all material provisions of your agreement with Propagenix, including
identifying your product candidates that are dependent on the agreement, and quantifying
any amounts paid, potential future milestone payments and royalty provisions.
The SBIR Program, page 63
22.Please clarify the material terms of each of your SBIR contracts, including funding
received to date, potential future funding and what you need to accomplish to qualify for
the future funding. Additionally, clarify the ownership of any intellectual property
developed during the course of the program. To the extent the NIH receives any rights to
the intellectual property, please clarify.
23.Please clarify your strategy for commercializing prostate cancer cell lines and and
predictive biomarkers. For example, your table on page 48 references a testing kit, but
there is no disclosure about plans to develop a testing kit.
Collaborative Arrangements, page 64
24.We note your response to our prior comment 12, stating that all relevant references to
Doranidazole have been removed from the prospectus. However, there are still several
references to Doranidazole throughout your disclosure. Please remove them or advise.
Executive Compensation, page 81
25.Please update your Summary Compensation Table.
Related Party Transactions, page 83
26.Please revise your descriptions of the related party transactions to also include the identify
the related party.
Signatures, page II-3
27.We have reviewed your response to our prior comment 24 and reissue. Please ensure that
the requisite signatures and dates are provided when you amend your registration
statement.
FirstName LastNameAnatoly Dritschilo
Comapany NameShuttle Pharmaceuticals Holdings, Inc.
March 18, 2022 Page 7
FirstName LastName
Anatoly Dritschilo
Shuttle Pharmaceuticals Holdings, Inc.
March 18, 2022
Page 7
You may contact Kevin Kuhar at 202-551-3662 or Tracie Mariner at 202-551-3744 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jordan Nimitz at 202-551-5831 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Penick, Esq.