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Dec 31, 2022
Lianbio-Adr Q4 2022 Earnings Report
LianBio reported financial results for Q4 2022 and provided a corporate update, highlighting progress in clinical trials and commercial agreements.
Key Takeaways
LianBio reported a net loss of $18.3 million for the fourth quarter of 2022, compared to a net loss of $21.2 million for the same period in 2021. The company's cash, cash equivalents, and marketable securities totaled $302.4 million, providing a cash runway through the end of 2024. Key milestones anticipated in 2023 include topline data from the Phase 3 EXPLORER-CN trial of mavacamten and the Phase 3 LIBRA trial of TP-03.
Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) is ongoing, with data expected mid-year 2023.
Phase 3 registrational trial of TP-03 in Chinese patients with Demodex blepharitis is ongoing, with data expected in the fourth quarter of 2023.
LianBio entered into a commercial agreement with Pfizer, with Pfizer opting into LianBio rights to RSV therapeutic candidate sisunatovir in LianBio territories.
Cash, cash equivalents, and marketable securities totaled $302.4 million, providing a cash runway through the end of 2024.
Forward Guidance
LianBio anticipates several key milestones in 2023, including reporting topline data from the Phase 3 EXPLORER-CN trial of mavacamten and the Phase 3 LIBRA trial of TP-03, as well as filing a New Drug Application (NDA) in 2023 to support regulatory approval of mavacamten in China.
Positive Outlook
- Expected topline data from Phase 3 EXPLORER-CN trial of mavacamten in mid-2023.
- Planned NDA filing for mavacamten in China in 2023.
- Expected topline data from Phase 3 LIBRA trial of TP-03 in Q4 2023.
- Planned initiation of a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the second half of 2023.
- Planned initiation of a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval in China.
Challenges Ahead
- Uncertainty regarding the successful initiation and conduct of planned clinical trials.
- Dependence on leveraging data generated in partners’ global registrational trials.
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