Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (December 2019)
24 slides from Oragenics's investor presentation, Dec 4, 2019
Slide 1: Developing Novel Antibiotics and Biotherapeutics Through Synthetic Biology
ORA(GEN)ICS DEVELOPING NOVEL ANTIBIOTICS AND BIOTHERAPEUTICS THROUGH SYNTHETIC BIOLOGY Investor Presentation NYSE American: OGEN
Slide 2: Forward-looking statements
: ialinent [ 1 ee 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
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 r
Slide 6: Economic and Clinical Impact of Severe Oral Mucositis
nomic and Severe ~ > e - Oral Mucositis Economic Impact:
Slide 7: Economic and Clinical Impact of Severe OM
pfoongmmie and Clinical Impact of Severe OM TABLE 3 Estimated Costs of Cancer ‘Treatment-related Toxicities Reported by the Northwestern University Costs of Cancer Program* ‘Treatment-related Toxicity (Reference) Oncology ‘Treatment Cancer Diagnosis ‘No. of Patients Medial Costs, $ Mucositis/pharyng
Slide 8: AG013 Target Product Profile
AG013:darget 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
AG013 delivers hTTF1 The bacteria is freeze- Patient mixes powder Patient swishes for 30 This activity promotes a via genetically modified dried into vials a raspberry- seconds after every meal protein called trefoil lactococcus flavored solution factor, which regrows the oral lining
Slide 10: AG013 vs Kepivance
if Kepivance Sales TBD $14,000,000 Patients 20,000 (indicated only for bone marrow transplant induction >500,000 chemo patients) Oral topical delivery, iS Intravenous, Method outpatient inpatient $600MM palliative care products provide temporary symptomatic relief ——— 2
Slide 11: Oral mucositis competitor landscape
Product Name Mechanism Route of Administration Phase of Clinical Development Market Cap(MM) (12.1.19) Listing/ ticker AGO013: dapatifagene navolactibac Trefoil Factor 1 Oral rinse system 2/3 27.63 NYSE American: OGEN GC 4419: avasopasem manganese Superoxide dismutase mimetic IV (1 hour infusion) 3 2
Slide 12: AG013 Treats a Large Addressable Market With Potential Cumulative Sales
AG013 Treats a Large Addressable M With Potential _ W-W.'Cumulative Sales >$2.0Bn for Oral Mucositis REVENUE-BASED FORECAST ASSUMPTIONS 6.0 MILLION+ @ 8 2% $90 new patients ww/yr Global Potential Cumulative Sales: $2.3bn
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: Near Term News Flow
Near Term News Flow: >, ae 4Q19: Anticipated announcement indicating ongoing clinical study in Head & Neck cancer patients has completed enrollment. DECEMBER 2, 2019 PRESS RELEASE ANNOUNCING COMPLETION 1Q20: Expected Release of topline data from ongoing clinical trial. 2/3Q20: Program meetings with
Slide 15: Timeline of Key Events
Timeline of Key Events YWwVWV Vv 3Q16 2Q17 3Q17 3Q17 2Q18 4Q19 ED 2 ED a mL FDA API Update IND Treat First Interim Safety Complete Program Manufacture Filing Patient in U.S. & Efficacy Enrollment Feedback & Packaging Activated 11 US. Review of of ~200 iat design & Completion dlinical sites First 20
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 Drug-Resitant Non-Typhoid Salmonella 100,000 Drug-Resistant Typhoid Salmonella 3,800 Drug-Resistant Shigella 27,000 Methicillin-Resistant Staphylococcus aureus (MRSA) 80,000 Drug-Resistant Streptococcus pneumoniae 1,200,000 EE a
Slide 18: C. difficile and C. difficile Infection
C. difficile and C. difficile Infection ( _ Epidemiology ya 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 5 _ 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 cr
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 Clindan i aa ! indamycin 100 BO ee eee nnenennennnenoennnnnnnnnnesenennsnuntes enna WANEO & rarer Venter erent nce reece ee aera ee ee —o6716 > —m-06253 BA Yi) coms cece Lerner pe stp i et Oe cc Vanco —=@=Ve
Slide 21: OG716 development timeline
4Q16 1Q17 3Q19 2Q20 (estimate: CD SED SE ED WD Tech Transfer of Manufacture Toxicology and File IND Manufacturing of API Microbiology 4 Zee aki iming of filing of the is Process engcag araonscaE: Underway subject to having adequate Fermentation complete; transitioning to GMP 14-day rat tox study und
Slide 22: Corporate Status Update
Corporate Status Update
Slide 23: Common Stock
Common Stock Equivalents* 46,124,803 941,701 1,320,002 Perpetual standing) : EP $1.08 26,538,593 ance und 8,009,250 Total 82,934,349 + Information is sof September 30,2019. ‘As of September 30, 2019, the Non-Votng,Non-Convetble Series C Preferred Shares have stated value of $33,887 par share and hav
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 Formetty sat on