Phase 3 registrational trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing
Mavacamten granted breakthrough therapy designation in
Infigratinib approved under special named patient program for the treatment of cholangiocarcinoma (CCA) in the Bo'Ao pilot zone of
Three additional pipeline programs expected to enter into registrational Phase 3 clinical trials in
Cash balance of
“We are proud of our progress over the past year, highlighted by the achievement of key clinical and corporate milestones, including the initiation of the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM, and the approval of infigratinib for the treatment of cholangiocarcinoma patients in the
Recent Business Highlights and Clinical Development Updates
Phase 3 EXPLORER-CN trial of mavacamten in symptomatic oHCM patients initiated and PK trial dosing completed
- In
November 2021 ,LianBio initiated and completed enrollment and dosing in a pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. - In
January 2022 ,LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM. - In
February 2022 ,LianBio's partner Bristol Myers Squibb (BMS) announced positive topline results from the Phase 3 VALOR-HCM trial, evaluating mavacamten in patients with oHCM who are eligible for septal reduction therapy. - In
February 2022 ,LianBio announced that theCenter for Drug Evaluation (CDE) of theNational Medical Products Administration (NMPA) granted Breakthrough Therapy Designation inChina for mavacamten for the treatment of patients with oHCM.
Infigratinib approved for the treatment of CCA in the Bo'ao pilot zone of
- In
December 2021 , infigratinib received approval from theHealth Commission andMedical Products Administration of Hainan Province , under the special Named Patient Program (NPP), for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. The approval enables early commercial access to infigratinib in the Bo’aoLecheng International Medical Tourism Pilot Zone based on the drug’s approval in other global jurisdictions.
Expanded leadership team with key executive hires and named two additions to board of directors
- In
October 2021 ,LianBio namedMichael Humphries , MBBS, as Chief Scientific Advisor to guide research and development (R&D) strategy, advance the pipeline, and lead assessment of new in-licensing opportunities. - In
October 2021 ,LianBio appointedJesse Wu andSusan Silbermann to the Board of Directors.
Raised
- In
November 2021 ,LianBio raised gross proceeds of$334.5 million and aggregate net proceeds of$304.8 million in connection with its initial public offering and subsequent exercise of the underwriters’ option to purchase additional ADSs.
Key Anticipated Milestones Expected in 2022
Mavacamten
BMS-partnered cardiac myosin inhibitor in development for the treatment of hypertrophic cardiomyopathy and certain forms of heart failure
- LianBio’s partner BMS has announced a Prescription Drug User Fee Act (PDUFA) target action date of
April 28, 2022 for its New Drug Application to theU.S. Food and Drug Administration (FDA) for mavacamten for the treatment of patients with oHCM.
TP-03
Tarsus Pharmaceuticals-partnered GABA-Cl channel blocker in development for the treatment of Demodex blepharitis (DB) and meibomian gland disease
LianBio expects to initiate a Phase 3 trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval inChina .- LianBio’s partner Tarsus has announced that it expects to report topline data in
April 2022 from the ongoing Phase 3 Saturn-2 trial of TP-03 in DB patients.
NBTXR3
Nanobiotix-partnered radioenhancer in development for multiple solid tumor indications
LianBio expects to begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
Infigratinib
QED-partnered FGFR1-3 inhibitor in development for the treatment of individuals with FGFR-driven cancers
LianBio expects to begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 trial of infigratinib in first-line CCA patients with FGFR2 gene fusions/translocations in the second half of 2022.
Fourth Quarter and Full-Year 2021 Financial Results:
Research & Development Expenses
R&D Expenses: Research and development expenses were
of increased employee headcount, development activities to support our clinical trials and professional
fees.
General & Administrative Expenses
G&A Expenses: General and administrative expenses were
Net Loss
Net Loss: Net loss was
Cash Balance
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,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” 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, its ability to bring transformative medicines to patients across
For investor inquiries, please contact:
IR@lianbio.com
For media inquiries, please contact:
katherine.smith@canalecomm.com
Consolidated Balance Sheets
(In thousands, except share and per share amounts) (Unaudited)
2021 | 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 228,182 | $ | 254,350 | ||||
Marketable securities | 155,067 | — | ||||||
Prepaid expenses and other current assets | 10,354 | 2,396 | ||||||
Other receivable | 6,044 | 20,000 | ||||||
Total current assets | 399,647 | 276,746 | ||||||
Restricted cash, non-current | 20,000 | — | ||||||
Property and equipment, net | 1,882 | 822 | ||||||
Operating lease right-of-use assets | 4,763 | 1,706 | ||||||
Other non-current assets | 51 | 12 | ||||||
Total assets | $ | 426,343 | $ | 279,286 | ||||
Liabilities, Redeemable Convertible Preferred Shares and Shareholders’ Equity (Deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,231 | $ | 4,329 | ||||
Accrued expenses | 9,976 | 998 | ||||||
Current portion of operating lease liabilities | 1,125 | 539 | ||||||
Other current liabilities | 760 | 360 | ||||||
Total current liabilities | 15,092 | 6,226 | ||||||
Operating lease liabilities | 3,709 | 1,341 | ||||||
Other liabilities | 206 | — | ||||||
Nonrefundable research deposit | 20,000 | 20,000 | ||||||
Total liabilities | 39,007 | 27,567 | ||||||
Commitments and contingencies (Note 8) | ||||||||
Redeemable convertible preferred shares, | — | 349,789 | ||||||
Shareholders’ equity (deficit): | ||||||||
Ordinary shares, | 2 | — | ||||||
Additional paid-in capital | 713,269 | 31,132 | ||||||
Accumulated other comprehensive income (loss) | 526 | (40 | ) | |||||
Accumulated deficit | (360,235 | ) | (163,935 | ) | ||||
Total | 353,562 | (132,843 | ) | |||||
Non-controlling interest | 33,774 | 34,773 | ||||||
Total shareholders’ equity (deficit) | 387,336 | (98,070 | ) | |||||
Total liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit) | $ | 426,343 | $ | 279,286 | ||||
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
Three Months Ended | Three Months Ended | Year Ended | Year Ended | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 7,653 | 2,712 | 158,692 | 120,885 | ||||||||||||
General and administrative | 14,383 | 6,492 | 36,878 | 13,984 | ||||||||||||
Total operating expenses | 22,036 | 9,204 | 195,570 | 134,869 | ||||||||||||
Loss from operations | (22,036 | ) | (9,204 | ) | (195,570 | ) | (134,869 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income (expense), net | 72 | (3,574 | ) | 243 | (4,854 | ) | ||||||||||
Other (expense) income, net | (265 | ) | 42 | (455 | ) | 123 | ||||||||||
Net loss before income taxes | (22,230 | ) | (12,736 | ) | (195,782 | ) | (139,600 | ) | ||||||||
Income taxes (benefit) expense | (1,035 | ) | — | 518 | 4 | |||||||||||
Net loss | (21,195 | ) | (12,736 | ) | (196,300 | ) | (139,604 | ) | ||||||||
Other comprehensive income (loss): | ||||||||||||||||
Foreign currency translation income (loss), net of tax | 408 | 25 | 512 | (40 | ) | |||||||||||
Unrealized gain on marketable securities, net of tax | 54 | — | 54 | — | ||||||||||||
Comprehensive loss | $ | (20,733 | ) | $ | (12,711 | ) | $ | (195,734 | ) | $ | (139,644 | ) | ||||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.28 | ) | $ | (0.73 | ) | $ | (5.71 | ) | $ | (11.58 | ) | ||||
Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted | 75,479,076 | 17,369,481 | 34,394,622 | 12,051,433 |
Source:
2022 GlobeNewswire, Inc., source