SHANGHAI and HONG KONG, March 26, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" or "the company", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, announced its annual financial results for the full year ended December 31, 2020.
"In the past year, Antengene achieved numerous breakthroughs in discovery and clinical development, business operations, and organizational development, a result of our outstanding teamwork and execution. As we continue to implement our combinatory and complementary R&D strategy, we have developed a highly differentiated pipeline consisting of 12 innovative assets. In addition, we have broadened our collaboration with other industry-leading biotechnology companies, and obtained the rights to develop and commercialize four in-licensed assets across 17 APAC countries and regions in 2020," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "As of today, we submitted NDAs for ATG-010 in five APAC markets, while we accelerate the completion of the first phase of our manufacturing facility and the build-out of our commercial teams in mainland China and other APAC markets. Furthermore, we were granted IND approvals for six additional clinical trials, and advanced three assets into clinical development in China and Australia. In 2020, we successfully completed our Series C financing and IPO on the Hong Kong Stock Exchange, and Antengene was selected as a constituent stock of the Heng Seng Composite Index and an eligible stock in the Shenzhen-Hong Kong Stock Connect in just four months after our IPO. Meanwhile, we officially opened Antengene's Drug Discovery Center as we continue to advance our in-house discovery and development as planned. At the same time, we entered into partnerships with leading CROs to further accelerate our R&D programs. All of this progress has forged Antengene's end-to-end fully integrated capabilities that will enable us to translate our robust R&D capabilities into commercial potential."
"In 2021, we remain committed to serving patients and plan to submit additional NDAs to offer patients around the world simultaneous access to our innovative therapies. Adopting a combinatory and complementary R&D strategy, we aim to initiate multiple clinical trials to develop therapies that will complement existing treatments and address treatment gaps in some of the most prevalent oncological indications. This year, we will continue to execute on our strategy of further developing our commercial infrastructure in China and the Asia Pacific region, in an effort to expedite the commercialization of our lead asset; and continue to enrich our pipeline and strengthen our core competitiveness by in-licensing additional highly promising assets. In 2021, we will present our research results at major international conferences, to further build a solid foundation for a first-in-class commercial launch of our lead asset in multiple markets, and to advance several pre-clinical novel assets into clinical stage. Honoring our commitment to patients and pursuing our mission as a member of the healthcare community, we will strive to bring hope to patients and deliver greater return to our investors," added Dr. Jay Mei.
Late-stage Assets
ATG-010 (selinexor, first-in-class XPO1 inhibitor)
Antengene made notable clinical development and regulatory progress to advance its lead hematological malignancy asset, and has submitted new drug applications (NDAs) for ATG-010 in multiple Asia Pacific (APAC) markets, including mainland China.
Events during the Reporting Period
Events after the Reporting Period
Clinical Progress by Partner Company
ATG-008 (onatasertib, mTORC1/2 inhibitor)
Events during the Reporting Period
Other Clinical Assets
ATG-019 (dual PAK4/NAMPT inhibitor)
Events during the Reporting Period
A Phase I clinical study of ATG-019 in solid tumor and lymphoma dosed its first patient in Taiwan.
Events after the Reporting Period
The company submitted an IND application to the NMPA for a Phase I clinical study of ATG-019 in solid tumor and lymphoma in January 2021.
ATG-017 (ERK1/2 inhibitor)
Events during the Reporting Period
A Phase I clinical study of ATG-017 in advanced solid tumors and hematological malignancies dosed its first patient in Australia.
ATG-016 (eltanexor, second generation XPO1 inhibitor)
Events during the Reporting Period
NMPA approved the IND application for a Phase I/II clinical study of ATG-016 in high-risk myelodysplastic syndrome (MDS).
Events after the Reporting Period
The company has submitted an IND application for the Phase I/II clinical study of ATG-016 in solid tumors in February 2021.
Pre-Clinical Assets
Antengene made steady progress with its pre-clinical pipeline assets, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-018 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-012 (KRAS inhibitor) and two other biologics that it has not yet disclosed target.
Events during the Reporting Period
The company is conducting IND enabling studies to support IND/CTA applications for ATG-101 and plans to submit the applications in 2021.
The company is conducting preclinical studies to support IND/CTA applications for ATG-018 and plans to submit the applications in the beginning of 2022.
The company is conducting preclinical studies to support IND/CTA applications for ATG-022 and plans to submit the applications in 2022.
The company is conducting preclinical studies to support IND/CTA applications for ATG-012 and plan to submit the applications in 2022.
Other Developments
Events during the Reporting Period
Events after the Reporting Period
Financial Highlights
IFRS Measures:
The company's adjusted loss and total comprehensive loss were RMB455.0 million for the year ended December 31, 2020, primarily attributable to the increased research and development costs and administrative expenses.
Non-IFRS Measures:
The company's cash and bank balances increased by RMB2,363.0 million, to RMB3,109.8 million for the year ended December 31, 2020. This increase was primarily attributable to the Series C financing in July and the IPO in November 2020.
The company's research and development costs increased by RMB231.9 million, to RMB347.7 million for the year ended December 31, 2020. This increase was primarily attributable to the increased payments made to the company's licensing partners, expansion of R&D personnel and other clinical-related fees.
The company's administrative expenses increased by RMB114.9 million, to RMB154.2 million for the year ended December 31, 2020. The increase was primarily attributable to the increase in employee costs and share issue expenses in relation to the initial public offering (IPO) of the company.
A non-cash, one time change of RMB2,356.3 million upon the listing in the fair value loss on convertible redeemable preferred shares as required under the IFRS for the year ended December 31, 2020. The increased of RMB2,141.8 million was primarily attribute to significant increase in the per share fair value upon the completion of the IPO of the Company when re-measuring convertible redeemable preferred shares previously issued to the investors before conversion into the Company's ordinary shares.
The company's other income and gains decreased by RMB26.1 million, to RMB26.8 million for the year ended December 31, 2020. This decrease was primarily attributable to the absence of the net foreign exchange gains recorded for the prior year.
The company's loss and total comprehensive loss increased by RMB2,605.1 million, to RMB2,928.9 million for the year ended December 31, 2020. This increase in loss includes (i) a loss of RMB463.3 million primarily due to the increase in research and development costs and administrative expenses. (ii) A non-cash, one time change of RMB2,141.8 million upon the listing in the fair value loss on convertible redeemable preferred shares as required under the IFRS.
Outlook
Leveraging its combinatory and complementary R&D strategy and through its strong R&D capabilities and strategic approach in developing novel therapies, Antengene continues to realize its vision of treating patients beyond borders and transforming their lives by discovering, developing and commercializing global first-in-class, only-in-class and/or best-in-class therapies.
Antengene will advance the clinical development of its six clinical stage products in multiple therapeutic areas, and continue to implement its dual-engine approach of external partnerships and internal discovery to build up a pipeline focusing on the key oncogenic pathways, tumor microenvironment and tumor associated antigens through its business development, clinical and commercial teams in place globally and across the APAC region. The company also intends to continue implementing its complementary approach to develop the in-licensed assets for additional indications to maximize their commercial potential.
Looking into 2021, Antengene expects to receive NDA approvals for selinexor (ATG-010) during the fourth quarter of 2021 and the first quarter of 2022, in five APAC markets including mainland China, Australia, South Korea, Hong Kong and Singapore. The company will also advance two of its in pre-clinical novel assets into the IND stage.
Antengene's commercial leadership team has experience in successfully launching multiple top hematology products in China, the wider APAC region, and across markets around the world. The company will continue to build out its commercial team in preparation for the first launch of ATG-010 in Greater China and the rest of APAC to address unmet medical needs in its territories. Antengene expects to build a commercial team of approximately 150 members by year end with dedicated in-house marketing, field force, pricing and market access, and medical affairs teams possessing proven track record and in-depth regional expertise in hematologic oncology.
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 12 investigational new drug approvals in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.