– Second Quarter 2023 Total Revenue of $38.3
Million; Net Product Revenue for QINLOCK® (ripretinib) Increased
18% to $37.3 Million Compared to Second Quarter 2022 –
– Top-line Results for MOTION Pivotal Phase 3
Study of Vimseltinib Expected in Fourth Quarter 2023 –
– INSIGHT Pivotal Phase 3 Study of QINLOCK in
Second-line GIST Patients with Mutations in KIT Exon 11 and 17/18
Initiated with First Sites Open for Enrollment –
– DCC-3116 Combination Escalation Cohorts with
QINLOCK and with Encorafenib and Cetuximab Initiated with First
Site Open for Enrollment; Combination Dose Escalation Cohorts with
MEK and KRAS G12C Inhibitors Ongoing –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today announced financial results for the
second quarter ended June 30, 2023 and provided a corporate
update.
“QINLOCK delivered record performance in the second quarter
based on continued growth in the U.S. and around the world. Moving
into a significant second half of 2023, we are looking forward to
the top-line results from the MOTION study of vimseltinib in
patients with tenosynovial giant cell tumor (TGCT), which has the
potential to become our second approved medicine,” said Steve
Hoerter, President and Chief Executive Officer of Deciphera
Pharmaceuticals. “Additionally, we have opened the first sites for
INSIGHT, the pivotal Phase 3 study of QINLOCK versus sunitinib in
second-line gastrointestinal stromal tumor (GIST) patients with
mutations in KIT exon 11 and 17 or 18 and for additional
combination cohorts of our ULK inhibitor DCC-3116, one in
combination with QINLOCK and another in combination with
encorafenib and cetuximab. We are on track to submit an
Investigational New Drug application to the FDA for DCC-3084, a
potential best-in-class pan-RAF inhibitor, in the fourth
quarter.”
Mr. Hoerter continued, “We are proud of the significant progress
across both our early-stage and late-stage programs that we have
already achieved in the first half of 2023. In addition to the
INTRIGUE Phase 3 ctDNA analysis presented at the ASCO Plenary
Session in the first quarter, we also presented eight poster
presentations at AACR that showcased the depth and breadth of our
kinase switch-control research engine along with the nomination of
our newest development candidate, DCC-3009, a potential
best-in-class pan-KIT inhibitor. At ASCO in June, we had one encore
presentation of our INTRIGUE Phase 3 ctDNA analysis and three
poster presentations, including overall survival and long-term
safety data from the INTRIGUE Phase 3 study of QINLOCK. Finally, on
behalf of everyone at Deciphera, I would like to thank Dan Flynn
for his dedication to Deciphera’s founding vision of improving the
lives of people with cancer, and for trailblazing the innovations
that have made all these advancements possible. We are excited to
build upon this foundation with Dash Dhanak as our new Chief
Scientific Officer.”
Second Quarter 2023 Highlights and Upcoming
Milestones
QINLOCK® (ripretinib)
- Recorded $37.3 million in QINLOCK net product revenue in the
second quarter of 2023, including $28.9 million in U.S. net product
revenue and $8.4 million in international net product revenue, an
increase of 18% compared to net product revenue of $31.5 million in
the second quarter of 2022. In addition, QINLOCK generated $1.0
million in collaboration revenue driven by royalties for sales of
QINLOCK by Zai Lab, the Company’s partner in Greater China.
- Presented one encore presentation and three poster
presentations at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting featuring an update from the ASCO Plenary
Series Session presenting circulating tumor DNA (ctDNA) analysis
results from the INTRIGUE Phase 3 study of QINLOCK, updated overall
survival (OS) and long-term safety results, and outcome data on
patients without detectable ctDNA at baseline from the INTRIGUE
Phase 3 study of QINLOCK in patients with advanced GIST previously
treated with imatinib, and information on the study design for the
upcoming INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib
in second-line GIST patients with KIT exon 11 and 17/18
mutations.
- Initiated the INSIGHT Phase 3 study by opening the first sites
for enrollment comparing QINLOCK versus sunitinib in second-line
GIST patients with mutations in KIT exon 11 and 17/18.
- Completed reimbursement negotiations process in Italy; launch
expected shortly. Completed negotiations with the pan-Canadian
Pharmaceutical Alliance (pCPA) in April 2023, which will enable
broad access to fourth-line GIST patients in Canada.
- Received regulatory approval for QINLOCK in Singapore in May
2023.
Vimseltinib
- Expects to announce top-line results from the MOTION pivotal
Phase 3 study of vimseltinib, an investigational, orally
administered, potent, and highly selective switch-control kinase
inhibitor of CSF1R for the potential treatment of tenosynovial
giant cell tumor (TGCT) in the fourth quarter of 2023.
- Expects to present updated data from the Phase 1/2 study of
vimseltinib in the fourth quarter of 2023.
DCC-3116
- Presented preclinical data on combinations with DCC-3116, an
investigational, orally administered, selective, and potent
switch-control kinase inhibitor of ULK1/2-mediated autophagy, at
the American Association for Cancer (AACR) Annual Meeting 2023,
including preclinical models in combination with QINLOCK in GIST
models and with encorafenib and cetuximab in colorectal cancer
(CRC) models.
- Completed the Phase 1 single agent dose escalation (n=28) of
DCC-3116 at doses from 50 mg - 300 mg BID; no maximum tolerated
dose was reached with one dose limiting toxicity (DLT) observed
(Grade 3 increased ALT at 100 mg BID) and no treatment-related
serious adverse events observed.
- As of August 4, 2023, combination dose escalations of DCC-3116
are ongoing with MEK inhibitors trametinib (n=11) and binimetinib
(n=10), and with KRAS G12C inhibitor, sotorasib (n=6) in patients
with advanced solid tumors. Evaluation of trametinib and
binimetinib cohorts in combination with 50 mg QD of DCC-3116 is
ongoing after dose reduction from 50 mg BID based on observed DLTs
for the trametinib combination (Grade 3 skin rash and diarrhea in
one patient and Grade 3 diarrhea in one patient) and the
binimetinib combination (Grade 3 decreased ejection fraction in one
patient and Grade 2 blurred vision in one patient).
- Evaluation of sotorasib cohort in combination with 200 mg QD of
DCC-3116 is ongoing; combination of sotorasib and DCC-3116 at 50 mg
BID was well tolerated with no DLTs observed in three evaluable
patients.
- Initiated new combination escalation cohorts with the first
site open for enrollment evaluating DCC-3116 (100 mg QD starting
dose) in combination with QINLOCK in patients with GIST and in
combination with encorafenib and cetuximab in patients with CRC.
Under the terms of the clinical trial collaboration and supply
agreement with Pfizer, Inc., Deciphera will sponsor the study and
Pfizer will supply encorafenib at no cost.
DCC-3084
- Presented preclinical data for DCC-3084, a pan-RAF inhibitor,
at the AACR Annual Meeting 2023, which demonstrated a potential
best-in-class profile based on its inhibition of Class I, II, and
III BRAF mutations, and BRAF fusions, and optimized pharmaceutical
properties.
- Expects to submit an investigational new drug (IND) application
to the U.S. Food and Drug Administration (FDA) for DCC-3084 in the
fourth quarter of 2023.
DCC-3009
- Presented preclinical data for DCC-3009, a potential
best-in-class pan-KIT inhibitor, at the AACR Annual Meeting 2023,
which demonstrated its ability to potently and selectively inhibit
the broad spectrum of known primary and secondary drug-resistant
mutations in GIST models, spanning KIT exons 9, 11, 13, 14, 17, and
18.
- Expects to submit an IND to the FDA for DCC-3009 in the first
half of 2024.
Kinase Switch-Control Research Engine
- Presented new preclinical data in eight poster presentations at
the AACR Annual Meeting 2023 from development candidates DCC-3116
(ULK), DCC-3084 (pan-RAF), DCC-3009 (pan-KIT) and research programs
focused on GCN2 and PERK, novel targets in the integrated stress
response pathway.
Corporate Update
- Announced that the Company’s Founder, Executive Vice President,
and Chief Scientific Officer, Daniel L. Flynn, Ph.D., will retire
effective September 5, 2023, and will transition to a role as
Senior Advisor to the Company. Dashyant Dhanak, Ph.D., has been
appointed Executive Vice President and Chief Scientific Officer
effective September 5, 2023. Dr. Dhanak brings over 30 years of
experience in pharmaceutical research and discovery including most
recently as Executive Vice President and Chief Scientific Officer
at Incyte Corporation.
- Announced that Ron Squarer has been appointed Chairperson of
the Board of Directors. Mr. Squarer has over 30 years of experience
in the pharmaceutical and biotechnology industry and joined
Deciphera as a Director in December 2019. James A. Bristol, Ph.D.,
who has served as either Chairperson or Co-Chairperson since 2007,
will remain a Board member of Deciphera.
Second Quarter 2023 Financial Results
- Revenue: Total revenue for the second quarter of 2023
was $38.3 million, which includes $37.3 million of net product
revenue of QINLOCK and $1.0 million of collaboration revenue
compared to $32.5 million of total revenue, including $31.5 million
of net product revenue of QINLOCK and $1.0 million of collaboration
revenue, for the same period in 2022.
- Cost of Sales: Cost of sales were $0.2 million in the
second quarter of 2023 compared to cost of sales of $1.8 million
for the second quarter of 2022. In the third quarter of 2022,
Deciphera completed the sale of zero cost inventories of QINLOCK
that had been expensed prior to FDA approval.
- R&D Expenses: Research and development expenses for
the second quarter of 2023 were $58.3 million, compared to $44.9
million for the same period in 2022. The increase was primarily due
to an increase in clinical study costs related to the Phase 1/2
study of DCC-3116, the MOTION Phase 3 study and Phase 1 /2 study of
vimseltinib, and clinical study costs for QINLOCK. Non-cash,
stock-based compensation was $5.7 million and $5.4 million for the
second quarters of 2023 and 2022, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the second quarter of 2023 were $32.6 million,
compared to $29.6 million for the same period in 2022. The increase
was primarily due to an increase in professional, consulting, and
other expenses as well as personnel-related costs. Non-cash,
stock-based compensation was $7.1 million and $7.6 million for the
second quarters of 2023 and 2022, respectively.
- Net Loss: For the second quarter of 2023, Deciphera
reported a net loss of $48.6 million, or $0.57 per share, compared
with a net loss of $43.1 million, or $0.60 per share, for the same
period in 2022.
- Cash Position: As of June 30, 2023, cash, cash
equivalents, and marketable securities were $389.4 million,
compared to $426.3 million as of March 31, 2023. Based on its
current operating plans, Deciphera expects its current cash, cash
equivalents, and marketable securities together with anticipated
product, royalty, and supply revenues, but excluding any potential
future milestone payments under its collaboration or license
agreements, will enable the Company to fund its operating and
capital expenditures into 2026.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, August 9, 2023, at 8:00 AM ET. The
conference call may be accessed via this link:
https://register.vevent.com/register/BI74ff2d04fe8541f48da1cf0ad35339ae.
A live webcast of the conference call will be available in the
“Events and Presentations” page in the “Investors & News”
section of the Company’s website at
https://investors.deciphera.com/events-presentations. A replay will
be available on the Company’s website approximately two hours after
the conference call and will be available for 30 days following the
call.
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
switch-control inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia, Canada, China, the European
Union, Hong Kong, Israel, Macau, New Zealand, Singapore,
Switzerland, Taiwan, the United Kingdom, and the United States. 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
and timing regarding the potential for our preclinical and/or
clinical stage pipeline assets to be first-in-class and/or
best-in-class treatments; our Phase 3 INSIGHT study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT
exon 11 and 17/18; plans to announce top-line results from the
pivotal Phase 3 MOTION study of vimseltinib in TGCT patients in the
fourth quarter of 2023 and the potential for vimseltinib to become
our second approved medicine; plans to present updated data from
the phase 1/2 study of vimseltinib in TGCT patients in the fourth
quarter of 2023; plans for our ongoing phase 1/2 studies of
DCC-3116; and cash guidance. 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, our ability to
successfully demonstrate the efficacy and safety of our drug or
drug candidates, the preclinical or clinical results for our
product candidates, which may not support further development of
such product candidates, 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, 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 and other risks identified in our Securities and Exchange
Commission (SEC) filings, including our Quarterly Report on Form
10-Q for the quarter ended June 30, 2023, 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.
The Deciphera logo, QINLOCK, and the QINLOCK logo are registered
trademarks and Deciphera is a trademark of Deciphera
Pharmaceuticals, LLC.
Deciphera Pharmaceuticals,
Inc. Consolidated Balance Sheets (Unaudited, in
thousands, except share and per share amounts)
June 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
81,394
$
64,741
Short-term marketable securities
247,346
259,745
Accounts receivable, net
23,200
22,429
Inventory
25,343
20,561
Prepaid expenses and other current
assets
27,767
25,482
Total current assets
405,050
392,958
Long-term marketable securities
60,683
14,550
Long-term investments—restricted and other
long-term assets
3,339
3,277
Property and equipment, net
6,213
6,707
Operating lease assets
34,333
36,547
Total assets
$
509,618
$
454,039
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
18,211
$
18,612
Accrued expenses and other current
liabilities
59,455
64,622
Operating lease liabilities
3,368
3,235
Total current liabilities
81,034
86,469
Operating lease liabilities, net of
current portion
24,154
25,879
Total liabilities
105,188
112,348
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.01 par value per
share; 5,000,000 shares authorized; no shares issued or
outstanding
—
—
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 78,772,870 shares and 67,637,351
shares issued and outstanding as of June 30, 2023 and December 31,
2022, respectively
788
676
Additional paid-in capital
1,736,143
1,575,361
Accumulated other comprehensive income
(loss)
(967
)
(983
)
Accumulated deficit
(1,331,534
)
(1,233,363
)
Total stockholders' equity
404,430
341,691
Total liabilities and stockholders'
equity
$
509,618
$
454,039
Deciphera Pharmaceuticals,
Inc. Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share
amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenues:
Product revenues, net
$
37,320
$
31,497
$
70,542
$
60,306
Collaboration revenues
984
997
1,207
1,411
Total revenues
38,304
32,494
71,749
61,717
Cost and operating expenses:
Cost of sales
173
1,799
661
2,181
Research and development
58,296
44,858
113,061
92,270
Selling, general, and administrative
32,610
29,625
64,059
57,946
Total cost and operating expenses
91,079
76,282
177,781
152,397
Loss from operations
(52,775
)
(43,788
)
(106,032
)
(90,680
)
Other income (expense):
Interest and other income, net
4,213
727
7,861
727
Total other income (expense), net
4,213
727
7,861
727
Net loss
$
(48,562
)
$
(43,061
)
$
(98,171
)
$
(89,953
)
Net loss per share—basic and diluted
$
(0.57
)
$
(0.60
)
$
(1.17
)
$
(1.31
)
Weighted average common shares
outstanding—basic and diluted
85,020,344
72,133,428
83,854,959
68,441,998
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809788143/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 212-600-1902 Media: David Rosen
Argot Partners david.rosen@argotpartners.com 212-600-1902
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