---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-033383"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2024-08-21T23:59:59+00:00"
generated_at: "2026-05-31T08:12:22.227111+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Oragenics completes spray-dry manufacturing of ONP-002 for Phase IIa concussion trial

## Summary
- ONP-002 produced as spray-dried nanoparticle powder and filled in Oragenics' breath-propelled intranasal device.
- Phase IIa trial to enroll 40 concussed patients (1:1 placebo/ONP-002), dosed twice daily for 5 days starting within 8 hours of injury in ED.
- Trial will be conducted in Australia; patient-reported outcomes and blood biomarkers included in evaluation.
- No approved pharmaceutical treatment for concussion; ONP-002 is a novel neurosteroid designed as first-in-class therapy.

## SEC filing metadata
- accession: 0001493152-24-033383
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2024-08-21T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000149315224033383/0001493152-24-033383-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000149315224033383/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-033383
- JSON: https://secwatch.observer/filing/0001493152-24-033383.json
- Plain text: https://secwatch.observer/filing/0001493152-24-033383.txt

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