Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (November 2020)
29 slides from Oragenics's investor presentation, Nov 10, 2020
Slide 1: Corporate Presentation
ORA\GEN)ICS Developing Vaccines & Novel Antibiotics to Treat Tomorrow’s Infections Corporate Presentation November 10, 2020
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: Committed to fighting infectious diseases
ed to Fighting i infectious diseases. It is focused on advancing its iccine candidate to combat the novel coronavirus pandemic,
Slide 4: Investment Highlights
Slide 5: Lead Program: NIH-created SARS-CoV-2 S-2P vaccine candidate
ORA\GEN)ICS Lead Program: NiH-created SARS-GoV2 S-2P (EOVID 19) vaccine candidate focused on the stabilized “Spike Protein’
Slide 6: Vaccine objective and benefits
Objective: To develop and commercialize a vaccine providing long lasting immunity from SARS- CoV-2 infection focusing on the spike protein. Benefits: Long lasting protection from SARS-CoV-2 virus, COVID- 19 infection prevention, more rapid immune response, lower antigen concentration required. Futur
Slide 7: Spike protein conformation and technology
Pr pike Proteins Continual! Corona Viruses Technology Over: Accessible antigenic sites depend on protein conformation: oy i * Pre sites: O, V ae Postfusion * Post site’: | & * Pre/post sites: Il, Ill, IV Piva Prefusion te Sry Absorption of human convalescent serum with 2; postfusion F modestly reduc
Slide 8: Technology Overview: Stabilized Spike Protein
s Technology Overview ng Stabilized Spike P 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 Viral membrane Da
Slide 9: Serum endpoint titers in mice
Reciprocal Serum Endpoint Titer (log 10) =NoRNaDaYE © At mRNA-1273 B6C3 ** 0.01 01 mRNA Dose (ug) 1 b SARS-CoV-2 S-2P Protein + SAS Reciprocal Serum Endpoint Titer (log10) aN OR ADYLE © B6C3 001 04 1 SARS-CoV-2 S-2P Dose (ug) Immunizations with mRNA-1273 and S-2P protein, delivered with TLR4 agonist
Slide 10: SARS-CoV-2 S-2P IgG subclass results
SARS-CoV-2 S-2P IgG subclass Result: Mice — b SARS cova aS SAS-adjuvanted S-2P protein elicit both IgG2a ae and IgG1 subclass S-binding antibodies. BALB/cJ ssi (b) or C57BL/6J (e) mice were immunized at 358) weeks 0 and 3 with 0.01 (green), 0.1 (blue), or 1 be 4 Ug (red) of SARSCoV- 2 S-2P protein a
Slide 11: 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* d 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 12: Well Established Production Process for 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) y Addition of FDA approved Adjuvant y Completion of Fill/Finish (Catalent)
Slide 13: Attributes
Attributes Well established vaccine product characteristics: recombinant protein + adjuvant (Hep B, HPV, Influenza vaccines) Potential for single dose efficacy (based on Phase 1 results) Provided in pre-filled syringes — ease of use...... Storage and transport at refrigerated (5°C) temperatures: not
Slide 14: NIH/NIAID license and progress to date
¢ 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 * Creation of cell line complete * Development of an
Slide 15: Proposed Clinical Trial Pathway and Timeline
Proposed Clinical Trial Pathway and Timeline FDA Pre-IND mtg, 9/20 File U.S. IND, 2Q21 4Q20 - 1Q21 3Q21 4Q21 - 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 acceptable for IND and
Slide 16: Upcoming milestones
* 1Q21: * Release of NIH confidential viral load data * Completion of mouse immunogenicity study * Completion of hamster challenge study « Announcement of adjuvant access deal ° 2Q21: * Complete creation of Master Cell Bank for GMP production ¢ File IND and initiate Phase 1clincal study activities *
Slide 17: Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
ORA\GEN)ICS Novel Lantibiotic Platform for Multidrug Resistant Bacterial Infections
Slide 18: 2019 CDC List of Antibiotic Resistant Bacteria and Fungi
2019.CDC List of Antibiotic Resistant Bacteria and Fungi Urgent Threats *Carbapenem-resistant Acinetobacter Concerning Threats *Candida auris -Erythromycin-Resistant Group A Streptococcus “Clostridioides difficile. *Clindamycin-resistant Group B Streptococcus *Carbapenem-resistant Enterobacteriaceae
Slide 19: Lantibiotics are a novel class of peptide antibacterial compounds
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, potentially generating a pipeline of new compounds Platform provides potential for
Slide 20: C. difficile and C. difficile infection epidemiology
_C.difficile and C. difficile infectic = eed pidemiology 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 infection
Slide 21: Oral OG716 Superior at Preventing C. difficile Deaths in Hamster Model
Oral OG716 Superior at Preventing G. difficile Deaths in Hamster Model Days
Slide 22: OG716 C. difficile Program Milestones
cs: OG716 C. difficile Program Milestones Tech Transfer of Manufacture Toxicology and File IND Manufacturing of API Microbiology Pe atta aN Iming of Tiling of the Is vncess Ongoing at 1400L scale: Underway subject to having adequate Fermentation complete; transitioning to GMP 14-day rat tox study un
Slide 23: Corporate Status Update
ORA\GEN)ICS Corporate Status Update
Slide 24: Capitalization
Capitalization Common Stock Equivalents 61,004,917 $1 0.0m” = 2,261,703 20,513,145 8,009,250 Total 91,789,015 (1)_ Information is as of September 30, 2020. (2) As of September 30, 2020, the Non-Voting, Non-Convertible Series C Preferred Shares have a stated value of $33,847 per share and have an acc
Slide 25: Anticipated milestones
3Q20 Complete CHO cell line Vaccine Development Initiate Vaccine CDMO work Complete FDA pre-IND meeting for Vaccine Candidate 4Q20 Initiate pre-clinical studies for Vaccine Candidate Advance Vaccine GMP manufacture at CDMO Initiate building of CHO MCB for the Vaccine 2Q21 File IND for Vaccine Initia
Slide 26: Investment summary
human clinical studies in early 2021; potential for long lasting protection for SARS- CoV-2 and other coronaviruses $Multi-billion market for COVID-19 vaccines likely to accommodate multiple players Cash through early 2021; Federal Grants for COVID-19 under review Novel class of peptide antibacteria
Slide 27: 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 28: Dr. David Zarley
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 Director for Wyeth Research
Slide 29: Corporate Investors and Media contacts
Corporate Investors: Media: Joslyn PH.D _ John Marco Jules Abraham s Managing Director CORE IR 813 286 7900 ext 232 » COREIR 917-885-737: ajoslyn@oragenics.com 516-222-2560 julesa@coreir.com \ johnm@coreir.com t