SEC Comment Letter 0000000000-24-005821 to ACTUATE THERAPEUTICS, INC. (ACTU)
ACTUATE THERAPEUTICS, INC.
Date: May 20, 2024 · CIK: 0001652935 · Accession: 0000000000-24-005821
AI Filing Summary & Sentiment
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Letter
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.
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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.