{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-038865","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2024-04-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.029952+00:00","generated_at":"2026-06-04T04:38:29.524959+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Fractyl Health Q4 2023: FDA approves IDE for Revita weight-maintenance study; gene therapy candidate RJVA-001 nominated","bullets":["FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.","Enrollment in Revitalize-1 T2D pivotal study expected to complete Q2 2024; topline data Q4 2024.","Announced RJVA-001 as first GLP-1 pancreatic gene therapy candidate; IND-enabling studies to complete H2 2024.","Completed IPO raising ~$100.3M net; cash on hand expected to fund operations through 2025.","FY 2023 net loss $77.1M vs $46.5M in 2022; revenue insignificant $0.1M; R&D expense $38.0M."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-038865","json":"https://secwatch.observer/filing/0000950170-24-038865.json","markdown":"https://secwatch.observer/filing/0000950170-24-038865.md","text":"https://secwatch.observer/filing/0000950170-24-038865.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/0000950170-24-038865-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/guts-20240401.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T04:38:29.524959+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":"f00cb36b86dd705269415cd793edc41dd3c09252","claim":"FRACTYL HEALTH, INC. reported financial results for quarter and year ended December 31, 2023.","evidence_excerpt":"On April 1, 2024, Fractyl Health, Inc. announced its financial results for the quarter and year ended December 31, 2023 and provided a corporate update.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024038865/0000950170-24-038865-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"quarter and year ended December 31, 2023"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}