---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-003334"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2025-04-09T23:59:59+00:00"
generated_at: "2026-05-23T17:59:20.846688+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Oragenics submits Phase II concussion trial protocol to NZ ethics committee

## Summary
- Submitted clinical trial protocol to Health and Disability Ethics Committee (HDEC) in New Zealand for Phase II trial of ONP-002 for mild traumatic brain injury.
- Pending HDEC approval, expects to initiate patient enrollment at Christchurch Hospital, one of the busiest emergency departments in Australasia.
- ONP-002 is an intranasal neurosteroid therapy; no approved pharmaceutical exists for concussion, an unmet medical need.
- Phase I study showed safety and tolerability; Phase II will evaluate efficacy in mTBI patients.
- Company plans to expand global clinical footprint with sites in both Australia and New Zealand.

## SEC filing metadata
- accession: 0001641172-25-003334
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2025-04-09T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000164117225003334/0001641172-25-003334-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000164117225003334/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-003334
- JSON: https://secwatch.observer/filing/0001641172-25-003334.json
- Plain text: https://secwatch.observer/filing/0001641172-25-003334.txt

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