---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-038865"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2024-04-01T23:59:59+00:00"
generated_at: "2026-06-04T04:38:29.524959+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health Q4 2023: FDA approves IDE for Revita weight-maintenance study; gene therapy candidate RJVA-001 nominated

## Summary
- FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.
- Enrollment in Revitalize-1 T2D pivotal study expected to complete Q2 2024; topline data Q4 2024.
- Announced RJVA-001 as first GLP-1 pancreatic gene therapy candidate; IND-enabling studies to complete H2 2024.
- Completed IPO raising ~$100.3M net; cash on hand expected to fund operations through 2025.
- FY 2023 net loss $77.1M vs $46.5M in 2022; revenue insignificant $0.1M; R&D expense $38.0M.

## SEC filing metadata
- accession: 0000950170-24-038865
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2024-04-01T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/0000950170-24-038865-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/guts-20240401.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-038865
- JSON: https://secwatch.observer/filing/0000950170-24-038865.json
- Plain text: https://secwatch.observer/filing/0000950170-24-038865.txt

## Key facts
- Earnings Releases
  FRACTYL HEALTH, INC. reported financial results for quarter and year ended December 31, 2023.
  - Period: quarter and year ended December 31, 2023
  - Result: reported results
  source text: On April 1, 2024, Fractyl Health, Inc. announced its financial results for the quarter and year ended December 31, 2023 and provided a corporate update.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/0000950170-24-038865-index.htm

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