Business Context and Reporting Period
Company: Actuate Therapeutics, Inc. (ACTU)
Filing Type: Form 8-K (Current Report)
Date of Report: January 12, 2026
Reporting Period: Event-based report regarding a specific corporate announcement on January 12, 2026.
Business Overview: The Company is an emerging growth company focused on developing therapies for cancer, specifically reporting on its Phase 2 clinical trial for metastatic pancreatic ductal adenocarcinoma (mPDAC).
Key Financial Metrics
This filing is a Current Report (Form 8-K) regarding a regulatory disclosure and does not contain audited financial statements, revenue, profit, cash flow, margin, debt, or liquidity data. The filing text does not provide a clear value for any financial metrics.
Material Changes
The material change reported is the issuance of a press release on January 12, 2026, announcing updated data from the Company's ongoing and fully enrolled randomized Phase 2 trial (Actuate-1801 Part 3B). The trial evaluates elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) for the first-line treatment of mPDAC.
Guidance, Outlook, and Risks
- Management Commentary: The Company highlighted the enrollment status of the Actuate-1801 Part 3B trial as "fully enrolled."
- Regulatory Disclosure: The information is disclosed under Item 7.01 (Regulation FD Disclosure) and is furnished as Exhibit 99.1.
- Legal Disclaimer: The press release and website information are not deemed "filed" under Section 18 of the Exchange Act and are not incorporated by reference into other filings unless expressly stated.
- Outlook: No specific financial guidance or future revenue projections are provided in this document.
Investor Verification Checklist
- Verify the specific clinical data points and statistical significance in the press release (Exhibit 99.1) referenced in this filing.
- Confirm the timeline for the next data readout or regulatory decision regarding the Actuate-1801 Part 3B trial.
- Review the Company's most recent 10-K or 10-Q filings for current cash runway and liquidity status, as this 8-K does not contain financial data.
- Monitor for any subsequent filings that may incorporate the clinical data by reference into future registration statements.