---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-009682"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2026-03-11T23:59:59+00:00"
generated_at: "2026-05-15T14:42:02.327800+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Oragenics gets HREC approval, starts Phase IIa site activation for ONP-002 in Australia; explores CNS asset acquisition

## Summary
- Received final HREC approval in Australia for Phase IIa trial of ONP-002 for concussion/mTBI.
- Completed first site initiation visit (SIV) for Phase IIa trial; two more sites in final RGO review.
- Phase IIa trial of 40 patients; first dose within 12 hours of injury; data readout expected before year-end 2026.
- Exploring discussions with third parties for potential acquisition of CNS assets focusing on brain health/recovery.
- No definitive agreements reached; platform expansion independent of Receptor.AI partnership.

## SEC filing metadata
- accession: 0001493152-26-009682
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2026-03-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000149315226009682/0001493152-26-009682-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000149315226009682/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-009682
- JSON: https://secwatch.observer/filing/0001493152-26-009682.json
- Plain text: https://secwatch.observer/filing/0001493152-26-009682.txt

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