All Primary Endpoints Met in Ph 2 Trial of SLS009 in R/R AML; FDA Guidance Received to Advance into 1L Therapy Study

“We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes. The remarkable response rates of 44% among AML MR patients, 50% among ASXL1-mutated AML MR, and 50% among M4/M5 patients at the optimal 30 mg BIW dose far exceed the targeted 20% benchmark.”