Phase IIa CBeyond Study Progress
The Phase IIa CBeyond study for nimacimab is advancing as planned, on budget, and ahead of schedule. Enrollment was completed in February, and the 26-week visit for the last patient is projected to occur very shortly. The Data Safety Monitoring Committee has reviewed the study four times with no recommendations for changes.
Promising Preclinical Data
The combination of nimacimab and a suboptimal tirzepatide dose demonstrated 44% vehicle-adjusted weight loss in a preclinical study. Nimacimab alone showed 21.5% weight loss, and it reduced rebound weight gain when used as a maintenance therapy post-incretin treatment.
Financial Stability
Skye ended the second quarter with $48.6 million in cash and cash equivalents, expecting to fund operations and key clinical milestones through at least Q1 2027. Research and development expenses increased, primarily due to contract manufacturing and clinical trial costs.
Strategic Developments and Hiring
Skye expanded its team to 20 employees, with key hires in regulatory affairs, quality, clinical operations, and CMC. The deliberate scaling aims to minimize downtime between clinical trials and support nimacimab's advancing development activities.