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MBA from The Florida State University 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 19 NYSE MKT: OGEN Share price (as of 10/9/13) : $3.00 Market cap (as of 10/9/13) : $83M* Shares outstanding (as of 6/30/13) : 27.5M* Cash (as of 6/30/13) : $6.4M* Debt (as of 6/30/13) : $142,000* Warrants and Options (as of 6/30/13) : 2.7M warrants and 670,000 options outstanding Corporate Summary *exclusive of shares, cash and promissory note from the second Intrexon ECC announced October 1, 2013
Bonfiglio, Ph.D., President, CEO Director 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 Mike Sullivan, CFO Has held 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 15 Blend of 3 naturally occurring, non pathogenic bacteria S.oralis , S.uberis , and S.rattus is available without prescription and taken daily Good probiotic bacteria in ProBiora3 compete for binding sites and nutrients with harmful bacteria ProBiora3 bacteria also 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 16 Significant Accomplishments in Last Year Novel Antibiotics (Lantibiotics) Significantly increased yield of MU1140 making commercialization a realistic goal Identified two new potentially viable purification methods for commercially producing MU1140 Progress toward a genetically modified bacteria capable of higher yields of MU1140 and potentially analogs Next Generation Probiotics Completed ECC with Intrexon announced October 1, 2013 Intrexon purchased $3.9M of OGEN shares, with net proceeds to support initial efforts in this new area 17 Upcoming Milestones Novel Antibiotics (Lantibiotics) Production of new lantibiotic analogs using genetically modified bacteria 1H 14 Animal study results on MU1140/analog 2H 13 Announcement of results from pre IND meeting with FDA Mid 14 Next Generation Probiotics (Preliminary Timelines) Generation of next bacterial prototypes 2H 14 GM probiotics producing cytokine therapeutics Mid 15 Proof of concept of a GM probiotic to be used for therapeutic purposes in animals 2H 15 OTC Probiotics Results from Indiana University clinical trial announced 1H 14 Publication of clinical study in children 1H 14 18 Experienced Management Team John N.
Lantibiotics (50+ known) 11 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 Significant valuations for Single Antibiotic Product companies Oragenics has potential to generate a pipeline of lantibiotics Cubist/Trius/Optimer Acquisitions Deal size: approx. $818M Trius approx. $808M Optimer Cubist Acquisitions (7/31/13 ) Approved/Late Stage 12 Next Generation Probiotics Potential to Revolutionize Probiotics for Oral Diseases We are also developing, in collaboration with Intrexon, novel probiotics focusing on the treatment of patients with oral cavity, throat, sinus, and esophageal diseases Initial indications: Beh et s disease a chronic relapsing multi systemic inflammatory disorder Recurrent aphthous stomatitis (aka canker sores) painful ulcers; the most common oral mucosal disease known As with lantibiotics, we expect to genetically manipulate bacteria; in this case beneficial bacteria that are naturally part of the human oral cavity microbiome The collaboration will focus on genetically engineered bacterial strains designed to deliver and release therapeutics locally at the site of disease to target pain management, reduce inflammation, and improve patient outcomes 13 Lead Probiotic Programs Beh et s Disease and Aphthous Stomatitis Beh et s disease a chronic relapsing multi systemic inflammatory disorder characterized by four major symptoms (oral aphthous ulcers, genital ulcers, skin lesions, and ocular lesions) Patients suffering from Beh et s disease are often in constant pain and have difficulty eating ~20,000 patients in the U.S.; similar for Europe Recurrent aphthous stomatitis (aka canker sores) painful ulcers; the most common oral mucosal disease known There are currently no effective treatments for aphthous stomatitis ~200,000 patients in the U.S. 14 Oragenics/Intrexon Solution GM Probiotics For Oral Health Bacteria Cell insert genes responsible for production of therapeutics agent(s) and deliver new therapeutic bacteria into the oral cavity to produce therapeutic benefits and supplement the natural oral microbiome.
MICs, MTD, primary efficacy in animals, protein binding, etc.) Fermentation optimization/scale up purification in progress IND filing expected by mid 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 * Current estimate may change depending on FDA pre IND meeting results 9 Synthetic Biology Enables Lantibiotics Synthetic biology is the application of engineering principles to the design of living organisms and their constituent parts (DNA, proteins, and cells) We are collaborating with Intrexon, a leading synthetic biology company, for the development and commercialization of lantibiotics for the treatment of infectious diseases in humans and companion animals Intrexon s toolset of modular molecular and cellular parts is expected to enable the engineering of specific functionality into cells to allow industrial scale production of lantibiotics 10 With Intrexon Collaboration 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.
Department of Health and Human Services Centers for Disease Control and Prevention 5 Trends Support CDC Concerns Resistance Increases While Approvals Decrease Resistant Bacterial Strains Spread Rapidly Resistant Bacterial Strains Spread Rapidly Total Approved Bacterials US 6 Lantibiotics A Promising Solution to the Growing Health Crisis of Antibacterial Resistance Lantibiotics are a novel class of peptide antibacterial compounds: Naturally produced by a variety of Gram positive bacterial strains to attack competing bacterial strains There are more than 50 known lantibiotics, potentially creating a pipeline of new compounds to target resistant infections Historically, their development as commercially viable products has been limited by technological hurdles Oragenics is well positioned to bring lantibiotics to the market: Collaboration with Intrexon, a leader in synthetic biology, expected to enable the production of lantibiotics at commercial scale Collaboration has already: Produced a significant increase in production titer yield Enabled development of robust purification methods compared to traditional approaches 7 Lead Lantibiotic Compound MU1140 Initial focus is on MU1140, a lantibiotic shown to be effective against: Methicillin resistant Staphylococcus aureus (MRSA) Vancomycin resistant Enterococcus (VRE) Clostridium difficile ( C. diff ) Resistant Tuberculosis Other Gram positive bacteria Preliminary preclinical data suggests: 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 Plasma concentration time profile declined bi exponentially with a half life 1.7 hr In vivo efficacy observed in a pilot rat peritonitis model using S. aureus (60xLD50) Synergy with aminoglycosides 8 Intrexon collaboration has already produced a significant increase in fermentation titer and is developing a promising new purification process Matrix of early experiments planned to screen MU1140 (and several analogs/homologs) for determining primary efficacy (e.g.
Lantibiotic Production 2. Next Generation Probiotics 4 Serious Need for New Antibiotics We Will Soon Be in a Post Antibiotic Era The Sep. 2013 CDC report making headlines highlighted the serious threats of antibiotic resistant infections and the need for new antibiotics: Over 2 million infections and 23,000 deaths each year in the U.S. are caused by resistant microbes Over $20 billion in direct healthcare spending as a result of resistance infections Over $35 billion in additional costs due to lost productivity Antibiotic Resistance Threats in the United States, 2013 U.S.
Next Generation Probiotics: bacteria based biotherapeutics for oral cavity, throat, sinus, and esophagus diseases, beginning with Beh et s disease and aphthous stomatitis Oragenics also markets proprietary OTC oral care probiotics (ProBiora3 ) 1 exclusive of shares from the second Intrexon ECC announced October 1, 2013 3 A Platform for Rapidly Engineering Bacterial Systems Inventoried DNA Modules Genetically Modified Bacterial Cell 1.
Safe Harbor Statement 2 Introduction Oragenics Inc. (NYSE MKT: OGEN , market cap $83M 1 ) is focused on leveragin g its expertise in lantibiotics and probiotics with Intrexon s leading synthetic biology platform via two exclusive channel collaborations (ECCs) to develop novel biotherapeutics, including: 1. Lantibiotics : a novel class of peptide antibacterial compounds produced by certain bacteria that display broad spectrum activity against antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus (VRE), Clostridium difficile ( C. diff ), Resistant Tuberculosis and other Gram positive bacteria 2.
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 October 2013 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.