SHANGHAI, China and PRINCETON, N.J., Aug. 14, 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 second quarter ended June 30, 2023.

"During the first half of 2023, we achieved multiple clinical development milestones and advanced our pipeline closer to patients in need of new treatment options," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Over the next twelve months, we are looking forward to our first anticipated approval in China, building and developing our cardiovascular sales force, filing an NDA to support approval of TP-03 in China, and initiating a pivotal trial of infigratinib in gastric cancer. We believe we are well positioned for LianBio's first launches in our territories later this year when we begin to commercialize mavacamten in Singapore and Macau."

Recent Business Highlights and Clinical Development Updates

Mavacamten commercial preparation ongoing in China with NDA under priority review; Asia Pacific regulatory milestones achieved with Singapore and Macau approvals granted and additional NDA under review in Hong Kong  

Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients completed enrollment; TP-03 approved in the United States

Positive topline data announced from Phase 2a trial of infigratinib in Chinese patients with gastric cancer and receipt of Breakthrough Therapy Designation in China

Phase 1 clinical trial of SHP2 inhibitor BBP-398 in combination with osimertinib in Chinese non-small cell lung cancer (NSCLC) patients with EGFR mutations initiated

Commercial infrastructure build continues with Chief Commercial Officer appointment

Business is well-positioned to achieve anticipated milestones

Key Anticipated Milestones

Mavacamten

TP-03

Infigratinib

BBP-398

Second Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $9.5 million for the second quarter of 2023 compared to $28.6 million for the second quarter of 2022, and $20.3 million for the six month period ended June 30, 2023 compared to $40.9 million for the six month period ended June 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 $15.6 million for the second quarter of 2023 compared to $14.6 million for the second quarter of 2022, and $30.7 million for the six month period ended June 30, 2023 compared to $30.6 million for the six month period ended June 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 $21.6 million for the second quarter of 2023 compared to net loss of $42.4 million for the second quarter of 2022, and $45.7 million for the six month period ended June 30, 2023 compared to $70.1 million for the six month period ended June 30, 2022.

Cash Balance

Cash, cash equivalents, marketable securities and restricted cash at June 30, 2023 totaled $267.3 million compared to $302.4 million as of December 31, 2022. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the first half of 2025.

About LianBio

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," "plan," "believe," "continue," "estimate," "expect," "potential," "may," "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 expectations regarding approval of its NDA for mavacamten in China and the submission of NDAs in Taiwan and Thailand; the Company's plans and expectations with respect to the initiation and completion of its clinical trials, including the Phase 3 ODYSSEY-HCM trial of mavacamten in non-obstructive HCM, the Phase 2 clinical trial of infigratinib in patients with FGFR2 gene amplification and the Phase 1 clinical trial of BBP-398 in combination with osimertinib in NSCLC; the Company's plans to present and report results and data from the Phase 3 LIBRA trial of TP-03 and the Phase 2a clinical trial of infigratinib; the advancement of its pipeline of therapeutic candidates; the continued growth of its organization; its ability to bring transformative medicines to patients in China and 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, including the anticipated commercial launch of mavacamten in China, Singapore and Macau; 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, 2022 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)

 June 30,

2023		 December 31,

2022
Assets   
Current assets:   
Cash and cash equivalents$104,059  $79,221 
Marketable securities 163,209   223,142 
Prepaid expenses and other current assets 4,805   8,640 
Other receivable 1,025   1,770 
Total current assets 273,098   312,773 
Restricted cash, non-current 69   73 
Property and equipment, net 2,562   3,116 
Operating lease right-of-use assets 3,049   3,978 
Other non-current assets 20   20 
Total assets$278,798  $319,960 
Liabilities and Shareholders' Equity   
Current liabilities:   
Accounts payable$1,908  $1,453 
Accrued expenses 16,879   19,826 
Current portion of operating lease liabilities 1,859   1,851 
Other current liabilities 996   485 
Total current liabilities 21,642   23,615 
Operating lease liabilities 1,441   2,488 
Other liabilities 210   210 
Nonrefundable research deposit —   — 
Total liabilities$23,293  $26,313 
Commitments and contingencies (Note 8)   
Ordinary shares, $0.000017100448 par value. Authorized 2,923,900,005 shares as of June 30, 2023; 107,167,609 shares issued and outstanding at June 30, 2023; Authorized 2,923,900,005 shares as of December 31, 2022; 107,043,924 shares issued and outstanding at December 31, 2022 2   2 
Additional paid-in capital 741,246   732,476 
Accumulated other comprehensive loss (3,326)  (2,080)
Accumulated deficit (516,191)  (470,525)
Total LianBio shareholders' equity 221,731   259,873 
Non-controlling interest 33,774   33,774 
Total shareholders' equity 255,505   293,647 
Total liabilities and shareholders' equity$278,798  $319,960 



LianBio

Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts) (Unaudited)

 Three Months Ended June 30, Six Months Ended June 30,
  2023   2022   2023   2022 
Operating expenses:       
Research and development$9,454  $28,591   20,285   40,920 
General and administrative 15,590   14,551   30,728   30,639 
Total operating expenses 25,044   43,142   51,013   71,559 
Loss from operations (25,044)  (43,142)  (51,013)  (71,559)
Other income:       
Interest income, net 2,754   553   5,160   833 
Other income, net 869   203   825   620 
Net loss before income taxes (21,421)  (42,386)  (45,028)  (70,106)
Income taxes 200   5   638   11 
Net loss (21,621)  (42,391)  (45,666)  (70,117)
Other comprehensive income (loss):       
Foreign currency translation loss, net of tax (1,641)  (421)  (1,537)  (814)
Unrealized gain (loss) on marketable securities, net of tax (154)  (291)  291   (1,114)
Comprehensive loss$(23,416) $(43,103) $(46,912) $(72,045)
Net loss per share attributable to ordinary shareholders, basic and diluted$(0.20) $(0.39) $(0.43) $(0.65)
Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted 107,164,401   107,922,501   107,163,220   107,600,767 


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