Syros Pharmaceuticals, Inc. (SYRS) has announced key updates regarding its clinical programs and strategic direction, according to its recent SEC Form 10-Q filing. The company is focused on advancing tamibarotene, a selective retinoic acid receptor alpha (RARα) agonist, for the treatment of higher-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML).
SELECT-MDS-1 Trial Progress
The SELECT-MDS-1 Phase 3 clinical trial, evaluating tamibarotene in combination with azacitidine for newly diagnosed HR-MDS patients with RARA overexpression, has completed enrollment with 190 patients for the primary endpoint analysis. The trial has cleared a pre-specified interim futility analysis, and pivotal complete response (CR) data is expected in mid-November 2024. An amendment to the trial protocol in March 2023 increased the total patient count to approximately 550 to assess overall survival (OS) as a key secondary endpoint, potentially allowing it to serve as a confirmatory study for full approval.
Strategic Realignment and Cost Reduction
In October 2023, Syros announced a strategic realignment to prioritize the development and pre-launch activities for tamibarotene. This realignment included discontinuing further investment in the clinical development of SY-2101 (oral arsenic trioxide) and preclinical programs. As part of this effort, the company reduced its employee base by approximately 35% and implemented cost reduction measures, including the closure of laboratory facilities.
Financial Overview
The company's financial results for the third quarter of 2024 reflect these strategic changes. Revenue decreased to $0 million from $3.8 million in the same period last year due to the termination of a collaboration. However, operating expenses decreased by 32% to $26.2 million, and the net loss improved significantly to $6.4 million, compared to $40.1 million in the previous year. These improvements are attributed to reduced research and development expenses and restructuring costs.
Diagnostic Development and Market Opportunity
Syros is actively working to develop and validate a laboratory-developed test for RARA overexpression and is partnered with Qiagen Manchester Limited to develop a kit-based testing solution for future commercialization. The company estimates the total market opportunity for HR-MDS therapeutics in the United States to be approximately $1.6 billion by 2029, with the market opportunity for tamibarotene in HR-MDS patients with RARA overexpression projected to exceed $800 million by 2029. The FDA granted Fast Track Designation to tamibarotene in combination with azacitidine for the treatment of adults with newly diagnosed HR-MDS who are positive for RARA overexpression in January 2023.
Challenges and Future Outlook
Despite these advancements, Syros acknowledges substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance date of the Quarterly Report on Form 10-Q, citing the need for additional capital. The company plans to raise additional capital through various means, including equity or debt financings and business development transactions. Syros faces competition from other pharmaceutical and biotechnology companies and relies on third parties for the development and commercialization of diagnostic tests. The company's future viability depends on obtaining regulatory approvals and achieving market acceptance for tamibarotene.
