Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (May 2020)
27 slides from Oragenics's investor presentation, May 8, 2020
Slide 1: Developing SARS-CoV-2 (COVID-19) Vaccine and Novel Antibiotics
“ ORA(GEN)ICS Developing SARS-CoV 2:(COVID.19) Vaccine and Novel Antibiotics Investor Presentation May 7, 2020
Slide 2: Forward-looking statements
: ialinent [ 1 oe 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
_Investment Highlights
Slide 4: Overview
Overview Objective: To develop and commercialize a vaccine providing lifetime immunity from SARS-CoV-2 infection. Benefits: Lifetime protection from SARS-CoV-2 virus, COVID-19 infection prevention, 1-2 doses, more rapid immune response, lower antigen concentration required, potential protection from
Slide 5: Technology Overview - Antigen
Technology Overview - Antigen Stabilized Prefusion Spike Protein Ectodomain Trimer * Class | fusion protein * Two amino acid substitutions stabilize prefusion conformation ¢ T4 fibritin trimerization domain * Expressed in mammalian cell line NOACHIS TERRA NTD vi Daniel Wrapp et al. Science 2020; 367
Slide 6: Technology Overview - RSV F Protein Example
Technology Overview - RSV F Protein Example Accessible antigenic sites depend on protein conformation: + Pre sites: 0, V + Post site’: | + Pre/post sites: Il, Ill, IV Absorption of human convalescent serum with postfusion F modestly reduces neutralizing antibodies Absorption of human convalescent se
Slide 7: Adjuvants
Adjuvants CpG 1018 - in HEPLISAV-B + 22-base synthetic oligonucleotide (ODN) containing immunostimulatory cytidine-phospho-guanosine (CpG) sequence motifs + the principal actions of 1018 in humans include: + activating pDCs to secrete interferons (IFNs) and cytokines, + converting pDCs into highly e
Slide 8: Regulatory Strategy: Fast Track Approach
Regulatory Strategy: Fast Track Approach Proposed Clinical Trial Pathway and Timeline 3-5 Months 3-6 Months 3-6 Months 9 Months Technology\ Pre-IND Phase 1 Phase 2 Transfer Enabling Clinical Clinical from NIH Studies Trial Trial Assumptions + Run initial batch with research CHO cell line + Initial P
Slide 9: Technology Overview - Current Status
Technology Overview - Current Status * NIH/NIAID License secured with acquisition of Noachis Terra ¢ NIH & BARDA grants submitted (other non-dilutive grants under development) ¢ Utilize NIAID Pre-Clinical services for pre-IND enabling Studies * Contracts in place for: * cell bank manufacture (work i
Slide 10: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
ORA\GEND)ICS Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
Slide 11: CDC Antibiotic-Resistant Threats, 2017
CDC Antibiotic-Resistant Threats, 2017 blue = gram (+) gre} 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 ak Ga)
Slide 12: C. difficile Infection
c . diffici cile 2 and C. difficile Infe a | (¢ 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 2000 He
Slide 13: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections
pentbictics Novel Platform of Antibiotics to Treat erious Life threatening Infectior Ss 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
Slide 14: 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 15: Lantibiotics: OG716 C. difficile Program Milestones
_Lantibiotics: OG716 C. difficile Program Milestones w~ 4Q16 2Q20 cam Tech Transfer of Manufacturing Process Fermentation complete; purification underway 1Q17 3Q19 Manufacture Toxicology and of API Microbiology Ongoing at 14001 scale: Undermay transitioning to GMP 14-day rat tox study underway manuf
Slide 16: AG013: First-in-Class Therapy for Prevention of Oral Mucositis
ORA\GEND)ICS AG013: First-in-Class Therapy-for Prevention of Oral Mucositis
Slide 17: 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 18: Economic and Severe Oral Mucositis Impact
nomic and Severe ~ > e - Oral Mucositis Economic Impact:
Slide 19: 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 20: How AG013 works
AG013 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 lining a
Slide 21: OM Products Under Development
OM Products Under Development a = Product Name AGO013: GC 4419: SGX942: dusquetide _Briliciden Clonidine dapatifagene avasopasem navolactibac manganese Mechanism Trefoil Factor? Superoxide Innate Defense Defensin mimetic @ 2 receptor dismutase mimetic Regulator agonist Route of Oral rinse IV (1 hour
Slide 22: 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 23: AG013: Near Term News Flow
AG013:,Near Term News Flow On April 15, 2020 the company release news that the study did not demonstrate statistical significance between AGO13 and Placebo for key efficacy endpoints. Analysis of various sub-groups are ongoing and the data will be released once those analyses are complete.
Slide 24: Corporate Status Update
ORA\GEND)ICS Corporate Status Update
Slide 25: Capitalization
_ Capitalization Common Stock Equivalents* 55,362,803 $18.3M* 2,261,703 35,700,593 8,009,250 101,334,349 Information is as of December 31 1, 2019 unless otherwise indicated. ** Includes 9,200,000 shares of common stock and warrants issued in connection with the acquisition of Noachis Terra. ** As of
Slide 26: 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 Over 25 years of
Slide 27: Experienced Management Team
_ Experienced Management Team David Zarley Consuttant More than 30 years in vaccine research and development in the private sector Vice-President of Progra Management for Vaccine Research and Development at Pfizer Senior Director /Medicines Team Leader for Pfizer Primary Care Business Unit Senior Di