---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-073945"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-05-19T23:59:59+00:00"
generated_at: "2026-05-21T01:34:02.525073+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health presents preclinical data for RJVA-001 gene therapy; CTA submission expected June 2025

## Summary
- Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.
- Systemic GLP-1 levels 10-20 pM, >5-fold lower than pharmacologic GLP-1 drugs (50-150 pM), potentially reducing side effects.
- Nutrient-responsive GLP-1 secretion demonstrated in human beta cells and islets, mimicking natural hormone regulation.
- Endoscopic ultrasound delivery in pigs achieved targeted pancreatic expression in <20 min with no observed toxicity.
- First CTA module submission for RJVA-001 expected by June 2025; preliminary human data anticipated in 2026.

## SEC filing metadata
- accession: 0000950170-25-073945
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-05-19T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000095017025073945/0000950170-25-073945-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017025073945/guts-20250517.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-073945
- JSON: https://secwatch.observer/filing/0000950170-25-073945.json
- Plain text: https://secwatch.observer/filing/0000950170-25-073945.txt

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