Albert Lowe

Albert Lowe of Craig-Hallum Capital Group LLC asked if the 13-week follow-up period to track weight loss durability is still planned after the extension study and when that data might be released.

Answer

President, CEO & Director Punit Dhillon confirmed that the 13-week follow-up period will still occur after the 52-week extension study is complete. However, he noted that the data from this follow-up period would likely not be available until 2026.

Albert Lowe of Craig-Hallum Capital Group LLC asked about the Data Safety Monitoring Committee (DMC) reviews and whether they would flag neuropsychiatric adverse events. He also sought clarification on the 8% weight loss expectation at 26 weeks and how to interpret data from the study's open-label extension.

Answer

Dr. Puneet Arora explained that the independent DMC, which includes two psychiatrists, meets quarterly to review all unblinded safety data, including neuropsychiatric events, and has raised no concerns. CEO Punit Dhillon reiterated the study is designed for an 8% placebo-adjusted weight loss but emphasized the primary goal is achieving a clear separation from placebo. He also noted that for the extension, key metrics will be collected at the start to account for any variability during the brief rollover period.

Albert Lowe, on for Joe Catanzaro, requested an update on the uliledlimab cohort expansion, specifically asking about the current enrollment stage and the timeline for future data releases. He also followed up regarding details on the potential Phase 3 trial design.

Answer

Andrew Zhu, President, reported that the non-small cell lung cancer cohort for uliledlimab has enrolled 47 of a targeted 60 patients, with full enrollment expected by October. He noted that encouraging efficacy signals and the correlation with CD73 expression continue to hold, with a more complete data readout anticipated by year-end or early 2023. For the Phase 3 trial, he confirmed it will target advanced NSCLC and that a companion diagnostic kit is being developed with WuXi Diagnostics.