LEGN Legend Biotech Corporation
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
LB1901
T-Cell Lymphoma
|
Phase 1
Phase 1
|
Phase 1 trial to be initiated.
|
|
LCAR-B38M/JNJ-4528 (CARTITUDE-1)
Multiple myeloma
|
BLA Filing
BLA Filing
|
BLA rolling submission announced December 21, 2020.
|
|
LB1904
Pancreatic Cancer
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
|
LB1904
Gastric cancer
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
|
LB1910
Acute myeloid leukemia (AML)
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
|
LB1909
Relapsed and refractory B-cell lymphoma
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
Latest News
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- Longer term follow-up data from the pivotal CARTITUDE-1 study of cilta-cel in heavily pretreated patients with relapsed or refractory multiple myeloma
- The first presentation of data from the CARTITUDE-2 study of cilta-cel in earlier lines of multiple myeloma treatment
Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that 15 abstracts have been accepted at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association's (EHA) 2021 Virtual Congress, including new and updated data from the CARTITUDE clinical development program being led by Janssen Research & Development, LLC (Janssen) for the investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel).
"The Legend Biotech team, together with our collaborator Janssen, look forward to sharing the updated efficacy and longer-term safety data for cilta-cel," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "These exciting data and a wide range of other abstracts highlight our continued commitment and efforts to developing innovative treatments that will make a difference in the lives of those living with multiple myeloma."
Longer-term follow-up efficacy and safety results from the Phase 1b/2 CARTITUDE-1 study of cilta-cel in patients with relapsed/refractory multiple myeloma (Abstract #8005) will be featured in an oral presentation at the 2021 ASCO Meeting and as a poster presentation at EHA (Abstract #EP964). Results from this study supported recent U.S. and European regulatory filings submitted by Legend Biotech's collaborator, Janssen.
For the first time, data from Cohort A of the CARTITUDE-2 study evaluating the safety and efficacy of cilta-cel in patients with progressive multiple myeloma who have received 1-3 prior lines of therapy, will be presented, being featured as a poster presentation at ASCO (Abstract #8013) and in an oral presentation at EHA (Abstract # S190). Poster presentations at both meetings will provide additional efficacy and safety information with cilta-cel in comparison to standard of care therapies and neurological adverse event mitigation measures.
Select abstracts from both Congresses are below.
ASCO Presentations (June 4-8, 2021)
Abstract No.
Title
Date/ Time
Abstract #8005
Oral Presentation
Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1
Tuesday, June 8th 8:00-11:00 AM EDT
Abstract #8013
Poster Discussion
CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy
Friday, June 4th @ 9:00AM EDT
Abstract #8028
Poster Presentation
Incidence, mitigation, and management of neurologic adverse events in patients with multiple myeloma (MM) treated with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-2
Friday, June 4th @ 9:00 AM EDT
Abstract #8045
Poster Presentation
Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 vs real-world standard of care (RW SOC) for patients (pts) with triple-class exposed relapsed/refractory multiple myeloma (RRMM)
Friday, June 4th @ 9:00 AM EDT
Abstract #8030
Poster Presentation
Cilta-cel vs. conventional treatment in patients with relapse/refractory multiple myeloma
Friday, June 4th @ 9:00 AM EDT
Abstract #8041
Poster Presentation
LocoMMotion: A prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma (RRMM) receiving ≥3 prior lines of therapy.
Friday, June 4th @ 9:00 AM EDT
The abstracts will be released on ASCO Meeting Library on May 19th, 2021 at 5:00 PM EDT.
EHA Presentations (June 9-17, 2021)
Abstract No.
Title
Date/ Time
Abstract #S190
Oral
Efficacy and safety of the BCMA-directed CAR-T cell therapy, ciltacabtagene autoleucel, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy: Initial results from CARTITUDE-2
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP964
EPoster
Updated CARTITUDE-1 results of ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP1003
EPoster
Incidence, mitigation, and management of neurologic adverse events in the phase 2 CARTITUDE-2 study of ciltacabtagene autoleucel in patients with multiple myeloma
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP987
EPoster
A prospective, non-interventional, multinational study of real-life standard of care in patients with relapsed/refractory multiple myeloma receiving ≥3 prior lines of therapy: Interim data from LocoMMotion
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP990
EPoster
Comparison of ciltacabtagene autoleucel versus conventional treatment in patients with relapsed/refractory multiple myeloma
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP1049
EPoster
Ciltacabtagene autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy: A matching adjusted indirect comparison
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP978
EPoster
Matching adjusted indirect comparison of ciltacabtagene autoleucel versus belantamab mafodotin in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy
Available starting Friday, June 11th @ 9:00AM CEST
Abstract #EP977
EPoster
Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 versus standard of care in triple-class exposed multiple myeloma patients in clinical trials of daratumumab
Available starting Friday, June 11th @ 9:00AM CEST
Abstract # EP972
EPoster
Ciltacabtagene autoleucel for triple-class exposed multiple myeloma: Adjusted comparison of CARTITUDE-1 outcomes versus real world clinical practice observed in German registry
Available starting Friday, June 11th @ 9:00AM CEST
The abstracts are available on the EHA website at: https://ehaweb.org/congress.
About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.
About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings. Cohort A included patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. The primary objective was percentage of patients with negative minimal residual disease (MRD).2
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient's disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections. 8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9
About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.
Legend Biotech is engaged in a strategic collaboration to develop and commercialize the lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's clinical efforts, its partnership with Janssen, and the data relating to CARTITUDE-1 and LEGEND-2 studies. 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the "Risk Factors" section of the Annual Report filed with the Securities and Exchange Commission on April 2, 2021. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.
References
1. CARTITUDE-1 (NCT03548207). Available: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed November 2020.
2. CARTITUDE-2 (NCT04133636). Available: https://clinicaltrials.gov/ct2/show/NCT04133636. Accessed April 2021.
3. American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed November 2020.
4. Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
5. National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed November 2020.
6. National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed November 2020.
7. Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
8. American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed November 2020.
9. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.
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Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European Medicines Agency of the application based on positive Phase 1b/2 CARTITUDE-1 study data
Legend Biotech Corporation (NASDAQ:LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma.
Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated as a treatment for multiple myeloma. The MAA is based on positive results from a Phase 1b/2 CARTITUDE-1 study, which were presented at the American Society of Hematology (ASH) 2020 Annual Meeting.1 The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend's collaboration partner for cilta-cel.
"Today's submission is a testimony to the promising results we have seen from the CARTITUDE-1 study showing the efficacy and safety of cilta-cel for treating patients with multiple myeloma who are heavily pretreated and in need of treatment options," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We are proud of our collaboration with Janssen and look forward to bringing this personalized treatment to patients in the EU following the accelerated assessment."
The EMA's Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for this MAA. An accelerated assessment is granted when the CHMP determines that a medicinal product is of major public health interest and therapeutic innovation and can significantly reduce the review timelines to evaluate an MAA.2 Cilta-cel previously received a PRIority MEdicines (PRIME) designation from the EMA. A Biologics License Application (BLA) seeking approval of cilta-cel based on the CARTITUDE-1 study is currently under review with the United States Food and Drug Administration.
About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], proteasome inhibitor [PI] and 1 anti-CD38 antibody).3 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.
About Ciltacabtagene autoleucel (cilta-cel)
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse.5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient's disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.
Legend is engaged in a strategic collaboration to develop and commercialize the lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's clinical efforts, its partnership with Janssen, and the regulatory submissions and reviews relating to cilta-cel, including the EMA's accelerated assessment of the MAA for cilta-cel. 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. 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; and unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; as well as the other factors discussed in the "Risk Factors" section of the Company's Annual Report filed with the Securities and Exchange Commission on April 2, 2021. 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 press release as anticipated, believed, estimated or expected. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Madduri, D et al. CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma. Oral Presentation. Presented at 2020 American Society of Hematology Annual Meeting.
2 EMA. Accelerated Assessment. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment. Last accessed April 2021.
3 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Last accessed April 2021.
4 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed April 2021.
5 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
6 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed April 2021.
7 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed April 2021.
8 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
9 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed April 2021
10 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.View source version on businesswire.com: https://www.businesswire.com/news/home/20210430005260/en/
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- Legend received approximately $659.8 million in gross proceeds through share capital increases during 2020, including a successful Nasdaq IPO with aggregate gross proceeds of $487.3 million.
- U.S. FDA clearance for IND application for a Phase 1 clinical trial to evaluate LB1901 in relapsed or refractory T-cell lymphoma (RR TCL).
- Rolling submission of BLA to the FDA initiated for cilta-cel for the treatment of relapsed or refractory multiple myeloma (RRMM).
- Cash and cash equivalents and time deposits of $505.7 million as of December 31, 2020.
Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported its unaudited financial results for the three months and year ended December 31, 2020.
"This was a defining year for Legend Biotech, as we achieved important pipeline advancements and completed our initial public offering and Nasdaq listing," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "Despite the challenges presented by the COVID-19 pandemic, we have achieved a strong 2020 and are continuing this momentum with significant advancements planned for our oncology pipeline during 2021. Through our collaboration with Janssen Biotech, Inc. (Janssen)*, in 2020, we initiated a global Phase 3 study and expanded the multi-cohort Phase 2 study as part of a comprehensive clinical development program for ciltacabtagene autoleucel (cilta-cel), including as an earlier lines of multiple myeloma treatment. In 2021, we expect to achieve important milestones in advancing the regulatory approval process for cilta-cel."
*In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.
Fourth Quarter 2020 & Recent Highlights
- In February 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) accepted a request from Janssen for the accelerated assessment of the cilta-cel Marketing Authorisation Application (MAA) for the treatment of adults with RRMM.
- In December 2020, Legend Biotech announced that Janssen had initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a biologics license application (BLA) for cilta-cel for the treatment of adults with RRMM. Pursuant to the terms of Legend Biotech's agreement with Janssen, Legend received a $75.0 million milestone payment relating to the clinical development of cilta-cel in connection with the initiation of the BLA submission.
- In December 2020, the FDA cleared an investigational new drug (IND) application for Legend Biotech to evaluate LB1901 in a Phase 1 clinical study for the treatment of adults with RR TCL.
- Data from the combined Phase 1b/2 CARTITUDE-1 study of cilta-cel was presented at the 62nd American Society of Hematology (ASH) Annual meeting in December 2020, showing a high overall response rate that deepened over time, with 97% of patients achieving an overall response and 67% of patients achieving a stringent complete response (sCR) at a median follow-up of 12.4 months.
Recent Appointments
- During 2020, Legend Biotech bolstered its leadership team with the appointment of Dr. Ying Huang as Chief Executive Officer, the appointment of Ye (Sally) Wang as Chairwoman of the Board of Directors, and the appointment of two new directors, Dr. Li Zhu and Dr. Patrick Casey.
- In March 2021, Lori Macomber was appointed as Legend Biotech's Vice President, Finance, in which capacity Ms. Macomber will serve as Legend Biotech's principal financial officer and principal accounting officer. Ms. Macomber has served as Legend Biotech's Vice President of Supply Chain Finance and Controller since September 2019. Prior to joining Legend Biotech, Ms. Macomber served as Business Unit Controller at Ametek PDS, a leading supplier of components and systems for the aerospace and defense industries, from April 2018 and as U.S. CFO and Controller of Cello Health from March 2017 until February 2018. Before this Ms. Macomber held various positions, most recently AVP Finance Site Leader, at Eli Lilly & Company where she was employed from May 2010 until March 2017. Ms. Macomber holds a Bachelor of Science in Accounting from Pennsylvania State University and is a Certified Public Accountant.
- In January 2021, Lida Pacaud, M.D., joined Legend Biotech as its Vice President of Clinical Development. Dr. Pacaud, joined Legend Biotech from Novartis International AG, where she held various positions from September 2013 through January 2021, most recently serving as the Global Clinical Program Head and Executive Medical Director in its Cell & Gene unit. Prior to this, Dr. Pacaud worked at Roche and Wyeth. Dr. Pacaud has been the Medical Lead on several global Phase I, II & III trials and led the clinical development and filling for the first approved CAR T therapy worldwide. Dr. Pacaud holds a Doctor of Medicine degree and certification in Pediatrics from Tbilisi State Medical University and has trained in Pediatric Oncology and hematology in France.
Key Upcoming Milestones
- Legend Biotech's collaborator, Janssen, anticipates submitting a MAA for cilta-cel for the treatment of adults with RRMM to the EMA in the first half of 2021.
- Legend Biotech intends to use the data from the CARTIFAN-1 study in support of a regulatory submission to the China Center for Drug Evaluation (CDE) seeking approval of cilta-cel for the treatment of adults with RRMM. Legend Biotech expects the submission of the application to occur in the second half of 2021.
- Legend Biotech's collaborator, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Ministry of Health, Labor and Welfare (JMHLW) in the second half of 2021 seeking approval of cilta-cel for the treatment of adults with RRMM.
- Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR TCL in the United States in 2021.
- Legend Biotech, in collaboration with Janssen, intends to present updated data from the CARTITUDE-1 and data from CARTITUDE-2 studies at major medical conferences in 2021.
- Legend Biotech anticipates supporting investigators with publishing a clinical data update from LEGEND-2 study in 2021.
As the global COVID-19 pandemic continues to evolve, Legend Biotech has continuously monitored the situation in regards to its operations and has put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. Given the dynamic global situation, Legend Biotech notes that certain clinical trial timelines may be impacted.
Financial Results for the Quarter and Year Ended December 31, 2020
Cash and Cash Equivalents and time deposits:
As of December 31, 2020, Legend Biotech had approximately $455.7 million of cash and cash equivalents and approximately $50.0 million in time deposits.
Revenue
Revenue for the three months ended December 31, 2020 was $40.8 million compared to $19.5 million for the three months ended December 31, 2019. The increase of $21.3 million was primarily due to revenue recognition of additional milestone payment achieved of higher amount pursuant to Legend Biotech's agreement with Janssen and the associated constrained variable consideration is relieved. Revenue for the year ended December 31, 2020 was $75.7 million compared to $57.3 million for the year ended December 31, 2019. Similarly, the increase of $18.4 million for the year ended December 31, 2020 was primarily driven by revenue recognized from an additional milestone achieved of higher amount. Legend Biotech has not generated any revenue from product sales to date.
Research and Development Expenses
Research and development expenses for the three months ended December 31, 2020 were $66.9 million compared to $66.1 million for the three months ended December 31, 2019. This increase of $0.8 million was primarily due to an increase in employee benefit expense and research and development expense, net-off by a decrease in collaborative research and development expenses. Research and development expenses for the year ended December 31, 2020 was $232.2 million compared to $161.9 million for the year ended December 31, 2019 with a $70.3 million increase. The year-over-year increase was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the year ended December 31, 2020.
Administrative Expenses
Administrative expenses for the three months ended December 31, 2020 were $9.2 million compared to $2.0 million for the three months ended December 31, 2019. The increase of $7.2 million was primarily due to Legend Biotech's expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the year ended December 31, 2020 increased by $16.3 million, which was $23.1 million compared to $6.8 million for the year ended December 31, 2019.
Selling and Distribution Expenses
Selling and distribution expenses for the three months ended December 31, 2020 were $24.2 million compared to $13.4 million for the three months ended December 31, 2019. This increase of $10.8 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the year ended December 31, 2020 was $49.6 million compared to $25.6 million for the year ended December 31, 2019.
Other Income and Gains
Other income and gains for the three months ended December 31, 2020 was $2.1 million compared to $0.5 million for the three months ended December 31, 2019. The increase was primarily driven by increase in foreign exchange gain. Other income and gains for the year ended December 31, 2020 was $6.1 million compared to $7.1 million for the year ended December 31, 2019. The decrease of $1.0 million was primarily driven by reduced average interest rate for holding of time deposits that generate interest income.
Finance Costs
Finance costs the year ended December 31, 2020 were $4.2 million compared to $0.2 million for the year ended December 31, 2019. The increase was primarily due to finance costs related to the issuance of convertible redeemable preferred shares, which have been fully converted into ordinary shares upon the completion of Legend Biotech's initial public offering in June 2020.
Loss for the Period
For the three months ended December 31, 2020, net loss was $57.8 million, or $0.22 per share, compared to a net loss of $63.9 million, or $0.32 per share, for the three months ended December 31, 2019. Net loss was $303.5 million, or $1.28 per share, for the year ended December 31, 2020 compared to $133.0 million, or $0.66 per share, for the year ended December 31, 2019.
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.
We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's strategies and objectives; the anticipated timing of, and ability to progress, clinical trials, including the initiation of the phase 1 clinical trial of LB1901 in RRTCL; the ability to make, the timing of, and the ultimate success of, regulatory submissions globally, including the rolling BLA for cilta-cel with the U.S. FDA, the MAA for cilta-cel to the EMA, and the submissions for cilta-cell to the CDE and the JMHLW; the ability to generate, analyze and present data from clinical trials; patient enrollment; the potential benefits of our product candidates, and the status and outcome of the investigation being conducted by the Customs Anti-Smuggling Department of Zhenjiang in China and its impact on the Company's operations. 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. 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. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSSThree months ended
December 31Year ended December 31
(in thousands, US$, except share and per share data)
2020
(Unaudited)2019
(Unaudited)2020
(Unaudited)2019
REVENUE
40,783
19,450
75,676
57,264
Other income and gains
2,079
476
6,119
7,125
Research and development expenses
(66,934)
(66,097)
(232,160)
(161,943)
Administrative expenses
(9,171)
(2,048)
(23,147)
(6,752)
Selling and distribution expenses
(24,182)
(13,374)
(49,571)
(25,620)
Other expenses
(290)
(5)
(346)
(221)
Fair value loss of convertible redeemable preferred shares
-
-
(79,984)
-
Finance costs
(40)
(84)
(4,209)
(223)
LOSS BEFORE TAX
(57,755)
(61,682)
(307,622)
(130,370)
Income tax (expense)/credit
(72)
(2,261)
4,145
(2,602)
LOSS FOR THE PERIOD
(57,827)
(63,943)
(303,477)
(132,972)
Attributable to:
Equity holders of the parent
(57,827)
(63,943)
(303,477)
(132,972)
Loss per share attributable to ordinary equity holders of the parent:
Ordinary shares – basic
(0.22)
(0.32)
(1.28)
(0.66)
Ordinary shares – diluted
(0.22)
(0.32)
(1.28)
(0.66)
Shares used in loss per share computation:
Ordinary shares – basic
264,720,588
200,000,000
236,305,234
200,000,000
Ordinary shares – diluted
264,720,588
200,000,000
236,305,234
200,000,000
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITIONDecember 31, 2020
(Unaudited)December 31, 2019
(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment
113,091
70,079
Other non-current assets
3,973
-
Advance payments for property, plant and equipment
224
665
Right-of-use assets
8,009
9,348
Intangible assets
2,852
519
Total non-current assets
128,149
80,611
CURRENT ASSETS
Inventories
1,800
1,157
Trade receivables
74,978
29,991
Prepayments, other receivables and other assets
10,007
16,777
Pledged short-term deposits
384
256
Time deposits
50,000
75,559
Cash and cash equivalents
455,689
83,364
Total current assets
592,858
207,104
Total assets
721,007
287,715
CURRENT LIABILITIES
Trade and notes payables
5,238
9,586
Other payables and accruals
99,168
70,854
Government grants
283
-
Lease liabilities
1,464
1,027
Contract liabilities
55,014
46,294
Total current liabilities
161,167
127,761
NON-CURRENT LIABILITIES
Contract liabilities
275,071
277,765
Lease liabilities
1,909
5,058
Other non-current liabilities
554
-
Government grants
2,051
-
Total non-current liabilities
279,585
282,823
Total liabilities
440,752
410,584
EQUITY
Share capital
27
20
Reserves/(deficits)
280,228
(122,889)
Total ordinary shareholders' equity/(deficit)
280,255
(122,869)
Total equity/(deficit)
280,255
(122,869)
Total liabilities and equity/(deficit)
721,007
287,715
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSThree months ended
December 31Year ended December 31
(in thousands, US$)
2020
(Unaudited)2019
(Unaudited)2020
(Unaudited)2019
LOSS BEFORE TAX
(57,755)
(61,682)
(307,622)
(130,370)
CASH FLOWS USED IN OPERATING ACTIVITIES
(55,952)
(59,987)
(223,005)
(83,065)
CASH FLOWS from/(USED IN) INVESTING ACTIVITIES
61,165
113,451
(24,169)
(58,652)
CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES
661
(6,680)
618,879
14,666
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
5,874
46,784
371,705
(127,051)
Effect of foreign exchange rate changes, net
434
304
620
249
Cash and cash equivalents at beginning of the period
449,381
36,276
83,364
210,166
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
455,689
83,364
455,689
83,364
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances
506,073
159,179
506,073
159,179
Less: Pledged short-term deposits
384
256
384
256
Time deposits
50,000
75,559
50,000
75,559
Cash and cash equivalents as stated in the statement of financial position
455,689
83,364
455,689
83,364
Cash and cash equivalents as stated in the statement of cash flows
455,689
83,364
455,689
83,364
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Legend Biotech Corporation (NASDAQ:LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, will release its fourth quarter and full-year 2020 financial results before U.S. financial markets open on Thursday, March 18, 2021.
Legend Biotech will conduct a conference call to discuss those results on March 18, 2021 at 8:00 am ET. To listen to the call via webcast visit Legend Biotech's website at https://investors.legendbiotech.com/events-and-presentations. To listen to the call via telephone dial (833) 665-0666 from locations in the United States or (914) 987-7318 from outside the United States. Please refer to conference ID number 2677312.
A replay of the webcast will be available on the "Events and Presentations" page within the Investors section of the website at https://investors.legendbiotech.com/events-and-presentations for 90 days following the conference call.
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.
We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.
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Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today in conjunction with an announcement to be issued by Legend Biotech's majority parent company, GenScript Biotech Corporation, pursuant to the rules of The Stock Exchange of Hong Kong Limited, announced preliminary, unaudited financial results for the year ended December 31, 2020.
For the year ended December 31, 2020, Legend Biotech expects to record a loss for the year of approximately US$292.2 million to US$324.9 million and an adjusted loss for the year of approximately US$202.4 million to US$234.4 million, in each case, including research and development expenses of approximately US$220.7 million to US$255.6 million, which was mainly caused by the continuous investment into its lead product candidate, ciltacabtagene autoleucel, and other product candidates in Legend Biotech's pipeline. See "Use of Non-IFRS Financial Measures" for a reconciliation of Loss for the year to Adjusted loss for the year.
In addition, Legend Biotech expects to report a one-time non-cash fair value loss of approximately US$80.0 million caused by the changes of fair value of Legend Biotech's Series A convertible redeemable preferred shares ("Series A Preferred Shares"), which was derived from the automatic conversion of all outstanding Series A Preferred Shares (plus dividends accrued but unpaid on the Series A Preferred Shares) into ordinary shares, par value $0.0001 per share, of Legend Biotech ("Ordinary Shares") upon Legend Biotech's listing on the Nasdaq Global Select Market. The details of the automatic conversion of the Series A Preferred Shares into Ordinary Shares are described in Legend Biotech's prospectus filed with the Securities and Exchange Commission on June 8, 2020. The changes in fair value led to an increase of share premium, which had no material impact on the net assets of Legend Biotech and its subsidiaries.
As of December 31, 2020, Legend Biotech had approximately US$455.7 million of cash and cash equivalents and approximately US$50.0 million in time deposits.
The financial information contained in this press release is preliminary and is based on the latest estimated unaudited management accounts for the year ended December 31, 2020. Because Legend Biotech has not yet completed its financial closing procedures for the year ended December 31, 2020, Legend Biotech has provided a range for the preliminary results described above. Such information is not a comprehensive statement of Legend Biotech's results for, and as of, this year, and are subject to the completion of management's and Legend Biotech's audit committee's reviews and other financial closing processes and potential adjustments. Accordingly, Legend Biotech's actual results as of, and for, the year ended December 31, 2020 may differ materially from the preliminary estimated data presented in this press release. As a result, it is possible that Legend Biotech's final results will not be within the ranges presented.
The information contained in this press release has not been, and is not based on information that has been, audited, or reviewed by Legend Biotech's independent auditor. Investors are cautioned not to place undue reliance on these preliminary estimates.
This preliminary estimated data should not be considered a substitute for the audited financial results for the year ended December 31, 2020, to be filed with the Securities and Exchange Commission (the "SEC") on Form 20-F, which Legend Biotech expects to occur before the end of April 2021.
Use of Non-IFRS Financial Measures
The following table provides a reconciliation of Legend Biotech's Loss for the year to Adjusted loss for the year:
Year ended
(in millions, US$)
December 31,
2020Loss for the year
(292.2)~(324.9)
Share based payment expenses, net
4.5~5.2
Exchange differences, net
(0.1)
Listing Expenses
1.4
Service fee for the issuance of Series A Preference Shares
4.0
Fair value loss of convertible redeemable Series A Preference Shares
80.0
Adjusted loss for the year
(202.4)~(234.4)
Adjusted loss for the year is a non-IFRS financial measure. Legend Biotech is reporting Adjusted loss for the year because this financial measure is to be reported as part of a Profit Warning announcement issued by Legend Biotech's majority parent company, GenScript Biotech Corporation, pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited. Adjusted loss for the year has limitations in that it does not reflect all expense items that affect Legend Biotech's results.
Non-IFRS measures are not meant to be considered in isolation or as a substitute for financial information presented in accordance with IFRS and should be viewed as supplemental and in addition to Legend Biotech's financial information presented in accordance with IFRS.
About Ciltacabtagene autoleucel (cilta-cel)
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.
In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.
We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to anticipated financial results for the year ended December 31, 2020, including expected research and development expenses. 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including as a result of items or events identified during the completion of management's and Legend Biotech's audit committee's reviews and other financial closing processes, potential audit adjustments related to the completion of the audit by Legend Biotech's independent auditor, and the factors discussed in the "Risk Factors" section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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