- Entered into agreement with
Bristol Myers Squibb for mavacamten inChina and other Asian markets - Phase 3 data from EXPLORER-CN trial of mavacamten presented in an oral late-breaking science session at the
European Society of Cardiology Congress 2023 with simultaneous publication in JAMA Cardiology - Topline data announced from Phase 3 trial of TP-03 in Chinese Demodex blepharitis patients
- Cash, cash equivalents and marketable securities of
$252.2 million as ofSeptember 30, 2023 - Strategic review ongoing
“We continue to make significant progress bringing innovative medicines to patients in our region, including the achievement of critical clinical development and market building milestones,” said
Recent Business Highlights and Clinical Development Updates
Entered into agreement with
- In
October 2023 ,LianBio entered into an agreement withBristol Myers Squibb (BMS), whereby BMS obtained LianBio’s exclusive rights to develop and commercialize mavacamten in Mainland China,Hong Kong ,Macau ,Taiwan ,Singapore andThailand , in conjunction with termination of the exclusive license agreementLianBio previously entered into withMyoKardia, Inc. , now a wholly owned subsidiary of BMS, inAugust 2020 to acquire such rights. Under the terms of the agreement,LianBio is entitled to receive a total consideration of$350 million . - In
August 2023 ,LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients were presented in a late-breaking science session at theEuropean Society of Cardiology (ESC) Congress 2023 and simultaneously published in a JAMA Cardiology paper titled, “Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy.”
Topline data announced from Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients; TP-03 approved in
- In
October 2023 ,LianBio announced topline data from the Phase 3 LIBRA study of TP-03 in Chinese patients with Demodex blepharitis. The co-primary endpoints of the LIBRA trial were mite eradication (mite density of 0 mites per lash) and complete collarette cure (collarette score of 0) at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.001). A positive, although not statistically significant trend (p=0.15) was demonstrated for complete collarette cure.LianBio plans to discuss these results with theChina National Medical Products Administration (NMPA) and expects to use these data to support a New Drug Application filing inChina . - In
July 2023 ,LianBio partner Tarsus Pharmaceuticals announced theU.S. Food and Drug Administration's approval of TP-03 for the treatment of adults with Demodex blepharitis.
Positive topline data presented from Phase 2a trial of infigratinib in Chinese patients with gastric cancer
- In
October 2023 ,LianBio announced data from a Phase 2a study evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification were presented at theEuropean Society for Medical Oncology (ESMO) Congress 2023. The data demonstrated confirmed objective response rate (cORR) of 23.8% (95% CI: 8.2 – 47.2), disease control rate (DCR) of 76.2% (95% CI: 52.8 – 91.8) and median duration of response (DOR) of 3.8 months (95% CI: 3.6 – NE). Median progression-free survival (mPFS) was 3.3 months (95% CI: 2.3 – 4.5) and median overall survival (mOS) was 8.0 months (95% CI: 4.1 – NE).
Initiated Phase 1 clinical trial of
- In
August 2023 ,LianBio announced the initiation of a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations. - In
July 2023 ,LianBio entered into a clinical supply agreement with AstraZeneca inChina to procure osimertinib for this clinical trial.
Comprehensive strategic review ongoing
- In
October 2023 ,LianBio announced that the company’s Board of Directors initiated a comprehensive strategic review of the company, with an update anticipated in the first half of 2024.
Third Quarter 2023 Financial Results
Research & Development Expenses
Research and development expenses were
General & Administrative Expenses
General and administrative expenses were
Net Loss
Net loss was
Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at
About
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
For investor inquiries, please contact:
E: IR@lianbio.com
For media inquiries, please contact:
E: katherine.smith@evokegroup.com
T: (619) 849-5378
Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) | |||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 103,457 | $ | 79,221 | |||
Marketable securities | 148,765 | 223,142 | |||||
Prepaid expenses and other current assets | 4,673 | 8,640 | |||||
Other receivable | 910 | 1,770 | |||||
Total current assets | 257,805 | 312,773 | |||||
Restricted cash, non-current | 69 | 73 | |||||
Property and equipment, net | 2,364 | 3,116 | |||||
Operating lease right-of-use assets | 2,644 | 3,978 | |||||
Other non-current assets | 20 | 20 | |||||
Total assets | $ | 262,902 | $ | 319,960 | |||
Liabilities and Shareholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,229 | $ | 1,453 | |||
Accrued expenses | 15,882 | 19,826 | |||||
Current portion of operating lease liabilities | 1,893 | 1,851 | |||||
Other current liabilities | 1,623 | 485 | |||||
Total current liabilities | 25,627 | 23,615 | |||||
Operating lease liabilities | 950 | 2,488 | |||||
Other liabilities | 213 | 210 | |||||
Total liabilities | $ | 26,790 | $ | 26,313 | |||
Commitments and contingencies (Note 8) | |||||||
Ordinary shares, | 2 | 2 | |||||
Additional paid-in capital | 745,786 | 732,476 | |||||
Accumulated other comprehensive loss | (3,220 | ) | (2,080 | ) | |||
Accumulated deficit | (540,230 | ) | (470,525 | ) | |||
Total | 202,338 | 259,873 | |||||
Non-controlling interest | 33,774 | 33,774 | |||||
Total shareholders’ equity | 236,112 | 293,647 | |||||
Total liabilities and shareholders’ equity | $ | 262,902 | $ | 319,960 |
Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 9,018 | $ | 8,258 | $ | 29,303 | $ | 49,178 | |||||||
General and administrative | 17,283 | 16,291 | 48,011 | 46,930 | |||||||||||
Total operating expenses | 26,301 | 24,549 | 77,314 | 96,108 | |||||||||||
Loss from operations | (26,301 | ) | (24,549 | ) | (77,314 | ) | (96,108 | ) | |||||||
Other income: | |||||||||||||||
Interest income, net | 2,707 | 1,405 | 7,867 | 2,238 | |||||||||||
Other income, net | 141 | 1,253 | 966 | 1,873 | |||||||||||
Net loss before income taxes | (23,453 | ) | (21,891 | ) | (68,481 | ) | (91,997 | ) | |||||||
Income taxes | 586 | 6 | 1,224 | 17 | |||||||||||
Net loss | (24,039 | ) | (21,897 | ) | (69,705 | ) | (92,014 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||
Foreign currency translation loss, net of tax | (130 | ) | (2,282 | ) | (1,667 | ) | (3,096 | ) | |||||||
Unrealized gain (loss) on marketable securities, net of tax | 236 | (160 | ) | 527 | (1,274 | ) | |||||||||
Comprehensive loss | $ | (23,933 | ) | $ | (24,339 | ) | $ | (70,845 | ) | $ | (96,384 | ) | |||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.22 | ) | $ | (0.20 | ) | $ | (0.65 | ) | $ | (0.85 | ) | |||
Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted | 107,167,691 | 108,353,831 | 107,164,699 | 107,854,547 |
Source:
2023 GlobeNewswire, Inc., source