Crescent Biopharma, Inc. Q1 FY2023 earnings call

• Continued progress in advancing uproleselan's clinical development, with the Phase III trial in relapsed and refractory AML projected to reach final survival event trigger in the first half of 2024. Median follow-up is now greater than 27 months.
• In February 2023, an interim utility analysis was carried out, with the independent data monitoring committee recommending continuing to the originally planned final analysis with no safety concerns.
• Partnering with the National Cancer Institute and the Alliance for Clinical Trials in Oncology for a Phase II/III trial in newly diagnosed older adults with AML, with expected updates on interim analysis.
• As of March 31, 2023, cash and cash equivalents were $65 million, up from $47.9 million in December 2022, with cash runway extending into late 2024.
• R&D expenses were $5.4 million in Q1 2023, down from $9.6 million in Q1 2022 due to lower clinical trial costs; G&A expenses increased to $5.5 million due to commercial readiness planning and patent fees.

No detailed financial breakdown by product segments provided in the transcript.

• Phase III trial of uproleselan in relapsed/refractory AML is projected to reach final survival event trigger in the first half of 2024.
• Cash runway extended to fund operations into late 2024, enabling execution of uproleselan's development program.
• Intends to use capital resources to advance clinical development, prepare regulatory filings, and plan for uproleselan's commercialization.

• Uncertainties around clinical trial event accumulation affecting the timing of primary endpoint results.
• Risks associated with forward-looking statements, including assumptions, risks, and uncertainties in clinical trials, regulatory interactions, and cash position.

Q: Confirm projection for primary endpoint of R&R AML Phase III data in first half 2024, and confidence in timeline.

A: Harout states the projection remains H1 2024, with an ongoing model projecting events trigger, and the DMC's interim analysis didn't change the timeline.

Q: Cash runway funds pipeline development, updates on pipeline outside uproleselan.

A: Harout mentions focus on uproleselan, with 1687 and others in pipeline but no new clinical programs yet; Brian details cash runway extension.

Q: Final analysis timeline for R&R AML Phase III, updates on IST trials.

A: Harout says data cleanup accelerated, DMC's analysis could be within H1; Ed Rock provides updates on IST trials at ASH with encouraging responses.

Q: Partnering interest for GMI 1687, SG&A and R&D expenses going forward.

A: Harout says partnering discussions ongoing for 1687; Brian anticipates ~$10 million burn per quarter, with guidance on launch expenses after trial results.