– 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 –
WALTHAM, Mass.–(BUSINESS WIRE)–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.
-
Deciphera expects to report top-line data from the INVICTUS
-
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.
-
Deciphera announced the initiation of an open-label, multicenter,
-
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.
-
Deciphera announced positive, preliminary top-line data from the
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 | ||||||||
Contacts
Investor Relations:
Jen Robinson
Deciphera Pharmaceuticals,
Inc.
jrobinson@deciphera.com
781-906-1112
Media:
Gina Nugent, The Yates Network
gina@theyatesnetwork.com
617-460-3579