---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-016294"
form_type: "8-K"
ticker: "OGEN"
cik: "0001174940"
company_name: "ORAGENICS INC"
filed_at: "2026-04-13T23:59:59+00:00"
generated_at: "2026-05-15T06:32:54.680328+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Oragenics dosed first patient in Phase IIa trial of ONP-002 for mild traumatic brain injury

## Summary
- First patient dosed at Mackay Hospital (Australia) days after site activation on March 31, 2026.
- Phase IIa is randomized, placebo-controlled, targeting 40 patients; dosing within 12 hours of concussion.
- Additional sites (Alfred Hospital, Royal Adelaide Hospital) expected to activate in Q2 2026.
- Company plans to submit IND to FDA in Q4 2026 for U.S. Phase IIb trials.
- Phase 1 safety data showed zero serious adverse events across all dose levels.

## SEC filing metadata
- accession: 0001493152-26-016294
- form_type: 8-K
- ticker: OGEN
- cik: 0001174940
- company_name: ORAGENICS INC
- filed_at: 2026-04-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1174940/000149315226016294/0001493152-26-016294-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1174940/000149315226016294/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-016294
- JSON: https://secwatch.observer/filing/0001493152-26-016294.json
- Plain text: https://secwatch.observer/filing/0001493152-26-016294.txt

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