0000000000-24-005821.txt : 20240910 0000000000-24-005821.hdr.sgml : 20240910 20240520143602 ACCESSION NUMBER: 0000000000-24-005821 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20240520 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: ACTUATE THERAPEUTICS, INC. CENTRAL INDEX KEY: 0001652935 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 473044785 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 377-07119 BUSINESS ADDRESS: STREET 1: 1751 RIVER RUN STREET 2: SUITE 400 CITY: FORT WORTH STATE: TX ZIP: 76107 BUSINESS PHONE: 847-986-4190 MAIL ADDRESS: STREET 1: 1751 RIVER RUN STREET 2: SUITE 400 CITY: FORT WORTH STATE: TX ZIP: 76107 FORMER COMPANY: FORMER CONFORMED NAME: Apotheca Therapeutics, Inc. 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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. Daniel Schmitt FirstName LastNameDaniel Actuate Therapeutics, Inc. Schmitt Comapany May NameActuate Therapeutics, Inc. 20, 2024 May 20, Page 2 2024 Page 2 FirstName LastName 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.