Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (October 2024)
16 slides from Oragenics's investor presentation, Oct 16, 2024
Slide 1: Corporate Presentation 2024
Corporate Presentation 2024 NYSE American: OGEN
Slide 2: 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, including without limitation statements regarding the ability of the Company to timely and successfully undertake clinical trials re
Slide 3: Expanding pipeline into nasal drug delivery
We are investing in the future and have expanded our pipeline further into nasal drug delivery. ONP-002 is a first-in-class neurosteroid being developed for the treatment of moderate to severe concussion. Concussion is a significant unmet need — No therapeutic is currently available for the treatmen
Slide 4: Concussion Landscape
Concussion Landscape * Concussion is a type of traumatic brain injury caused by a blow or bump to the head or violent Leading Causes of Traumatic Brain Injury shaking of the body and head. Sie mi See 1 % struck by» ‘or Against * Common symptoms include nausea, headache, 0, dizziness, fatigue, drowsi
Slide 5: New chemical entity: Proprietary neurosteroid
New chemical entity: Proprietary neurosteroid that reduces inflammation, oxidative stress and swelling in the brain. Nasal administration with novel device allows for fast and efficient delivery to the brain with less systemic exposure. ONP-002 is spray-dry manufactured into a powder and filled into
Slide 6: Intranasal administration allows rapid and direct accessibility 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. Enhances dispersion to the superior nasal roof for
Slide 7: Pre-Clinical Summary
Pre-Clinical Summary: In cell culture, ONP-002 has a positive effect on neuronal survival and reconnectivity In animal models, ONP-002 has positive effects on oxidative stress, swelling, cell clean-up, blood brain-barrier integrity and inflammation following brain-injury. n=6/group, p<0.05 In animal
Slide 8: Phase I Summary
tf 5Phase | Summary ace * Phase | was designed to determine the * The SAD component was a 1X treatment (low, safety profile of the drug in healthy human medium, or high dose) and the MAD component subjects. was a 1X/day treatment for five consecutive days (low and medium dose). It was double-blinded
Slide 9: Planned Phase II clinical trials
A Phase II clinical trial is anticipated to be performed administering ONP-002 intranasally to concussed patients 2x a day for 10 days. The Phase Ila feasibility study is anticipated to be performed in AUS with a target initiation date in the 4th quarter of 2024 to be followed closely by a Phase IIb
Slide 10: ONP-002 Regulatory Opportunities as an Unmet Medical Need
ONP-002 Regulatory Opportunities as an Unmet Medical Need 1. Fast-Track - Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (concussion). The purpose is to get important new drugs to the patient
Slide 11: Intellectual property filings
1. New chemical entity IP filing—- USPTO pending, approved Europe and Canada * C-20 steroid compounds, composition and uses thereof to treat traumatic brain injury (TBI), including concussion. * The invention relates to ONP-002 composition and methods of use thereof to treat, minimize and/or prevent
Slide 12: Development milestones timeline 4Q24-4Q26
* Submit and open IND package to FDA + Launch formulation bridge study Complete Phase Ila trial enrolment in AUS submit to FDA Initiate Phase IIb trial In Complete Phase IIb trial enrolment in US Submit US Ib trial findings to FDA US * Activate Phase IIb trial Close Phase Submit Investigators sites
Slide 13: J. Michael Redmond (President)
J. Michael Redmond (President) Mr. Redmond has over 35 years experience in various commercial leadership positions with likes of, Abbott Laboratories KMC Medical Systems and Bioject Medical Technologies Inc. Mr. Redmond is currently the CEO of Odyssey Health, Inc. Mr. Redmond has joined the executiv
Slide 14: James P. Kelly, Chief Medical Officer
James P. Kelly, MA, MD, FAAN, (Chief Medical Officer) Dr. Kelly is the Executive Director of the Marcus Institute for Brain Health (MIBH) and Professor of Neurology at the University of Colorado Anschutz Medical Campus in Aurora, CO. He is National Director of the Gary Sinise Foundation Avalon Netwo
Slide 15: Pre-Offering Cap Table
Pre-Offering Cap Table As of October 9, 2024 Balance Sheet Data As of June 30, 2024 Common Shares 10,535,873 Preferred Shares ' 7,511,220 Options (WAEP: $4.67) 1,022,053 Warrants (WAEP: $61.52) 293,827 Pre-funded warrants 2 2,901,404 Pre-Offering Cap Table 1. 2. Total assets $2,709,705 Total liabili
Slide 16: Over 5mm annual concussion occurrences in the US
Over 5mm annual concussion occurrences in the US territory alone, 69M worldwide. ' Positive animal and cell culture model efficacy results. Sound safety data in animal and Phase 1 human studies. Phase lla clinical studies are expected to start in 4Q-24. Phase IIb IND expected to open first clinical