{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-25-001431","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2025-09-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.551347+00:00","generated_at":"2026-05-17T08:14:02.758709+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vivani Medical plans Phase 1/2 trials for NPM-139 semaglutide implant; H1 2026 start","bullets":["NPM-139 is a semaglutide implant for chronic weight management in obese/overweight patients.","Phase 1 study expected to start H1 2026 pending regulatory clearance; designed for safety, tolerability, PK.","Phase 2 dose-ranging study planned to follow Phase 1, pending enabling results and regulatory feedback.","NPM-139 aims to deliver Wegovy-level efficacy with once or twice-yearly administration.","Positive preclinical data and promising LIBERATE-1 results for NPM-115 (exenatide) support program."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-25-001431","json":"https://secwatch.observer/filing/0001753926-25-001431.json","markdown":"https://secwatch.observer/filing/0001753926-25-001431.md","text":"https://secwatch.observer/filing/0001753926-25-001431.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392625001431/0001753926-25-001431-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392625001431/vani-20250904.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T08:14:02.758709+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"}