Ocugen, Inc. · NASDAQ:OCGN

Ocugen — Investor Presentation (August 2021)

35 slides from Ocugen's investor presentation, Aug 6, 2021

  1. Slide 1: Corporate Deck: August 2021

    Our Mission is to Develop Gene Therapies to Cure Blindness Diseases and Develop a Vaccine to Save Lives from COVID‐19 NASDAQ: OCGN Corporate Deck: August 2021

  2. Slide 2: Forward Looking Statement

    1©2021 Ocugen. All Rights Reserved. Forward Looking Statement This presentation contains forward‐looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our business

  3. Slide 3: Ocugen Overview

    2©2021 Ocugen. All Rights Reserved. Ocugen Overview VACCINE • COVAXIN™: Whole‐virion inactivated COVID‐19 vaccine candidate (with adjuvant). Licensed rights from Bharat Biotech for the US and Canadian markets (currently received EUA in India). Standard vaccine storage condition (2‐8°C) • Demonstrate

  4. Slide 4: Management Team

    3©2021 Ocugen. All Rights Reserved. Leadership Team Sanjay Subramanian, MBA CFO and Head of Corporate Development Vijay Tammara, PhD SVP, Regulatory & Quality Jessica Crespo, CPA Corporate Controller and Treasurer Arun Upadhyay, PhD VP, Head of Research & Development Shankar Musunuri, PhD, MBA Chair

  5. Slide 5: Scientific Advisory Boards

    4©2021 Ocugen. All Rights Reserved. Scientific Advisory Boards Satish Chandran, PhD David Fajgenbaum, MD, MBA, MSc, FCPP Bruce D. Forrest, MB, BS, MD, MBA Catherine Pachuk, PhD Harvey Rubin, MD, PhD Susan Weiss, PhD Carl D. Regillo, MD, FACS Mark Pennesi, MD, PhD Geeta Lalwani, MDDavid Boyer, MD Ret

  6. Slide 6: Pipeline and Regulatory Overview

    5©2021 Ocugen. All Rights Reserved. Pipeline and Regulatory overview VACCINE MODIFIER GENE THERAPY PLATFORM NOVEL BIOLOGIC Asset/Program Indication NotesPhase COVAXIN™ Whole‐Virion Inactivated Vaccine COVID‐19 Phase 3* Rolling submission with Health Canada completed (July 2021); Discussions with FDA

  7. Slide 7: COVAXIN Investigational Whole-Virion Inactivated COVID-19 Vaccine

    6 COVAXIN™ Investigational Whole‐Virion Inactivated COVID‐19 Vaccine Licensed from Bharat Biotech (BBIL) for the US and Canadian Markets

  8. Slide 8: COVAXIN - Product Profile

    7©2021 Ocugen. All Rights Reserved. COVAXIN™ ‐ Product Profile DOSE LEVEL and REGIMEN PRESENTATION STORAGE 0.5mL per dose suspension 2 Doses: Day 0 & Day 28 2°‐ 8°C (Expected shelf‐life ~2 Yrs.) Room temp (25ºC): 3 Months 10 doses per vial PROPOSED INDICATION TARGET POPULATION 12 years of age and ol

  9. Slide 9: Why COVAXIN

    8©2021 Ocugen. All Rights Reserved. B Both humoral & cellular responses generated against multiple viral proteins Induces a Th1 response (cell‐mediated immunity) Broad Spectrum Immune Response E Effective in neutralizing multiple variants, including rapidly‐spreading Delta variant (65.2% efficacy) P

  10. Slide 10: COVAXIN Presents Multiple Protein Targets to the Immune System

    9©2021 Ocugen. All Rights Reserved. Spike (S)Nucleocapsid (N) Membrane (M) Small membrane Protein (E) COVAXIN™ Presents Multiple Protein Targets to the Immune System Resulting in Broad Spectrum Response Spike (S) COVAXIN™ mRNA and Adenovirus‐Based Vaccines COVAXIN™, an adjuvanted inactivated virus v

  11. Slide 11: COVAXIN Developed and Manufactured by Bharat Biotech

    10©2021 Ocugen. All Rights Reserved. COVAXIN™ Developed and Manufactured by Bharat Biotech Established Robust Manufacturing Process for COVAXIN Ocugen licensed COVAXIN™ on the back of Bharat’s strong track record of developing & commercializing vaccines globally Inactivated Vero cell derived vaccine

  12. Slide 12: Amongst Leading COVID-19 Vaccines and Select Candidates in US and Canada

    11©2021 Ocugen. All Rights Reserved. COVAXIN™ is Distinct Amongst Leading COVID‐19 Vaccines and Select Vaccine Candidates in the United States and Canada Company Technology Antigen Status in US & Canada COVAXIN™ Inactivated SARS CoV‐2 Virus, Aluminum hydroxide, TLR agonist Whole virus (Including S &

  13. Slide 13: Technology Comparisons: Target Product Profile

    12©2021 Ocugen. All Rights Reserved. Technology Comparisons: Target Product Profile Characteristic mRNA Adeno‐ Based COVAXIN™ Acceptable Safety ✓ ✓ ✓ Neutralizing antibody response ✓ ✓ ✓+ Cellular responses against multiple viral antigens ✓ ✓ ✓+ Efficacy ✓ ✓ ✓+ Stability at 2‐8oC X ✓ ✓ Multiple Vira

  14. Slide 14: COVAXIN Progress and Planned Milestones for North American Development

    13©2021 Ocugen. All Rights Reserved. COVAXIN™ Progress and Planned Milestones for North American Development Ocugen signs Definitive Agreement for COVAXIN™ in US 1H 2021 2H 2021 EUA in India Start of mass immunization Phase 3 Interim Analysis Results Establish COVAXIN™ Manufacturing in US • Phase 3

  15. Slide 15: Final Phase 3 Clinical Trial Results

    14©2021 Ocugen. All Rights Reserved. FINAL Phase 3 Clinical Trial Results Demonstrate Protective Effect of COVAXIN™  Overall vaccine efficacy: 77.8% (95% CI: 65.2 – 86.4)  Efficacy against severe disease: 93.4% (95% CI: 57.1 – 99.8)  Efficacy against asymptomatic disease: 63.6% (95% CI: 29.0 – 82

  16. Slide 16: Phase 3: Study Outline

    15©2021 Ocugen. All Rights Reserved. Phase 3: Study Outline

  17. Slide 17: Phase 2: Study Results

    16©2021 Ocugen. All Rights Reserved. Phase 2: Study Results • 6µg +Algel‐IMDG demonstrated high neutralizing Abs responses compared to 3µg + Algel‐IMDG group • Mean GMT (95% CI) higher than human convalescent serum (HCS) • 6µg +Algel‐IMDG (Covaxin™) selected for Phase 3 study

  18. Slide 18: Phase 2: Study Results (Safety)

    17©2021 Ocugen. All Rights Reserved. Phase 2: Study Results • High Seroconversion rates (>96%) in both MNT50 and PRNT50 measured up to day 56 • Induction of Th1 cell mediated immunity as measured by IFN‐ƴ, IL‐2, TNF‐α • No vaccine‐related severe or life‐ threatening adverse events reported to date E

  19. Slide 19: Additional Research Demonstrating Effect Against Multiple Variants

    18©2021 Ocugen. All Rights Reserved. Additional Research Demonstrating Effect Against Multiple Variants  B.1.617 (India ‐ Kappa)  B.1.1.7 (United Kingdom ‐ Alpha)  B.1.1.28 (Brazil P2 ‐ Zeta) • COVAXIN‐vaccinated sera effectively neutralized several SARS‐CoV‐2 variants in an in‐vitro plaque reduc

  20. Slide 20: Ocugen's Modifier Gene Therapy Platform

    19 Ocugen’s Modifier Gene Therapy Platform Breakthrough Technology Designed to Address Multiple Diseases with One Product Approach Complex Diseases Through Multiple Factors

  21. Slide 21: Modifier Gene Therapy vs Gene Augmentation

    20©2021 Ocugen. All Rights Reserved. Novel approach that targets nuclear hormone genes (NHRs), which regulate multiple functions within the retina Smoother regulatory pathway due to ability to target multiple diseases with one product Ability to recoup development costs over multiple therapeutic ind

  22. Slide 22: Why Target Nuclear Hormone Receptor Genes (NHRs)?

    21©2021 Ocugen. All Rights Reserved. Why Target Nuclear Hormone Receptor Genes (NHRs)?  Modulators of retinal development & function  Act as “master genes” in the retina  Molecular reset of key transcription factors and associated gene networks – retinal homeostasis  Gene modifier concept includ

  23. Slide 23: Preclinical POC Data for Nr2e3 Published in Nature Gene Therapy

    22©2021 Ocugen. All Rights Reserved.  Efficacy results shown in 5 unique mouse models of RP  Technology developed at Harvard Medical School, Dr. Neena Haider’s Lab  Study demonstrates potency of modifier gene therapy to elicit broad‐spectrum therapeutic benefits in early and advanced stages of RP

  24. Slide 24: OCU400 - Rescue in Early & Advanced Stage of Disease

    23©2021 Ocugen. All Rights Reserved. Human Diseases: Control PDE6 associated RP Rhodopsin associated adRP Leber Congenital Amaurosis Enhanced S‐cone Syndrome • P0 single subretinal injection, evaluation 3‐4 months post injection • rd1 evaluated one‐month post injection ONL: Outer Nuclear Layer • P2

  25. Slide 25: OCU400 - Demonstrates Improved Vision Signals in Retina

    24©2021 Ocugen. All Rights Reserved. ERG response: P0 single subretinal injection, evaluation 3‐4 months post injection Human vision is enabled by three primary modes: • Photopic vision: Vision under well‐lit conditions, which provides for color perception and functions primarily due to cone cells i

  26. Slide 26: OCU400 - Demonstrated Safety in Mouse Model

    25©2021 Ocugen. All Rights Reserved. https://www.nature.com/articles/s41434‐020‐0134‐z Study Results Confirm Overexpression of Nr2e3 by subretinal AAV8‐Nr2e3 Injection Is Not Detrimental to Retina – No Off‐Target Effects OCU400 – Demonstrated Safety in Mouse Model

  27. Slide 27: OCU400 - Clinical and Regulatory Strategy

    26©2021 Ocugen. All Rights Reserved. Phase 2b/3Phase 1/2a NR2E3 RHO NR2E3 RHO CEP290 Potential Approval Proposed Broad RP Indication Phase 4 Commitments OCU400 NR2E3 Mutation-Enhanced S-cone Syndrome Rhodopsin Mutation-Associated Retinal Disease CEP290 Mutation-Leber Congenital Amaurosis Broad Spect

  28. Slide 28: OCU400 - Competitive Overview

    27©2021 Ocugen. All Rights Reserved. Features OCU400 Traditional Gene Therapy Cell Therapy One product for many IRDs (including broad RP indication) Limited Technology established in the ocular disease space POC data in RP models with different genetic mutations Expected long‐term outcome Potentiall

  29. Slide 29: OCU410 (AAV-RORA) - Dry Age-Related Macular Degeneration

    28©2021 Ocugen. All Rights Reserved. Dry AMD  Leads to irreversible blindness due to degeneration of the retina  ~9‐10M patients in the U.S.  Currently no approved treatment for Dry AMD Contributing Factors  Aging  Genetics  Environmental Factors Normal Retina Dry AMD Oxidative Stress RORA Inf

  30. Slide 30: OCU200: Novel Biologic Offering Benefits Beyond Anti-VEGF

    29 OCU200: Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Wet Age‐Related Macular Degeneration (Wet AMD) Novel Biologic Offering Benefits Beyond Anti‐VEGF

  31. Slide 31: OCU200 - Potential to Treat DME, DR & Wet AMD

    30©2021 Ocugen. All Rights Reserved. DME  ~0.7M patients in the US* DR  ~7.7M patients in the US* Wet AMD  ~1.1M patients in the US*  OCU200 is a Transferrin‐Tumstatin Fusion Protein • Tumstatin: Multiple MOAs for treatment and prevention of macular degeneration and neovascularization • Transfer

  32. Slide 32: OCU200 Demonstrated Superior Efficacy Compared to Anti-VEGF Therapies

    31©2021 Ocugen. All Rights Reserved. Data expressed as percentage of CNV lesions on Day 10 after treatment. Laser induction & treatment start on Day 0 Wet AMD In‐Vivo Laser‐Induced Mouse CNV Model * indicates p<0.05 when compared to PBS and/or tumstatin treatment † indicates p<0.05 when compared to

  33. Slide 33: OCU200 - Distinct Mechanism of Action

    32©2021 Ocugen. All Rights Reserved. Features OCU200 Anti‐VEGF Anti‐Integrin Reduces VEGF level/Fluid Selectively works on active endothelial cells (Neovascular) Activates native anti‐angiogenic response Enhanced effective delivery through Transferrin Pro‐apoptotic and anti‐oxidative Dosing Frequenc

  34. Slide 34: Key Inflection Points

    33©2021 Ocugen. All Rights Reserved. Key Inflection Points  COVAXIN™ ‐ Vaccine candidate for the US and Canadian markets with potential for revenues this year Ophthalmology • Modifier Gene Therapy Platform has the potential for one product to treat many diseases • Novel biologic has the potential

  35. Slide 35: Our Mission - Contact IR@ocugen.com

    Our Mission is to Develop Gene Therapies to Cure Blindness Diseases and Develop a Vaccine to Save Lives from COVID‐19 For more information, contact: IR@ocugen.com

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