secwatch.observer — SEC 8-K summary
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Issuer:     FRACTYL HEALTH, INC. (GUTS)
CIK:        0001572616
Form:       8-K
Filed at:   2026-05-12T20:05:16+00:00
Accession:  0001193125-26-219365
Event type: earnings
Sentiment:  neutral
Materiality: 0.55
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Fractyl Health Q1 net income $9.2M on non-cash warrant change; Revita pivotal data on track for early Q4
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- Q1 R&D expenses $15.6M (down from $19.4M YoY); SG&A $5.2M; adjusted EBITDA -$18.0M.
- Cash $63.2M; runway into early 2027, beyond anticipated pivotal data readout.
- Revita REMAIN-1 Pivotal topline 6-month data expected early Q4 2026; FDA De Novo submission target late Q4 2026.
- 1-year REVEAL-1 Cohort data in Q2 2026; 1-year randomized REMAIN-1 Midpoint data in Q3 2026.
- RJVA-001 first-in-human dosing and preliminary data expected in H2 2026 after Netherlands CTA authorization.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1572616/000119312526219365/0001193125-26-219365-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1572616/000119312526219365/guts-20260512.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-219365

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer