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 third quarter ended September 30, 2018 and provided an update on clinical and corporate developments.
“Recent clinical and corporate achievements support Deciphera’s transition to a late-stage, pre-commercial company,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. “Data presented at ESMO have bolstered our confidence in DCC-2618’s potential to transform the current treatment paradigm for GIST patients. As we approach the completion of enrollment for our pivotal Phase 3 INVICTUS study in the coming weeks, we look forward to the data readout from that study expected next year. In addition, we remain on track to initiate our Phase 3 INTRIGUE study later this year. We are building our commercial capabilities for DCC-2618 in the United States and are continuing to invest in our clinical-stage pipeline, with the recent initiation of our Phase 1b/2 clinical study of our investigational agent rebastinib in combination with paclitaxel.”
Clinical Programs
Corporate Updates
“On behalf of the management team and board of directors, I want to thank Oliver for his many contributions to Deciphera over the past four and a half years,” said Dr. Taylor. “During his tenure, Oliver was instrumental in developing DCC-2618 from a promising preclinical asset into a robust late-stage clinical program with a pivotal Phase 3 study expected to read out in 2019, a second Phase 3 study that is planned to initiate soon and a series of expansion studies in multiple indications. We wish Oliver all the best in his future endeavors.”
“It has been a privilege to be a part of Deciphera’s successful growth since 2014 led by the rapid development of DCC-2618,” said Dr. Rosen. “I am proud of the progress the Company has made in translating the promise of its kinase switch control platform into an exciting pipeline of clinical-stage drug candidates designed to provide cancer patients with novel therapies that address unmet medical needs.”
Third 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 planned initiation of our Phase 3 INTRIGUE study, expectations on the timing of updates on and data from our Phase 3 INVICTUS study and our Phase 1 DCC-3014 study, cash guidance, the potential for our drug candidates to treat cancers and our strategy, our commercial readiness plan, our business plans and our 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 studies or the development of our drug candidates, including DCC-2618, 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 SEC filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 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) | |||||||||
September 30, 2018 | December 31, 2017 | ||||||||
Assets | |||||||||
Cash and cash equivalents | $ | 320,875 | $ | 196,754 | |||||
Prepaid expenses and other current assets | 4,734 | 1,428 | |||||||
Long-term investment restricted | 1,069 | — | |||||||
Property and equipment, net (1) | 19,238 | 838 | |||||||
Other assets | - | 75 | |||||||
Total assets | $ | 345,916 | $ | 199,095 | |||||
Liabilities and Stockholders' Equity | |||||||||
Accounts payable, accrued expenses and other liabilities
|
$ | 17,669 | $ | 13,641 | |||||
Debt obligations | 1,341 | 1,481 | |||||||
Lease liability, net of current portion(1) | 17,538 | — | |||||||
Total liabilities | 36,548 | 15,122 | |||||||
Total stockholders' equity | 309,368 | 183,973 | |||||||
Total liabilities and stockholders' equity | $ | 345,916 | $ | 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 $17.9 million build-to-suit asset in property and equipment and a corresponding build-to-suit facility lease financing obligation as of September 30, 2018. |
Deciphera | |||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
Operating expenses: | |||||||||||||||||
Research and development | 20,630 | 9,751 | 55,531 | 23,856 | |||||||||||||
General and administrative | 5,259 | 2,430 | 14,738 | 6,741 | |||||||||||||
Total operating expenses | 25,889 | 12,181 | 70,269 | 30,597 | |||||||||||||
Loss from operations | (25,889) | (12,181) | (70,269) | (30,597) | |||||||||||||
Other income (expense): | |||||||||||||||||
Interest expense | (21) | (23) | (64) | (72) | |||||||||||||
Interest and other income, net | 1,475 | 166 | 2,778 | 297 | |||||||||||||
Total other income (expense), net | 1,454 | 143 | 2,714 | 225 | |||||||||||||
Net loss and comprehensive loss | $ | (24,435) | $ | (12,038) | $ | (67,555) | $ | (30,372) | |||||||||
Net loss per share—basic and diluted | $ | (0.65) | $ | (1.04) | $ | (1.95) | $ | (2.61) | |||||||||
Weighted average common shares outstanding—basic and diluted | 37,654,324 | 11,626,287 | 34,623,773 | 11,626,287 | |||||||||||||
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