secwatch.observer — SEC 8-K summary
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Issuer:     Skye Bioscience, Inc. (SKYE)
CIK:        0001516551
Form:       8-K
Filed at:   2025-10-06T23:59:59+00:00
Accession:  0001628280-25-044223
Event type: other_material
Sentiment:  neutral
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Skye Bioscience Reports Phase 2a Data: Nimacimab Monotherapy Misses Endpoint, Combination Shows Added Weight Loss
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1516551/000162828025044223/0001628280-25-044223-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1516551/000162828025044223/skye-20251006.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-044223

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer