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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 Group (NASDAQ: SLS) has announced a $25 million registered direct offering priced at-the-market. The company will sell 19,685,040 shares of common stock (or equivalents) and warrants at a combined price of $1.27 per share. The warrants, exercisable at $1.20 per share, will be immediately available and expire in 5 years.
The offering, expected to close around January 29, 2025, is being led by A.G.P./Alliance Global Partners with Maxim Group as co-placement agent. The net proceeds will be used for working capital and general corporate purposes, including potential acquisitions. The offering is being made through an effective shelf registration statement on Form S-3.
SELLAS Life Sciences (NASDAQ: SLS) announced positive interim analysis results for its Phase 3 REGAL trial of GPS in Acute Myeloid Leukemia (AML). The Independent Data Monitoring Committee (IDMC) recommended trial continuation without modifications after reviewing 60 death events. Key findings include:
- Less than 50% of enrolled patients deceased after 13.5 months median follow-up, suggesting survival over 13.5 months versus historical 6 months with conventional therapy
- 80% of randomly selected GPS patients showed specific T-Cell immune response, surpassing previous Phase 2 results
- Final analysis planned upon reaching 80 death events, expected this year
The trial evaluates GPS in AML patients who achieved complete remission following second-line salvage therapy. No drug has been approved specifically for maintenance of remission in AML patients in CR2. The company is preparing for Biologics License Application (BLA) submission.
SELLAS Life Sciences Group (NASDAQ: SLS) outlined key business objectives for 2025, highlighting two major upcoming milestones. The company expects an interim analysis of its Phase 3 REGAL study by an Independent Data Monitoring Committee in January 2025, which will determine whether to stop the trial early for efficacy, stop for futility, or continue without modification.
Additionally, full topline Phase 2 data for SLS009 (tambiciclib) in Acute Myeloid Leukemia (AML) and FDA regulatory review are expected in 1H 2025. The company reported positive 2024 results for SLS009, with median overall survival exceeding 7.7 months compared to historical 2.5 months, and a 56% Overall Response Rate in AML-MRC patients. The drug received multiple regulatory designations, including FDA Fast Track Designation for AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma.
SELLAS Life Sciences Group (NASDAQ: SLS), a late-stage clinical biopharmaceutical company specializing in cancer therapy development, has announced a corporate update call scheduled for Wednesday, January 8, 2025, at 9:00 a.m. Eastern Time.
The call will feature Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS, who will present the company's 2025 outlook. He will be joined by Dr. Yair Levy, Director of Hematologic Malignancies at the Baylor University Medical Center and member of the REGAL Steering Committee.
The presentation will be accessible via webcast under the title '2025 Business Outlook'.
SELLAS Life Sciences Group (NASDAQ: SLS) announced reaching a critical milestone in its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) for acute myeloid leukemia (AML). The study has achieved its pre-specified threshold of 60 events (deaths), triggering an interim analysis by the Independent Data Monitoring Committee (IDMC).
The IDMC will conduct a comprehensive review of the REGAL data in January 2025, assessing the efficacy, futility, and safety of GPS as a potential new treatment option for AML patients. The analysis represents a significant step in SELLAS's mission to develop novel cancer therapies.
SELLAS Life Sciences Group announced positive data from Phase 2 trial of SLS009, a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). Key findings include:
- Median Overall Survival exceeding 7.7 months in the 30 mg BIW cohort for venetoclax-refractory patients (vs. historical 2.5 months)
- 56% Overall Response Rate in AML-MRC patients, surpassing the 33% target
- Well-tolerated safety profile with no new safety signals
The trial included 14 patients in Cohort 3 and 14 in Cohorts 4-5, with 9 evaluable patients at analysis. The study evaluates SLS009 in combination with venetoclax and azacitidine at different dose levels, focusing on ASXL1 mutated AML patients and those with myelodysplasia-related molecular abnormalities.
SELLAS Life Sciences Group announced promising preclinical study results showing ASXL1 mutations as a key predictor of SLS009 response in solid cancers. The study revealed high efficacy in 67% of ASXL1 mutated solid cancers compared to 0% in non-ASXL1 mutated cancers. In colorectal cancer (CRC MSI-H), ASXL1 mutations were found in 58% of cases, with high efficacy in 57% of mutated cell lines. In non-small cell lung cancer (NSCLC), 100% efficacy was observed in ASXL1 mutated cell lines. SLS009 outperformed the positive control in 5 out of 9 cell lines, positioning it as a promising therapeutic candidate.
SELLAS Life Sciences Group (NASDAQ: SLS) reported Q3 2024 financial results and pipeline updates. The company's Phase 3 REGAL study interim analysis for AML treatment remains on track for Q4 2024. Their drug candidate SLS009 showed promising results in Phase 2a trials, with a 31% overall response rate in relapsed/refractory AML patients. Financial highlights include Q3 R&D expenses of $4.4M (down from $5.8M in 2023), G&A expenses of $3.0M (down from $3.5M), and a net loss of $7.1M ($0.10 per share). Cash position stands at $21M as of September 30, 2024.
SELLAS Life Sciences (NASDAQ: SLS) announced promising results from its Phase 2a trial of SLS009, a CDK9 inhibitor, in treating relapsed/refractory acute myeloid leukemia (r/r AML). The findings will be presented at the 66th ASH Annual Meeting in December 2024.
The trial, involving 30 patients, demonstrated a 50% response rate at the optimal dose level of 30 mg twice weekly. Notable outcomes include a median overall survival of 5.5 months at 45 mg once weekly, compared to less than 2.5 months with standard care. The treatment showed particular effectiveness in patients with AML-myelodysplasia-related changes, especially those with ASXL1 mutations, achieving a 56% response rate in this group.
SELLAS Life Sciences Group (NASDAQ: SLS) has received Rare Pediatric Disease Designation (RPDD) from the FDA for Galinpepimut-S (GPS) in treating pediatric acute myeloid leukemia (AML). GPS, an immunotherapeutic targeting Wilms Tumor-1, is currently in a Phase 3 REGAL trial for adult AML patients, with an interim analysis expected in Q4 2024.
The RPDD makes GPS eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be transferred or sold, with recent valuations around $100 million. GPS has shown promise in clinical settings, particularly in younger patients. In a Phase 2 trial with adult AML patients, GPS demonstrated a median overall survival of 67.6 months across all ages, with even better outcomes in younger patients.
AML prognosis in refractory/relapsed pediatric patients remains poor, with a 5-year overall survival rate of 33% for all patients, and only 15.7% for those whose remission lasted less than 12 months. About 50% of children with pediatric AML relapse, highlighting the need for new treatment options.