On November 10, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, LianBio, NOV 10, 2022, View Source [SID1234623725]).

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"The LianBio team continues to execute across our clinical development strategies, and we have initiated three pivotal trials of our late-stage, clinically validated programs year-to-date," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We believe the progress we are making across our pipeline ensures we are well-positioned to bring innovative medicines to patients in China, with our first launch anticipated in 2024. We are investing in our team and in our commercial infrastructure, and working closely with patient communities, healthcare professionals and regulators in anticipation of the topline results from our Phase 3 EXPLORER-CN study next year that we expect will support potential registration of mavacamten in China."
Recent Business Highlights and Clinical Development Updates
Following enrollment completion in the Phase 3 EXPLORER-CN trial of mavacamten in Chinese oHCM patients in August 2022, launch and market building initiatives are underway in China
•In August 2022, LianBio submitted a New Drug Application (NDA) to the Department of Health, the Hong Kong Special Administrative Region, China, for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The submission was based on the U.S. Food and Drug Administration approval of mavacamten.
•In September 2022, LianBio collaborated with Beijing Lisheng Cardiovascular Health Foundation to launch Joy from Heart, a hypertrophic cardiomyopathy (HCM) disease awareness campaign in China. Joy from Heart is China’s first disease awareness program dedicated to improving HCM diagnosis rates and supporting HCM education initiatives for patients and healthcare providers.
•In September 2022, mavacamten was added as a Class Ib recommended drug in the 2022 Chinese Guidelines on Hypertrophic Cardiomyopathy published in the Chinese Journal of Heart Failure and Cardiomyopathy.

•LianBio has hired key leadership roles to support the expected mavacamten commercial launch in China, including medical affairs personnel, medical science liaisons, and business unit leaders for key regions.
Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of head and neck cancer initiated in Asia
•In September 2022, LianBio began treating patients in Asia in the global Phase 3 NANORAY-312 trial evaluating NBTXR3 for the treatment of head and neck cancer. LianBio expects this trial to support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China
•In September 2022, LianBio’s development partner Tarsus submitted an NDA to the U.S. FDA for TP-03 for the treatment of Demodex blepharitis. The submission was based on two pivotal studies of TP-03 demonstrating disease resolution. Tarsus subsequently communicated that the FDA accepted the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2023.
•In November 2022, LianBio announced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis. LianBio expects the LIBRA trial to support registration in China.
Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China
•In November 2022, LianBio announced that it began treating patients with advanced solid tumors in a Phase 1 monotherapy dose escalation trial of BBP-398.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend into the second half of 2024.
Key Milestones Anticipated in 2023
Mavacamten
•LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial in the fourth quarter of 2023.
Infigratinib
•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.

BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the first half of 2023.
Third Quarter 2022 Financial Results
Research & Development Expenses
Research and development expenses were $8.3 million for the third quarter of 2022 compared to $4.7 million for the third quarter of 2021, and $49.2 million for the nine month period ended September 30, 2022 compared to $151.0 million for the nine month period ended September 30, 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.
General & Administrative Expenses
General and administrative expenses were $16.3 million for the third quarter of 2022 compared to $8.9 million for the third quarter of 2021, and $46.9 million for the nine month period ended September 30, 2022 compared to $22.5 million for the nine month period ended September 30, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.
Net Loss
Net loss was $21.9 million for the third quarter of 2022 compared to net loss of $13.1 million for the third quarter of 2021, and $92.0 million for the nine month period ended September 30, 2022 compared to $175.1 million for the nine month period ended September 30, 2021.
Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at September 30, 2022 totaled $331.8 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the second half of 2024.