– Plans to Initiate Pivotal Phase 3 INSIGHT
Study of QINLOCK® Versus Sunitinib in Second-Line GIST Patients
with Mutations in KIT Exon 11 and 17/18 Only in the Second Half of
2023 Based on ctDNA Analysis from INTRIGUE Study –
– Expects to Complete Enrollment in the Pivotal
Phase 3 MOTION Study of Vimseltinib in the First Half of 2023 and
Announce Top-line Results in the Fourth Quarter of 2023 –
– Expects to Evaluate DCC-3116 in a Combination
Study with Encorafenib and Cetuximab in Patients with Colorectal
Cancer; Announces Clinical Trial Collaboration and Supply Agreement
for Encorafenib with Pfizer –
– Preliminary Unaudited Revenue of
Approximately $36 Million for the Fourth Quarter 2022 and
Approximately $134 Million for the Full Year 2022; Cash, Cash
Equivalents, and Marketable Securities Approximately $339 million
as of December 31, 2022 –
– Conference Call to be Held Today at 5:00 PM
ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today highlighted its strategic outlook for
2023 and planned 2023 corporate milestones, and announced
preliminary unaudited fourth quarter and full year 2022
revenue.
In a separate press release issued today, Deciphera announced
results from an exploratory analysis of circulating tumor DNA
(ctDNA) from the INTRIGUE Phase 3 clinical study of QINLOCK in
patients with gastrointestinal stromal tumor (GIST) previously
treated with imatinib, demonstrating substantial clinical benefit
of QINLOCK in second-line GIST patients with mutations in KIT exon
11 and 17/18 only. The Company also announced plans to initiate the
INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib
in this patient population in the second half of 2023.
“We are extremely proud of the significant progress made across
our pipeline in 2022 and are in a strong position to build upon
this momentum in 2023 with key commercial, clinical, and
preclinical milestones on the horizon,” said Steve Hoerter,
President and Chief Executive Officer of Deciphera Pharmaceuticals.
“We believe that Deciphera is on track to become a company with
multiple approved products, and that QINLOCK and vimseltinib
together have the potential to exceed one billion dollars in global
revenue annually. At the same time, we continue to complement these
commercial goals with research and development innovation powered
by our proprietary switch-control discovery platform to drive new
growth opportunities with potential first-in-class or best-in-class
kinase inhibitors.”
Business updates and planned 2023 corporate milestones
include:
QINLOCK® (ripretinib)
- Present additional data from the INTRIGUE Phase 3 exploratory
ctDNA analysis at a medical meeting in January 2023.
- Initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT
exon 11 and 17/18 only in the second half of 2023.
- Continue European geographic expansion of QINLOCK in 2023, with
planned commercial launches following conclusion of pricing and
reimbursement negotiations in key European markets.
Vimseltinib
- Complete enrollment for the pivotal Phase 3 MOTION study of
vimseltinib, an investigational, orally administered, potent, and
highly selective switch-control kinase inhibitor of CSF1R for the
potential treatment of tenosynovial giant cell tumor (TGCT), in the
first half of 2023 and announce top-line results from the study in
the fourth quarter of 2023.
- Present updated data from the Phase 1/2 study of vimseltinib in
the second half of 2023.
DCC-3116
- Present updated data from the single agent dose escalation
phase and initial data from the combination dose escalation cohorts
of the Phase 1/2 study of DCC-3116, an investigational
switch-control kinase inhibitor of ULK1/2 designed to inhibit
autophagy, in the second half of 2023.
- Initiate one or more expansion cohorts in the ongoing Phase 1/2
study of DCC-3116 in the second half of 2023 in combination with
the MEK inhibitors trametinib or binimetinib, or the KRASG12C
inhibitor sotorasib.
- Initiate a new dose escalation combination study evaluating
DCC-3116 in combination with encorafenib and cetuximab in patients
with colorectal cancer in the second half of 2023. Under the terms
of the clinical trial collaboration and supply agreement with
Pfizer, Inc., Deciphera will sponsor the trial and Pfizer will
supply encorafenib at no cost.
- Present preclinical data on new clinical combinations with
DCC-3116 in the first half of 2023.
DCC-3084
- Submit an investigational new drug (IND) application with the
FDA for DCC-3084, a potential best-in-class pan-RAF inhibitor, in
the second half of 2023.
- Present in vitro and in vivo data demonstrating a preclinical
profile as a potent and selective inhibitor of BRAF/CRAF kinases,
with optimized pharmaceutical properties for development in both
single-agent and combination opportunities, in the first half of
2023.
Kinase Switch-Control Research Engine
- Nominate a new development candidate from Deciphera’s
proprietary discovery engine of novel switch-control inhibitors in
the first half of 2023.
- Present new preclinical data from research programs at medical
meetings in 2023.
Preliminary 2022 Financial Results
Based on preliminary unaudited financial information, Deciphera
expects total fourth quarter 2022 revenue to be approximately $36
million and total full year 2022 revenue to be approximately $134
million. QINLOCK net product revenue is estimated to be
approximately $33 million, including approximately $26 million in
U.S. net product revenue and approximately $7 million in
international net product revenue, in addition to approximately $3
million in collaboration revenue. International and total net
product revenue for the fourth quarter includes a one-time reserve
for QINLOCK product sales in Germany due to a change in German law
effective retroactively as of November 2022 shortening the free
pricing period to six months from twelve months.
In addition, cash, cash equivalents, and marketable securities
was approximately $339 million as of December 31, 2022. Based on
its current operating plans, Deciphera expects its current cash,
cash equivalents, and marketable securities together with
anticipated product, royalty, and supply revenues, but excluding
any potential future milestone payments under its collaboration or
license agreements, will enable the Company to fund its operating
and capital expenditures into 2025.
Preliminary selected financial information presented in this
release are unaudited, subject to adjustment, and provided as an
approximation in advance of the Company's announcement of complete
financial results expected in February 2023.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss the
ctDNA analysis results from the INTRIGUE Phase 3 clinical study,
its planned 2023 corporate milestones and a general business
update, today, January 3, 2023, at 5:00 PM ET. The conference call
may be accessed via this link:
https://register.vevent.com/register/BI4841f7cb08a04e5ba80127e42e643432.
A live webcast of the conference call will be available in the
“Events and Presentations” page in the “Investors & News”
section of the Company’s website at
https://investors.deciphera.com/events-presentations. A replay will
be available on the Company’s website approximately two hours after
the conference call and will be available for 30 days following the
call.
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, the European
Union, Hong Kong, Switzerland, Taiwan, the United Kingdom, 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 the potential for our preclinical and/or
clinical stage pipeline assets to be first-in-class and/or
best-in-class treatments, our planned Phase 3 INSIGHT clinical
study of QINLOCK versus sunitinib in second-line GIST patients with
mutations in KIT exon 11 and 17/18 only, our plans to present
results from the Phase 3 INTRIGUE ctDNA analysis, our plans to
continue our geographic expansion of QINLOCK in key European
markets; the vimseltinib enrollment and topline readout for the
pivotal Phase 3 MOTION study and our phase 1/2 study of
vimseltinib, each in TGCT patients; plans to present updated data
from the dose escalation phase and initial data from the
combination dose escalation cohorts of the Phase 1 study of
DCC-3116, plans to initiate one or more combination cohorts in the
Phase 1/2 study of DCC-3116, plans to initiate a new dose
escalation cohort evaluating DCC-3116 in combination with
encorafenib and cetuximab in patients with colorectal cancer in the
second half of 2023, the benefits anticipated pursuant to our
collaboration and supply agreement with Pfizer, plans to present
additional preclinical data for DCC-3116; plans to submit an IND
for DCC-3084 and present preclinical data for DCC-3084; plans to
nominate a development candidate from our proprietary discovery
engine of novel switch control inhibitors; statements regarding the
Company’s preliminary unaudited fourth quarter, year-end, and net
product revenue for the quarter and year-ended December 31, 2022
and preliminary unaudited cash, cash equivalents, and marketable
securities for the quarter and year-ended December 31, 2022. 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 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, 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 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, 2022, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230103005741/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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