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Science & Technology

The Science of Getting There First

Every drug in development faces the same fundamental challenge: getting the right molecule to the right place in the body, at the right time. For neurological conditions, that challenge is especially acute — the brain is one of the most protected organs in the human body, shielded by a barrier that blocks most drugs from ever reaching it.

We solved that problem. And it changes everything.

The Blood-Brain Barrier Problem

Why Most Drugs Never Reach the Brain

The blood-brain barrier is the brain’s natural defense system — a tightly regulated network of cells that prevents harmful substances from entering. It’s also the reason most pharmacological treatments for neurological conditions either fail to work or require high systemic doses that cause unacceptable side effects.

Traditional drug delivery — oral pills, intravenous infusions, injections — relies on systemic circulation to transport medicine through the body. For most CNS drugs, the result is low brain uptake, high systemic exposure, and a long list of side effects.

90%
of CNS drugs fail due to poor brain penetration
ZERO
FDA-approved pharmacological treatments for concussion
69M
concussions annually worldwide with no treatment option
Oragenics takes a different path entirely.

Our Approach: Intranasal Direct-To-Brain Delivery

Bypassing the Barrier. Targeting the Brain.

Our proprietary intranasal delivery platform routes therapeutics directly to the brain via the olfactory and trigeminal nerve pathways — two neurological highways that connect the nasal cavity to the brain without crossing the blood-brain barrier.

The result: rapid brain distribution, minimal systemic exposure, and targeted action exactly where it’s needed.

How It Works
1
Administer
Blow-activated device delivers precise dose to nasal cavity
2
Travel
Therapeutic travels via olfactory nerve pathway, bypassing bloodstream
3
Act
ONP-002 reaches injury site rapidly — distribution confirmed across all brain regions
4
Protect
Drug engages receptors in neurons and glial cells, triggering neuroprotective response

The Intranasal Device

Purpose-Built for Where Care Happens

Our intranasal delivery device isn’t an adapted consumer product. It’s a purpose-engineered, single-use medical device designed for the environments where concussion occurs — emergency rooms, sports sidelines, military settings, and first-responder units.

Blow-activated

One-step activation — no training or coordination required.

Soft palate closure

Ensures delivery to the target pathway — not swallowed or inhaled.

Compact & portable

No power, refrigeration, or complex preparation required.

Non-invasive

No needles, no IVs — patients remain alert throughout treatment.

Precise dosing

Consistent, reproducible delivery across patient populations.

IP through 2040+

Proprietary asset with commercial exclusivity alongside drug compound portfolio.

The Science Behind ONP-002

A Neurosteroid Designed for Brain Injury

ONP-002 is a first-in-class intranasal neurosteroid engineered to interrupt the damaging biological cascade triggered by concussion — inflammation, oxidative stress, and swelling — at its source.

Reduces neuroinflammation

Modulates inflammatory pathways at the cellular level, limiting post-injury damage cascade.

Decreases oxidative stress

Neutralizes free radicals that damage neurons and surrounding tissue.

Minimizes cerebral edema

Reduces brain swelling that compresses neural tissue and impairs function.

Clears cellular debris

Activates mechanisms that remove damaged material before it causes further harm.

Preserves BBB integrity

Supports the brain’s own protective systems during the acute injury phase.

Nanoparticle formulation

Enhances absorption through nasal mucosa for rapid uptake and fast brain distribution.

Clinical Validation

The Science Has Been Tested

ONP-002 is not a theoretical compound. The safety and delivery science has been validated in human clinical trials.

✓ Phase 1 — Complete ● Phase 2a — Active Phase 2b — Planned Phase 3 — Planned
Phase 1 Results
  • Safe and well-tolerated — zero serious adverse events
  • Rapid brain distribution confirmed via intranasal delivery
  • Minimal systemic exposure — the drug reaches the brain, not the body
  • Strong tolerability across all ascending dose cohorts
Phase 2a — Active
  • 40-patient randomized, placebo-controlled trial underway in Australia
  • First dose within 12 hours of concussion
  • Twice daily treatment for 5 days post-injury

Platform Potential

One Platform. Multiple Neurological Conditions.

The intranasal delivery platform underlying ONP-002 is not a single-use asset. The same proprietary technology that delivers ONP-002 directly to the brain has potential applications across a broad range of neurological conditions — from acute emergencies to chronic neurodegenerative diseases.

The nasal drug delivery market is projected to exceed $125 billion by 2030, with neurological applications representing one of the fastest-growing segments.

In collaboration with Receptor.AI, we are accelerating the exploration of additional CNS indications using AI-driven drug discovery — building a diversified pipeline on top of a validated delivery platform.

Platform technology with potential applications across:
PTSD
Stroke
Seizures
Alzheimer’s Disease
Parkinson’s Disease
Other CNS Disorders
All pipeline molecules beyond ONP-002 are in exploratory or pre-clinical stages.