Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
2024年11月8日 - 6:05AM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical
biotechnology company and leader in the discovery and development
of novel therapeutics for the treatment of fibrotic diseases, today
provided a corporate update and reported third quarter 2024
financial results.
“A highlight to this quarter’s progress was the continued strong
execution of our BEACON-IPF Phase 2b/3 trial which is enrolling
well and on track to complete enrollment in the first quarter of
2025,” said Bernard Coulie, M.D., Ph.D., President and Chief
Executive Officer of Pliant. “We are pleased with the interest from
the global physician and patient communities in participating in
BEACON-IPF and look forward to sharing data in mid-2026.
Additionally, we made progress across the portfolio with the goal
of bringing potential therapies to patients.”
Third Quarter and Recent Highlights
Bexotegrast Highlights
- Enrollment remains on track in
BEACON-IPF, a pivotal adaptive Phase 2b/3 trial of bexotegrast in
patients with idiopathic pulmonary fibrosis (IPF). The
BEACON-IPF Phase 2b/3 trial is a 52-week, multinational,
randomized, dose-ranging, double-blind, placebo-controlled trial
evaluating bexotegrast at once-daily doses of 160 mg or 320 mg. The
Phase 2b portion of BEACON-IPF will enroll 360 patients with IPF.
Enrollment in this portion of this trial is expected to
be complete in the first quarter of 2025 with data anticipated in
mid-2026.
- Results from Phase 2a PET
imaging target engagement trial published in the American Journal
of Respiratory and Critical Care Medicine (AJRCCM). Also
known as the “Blue Journal,” AJRCCM is a leading peer-reviewed
journal published by the American Thoracic Society. The publication
reviews the previously reported positive results from an open-label
trial in which bexotegrast showed dose-dependent αvβ6 integrin
receptor occupancy in lungs of patients with IPF.
Pipeline Programs
- Phase 1 trial of PLN-101095 in
solid tumors is progressing with dosing of the third of five
cohorts. PLN-101095 is an oral, small molecule, dual
selective inhibitor of αvβ8 and αvβ1 integrins designed to block
TGF-β activation in the tumor microenvironment. The
Company has completed enrollment in the third of five cohorts
in the Phase 1 open-label, dose-escalation trial. In this trial,
PLN-101095 is being tested as monotherapy and in combination with
pembrolizumab in patients with solid tumors that are resistant to
immune checkpoint inhibitors. Preliminary data is expected in early
2025.
- PLN-101325 applications beyond
muscular dystrophies. PLN-101325 is a monoclonal antibody
that acts as an allosteric agonist of integrin α7β1, currently in
development for treatment of muscular dystrophies. The Company is
currently generating additional evidence in support of potential
expansion of the scope of PLN-101325 prior to initiating a Phase 1
trial.
Corporate Highlights
- Appointment of Gary Palmer,
M.D. as Senior Vice President of Medical Affairs. Dr.
Palmer brings over 25 years of global leadership experience in
medical affairs from biopharmaceutical companies of various sizes
and stages, and across multiple therapeutic areas including
pulmonary medicine, immunology and neurology. Most recently, Dr.
Palmer served as Senior Vice President of Global Medical Affairs,
Immunology and Neuroscience at Bristol Myers Squibb.
Third Quarter 2024 Financial
Results
- Research and development expenses were
$47.8 million, as compared to $32.3 million for the prior-year
quarter. The increase was primarily driven by BEACON-IPF, a Phase
2b/3 trial of bexotegrast in patients with IPF.
- General and administrative expenses
were $14.3 million, as compared to $15.3 million for the prior-year
quarter. The decrease was primarily due to professional service
expenses.
- Net loss of $57.8 million as compared
to $41.5 million for the prior-year quarter. The increase was
primarily due to higher operating expenses driven by
BEACON-IPF.
- As of September 30, 2024, the Company
had cash, cash equivalents and short-term investments of $406.0
million.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a late-stage biopharmaceutical company
and leader in the discovery and development of novel therapeutics
for the treatment of fibrotic diseases. Pliant's lead product
candidate, bexotegrast (PLN-74809), is an oral, small molecule,
dual selective inhibitor of αvß6 and αvß1 integrins that is in
development in the lead indications for the treatment of idiopathic
pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or
PSC. Bexotegrast has received Fast Track Designation and Orphan
Drug Designation from the U.S. Food and Drug Administration (FDA)
in IPF and PSC and Orphan Drug Designation from the European
Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF,
an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is
conducting a Phase 1 study for its third clinical program,
PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and
αvß1 integrins, that is being developed for the treatment of solid
tumors. In addition, Pliant has received regulatory clearance for
the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody
agonist of integrin α7β1 targeting muscular dystrophies.
For additional information, please visit: www.PliantRx.com.
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Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
"may," "will," "expect," "anticipate," "estimate," "intend," and
similar expressions (as well as other words or expressions
referencing future events, conditions, or circumstances) are
intended to identify forward-looking statements. These statements
include those regarding the safety, tolerability, pharmacodynamics
and therapeutic potential of bexotegrast; our ability to complete
enrollment in BEACON-IPF in the first quarter of 2025; our plans
for the future development of bexotegrast, PLN-101325 and
PLN-101095, including the potential expansion of PLN-101325 into
additional indications in organ systems outside of muscle;
bexotegrast’s potential to become a treatment for IPF or PSC; the
anticipated timing of data and progress from our clinical studies
and public announcements related thereto; and discussions with
regulatory authorities. Because such statements deal with future
events and are based on our current expectations, they are subject
to various risks and uncertainties and actual results, performance
or achievements of Pliant Therapeutics could differ materially from
those described in or implied by the statements in this press
release. These forward-looking statements are subject to risks and
uncertainties, including those related to the development and
commercialization of our product candidates, including any delays
in our ongoing or planned preclinical or clinical trials, the
impact of current macroeconomic and marketplace conditions,
including the effects of COVID-19, on our business, operations,
clinical supply and plans, our reliance on third parties for
critical aspects of our development operations, the risks inherent
in the drug development process, the risks regarding the accuracy
of our estimates of expenses and timing of development, our capital
requirements and the need for additional financing, including the
availability of additional term loans under our loan facility, and
our ability to obtain and maintain intellectual property protection
for our product candidates. These and additional risks are
discussed in the sections titled "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" in our Quarterly Report on Form 10-Q for the period
ended September 30, 2024 which we are filing with the SEC today,
available on the SEC's website at www.sec.gov. Unless otherwise
noted, Pliant is providing this information as of the date of this
news release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or otherwise.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate
Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
Pliant Therapeutics, Inc.Condensed
Statements of Operations(Unaudited)(In
thousands, except number of shares and per share amounts) |
|
|
Three Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
Revenue |
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
|
(47,754 |
) |
|
|
(32,339 |
) |
General and administrative |
|
(14,260 |
) |
|
|
(15,346 |
) |
Total operating expenses |
|
(62,014 |
) |
|
|
(47,685 |
) |
Loss from operations |
|
(62,014 |
) |
|
|
(47,685 |
) |
Interest and other income (expense), net |
|
5,128 |
|
|
|
6,515 |
|
Interest expense |
|
(877 |
) |
|
|
(317 |
) |
Net loss |
$ |
(57,763 |
) |
|
$ |
(41,487 |
) |
Net loss per share - basic and
diluted |
$ |
(0.95 |
) |
|
$ |
(0.70 |
) |
Shares used in computing net
loss per share - basic and diluted |
|
60,730,935 |
|
|
|
59,688,451 |
|
Pliant Therapeutics, Inc.Condensed Balance
Sheets(Unaudited)(In thousands) |
|
|
September 30,2024 |
|
December 31,2023 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
79,616 |
|
|
$ |
63,234 |
|
Short-term investments |
|
324,897 |
|
|
|
431,011 |
|
Prepaid expenses and other current assets |
|
5,518 |
|
|
|
11,257 |
|
Total current assets |
|
410,031 |
|
|
|
505,502 |
|
Property and equipment,
net |
|
5,671 |
|
|
|
3,567 |
|
Operating lease right-of-use
assets |
|
28,054 |
|
|
|
1,211 |
|
Restricted cash |
|
1,482 |
|
|
|
1,482 |
|
Other non-current assets |
|
427 |
|
|
|
392 |
|
Total assets |
$ |
445,665 |
|
|
$ |
512,154 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
6,890 |
|
|
$ |
4,531 |
|
Accrued research and development |
|
23,025 |
|
|
|
12,456 |
|
Accrued liabilities |
|
9,715 |
|
|
|
10,219 |
|
Operating lease liabilities, current |
|
322 |
|
|
|
1,318 |
|
Total current liabilities |
|
39,952 |
|
|
|
28,524 |
|
Operating lease liabilities, non-current |
|
29,752 |
|
|
|
— |
|
Long-term debt |
|
30,139 |
|
|
|
10,054 |
|
Total liabilities |
|
99,843 |
|
|
|
38,578 |
|
Stockholders’ equity |
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
6 |
|
|
|
6 |
|
Additional paid-in capital |
|
1,005,288 |
|
|
|
972,973 |
|
Accumulated deficit |
|
(660,320 |
) |
|
|
(499,748 |
) |
Accumulated other comprehensive gain |
|
848 |
|
|
|
345 |
|
Total stockholders’ equity |
|
345,822 |
|
|
|
473,576 |
|
Total liabilities and
stockholders’ equity |
$ |
445,665 |
|
|
$ |
512,154 |
|
|
|
|
|
Pliant Therapeutics (NASDAQ:PLRX)
過去 株価チャート
から 10 2024 まで 11 2024
Pliant Therapeutics (NASDAQ:PLRX)
過去 株価チャート
から 11 2023 まで 11 2024