Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (August 2020)
27 slides from Oragenics's investor presentation, Aug 18, 2020
Slide 1: Developing Vaccines & Novel Antibiotics to Treat Tomorrow's Infections
\ Developing Vaccines & Novel Antibiotics ‘to Treat Tomorrow's Infections Corporate Presentation \
Slide 2: Forward-Looking Statement
——— r Statement 4 ’ —— 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 indica
Slide 3: ated to fighting infectious diseases. It is focused on advancing its
ated to fighting infectious diseases. It is focused on advancing its raccine candidate to combat the novel coronavirus pandemic, foping lantibiotics, a novel class of multidrug-resistant organisms.
Slide 4: Investment Highlights
Investment Highlights
Slide 5: Lead Program: NIH-created SARS-CoV-2 S-2P vaccine candidate
- Lead Program: NiH-created SARS-CoV2 S-2P (COVID 19) vaccine candidate focused on the stabilized “Spike Protein’
Slide 6: Vaccine objective and benefits
Objective: To develop and commercialize a vaccine providing lifetime immunity from SARS-CoV-2 yf. infection focusing on the spike protein. Benefits: Lifetime protection from SARS-CoV-2 virus, COVID- 19 infection prevention, more rapid immune response, lower antigen concentration required. Future: Po
Slide 7: Technology Overview — RSV F Proteins Continually Changing
Technology Overview — RSV F | _ Proteins Continually Changing | Accessible antigenic sites depend on protein conformation: + Pre sites: O, V + Post site': | + Pre/post sites: II, III, IV Postfusion Prefusion Absorption of human convalescent serum with postfusion F modestly reduces neutralizing antib
Slide 8: Technology Overview - Enhanced Immunity Utilizing Stabilized Spike Protein
Technology Overview - Enhanced Im ee, ee 4 es ilizing Stabilized Sp 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 Wire membrane Daniel Wrapp e
Slide 9: Reciprocal Serum Endpoint Titer: mRNA-1273 and S-2P Protein
Reciprocal Serum Endpoint Titer (log10) mRNA-1273 B6C3 ae bad 0.014 01 mRNA Dose (\ug) Db _ SARS-CoV-2 $-2P Protein + SAS Immunizations with mRNA-1273 and S-2P protein, B6C3 ° Reciprocal Serum Endpoint Titer (log10) ayeaaaa oe 0.01 01 1 SARS-CoV-2 S-2P Dose (ig) ° ae Ed %#* =e IgG2a/c Or SAS-adjuvan
Slide 10: SARS-CoV-2 S-2P IgG Subclass Results
SARS-CoV-2 S-2P IgG subclass Results: BA Mice a bb SARS-CoV-2 S-2P Protein + SAS BALBic Qa eke eR tek OO IGGT Soe ee ‘bee Reciprocal Serum Endpoint Titer (log 0) peer eye on ott ‘SARS-CoV.2 $-2P Dose (1g) @ SARS-CoV-2 S-2P Protein + SAS CS57BLI6 ek " — 32% fe i ih ie Go ob ott 'SARS-CoV.2 $-2P Dose
Slide 11: Concordance of Pseudovirus Neutralization Assay and PRNT
Extended Data Table 1. Concordance of Pseudovirus Neutralization Assay and PRNT. Reciprocal |Cso Titer Mouse Serum Fold Pool #" Pseudovirus Neutralization? PRNT® Difference* 1 893.5 +/- 1.4 933.5 1.0 2 211.6 +/- 1.5 314.5 0.7 3 159.8 +/- 1.3 397.1 0.5 1. BALB/cJ mice were immunized at weeks 0 and 3
Slide 12: Well Established Production Process for SARS-CoV-2 Vaccine
Well Established Production Process for Terra Cov-2 Vaccine Creation Creation of Antigen Producing cell line (CHO) ( Aragen) Examples of recombinant protein + Adjuvant Hepatitis B HPV Production of Antigen under GMP (Avid) -. Addition of FDA approved Adjuvant (Example: CpG 1018: Dynavax ) J Completi
Slide 13: NIH/NIAID license secured with acquisition of Noachis Terra
a NIH/NIAID license secured with acquisition of Noachis Terra Non-dilutive grants, including BARDA submitted or under development Utilize NIAID pre-clinical services for pre-IND enabling studies Contracts in place for: * Cell bank manufacture * Vaccine manufacture * Clinical Research Organization &
Slide 14: Regulatory Strategy: Aggressive Fast Track Approach
Regulatory Strategy: Aggressiv Fa Track _ Approach Proposed Clinical Trial Pathway and Timeline FDA Pre-IND mtg, 9/20 __ File U.S. IND, 1Q21 4Q20 - 1Q21 2/3Q21 4Q21 - 4Q22 Technology Pre-IND Phase 1 Transfer Enabling Clinical from NIH Studies Trial Assumptions: 1. RCB used as GMP cell line 2. Pilot
Slide 15: Novel Lantibiotic Platform for Multi-Drug Resistant Bacterial Infections
‘Novel Lantibiotic Platform for Mul Resistant Bacterial Infections”
Slide 16: 2019 CDC List of Antibiotic Resistant Bacteria and Fungi
2019.CDG List of Antibiotic Resistant Bacteria and Fungi Urgent Threats Cc aaeieee Concerning Threats Serious Threats
Slide 17: Lantibiotics: Novel Platform of Antibiotics to Treat Serious Life-Threatening Infections
— _Lantibiotics: Novel Platform of ntibiotics to Treat erious Life-Threatening Infections Lantibiotics are a novel class of peptide antibacterial compounds naturally produced by a variety of Gram-positive bacterial strains to attack competing bacterial strains Platform: >700 lantibiotic structures c
Slide 18: C. difficile and C. difficile Infection
“= ae {e] h _C. diffi cile and C. diffi cile Infect 2 C. difficile is an infection of the colon causing colitis by producing toxins that damage lining of the colon 223,900 infections annually resulting in 12,800 deaths 83,000 will experience at least one recurrence Healthcare-associated infections o
Slide 19: Oral OG716 Superior at Preventing C. difficile
Oral OG716 Superior at Preventing C. difficile Hamster Model DAY 1 - Infection DAY 2 Clindamycin 120 Recurrence Phase OG716 Vanco 06716 = -m-06253 Survival (%) 3 —vanco — —e=Vehicle 20 25 Days
Slide 20: OG716 C. difficile Program Milestones
0G716 C. difficile Program Milestones 2Q21 (estimate) Tech Transfer of Manufacture Manufacturing of API bigcess Ongoing at 1400L scale: Fermentation complete; transitioning to GMP Purification underway manufacture; Enough material generated for rat tox study, lots for monkey tox study ongoing Toxico
Slide 21: Corporate Status Update
Corporate Status Update
Slide 22: Capitalization
Capitalization Common Stock Equi nts 61,004,917 $9 6M” 2,261,703 20,513,145 8,009,250 Total 91,789,015, (1) Information is as of August 7, 2020. (2)_As of June 30, 2020, the Non-Voting, Non-Convertible Series C Preferred Shares have a stated value of $33,847 per share and have an accruing dividend o
Slide 23: Dr. Alan F. Joslyn and 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 Over 25 years of drug development experi
Slide 24: Advanced Management Team
ced Management Team Dr. David Zarley Consultant ~ More than 30 years in vaccine research and development in the private sector ~ Vice-President of Program Management for Vaccine Research and Development at Pfizer ~ Senior Director /Medicines Team Leader for Pfizer Primary Care Business Unit ~ _ Seni
Slide 25: Upcoming milestones 3Q20 to 2Q21
3Q20 Complete CHO cell line Vaccine Development Initiate Vaccine CDMO work Complete FDA pre-IND meeting for Vaccine Candidate 4Q20 Complete pre-clinical studies for Vaccine Candidate Advance Vaccine GMP manufacture at CDMO Initiate building of CHO MCB for the Vaccine 1Q21 File IND for Vaccine 2Q21 I
Slide 26: Summary
it. Summary License to NIH-created SARS-CoV-2 Spike Protein Vaccine Technology set to enter human clinical studies in early 2021; potential for permanent protection for SARS- CoV-2 and other coronaviruses $Multi-billion market for COVID-19 vaccines likely to accommodate multiple players Cash through
Slide 27: Corporate Investors and Media Contacts
_ Corporate Investors: “Alan F. Joslyn PH.D ~~ John Marco President & CEO Managing Director CORE IR ajoslyn@oragenics.com 516-222-2560 johnm@coreir.com Media: Jules Abraham CORE IR 917-885-7378, julesa@coreir.com