Skye Bioscience, Inc. 8-K

What Happened
On February 2, 2026 Skye Bioscience (SKYE) announced interim results from the combination cohort of its Phase 2a extension study of nimacimab (press release and updated investor presentation furnished as exhibits). The report covers participants who continued blinded treatment for an additional 26 weeks (to 52 weeks total) while maintaining their original assignments of nimacimab plus semaglutide or placebo plus semaglutide.

Key Details

• 19 participants in the combination cohorts were eligible and entered the 26-week blinded extension (10 nimacimab + semaglutide; 9 placebo + semaglutide). Another 22 completed week 26 but did not enter the extension (11 nimacimab; 11 placebo).
• Nimacimab + semaglutide arm (10 entered): mean weight loss at 26 weeks = 14.4%; 7 completers lost an additional 7.9% during the extension for a mean 52-week loss of 22.3%. No serious adverse events (SAEs) or adverse events of special interest (AESIs) reported during the extension.
• Placebo + semaglutide arm (9 entered): mean weight loss at 26 weeks = 13.9%; 7 completers lost an additional 5.8% during the extension for a mean 52-week loss of 19.7%.
• Full topline reporting (including nimacimab monotherapy data and 13-week off-therapy follow-up) is expected in Q3 2026.
• The company expects current cash to fund operations and key milestones into Q4 2026 (including the Phase 2a extension topline data and certain manufacturing/clinical activities) but excludes the anticipated costs of a potential Phase 2b study and related additional manufacturing.

Why It Matters
These interim results provide early evidence that adding nimacimab to semaglutide may increase mean weight loss versus semaglutide alone through 52 weeks in a small, blinded extension cohort, and reported tolerability was acceptable in this subset. For investors, the release also clarifies near-term milestones and the company’s cash runway (into Q4 2026), while noting that larger, higher‑dose studies (and their costs) remain to be initiated and funded. Full, formal topline data due in Q3 2026 will be material for assessing clinical and commercial prospects.