Non-IFRS loss was less than expected. Antengene reported net loss of RMB2,929mn in 2020 vs RMB324mn in 2019, which was mainly due to the RMB2,142mn fair value loss on convertible redeemable preferred shares. Non-IFRS loss (adjusted loss) excluding the fair value loss on convertible redeemable preferred shares, share issue expenses and equity settled share option expense was RMB455mn in 2020 (vs loss of RMB109mn in 2019), less than our estimate of RMB680mn in 2020E. R&D expenses rose to RMB348mn in 2020, +200% YoY, including RMB163mn in licensing fees and RMB85mn in clinical-related fees.
Smooth progress of clinical-stage assets. Antengene has established a robust and highly differentiated pipeline of 12 innovative assets, including two late-stage assets ATG-010 and ATG-008 in-licensed from Karyopharm and Celgene, respectively. For ATG-010 (selinexor, XPO1 inhibitor): As of 31 Dec 2020, Antengene had submitted NDAs for ATG-010 in 4 APAC markets (Australia, Singapore, Hong Kong and South Korea)。 In Jan 2021, the Company submitted an NDA to the NMPA of selinexor for r/r-MM, which was subsequently granted priority review by the NMPA. Meanwhile, Antengene received the NMPA approval to initiate a Phase II/III clinical trial of selinexor in combination with rituximab, gemcitabine dexamethasone cisplatin (R-GDP) in r/r-DLBCL. For ATG-008 (onatasertib, mTORC1/2 inhibitor): First patient was dosed in the third cohort of the Phase II study in patients with 2L+ HCC. Antengene also initiated a phase I/II study of ATG-008 in combination with PD-1 in solid tumors and a phase II study in NFE2L2-mutant NSCLC, respectively. ATG-008 also received NMPA approval of a phase II biomarker- driven solid tumor basket trial. For other clinical stage pipelines, ATG-019 (dual PAK4/NAMPT inhibitor) and ATG-017 (ERK1/2 inhibitor) completed first patient dosing in 2020. ATG-016 (Eltanexor, XPO1 inhibitor) obtained IND approval of a Phase I/II study in high-risk MDS from the NMPA.
Rich early-stage pipelines. Antengene has disclosed 6 preclinical assets. The Company targets to file IND/CTA for ATG-101 (PD-L1/4-1BB bispecific antibody) in 2021. Another 3 pre-clincial assets, including ATG-018 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate) and ATG-012 (KRAS inhibitor) may complete IND/CTA application by 2022.