Exhibit 99.1
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 this presentation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Legend Biotech's own internal estimates and research. While Legend Biotech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. While Legend Biotech believes its internal research is reliable, such research has not been verified by any independent source. Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements relating to the Company’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions in the United States, Europe and Asia, including the ongoing BLA filings for cilta-cel to the U.S. FDA, the submission of a marketing authorization application for cilta-cel to the EMA, and the submission of an IND LB1901 in relapsed or refractory TCL; the ability to generate, analyze and present data from clinical trials; patient enrollment; anticipated timing regarding regulatory approvals by the FDA, EMA or CDE; and the potential benefits of Legend Biotech’s product candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Company’s prospectus filed with the Securities and Exchange Commission on June 8, 2020. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this presentation as anticipated, believed, estimated or expected. Any forward-looking statements contained in this presentation speak only as of the date of this presentation. None of the Company nor any of its affiliates, advisers, or representatives has any obligation and does not undertake to update any forward-looking statements to reflect future events or circumstances. 2
Cell Therapy Platform Overview
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 Integrated Global Cellular Therapy Company 4 RRMM: Relapsed and/or Refractory Multiple Myeloma; AML: acute myeloid leukemia; KOL: key opinion leaders*Legal entity to the agreement is Janssen Biotech, Inc. COMPELLING DATA WITHINNOVATIVE PIPELINE GLOBAL COLLABORATION WITH JANSSEN* INTEGRATED CELL THERAPY PLATFORM In-house antibody generation and CAR-T specific functional screening technologiesEarly clinical proof-of-concept, leveraging KOL relationships in China, the US and globallyBuilding large-scale manufacturing facilities in the United States, Europe and China>800 employees worldwide in US, China and Europe Lead product candidate ciltacabtagene autoleucel (cilta-cel) may have the potential to deliver deep and durable anti-tumor responses in RRMMBroad portfolio of earlier-stage autologous product candidates targeting both hematologic and solid cancers, as well as allogeneic CAR-T approaches AML LYMPHOMA GASTRIC CANCER OVARIAN CANCER INFECTIOUS DISEASE
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 Tumors Infectious Diseases
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 capability including single-domain antibodies generated from Llama and conventional antibodies Binding Domain Selection and Construct Design Pre-clinical Validation Antibody Screening Platforms Clinical Proof of Concept Efficient clinical translation, leveraging deep relationships with KOLs in US and China
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 18.2) Gastric Cancer(Claudin 18.2) Ovarian Cancer (MSLN) Hematologic Malignancies CARTITUDE-1 CARTIFAN-1 CARTITUDE-2 US / RoW China AML=acute myeloid leukemia, BCMA=B-cell maturation antigen, DLBCL=diffuse large B-cell lymphoma, FL=follicular lymphoma, HIV= human immunodeficiency virus, MCL=mantle cell lymphoma, NHL=non-Hodgkin lymphomas, MM= multiple myeloma, MSLN=mesothelin, RoW=Rest of World, SLL=small lymphocytic lymphoma, TCL=T-cell lymphoma*In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson MM (BCMA) US / China
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 Milestone Paymentsup to $125 million First Milestone$25 millionDec 2018 Fourth Milestone$30 millionJan 2020 Third Milestone$30 millionJul 2019 Second Milestone$25 millionJul 2019 Upfront Payment$350 millionQ1 2018 Fifth Milestone$75 millionDecember 2020
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 CHATTERJEEGlobal Business Development QIONG WANGResearch & Development YING HUANG Chief Executive Officer/ Chief Financial Officer
Cilta-celClinical Development
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. N Engl J Med. 2011;364(11):1046–60. 3 Globocan 2018 World Fact Sheet: World. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed March 2020. 4 Globocan 2018 World Fact Sheet: United States of America. http://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf. Accessed March 2020. 5 Globocan 2018 World Fact Sheet: Europe. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Accessed March 2020. 6 Globocan 2018 World Fact Sheet: China. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed March 2020. 7 Gandhi UH, et al. Leukemia. 2019;33:2266-75. US: Incidence is 25,962, with mortality of 13,6484 EUROPE: Incidence is 48,297, with mortality of 30,8605 CHINA: Incidence is 20,066, with mortality of 14,6556 160,000 NEW CASES WORLDWIDE IN 2018,accounting for 1% of worldwidenew cancer cases3 1.0 0.8 0.6 0.4 0.2 0.0 0 10 20 30 40 50 Months Proportion Surviving Non-triple-refractory (N=57) Triple-and quad-refractory (N=148) Penta-refractory (N=70) P=0.002 POOR SURVIVAL OUTCOMES IN MULTIPLE REFRACTORY MMMedian OS < 12 months 3RD MOST COMMON BLOOD CANCER1, accounting for >10% of all hematologic cancer2 in patients refractory to anti-CD38, ≥ 1 PI(s) and / or ≥ 1 IMiD(s)7 Median OS for each group Median OS(months) 95% Cl Non-triple-refractory 11.2 (5.4–17.1) Triple-and quad-refractory 9.2 (7.1–11.2) Penta-refractory 5.6 (3.5–7.8)
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 October 2019 (N=17);1 Wang B-Y et al. Abstract presented at: 61st ASH Annual Meeting 2019; December 7-10, 2019; Orlando, FL2 Chen, et al. ASH 2019. Abstract #1858; Orlando, FL Shanghai Ruijin Hospital2Chen, ASH 2019 Poster Shanghai Changzheng Hospital2Chen, ASH 2019 Poster Xi’an Nanjing Shanghai Enrollment Total: 74 patients (4 sites in China) Xi’an: N=57, Wang, et al. ASH 2019JS/RJ/CZ sites: N=17, Chen, et al. ASH 2019 Active MM defined by IMWG criteria with documented disease progression during or within 12 months of most recent anti-MM drugs or auto-HSCTRelapsed on prior regimens Key Inclusion Criteria1,2 Administered dose (CAR+ viable T cells/kg) Xi'an1 (median)=0.5x106 (0.07-2.1x106)RJ/CZ/JS2 (mean)=0.70x106 (0.2–1.5x106) Preconditioning Cyclophosphamide only (Xi’an, Jiangsu)1,2Cyclophosphamide + fludarabine (Changzheng, Ruijin)2 Safety & Tolerability Cilta-cel CAR-T cells displayed a safety profile consistent with other safety reports of BCMA-targeting CAR-T cell therapy1,2
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 for CR= 29.1 months)1Median time to initial response= 1 month1mPFS= 19.9 months (mPFS for CR= 28.2 months)1 mOS = 36.1 months (mOS for CR not reached)1 Ruijin (RJ), Jiangsu (JS), Changzheng (CZ): Best overall response (N=17)2 Median follow-up 25 months Median follow-up 26 months Data cut-off: 31 July 2019 (N=57) and 31 October 2019 (N=17); Xi'an: NE patient died of PE/ACS prior to first evaluation. RJ,JS, CZ: For NE patients, 1 patient died on Day 13 due to CRS and tumor lysis syndrome; 1 patient received chemotherapy prior to first assessment and was censored. a ORR=PR or better; response assessed per International Myeloma Working Group criteriaCR, complete response; VGPR, very good partial response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable; mDOR, median duration of response; MRD, minimal residual disease; ORR, overall response rate; mPFS, median progression free survival; mOS, median overall survival.1 Wang B-Y et al. Abstract presented at: 61st ASH Annual Meeting 2019; December 7-10, 2019; Orlando, FL; 2 Chen, et al. ASH 2019. Abstract #1858
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 Primary Objectives Key Inclusion Criteria Administered dose Median administered dose was 0.71x106(0.51 – 0.95x106) CAR+ viable T cells/kg Progressive MM per IMWG criteriaECOG PS ≤1 Measurable diseaseReceived ≥3 prior therapies or double refractoryPrior PI, IMiD, anti-CD38 therapy Phase 1b: Characterize the safety of cilta-cel and confirm the recommended phase 2 dosePhase 2: Evaluate the efficacy of cilta-cel by ORR NCT03548207; Data cut-off: 01 Sept 2020; a Treatment that was received previously and resulted in at least stable disease. Cy=cyclophosphamide; ECOG PS=Eastern Cooperative Oncology Group performance status; Flu=fludarabine; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; PI=proteasome inhibitor; PD=pharmacodynamic; PK=pharmacokinetic ; MM=multiple myelomaMadduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177..
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 profile, n (%) 23 (23.7) del17p 19 (19.6) t(14;16) 2 (2.1) t(4;14) 3 (3.1) Tumor BCMA expression ≥50%, n (%) 57 (91.9)b Characteristic N=97 Prior lines of therapy, median (range) 6.0 (3–18) Previous stem-cell transplantation, n (%) Autologous 87 (89.7) Allogenic 8 (8.2) Triple-class exposed,c n (%) 97 (100) Penta-exposed,d n (%) 81 (83.5) Triple-class refractoryc 85 (87.6) Penta-refractoryd 41 (42.3) Refractory status, n (%) Carfilzomib 63 (64.9) Pomalidomide 81 (83.5) Anti-CD38 antibody 96 (99.0) Refractory to last line of therapy, n (%) 96 (99.0) Data cut-off: 01 Sept 2020; aAdditional 6 patients had a soft-tissue component of a bone-based plasmacytoma (total plasmacytomas, 19.6%). bDenominator n=62, the number of evaluable samples; BCMA expression detected in all evaluable samples. cAt least 1 PI, at least 1 IMiD, and 1 anti-CD38 antibody. dAt least 2 PIs, at least 2 IMiDs, and 1 anti-CD38 antibody.BCMA, B-cell maturation antigen; IMiD, immunomodulatory drug; PI, proteasome inhibitor. Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177
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) Lymphopenia 51 (52.6) 48 (49.5) Non-hematologic AEs (≥30%), n (%) Hypocalcemia 31 (32.0) 3 (3.1) Hypophosphatemia 30 (30.9) 7 (7.2) Fatigue 36 (37.1) 5 (5.2) Cough 34 (35.1) 0 CAR-T-associated AEs, n (%) CRS 92 (94.8) 4 (4.1) Neurotoxicity 20 (20.6) 9 (9.3) Data cut-off: 01 Sept 2020; aEvents not reported as ICANS [ie, onset after a period of recovery from CRS and/or ICANS]). bAmong 12 patients with other NTX, 5 had AEs including movement and/or neurocognitive changes, and 7 had AEs including nerve palsy and peripheral motor neuropathy. AE, adverse event; CAR-T, chimeric antigen receptor T cell; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome. CARTITUDE-1: Safety CRS94.6% of patients experienced low-grade CRS (n=92)Median time to onset of 7 days (range, 1-12)Median duration of 4 days (range, 1-97) and managed with supportive care measures Neurotoxicity20.6% of patients experienced neurotoxicity in total with overlap between ICANS and Other Neurotoxicities (Grade ≥3: 10.3%)ICANS observed in 16.5% (Grade ≥3: 2.1%)Other Neurotoxicities observed in 12.4% (Grade ≥3: 9.3%)Deaths14 total deaths observedDeaths due to progressive disease (n=5)Deaths due to adverse events unrelated to treatment (n=3)Deaths due to adverse events related to treatment (n=6)
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, Adaptive Biotechnologies) in all treated patients at Day 28, and at 6, 12, 18, and 24 months regardless of the status of disease measured in blood or urine; patients were not evaluable primarily due to lack of an identifiable clone in the baseline bone marrow sample. dAll treated patients. CAR, chimeric antigen receptor; CR, complete response; MRD, minimal residual disease; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177 Median time to first response: 1 month (0.9–8.5)Responses ongoing in 70 (72.2%) patientsOf evaluable patients, 93.0% achieved MRD 10-5 negativityMedian time to MRD 10-5 negativity: 1 month (0.8–7.7) ≥VGPR: 92.8% sCR: 67.0% sCR VGPR PR Best responseb =
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 Meeting Virtual Experience; December 2-11, 2020; Abstract 177 PFS by sCR and VGPR At median duration of follow-up of 12.4 months (range, 1.5–24.9), median PFS has not been reached12-month PFS rate: 76.6% (95% CI, 66.0–84.3)12-month OS rate: 88.5% (95% CI, 80.2–93.5) No. at risk sCR VGPR 25 24 19 15 3 2 0 0 0 0 65 65 62 53 27 12 2 1 1 0 12-month PFSsCR: 84.5% (95% CI, 72.0–91.8)VGPR: 68.0% (95% CI, 46.1–82.5) Median PFS not reached in either group
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.gov website. https://clinicaltrials.gov/ct2/show/NCT03090659. Accessed Jan 2021; 2 NCT03548207. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed Jan 2021;3 NCT03758417. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03758417. Accessed Jan 2021; 4 NCT04133636. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT04133636. Accessed Jan 2021; 5 NCT04181827. Clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT04181827. Accessed Jan 2021 FIH Study in ChinaLong-term Follow-up Registrational Studies Earlier Lines of Therapy LEGEND-21 NCT03090659 NCT03548207 NCT03758417 NCT04133636 NCT04181827 Phase 1, multi-centerstudy of LCAR-B38M CAR-T cells in RRMMFully enrolled and ongoing in China Phase 2, multi-center confirmatory study ofcilta-cel in RRMMOngoing in China Phase 1b/2, multi-center registration study of cilta-cel in RRMMFully enrolled and ongoing in US and Japan Global, multi-cohort studyPhase 2 open-label study of cilta-cel in various clinical settings to evaluate MRD negativityEnrolling in US / EU/ Israel Global, randomized studyPhase 3 open-label study of cilta-cel vs DPd or PVd in patients with RRMM, 1–3 lines of prior therapy and refractory to lenalidomideEnrolling in US/EU/JP/AUS/ Israel CARTITUDE-1MMY20012 CARTIFAN-1MMY20023 CARTITUDE-2MMY20034 CARTITUDE-4MMY30025
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 in progress US / EU / JP Legend Clinical Supply SiteInitiating construction phase State-of-the Art Manufacturing Robust and Scalable Global Supply of Cell Therapies EU launch from Raritan, NJ, USEU Site in planning phase
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 achievement of specified manufacturing milestones Manufacturing Milestones: $125M $210 million for the achievement of specified net trade sales milestones. Commercial Milestones: $210M Future Milestones
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 approval for cilta-cel in China 2022 Targeted EMA approval for cilta-cel in EU 2022 Initiate phase 1 study for LB1901 for T-cell Lymphoma in US 2021 File MAA with EMA for cilta-cel 2H21
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 Clinical Data End-to-end R&D and manufacturing capabilities with two core technologies (CAR and TCR) and two platforms (Autologous and Allogeneic) Experienced team with broad involvement in biopharmaceutical drug discovery, development and commercialization Fully Integrated Platform Strong Management
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