SELLAS Reports Positive Q2 Results, $25.3mln in Cash, GPS Trial Continues.

• SELLAS reports Q2 2025 financial results • Galinpepimut-S (GPS) Phase 3 trial to continue without modification • Positive Phase 2 results for SLS009 in r/r AML • SLS009 meets all primary endpoints • Full data presentation expected later this year • Alignment with FDA to advance SLS009 in first-line AML trial • Enrollment anticipated by Q1 2026 • $25.3 million in cash and cash equivalents as of June 30, 2025 • Additional $4.0 million proceeds received in July 2025

SELLAS Life Sciences Group, Inc. (SLS), a biopharmaceutical company specializing in innovative cancer immunotherapies, has released its Form 10-Q report for the second quarter of 2025. The report highlights significant improvements in financial performance and notable progress in its clinical development programs.

Financial Highlights:
- The company reported a net loss of $6.6 million for the three months ended June 30, 2025, an improvement of $0.9 million compared to the same period in 2024. For the six months ended June 30, 2025, the net loss was $12.4 million, showing an improvement of $4.6 million from the same period in 2024. These improvements were primarily driven by decreased research and development expenses and overall reduced operating expenses.
- The net loss per share for the three months ended June 30, 2025, was $0.07, down from $0.13 in the same period in 2024. For the six months ended June 30, 2025, the net loss per share decreased to $0.13 from $0.33 in the same period in 2024, reflecting improved financial performance.
- Operating expenses for the three months ended June 30, 2025, were $6.9 million, a decrease of $0.7 million compared to the same period in 2024. For the six months ended June 30, 2025, operating expenses decreased by $4.3 million to $12.9 million, indicating effective cost management efforts.
- Interest income for the three months ended June 30, 2025, was $0.3 million, an increase of $0.1 million compared to the same period in 2024. For the six months ended June 30, 2025, interest income increased by $0.3 million to $0.5 million, contributing positively to the financial results.

Clinical Trial Updates:
- The company is advancing its lead product candidate, galinpepimut-S (GPS), a cancer immunotherapeutic agent targeting the WT1 protein. The REGAL Phase 3 clinical trial for GPS in acute myeloid leukemia (AML) is ongoing, with a positive recommendation from the Independent Data Monitoring Committee to continue without modifications. The final analysis is expected once 80 events (deaths) are reached, anticipated this year.
- SLS009, a highly selective CDK9 inhibitor, is progressing through clinical trials. The Phase 2a trial in relapsed/refractory AML met all primary endpoints, showing promising efficacy and safety. The FDA has recommended advancing to a trial for newly diagnosed, first-line AML patients, expected to begin enrollment by Q1 2026.

Cash Position:
- As of June 30, 2025, the company had $25.3 million in cash and cash equivalents. Additionally, the company received an additional $4.0 million in proceeds in July 2025.

Future Outlook:
- The company is preparing for a potential Biologics License Application (BLA) filing for GPS following the final analysis of the REGAL study. The outcome of this study will be crucial for the future commercialization of GPS.
- Following successful Phase 2a results, the company plans to initiate a randomized trial for SLS009 in newly diagnosed AML patients. This trial will focus on patients unlikely to benefit from standard therapies, with enrollment expected to start by early 2026.

Reference List:
[1] https://www.stocktitan.net/sec-filings/SLS/8-k-sellas-life-sciences-group-inc-reports-material-event-31b4259756fe.html
[2] https://www.tradingview.com/news/tradingview:7f5b531f83156:0-sellas-life-sciences-group-inc-sec-10-q-report/