Oragenics Inc. · AMEX:OGEN
Oragenics — Corporate Update (May 2025)
28 slides from Oragenics's corporate update, May 20, 2025
Slide 1: Oragenics Management Update Call
ORAGENJICS ORAGENICS, INC MANAGEMENT UPDATE CALL MAY 20TH, 2025 NYSE: OGEN MAY 2025
Slide 2: Forward Looking Statements
FORWARD LOOKING STATMENTS 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, including without limitation statements regarding the Company's future performance, prospects, outlook, an
Slide 3: Janet Huffman, Chief Executive Officer
ORAGENJICS JANET HUFFMAN CHIEF EXECUTIVE OFFICER NYSE: OGEN MAY 2025
Slide 4: Overview - Key Objectives for the Call
OVERVIEW - KEY OBJECTIVES FOR THE CALL Leadership & Strategic Vision - Introduce the team guiding Oragenics through transformation and explain our focused mission in concussion care. Investor Alignment & Market Opportunity - Discuss how our strategy aligns with unmet market needs—and why ONP-002 rep
Slide 5: Management Overview
MANAGEMENT OVERVIEW Janet Huffman, Chief Executive Officer: Bio Highlights: « Appointed CEO of Oragenics in April 2025 after joining the company in Our Team Board and March 2023. Scientific Team * Brings over 15 years of executive leadership experience across Board of Directors Highlights: Long- hea
Slide 6: The Problem - Concussion Is a Public Health Crisis
THE PROBLEM - CONCUSSION IS A PUBLIC HEALTH CRISIS Concussions Are a Subset of Traumatic Brain Injury (TBI) e Aconcussion is classified as a mild traumatic brain injury (mTBI)—the most common form of TBI. While considered "mild," concussions can cause serious neurological symptoms that may last week
Slide 7: Our Solution - ONP-002 Intranasal Therapy
OUR SOLUTION - ONP-002 INTRANASAL THERAPY ONP-002: First-in-class intranasal drug for moderate-to-severe concussion e Rapid brain biodistribution e Reduces swelling, inflammation, and oxidative stress ¢ Completed Phase 1 clinical trial: Safe and well-tolerated Strategic Impact e Expanded Oragenics’
Slide 8: Recent Clinical Accomplishments
RECENT CLINICAL ACCOMPLISHMENTS Clinical Progress: Significant progress, with patient enrollment expected to begin in Q2 2025 in Level 1 trauma emergency departments in Australasia. Phase 1: Clinical trial reports and data have been finalized and delivered. The regulatory team is organizing the data
Slide 9: Recent Strategic Accomplishments
RECENT STRATEGIC ACCOMPLISHMENTS Department of Defense (DoD): Submitted a grant application to support ONP-002 development for concussion care. Strategic partnership with BRAINBox Solutions: Entered into a partnership with BRIANBox to create a first-of-its-kind test-to-treat platform for concussion.
Slide 10: Dr. Jim Kelly, Chief Medical Officer
ORAGENJICS DR. JIM KELLY CHIEF MEDICAL OFFICER NYSE: OGEN MAY 2025
Slide 11: Dr. Jim Kelly
DR. JIM KELLY CHIEF MEDICAL OFFICER ONE OF THE NATION’S FOREMOST AUTHORITIES ON CONCUSSION AND TRAUMATIC BRAIN INJURY, LEADING CLINICAL STRATEGY FOR ONP-002. Former Director, NICoE at Walter Reed, advancing military TBI care Longtime neurological consultant to the NFL; helped shape modern concussion
Slide 12: What Happens in the Brain After a Concussion?
WHAT HAPPENS IN THE BRAIN AFTER A CONCUSSION? Head Trauma > Ionic Shift » Inflammation » Oxidative Stress » Brain Swelling » Synaptic Dysfunction e There are approximately SM documented concussions in the US a year which exceeds the combined incidence of Stroke, Alzheimer’s Disease, Parkinson's Dise
Slide 13: Mild vs Severe TBI
MILD VS SEVERE TBI ACUTE BRAIN RESPONSE Mild GCS 15 Severe GCS 5
Slide 14: Concussion Clinical Assessment
CONCUSSION CLINICAL ASSESSMENT Standardized Assessment of Concussion 3) ConcentRaTIon; : tect go nox zung eng. Sincere rod FORM A ei 2 op alec co beh ui) 4-93 2-9 o1 3-8-1-4 3279 o1 6-29-71 1-52.86 ot 721-8462 $.3.0-1-4-8 o1 Montes in reer: (ents reveno ve wen conse fr 838) 01 Dee-Nov-Oet-Sep-Aug-Fu
Slide 15: Concussion Clinical Assessment
CONCUSSION CLINICAL Nain Moderate Severe Symptom Recovery ding oO a 2 > 6 Preseason fp HoursPost-Ipay3Post- Daya Post Post — faaseline injury injury injury injury Blurred Vision Sleeping More than Uswal aly Distracted Feeling “Ina Fog! Feeling “Slowed Down! leadache inusually Emotional ritability so
Slide 16: ONP-002 - Preclinical Efficacy
ONP-00O2 - PRECLINICAL EFFICACY ONP-002 - Molecular Studies: e Rodent - Reduces inflammation, oxidative stress and swelling in the injured brain e Neuronal Culture - Enhances brain cell survival and growth when challenged with low oxygen and glucose e ONP-002 - Behavioral Studies o Rodent - Improves
Slide 17: ONP-002 - Preclinical Safety and Biodistribution
ONP-OO2 - PRECLINICAL SAFETY AND BIODISTRIBUTION ONP-002 - Toxicology Studies: « Rodent, Canine, and Monkey — Well-tolerated 2X-daily/14-days intranasally e High safety margin (>20X) between animal dose and human dose (Phase | and upcoming Phase II trial) ONP-002 Brain Biodistribution e Canine - Int
Slide 18: ONP-002 - Clinical Product Manufacturing
ONP-002 - CLINICAL PRODUCT MANUFACTURING e ONP-O02 is a novel, neuro-steroid created through a synthetic process that results in a pure, well defined compound. e ONP-O02 is formulated as a intranasal powder formulation manufactured into a nanoparticle size improving uptake from nose to brain. e ONP-
Slide 19: A Winning Combination: ONP-002 + Intranasal Delivery
A WINNING COMBINATION: ONP-002 + INTRANASAL DELIVERY e Rapid and direct access to the brain Yn « Swift therapeutic effects ¢ Quicker onset compared to oral Z Intranasal Delivery Advantages medications Innovative Design « Patients blow into the device, elevating the soft palate e Minimizes systemic e
Slide 20: Dr. William Frank Peacock, Chief Clinical Officer
ORAGENJICS DR. WILLIAM “FRANK” PEACOCK CHIEF CLINICAL OFFICER NYSE: OGEN MAY 2025
Slide 21: Dr. Frank Peacock
DR. FRANK PEACOCK CHIEF CLINICAL OFFICER A NATIONALLY RECOGNIZED EXPERT IN EMERGENCY MEDICINE AND BRAIN INJURY DIAGNOSTICS, LEADING REAL-WORLD CLINICAL IMPLEMENTATION FOR ONP-002. e Vice Chair of Emergency Medicine Research, Baylor College of Medicine e Former Professor at the Cleveland Clinic e Pri
Slide 22: ONP-002 - Clinical R&D
ONP-002 - CLINICAL R&D PHASE | CLINICAL STUDY REPORT (CSR) AND TRIAL MASTER FILE (TMF) COMPLETED — ONP-002 WAS SAFE AND WELL TOLERATED IN 40 HEALTHY HUMAN VOLUNTEERS Lead site for Phase Ila —- Christchurch Hospital, New Zealand (NZ) -CRO- Comprehensive Research Associates -Clinical Protocol Submitte
Slide 23: Phase IIa - Enrollment Criteria
PHASE IIA - ENROLLMENT CRITERIA Enrolment criteria designed to identify most at risk for developing Persistent Concussion Symptoms beyond 30-days of injury First treatment within 12-hrs of injury e Glasgow Coma Score of 13-15 e Negative CT Scan e Positive GFAP score e Report of Headache e History of
Slide 24: Phase IIa Trial - Outcome and Safety Measures
PHASE IIA TRIAL - OUTCOME AND SAFETY MEASURES Safety e Monitoring for AEs/SAEs — Patient reported and Physical Examination e EKG e Drug PK levels e Intranasal evaluation for irritation Clinical Outcomes Patient reported symptoms — Rivermead Neurocognitive performance — DANA and Braincheck Visual-Ves
Slide 25: BrainBox Partnership - Phase IIa
BRAINBOX PARTNERSHIP PHASE IIA Trigger to Treat Model Kit provisions for blood draws, strips for blood biomarker analysis, and tabletop readers Blood draw timepoints, per-dose (within 12 hours of injury), 24 hours, 72 hours, 5-days, 10- days, and 30-days GFAP - elevation required for study admission
Slide 26: Clinical Milestones
CLINICAL MILESTONES PHASE 2B Submit IND for Complete Submit AUS Ila Activate Phase First Patient Submit US IIb initiate Bhase IIb US clinical Phase Ila trial trial findings lb trial sites Enrollment trial findings Ila trial trials AU/NZ to FDA Phase Ilb trial to FDA In AUS inUS Apply for Accelarate
Slide 27: Why ONP-002? Why Oragenics? Why Now?
WHY ONP-002? WHY ORAGENICS? WHY NOW? The Opportunity Is Clear e Large Market Opportunity: Concussions affect 5M+ Americans annually e First of its kind: No FDA-approved treatment ¢ ONP-002 targets the root causes of concussion damage: inflammation, oxidative stress, and brain swelling e Intranasal d
Slide 28: Q&A Session - Thank You
ORAGENJICS MAY 2025 Q&A SESSION THANK YOU