{"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","discovered_at":"2026-05-14T18:02:48.834171+00:00","generated_at":"2026-05-21T15:56:38.897334+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-070294","json":"https://secwatch.observer/filing/0000950170-25-070294.json","markdown":"https://secwatch.observer/filing/0000950170-25-070294.md","text":"https://secwatch.observer/filing/0000950170-25-070294.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T15:56:38.897334+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}