Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results
09 Novembre 2023 - 10:05PM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage
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 2023
financial results.
“The third quarter was highlighted by positive interim data from
the INTEGRIS-PSC trial of bexotegrast demonstrating a favorable
safety profile and encouraging antifibrotic activity in PSC.
Coupled with positive data reported from INTEGRIS-IPF, these data
illustrate the broad potential of bexotegrast in fibrotic
diseases across multiple organ systems,” said Bernard Coulie, M.D.,
Ph.D., President and Chief Executive Officer of Pliant
Therapeutics. “Our pipeline continues to advance, led by the
ongoing enrollment of our Phase 2b BEACON-IPF trial. We have also
taken active steps to strengthen our leadership team with the
appointments of Minnie Kuo as Chief Development Officer and Mishima
Gerhart as Chief Regulatory Officer, coming at an important time in
Pliant’s evolution into a late-stage clinical development
company.”
Third Quarter and Recent Highlights
Bexotegrast Highlights
- Enrollment continues in
BEACON-IPF, a Phase 2b trial of bexotegrast in patients
with idiopathic pulmonary fibrosis
(IPF). BEACON-IPF 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. BEACON-IPF is expected to enroll approximately
270 patients with IPF.
- Positive safety and efficacy
data from INTEGRIS-PSC Phase 2a trial in patients with primary
sclerosing cholangitis (PSC). At once-daily doses of 40
mg, 80 mg and 160 mg, bexotegrast was well tolerated over 12 weeks
of treatment with no drug-related severe or serious adverse events.
At all doses tested, bexotegrast reduced both Enhanced Liver
Fibrosis (ELF) scores and PRO-C3 levels at Week 12 relative to
placebo, with statistically significant differences at the 160 mg
dose. These data were selected for an oral late-breaker
presentation at next week’s American Association for the Study of
Liver Diseases’ (AASLD) The Liver Meeting® 2023.
- Positive independent Data
Safety Monitoring Board (DSMB) review of the ongoing of
INTEGRIS-PSC Phase 2a trial. This regularly scheduled DSMB
review was held in October after the completion of enrollment of
the 320 mg dose cohort. The DSMB examined the safety data from all
patients enrolled, with all patients completing at least 12 weeks
of treatment, and recommended the INTEGRIS-PSC trial continue
without modification.
- INTEGRIS-PSC interim 12-week
320 mg dose data expected in the first quarter of 2024.
This trial is evaluating the safety, tolerability and
pharmacokinetics of bexotegrast at 320 mg versus placebo at 12 and
24 weeks of treatment in approximately 28 patients with PSC. The
trial is also evaluating exploratory efficacy endpoints including
fibrosis biomarkers such as serum PRO-C3 and ELF score, changes in
alkaline phosphatase (ALP) and liver imaging. Twenty-four week data
from the 320 mg dose group is expected in mid-2024.
Pipeline Programs
- Phase 1 trial of PLN-101095 in solid tumors is
enrolling. This is a Phase 1 open-label trial of
PLN-101095, an oral, small-molecule, dual selective inhibitor of
αvβ8 and αvβ1 integrins designed to block TGF-β activation in the
tumor microenvironment. This trial is enrolling patients with solid
tumors that are resistant to immune checkpoint inhibitors.
- Muscular dystrophy program on track for regulatory
filing in the first quarter of 2024. PLN-101325 is a
monoclonal antibody designed to act as an allosteric agonist of
integrin α7β1. Filing for first-in-human clinical studies in
Duchenne muscular dystrophy (DMD) is expected in the first quarter
of 2024.
Corporate Highlights
- Appointment of Minnie Kuo as
Chief Development Officer. Ms. Kuo is an experienced
biopharma executive hired to oversee all clinical and non-clinical
development activities.
- Appointment of S. Mishima Gerhart as Chief Regulatory
Officer Ms. Gerhart is a recognized leader in the
biotechnology and pharmaceutical industries hired to lead all
regulatory activities and quality functions.
Third Quarter 2023 Financial
Results
- Research and development expenses were $32.3 million, as
compared to $24.6 million for the prior-year quarter. The increase
was due primarily to higher employee-related expenses and increased
clinical and manufacturing-related costs associated with our lead
program, bexotegrast, partially offset by a decrease in preclinical
manufacturing costs for our pipeline product candidates.
- General and administrative expenses were $15.3 million, as
compared to $8.8 million for the prior-year quarter. The increase
was due to higher employee-related expenses.
- Net loss of $41.5 million as compared to $30.6 million for the
prior-year quarter due to an increase in operating expenses coupled
with a decrease in collaboration revenues under the Novartis
collaboration during the quarter.
- As of September 30, 2023, the Company had cash, cash
equivalents and short-term investments of $523.6 million which the
Company expects to be sufficient to fund operations into the second
half of 2026.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a clinical-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, a Phase 2b trial of bexotegrast in IPF.
Pliant has also developed PLN-1474, a small molecule, selective
inhibitor of αvß1 integrin for the treatment of nonalcoholic
steatohepatitis, or NASH with liver fibrosis. Pliant has initiated
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
to clinical-stage programs, Pliant currently has a preclinical
program targeting muscular dystrophies. For additional information,
please visit: www.PliantRx.com. Follow us on social media: X,
LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements 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
plans for the future development of bexotegrast, PLN-101325 and
PLN-101095; bexotegrast’s potential to become a treatment for IPF
or PSC; the anticipated timing of data and progress from our
clinical studies; discussions with regulatory authorities and the
sufficiency of our cash runway to fund operations into the second
half of 2026. 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, 2023 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, |
|
2023 |
|
2022 |
Revenue |
$ |
— |
|
|
$ |
1,482 |
|
Operating expenses: |
|
|
|
Research and development |
|
(32,339 |
) |
|
|
(24,606 |
) |
General and administrative |
|
(15,346 |
) |
|
|
(8,823 |
) |
Total operating expenses |
|
(47,685 |
) |
|
|
(33,429 |
) |
Loss from operations |
|
(47,685 |
) |
|
|
(31,947 |
) |
Interest and other income
(expense), net |
|
6,515 |
|
|
|
1,633 |
|
Interest expense |
|
(317 |
) |
|
|
(301 |
) |
Net loss |
$ |
(41,487 |
) |
|
$ |
(30,615 |
) |
Net loss attributable to common stockholders |
$ |
(41,487 |
) |
|
$ |
(30,615 |
) |
Net loss per share,
attributable to common stockholders - basic and diluted |
$ |
(0.70 |
) |
|
$ |
(0.65 |
) |
Shares used in computing net
loss per share attributable to common stockholders - basic and
diluted |
|
59,688,451 |
|
|
|
46,799,058 |
|
Pliant Therapeutics, Inc. |
Condensed Balance Sheets |
(Unaudited) |
(In thousands) |
|
|
September 30,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
57,679 |
|
|
$ |
33,685 |
|
Short-term investments |
|
465,933 |
|
|
|
297,502 |
|
Accounts receivable |
|
— |
|
|
|
1,983 |
|
Tax credit receivable |
|
83 |
|
|
|
83 |
|
Prepaid expenses and other current assets |
|
10,640 |
|
|
|
7,058 |
|
Total current assets |
|
534,335 |
|
|
|
340,311 |
|
Property and equipment, net |
|
3,969 |
|
|
|
4,486 |
|
Operating lease right-of-use assets |
|
1,768 |
|
|
|
5,422 |
|
Other non-current assets |
|
392 |
|
|
|
394 |
|
Total assets |
$ |
540,464 |
|
|
$ |
350,613 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
3,360 |
|
|
$ |
1,580 |
|
Accrued research and development |
|
13,664 |
|
|
|
11,218 |
|
Accrued liabilities |
|
8,310 |
|
|
|
8,658 |
|
Lease liabilities, current |
|
2,061 |
|
|
|
2,457 |
|
Total current liabilities |
|
27,395 |
|
|
|
23,913 |
|
Lease liabilities, non-current |
|
— |
|
|
|
3,429 |
|
Long-term debt |
|
10,021 |
|
|
|
9,929 |
|
Total liabilities |
|
37,416 |
|
|
|
37,271 |
|
Stockholders’ equity |
|
|
|
Common stock |
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
963,588 |
|
|
|
653,707 |
|
Accumulated deficit |
|
(458,639 |
) |
|
|
(338,412 |
) |
Accumulated other comprehensive loss |
|
(1,907 |
) |
|
|
(1,958 |
) |
Total stockholders’ equity |
|
503,048 |
|
|
|
313,342 |
|
Total liabilities and
stockholders’ equity |
$ |
540,464 |
|
|
$ |
350,613 |
|
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