{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-003334","form_type":"8-K","ticker":"OGEN","cik":"0001174940","company_name":"ORAGENICS INC","filed_at":"2025-04-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.704392+00:00","generated_at":"2026-05-23T17:59:20.846688+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.55,"confidence":"high","headline":"Oragenics submits Phase II concussion trial protocol to NZ ethics committee","bullets":["Submitted clinical trial protocol to Health and Disability Ethics Committee (HDEC) in New Zealand for Phase II trial of ONP-002 for mild traumatic brain injury.","Pending HDEC approval, expects to initiate patient enrollment at Christchurch Hospital, one of the busiest emergency departments in Australasia.","ONP-002 is an intranasal neurosteroid therapy; no approved pharmaceutical exists for concussion, an unmet medical need.","Phase I study showed safety and tolerability; Phase II will evaluate efficacy in mTBI patients.","Company plans to expand global clinical footprint with sites in both Australia and New Zealand."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-003334","json":"https://secwatch.observer/filing/0001641172-25-003334.json","markdown":"https://secwatch.observer/filing/0001641172-25-003334.md","text":"https://secwatch.observer/filing/0001641172-25-003334.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1174940/000164117225003334/0001641172-25-003334-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1174940/000164117225003334/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T17:59:20.846688+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"}