Syros Pharmaceuticals, Inc. Q2 FY2024 earnings call

• Conley Chee emphasized the mission to develop new standards of care for hematologic malignancies and progress in preparation for data readouts of tamibarotene for AML and higher-risk MDS. He highlighted plans for commercialization in the U.S. with own efforts post-approval.
• David Roth discussed tamibarotene's trials: SELECT-MDS-1 Phase III in higher-risk MDS with RARA overexpression, focusing on CR endpoint; SELECT-AML-1 Phase II in Unfit AML with RARA overexpression, noting positive initial data and upcoming SOHO 2024 update.
• Jason Haas reviewed financial results, noting decreased R&D and G&A expenses, and stated cash position is sufficient to fund operations into Q3 2025.

In the second quarter of 2024, Syros Pharmaceuticals recognized no revenue, whereas in the second quarter of 2023, revenue was $2.8 million. R&D expenses were $22 million in Q2 2024 compared to $29.6 million in Q2 2023, primarily due to reductions in external R&D consulting, contract manufacturing, and headcount-related expenses. G&A expenses were $5.5 million in Q2 2024 versus $7.2 million in Q2 2023, mainly due to reductions in headcount, consulting, and facilities expenses. The net loss for Q2 2024 was $23.3 million or $0.59 per share, compared to a net loss of $36.3 million or $1.30 per share in the same period in 2023. Cash, cash equivalents, and marketable securities as of June 30, 2024, were $79 million.

• Anticipates data readouts for tamibarotene in AML in September and pivotal Phase III MDS data by mid-Q4 2024.
• Cash position is sufficient to fund operating expenses and capital expenditures into Q3 2025, covering pivotal Phase III data from SELECT-MDS-1 and additional SELECT-AML-1 data.

Forward-looking statements are subject to risks and uncertainties outlined in SEC filings, including those in the quarterly report on Form 10-Q and annual report on Form 10-K. No specific detailed operational failures discussed beyond standard forward-looking statement disclaimers.

Q: In AML, when would Syros be in a position to make a go/no-go decision on advancing tamibarotene into a pivotal study? What's needed for the decision?

A: David Roth said it's premature to directly answer, but data from the SELECT-AML-1 trial in September will be key. The magnitude of complete response, CR/CRi response, and duration of remissions will be important factors.

Q: Plans for commercialization in Europe for tamibarotene?

A: David Roth stated Europe is fragmented, and Syros plans to license or find a partner in Europe for commercialization there.

Q: On financial expenses, was the decrease due to timing or cost-cutting?

A: Jason Haas said expenses are down due to reprioritization, focusing resources on MDS and AML data and commercial launch preparation, indicating a new run rate on expenses.

Q: Reminder on SELECT-MDS Phase III trial power and delta needed?

A: David Roth said SELECT-MDS-1 is powered to over 90% to show a difference in CR rates across arms, with assumptions based on two-to-one randomization and standard performance of aza in the control arm.

Q: Follow-up on SELECT-AML-1 and enrollment status for SELECT-MDS survival analysis?

A: David Roth said SELECT-AML-1 update in September will include data from pre-specified analysis, and SELECT-MDS-1 study continued enrolling, making progress toward 550 patients for survival secondary endpoint but no specific timing for enrollment completion or analysis.

Q: Characterization of high-risk vs low-risk MDS patients and treatment paradigms?

A: David Roth explained high-risk MDS patients are closer to life-threatening disease, focusing on CR endpoints related to complete response and hematologic improvement, while low-risk patients have longer prognosis and focus on anemia-related symptoms and different treatment approaches.