Business Context and Reporting Period
Company: Actuate Therapeutics, Inc. (Nasdaq: ACTU)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Business Overview: Actuate is a clinical-stage biopharmaceutical company developing elraglusib, a GSK-3β inhibitor, for the treatment of high-impact cancers. The company has no approved products and has not generated revenue from product sales. Its primary focus is the advancement of elraglusib for metastatic pancreatic ductal adenocarcinoma (mPDAC) and pediatric cancers (Ewing sarcoma and neuroblastoma).
Key Financial Metrics
| Metric | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(22,227,852) | $(27,285,328) |
| Operating Expenses | $22,495,312 | $25,160,734 |
| Cash and Cash Equivalents (Dec 31, 2025) | $13,159,423 | $8,641,622 |
| Working Capital (Dec 31, 2025) | $7,936,503 | $405,397 |
| Accumulated Deficit | $(154,607,701) | $(132,379,849) |
| Net Cash Used in Operating Activities | $(19,206,253) | $(21,842,648) |
| Net Cash Provided by Financing Activities | $23,724,054 | $27,525,611 |
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $5.1 million (18.5%) compared to 2024, primarily driven by a significant reduction in Research and Development (R&D) expenses.
- R&D Expenses: Decreased by $8.4 million to $10.3 million. This was largely due to lower external clinical trial costs ($8.3 million decrease) as the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) wound down, and reduced Chemistry, Manufacturing & Control (CMC) costs.
- General and Administrative (G&A) Expenses: Increased by $5.7 million to $12.2 million. This increase was driven by higher personnel-related expenses (including a $3.7 million increase in stock-based compensation) and increased professional fees for investor relations and legal services.
- Capital Raises: In 2025, the company raised approximately $24.0 million in net proceeds through a September public offering ($15.6 million), a June private placement ($4.6 million), and sales under a Committed Equity Facility ($3.8 million).
Guidance, Outlook, and Risks
Clinical Progress and Outlook
- mPDAC Phase 2 Results: Updated data presented in January 2026 showed elraglusib plus gemcitabine/nab-paclitaxel (GnP) met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) of 10.1 months vs. 7.2 months for GnP alone (HR=0.62, p=0.02).
- Regulatory Plans: The company plans to meet with the FDA and EMA in the first half of 2026 to discuss the design of a Phase 3 global registration study.
- Pediatric Indications: Promising data in Ewing sarcoma and neuroblastoma has led to the identification of these as new indications for further development.
Liquidity and Going Concern
- Substantial Doubt: Management has concluded there is substantial doubt regarding the company's ability to continue as a going concern. The independent auditor included an explanatory paragraph regarding this uncertainty.
- Cash Runway: Based on the current operating plan, existing cash ($13.2 million) is estimated to satisfy operational and capital requirements only through July 2026.
- Financing Needs: The company will require substantial additional capital to fund Phase 3 trials and operations. It has access to a $50 million Committed Equity Facility and a $100 million At-The-Market (ATM) facility, though no assurance exists that these will be sufficient or available on acceptable terms.
Key Risks
- Single Product Dependence: The business depends entirely on the success of elraglusib.
- Supply Chain: The drug substance (DS) is manufactured by a single supplier in China, creating geopolitical and supply chain risks.
- Capital Requirements: Failure to raise additional capital could force the company to delay, limit, or terminate development programs.
Investor Verification Checklist
- Cash Runway Validation: Verify the accuracy of the July 2026 cash runway estimate and the company's specific plan to secure funding before this date.
- Phase 3 Design: Monitor the outcome of the planned FDA/EMA meetings in H1 2026 regarding the Phase 3 trial design and potential costs.
- Supply Chain Mitigation: Assess the company's strategy to mitigate risks associated with its sole drug substance manufacturer in China.
- Dilution Impact: Review the terms of the Committed Equity Facility and ATM facility to understand potential dilution from future capital raises.
- License Obligations: Note the $404,991 deferred payment obligation to UIC (University of Illinois-Chicago) which accrues interest and has specific trigger events for payment.