RARE Daily

Salarius to Explore Strategic Alternatives and Implement Measures to Extend its Resources

August 9, 2023

Rare Daily Staff

Salarius Pharmaceuticals said it will eliminate half its staff as part of an effort to implement measures to extend its cash runway and consider strategic alternatives.

The remaining employees will focus on limited drug development activities, completing the FDA process to determine the clinical trial registration requirements for its experimental therapy seclidemstat as a treatment for Ewing sarcoma program, and supporting the exploration of potential transactions and other options.

Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the U.S. Food and Drug Administration. Seclidemstat is currently in a phase 1/2 clinical trial evaluating its use in combination with topetecan and cyclophophsomide for the treatment of relapsed/refractory Ewing sarcoma.

In December 2022, Salarius reported interim Ewing sarcoma clinical data that showed a 60 percent confirmed disease control rate and 7.4 months median time to tumor progression for first-relapse patients, with no disease progression observed in either first- or second-relapse patients who achieved confirmed disease control. Salarius has continued to monitor patients in the Ewing sarcoma trial and plans to release updated survival data in the coming months.

“The second quarter and recent weeks were highlighted by significant advancements in both of our development programs, but after a review of each program’s future funding needs and the current financial markets, the board of directors has made the difficult decision to limit further drug development while we explore strategic alternatives for both Salarius and continued development of our drugs,” said David Arthur, president and chief executive officer of Salarius Pharmaceuticals. “This was an exceptionally difficult decision in light of the promising early seclidemstat Ewing sarcoma clinical data, seclidemstat hematological clinical data and the recent U.S. Food and Drug Administration clearance to begin the SP-3164 phase 1 trial.”

The company has retained Canaccord Genuity to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the company.

If the company is unable to complete a transaction, it said it may be necessary to seek other alternatives for restructuring and resolving its liabilities, including a wind-down of operations. Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has determined it is appropriate or legally required.

Photo: David Arthur, president and chief executive officer of Salarius Pharmaceuticals

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