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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
↓
INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-01-21
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-12-26
INTENSITY THERAPEUTICS, INC.
References: October 28, 2021
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2025-01-07
INTENSITY THERAPEUTICS, INC.
References: December 26, 2024 | October 28, 2021
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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-12-17
INTENSITY THERAPEUTICS, INC.
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2024-12-17
INTENSITY THERAPEUTICS, INC.
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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-08
INTENSITY THERAPEUTICS, INC.
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2024-07-09
INTENSITY THERAPEUTICS, INC.
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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-08
INTENSITY THERAPEUTICS, INC.
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2024-07-09
INTENSITY THERAPEUTICS, INC.
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INTENSITY THERAPEUTICS, INC.
Response Received
32 company response(s)
High - file number match
SEC wrote to company
2021-11-09
INTENSITY THERAPEUTICS, INC.
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2021-11-12
INTENSITY THERAPEUTICS, INC.
References: November 9, 2021
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2021-11-18
INTENSITY THERAPEUTICS, INC.
References: November 16, 2021
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2021-12-07
INTENSITY THERAPEUTICS, INC.
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2021-12-07
INTENSITY THERAPEUTICS, INC.
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2021-12-09
INTENSITY THERAPEUTICS, INC.
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2021-12-10
INTENSITY THERAPEUTICS, INC.
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2021-12-10
INTENSITY THERAPEUTICS, INC.
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2022-05-16
INTENSITY THERAPEUTICS, INC.
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2022-10-03
INTENSITY THERAPEUTICS, INC.
References: September 29, 2022
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2022-10-11
INTENSITY THERAPEUTICS, INC.
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2022-10-11
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2022-10-13
INTENSITY THERAPEUTICS, INC.
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2022-10-13
INTENSITY THERAPEUTICS, INC.
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2022-10-13
INTENSITY THERAPEUTICS, INC.
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2022-10-13
INTENSITY THERAPEUTICS, INC.
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2022-11-02
INTENSITY THERAPEUTICS, INC.
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2022-11-03
INTENSITY THERAPEUTICS, INC.
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2022-11-03
INTENSITY THERAPEUTICS, INC.
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2022-11-09
INTENSITY THERAPEUTICS, INC.
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2022-11-09
INTENSITY THERAPEUTICS, INC.
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2023-01-27
INTENSITY THERAPEUTICS, INC.
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2023-02-06
INTENSITY THERAPEUTICS, INC.
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2023-02-06
INTENSITY THERAPEUTICS, INC.
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2023-02-08
INTENSITY THERAPEUTICS, INC.
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2023-02-08
INTENSITY THERAPEUTICS, INC.
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2023-02-09
INTENSITY THERAPEUTICS, INC.
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2023-02-09
INTENSITY THERAPEUTICS, INC.
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2023-02-14
INTENSITY THERAPEUTICS, INC.
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2023-02-14
INTENSITY THERAPEUTICS, INC.
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2023-06-09
INTENSITY THERAPEUTICS, INC.
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2023-06-27
INTENSITY THERAPEUTICS, INC.
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2023-06-27
INTENSITY THERAPEUTICS, INC.
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-06-07
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-01-23
INTENSITY THERAPEUTICS, INC.
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-31
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-09-29
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-04-28
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-09
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-11-16
INTENSITY THERAPEUTICS, INC.
Summary
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INTENSITY THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-10-18
INTENSITY THERAPEUTICS, INC.
Summary
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Company responded
2021-10-28
INTENSITY THERAPEUTICS, INC.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-22 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-04-02 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 377-07829 | Read Filing View |
| 2025-01-21 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 001-41109 | Read Filing View |
| 2025-01-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-12-26 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 001-41109 | Read Filing View |
| 2024-12-17 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-283797 | Read Filing View |
| 2024-12-17 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-08 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-280681 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-280684 | Read Filing View |
| 2023-06-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-07 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-14 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-14 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-08 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-08 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-01-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-01-23 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-02 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-31 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-09-29 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-05-16 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-04-28 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-10 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-10 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-09 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-18 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-16 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-12 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-09 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-10-28 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-10-18 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-02 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 377-07829 | Read Filing View |
| 2025-01-21 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 001-41109 | Read Filing View |
| 2024-12-26 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 001-41109 | Read Filing View |
| 2024-12-17 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-283797 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-280681 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | 333-280684 | Read Filing View |
| 2023-06-07 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-01-23 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-31 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-09-29 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-04-28 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-09 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-16 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-09 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-10-18 | SEC Comment Letter | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-22 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-01-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-12-17 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-06-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-14 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-14 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-08 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-08 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-01-27 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-11-02 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-10-03 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2022-05-16 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-10 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-10 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-09 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-12-07 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-18 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-11-12 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2021-10-28 | Company Response | INTENSITY THERAPEUTICS, INC. | DE | N/A | Read Filing View |
2025-04-22 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP 1 filename1.htm Document INTENSITY THERAPEUTICS, INC. 1 ENTERPRISE DRIVE, SUITE 430 SHELTON, CT 06484 April 22, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Joshua Gorsky Re: Intensity Therapeutics, Inc. Registration Statement on Form S-1 Filed April 22, 2025 File No. 333-286683 (the “Registration Statement”) Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Intensity Therapeutics, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement to Thursday, April 24, 2025, at 5:15 p.m., Eastern Time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Jeffrey Schultz or Ivan Blumenthal of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6732 or (212) 692-6784, respectively, with any questions regarding this request. Very truly yours, Intensity Therapeutics, Inc. /s/ Lewis H. Bender Lewis H. Bender, President & Chief Executive Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey Schultz, Esq. Ivan Blumenthal, Esq.
2025-04-02 - UPLOAD - INTENSITY THERAPEUTICS, INC. File: 377-07829
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 2, 2025 Lewis H. Bender President, Chief Executive Officer and Chairman Intensity Therapeutics, Inc. 1 Enterprise Drive, Suite 430 Shelton, CT 06484-4779 Re: Intensity Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted March 28, 2025 CIK No. 0001567264 Dear Lewis H. Bender: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ivan K. Blumenthal, Esq. </TEXT> </DOCUMENT>
2025-01-21 - UPLOAD - INTENSITY THERAPEUTICS, INC. File: 001-41109
January 21, 2025
Lewis H. Bender
President & Chief Financial Officer
INTENSITY THERAPEUTICS, INC.
1 Enterprise Drive
Suite 430
Shelton, CT 06484
Re:INTENSITY THERAPEUTICS, INC.
Form 10-K for the year ended December 31, 2023
Filed March 14, 2024
File No. 001-41109
Dear Lewis H. Bender:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2025-01-07 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Document
INTENSITY THERAPEUTICS, INC.
1 ENTERPRISE DRIVE, SUITE 430
SHELTON, CT 06484
January 7, 2025
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
Attention: Sasha Parikh
Kevin Vaughn
Re: Intensity Therapeutics, Inc.
Form 10-K for the year ended December 31, 2023
Filed March 14, 2024
File No. 001-41109
Dear Sir or Madam:
This letter sets forth the response of Intensity Therapeutics, Inc., a Delaware corporation (the “Company”), to the comment from the staff of the Division of Corporate Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter, dated December 26, 2024 (the “Comment Letter”), relating to the above referenced Form 10-K for the year ended December 31, 2023 (File No. 001-41109) filed by the Company on March 14, 2024 (the “Form 10-K”).
Set forth below is the Company’s response to the Staff’s comment. For convenience, the Staff’s comment is repeated below in bold, followed by the Company’s response to the comment.
Form 10-K for the year ended December 31, 2023
Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 83
1.We note your disclosure on page F-9 that you track external research and development expenses based on research and development initiative, including preclinical, individual clinical study, and manufacturing activities but not by program. We also note the tabular disclosure of research and development expenses on page 48 of your Form S-1 amended on June 23, 2023, consistent with your response letter dated October 28, 2021. In this regard, please provide us in your response, revised disclosure of the costs incurred for the periods ended December 31, 2023 and nine-months ended September 30, 2024, for each of your key research and development initiatives which should reconcile to total research and development expense on the Statements of Operations. In addition, please provide similar revised disclosure in future periodic filings, beginning with your Form 10-K for the year ended December 31, 2024.
Response: In response to the Staff’s comment, the Company has provided the following revised disclosure of the costs incurred for the periods ended December 31, 2023 and nine-months ended September 30, 2024 for each of our key research and development initiatives. This revised disclosure provides a detailed breakdown of clinical trial expenses by key clinical study. Similar revised disclosures will be included in future periodic filings, beginning with our Form 10-K for the year ended December 31, 2024.
(in thousands)
Nine-Months Ended September 30, 2024 Year Ended December 31, 2023
Research and development expenses:
Clinical trial expenses:
IT-01 Study (Phase 1/2 Metastatic Cancers) $ 9 $ 984
INVINCIBLE-2 Study (Phase 2 Breast) 233 402
INVINCIBLE-3 Study (Phase 3 Sarcoma) 4,613 578
INVINCIBLE-4 Study (Phase 2 Breast) 424 19
Other 163 4
Clinical trial expenses 5,442 1,987
Contract manufacturing 651 922
Salaries and benefits related 1,340 896
Consulting 126 267
Stock-based compensation 970 714
Research and development expenses $ 8,529 $ 4,786
Please contact me at (203) 221-7377 if you have any questions or require any additional information in connection with this letter.
Sincerely,
Intensity Therapeutics, Inc.
/s/ Lewis H. Bender
Lewis H. Bender, President & Chief Executive Officer
cc: Joseph Talamo, Chief Financial Officer
Jeffrey Schultz, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Kostantinos Skordalos, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2024-12-26 - UPLOAD - INTENSITY THERAPEUTICS, INC. File: 001-41109
December 26, 2024
Lewis H. Bender
President & Chief Financial Officer
INTENSITY THERAPEUTICS, INC.
1 Enterprise Drive
Suite 430
Shelton, CT 06484
Re:INTENSITY THERAPEUTICS, INC.
Form 10-K for the year ended December 31, 2023
Filed March 14, 2024
File No. 001-41109
Dear Lewis H. Bender:
We have reviewed your filing and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe
the 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.
Form 10-K for the year ended December 31, 2023
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations , page 83
1.We note your disclosure on page F-9 that you track external research and
development expenses based on research and development initiative, including
preclinical, individual clinical study, and manufacturing activities but not by program.
We also note the tabular disclosure of research and development expenses on page 48
of your Form S-1 amended on June 23, 2023, consistent with your response letter
dated October 28, 2021. In this regard, please provide us in your response, revised
disclosure of the costs incurred for the periods ended December 31, 2023 and nine-
months ended September 30, 2024, for each of your key research and development
initiatives which should reconcile to total research and development expense on the
Statements of Operations. In addition, please provide similar revised disclosure in
future periodic filings, beginning with your Form 10-K for the year ended December
31, 2024.
December 26, 2024
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.
Please contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-12-17 - UPLOAD - INTENSITY THERAPEUTICS, INC. File: 333-283797
December 17, 2024
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
1 Enterprise Drive, Suite 430
Shelton, CT 06484
Re:Intensity Therapeutics, Inc.
Registration Statement on Form S-1
Filed December 13, 2024
File No. 333-283797
Dear Lewis Bender:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeffrey Schultz
2024-12-17 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP 1 filename1.htm Document INTENSITY THERAPEUTICS, INC. 1 ENTERPRISE DRIVE, SUITE 430 SHELTON, CT 06484 December 17, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jason Drory Re: Intensity Therapeutics, Inc. Registration Statement on Form S-1 Filed December 13, 2024 File No. 333-283797 (the “Registration Statement”) Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Intensity Therapeutics, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement to Thursday, December 19, 2024, at 4:01 p.m., Eastern Time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Jeffrey Schultz, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6732 with any questions regarding this request. Very truly yours, INTENSITY THERAPEUTICS, INC. /s/ Lewis H. Bender Lewis H. Bender, Chief Executive Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey Schultz, Esq.
2024-07-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP 1 filename1.htm Document INTENSITY THERAPEUTICS, INC. 1 ENTERPRISE DRIVE, SUITE 430 SHELTON, CT 06484 July 9, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards Re: Intensity Therapeutics, Inc. Registration Statement on Form S-3 Filed July 3, 2024 File No. 333-280684 (the “Registration Statement”) Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Intensity Therapeutics, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement to Thursday, July 11, 2024, at 4:01p.m., Eastern Time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Jeffrey Schultz or Ivan Blumenthal of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6732 or (212) 692-6784, respectively, with any questions regarding this request. Very truly yours, Intensity Therapeutics, Inc. /s/ Lewis H. Bender Lewis H. Bender, President & Chief Executive Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey Schultz, Esq. Ivan Blumenthal, Esq.
2024-07-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP 1 filename1.htm Document INTENSITY THERAPEUTICS, INC. 1 ENTERPRISE DRIVE, SUITE 430 SHELTON, CT 06484 July 9, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards Re: Intensity Therapeutics, Inc. Registration Statement on Form S-3 Filed July 3, 2024 File No. 333-280681 (the “Registration Statement”) Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Intensity Therapeutics, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement to Thursday, July 11, 2024, at 4:01p.m., Eastern Time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. lease contact Jeffrey Schultz or Ivan Blumenthal of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6732 or (212) 692-6784, respectively, with any questions regarding this request. Very truly yours, Intensity Therapeutics, Inc. /s/ Lewis H. Bender Lewis H. Bender, President & Chief Executive Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey Schultz, Esq. Ivan Blumenthal, Esq.
2024-07-08 - UPLOAD - INTENSITY THERAPEUTICS, INC. File: 333-280684
July 8, 2024
Lewis H. Bender
President, Chief Executive Officer and Chairman
Intensity Therapeutics, Inc.
1 Enterprise Drive, Suite 430
Shelton, CT 06484-4779
Re:Intensity Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 3, 2024
File No. 333-280684
Dear Lewis H. Bender:
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:Jeffrey P. Schultz
2023-06-27 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
June 27, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, 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 (the “Securities Act”), so that it may become effective
on June 29, 2023 at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2023-06-27 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
June 27, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 4:30 PM, Eastern Time, on June 29, 2023, or as soon thereafter as practicable, or at such other
time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement be declared
effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
THE BENCHMARK COMPANY, LLC
By:
/s/ Michael S. Jacobs
Name:
Michael S. Jacobs
Title:
Managing Director
2023-06-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
June 9, 2023
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 13 to Registration Statement
on Form S-1
Filed May 18, 2023
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated June 7, 2023 (the “Comment Letter”),
relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565) filed by the Company on May 18, 2023 (the “Registration
Statement”). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement
and is filing it with the Commission together with its submission of this response letter. Set forth below is the Company’s response
to the Staff’s comments. For convenience, the Staff’s comments are repeated below in bold, followed by the Company’s
response.
Amendment No. 13 to Form S-1 filed May 18, 2023
Facilities, page 101
1.
We note your disclosure on page 101 that you have provided notice that the Westport lease would terminate on June 30, 2023. However, you also disclose on page F-43 that the lease expires as of September 2023. Please clarify the term of the lease and revise accordingly. Please also file the lease agreement as an exhibit to the registration statement pursuant to Item 601(b)(10) of Regulation S-K.
Response: In response to the Staff’s comment, the Company has revised its
disclosure on pages 101 and F-43 of the revised Registration Statement to clarify that while the lease’s term ends in September
2023, pursuant to the terms of the lease, the landlord terminated the Company’s lease early such that it would terminate on June
30, 2023. The Company has filed the lease, the first lease amendment, the second lease amendment and the lease modification/termination
agreement as exhibits to the revised Registration Statement.
Please contact me at +1 212 547 5553 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Daniel Woodard
cc: Lewis Bender, Chief Executive Officer
2023-06-07 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
June 7, 2023
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 13 to Registration Statement on Form S-1
Filed May 18, 2023
File No. 333-260565
Dear Lewis Bender:
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. 13 to Form S-1 filed May 18, 2023
Facilities, page 101
1.We note your disclosure on page 101 that you have provided notice that the Westport
lease would terminate on June 30, 2023. However, you also disclose on page F-43 that
the lease expires as of September 2023. Please clarify the term of the lease and revise
accordingly. Please also file the lease agreement as an exhibit to the registration statement
pursuant to Item 601(b)(10) of Regulation S-K.
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Suzanne Hayes at 202-551-3675 with any other questions.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
June 7, 2023 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
June 7, 2023
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2023-02-14 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
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February 14, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on February 9, 2023, in which we, as representative of the several underwriters of Intensity Therapeutics, Inc.’s proposed
public offering, joined Intensity Therapeutics, Inc.’s request for acceleration of the effective date of the above-referenced Registration
Statement for February 13, 2023, at 4:30 p.m. Eastern Time. Intensity Therapeutics, Inc. is no longer requesting that such Registration
Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very truly yours,
THE
BENCHMARK COMPANY, LLC
As representative of the
several Underwriters
By:
/s/ Michael Jacobs
Name:
Michael Jacobs
Title:
MD/Head of ECM
2023-02-14 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
February 14, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, Inc.
(the “Registrant”) hereby withdraws its request submitted on February 9, 2023 for acceleration of the effectiveness
of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities
Act”), for February 13, 2023 at 4:30 p.m., Eastern Time.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2023-02-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
February 9, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, 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 (the “Securities Act”), so that it may become effective
on February 13, 2023 at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2023-02-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
February 9, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 4:30 PM, Eastern Time, on February 13, 2023, or as soon thereafter as practicable, or at such
other time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement
be declared effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
THE BENCHMARK COMPANY, LLC
By:
/s/ Michael Jacobs
Name:
Michael Jacobs
Title:
MD/Head of ECM
2023-02-08 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
February 8, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on February 6, 2023, in which we, as representative of the several underwriters of Intensity Therapeutics, Inc.’s proposed
public offering, joined Intensity Therapeutics, Inc.’s request for acceleration of the effective date of the above-referenced Registration
Statement for February 8, 2023, at 4:30 p.m. Eastern Time. Intensity Therapeutics, Inc. is no longer requesting that such Registration
Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very truly yours,
THE
BENCHMARK COMPANY, LLC
As representative of the
several Underwriters
By:
/s/ Michael Jacobs
Name:
Michael Jacobs
Title:
MD/Head of ECM
2023-02-08 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
February 8, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, Inc.
(the “Registrant”) hereby withdraws its request submitted on February 6, 2023 for acceleration of the effectiveness
of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities
Act”), for February 8, 2023 at 4:30 p.m., Eastern Time.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2023-02-06 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
February 6, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, 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 (the “Securities Act”), so that it may become effective
on February 8, 2023 at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2023-02-06 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
February 6, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 4:30 PM, Eastern Time, on February 8, 2023, or as soon thereafter as practicable, or at such
other time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement
be declared effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
THE BENCHMARK COMPANY, LLC
By:
/s/ Michael Jacobs
Name:
Michael Jacobs
Title:
MD/Head of ECM
2023-01-27 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
January 27, 2023
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 11 to Registration Statement
on Form S-1
Filed January 13, 2023
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated January 23, 2023 (the “Comment Letter”),
relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565) filed by the Company on January 13, 2023 (the
“Registration Statement”). In response to the comments set forth in the Comment Letter, the Company has revised the
Registration Statement and is filing it with the Commission together with its submission of this response letter. Set forth below is the
Company’s response to the Staff’s comments. For convenience, the Staff’s comments are repeated below in bold, followed
by the Company’s response.
Amendment No. 11 to Form S-1 filed January 13, 2023
Our Strengths, page 54
1.
Please expand your discussion to describe the grade 3 and 4 adverse events in your IT-01 study and quantify the number of each type of event, as well as all other serious adverse events. Make similar revisions throughout your document, including in the discussion of your results, to identify all serious adverse events and quantify the number of each type of event.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on pages 1, 55, 56, 65, 66, 67 and 76 of the revised Registration Statement to expand its disclosure of adverse
events in its IT-01 study, including quantifying the number of each type of event.
Please contact me at +1 212 547 5553 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Daniel Woodard
cc: Lewis Bender, Chief Executive Officer
2023-01-23 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
January 23, 2023
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 11 to Registration Statement on Form S-1
Filed January 13, 2023
File No. 333-260565
Dear Lewis Bender:
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. 11 to Form S-1 filed January 13, 2023
Our Strengths, page 54
1.Please expand your discussion to describe the grade 3 and 4 adverse events in your IT-01
study and quantify the number of each type of event, as well as all other serious adverse
events. Make similar revisions throughout your document, including in the discussion of
your results, to identify all serious adverse events and quantify the number of each type of
event.
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Suzanne Hayes at 202-551-3675 with any other questions.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
January 23, 2023 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
January 23, 2023
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2022-11-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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November 9, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on November 3, 2022, in which we, as representative of the several underwriters of Intensity Therapeutics,
Inc.’s proposed public offering, joined Intensity Therapeutics, Inc.’s request for acceleration of the effective date of the
above-referenced Registration Statement for November 7, 2022, at 5:30 p.m. Eastern Time. Intensity Therapeutics, Inc. is no longer requesting
that such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the
effective date.
Very truly yours,
ROTH CAPITAL PARTNERS,
LLC
As representative of the
several Underwriters
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2022-11-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
November 9, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on November 3, 2022, in which we requested the acceleration of the effective date of the above-referenced
Registration Statement for Monday, November 7, 2022 at 5:30 p.m. Eastern Standard Time. We are no longer requesting that such Registration
Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2022-11-03 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
November 3, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics,
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 (the “Securities Act”), so that it
may become effective on November 7, 2022 at 5:30 P.M., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2022-11-03 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
November 3, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 5:30 PM, Eastern Time, on November 7, 2022, or as soon thereafter as practicable, or at such
other time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement
be declared effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2022-11-02 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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mwe.com
November 2, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Suzanne Hayes
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 9 to Registration Statement on
Form S-1
Filed October 3, 2022
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated October 31, 2022 (the “Comment Letter”),
relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565) filed by the Company on October 3, 2022 (the
“Registration Statement”). In response to the comments set forth in the Comment Letter, the Company has revised the
Registration Statement and is filing it with the Commission together with its submission of this response letter. Set forth below is the
Company’s response to the Staff’s comments. For convenience, the Staff’s comments are repeated below in bold, followed
by the Company’s response.
Amendment No. 9 to Form S-1 filed October 3,
2022
Cover Page
1.
Disclose whether your offering is contingent upon final approval of your Nasdaq listing on your cover page. Please ensure the disclosure is consistent with your underwriting agreement.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on the cover page and pages 1, 4, 6, 31, 118 and 126 of the revised Registration Statement.
We have also revised Sections 2.2 and 8.2 of the underwriting agreement to clarify that the offering is contingent upon final approval
of our Nasdaq listing.
Risk Factors, page 9
2.
We note recent instances of extreme stock price run-ups followed by rapid price declines and stock price volatility seemingly unrelated to company performance following a number of recent initial public offerings, particularly among companies with relatively smaller public floats. Revise to include a separate risk factor addressing the potential for rapid and substantial price volatility and any known factors particular to your offering that may add to this risk and discuss the risks to investors when investing in stock where the price is changing rapidly. Clearly state that such volatility, including any stock run-up, may be unrelated to your actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of your stock.
Response: In response to the Staff’s
comment, the Company has revised pages 3 and 9 of the revised Registration Statement.
Please contact me at +1 212 547 5553 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Daniel Woodard
cc: Lewis Bender, Chief Executive Officer
2022-10-31 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
October 31, 2022
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 9 to Registration Statement on Form S-1
Filed September 20, 2022
File No. 333-260565
Dear Lewis Bender:
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 [Month day, year] letter.
Amendment No. 9 to Form S-1 filed October 3, 2022
Cover Page
1.Disclose whether your offering is contingent upon final approval of your Nasdaq listing
on your cover page. Please ensure the disclosure is consistent with your underwriting
agreement.
Risk Factors, page 9
2.We note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively
smaller public floats. Revise to include a separate risk factor addressing the potential for
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 31, 2022 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
October 31, 2022
Page 2
rapid and substantial price volatility and any known factors particular to your offering that
may add to this risk and discuss the risks to investors when investing in stock where the
price is changing rapidly. Clearly state that such volatility, including any stock run-up,
may be unrelated to your actual or expected operating performance and financial
condition or prospects, making it difficult for prospective investors to assess the rapidly
changing value of your stock.
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2022-10-13 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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October 13, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 5:30 PM, Eastern Time, on October 18, 2022, or as soon thereafter as practicable, or at such
other time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement
be declared effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2022-10-13 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
October 13, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on October 11, 2022, in which we, as representative of the several underwriters of Intensity Therapeutics, Inc.’s proposed
public offering, joined Intensity Therapeutics, Inc.’s request for acceleration of the effective date of the above-referenced Registration
Statement for October 13, 2022, at 5:30 p.m. Eastern Time. Intensity Therapeutics, Inc. is no longer requesting that such Registration
Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very truly yours,
ROTH CAPITAL PARTNERS,
LLC
As representative of the
several Underwriters
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2022-10-13 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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Intensity
Therapeutics, Inc.
61
Wilton Road, 3rd Floor
Westport,
CT 068809
October
13, 2022
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
RE:
Intensity
Therapeutics, Inc. (CIK 0001567264)
Registration
Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies
and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on October 11, 2022, in which we requested the acceleration of the effective date of the above-referenced
Registration Statement for Thursday, October 13, 2022 at 5:30 p.m. Eastern Standard Time. We are no longer requesting that such Registration
Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very
truly yours,
INTENSITY
THERAPEUTICS, INC.
By:
/s/
Lewis H. Bender
Lewis
H. Bender
Chief
Executive Officer
2022-10-13 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
October 13, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, 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 (the “Securities Act”), so that it may become effective
on October 18, 2022 at 5:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Daniel L. Woodard at (212) 547-5553. The Company hereby authorizes Mr. Woodard to orally modify or withdraw this
request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2022-10-11 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
October 11, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-260565
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request
of Intensity Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration
Statement so that it becomes effective at 5:30 PM, Eastern Time, on October 13, 2022, or as soon thereafter as practicable, or at such
other time as the Company or its outside counsel, McDermott Will & Emery LLP, request by telephone that such Registration Statement
be declared effective.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others
prior to the requested effective time of the Registration Statement.
We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Acting severally on behalf of itself and the several underwriters
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2022-10-11 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 068809
October 11, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Intensity Therapeutics, Inc. (CIK 0001567264)
Registration Statement No. 333-260565 on Form S-1 (the “Registration Statement”)
Ladies and Gentlemen:
Intensity Therapeutics, 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 (the “Securities Act”), so that it may become effective
on October 13, 2022 at 5:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned
respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel,
McDermott Will & Emery LLP, by calling Daniel L. Woodard at +1 212 547 5553. The Company hereby authorizes Mr.
Woodard to orally modify or withdraw this request for acceleration.
Very truly yours,
INTENSITY THERAPEUTICS, INC.
By:
/s/ Lewis H. Bender
Lewis H. Bender
Chief Executive Officer
2022-10-03 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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mwe.com
October 3, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 8 to Registration Statement on
Form S-1
Filed September 20, 2022
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a
Delaware corporation (the “Company”), we are responding to the comments from the Staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) dated September 29, 2022
(the “Comment Letter”), relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565)
filed by the Company on September 20, 2022 (the “Registration Statement”). In response to the comments set forth
in the Comment Letter, the Company has revised the Registration Statement and is filing it with the Commission together with its
submission of this response letter. Set forth below is the Company’s response to the Staff’s comments. For convenience,
the Staff’s comments are repeated below in bold, followed by the Company’s response.
Amendment No. 8 to Form S-1 filed September
20, 2022
Use of Proceeds, page 37
1.
We note your revised disclosure on page 37 that approximately 25% of the net proceeds from the offering will be allocated toward "initiating/conducting a Phase 3 sarcoma and/or Phase 2/3 early-stage breast cancer studies (IT-03 and IT-04)," your two most advanced programs. Please clarify the approximate amount of proceeds you intend to allocate towards each of the IT-03 and IT-04 programs identified and how far the proceeds from the offering will allow you to proceed with the continued development of each of these programs.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 14 and 37 of the revised Registration Statement.
Our Pipeline, page 52
2.
We note your references to the IT-01, IT-02, IT-03 and IT-04 studies throughout the prospectus, including in the Use of Proceeds and Business sections. Please update your pipeline table to identify the relevant IT-01, IT-02, IT-03 and IT-04 studies accordingly.
Response: In response to the Staff’s
comment, the Company has revised Figure 2 on page 53 of the revised Registration Statement to identify the relevant IT-01, IT-02, IT-03,
IT-04 studies accordingly.
INT230-6 Efficacy in Soft Tissue Sarcoma, page
75
3.
We refer to your disclosure on page 76 that the escalation in dosage of up to 175 mL of INT230-6 per session had "favorable safety." Please expand your disclosure to discuss whether any adverse events were observed in this trial.
Response: In response to the Staff’s comment, the Company has removed the referenced disclosure from the revised Registration Statement.
Employment Agreements, page 106
4.
We note your disclosure on page 107 that you are currently negotiating an agreement with Portage Development Services, Inc. for "use of staff time," which includes time for Dr. Walters. Please expand your disclosure to discuss your relationship with Portage Development Services, whether the working time of additional employees of the company, and the percentage of working time Dr. Walters and other employees will continue to devote to the company, as applicable.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 28 and 107 of the revised Registration Statement.
2
Please contact me
at +1 212 547 5553 if you have any questions or require any additional information in connection with this letter or the
Company’s submission of its revised Registration Statement on Form S-1.
Sincerely,
/s/ Daniel Woodard
cc: Lewis Bender, Chief Executive Officer
3
2022-09-29 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
September 29, 2022
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 8 to Registration Statement on Form S-1
Filed September 20, 2022
File No. 333-260565
Dear Mr. Bender:
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. 8 to Form S-1 filed September 20, 2022
Use of Proceeds, page 37
1.We note your revised disclosure on page 37 that approximately 25% of the net proceeds
from the offering will be allocated toward "initiating/conducting a Phase 3 sarcoma and/or
Phase 2/3 early-stage breast cancer studies (IT-03 and IT-04)," your two most advanced
programs. Please clarify the approximate amount of proceeds you intend to allocate
towards each of the IT-03 and IT-04 programs identified and how far the proceeds from
the offering will allow you to proceed with the continued development of each of these
programs.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
September 29, 2022 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
September 29, 2022
Page 2
Our Pipeline, page 52
2.We note your references to the IT-01, IT-02, IT-03 and IT-04 studies throughout the
prospectus, including in the Use of Proceeds and Business sections. Please update your
pipeline table to identify the relevant IT-01, IT-02, IT-03 and IT-04 studies accordingly.
INT230-6 Efficacy in Soft Tissue Sarcoma, page 75
3.We refer to your disclosure on page 76 that the escalation in dosage of up to 175 mL of
INT230-6 per session had "favorable safety." Please expand your disclosure to discuss
whether any adverse events were observed in this trial.
Employment Agreements, page 106
4.We note your disclosure on page 107 that you are currently negotiating an agreement with
Portage Development Services, Inc. for "use of staff time," which includes time for Dr.
Walters. Please expand your disclosure to discuss your relationship with Portage
Development Services, whether the working time of additional employees of the
company, and the percentage of working time Dr. Walters and other employees will
continue to devote to the company, as applicable.
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2022-05-16 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
May 16, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re: Intensity Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed November 12, 2021
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comment from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated April 28, 2022 (the “Comment Letter”),
relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565) filed by the Company on April 20, 2022 (the
“Registration Statement”). Set forth below is the Company’s response to the Staff’s comment. For convenience,
the Staff’s comment is repeated below in bold, followed by the Company’s response.
Amendment No. 6 to Form S-1 filed April 20,
2022
Prospectus Summary, page 1
1.
We note your disclosure of one grade 4 treatment related adverse event reported in your Phase 1 study. Please expand your disclosure to describe the type of adverse event observed.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 1 of the revised Registration Statement to describe the grade 4 adverse event
and add a cross reference to the longer description of the event on page 66 of the revised Registration Statement.
Business, page 52
2.
Please clarify the meaning and significance of scientific or technical terms the first time they are used to ensure the meaning of neutrophil decrease, STS, MTD and cosmesis.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 1 and 66 of the revised Registration Statement to clarify the meaning and significance
of “neutrophil”. In addition the Company has revised its disclosure on pages 75 76 and 80 of the revised Registration Statement
to clarify the meaning and significance of “STS, “MTD”, and cosmesis, respectively.
Please contact me at +1 202 756 8298 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Dan Woodard
cc: Lewis Bender, Chief Executive Officer
2022-04-28 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
April 28, 2022
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 6 to Registration Statement on Form S-1
Filed April 20, 2022
File No. 333-260565
Dear Mr. Bender:
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. 6 to Form S-1 filed April 20, 2022
Prospectus Summary, page 1
1.We note your disclosure of one grade 4 treatment related adverse event reported in your
Phase 1 study. Please expand your disclosure to describe the type of adverse event
observed.
Business, page 52
2.Please clarify the meaning and significance of scientific or technical terms the first time
they are used to ensure that lay readers will understand the disclosure. For example,
please explain the meaning of neutrophil decrease, STS, MTD and cosmesis.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
April 28, 2022 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
April 28, 2022
Page 2
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2021-12-10 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Intensity
Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport,
CT 06880
December
9, 2021
VIA
EDGAR
Division
of Corporation Finance
Office of Trade and Services
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
(File No. 333-260565)
Ladies and
Gentlemen:
Reference
is made to our letter, filed as correspondence via EDGAR on December 7, 2021, in which we requested the acceleration of the effective
date of the above-referenced Registration Statement for Thursday, December 9, 2021 at 5:00 p.m. EST. We are no longer requesting that
such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective
date.
Very truly yours,
Intensity Therapeutics, Inc.
By:
/s/
Lewis H. Bender
Name:
Lewis H. Bender
Title:
President and Chief Executive
Officer, Chairman
2021-12-10 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
December
9, 2021
U.S. Securities
and Exchange Commission
Division
of Corporation Finance
100 F Street,
N.E.
Washington,
D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
(File No. 333-260565)
Ladies and
Gentlemen:
Reference
is made to our letter, filed as corrvespondence via EDGAR on December 7, 2021, in which we, as representative of the underwriters of the
offering, joined Intensity Therapeutics, Inc.’s request for acceleration of the effective date of the above-referenced Registration
Statement for December 9, 2021, at 5:00 p.m. EST. Intensity Therapeutics, Inc. is no longer requesting that such Registration Statement
be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
[Signature
Page Follows]
Very truly yours,
A.G.P./Alliance
Global Partners
By:
/s/ Thomas
J. Higgins
Name: Thomas J. Higgins
Title: Managing Director
2021-12-09 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
December 9, 2021
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 3 to Registration Statement on
Form S-1
Filed December 8, 2021
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comment from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated December 9, 2021 (the “Comment Letter”),
relating to the above referenced Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-260565) filed by the Company on December
8, 2021 (the “Registration Statement”). Set forth below is the Company’s response to the Staff’s comment.
For convenience, the Staff’s comment is repeated below in bold, followed by the Company’s response.
Amendment No. 3 to Form S-1 filed December
8, 2021
Our amended and restated certificate of incorporation
that will be in effect at the closing..., page 33
1.
We note your disclosure that the federal courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. We also note that your amended and restated certificate of incorporation does not expressly include a forum selection provision for causes of action arising under the Securities Act. Please reconcile your disclosure and your governing documents as appropriate.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 33 and 113 of the revised Registration Statement.
Please contact me at 914 329 6625 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Robert H. Cohen
cc: Lewis Bender, Chief Executive Officer
2021-12-09 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
December 9, 2021
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 3 to Registration Statement on Form S-1
Filed December 8, 2021
File No. 333-260565
Dear Mr. Bender:
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 Form S-1 filed December 8, 2021
Our amended and restated certificate of incorporation that will be in effect at the closing..., page
33
1.We note your disclosure that the federal courts shall be the exclusive forum for the
resolution of any complaint asserting a cause of action arising under the Securities Act.
We also note that your amended and restated certificate of incorporation does
not expressly include a forum selection provision for causes of action arising under the
Securities Act. Please reconcile your disclosure and your governing documents as
appropriate.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
December 9, 2021 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
December 9, 2021
Page 2
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2021-12-07 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
EXECUTION VERSION
December 7, 2021
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Intensity Therapeutics, Inc.
Registration Statement on Form S-1
(File No. 333-260565)
Acceleration Request
Requested Date: December 9, 2021
Requested Time: 5:00 p.m. Eastern Standard Time
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended (the “Act”), A.G.P./Alliance Global Partners, as representative
on behalf of the underwriters, hereby join Intensity Therapeutics, Inc. in requesting that the Securities and Exchange Commission take
appropriate action to cause the Registration Statement on Form S-1 (File No. 333-260565) (the “Registration Statement”)
to become effective on December 9, 2021, at 5:00 p.m. Eastern Standard Time, or as soon thereafter as may be practicable.
Pursuant to Rule 460 under
the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters,
dealers, institutions and others, prior to the requested effective time of the Registration Statement.
We advise that we have complied
and will continue to comply, and that we have been informed by the participating underwriters that they have complied and will continue
to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
[Signature Page Follows]
Very truly yours,
A.G.P./Alliance Global Partners
By:
/s/ Thomas J. Higgins
Name: Thomas J. Higgins
Title: Managing Director
[Signature Page to Acceleration Reque
2021-12-07 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
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Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
December 7, 2021
VIA EDGAR
Division of Corporation Finance
Office of Trade and Services
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
RE: Intensity Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1
(File No. 333-260565) (the “Registration Statement”)
Ladies and Gentlemen:
The Company hereby requests,
pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement
so that such Registration Statement will become effective as of 5:00 p.m. EST on December 9, 2021, or as soon thereafter as practicable.
Very truly yours,
Intensity Therapeutics, Inc.
By:
/s/ Lewis H. Bender
Name:
Lewis H. Bender
Title:
President and Chief Executive Officer, Chairman
2021-11-18 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
November 18, 2021
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jane Park
Christopher Edwards
Sasha Parikh
Al Pavot
Re:
Intensity Therapeutics, Inc.
Amendment No. 1 to Registration Statement on
Form S-1
Filed November 12, 2021
File No. 333-260565
Dear Ms. Park:
On behalf of Intensity Therapeutics, Inc., a
Delaware corporation (the “Company”), we are responding to the comment from the Staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) dated November 16, 2021
(the “Comment Letter”), relating to the above referenced Registration Statement on Form S-1 (File No. 333-260565)
filed by the Company on November 12, 2021 (the “Registration Statement”). In response to the comment set forth in
the Comment Letter, the Company has revised the Registration Statement and is filing it with the Commission together with its
submission of this response letter. The revised Registration Statement also contains certain additional updates and revisions.
Set
forth below is the Company’s response to the Staff’s comment. For convenience, the Staff’s comment is repeated
below in bold, followed by the Company’s response.
Form S-1 filed November 12, 2021
Dilution, page 40
1.
Please revise the presentation to disclose historical net tangible book value (deficit) prior to the presentation of pro forma net tangible book value. We note that you followed this presentation in your prior filing. See Item 506 of Regulation S-K.
Response: In response to the Staff’s comment, the Company has included disclosure regarding its historical net tangible book value (deficit)
prior to the presentation of pro forma net tangible book value on page 40 of the revised Registration Statement.
2
Please contact me at 914 329 6625 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its revised Registration
Statement on Form S-1.
Sincerely,
/s/ Robert H. Cohen
cc: Lewis Bender, Chief Executive Officer
3
2021-11-16 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
November 16, 2021
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed November 12, 2021
File No. 333-260565
Dear Mr. Bender:
We have reviewed your amended registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to the comment, we may have additional comments.
Form S-1 amendment 1 filed November 12, 2021
Dilution, page 40
1.Please revise the presentation to disclose historical net tangible book value (deficit) prior
to the presentation of pro forma net tangible book value. We note that you followed this
presentation in your prior filing. See Item 506 of Regulation S-K.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
November 16, 2021 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
November 16, 2021
Page 2
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2021-11-12 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
November
12, 2021
VIA
EDGAR AND EMAIL
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane
Park
Christopher
Edwards
Sasha
Parikh
Al
Pavot
Re:
Intensity
Therapeutics, Inc.
Registration
Statement on Form S-1
Filed
October 28, 2021
File
No. 333-260565
Dear
Ms. Park:
On
behalf of Intensity Therapeutics, Inc., a Delaware corporation (the “Company”), we are responding to the comments
from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated
November 9, 2021 (the “Comment Letter”), relating to the above referenced Registration Statement on Form S-1 (File
No. 333-260565) filed by the Company on October 28, 2021 (the “Registration Statement”). In response to the comments
set forth in the Comment Letter, the Company has revised the Registration Statement and is filing it with the Commission together with
its submission of this response letter. The revised Registration Statement also contains certain additional updates and revisions.
Set
forth below are the Company’s responses to the Staff’s comments. For convenience, the Staff’s comments are repeated
below in bold, followed by the Company’s response to each comment as well as a summary of the responsive actions taken. We have
included page numbers to refer to the location in the revised Registration Statement, submitted on the date hereof, where the revised
language addressing a particular comment appears.
Form
S-1 filed October 28, 2021
Our
Pipeline, page 52
1.
We
note your response to prior comment 12. We note that you do not identify a specific target or indication or provide any other disclosure
in the registration statement regarding your INT33X product candidate. Given the status of development and limited disclosure regarding
the discovery program, it does not appear appropriate to highlight this program in your pipeline table. If this program is material
to your business to warrant inclusion in your pipeline table, please expand your disclosure in your Business section to provide a
more fulsome discussion of this program, including a description of preclinical studies or other development activities conducted.
Alternatively, please remove this program from the pipeline table or advise.
Response:
In response to the Staff’s comment, the Company has removed its INT33X product candidate from its pipeline table appearing on page
52 of the revised Registration Statement.
Clinical
Collaborations, page 63
2.
We
note your response to prior comment 17 relating to your collaboration agreements with Merck and Bristol-Myers Squibb (BMS). Please
expand your disclosure of the material terms of the collaboration agreements, such as the duration of the agreements, termination
provisions, aggregate potential milestone payments, royalty rates, royalty term and the aggregate amounts paid or received to date
(including the payment of any upfront or execution fees), as applicable.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 63 and 64 of the revised Registration Statement
to include additional terms of the collaboration agreements. The Company notes that neither agreement includes milestone payments, royalties
or other fees.
Exhibits
3.
We
note your headers to Exhibits 10.7 and 10.8 state that you have excluded certain information because it is both not material and
the type of information that the registrant treats as private or confidential. Please revise the footnotes to the exhibit index to
disclose that certain information in Exhibits 10.7 and 10.8 have been omitted in reliance upon Item 601(b)(10)(iv) of Regulation
S-K.
Response:
In response to the Staff’s comment, the Company has revised the footnotes to the exhibit index to disclose that certain information
in Exhibits 10.7 and 10.8 have been omitted in reliance upon Item 601(b)(10)(iv) of Regulation S-K.
2
Please
contact me at 914 329 6625 if you have any questions or require any additional information in connection with this letter or the Company’s
submission of its revised Registration Statement on Form S-1.
Sincerely,
/s/
Robert H. Cohen
cc:
Lewis Bender, Chief Executive Officer
3
2021-11-09 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
November 9, 2021
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Registration Statement on Form S-1
Filed October 28, 2021
File No. 333-260565
Dear Mr. Bender:
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 October 28, 2021
Our Pipeline, page 52
1.We note your response to prior comment 12. We note that you do not identify a specific
target or indication or provide any other disclosure in the registration statement regarding
your INT33X product candidate. Given the status of development and limited disclosure
regarding the discovery program, it does not appear appropriate to highlight this program
in your pipeline table. If this program is material to your business to warrant inclusion in
your pipeline table, please expand your disclosure in your Business section to provide a
more fulsome discussion of this program, including a description of preclinical studies or
other development activities conducted. Alternatively, please remove this program from
the pipeline table or advise.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
November 9, 2021 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
November 9, 2021
Page 2
Clinical Collaborations, page 63
2.We note your response to prior comment 17 relating to your collaboration agreements
with Merck and Bristol-Myers Squibb (BMS). Please expand your disclosure of the
material terms of the collaboration agreements, such as the duration of the agreements,
termination provisions, aggregate potential milestone payments, royalty rates, royalty term
and the aggregate amounts paid or received to date (including the payment of any upfront
or execution fees), as applicable.
Exhibits
3.We note your headers to Exhibits 10.7 and 10.8 state that you have excluded certain
information because it is both not material and the type of information that the registrant
treats as private or confidential. Please revise the footnotes to the exhibit index to disclose
that certain information in Exhibits 10.7 and 10.8 have been omitted in reliance upon Item
601(b)(10)(iv) of Regulation S-K.
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 Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.
2021-10-28 - CORRESP - INTENSITY THERAPEUTICS, INC.
CORRESP
1
filename1.htm
mwe.com
October 28, 2021
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Sasha Parikh
Al Pavot
Jane Park
Christopher Edwards
Re:
Intensity Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted September 20, 2021
CIK No. 0001567264
Dear Ms. Parikh:
On behalf of Intensity Therapeutics, Inc., a Delaware
corporation (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) dated October 18, 2021 (the “Comment Letter”),
relating to the above referenced draft Registration Statement on Form S-1 (CIK No. 0001567264) confidentially submitted by the Company
on September 20, 2021 (the “Registration Statement”). In response to the comments set forth in the Comment Letter,
the Company has revised the Registration Statement and is filing it with the Commission together with its submission of this response
letter. The revised Registration Statement also contains certain additional updates and revisions.
Set forth below are the Company’s responses
to the Staff’s comments. For convenience, the Staff’s comments are repeated below in bold, followed by the Company’s
response to each comment as well as a summary of the responsive actions taken. We have included page numbers to refer to the location
in the revised Registration Statement, submitted on the date hereof, where the revised language addressing a particular comment appears.
Draft Registration Statement on Form S-1 submitted
September 20, 2021
Prospectus Summary: Our Company, page 1
1.
We refer to your disclosure that your product candidate INT230-6 utilizes a combination of two proven anticancer cytotoxic agents, cisplatin and vinblastine. Please revise to clarify in the Summary and elsewhere, if true, that both are generic and FDA-approved drugs. Where appropriate, please also provide a brief overview of the FDA approved uses of cisplastin and vinblastine.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 1 and page 51 of the revised Registration Statement.
2.
We refer to your disclosure on page 1 and throughout the prospectus that your lead product candidate INT230-6 has an “excellent safety profile” and has shown “excellent safety” in clinical studies. Please note that determinations of safety and efficacy are solely within the authority of the FDA; therefore, please revise the prospectus to remove all references and/or implications of safety and efficacy, including those cited above.
Response: In response to the Staff’s
comment, the Company has revised its disclosure throughout the revised Registration Statement to remove references and/or implications
of the safety and efficacy of our lead product candidate INT230-6.
3.
We note your statement on pages 1 and 51 and elsewhere in the prospectus that you seek to develop and commercialize first and best-in-class medicines to treat cancer. The term “first-in-class” and “best-in-class” suggests that your product candidates are effective and likely to be approved as a new class of cancer therapeutics. Given the early stage of development of INT120-6 and your other product candidates, it is not appropriate to suggest that your products are likely to be effective or receive regulatory approval. Please delete these references throughout your registration statement. If your use of the term was intended to convey your believe that the product is based on a novel technology or approach, you may discuss how your technology differs from technology sued by competitors.
Response: In response to the Staff’s
comment, the Company has revised its disclosure throughout the revised Registration Statement to remove references to “first-in-class”
and “best-in-class” technologies.
2
The report by our auditors includes a paragraph
that states that substantial doubt exists about the Company’s ability..., page 8
4.
Please quantify the total dollar amount to redeem all of the shares of Series A Preferred Stock.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 9 of the revised Registration Statement.
We purchase components for our products from
third parties, some of which may be sole source suppliers, page 20
5.
We note your disclosure here that in certain cases, the components used to manufacture your product candidates may be sourced from single-source suppliers. Please expand your disclosure to discuss your sources, the availability of raw materials and the names of any principal suppliers. See Item 101(h)(4)(v) of Regulation S-K.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 22 of the revised Registration Statement.
Cautionary Note Regarding Forward-Looking Statements,
page 33
6.
You state on page 33 that investors are cautioned not to “place undue reliance on” statements that reflect your intentions and expectations disclosed in forward-looking statements. Please note that you are responsible for the disclosure contained in your registration statement and you may not use language that could be interpreted as a disclaimer of information contained in your filing. Please revise.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 35 of the revised Registration Statement.
3
Use of Proceeds, page 34
7.
Please revise to identify the specific product candidates (and target indications, as applicable) for which you intend to use the proceeds of the offering. Please also disclose the approximate amount of proceeds you intend to allocate toward each of the programs identified in the pipeline table and how far the proceeds from the offering will allow you to proceed with the continued development of each of your programs. Refer to Instruction 3 to Item 504 of Regulation S-K.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 36 of the revised Registration Statement.
Management’s Discussion and Analysis
of Financial Condition and Results of Operations Results of Operations, page 43
8.
Regarding your research and development expenses, please disclose the costs incurred during each period presented for each of your key research and development 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 research and development expenses incurred (i.e. by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 45 of the revised Registration Statement to include disclosure of the costs incurred
during each period presented for each of our key research and development projects.
9.
Regarding your general and administrative expenses, separately quantify each item noted for the change from prior periods.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 46 of the revised Registration Statement to include disclosure of the costs incurred during each period
presented for each of our general and administrative costs.
4
Our Pipeline, page 48
10.
Please revise your pipeline table to standardize the width of each of the Phase I, II and III columns. Revise the table to eliminate the separate columns for Preclinical Animal Pharmacology TE and GLP Toxicology, as those stages are not sufficiently distinct. Please also clarify the meaning of the abbreviated target indications included in the first column, such as mTNBC, CRC, SCC, PC, BC and HCC, and delete references to “P3” and “P2/3”. Please also discuss, where appropriate, the significance of the different colored circles at the end of the first column of your pipeline table.
Response: In response to the Staff’s
comment, the Company has revised the pipeline table on page 52 of the revised Registration Statement.
11.
We refer to your disclosure that that you have designed a Phase 3 study for soft tissue sarcoma, for which you have submitted a protocol synthesis to the FDA, and a Phase 2/3 development plan for the treatment of metastatic triple negative breast cancer (mTNBC). Please clarify whether you have completed Phase 2 studies, as well as the status of the FDA’s review and approval of (if applicable) your Phase 3 program for sarcoma and Phase 2/3 program for mTNBC. If the FDA has not approved your planned programs, please shorten the bars under the heading “INT230-6 Sarcomas P3” and “INT230-6 mTNBC P2/3” in your table accordingly.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 54 of the revised Registration Statement to include disclosure regarding the Company’s
discussions with the FDA on receiving approval for our Phase 3 study. The Company has also revised the pipeline table on page 52 of the
revised Registration Statement accordingly.
12.
We note the inclusion of your INT33X (Next Generation) discovery program in your pipeline table. Given the status of development and absence of disclosure relating to this program in the Business section, it seems premature to highlight this program prominently in your pipeline table. Please remove this program from the table or advise.
Response: The Company acknowledges the
Staff’s comment. The Company believes that it is important for investors that the INT33X (Next Generation) discovery program is
included the new product candidate research in the pipeline table in the Registration Statement. The product is currently in preclinical
testing and the Company plans to use proceeds from the offering to finance the development of the product candidate.
In response to the Staff’s comment, the
Company has revised its disclosure on page 52 of the revised Registration Statement to decrease the prominence of the new product development
in the pipeline table and provide additional disclosure regarding its preclinical status.
5
Our Strengths, page 49
13.
We refer to your disclosure on page 51 that you have designed and plan to conduct a Phase 3 study of INT230-6 for the treatment of sarcoma based on the data from your metastatic study in sarcoma patients. Please disclose the timeline for the use of INT230-6 for the treatment of sarcoma and your prior discussions with the FDA regarding the review of the trial design for your Phase 1, 2 and 3 programs for the treatment of sarcoma.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 54 of the revised Registration Statement to include disclosure regarding the Company’s
proposed timeline and its discussions with the FDA on receiving approval for our Phase 3 study.
INT230-6, Our Lead Product Candidate, page
55
14.
We refer to your disclosure of your collaboration with the National Cancer Institute (NCI). Please expand your disclosure to address related statistical significance and/or p-values in your mouse model showing increased absorption with your DfuseRx technology and the growth inhibition experiments. Please also expand your disclosure of your growth inhibition experiments to include the design and scope of your study and to discuss the data from the results to support the conclusions drawn.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 59 and 60 of the revised Registration Statement to include the requested disclosure.
Clinical Collaborations, page 58
15.
You disclose on page 58 that there were no drug-related serious adverse events in your IT-01 cohort combining INT230-6 and Keytruda. We note your disclosure on page 50 that a few low grade immune-related adverse events were reported in the combination. Please expand your disclosure here to discuss the immune-related adverse events observed, including the number of patients who experienced such symptoms.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 63 of the revised Registration Statement to include the requested disclosure.
16.
We note your disclosure on page 59 that Yervoy is a potent drug that has a relatively high percentage of severe side effects. Please expand your disclosure of the severe side effects of Yervoy. You also disclose that the combination of INT230-6 and Yervoy is being evaluated in patients in your Phase 2 cohorts. Please revise to discuss the design and scope of your studies using Yervoy and any immune-related adverse events that have been observed to date. We refer to your disclosure on page 50.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 63 of the revised Registration Statement to include the requested disclosure.
6
17.
We refer to your collaborations with Merck, Bristol-Myers Squibb (BMS) and Ottawa Hospital Research Institute and note that you have entered into clinical trial collaboration and supply agreements with Merck and BMS, both of which will be filed as exhibits to the registration statement. Please confirm if there is a collaboration agreement in place with the Ottawa Hospital Research Institute, and if so, please provide a brief description of the material terms of the arrangement and file the agreement as an exhibit to the registration statement or explain to us why you believe you are not required to do so. Please also revise to include descriptions of the material terms of your collaboration agreements with Merck and BMS. Refer to Item 601(b)(10) of Regulation S-K.
Response: The Company acknowledges the
Staff’s comment and advises that it has filed the Merck and BMS agreements as exhibits to the revised Registration
Statement. The Company will file its agreements with Ottawa Hospital Research Institute as part of a subsequent amendment.
In response to the Staff’s comment, the
Company has also revised its disclosure on pages 63 and 64 of the revised Registration Statement to include a brief description of the
material terms of each arrangement.
Clinical Trial Results, page 59
18.
We note your disclosure on pages 50 and 59 that eight patients experienced grade 3 related adverse events. Please describe the type of grade 3 adverse events observed in your Phase 1/2 study. You also disclose that the most frequent related adverse event included localized tumor related pain. If distinct from the grade 3 adverse events referenced above, please specify the number of patients who experienced localized tumor related pain. Please also include descriptions of the types of grade 1 or 2 adverse events that were observed throughout the prospectus, where applicable.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 65 of the revised Registration Statement to include the requested disclosure.
7
Data shows that INT230-6 may increase survival
in refractory cancer patients, page 60
19.
We refer to the results of your metastatic study disclosed on page 61 and study of different markers of cancer proliferation on page 63. Please revise to clarify whether the studies were powered for statistical significance and expand your discussion of the statistical significance and p-values with respect to the survival probability and reduction in the number of tumor cells, respectively (as applicable).
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 70 of
2021-10-18 - UPLOAD - INTENSITY THERAPEUTICS, INC.
United States securities and exchange commission logo
October 18, 2021
Lewis Bender
Chief Executive Officer
Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880
Re:Intensity Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted September 20, 2021
CIK No. 0001567264
Dear Mr. Bender:
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 submitted September 20, 2021
Prospectus Summary
Our Company, page 1
1.We refer to your disclosure that your product candidate INT230-6 utilizes a combination
of two proven anticancer cytotoxic agents, cisplastin and vinblastine. Please revise to
clarify in the Summary and elsewhere, if true, that both are generic and FDA-approved
drugs. Where appropriate, please also provide a brief overview of the FDA approved uses
of cisplastin and vinblastine.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 18, 2021 Page 2
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 2
2.We refer to your disclosure on page 1 and throughout the prospectus that your lead
product candidate INT230-6 has an “excellent safety profile” and has shown “excellent
safety” in clinical studies. Please note that determinations of safety and efficacy are solely
within the authority of the FDA; therefore, please revise the prospectus to remove all
references and/or implications of safety and efficacy, including those cited above.
3.We note your statement on pages 1 and 51 and elsewhere in the prospectus that you seek
to develop and commercialize first and best-in-class medicines to treat cancer. The term
“first-in-class” and “best-in-class” suggests that your product candidates are effective and
likely to be approved as a new class of cancer therapeutics. Given the early stage of
development of INT120-6 and your other product candidates, it is not appropriate to
suggest that your products are likely to be effective or receive regulatory approval. Please
delete these references throughout your registration statement. If your use of the term was
intended to convey your believe that the product is based on a novel technology or
approach, you may discuss how your technology differs from technology sued by
competitors.
The report by our auditors includes a paragraph that states that substantial doubt exists about the
Company's ability..., page 8
4.Please quantify the total dollar amount to redeem all of the shares of Series A Preferred
Stock.
We purchase components for our products from third parties, some of which may be sole source
suppliers, page 20
5.We note your disclosure here that in certain cases, the components used to manufacture
your product candidates may be sourced from single-source suppliers. Please expand
your disclosure to discuss your sources, the availability of raw materials and the names of
any principal suppliers. See Item 101(h)(4)(v) of Regulation S-K.
Cautionary Note Regarding Forward-Looking Statements, page 33
6.You state on page 33 that investors are cautioned not to “place undue reliance on”
statements that reflect your intentions and expectations disclosed in forward-looking
statements. Please note that you are responsible for the disclosure contained in your
registration statement and you may not use language that could be interpreted as a
disclaimer of information contained in your filing. Please revise.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 18, 2021 Page 3
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 3
Use of Proceeds, page 34
7.Please revise to identify the specific product candidates (and target indications, as
applicable) for which you intend to use the proceeds of the offering. Please also disclose
the approximate amount of proceeds you intend to allocate toward each of the programs
identified in the pipeline table and how far the proceeds from the offering will allow you
to proceed with the continued development of each of your programs. Refer to Instruction
3 to Item 504 of Regulation S-K.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 43
8.Regarding your research and development expenses, please disclose the costs incurred
during each period presented for each of your key research and development 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 research and development expenses incurred (i.e. by nature
or type of expense) which should reconcile to total research and development expense on
the Statements of Operations.
9.Regarding your general and administrative expenses, separately quantify each item noted
for the change from prior periods.
Our Pipeline, page 48
10.Please revise your pipeline table to standardize the width of each of the Phase I, II and III
columns. Revise the table to eliminate the separate columns for Preclinical Animal
Pharmacology TE and GLP Toxicology, as those stages are not sufficiently distinct.
Please also clarify the meaning of the abbreviated target indications included in the first
column, such as mTNBC, CRC, SCC, PC, BC and HCC, and delete references to “P3”
and “P2/3”. Please also discuss, where appropriate, the significance of the different
colored circles at the end of the first column of your pipeline table.
11.We refer to your disclosure that that you have designed a Phase 3 study for soft tissue
sarcoma, for which you have submitted a protocol synthesis to the FDA, and a Phase 2/3
development plan for the treatment of metastatic triple negative breast cancer (mTNBC).
Please clarify whether you have completed Phase 2 studies, as well as the status of the
FDA’s review and approval of (if applicable) your Phase 3 program for sarcoma and
Phase 2/3 program for mTNBC. If the FDA has not approved your planned programs,
please shorten the bars under the heading “INT230-6 Sarcomas P3” and “INT230-6
mTNBC P2/3” in your table accordingly.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 18, 2021 Page 4
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 4
12.We note the inclusion of your INT33X (Next Generation) discovery program in your
pipeline table. Given the status of development and absence of disclosure relating to this
program in the Business section, it seems premature to highlight this program prominently
in your pipeline table. Please remove this program from the table or advise.
Our Strengths, page 49
13.We refer to your disclosure on page 51 that you have designed and plan to conduct a
Phase 3 study of INT230-6 for the treatment of sarcoma based on the data from your
metastatic study in sarcoma patients. Please disclose the timeline for the use of INT230-6
for the treatment of sarcoma and your prior discussions with the FDA regarding the
review of the trial design for your Phase 1, 2 and 3 programs for the treatment of sarcoma.
INT230-6, Our Lead Product Candidate, page 55
14.We refer to your disclosure of your collaboration with the National Cancer Institute
(NCI). Please expand your disclosure to address related statistical significance and/or p-
values in your mouse model showing increased absorption with your DfuseRx technology
and the growth inhibition experiments. Please also expand your disclosure of your growth
inhibition experiments to include the design and scope of your study and to discuss the
data from the results to support the conclusions drawn.
Clinical Collaborations, page 58
15.You disclose on page 58 that there were no drug-related serious adverse events in your IT-
01 cohort combining INT230-6 and Keytruda. We note your disclosure on page 50 that a
few low grade immune-related adverse events were reported in the combination. Please
expand your disclosure here to discuss the immune-related adverse events observed,
including the number of patients who experienced such symptoms.
16.We note your disclosure on page 59 that Yervoy is a potent drug that has a relatively high
percentage of severe side effects. Please expand your disclosure of the severe side effects
of Yervoy. You also disclose that the combination of INT230-6 and Yervoy is being
evaluated in patients in your Phase 2 cohorts. Please revise to discuss the design and
scope of your studies using Yervoy and any immune-related adverse events that have been
observed to date. We refer to your disclosure on page 50.
17.We refer to your collaborations with Merck, Bristol-Myers Squibb (BMS) and Ottawa
Hospital Research Institute and note that you have entered into clinical trial collaboration
and supply agreements with Merck and BMS, both of which will be filed as exhibits to the
registration statement. Please confirm if there is a collaboration agreement in place with
the Ottawa Hospital Research Institute, and if so, please provide a brief description of the
material terms of the arrangement and file the agreement as an exhibit to the registration
statement or explain to us why you believe you are not required to do so. Please also
revise to include descriptions of the material terms of your collaboration agreements with
Merck and BMS. Refer to Item 601(b)(10) of Regulation S-K.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 18, 2021 Page 5
FirstName LastNameLewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 5
Clinical Trial Results, page 59
18.We note your disclosure on pages 50 and 59 that eight patients experienced grade 3
related adverse events. Please describe the type of grade 3 adverse events observed in
your Phase 1/2 study. You also disclose that the most frequent related adverse event
included localized tumor related pain. If distinct from the grade 3 adverse events
referenced above, please specify the number of patients who experienced localized tumor
related pain. Please also include descriptions of the types of grade 1 or 2 adverse events
that were observed throughout the prospectus, where applicable.
Data shows that INT230-6 may increase survival in refractory cancer patients, page 60
19.We refer to the results of your metastatic study disclosed on page 61 and study of different
markers of cancer proliferation on page 63. Please revise to clarify whether the studies
were powered for statistical significance and expand your discussion of the statistical
significance and p-values with respect to the survival probability and reduction in the
number of tumor cells, respectively (as applicable).
20.We note your discussion of the marked reduction in the amount of live cancer following
the first dose of treatment as depicted in the absence of a blue stain in Image B shown on
page 63. Please revise the graphic on page 63 to ensure that the significant reduction or
absence of blue stain is clearly visible to the lay reader.
Results from Sarcoma Tissue, page 64
21.Please expand your disclosure to specify the primary endpoint of the sarcoma study,
whether any adverse events were observed, the number of patients with metastatic soft
tissue sarcomas enrolled in the study to date and the number of patients who experienced
significant reduction of cancer as shown in Images A and B of the graphic at the bottom of
page 64. Please clarify whether there is any overlap between the sarcoma study discussed
on page 64 and the 18 sarcoma patients treated in your IT-01 study referenced on page 65.
Competition, page 83
22.We refer to your disclosure on pages 10 and 84 that some of your competitors have
developed products and therapies that are similar to your approach of intratumoral
delivery or the activation of the immune system, and may also be focused on treating the
same disease indications that your product candidates are focused on treating. Please
identify any competitors that to your knowledge are using intratumoral technology for the
treatment of cancer, including but not limited to, refractory or metastatic cancers.
Intellectual Property, page 84
23.Please revise your disclosure to identify for each issued U.S. patent and patent application
the scope of the technology to which each patent or patent application relates, the patent
protection and the expiration dates, as applicable.
FirstName LastNameLewis Bender
Comapany NameIntensity Therapeutics, Inc.
October 18, 2021 Page 6
FirstName LastName
Lewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 6
Management, page 86
24.For your directors, please disclose the specific skills, qualifications and attributes that led
you to the conclusion that the person should serve as your director. Refer to Item 401(e) of
Regulation S-K.
Principal Stockholders, page 97
25.Please revise footnote 9 to identify the natural persons who are the beneficial owners of
the shares held by Portage Biotech Inc., as well as to list the address of each such natural
person.
General
26.Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Woodard, Esq.