{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-009335","form_type":"8-K","ticker":"OGEN","cik":"0001174940","company_name":"ORAGENICS INC","filed_at":"2025-03-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.088002+00:00","generated_at":"2026-05-25T04:58:26.359311+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"confidence":"high","headline":"Oragenics submits Investigator's Brochure for Phase II trial of ONP-002 in Australia","bullets":["Phase II trial of intranasal neurosteroid ONP-002 for mild traumatic brain injury (mTBI); up to 40 participants enrolled across two arms.","Trial is randomized, double-blind, placebo-controlled; nine doses over five days, first dose within 12 hours of injury.","Prior Phase I confirmed safety and tolerability at multiple intranasal doses in healthy adults.","No FDA-approved drug therapies currently exist for concussion, an unmet medical need.","Interim CEO Janet Huffman anticipates final regulatory approvals in coming weeks to initiate trial."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-009335","json":"https://secwatch.observer/filing/0001493152-25-009335.json","markdown":"https://secwatch.observer/filing/0001493152-25-009335.md","text":"https://secwatch.observer/filing/0001493152-25-009335.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1174940/000149315225009335/0001493152-25-009335-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1174940/000149315225009335/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T04:58:26.359311+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"}