FAQ on Oragenics Inc.'s Q2 2025 Progress and Phase IIa Concussion Trial Preparation

What is Oragenics Inc. working on?

Oragenics Inc. is developing brain-targeted therapeutics, including its lead candidate ONP-002, aimed at becoming the first FDA-approved pharmacological treatment for concussion, using proprietary intranasal delivery technology.

Why is Oragenics’ work significant?

Their work is significant because it could revolutionize neurological care by providing the first FDA-approved treatment for concussion and potentially addressing other neurological conditions with their intranasal delivery platform.

How does Oragenics’ intranasal delivery technology work?

The technology enables rapid, targeted drug delivery to the brain, bypassing systemic circulation to reduce side effects, with applications in treating concussion, acute neurological emergencies, and chronic neurodegenerative diseases.

Who is involved in the Phase IIa trial for ONP-002?

Oragenics has appointed Southern Star Research as the CRO for the trial and secured a U.S.-based cGMP manufacturing agreement with Sterling Pharma Solutions.

When is the Phase IIa trial for ONP-002 expected to launch?

The Phase IIa trial is expected to launch in Q3 2025.

Where is Oragenics conducting its research?

Oragenics has secured Human Research Ethics Committee approval in Australia and is preparing for trials, indicating research activities in Australia and the U.S.

What are the potential applications of Oragenics’ technology beyond concussion?

Beyond concussion, the technology has potential applications in treating acute neurological emergencies and chronic neurodegenerative diseases.

What is the projected size of the global nasal drug delivery market?

The global nasal drug delivery market is projected to exceed $40 billion by 2030.

How can I get more information about Oragenics Inc.?

More information is available in the company’s newsroom at https://ibn.fm/OGEN.