Press Release Details
Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Year-end 2018 Financial Results
- Enrollment Completed in INVICTUS Pivotal Phase 3 Clinical Study in Fourth-line and Fourth-line Plus GIST; Top-line Data Expected in Mid-2019 -
- INTRIGUE Pivotal Phase 3 Clinical Study Initiated in Second-line Patients with GIST -
- Ended 2018 with Cash and Cash Equivalents of
“2018 was punctuated by significant progress in advancing our diverse
pipeline of targeted drug candidates,” said
Dr. Taylor continued, “As we near the reporting of top-line data from
the INVICTUS study, expected in mid-2019, we are actively working to
build out our commercial capabilities for ripretinib’s potential launch
Recent Clinical Updates
- Ripretinib (DCC-2618)
Deciphera announced completion of enrollment in the INVICTUS
pivotal Phase 3 clinical study evaluating the safety and efficacy
of ripretinib (DCC-2618), the Company’s investigational
broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and
fourth-line plus gastrointestinal stromal tumor (GIST) patients.
The Company expects to report top-line data from this study in
mid-2019 and is building commercial capabilities to support the
planned launch of ripretinib in
the United States, if approved.
- Deciphera announced the initiation of its INTRIGUE pivotal Phase 3 clinical study evaluating the efficacy and tolerability of ripretinib compared to sunitinib in second-line GIST patients.
European Society of Medical Oncology( ESMO) 2018 Congressin October, Deciphera presented updated preliminary Phase 1 clinical study results of ripretinib in patients with GIST that the Company believes demonstrate the potential of ripretinib to provide improved, durable clinical benefit for GIST patients from second-line through fourth-line-plus. These data were also presented at the Annual Meeting of the Connective Tissue Oncology Society(CTOS) in November 2018.
- Deciphera expanded the ongoing Phase 1 study of ripretinib to include additional cohorts for patients with various solid tumors, including melanoma, non-small cell lung cancer, germ cell cancer, penile cancer, soft tissue sarcoma, and GIST or other solid tumor patients with renal impairment.
During a poster session at the EORTC-NCI-AACR Molecular Targets
and Cancer Therapeutics Symposium in
November 2018, Deciphera presented preclinical data on the effects of the combination of ripretinib and MAPK pathway inhibitors on cell death and apoptosis in cellular assays of GIST and mastocytosis.
- Deciphera announced completion of enrollment in the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib (DCC-2618), the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and fourth-line plus gastrointestinal stromal tumor (GIST) patients. The Company expects to report top-line data from this study in mid-2019 and is building commercial capabilities to support the planned launch of ripretinib in
Deciphera recently announced the initiation of two open-label,
multicenter, Phase 1b/2 combination studies of rebastinib, the
Company’s investigational small molecule switch control inhibitor
of TIE2 kinase:
- Phase 1b/2 study in combination with carboplatin in patients with advanced or metastatic solid tumors.
- Phase 1b/2 study in combination with paclitaxel in patients with advanced or metastatic solid tumors. The Company expects to report initial data from this study in 2019.
- Deciphera recently announced the initiation of two open-label, multicenter, Phase 1b/2 combination studies of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase:
- Deciphera announced positive, preliminary, top-line 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. A review of further data from this Phase 1 study is planned to be presented at a medical meeting in 2019.
- The Company also announced a plan to expand the Phase 1 study to evaluate DCC-3014 in patients diagnosed with Tenosynovial Giant Cell Tumors (TGCT).
Earlier this month, Deciphera announced the appointment of
Steve Hoerteras President & Chief Executive Officer, effective March 18, 2019. Mr. Hoerter, who currently serves as a member of the Deciphera Board of Directors, joins the Company from Agios, where he was Chief Commercial Officer. He will succeed Dr. Taylor, who will retire as President & Chief Executive Officer of the Company. Dr. Taylor will be available to support the transition and will remain as a member of the Company’s Board of Directors.
Fourth Quarter 2018 Financial Results
- Cash Position: As of
December 31, 2018, cash and cash equivalents were $293.8 million, compared to cash and cash equivalents of $196.8 millionas of December 31, 2017. This increase was primarily related to proceeds obtained from the Company’s June 2018underwritten public offering, offset by cash used in operating activities. We expect our current cash and cash equivalents will enable us to fund our operating and capital expenditures and debt service payments into the second half of 2020.
- R&D Expenses: Research and development expenses for the
fourth quarter of 2018 were
$27.4 million, compared to $15.7 millionfor the same period in 2017. The increase was primarily due to an increase in spending on the ripretinib (DCC-2618) program of $5.8 millionas a result of clinical trial start-up activities related to the Phase 3 INTRIGUE study in second-line GIST, which the Company initiated in December 2018. Expenses related to the rebastinib program increased $1.8 million, primarily due to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which the Company initiated in October 2018, and start-up activities related to the second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin, which the Company initiated in January 2019. Personnel-related costs increased $2.5 milliondue primarily to increased headcount in our research and development functions. Personnel-related costs for the fourth quarters of 2018 and 2017 included non-cash stock-based compensation expense of $1.0 millionand $0.5 million, respectively. Facility-related and other costs included in unallocated expenses increased $2.0 millionprimarily due to increased costs incurred in connection with our early-stage drug discovery programs.
- G&A Expenses: General and administrative expenses for the
fourth quarter of 2018 were
$6.5 million, compared to $4.7 millionfor the same period in 2017. The increase was primarily due to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company. Facility-related and other costs increased due to insurance costs and higher rent expense related to the Company’s new lease. Non-cash stock-based compensation was $1.8 millionand $2.3 millionfor the fourth quarters of 2018 and 2017, respectively.
- Net Loss: For the fourth quarter of 2018, Deciphera reported a
net loss of
$32.3 million, or $0.86per share, compared with a net loss of $19.9 million, or $0.62per share, for the same period in 2017.
Investors and others should note that
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 study, the potential for ripretinib (DCC-2618)
to provide clinical benefit and treat cancers such as GIST and other
possible indications, expectations for and the timing of data from our
clinical trials with our investigational agent rebastinib, including,
without limitation, our study of rebastinib in combination with
carboplatin and in combination with paclitaxel, and the potential for
rebastinib, alone or in combination with other agents or chemotherapy to
treat cancers, expectations for presenting data from our studies of
DCC-3014 at a medical meeting, our plans to add TGCT patients to our
ongoing Phase 1 trial for DCC-3014, expectations regarding cash
guidance, launch preparations for a possible commercial launch of
ripretinib in fourth-line and fourth-line plus GIST, if approved, and
expectations regarding designating a new clinical candidate and
IND-enabling studies to support such candidate. 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, and DCC-3014, 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 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
|CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||293,764||$||196,754|
Prepaid expenses and other current assets
Long-term investment restricted
|Property and equipment, net (1)||13,453||838|
Liabilities and Stockholders' Equity
Accounts payable, accrued expenses and other liabilities
Lease liability, net of current portion(1)
|Total stockholders' equity||279,981||183,973|
|Total liabilities and stockholders' equity||$||315,559||$||199,095|
|(1) In May 2018, we entered into a lease for office space in Waltham, MA. We are not the legal owners of the leased space, however, we are deemed to be the owner during the construction phase because of certain provisions within the lease. As a result, we recorded a $11.9 million build-to-suit asset in property and equipment and a corresponding build-to-suit facility lease financing obligation as of December 31, 2018.|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(In thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Research and development||27,356||15,658||82,887||39,514|
|General and administrative||6,474||4,680||21,212||11,421|
|Total operating expenses||33,830||20,338||104,099||50,935|
|Loss from operations||(33,830||)||(20,338||)||(104,099||)||(50,935||)|
|Other income (expense):|
|Interest and other income, net||1,551||449||4,329||746|
|Total other income (expense), net||1,531||426||4,245||651|
|Net loss and comprehensive loss||$||(32,299||)||$||(19,912||)||$||(99,854||)||$||(50,284||)|
|Net loss per share—basic and diluted||$||(0.86||)||$||(0.62||)||$||(2.82||)||$||(2.99||)|
|Weighted average common shares outstanding—basic and diluted||37,665,599||32,121,428||35,390,480||16,792,179|
Gina Nugent, The Yates Network
Laura Perry or Sam Martin, Argot Partners
Laura@argotpartners.com or Sam@argotpartners.com
Christopher J. Morl, Chief Business Officer
Deciphera Pharmaceuticals, Inc.