Successful $90 Million Investment
In early 2024, Skye Bioscience secured a $90 million investment from top life science institutional investors, which enabled the company to execute its clinical and operational goals for the year.
Accelerated Clinical Trial Enrollment
The CBeyond clinical trial for nimacimab exceeded expectations with an over-enrollment of 136 patients, compared to the originally planned 120. The trial is expected to yield data 3 months earlier than initially planned.
Positive Safety Profile
The independent Data Safety Monitoring Board (DSMB) held two meetings for nimacimab's Phase IIa trial and recommended continuing the study as planned, indicating a favorable safety profile.
Manufacturing Process Advancements
Skye successfully transferred the manufacturing process for nimacimab to a partner and began GMP manufacturing runs, preparing for scale-up and commercialization.
Strategic Focus on Nimacimab
The company decided to discontinue SBI-100 development to focus resources on nimacimab, which demonstrated significant weight loss in preclinical studies without crossing the blood-brain barrier.
Financial Improvements
Skye reported a decrease in net loss from $37.6 million in 2023 to $26.6 million in 2024, and maintained cash and cash equivalents of $68.4 million at the end of 2024.