---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-042843"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2026-09-16T12:30:43+00:00"
generated_at: "2026-09-16T12:35:14.539150+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Oragenics CMO to present ONP-002 at IPAC-RS; IND submission planned Q4 2026

## Summary
- CMO James P. Kelly presents ONP-002 intranasal neurosteroid for concussion at IPAC-RS 2026 Nasal Innovation Forum on Sept 17, 2026.
- Phase IIa feasibility trial enrolling at 3 Australian sites; IND submission anticipated Q4 2026.
- U.S. Phase IIb trials planned post-IND; no FDA-approved pharmacological treatment for mTBI exists.
- Phase I safety trials completed with favorable safety/tolerability; ONP-002 targets neuroinflammation, oxidative stress, edema.

## SEC filing metadata
- accession: 0001493152-26-042843
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2026-09-16T12:30:43+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000149315226042843/0001493152-26-042843-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000149315226042843/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-042843
- JSON: https://secwatch.observer/filing/0001493152-26-042843.json
- Plain text: https://secwatch.observer/filing/0001493152-26-042843.txt

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