Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (April 2017)
31 slides from Oragenics's investor presentation, Apr 18, 2017
Slide 1: Investor Presentation April 2017
Investor Presentation April 2017 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: Oragenics Value Proposition
Oragenics Value Proposition First-In-Class Therapy for Prevention of Oral Mucositis in Cancer Patients moving to registration-level trial in 1H 2017 Novel Antibiotic Platform Capable of Treating Multi-Drug Resistant Gram (+) Infections – MRSA, Streptococcus, C. difficile, VRE Clinical trial initiati
Slide 4: Executive Summary
Executive Summary Oragenics Inc: Develops novel biotherapeutics leveraging its R&D expertise with Intrexon’s leading synthetic biology platform via two exclusive channel collaborations. Phase 2 First-In-Class Oral Mucositis (OM) Program: No drug is approved to prevent OM in out-patient setting AG013
Slide 5: Development Program Overview
PROGRAM AREA RESEARCH IND STUDIES PHASE 1 PHASE 2 PHASE 3 AG013 Oral Mucositis OG716 Clostridium Difficile Infections Lantibiotic Library Expand Indications Development Program Overview
Slide 6: Intrexon / Oragenics Relationship
Intrexon / Oragenics Relationship Relationship initiated in 2012 Significant Shareholder: Owns 30% of outstanding shares in Oragenics Funding Support: Provided funding for Research and Development of Product Candidates Synthetic Biology & gene manipulation capability for advancement of lantibiotic p
Slide 7: Engineering Solutions In Conjunction With Intrexon
Engineering Solutions In Conjunction With Intrexon (NYSE:XON) Extract genes responsible for protein production from native bacteria… …insert genes into modified bacteria to maximize protein production… …and produce Biotherapeutics via fermentation at commercial scale, while also conducting clinical
Slide 8: AG013: Phase Ready First-In-Class Therapy for Oral Mucositis
AG013:Phase 2 Ready First-In-Class Therapy for Oral Mucositis
Slide 9: Oral Mucositis
Oral Mucositis Epidemiology for Oral Mucositis Most common and debilitating complication of cancer chemo and radiation therapy. Caused by the breakdown of mucosal lining resulting in formation of oral ulcer. Causes nutritional deficits due to inability to eat and drink resulting in potential alterat
Slide 10: AG013 for Oral Mucositis
AG013 for Oral Mucositis No drug is approved to prevent OM in broad cancer population and therapies are primarily palliative. AG013 received FDA Fast Track designation in November 2016. AG013 granted Orphan Drug status in European Union. Oragenics has exclusive worldwide license of AG013 from Intrex
Slide 11: AG013 Target Product Profile
AG013 Target Product Profile AG013 is a convenient raspberry flavored oral rinsing solution composed of genetically modified Lactococcus lactis (non-pathologic food grade bacterium) engineered to deliver mucosal protectant human Trefoil Factor 1 (hTFF1) to mucosal tissues. Trefoil Factors (TFF’s) ar
Slide 12: AG013 Treats the Underlying Cause of OM With a Convenient Delivery System
AG013 Treats the Underlying Cause of OM With a Convenient to Use Delivery System 2017 Projected Worldwide Competitor Sales: $974MM* Therapeutic Options Kepivance (IV) Ethyol Marketed Palliative Products (Oral Bleeding, Dry Mouth, Pain, Oral Decontamination) Gelclair Mugard NeutraSal Episil Caphosol
Slide 13: AG013: Phase 1B Results
AG013: Phase 1B Results Safety: Most Common Drug Related Adverse Event (AE): Nausea No drug related discontinuations due to AEs and no drug related SAEs 100% compliance for QD and TID dosing Pharmacokinetics: Live AG013 levels exist for 90 minutes post rinse hTFF levels similar across all doses (CFU
Slide 14: AG013: Phase 2 Study Design
AG013: Phase 2 Study Design Double-Blind, Placebo – Controlled Evaluation of daily AG013 (2x10¹¹CFU) TID oral rinse for the duration of the cancer treatment regimen 160-180 patients with Head and Neck cancer receiving chemoradiation therapy over 7-9 weeks and standard of care for prevention of oral
Slide 15: AG013: Timeline of Key Events
AG013: Timeline of Key Events FDA Feedback API Manufacture Treat First Patient Announce Study Results 3Q16 4Q16 1H17 4Q18 Received: August 12, 2016 Initiated: August 26, 2016 Interim Safety Review of First 20 Patients 4Q17 Update IND Filing 1Q17
Slide 16: Novel Lantibiotic Platform for Serious Life-Threatening Gram(+) Bacterial Infections
Novel Lantibiotic Platform for Serious Life-Threatening Gram(+) Bacterial Infections
Slide 17: Lantibiotics are a novel class of peptide antibacterial compounds
Lantibiotics are novel class of peptide antibacterial compounds naturally produced by variety of Gram-positive bacterial strains to attack competing bacterial strains. Platform: More than >50 lantibiotics identified, potentially creating a pipeline of new compounds to target resistant infections. Pr
Slide 18: Lantibiotics: A Potent Novel Class of Bioengineered Antibiotics
Lantibiotics: A Potent Novel Class of Bioengineered Antibiotics Oragenics is developing a pipeline of lantibiotics through a collaboration with Intrexon that allows for production at commercial scale. The collaboration has already: Produced a significant increase in production titer yield. Enabled d
Slide 19: Clostridium difficile Infection (CDI): Epidemiology
Clostridium difficile and Clostridium difficile Infection (CDI): Epidemiology C. difficile is an infection of the colon causing colitis by producing toxins that damage the lining of the colon. 500,000 infections annually resulting in 29,000 deaths. 83,000 will experience at least one recurrence. Dea
Slide 20: Clostridium difficile Infections
Clostridium difficile Infections Primary bacterial infection treated with Cephalosporin, Ampicillin/Amoxicillin Clindamycin, Fluroquinolones, Aminoglycosides Disrupt Gastrointestinal Microbiome Develop Clostridium difficile Infection Relapse Infect New Patient Inflammation & Diarrhea Spores Produces
Slide 21: Competitive Overview
Competitive Overview Currently Approved Therapies: Metronidazole Vancomycin Fidaxomicin Rifaximin Therapies under development: Follow-on generations of existing antibiotics, enzymes and enzyme/protein synthesis inhibitors, vaccines, microbiome/fecal transplant therapies, and toxin binding polyclonal
Slide 22: Discovery and Initial Characterization of Mutacin-1140 (MU1140)
OGEN’s Discovery and Initial Characterization of Mutacin-1140 (MU1140) Seminal work on MU1140 (native molecule) suggested lantibiotic activity against essentially all clinically-relevant Gram (+) bacteria, including: Methicillin-resistant Staphylococcus aureus (MRSA) Vancomycin-resistant Enterococcu
Slide 23: Transition to OG716 for Clostridium Difficile
Transition to OG716 for Clostridium Difficile MU1140 Difficulty with expansion of fermentation/purification process Unable to manufacture sufficient quantities to test therapeutically OG253 Unstable in gastric and small intestinal fluid Requires specific colonic delivery OG716 Orally active without
Slide 24: Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model
Oral OG716 Superior at Preventing Clostridium difficile Deaths in Hamster Model OG716 Vanco Vehicle OG253 DAY 2 Clindamycin DAYS 3-7 Antibiotic Treatment Phase DAYS 8-22 Recurrence Phase DAY 1 Infection
Slide 25: Lantibiotics: Second Generation Program Milestones
Lantibiotics: Second Generation Program Milestones Tech Transfer of Manufacturing Process Manufacture of API Toxicology and Microbiology File IND 4Q16 1Q17 3 Q17 4Q17 Underway at 1400L scale: Began August 2016 Underway: January 2017
Slide 26: Upcoming Milestones
Upcoming Milestones 2017 Milestones: 1Q: Successful FDA pre-IND meeting for OG716 lantibiotic (Complete April 2017) 1H: Anticipate treatment of first patient in AG013 Phase 2 study 4Q: Complete Interim Safety Review of first 20 patients enrolled at 5 clinical sites in AG013 Phase 2 study 4Q: Initiat
Slide 27: Experienced Management Team
Experienced Management Team DR. ALAN F. JOSLYN, Director, President and Chief Executive Officer Assumed CEO position at Oragenics in June 2016 Held CEO positions at several private biotechnology companies including Sentinella Pharmaceuticals, Edusa Pharmaceuticals and Mt. Cook Pharma Presently sits
Slide 28: Experienced Board Leadership
Experienced Board Leadership DR. FREDERICK W. TELLING, Chairman of the Board of Directors Retired from Pfizer Inc. in June 2007 after 30 years of service, where he served as Corporate Vice President and Vice President of Corporate Strategic Planning and Policy. Holds a B.A. in History and Economics
Slide 29: Experienced Board Leadership
Experienced Board Leadership DR. ALAN W. DUNTON, Director Currently the Senior Vice President of Research and Development at Purdue Pharma and the principal owner of Danerius, LLC, a biotechnology consulting company which he founded in 2006. Also a Director at Palatin (AMEX: PTN) and Targacept (NASD
Slide 30: Corporate Summary
Corporate Summary NYSE MKT OGEN.BC Share Price* $0.44 Market Cap $21.65M Shares Outstanding* 49,274,219 Cash** $4.1M Debt** $66,400 Warrants & Options** 175,584 | 1,621,523 * As of March 31, 2017 ** As of December 31, 2016
Slide 31: Thank You
Thank You Alan Joslyn, CEO [email protected] (813) 286-7900 X232 4902 Eisenhower Blvd; Suite 125 Tampa, FL 33634