Skye Bioscience, Inc. Q4 FY2024 earnings call

• In January 2024, submitted and received clearance of obesity IND.
• Completed $90 million fundraising and initiated CBeyond clinical trial in August 2024, with enrollment completed in February 2025 with 136 patients (over-enrolled from 120).
• Expect final topline data from CBeyond in late Q3 or early Q4, potentially 3 months earlier than prior guidance, forgoing interim analysis.
• Transferred manufacturing process for nimacimab to partner, initiated GMP manufacturing runs, and planned optimization, scale-up, and commercial capabilities for nimacimab.
• Discontinued SBI-100 development to reallocate resources to nimacimab.
• Phase IIa safety data reviewed by DSMB, recommended continuing study, with third review scheduled in April.
• Preclinical and modeling work supports nimacimab's safety advantage and peripheral CB1 inhibition sufficiency for weight loss.
• Implemented protocol extension for CBeyond trial, extending treatment period to 52 weeks.

No detailed product segment financial performance provided in the transcript as the focus is on clinical trial and overall company operations.

• Originally planned interim analysis for CBeyond is forgoing, expecting full 26-week data in late Q3/early Q4, 3 months earlier than prior guidance.
• Plan to initiate Phase IIb dose-escalation study by Q2 2026.
• Cash runway to fund operations through at least Q1 2027, including completing Phase IIa study and key milestones.

• Forward-looking statements subject to risks and uncertainties causing actual results to differ.
• Neuropsychiatric side effects concerns with CB1 inhibitors, though nimacimab's peripheral mechanism aims to address this.
• Dependence on successful clinical trial outcomes and regulatory approvals.

Q: Kristen Kluska asked about translating preclinical model work to weight loss curves and 52-week extension.

A: Punit and Chris Twitty discussed preclinical exposure analysis, PK profile, and historical data relevance.

Q: Kristen Kluska asked about DSMB reviews and safety reporting.

A: Punit said DSMB reviews data quarterly, trial continuing is a safety signal.

Q: Edward Tenthoff asked about timing of Phase IIb and impact of removing interim analysis.

A: Punit said 52-week results in H1 2026, will engage regulators with robust data, timelines accelerated.

Q: Jay Olson asked about preclinical data to be presented in Q2.

A: Chris Twitty said preclinical data includes biomarker work, mechanistic differentiation, and combination approaches.

Q: Andy Hsieh asked about physician feedback, DEXA scans, and powering after removing interim.

A: Puneet Arora discussed investigator enthusiasm, continued DEXA scans, and preserved power with no interim analysis.

Q: George Farmer asked about 52-week read, placebo follow-up.

A: Puneet Arora said placebo patients will cross over to active drug, combination arm continues blinded.

Q: Jonathan Wolleben asked about quicker enrollment despite monlunabant data.

A: Punit discussed investigator enthusiasm, alternative mechanism, and recruitment tactics.

Q: Jonathan Wolleben asked about monthly dosing optimization and diabetic utility.

A: Tu Diep discussed monthly dosing convenience and cost, Puneet and Chris discussed diabetic mechanism relevance.

Q: Albert Lowe asked about open-label extension design and follow-up.

A: Punit and Puneet Arora discussed extension design and 13-week follow-up.