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) entered an agreement with IMPACT-AML to expand the SLS009 clinical program into Europe, leveraging the IMPACT-AML STREAM platform and EU Mission Cancer network.
The collaboration plans U.S. enrollment of SLS009 plus azacitidine and venetoclax (AZA/VEN) in newly diagnosed, high-risk AML in Q1 2026, with European site initiation anticipated in Q2 2026, subject to regulatory and site readiness. The European study is planned to enroll approximately 40 patients. SELLAS describes the arrangement as capital-efficient and intended to broaden and accelerate patient access and enrollment.
SELLAS Life Sciences (NASDAQ: SLS) provided an update on the pivotal Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) on Dec 29, 2025. The contract research organization reported 72 pooled events (deaths) as of Dec 26, 2025; the trial requires 80 events to trigger the event-driven final overall survival analysis. SELLAS remains fully blinded to efficacy and survival data and says this aggregate update does not affect planned statistical analyses. The company will announce when the 80th event occurs.
Additional context: the Independent Data Monitoring Committee previously recommended continuing the trial without modification.
SELLAS Life Sciences (NASDAQ: SLS) presented Phase 2 data showing that SLS009 plus azacitidine (AZA) and venetoclax (VEN) produced a 46% overall response rate (ORR) in 35 evaluable relapsed/refractory AML-MR patients previously treated with VEN-based regimens.
Key metrics: ORR 46% overall, 58% ORR in patients with one prior line of therapy (mOS not yet reached), median overall survival 8.9 months in the least pretreated cohort versus a ~2.5–2.6-month historical benchmark, and no dose-limiting toxicities or treatment-related deaths. Study expansion into newly diagnosed high-risk AML is planned for Q1 2026. Results were presented at ASH 2025 on December 7, 2025.
SELLAS Life Sciences (NASDAQ: SLS) reported Q3 2025 results and a corporate update on Nov 12, 2025. Key clinical highlights include the Phase 3 REGAL trial of GPS remaining on track with a final, event‑driven analysis at 80 deaths anticipated by year‑end 2025, and positive Phase 2 SLS009 data accepted for presentation at ASH 2025. An 80‑patient trial for newly diagnosed AML is planned to begin in Q1 2026. Preclinical SLS009 data showed statistically significant survival benefit in T‑PLL at ESMO 2025. Financially, cash and cash equivalents were $44.3M as of Sept 30, 2025, with approximately $54.6M gross proceeds from warrant exercises and $29.1M net proceeds received in Oct 2025. GAAP net loss was $6.8M in Q3 2025 and $19.2M year‑to‑date.
SELLAS Life Sciences (NASDAQ: SLS) will present Phase 2 data for SLS009, a selective CDK9 inhibitor, in combination with azacitidine and venetoclax for relapsed/refractory AML with MDS-related changes after prior venetoclax therapy at the ASH Annual Meeting, Dec 6–9, 2025.
A poster presentation is scheduled for Dec 7, 2025, 6:00–8:00 PM EST (Session 616). A preclinical abstract showing cytotoxic effects in ASXL1-mutated and TP53 knockout AML cell lines is published in Blood.
SELLAS Life Sciences (NASDAQ: SLS) announced the immediate exercise of existing warrants to purchase up to 22,363,714 shares of common stock for gross proceeds of approximately $31.0 million. In exchange, the investor will receive new registered warrants to purchase up to 22,363,714 shares at an exercise price of $2.00, exercisable immediately and expiring five years from issuance. The transaction is expected to close on or about October 28, 2025, subject to customary closing conditions, and the shares are registered under effective Form S-3 filings. SELLAS will host a virtual R&D Day on October 29, 2025 at 10:00 AM ET to discuss AML developments.
SELLAS Life Sciences (NASDAQ: SLS) announced that Dr. Angelos Stergiou, President and CEO, will participate in the J.P. Morgan U.S. Opportunities Forum with 1x1 investor meetings on Wednesday, November 12, 2025 at the Kimpton EPIC Hotel in Miami, Florida.
The company will host one-on-one meetings; investors should register via J.P. Morgan or contact their J.P. Morgan representative for access.
SELLAS Life Sciences (NASDAQ: SLS) will present preclinical in vivo data showing that its selective CDK9 inhibitor SLS009 (tambiciclib) prolonged survival in a T-cell prolymphocytic leukemia (T-PLL) patient-derived xenograft (PDX) model at ESMO Congress 2025 (Oct 17–21, 2025).
In the PDX model, SLS009 monotherapy and SLS009 plus venetoclax yielded median overall survival of 7.4 weeks and 7.9 weeks versus 4.4 weeks for venetoclax alone (statistically significant, p<0.05), with better control of circulating T-PLL cells and acceptable tolerability for the combination.
SELLAS Life Sciences (NASDAQ: SLS), a late-stage biopharmaceutical company, announced a virtual R&D Day scheduled for October 29, 2025, at 10:00 AM ET. The event will focus on acute myeloid leukemia (AML) treatments and feature key opinion leaders alongside company management.
The presentation will highlight two key programs: the Phase 3 REGAL trial of GPS with results expected by year-end, addressing AML patients in complete second remission (CR2), and an update on SLS009, their selective CDK9 inhibitor. The company will discuss recently reported Phase 2 data for SLS009 and plans for a frontline AML study set to begin in Q1 2026.
SELLAS Life Sciences (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, announced the exercise of warrants from a January 2025 issuance, generating $23.6 million in gross proceeds. The transaction involves the purchase of 19,685,040 shares of common stock.
In exchange for this immediate exercise, the institutional investor will receive new unregistered warrants to purchase an equal number of shares at an exercise price of $1.88. These new warrants will be exercisable immediately with a 5.5-year expiration period. The transaction is expected to close around September 12, 2025.