SKYE News & Events

"Since our March update, execution has focused on turning CBeyond into a Phase 2b-ready development program," said Punit Dhillon, President & CEO of Skye. "We have now initiated enrollment of Cohort 1 of the CBeyond Expansion Study, executed the compatibility and in-use study with ENHANZE to support a practical high-volume subcutaneous approach, and engaged external development advisors to help pressure-test our target product profile, dose-selection rationale and Phase 2b trial design. Our objective in 2026 remains focused on defining the dose and exposure that can support a larger Phase 2b study evaluating nimacimab as a complementary add-on approach for GLP-1-experienced patients."

Cash, cash equivalents, and short-term investments totaled $25.7M as of December 31, 2025. "All of the data generated and reported in the past year along with the incremental data highlighted in todays release reinforces our strategy to develop nimacimab as a differentiated peripheral CB1 program designed to complement current incretin therapies and next-generation combination regimens. CBeyond confirmed the safety foundation and combination potential of peripheral CB1 inhibition, including a 22.3% mean weight loss at 52 weeks with nimacimab plus semaglutide and no plateau observed," said Punit Dhillon, president and CEO of Skye. "Just as important, CBeyond has now given us three practical learnings that shape what comes next: a meaningful combination signal, clean safety with no drug-related central nervous system toxicity at the tested dose, and a clear exposure question to solve in monotherapy. Our next step is straightforward: define the peripheral exposure-response at higher doses through the Expansion Study while using the FDA Type C feedback to shape a disciplined Phase 2b evaluation with clear dose-selection logic and success criteria across monotherapy and combination development."

Skye Bioscience announced interim 52-week data from the combination therapy arms in the extension phase of the Phase 2a CBeyond proof-of-concept study of nimacimab, its peripherally-restricted CB1 inhibitor antibody. The blinded extension of the CBeyond study for combination cohorts was opened in May 2025 for participants assigned to either nimacimab plus semaglutide or placebo plus semaglutide arms. Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was 13.9%. Seven participants completed treatment of the additional 26 weeks and lost an additional 5.8% of weight during the extension period, resulting in a mean weight loss of 19.7% after 52 weeks of treatment. In October 2025, Skye reported top-line 26-week data from CBeyond showing that the nimacimab and semaglutide combination cohort achieved clinically meaningful weight loss compared with semaglutide alone, with no plateau observed.