On November 13, 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 third quarter ended September 30, 2023 (Press release, LianBio, NOV 13, 2023, View Source [SID1234637547]).

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"We continue to make significant progress bringing innovative medicines to patients in our region, including the achievement of critical clinical development and market building milestones," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Following our recent transaction granting development and commercial rights to BMS for mavacamten in our territories, we look forward to conducting a comprehensive strategic review aimed at realizing the value of our platform and product candidates."

Recent Business Highlights and Clinical Development Updates

Entered into agreement with Bristol Myers Squibb for mavacamten in China and other Asian markets
•In October 2023, LianBio entered into an agreement with Bristol Myers Squibb (BMS), whereby BMS obtained LianBio’s exclusive rights to develop and commercialize mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Singapore and Thailand, in conjunction with termination of the exclusive license agreement LianBio previously entered into with MyoKardia, Inc., now a wholly owned subsidiary of BMS, in August 2020 to acquire such rights. Under the terms of the agreement, LianBio is entitled to receive a total consideration of $350 million.
•In August 2023, LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients were presented in a late-breaking science session at the European Society of Cardiology (ESC) Congress 2023 and simultaneously published in a JAMA Cardiology paper titled, "Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy."
Topline data announced from Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients; TP-03 approved in the United States
•In October 2023, LianBio announced topline data from the Phase 3 LIBRA study of TP-03 in Chinese patients with Demodex blepharitis. The co-primary endpoints of the LIBRA trial were mite eradication (mite density of 0 mites per lash) and complete collarette cure (collarette score of 0) at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.001). A positive, although not statistically significant trend (p=0.15) was demonstrated for complete collarette cure. LianBio plans to discuss these results with the China National Medical Products Administration (NMPA) and expects to use these data to support a New Drug Application filing in China.

•In July 2023, LianBio partner Tarsus Pharmaceuticals announced the U.S. Food and Drug Administration’s approval of TP-03 for the treatment of adults with Demodex blepharitis.

Positive topline data presented from Phase 2a trial of infigratinib in Chinese patients with gastric cancer
•In October 2023, LianBio announced data from a Phase 2a study evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. The data demonstrated confirmed objective response rate (cORR) of 23.8% (95% CI: 8.2 – 47.2), disease control rate (DCR) of 76.2% (95% CI: 52.8 – 91.8) and median duration of response (DOR) of 3.8 months (95% CI: 3.6 – NE). Median progression-free survival (mPFS) was 3.3 months (95% CI: 2.3 – 4.5) and median overall survival (mOS) was 8.0 months (95% CI: 4.1 – NE).

Initiated Phase 1 clinical trial of SHP2 inhibitor BBP-398 in combination with EGFR inhibitor osimertinib in Chinese non-small cell lung cancer (NSCLC) patients with EGFR mutations
•In August 2023, LianBio announced the initiation of a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations.
•In July 2023, LianBio entered into a clinical supply agreement with AstraZeneca in China to procure osimertinib for this clinical trial.

Comprehensive strategic review ongoing

•In October 2023, LianBio announced that the company’s Board of Directors initiated a comprehensive strategic review of the company, with an update anticipated in the first half of 2024.
Third Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $9.0 million for the third quarter of 2023 compared to $8.3 million for the third quarter of 2022, and $29.3 million for the nine month period ended September 30, 2023 compared to $49.2 million for the nine month period ended September 30, 2022. The decrease was primarily attributable to increased milestone payments in 2022 and was partially offset by higher development activities to support clinical trials in 2023.

General & Administrative Expenses

General and administrative expenses were $17.3 million for the third quarter of 2023 compared to $16.3 million for the third quarter of 2022, and $48.0 million for the nine month period ended September 30, 2023 compared to $46.9 million for the nine month period ended September 30, 2022. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and was partially offset by lower expenses for legal, consulting and accounting services.

Net Loss

Net loss was $24.0 million for the third quarter of 2023 compared to net loss of $21.9 million for the third quarter of 2022, and $69.7 million for the nine month period ended September 30, 2023 compared to $92.0 million for the nine month period ended September 30, 2022.