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Name | Symbol | Market | Type |
---|---|---|---|
LianBio | NASDAQ:LIAN | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.319 | 0.3101 | 0.3449 | 0 | 01:00:00 |
“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 RelationsE: elizabeth.anderson@lianbio.com T: (646) 655-8390
For media inquiries, please contact:
Josh Xu, Director of CommunicationsE: josh.xu@lianbio.comT: +86 136 6140 8315
Katherine Smith, Evoke CanaleE: katherine.smith@evokegroup.comT: (619) 849-5378
LianBioConsolidated 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 |
LianBioStatements 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 |
1 Year LianBio Chart |
1 Month LianBio Chart |
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