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 first quarter ended March 31, 2018, and provided an update on recent clinical and corporate developments.
“Deciphera is off to a strong start in 2018, with data presented at last month’s AACR Annual Meeting adding to the growing body of research supporting the favorable safety and tolerability profile of DCC-2618, our lead product candidate, and its ability to inhibit a broad range of primary and secondary KIT mutations and primary PDGFRα mutations that arise in drug resistant gastrointestinal stromal tumor patients,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. “We look forward to presenting additional data from the Phase 1 DCC-2618 expansion study throughout the year, including at the upcoming ASCO meeting in June. Enrollment in our ongoing Phase 3 INVICTUS study in fourth-line and fourth-line plus GIST is proceeding on track, and we continue to expect the initiation of a second pivotal study in second-line GIST later this year.”
Clinical Programs
First 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.
Availability of Other Information About Deciphera Pharmaceuticals
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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 the potential for DCC-2618 to treat GIST; statements regarding the potential benefits to patients of DCC-2618; statements regarding plans and timelines for the clinical development of DCC-2618; and Deciphera Pharmaceuticals’ 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 Deciphera Pharmaceuticals’ drug candidates, including DCC-2618; Deciphera Pharmaceuticals‘ advancement of multiple early-stage efforts; Deciphera Pharmaceuticals’ ability to successfully demonstrate the efficacy and safety of its drug candidates; the preclinical and clinical results for Deciphera Pharmaceuticals’ drug candidates, which may not support further development of such drug candidates; and actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Deciphera Pharmaceuticals’ most recent quarterly report on Form 10-Q, and other filings that Deciphera Pharmaceuticals may make with the SEC in the future. Any forward-looking statements contained in this press release represent Deciphera Pharmaceuticals' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Deciphera Pharmaceuticals explicitly disclaims any obligation to update any forward-looking statements.
CONSOLIDATED BALANCE SHEETS | ||||||
(In thousands) | ||||||
(Unaudited) | ||||||
March 31, | December 31, | |||||
2018 | 2017 | |||||
Assets | ||||||
Cash and cash equivalents | $ | 179,873 | $ | 196,754 | ||
Prepaid expenses and other current assets | 1,241 | 1,428 | ||||
Property and equipment, net | 952 | 838 | ||||
Other assets | 75 | 75 | ||||
Total assets | $ | 182,141 | $ | 199,095 | ||
Liabilities and Stockholders' Equity | ||||||
Accounts payable, accrued expenses and other liabilities |
$ | 16,116 | $ | 13,641 | ||
Debt obligations | 1,435 | 1,481 | ||||
Total liabilities | 17,551 | 15,122 | ||||
Total stockholders' equity | 164,590 | 183,973 | ||||
Total liabilities and stockholders' equity | $ | 182,141 | $ | 199,095 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(In thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2018 | 2017 | |||||||
Revenue | $ | — | $ | — | ||||
Operating expenses: | ||||||||
Research and development | 16,925 | 5,659 | ||||||
General and administrative | 5,026 | 2,067 | ||||||
Total operating expenses | 21,951 | 7,726 | ||||||
Loss from operations | (21,951 | ) | (7,726 | ) | ||||
Other income (expense): | ||||||||
Interest expense | (22 | ) | (25 | ) | ||||
Interest and other income, net | 543 | 42 | ||||||
Total other income (expense), net | 521 | 17 | ||||||
Net loss and comprehensive loss | $ | (21,430 | ) | $ | (7,709 | ) | ||
Net loss per share—basic and diluted | $ | (0.66 | ) | $ | (0.66 | ) | ||
Weighted average common shares outstanding—basic and diluted | 32,594,074 | 11,626,287 |
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