SELLAS Life Sciences Q1 2024 Financial Results and Corporate Update

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported its financial results for the first quarter ending March 31, 2024, showcasing significant progress in its clinical trials and financial health. The company, a late-stage biopharmaceutical firm concentrating on innovative cancer therapies, highlighted several key developments in its pipeline.

Dr. Angelos Stergiou, President and CEO of SELLAS, announced promising preliminary results from the Phase 2a study of SLS009. The data revealed a 100% response rate in patients with the ASXL1 mutation at the 30 mg BIW dose, demonstrating substantial anti-leukemic activity. This mutation, common in acute myeloid leukemia (AML) and other cancers like colon cancer, generally indicates a poor prognosis. Encouraged by these findings, SELLAS is expanding the study cohort to include more participants with the ASXL1 mutation. Dr. Stergiou expressed optimism about SLS009’s potential to provide significant benefits to a heavily pretreated and underserved patient population.

In addition to the SLS009 study, SELLAS made strides in its Phase 3 REGAL study of Galinpepimut-S (GPS). The Independent Data Monitoring Committee (IDMC) recently reviewed the study's data and recommended continuing the trial without modifications. The IDMC will reconvene in June 2024 to evaluate safety and efficacy data from all 127 enrolled patients. The study aims to assess the effectiveness of GPS, an immunotherapeutic targeting the Wilms Tumor-1 (WT1) protein, in patients with AML.

Other pipeline highlights include a provisional patent application for SLS009 based on its efficacy in patients with the ASXL1 mutation. SELLAS is also conducting a Phase 1b/2 clinical trial in collaboration with GenFleet Therapeutics and BeiGene Switzerland GmbH. This trial, focusing on relapsed/refractory diffuse large B-cell lymphoma (DLBCL), involves combining SLS009 with the BTK inhibitor Brukinsa® (zanubrutinib). The first patient was dosed in March 2024, and the study is progressing in China, funded by GenFleet.

Furthermore, SELLAS is collaborating with the National Cancer Institute (NCI) under the NIH PIVOT program to explore SLS009’s potential in pediatric tumors. Initial safety and efficacy data from this program are expected in the second half of 2024.

Financially, SELLAS reported research and development expenses of $5.1 million for Q1 2024, down from $7.2 million in the same period of 2023. The decrease was attributed to the timing of clinical drug supply purchases, reduced consultant fees, personnel expenses, and licensing fees. General and administrative expenses were slightly higher at $4.5 million, compared to $4.1 million in Q1 2023, primarily due to a one-time severance charge, partially offset by reductions in outside services and other personnel-related costs.

The net loss for Q1 2024 was $9.6 million, or $0.21 per share, compared to a net loss of $11.1 million, or $0.47 per share, in Q1 2023. As of March 31, 2024, SELLAS had cash and cash equivalents totaling approximately $18.4 million, reflecting a strengthened financial position.

SELLAS remains focused on advancing its lead product candidate, GPS, and SLS009, aiming to provide novel therapeutics for a broad range of cancer indications. GPS, licensed from Memorial Sloan Kettering Cancer Center, and SLS009, a selective CDK9 inhibitor licensed from GenFleet Therapeutics, are central to SELLAS' strategy to address various hematologic malignancies and solid tumors.