{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-044223","form_type":"8-K","ticker":"SKYE","cik":"0001516551","company_name":"Skye Bioscience, Inc.","filed_at":"2025-10-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.605710+00:00","generated_at":"2026-05-17T04:34:12.454510+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Skye Bioscience Reports Phase 2a Data: Nimacimab Monotherapy Misses Endpoint, Combination Shows Added Weight Loss","bullets":["Nimacimab monotherapy at 200 mg failed primary endpoint with placebo-subtracted weight loss of -1.26% (p=0.2699, mITT).","Combination of nimacimab + semaglutide achieved -13.2% weight loss vs -10.25% for semaglutide alone (-2.95%, p=0.0372, mITT).","In per protocol analysis, 100% of combination arm achieved >5% weight loss and 67% achieved >10% weight loss.","No increase in gastrointestinal or neuropsychiatric adverse events with nimacimab, and clean safety profile reported.","Preliminary PK showed lower than expected exposure, supporting evaluation of higher dosing in future trials."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-044223","json":"https://secwatch.observer/filing/0001628280-25-044223.json","markdown":"https://secwatch.observer/filing/0001628280-25-044223.md","text":"https://secwatch.observer/filing/0001628280-25-044223.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1516551/000162828025044223/0001628280-25-044223-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1516551/000162828025044223/skye-20251006.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-17T04:34:12.454510+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}