Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2023 Financial Results
09 Maio 2023 - 5:02PM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage
biotechnology company focused on discovering and developing novel
therapeutics for the treatment of fibrosis, today provided a
corporate update and reported first quarter 2023 financial results.
“So far in 2023 we have made significant progress in advancing
the portfolio including positive 12- and 24-week data readouts from
our INTEGRIS-IPF trial and a successful follow-on offering that
extended our expected operating runway into the second half of
2026,” said Bernard Coulie, M.D., Ph.D., President and Chief
Executive Officer of Pliant Therapeutics. “With clinical data and
development milestones expected throughout the remainder of 2023,
including Phase 2a data from INTEGRIS-PSC and initiation of our
BEACON-IPF Phase 2b and our oncology Phase 1 trials, we look
forward to building upon an already productive year.”
First Quarter and Recent
Highlights
Bexotegrast (PLN-74809) Highlights
- INTEGRIS-IPF Phase 2a
24-week 320 mg clinical data showed bexotegrast was well tolerated
and demonstrated durable improvements in exploratory
endpoints. This 24-week Phase 2a data from the 320 dose
group showed bexotegrast was well tolerated up to 40 weeks,
displayed a favorable pharmacokinetic profile and in exploratory
efficacy endpoints showed improvements in forced vital capacity
(FVC), Quantitative Lung Fibrosis (QLF) imaging, patient reported
cough severity and biomarkers in patients with idiopathic pulmonary
fibrosis (IPF) to Week 24. In January, 12-week data from the 320 mg
dose group showed bexotegrast demonstrated statistically
significant FVC increases at all time points, was well tolerated
with no drug-related severe or serious adverse events and showed
dose-proportional increases in plasma concentrations, consistent
with prior dose groups.
- Initiation of BEACON-IPF, a
Phase 2b trial of bexotegrast in patients with IPF, expected in
mid-2023. BEACON-IPF is a 52-week, multinational,
randomized, placebo-controlled trial evaluating bexotegrast at
doses of 160 mg or 320 mg in approximately 270 patients with
IPF.
- INTEGRIS-PSC Phase 2a
12-week clinical data expected in the third quarter of
2023. INTEGRIS-PSC is a 12-week randomized, dose-ranging,
double-blind, placebo-controlled trial evaluating safety,
tolerability and pharmacokinetics of bexotegrast at doses of 40, 80
or 160 mg in approximately 84 patients with primary sclerosing
cholangitis (PSC). Exploratory efficacy endpoints include fibrosis
biomarkers such as PRO-C3 and enhanced liver fibrosis (ELF) score,
changes in alkaline phosphatase (ALP), and liver imaging.
INTEGRIS-PSC is fully enrolled.
- First patient dosed in the
INTEGRIS-PSC Phase 2a 320 mg dose cohort, evaluating bexotegrast
for at least 24 weeks. This cohort is evaluating the
safety, tolerability and pharmacokinetics of bexotegrast at a dose
of 320 mg versus placebo over at least 24 weeks of treatment in
approximately 28 patients with PSC. The trial is also evaluating
exploratory efficacy endpoints including fibrosis biomarkers such
as PRO-C3 and ELF score, changes in ALP and liver imaging.
Early-Stage Development Programs
- Initiation of a Phase 1
first-in-human trial of PLN-101095 in oncology expected in the
second quarter of 2023. 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.
Initiation of a Phase 1 trial in patients with solid tumors that
are resistant to immune checkpoint inhibitors is expected in the
second quarter of 2023.
- Muscular dystrophy program
progressing through IND enabling activities. PLN-101325 is
a monoclonal antibody designed to act as an allosteric agonist of
the integrin α7β1. An IND submission for Duchenne muscular
dystrophy (DMD) is expected in 2023.
Corporate Highlights
- Closing of underwritten
public offering of $287.5 million in common stock. The
Company closed a public offering in January 2023, yielding $269.9
million in net proceeds to the Company, which included the
underwriter’s exercise in full of their option to purchase
additional shares.
First Quarter 2023 Financial Results
- Research and development expenses
were $29.3 million, as compared to $20.9 million for the prior-year
quarter. The increase was due primarily to 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 $14.2 million, as compared to $8.6 million for the prior-year
quarter. The increase was due to higher personnel-related and
professional services expenses.
- Net loss of $37.5 million as
compared to $28.1 million for the prior-year quarter due to an
increase in operating expenses coupled with a slight decrease in
collaboration revenues under the Novartis collaboration during the
quarter.
- As of March 31, 2023, the
Company had cash, cash equivalents and short-term investments of
$577.3 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 focused on discovering and developing novel therapies for
the treatment of fibrosis. Pliant's lead product candidate,
bexotegrast, 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 in IPF and PSC and Orphan
Drug Designation from the European Medicines Agency in IPF and PSC.
Pliant is currently conducting a Phase 2a trial of bexotegrast in
the PSC and is planning a Phase 2b trial in IPF. Pliant has also
developed PLN-1474, a small molecule selective inhibitor of αvß1
for the treatment of nonalcoholic steatohepatitis, or NASH with
liver fibrosis. In December 2022, Pliant submitted an IND for its
third clinical program, PLN-101095, a small molecule dual-selective
inhibitor of αvβ8 and αvβ1 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 about Pliant
Therapeutics, visit www.pliantrx.com and follow us on Twitter,
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 and PLN-101095;
bexotegrast’s potential to become a treatment for IPF; the
anticipated timing of data and progress from our clinical studies;
discussions with regulatory authorities; 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 the ongoing
COVID-19 pandemic 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 three months ended March 31,
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 KeenanVice President, Investor Relations and
Corporate CommunicationsPliant 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 EndedMarch 31, |
|
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
1,332 |
|
|
$ |
1,249 |
|
Operating expenses: |
|
|
|
Research and development |
|
(29,273 |
) |
|
|
(20,881 |
) |
General and administrative |
|
(14,154 |
) |
|
|
(8,579 |
) |
Total operating expenses |
|
(43,427 |
) |
|
|
(29,460 |
) |
Loss from operations |
|
(42,095 |
) |
|
|
(28,211 |
) |
Interest and other income
(expense), net |
|
4,858 |
|
|
|
111 |
|
Interest expense |
|
(311 |
) |
|
$ |
— |
|
Net loss |
$ |
(37,548 |
) |
|
$ |
(28,100 |
) |
Net loss attributable to common
stockholders |
$ |
(37,548 |
) |
|
$ |
(28,100 |
) |
Net loss per share attributable
to common stockholders: |
|
|
|
Basic and diluted |
$ |
(0.67 |
) |
|
$ |
(0.78 |
) |
Shares used in computing net loss
per share attributable to common stockholders: |
|
|
|
Basic and diluted |
|
56,057,603 |
|
|
|
36,116,440 |
|
Pliant Therapeutics,
Inc.Condensed Balance
Sheets(Unaudited)(In thousands)
|
March 31,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
102,527 |
|
|
$ |
33,685 |
|
Short-term investments |
|
474,787 |
|
|
|
297,502 |
|
Accounts receivable |
|
3,297 |
|
|
|
1,983 |
|
Tax credit receivable |
|
83 |
|
|
|
83 |
|
Prepaid expenses and other current assets |
|
7,533 |
|
|
|
7,058 |
|
Total current assets |
|
588,227 |
|
|
|
340,311 |
|
Property and equipment, net |
|
4,197 |
|
|
|
4,486 |
|
Operating lease right-of-use assets |
|
4,813 |
|
|
|
5,422 |
|
Other non-current assets |
|
644 |
|
|
|
394 |
|
Total assets |
$ |
597,881 |
|
|
$ |
350,613 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,419 |
|
|
$ |
1,580 |
|
Accrued research and development |
|
14,621 |
|
|
|
11,218 |
|
Accrued liabilities |
|
4,733 |
|
|
|
8,658 |
|
Lease liabilities, current |
|
2,380 |
|
|
|
2,457 |
|
Total current liabilities |
|
23,153 |
|
|
|
23,913 |
|
Lease liabilities, non-current |
|
2,850 |
|
|
|
3,429 |
|
Long-term Debt |
|
9,958 |
|
|
|
— |
|
Total liabilities |
|
35,961 |
|
|
|
37,271 |
|
Stockholders’ equity |
|
|
|
Common stock |
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
939,205 |
|
|
|
653,707 |
|
Accumulated deficit |
|
(375,960 |
) |
|
|
(338,412 |
) |
Accumulated other comprehensive loss |
|
(1,331 |
) |
|
|
(1,958 |
) |
Total stockholders’ equity |
|
561,920 |
|
|
|
313,342 |
|
Total liabilities and
stockholders’ equity |
$ |
597,881 |
|
|
$ |
350,613 |
|
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