Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
ACTUATE THERAPEUTICS, INC.
Response Received
2 company response(s)
Medium - date proximity
↓
↓
ACTUATE THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
↓
ACTUATE THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
↓
ACTUATE THERAPEUTICS, INC.
Response Received
16 company response(s)
High - file number match
↓
Company responded
2024-06-11
ACTUATE THERAPEUTICS, INC.
References: May 31, 2024
↓
Company responded
2024-06-21
ACTUATE THERAPEUTICS, INC.
References: June 18, 2024
↓
↓
↓
↓
↓
↓
↓
↓
↓
↓
↓
↓
↓
↓
ACTUATE THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
ACTUATE THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
↓
Company responded
2024-05-24
ACTUATE THERAPEUTICS, INC.
References: May 20, 2024
ACTUATE THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
ACTUATE THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
ACTUATE THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-04 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-09-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-08-26 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-08342 | Read Filing View |
| 2025-07-31 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-07-31 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 333-288952 | Read Filing View |
| 2025-04-14 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-04-01 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 333-286201 | Read Filing View |
| 2024-08-12 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-12 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-19 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-19 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-17 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-17 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-15 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-15 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-06-18 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-06-11 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-05-31 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-05-24 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-05-20 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-04-19 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-04-01 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-26 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-08342 | Read Filing View |
| 2025-07-31 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 333-288952 | Read Filing View |
| 2025-04-01 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 333-286201 | Read Filing View |
| 2024-06-18 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-05-31 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-05-20 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-04-19 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| 2024-04-01 | SEC Comment Letter | ACTUATE THERAPEUTICS, INC. | DE | 377-07119 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-04 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-09-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-07-31 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2025-04-14 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-12 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-12 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-08-02 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-26 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-19 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-19 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-17 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-17 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-15 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-07-15 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-06-11 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2024-05-24 | Company Response | ACTUATE THERAPEUTICS, INC. | DE | N/A | Read Filing View |
2025-09-04 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP 1 filename1.htm Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, TX 76107 September 4, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Actuate Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-289988 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on September 2, 2025, in which we requested the acceleration of the effective date of the above-referenced registration statement (the " Registration Statement ") for September 4, 2025 at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, requested by telephone that such Registration Statement be declared effective at some other time, in accordance with Rule 461 under the Securities Act of 1933, as amended (the " Act "). We are no longer requesting that such Registration Statement be declared effective at that date and time and we hereby formally withdraw our request for acceleration of the effective date for September 4, 2025 at 4:00 p.m. Eastern Time. Further, by this letter, pursuant to Rule 461 under the Act, Actuate Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the Registration Statement be accelerated to September 8, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. If you have any questions regarding this request, please contact Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564. We also request that we be notified of such effectiveness by a telephone call to Ms. Spreen and that such effectiveness also be confirmed in writing. Very truly yours, Actuate Therapeutics, Inc. By: /s/ Daniel M. Schmitt Daniel M. Schmitt President and Chief Executive Officer
2025-09-02 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP 1 filename1.htm Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, TX 76107 September 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Actuate Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-289988 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Act "), Actuate Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the above-referenced registration statement (the " Registration Statement ") be accelerated to September 4, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. We request that we be notified of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564 and that such effectiveness also be confirmed in writing. Very truly yours, Actuate Therapeutics, Inc. By: /s/ Daniel M. Schmitt Daniel M. Schmitt President and Chief Executive Officer
2025-08-26 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-08342
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 26, 2025 Daniel Schmitt President and Chief Executive Officer Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, Texas 76107 Re: Actuate Therapeutics, Inc. Draft Registration Statement on Form S-3 Submitted August 18, 2025 CIK No. 0001652935 Dear Daniel Schmitt: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Janet Spreen, Esq. </TEXT> </DOCUMENT>
2025-07-31 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP 1 filename1.htm Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, TX 76107 July 31, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tyler Howes Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-288952 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Act "), Actuate Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the above-referenced registration statement (the " Registration Statement ") be accelerated to August 4, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. We request that we be notified of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564 and that such effectiveness also be confirmed in writing. Very truly yours, Actuate Therapeutics, Inc. By: /s/ Daniel M. Schmitt Daniel M. Schmitt President and Chief Executive Officer
2025-07-31 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 333-288952
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 31, 2025 Daniel Schmitt Chief Executive Officer Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, TX 76107 Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 Filed July 25, 2025 File No. 333-288952 Dear Daniel Schmitt: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Janet Spreen, Esq. </TEXT> </DOCUMENT>
2025-04-14 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP 1 filename1.htm Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, TX 76107 April 14, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-286201 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Act "), Actuate Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the above-referenced registration statement (the " Registration Statement ") be accelerated to April 16, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. We request that we be notified of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564 and that such effectiveness also be confirmed in writing. Very truly yours, Actuate Therapeutics, Inc. By: /s/ Daniel M. Schmitt Daniel M. Schmitt President and Chief Executive Officer
2025-04-01 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 333-286201
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Daniel Schmitt President and Chief Executive Officer Actuate Therapeutics, Inc. 1751 River Run, Suite 400 Fort Worth, Texas 76107 Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 Filed March 28, 2025 File No. 333-286201 Dear Daniel Schmitt: 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: Janet Spreen, Esq. </TEXT> </DOCUMENT>
2024-08-12 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
August 12, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Titan Partners Group LLC, a division of American
Capital Partners, LLC as representative of several underwriters, hereby join Actuate Therapeutics, Inc. (the
“Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration
Statement on Form S-1 (File No. 333-279734) (the “Registration Statement”) to become effective on Monday,
August 12, 2024, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such other time as the Company or its
outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that copies of
the Company’s Preliminary Prospectus, dated July 23, 2024, were furnished to several prospective underwriters and distributed
by the underwriters approximately as follows through the date hereof: approximately 500 copies to institutional investors and approximately
1000 copies to others.
The undersigned advise that
they have complied and will continue to comply with, and that they have been informed by the participating underwriters and dealers that
they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Adam Sands
Name:
Adam Sands
Title:
Authorized Representative
2024-08-12 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
August 12, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Act”), Actuate Therapeutics, Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to August 12, 2024, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel,
Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making
this acceleration request, the Company acknowledges that it is aware of its obligations under the Act.
We request that we be notified
of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564
and that such effectiveness also be confirmed in writing.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/
Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-08-02 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
August 2, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Withdrawal of Prior Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
with the U.S. Securities and Exchange Commission via EDGAR on July 30, 2024, in which we requested the acceleration of the effective
date of the above-captioned Registration Statement, as amended, to 5:00 p.m., Eastern Time, on August 1, 2024, or as soon thereafter
as reasonably practicable, unless the Company or its outside counsel, Baker & Hostetler LLP, requested by telephone that such
Registration Statement be declared effective at some other time, in accordance with Rule 461 under the Securities Act of 1933, as
amended. We are no longer requesting that the Registration Statement be declared effective at that date and time, and we hereby formally
withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Adam Sands
Name:
Adams Sands
Title:
Authorized Representative
2024-08-02 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate
Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
August 2, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on July 30, 2024, in which we requested the acceleration of the effective date of the above-referenced
registration statement (the “Registration Statement”) for August 1, 2024 at 5:00 p.m., Eastern Time, or as soon
thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, requested by telephone that such Registration
Statement be declared effective at some other time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We
are no longer requesting that such Registration Statement be declared effective at that date and time and we hereby formally withdraw
our request for acceleration of the effective date.
If you have any questions
regarding this request, please contact Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/ Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-07-30 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
July 30, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended (the “Act”), Titan Partners Group LLC, a division of American Capital Partners,
LLC as representative of several underwriters, hereby join Actuate Therapeutics, Inc. (the “Company”) in requesting that
the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-279734)
(the “Registration Statement”) to become effective on Thursday, August 1, 2024, at 5:00 p.m., Eastern Time, or as soon
thereafter as practicable, or at such other time as the Company or its outside counsel, Baker & Hostetler LLP, request by telephone
that such Registration Statement be declared effective.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that copies of
the Company’s Preliminary Prospectus, dated July 23, 2024, were furnished to several prospective underwriters and distributed
by the underwriters approximately as follows through the date hereof: approximately 500 copies to institutional investors and approximately
1000 copies to others.
The undersigned advise that
they have complied and will continue to comply with, and that they have been informed by the participating underwriters and dealers that
they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners,
LLC
By:
/s/ Adam Sands
Name:
Adam Sands
Title:
Authorized Representative
2024-07-30 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate
Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
July 30, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Act”), Actuate Therapeutics, Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to August 1, 2024, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel,
Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making
this acceleration request, the Company acknowledges that it is aware of its obligations under the Act.
We request that we be notified
of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564
and that such effectiveness also be confirmed in writing.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/ Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-07-26 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
July 26, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Withdrawal of Prior Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
with the U.S. Securities and Exchange Commission via EDGAR on July 19, 2024, in which we requested the acceleration of the effective date
of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern Time, on July 23, 2024, or as soon thereafter as reasonably
practicable. We are no longer requesting that the Registration Statement be declared effective at that date and time, and we hereby formally
withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Sanjay Allahdad
Name:
Sanjay Allahdad
Title:
Authorized Representative
2024-07-26 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate
Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
July 26, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on July 19, 2024, in which we requested the acceleration of the effective date of the above-referenced
registration statement (the “Registration Statement”) for July 23, 2024 at 4:30 p.m., Eastern Time, or as soon
thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, requested by telephone that such Registration
Statement be declared effective at some other time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We
are no longer requesting that such Registration Statement be declared effective at that date and time and we hereby formally withdraw
our request for acceleration of the effective date.
If you have any questions
regarding this request, please contact Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/
Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive
Officer
2024-07-19 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
July 19, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended (the “Act”), Titan Partners Group LLC, a division of American Capital Partners,
LLC as representative of several underwriters, hereby join Actuate Therapeutics, Inc. (the “Company”) in requesting that the
Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-279734) (the
“Registration Statement”) to become effective on Tuesday, July 23, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter
as practicable, or at such other time as the Company or its outside counsel, Baker & Hostetler LLP, request by telephone that such
Registration Statement be declared effective.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that copies of the Company’s
Preliminary Prospectus, dated July 19, 2024, were furnished to several prospective underwriters and distributed by the underwriters approximately
as follows through the date hereof: approximately 500 copies to institutional investors and approximately 1000 copies to others.
The undersigned advise that
they have complied and will continue to comply with, and that they have been informed by the participating underwriters and dealers that
they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as
amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Adam Sands
Name:
Adam Sands
Title:
Authorized Representative
2024-07-19 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
July 19, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Act”), Actuate Therapeutics, Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to July 23, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel,
Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making
this acceleration request, the Company acknowledges that it is aware of its obligations under the Act.
We request that we be notified
of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564
and that such effectiveness also be confirmed in writing.
Very
truly yours,
Actuate
Therapeutics, Inc.
By:
/s/ Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-07-17 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate
Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
July 17, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on July 15, 2024, in which we requested the acceleration of the effective date of the above-referenced
registration statement (the “Registration Statement”) for July 17, 2024 at 4:30 p.m., Eastern Time, in accordance
with Rule 461 under the Securities Act of 1933, as amended. 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.
If you have any questions
regarding this request, please contact Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/ Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-07-17 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
July 17, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Withdrawal of Prior Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
with the U.S. Securities and Exchange Commission via EDGAR on July 15, 2024, in which we requested the acceleration of the effective
date of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern Time, on July 17, 2024. We are no longer requesting
that the Registration Statement be declared effective at that date and time, and we hereby formally withdraw our prior request for acceleration
of the effective date of the above-captioned Registration Statement, as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Sanjay Allahdad
Name:
Sanjay Allahdad
Title:
Authorized Representative
2024-07-15 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
July 15, 2024
VIA EDGAR
U.S. Securities and Exchange Commission Division
of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Re:
Actuate Therapeutics Inc.
Registration Statement on Form S-1, as amended (File No. 333-279734)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Titan Partners Group LLC, a division of American
Capital Partners, LLC as representative of several underwriters, hereby join Actuate Therapeutics, Inc. (the
“Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration
Statement on Form S-1 (File No. 333-279734) (the “Registration Statement”) to become effective on Wednesday,
July 17, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such other time as the Company or its
outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective.
Pursuant to
Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise
you that copies of the Company’s Preliminary Prospectus, dated June 21, 2024, were furnished to several prospective
underwriters and distributed by the underwriters approximately as follows through the date hereof: approximately 500 copies to
institutional investors and 500 copies to others.
The undersigned advise that
they have complied and will continue to comply with, and that they have been informed by the participating underwriters and dealers that
they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.
Very truly yours,
Titan Partners Group LLC,
a division of American Capital Partners, LLC
By:
/s/ Sanjay Allahdad
Name:
Sanjay Allahdad
Title:
Authorized Representative
2024-07-15 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
July 15, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Attalah, Kevin Kuhar, Jessica Dickerson
and Tim Buchmiller
Re: Actuate Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-279734
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the “Act”), Actuate Therapeutics, Inc. (the “Company”) hereby
requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated
to July 17, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler
LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request,
the Company acknowledges that it is aware of its obligations under the Act.
We request that we be notified
of such effectiveness by a telephone call to Janet Spreen of Baker & Hostetler LLP, counsel to the Company, at (216) 861-7564 and
that such effectiveness also be confirmed in writing.
Very truly yours,
Actuate Therapeutics, Inc.
By:
/s/ Daniel M. Schmitt
Daniel M. Schmitt
President and Chief Executive Officer
2024-06-21 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
June 21, 2024
Janet Spreen
direct dial: 216.861.7090
jspreen@bakerlaw.com
Office of Life Sciences
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Atallah, Kevin Kuhar, Jessica Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 Filed May 24, 2024 File No. 333-279734 (the “Registration
Statement”)
Ladies and Gentlemen:
On behalf of Actuate Therapeutics, Inc. (the “Company”),
we hereby respond as set forth below to the letter dated June 18, 2024 from the staff of the U.S. Securities and Exchange Commission
(the “Staff”) with respect to the above-referenced Registration Statement. Simultaneously with the submission of this letter,
the Company is publicly filing via EDGAR Amendment No. 2 to the Registration Statement responding to the Staff’s comment and
updating its disclosures in the Registration Statement.
To assist your review, we have retyped the text of the Staff’s
comment in italics below. Please note that all references to page numbers in our response refer to the page numbers of the Registration
Statement. Capitalized terms used in our responses below that are not otherwise defined have the meanings ascribed to them in the Registration
Statement.
June 21, 2024
Page 2
Amendment No. 1 to Registration Statement on Form S-1,
Filed June 11, 2024
Capitalization, page 76
1. Please
explain to us why your Capitalization table presents only total stockholders' (deficit) equity without providing a
line item depicting total capitalization.
In response to the Staff’s comment, the Company has
revised its disclosure on page 76 to add a line item depicting total capitalization.
2. We
note from your disclosures on page F-17 that your redeemable convertible preferred stock will automatically convert upon the closing
of a public offering resulting in at least $100 million in gross proceeds. Given that the proceeds from your current offering are expected
to be approximately $50 million, please tell us and revise your disclosure here to address how you determined it was appropriate to assume
the automatic conversion of your redeemable convertible preferred stock in your pro forma presentation. Revise your presentation as needed.
Similarly revise the related disclosures throughout your document that discuss the assumption that your preferred stock will convert
immediately prior to the offering.
In response to the Staff’s comment, the Company has
revised its disclosure on pages 9, 76, 172 and 180 to explain that the terms of each series of the redeemable convertible preferred stock provide
that the holders of at least a majority of the then outstanding shares of such series can vote to cause all shares of such series to be
automatically converted into common stock upon the occurrence of a specified event. The holders of at least a majority of the shares of
each series consented to the conversion of such shares immediately prior to the completion of this offering.
Sincerely,
/s/
Janet Spreen
Partner
2024-06-18 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
June 18, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 11, 2024
File No. 333-279734
Dear Daniel Schmitt:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our May 31, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-1, Filed June 11, 2024
Capitalization, page 76
1.Please explain to us why your Capitalization table presents only total stockholders'
(deficit) equity without providing a line item depicting total capitalization.
2.We note from your disclosures on page F-17 that your redeemable convertible preferred
stock will automatically convert upon the closing of a public offering resulting in at least
$100 million in gross proceeds. Given that the proceeds from your current offering are
expected to be approximately $50 million, please tell us and revise your disclosure here to
address how you determined it was appropriate to assume the automatic conversion of
your redeemable convertible preferred stock in your pro forma presentation. Revise your
presentation as needed. Similarly revise the related disclosures throughout your document
that discuss the assumption that your preferred stock will convert immediately prior to the
offering.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
June 18, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
June 18, 2024
Page 2
Please contact Eric Atallah at 202-551-3663 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Janet Spreen, Esq.
2024-06-11 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
June 11, 2024
Janet Spreen
direct dial: 216.861.7090
jspreen@bakerlaw.com
Office of Life Sciences
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Atallah, Kevin Kuhar, Jessica
Dickerson and Tim Buchmiller
Re: Actuate Therapeutics, Inc. Registration Statement on Form S-1 Filed May 24, 2024 File No. 333-279734 (the “Registration
Statement”)
Ladies and Gentlemen:
On behalf of Actuate Therapeutics, Inc. (the “Company”),
we hereby respond as set forth below to the letter dated May 31, 2024 from the staff of the U.S. Securities and Exchange Commission
(the “Staff”) with respect to the above-referenced Registration Statement. Simultaneously with the submission of this letter,
the Company is publicly filing via EDGAR Amendment No. 1 to the Registration Statement responding to the Staff’s comment and
updating its disclosures in the Registration Statement.
To assist your review, we have retyped the text of the Staff’s
comment in italics below. Please note that all references to page numbers in our response refer to the page numbers of the Registration
Statement. Capitalized terms used in our responses below that are not otherwise defined have the meanings ascribed to them in the Registration
Statement.
Registration Statement on Form S-1, Filed May 24, 2024
Prospectus Summary
The Offering, page 8
June 11, 2024
Page 2
1. We note your disclosure that the
number of shares of common stock outstanding does not include the shares issuable under restricted stock units to be granted to your
president and chief executive officer upon the closing of this offering pursuant to his employment agreement. You make additional
references to this grant on pages 10 and 62. However, in the description of your employment agreement with Daniel Schmitt on
page 159, you disclose that Mr. Schmitt would be entitled to receive shares of common stock rather than restricted stock
units. Such disclosure appears to be consistent with the employment agreement filed as Exhibit 10.6. Please revise your
disclosures as appropriate to reconcile this apparent inconsistency or otherwise advise.
In response to the Staff’s comment, the Company has
revised its disclosure on page 160 and refiled an amended and restated Exhibit 10.6 to reflect the Company’s intent to
issue restricted stock units rather than restricted stock to the Company’s president and chief executive officer under his employment
agreement upon the closing of the offering.
Sincerely,
/s/ Janet Spreen
Partner
2024-05-31 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
May 31, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 24, 2024
File No. 333-279734
Dear Daniel Schmitt:
We have reviewed your registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-1, Filed May 24, 2024
Prospectus Summary
The Offering, page 8
1.We note your disclosure that the number of shares of common stock outstanding does not
include the shares issuable under restricted stock units to be granted to your president and
chief executive officer upon the closing of this offering pursuant to his employment
agreement. You make additional references to this grant on pages 10 and 62. However, in
the description of your employment agreement with Daniel Schmitt on page 159, you
disclose that Mr. Schmitt would be entitled to receive shares of common stock rather than
restricted stock units. Such disclosure appears to be consistent with the employment
agreement filed as Exhibit 10.6. Please revise your disclosures as appropriate to reconcile
this apparent inconsistency or otherwise advise.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
May 31, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
May 31, 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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Janet Spreen, Esq.
2024-05-24 - CORRESP - ACTUATE THERAPEUTICS, INC.
CORRESP
1
filename1.htm
May 24, 2024
Janet Spreen
direct dial: 216.861.7090
jspreen@bakerlaw.com
Office of Life
Sciences
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Atallah, Kevin Kuhar, Jessica
Dickerson and Tim Buchmiller
Re: Actuate
Therapeutics, Inc. Amendment No. 3 Draft Registration Statement on Form S-1
Submitted May 13, 2024 (the “Draft Registration Statement”)
Ladies and Gentlemen:
On behalf of Actuate Therapeutics, Inc. (the “Company”),
we hereby respond as set forth below to the letter dated May 20, 2024 from the staff of the U.S. Securities and Exchange Commission
(the “Staff”) with respect to the above-referenced confidential draft Amendment No. 3 to Draft Registration Statement.
Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR a Registration Statement on Form S-1
(the “Registration Statement”) responding to the Staff’s comments and updating its disclosures in the Registration
Statement.
To assist your review, we have retyped the text of the Staff’s
comments in italics below. Please note that all references to page numbers in our responses refer to the page numbers of the
Registration Statement. Capitalized terms used in our responses below that are not otherwise defined have the meanings ascribed to them
in the Registration Statement.
Business
Developing Elraglusib for the Treatment of Ewing Sarcoma Development
Plan in Ewing Sarcoma, page 125
May 24, 2024
Page 2
1. We note your response to prior comment 1, and we reissue the
comment in part. Please further revise the added disclosure in the first paragraph of this section to clarify whether any action on the
amended 1902 Phase 1/2 protocol will be required by the FDA. Please also clarify the status and timing for the planned amendment, including
for your central IRB approval and, if applicable, any other required regulatory approvals.
In response to the Staff’s comment, the Company has
revised its disclosure on page 125 to clarify whether any action on the amended 1902 Phase 1/2 protocol will be required by the
FDA and also clarify the status and timing for the planned amendment, including for the Company’s central IRB approval and, if
applicable, any other required regulatory approvals.
Sincerely,
/s/
Janet Spreen
Partner
2024-05-20 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
May 20, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted May 13, 2024
CIK No. 0001652935
Dear Daniel Schmitt:
We have reviewed your amended draft registration statement and have the following
comment.
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 a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in our
May 8, 2024 letter.
Amendment No. 3 to Draft Registration Statement on Form S-1, Submitted May 13, 2024
Business
Developing Elraglusib for the Treatment of Ewing Sarcoma
Development Plan in Ewing Sarcoma, page 125
1.We note your response to prior comment 1, and we reissue the comment in part. Please
further revise the added disclosure in the first paragraph of this section to clarify whether
any action on the amended 1902 Phase 1/2 protocol will be required by the FDA. Please
also clarify the status and timing for the planned amendment, including for your central
IRB approval and, if applicable, any other required regulatory approvals.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
May 20, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
May 20, 2024
Page 2
Please contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Janet Spreen, Esq.
2024-05-08 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
May 8, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted April 30, 2024
CIK No. 0001652935
Dear Daniel Schmitt:
We have reviewed your amended draft registration statement and have the following
comments.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in our
April 19, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1, Submitted April 30, 2024
Prospectus Summary
Pipeline and Development Timeline, page 2
1.We note your response to prior comment 4, and we reissue the comment. Given your
disclosure that the Actuate-1902 study is only accruing patients with refractory Ewing
sarcoma into the Phase 1 portion of the study and that you plan to amend the Phase 2
portion of the Actuate-1902 protocol to focus only on those patients with Ewing sarcoma,
please revise the pipeline table to shorten the arrow related to this study to avoid
indicating that the Phase 2 portion of the study has already commenced and is ongoing.
Please also disclose in an appropriate location if amending the Actuate-1902 protocol
would require regulatory approval, and, if so, the status and timing of such approval.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
May 8, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
May 8, 2024
Page 2
Business
License Agreements
Collaboration Agreement, page 117
2.We note the added disclosure regarding your Collaboration Agreement with Lantern
Pharma. Please tell us what consideration you gave to discussing your entry into the
Collaboration Agreement under "Certain Relationships and Related Party
Transactions" and filing a copy of the agreement as an exhibit to the registration
statement. Refer to Items 404 and 601(b)(10) of Regulation S-K.
Please contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Janet Spreen, Esq.
2024-04-19 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
April 19, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted April 9, 2024
CIK No. 0001652935
Dear Daniel Schmitt:
We have reviewed your amended draft registration statement and have the following
comments.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in our
April 1, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1, Submitted April 9, 2024
Prospectus Summary
Our Market Opportunity, page 2
1.We note your statement on pages 2 and 92 that, "[s]ubject to [y]our receipt of the proceeds
of this offering, the manufacture of Elraglusib Oral Tablet under current Good
Manufacturing Practices (cGMP) is expected to be available in the third quarter of
2024...." Please reconcile this statement with your statement on page 108 that "GMP
investigational product has already been manufactured...."
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 19, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 19, 2024
Page 2
Pipeline and Development Timeline, page 2
2.We note that the revised pipeline table now separately depicts Part 1 and 2, Part 3A, and
Part 3B of the Actuate-1801 study; Phase 1 and Phase 2 of the Actuate-1902 study; and
Phase 1 and Phase 2 of the Actuate-2401 study. Please include footnote disclosure to the
table clarifying, if true, that within each study, each subsequent part or phase is successive
to the preceding part or phase and not a separate study that will individually proceed
through each of phases 1, 2, and 3 of clinical trials. Alternatively, please tell us why you
do not believe such disclosure would be appropriate.
3.We note your response to prior comment 3. Specifically, we note that the revised pipeline
table now separately depicts Part 1 and 2, Part 3A, and Part 3B of the Actuate-1801 study,
with the arrow for the Part 3A study indicating that the Part 3A study has completed phase
2. However, although we note a discussion of results of this study on page 110 of the
prospectus, certain other disclosures in the prospectus suggest that the study is not yet
complete. For example, on pages 4 and 109, you state that you "have initiated a Phase 2
trial testing Elraglusib Injection in combination with chemotherapy in pancreatic cancer
under this Master protocol (Actuate-1801 Part 3A)." In addition, on page 91, you state that
you have "amended and expanded the Stage 2 of the study to a randomized, controlled
trial now powered for statistical significance (Actuate-1801 Part 3A)." Please revise your
disclosures and, if applicable, your pipeline table as appropriate to clarify whether the
Actuate-1801 Part 3A study has completed, or is ongoing in, phase 2.
4.We note that the revised pipeline table now indicates that the Actuate-1902 study for
Ewing Sarcoma has commenced, or is initiating, phase 2, rather than being "in planning,"
as originally indicated. However, we note your disclosures on pages 2, 4, 92, 94, and 116
that you plan to amend the phase 2 protocol and reopen the phase 2 portion of the study to
focus on Ewing Sarcoma. We further note your disclosure on page 116 that your plan to
amend this protocol is subject to you having sufficient funding from the proceeds of this
offering. Please revise the pipeline table to indicate, if true, that you have not yet
commenced the Actuate-1902 phase 2 study for the given indication, or tell us why you do
not believe such revision is appropriate.
Our Strategy, page 4
5.We note your response to prior comment 6, and we reissue the comment in part. Please
further balance your disclosure in the third bullet point with a statement that the
designations described in the bullet point do not increase the likelihood that a product
candidate will receive FDA approval. This comment also applies to the disclosure in the
third bullet point on page 109.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 19, 2024 Page 3
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 19, 2024
Page 3
Risk Factors
We may also rely on certain third party vendors located in China...., page 31
6.We note your disclosure regarding the adverse impact on your current clinical
development programs if your third-party vendors who are located in China, or who are
owned by or associated with certain Chinese companies, were no longer permitted to
provide services or products due to geopolitical pressures. Specifically, we note your
disclosure that you could experience delays in finding suitable replacement service
providers located outside China or not otherwise associated with Chinese companies. If
known, please disclose whether you believe suitable alternative vendors are, or would be,
available, particularly for your sole source manufacturer for elraglusib, as disclosed on
page 29.
Use of Proceeds, page 71
7.We note your response to prior comment 9, and we reissue the comment in part. Please
disclose the approximate amount of offering proceeds you intend to use for each identified
purpose. In this regard, although we note a placeholder for the approximate amount of
proceeds you intend to use to fund the research and development of elraglusib, including
certain manufacturing activities, it is unclear how much of these proceeds you intend to
use for each of the elraglusib trials and studies discussed in this section.
Business
Our Pipeline and Development Timeline, page 93
8.We note your response to prior comment 12. Specifically, we note your disclosure on
page 79, and similar disclosures on pages 2, 92, 94, 95, and 116, that, subject to your
receipt of the proceeds of this offering, you are "planning a Phase 1 study (Actuate-2401)
to identify the RP2D for Elraglusib Oral Tablet in patients with advanced, refractory adult
cancers" and that "[s]everal Phase 2 indications, including refractory, metastatic
melanoma and refractory, metastatic colorectal cancer have been identified for further
clinical development of Elraglusib Oral Tablet...." Please revise your disclosure to clarify,
if true, that, although you intend to use a portion of the proceeds of this offering to finalize
development plans for the Actuate-2401 phase 1 and phase 2 studies, you may require
additional funds to initiate and complete the studies. In this regard, we note your
disclosure on page 71 that you expect the net proceeds from this offering, together with
your existing cash and cash equivalents, will allow you "to finalize development plans and
to potentially initiate and complete a Phase 1 dose escalation study in patients with
advanced, refractory solid cancer; and to finalize development plans for and potentially
initiate a Phase 2 study in refractory metastatic melanoma."
Developing Elraglusib for the Treatment of mPDAC
Summary of Investigator-Initiated Trials, page 113
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 19, 2024 Page 4
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 19, 2024
Page 4
9.Here, or in another appropriate section of the registration statement, please describe the
material terms of your arrangements with the IIT investigators or other sponsors of the
investigator-initiated trials. In this regard, we note your added disclosure in the second
bullet point on page 4 that you provide financial and resource support for IITs in exchange
for rights to the trial data. We further note similar disclosure on pages 13, 71, and 109
regarding your "funding commitments for ongoing IIT studies for the use of Elraglusib
Injection with other chemotherapy agents to treat mPDAC and a separate trial to treat
recurrent salivary gland cancer." Your description should include the nature and extent of
your obligations to fund the ongoing IIT studies, any material rights you have pursuant to
these arrangements, and the termination provisions for such arrangements.
License Agreements, page 116
10.We note from Section 2.4 of the UIC License Agreement and Section 2.2 of the NU
License Agreement that you agreed to manufacture products related to these license
agreements in the United States, unless waived. Describe these provisions and indicate
how you are currently in compliance with these provisions given your disclosure on page
29 that your current manufacturer is in China. Include risk factor disclosure if appropriate.
11.We note your response to prior comment 14. We also note that, consistent with your prior
disclosure, Section 8.1 of the NU License Agreement provides that the "Agreement shall
continue in effect, on a country-by-country basis, until the expiration of the last to expire
patent rights covering 9-ING-41 and related GSK-3 inhibitors." Please tell us how to
reconcile your current disclosure, that no patent rights are licensed by you under the NU
License Agreement, with Section 8.1 of the NU License Agreement, and revise your
disclosure, if appropriate, for clarification.
Intellectual Property, page 117
12.We note the added disclosure in the penultimate paragraph that you "may apply for PTE
under Title II of Hatch-Waxman." Please clarify whether this statement applies generally
to the U.S. patents described in this section or to specific patents. Please also disclose, if
true, that there is no guarantee that PTE would be granted for any patent.
Manufacturing, page 118
13.We note your disclosure on page 29 that you rely upon a single company to manufacture
the drug substance for your sole product candidate, elraglusib. Please expand your
disclosure to include the name of your principal supplier. Refer to Item 101(h)(4)(v) of
Regulation S-K.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 19, 2024 Page 5
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 19, 2024
Page 5
Principal Securityholders, page 158
14.We note your response to prior comment 26. Please tell us how you determined that
Daniel Zabrowski does not have voting and/or investment power with respect to the shares
held in the Catherine A. Zabrowski Irrevocable Trust, for which Daniel Zabrowski’s wife,
Catherine A. Zabrowski, serves as trustee. Refer to Exchange Act Rule 13d-3 and
Question 105.05 of the "Exchange Act Sections 13(d) and 13(g) and Regulation 13D-G
Beneficial Ownership Reporting" Compliance and Disclosure Interpretations, available on
our website. In your response, please explain to us, to the extent applicable:
•the arrangement pursuant to which Daniel Zabrowski’s equity compensation received
for his services as a director is deposited into the trust, as disclosed in footnote 4 to
the director compensation table on page 147;
•whether Daniel Zabrowski has direct or indirect control or influence over the exercise
of any voting and/or dispositive power over Company shares held in the trust; and
•whether the trust agreement includes a mechanism to return voting and/or dispositive
power over the shares to Daniel Zabrowski.
General
15.We note your response to prior comment 30. However, the left column of the charts in
Figure 10 on page 103 and in Figure 16 on page 108 still appears to be illegible. In
addition, it is difficult to read the axes and legends in Figure 15 on page 108. Please revise
these figures to make them more legible.
Please contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Janet Spreen, Esq.
2024-04-01 - UPLOAD - ACTUATE THERAPEUTICS, INC. File: 377-07119
United States securities and exchange commission logo
April 1, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted March 4, 2024
CIK No. 0001652935
Dear Daniel Schmitt:
We have reviewed your draft registration statement and have the following comments.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1 Submitted March 4, 2024
Prospectus Summary
Our Lead Product Candidate, page 1
1.We note your disclosure in the last paragraph on page 1 that "[o]bjective responses and
durable disease control were observed in both the single agent and combination treatment
arms of the study" and that you observed a "median overall survival (mOS) of 15.3
months in the efficacy evaluable (n=29) patient population." Please clarify if these results
were based on studies powered for statistical significance.
Pipeline and Development Timeline, page 2
2.We note that your pipeline table includes the investigator-initiated studies with elraglusib.
We further note your disclosure on page 90 that “[t]hese studies are exploratory and not
considered critical path for [you] at this stage and will not be discussed further beyond the
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 1, 2024 Page 2
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 1, 2024
Page 2
summary in Figure 14.” Please provide us with your analysis as to whether these
investigator-initiated studies are material and should be included in your pipeline table.
3.For clarity, please revise your pipeline table to identify the study names (e.g., Actuate-
1801) covered by each row. Please also shorten the length of the arrow in the first row of
the pipeline table, or tell us why you do not believe the revision is appropriate. In this
regard, the arrow appears to indicate that you are further along in your phase 2 trials,
nearing phase 3, than indicated in your disclosures throughout the registration statement.
For example, we note your disclosure on page 90 that a randomized, controlled phase 2
trial has finished accrual.
4.We note your disclosure on page 2 that you are also evaluating the potential for additional
exploratory development of Elraglusib Injection in other pediatric cancer indications,
including neuroblastoma. Please tell us why your pipeline table shows you may be
pursuing Elraglusib Oral Tablet for neuroblastoma or revise your disclosure as
appropriate.
5.We note your disclosure on page 2 that "[s]everal Phase 2 indications, including
refractory, metastatic melanoma and refractory, metastatic colorectal cancer have been
identified for further clinical development of Elraglusib Oral Tablet based on data from
the Actuate-1801 study once the RP2D has been identified." If the RP2D for these
indications has not been established, please tell us why your pipeline table shows
Elraglusib Oral Tablet for melanoma and colorectal cancer as being part way through
Phase 2 or revise your disclosure as appropriate.
Our Strategy, page 4
6.We note your disclosure in the third bullet point that "[o]ne of [y]our strategic objectives
is to obtain development incentives in the United States and in other countries that could
accelerate [y]our path to drug approval: Orphan Drug Designation, Fast-Track designation
and Breakthrough Therapy Designation (BTD) in the United States; Orphan and priority
medicines (PRIME) designations in the EU; and Orphan designations in Japan and
Australia." Please balance this disclosure with a statement similar to the one on page 22
that such designations may not lead to a faster development or regulatory review or
approval process, and does not increase the likelihood that a product candidate will
receive FDA approval.
The Offering
Assumed offering price, page 8
7.We note that the assumed offering price is based on the purchase of "one-half of a share"
of your common stock. Please revise this disclosure to reconcile to the remainder of your
disclosure or advise.
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 1, 2024 Page 3
FirstName LastName
Daniel Schmitt
Actuate Therapeutics, Inc.
April 1, 2024
Page 3
Risks Related to Clinical Development and Regulatory Approval
We rely on third parties for the manufacture and shipping of elraglusib . . . , page 26
8.We note your disclosure in this risk factor regarding the risk of your suppliers’ inability to
manufacture your products in sufficient quantities or at defined quality specifications.
Please also address the risk, to the extent applicable, that your suppliers are under no
obligation to supply products to you. In this regard, we note your disclosure on page 110
that you currently obtain your supplies on a purchase order basis and do not have any
long-term supply agreements in place.
Use of Proceeds, page 67
9.We note your disclosure in the third paragraph that you currently intend to use proceeds
from this offering, together with your existing cash and cash equivalents, to fund clinical
trials and product development, research and development, clinical manufacturing, as well
as for working capital and other general corporate purposes, including pre-commercial
activity. We further note your disclosure in the penultimate paragraph that these funds will
not be sufficient to complete development in all potential indications of elraglusib. Please
revise your disclosure to identify how you intend to allocate the proceeds among these
different purposes. Please also clarify which elraglusib trials you currently intend to fund
with the proceeds from this offering, how the proceeds will be allocated among these trials
and indications, and how far into the development process you anticipate such proceeds to
enable you to reach.
10.We note your disclosure on page 8 that some shares of your common stock are subject to a
right of repurchase by you. If a portion of the proceeds from this offering will be used to
repurchase shares, please make that clear or otherwise disclose how the repurchase rights
will be impacted by your offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 83
11.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will help
facilitate our review of your accounting for equity issuances including stock
compensation. Please discuss with the staff how to submit your response.
Business
Our Pipeline and Development Timeline, page 89
12.When discussing your clinical studies, we note several references to your pursuit of
certain studies if “adequate funding” or “requisite funding” is secured. Please clarify
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 1, 2024 Page 4
FirstName LastNameDaniel Schmitt
Actuate Therapeutics, Inc.
April 1, 2024
Page 4
whether the proceeds from this offering will provide “adequate funding” or the “requisite
funding” for these studies or parts thereof.
Elraglusib Clinical Development, page 94
13.We note your disclosure that a "safe" dose was identified. Please revise to remove any
statements regarding safety or efficacy determinations as such determinations are solely
within the authority of the FDA.
Northwestern University License Agreement, page 108
14.Please revise your disclosure to specify when the last to expire of the patent rights
licensed under the NU License Agreement is scheduled to expire.
University of Illinois-Chicago Exclusive License Agreement with Equity, page 108
15.Please revise your disclosure to briefly describe the "Patent Rights" licensed to you under
the UIC License Agreement and specify when the last of those patent rights is scheduled
to expire.
Intellectual Property, page 109
16.We note your disclosure that you “own or have licensed 76 issued patents and pending
patent applications worldwide.” Please disclose the specific product candidates or product
candidate groups to which these patents and patent applications relate. Please also disclose
the expected expiration of any issued patents that are material to your business, including
the original composition of matter patents covering elraglusib in-licensed from The
University of Illinois-Chicago and the new composition of matter patent applications that
cover elraglusib polymorphs.
Management
Background of Directors and Executive Officers, page 128
17.Please revise your disclosure regarding Andrew P. Mazar, Ph.D., to identify his business
experience between April 2019 through June 2022. Refer to Item 401(e)(1) of Regulation
S-K.
Executive Compensation, page 136
18.We note that you have identified Daniel M. Schmitt, your President and Chief Executive
Officer, and Andrew P. Mazar, Ph.D., your Chief Operating Officer, as your named
executive officers for the year ended December 31, 2023. We further note that you have
excluded Paul Lytle, your Interim Chief Financial Officer, from your list of named
executive officers given that he was not appointed to his position until February 2024.
Please confirm to us that no other person served as an executive officer (e.g., a
predecessor Chief Financial Officer) for the Company in 2023. Alternatively, please
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 1, 2024 Page 5
FirstName LastNameDaniel Schmitt
Actuate Therapeutics, Inc.
April 1, 2024
Page 5
revise your disclosure to include such other executive officer(s) in your list of named
executive officers. Refer to Item 402(m)(2)(ii) and (iii) of Regulation S-K.
Summary Compensation Table, page 136
19.We note from footnote 3 to your Summary Compensation Table that Andrew P. Mazar,
Ph.D., assumed the role of Chief Operating Officer on April 1, 2022 as a consultant and
that he became your employee on June 1, 2022. However, it does not appear that Dr.
Mazar’s consulting fees are included in the table. Please revise the table to include all
compensation awarded to, earned by, or paid to Dr. Mazar for all services rendered to the
Company in all capacities, including as a consultant, during the periods presented in the
table. Refer to Item 402(m)(1) of Regulation S-K. Please also revise footnote 3 to provide
context for the option awards granted to Dr. Mazar in 2023 and to include the information
required by Instruction 1 to Item 402(n)(2)(vi) of Regulation S-K.
Employment Agreements
Interim Chief Financial Officer, page 138
20.Please disclose the material terms upon which the consulting agreement with Paul Lytle,
your Interim Chief Financial Officer, may be terminated.
Outstanding Equity Awards at Year End, page 138
21.Please revise footnote 3 to the table to clarify which, if any, of the vesting conditions
described in the footnote have been satisfied, and clarify how you arrived at the
corresponding number of remaining unearned shares presented in the table.
Director Compensation, page 139
22.For each director, please disclose by footnote to the appropriate column of the Director
Compensation Table the aggregate number of stock awards, if any, and the aggregate
number of option awards outstanding at December 31, 2023. Refer to Instruction to Item
402(r)(2)(iii) and (iv) of Regulation S-K.
Certain Relationships and Related Party Transactions, page 146
23.If appropriate, in accordance with Item 404 of Regulation S-K, please disclose in this
section the transactions described in Note 12 (Related Party) to the financial statements on
page F-21, or tell us why such disclosure would not be appropriate. Please also provide us
with your analysis as to whether Richard Kenley, your Vice President of Manufacturing,
should be disclosed in the "Management" section pursuant to Item 401(b) of Regulation S-
K.
Principal Securityholders, page 150
24.We note your disclosure on page 150 that the applicable percentage ownership presented
in the beneficial ownership table gives effect to a number of actions, including the
FirstName LastNameDaniel Schmitt
Comapany NameActuate Therapeutics, Inc.
April 1, 2024 Page 6
FirstName LastNameDaniel Schmitt
Actuate Therapeutics, Inc.
April 1, 2024
Page 6
conversion of all outstanding shares of your redeemable convertible preferred stock into
shares of your common stock immediately prior to the closing of this offering.
Accordingly, the beneficial ownership table appears to present the percentage ownership
of your common stock only. However, your disclosures in footnotes 4 and 5 to the table
indicate that the corresponding rows in the table include shares of preferred stock. Please
revise the table and/or these footnotes as appropriate, including, if applicable, to clarify
whether the numbers presented in the footnotes actually reflect the shares of common
stock underlying the outstanding shares of preferred stock and, if so, how such numbers
were calculated. Alternatively, please tell us why you do not believe such presentation is
appropriate.
25.In footnote 5, we note your disclosure that Mr. Thomson shares voting and investment
control with respect to shares held by the Kairos Venture Affiliated Funds. Please revise
your disclosure to identify any other natural persons with whom Mr. Thomson shares
voting and investment control of such shares.
26.In footnote 7, we note your disclosure that certain shares of common stock are held by the
Catharine A. Zabrowski Irrevocable Trust, of which Catherine A. Zabrowski is the trustee.
Although we also note your disclosure on page 150 that, unless otherwise indicated, you
believe that all persons named in the table have sole voting and investment power with
respect to all the common stock beneficially owned by them, please revise footnote 7 to
clarify whether Daniel Zabrowski, as listed in the table, has sole voting and investment
power over the shares held in the Catherine A. Zabrowski Irrevocable Trust or whether
Catherine A. Zabrowski, in her capacity as trustee of such trust or otherwise, shares or has
sole voting and investment power of such shares.
Description of Capital Stock
Choice of Forum, page 158
27.We note your disclosure that your amended and restated certificate of incorporation will
provide that the federal district courts of the United States shall be the exclusive forum for
resolving any complaint asserting a cause of action arising under the Securities Act.
Please include a risk factor regarding the potential risks to investors from this forum
provision, including, as examples only, increased costs to bring a claim and the possibility
that such provision may discourage the filing of claims or limit investors’ ability to bring a
claim in a judicial forum that they find favorable.
Note 8 - Warrants, page F-17
28.Please revise to disclose the exercise price of all the warrants to purchase shares of your
Series B-1 redeemable convertible preferred stock.
Item 16. Exhibits, page II-3
29.Please include the form of representative’s warrants, as discussed on page 168, as an
exhibit to the registration statement.
FirstName LastNameDaniel Schmitt
Comapa