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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 7.01 | Regulation 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. |
| 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) |
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 |
