Transforming Concussion Care with Innovative Intranasal Delivery
The first potential FDA-approved therapy
for concussion.
Brain-First Neurotherapeutics
Pioneering a New Standard of Care for Concussion
First-in-class neurosteroid for concussion (mTBI)
Intranasal direct-to-brain delivery
Entering Phase 2 trials; clear FDA pathway
Massive TAM in target markets
Expert leaders; renowned scientists
NYSE American: OGEN 3
Investment Highlights
Multiple Levers for Value Creation
First & only neurotherapeutic for most prominent neurological condition without an FDA-
approved solution
Expanding IP Portfolio and new chemical entity (NCE) designation
Zero competition in massive markets for concussion and mild traumatic brain injury (mTBI)
69M concussions annually worldwide; many develop post-concussion symptoms
Phase 2-ready lead asset with validated efficacy and strong safety profile
Targets the biology of brain injury, not just symptoms
De-risked U.S. clinical and regulatory pathways following Phase 2a trial in Australia
Positioned for IND submission to FDA for U.S. based clinical trials
Demonstrated financial discipline and transparency supporting clinical development
Strong balance sheet with zero debt; proven capital efficiency
Value-creating milestones and near-term clinical catalysts
Phase 2a first patient dosing expected in Q1 '26; data readout expected by end of 2026
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Proven Leadership,
Scientific ExpertiseJanet Huffman | Chief Executive Officer & Chief Financial Officer
CFO for Nasdaq-listed TRxADE HEALTH (Scienture Holdings); founding member, CFO for Banyan Pediatric Care Centers, leading merger with Assisted 4 Living (Arboreta Healthcare Inc.); CFO for Signature HomeNow.
James P. Kelly, MA, MD, FAAN, FANA | Chief Medical Officer & Scientific Advisor
Current Executive Director for Marcus Institute for Brain Health (MIBH), Professor of Neurology at University of Colorado's Anschutz Medical Campus, and National Director of Gary Sinise Foundation Avalon Network TBI Medical Programs; former Director of National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center.
William "Frank" Peacock MD | Chief Clinical Officer
Current Vice Chair for Emergency Medicine Research at Baylor College of Medicine; past Professor at Cleveland Clinic Lerner College of
Medicine; world-renowned speaker and researcher on biomarkers of traumatic brain injury.
Charles L. Pope | Chairman of the Board
CFO for five companies in various industries including TRxADE HEALTH (Scienture Holdings); Partner in in Audit and Financial Advisory
Consulting Divisions and Accounting and SEC Directorate at PricewaterhouseCoopers.
Mark Gandolfo | Project Manager
Project Manager at Odyssey Health; Oakland Spine and Physical Therapy.
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Massive Markets, Zero Competition
$8.9B $100B +Concussion Market by 2027 Nasal drug delivery market by 2030
TAM = $49B+
First and Only Treatment
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Unmet Medical Need for Concussion & Mild TBI
Causes of Concussion
Falls
52%
Motor Vehicles
17%
17%
Sports
17%
Assault
What is a Concussion?
Mild traumatic brain injury (mTBI) affecting 69M annually worldwide
Symptoms: Headache, confusion, dizziness, memory problems, nausea
Risk: 30-80% develop post-concussion syndrome; increased dementia risk
Current Standard of Care
"Rest, observe, wait" = symptom management only
No approved pharmacological intervention
Patients risk chronic complications
Current treatment: Rest and hope
NYSE American: OGEN 7
Overview
ONP- 002:Phase 2 Lead Asset
ONLY pharmacological treatment in clinical development with FDA pathway for acute concussion
First-in-class intranasal neurosteroid
Intellectual property protection through 2040+
Mechanism
Reduces swelling, inflammation, oxidative stress
Targets the biology of brain injury, not just symptoms
Phase I Results:
Safe and well tolerated in 40 patients
Zero serious adverse events (SAEs)
"Treating the injury, not just the symptoms."
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Intranasal Mechanism of Action
Delivery Pathway:
Delivered via custom intranasal device
Travels through olfactory pathway directly to brain
Fast-acting with low systemic exposure
Biological Action:
Preserves blood-brain barrier integrity
Promotes cell survival and neuroprotection
Reduces inflammation and oxidative stress
NYSE American: OGEN 9
The Direct-to-Brain Intranasal
Advantage
Non-Invasive Delivery
Automatic
Soft Palate Closure
Blow-Activated
Mechanism
Compact Design
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