SELLAS Life Sciences Group (SLS) Q3 2025 earnings summary

Executive summary

• Focused on late-stage clinical development of cancer therapeutics, with lead candidates GPS and SLS009 targeting hematologic and solid tumors.

• REGAL Phase 3 trial for GPS in AML ongoing, with interim analysis completed and final analysis expected by year-end 2025, pending event-driven criteria.

• SLS009 Phase 2a trial in relapsed/refractory AML met all primary endpoints, with strong efficacy in biomarker-defined subgroups and FDA guidance to advance to first-line therapy study; new trial in first-line AML to begin Q1 2026.

• Hosted a successful R&D Day highlighting GPS and SLS009 programs, with strong expert enthusiasm.

• No product sales revenue; licensing revenue from 3D Medicines Agreement, with $191.5 million in potential future milestones.

Financial highlights

• Net loss of $6.8 million for Q3 2025, improved from $7.1 million in Q3 2024; net loss of $19.2 million for nine months ended September 30, 2025, improved from $24.1 million year-over-year.

• Operating expenses decreased to $7.1 million in Q3 2025 from $7.3 million in Q3 2024, and to $20.0 million for the nine months from $24.6 million year-over-year.

• Cash and cash equivalents of $44.3 million as of September 30, 2025, with an additional $29.1 million raised in October 2025 from warrant exercises.

• Accumulated deficit of $267.3 million as of September 30, 2025.

• R&D expenses for Q3 2025 were $4.2 million, down from $4.4 million in Q3 2024; nine-month R&D expenses were $11.3 million, down from $14.7 million.

Outlook and guidance

• Cash position, including October 2025 proceeds, expected to fund operations for at least the next twelve months.

• Enrollment for an 80-patient trial of SLS009 in newly diagnosed and early refractory AML patients expected to begin in Q1 2026.

• Anticipates increased R&D expenses as GPS approaches potential BLA filing and SLS009 advances to first-line AML trial.

• May seek additional capital through equity, debt, or partnerships to support future operations.

• Final analysis of the REGAL trial anticipated by year-end 2025, but timing may vary due to event-driven design.