Legend Biotech Corp. · NASDAQ:LEGN
Legend Biotech — Investor Presentation (January 2021)
25 slides from Legend Biotech's investor presentation, Jan 11, 2021
Slide 1: Inspired by the human element to advance cell therapy
Inspired by the human element to advance cell therapy “LEGEND B ! O FT EsGar Unleashing the power of patients
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Legend Biotech Corporation (“Legend Biotech” or the “Company”) solely for information purpose and does not contain all relevant information relating to the Company.The safety and efficacy of the agents and/or uses under investigation discussed in thi
Slide 3: Cell Therapy Platform Overview
Cell Therapy Platform Overview
Slide 4: We Are A Fully Integrated Global Cellular Therapy Company
FUTURE PIPELINE Global collaboration with Janssen for the development of cilta-cel established December 2017Received an upfront payment of $350 million and a total of $110 million in milestone payments to dateUp to an additional $1,165 million in potential future milestone payments We Are A Fully In
Slide 5: Legend Biotech's Global R&D Strategy
Legend Biotech’s Global R&D Strategy 5 With a Presence in Major Geographies, our Mission is to Improve the Lives of Patients Worldwide CAR, Chimeric Antigen Receptor; TCR, T-Cell Receptor CoreTechnologies Disease Areas Product Platforms Hematologic Malignancies CAR Autologous Allogeneic TCR Solid Tu
Slide 6: End-to-End R&D Capability
End-to-End R&D Capability 6 Proprietary methodology to optimize the selection of binding domains and design CAR-T constructs with two or more antigen-binding domains Robust in vitro and in vivo screening platforms to prioritize pipeline assets High-throughput antibody screening and engineering capab
Slide 7: Robust Pipeline of Next-Generation Cell Therapies
Robust Pipeline of Next-Generation Cell Therapies 7 InfectiousDiseases SolidTumors Preclinical Phase 1 Phase 2 Phase 3 Autologous TCL(CD4) NHL-DLBCL(CD19 x CD22) AML(CD33 x CLL-1) MM*(BCMA) Allogeneic NHL-DLBCL, FL, MCL, SLL (CD20) HIV (Undisclosed) LEGEND-2 CARTITUDE-4 Pancreatic Cancer(Claudin 18.
Slide 8: Legend and Janssen Global Collaboration
Legend and Janssen Global Collaboration 8 Worldwide collaboration and license agreement to develop and commercialize cilta-cel US 50 / 50 Europe 50 / 50 Greater China 70 / 30 Legend / Janssen Japan50 / 50 Potential Additional Milestone Paymentsup to $1,040 million Potential Additional Manufacturing
Slide 9: Highly Experienced Management Team
Highly Experienced Management Team 9 CHINA US TRACY LUOClinical Development CHONG YANGCommercial Development FRANK FANResearch & Development SIMON WUResearch & Development YUHONG QIUGlobal Regulatory STEVE GAVELCommercial Development ALAN KICKGlobal Quality ELIZABETH GOSENGlobal Manufacturing MEETA
Slide 10: Cilta-cel Clinical Development
Cilta-celClinical Development
Slide 11: Multiple Myeloma: Blood Cancer with a High Unmet Need
Multiple Myeloma: Blood Cancer with a High Unmet Need 11 CI, confidence interval; PI, Protease Inhibitor; IMiD, immunomodulatory drug; MM, multiple myeloma; OS, overall survival 1 Cancer Stat Facts: Myeloma. https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed March 2020. 2 Palumbo A, et al.
Slide 12: First-in-Human, Phase 1, Dose Finding Study in RRMM
First-in-Human, Phase 1, Dose Finding Study in RRMM LEGEND-2: LCAR-B38M CAR-T cells 12 Shanghai Jiangsu Province Hospital2 Chen, ASH 2019 Poster Nanjing Second Affiliated Hospital of Xi’an Jiaotong University1 Wang et al, ASH 2019 Oral Presentation Xi’an Data cut-off: 31 July 2019 (N=57) and 31 Octo
Slide 13: LEGEND-2: Long-Term Deep Responses and High Response Rate
LEGEND-2: Long-Term Deep Responses and High Response Rate 13 ORRa = 88% 74%(n=42) 4%(n=2) 11%(n=6) 9%(n=5) 2%(n=1) 2%(n=1) 82%(n=14) 6%(n=1) 12%(n=2) Xi'an: Best overall response (N=57)1 ORRa = 88% Median time to initial response= 1 month2mPFS = 18 months; mOS= not reached2 mDOR= 27.0 months (mDOR f
Slide 14: CARTITUDE-1: Phase 1b/2 Study Design
Post-infusion AssessmentsSafety, Efficacy, PK, PD, Biomarker Screening (28 Days) Apheresis Bridging Therapya (as needed) Cy (300 mg/m2) + Flu (30 mg/m2) Cilta-cel InfusionTarget: 0.75x106 (0.5 – 1.0x106) CAR+ viable T cells/kg Follow-up CARTITUDE-1: Phase 1b/2 Study Design 14 14 Day -5 to -3 Day 1 P
Slide 15: CARTITUDE-1: Baseline Characteristics
15 CARTITUDE-1: Baseline Characteristics Characteristic N=97 Age, median (range) years 61.0 (43–78) Male, n (%) 57 (58.8) Extramedullary plasmacytomas ≥1, n (%) 13 (13.4)a Bone-marrow plasma cells ≥60%, n (%) 21 (21.9) Years since diagnosis, median (range) 5.9 (1.6–18.2) High-risk cytogenetic profil
Slide 16: CARTITUDE-1: Safety
16 Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177. N = 97 Any Grade Grade 3/4 Hematologic AEs, (≥30%), n (%) 97 (100) 96 (99.0) Neutropenia 93 (95.9) 92 (94.8) Anemia 79 (81.4) 66 (68.0) Thrombocytopenia 77 (79.4) 58 (59.8) Leukopenia 60 (61.9) 59 (60.8) Lymp
Slide 17: CARTITUDE-1: Early, Deep Responses and High Response Rate
17 CARTITUDE-1: Early, Deep Responses and High Response Rate Data cut-off: 01 Sept 2020; aPR or better, Independent Review Committee assessed. bNo patient had CR or stable disease as best response. cMRD was assessed in evaluable samples at 10-5 threshold by next-generation sequencing (clonoSEQ, Adap
Slide 18: CARTITUDE-1: PFS
18 CARTITUDE-1: PFS Overall PFS Overall 12-month PFS: 76.6% (95% CI, 66.0–84.3)Median PFS not reached Data cut-off: 01 Sept 2020; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.Madduri et al. ASH Annual M
Slide 19: Clinical Program: Cilta-cel Studies in Multiple Myeloma
Clinical Program: Cilta-cel Studies in Multiple Myeloma 19 DPd=daratumumab, pomalidomide, dexamethasone; EU=European Union; JP=Japan; PVd=pomalidomide, bortezomib, dexamethasone; RRMM=relapsed and/or refractory multiple myeloma; SoC=standard of care; US=United States. 1 NCT03090659. Clinicaltrials.g
Slide 20: Global Manufacturing Network
Global Manufacturing Network 20 EU Facility In Planning US Facilities China Facilities Raritan, NJ Nanjing Zhenjiang Somerset, NJ BCMA US / EU / JP / ROW Launch/ Commercial SiteGMP Operational BCMA China Launch Site & Legend Clinical Supply SiteGMP Operational Additional Commercial Site Construction
Slide 21: Future Potential Milestone Payments
Future Potential Milestone Payments 21 Clinical Milestones: $105M $105 million for the achievement of specified future development milestones $725 million for the achievement of specified regulatory milestones Regulatory Milestones: $725M Further milestone payments of up to $125 million for the achi
Slide 22: Near-Term Targets for Legend Biotech
Near-Term Targets for Legend Biotech 22 File BLA in China for cilta-cel Targeted FDA approval for cilta-cel in US 1H21 2H21 US: United States; BLA: Biologics License Application; FDA: Federal Drug Administration; MAA: Marketing Authorization Application; EMA: European Medicines Agency Targeted CDE a
Slide 23: Investment Highlights
Investment Highlights 23 Global Collaboration Global collaboration with Janssen for the development of cilta-cel with ongoing clinical trials Deep and durable anti-tumor responses observed in heavily pretreated patients; initiation of BLA submission with the FDA took place in December 2020 Promising
Slide 24: In the world of cell therapy, some biotechs have an Eastern perspective
Inthe world of cell therapy, some biotechs have an Eastern perspective. Others have a Western perspective.
Slide 25: Thank You!
Thank You ! BIOTECH
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