NEW YORK - The Independent Data Monitoring Committee (IDMC) has advised SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS) to proceed without changes with its Phase 3 REGAL trial of galinpepimut-S (GPS) for patients with acute myeloid leukemia (AML), the company announced today. Following a prespecified assessment of unblinded data, the IDMC found no safety concerns and deemed the efficacy and safety data sufficient to continue the study as planned.
The IDMC will reconvene in June 2024 for another assessment, which is earlier than initially scheduled according to the IDMC charter. This meeting will review the efficacy and safety data from all enrolled patients (n=127) with a cutoff date around the end of May 2024.
SELLAS recently completed enrollment for the REGAL trial across the US, Europe, and Asia. The primary endpoint of the trial is overall survival for AML patients who have achieved complete remission following second-line salvage therapy. The company reported that as of March 2024, 66 patients had discontinued the treatment for various reasons, including relapse or death, but no intolerable toxicities were observed in the GPS arm of the study.
The IDMC, composed of experts in medicine, science, and biostatistics, is tasked with ensuring the validity and scientific merit of the study by periodically reviewing patient safety, efficacy, and futility data. The IDMC's recommendation to continue the trial is based on the current data available, which indicates a favorable risk-benefit profile for GPS.
SELLAS Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company, is developing GPS, licensed from Memorial Sloan Kettering Cancer Center, to target the WT1 protein found in various tumor types. The company's portfolio also includes SLS009, a selective CDK9 inhibitor for cancer treatment.
This news is based on a press release statement from SELLAS Life Sciences Group, Inc. and does not include any promotional content or endorsement of claims regarding GPS or the REGAL trial. The information presented is subject to confirmation by further clinical studies and regulatory review.
InvestingPro Insights
As SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) continues its Phase 3 REGAL trial with optimism, investors and industry observers are closely monitoring the company's financial health and stock performance. According to data from InvestingPro, SELLAS has a market capitalization of $82.15 million, which positions it within the small-cap segment of the market – often associated with higher growth potential but also with higher risk.
InvestingPro Tips suggest that SELLAS suffers from weak gross profit margins and that its stock price movements have been quite volatile. This volatility is reflected in the recent price total returns, with a notable 44.55% increase over the last month and an impressive 149.15% over the last three months. However, the company's short-term obligations exceeding its liquid assets and the analysts' anticipation that the company will not be profitable this year could be points of concern for potential investors.
Additionally, the InvestingPro Tips highlight that SELLAS does not pay a dividend to shareholders, which may influence the investment decisions of those seeking regular income streams from their investments. The company's performance metrics, such as a negative P/E ratio of -2.2 for the last twelve months as of Q4 2023, and an operating income of approximately -$37.87 million, further underscore the financial challenges it faces.
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The next earnings date on May 9, 2024, will be a critical event for the company, providing further clarity on its financial state and the potential impact of ongoing clinical trials on its future prospects. With a total of 11 InvestingPro Tips available, investors can gain comprehensive insights into SELLAS's market position and make more informed decisions.
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