Skye Bioscience, Inc. Q3 FY2024 earnings call

• Punit Dhillon discussed preclinical data on peripheral CB1 inhibition and Phase 2 obesity trial (CBeyond) enrolling well, targeting 50% enrollment by year-end with interim data in Q2 2025. - Kaitlyn Arsenault provided financial overview, noting R&D and G&A expenses, net loss, cash position, and burn rate projections. - Emphasis on maintaining a focused team, strategic roadmap for metabolic programs, and key hires like CMO Dr. Puneet Arora and new board member Karen Smith.

Research and development expenses for Q3 2024 were $4.9 million, up from $1.3 million in Q3 2023, primarily due to clinical and manufacturing costs for Phase 2 trial. General and administrative expenses were $4.6 million in Q3 2024 vs $2.2 million in Q3 2023, driven by regulatory filings and IP costs. Net loss for Q3 2024 was $3.9 million, down from $24.9 million in Q3 2023. Cash and cash equivalents as of 9/30/2024 were $76.5 million. Burn rate expected to increase to ~$9M per quarter in 2025, with capital funding through Q3 2027.

• Expect to burn approximately $9 million per quarter in 2025. - Capital will fund Phase 2 clinical trial for nimacimab and operations through Q3 2027. - Priority on high-value metabolic programs with strong financial footing to focus on critical milestones.

• Forward-looking statements subject to risks and uncertainties affecting actual results. - Concerns about neuropsychiatric adverse events with CB1 inhibitors. - Litigation risks, though a judgment was vacated, releasing $9M restriction on cash.

Q: Edward Tenthoff asked about CBeyond enrollment and monotherapy vs combination data.

A: Punit Dhillon said CBeyond is enrolling well, on track for 50% enrollment by year-end, with primary endpoint on monotherapy weight loss and exploratory endpoint on combination with GLP-1.

Q: Jay Olson asked about KOL feedback and commercial path for combinations.

A: Punit Dhillon and Dr. Puneet Arora discussed KOL appreciation of peripheral CB1 inhibition benefits, and commercial path focusing on nimacimab's unique mechanism as an alternative to incretin mimetics with potential in Class 1 obesity and comorbidities.

Q: George Farmer asked about preclinical work with nimacimab.

A: Chris Twitty mentioned expanding preclinical studies, including comparing with other compounds and combinations, focusing on body composition and mechanistic biomarkers.

Q: Albert Lowe asked about nimacimab's well-tolerated profile.

A: Chris Twitty and Dr. Puneet Arora discussed antibody's specificity and favorable GI and neuropsych profiles compared to small molecules.

Q: Unidentified Analyst asked about contextualizing preclinical data.

A: Punit Dhillon and Chris Twitty discussed nimacimab's pharmacokinetic advantage, allosteric binding, and differentiation from small molecules, with focus on sustained peripheral exposure and minimal brain exposure.

Q: Ayan Hussein asked about neuropsychiatric events and commercial use.

A: Dr. Puneet Arora explained central CB1 targeting risks, early observation of events, and Punit Dhillon discussed commercial use focusing on nimacimab's monotherapy regulatory path with potential for combination use.