Skye Bioscience, Inc. Q4 FY2025 earnings call

Puneet Dhillon discussed C-Beyond's progress with namazumab, including combination signal, safety profile, and monotherapy learnings. Chris Twitty spoke about dosing and exposure rationale. Updates on expansion study, formulation work with Halozyme, FDA feedback, durability data, and antibody peptide conjugate program were provided. Operational highlights included cost structure alignment.

Anticipated catalysts in 2026 include interim CB1 extension data, FDA type C meeting minutes review, enhanced compatibility study completion, cohort enrollment, preclinical bioconjugation data sharing, feasibility work on high concentration formulation, top line clinical data from expansion study, and phase 2B final study design and execution readiness.

Q: Can you talk about plans to share data from higher dose cohorts above 200 milligrams and status of formulation work using halozyme technology?

A: Expanding into part C study for higher dose data, formulation work ongoing with halozyme, aiming for Phase 2b.

Q: When it comes to expansion, do you think you're going high enough?

A: Confident in selected doses with clean exposure separation.

Q: What's the profile for the new program?

A: Long term optionality, not near-term value driver.

Q: How do you think about which peripheral tissues are most important for nemacimab's clinical effect?

A: Adipose tissue, liver, etc.

Q: Why use IV in Part C phase instead of enhanced?

A: IV provides fastest way to generate high exposure PK and safety info.

Q: What is the basis for 400 mg IV equivalent to 700 mg subcutaneous?

A: Based on bioavailability study.

Q: What's the bar for success from the expanded study for monotherapy?

A: PK and safety validation for phase 2B dosing.