UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On May 11, 2026, Actuate Therapeutics, Inc. (the “Company”) issued a press release announcing FDA clearance of an Investigational New Drug (“IND”) application to conduct a Phase 1/2 study and future plans to advance the elraglusib development program. A copy of the press release and the Company’s updated corporate presentation is furnished herewith as Exhibit 99.1 and 99.2, respectively, to this Current Report and is incorporated herein by reference into this Item 7.01.
The information in this Item 7.01, including Exhibit 99.1 and 99.2, and the information on the Company’s website, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filings, unless expressly incorporated by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are furnished with this report:
| Exhibit No. | Description | |
| 99.1 | Press release issued by Actuate Therapeutics, Inc. on May 11, 2026 | |
| 99.2 | Corporate Presentation dated May 11, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Actuate Therapeutics, Inc. | ||
| Date: May 11, 2026 | By: | /s/ Daniel M. Schmitt |
| Name: Daniel M. Schmitt | ||
| Title: President and Chief Executive Officer | ||
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