Syros Pharmaceuticals, Inc. Q3 FY2024 earnings call

Conley Chee - CEO

• Advancing tamibarotene for higher-risk MDS with RARA gene overexpression, nearing pivotal data readout in mid-November from SELECT-MDS-1 Phase 3 trial.
• Anticipated commercial opportunity for tamibarotene in U.S. higher-risk MDS patients, with market opportunity for tamibarotene in U.S. over $800 million by 2029.
• Preparing for NDA filing and U.S. commercial launch once approved.

David Roth - CMO

• SELECT-MDS-1 is a global randomized double-blind placebo-controlled trial evaluating tamibarotene + azacitidine vs. placebo + azacitidine. Primary endpoint is complete response (CR) in initial 190 enrolled patients, with global enrollment at over 130 sites.
• Favorable tolerability profile and passed futility analysis in Q1 2024, supporting doublet strategy of tamibarotene plus azacitidine.

Jason Haas - CFO

• No revenue in Q3 2024 vs. $3.8 million in Q3 2023 due to termination of collaboration with Pfizer.
• R&D expenses decreased to $20.5 million in Q3 2024 from $28.3 million in Q3 2023.
• G&A expenses decreased to $5.7 million in Q3 2024 from $7.8 million in Q3 2023.
• Net loss for Q3 2024 was $6.4 million vs. $40.1 million in Q3 2023. Cash and cash equivalents as of Sept 30, 2024 were $58.3 million, sufficient to fund operating expenses into Q3 2025.

No product segments reported as Syros did not recognize any revenue in the third quarter of 2024. R&D expenses were $20.5 million in Q3 2024 vs. $28.3 million in Q3 2023, primarily due to reduced external R&D, consulting, contract manufacturing, and headcount. G&A expenses were $5.7 million in Q3 2024 vs. $7.8 million in Q3 2023, due to reduced headcount, consulting, and facilities expenses.

Forward-looking Statements

• Anticipation of pivotal data readout from SELECT-MDS-1 Phase 3 trial in mid-November.
• Preparation for first NDA filing and U.S. commercial launch of tamibarotene once approved.
• Goal to quickly deliver tamibarotene to higher-risk MDS patients with RARA overexpression upon approval.

Q: Reemphasize historical aza controls in label and recent clinical experience, and how to interpret AML data for MDS?

A: David Roth explained aza label has 17% complete remission rate, recent trials show variation, and AML data with tamibarotene, aza, and venetoclax not predictive for MDS trial as MDS trial uses doublet of tamibarotene and azacitidine.

Q: Sense of data disclosure in mid-November, including CR rate, safety, durability data?

A: Conley Chee stated primary endpoint is CR rate in first 190 enrolled patients, will report CR rate, duration of CR, time to CR, overall response rate, and safety data; overall survival not expected at top line.

Q: Post-data release steps for FDA filing, need for pre-NDA meeting?

A: Conley Chee said will pull in corroborated data, have routine regulatory interactions, and work to get NDA submission in good order, no specific need for new pre-NDA meeting mentioned.

Q: Commercial work preparation for tamibarotene launch post-positive data?

A: Conley Chee said team has been preparing, including market awareness, infrastructure sizing, brand plan, and ensuring manufacturing and diagnostic readiness.

Q: Plans for AML data presentation at medical meetings and status of 5609 asset?

A: David Roth said AML data presented at SOHO meeting; Conley Chee said 5609 is an asset with high potential, seeking business development opportunities for it as better suited for larger pharma with resources.