Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (May 2026)
15 slides from Oragenics's investor presentation, May 2026
Slide 1: Transforming Concussion Care with Innovative Intranasal Delivery
Transforming Concussion Care with Innovative Intranasal Delivery The first potential FDA-approved therapy for concussion.
Slide 2: Forward Looking Statements
Forward Looking Statements This communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's beliefs and assumptions and information curren
Slide 3: Brain-First Neurotherapeutics
Brain-First Neurotherapeutics Pioneering a New Standard of Care for Concussion First-in-class Intranasal direct- Entering Phase 2 Massive TAM in Expert leaders; neurosteroid for to-brain delivery trials; clear FDA target markets renowned concussion (mTBI) pathway scientists NYSE American: OGEN 3
Slide 4: 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 Investment Zero competition in massive markets for concussion and mild traumatic brain injur
Slide 5: Proven Leadership, Scientific Expertise
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 Signat
Slide 6: Massive Markets, Zero Competition
Massive Markets, Zero Competition $8.9B Concussion Market by 2027* $125B+ Nasal drug delivery market by 2030* TAM = $49B+ First and Only Treatment *Grand View Research, Concussion Market Size Worth $8.9 Billion By 2027 | CAGR: 3.6%: Read more on the data: *Premier Health, Concussion and Mild Traumat
Slide 7: Unmet Medical Need for Concussion & Mild TBI
Unmet Medical Need for Concussion & Mild TBI Causes of Concussion What is a Concussion? • Mild traumatic brain injury (mTBI) affecting 69M annually worldwide • Symptoms: Headache, confusion, dizziness, memory problems, nausea Falls 52% • Risk: 30-80% develop post-concussion syndrome; increased demen
Slide 8: ONP-002: Overview
Overview ONP- 002: Phase 2 Lead Mechanism Asset 8
Slide 9: Intranasal Mechanism of Action
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
Slide 10: ONP-002: Safety Validation, Phase Progression
ONP-002: Phase 1 Safety Validation, Phase 2 Progression Phase I Single and Multiple Ascending Dose (SAD/MAD) safety study of ONP-002: • Neuroprotective molecular and behavioral effects within hours • Pharmacokinetic profile confirms minimal systemic exposure • Excellent safety profile with zero seve
Slide 11: Strategic Phase 2 Trial Design
Strategic Phase 2 Trial Design Study Design Enrollment Criteria Primary Endpoints Phase 2a Regulatory Foundation 2026: Data & U.S. Expansion Built NYSE American: OGEN 11
Slide 12: Clear Regulatory Pathway to Market
Clear Regulatory Pathway to Market A thorough regulatory process ensures trial integrity, while diligent preparation de-risks the U.S. pathway and positions positive Phase 2a results to provide a strong rationale for an IND submission. Phase 2 Regulatory Foundation Built Near Term Milestones 2026: D
Slide 13: Scalable Platform for Pipeline Expansion
Scalable Platform for Pipeline Expansion Possible Future CNS Therapeutic Applications: Technology Platform Traumatic Brain Injury (TBI) • Proprietary intranasal delivery system with broad applications • Same technology applicable across multiple neurological conditions Stroke Seizures Market Context
Slide 14: Value-Creating Near-Term Clinical Catalysts
Value-Creating Near-Term Clinical Catalysts Milestones Achieved + Q2 2026 2026 Value Catalysts(2026) Momentum • Final HREC amendment approval enabling • Phase 2a data readout from Australia trials clinical site onboarding • IND submission to FDA for U.S. based Phase 2 • Phase 2a clinical trial initi
Slide 15: Brain-First Recovery
Brain-First Recovery Unlocking the Brain’s Capacity for Healing- One Breakthrough at a Time 15