---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-277524"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-11-12T23:59:59+00:00"
generated_at: "2026-05-16T21:10:53.305207+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health Q3 net loss $45.6M; Revita post-GLP-1 weight maintenance data positive

## Summary
- Net loss of $45.6M includes $23.5M non-cash warrant fair-value change; operating expenses down $1.1M YoY.
- R&D spend $17.5M vs $19.0M year-ago; SG&A $5.2M vs $4.8M.
- Cash $77.7M at Sep 30 2025; $83M in August/September offerings extend runway into early 2027.
- REMAIN-1 Midpoint Cohort met endpoint: Revita patients lost 2.5% additional weight vs 10% regain for sham (p=0.014).
- REMAIN-1 Pivotal enrollment >60% randomized; 6-month primary data expected H2 2026 with potential PMA filing.

## SEC filing metadata
- accession: 0001193125-25-277524
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-11-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312525277524/0001193125-25-277524-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312525277524/guts-20251112.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-277524
- JSON: https://secwatch.observer/filing/0001193125-25-277524.json
- Plain text: https://secwatch.observer/filing/0001193125-25-277524.txt

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