SELLAS Life Sciences Hits 72 of 80 Trial Events and Doses First AML Patient with $114M Cash
SELLAS Life Sciences ended 2025 with $71.8 million in cash and cash equivalents and has secured an additional $42.6 million in Q1 2026 warrant proceeds, bolstering its financial runway. The company has recorded 72 of 80 events in its pivotal Phase 3 REGAL trial and dosed the first patient in its Phase 2 SLS009 expansion for newly diagnosed AML.
1. Financial Position
SELLAS Life Sciences closed 2025 with $71.8 million in cash and cash equivalents and raised an additional $42.6 million through warrant exercises in Q1 2026, marking its strongest liquidity position to date and extending its operational runway for ongoing clinical programs.
2. Phase 3 REGAL Trial Progress
The pivotal Phase 3 REGAL trial of galinpepimut-S (GPS) in second-line salvage AML has achieved 72 of the pre-specified 80 events required for final analysis. Upon reaching the 80th event, the company will complete database lock, unblinding and statistical review to disclose topline overall survival results.
3. SLS009 Development Milestones
Following positive Phase 2 data in relapsed/refractory AML showing a 46% overall response rate and 29% CR/CRi among 35 evaluable patients, no dose-limiting toxicities were observed. SELLAS has dosed the first patient in an 80-patient expansion cohort evaluating SLS009 in newly diagnosed, first-line AML patients.
4. European Collaboration
In January 2026, SELLAS entered a strategic agreement with IMPACT-AML’s STREAM network to conduct a study of SLS009 combined with azacitidine and venetoclax in approximately 40 newly diagnosed AML patients. Enrollment is anticipated to begin in Q2 2026, expanding the program into European centers.