LianBio Reports First Quarter 2023 Financial Results and Provides Corporate Update
11 Mai 2023 - 10:15PM
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 first
quarter ended March 31, 2023.
“We continue to achieve multiple significant milestones,
propelling the company towards the anticipated commercial launch of
mavacamten in China,” said Yizhe Wang, Ph.D., Chief Executive
Officer of LianBio. “Our team’s demonstrated proficiency in
navigating the Chinese regulatory landscape instills confidence in
our cross-border model. With the recent progress we’ve made, we
believe we are on track to bring our first drug to market in China
next year, while we continue to advance our other key programs
through the clinic.”
Recent Business Highlights and Clinical Development
Updates
Mavacamten late-stage clinical development and launch
readiness activities on track in China with NDA on file; mavacamten
approved in Macau; NDAs under review in Singapore and Hong
Kong
- In 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 Exchange and
Promotive Association for Medical and Health Care’s 2023 Guidelines
for the Diagnosis and Treatment of Patients with Hypertrophic
Cardiomyopathy.
- In April 2023, the China NMPA accepted
with priority review the NDA for mavacamten for the treatment of
adults with symptomatic oHCM.
- 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 demonstrated a safety profile consistent with
previous studies.
- 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.
Commercial infrastructure build continues in preparation
for anticipated 2024 mavacamten launch
- In April 2023, Pascal Qian was promoted
to Chief Commercial Officer to oversee the continued growth of the
company’s commercial capabilities in preparation for the
anticipated mavacamten commercial launch in China. 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 through the end of 2024.
Key Anticipated Milestones
Mavacamten
- LianBio plans to present detailed
results from EXPLORER-CN at an upcoming medical meeting.
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
- LianBio expects 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.
- 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 an EGFR-inhibitor in
non-small cell lung cancer in the second half of 2023.
First Quarter 2023 Financial Results
Research & Development Expenses
Research and development expenses were $10.8 million for the
first quarter of 2023 compared to $12.3 million for the first
quarter of 2022. The decrease was primarily attributable to
increased milestone payments in 2022, and was offset by higher
development activities to support clinical trials in 2023.
General & Administrative Expenses
General and administrative expenses were $15.1 million for the
first quarter of 2023 compared to $16.1 million for the first
quarter of 2022. The decrease was primarily attributable to
decreases in expenses for legal, consulting and accounting
services.
Net
Loss
Net loss was $24.0 million for the first quarter of 2023
compared to net loss of $27.7 million for the first quarter of
2022.
Cash Balance
Cash, cash equivalents, marketable securities and restricted
cash at March 31, 2023 totaled $286.6 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 through the end of 2024.
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 plans and expectations with
respect to the initiation and completion of its clinical trials,
including the Phase 2 clinical trial of infigratinib in patients
with FGFR2 gene amplification and a Phase 1 clinical trial of
BBP-398 in combination with an EGFR-inhibitor in non-small cell
lung cancer; the Company’s plans to present and report results and
data from EXPLORER-CN, the Phase 3 LIBRA trial of TP-03 and the
ongoing 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; 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, 2021 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 Relations
E: elizabeth.anderson@lianbio.com
T: (646) 655-8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com
T: +86 136 6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: (619) 849-5378
|
LianBio |
Consolidated Balance Sheets |
(In thousands, except share and per share amounts)
(Unaudited) |
|
|
March 31,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
102,334 |
|
|
$ |
79,221 |
|
Marketable securities |
|
184,203 |
|
|
|
223,142 |
|
Prepaid expenses and other current assets |
|
8,500 |
|
|
|
8,640 |
|
Other receivable |
|
1,013 |
|
|
|
1,770 |
|
Total current assets |
|
296,050 |
|
|
|
312,773 |
|
Restricted cash, non-current |
|
73 |
|
|
|
73 |
|
Property and equipment, net |
|
2,836 |
|
|
|
3,116 |
|
Operating lease right-of-use assets |
|
3,604 |
|
|
|
3,978 |
|
Other non-current assets |
|
20 |
|
|
|
20 |
|
Total assets |
$ |
302,583 |
|
|
$ |
319,960 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,431 |
|
|
$ |
1,453 |
|
Accrued expenses |
|
16,627 |
|
|
|
19,826 |
|
Current portion of operating lease liabilities |
|
1,906 |
|
|
|
1,851 |
|
Other current liabilities |
|
1,961 |
|
|
|
485 |
|
Total current liabilities |
|
25,925 |
|
|
|
23,615 |
|
Operating lease liabilities |
|
2,014 |
|
|
|
2,488 |
|
Other liabilities |
|
217 |
|
|
|
210 |
|
Nonrefundable research deposit |
|
— |
|
|
|
— |
|
Total liabilities |
$ |
28,156 |
|
|
$ |
26,313 |
|
Commitments and contingencies
(Note 8) |
|
|
|
Ordinary shares,
$0.000017100448 par value. Authorized 2,923,900,005 shares as of
March 31, 2023; 107,164,175 shares issued and outstanding at March
31, 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 |
|
736,752 |
|
|
|
732,476 |
|
Accumulated other comprehensive loss |
|
(1,531 |
) |
|
|
(2,080 |
) |
Accumulated deficit |
|
(494,570 |
) |
|
|
(470,525 |
) |
Total LianBio shareholders’ equity |
|
240,653 |
|
|
|
259,873 |
|
Non-controlling interest |
|
33,774 |
|
|
|
33,774 |
|
Total shareholders’ equity |
|
274,427 |
|
|
|
293,647 |
|
Total liabilities and shareholders’
equity |
$ |
302,583 |
|
|
$ |
319,960 |
|
|
LianBio |
Statements of Operations and Comprehensive
Loss |
(In thousands, except share and per share amounts)
(Unaudited) |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
10,831 |
|
|
$ |
12,329 |
|
General and administrative |
|
15,138 |
|
|
|
16,088 |
|
Total operating expenses |
|
25,969 |
|
|
|
28,417 |
|
Loss from operations |
|
(25,969 |
) |
|
|
(28,417 |
) |
Other income (expense): |
|
|
|
Interest income, net |
|
2,406 |
|
|
|
280 |
|
Other (expense) income, net |
|
(44 |
) |
|
|
417 |
|
Net loss before income taxes |
|
(23,607 |
) |
|
|
(27,720 |
) |
Income taxes |
|
438 |
|
|
|
6 |
|
Net loss |
|
(24,045 |
) |
|
|
(27,726 |
) |
Other comprehensive income
(loss): |
|
|
|
Foreign currency translation income (loss), net of tax |
|
104 |
|
|
|
(393 |
) |
Unrealized gain (loss) on marketable securities, net of tax |
|
445 |
|
|
|
(823 |
) |
Comprehensive loss |
$ |
(23,496 |
) |
|
$ |
(28,942 |
) |
Net loss per share attributable
to ordinary shareholders, basic and diluted |
$ |
(0.22 |
) |
|
$ |
(0.26 |
) |
Weighted-average shares
outstanding used in computing net loss per share attributable to
ordinary shareholders, basic and diluted |
|
107,162,025 |
|
|
|
107,275,458 |
|
|
|
|
|
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