- Top-line Data from INVICTUS Pivotal Phase 3
Clinical Study of Ripretinib in Fourth-line and Fourth-line Plus
GIST Patients Expected in Mid-2019 -
- Recommended Phase 2 Dose Selected for Part 2
of Phase 1b/2 Study of Rebastinib plus Paclitaxel; Enrollment in
Part 2 with Expansion Cohorts Expected to Commence Second Quarter
2019 -
- Ended First Quarter 2019 with Cash, Cash
Equivalents and Marketable Securities of $262 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
first quarter ended March 31, 2019 and provided an update on
clinical and corporate developments.
“Our team made significant progress during the first quarter of
2019 advancing our portfolio of novel drug candidates from our
proprietary kinase switch control inhibitor platform,” said Steve
Hoerter, President and Chief Executive Officer of Deciphera. “We
expect top-line data from our INVICTUS pivotal Phase 3 study of
ripretinib for the treatment of fourth-line and fourth-line plus
GIST patients in mid-2019 and pending favorable results from this
study, we look forward to our first NDA submission and laying the
groundwork for our first potential launch in the United States. In
addition, we continue to advance key clinical trials of DCC-3014
and rebastinib and we expect to announce the initiation of
IND-enabling preclinical studies for a new clinical candidate later
this year.”
Recent Clinical Updates
- Ripretinib (DCC-2618)
- Deciphera expects to report top-line
data from the INVICTUS pivotal Phase 3 clinical study evaluating
the safety and efficacy of ripretinib, the Company’s
investigational broad-spectrum KIT and PDGFRα inhibitor, in
fourth-line and fourth-line plus gastrointestinal stromal tumor
(GIST) patients in mid-2019. The Company is building its commercial
and medical affairs capabilities to support the planned launch of
ripretinib in the United States, if approved.
- Deciphera is actively enrolling
patients in the INTRIGUE Phase 3 clinical study comparing
ripretinib to sunitinib for the treatment of second-line GIST
patients who have previously received imatinib.
- Rebastinib
- Deciphera announced the initiation of
an open-label, multicenter, Phase 1b/2 combination study of
rebastinib, the Company’s investigational small molecule switch
control inhibitor of TIE2 kinase, with carboplatin in patients with
advanced or metastatic solid tumors.
- Deciphera completed enrollment of 40
patients in Part 1 of the Phase 1b/2 combination study of
rebastinib with paclitaxel. In April 2019, Deciphera selected a 100
mg BID dose of rebastinib in combination with a weekly dose of 80
mg/m2 of paclitaxel as the recommended Phase 2 dose for Part 2 of
the study, which is expected to begin enrollment later this
quarter. The Company expects to report initial data from Part 1 of
this study in the second half of 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. The Company plans to
present a review of further data from this Phase 1 study in the
second half of 2019.
- The Company is currently enrolling
patients diagnosed with tenosynovial giant cell tumors (TGCT) in
its expanded Phase 1 study evaluating DCC-3014.
Corporate Update
- Deciphera announced the appointment of
Steve Hoerter as President & Chief Executive Officer, effective
March 18, 2019. Mr. Hoerter has served as a member of the Deciphera
Board of Directors since May 2018. He joined the Company from
Agios, where he was Chief Commercial Officer. He succeeded Michael
D. Taylor, Ph.D., who retired as President & Chief Executive
Officer of the Company. Dr. Taylor remains as senior advisor to the
Company and a member of the Company’s Board of Directors.
First Quarter 2019 Financial Results
- Cash Position: As of March 31,
2019, cash, cash equivalents and marketable securities were $262.3
million, compared to cash and cash equivalents of $293.8 million as
of December 31, 2018. Deciphera expects its current cash, cash
equivalents and marketable securities will enable the Company to
fund its operating, capital expenditures and debt service payments
into the second half of 2020.
- R&D Expenses: Research and
development expenses for the first quarter of 2019 were $35.8
million, compared to $16.9 million for the same period in 2018. The
increase was primarily due to an increase in spending on the
ripretinib program of $10.7 million as a result of
clinical trial costs related to the Phase 3 INTRIGUE study in
second-line GIST, which the Company initiated in December
2018, and includes $5.3 million for comparator drug to be used in
this trial. Expenses related to the rebastinib program
increased $3.2 million, primarily due to the Phase 1b/2 study
of rebastinib in combination with paclitaxel, which the Company
initiated in October 2018, and the second Phase 1b/2 clinical
trial of rebastinib in combination with carboplatin, which the
Company initiated in January 2019. Personnel-related costs
increased $3.7 million due primarily to increased
headcount and stock-based compensation expense in research and
development functions. Personnel-related costs for the first
quarters of 2019 and 2018 included non-cash stock-based
compensation expense of $1.7 million and $1.0
million, respectively. Facility-related and other costs included in
unallocated expenses increased $1.7 million primarily due
to increased costs incurred in connection with early-stage drug
discovery programs and increased consulting fees.
- G&A Expenses: General and
administrative expenses for the first quarter of 2019 were $13.2
million, compared to $5.0 million for the same period in 2018. The
increase was primarily a result of increases in stock-based
compensation expense and headcount in general and administrative
functions. Non-cash stock-based compensation was $4.5 million and
$1.1 million for the first quarters of 2019 and 2018, respectively.
The increase in stock-based compensation expense was primarily
related to the modification of stock options pursuant to the
transition agreement with the Company’s former President and Chief
Executive Officer and additional employee stock options. In
addition, professional and consultant fees increased due to various
advisory fees, including those related to commercialization
preparedness.
- Net Loss: For the first quarter
of 2019, Deciphera reported a net loss of $47.4 million, or $1.25
per share, compared with a net loss of $21.4 million, or $0.66 per
share, for the same period in 2018.
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) and our other drug candidates based on our
kinase switch control inhibitor platform to provide clinical
benefit and treat cancers such as GIST and other possible
indications, initiation of and enrollment for our INTRIGUE pivotal
Phase 3 study, expectations for, progress with respect to and the
timing of enrollment and 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, enrollment of TGCT patients in our ongoing Phase 1 trial
for DCC-3014, expectations regarding cash guidance, preparations
for a possible NDA, pending positive study results, and 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 and manage 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 Annual Report on Form 10-K for the year ended December 31,
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)
March 31, 2019 December 31, 2018 Assets Cash
and cash equivalents and marketable securities $ 262,342 $ 293,764
Prepaid expenses and other current assets 4,103 7,273 Long-term
investment restricted 1,069 1,069 Property and equipment, net 1,504
13,453 Operating lease, right-of-use assets 670 —
Total assets $ 269,688 $ 315,559
Liabilities and
Stockholders' Equity Accounts payable, accrued expenses and
other
liabilities
$ 27,751 $ 22,398 Debt obligations 1,263 1,294 Operating lease
liabilities 678 11,886 Total liabilities
29,692 35,578 Total stockholders' equity
239,996 279,981 Total liabilities and stockholders' equity $
269,688 $ 315,559
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except
share and per share data) (Unaudited)
Three Months Ended
March 31, 2019 2018
Revenue $ — $ — Operating expenses:
Research and development 35,789 16,925 General and administrative
13,236 5,026 Total operating expenses
49,025 21,951 Loss from operations
(49,025 ) (21,951 ) Other income (expense): Interest
expense (13 ) (22 ) Interest and other income, net 1,654
543 Total other income (expense), net
1,641 521 Net loss $ (47,384 ) $ (21,430 ) Net
loss per share—basic and diluted $ (1.25 ) $ (0.66 ) Weighted
average common shares outstanding—basic and diluted
38,057,018 32,594,074
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005065/en/
Investor Relations:Jen RobinsonDeciphera Pharmaceuticals,
Inc.jrobinson@deciphera.com781-906-1112
Media:Gina Nugent, The Yates
Networkgina@theyatesnetwork.com617-460-3579
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