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Executive Summary

Skye Bioscience has dosed the first patient in the Part C expansion of its Phase 2a trial for nimacimab, testing higher IV doses (400 mg and 600 mg) to evaluate improved peripheral exposure and safety. The company highlighted strong prior results from combination therapy with semaglutide, showing 22.3% mean weight loss at 52 weeks, and received FDA feedback on its proposed Phase 2b design, though trial progression depends on Part C data and capital availability.

Key Facts

• First patient dosed in Part C expansion study of nimacimab Phase 2a trial, testing 400 mg IV and 600 mg IV doses.
• Higher doses correspond to ~700 mg and ~1,000 mg subcutaneous dosing, aiming for greater peripheral tissue exposure.
• Prior combination data with semaglutide showed 22.3% mean weight loss at 52 weeks, no plateau, and reduced weight regain off-treatment.
• No drug-related neuropsychiatric adverse events reported in any arm through full study period.
• Topline data from Part C expected in Q4 2026; Phase 2b trial design contingent on results, regulatory input, and funding.

Financial Impact

No immediate financial impact disclosed; future trial progression dependent on capital availability.

Risk Factors

• Development is contingent on capital availability — risk of delay or halt if financing is not secured.
• Higher dosing may compromise the CNS-sparing safety profile, undermining nimacimab’s key differentiator.
• Enrollment in higher-dose cohort depends on safety review, creating binary risk at early stage.

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This report is based on 1 press release from GlobeNewswire.

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