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MBA from The Florida State University 30 years of management and pharmaceutical experience Prior CEO Argos Therapeutics, CEO Immune Response, CEO Peregrine Pharmaceuticals, COO Cypress Bio Senior Management positions at Allergan Pharmaceuticals and Baxter Healthcare MS and PhD in Chemistry, University of California, MBA Pepperdine University 24 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 potentially analogs Next Generation Probiotics Established ECC with Intrexon announced October 1, 2013 Completed initial research program; commenced activity in 2014 Finance Raised $3.9M in PIPE with Intrexon to support new ECC Raised $11M in shelf takedown Relisted on NYSE:MKT 25 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 bacterial prototypes 2H 2014 GM probiotics producing cytokine therapeutics Mid 2015 Proof of concept of GM probiotic for therapeutic purposes in animals 2H 2015
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 research surrounding antimicrobials Over 40 publications and 6 patents Prior Senior level financial positions for both publicly and privately held businesses Significant experience in product licensing and IP issues Strong background in both domestic and international retail operations Florida Certified Public Accountant, ex Big 4.
Choose the appropriate bacterial strain to engineer Bacteria Cell Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology ProBiora3 Only OTC Probiotic Product Specifically Designed for Oral Health 22 Blend of 3 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 harmful bacteria Release hydrogen peroxide to reduce population of pathogens in mouth Poor oral health linked to serious health problems, including heart disease and diabetes Total consumer oral care market expected to reach $10.9 billion by 2014 1 Also marketed for companion animals ProBiora3 OTC Product First and Only Patented Probiotic Technology for Oral Care 1 The US Market for Oral Care Products (2009) , published by Packaged Facts 23 Experienced Management Team John N.
Characterized by multiple, recurrent, small, round, or ovoid ulcers Usually presents first in childhood or adolescence 20 Oragenics/Intrexon Solution GM Probiotics For Oral Health 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.
Lantibiotics (50+ known) 14 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.) Fermentation optimization/scale up purification in progress IND filing expected by 2H 2015* 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 Animal studies Animal studies Pre IND FDA meeting IND* Plan for MU1140 First of 50+ Known Lantibiotics and Analogs * Current estimate may change depending on FDA pre IND meeting results 15 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: approx. $818M Trius approx. $808M Optimer Cubist Acquisitions (7/31/13 ) Approved/Late Stage Significant valuations for Single Antibiotic Product companies Oragenics has potential to generate a pipeline of lantibiotics Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Next Generation Probiotics For Therapeutic Use 17 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 program Beneficial bacteria naturally part of the human oral cavity microbiome Genetically engineered bacterial strains designed to deliver and release therapeutics locally at disease site to target pain management, reduce inflammation, and improve patient outcomes Initial indications: Beh et s disease Recurrent aphthous stomatitis (aka canker sores) 18 Beh et 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 19 Recurrent Apthous Stomatitis (aka canker sores) Painful ulcers; most common oral mucosal disease known No effective treatments ~200,000 patients in the U.S.
Department of Health and Human Services Centers for Disease Control and Prevention 2 million infections and ~23,000 deaths each year in U.S. caused by resistant microbes $20 billion in direct healthcare spending from resistance infections $35 billion in additional costs due to lost productivity 7 Trends Support CDC Concerns Resistance Increases While Approvals Decrease Total Approved Bacterials US Resistant Bacterial Strains Spread Rapidly 8 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 potential analogs Pipeline of new compounds to target resistant infections Development as commercially viable products previously limited by technological hurdles 9 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 analogs Well positioned to bring lantibiotics to market: Intrexon collaboration expected to enable production of lantibiotics at commercial scale Progress to date through Intrexon/Oragenics ECC 10 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 observed in a pilot rat peritonitis model using S. aureus (60xLD50) Apparent synergy with aminoglycosides Preliminary preclinical data suggests: Methicillin resistant Staphylococcus aureus (MRSA) Vancomycin resistant Enterococcus (VRE) Clostridium difficile ( C. diff ) Resistant Tuberculosis and others 11 ECC with Intrexon Platform for Engineering Bacterial Systems Through Synthetic Biology Inventoried DNA Modules Genetically Modified Bacterial Cell 12 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 expected to enable the engineering of specific functionality into cells to allow industrial scale production of lantibiotics 13 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 commercial scale.
Lantibiotics : 1. Next Generation Probiotics: bacteria based biotherapeutics for oral cavity, throat, sinus, and esophagus diseases Market proprietary OTC oral care probiotics (ProBiora3 ) novel class of peptide antibacterial compounds produced by specific strains of bacteria Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Lantibiotics and the Need for New Antibiotics 6 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.
Safe Harbor Statement 1 2 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 health 3 At A Glance Oragenics NYSE MKT: OGEN (market cap ~$83M) Founded in 1999 Based in Tampa, FL Experienced management team 4 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.
Such statements are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. While Oragenics believes that the expectations reflected in such forward looking statements are reasonable, it can give no assurance that such statements will prove to be correct. The risks associated with the Company are detailed in the Company s various reports filed by the Company with the Securities and Exchange Commission.
Investor Presentation January 2014 Engineering New Antibiotics and Probiotics Through Synthetic Biology Exhibit 99.1 1 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 indicating uncertainty in facts, figures and outcomes.