SELLAS Life Sciences Group, Inc. develops novel cancer therapeutics as a late-stage clinical biopharmaceutical company. News about SLS centers on its acute myeloid leukemia programs, including galinpepimut-S (GPS), a WT1-directed peptide immunotherapy evaluated in the REGAL Phase 3 trial, and SLS009 (tambiciclib), a selective CDK9 inhibitor studied in AML settings.
Recurring updates include clinical and preclinical data presentations, trial progress, regulatory and corporate updates, financial results, cash-position disclosures, warrant exercises, and other capital-structure developments tied to funding its oncology pipeline.
SELLAS Life Sciences (NASDAQ: SLS) reported Q2 2025 financial results and significant progress in its AML-focused pipeline. The company's Phase 3 REGAL trial of GPS received a positive IDMC recommendation to continue without modification, with final analysis expected by year-end 2025.
Their Phase 2 trial of SLS009 in r/r AML achieved impressive results, with a 44% response rate in AML-MRC patients and median overall survival of 8.9 months, significantly exceeding historical benchmarks. The FDA has recommended advancing SLS009 to first-line AML treatment, with an 80-patient trial expected to begin by Q1 2026.
Financially, SELLAS reported a Q2 2025 net loss of $6.6 million ($0.07 per share), with $25.3 million in cash as of June 30, 2025, plus an additional $4.0 million from warrant exercises in July 2025.
SELLAS Life Sciences (NASDAQ: SLS) announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC's review supports continuing the trial without modifications, confirming GPS's favorable risk-benefit profile.
The study, which completed enrollment in April 2024 with 126 patients, predominantly recruited from U.S. and European sites (75% of total enrollment). The final analysis, expected by year-end, will be triggered when 80 events (deaths) occur, which will determine GPS's potential effectiveness in AML treatment.
SELLAS Life Sciences (NASDAQ: SLS) announced successful completion of its Phase 2 trial for SLS009 (tambiciclib) in relapsed/refractory acute myeloid leukemia (r/r AML), meeting all primary endpoints. The trial demonstrated an impressive 44% response rate among AML-MR patients and 50% in AML-MR with M4/M5 subtype at the optimal 30mg twice-weekly dose.
Key achievements include median overall survival of 8.9 months in AML-MR patients and 8.8 months in venetoclax-refractory patients, significantly surpassing the historical benchmark of 2.4 months. Following FDA guidance, SELLAS will advance to a randomized 80-patient trial including newly diagnosed first-line AML patients, with enrollment expected to begin by Q1 2026.
SELLAS Life Sciences (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, has appointed Dr. Linghua Wang to its Scientific Advisory Board. Dr. Wang, a tenured Associate Professor at MD Anderson's Department of Genomic Medicine, brings extensive expertise in cancer immunogenomics and computational biology.
Dr. Wang leads the Computational Biology Laboratory at MD Anderson and holds multiple prestigious positions, including Associate Member of The James P. Allison Institute. Her research focuses on understanding tumor ecosystems using advanced technologies like single-cell and spatial omics, AI-driven pathology, and machine learning. With over 100 publications and multiple NIH/NCI grants, her expertise aligns with SELLAS's focus on translational research and precision medicine.
SELLAS Life Sciences (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, announced its upcoming addition to the Russell 3000® and Russell 2000® Indexes, effective June 27, 2025. This inclusion marks a significant milestone for the company, reflecting its progress in pipeline development.
The Russell 3000® Index tracks the top 3,000 U.S. public companies, while the Russell 2000® Index focuses on small-cap stocks representing about 10% of the U.S. equity market capitalization. The company is approaching key milestones, including topline Phase 2 data readout for SLS009 in acute myeloid leukemia (AML) and final analysis of the Phase 3 REGAL trial of GPS in AML.
SELLAS Life Sciences Group (NASDAQ: SLS), a late-stage clinical biopharmaceutical company specializing in cancer therapy development, has announced its participation in the upcoming A.G.P. Virtual Healthcare Company Showcase. The company's President and CEO, Dr. Angelos Stergiou, will engage in a fireside chat scheduled for Wednesday, May 21, 2025, at 8:20 am ET.
SELLAS Life Sciences (NASDAQ: SLS) has announced the dosing of its first pediatric patient in the ongoing Phase 2 trial of SLS009 (tambiciclib) for relapsed/refractory acute myeloid leukemia (r/r AML). The trial evaluates SLS009, a highly selective CDK9 inhibitor, in combination with venetoclax and azacitidine at 45mg and 60mg dose levels. The company received FDA Rare Pediatric Disease Designation (RPDD) in July 2024, making it eligible for a Priority Review Voucher upon potential NDA approval, which could be worth approximately $100 million.
The Phase 2 trial targets a 20% response rate with a median survival of at least 3 months. The study includes additional cohorts for ASXL1-mutated AML patients and those with myelodysplasia-related molecular abnormalities.
SELLAS Life Sciences (NASDAQ: SLS) reported significant progress in Q1 2025, highlighted by positive results from their Phase 2 trial of SLS009 in relapsed/refractory AML. The trial showed remarkable median overall survival of 8.9 months in AML-MRC patients and 8.8 months in venetoclax-resistant patients, substantially exceeding historical benchmarks of 2.5 months. The drug achieved a 67% overall response rate in AML-MRC patients.
The company's Phase 3 REGAL trial of GPS in AML showed promising interim results with median survival exceeding 13.5 months versus historical 6 months. Financial results showed reduced losses with Q1 net loss of $5.8 million ($0.07 per share) compared to $9.6 million in Q1 2024. SELLAS maintained a strong financial position with $28.4 million cash as of March 31, 2025, plus additional $4.0 million from warrant exercises in April 2025.