SELLAS Life Sciences Group (SLS) R&D Day 2025 summary

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.

• GPS is in a global phase III REGAL trial for AML maintenance; SLS009 is advancing to frontline AML and early refractory settings.

• Both programs are supported by strong preclinical and clinical data, with GPS showing broad applicability and SLS009 demonstrating activity in aggressive leukemias.

• The pipeline is diversified, positioning the company as an emerging leader in targeted cancer therapeutics.

Clinical trial data and development milestones

• GPS has shown consistent positive trends in overall survival and durable immune responses in AML, mesothelioma, ovarian cancer, and multiple myeloma.

• REGAL trial enrollment completed in April 2024; 126 patients randomized, with longer-than-expected survival delaying the 80th event for final analysis.

• SLS009 phase II trial in relapsed/refractory AML showed strong response rates, including in high-risk mutations (TP53, ASXL1), and favorable safety.

• Upcoming SLS009 trial, with FDA input, will assess efficacy as add-on therapy in frontline and early refractory AML, with initial data expected in 2026.

R&D strategy and innovation priorities

• Focus on rigorous, high-quality science and leveraging AI-driven biomarker strategies to identify patients most likely to benefit from SLS009.

• Ongoing transcriptomic, genomic, and proteomic analyses to refine patient selection and optimize clinical development.

• Commitment to advancing both GPS and SLS009 through disciplined execution and capital allocation.