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 second
quarter ended June 30, 2023.
“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 Yizhe Wang, Ph.D., Chief
Executive Officer of LianBio. “Over the next twelve months, we are
looking forward to our first anticipated approval in China,
building and developing our cardiovascular sales force, filing an
NDA to support approval of TP-03 in China, and initiating a pivotal
trial of infigratinib in gastric cancer. We believe we are well
positioned for LianBio’s first launches in our territories later
this year when we begin to commercialize mavacamten in Singapore
and Macau.”
Recent Business Highlights and Clinical Development
Updates
Mavacamten commercial preparation ongoing in China with
NDA under priority review; Asia Pacific regulatory milestones
achieved with Singapore and Macau approvals granted and additional
NDA under review in Hong Kong
- In the second quarter of 2023, LianBio
continued to progress the Company's collaboration with the Chinese
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 the European Society of Cardiology (ESC) Congress
2023.
- In June 2023, mavacamten was approved
for the treatment of adults with symptomatic oHCM in
Singapore.
- In May 2023, mavacamten was approved
for the treatment of adults with symptomatic New York Heart
Association Class II-III oHCM in the Macau 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 the United States
- In July 2023, LianBio partner Tarsus
Pharmaceuticals announced the U.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 in China.
Positive topline data announced from Phase 2a trial of
infigratinib in Chinese patients with gastric cancer and receipt of
Breakthrough Therapy Designation in China
- 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 SHP2 inhibitor BBP-398 in
combination with osimertinib in Chinese non-small cell lung cancer
(NSCLC) patients with EGFR mutations initiated
- 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 in China 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) in China in mid-2024.
- LianBio anticipates NDA approval in
China in mid-2024, and commercial launch in China in the second
half of 2024.
- LianBio expects to launch mavacamten in
Singapore and Macau in the fourth quarter of 2023.
- LianBio plans to file NDAs to support
mavacamten approval in Taiwan and Thailand 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
held October 20-24 in Madrid.
- 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 in China.
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 $9.5 million for the
second quarter of 2023 compared to $28.6 million for the second
quarter of 2022, and $20.3 million for the six month period ended
June 30, 2023 compared to $40.9 million for the six month
period ended June 30, 2022. The decrease was primarily
attributable to increased milestone payments in 2022 and was
partially offset by higher development activities to support
clinical trials in 2023.
General & Administrative Expenses
General and administrative expenses were $15.6 million for the
second quarter of 2023 compared to $14.6 million for the second
quarter of 2022, and $30.7 million for the six month period ended
June 30, 2023 compared to $30.6 million for the six month
period ended June 30, 2022. The increase was primarily
attributable to increases in payroll and personnel-related expenses
(including share-based compensation expense) for increased employee
headcount and was partially offset by lower expenses for legal,
consulting and accounting services.
Net
Loss
Net loss was $21.6 million for the second quarter of 2023
compared to net loss of $42.4 million for the second quarter of
2022, and $45.7 million for the six month period ended
June 30, 2023 compared to $70.1 million for the six month
period ended June 30, 2022.
Cash Balance
Cash, cash equivalents, marketable securities and restricted
cash at June 30, 2023 totaled $267.3 million compared to
$302.4 million as of December 31, 2022. LianBio projects its
current cash, cash equivalents, marketable securities, and
restricted cash will be sufficient to fund its current operating
plan into the first half of 2025.
About LianBio
LianBio is a cross-border biotechnology company on a mission to
bring transformative medicines to historically underserved 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, and inflammatory disease
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
more information, please visit 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,” “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 China and the submission of NDAs in
Taiwan and Thailand; the Company’s plans and expectations with
respect to the initiation and completion of its clinical trials,
including the Phase 3 ODYSSEY-HCM trial of mavacamten in
non-obstructive HCM, the Phase 2 clinical trial of infigratinib in
patients with FGFR2 gene amplification and the Phase 1 clinical
trial of BBP-398 in combination with osimertinib in NSCLC; the
Company’s plans to present and report results and data from the
Phase 3 LIBRA trial of TP-03 and the Phase 2a clinical trial of
infigratinib; the advancement of its pipeline of therapeutic
candidates; the continued growth of its organization; its ability
to bring transformative medicines to patients in China and 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, including the anticipated commercial launch of mavacamten
in China, Singapore and Macau; 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, 2022 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 RelationsE:
elizabeth.anderson@lianbio.com T: (646) 655-8390
For media inquiries, please contact:
Josh Xu, Director of
CommunicationsE: josh.xu@lianbio.comT: +86 136 6140 8315
Katherine Smith, Evoke CanaleE: katherine.smith@evokegroup.comT:
(619) 849-5378
LianBioConsolidated
Balance Sheets(In thousands, except share and per
share amounts) (Unaudited)
|
June 30,2023 |
|
December 31,2022 |
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, $0.000017100448 par value. Authorized
2,923,900,005 shares as of June 30, 2023; 107,167,609 shares issued
and outstanding at June 30, 2023; Authorized 2,923,900,005 shares
as of December 31, 2022; 107,043,924 shares issued and outstanding
at December 31, 2022 |
|
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 LianBio shareholders’ equity |
|
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 |
|
LianBioStatements of
Operations and Comprehensive Loss(In thousands,
except share and per share amounts) (Unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
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 |
|
LianBio (NASDAQ:LIAN)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
LianBio (NASDAQ:LIAN)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024