– First Quarter 2023 Total Revenue of $33.4
Million; Net Product Revenue for QINLOCK® Increased 15% to $33.2
Million Compared to First Quarter 2022 –
– Enrollment Complete in the MOTION Pivotal
Phase 3 Study of Vimseltinib; Top-line Results Expected in the
Fourth Quarter of 2023 –
– QINLOCK Granted FDA Breakthrough Therapy
Designation in Second-line GIST Patients with Mutations in KIT Exon
11 and 17/18 and Included in NCCN Guidelines as a Preferred Regimen
for Second-line GIST Patients Intolerant to Sunitinib; INSIGHT
Study in Second-line GIST Patients with Mutations in KIT Exon 11
and 17/18 Expected to Initiate in Second Half 2023 –
– Preclinical Data at AACR Supporting DCC-3116
(ULK inhibitor) in Combination with QINLOCK in GIST and in
Combination with Encorafenib and Cetuximab in Colorectal Cancer;
Two New Combination Escalation Studies Expected to Initiate in
Second Half of 2023 –
– Generated Gross Proceeds of Approximately
$143.7 Million from Public Offering in January 2023; Cash Expected
to Fund Operating and Capital Expenditures into 2026 –
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 first
quarter ended March 31, 2023 and provided a corporate update.
“We have had a very strong start to 2023, achieving significant
milestones including the completion of enrollment for the MOTION
pivotal Phase 3 study of vimseltinib in TCGT patients, presentation
of the ctDNA data for QINLOCK in second-line GIST patients with
mutations in KIT Exon 11 and 17/18, and receiving Breakthrough
Therapy Designation from the FDA for QINLOCK in this patient
population,” said Steve Hoerter, President and Chief Executive
Officer of Deciphera Pharmaceuticals. “These advancements in our
late-stage pipeline position us for a catalyst-rich remainder of
2023, in which we expect top-line results from the MOTION study and
plan to initiate INSIGHT, the pivotal Phase 3 study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT
exon 11 and 17/18.”
Mr. Hoerter continued, “We continue to complement this
impressive momentum with progress in our early-stage programs,
including the recent presentations at AACR, which highlighted the
productivity of our kinase switch-control research engine. We were
excited to present the preclinical data for DCC-3084, a potential
best-in-class pan-RAF inhibitor, and announce the nomination of our
newest development candidate, DCC-3009, a potential best-in-class
pan-KIT inhibitor. We also presented preclinical data supporting
the study of DCC-3116 in combination with QINLOCK in GIST and with
encorafenib and cetuximab in colorectal cancer. This encouraging
progress demonstrates that, as we work toward becoming a company
with multiple approved medicines, our proprietary drug discovery
platform continues to fuel our pipeline with innovative, potential
first- and best-in-class kinase inhibitors.”
First Quarter 2023 Highlights and Upcoming Milestones
QINLOCK® (ripretinib)
- Recorded $33.2 million in QINLOCK net product revenue in the
first quarter of 2023, including $24.6 million in U.S. net product
revenue and $8.6 million in international net product revenue, an
increase of 15% compared to net product revenue of $28.8 million in
the first quarter of 2022.
- Granted Breakthrough Therapy Designation (BTD) by the U.S. Food
and Drug Administration (FDA) for the treatment of adult patients
with unresectable or metastatic gastrointestinal stromal tumor
(GIST) who received prior treatment with imatinib, and who harbor a
KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18
mutations. The Company expects to initiate the INSIGHT study in the
second half of 2023.
- Included in the latest National Comprehensive Cancer Network®
(NCCN®) Clinical Practice Guidelines in Oncology as a preferred
regimen for second-line GIST patients intolerant to sunitinib.
- Will present posters at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting featuring updated overall survival
(OS) and outcome data on patients without circulating tumor DNA
(ctDNA) at baseline from the INTRIGUE Phase 3 study of QINLOCK in
patients with advanced GIST previously treated with imatinib, along
with information on the upcoming INSIGHT pivotal Phase 3 study of
QINLOCK versus sunitinib in second-line GIST patients with KIT exon
11 and 17/18 mutations.
- Concluded successful price negotiations in Germany. In 2022,
QINLOCK received a “major additional benefit” rating from Germany’s
Federal Joint Committee (G-BA). QINLOCK is the first orphan
oncology treatment in Germany to receive this rating for its lead
indication and the only GIST treatment awarded with this
recognition.
Vimseltinib
- Completed enrollment for 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) and
expects to announce top-line results from the study in the fourth
quarter of 2023.
- Expects to present updated data from the Phase 1/2 study of
vimseltinib in the second half 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 ripretinib in GIST
models and with encorafenib and cetuximab in colorectal cancer
(CRC) models.
- Expects to initiate new combination escalation studies
evaluating DCC-3116 in combination with ripretinib in patients with
GIST and in combination with encorafenib and cetuximab in patients
with CRC in the second half of 2023. 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.
- Expects to initiate one or more expansion cohorts in the
ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in
combination with the MEK inhibitors trametinib or binimetinib, or
the KRAS G12C inhibitor sotorasib.
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, BRAF fusions, and BRAF/CRAF heterodimers, and
optimized pharmaceutical properties.
- Expects to submit an investigational new drug (IND) application
to the FDA for DCC-3084 in the second half 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 from research programs focused
on GCN2 and PERK, novel targets in the integrated stress response
pathway, at the AACR Annual Meeting 2023.
Corporate Update
- Announced the closing in January 2023 of its underwritten
public offering of 7,986,111 shares of its common stock at a public
offering price of $18.00. The aggregate gross proceeds to Deciphera
from this offering were approximately $143.7 million, before
deducting underwriting discounts and commissions and other
estimated offering expenses.
First Quarter 2023 Financial Results
- Revenue: Total revenue for the first quarter of 2023 was
$33.4 million, which includes $33.2 million of net product revenue
of QINLOCK and $0.2 million of collaboration revenue compared to
$29.2 million of total revenue, including $28.8 million of net
product revenue of QINLOCK and $0.4 million of collaboration
revenue, for the same period in 2022.
- Cost of Sales: Cost of sales were $0.5 million in the
first quarter of 2023, which includes $0.4 million in cost of
product sales, compared to cost of sales of $0.4 million for the
first 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 first quarter of 2023 were $54.8 million, compared to $47.4
million for the same period in 2022. The increase was primarily due
to an increase in clinical study costs related to the MOTION Phase
3 study of vimseltinib, the Phase 1/2 study of DCC-3116, and
clinical study costs for QINLOCK, including the Phase 3 INTRIGUE
study. Non-cash, stock-based compensation was $5.4 million and $6.3
million for the first quarters of 2023 and 2022, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the first quarter of 2023 were $31.4 million, compared
to $28.3 million for the same period in 2022. The increase was
primarily due to an increase in professional, consulting, and other
expenses, partially offset by a decrease in personnel-related
costs. Non-cash, stock-based compensation was $7.0 million and $8.0
million for the first quarters of 2023 and 2022, respectively.
- Net Loss: For the first quarter of 2023, Deciphera
reported a net loss of $49.6 million, or $0.60 per share, compared
with a net loss of $46.9 million, or $0.80 per share, for the same
period in 2022.
- Cash Position: As of March 31, 2023, cash, cash
equivalents, and marketable securities were $426.3 million,
compared to $339.0 million as of December 31, 2022. 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, May 3, 2023, at 8:00 AM ET. The conference
call may be accessed via this link:
https://register.vevent.com/register/BI75fb53c225a648b486e50d922b166468.
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, 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 planned Phase 3 INSIGHT study of
QINLOCK versus sunitinib in second-line GIST patients with
mutations in KIT exon 11 and 17/18; plans to present posters at the
2023 ASCO Annual Meeting; plans to announce top-line results from
the pivotal Phase 3 MOTION study of vimseltinib in TGCT patients in
the fourth quarter of 2023; plans to present updated data from the
phase 1/2 study of vimseltinib in TGCT patients in the second half
of 2023; plans to initiate one or more expansion cohorts in the
Phase 1/2 study of DCC-3116 in the second half of 2023 in
combination with trametinib, binimetinib, or sotorasib; plans to
initiate two new dose escalation studies evaluating DCC-3116 in
combination with ripretinib in GIST patients and in combination
with encorafenib and cetuximab in patients with CRC; the
anticipated benefits of our collaboration and supply agreement with
Pfizer; plans to submit an IND for DCC-3084 in the second half of
2023; plans to submit an IND for DCC-3009 in the first half of
2024; 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 Annual Report on Form 10-K for the year ended
December 31, 2022, 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)
March 31, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
114,637
$
64,741
Short-term marketable securities
283,996
259,745
Accounts receivable, net
22,439
22,429
Inventory
25,528
20,561
Prepaid expenses and other current
assets
29,559
25,482
Total current assets
476,159
392,958
Long-term marketable securities
27,627
14,550
Long-term investments—restricted and other
long-term assets
3,277
3,277
Property and equipment, net
6,511
6,707
Operating lease assets
35,445
36,547
Total assets
$
549,019
$
454,039
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
19,670
$
18,612
Accrued expenses and other current
liabilities
60,942
64,622
Operating lease liabilities
3,301
3,235
Total current liabilities
83,913
86,469
Operating lease liabilities, net of
current portion
25,022
25,879
Total liabilities
108,935
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; 78,507,752 shares and 67,637,351
shares issued and outstanding as of March 31, 2023 and December 31,
2022, respectively
785
676
Additional paid-in capital
1,722,452
1,575,361
Accumulated other comprehensive income
(loss)
(181
)
(983
)
Accumulated deficit
(1,282,972
)
(1,233,363
)
Total stockholders' equity
440,084
341,691
Total liabilities and stockholders'
equity
$
549,019
$
454,039
Deciphera Pharmaceuticals,
Inc.
Consolidated Statements of
Operations
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended March
31,
2023
2022
Revenues:
Product revenues, net
$
33,222
$
28,809
Collaboration revenues
223
414
Total revenues
33,445
29,223
Cost and operating expenses:
Cost of sales
488
382
Research and development
54,765
47,412
Selling, general, and administrative
31,449
28,321
Total cost and operating expenses
86,702
76,115
Loss from operations
(53,257
)
(46,892
)
Other income (expense):
Interest and other income, net
3,648
—
Total other income (expense), net
3,648
—
Net loss
$
(49,609
)
$
(46,892
)
Net loss per share—basic and diluted
$
(0.60
)
$
(0.80
)
Weighted average common shares
outstanding—basic and diluted
82,676,624
58,616,458
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230503005213/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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