SELLAS Life Sciences Group (SLS) Q3 2024 earnings summary

Executive summary

• Focused on late-stage clinical development of cancer therapeutics, with lead candidates GPS (immunotherapy targeting WT1 antigen) and SLS009 (CDK9 inhibitor).

• Advanced clinical pipeline with key milestones expected in Q4 2024, including interim analysis of Phase 3 REGAL study in AML and new data from SLS009 Phase 2a trial in relapsed/refractory AML.

• GPS and SLS009 received FDA Rare Pediatric Disease Designation for pediatric AML and ALL, and EMA Orphan Drug Designations.

• SLS009 Phase 2a trial in relapsed/refractory AML showed promising response rates, especially in patients with ASXL1 mutations.

• No product sales; revenue to date from licensing agreements.

Financial highlights

• Net loss for Q3 2024 was $7.1 million ($0.10/share), improved from $9.3 million ($0.33/share) in Q3 2023; nine-month net loss was $24.1 million ($0.42/share) vs. $29.2 million ($1.09/share) prior year.

• Operating expenses for Q3 2024 were $7.3 million, down from $9.4 million in Q3 2023.

• R&D expenses decreased to $4.4 million in Q3 2024 from $5.8 million in Q3 2023, mainly due to lower clinical supply, consulting, and personnel costs.

• G&A expenses fell to $3.0 million from $3.5 million year-over-year, attributed to reduced personnel and insurance costs.

• Cash and cash equivalents as of September 30, 2024 were $21.0 million.

Outlook and guidance

• Expects research and development expenses to increase as clinical programs advance.

• Interim analysis of Phase 3 REGAL study in AML and additional topline data from SLS009 cohorts and pediatric tumor program anticipated in Q4 2024.

• SLS009 Phase 2a data to be presented at ASH in December 2024.

• Cash and cash equivalents are not sufficient to fund operations for the next twelve months; substantial doubt exists about ability to continue as a going concern.

• Additional financing will be required to support planned activities and future growth.