{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-030826","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-03-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.039787+00:00","generated_at":"2026-05-25T17:43:29.622939+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 reports Q4 2024 net loss $25.0M; REMAIN-1 enrollment surges to 189+ patients","bullets":["Q4 2024 net loss $25.0M vs $19.2M in Q4 2023; R&D expense rose to $20.3M from $10.1M.","Cash and equivalents $67.5M; cash runway extended into 2026 after pausing T2D Revita programs.","REMAIN-1 pivotal study enrolled >189 patients across 13 sites; midpoint data expected Q2 2025, full enrollment summer 2025.","Rejuva RJVA-001 CTA for T2D submission expected H1 2025; preliminary data (if authorized) in 2026.","Strategic shift: focus Revita on weight maintenance, pause T2D Revita programs (REVITALIZE-1, Germany Registry)."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-030826","json":"https://secwatch.observer/filing/0000950170-25-030826.json","markdown":"https://secwatch.observer/filing/0000950170-25-030826.md","text":"https://secwatch.observer/filing/0000950170-25-030826.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025030826/0000950170-25-030826-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025030826/guts-20250303.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T17:43:29.622939+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"}