- Enrollment Completed in INVICTUS Pivotal
Phase 3 Clinical Study in Fourth-line and Fourth-line Plus GIST;
Top-line Data Expected in Mid-2019 -
- INTRIGUE Pivotal Phase 3 Clinical Study
Initiated in Second-line Patients with GIST -
- Ended 2018 with Cash and Cash Equivalents of
$294 Million -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage
biopharmaceutical company focused on addressing key mechanisms of
tumor drug resistance, today announced financial results for the
fourth quarter and year ended December 31, 2018 and provided an
update on clinical and corporate developments.
“2018 was punctuated by significant progress in advancing our
diverse pipeline of targeted drug candidates,” said Michael D.
Taylor, Ph.D. President and Chief Executive Officer. “We continued
to add to the growing body of data that we believe supports
ripretinib’s potential to provide improved, durable clinical
benefit for GIST patients across multiple lines of therapy.
Notably, we initiated two pivotal Phase 3 studies in 2018, INVICTUS
and INTRIGUE, in fourth-line and fourth-line plus and second-line
GIST, respectively.”
Dr. Taylor continued, “As we near the reporting of top-line data
from the INVICTUS study, expected in mid-2019, we are actively
working to build out our commercial capabilities for ripretinib’s
potential launch in the United States. In parallel, we continue to
advance our earlier stage pipeline candidates, DCC-3014 and
rebastinib, and expect to announce one new clinical candidate and
commence IND-enabling studies during 2019.”
Recent Clinical Updates
- Ripretinib (DCC-2618)
- Deciphera announced completion of
enrollment in the INVICTUS pivotal Phase 3 clinical study
evaluating the safety and efficacy of ripretinib (DCC-2618), the
Company’s investigational broad-spectrum KIT and PDGFRα inhibitor,
in fourth-line and fourth-line plus gastrointestinal stromal tumor
(GIST) patients. The Company expects to report top-line data from
this study in mid-2019 and is building commercial capabilities to
support the planned launch of ripretinib in the United States, if
approved.
- Deciphera announced the initiation of
its INTRIGUE pivotal Phase 3 clinical study evaluating the efficacy
and tolerability of ripretinib compared to sunitinib in second-line
GIST patients.
- At the European Society of Medical
Oncology (ESMO) 2018 Congress in October, Deciphera presented
updated preliminary Phase 1 clinical study results of ripretinib in
patients with GIST that the Company believes demonstrate the
potential of ripretinib to provide improved, durable clinical
benefit for GIST patients from second-line through
fourth-line-plus. These data were also presented at the Annual
Meeting of the Connective Tissue Oncology Society (CTOS) in
November 2018.
- Deciphera expanded the ongoing Phase 1
study of ripretinib to include additional cohorts for patients with
various solid tumors, including melanoma, non-small cell lung
cancer, germ cell cancer, penile cancer, soft tissue sarcoma, and
GIST or other solid tumor patients with renal impairment.
- During a poster session at the
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium
in November 2018, Deciphera presented preclinical data on the
effects of the combination of ripretinib and MAPK pathway
inhibitors on cell death and apoptosis in cellular assays of GIST
and mastocytosis.
- Rebastinib
- Deciphera recently announced the
initiation of two open-label, multicenter, Phase 1b/2 combination
studies of rebastinib, the Company’s investigational small molecule
switch control inhibitor of TIE2 kinase:
- Phase 1b/2 study in combination with
carboplatin in patients with advanced or metastatic solid
tumors.
- Phase 1b/2 study in combination with
paclitaxel in patients with advanced or metastatic solid tumors.
The Company expects to report initial data from this study in
2019.
- DCC-3014
- Deciphera announced positive,
preliminary, top-line data from the ongoing dose escalation portion
of the Phase 1 clinical study of DCC-3014, the Company’s
investigational small molecule switch control inhibitor of CSF1R,
in patients with advanced malignancies. A review of further data
from this Phase 1 study is planned to be presented at a medical
meeting in 2019.
- The Company also announced a plan to
expand the Phase 1 study to evaluate DCC-3014 in patients diagnosed
with Tenosynovial Giant Cell Tumors (TGCT).
Corporate Update
- Earlier this month, Deciphera announced
the appointment of Steve Hoerter as President & Chief Executive
Officer, effective March 18, 2019. Mr. Hoerter, who currently
serves as a member of the Deciphera Board of Directors, joins the
Company from Agios, where he was Chief Commercial Officer. He will
succeed Dr. Taylor, who will retire as President & Chief
Executive Officer of the Company. Dr. Taylor will be available to
support the transition and will remain as a member of the Company’s
Board of Directors.
Fourth Quarter 2018 Financial Results
- Cash Position: As of December
31, 2018, cash and cash equivalents were $293.8 million, compared
to cash and cash equivalents of $196.8 million as of December 31,
2017. This increase was primarily related to proceeds obtained from
the Company’s June 2018 underwritten public offering, offset by
cash used in operating activities. We expect our current cash and
cash equivalents will enable us to fund our operating and capital
expenditures and debt service payments into the second half of
2020.
- R&D Expenses: Research and
development expenses for the fourth quarter of 2018 were $27.4
million, compared to $15.7 million for the same period in 2017. The
increase was primarily due to an increase in spending on the
ripretinib (DCC-2618) program of $5.8 million as a result of
clinical trial start-up activities related to the Phase 3 INTRIGUE
study in second-line GIST, which the Company initiated in December
2018. Expenses related to the rebastinib program increased $1.8
million, primarily due to the Phase 1b/2 study of rebastinib in
combination with paclitaxel, which the Company initiated in October
2018, and start-up activities related to the second Phase 1b/2
clinical trial of rebastinib in combination with carboplatin, which
the Company initiated in January 2019. Personnel-related costs
increased $2.5 million due primarily to increased headcount in our
research and development functions. Personnel-related costs for the
fourth quarters of 2018 and 2017 included non-cash stock-based
compensation expense of $1.0 million and $0.5 million,
respectively. Facility-related and other costs included in
unallocated expenses increased $2.0 million primarily due to
increased costs incurred in connection with our early-stage drug
discovery programs.
- G&A Expenses: General and
administrative expenses for the fourth quarter of 2018 were $6.5
million, compared to $4.7 million for the same period in 2017. The
increase was primarily due to an increase in legal and professional
fees as a result of various advisory fees related to ongoing
operations as a public company. Facility-related and other costs
increased due to insurance costs and higher rent expense related to
the Company’s new lease. Non-cash stock-based compensation was $1.8
million and $2.3 million for the fourth quarters of 2018 and 2017,
respectively.
- Net Loss: For the fourth quarter
of 2018, Deciphera reported a net loss of $32.3 million, or $0.86
per share, compared with a net loss of $19.9 million, or $0.62 per
share, for the same period in 2017.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on improving the lives of cancer patients by
tackling key mechanisms of drug resistance that limit the rate
and/or durability of response to existing cancer therapies. Our
small molecule drug candidates are directed against an important
family of enzymes called kinases, known to be directly involved in
the growth and spread of many cancers. We use our deep
understanding of kinase biology together with a proprietary
chemistry library to purposefully design compounds that maintain
kinases in a “switched off” or inactivated conformation. These
investigational therapies comprise tumor-targeted agents designed
to address therapeutic resistance causing mutations and
immuno-targeted agents designed to control the activation of
immunokinases that suppress critical immune system regulators, such
as macrophages. We have used our platform to develop a diverse
pipeline of tumor-targeted and immuno-targeted drug candidates
designed to improve outcomes for patients with cancer by improving
the quality, rate and/or durability of their responses to
treatment.
Availability of Other Information About Deciphera
Pharmaceuticals
Investors and others should note that Deciphera Pharmaceuticals
communicates with its investors and the public using its company
website (www.deciphera.com), including but not limited to investor
presentations and scientific presentations, Securities and Exchange
Commission filings, press releases, public conference calls and
webcasts. The information that Deciphera Pharmaceuticals posts on
these channels and websites could be deemed to be material
information. As a result, Deciphera Pharmaceuticals encourages
investors, the media and others interested in Deciphera
Pharmaceuticals to review the information that it posts on these
channels, including Deciphera Pharmaceuticals’ investor relations
website, on a regular basis. This list of channels may be updated
from time to time on Deciphera Pharmaceuticals' investor relations
website and may include other social media channels than the ones
described above. The contents of Deciphera Pharmaceuticals' website
or these channels, or any other website that may be accessed from
its website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
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, statements
regarding our expectations regarding timing of reporting top-line
data from our INVICTUS pivotal Phase 3 study, the potential for
ripretinib (DCC-2618) to provide clinical benefit and treat cancers
such as GIST and other possible indications, expectations for and
the timing of data from our clinical trials with our
investigational agent rebastinib, including, without limitation,
our study of rebastinib in combination with carboplatin and in
combination with paclitaxel, and the potential for rebastinib,
alone or in combination with other agents or chemotherapy to treat
cancers, expectations for presenting data from our studies of
DCC-3014 at a medical meeting, our plans to add TGCT patients to
our ongoing Phase 1 trial for DCC-3014, expectations regarding cash
guidance, launch preparations for a possible commercial launch of
ripretinib in fourth-line and fourth-line plus GIST, if approved,
and expectations regarding designating a new clinical candidate and
IND-enabling studies to support such candidate. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “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 delay of any current or planned
clinical studies or the development of our drug candidates,
including ripretinib, rebastinib, and DCC-3014, our advancement of
multiple early-stage and later-stage efforts, our ability to
successfully demonstrate the efficacy and safety of our drug
candidates including in later-stage studies, the preclinical and
clinical results for our drug candidates, which may not support
further development of such drug candidates, our efforts to scale
up drug product manufacturing, our ability to implement commercial
readiness, actions of regulatory agencies, any or all of which may
affect the initiation, timing and progress of clinical studies and
other risks identified in our SEC filings, including our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018, 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 its views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
CONSOLIDATED BALANCE SHEETS (In thousands)
(Unaudited)
December 31,
2018 2017
Assets
Cash and cash equivalents $ 293,764 $ 196,754
Prepaid expenses and other current
assets
7,273 1,428
Long-term investment restricted
1,069 — Property and equipment, net (1) 13,453 838 Other assets
- 75 Total assets $ 315,559 $ 199,095
Liabilities and Stockholders'
Equity
Accounts payable, accrued expenses and
other liabilities
$ 22,937 $ 13,641 Debt obligations 1,294 1,481
Lease liability, net of current
portion(1)
11,347 — Total liabilities 35,578
15,122 Total stockholders' equity 279,981
183,973 Total liabilities and stockholders' equity $ 315,559 $
199,095 (1) In May 2018, we entered into a lease for office space
in Waltham, MA. We are not the legal owners of the leased space,
however, we are deemed to be the owner during the construction
phase because of certain provisions within the lease. As a result,
we recorded a $11.9 million build-to-suit asset in property and
equipment and a corresponding build-to-suit facility lease
financing obligation as of December 31, 2018.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited) Three Months Ended
Year Ended December 31, December 31,
2018 2017 2018 2017
Revenue
$
—
$ — $ — $ — Operating expenses:
Research and development 27,356 15,658 82,887 39,514 General and
administrative 6,474 4,680
21,212 11,421 Total operating expenses
33,830 20,338 104,099
50,935 Loss from operations (33,830 ) (20,338
) (104,099 ) (50,935 ) Other income (expense):
Interest expense (20 ) (23 ) (84 ) (95 ) Interest and other income,
net 1,551 449 4,329
746 Total other income (expense), net 1,531
426 4,245 651 Net
loss and comprehensive loss $ (32,299 ) $ (19,912 ) $ (99,854 ) $
(50,284 ) Net loss per share—basic and diluted $ (0.86 ) $ (0.62 )
$ (2.82 ) $ (2.99 ) Weighted average common shares
outstanding—basic and diluted 37,665,599
32,121,428 35,390,480 16,792,179
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190314005744/en/
Media:Gina Nugent, The Yates Networkgina@theyatesnetwork.com617-460-3579Investor
Relations:Laura Perry or Sam Martin, Argot PartnersLaura@argotpartners.com or Sam@argotpartners.com212-600-1902Company:Christopher
J. Morl, Chief Business OfficerDeciphera Pharmaceuticals,
Inc.cmorl@deciphera.com781-209-6418
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Apr 2023 to Apr 2024