---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-070294"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-05-13T23:59:59+00:00"
generated_at: "2026-05-21T15:56:38.897334+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete

## Summary
- Net loss $23.7M vs $3.3M YoY, driven by non-cash fair value change and $3.2M operating expense increase.
- Cash $42.1M expected to fund operations into Q4 2025; R&D expenses rose to $19.4M from $14.4M.
- REMAIN-1 Pivotal Cohort (315 patients) enrollment completed ahead of schedule; 6-month primary endpoint data H2 2026.
- REVEAL-1 3-month open-label data update expected June 2025; REMAIN-1 Midpoint Cohort data Q3 2025.
- Rejuva gene therapy advancing; first CTA module submission for RJVA-001 expected June 2025.

## SEC filing metadata
- accession: 0000950170-25-070294
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-05-13T23:59:59+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/1572616/000095017025070294/0000950170-25-070294-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017025070294/guts-20250513.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-070294
- JSON: https://secwatch.observer/filing/0000950170-25-070294.json
- Plain text: https://secwatch.observer/filing/0000950170-25-070294.txt

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