On March 28, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the fourth quarter ended December 31, 2017 and provided an update on recent clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAR 28, 2018, View Source [SID1234525037]).
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"2017 was a highly productive year for Deciphera marked by significant progress with our lead program, DCC-2618. Data presented throughout the year continue to support our belief that DCC-2618 has the potential to serve as a much-needed therapy across multiple disease indications where treatment options for patients are limited," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We have entered 2018 with strong momentum, and we were pleased to announce the initiation of our pivotal Phase 3 INVICTUS study of DCC-2618 in fourth-line plus GIST, which, if successful, could serve as the basis for a New Drug Application (NDA). Pending regulatory feedback in the US and Europe, we expect to initiate an additional pivotal Phase 3 study in second-line GIST patients later this year, and we plan to report data emerging from our Phase 1 expansion study cohorts over the course of the year."
Dr. Taylor added, "Following our successful IPO last year, we have a strong balance sheet and believe we are well-positioned for continued success across our full clinical-stage pipeline, including DCC-3014 and rebastinib, and look forward to sharing our progress throughout the coming months."
Recent Clinical and Corporate Developments
DCC-2618
Announced the initiation of the Phase 3 INVICTUS pivotal study in January 2018 evaluating the safety and efficacy of DCC-2618, in heavily pretreated patients with advanced gastrointestinal stromal tumors (GIST). The Company expects to report top-line data from the study in 2019.
Received Orphan Drug Designation from the European Medicines Agency in November 2017 for the treatment of GIST.
Provided an enrollment update from the ongoing Phase 1 clinical trial of DCC-2618 at the Annual Meeting of The Connective Tissue Oncology Society in November 2017. As of October 31, 2017, a total of 125 patients had been dosed with DCC-2618 of which 109 were GIST patients, including 54 GIST patients in three expansion cohorts of the Phase 1 trial, which are enrolling second-line, third-line, and fourth-to-fifth line GIST patients, respectively.
Reported data on eight patients with malignant gliomas in the ongoing Phase 1 clinical trial of DCC-2618 at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in November 2017, including a 94% tumor reduction per RANO after 84 weeks (cycle 23, day 1) from a patient with glioblastoma multiforme (GBM) and amplification of three kinase genes, KIT, PDGFRα and VEGFR2.
Corporate Updates
Completed an initial public offering of 8,166,496 shares of its common stock in October 2017 at a public offering price of $17.00 per share, including shares pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Deciphera Pharmaceuticals received net proceeds of approximately $124.6 million from the offering, after deducting underwriting discounts, commissions and offering expenses.
Fourth Quarter 2017 Financial Results
Cash Position: As of December 31, 2017, Deciphera Pharmaceuticals reported cash and cash equivalents of $196.8 million.
R&D Expenses: Research and development expenses for the fourth quarter of 2017 were $15.7 million compared to $6.5 million for the same period in 2016. The increase was primarily due to an increase in spending on the DCC-2618 program of $6.3 million as a result of clinical trial costs related to the Phase 1 trial as well as start-up activities related to the pivotal Phase 3 trial in fourth-line GIST, and increased manufacturing and preclinical study costs to support the current and planned clinical trials. In addition, facility and personnel related costs increased an aggregate of $2.9 million as the result of an increase in costs associated with early-stage drug discovery programs and headcount. Personnel costs for each of the fourth quarters of 2017 and 2016 included non-cash share-based compensation expense of $0.5 million and $0.2 million, respectively.
G&A Expenses: General and administrative expenses for the fourth quarter of 2017 were $4.7 million, compared to $2.0 million for the same period in 2016. The increase was primarily due to an increase in non-cash share-based compensation, which was $2.3 million and $0.4 million for each of the fourth quarters of 2017 and 2016, respectively. In addition, legal and professional fees increased as a result of ongoing business activities and operations as a public company.
Net Loss: For the fourth quarter of 2017, Deciphera reported a net loss of $19.9 million, or $0.62 per share, compared with a net loss of $8.6 million, or $0.74 per share, for the same period in 2016.