Welcome to our dedicated page for Sellas Life Sciences Group news (Ticker: SLS), a resource for investors and traders seeking the latest updates and insights on Sellas Life Sciences Group stock.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on developing novel therapies for cancer, with a strong emphasis on acute myeloid leukemia (AML) and other hematologic malignancies. This news page aggregates company announcements, clinical updates, financial disclosures, and collaboration news related to SLS.
Readers can follow developments around SELLAS’ lead product candidate galinpepimut-S (GPS), a WT1-targeted peptide immunotherapy licensed from Memorial Sloan Kettering Cancer Center, which is being evaluated in the pivotal Phase 3 REGAL trial as a potential maintenance therapy in AML after second complete remission. News items include updates on the REGAL trial’s progress, Independent Data Monitoring Committee recommendations, and commentary from investigators and key opinion leaders.
The SLS news feed also covers SLS009 (tambiciclib), SELLAS’ highly selective CDK9 inhibitor. Articles highlight Phase 2 clinical data in relapsed or refractory AML with myelodysplastic syndrome-related changes (AML-MR) after prior venetoclax-based treatment, including reported response rates, survival outcomes, and safety findings for SLS009 in combination with azacitidine and venetoclax. Preclinical results in T-cell prolymphocytic leukemia (T-PLL) and mechanistic studies in AML cell lines are also featured in conference-related releases.
In addition to clinical and scientific news, this page includes corporate updates such as participation in investor conferences, warrant exercise transactions, and quarterly financial results as reported in press releases referenced by Form 8-K filings. Investors and followers of SLS can use this page to review the sequence of material events, from R&D days and conference presentations to financing activities and operational updates, in one organized stream of company-specific news.
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.
SELLAS Life Sciences Group (NASDAQ: SLS) has presented breakthrough preclinical data for SLS009 in treating TP53 mutated Acute Myeloid Leukemia (AML) at the 2025 AACR Conference. The study shows that SLS009, a selective CDK9 inhibitor, reduced TP53-mutated leukemia cells by up to 97% in combination with azacitidine-venetoclax, and 80% as monotherapy.
In ongoing Phase 2 trials, patients receiving 30mg of SLS009 BIW achieved a median overall survival of 8.8 months, significantly exceeding the historical benchmark of 2.5 months. Response rates were notable across various mutations: 67% for ASXL1, 60% for RUNX1, and 33% for TP53.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced its upcoming presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled for May 30-June 3, 2025. The presentation will showcase preclinical efficacy data of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer.
The poster presentation, scheduled for June 2, 2025 (1:30 PM-4:30 PM CDT), will be displayed in Hall A under abstract #3121. The full abstract will be released on ASCO's website on May 22, 2025. Currently, SLS009 is undergoing a Phase 2 clinical trial evaluating its safety and efficacy in combination with venetoclax and azacitidine for AML patients with ASXL1 mutations.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced positive results from Cohort 3 of its Phase 2 trial of SLS009 (tambiciclib) in relapsed/refractory acute myeloid leukemia (r/r AML). The trial showed remarkable survival benefits with a median Overall Survival (mOS) of 8.8 months in patients relapsed or refractory to venetoclax-based regimens, significantly exceeding the historical benchmark of 2.5 months.
The study enrolled 14 r/r AML patients, with 71% having AML-MRC. Key findings include an Overall Response Rate (ORR) of 67% in AML-MRC patients and 46% in all evaluable patients, surpassing the targeted 20% ORR. Notable response rates were observed across different genetic mutations: 67% in ASXL1, 60% in RUNX1, and 33% in TP53 patients.
The trial continues with expansion cohorts 4 and 5, focusing on AML-MRC patients with various mutations. Full data and FDA regulatory path feedback are expected in 1H 2025.
SELLAS Life Sciences Group (NASDAQ: SLS) reported its full year 2024 financial results and corporate updates. The company announced positive interim analysis results for its Phase 3 REGAL trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia, with final analysis expected in 2025.
Key highlights include:
- Phase 2 trial of SLS009 showed 56% overall response rate in AML patients with myelodysplasia-related changes
- Raised $25 million in gross proceeds through a registered direct offering in January 2025
- R&D expenses decreased to $19.1 million from $24.0 million in 2023
- G&A expenses reduced to $12.4 million from $13.9 million in 2023
- Net loss of $30.9 million ($0.50 per share) compared to $37.3 million ($1.34 per share) in 2023
- Cash position of $13.9 million as of December 31, 2024
SELLAS Life Sciences Group (NASDAQ: SLS) announced positive results from a Phase 2a trial of SLS009 (tambiciclib) combined with zanubrutinib in relapsed/refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL). The trial, conducted by GenFleet Therapeutics in China, showed a 67% overall response rate, more than double that of zanubrutinib alone.
Among the 9 enrolled patients, one achieved complete response, while three had partial responses with target lesion shrinkages of 89%, 78%, and 56%. After a median follow-up of 4.6 months, 67% of patients remained alive. In the non-GCB DLBCL subgroup, the disease control rate reached 83%. Grade ≥ 3 adverse events were reported in 55.6% of patients, comparable to zanubrutinib's safety profile. Notably, genetic analysis revealed the complete response patient had MYC amplification and TP53 mutations, suggesting SLS009 could potentially overcome TP53-mutated cancer drug resistance.
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.