Actuate's Phase 2 pancreatic cancer trial meets primary endpoint; going concern disclosed

Filed May 14, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 15, 2025 · ~2 min read

Key Changes

• high

  Phase 2 mPDAC trial met primary endpoint with statistically significant survival benefit: median overall survival 10.1 months vs 7.2 months control (p=0.02, HR=0.62), near-doubling of 12-month survival rate to 44.4%, and fivefold increase in 24-month survival to 12.9%.

  MD&A: Phase 2 mPDAC trial verify on EDGAR →
• high

  Company disclosed substantial doubt about ability to continue as going concern, estimating cash will not fund operations beyond July 2026 without additional capital. Cash balance $8.1M at March 31, 2026, up from $3.9M year prior.

  MD&A: Going concern & liquidity verify on EDGAR →
• high

  FDA cleared IND for oral tablet formulation of elraglusib in April 2026, enabling Phase 1/2 study in advanced refractory cancers to identify maximum tolerated dose and recommended Phase 2 dose.

  MD&A: Oral tablet IND verify on EDGAR →