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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 (NASDAQ:SLS) announced that President and CEO Angelos Stergiou will present at three investor events in May 2026 focused on oncology and healthcare.
Appearances include the 2026 Stifel Virtual Targeted Oncology Forum, A.G.P.'s Annual Virtual Healthcare Conference, and TD Cowen’s 7th Annual Oncology Innovation Summit.
SELLAS Life Sciences (NASDAQ:SLS) reported Q1 2026 results and key clinical milestones in AML. The pivotal Phase 3 REGAL trial of GPS has reached 78 of 80 events, which will trigger final analysis at the 80th event.
SELLAS began dosing an 80-patient Phase 2 trial of SLS009 in newly diagnosed AML and presented preclinical AML data at AACR. Q1 research and development expenses were $5.1M, general and administrative expenses were $4.1M, and net loss was $8.4M. Cash and equivalents were $107.1M plus $7.5M from warrant exercises in Q2. An ATM facility up to $150M was established but not yet used.
SELLAS Life Sciences (NASDAQ: SLS) reported full-year 2025 results and a corporate update on March 19, 2026. Key highlights include $71.8M cash at year-end and an additional $42.6M received in Q1 2026 from warrant exercises, advancement of the pivotal Phase 3 REGAL GPS trial toward its pre-specified 80-event final analysis, and dosing of the first patient in a Phase 2 expansion of SLS009 in newly diagnosed AML after positive Phase 2 r/r AML data.
Phase 2 SLS009 showed a 46% overall response rate (29% CR/CRi) in 35 evaluable r/r AML patients, with notable responses in ASXL1 and TP53 subgroups.
SELLAS Life Sciences (NASDAQ: SLS) announced preclinical data showing that SLS009 (tambiciclib), a selective CDK9 inhibitor, lowers the apoptotic threshold in AML cell lines by reducing MCL-1 and survivin and increasing active caspase-3.
Key findings: IC50 fell from 50 nM to ~20 nM with repeated dosing, effects appeared as early as 6 hours and strengthened by 24 hours, and activity was seen in AML models with ASXL1 and TP53 mutations. Results will be presented as a poster at AACR on April 21, 2026.
SELLAS (NASDAQ: SLS) enrolled the first patient in a randomized Phase 2 trial of SLS009 (tambiciclib) for newly diagnosed, first-line AML on March 12, 2026. The study will enroll ~80 patients in two cohorts and expects topline data in Q4 2026.
The trial uses SELLAS' predictive biomarker and AI precision‑medicine models, and follows prior r/r AML Phase 2 results where SLS009 plus aza/ven achieved an overall response rate of 33% (40% at the 30mg BIW dose) and median overall survival of 8.8 months at 30mg BIW.
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.