Skye is limitless

Nimacimab is a potentially first-in-class peripheral CB1-inhibiting antibody being developed to realize the potential differentiated mechanism of action and clinical outcomes that could position CB1 inhibition and this molecule as an anti-obesity therapeutic that we believe is complementary to current approved drugs. Targeting the CB1 receptor in peripheral tissue including adipose, liver, and muscle, with very limited accumulation in the CNS based on studies to date, nimacimab offers the prospect of reducing hunger and increasing energy expenditure to cause fat breakdown with better gastrointestinal tolerability and muscle preservation compared to GLP1 therapeutics, along with more limited weight rebound after treatment completion and a more sustainable weight loss result. Nimacimab has in preclinical studies also improved other metabolic, inflammatory and fibrotic processes. Nimacimab achieved a positive Phase 1 tolerability and safety profile, with no neuropsychiatric adverse events.

Skye reported CBeyond^TM Phase 2a clinical trial 26-week topline data (see news release) in October 2025. In this obesity study, a nimacimab/semaglutide combination showed additional weight loss compared to semaglutide alone, with no increase in gastrointestinal disorders and no neuropsychiatric concerns. Pharmacokinetic data revealed that the 200mg nimacimab monotherapy arm, which did not meet its primary endpoint, did not achieve the serum exposure predicted by preclinical models, warranting potential further study of nimacimab at higher doses.

The 26-week treatment period was designed to evaluate efficacy, safety, and pharmacokinetics and exploratory endpoints. An ongoing 26-week extension is further assessing these endpoints, along with weight loss durability and weight regain, for a potential full treatment duration of 52 weeks with a 13-week follow-up period.