Legend Biotech Corp. · NASDAQ:LEGN
Legend Biotech — Investor Presentation (June 2021)
32 slides from Legend Biotech's investor presentation, Jun 9, 2021
Slide 1: Inspired by the human element to advance cell therapy
Inspired by the human element to advance cell therapy June 2021 “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 $200 million in milestone payments to dateUp to an additional $1,150 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
InfectiousDiseases SolidTumors Preclinical Phase 1 Phase 2 Phase 3 Autologous TCL(CD4) AML(CD33 x CLL-1) NHL-DLBCL(CD19 x CD20 x CD22) MM*(BCMA) Allogeneic NHL-DLBCL, FL, MCL, SLL (CD20) HIV (Undisclosed) LEGEND-2+ CARTITUDE-4 Gastric(Claudin 18.2) Ovarian (MSLN) Hematologic Malignancies CARTIFAN-1
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 $1,025 million Potential Additional Manufacturing
Slide 9: Highly Experienced Management Team
Highly Experienced Management Team 9 CHINA US FRANK FANChief Scientific Officer & Co-Founder ELIZABETH GOSENGlobal Manufacturing YING HUANG Chief Executive Officer/ Chief Financial Officer Lida PacaudClinical Development TRACY LUOClinical Development CHONG YANGCommercial Development SIMON WUResearch
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, Proteasome Inhibitor; IMiD, immunomodulatory drug; MM, multiple myeloma; OS, overall survival 1. Cancer Stat Facts: Myeloma. https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed June 2021. 2. Facts and Stati
Slide 12: LEGEND-2: 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) Black/African American, n (%) 17 (17.5) All plasmacytomas,a n (%) 19 (19.6) Extramedullary plasmacytomas, n (%) 13 (13.4) Bone-based plasmacytomas, n (%) 6 (6.2) Bone-marrow pl
Slide 16: CARTITUDE-1: Overall Response Rate
CARTITUDE-1: Overall Response Rate Data cut-off: Feb 11, 2021; CR, complete response; MRD, minimal residual disease; ORR, overall response rate; sCR, stringent complete response; VGPR, very good partial response. ORR assessed by independent review committee. aSubgroups by number of prior lines of th
Slide 17: CARTITUDE-1: Progression Free Survival
CARTITUDE-1: Progression Free Survival 17 Progression-Free Survival, Patients (%) Months All Patients sCR Median: 22.8 months (95% CI, 22.8–NE) Median: not reached 18-month PFS:All Patients: 66.0% (95% CI, 54.9–75.0)sCR: 75.9% (95% CI, 63.6–84.5)18-month OS:All patients: 80.9% (95% CI, 71.4–87.6) 97
Slide 18: CARTITUDE-1: Safety
18 CARTITUDE-1: Safety Data cut-off: Feb 11, 2021; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; HLH, hemophagocytic lymphohistiocytosis. aCRS was graded using Lee e
Slide 19: CARTITUDE-2: Multicohort Study, Cohort A
CARTITUDE-2: Multicohort StudyCohort A: 1 – 3 prior lines, lenalidomide refractory RRMM 19 CARTITUDE-2 is a phase 2, multicohort, open-label study assessing the efficacy and safety of cilta-cel in patients with multiple myeloma in various clinical settingsCohort A:Cohort A patients had progressive M
Slide 20: CARTITUDE-2: Phase 2 Multi-Cohort Study
20 CARTITUDE-2: Phase 2 Multi-Cohort Study Cohort A included 20 patients who had progressive MM after 1–3 prior lines of therapy and were refractory to lenalidomideMedian prior lines of therapy: 2 (range, 1-3); 1 patient treated in an outpatient setting ≥VGPR 85% ≥CR 75% ORR: 95% (19/20a) Patients,
Slide 21: AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell–associated neurotoxicity syndrome; TEAE,
21 AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell–associated neurotoxicity syndrome; TEAE, treatment-emergent AE. aTwo patients with ongoing symptoms continued to improve at the time of data cutoff; patient management strategies were implemented, including enhanced br
Slide 22: Clinical Program: Cilta-cel Studies in Multiple Myeloma
Clinical Program: Cilta-cel Studies in Multiple Myeloma 22 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. Clinicalt
Slide 23: Global Manufacturing Network
Global Manufacturing Network 23 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 24: Future Potential Milestone Payments
Future Potential Milestone Payments 24 Clinical Milestones: $105M $105 million for the achievement of specified future development milestones $710 million for the achievement of specified regulatory milestones Regulatory Milestones: $710M Further milestone payments of up to $125 million for the achi
Slide 25: Program Areas of Development
Program Areas of DevelopmentLegend Biotech is utilizing the extensive cell therapy experience of our leadership and R&D staff, global clinical partners, and expanding research facilities to realize the potential of cell therapy to treat diseases that are thought to be incurable, such as hematologic
Slide 26: LB1901: Investigational CAR-T for T Cell Lymphoma
LB1901: Investigational CAR-T for T Cell Lymphoma 26 MoA/ Scientific Rationale Target Clinical Development LB1901 targets CD4 antigen that is expressed in most T cell lymphoma (TCL) subtypes and in subsets of normal immune cellsLB1901 is a CD8-enriched anti-CD4 CAR-T and contains a unique binder to
Slide 27: LB1908: Investigational CAR-T for Gastric Cancer
LB1908: Investigational CAR-T for Gastric Cancer 27 MoA/ Scientific Rationale Target Clinical Development LB1908 targets Claudin (CLDN) 18.2 through high-affinity VHH antibodyVHH antibody, identified via in-house, selectively binds to CLDN 18.2 Claudins are a family of tight junction proteins1CLDN18
Slide 28: LB1905: Investigational Allogenic CAR-T
LB1905: Investigational Allogenic CAR-T MoA/ Scientific Rationale Target Clinical Development LB1905 targets CD20 that is expressed in B cell lymphoma LB1905 applied Legend UniCAR technology which is an unique non-gene-editing allogeneic CAR-T platformSimple and efficient manufacturing promote produ
Slide 29: Near-Term Targets for Legend Biotech
Near-Term Targets for Legend Biotech 29 File BLA in China for cilta-cel Targeted FDA approval for cilta-cel in US (PDUFA target action date Nov 29, 2021) 2H21 US: United States; BLA: Biologics License Application; FDA: Federal Drug Administration; PDUFA: Prescription Drug User Fee Act; MAA: Marketin
Slide 30: Investment Highlights
Investment Highlights 30 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 with MM; BLA for cilta-cel submitted to US FDA (PDUFA target action date Nov 29,
Slide 31: 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 32: Thank You!
Thank You ! BIOTECH