Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (January 2014)
26 slides from Oragenics's investor presentation, Jan 16, 2014
Slide 1: Engineering New Antibiotics and Probiotics Through Synthetic Biology
Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements made in this presentation include forward-looking actions that Oragenics, Inc. (“Oragenics,” or the “Company”) anticipates based on certain assumptions. These statements are indicated by words such as “expect,” “anticipate,” “should” and similar words indicat
Slide 3: At A Glance - Oragenics
At A Glance - Oragenics • Expertise in bacteria – especially related to the oral cavity • Lantibiotics – Capable of killing bacteria, including antibiotic-resistant strains • Next Generation Probiotics – Designed to be therapeutically useful • ProBiora3 ® - OTC probiotic used to improve overall oral
Slide 4: At A Glance - Oragenics
At A Glance - Oragenics NYSE MKT: OGEN (market cap ~$83M) Founded in 1999 Based in Tampa, FL Experienced management team
Slide 5: Overview
Overview Leverage expertise in lantibiotics and probiotics with Intrexon’s leading synthetic biology platform via two exclusive channel collaborations (ECCs) to develop novel biotherapeutics: 1. Lantibiotics : 1. Next Generation Probiotics: bacteria-based biotherapeutics for oral cavity, throat, sin
Slide 6: Lantibiotics and the Need for New Antibiotics
Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Lantibiotics and the Need for New Antibiotics
Slide 7: Serious Need for New Antibiotics
Serious Need for New Antibiotics Sept. 2013 CDC report highlighted serious threats of antibiotic-resistant infections and need for new antibiotics: “Antibiotic Resistance Threats in the United States, 2013” U.S. Department of Health and Human Services Centers for Disease Control and Prevention >2 mi
Slide 8: Trends Support CDC Concerns: Resistance Increases While Approvals Decrease
Trends Support CDC Concerns Resistance Increases While Approvals Decrease Total Approved Bacterials - US Resistant Bacterial Strains Spread Rapidly
Slide 9: Lantibiotics: A Promising Solution to Antibacterial Resistance
Lantibiotics A Promising Solution to the Growing Health Crisis of Antibacterial Resistance Novel class of peptide antibacterial compounds: • Naturally-produced by variety of bacterial strains to attack competing gram-positive bacterial strains • >50 known lantibiotics and a very large number of pote
Slide 10: Lantibiotics: Progress to Date
Lantibiotics A Promising Solution to the Growing Health Crisis of Antibacterial Resistance • • Achieved significant increase in production titer yield Developing robust purification methods compared to traditional approaches Completed POC that genetically modified bacteria can produce MU1140 and ana
Slide 11: Lead Lantibiotic Compound MU1140
Lead Lantibiotic Compound MU1140 Initial focus on MU1140, a lantibiotic shown to be effective against: • Excellent therapeutic index • Minimal cytotoxicity in vitro using mouse and human cell lines; minimal immunogenicity • Maximum tolerated dose in mice and rats >50 mg/Kg • In vivo efficacy observe
Slide 12: ECC with Intrexon Platform for Engineering Bacterial Systems
ECC with Intrexon Platform for Engineering Bacterial Systems Through Synthetic Biology Inventoried DNA Modules Genetically Modified Bacterial Cell
Slide 13: ECC with Intrexon: Development of Lantibiotics
ECC with Intrexon Development of lantibiotics for treatment of infectious diseases in humans and animals Application of engineering principles to the design of living organisms and their constituent parts (DNA, proteins, and cells) Intrexon’s toolset of modular molecular and cellular systems expecte
Slide 14: ECC with Intrexon: Lantibiotics for Resistant Bacterial Infections
ECC with Intrexon Lantibiotics – For Resistant Bacterial Infections Bacteria Cell Extract genes responsible for lantibiotic production from native bacteria… …insert genes into modified bacteria to maximize lantibiotic production… …and produce MU1140 and pipeline lantibiotics via fermentation at comm
Slide 15: Plan for MU1140, First of 50+ Known Lantibiotics and Analogs
Animal studies Animal studies Pre-IND FDA meeting Plan for MU1140 First of 50+ Known Lantibiotics and Analogs Matrix of early experiments initiated to screen MU1140 (and several analogs/homologs) for determining primary efficacy (e.g. MICs, MTD, primary efficacy in animals, protein binding, etc.) Fe
Slide 16: Rising Market Demand for Novel Antibiotic Platforms
Rising Market Demand for Novel Antibiotic Platforms $ Market cap: approx. $83M Deal size: approx. $775M total approx. $10M upfront Cubist Market cap: approx. $4.2B Validated Technology Leads to Deals Commercial Oragenics Cubist Preclinical Rib-X and Sanofi Cubist/Trius/Optimer Acquisitions Deal size
Slide 17: Next Generation Probiotics For Therapeutic Use
Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Next Generation Probiotics For Therapeutic Use
Slide 18: Next Generation Probiotics for Oral Diseases
Next Generation Probiotics Potential to Revolutionize Probiotics for Oral Diseases Developing novel probiotics focusing on treatment of patients with oral cavity, throat, sinus, and esophageal diseases through ECC with Intrexon Expect to genetically manipulate bacteria similar to lantibiotics progra
Slide 19: Behçet's disease
Behçet’s disease Chronic relapsing multi-systemic inflammatory disorder Characterized by four major symptoms (oral aphthous ulcers, genital ulcers, skin lesions, and ocular lesions) Patients often in constant pain and have difficulty eating ~20,000 patients in the U.S.; similar for Europe
Slide 20: Recurrent Aphthous Stomatitis (canker sores)
Recurrent Apthous Stomatitis (aka canker sores) Painful ulcers; most common oral mucosal disease known No effective treatments ~200,000 patients in the U.S. Characterized by multiple, recurrent, small, round, or ovoid ulcers Usually presents first in childhood or adolescence
Slide 21: Oragenics/Intrexon Solution: GM Probiotics For Oral Health
Oragenics/Intrexon Solution GM Probiotics For Oral Health Bacteria Cell …insert genes responsible for production of therapeutics agent(s)… …deliver new therapeutic bacteria into oral cavity to produce therapeutic benefits and supplement natural oral microbiome. Choose the appropriate bacterial strai
Slide 22: ProBiora3 - Only OTC Probiotic Specifically Designed for Oral Health
Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology ProBiora3 ® - Only OTC Probiotic Product Specifically Designed for Oral Health
Slide 23: ProBiora3 - OTC Product, Patented Probiotic Technology for Oral Care
ProBiora3 ® - OTC Product First and Only Patented Probiotic Technology for Oral Care Blend of naturally occurring, non-pathogenic bacteria – S.oralis , S.uberis , and S.rattus – available without prescription and taken daily “Good” probiotic bacteria compete for binding sites and nutrients with “har
Slide 24: Experienced Management Team
Experienced Management Team John N. Bonfiglio, Ph.D., President, CEO & Director Mike Sullivan, CFO Dr. Martin Handfield, VP of Research & Development Former Tenured Associate Professor, College of Dentistry at The University of Florida Over 14 years experience with Oragenics Expert in biomarkers and
Slide 25: Significant Accomplishments in 2013
Significant Accomplishments in 2013 Novel Antibiotics (Lantibiotics) Significantly increased yield of MU1140 Identified two new potentially viable purification methods for commercially producing MU1140 Obtained proof of concept for genetically modified bacteria capable of higher yields of MU1140 and
Slide 26: Upcoming Potential Milestones
Upcoming Potential Milestones Novel Antibiotics (Lantibiotics) Production of new lantibiotic analogs using genetically modified bacteria – 1H 2014 Animal study results for MU1140/analog – 1H 2014 Pre-IND meeting with FDA - 2H 2014 Next Generation Probiotics (Preliminary Timelines) Generation of next