secwatch.observer — SEC 8-K summary ====================================== Issuer: Vivani Medical, Inc. (VANI) CIK: 0001266806 Form: 8-K Filed at: 2026-06-30T12:03:55+00:00 Accession: 0001753926-26-001109 Event type: regulatory Sentiment: positive Materiality: 0.65 Item codes: 5.02, 5.07, 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Vivani Medical receives HREC approval to initiate Phase 1 trial of NPM-139 semaglutide implant for obesity -------------------------------------------------------------------------------- - Received approval from Bellberry HREC in Australia to start SLIM-1 Phase 1 trial of NPM-139 semaglutide implant. - SLIM-1 trial initiation expected mid-2026; builds on prior Phase 1 success with NPM-119 exenatide implant in 2025. - Company plans SLIM-2 dose-ranging efficacy trial pending SLIM-1 results to accelerate NPM-139 development. - CEO cites strong market demand for miniature, reversible GLP-1 implant technology. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1266806/000175392626001109/0001753926-26-001109-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1266806/000175392626001109/vani-20260624.htm HTML page: https://secwatch.observer/filing/0001753926-26-001109 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer