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Dec 31, 2021
Lianbio-Adr Q4 2021 Earnings Report
LianBio reported its financial results for the fourth quarter and full year 2021.
Key Takeaways
LianBio reported a net loss of $21.2 million for the fourth quarter of 2021. The company's cash balance totaled $403.2 million, which is projected to fund operations through 2023. Key milestones included the initiation of the Phase 3 EXPLORER-CN trial of mavacamten and the approval of infigratinib for cholangiocarcinoma patients in Hainan Province.
Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM is ongoing.
Mavacamten was granted breakthrough therapy designation in China for the treatment of patients with oHCM.
Infigratinib was approved under a special named patient program for the treatment of cholangiocarcinoma (CCA) in the Bo'Ao pilot zone of Hainan Province in China.
Cash balance of $403.2 million is expected to provide runway through 2023.
Forward Guidance
LianBio expects to initiate pivotal studies of three additional programs, TP-03, NBTXR3 and infigratinib, in China by year-end. LianBio’s partner BMS has announced a Prescription Drug User Fee Act (PDUFA) target action date of April 28, 2022 for its New Drug Application to the U.S. Food and Drug Administration (FDA) for mavacamten for the treatment of patients with oHCM.
Positive Outlook
- Initiate a Phase 3 trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
- Begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
- Begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 trial of infigratinib in first-line CCA patients with FGFR2 gene fusions/translocations in the second half of 2022.
- LianBio’s partner BMS has announced a Prescription Drug User Fee Act (PDUFA) target action date of April 28, 2022 for its New Drug Application to the U.S. Food and Drug Administration (FDA) for mavacamten for the treatment of patients with oHCM.
- LianBio expects to initiate pivotal studies of three additional programs, TP-03, NBTXR3 and infigratinib, in China by year-end.
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