---
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"
generated_at: "2026-05-17T04:34:12.454510+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-044223
- JSON: https://secwatch.observer/filing/0001628280-25-044223.json
- Plain text: https://secwatch.observer/filing/0001628280-25-044223.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.