Business Context and Reporting Period
Company: Actuate Therapeutics, Inc. (ACTU)
Filing Type: Form 10-Q (Quarterly Report)
Period Ended: March 31, 2026
Business Overview: Actuate is a clinical-stage biopharmaceutical company developing elraglusib, a GSK-3β inhibitor, for the treatment of various cancers. The company has no product revenue and relies on capital raises to fund operations. Key developments include positive Phase 2 data for metastatic pancreatic ductal adenocarcinoma (mPDAC) and FDA clearance for a Phase 1/2 study of an oral tablet formulation.
Key Financial Metrics
| Metric | Q1 2026 | Q1 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(5,625,749) | $(6,317,024) |
| Loss Per Share (Basic & Diluted) | $(0.24) | $(0.32) |
| Cash and Cash Equivalents (End of Period) | $8,134,004 | $3,889,405 |
| Working Capital | $3,797,551 | Filing text does not provide a clear value |
| Net Cash Used in Operating Activities | $(5,017,327) | $(4,618,740) |
| Accumulated Deficit | $(160,233,450) | $(138,696,873) |
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $691,000 compared to Q1 2025, primarily driven by a $655,000 reduction in operating expenses.
- Operating Expenses: Total operating expenses declined to $5.71 million from $6.37 million.
- R&D Expenses: Decreased by $655,000 to $2.57 million. This was due to a $1.25 million drop in external clinical study costs (fewer patients on study) and lower CMC costs, partially offset by increased nonclinical studies and personnel costs.
- G&A Expenses: Remained relatively flat at $3.14 million, with a slight decrease of $4,553.
- Interest Income: Increased to $85,269 from $53,623 due to higher average cash balances.
- Cash Position: Cash reserves increased significantly from $3.89 million in Q1 2025 to $8.13 million in Q1 2026, aided by proceeds from an At-the-Market (ATM) facility.
Guidance, Outlook, and Risks
- Liquidity and Going Concern: Management has concluded there is substantial doubt regarding the company's ability to continue as a going concern. Cash on hand is estimated to fund operations only until July 2026 without additional capital.
- Capital Resources: The company has an ATM facility with approximately $99.5 million remaining capacity and a Committed Equity Facility with $50 million capacity (though no shares were sold under the latter in Q1 2026). Future funding is critical for clinical trials and commercialization.
- Clinical Outlook:
- mPDAC: Phase 2 data showed statistically significant improvement in median overall survival (10.1 months vs. 7.2 months) with elraglusib plus chemotherapy.
- Oral Formulation: FDA cleared a Phase 1/2 study for the oral tablet formulation in April 2026.
- Pediatric: Advancing development in Ewing sarcoma and neuroblastoma.
- Risks: Risks include the inability to raise additional capital, delays in clinical trials, regulatory hurdles, and the inherent uncertainty of drug development. The company has no approved products and has incurred losses since inception.
Investor Verification Checklist
- Cash Runway: Verify the specific burn rate and confirm the July 2026 liquidity horizon given the "substantial doubt" disclosure.
- Capital Raise Status: Monitor subsequent filings for new equity issuances under the ATM or Committed Equity Facility to ensure operations continue beyond mid-2026.
- Clinical Trial Progress: Track enrollment and data readouts for the newly cleared oral tablet Phase 1/2 study and the ongoing mPDAC Phase 2 trial.
- Debt Obligations: Review the $404,991 license payable to the University of Illinois (UIC) and its interest accrual terms, noting triggers for immediate payment (e.g., Change in Control, financing milestones).
- Dilution: Assess the impact of potential future equity raises on existing shareholders, noting the significant number of anti-dilutive shares (options, warrants, RSUs) currently outstanding.