Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (September 2019)
24 slides from Oragenics's investor presentation, Sep 6, 2019
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 NYSE American: OGEN 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 Ongoing clinical program in a ~$20MM market cap company with near-term catalysts and sufficient cash through 2020 AG013 for Oral Mucositis: Large unmet clinical need - no drug is approved to prevent OM in the broad cancer population; Addressable Population: >770,000 cancer pati
Slide 4: AG013: First-in-Class Therapy for Prevention of Oral Mucositis
AG013: First-in-Class Therapy for Prevention of Oral Mucositis
Slide 5: 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 6: 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 7: 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 8: 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 9: AG013 in Action
AG013 in Action AG013 delivers hTTF1 via genetically modified lactococcus The bacteria 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 lin
Slide 10: 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 topical delivery, outpatient Intravenous, inpatient $600MM palliative care products provide temporary symptomatic relief * All
Slide 11: Potential Addressable Patients
Potential Addressable Patients Global Market: 6.0 MILLION+ new patients ww/yr Estimated Cost: $90 per day 20- 25% Estimated Peak Share: AG013 Treats a Large Addressable Market With Potential W.W. Cumulative Sales >$2.0Bn for Oral Mucositis Global Potential Cumulative Sales: $2.3bn Treatment Days: ~7
Slide 12: AG013: Current Study Design Agreed with FDA
AG013: Current Study Design Agreed with FDA Double-blind, placebo – controlled evaluation of daily AG013 (2x10¹¹ CFU) TID oral suspension 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
Slide 13: 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 14: AG013: Near Term News Flow
AG013: Near Term News Flow 3Q19: Clinical Trial as of Sept. 1, 2019: 140 of 200 patients randomized 3Q19: Poster presentation of ongoing clinical trial at European Society of Medical Oncology (ESMO) meeting in Barcelona, Spain September 29 - Oct 2. 4Q19: Anticipated announcement indicating ongoing c
Slide 15: 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 16: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
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: 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: 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 20: 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 21: 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; Enough material generated for rat tox study, lots for monkey tox study ongoing
Slide 22: Corporate Status Update
Corporate Status Update
Slide 23: Capitalization
Capitalization Common Stock Equivalents* Common Stock Outstanding 46,124,803 Series A Convertible Preferred (As Converted) 941,701 Series B Convertible Preferred (As Converted) 1,320,002 Series C Non-Convertible Perpetual Preferred** (113.941 shares outstanding) - Warrants (WAEP $1.08) 26,538,593 Re
Slide 24: 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 Formerly sat on