Ocugen, Inc. · NASDAQ:OCGN
Ocugen — Q1 2023 Earnings Presentation
18 slides from Ocugen's earnings presentation, May 5, 2023
Slide 1: Q1 2023 Business Update
Q1 2023 Business Update May 5, 2023 NASDAQ:OCGN
Slide 2: Forward-Looking Statements
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,” “continue,” “estimates,” “antici
Slide 3: 2023 Accomplishments to Date — A Strong Start to the Year
2023 Accomplishments to Date — A Strong Start to the Year Modifier Gene Therapy Announced positive preliminary safety and efficacy results from Phase 1/2 trial of OCU400 FDA approved enrollment of pediatric patients in ongoing Phase 1/2 trial of OCU400 Orphan Drug Designation granted to OCU410ST
Slide 4: 2023: Several Significant Milestones Expected
4 OCU500 series NeoCart® OCU400 OCU410ST OCU200 Q1 Q2 Q3 Q4 IND filing to initiate clinical trial* cGMP facility completion Initiation of Phase 3 trial IND submission: Phase 1/2 trial in dry AMD Begin dosing patientsIND filed for Phase 1 trial 2023: Several Significant Milestones Expected Preliminar
Slide 5: Modifier Gene Therapy: A Broader Reach
Modifier Gene Therapy: A Broader Reach Gene modifier therapy canpotentially address multiple genetic defects with a single product utilizing a gene agnostic approach. In patients with IRDs,this could mean: Improved visual outcomes and quality of life GENEX GENEM cell NR2E3 Delivery “Molecular reset”
Slide 6: Positive Preliminary Safety and Efficacy Results from Phase 1/2 Trial of OCU400
Ocugen Announced Positive Preliminary Safety and Efficacy Results from the Ongoing Phase 1/2 Trial of OCU400 • Favorable safety and tolerability profile related to OCU400 investigational product candidate • Initial clinical data from low- and medium-dose cohorts indicates a positive trend in MLMT an
Slide 7: Study Overview
Study Overview Clinical Trials.gov Identifier: NCT05203939 Safety of subretinal administration of OCU400 Best Corrected Visual Acuity (BCVA) Multi-Luminance Mobility Test (MLMT) Primary Endpoint: Safety Exploratory Endpoint: Efficacy 37 Enrollment Status
Slide 8: Multi-Luminance Mobility Test
Multi-Luminance Mobility Test Total Subjects for analyses (N=7); pooled analyses Subjects with 9-months follow-up : Cohort 1, N=3 Subjects with 6 months follow-up: N=1 from Cohort 1 and N=3 from Cohort 2 Total Subject for analyses (N=3) Cohort 1 with 9 month follow-up Improvement ≥ 1 Lux Improvement
Slide 9: Best Corrected Visual Acuity (BCVA) Score
Best Corrected Visual Acuity (BCVA) Score Total Subjects for analyses (N=7) Subjects with 9-months follow-up : Cohort 1, N=3 Subjects with 6 months follow-up: N=1 from Cohort 1 and N=3 from Cohort 2 Improvement ≥ 8 Letters Treated Eye 42.9% Untreated Eye 0.0% 9
Slide 10: OCU400: Expected Pathway to Clinical Development & Potential Approval
OCU400: Expected Pathway to Clinical Development & Potential Approval Both FDA & EMA granted broad orphan drug designation for RP & LCA • Ocugen plans to meet with regulatory agencies in 3Q to potentially finalize Phase 3 clinical program and overall package • Continuing to enroll LCA and pediatric
Slide 11: OCU410ST: Received ODD for ABCA4-Associated Retinopathies
11 OCU410ST: Received ODD for the Treatment of ABCA4-Associated Retinopathies Including Stargardt, Retinitis Pigmentosa 19 (RP19) and Cone-rod Dystrophy 3 (CORD3) ABCA4-associated retinopathies—Genetic Rare Disease • ABCA4 gene produces an ATP-binding cassette (ABC) superfamily transmembrane protein
Slide 12: OCU410 for the Treatment of Dry Age-related Macular Degeneration
12 OCU410 for the Treatment of Dry Age-related Macular Degeneration (dAMD) dAMD Limited options, presenting significant unmet medical need • US: 10M • Worldwide: condition affects more than 266M people Recently approved therapy for geographic atrophy (GA)— advanced form of dAMD–has limitations • Fre
Slide 13: OCU500 Series: Next-Generation Inhaled Vaccine Candidates
13 OCU500 Series: Next-Generation Vaccine Candidates Using Inhalation Technology OCU500 A bivalent COVID-19 vaccine OCU510 A seasonal quadrivalent flu vaccine OCU520 A combination quadrivalent flu and bivalent COVID19 vaccine Current focus solely on the development of our inhaled mucosal vaccine pla
Slide 14: Pipeline Updates
Pipeline Updates OCU200 • IND submitted. The Company plans to respond promptly to get FDA clearance to initiate Phase 1 trial. NeoCart® • Renovations continue on cGMP manufacturing facility for NeoCart • Completion planned for 4Q 2023 14
Slide 15: Financial Update
Financial Update 15
Slide 16: Financial Update
Financial Update Statement of Operations Three months ended March 31, 2023 2022 Research and development expense $9.6 $7.9 General and administrative expense 8.2 10.1 Other income (expense), net 1.3 - Net loss $(16.5) $(18.0) Net loss per share of common stock — basic and diluted $(0.07) $(0.09) Bal
Slide 17: Questions & Answers
Questions & Answers ocugen.
Slide 18: Thank you
May 2023 NASDAQ:OCGN Thankyou!