Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing, with data expected mid-year 2023
Phase 3 registrational trial of TP-03 in Chinese patients with Demodex blepharitis ongoing, with data expected in the fourth quarter of 2023
Entered into commercial agreement with Pfizer, with Pfizer opting into
Cash, cash equivalents and marketable securities of
“2022 marked a pivotal year for
Recent Business Highlights and Clinical Development Updates
Mavacamten late-stage clinical development and launch readiness activities on track in
March 2023, patient visits in the double-blinded placebo-controlled treatment period were completed in the Phase 3 EXPLORER-CN study of mavacamten in Chinese symptomatic oHCM patients.
February 2023, LianBiosubmitted an NDA for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM) in the Macau Special Administrative Region. The submission was based on the U.S. Food and Drug Administration(FDA) approval of mavacamten. LianBiohas now filed New Drug Applications to support approval of mavacamten in Hong Kong, Singaporeand Macau.
January 2023, mavacamten was added to The Joint Committee of Cardiomyopathy Specialty Alliance, National Center for Cardiovascular Diseases/Cardiovascular Precision Medicine Branch of China International Exchangeand Promotive Associationfor Medical and Health Care’s 2023 Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy. LianBiocontinues to hire key leadership roles to support the expected mavacamten commercial launch in China, including sales and marketing, market access, distribution, and medical affairs personnel. LianBiocontinues to work with the physician community and academic societies in Chinato drive disease awareness and improve the standardization of diagnosis and treatment of HCM.
Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in
November 2022, LianBioannounced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis. LianBioexpects the LIBRA trial to support TP-03 registration in China.
Phase 1 clinical trial of BBP-398
November 2022, LianBioannounced the initiation of a Phase 1 monotherapy dose escalation trial of BBP-398 in Chinese patients with advanced solid tumors.
Entered into commercial agreement with Pfizer for the development and commercialization of sisunatovir
December 2022, LianBioentered into a commercial agreement with Pfizer and ReViral Ltd., now a wholly owned subsidiary of Pfizer, with respect to sisunatovir as the first opted-in product under LianBio’s existing strategic collaboration with Pfizer. Pursuant to the commercial agreement, LianBioassigned and transferred development and commercialization rights to sisunatovir in Mainland China, Hong Kong, Macauand Singaporeto Pfizer. LianBioreceived a $20.0 millionupfront payment, which was released as part of previously restricted cash paid to LianBioby Pfizer in 2020 pursuant to the Pfizer strategic collaboration agreement. LianBiois eligible to receive up to $135.0 millionin potential development and sales milestones. LianBiois further entitled to receive tiered payments in the low single digits on a percentage of net sales of sisunatovir in the territory. Pfizer will assume all development and commercial activities and costs in the region and will release LianBiofrom its royalty and milestone obligations for sisunatovir.
Business is well-positioned to achieve anticipated milestones
- Current cash runway is projected to extend through the end of 2024.
Key Milestones Anticipated in 2023
LianBioexpects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023. LianBioexpects to file a New Drug Application (NDA) in 2023 to support regulatory approval of mavacamten in China.
LianBioexpects 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.
LianBioexpects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023. LianBioexpects 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 in China.
LianBioexpects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the second half of 2023.
Fourth Quarter and Full-Year 2022 Financial Results:
Research & Development Expenses
Research and development expenses were
General & Administrative Expenses
General and administrative expenses were
Net loss was
Cash, cash equivalents and marketable securities at
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,” “believe,” “continue,” “estimate,” “potential,” “expect,” “may,” 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 becoming a commercial-stage company, the Company’s expectations in 2023 with regards to filing the mavacamten NDA to support the registration of mavacamten in
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|Cash and cash equivalents||$||79,221||$||228,182|
|Prepaid expenses and other current assets||8,640||10,354|
|Total current assets||312,773||399,647|
|Restricted cash, non-current||73||20,000|
|Property and equipment, net||3,116||1,882|
|Operating lease right-of-use assets||3,978||4,763|
|Other non-current assets||20||51|
|Liabilities and Shareholders’ Equity|
|Current portion of operating lease liabilities||1,851||1,125|
|Other current liabilities||485||760|
|Total current liabilities||23,615||15,092|
|Operating lease liabilities||2,488||3,709|
|Nonrefundable research deposit||—||20,000|
|Commitments and contingencies (Note 8)|
|Shareholders’ equity (deficit):|
|Additional paid-in capital||732,476||713,269|
|Accumulated other comprehensive (loss) income||(2,080||)||526|
|Total shareholders’ equity||293,647||387,336|
|Total liabilities and shareholders’ equity||$||319,960||$||426,343|
Statement of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
|Three Months Ended
||Three Months Ended
|Research and development||$||10,577||$||7,653||$||59,755||$||158,692|
|General and administrative||18,668||14,383||65,598||36,878|
|Total operating expenses||29,245||22,036||125,353||195,570|
|Loss from operations||(29,245||)||(22,036||)||(125,353||)||(195,570||)|
|Other income (expense):|
|Interest income, net||2,083||72||4,321||243|
|Other income (expense), net||8,536||(265||)||10,409||(455||)|
|Net loss before income taxes||(18,626||)||(22,229||)||(110,623||)||(195,782||)|
|Income tax (benefit) expenses||(350||)||(1,035||)||(333||)||518|
|Other comprehensive (loss) income:|
|Foreign currency translation (loss) income, net of tax||1,384||408||(1,712||)||512|
|Unrealized (loss) gain on marketable securities, net of tax||380||54||(894||)||54|
|Net loss per share attributable to ordinary shareholders, basic and diluted||$||(0.17||)||$||(0.28||)||$||(1.02||)||$||(5.71||)|
|Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted||108,127,303||75,479,076||107,923,296||34,394,622|
2023 GlobeNewswire, Inc., source
Technical analysis trends LIANBIO
|Short Term||Mid-Term||Long Term|
Income Statement Evolution
|Number of Analysts||4|
|Last Close Price||1,67 $|
|Average target price||7,98 $|
|Spread / Average Target||378%|