{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-277524","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.792380+00:00","generated_at":"2026-05-16T21:10:53.305207+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Fractyl Health Q3 net loss $45.6M; Revita post-GLP-1 weight maintenance data positive","bullets":["Net loss of $45.6M includes $23.5M non-cash warrant fair-value change; operating expenses down $1.1M YoY.","R&D spend $17.5M vs $19.0M year-ago; SG&A $5.2M vs $4.8M.","Cash $77.7M at Sep 30 2025; $83M in August/September offerings extend runway into early 2027.","REMAIN-1 Midpoint Cohort met endpoint: Revita patients lost 2.5% additional weight vs 10% regain for sham (p=0.014).","REMAIN-1 Pivotal enrollment >60% randomized; 6-month primary data expected H2 2026 with potential PMA filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-277524","json":"https://secwatch.observer/filing/0001193125-25-277524.json","markdown":"https://secwatch.observer/filing/0001193125-25-277524.md","text":"https://secwatch.observer/filing/0001193125-25-277524.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525277524/0001193125-25-277524-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525277524/guts-20251112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T21:10:53.305207+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"}