- Ripretinib Granted Breakthrough Therapy
Designation by the U.S. Food and Drug Administration (FDA) for the
Treatment of Patients with Advanced Gastrointestinal Stromal Tumors
(GIST) -
- Clinical Progress Across Pipeline with Data
Presentations for Ripretinib, Rebastinib and DCC-3014 -
- Completed Follow-On Offering Raising Net
Proceeds of $432 Million; Ended Third Quarter 2019 with Cash, Cash
Equivalents and Marketable Securities of $635 Million -
- Company to Host Conference Call Today at 4:30
PM ET -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced
financial results for the third quarter ended September 30, 2019
and provided a general update on clinical and corporate
developments.
“We believe the Breakthrough Therapy Designation we received
from the FDA underscores the potential for ripretinib to transform
the treatment landscape for patients with advanced GIST," said
Steve Hoerter, President and Chief Executive Officer of Deciphera.
"Based on the positive results from the Phase 3 INVICTUS study, we
remain on track for our planned NDA submission for ripretinib in
the first quarter of 2020. In addition, we provided important new
clinical updates on rebastinib and DCC-3014 at the recent
AACR-NCI-EORTC meeting and we continue to progress our broad
portfolio of novel product candidates all discovered here at
Deciphera.”
Recent Highlights and Upcoming Milestones
- Ripretinib
- Presented positive top-line data from the INVICTUS pivotal
Phase 3 clinical study evaluating the safety and efficacy of
ripretinib in fourth-line and fourth-line plus GIST patients.
- FDA granted Breakthrough Therapy Designation (BTD) for
ripretinib for the treatment of patients with advanced GIST who
have received prior treatment with imatinib, sunitinib and
regorafenib.
- Company expects to submit a New Drug Application (NDA) to the
FDA for ripretinib for the treatment of patients with advanced GIST
who have received prior treatment with imatinib, sunitinib and
regorafenib in the first quarter of 2020.
- Presented updated data from the ongoing Phase 1 clinical study
of ripretinib in patients with second-line through fourth-line plus
GIST at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics. The Company believes the updated
data continue to support the ongoing INTRIGUE pivotal Phase 3
clinical study comparing ripretinib to sunitinib for the treatment
of second-line GIST patients who have previously received
imatinib.
- Established ripretinib Expanded Access Program (EAP) for
patients with locally advanced unresectable or metastatic GIST who
have received treatment with prior therapies. The ripretinib EAP
provides a pathway for eligible patients to gain access to this
investigational medicine outside of clinical trials when no
comparable or satisfactory alternative therapy option is
available.
- DCC-3014
- Presented data from the Phase 1 dose escalation study of
DCC-3014, an oral inhibitor of CSF1R, in patients with advanced
solid tumors, at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics. The Phase 1 data
demonstrated tolerability, pharmacokinetics and biomarker
mechanistic proof-of-concept in patients with advanced
malignancies.
- Company plans to present preliminary data from initial
tenosynovial giant cell tumor (TGCT) patients at the 2019
Connective Tissue Oncology Society (CTOS) Annual Meeting being held
November 13-16 in Tokyo, Japan.
- Rebastinib
- Presented data from the ongoing Phase 1b/2 clinical study of
rebastinib, an oral TIE2 kinase inhibitor, in combination with
paclitaxel at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics. In Part 1 of the ongoing
Phase 1b/2 study, the combination of rebastinib and paclitaxel
exhibited encouraging preliminary anti-tumor activity across
treatment arms and was generally well tolerated.
- DCC-3116
- Presented preclinical data for DCC-3116, a potential
first-in-class autophagy inhibitor designed to treat mutant RAS
cancers at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics. In vivo and in vitro data
demonstrated DCC-3116 is a potent, selective and tight-binding
inhibitor of ULK kinase, and represents a differentiated approach
to autophagy inhibition and a potential first-in-class opportunity
for a new therapeutic modality in mutant RAS cancers.
Recent Corporate Updates
- In October 2019, Deciphera announced the appointment of Matthew
L. Sherman, M.D. as Executive Vice President and Chief Medical
Officer. Dr. Sherman brings over 25 years of experience as a
physician-scientist in clinical drug development in oncology and
hematology at leading biotechnology and pharmaceutical
companies.
- In the third quarter of 2019, Deciphera announced the closing
of an underwritten public offering of 12,432,431 shares at a public
offering price of $37.00 per share, which included the exercise in
full by the underwriters of their option to purchase up to
1,621,621 shares of common stock. Total net proceeds to Deciphera
were approximately $431.8 million, after deducting underwriting
discounts and commissions and other offering expenses.
Third Quarter 2019 Financial Results
- Cash Position: As of September 30, 2019, cash, cash
equivalents and marketable securities were $634.6 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 September 30, 2019 will enable the Company to fund
its operating expenses, capital expenditure requirements and debt
service payments into 2022.
- R&D Expenses: Research and development expenses for
the third quarter of 2019 were $40.4 million, compared to $20.6
million for the same period in 2018. The increase was primarily due
to the Company’s clinical trial costs related to the INTRIGUE
pivotal Phase 3 study in second-line GIST. Personnel-related costs
increased to $11.6 million primarily due to an increase in
headcount and stock-based compensation expense in the research and
development function. Personnel-related costs for the third
quarters of 2019 and 2018 included non-cash, stock-based
compensation expense of $2.0 million and $1.1 million,
respectively. Facility-related and other costs included increased
consultant fees of $0.4 million and increased costs incurred in
connection with our early-stage drug discovery programs of $0.2
million.
- G&A Expenses: General and administrative expenses
for the third quarter of 2019 were $18.0 million, compared to $5.3
million for the same period in 2018. The increase was primarily due
to increases in headcount and stock-based compensation expense in
the Company’s general and administrative function. Non-cash,
stock-based compensation was $2.7 million and $1.5 million for the
third quarters of 2019 and 2018, respectively.
- Net Loss: For the third quarter of 2019, Deciphera
reported a net loss of $56.2 million, or $1.28 per share, compared
with a net loss of $24.4 million, or $0.65 per share, for the same
period in 2018.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, November 4, 2019, 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 1181263. 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 Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on improving the lives of cancer patients by
addressing 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, and
agents designed to inhibit reprogramming of cancer cell metabolism.
We have used our platform to develop a diverse pipeline of
tumor-targeted, immuno-targeted, and metabolism-targeted drug
candidates designed to improve outcomes for patients with cancer by
improving the quality, rate and/or durability of their responses to
treatment.
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 our planned potential NDA
submission with FDA for ripretinib for patients with advanced GIST
and the timing of such filing, the BTD designation of ripretinib
for patients with advanced GIST, our EAP program, the updated Phase
1 study of ripretinib in patients with GIST to support our pivotal
Phase 3 INTRIGUE study in second-line GIST patients, the potential
of our pipeline drug candidates to improve the lives of patients
with cancer, the expectation to present additional data from our
Phase 1 study of DCC-3014 in patients with diffuse-type
tenosynovial giant cell tumor at an upcoming medical meeting,
continuation of Part 2 of our Phase 1b/2 study of rebastinib in
combination with paclitaxel, advancing DCC-3116 and the potential
of DCC-3116 to be a new modality for treating mutant RAS cancers,
and cash guidance. 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, 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, the possibility that results
experienced in early, preliminary, top-line or initial data may not
be indicative of the results experienced in final data, our ability
to timely complete and prepare the information required for and
file an NDA for ripretinib, the fact receipt of a breakthrough
therapy designation for a drug candidate, such as ripretinib, may
not result in us receiving any of the benefits of such designation
such as a faster development process, review or approval compared
to drugs considered for approval under conventional FDA procedures,
the fact such designation does not assure ultimate approval by FDA
and is subject to the risk FDA may later decide that the products
no longer meet the conditions for qualification or decide that the
time period for FDA review or approval will not be shortened, our
ability to manage and our reliance on third parties such as our
third party drug substance and drug product contract manufacturers,
actions of regulatory agencies, any or all of which may affect the
initiation, timing and progress of clinical studies and the timing
of and our ability to obtain regulatory approval, if at all, and
make our investigational drugs available to patients, and other
risks identified in our SEC filings, including our Quarterly Report
on Form 10-Q for the quarter ended June 30, 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.
Deciphera Pharmaceuticals,
Inc.
Consolidated Balance
Sheets
(Unaudited, in thousands,
except share and per share amounts)
September 30, 2019
December 31, 2018
Assets
Current assets:
Cash and cash equivalents
$
173,712
$
293,764
Marketable securities
460,883
—
Prepaid expenses and other current
assets
7,700
7,273
Total current assets
642,295
301,037
Long-term investment—restricted
1,510
1,069
Property and equipment, net
5,274
13,453
Operating lease assets
522
—
Total assets
$
649,601
$
315,559
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
14,770
$
8,308
Accrued expenses and other current
liabilities
26,884
13,709
Operating lease liabilities
415
539
Notes payable to related party
187
187
Total current liabilities
42,256
22,743
Notes payable to related party, net of
current portion
967
1,107
Operating lease liabilities, net of
current portion
107
11,347
Other long-term liabilities
718
381
Total liabilities
44,048
35,578
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; 51,043,912 shares and 37,676,760
shares issued and outstanding as of September 30, 2019 and December
31, 2018, respectively
510
377
Additional paid-in capital
1,025,745
575,327
Accumulated other comprehensive income
61
—
Accumulated deficit
(420,763
)
(295,723
)
Total stockholders’ equity
605,553
279,981
Total liabilities and stockholders’
equity
$
649,601
$
315,559
Deciphera Pharmaceuticals,
Inc.
Consolidated Statements of
Operations
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Revenues
$
—
$
—
$
25,000
$
—
Operating expenses:
Research and development
40,374
20,630
110,974
55,531
General and administrative
17,979
5,259
44,379
14,738
Total operating expenses
58,353
25,889
155,353
70,269
Loss from operations
(58,353
)
(25,889
)
(130,353
)
(70,269
)
Other income (expense):
Interest and other income, net
2,174
1,475
5,368
2,778
Interest expense
(17
)
(21
)
(55
)
(64
)
Total other income (expense), net
2,157
1,454
5,313
2,714
Net loss
$
(56,196
)
$
(24,435
)
$
(125,040
)
$
(67,555)
Net loss per share—basic and diluted
$
(1.28
)
$
(0.65
)
$
(3.12
)
$
(1.95)
Weighted average common shares
outstanding—basic and diluted
43,803,508
37,654,324
40,041,321
34,623,773
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191104005832/en/
Contacts: 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
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Apr 2023 to Apr 2024