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Skye Initiates Enrollment for Cohort 1 of CBeyond Expansion Study
"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."
Skye Reports Cash and Short-term Investments Totaling $25.7M
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 Reports 52-Week Efficacy Data for Nimacimab
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.
Skye Bioscience Presents Nimacimab Study Results at Conference
Skye Bioscience presented a poster titled "Investigating the Efficacy of Nimacimab Alone or in Combination with Tirzepatide, and as a Maintenance Therapy Post Tirzepatide Discontinuation in a Diet-Induced Obesity Mouse Model" at Keystone's conference, Obesity Therapeutics: Unlocking Benefits and Minimizing Side Effects. Key takeaways from the DIO studies: Nimacimab showed significant additive weight loss effects when combined with suboptimal or clinically active dose levels of tirzepatide. Nimacimab weight loss was durable after treatment discontinuation. Nimacimab treatment after tirzepatide discontinuation improved the weight rebound profile. Nimacimab weight loss was not primarily driven by caloric restriction. Nimacimab enhanced weight loss induced by semaglutide.
Skye's 2026 Clinical Program Focuses on Nimacimab
"In 2025 we generated our Phase 2a clinical data, deepened our understanding of nimacimab's exposure-response dynamics, and built the technical foundation required to test higher doses and prepare the framework for a potential subsequent Phase 2 trial with broader clinical endpoints," said Punit Dhillon, CEO. "In 2026, our focus and goals are straightforward: deliver additional clinical readouts from our CBeyond extension study, assess and select higher doses of nimacimab, and launch a Phase 2b study designed to evaluate multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy. We believe emerging data across the obesity treatment landscape underscore the need for modalities complementary to incretin-based therapies," added Mr. Dhillon. "We believe peripheral CB1 inhibition offers a distinctive opportunity to help achieve incremental weight loss, improve treatment tolerability and sustainability, enhance post-treatment durability, as well as offer additional metabolic and inflammatory benefits." Skye's 2026 clinical program goals are designed to evaluate multiple higher doses of nimacimab, and (nitiate a Phase 2b study that supports combination development. Planned clinical milestones include: CBeyond Phase 2a 26-week extension data update and interim results expected in Q1 2026. CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026. Phase 2b plan will be finalized and aligned with regulators, including completion of a Type C meeting in Q1 2026, with initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026.
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