CRESCENT BIOPHARMA, INC. Q2 FY2022 earnings call

Harout Semerjian discussed the progress of the Phase III trial for uproleselan in relapsed refractory acute myeloid leukemia (AML), including patient demographics, timing of the event trigger projection (mid-2023), and the NCI trial in frontline newly diagnosed AML. He also mentioned the acceptance of the IND application for GMI-1687. Bruce Johnson talked about early commercial development efforts for uproleselan, the AML market opportunity, and the limitations of existing standard-of-care therapies. Brian Hahn provided financial results, noting cash equivalents, R&D and G&A expenses changes.

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

Harout stated the Phase III trial's overall survival event trigger is projected for mid-2023. The NCI trial's Phase II portion completed enrollment in November 2021, and results from the EFS analysis will be communicated and a press release issued when available. The IND application for GMI-1687 was accepted, positioning it for potential partnership.

Forward-looking statements involve assumptions, risks, and uncertainties. These include uncertainties regarding clinical trial results, regulatory approvals, and the company's ability to commercialize products. Risks also pertain to the uncertainties in the development and market acceptance of uproleselan and other pipeline programs.

Q: On upro Phase III trial, how are OS events tracking versus projections?

A: Tracking in line with previous projections, still mid-2023.

Q: When will initial results from uproleselan combo with venetoclax be seen?

A: Possibly as early as this coming ASH.

Q: Characterize 301 study patient baseline vs 201?

A: Broadly similar to Phase II, with some granular differences but similar to historical market practices.

Q: How often updates from NCI on the study?

A: Updates when analysis is completed, will issue press release once data is available.

Q: BD activity and cash runway?

A: BD is a focus, 1687 IND accepted, cash runway into Phase III data readout, reprioritizing investment.

Q: Workforce reduction and expense reductions?

A: Workforce reduced, slight decrease in cash burn anticipated but not material.