Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (September 2018)
19 slides from Oragenics's investor presentation, Sep 25, 2018
Slide 1: Lantibiotics for the Treatment of Clostridium difficile Associated Disease
Martin Handfield, MS, PhD SVP, Research 386 418 4018 ext 241 mhandfield@oragenics.com Oragenics, Inc. (NYSE: OGEN) 13700 Progress Blvd Alachua, FL 32615 www.oragenics.com Lantibiotics for the Treatment of Clostridium difficile Associated Disease 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: Development Program Overview
RESEARCH IND STUDIES PHASE 1 PHASE 2 PHASE 3 AG013 Oral Mucositis OG716 Clostridium Difficile Infections Lantibiotic Library Expand Indications Development Program Overview
Slide 4: Lantibiotics: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections
Lantibiotics: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections Lantibiotics (aka lanthipeptide antibiotics) are naturally produced by variety of Gram-positive bacteria Prior development limited by manufacturing hurdles Platform: >700 lantibiotic structures created, potentia
Slide 5: Naturally Produced Lantibiotics and Mutacin 1140
Naturally Produced Lantibiotics and Mutacin 1140 Tooth decay caused by Streptococcus mutans
Slide 6: Mutacin 1140 Binds to Lipid II
Mutacin 1140 Binds to Lipid II Molecular model credit: Rudramani Pokhrel and Prem Chapagain (Florida International University)
Slide 7: An Alternative Bactericidal Mechanism of Action for Lantibiotics That Target Lipid II
|. 2. Nisin segregates tid 1 into nonphysio- were incubated for 1( with labeled vanco- me (2 wor The ar- ‘Ons point at med divebn sites or ede r- rs. (OB. subtilis after incubation for 10 min with fluorescein-labeled nisin (0.5 g/ml). The arrow marks where the bacterium has already divided. (E) B. s
Slide 8: Challenges in Developing a "Druggable" Lantibiotic
Challenges in Developing a “Druggable” Lantibiotic Prior development limited by: 1-Manufacturability Low titers at fermentation Technical hurdles during solid-phase synthesis Ability to purify pharmaceutical grade compounds Process scalability 2- Physico-chemical and biological properties Sensitivit
Slide 9: How Oragenics Addressed the Manufacturability Challenges
How Oragenics Addressed the Manufacturability Challenges Combining: Genetic modifications of the natural host Fermentation optimization by DOE Out-of-the-box purification scheme Historical Fermentation Titer Timeline
Slide 10: How Oragenics Addressed the Physico-Chemical and Biological Challenges
How Oragenics Addressed the Physico-Chemical and Biological Challenges Platform: >700 lantibiotic structures created, generating a pipeline of new compounds: Gen-1: single AA substitution Gen-2: multiple AA substitution Gen-3: semi-synthetics
Slide 11: How Oragenics Addressed the Physico-Chemical and Biological Challenges
How Oragenics Addressed the Physico-Chemical and Biological Challenges
Slide 12: OG716 - Lantibiotic Lead against C. difficile
OG716 - Lantibiotic Lead against C. difficile Preliminary MU1140 (parent compound) preclinical data: Novel mechanism of action (unique binding to Lipid II) No cross-reactivity with existing classes of antibiotics Minimal in vitro cytotoxicity in mouse and human cell lines; minimal immunogenicity OG7
Slide 13: Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model
Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model OG716 Vanco Vehicle OG253 DAY 2 Clindamycin DAYS 3-7 DAYS 8-22 Recurrence Phase DAY 1 Infection Antibiotic Treatment Phase
Slide 14: Lantibiotics: OG716 C. difficile Program Milestones
Lantibiotics: OG716 C. difficile Program Milestones Tech Transfer of Manufacturing Process ● Fermentation complete; purification underway 4Q16 Manufacture of API ● Ongoing at 1400L scale: transitioning to GMP manufacture 1Q17 Toxicology and Microbiology Underway ● Single dose-escalating rat study co
Slide 15: Acknowledgements
Achnowledgements Christopher McGee, Ph.D. , DeAnna Long, Ph.D., Lara Hurant, MBA, Matteo Villain, Ph.D., Andrea Lee and the rest of the Team Dr. Jeffrey D. Hillman Founder and CSO 1996-2010
Slide 16: Appendix
APPENDIX
Slide 17: CDC Antibiotic-Resistant Threats, 2017
CDC Antibiotic-Resistant Threats, 2017 (cases/yr, US) Drug-resistant pathogen blue = gram (+) grey= gram (-) Infections/year Clostridium difficile 500,000 Carbapenem-Resistant Enterobacteriaceae (CRE) 9,000 Neisseria gonorrhoeae 246,000 MDR Acinetobacter 7,300 Drug-Resistant Campylobacter 310,000 Ex
Slide 18: C. difficile and C. difficile Infection (CDI): Epidemiology
C. difficile and C. difficile Infection (CDI): Epidemiology C. difficile is an infection of the colon causing colitis by producing toxins that damage lining of the colon 500,000 infections annually resulting in 29,000 deaths 83,000 will experience at least one recurrence Deaths have increased 400% s
Slide 19: Competitive Overview
Competitive Overview Currently Approved Therapies: Metronidazole Vancomycin Fidaxomicin Rifaximin Zinplava (monoclonal antibody) Therapies under development: Follow-on generations of existing antibiotics, enzymes and enzyme/protein synthesis inhibitors, vaccines, microbiome/fecal transplant therapie