Crescent Biopharma, Inc. Q3 FY2023 earnings call

• Continued progress in clinical pipeline, aiming to advance uproleselan and GMI-1687 programs.
• Expect top line results from uproleselan's Phase III trial in relapsed and refractory AML by end of Q2 2024, with potential U.S. filing by end of 2024 if positive.
• MD Anderson to present updated clinical data on uproleselan in treated secondary AML at ASH 2023.
• GMI-1687 Phase Ia study on track for safety data by end of Q1 2024.
• Strategically expanded commercial and medical affairs capabilities, with new hires like Gaetano Bonifacio and Debora Peralta.
• Cash runway to fund operations into late Q4 2024, allowing execution of clinical development plan.

No detailed product segment financial performance with absolute revenue and contribution % provided in the transcript.

• Expect top line results from uproleselan's Phase III trial in relapsed and refractory AML by end of Q2 2024.
• Potential U.S. filing for uproleselan by end of 2024 if Phase III results are positive.
• GMI-1687 Phase Ia study expected to have safety data by end of Q1 2024.
• Cash runway to fund operations into late Q4 2024.

Risks related to clinical trials, regulatory interactions, and product safety are discussed in the company's SEC filings, which are available from the SEC or the GlycoMimetics website.

Q: Can you share how likely by end of 2Q 2024 the primary analysis of uproleselan's Phase III trial will be event based versus time based?

A: Currently monitoring event accumulation carefully, with a definitive cutoff by end of Q2 2024 whether through event-based or time-based trigger.

Q: Any outstanding CMC or preclinical work needed before filing NDA for uproleselan?

A: In good shape with CMC conversations advanced, preparing for rapid NDA filing after positive data if it occurs.

Q: What to look for in GMI-1687's Phase Ia healthy volunteer data?

A: Safety data and pharmacokinetics, including if pharmacokinetics support achievement of therapeutic level.

Q: How many patients in uproleselan's study went on to transplant and dropout rate?

A: Phase III trial has a transplant rate north of 31%, dropout rate is 3%.

Q: Why is the NCI study of uproleselan taking so long?

A: Waiting for event accumulation as last patient enrolled in Dec 2021, and NCI will inform when events are reached.