Syros Pharmaceuticals, Inc. Q1 FY2024 earnings call

• 2024 is an important year for Syros, with focus on execution across clinical development programs and pre-commercial activities for tamibarotene.
• SELECT-MDS-1 Phase III trial passed a prespecified interim futility analysis, with independent data monitoring committee recommending trial continue without modification; no concerning safety signals noted.
• FDA granted Fast Track Designation for tamibarotene in combination with venetoclax and azacitidine for unfit AML with RARA overexpression; previously granted for tamibarotene in combination with azacitidine for higher-risk MDS with RARA overexpression.
• Ongoing SELECT-MDS-1 trial is a randomized double-blind placebo-controlled trial evaluating tamibarotene and azacitidine vs placebo and azacitidine in higher-risk MDS; pivotal data expected by mid-Q4 2024.
• SELECT-AML-1 Phase II trial in unfit AML with RARA overexpression; data from prespecified analysis of over 40 patients expected in Q3 2024.
• Advancements in launch readiness activities for tamibarotene in the U.S. following approval.

In the first quarter of 2024, Syros Pharmaceuticals recognized no revenue, compared to $3 million in the first quarter of 2023. R&D expenses were $24.7 million in Q1 2024, down from $28.8 million in Q1 2023, primarily due to reduced external R&D consulting, contract manufacturing, and headcount-related expenses. G&A expenses were $6.3 million in Q1 2024, down from $7.4 million in Q1 2023, mainly due to reduced headcount, consulting, and facilities expenses. The net loss was $3.7 million or $0.10 per share in Q1 2024, compared to a net loss of $23.8 million or $0.85 per share in Q1 2023. Cash, cash equivalents, and marketable securities as of March 31, 2024, were $108.3 million, down from $139.5 million on December 31, 2023.

• Oxford loan amendment extends interest-only period from September 1, 2024 to November 1, 2025, with further extensions to Nov 1, 2026 upon milestones; increases term loans available from $40 million to $100 million.
• Current cash position sufficient to fund operating expenses and capital expenditures into Q3 2025, beyond pivotal Phase III data from SELECT-MDS-1 and additional data from SELECT-AML-1.

• Forward-looking statements may differ materially due to risks, uncertainties, and factors set forth in the Risk Factors section of quarterly report on Form 10-Q, annual report on Form 10-K, and other SEC filings; no specific operational failures discussed in detail.

Q: On the interim analysis in SELECT-MDS-1, was the analysis looking at 50% of the patients involved in the primary endpoint? Could you give additional info on the statistical bar for the futility analysis? And in AML, do you think you'll have enough info post Q3 update to make a go/no-go decision on pivotal development in AML?

A: David Roth responded that the interim analysis was a prespecified futility analysis, triggered when 50% of patients contributing to the final primary analysis had sufficient time on study. Data was reviewed blinded by independent data monitoring committee, who said they passed and no new safety signals. On AML, at this point, anticipating reporting prespecified analysis from study in Q3 based on at least 40 patients, but hard to project go/no-go without seeing data yet.