- First Quarter 2021 QINLOCK® Net Product
Revenue of $20.0 Million; QINLOCK Approved in China and Hong Kong
for Fourth-line GIST -
- Top-line Results from INTRIGUE Phase 3 Study
of QINLOCK in Patients with Second-line GIST Expected in the Fourth
Quarter of 2021; Plans to Initiate a Phase 1b/2 Study of QINLOCK in
Combination with Binimetinib in Patients with Post-Imatinib GIST
-
- Updated Data from Phase 1b/2 Study of
Rebastinib in Combination with Paclitaxel in Patients with
Endometrial Cancer to be Presented at ASCO -
- Initiation of Phase 1 Study of DCC-3116,
Potential First-in-Class ULK Kinase Inhibitor for the Treatment of
Patients with Mutant RAS and RAF Cancers, Expected in the Second
Quarter of 2021 –
– Company to Host Conference Call Today at 4:30
PM ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH)
today announced financial results for the first quarter ended March
31, 2021, and provided a corporate update.
“We are excited by the continuing successful commercial launch
of QINLOCK in the U.S. as we solidify its position among GIST
prescribers and patients and expand access to this important
medicine globally. We also remain focused on realizing QINLOCK’s
potential in earlier lines of therapy,” said Steve Hoerter,
President and Chief Executive Officer of Deciphera. “We expect the
INTRIGUE Phase 3 top-line results in the fourth quarter of this
year and believe QINLOCK has the potential to transform the
treatment of GIST for this larger, second-line patient population.
Building on our commitment to fully explore the potential of
QINLOCK to benefit patients with GIST, we are excited to announce
today our plans to initiate a Phase 1b/2 study combining QINLOCK
with binimetinib, an approved MEK inhibitor. Our enthusiasm for
this combination is based on compelling pre-clinical data showing
that this combination can induce apoptosis and has the potential to
deepen and prolong responses.”
Mr. Hoerter continued, “We remain very pleased with the progress
and growth for the balance of our pipeline, including the upcoming
initiation of the Phase 1 study for our potential first-in-class
ULK kinase inhibitor, DCC-3116, in patients with cancers driven by
mutant RAS or RAF genes. We look forward to presenting updated data
from both the vimseltinib and rebastinib programs in the coming
months and plan to finalize registration-enabling studies for both
programs before the end of the year.”
First Quarter 2021 Highlights and Upcoming Milestones
- QINLOCK(ripretinib)
- Recorded $20.0 million in QINLOCK net product revenue in the
first quarter of 2021, including $19.3 million in U.S. net product
revenue.
- Received approval in China from the China National Medical
Products Administration (NMPA) and from the Hong Kong Department of
Health, via our collaboration with Zai Lab, for the treatment of
adult patients with fourth-line gastrointestinal stromal tumors
(GIST).
- Expects potential approval from the European Medicines Agency
(EMA) for QINLOCK in the fourth quarter of 2021.
- Expects to announce top-line results from the INTRIGUE Phase 3
study in the fourth quarter of 2021.
- Expects to present data for QINLOCK patients undergoing
intra-patient dose escalation after disease progression in the
INVICTUS Phase 3 study at the American Society of Clinical Oncology
(ASCO) Annual Meeting in June.
- Today announced that the Company plans to initiate a Phase 1b/2
study of QINLOCK in combination with binimetinib, an approved MEK
inhibitor, to address one of the potential mechanisms of resistance
to kinase inhibition, reactivation of the MAPK pathway, in
post-imatinib GIST patients.
- A publication supporting this approach was recently published
online by Molecular Cancer Therapeutics. The results showed that
treatment with QINLOCK in combination with MEK inhibitors
effectively induced and enhanced apoptotic responses and prevented
growth of resistant colonies in both imatinib-sensitive and
-resistant GIST cell lines.
- Vimseltinib
- Expects to present updated data from the ongoing Phase 1/2
study in patients with tenosynovial giant cell tumor (TGCT) in the
third quarter of 2021.
- Plans to finalize the pivotal development plan for vimseltinib
in TGCT in the second half of 2021.
- Rebastinib
- Expects to present updated data from the ongoing Phase 1b/2
study of rebastinib in combination with paclitaxel in the
endometrial cancer cohort at the ASCO Annual Meeting in June.
- Expects to present updated data from the ongoing Phase 1b/2
study of rebastinib in combination with paclitaxel in the
platinum-resistant ovarian cancer cohort in the third quarter of
2021.
- Plans to finalize the pivotal development plan for rebastinib
in combination with paclitaxel in the second half of 2021.
- DCC-3116
- Expects to initiate the Phase 1, multicenter, open-label,
first-in-human study of DCC-3116 in the second quarter of 2021. The
study will evaluate DCC-3116 as a single agent and in combination
with trametinib in patients with advanced or metastatic tumors with
a mutant RAS or RAF gene. Currently, expansion cohorts are planned
in patients with advanced or metastatic pancreatic ductal
adenocarcinoma with KRAS or BRAF mutations, non-small cell lung
cancer with KRAS, NRAS, or BRAF mutations, colorectal cancer with
KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF
mutations.
Upcoming Scientific Congress Presentations
- 2021 ASCO Annual Meeting, June 4-8. E-poster
presentations will be available on-demand via the ASCO Meeting
Library beginning on Friday, June 4 at 9:00 AM ET.
- QINLOCK
- E-poster presentation: Intra-patient dose escalation (IPDE) of
ripretinib after disease progression in patients with advanced
gastrointestinal stromal tumor (GIST): Analyses from the phase 3
INVICTUS study.
- Rebastinib
- E-poster presentation: Open-label, multicenter, phase 1b/2
study of rebastinib in combination with paclitaxel to assess safety
and efficacy in patients with advanced or metastatic endometrial
cancer.
First Quarter Financial Results
- Revenue: Total revenue for the first quarter of 2021 was
$25.2 million, which includes $20.0 million of net product revenue
from sales of QINLOCK and $5.2 million of collaboration revenue.
Net product revenues for the first quarter of 2021 included U.S.
sales of QINLOCK of $19.3 million and ex-U.S. sales of QINLOCK of
$0.7 million. The Company also recognized $5.0 million in
collaboration revenue under its license agreement with Zai Lab
based on the approval of QINLOCK in China. In the first quarter of
2020, the Company did not generate product revenue.
- Cost of Sales: Cost of sales were $0.2 million in the
first quarter of 2021. There were no cost of sales in the first
quarter of 2020 as no product sales were generated during that
period. Cost of sales will not be significant until the initial
pre-launch inventory is depleted, and additional inventory is
manufactured and sold.
- R&D Expenses: Research and development expenses for
the first quarter were $55.7 million, compared to $51.4 million for
the same period in 2020. The increase was primarily due to
personnel and preclinical costs, partially offset by a decrease in
clinical trial expenses related to the INTRIGUE Phase 3 study in
second-line GIST and the INVICTUS Phase 3 study in fourth-line and
fourth-line plus GIST. Non-cash, stock-based compensation was $5.0
million and $3.3 million for the first quarters of 2021 and 2020,
respectively.
- SG&A Expenses: Selling, general and administrative
expenses for the first quarter of 2021 were $30.7 million, compared
to $23.9 million for the same period in 2020. The increase was
primarily due to personnel costs as well as external spend related
to professional fees, including those associated with establishing
a targeted commercial infrastructure in key European markets to
support a potential launch of QINLOCK in Europe, if approved.
Non-cash, stock-based compensation was $6.2 million and $3.7
million for the first quarters of 2021 and 2020, respectively.
- Net Loss: For the first quarter of 2021, Deciphera
reported a net loss of $61.3 million, or $1.06 per share, compared
with a net loss of $72.8 million, or $1.36 per share, for the same
period in 2020. The decrease in net loss was primarily a result of
product sales during the first quarter of 2021, partially offset by
an increase in R&D and SG&A expenses as described
above.
- Cash Position: As of March 31, 2021, cash, cash
equivalents and marketable securities were $502.2 million, compared
to $561.3 million as of December 31, 2020. Based on its current
operating plans, Deciphera expects its current cash, cash
equivalents, and marketable securities together with anticipated
product and royalty revenues, but excluding any potential future
milestone payments or other payments under its collaboration or
license agreements, will enable the Company to fund its operating
and capital expenditures into the first half of 2023.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, May 4, 2021 at 4:30 PM ET. To access the
live call by phone please dial (866) 930-5479 (domestic) or (409)
216-0603 (international); the conference ID is 5470938. A live
audio webcast of the event may also be accessed through the
“Investors” section of Deciphera’s website at www.deciphera.com. A
replay of the webcast will be available for 30 days following the
event.
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
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also
approved for fourth-line GIST in Australia, Canada, China, and Hong
Kong. 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
regarding timing for top-line data from our Phase 3 INTRIGUE study
in second-line GIST, expanding access to QINLOCK globally, the
potential of QINLOCK in earlier lines of therapy such as
second-line GIST and the potential to transform the treatment for
such patients, plans to initiate a phase 1b/2 study of QINLOCK with
a MEK inhibitor in post-imatinib GIST patients and the potential
for a deeper and prolonged response, plans to present data on
patients undergoing intra-patient dose escalation following disease
progression from the phase 3 INVICTUS study, potential EMA approval
of QINLOCK for the treatment of fourth-line GIST, finalizing
pivotal study plans for vimseltinib (DCC-3014) in TGCT patients and
for the rebastinib/paclitaxel combination, presenting updated data
from the Phase 1/2 study of vimseltinib (DCC-3014) in TGCT
patients, presenting updated data from the Phase 1b/2 study of
rebastinib in combination with paclitaxel for patients with
endometrial cancer and also from patients with platinum-resistant
ovarian cancer, initiating a phase 1 study of DCC-3116 in patients
with cancers driven by mutant RAS/RAF genes; and cash runway
expectations. 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 candidates and in additional indications for our existing
drug, the preclinical or clinical results for our product
candidates, which may not support further development of such
product candidates, our ability to manage our reliance on
sole-source third parties such as our third party drug substance
and drug product contract manufacturers, 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, our ability to
build and scale our operations to support growth in additional
geographies, 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, our ability to
comply with healthcare regulations and laws, our ability to obtain,
maintain and enforce our intellectual property rights, any or all
of which may affect the initiation, timing and progress of clinical
studies and the timing of and our ability to obtain additional
regulatory approvals, and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2021, 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 our views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
QINLOCK and the QINLOCK logo are registered trademarks, and
Deciphera and the Deciphera logo are trademarks, of Deciphera
Pharmaceuticals, LLC.
Deciphera Pharmaceuticals, Inc. Consolidated
Balance Sheets (Unaudited, in thousands, except share and per share
amounts)
March 31, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
201,648
$
135,897
Short-term marketable securities
300,527
416,033
Accounts receivable, net
21,821
13,896
Inventory
7,090
5,716
Prepaid expenses and other current
assets
15,546
12,489
Total current assets
546,632
584,031
Long-term marketable securities
—
9,375
Long-term investments—restricted
3,102
3,102
Property and equipment, net
9,633
9,583
Operating lease assets
35,879
36,341
Total assets
$
595,246
$
642,432
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
11,905
$
12,308
Accrued expenses and other current
liabilities
49,344
55,227
Operating lease liabilities
2,540
2,457
Total current liabilities
63,789
69,992
Operating lease liabilities, net of
current portion
28,444
28,764
Total liabilities
92,233
98,756
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 57,901,020 shares and 57,596,144
shares issued and outstanding as of March 31, 2021 and December 31,
2020, respectively
579
576
Additional paid-in capital
1,318,157
1,297,557
Accumulated other comprehensive income
(loss)
43
11
Accumulated deficit
(815,766
)
(754,468
)
Total stockholders' equity
503,013
543,676
Total liabilities and stockholders'
equity
$
595,246
$
642,432
Deciphera Pharmaceuticals, Inc. Consolidated
Statements of Operations and Comprehensive Loss (Unaudited, in
thousands, except share and per share amounts)
Three Months Ended March
31,
2021
2020
Revenues:
Product revenues, net
$
19,962
$
—
Collaboration revenues
5,194
62
Total revenues
25,156
62
Cost and operating expenses:
Cost of sales
222
—
Research and development
55,681
51,388
Selling, general, and administrative
30,747
23,936
Total cost and operating expenses
86,650
75,324
Loss from operations
(61,494
)
(75,262
)
Other income (expense):
Interest and other income, net
196
2,455
Total other income (expense), net
196
2,455
Net loss
$
(61,298
)
$
(72,807
)
Net loss per share—basic and diluted
$
(1.06
)
$
(1.36
)
Weighted average common shares
outstanding—basic and diluted
57,747,168
53,567,434
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210504006277/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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