NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a late-stage clinical biopharmaceutical company with a market capitalization of $74 million, today announced an update on the progress of its novel cancer therapies, highlighting upcoming clinical milestones for 2025. The company's stock has shown remarkable strength, delivering a 91% return over the past year, according to InvestingPro data. The company is poised for a pivotal year as it awaits the interim analysis of its Phase 3 REGAL study in acute myeloid leukemia (AML) and full topline data from its Phase 2 trial of SLS009.
SELLAS's REGAL study, focusing on the immunotherapeutic agent Galinpepimut-S (GPS), targets patients with AML who have achieved complete remission following second-line salvage therapy. The Independent (LON:IOG) Data Monitoring Committee (IDMC) is set to conduct an interim analysis this January, which could result in a recommendation to stop the trial for efficacy, futility, or continue without modification.
The company's other key asset, SLS009, a highly selective CDK9 inhibitor, is expected to deliver full topline data from its Phase 2 trial in the first half of 2025. This trial includes patients resistant to venetoclax combination therapies. SLS009 has shown promise, particularly in patients with mutations associated with poor prognosis. Analysts maintain a strong bullish stance on SELLAS's potential, with a consensus target range of $4.00 to $7.50, significantly above current trading levels. InvestingPro subscribers can access 8 additional key insights about SELLAS's market position and growth potential.
In 2024, SELLAS achieved significant regulatory milestones. GPS received FDA Rare Pediatric Disease Designation for pediatric AML, and SLS009 received the same designation for pediatric AML and pediatric acute lymphoblastic leukemia. Additionally, SLS009 was granted FDA Fast Track Designation for AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma.
SELLAS also reported positive data from the ongoing Phase 2 trial of SLS009 in the fourth quarter of 2024, with a median overall survival that has not yet been reached but exceeds 7.7 months, surpassing historical expectations.
The company is also expanding the development of SLS009 into the frontline setting in AML through non-dilutive grant funding applications and is developing pediatric programs for hematological and potentially other malignancies.
The regulatory agencies have recognized the potential of SELLAS's assets, as evidenced by the multiple designations granted in 2024, reflecting the significant unmet medical needs these therapies aim to address.
SELLAS will host a webinar today at 9:00 am ET to provide a corporate update. The company's focus remains on advancing its clinical stage portfolio and achieving the anticipated milestones that could transform the treatment landscape for patients with hematologic malignancies. InvestingPro analysis shows the company maintains a healthy financial position with a current ratio of 2.26, indicating strong liquidity to fund its development programs. The company holds more cash than debt on its balance sheet, providing financial flexibility for its clinical initiatives.
This news is based on a press release statement from SELLAS Life Sciences Group, Inc.
In other recent news, SELLAS Life Sciences Group has reached a significant milestone in its Phase 3 REGAL clinical trial for acute myeloid leukemia (AML). The trial has met the pre-specified threshold of 60 events, prompting an interim analysis by the Independent Data Monitoring Committee. The analysis will assess the efficacy, safety, and potential of the company's lead product candidate, galinpepimut-S. Additionally, SELLAS reported promising results from their Phase 2 clinical trial for the drug SLS009, showing a significant improvement in the median overall survival for patients.
The U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to SELLAS's drugs SLS009 and Galinpepimut-S, recognizing their potential in treating pediatric acute myeloid leukemia and pediatric acute lymphoblastic leukemia. In other developments, SELLAS has extended its lease agreement for its Times Square Tower headquarters through September 2026 and is set to raise approximately $21 million through a registered direct offering. These recent developments reflect SELLAS's ongoing commitment to research and development in the field of cancer therapies.
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