{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-121780","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-03-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.494057+00:00","generated_at":"2026-05-15T09:12:18.081632+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete","bullets":["Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.","Cash $81.5M as of Dec 31, 2025; cash runway into early 2027 beyond pivotal readout.","Completed REMAIN-1 Pivotal Cohort randomization; topline 6-month data expected early Q4 2026.","FDA feedback supports Class II De Novo pathway; potential De Novo submission late Q4 2026.","Post-hoc analyses show ablation-length-dependent treatment effect; 70% reduction in weight regain in above-median GLP-1 loss group."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-121780","json":"https://secwatch.observer/filing/0001193125-26-121780.json","markdown":"https://secwatch.observer/filing/0001193125-26-121780.md","text":"https://secwatch.observer/filing/0001193125-26-121780.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/0001193125-26-121780-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/guts-20260324.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:12:18.081632+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":[{"claim_id":"59b46fc933a034265533011a52e38987e7fed907","claim":"FRACTYL HEALTH, INC. updated its quarter and full year ended December 31, 2025 guidance (reaffirmed).","evidence_excerpt":"On March 24, 2026, Fractyl Health, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2025 and provided a corporate update.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526121780/0001193125-26-121780-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"quarter and full year ended December 31, 2025"},{"label":"Guidance","value":"reaffirmed"},{"label":"Result","value":"preliminary results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}