Skye Bioscience (NasdaqGM:SKYE) Earnings Call Presentation

Clinical Trial Results - Nimacimab monotherapy (200 mg QW) did not meet the primary endpoint, with a placebo-adjusted weight loss of -126% (p=02699, mITT) and -133% (p=02878, PP) at 26 weeks[98] - Combination therapy with Semaglutide achieved a clinically meaningful placebo-adjusted weight loss compared to Semaglutide alone (-129% vs -999%, p=00372, mITT and -143% vs -108%, p=00178, PP)[98] - The combination arm showed an improved lean to fat mass ratio (026 vs 013, p = 00126)[98] Safety and Tolerability - The trial demonstrated a clean safety profile with no neuropsychiatric adverse events observed[98] - The combination of Nimacimab and Semaglutide did not add to the gastrointestinal (GI) burden compared to Semaglutide alone[98] Exposure and Dosing - The monotherapy effect was limited at the 200 mg dose, but exposure modeling and preclinical data suggest potential efficacy at higher doses[98] - A preliminary average AUC at 26 weeks for the 200 mg SC QW clinical dose was 243013 h*ug/mL, while DIO studies demonstrate a wide and effective dose range[73] Next Steps - The company will evaluate exposure/response data to determine next steps, including potential future clinical studies to confirm optimal exposure and regimen[98] - The company will focus on the combination strategy while continuing to evaluate higher-dose monotherapy[98] - The company is assessing a path for a monotherapy maintenance setting[98]