{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-342343","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-08-10T20:05:17+00:00","discovered_at":"2026-08-10T20:06:03.258769+00:00","generated_at":"2026-08-10T20:06:13.602376+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 Q2 net loss $25.5M; REMAIN-1 data show 84% weight-loss maintenance","bullets":["Net loss $25.5M vs $27.9M YoY; R&D down to $13.8M from $21.2M.","Cash $47.1M at 6/30/26; runway into early 2027, beyond pivotal readout.","REMAIN-1 Midpoint: Revita patients maintained 84% of weight loss vs 46% sham (optimized subgroup).","REVEAL-1: ~78% weight-loss maintenance after single Revita; no serious device-related AEs.","Pivotal topline due early Q4 2026; potential FDA De Novo submission late Q4 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-342343","json":"https://secwatch.observer/filing/0001193125-26-342343.json","markdown":"https://secwatch.observer/filing/0001193125-26-342343.md","text":"https://secwatch.observer/filing/0001193125-26-342343.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526342343/0001193125-26-342343-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526342343/guts-20260810.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-10T20:06:13.602376+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"}