Overview
- The REGAL Phase 3 trial reached its prespecified 80th event on October 28, triggering database lock, unblinding and final statistical analysis ahead of a fourth‑quarter topline result.
- SELLAS shares rose roughly 20% in after‑hours trading as investors reacted to the near‑term readout timeline.
- The company reported a third‑quarter net loss of $10.1 million with no revenue and held $134.7 million in cash and equivalents on September 30, while share count and R&D spending increased year over year.
- SELLAS’s separate CDK9 inhibitor program SLS009 posted Phase 2 subgroup response rates of 54% in monocytic AML and 57% in TP53‑mutated cases, and preliminary data from a newly diagnosed AML cohort is due in the fourth quarter with full findings slated for presentation at ASH in December.
- A final‑analysis overall survival readout is a decisive regulator and market event but does not guarantee a positive outcome, so the upcoming topline results and the ASH presentation will be pivotal for SELLAS’s clinical and commercial prospects.