Syros Pharmaceuticals (SYRS) Q3 2024 earnings summary

Executive summary

• Advancing tamibarotene as a potential new standard of care for newly diagnosed higher-risk MDS patients with RARA overexpression, representing about 50% of this population.

• Pivotal data readout from the SELECT-MDS-1 Phase 3 trial expected in mid-November 2024, a key milestone for the company.

• Preparing for first NDA filing and commercial launch of tamibarotene in the U.S., targeting a significant unmet need.

• The company discontinued enrollment in SELECT-AML-1 and prioritized tamibarotene after a 2023 restructuring and cost reduction.

• No product sales revenue has been generated; operations are funded by equity, debt, and collaborations.

Financial highlights

• No revenue recognized in Q3 2024, compared to $3.8 million in Q3 2023, due to the prior termination of a collaboration agreement.

• R&D expenses decreased to $20.5 million from $28.3 million year-over-year; G&A expenses fell to $5.7 million from $7.8 million.

• Net loss for Q3 2024 was $6.4 million ($0.16 per share), a significant improvement from $40.1 million ($1.43 per share) in Q3 2023.

• Cash and cash equivalents were $58.3 million as of September 30, 2024, expected to fund operations into Q3 2025.

• Gain from change in fair value of warrant liabilities was $20.3 million in Q3 2024, reflecting a decrease in stock price.

Outlook and guidance

• SELECT-MDS-1 Phase 3 trial data to be reported in mid-November 2024, focusing on complete response (CR) rate as the primary endpoint.

• NDA submission preparations underway, with routine regulatory steps planned post-data release.

• Commercial launch plans for tamibarotene are in place, with accelerated activities expected following positive data.

• Cash runway is expected to fund operations into Q3 2025; additional funding will be required beyond that point.

• Management is pursuing additional capital through equity, debt, or business development transactions.