- Top-line Data from INVICTUS Pivotal Phase 3
Clinical Study of Ripretinib in Fourth-line and Fourth-line Plus
Gastrointestinal Stromal Tumor (GIST) Patients Expected this Month
-
- Ripretinib Granted Fast Track Designation by
the U.S. Food and Drug Administration for Treatment of Patients
with Fourth-line and Fourth-line Plus GIST -
- Exclusive License Agreement with Zai Lab Ltd.
Established for the Development and Commercialization of Ripretinib
in Greater China -
- DCC-3116 Added to Pipeline as Potential
First-in-Class Autophagy Inhibitor to Treat Mutant RAS Cancers
-
- Ended Second Quarter 2019 with Cash, Cash
Equivalents and Marketable Securities of $225 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
second quarter ended June 30, 2019 and provided an update on
clinical and corporate developments.
“In recent months, we’ve made substantial progress across our
pipeline of novel candidates from our two Phase 3 GIST trials with
ripretinib to the addition of DCC-3116, a potential first-in-class
autophagy inhibitor aimed at treating mutant RAS cancers,” said
Steve Hoerter, President and Chief Executive Officer of Deciphera.
“Later this month, we expect to announce top-line data from the
INVICTUS pivotal Phase 3 clinical study, the results of which, if
favorable, could serve as the basis for our first new drug
application, or NDA, filing. We also recently established our first
license agreement for ripretinib outside of the U.S., which we
believe reflects the growing recognition that ripretinib has the
potential to alter the treatment landscape for patients with
GIST.”
Recent Pipeline Updates
- Ripretinib
- 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 GIST patients
in August 2019. The Company is building its commercial and medical
affairs capabilities to support the planned launch of ripretinib in
the United States, if approved.
- In June 2019, the U.S. Food and Drug Administration (FDA)
granted Fast Track Designation for ripretinib for the investigation
of the treatment of patients with advanced GIST who have received
prior treatment with imatinib, sunitinib and regorafenib.
- Deciphera continues to activate sites and enroll 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. As of July 26, 2019, 45 sites have
been activated.
- Rebastinib
- Deciphera previously 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 43 patients in Part 1 of the
Phase 1b/2 combination study of rebastinib with paclitaxel. Part 2
of the Phase 1b/2 study is now enrolling patients. The Company
expects to report initial data from Part 1 of this study in the
second half of 2019.
- DCC-3014
- The Company plans to present updated 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, in the second
half of 2019.
- The Company continues to enroll patients diagnosed with
tenosynovial giant cell tumors (TGCT) in the Phase 1 study
evaluating DCC-3014.
- DCC-3116
- In June 2019, Deciphera announced the addition of a new
candidate to its pipeline, DCC-3116, a potential first-in-class
small molecule designed to inhibit cancer autophagy, a key tumor
survival mechanism, by inhibiting the ULK kinase. Subject to
favorable investigational new drug (IND)-enabling studies and
filing and activation of an IND, expected in mid-2020, Deciphera
intends to develop DCC-3116 for the potential treatment of mutant
RAS cancers in combination with inhibitors of downstream RAS
effector targets including RAF, MEK, or ERK inhibitors as well as
with direct inhibitors of mutant RAS.
Corporate Updates
- Ripretinib License Agreement for Greater China.
- In June 2019, Deciphera announced an exclusive license
agreement with Zai Lab (Shanghai) Co., Ltd. (Zai) to advance the
development and commercialization of ripretinib in Greater China,
including mainland China, Hong Kong, Macau and Taiwan. Under the
terms of the agreement, Deciphera has received an upfront cash
payment of $20 million and will be eligible to receive up to $185
million in potential development and commercial milestone payments,
including $5 million for an INTRIGUE study-related milestone the
Company achieved. In addition, Zai will be obligated to pay
Deciphera royalties ranging from low to high teens on annual net
sales of ripretinib in Greater China.
- New Member of the Board of Directors
- In July 2019, Deciphera announced the appointment of Susan L.
Kelley, M.D. to its Board of Directors. Dr. Kelley has over 25
years of experience across all stages of oncology drug research and
development.
Second Quarter 2019 Financial Results
- Cash Position: As of June 30, 2019, cash, cash
equivalents and marketable securities were $225.4 million, compared
to cash and cash equivalents of $293.8 million as of December 31,
2018. Deciphera expects its cash, cash equivalents and marketable
securities as of June 30, 2019, along with the $20.0 million
up-front payment from the Company’s recent license agreement with
Zai received in the third quarter of 2019, will enable the Company
to fund its operating expenses, capital expenditure requirements
and debt service payments into the fourth quarter of 2020. This
excludes any potential milestone or royalty payments, if any, under
Deciphera’s license agreement with Zai.
- Revenue: Revenue for the second quarter of 2019 was
$25.0 million which was related to the Company’s exclusive license
agreement with Zai to advance the development and commercialization
of ripretinib in Greater China. Deciphera recognized license
revenue of $20.0 million for an upfront fee and $5.0 million for a
development milestone related to the INTRIGUE study.
- R&D Expenses: Research and development expenses for
the second quarter of 2019 were $34.8 million, compared to $18.0
million for the same period in 2018. The increase was primarily due
to the INTRIGUE Phase 3 clinical study in second-line GIST, which
the Company initiated in December 2018, and to the INVICTUS Phase 3
clinical study in fourth-line and fourth-line plus GIST, which the
Company initiated in January 2018. The Company also incurred costs
related to other supporting clinical trials for ripretinib.
Additionally, expenses related to the rebastinib program increased
primarily as a result of an increase in clinical trial costs
related to the Phase 1b/2 trial 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 $4.0 million primarily due to
increased headcount and stock-based compensation expense in
research and development functions. Personnel-related costs for the
second quarters of 2019 and 2018 included non-cash stock-based
compensation expense of $1.8 million and $1.0 million,
respectively. Facility-related and other costs included in
unallocated expenses increased $2.3 million primarily due to
increased consultant fees and other costs in connection with our
early-stage drug discovery programs.
- G&A Expenses: General and administrative expenses
for the second quarter of 2019 were $13.2 million, compared to $4.5
million for the same period in 2018. The increase was primarily due
to an increase in professional, consultant and various advisory
fees, including those related to commercialization preparedness.
Non-cash stock-based compensation was $2.3 million and $1.2 million
for the second quarters of 2019 and 2018, respectively. The
increase in non-cash stock-based compensation expense was primarily
related to the granting of additional employee stock option
awards.
- Net Loss: For the second quarter of 2019, Deciphera
reported a net loss of $21.5 million, or $0.56 per share, compared
with a net loss of $21.7 million, or $0.65 per share, for the same
period in 2018.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals (NASDAQ: DCPH) 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 clinical study, the
potential for ripretinib (DCC-2618) and our other drug candidates
(DCC-3116, rebastinib and DCC-3014) based on our kinase switch
control inhibitor platform to provide clinical benefit and treat
cancers such as GIST and other possible indications, preparations
for a possible NDA, pending positive study results, and commercial
launch of ripretinib in fourth-line and fourth-line plus GIST, if
approved, expectations for timing of filing and activation of an
IND for DCC-3116, expectations of timing of data for, and
enrollment with respect to, the Company’s rebastinib and DCC-3014
programs and expectations of benefits from the Company’s license
agreement with Zai. 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, DCC-3014 and
DCC-3116, 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, 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) June 30,
2019 December 31, 2018 Assets Cash and cash
equivalents and marketable securities
$
225,416
$
293,764
Accounts receivable and unbilled receivable
25,000
— Prepaid expenses and other current assets
6,010
7,273
Long-term investment restricted
1,510
1,069
Property and equipment, net
1,595
13,453
Operating lease, right-of-use assets
476
— Total assets
$
260,007
$
315,559
Liabilities and Stockholders' Equity Accounts
payable, accrued expenses and other
liabilities
$
35,451
$
22,398
Debt obligations
1,201
1,294
Operating lease liabilities
477
11,886
Total liabilities
37,129
35,578
Total stockholders' equity
222,878
279,981
Total liabilities and stockholders' equity
$
260,007
$
315,559
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited) Three Months Ended June 30,
Six Months Ended June 30,
2019
2018
2019
2018
Revenue
$ 25,000
$
—
$ 25,000
$
— Operating expenses: Research and development
34,811
17,976
70,600
34,901
General and administrative
13,164
4,453
26,400
9,479
Total operating expenses
47,975
22,429
97,000
44,380
Loss from operations
(22,975)
(22,429)
(72,000)
(44,380)
Other income (expense): Interest expense
(25)
(21)
(38)
(43)
Interest and other income, net
1,540
760
3,194
1,303
Total other income (expense), net
1,515
739
3,156
1,260
Net loss
$ (21,460)
$ (21,690)
$ (68,844)
$ (43,120)
Net loss per share—basic and diluted
$
(0.56)
$
(0.65)
$
(1.81)
$
(1.30)
Weighted average common shares outstanding—basic and diluted
38,200,288
33,567,314
38,129,049
33,083,383
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version on businesswire.com: https://www.businesswire.com/news/home/20190802005091/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc.
jrobinson@deciphera.com 781-906-1112
Media: David Rosen Argot Partners David.Rosen@argotpartners.com
212-600-1902
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