---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-121780"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-03-24T23:59:59+00:00"
generated_at: "2026-05-15T09:12:18.081632+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete

## Summary
- Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.
- Cash $81.5M as of Dec 31, 2025; cash runway into early 2027 beyond pivotal readout.
- Completed REMAIN-1 Pivotal Cohort randomization; topline 6-month data expected early Q4 2026.
- FDA feedback supports Class II De Novo pathway; potential De Novo submission late Q4 2026.
- Post-hoc analyses show ablation-length-dependent treatment effect; 70% reduction in weight regain in above-median GLP-1 loss group.

## SEC filing metadata
- accession: 0001193125-26-121780
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-03-24T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/0001193125-26-121780-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/guts-20260324.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-121780
- JSON: https://secwatch.observer/filing/0001193125-26-121780.json
- Plain text: https://secwatch.observer/filing/0001193125-26-121780.txt

## Key facts
- Earnings Releases
  FRACTYL HEALTH, INC. updated its quarter and full year ended December 31, 2025 guidance (reaffirmed).
  - Period: quarter and full year ended December 31, 2025
  - Guidance: reaffirmed
  - Result: preliminary results
  source text: On March 24, 2026, Fractyl Health, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2025 and provided a corporate update.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/0001193125-26-121780-index.htm

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