Oragenics Inc.AMEX: OGEN

Investor Presentation - January 2026

· Issued by Oragenics Inc.


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

4



Proven Leadership,

Scientific Expertise

Janet 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.

5



Massive Markets, Zero Competition

$8.9B $100B +

Concussion Market by 2027 Nasal drug delivery market by 2030

TAM = $49B+

First and Only Treatment

6





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."

8





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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