On March 27, 2023 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 fourth quarter and year ended December 31, 2022 (Press release, LianBio, MAR 27, 2023, View Source [SID1234629383]).

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"2022 marked a pivotal year for LianBio, with sustained progress across our pipeline and building of our commercial infrastructure in anticipation of registration of mavacamten in China," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "This year, we look forward to pivotal data in the EXPLORER-CN trial of mavacamten and the LIBRA trial of TP-03, and to filing the mavacamten NDA in China. With a cash runway through the end of 2024, we believe LianBio is well positioned to become a commercial-stage company. Looking ahead, we are excited to continue advancing our mission to bring innovative medicines to patients in Asia."

Recent Business Highlights and Clinical Development Updates

Mavacamten late-stage clinical development and launch readiness activities on track in China; New Drug Applications now on file in Singapore, Hong Kong and Macau

•In March 2023, patient visits in the double-blinded placebo-controlled treatment period were completed in the Phase 3 EXPLORER-CN study of mavacamten in Chinese symptomatic oHCM patients.
•In February 2023, LianBio submitted an NDA for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM) in the Macau Special Administrative Region. The submission was based on the U.S. Food and Drug Administration (FDA) approval of mavacamten. LianBio has now filed New Drug Applications to support approval of mavacamten in Hong Kong, Singapore and Macau.
•In January 2023, mavacamten was added to The Joint Committee of Cardiomyopathy Specialty Alliance, National Center for Cardiovascular Diseases/Cardiovascular Precision Medicine Branch of China International Exchange and Promotive Association for Medical and Health Care’s 2023 Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.

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•LianBio continues to hire key leadership roles to support the expected mavacamten commercial launch in China, including sales and marketing, market access, distribution, and medical affairs personnel.
•LianBio continues to work with the physician community and academic societies in China to drive disease awareness and improve the standardization of diagnosis and treatment of HCM.

Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China

•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 TP-03 registration in China.

Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China

•In November 2022, LianBio announced the initiation of a Phase 1 monotherapy dose escalation trial of BBP-398 in Chinese patients with advanced solid tumors.

Entered into commercial agreement with Pfizer for the development and commercialization of sisunatovir

•In December 2022, LianBio entered into a commercial agreement with Pfizer and ReViral Ltd., now a wholly owned subsidiary of Pfizer, with respect to sisunatovir as the first opted-in product under LianBio’s existing strategic collaboration with Pfizer. Pursuant to the commercial agreement, LianBio assigned and transferred development and commercialization rights to sisunatovir in Mainland China, Hong Kong, Macau and Singapore to Pfizer. LianBio received a $20.0 million upfront payment, which was released as part of previously restricted cash paid to LianBio by Pfizer in 2020 pursuant to the Pfizer strategic collaboration agreement. LianBio is eligible to receive up to $135.0 million in potential development and sales milestones. LianBio is further entitled to receive tiered payments in the low single digits on a percentage of net sales of sisunatovir in the territory. Pfizer will assume all development and commercial activities and costs in the region and will release LianBio from its royalty and milestone obligations for sisunatovir.

Business is well-positioned to achieve anticipated milestones

•Current cash runway is projected to extend through the end 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.
•LianBio expects to file a New Drug Application (NDA) in 2023 to support regulatory approval of mavacamten in China.

TP-03

•LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis 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.
•LianBio expects to initiate 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.

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 second half of 2023.

Fourth Quarter and Full-Year 2022 Financial Results:
Research & Development Expenses

Research and development expenses were $10.6 million for the fourth quarter of 2022 compared to $7.7 million for the fourth quarter of 2021, and $59.8 million for the year ended December 31, 2022 compared to $158.7 million for the year ended December 31, 2021. The decrease was primarily attributable to decreased milestone and upfront licensing payments. These decreases were partially offset by increases in development activities to support clinical trials and personnel-related expenses (including share-based compensation expense) as a result of increased employee headcount, development activities to support our clinical trials and professional fees.

General & Administrative Expenses

General and administrative expenses were $18.7 million for the fourth quarter of 2022 compared to $14.4 million for the fourth quarter of 2021, and $65.6 million for the year ended December 31, 2022 compared to $36.9 million for the year ended December 31, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and increases in legal service costs, consulting costs and accounting services.

Net Loss
Net loss was $18.3 million for the fourth quarter of 2022 compared to net loss of $21.2 million for the fourth quarter of 2021, and $110.3 million for the year ended December 31, 2022 compared to $196.3 million for the year ended December 31, 2021.

Cash Balance

Cash, cash equivalents and marketable securities at December 31, 2022 totaled $302.4 million, reflecting a net decrease of $100.8 million from December 31, 2021. LianBio projects its cash position is sufficient to fund current operations through the end of 2024.