UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 11, 2026
Actuate Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-42139 | 47-3044785 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 1751 River Run, Suite 400 Fort Worth, Texas |
76107 |
| (Address of Principal Executive Offices) | (Zip Code) |
(817) 887-8455
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $0.000001 per share | ACTU | The Nasdaq Stock Market LLC | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| 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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