Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (October 2019)
22 slides from Oragenics's investor presentation, Oct 22, 2019
Slide 1: Developing Novel Antibiotics and Biotherapeutics Through Synthetic Biology
Al ORA\GEN)ICS DEVELOPING NOVEL ANTIBIOTICS AND BIOTHERAPEUTICS THROUGH SYNTHETIC BIOLOGY Investor Presentation NYSE American: OGEN
Slide 2: Forward-Looking Statement
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 indicating uncertai
Slide 3: Investment Highlights
Slide 4: AG013: First-in-Class Therapy for Prevention of Oral Mucositis
~AGO13: First-in-Class Therapy,fo 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
Slide 6: Severe Oral Mucositis Economic Impact
6 Severe ani) m—_———"e Oral P Mucositis Economic Impact:
Slide 7: Economic and Clinical Impact of Severe OM
Economicand Clinical Impact of Severe OM = Ew ‘TABLE 3 Estimated Costs of Cancer Treatment-related Toxicties Reported by the Northwestern University Costs of Cancer Program* ‘Treatment related Toll (Reference) Oncology Treatment Cancer Diagnosis Novof Patients Medical Costs $ Mucosti/pharyngs (curre
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: How AG013 delivers hTFF1
AGO13 delivers hTTF1 The bacteria is freeze- Patient mixes powder Patient swishes for 30 via genetically modified dried into vials with a raspberry- seconds after every meal protein called trefoil lactococcus flavored solution factor, which regrows the oral lining = wile,
Slide 10: Kepivance comparison
=! Kepivance Sales TBD $14,000,000 Patients 20,000 (indicated only for bone mamow transplant induction >500,000 chemo patients) Oral topical delivery, m% Intravenous, Metiod 7 outpatient inpatient $600MM palliative care products provide temporary symptomatic relief Een)
Slide 11: AG013 Treats a Large Addressable Market
AGO13 Treats a Large Addressable With Potential lative Sales >$2.0Bn for _ REVENUE-BASED FORECAST ASSUMPTIONS Patients Global Mark 20- 6.0 MILLION+ 25% $90 new patients ww/yr ot Global Potential Cumulative Sales: $2.3bn
Slide 12: Ongoing Phase 2 Study Design Agreed with FDA
ent Study Design d 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 for prevention
Slide 13: Clinical Trial Status and Upcoming Milestones
3Q19: Clinical Trial as of Oct. 15, 2019: 180 of 200 patients randomized 3Q19: Successful 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 clinical study in
Slide 14: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
“Novel Lantibiotic Platform for: ' Multidrug Resistant Bacterial‘Infections =
Slide 15: 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-ReséstantErterobacteiaceae(CRE) 9,000 ‘Neiseria gonorthoece 246,000 MDR Acinetobacter 7,300 Drug Resistant Campylobacter 310,000 Exten
Slide 16: C. difficile and C. difficile Infection Epidemiology
C. difficile and C. difficile Infectio _Epidemioloc 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% since 200
Slide 17: Lantibiotics: Novel Platform of Antibiotics
Lantibiotics: Novel | Platform of Antibiotics to Treat 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 created, potentially generating a pipeli
Slide 18: Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model
Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model Survival (%)
Slide 19: Tech Transfer of Manufacture
4Q16 1Q17 Tech Transfer of Manufacture Manufacturing of API Process Ongoing at 14001 scale Fermentation complete; transitioning to GMP purification underway manufacture; Enough material generated for rat tox study, lots for monkey tox study ongoing 3Q19 Toxicology and Microbiology Underway 14-day ra
Slide 20: Corporate Status Update
Corporate Status Update
Slide 21: Capitalization
Capitalization Number Of Shares Common Stock Beneficially Percentage ee Significant Shareholders*** Owned Ownership Common Stock Outstanding 46,124,803 CVI Investments, nc. 4,000,000 870% <A Convertible oatz01 Anson Funds Management LP 4,000,000 810% Converted) 3 Intracoastal Capital LLC 3.858.977 7
Slide 22: Management Team
Dr. Alan F. Josiyn Director, President and Chief Executive Officer ‘Assumed CEO postion at Oragenics in June 2016 Held CEO postions at several private biotechnology companies induding Sentinela Pharmaceuticals, Edusa Pharmaceuticals and Mt. Cook Pharma Formerly sat on the board of Synergy Pharmaceut