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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): January 12, 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)

 

 

(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 7.01Regulation FD Disclosure.

 

On January 12, 2026, Actuate Therapeutics, Inc. (the “Company”) issued a press release announcing updated data from its ongoing and fully enrolled randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (“GnP”) in first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Actuate-1801 Part 3B). A copy of the press release is furnished herewith as Exhibit 99.1 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 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  

 

Exhibit No.   Description
   
99.1   Press Release of Actuate Therapeutics, Inc. dated January 12, 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: January 12, 2026 By: /s/ Daniel M. Schmitt
    Name: Daniel M. Schmitt
  Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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