Actuate Therapeutics (NASDAQ: ACTU) updates Phase 2 elraglusib trial

Rhea-AI Filing Summary

Actuate Therapeutics, Inc. filed a current report to furnish a press release that shares updated data from its ongoing, fully enrolled randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma. The study is identified as Actuate-1801 Part 3B. The press release is included as Exhibit 99.1 under a Regulation FD disclosure item and, along with related website information, is designated as being furnished rather than filed, which limits how it is treated for certain securities law liability and incorporation-by-reference purposes.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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.

(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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FAQ

What did Actuate Therapeutics (ACTU) disclose in this 8-K?

Actuate Therapeutics furnished a press release announcing updated data from its ongoing, fully enrolled randomized Phase 2 trial of elraglusib plus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma.

Which clinical trial is discussed by Actuate Therapeutics (ACTU)?

The report refers to Actuate-1801 Part 3B, a randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma.

How is the press release treated under securities laws in this Actuate Therapeutics 8-K?

The press release in Exhibit 99.1, along with related website information, is furnished under Item 7.01 and is expressly stated not to be deemed filed for purposes of Section 18 of the Exchange Act or automatically incorporated into other Securities Act or Exchange Act filings.

Where can investors find the detailed Phase 2 data from Actuate Therapeutics (ACTU)?

The detailed updated data are contained in the press release attached as Exhibit 99.1 to the report, which is incorporated by reference into Item 7.01.

What exchange lists Actuate Therapeutics (ACTU) common stock?

Actuate Therapeutics’ common stock, par value $0.000001 per share, is listed on The Nasdaq Stock Market LLC under the trading symbol ACTU.

Who signed this Actuate Therapeutics (ACTU) 8-K?

The report was signed on behalf of Actuate Therapeutics, Inc. by Daniel M. Schmitt, the company’s Chief Executive Officer.