Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (March 2020)
24 slides from Oragenics's investor presentation, Mar 13, 2020
Slide 1: Developing Novel Antibiotics and Biotherapeutics Through Synthetic Biology
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
Slide 4: AG013: First-in-Class Therapy for Prevention of Oral Mucositis
oRAGEN)ICs AG013: First-in-Class Therapy-for Prevention of Oral Mucositis
Slide 5: Oral Mucositis
Oral.Mucositis Caused by | formatio Control
Slide 6: Economic and Clinical Impact of Severe OM
Economic.and Clinical Impact of Severe OM 3-4x more likely to Clinical experience interruption in Impact: 2x chemo regimen 2x ; 4 more likely to more likely N have unplanned to receive d break in TPN diati 2-8x Economic higher direct 2 hospital costs Impact: due to longer stay/delivery of alimentati
Slide 7: Economic Impact of Severe OM
Economic,|mpact of Severe OM TABLE 3 Estimated Costs of Cancer Treatment-related Toxicites Reported by the Northwestern University Costs of Cancer Program’ ‘Treatment-related Toxicity (Reference) Cancer Diagnosis No of Patients ‘Mucositis/ pharyngitis (current study) Nonsmall cell lung cancer Neutro
Slide 8: AG013: Target Product Profile
AG013:Jarget 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 peptides
Slide 9: AG013 in Action
AG013.in-Action AGO13 delivers hTTF1 The bacteria is freeze- Patient mixes powder Patient swishes for 30 This activity promotes a via genetically modified dried into vials with a raspberry- seconds after every meal protein called trefoil lactococcus flavored solution factor, which regrows the oral l
Slide 10: AG013 Superior to Available Treatments
AG013,Superior to Available Treatments AG013 #8 Kepivance Sales TBD $14,000,000 Patients 20,000 (indicated only for bone marrow transplant induction ‘chemo patients) 5 Oral topical delivery, a Intravenous, Bacto iwi] outpatient inpatient $600MM palliative care products provide temporary symptomatic
Slide 11: OM Products Under Development
OM.Products Under Development [canon [oregenis[eaiva[Soigenx[Ionovoton[Wononar | Product Name — AG013: GC 4419: SGX942: dusquetide _Briliciden Clonidine dapatifagene _ avasopasem navolactibac manganese Mechanism Trefoil Factor1 Superoxide Innate Defense Defensin mimetic 2 receptor dismutase mimetic
Slide 12: AG013 Treats a Large Addressable Market With Potential
AG013 Treats a Large Addressable Market With Potential W.W: Cumulative Sales >$2.0Bn for Oral Mucositis REVENUE-BASED FORECAST ASSUMPTIONS Potential Addressable Estimated Peak Share: Estimated Cost: Patients Global Market: 20- $ 9 0 6.0 MILLION+ 25% new patients ww/yr FY : —, Days: Gross Margin: 90%
Slide 13: AG013: Current Study Design Agreed with FDA
AG013:,Current Study Design Agreed with FDA Double-blind, placebo — controlled evaluation of daily AGO13 (2x10" 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 14: AG013: Near Term News Flow
AG013:,Near Term News Flow 4Q19: Anticipated announcement indicating ongoing clinical study in Head & Neck cancer patients has completed enrollment. DECEMBER 2, 2019 PRESS RELEASE ANNOUNCING COMPLETION 2.27.20: Last patient completed clinical phase of the study. Release of topline data: early 2Q20 2
Slide 15: AG013: Timeline of Key Events
AG013:Timeline of Key Events Sr a Aa ae, ae, 3Q16 2Q17 3Q17 3Q17 2Q18 4Q19 Update IND Treat First Interim Safety Complete eg neaeteiee Filing Patient in U.S. & Efficacy Enrollment Feedback & Packaging Activated 11 US. Review of of ~200 otooo Ges & Completion clinical sites First 20 patients pean Pat
Slide 16: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
oRAGEN)ICs 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 ahead eae 9,000 ‘Neisseria gonorrhoeae 246000 MOR Acinetobacter 7,300 ‘Drug-Resistant Campylobacter 310,000 Vancomycin-Resistant Enterococcus (V
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: Lantibiotics: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections
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 DAY1 Infection DAY2 Clindar i DAYS 3-7 re Antibiotic Treatment Phase fecurrence Phase ana 0G716_ = #0 <_Vanco__ x 3 06716 > —m-06253 dv —Vaneo —Vehicle 20 —— 0G253 Vehicle ° oO 5 10 15 20 25 Days 5 oRAGEN)ICS
Slide 21: Lantibiotics: OG716 C. difficile Program Milestones
Lantibiotics: OG716 C. difficile Program Milestones w wv wv 4Q16 1Q17 3Q19 2Q20 (estimate) Tech Transfer of Manufacture Toxicology and File IND Manufacturing of API Microbiology - ‘in te i Process ongoing at 14001 scale: Underway subject to having adequate Fermentation complete; transitioning to GMP
Slide 22: Corporate Status Update
oRAGEN)ICs Corporate Status Update
Slide 23: Capitalization
Capitalization Equivalents* ‘Common Stock Outstanding 46,124,803 Series A Convertible Preferred (As eanzer Cash* $18.3M Converted) " Series B Convertible Preferred (As 41,320,002 Converted) Series C Non-Convertible Perpetual Preferred** - (113.941 shares outstanding) Warrants (WAEP $1.08) 26,538,593
Slide 24: Experienced Management Team
Experienced Management Team Dr. Alan F. Josiyn 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 s