LianBio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing, with data expected mid-year 2023
Phase 3 registrational trial of TP-03 in Chinese patients with Demodex blepharitis ongoing, with data expected in the fourth quarter of 2023
Entered into commercial agreement with Pfizer, with Pfizer opting into LianBio rights to RSV therapeutic candidate sisunatovir in LianBio territories
Cash, cash equivalents and marketable securities of $302.4 million with runway through the end of 2024
SHANGHAI, China and PRINCETON, N.J., March 27, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today reported financial results for the fourth quarter and year ended December 31, 2022.
“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
Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China
Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China
Entered into commercial agreement with Pfizer for the development and commercialization of sisunatovir
Business is well-positioned to achieve anticipated milestones
Key Milestones Anticipated in 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 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, 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.
LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to historically underserved patients in China and other Asian markets. Through partnerships with highly innovative biopharmaceutical companies around the world, LianBio is advancing a diversified portfolio of clinically validated product candidates with the potential to drive new standards of care across cardiovascular, oncology, ophthalmology, and inflammatory disease indications. LianBio is establishing an international infrastructure to position the company as a partner of choice with a platform to provide access to China and other Asian markets. For more information, please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements. The words “anticipate,” “believe,” “continue,” “estimate,” “potential,” “expect,” “may,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, but are not limited to, statements concerning becoming a commercial-stage company, the Company’s expectations in 2023 with regards to filing the mavacamten NDA to support the registration of mavacamten in China and its plans to initiate a clinical trial for BBP-398 as well as its plans to initiate a Phase 2 trial of infigratinib in 2024, the Company’s efforts to build out its commercial infrastructure related to mavacamten, the Company’s plans and expectations with respect to its ability to develop and bring TP-03 and its other product candidates to patients in China such as the potential for the LIBRA trial to support registration of TP-03 in China, and the Company’s plans and expectations with respect to the timing of initiation, completion and reporting of topline data from the EXPLORER-CN trial of mavacamten, the LIBRA trial of TP-03, the Phase 2a clinical trial of infigratinib as well as results from its planned and ongoing clinical trials in China and its other licensed territories. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully initiate and conduct its planned clinical trials and complete such clinical trials and obtain results on its expected timelines, or at all; the Company’s plans to leverage data generated in its partners’ global registrational trials and clinical development programs to obtain regulatory approval and maximize patient reach for its product candidates; the Company’s ability to identify new product candidates and successfully acquire such product candidates from third parties; competition from other biotechnology and pharmaceutical companies; general market conditions; the impact of changing laws and regulations and those risks and uncertainties described in LianBio’s filings with the U.S. Securities and Exchange Commission (SEC), including LianBio’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022 and subsequent filings with the SEC including, when available, the Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statements contained in this press release speak only as of the date hereof, and LianBio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon this information as current or accurate after its publication date.
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