---
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"
generated_at: "2026-05-25T04:58:26.359311+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Oragenics submits Investigator's Brochure for Phase II trial of ONP-002 in Australia

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-009335
- JSON: https://secwatch.observer/filing/0001493152-25-009335.json
- Plain text: https://secwatch.observer/filing/0001493152-25-009335.txt

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