Ocugen, Inc. · NASDAQ:OCGN
Ocugen — Investor Presentation (May 2022)
17 slides from Ocugen's investor presentation, May 6, 2022
Slide 1: Courageous Innovation May 2022
Courageous Innovation May 2022 NASDAQ: OCGN
Slide 2: Forward Looking Statement
Forward Looking Statement 2 This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “conti
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 disease. Vision We are fostering a future where no one feels ho
Slide 4: Pipeline Overview
4 Pipeline Overview Asset/Program Indication Status Vaccine COVAXIN™ (BBV152) Whole-Virion Inactivated Vaccine COVID-19 • EUA for adults in Mexico; EUA for 2–18 year olds under review* • US Phase 2/3 clinical trial* (Temporarily paused dosing/clinical hold) • Health Canada NDS under review* Modifier
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 the US and Canadian Markets
Slide 6: Product Profile COVAXIN (BBV152)
Product Profile 6 COVAXIN™ (BBV152): Whole Virion Inactivated SARS- CoV-2 Antigen & Adjuvant: 6ug/SHD + Algel-IMDG (TLR7/8 Agonist) Dose Level and Regimen 6 ug per 0.5 mL suspension; 2 Doses: Day 0 & Day 28 Presentation Ten doses per vial Expected Shelf Life Two years in storage conditions of 2°- 8°
Slide 7: Why COVAXIN (BBV152)?
7 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 8: Why COVAXIN (BBV152)? Phase 3 Clinical Trial Highlights
8 Why COVAXIN™ (BBV152)? Phase 3 Clinical Trial Highlights 77.8% 93.4% 65.2% Overall efficacy Efficacy vs severe disease Efficacy vs B.1.617.2 (Delta) Serious Adverse Events Adverse Events Placebo Arm Adverse Events COVAXIN™ Arm 12.4% <0.5% n = 25,800 participants Participants recruited between Nove
Slide 9: Pathway for COVAXIN (BBV152) development
9 Pathway for COVAXIN™ (BBV152) development NCT: 05258669 Immuno-bridging and broadening (OCU-002) Booster and Safety* Proposed Interim Analysis BLA Submission Window *Protocol to be submitted OCU-002 A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated Severe A
Slide 10: Modifier Gene Therapy Platform
10 MODIFIER GENE THERAPY PLATFORM Breakthrough technology designed to address many rare diseases as well as complex diseases that affect millions
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 ar
Slide 12: Our Vision: Modifier Gene Therapy vs Traditional Gene Augmentation
12 Our Vision: 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 genes, gene-networks and
Slide 13: Our Proof of Principle: Published in Nature Gene Therapy
13 Our Proof of Principle: Published in Nature Gene Therapy Efficacy results shown in 5 unique mouse models of RP Technology developed at Harvard Medical School, Dr. Neena Haider’s Lab Study suggests potency of modifier gene therapy to elicit broad-spectrum therapeutic benefits in early and advanced
Slide 14: OCU400 – Pathway to Phase 1/2 Clinical Trials
14 OCU400 – Pathway to Phase 3 Clinical Trials Just 30 days to receive FDA clearance for Phase 1/2 gene therapy clinical trial • NCT: 05203939 • Seven clinical trial sites being activated • Escalation study involving low, medium, high doses • First patient dosed by end of Q1 2022 • Periodic updates
Slide 15: Summary of activities at Ocugen
15 First and second patients dosed in Phase 1/2 clinical trial studying OCU400 for the treatment of retinitis pigmentosa resulting from genetic mutations of NR2E3 and RHO Successfully completed manufacturing at commercial scale (200L) at CanSinoBio to support clinical studies Expanded manufacturing
Slide 16: Experienced Leadership
16 Experienced Leadership Shankar Musunuri, PhD, MBA Chairman, CEO, & Co-Founder Zara Gaudioso, SHRM-CP AVP, Human Resources, Chief of Staff Nirdosh Jagota, PhD SVP, Regulatory Affairs, Compliance and Safety Jessica Crespo, CPA Chief Accounting Officer & SVP, Finance Bruce Forrest, MD Acting Chief M
Slide 17: Thank you!
May 2022 NASDAQ: OCGN Thank you!