HOUSTON, TX – Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX), a biotechnology company focused on cancer treatments, announced today that it is discontinuing its ongoing Phase 1/2 clinical trial of seclidemstat for Ewing sarcoma. The decision to terminate the trial is part of the company's strategy to conserve cash while seeking strategic alternatives to maximize shareholder value.
The clinical trial, which was assessing the efficacy of seclidemstat, a drug candidate for the treatment of Ewing sarcoma, will cease operations across all sites. This move follows previous discussions with the U.S. Food and Drug Administration (FDA) and amendments made to the trial protocol in January 2024 based on FDA guidance.
Despite this setback, Salarius will continue to support a separate clinical trial conducted by The University of Texas MD Anderson Cancer Center (MDACC). This MDACC-sponsored study evaluates seclidemstat in combination with azacitidine in adults with myelodysplastic syndromes and chronic myelomonocytic leukemia. The trial is currently on partial clinical hold following a serious grade 4 adverse event.
The company's announcement includes forward-looking statements regarding the pursuit of strategic alternatives and the potential future of its operations and product candidates. Salarius has indicated that without raising capital or completing a strategic transaction in the coming months, it may have to consider dissolution and an orderly wind-down of operations.
Salarius has faced challenges, including the need to manage costs and expenses amidst limited financial and operational resources. The uncertainty surrounding the company's ability to continue as a going concern and the sufficiency of its capital resources are factors that may affect its planned activities.
Investors are cautioned not to place undue reliance on these forward-looking statements, which are subject to various risks and uncertainties. These include the potential distraction or adverse effects of exploring strategic alternatives, the likelihood of needing to seek dissolution, uncertainties in research and development, and competitive industry risks.
In other recent news, Salarius Pharmaceuticals encountered a serious setback in its clinical trial for the drug seclidemstat, as disclosed in a filing with the Securities and Exchange Commission. A patient experienced a grade 4 adverse event, leading the U.S. Food and Drug Administration to place a partial clinical hold on the trial. Despite this, current participants may continue their treatment if deemed beneficial.
In parallel, Salarius Pharmaceuticals announced a 1-for-8 reverse stock split to meet Nasdaq's minimum bid price requirement. This move, approved by Salarius' stockholders, will reduce the number of issued and outstanding common stock shares from approximately 4.7 million to about 0.6 million. The reverse split is intended to be uniform for all stockholders, maintaining unchanged ownership percentages except where fractional shares result in cash payouts.
Equiniti Trust Company, LLC, has been appointed as the exchange agent and transfer agent for the reverse split process. These developments reflect Salarius Pharmaceuticals' efforts to understand the implications of the adverse event in the clinical trial and to comply with Nasdaq's requirements.
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