Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced financial results for the second quarter ended June 30, 2018, and provided an update on recent clinical and corporate developments.
“The first half of 2018 was marked by exceptional progress, with data presented at the ASCO Annual Meeting in June demonstrating the potential of DCC-2618, our lead product candidate, in second- and third-line GIST patients, and supporting the planned Phase 3 trial, INTRIGUE, in second-line GIST patients,“ said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. “In addition, we observed continued robust clinical activity in heavily pretreated patients. For the balance of this year, we look forward to presenting additional data from the Phase 1 DCC-2618 study, as well as to the planned initiation of the INTRIGUE study.”
Dr. Taylor continued, “In addition to our clinical progress, we also strengthened both our leadership team and balance sheet, and we are well positioned to advance our pipeline of novel kinase switch control inhibitors toward key milestones.”
Clinical Programs
Corporate Updates
Second Quarter 2018 Financial Results
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling 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, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.
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 the anticipated use of proceeds from the offering, the potential for our drug candidates to treat cancers and our strategy, business plans and focus. 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 trials or the development of our drug candidates, including DCC-2618, our advancement of multiple early-stage efforts, our ability to successfully demonstrate the efficacy and safety of our drug candidates, the preclinical and clinical results for our drug candidates, which may not support further development of such drug candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and other risks identified in our SEC filings, including our Prospectus filed with the SEC on June 7, 2018, as amended, our Annual Report on Form 10-K for the year ended December 31, 2017, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, 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 | ||||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||||
(In thousands) | ||||||||||
(Unaudited) | ||||||||||
June 30, 2018 | December 31, 2017 | |||||||||
Assets | ||||||||||
Cash and cash equivalents | $ | 346,527 | $ | 196,754 | ||||||
Prepaid expenses and other current assets | 2,221 | 1,428 | ||||||||
Long-term investment restricted | 1,069 | — | ||||||||
Property and equipment, net (1) | 18,264 | 838 | ||||||||
Other assets | 75 | 75 | ||||||||
Total assets | $ | 368,156 | $ | 199,095 | ||||||
Liabilities and Stockholders' Equity | ||||||||||
Accounts payable, accrued expenses and other
liabilities |
$ | 18,775 | $ | 13,641 | ||||||
Debt obligations | 1,388 | 1,481 | ||||||||
Lease liability, net of current portion(1) | 16,896 | — | ||||||||
Total liabilities | 37,059 | 15,122 | ||||||||
Total stockholders' equity | 331,097 | 183,973 | ||||||||
Total liabilities and stockholders' equity | $ | 368,156 | $ | 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 beacuse of certain provisions within the lease. As a result, we recorded a $17.0 million build-to-suit asset in property and equipment and a corresponding build-to-suit facility lease financing obligation. |
Deciphera | ||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 17,976 | 8,446 | 34,901 | 14,105 | ||||||||||||||||
General and administrative | 4,453 | 2,244 | 9,479 | 4,311 | ||||||||||||||||
Total operating expenses | 22,429 | 10,690 | 44,380 | 18,416 | ||||||||||||||||
Loss from operations | (22,429 | ) | (10,690 | ) | (44,380 | ) | (18,416 | ) | ||||||||||||
Other income (expense): | ||||||||||||||||||||
Interest expense | (21 | ) | (24 | ) | (43 | ) | (49 | ) | ||||||||||||
Interest and other income, net | 760 | 89 | 1,303 | 131 | ||||||||||||||||
Total other income (expense), net | 739 | 65 | 1,260 | 82 | ||||||||||||||||
Net loss and comprehensive loss | $ | (21,690 | ) | $ | (10,625 | ) | $ | (43,120 | ) | $ | (18,334 | ) | ||||||||
Net loss per share—basic and diluted | $ | (0.65 | ) | $ | (0.91 | ) | $ | (1.30 | ) | $ | (1.58 | ) | ||||||||
Weighted average common shares outstanding—basic and diluted | 33,567,314 | 11,626,287 | 33,083,383 | 11,626,287 | ||||||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180807005729/en/
Media:
The Yates Network
Gina Nugent, 617-460-3579
[email protected]
or
Investor
Relations:
Argot Partners
Laura Perry, 212-600-1902
[email protected]
or
Sam
Martin, 212-600-1902
[email protected]
or
Deciphera
Pharmaceuticals, Inc.
Christopher J. Morl, 781-209-6418
Chief
Business Officer
[email protected]