Ocugen, Inc. · NASDAQ:OCGN
Ocugen — Investor Presentation (August 2022)
23 slides from Ocugen's investor presentation, Aug 26, 2022
Slide 1: Courageous Innovation August 2022
Courageous Innovation August 2022 NASDAQ: OCGN
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are based on the beliefs and assumptions of Ocugen, Inc. and on information currently available to management. All statements contained
Slide 3: We're Here to Make an Impact Through Courageous Innovation
We’re Here to Make an Impact Through Courageous Innovation 3 Mission: At Ocugen, we are developing novel solutions to medical challenges, approaching healthcare innovation with purpose and agility to deliver new options for people facing serious disease and conditions Pioneering a breakthrough modif
Slide 4: Pipeline Overview
4 Pipeline Overview Asset/Program Indication Status Vaccine COVAXIN™ (BBV152) SARS-CoV-2 virus COVID-19 • EUA for adults in Mexico; EUA for 5 to 18-year-olds submitted • U.S. Phase 2/3 Immuno-bridging and broadening clinical trial in-progress • Health Canada NDS withdrawn, to be resubmitted with add
Slide 5: COVAXIN (BBV152) A Whole-Virion Inactivated COVID-19 Vaccine Candidate
5 COVAXIN™ (BBV152) A Whole-Virion Inactivated COVID-19 Vaccine Candidate Licensed from Bharat Biotech (BBIL) for North American Markets
Slide 6: Why COVAXIN (BBV152)?
6 Why COVAXIN™ (BBV152)? Designed to augment our North American arsenal of vaccines against COVID-19 • Adult and pediatric phase 2/3 data suggest both humoral & cellular responses generated against multiple viral proteins • Data support that the vaccine induces a Th1 response (cell-mediated immunity
Slide 7: COVAXIN (BBV152) Adult and Pediatric Clinical Trial Data
7 COVAXIN™ (BBV152) Adult and Pediatric Clinical Trial Data Phase 3 Clinical Trial n = 25,798 • Nov 2020 - Jan 2021 across 25 sites • Two doses, 28 days apart Phase 2/3 Clinical Trial in Children (2-18 years) • Observed GMTR = 1.32 (0.92, 1.90 [CI 95%]) n = 526 • May 2021 - Jul 2021 across 6 sites •
Slide 8: Pathway for COVAXIN (BBV152) development
8 Pathway for COVAXIN™ (BBV152) development NCT: 05258669 Immuno-bridging and broadening (OCU-002) Safety Proposed Interim Analysis BLA Submission Window OCU-002 A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated Severe Acute Respiratory Syndrome Coronavirus (
Slide 9: Modifier Gene Therapy Platform
9 MODIFIER GENE THERAPY PLATFORM Breakthrough technology designed to address many rare diseases as well as complex diseases that affect millions
Slide 10: Our Vision: Inherited Retinal Diseases, Modifier Gene Therapy vs Traditional Gene Augmentation
10 Our Vision: Inherited Retinal Diseases Modifier Gene Therapy vs Traditional Gene Augmentation Normal gene X Gene Augmentation: Transfer functional version of a non-functional gene into the target cells Modifier Gene Therapy: Designed to introduce a functional gene to modify the expression of many
Slide 11: Our Focus: Nuclear Hormone Receptor Genes (NHRs)
11 Our Focus: Nuclear Hormone Receptor Genes (NHRs) *References: https://pubmed.ncbi.nlm.nih.gov/28556246/ | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409218/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339951/ | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183526 NHRs in
Slide 12: Proof of Principle: Published in Nature Gene Therapy
12 Proof of Principle: Published in Nature Gene Therapy OCU400 NR2E3 Mutation-Associated Retinal Disease CEP290 Mutation-Associated Retinal Disease ONE Disease GENE X GNE X https://www.nature.com/articles/s41434-020-0134-z Important milestone for development of therapy; demonstrated proof of princip
Slide 13: OCU400 Phase 1/2 U.S. Clinical Trial Progress
13 OCU400 Phase 1/2 U.S. Clinical Trial Progress ⌛ OCU400 A Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa Associated with NR2E3 (Nuclear Receptor Subfamily 2 Group E Member 3) and RHO (Rhodopsin) Mutations NCT: 05203939 Study Type: Interventional (Clinical Tria
Slide 14: OCU400 Expected Pathway to Clinical Development & Potential Approval
14 OCU400 Expected Pathway to Clinical Development & Potential Approval RP LCA Proposed Indication RP & LCA
Slide 15: OCU410 (AAV-RORA) Dry Age-Related Macular Degeneration
Phase 1/2 clinical trial 15 OCU410 (AAV-RORA) Dry Age-Related Macular Degeneration 30 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
Slide 16: OCU410 Reduces Drusen in Abca4-/- Mice, Improves Function
OCU410 Reduces Drusen in Abca4 -/- Mice, Improves Function • ABCA4 is a retina-specific protein localized in outer segment disk edges of rod photoreceptors • Mutations in ABCA4 have been linked to: a) Age-related macular degeneration (AMD) b) Stargardt macular dystrophy (STGD) c) Recessive RP d) Rec
Slide 17: OCU410 Restores Cd59 Expression in Abca4-/- mice
OCU410 Restores Cd59 Expression in Abca4-/- mice IV - Intravitreal; SR-Subretinal; B6 - C57BL/6mice INL - Inner nuclear layer, ONL - outer nuclear layer RPE – Retinal Pigment Epithelium ONL RPE INL • Abca4 -/- mice show very low CD59 expression in their retinas • CD59 prevents the formation of the c
Slide 18: OCU200 Novel biologic for DME, DR and Wet AMD
18 OCU200 Novel biologic for treating Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Wet Age-Related Macular Degeneration (Wet AMD)
Slide 19: OCU200 Potential to Treat DME, DR & Wet AMD
19 OCU200 Potential to Treat DME, DR & Wet AMD 30 DME DR Wet AMD OCU200 is a Transferrin-Tumstatin Fusion Protein • Tumstatin: Multiple Mechanisms of Action (MOAs) for treatment and prevention of macular edema and neovascularization • Transferrin: Targets the site of action and improves uptake (bett
Slide 20: NeoCart (Autologous chondrocyte-derived neocartilage)
20 NeoCart® (Autologous chondrocyte-derived neocartilage)
Slide 21: NeoCart: Restorative Cell Therapy
21 NeoCart®: Restorative Cell Therapy Designated by FDA as “Regenerative Medicine Advanced Therapy” • Combines breakthroughs in bio-engineering and cell processing to enhance the autologous cartilage repair process • Merges a patient’s own cells with a fortified 3-D scaffold designed to accelerate h
Slide 22: Ocugen Vision
22 Ocugen™ Vision Fully integrated, patient-centric biotech company focused on vaccines in support of public health and gene and cell therapies targeting unmet medical needs through Courageous Innovation
Slide 23: ocugen.
———— ~ ocugen. > ee August 2022 NASDAQ: OCGN