secwatch.observer — SEC 8-K summary
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Issuer:     ORAGENICS INC (OGEN)
CIK:        0001174940
Form:       8-K
Filed at:   2026-09-16T12:30:43+00:00
Accession:  0001493152-26-042843
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1174940/000149315226042843/0001493152-26-042843-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1174940/000149315226042843/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-042843

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer