Sellas Life Sciences Group Inc Stock Price, News & Analysis

SELLAS Life Sciences (NASDAQ: SLS) presented preclinical data for SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer at ASCO 2025. The study showed promising efficacy with 50% of ASXL1 mutant cell lines demonstrating strong anti-proliferative activity (IC50<100 nM) compared to 0% in wild-type lines. Notably, 75% of cell lines with ASXL1 frameshift mutations responded well, with all cell lines containing FSMs in the 637-638 protein region showing response. The effective concentrations were below safety thresholds observed in patients, suggesting a favorable therapeutic window. SLS009 is currently in Phase 2 trials for AML patients with ASXL1 mutations in combination with venetoclax and azacitidine.

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.