---
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"
generated_at: "2026-05-31T10:41:55.037159+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Oragenics' concussion drug ONP-002 passes FDA cardiotoxicity test, Phase II planned

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-030682
- JSON: https://secwatch.observer/filing/0001493152-24-030682.json
- Plain text: https://secwatch.observer/filing/0001493152-24-030682.txt

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