Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (August 2018)
28 slides from Oragenics's investor presentation, Aug 15, 2018
Slide 1: Investor Presentation
Investor Presentation Alan F. Joslyn, PhD President & CEO 813 286 7900 ext 232 ajoslyn@oragenics.com Oragenics, Inc. 4902 Eisenhower Blvd., Suite 125 Tampa, FL 33634 www.oragenics.com 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: Investment Highlights
Investment Highlights Phase 2 ongoing clinical program in a ~$13MM market cap company with near-term catalysts; recent positive interim safety results AG013 for Oral Mucositis: Large unmet clinical need - no drug is approved to prevent OM in the broad cancer population; Affects >770,000 cancer patie
Slide 4: 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 5: AG013: First-in-Class Therapy for Oral Mucositis
AG013: First-in-Class Therapy for Oral Mucositis
Slide 6: Oral Mucositis
Oral Mucositis Most common and debilitating complication of cancer chemo and radiation therapy. Caused by breakdown of mucosal lining resulting in formation of oral ulcers. Inability to eat/drink (WHO grades 3 & 4) resulting in nutritional deficits and potential alterations of cancer treatment regim
Slide 7: Oral Mucositis: Large Addressable Market Opportunity
Oral Mucositis: Large Addressable Market Opportunity Cisplatin (inc. Carboplatin) 5-Fluorouracil Irinotecan Methotrexate Cytarabine Radiation therapy in head and neck cancer is synergistic Biologics: mTOR inhibitors, including sirolimus, temsirolimus and everolimus No drug is approved to prevent OM
Slide 8: Economic and Clinical Impact of Severe OM
Economic and Clinical Impact of Severe OM Clinical Impact: Economic Impact: 2x more likely to receive TPN 3-4x more likely to experience interruption in chemo regimen 2x more likely to have unplanned break in radiation 9 extra days in the hospital 2-8x higher direct hospital costs due to longer stay
Slide 9: AG013: Target Product Profile
AG013: Target Product Profile Convenient, 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) are a class of peptide
Slide 10: AG013 in Action
AG013 in Action AG013 is delivered via lactococcus The combination is freeze-dried into vials Patient mixes powder with a raspberry-flavored solution Patient swishes for 30 seconds after every meal This activity promotes a protein called trefoil factor, which regrows the oral lining 1 2 3 4 5
Slide 11: AG013 Superior to Available Treatments
AG013 Superior to Available Treatments AG013 Sales TBD $14,000,000 Patients >500,000 20,000 (indicated only for bone marrow transplant induction chemo patients) Method Oral rinse, outpatient Intravenous, inpatient $600MM palliative care products provide temporary symptomatic relief * All figures app
Slide 12: AG013 Has Potential for Global Peak Sales of $2.2B
Potential Global Market: 6.2 MILLION+ new patients ww/yr (1.2MM develop OM) Cost: $100 per day 20- 25% Peak Share: AG013 Has Potential for Global Peak Sales of $2.2B for Oral Mucositis Global Peak Sales: $635M $458M $229M U.S. E.U. Japan Gross Margin: 90% Intellectual property relating to AG013 exte
Slide 13: AG013: Established Regulatory Path
AG013: Established Regulatory Path Backdrop: No approved drug to prevent oral mucositis in broad cancer population and current therapies are primarily palliative creates favorable regulatory environment. Received FDA Fast Track designation in November 2016 Frequent program interactions Shorter NDA r
Slide 14: AG013 Phase 1B Results: Safe and Effective
AG013 Phase 1B Results: Safe and Effective Exploratory Efficacy 35% reduction in mean number of days of ulcerative OM vs. placebo over 14-day treatment, which is the primary endpoint for Phase 2 study 29% (4/14) of AG013 patients had 0 or 1 day of ulcerative OM vs. 0% (0/7) placebo Pharmacokinetics
Slide 15: AG013: Phase 2 Study Design Agreed with FDA
AG013: Phase 2 Study Design Agreed with FDA Double-blind, placebo – controlled evaluation of daily AG013 (2x10¹¹ CFU) TID oral rinse for duration of cancer treatment regimen 160-180 evaluable patients with head and neck cancer receiving chemoradiation therapy over 7-9 weeks and standard of care for
Slide 16: AG013 Clears FDA Safety Hurdle: Positive Interim Safety Results
AG013 Clears FDA Safety Hurdle: Positive Interim Safety Results 24 Patients randomized with 19 patients completing therapy. Adverse event profiles similar between AG013 and Placebo. Serious Adverse Events consistent with Head and Neck Cancer Patients: fever, neutropenia, infections, nausea & vomitin
Slide 17: AG013: Timeline of Key Events
AG013: Timeline of Key Events FDA Program Feedback API Manufacture & Packaging Completion Treat First Patient in U.S. Complete Enrollment of ~200 patients Interim Safety & Efficacy Review of First 20 Patients Update IND Filing ● ● ● ● ● ● Protocol design & manufacturing specifications agreement Acti
Slide 18: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
Slide 19: 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 20: 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 21: 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
Slide 22: Lantibiotics: Novel Platform of Antibiotics
Lantibiotics: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections Lantibiotics are novel class of peptide antibacterial compounds naturally produced by variety of Gram-positive bacterial strains to attack competing bacterial strains Platform: >700 lantibiotic structures create
Slide 23: Lantibiotic Profile
Lantibiotic Profile 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 OG716 selected as lead compou
Slide 24: 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 25: 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 26: Corporate Status Update
Corporate Status Update
Slide 27: Capitalization
Capitalization Common Stock Equivalents Common Stock Outstanding * 11,837,635 Series A Convertible Preferred* 941,701 Series B Convertible Preferred* 1,320,002 Series C Non-Convertible Perpetual Preferred*** (101.733 shares outstanding) - Series D Convertible Preferred* 8,065,000 Warrants (WAEP $1.3
Slide 28: 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 o