Sellas Life Sciences Group Inc Stock Price, News & Analysis

SELLAS Life Sciences Group, Inc. (SLS) reported a cash position of $21.3 million as of September 30, 2022, along with its financial results for Q3 2022. The company is advancing its Phase 3 REGAL study of galinpepimut-S (GPS) for acute myeloid leukemia (AML) and exploring further developments in ovarian cancer treatments. Research and development (R&D) expenses were $4.3 million for Q3 2022, a slight decrease year-over-year. The net loss narrowed to $7.0 million for Q3 2022 compared to $7.1 million in Q3 2021, reflecting ongoing clinical advancements.

SELLAS Life Sciences Group (NASDAQ: SLS) has provided significant updates on its Phase 3 REGAL clinical trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients. The trial will now include 125 to 140 patients, and interim analyses will be based on 60 events, with final results anticipated by the end of 2024. Preliminary findings indicate a potential two-fold increase in median overall survival (OS). Furthermore, 3D Medicines will enroll around 20 patients, triggering milestone payments to SELLAS, potentially facilitating earlier market access in China.

SELLAS Life Sciences Group (NASDAQ: SLS) announced promising results from its Phase 1/2 clinical trial of galinpepimut-S (GPS) combined with Keytruda for advanced ovarian cancer. The median overall survival was 18.4 months, surpassing 13.8 months from similar studies using checkpoint inhibitors alone. Progression-free survival also improved to 12 weeks compared to 8 weeks previously. A notable finding was the enhanced efficacy seen in patients with detectable PD-L1 biomarkers, suggesting broader applicability for GPS in cancer treatment. Full trial data will be presented at a major medical conference in 1H 2023.

SELLAS Life Sciences Group (NASDAQ: SLS) announced its plans to present data on GFH009, a selective CDK9 inhibitor, at the ASH Annual Meeting from December 10-13, 2022, in New Orleans. The presentations will include GFH009’s mechanism of anti-proliferative activity in hematologic cancers and preliminary safety and efficacy from its first-in-human study. Key presentation details include:

• Title: In Vitro and In Vivo Studies Support GFH009
• Date: December 11, 2022
• Presenter: Dragan Cicic

SELLAS is dedicated to developing novel cancer therapies.

SELLAS Life Sciences Group (NASDAQ: SLS) will host a virtual investor event on November 14, 2022, at 8:30 a.m. ET, to discuss the Phase 3 REGAL clinical trial of galinpepimut-S (GPS) for acute myeloid leukemia. The event will feature company leadership including President and CEO Angelos Stergiou and expert M. Yair Levy from Baylor University Medical Center. GPS targets the WT1 protein, with potential applications in various cancer types. The company is also developing GFH009, a selective CDK9 inhibitor, licensed from GenFleet Therapeutics.

SELLAS Life Sciences Group (NASDAQ: SLS) has announced an update call regarding its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients, scheduled for November 14, 2022. The call will feature company leadership and industry experts, including M. Yair Levy from the Baylor University Medical Center. Additionally, SELLAS is developing GFH009, a CDK9 inhibitor, licensed from GenFleet Therapeutics. This update could be pivotal for investors monitoring SLS' potential in the oncology market.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that its partner, 3D Medicines Inc., has successfully dosed the first patient in a Phase 1 clinical trial for its lead candidate, galinpepimut-S (GPS), in China. This open-label trial aims to recruit 15 patients with specific hematologic malignancies who have had prior treatments. SELLAS views this milestone as critical for the global development of GPS. The company continues to progress with its focus on innovative cancer therapies, with GPS targeting the WT1 protein in various tumor types.

SELLAS Life Sciences Group (NASDAQ: SLS) has announced data from a bioequivalence study for GFH009, a selective small molecule inhibiting CDK9, presented at the Society of Hematologic Oncology. The study demonstrates that GFH009's formulation at pH 6.0 is less acidic than the previous pH 4.5 formulation, leading to improved patient tolerability during prolonged dosing. The study supports ongoing Phase 1 trials for relapsed/refractory hematologic cancers, indicating potential for better therapeutic strategies and reduced infusion reactions.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced a poster presentation at the Tenth Annual Meeting of the Society of Hematologic Oncology on September 28, 2022, showcasing preclinical pharmacokinetic profiles of GFH009. This selective CDK9 inhibitor, under development for various cancer types, demonstrates an important step in its clinical development.

The presentation will be led by Dragan Cicic, MD, and highlights two GFH009 formulations with distinct pH levels. SELLAS aims to advance therapeutic options targeting hematologic malignancies and solid tumors.