LEGN Legend Biotech Corporation
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
LCAR-B38M/JNJ-4528 (CARTITUDE-1)
Multiple myeloma
|
Phase 2
Phase 2
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
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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Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech) today announced that it will host a virtual Key Opinion Leader (KOL) event on Monday, December 7 at 7 pm ET highlighting the latest data from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) of ciltacabtagene autoleucel (cilta-cel), an investigational BCMA-directed CAR-T cell therapy being studied for the treatment of patients with relapsed or refractory multiple myeloma. This will follow the oral presentation of the study results (Abstract #177) at the 2020 ASH Annual Meeting.
Intended for investors and other interested audiences, the event includes presentations by Ying Huang, PhD, CEO and CFO of Legend Biotech, along with the following leading professionals in hematology and oncology:
- Sundar Jagannath, MD, Professor of Medicine, Hematology and Medical Oncology, Mount Sinai School of Medicine; Director, Multiple Myeloma Program at Mount Sinai Hospital.
- Thomas G. Martin, MD, Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program, and Associate Director, Myeloma Program, UCSF; Co-Leader, Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center.
To register and to view the live webcast, please visit: LegendBiotechASH2020.Convene.com.
About CARTITUDE-1
Cilta-cel is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study conducted in the US and Japan for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD®, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.
About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T (CAR-T) cell therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed 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. (Janssen) 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 PRIority MEdicines (PRiME) designation from the European Commission in April 2019 and 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 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.
Cautions Concerning Forward-Looking Statements
This information constitutes forward-looking statements relating to the business of Legend, including express or implied discussions regarding the clinical development of its product candidates and potential attributes and benefits of such product candidates. Such forward-looking statements reflect the current views of Legend's management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, Legend's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; Legend's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing and other political pressures. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
The safety and efficacy of the product candidates and/or uses under investigation have not been established. There is no guarantee that the product candidates will receive health authority approval or become commercially available in any country for the uses being investigated.
The information in this press release speaks only as of the date hereof. Legend assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information on this page as current or accurate after its publication date.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201124005327/en/
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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, announced today that it has appointed Dr. Li Zhu to Legend Biotech's Board of Directors. Dr. Zhu will serve as a Class III director.
In addition, Dr. Fangliang Zhang tendered his resignation from the Board of Directors of Legend Biotech and its committees, effective as of November 22, 2020. As announced on September 21, 2020, Dr. Zhang had been under residential surveillance in connection with an investigation by the Customs Anti-Smuggling Department of Zhenjiang (the "Authority") in the People's Republic of China, and he has now been formally placed under arrest. While no charges have been filed against him, Dr. Zhang decided that to avoid unnecessary distraction to Legend Biotech, his resignation would be in the interests of Legend Biotech and its shareholders. To date, no charges have been filed against Legend Biotech or any of its officers or directors, and Legend Biotech does not believe that it is a subject of the Authority's investigation.
"The Board of Legend Biotech would like to take this opportunity to express its sincere gratitude and appreciation to Dr. Zhang for his valuable contribution to the company during his tenure of service," said Sally Wang, Chairwoman of Legend Biotech. "We are excited to welcome Dr. Zhu to our Board of Directors. The addition of Dr. Zhu complements our Board's skills and experiences, and we are confident he will provide valuable support to Legend Biotech's strategic development and objective to bring innovative and impactful cell therapies toward potential registration and commercialization."
Dr. Zhu served as the vice president of strategy of GenScript Biotech Corporation ("GenScript") from March 2010 to February 2017, served as the chief strategy officer of GenScript from February 2017 to July 2019, and has served as a consultant for GenScript since July 2019. Upon his appointment as executive director of GenScript on November 22, 2020, he resumed his role as the chief strategy officer of GenScript. Before joining GenScript, Dr. Zhu worked at California-based Clontech Laboratories, Inc. as a director of molecular biology from January 1990 to March 2000. Dr. Zhu founded Genetastix Corporation, Inc., a biotech company focused on yeast-based antibody discovery, and served as president and chief executive officer from May 2000 to December 2005. Dr. Zhu then worked at biotech companies in China, serving as vice president of research at Cathay Biotech, Inc. from July 2006 to December 2008, and as vice president of HUYA Biomedical Technology (Shanghai) Co., Limited from January 2009 to December 2009. Dr. Zhu obtained a Bachelor of Science of Biology degree from the East China Normal University in June 1982 and a Doctor of Philosophy in molecular biology and immunology from Stanford University in July 1989.
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 with Janssen Biotech, Inc. 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.
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 statements relating to the investigation of the Customs Anti-Smuggling Department of the People's Republic of China, Legend Biotech's strategic development and objectives, and the potential contributions of its new board member. 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 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. Readers should not rely upon the information on this page as current or accurate after its publication date.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201123005673/en/
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Legend Biotech Corporation (NASDAQ:LEGN) ("Legend Biotech" or the "Company"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended September 30, 2020.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005237/en/
Legend Biotech's Development Pipeline (Graphic: Business Wire)
"Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs," said Dr. Ying Huang, Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") of Legend Biotech. "We look forward to initiation of the Biologics License Application ("BLA") filing for cilta-cel by Janssen Biotech, Inc."
Third Quarter 2020 & Recent Highlights
- On November 9, 2020, Legend Biotech announced that Ms. Ye (Sally) Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech. The Board of Directors also named Dr. Ying Huang as CEO of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position as CFO until such time as a successor CFO is identified.
- On November 5, 2020, Legend Biotech announced that the Company will present new and updated data from its CARTITUDE-1 and LEGEND-2 studies at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
- On September 21, 2020, Legend Biotech announced that the Customs Anti-Smuggling Department of the People's Republic of China ("PRC") had inspected places of business in China of Legend Biotech and GenScript Biotech Corporation, Legend Biotech's majority shareholder, in connection with what Legend Biotech understands to be an investigation relating to suspected violations of import and export regulations under the laws of the PRC (the "Investigation") and that Dr. Fangliang Zhang, the Chairman of the Board of Directors and CEO of Legend at that time, had been placed under "residential surveillance" in the PRC. No charges have been filed against Legend Biotech, Dr. Zhang, or any of its other officers or directors, and the Company does not believe that Legend Biotech is a subject of the investigation.
- On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation ("CDE") of National Medical Products Administration ("NMPA") recommended Breakthrough Therapy Designation ("BTD") for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.
Key Upcoming Milestones
- On Saturday, December 5, 2020, during the Myeloma session at ASH entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data from the CARTITUDE-1 study will be presented.
- During the ASH Annual Meeting and Exposition, LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will be presented as a poster.
- Legend Biotech's collaboration partner Janssen Biotech, Inc. anticipates initiating the BLA submission for cilta-cel to the U.S. Food and Drug Administration ("FDA") by the end of 2020 and submitting a marketing authorization application to the European Medicines Agency ("EMA") in early 2021.
- Legend Biotech expects to use data from CARTIFAN-1 study to file a regulatory submission in China in 2021.
- Please see Legend Biotech's comprehensive development pipeline as shown below.
Development Pipeline
The extent to which the COVID-19 pandemic may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
Financial Results for the Three-month and Nine-month Periods Ended September 30, 2020
Cash and Cash Equivalents:
As of September 30, 2020, Legend Biotech had approximately $449.4 million of cash and cash equivalents and approximately $125.6 million in time deposits.
Revenue
Revenue for the three months ended September 30, 2020 was $11.7 million compared to $17.7 million for the three months ended September 30, 2019. The decrease of $6.0 million was primarily due to milestone achieved in July 2019 under the agreement with Janssen Biotech, Inc., which resulted in additional consideration being allocated to the licensing of intellectual property and the steering committee service for the three months ended September 30, 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the three months ended September 30, 2020. Revenue for the nine months ended September 30, 2020 was $34.9 million compared to $37.8 million for the nine months ended September 30, 2019. Similarly, the decrease of the nine months period in 2020 was primarily driven by additional milestone payment received from Janssen Biotech, Inc. that was achieved in July 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the nine month ended September 30, 2020. 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 September 30, 2020 were $63.7 million compared to $41.9 million for the three months ended September 30, 2019. This increase of $21.8 million 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 three months ended September 30, 2020. Consistently, research and development expenses for the nine months ended September 30, 2020 was $165.2 million compared to $95.8 million for the nine months ended September 30, 2019 with a $69.4 million increase.
Administrative Expenses
Administrative expenses for the three months ended September 30, 2020 were $6.0 million compared to $2.0 million for the three months ended September 30, 2019. The increase of $4.0 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 nine months ended September 30, 2020 increased by $9.3 million, which was $14.0 million compared to $4.7 million for the nine months ended September 30, 2019.
Selling and Distribution Expenses
Selling and distribution expenses for the three months ended September 30, 2020 were $9.3 million compared to $4.5 million for the three months ended September 30, 2019. This increase of $4.8 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 nine months ended September 30, 2020 was $25.4 million compared to $12.2 million for the nine months ended September 30, 2019.
Other Income and Gains
Other income and gains for the three months ended September 30, 2020 was $1.5 million compared to $3.0 million for the three months ended September 30, 2019. The decrease was primarily driven by net foreign exchange loss incurred, net of an increase in government grant received. Other income and gains for the nine months ended September 30, 2020 was $5.3 million compared to $6.6 million for the nine months ended September 30, 2019. The decrease of the nine months period was primarily driven by reduced average interest rate for holding of time deposits that generate interest income.
Other Expenses
Other expenses for the three months ended September 30, 2020 was $1.2 million compared to $0.002 million for the three months ended September 30, 2019. Other expenses for the nine months ended September 30, 2020 was $1.3 million compared to $0.2 million for the nine months ended September 30, 2019. The increase was primarily due to foreign exchange loss.
Loss for the Period
For the three months ended September 30, 2020, net loss was $66.5 million, or $0.25 per share, compared to a net loss of $27.8 million, or $0.14 per share, for the three months ended September 30, 2019. Net loss was $245.7 million for the nine months ended September 30, 2020 compared to $69.0 million for the nine months ended September 30, 2019.
Grant of restricted share units and share options
On September 1, 2020, we granted a total number of 777,382 restricted share units (each representing the right to receive one ordinary share) to grantees with a grant date fair market value of $16.335 per share. On September 1, 2020, we granted share options, representing the right to acquire a total number of 569,000 shares to grantees with an exercise price of $16.335 per share.
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 with Janssen Biotech, Inc. 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.
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; the ability to make, and the timing of, regulatory submissions globally, including the BLA for cilta-cel to the U.S. FDA, the marketing authorization application (MAA) for cilta-cel to the EMA, regulatory submission filing for CARTIFAN-1 in China and the Investigational New Drug Application (IND) of LB1901, a CAR T product under development for the treatment of relapsed or refractory T-cell lymphoma (TCL), to the U.S. FDA; the ability to generate, analyze and present data from clinical trials; patient enrollment; the potential benefits of our product candidates, the status and outcome of the Investigation 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, including 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. Readers should not rely upon the information on this page as current or accurate after its publication date.
LEGEND BIOTECH CORPORATION
UNAUDITED INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
Three months ended
September 30Nine months ended
September 30(in thousands, US$, except per share data)
2020
(unaudited)2019
(unaudited)2020
(unaudited)2019
(unaudited)REVENUE
11,747
17,674
34,893
37,814
Other income and gains
1,519
2,987
5,315
6,649
Research and development expenses
(63,656
)
(41,917
)
(165,226
)
(95,846
)
Administrative expenses
(6,038
)
(1,992
)
(13,976
)
(4,704
)
Selling and distribution expenses
(9,287
)
(4,460
)
(25,389
)
(12,246
)
Other expenses
(1,249
)
(2
)
(1,331
)
(216
)
Fair value loss of convertible redeemable preferred shares
—
—
(79,984
)
—
Finance costs
(90
)
(82
)
(4,169
)
(139
)
LOSS BEFORE TAX
(67,054
)
(27,792
)
(249,867
)
(68,688
)
Income taxes credits / (expenses)
508
(5
)
4,217
(341
)
LOSS FOR THE PERIOD
(66,546
)
(27,797
)
(245,650
)
(69,029
)
Attributable to:
Equity holders of the parent
(66,546
)
(27,797
)
(245,650
)
(69,029
)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
Ordinary shares—basic
(0.25
)
(0.14
)
(1.08
)
(0.35
)
Ordinary shares—diluted
(0.25
)
(0.14
)
(1.08
)
(0.35
)
ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION
Ordinary shares—basic
264,328,630
200,000,000
226,764,437
200,000,000
Ordinary shares—diluted
264,328,630
200,000,000
226,764,437
200,000,000
LEGEND BIOTECH CORPORATION
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
AS AT SEPTEMBER 30, 2020 AND DECEMBER 31, 2019
September 30, 2020
(Unaudited)December 31,
2019(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment
96,125
70,079
Advance payments for property, plant and equipment
675
665
Right-of-use assets
8,077
9,348
Intangible assets
1,042
519
Total non-current assets
105,919
80,611
CURRENT ASSETS
Inventories
1,513
1,157
Trade receivables
—
29,991
Prepayments, other receivables and other assets
24,662
16,777
Financial assets at fair value through profit or loss
1,175
—
Pledged short-term deposits
430
256
Time deposits
125,559
75,559
Cash and cash equivalents
449,381
83,364
Total current assets
602,720
207,104
Total assets
708,639
287,715
CURRENT LIABILITIES
Trade and notes payables
7,399
9,586
Other payables and accruals
67,889
70,854
Lease liabilities
1,445
1,027
Contract liabilities
46,789
46,294
Total current liabilities
123,522
127,761
NON-CURRENT LIABILITIES
Contract liabilities
245,641
277,765
Lease liabilities
2,543
5,058
Government grants
2,033
—
Total non-current liabilities
250,217
282,823
Total liabilities
373,739
410,584
EQUITY
Share capital
26
20
Reserves / (deficits)
334,874
(122,889
)
Total ordinary shareholders' equity / (deficit)
334,900
(122,869
)
Total equity / (deficit)
334,900
(122,869
)
Total liabilities and equity
708,639
287,715
LEGEND BIOTECH CORPORATION
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
Three months ended
September 30Nine months ended
September 30(in thousands, US$)
2020
(Unaudited)2019
(Unaudited)2020
(Unaudited)2019
(Unaudited)LOSS BEFORE TAX
(67,054
)
(27,792
)
(249,867
)
(68,688
)
CASH FLOWS (USED IN)/GENERATED FROM OPERATING ACTIVITIES
(64,375
)
19,947
(167,056
)
(23,078
)
CASH FLOWS USED IN INVESTING ACTIVITIES
(58,623
)
(21,194
)
(85,334
)
(172,103
)
CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES
9,663
(154
)
618,221
21,346
NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
(113,335
)
(1,401
)
365,831
(173,835
)
Effect of foreign exchange rate changes, net
325
(44
)
186
(55
)
Cash and cash equivalents at beginning of the period
562,391
37,721
83,364
210,166
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
449,381
36,276
449,381
36,276
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances
575,370
147,592
575,370
147,592
Less: Pledged short-term deposits
430
255
430
255
Time deposits
125,559
111,061
125,559
111,061
Cash and cash equivalents as stated in the statement of financial position
449,381
36,276
449,381
36,276
Cash and cash equivalents as stated in the statement of cash flows
449,381
36,276
449,381
36,276
View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005237/en/
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Ye (Sally) Wang Appointed Chairwoman of the Board
Ying Huang Named CEO
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 Ms. Ye (Sally) Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech.
The Board of Directors also named Dr. Ying Huang as Chief Executive Officer of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position of Chief Financial Officer until such time as a successor CFO is identified.
Both appointments were made with the unanimous approval of the Board of Directors, including by means of a written proxy of Dr. Fangliang Zhang. In a written statement, Dr. Zhang, who remains a member of the Board of Directors, expressed his support for Dr. Huang's assumption of the Chief Executive Officer role on a non-interim basis, and noted that the transition further enhances the operational execution of Legend Biotech.
"The entire Board is very pleased to have Ms. Wang as Legend Biotech's Chairwoman," said Mr. Philip Yau, Chair of the Audit Committee. "Sally's extensive experience and expertise in strategic planning and operational management will be instrumental as she leads our Board and supports Legend Biotech's management team in continuing to develop therapies for patients in need."
"Since taking on the role of interim CEO in September, Dr. Huang has seamlessly led Legend Biotech during a challenging time," said Ms. Wang. "Dr. Huang's strong business acumen and biotechnology expertise make him uniquely suited to advance Legend Biotech's mission, and the Board of Directors has great confidence that he will continue to advance the important work that Legend Biotech is undertaking."
Ms. Wang has served as a member of Legend Biotech's Board of Directors since May 2015. Ms. Wang has been the Chief Operating Officer of GenScript Biotech Corporation ("GenScript"), Legend Biotech's parent majority shareholder, since 2014, has served on GenScript's board of directors since 2009 and has served as GenScript's President since December 2017, responsible for GenScript's strategies and overall operational management. She co-founded the GenScript group in 2002 and has served in various managerial positions in GenScript Corporation. Ms. Wang holds an M.S. degree from Wuhan University, a Master's degree in Computer Sciences from the University of Bridgeport and an Executive M.B.A. degree from the China Europe International Business School.
Since joining Legend Biotech in July 2019, Dr. Huang played a central role during the company's crossover round financing and IPO, which was among the largest biotech IPOs of 2020. In addition to his responsibility for Legend Biotech's financial function, he is a core member of the Legend team that manages the company's collaborative efforts. Dr. Huang brings more than nine years of experience in research and development at major pharma and 12 years of experience as a biotechnology analyst on Wall Street, where he was recognized by the Institutional Investor survey as a top-ranked biotechnology analyst. Prior to joining Legend Biotech, Dr. Huang was Managing Director and Head of Biotech Equity Research at Bank of America Merrill Lynch and, prior to that, held posts at Wachovia, Credit Suisse, Gleacher and Barclays. Prior to his Wall Street career, Dr. Huang was a Principal Scientist at Schering-Plough (now Merck & Co.) in the Department of Chemical Research, where he focused on small molecule drug discovery in the therapeutic areas of cardiovascular and the central nervous system. He is a co-author of several patents and peer reviewed publications. Dr. Huang received his Ph.D. in Bio-Organic Chemistry from Columbia University. Dr. Huang also studied at Columbia Business School and in the Special Class for the Gifted Young at University of Science and Technology of China.
In addition to the leadership announcements regarding the chairwoman and CEO, Legend Biotech also announced updates to its comprehensive development pipeline.
Our pipeline is available at our website, at https://www.legendbiotech.com/pipeline.
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 with Janssen Biotech, Inc. 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.
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 the development and advancement of Legend Biotech's program pipeline and the potential contribution of Ms. Wang as Chairwoman and Dr. Huang as Chief Executive Officer. 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 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. Readers should not rely upon the information on this page as current or accurate after its publication date.
We use our website our corporate Twitter account (@LegendBiotech) and our corporate LinkedIn account (https://www.linkedin.com/company/legendbiotechco.) as routine channels of distribution of company information, including press releases, analyst presentations, and supplemental financial information, as a means of disclosing material non-public information and for complying with our disclosure obligations. Accordingly, investors should monitor our website and our corporate Twitter and LinkedIn accounts in addition to following press releases, filings with the SEC and public conference calls and webcasts. Additionally, we provide notifications of announcements as part of our website.
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- New Results from Phase 1b/2 CARTITUDE-1 Study of BCMA-directed CAR-T Cell Therapy Cilta-cel in Treatment of Patients with RRMM to be Featured in Oral Presentation
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 new and updated data from CARTITUDE-1 and LEGEND-2 studies, respectively, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
CARTITUDE-1 data for oral presentation will highlight Phase 1b/2 efficacy and safety results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel). Additional poster presentations for cilta-cel data will include detailed analyses of cytokine release syndrome and health-related quality of life outcomes from CARTITUDE-1. LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will also be presented as a poster.
"We look forward to sharing new data from the CARTITUDE-1 study in the US and the LEGEND-2 study in China," said Ying Huang, PhD, interim-CEO and CFO of Legend Biotech. "With our successful clinical efforts and the Company's collaboration with Janssen, we are uniquely positioned to deliver a novel therapy to patients with multiple myeloma."
On Saturday, December 5th, during the Myeloma session entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data for cilta-cel from the CARTITUDE-1 study will be presented.
Following are details of the five abstracts that have been accepted for presentation at the 62nd ASH Annual Meeting & Exposition. For additional information visit: https://www.hematology.org/meetings/annual-meeting/schedule-and-program.
Abstract No.
Title
Date/Time
Oral Presentation
Abstract #177
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
Saturday, Dec. 5
12:00 p.m. PTPoster Presentations
Abstract #1412
Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma
Saturday, Dec. 5
7:00 a.m. - 3:30 p.m. PTAbstract #2291
Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
Sunday, Dec. 6
7:00 a.m. - 3:30 p.m. PTAbstract #2304
Chimeric Antigen Receptor T Cell Therapy in the Relapsed or Refractory Multiple Myeloma with Extramedullary Disease--a Single Institution Observation in China (LEGEND-2)
Sunday, Dec. 6
7:00 a.m. - 3:30 p.m. PT
Abstract #3240
Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study
Monday, Dec. 7
7:00 a.m. - 3:30 p.m. PTAbout CARTITUDE-1
Cilta-cel is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study conducted in the US and Japan for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD®, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M CAR-T cells for the treatment of relapsed or refractory multiple myeloma.2About 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.9About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe 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 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. (Janssen) 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 PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and 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 with Janssen Biotech, Inc. 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, 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 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. Readers should not rely upon the information on this page as current or accurate after its publication date.References
- CARTITUDE-1 (NCT03548207). Available: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed November 2020.
- LEGEND-2 (NCT03090659). Available: https://clinicaltrials.gov/ct2/show/NCT03090659. Accessed November 2020.
- American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction . Accessed November 2020.
- 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.
- National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed November 2020.
- National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed November 2020.
- 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.
- 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.
- 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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