---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-342343"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-08-10T20:05:17+00:00"
generated_at: "2026-08-10T20:06:13.602376+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Fractyl Q2 net loss $25.5M; REMAIN-1 data show 84% weight-loss maintenance

## Summary
- Net loss $25.5M vs $27.9M YoY; R&D down to $13.8M from $21.2M.
- Cash $47.1M at 6/30/26; runway into early 2027, beyond pivotal readout.
- REMAIN-1 Midpoint: Revita patients maintained 84% of weight loss vs 46% sham (optimized subgroup).
- REVEAL-1: ~78% weight-loss maintenance after single Revita; no serious device-related AEs.
- Pivotal topline due early Q4 2026; potential FDA De Novo submission late Q4 2026.

## SEC filing metadata
- accession: 0001193125-26-342343
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-08-10T20:05:17+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312526342343/0001193125-26-342343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526342343/guts-20260810.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-342343
- JSON: https://secwatch.observer/filing/0001193125-26-342343.json
- Plain text: https://secwatch.observer/filing/0001193125-26-342343.txt

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