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SELLAS Life Sciences Group (SLS) investor relations material
SELLAS Life Sciences Group Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
SLS009 showed positive Phase 2 results in relapsed/refractory AML, meeting all primary endpoints with a 44% response rate in AML-MRC and median overall survival of 8.9 months, nearly tripling historical benchmarks; FDA guidance received to advance to first-line AML trial by Q1 2026.
REGAL Phase 3 trial for GPS in AML is ongoing, with interim analysis completed and a positive IDMC recommendation to continue; final analysis expected by year-end 2025.
Expanded Scientific Advisory Board with oncology experts and presented promising preclinical data for SLS009 in ASXL1-mutated colorectal cancer and T-PLL.
No product sales revenue; licensing revenue only from 3D Medicines Agreement, with ongoing arbitration over milestone payments.
Inclusion in the Russell 3000 and Russell 2000 indexes, enhancing market visibility.
Financial highlights
Net loss for Q2 2025 was $6.6 million ($0.07 per share), improved from $7.5 million ($0.13 per share) in Q2 2024; net loss for the first half of 2025 was $12.4 million ($0.13 per share), down from $17.0 million ($0.33 per share) prior year.
R&D expenses for Q2 2025 were $3.9 million, down from $5.2 million in Q2 2024, mainly due to completion of REGAL study enrollment; first half 2025 R&D expenses were $7.1 million, down from $10.3 million year-over-year.
G&A expenses for Q2 2025 were $3.0 million, up from $2.4 million in Q2 2024; first half 2025 G&A expenses were $5.9 million, down from $7.0 million year-over-year.
Cash and cash equivalents were $25.3 million as of June 30, 2025, up from $13.9 million at year-end 2024, with an additional $4.0 million received in July 2025 from warrant exercises.
No revenue recognized in the quarter; $191.5 million in potential future milestones under the 3D Medicines Agreement remain.
Outlook and guidance
Cash and cash equivalents are not sufficient to fund planned operations for the next twelve months; substantial doubt exists about ability to continue as a going concern.
Additional financing will be required to support ongoing development and operations; management is evaluating funding strategies.
Research and development expenses expected to increase as GPS approaches potential BLA filing and SLS009 advances to first-line AML trial.
Final analysis of the Phase 3 REGAL trial of GPS in AML expected by year-end 2025.
Enrollment for the first-line SLS009 AML trial anticipated to begin by Q1 2026.
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