{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-030682","form_type":"8-K","ticker":"OGEN","cik":"0001174940","company_name":"ORAGENICS INC","filed_at":"2024-08-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.342873+00:00","generated_at":"2026-05-31T10:41:55.037159+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Oragenics' concussion drug ONP-002 passes FDA cardiotoxicity test, Phase II planned","bullets":["ONP-002 showed no cardiotoxicity in GLP hERG study conducted by Charles River Laboratories.","Inhibitory concentration >10 µM; large cardiac safety margin based on Phase I plasma levels.","Phase II trial planning underway to evaluate ONP-002 in concussed patients.","Concussion market estimated at 69M cases globally; annual US healthcare cost for TBIs exceeds $40.6B.","ONP-002 is an intranasal neurosteroid new chemical entity targeting mild traumatic brain injury."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-030682","json":"https://secwatch.observer/filing/0001493152-24-030682.json","markdown":"https://secwatch.observer/filing/0001493152-24-030682.md","text":"https://secwatch.observer/filing/0001493152-24-030682.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1174940/000149315224030682/0001493152-24-030682-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1174940/000149315224030682/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T10:41:55.037159+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"}