– Resources Focused on the Clinical Development
of Vimseltinib and DCC-3116; Rebastinib Program Discontinued –
– US Commercial Operations Streamlined and
Launches Planned in Select European Markets for QINLOCK® –
– Workforce Reduction of Approximately 35%
–
– Cash Runway Extended into 2024 –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced a corporate restructuring intended to prioritize clinical
development of select programs, streamline commercial operations,
maintain a focus on discovery research and extend the Company’s
cash runway.
Following a detailed review of its portfolio and growth
opportunities, Deciphera will focus its resources on the continued
advancement of vimseltinib and DCC-3116, while discontinuing the
rebastinib program. The Company will streamline commercial
operations for QINLOCK® in the U.S. and focus commercialization
efforts on a select number of key European markets. These changes
are expected to result in a significant reduction in operating
expenses and extend the Company’s cash runway into 2024.
“The decision to realign our resources and restructure our
organization was difficult, but one which will allow us to focus on
the critical programs that will drive our future growth. I would
like to personally express my appreciation to our colleagues who
are impacted by this decision. We are immensely grateful for their
dedication and their contributions to advancing our mission,” said
Steve Hoerter, President and Chief Executive Officer of Deciphera.
“We remain excited by the strength of our pipeline and the
opportunity for QINLOCK to continue to benefit patients with
advanced GIST. We have a clear and positive path forward with a
committed team that is fully invested in the future of
Deciphera.”
The Company intends to reduce expenses and extend its existing
cash runway through the following restructuring initiatives and
prioritization of its pipeline:
- The Company will implement an organizational restructuring that
will result in a workforce reduction of approximately 35%, or
approximately 140 positions. The restructuring is expected to
affect U.S. employees across all areas of the organization
including the QINLOCK commercial team, research and development,
and general and administrative support functions.
- Deciphera will remain focused on the commercialization of
QINLOCK for the treatment of fourth-line GIST in the U.S. with a
reduced commercial team. In Europe, Deciphera will maintain a
limited direct commercial presence that will support the launch of
QINLOCK in two key markets, Germany and France, and work to provide
access to QINLOCK in additional European countries through other
channels. Further clinical development of QINLOCK will be
discontinued, including the Phase 1b/2 MEK combination study, which
had been planned to start in the fourth quarter of 2021.
- Deciphera is prioritizing the clinical development of its
vimseltinib and DCC-3116 programs, discontinuing the development of
the rebastinib program, and continuing with a focused investment in
its next generation of research programs, designed to provide
first-in-class or best-in-class treatments for patients.
- Vimseltinib: The Company expects to initiate the Phase 3 MOTION
study for vimseltinib, an orally administered, potent, and highly
selective switch-control kinase inhibitor of CSF1R, for the
treatment of tenosynovial giant cell tumor (TGCT) before the end of
the year.
- DCC-3116: Deciphera will continue to advance the clinical
development of DCC-3116, a first-in-class ULK kinase inhibitor
designed to inhibit autophagy for the treatment of patients with
advanced or metastatic tumors with a mutant RAS or RAF gene.
DCC-3116 is currently being investigated as a single agent and in
combination with trametinib in an ongoing Phase 1 study. Deciphera
expects to present initial data from the dose escalation phase of
the Phase 1 study in 2022. In addition to the ongoing Phase 1
study, the Company is actively exploring preclinical combinations
of DCC-3116 with multiple additional targeted oncology agents with
diverse mechanisms of action.
- Rebastinib: Deciphera will discontinue development of
rebastinib, which was expected to enter a Phase 3 study in patients
with platinum-resistant ovarian cancer in 2022.
- Research: The Company intends to continue to invest in the
development of new product candidates using its novel
switch-control inhibitor approach.
Deciphera had cash, cash equivalents, and marketable securities
of $392 million as of September 30, 2021. Collectively, these
changes are expected to extend the Company’s cash runway into 2024
through significant reductions in the Company’s operating expenses
including personnel-related costs and external expenses. Deciphera
expects to recognize a one-time cash charge in the fourth quarter
of approximately $32 million associated principally with the
workforce reduction and discontinuation of continued clinical
development of rebastinib and ripretinib.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering,
developing, and commercializing important new medicines to improve
the lives of people with cancer. We are leveraging our proprietary
switch-control kinase inhibitor platform and deep expertise in
kinase biology to develop a broad portfolio of innovative
medicines. In addition to advancing multiple product candidates
from our platform in clinical studies, QINLOCK® is Deciphera’s
switch-control inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia, Canada, China, European Union,
Hong Kong, Switzerland, Taiwan, and the United States. For more
information, visit www.deciphera.com and follow us on LinkedIn and
Twitter (@Deciphera).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, our expectations
and timing regarding our areas of focus following our corporate
restructuring, expected extended cash runway, expected charges and
cost savings from our restructuring and workforce reduction, the
benefits of and potential of our portfolio prioritization,
including vimseltinib and the MOTION study in TGCT patients, and
our Phase 1 study of DCC-3116 in patients with mutant RAS or RAF
cancers, streamlining our U.S. commercial operations, launches
planned in and focus on key markets (Germany and France) in Europe
for QINLOCK for fourth-line GIST patients, as well as exploring
other channels for patient access in other European territories,
our maintenance of focus on and investment in discovery research
designed to provide first-in-class or best-in-class treatments,
initiation of the Phase 3 MOTION study, and initial data from the
dose escalation phase of the Phase 1 study of DCC-3116 and
exploration of pre-clinical combinations of DCC-3116 with multiple
additional targeted oncology agents. The words “may,” “will,”
“could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “seek,” “target” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, risks and
uncertainties related to the possibility we will not achieve the
expected cost savings we expect from the restructuring, our
expectations regarding the prioritization of our development
programs, the severity and duration of the impact of COVID-19 on
our business and operations, our ability to successfully
demonstrate the efficacy and safety of our drug or drug candidates,
the preclinical or clinical results for our product candidates,
which may not support further development of such product
candidates, our ability to manage our reliance on sole-source third
parties such as our third party drug substance and drug product
contract manufacturers, comments, feedback and actions of
regulatory agencies, our ability to commercialize QINLOCK and
execute on our marketing plans for any drugs or indications that
may be approved in the future, the inherent uncertainty in
estimates of patient populations, competition from other products,
our ability to obtain and maintain reimbursement for any approved
product and the extent to which patient assistance programs are
utilized, our ability to comply with healthcare regulations and
laws, our ability to obtain, maintain and enforce our intellectual
property rights, any or all of which may affect the initiation,
timing and progress of clinical studies and the timing of and our
ability to obtain additional regulatory approvals, and other risks
identified in our Securities and Exchange Commission (SEC) filings,
including our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, and subsequent filings with the SEC. We caution
you not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. We disclaim any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent our views only as of the date hereof and should not be
relied upon as representing our views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20211130005156/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 212-600-1902
Media: David Rosen Argot Partners
David.Rosen@argotpartners.com 212-600-1902
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