Skye Bioscience, Inc. Q3 FY2025 earnings call

• Clinical development: Delivered on commitments from Q2, including top-line data from CBEYOND, using dataset to inform dose-ranging strategy, and maintaining operational/regulatory readiness. CBEYOND results showed synergistic efficacy with Nimazumab plus semaglutide, improved body composition, durability, and positive safety signal. Enrollment completed for twenty-six-week extension study with strong retention, and monotherapy extension study evaluating higher dose. - CMC and product economics: Progress made on high concentration formulation strategy, focused on scalability, market penetration, reducing injection volume, lowering costs, and evaluating delivery devices. - R&D: Preclinical and translational work validate Nimazumab's mechanisms, including reducing fat mass, preserving lean mass, improving metabolic markers, and complementing incretin biology. - Accountability: Remains focused on discipline and delivery, having met Q2 commitments and continuing to advance the program.

At the end of the third quarter ended September 30, 2025, Skye Bioscience, Inc. had cash and cash equivalents and short-term investments totaling $35.3 million. R&D expenses for the three months ended September 30, 2025, were $9.4 million compared to $4.9 million in the same period of 2024. General and administrative expenses for the same period were $3.9 million compared to $4.6 million in 2024. The net loss for the three months ended September 30, 2025, was $12.8 million, including non-cash share-based compensation expense of $1.9 million, whereas the net loss in the same period of 2024 was $3.9 million with non-cash share-based compensation expense of $1.9 million.

• Key milestones and catalysts over the coming ninety days will be outlined, including progress on clinical development, CMC, and R&D. - Focus on converting clinical data into further execution, finalizing next Phase 2 design, and advancing formulation and manufacturing work.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expected results. Risks include those related to clinical trial outcomes, regulatory approvals, manufacturing challenges, and market competition.

Q: Can you please talk about any KOL feedback you've received following your top-line, CBEYOND Phase 2a data and also any feedback you may have received at Obesity Week?

A: Christopher Twitty and Puneet Arora mentioned positive reaction to combination data, interest in dose-ranging study, rekindled interest in the class due to no neuropsychiatric adverse events, and recognition of the biological activity and safe tolerability of Nimazumab.

Q: What do you expect from the monotherapy arm in the twenty-sixth-week update? What do you want to see in order to give you confidence in choosing the dosage?

A: Punit Dhillon and Puneet Arora stated they are looking for better understanding from the twenty-six-week data to refine PK models, expecting improvement in efficacy sensitivity, and that higher doses are expected to unlock efficacy, with a target of over 5% weight loss at twenty-six weeks for higher doses evaluated.

Q: I wanted to maybe dig into the other side of going higher on dose. And from the combination of earlier studies preclinical data, and then the initial CBEYOND results, obviously, we're going to keep a close eye on potential CNS side effects. Is there anything else that we should be really focused on or that could sneak up on us from a safety standpoint of taking the doses to the substantially higher level?

A: Punit Dhillon and Puneet Arora mentioned confidence in safety signal, no expected exacerbated GI burden due to different mechanism, and historical data on rimonabant suggesting muted GI effects with CB1 inhibition, and Nimazumab showing neutral effects at tested doses.