SELLAS Life Sciences Group (SLS) investor relations material

Pipeline overview and program updates

• Two late-stage clinical assets, GPS (WT1-targeted immunotherapy) and SLS009 (CDK9 inhibitor), address significant unmet needs in AML and other cancers, with first- or best-in-class potential.

• GPS is in a global phase 3 RIGEL trial for AML maintenance; SLS009 is advancing to frontline AML and early refractory settings, with initial data expected in 2026.

• Both programs are supported by strong preclinical and clinical data, with GPS showing durable responses and SLS009 demonstrating activity in high-risk, refractory AML.

• The pipeline is diversified, targeting both maintenance and frontline AML, and leverages biomarker-driven patient selection.

Clinical trial data and development milestones

• GPS has shown prolonged survival in earlier phase studies: over 60 months in first remission and 21 months in second remission, far exceeding standard care.

• The phase 3 RIGEL trial is event-driven, with the 80th event as a key near-term catalyst; survival times are longer than expected, delaying final analysis.

• SLS009 phase 2 data in venetoclax-refractory AML showed response rates of 44–57% in high-risk subgroups and extended survival to 8–9 months.

• Upcoming SLS009 trial, with FDA input, will assess efficacy as add-on therapy in newly diagnosed and early refractory AML, aiming for at least 50% improvement in response and survival.

R&D strategy and innovation priorities

• Focus on rigorous, high-quality science, leveraging transcriptomic, genomic, and proteomic analyses and AI models to optimize patient selection for SLS009.

• Biomarker-driven approach enables identification of patients unlikely to benefit from standard care, supporting precision medicine strategies.

• Ongoing innovation in immunotherapy and targeted therapy, with GPS designed as a universal, non-HLA-restricted vaccine and SLS009 as a highly selective CDK9 inhibitor.