secwatch.observer — SEC 8-K summary
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Issuer:     ORAGENICS INC (OGEN)
CIK:        0001174940
Form:       8-K
Filed at:   2026-04-13T23:59:59+00:00
Accession:  0001493152-26-016294
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1174940/000149315226016294/0001493152-26-016294-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1174940/000149315226016294/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-016294

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