Oragenics Inc. · AMEX:OGEN
Oragenics — IPAC-RS Successful Studies Case (September 2026)
21 slides from Oragenics's conference presentation, Sep 16, 2026
Slide 1: IPAC-RS Successful Studies Case
IPAC-RS Successful Studies Case September 17, 2026 Jersey City, NJ James P. Kelly, MD Chief Medical Officer Oragenics, Inc
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 o 1995. These forward-looking statements are based on management's beliefs and assumptions and information current
Slide 3: What is Traumatic Brain Injury (TBI)?
What is Traumatic Brain Injury (TBl)? > New or worsening of at least one of the following clinical signs * Loss of consciousness or decreased consciousness * Loss of memory immediately before or after injury ¢ Alteration in mental status at the time of injury (confused, disoriented, slow thinking) *
Slide 4: TBI: 4.8 Million/Year in US
TBI 4.8 Million/Year in US Stroke Alzheimer’s Disease Parkinson’s Disease Multiple Scerosis ALS (Lou Gehrig’s Disease)
Slide 5: Time Course of Concussion
Figure 1 Time Course of Concussion Injury Confusion RGA = retrograde amnesia, LOC = loss of consciousness, PTA = posttraumatic amnesia
Slide 6: Standardized Assessment of Concussion (SAC)
SAC Standardized Assessment of Concussion FORM A Name: Age:___S Examiner, Nature of Injury: Date of Exam: ime: 1) Onwyrarion: Time (within 1 hej: Orientation Total Score i 2) IMMEDIATE. MEMORY: (a3 vials we comploecreqase of scone nl 1&2 sore es som nrseal 3 wa) “List “Trial L “Trial [nas a ot fot ‘
Slide 7: SAC Total Score: LOC vs PTA
SAC Total Score: LOC vs PTA Baseline, Concussion, and Follow-Up 30 28 26 a 24 22 20 18 16 14 12 Baseline 15 Min.*+ 48 Hr. Injury *+ —*- NO LOC/PTA PTA, No LOC LOC & PTA * Group Effect + Interval Effect 90 Days
Slide 8: Incidence, Clinical Course, and Predictors of Prolonged Recovery Following Sport-Related Concussion
‘eal fl ara NargolealSae OBD ‘epgteNsPse ty Cateye Urey Pr 212 asnotosisssmti Incidence, Clinical Course, and Predictors of Prolonged Recovery Time Following Sport-Related Concussion in High School and College Athletes Misael McCrea? Kevn Guskenvz*** Chistoper Randolph’ Wiliam B, Bar Thomas A. anmek
Slide 9: An Imaging Biomarker of MTBI?
An Imaging Biomarker of MTBI ? D> ORAGENICS Na
Slide 10: MRI Findings
MRI Findings CT Routine MRI- GRE New TBI Study- SWI Read as Normal Possible Lesion Multiple Lesions Detected Corpus Callosum
Slide 11: Hypothesis
Hypothesis * Diffuse Axonal Injury (DAI) * Stretching of neurons ¢ Leakage of proteins in the cerebrospinal fluid (CSF) and the blood stream ¢ NFL (axons) ¢ GFAP (astrocytes) * Tau (neurons)
Slide 12: Pathophysiology
Pathophysiology — 1 Neurotransmitters/neurochemicals are released in excessive amounts, releasing toxic levels of glutamate, driving up cellular metabolism and lactic acid levels causing oxidative stress = Sources: Hovda, DA and Giza, CC. (2001). The Neurometabolic Cascade of Concussion. Journal of
Slide 13: Pathophysiology
Pathophysiology - 2 ¢ Rotational injuries lead to diffuse shearing of small vessels * Diffuse axonal injury is underlying lesion Source: Povlishock, J. (1993). Pathobiology of Traumatically Induced Axonal Injury in Animals and Man. Annals of Emergency Medicine, 22(6), 980-6.
Slide 14: No two TBI injuries are the same
No two TBI injuries are the same- heterogeneous in location and severity Individual and personalize analysis are needed Sample DTI findings in pt with a normal structural MRI scan: Right Sided Blast TBI subject presents 70+% less tracks in the injured area onaGentcs Cy
Slide 15: No Current Pharmaceutical for Concussion
No Current Pharmaceutical for Concussion Concussion is a significant unmet need - No pharmacological therapy is currently available for treating the root cause of concussion and its lingering effects. Current Options for Treatment * Symptomatic treatment Rx for HA/ rest / sleep « Non-pharma therapie
Slide 16: New Developmental Drug, ONP-002
New Developmental Drug, ONP-002 New chemical entity: Proprietary neurosteroid * Improvements post-concussion in animal behavior that reduces inflammation, oxidative stress and including memory, anxiety and sensory-motor swelling in the brain. performance. Nasal administration with novel device allow
Slide 17: The Nose has a Direct Pathway to the Brain
The Nose has a Direct Pathway to the Brain Intranasal (IN) administration allows rapid and direct accessibility to the brain. Allows patients to blow into device which closes the soft palate eliminating the flow of drug to the lungs or esophagus. Minimizes systemic exposure and side effects. Enhance
Slide 18: Nasopharynx
Nasopharynx Soft palate Oropharynx Laryngopharynx
Slide 19: Double tube airflow
Double tube airflow Single tube airflow
Slide 20: ONP-002 Emergency Department Phase II Clinical Design
ONP-002 Emergency Department Phase II Clinical Design A Phase lla clinical trial feasibility study is currently being performed in AUS administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen days. Planned Phase Ila Feasibility study n (40) - 20 patients per arm * Two arm
Slide 21: Design Advantages that Increase Trial Success
Design Advantages that Increase Trial Success * For concussion the initial treatment must be acute to reduce compounding of the pathological cascade over time— delayed treatments beyond 24-hrs from injury will have an uphill battle + ONP-002 crosses the blood brain:barrier — most promising drugs for
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