Shanghai, China, March 26, 2020 – JW Therapeutics (stock code: 2126.HK), a leading cellular immunotherapy company, today announced 2020 annual results.
2020 was a transformative year in our Company’s history. In June 2020, we submitted a new drug application (NDA) to the National Medical Products Administration of China (NMPA) relating to relmacabtagene autoleucel (relma-cel) as a third-line treatment for diffuse large B-cell lymphoma (DLBCL), and the NMPA accepted our NDA for review shortly thereafter. In September 2020, the NMPA granted priority review to our NDA and Breakthrough Therapy Designation for relma-cel as a treatment for follicular lymphoma (FL). Moreover, in May 2020 we completed our Series B financing round for total consideration of US$100 million, and on November 3, 2020 (the Listing Date), we successfully completed our listing on the Hong Kong Stock Exchange, raising HKD2.5 billion after exercise of the underwriters’ over-allotment option. Moreover, in terms of business development, we entered into significant agreements with Eureka Therapeutics, Inc. (Eureka) and Lyell Immunopharma, Inc. (Lyell), which we anticipate will permit synergies by complementing our historical hematological franchise with a pipeline of solid tumor focused cell therapy candidates.
Since the Listing Date, we have achieved the following further milestones:
- In December 2020, we reported safety and efficacy results from our Phase II registrational clinical trial of relma-cel as a third-line treatment for DLBCL at the 62nd Annual Meeting of the American Society of Hematology.
- In December 2020, the NMPA completed Good Clinical Practice inspections at our clinical sites located in Beijing, Shanghai, Nanjing and Guangzhou; and in February 2021, the Shanghai Medical Products Administration granted us a Drug Production License for relma-cel. These approvals represent important steps toward NPMA approval of our NDA relating to relma-cel.
- In January 2021, we commenced patient enrollment for a Phase II registrational trial in China to evaluate relma-cel in mantle cell lymphoma (MCL) patients who previously received chemotherapy, anti-CD20 agent or Bruton’s tyrosine kinase inhibitor.
- Our research and development expenses increased by RMB89.1 million to RMB225.2 million for the year ended December 31, 2020, compared to RMB136.1 million for the year ended December 31, 2019, primarily due to an increase in staff costs allocated to research and development and increase in testing and clinical fees, which resulted principally from clinical research activities including on-going clinical trial on third-line DLBCL and initiative cost incurred on indications for relma-cel such as FL, MCL and second-line DLBCL.
- Our general and administrative expenses increased by RMB158.4 million to RMB231.3 million for the year ended December 31, 2020, compared to RMB72.9 million for the year ended December 31, 2019, primarily due to an increase of RMB103.9 million in share-based compensation allocated to general and administrative expenses, as well as RMB35.6 million in listing expenses associated with our listing on The Stock Exchange of Hong Kong Limited (the Hong Kong Stock Exchange) in November 2020.
- Our selling expenses amounted to RMB13.3 million for the year ended December 31, 2020, compared to nil for the year ended December 31, 2019, as we established our sales and marketing capabilities in advance of the anticipated commercialization of relma-cel in 2021.
- Loss for the year increased by RMB1,030.5 million to RMB1,663.8 million for the year ended December 31, 2020, compared to RMB633.3 million for the year ended December 31, 2019, primarily due to increases in loss on fair value changes of preferred shares and in operating loss, and partially offset by the decrease in fair value loss on warrants. Fair value changes of preferred shares and warrants were one-time, non-cash adjustments resulting from our listing on the Hong Kong Stock Exchange as required under International Financial Reporting Standards (IFRS).
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About JW Therapeutics
Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and Wuxi AppTec, JW Therapeutics (HKEx: 2126) is a leading cellular immunotherapy company with an integrated platform focusing on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors.
JW Therapeutics’ vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. The company has built a comprehensive and differentiated cell therapy pipeline covering both hematological cancers and solid tumors. Its lead product, relmacabtagene autoleucel (relma-cel), an anti-CD19 CAR-T therapy for relapsed or refractory B-cell lymphoma, is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
For more information, please visit www.jwtherapeutics.com.