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 | ||||||||||||
