SHANGHAI, China and PRINCETON, N.J., Nov. 10, 2022 (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 third quarter ended September 30, 2022 and provided a corporate update.

“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

Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of head and neck cancer initiated in Asia

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

Business is well-positioned to achieve anticipated milestones

Key Milestones Anticipated in 2023

Mavacamten

TP-03

Infigratinib

BBP-398

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.

About LianBio

LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to 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, inflammatory disease and respiratory 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 additional information, please visit the company’s website at 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,” "plan," " believe," “continue,” “expect,” “potential,” “project,” 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 the Company’s plans and expectations with respect to the initiation and completion of its clinical trials, the advancement of its pipeline of therapeutic candidates, the continued growth of its organization, its ability to bring transformative medicines to patients across Asia, its ability to navigate complex regulatory environments in Greater China and Asia, the Company's plans and expectations with respect to preparation for potential commercialization and product launch, and the timeline through which it expects to be able to fund its operating expenses and capital expenditure requirements, as well as statements regarding its partners’ announced plans and expectations with respect to their planned product development activities, preclinical studies and clinical trials. 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 and subsequent filings with the SEC. 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.

For investor inquiries, please contact:

Elizabeth Anderson, VP Communications and Investor Relations
E: elizabeth.anderson@lianbio.com
T: (646) 655-8390

For media inquiries, please contact:

Josh Xu, Director of Communications
E: josh.xu@lianbio.com
T: +86 136 6140 8315

Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: (619) 849-5378



LianBio
Consolidated Balance Sheets
(In thousands, except share and per share amounts) (Unaudited)

  September 30,
2022		 December 31,
2021
Assets    
Current assets:    
Cash and cash equivalents $78,862  $228,182 
Marketable securities  232,866   155,067 
Prepaid expenses and other current assets  5,117   10,354 
Other receivable  7,393   6,044 
Total current assets  324,238   399,647 
Restricted cash, non-current  20,070   20,000 
Property and equipment, net  3,135   1,882 
Operating lease right-of-use assets  4,362   4,763 
Other non-current assets  37   51 
Total assets $351,842  $426,343 
Liabilities and Shareholders’ Equity    
Current liabilities:    
Accounts payable $2,019  $3,231 
Accrued expenses  17,871   9,976 
Current portion of operating lease liabilities  1,750   1,125 
Other current liabilities  387   760 
Total current liabilities  22,027   15,092 
Operating lease liabilities  3,017   3,709 
Other liabilities  200   206 
Nonrefundable research deposit  20,000   20,000 
Total liabilities $45,244  $39,007 
Commitments and contingencies (Note 8)    
Ordinary shares, $0.000017100448 par value. Authorized 2,923,900,005 shares as of September 30, 2022; 108,353,831 shares issued and outstanding at September 30, 2022; Authorized 2,923,900,005 shares as of December 31, 2021; 107,275,458 shares issued and outstanding at December 31, 2021  2   2 
Additional paid-in capital  728,915   713,269 
Accumulated other comprehensive (loss) income  (3,844)  526 
Accumulated deficit  (452,249)  (360,235)
Total LianBio shareholders’ equity  272,824   353,562 
Non-controlling interest  33,774   33,774 
Total shareholders’ equity  306,598   387,336 
Total liabilities and shareholders’ equity $351,842  $426,343 


LianBio
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)

  Three Months Ended
September 30,		 Nine Months Ended
September 30,
   2022   2021   2022   2021 
Operating expenses:        
Research and development $8,258  $4,655   49,178  $151,038 
General and administrative  16,291   8,889   46,930   22,496 
Total operating expenses  24,549   13,544   96,108   173,534 
Loss from operations  (24,549)  (13,544)  (96,108)  (173,534)
Other income (expense):        
Interest income, net  1,405   32   2,238   171 
Other income (expense), net  1,253   3   1,873   (189)
Net loss before income taxes  (21,891)  (13,509)  (91,997)  (173,552)
Income taxes (benefit)  6   (397)  17   1,553 
Net loss  (21,897)  (13,112)  (92,014)  (175,105)
Other comprehensive (loss) income:        
Foreign currency translation (loss) income, net of tax  (2,282)  (26)  (3,096)  104 
Unrealized loss on marketable securities, net of tax  (160)  —   (1,274)  — 
Comprehensive loss $(24,339) $(13,138) $(96,384) $(175,001)
Net loss per share attributable to ordinary shareholders, basic and diluted $(0.20) $(0.63) $(0.85) $(8.52)
Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted  108,353,831   20,690,908   107,854,547   20,549,310