Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (March 2021)
30 slides from Oragenics's investor presentation, Mar 9, 2021
Slide 1: Developing Vaccines & Novel Antibiotics to Treat Tomorrow's Infections: Corporate Presentation
' DeVeloping Vaccines & Novel An ‘to Treat Tomorrow’s Infections: Corporate Presentation ea
Slide 2: Forward-looking statements
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 uncertainty in fa
Slide 3: Company focused on fighting infectious diseases and COVID-19 vaccine
ed to fighting i infectious diseases. It is focused on advancing its ccine candidate to combat the novel coronavirus, Covid-19,
Slide 4: Company Highlights
Company Highlights
Slide 5: Program: NIH-created SARS-CoV-2 S-2P vaccine candidate
Program: ~ NiIH-created SARS-CoV2 S-2P (COV 19) vaccine candidate.focused'ont! _. stabilized “Spike KTOtEI yiarintr - Delivery Se
Slide 6: Objective: Develop an intranasal vaccine
Objective: To develop and commercialize an intranasal vaccine providing long lasting immunity from SARS-CoV-2 infection focusin on the spike protein. Benefits: Long lasting protection from SARS-CoV-2 virus, COVID- 19 infection prevention, reduced viral spread,more rapid immune response, lower antige
Slide 7: Coronavirus Technology Overview
Corona Viruses Technology Overv _ Protein: Spike Proteins Continually Accessible antigenic sites depend on protein conformation: ¢ Pre sites: O, V * Post site’: | * Pre/post sites: Il, Ill, IV Prefusion Absorption of human convalescent serum with postfusion F modestly reduces neutralizing antibodies
Slide 8: Technology Overview: Stabilized Prefusion Spike Protein
is Technology Overview ng Stabilized Spike Pr 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; Chinese Hamster Ovary (CHO) cells Vil membrane Da
Slide 9: Immunizations with mRNA-1273 and S-2P protein in mice
Reciprocal Serum Endpoint Titer (log 10) o mRNA-1273 B6C3 0.01 0.1 mRNA Dose (ug) 1 Db SARS-Cov-2 $-2P Protein + SAS Reciprocal Serum Endpoint Titer (log10) AN ORaO YL O B6C3 001 0.4 1 SARS-CoV-2 S-2P Dose (yg) Immunizations with mRNA-1273 and S-2P protein, delivered with TLR4 agonist, elicit S-spec
Slide 10: Concordance of Pseudovirus Neutralization Assay and PRNT
Extended Data Table 1. Concordance of Pseudovirus Neutralization Assay and PRNT. Reciprocal ICso 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/c) mice were immunized at weeks 0 and 3
Slide 11: SARS-CoV-2 Spike Protein Demonstrates Immunogenicity
~ SARS-CoV-2 Spike Protein Demonstrates I a A Lung Viral Load 7 Day 2 4 3g 2 Z 2 & 3 : 5 z & s F 2 PBSWT 2P WT 2P WT 2P PBS WT 2P WT 2P WT 2P 0.01 01 i) 0.01 01 1 4g Hg Hg Hg ug ug F Gray dashed line = p<0.05_ Gray solid line = p<0.01 ae Gen)
Slide 12: Well Established Production Process for Terra Cov-2
Well Established Production Pro cess for Terra Cov-2 Creation of Antigen Producing cell line (CHO) ( Aragen) Examples of recombinant protein + Adjuvant | | Hepatitis B . N y . HPV Production of Antigen under GMP (Avid) Addition of Adjuvant (TQL1055 or Intranasal BDX100, BDX 300, BDX 301) vy Completi
Slide 13: Well established vaccine product characteristics
Well established vaccine product characteristics: recombinant protein + adjuvant (Hep B, HPV, Influenza vaccines) Intranasal Delivery — ideal for children and self administration Potential for single dose efficacy (based on Phase 1 results) Low COGs based on production scheme Storage and transport a
Slide 14: BDX100 (Protollin) adjuvant developed by Biodextris
BDX100 (Protollin), BDX 300 & BDX 301 developed by Biodextris Intranasal delivery of adjuvant stimulates production of IgA in the nasal cavity mm Reduces spread of virus Systemic IgG production reduces severity of Covid-19 infection Ease of use ideal for children and populations adverse to needles E
Slide 15: Vaccine program progress and agreements
¢ NIH/NIAID license secured with acquisition of Noachis Terra ¢ Non-dilutive grants, primarily DoD, under development * Contracts in place for: * Cell bank manufacture * Vaccine manufacture * Clinical Research Organization & Regulatory Consultants ¢ Formulation & fill/finish « Adjuvant agreement for
Slide 16: Strategy: Proposed Clinical Trial Pathway and Timeline
Strategy: Aggressive Proposed Clinical Trial Pathway and Timeline FDA Pre-IND mtg, 9/20 File U.S. IND, 3Q21 4Q20 - 3Q21 4Q21 1Q22 - 4Q22 Technology = Pre-IND Phase 1 Phase 2/3 Transfer Enabling Clinical Clinical from NIH Studies Trial Trial Assumptions: 1. RCB used as GMP cell line 2. Pilot batch ac
Slide 17: Vaccine News Flow
Vaccine News Flo’ * 1/2Q21: v Release of NIH viral load data ¥ Announcement of adjuvant access deal, including intranasal adjuvant delivery through Biodextris * Initiation of mouse immunogenicity study ¢ Initiation of hamster challenge study * 3/4Q21: * Complete creation of Master Cell Bank for GMP
Slide 18: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
“Novel Lantibiotic Platform forMu Resistant Bacterial Infections
Slide 19: CDC List of Antibiotic Resistant Bacteria and Fungi
CDC List,of Antibiotic Resistant Bacteria and Fungi Urgent Threats «Carbapenem-resis Concerning Threats Watch List Serious Threats ; «| = z IFEptoc us pneumoniae Drug-resista' losis en) 19 ORA 1cs
Slide 20: C. difficile and C. difficile Infection (CDI)
ae sould cile and C. difficile Infecti ion (CDI): ey ology niology 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
Slide 21: Lantibiotics: Novel Platform of Antibiotics
Lantil biotics: Novel Platform of Antibiotics to Treat hreatening 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 created, pote
Slide 22: Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model
Oral OG716 Superior at Preventing CG. difficile Deaths in Hamster Model Days
Slide 23: OG716 C. difficile Program Milestones
Tech Transfer of Manufacturing Process Fermentation complete; purification underway s: OG716 C. difficile Program Milestones Manufacture of API Ongoing at 1400L scale: transitioning to GMP manufacture; Enough material generated for rat tox study, lots for monkey tox study ongoing Toxicology and Micr
Slide 24: Corporate Status Update
Corporate Status Update
Slide 25: Common Stock and Equivalents
Common Stock Equivalents 109,646,119 C $33.5M 2,261,703 18,040,572 8,009,250 137,957,644 The Information is as of February 25, 2021 and includes 15,406,618 shares of common stock issued in February as a result of the ATM offering (providing net proceeds of approximately $19.2 million) and 2,472,573
Slide 26: 2021 anticipated milestones
1/2Q21 Initiate pre-clinical studies for Vaccine Candidate utilizing Intranasal adjuvant technology Advance Vaccine GMP manufacture at CDMO Initiate building of CHO MCB for the Vaccine 3/4Q21 File IND for Vaccine Initiate Phase 1 Clinical Study 4Q21 File IND for OG716 (tentative)
Slide 27: Investment highlights summary
License to NIH-created SARS-CoV-2 Spike Protein Vaccine Technology set to enter human clinical studies in 2021; potential for long lasting protection for SARS-CoV- 2 and new variants and potentially other coronaviruses Improved vaccine access through development of Intranasal delivery technology and
Slide 28: Experienced Management Team
Experienced 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
Slide 29: Experienced Management Team (consultants)
Experienced Management Tea 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 Senior
Slide 30: Corporate contact
Corporate Alan F. Joslyn PH.D 813 2867900 ext 232 ajoslyn@oragenics.com \ Investors: Kim Golodetz, Senior Vice President, Principal LHA Investor Relations: Results that Matter ~~ T: 212.838.3777 | KGolodetz@lhaiicom’ /