- Mavacamten New Drug Application (NDA) under priority review with
China National Medical Products Administration (NMPA) - Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) met primary endpoint
- Data from EXPLORER-CN trial to be presented in an oral late-breaking science session at
European Society of Cardiology Congress 2023 - Cash, cash equivalents and marketable securities of
$267.3 million with runway into the first half of 2025
“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
Recent Business Highlights and Clinical Development Updates
Mavacamten commercial preparation ongoing in
- In the second quarter of 2023,
LianBio continued to progress the Company's collaboration with theChinese Cardiovascular Association (CCA) to develop HCM centers of excellence (COE), with 17 key hospitals now taking part in the CCA's HCM COE pilot program. - In
July 2023 ,LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic oHCM patients were accepted for a late-breaking presentation at theEuropean Society of Cardiology (ESC) Congress 2023. - In
June 2023 , mavacamten was approved for the treatment of adults with symptomatic oHCM inSingapore . - In
May 2023 , mavacamten was approved for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM in theMacau Special Administrative Region . - In
April 2023 ,LianBio announced topline results from the Phase 3 EXPLORER-CN trial evaluating mavacamten in Chinese patients with oHCM. EXPLORER-CN met the primary endpoint, demonstrating statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract gradient from baseline to week 30 compared to placebo. Mavacamten also demonstrated improvement across all secondary endpoints. Mavacamten demonstrated a safety profile consistent with previous studies. - In
April 2023 , the China NMPA accepted with priority review the NDA for mavacamten for the treatment of adults with symptomatic oHCM.
Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients completed enrollment; TP-03 approved in
- 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. - In
June 2023 ,LianBio announced completion of enrollment in the Phase 3 LIBRA clinical trial of TP-03 in Chinese Demodex blepharitis patients.LianBio expects the LIBRA trial to support TP-03 registration inChina .
Positive topline data announced from Phase 2a trial of infigratinib in Chinese patients with gastric cancer and receipt of Breakthrough Therapy Designation in
- In
June 2023 ,LianBio announced topline results from the Company’s Phase 2a proof of concept trial evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification. The trial demonstrated a confirmed objective response rate (ORR) of 25.0% (n=20). The observed mediation duration of response was 3.8 months. - Based on these data, the NMPA granted Breakthrough Therapy Designation to infigratinib for the treatment of gastric cancer.
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.
Commercial infrastructure build continues with Chief Commercial Officer appointment
- In
April 2023 ,Pascal Qian was promoted to Chief Commercial Officer to oversee the continued growth of the company’s commercial capabilities. He will continue to also serve as the company’s China General Manager.
Business is well-positioned to achieve anticipated milestones
- Current cash runway is projected to extend into the first half of 2025.
Key Anticipated Milestones
Mavacamten
LianBio expects to begin enrolling patients in BMS's ongoing Phase 3 ODYSSEY-HCM trial of mavacamten in non-obstructive HCM (nHCM) inChina in mid-2024.LianBio anticipates NDA approval inChina in mid-2024, and commercial launch inChina in the second half of 2024.LianBio expects to launch mavacamten inSingapore andMacau in the fourth quarter of 2023.LianBio plans to file NDAs to support mavacamten approval inTaiwan andThailand in the fourth quarter of 2023.
TP-03
LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis in the fourth quarter of 2023.
Infigratinib
- Data from the Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification were accepted for a poster presentation at the
European Society of Medical Oncology (ESMO) Congress 2023, to be heldOctober 20-24 inMadrid . LianBio expects to initiate a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval inChina .
BBP-398
LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with a PD-1 inhibitor in advanced solid tumors in the first half of 2024.
Second 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: elizabeth.anderson@lianbio.com
T: (646) 655-8390
For media inquiries, please contact:
E: josh.xu@lianbio.com
T: +86 136 6140 8315
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 | $ | 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, | 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 | 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 |
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||
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 |
Source:
2023 GlobeNewswire, Inc., source