Skye Bioscience, Inc.

CBeyond TMTrial Design

The randomized, placebo- and active-controlled, double-blind CBeyond TM Phase 2a trial enrolled 136 adults with overweight or obesity, including individuals with a BMI ≥27 kg/m² with at least one comorbidity. Patients were randomized across four arms, 2:2:1:1 to arms with weekly nimacimab 200 mg subcutaneously, placebo, nimacimab 200 mg plus semaglutide (Wegovy®), or placebo plus semaglutide, and were dosed weekly for 26 weeks. Patients not participating in a 26-week extension were monitored for 13 weeks post-treatment.

Patients who completed 26 weeks of treatment in the primary phase of the study were eligible to enroll in a 26-week extension for a potential full treatment duration of 52 weeks with a 13-week follow-up period. In the combination arms, patients will continue with blinded treatment with nimacimab or placebo and will continue receiving semaglutide (Wegovy®). Patients in the monotherapy arm will receive nimacimab 300 mg during the extension. Enrollment for the extension is complete. Skye expects to report data from the extension study in Q1 2026.

The 26 week treatment period was designed to evaluate efficacy, safety, and pharmacokinetics and exploratory endpoints, with the extension ongoing to further assess these endpoints, and follow-up to assess durability and weight regain. The trial population was broadly representative of adults living with obesity, with a mean BMI of ~36.84 kg/m 2 and majority female participants.