• NeoCart: bio-engineering breakthroughs enhance the autologous cartilage repair • Accelerated healing and reduced pain using patient’s own cells in a 3D scaffold • Patients receive functional cartilage at the time of treatment Current treatment options are sub- optimal with variable outcomes due to variable cellular response Patients and physicians seeking alternatives that offer a more rapid and durable recovery Cartilage Injury Focal Chondral Defect NeoCart®: The Cutting-Edge Treatment for Knee Articular Cartilage Defects. List of Authors Ocugen Inc. Malvern, PA, United States Knee Cartilage Damage: A Complex Problem Cartilage: • A complex shock absorber • Withstands significant pressure • Allows for rolling & sliding Immediate Problems: • Damage from acute injury or repetitive trauma • Debilitating pain and loss of function Long term Problems: • Limited regeneration - lack of vascularity • Strong correlation with Osteoarthritis 9% 41% 43% 8%Extremely likely Likely Neutral Unlikely Willingness to prescribe NeoCart (N=79 surgeons) Annual procedures for knee cartilage defects Large market opportunity to treat knee cartilage damage approximately 1.2M defects identified each year Clinically meaningful Phase 3 top-line results reported in Q3:18 Planned expansion of NeoCart platform into additional markets and indications Powerful, proprietary platform that provides restorative cell therapies (RCTs) for active living NeoCart®, is a proprietary RCT that rebuilds patients’ own knee cartilage, reducing pain at the source and potentially prevents progression to osteoarthritis (OA) Follow-up Arthroscopy Demonstrates NeoCart Integration Initial Lesion Implantation 8 Weeks 6 Months Reduces pain Improves function Promotes repair of damaged cartilage Short rehabilitation / rapid return to daily activities Durable response No specialized surgical techniques and less operating room time Non-opioid approach Attributes of an Optimal Treatment for Knee Cartilage Damage Assessment of defect & biopsy Implantation into defect with CT3 bioadhesive Su rg ic al S te ps 6-8 Week Process M an uf ac tu rin g St ep s Cell isolation expansion, & seeding of 3D scaffold Quality control: histology & biomarkers Implant processing Continued growth in static culture • Patient Satisfaction: pain relief, better QoL, improved productivity • Physician Satisfaction: robust clinical data – 1-year superiority endpoint • Payer Cost Effectiveness Potential Benefits of NeoCart®Economics & Unmet Needs of Knee Repair: The NeoCart Advantage The NeoCart® Breakthrough Phase I Study parameters: • Treatment group – 8 patients • Cartilage injury – 1-2 cm Evaluations: • Through 60 months post-op • International Knee Documentation Committee (IKDC) questionnaire • Visual analog scale • Range of motion • Cartilage-sensitive MRI Results: • Lowered pain and improved functions after NeoCart • Six patients had substantial defect fill at 24 months • Improved IKDC score in 7 out of 8 patients Safety: • No adverse events reported • No patient developed arthrofibrosis or implant hypertrophy • Sagittal MRI and arthroscopic image of the NeoCart implant (blue arrow) at 12 weeks with meniscal tear (red arrow). • The NeoCart (blue arrow) is flush & integrated to repaired region (border shown by black line) (Crawford et al., AJSM 2009) Phase II Coronal MRI shows good fill of the cartilage defect 10 days to 6 months after NeoCart Implantation (Crawford et al., AJSM 2009). Clinical Trials: NeoCart Publications Phase III Ocugen Phase III Study parameters: • 30 patients at 6 U.S. centers • 2:1 randomization (NeoCart v. Microfracture) • Lesion size – 1-3 cm Evaluations: 60 months post-op • IKDC questionnaire • Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, symptoms, activities of daily living (ADL), quality of life (QOL), sports scales, Visual analog scale and Short Form-36 (SF-36) questionnaire Results: • More patients responded to NeoCart than microfracture – at 6 months (43% Vs 25%) – at 12 months (76% Vs 22%) • Improvement with NeoCart was significantly greater – at 6, 12 and 24 months for IKDC, SF-36 & KOOS-ADL / pain – at 6 months for KOOS-symp – at 12 & 24 months for KOOS sports & VAS Safety: • No serious adverse events reported • None of the AE were related to either treatments Responders Non-Responders +12 points +20 points IK DC Su bj ec tiv e KOOS PainBaseline N on -R es po nd er s Superiority Endpoint: % of NeoCart “Responders” vs Mfx “Responders” Change in Patient-Reported Outcomes From Baseline to Final Follow-up Parameter Baseline Final Follow-up Change From Baseline P -Value n IKDC subjective 47.9 ± 17.4 75.5 ± 22.1 27.6 ± 19.1 <0.0001 29 VAS mean 34.6 ± 22.5 14.3 ± 18.4 –20.3 ± 24.6 <0.0001 29 VAS highest 60.1 ± 20.6 23.5 ± 27.0 –36.6 ± 29.7 <0.0001 21 KOOS-Pain 64.8 ± 12.1 86.1 ± 17.3 21.4 ± 10.7 <0.0001 21 KOOS-ADL 75.5 ± 14.8 91.6 ± 13.8 16.1 ± 11.0 <0.0001 21 KOOS-QoL 28.6 ± 15.5 69.4 ± 28.0 40.8 ± 27.5 <0.0001 21 KOOS-Symptoms 65.8 ± 13.8 86.6 ± 13.4 20.8 ± 15.4 <0.0001 21 KOOS-Sports 41.4 ± 24.3 72.4 ± 28.8 31.0 ± 26.4 <0.0001 21 SF-36 physical 40.5 ± 7.2 51.4 ± 8.1 11.0 ± 7.1 <0.0001 21 SF-36 mental 55.1 ± 9.2 54.8 ± 6.7 –0.3 ± 9.5 0.8858 21 Active ROM 131.5 ± 7.9 140.7 ± 6.3 9.2 ± 9.6 <0.0001 29 Data are reported as mean ± SD unless otherwise indicated. Anderson et al AJSM 2017 *76% 89% 69% 22% 44% 29% 1 YR 2 YR 3 YR 21 9 18 9 16 7Evaluable Patients: NeoCart Microfracture *p < 0.05 1 year primary superiority endpoint Phase 3 requires only ~15-20% difference between NeoCart and microfracture HIGHLIGHTS FROM HISTOGENICS PHASE III STUDY —A prospective randomized trial comparing NeoCart to the microfracture in the treatment of cartilage defects in the knee —NeoCart narrowly missed the primary endpoint of a statistically significant improvement in pain and function —Both NeoCart & microfracture were well tolerated with strong safety profiles —Improvements in KOOS subscales (p≤ 0.050) and IKDC subscales (P=0.0126) favoring NeoCart® at 1 year —Secondary outcomes met their target goals Primary endpoint narrowly missed NeoCart Micro- fracture ACI & other Products • Accelerated recovery and improved clinical efficacy    • Shorter recovery times    • Excellent safety profile    • Long term performance    • Fewer complications and re-operations    • Tissue quality and competence at implantation    • Biomechanical competence after 1 year    • Earlier weight-bearing and return to activity    NeoCart Highlights: Improved Outcomes Versus Established Suboptimal Alternatives COMBATING CONFOUNDERS: PROPOSED ALTERATIONS IN STUDY DESIGN  A dynamic randomization design should result in equipoise in the baseline confounders.  Ad hoc analyses demonstrated improvement in pain and function for the NeoCart group vs. microfracture for the following factors: • Larger lesion sizes • Younger patients • Larger BMI (Body Mass Index)  These confounding factors will be controlled for using dynamic randomization in addition to: • Baseline KOOS (Knee Injury and Osteoarthritis Outcome Score) pain • Baseline KOOS ADL (Activities of Daily Living) • Maximum ICRS (International Cartilage Repair Society) Score on MRI PRIMARY OUTCOMES EFFICACY: To demonstrate that NeoCart®, improves pain and function in the repair of knee cartilage defects and is superior to the comparator. SAFETY: To evaluate NeoCart® safety up to 5 years post-implantation CO-PRIMARY EFFICACY ENDPOINT Mean change from baseline to 2 years for the Patients’ Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function Activities of Daily Living (ADL) subscale scores. SECONDARY SAFETY OBJECTIVE To evaluate NeoCart® safety in the repair of cartilage defects of the femoral condyles and/or trochlea. A PROPOSED RANDOMIZED COMPARISON OF NEOCART® TO A COMPARATOR ARM FOR THE KNEE ARTICULAR CARTILAGE REPAIR Screening n = 249 Endpoints at 1 Year Key Inclusion Criteria • Age: 18-59 • Severe and symptomatic cartilage lesions (0.5-6cm2) • Femoral condyle and/or trochlear lesions Ra nd om iz at io n Primary • Knee pain/function improvement: ‒ ≥12 pts KOOS pain ‒ ≥20 pts IKDC Subjective Key Exclusion Criteria • Prior lesion treatment • High BMI • Significant arthritis • Concomitant surgeries Secondary • Time to full weight-bearing • Failure: Reop or deterioration • Collagen layering via MRI Arm 1: NeoCart (n = 169) Arm 2: Microfracture (n = 80) Study parameters: