---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-031163"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2024-08-12T23:59:59+00:00"
generated_at: "2026-05-31T09:58:10.261996+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Oragenics: concussion drug ONP-002 shows no genotoxicity in animal study; Phase II planned

## Summary
- ONP-002 completed in vivo micronucleus assay; no evidence of genetic mutations or DNA damage across low, medium, high doses.
- Study conducted under GLP conditions with VivoPharm; supports safety for planned Phase II clinical trial for concussion.
- Company previously reported safety margin in two-species tox and cardiac safety (GLP hERG); now genotoxicity cleared.
- Concussion affects ~69M annually globally; post-concussion symptoms cause long-term disability in up to 20% of patients.

## SEC filing metadata
- accession: 0001493152-24-031163
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2024-08-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000149315224031163/0001493152-24-031163-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000149315224031163/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-031163
- JSON: https://secwatch.observer/filing/0001493152-24-031163.json
- Plain text: https://secwatch.observer/filing/0001493152-24-031163.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.