On May 9, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the first quarter ended March 31, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 9, 2019, View Source [SID1234536053]).

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"Our team made significant progress during the first quarter of 2019 advancing our portfolio of novel drug candidates from our proprietary kinase switch control inhibitor platform," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We expect top-line data from our INVICTUS pivotal Phase 3 study of ripretinib for the treatment of fourth-line and fourth-line plus GIST patients in mid-2019 and pending favorable results from this study, we look forward to our first NDA submission and laying the groundwork for our first potential launch in the United States. In addition, we continue to advance key clinical trials of DCC-3014 and rebastinib and we expect to announce the initiation of IND-enabling preclinical studies for a new clinical candidate later this year."

Recent Clinical Updates

Ripretinib (DCC-2618)
Deciphera expects to report top-line data from the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and fourth-line plus gastrointestinal stromal tumor (GIST) patients in mid-2019. The Company is building its commercial and medical affairs capabilities to support the planned launch of ripretinib in the United States, if approved.
Deciphera is actively enrolling patients in the INTRIGUE Phase 3 clinical study comparing ripretinib to sunitinib for the treatment of second-line GIST patients who have previously received imatinib.
Rebastinib
Deciphera announced the initiation of an open-label, multicenter, Phase 1b/2 combination study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, with carboplatin in patients with advanced or metastatic solid tumors.
Deciphera completed enrollment of 40 patients in Part 1 of the Phase 1b/2 combination study of rebastinib with paclitaxel. In April 2019, Deciphera selected a 100 mg BID dose of rebastinib in combination with a weekly dose of 80 mg/m2 of paclitaxel as the recommended Phase 2 dose for Part 2 of the study, which is expected to begin enrollment later this quarter. The Company expects to report initial data from Part 1 of this study in the second half of 2019.
DCC-3014
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. The Company plans to present a review of further data from this Phase 1 study in the second half of 2019.
The Company is currently enrolling patients diagnosed with tenosynovial giant cell tumors (TGCT) in its expanded Phase 1 study evaluating DCC-3014.
Corporate Update

Deciphera announced the appointment of Steve Hoerter as President & Chief Executive Officer, effective March 18, 2019. Mr. Hoerter has served as a member of the Deciphera Board of Directors since May 2018. He joined the Company from Agios, where he was Chief Commercial Officer. He succeeded Michael D. Taylor, Ph.D., who retired as President & Chief Executive Officer of the Company. Dr. Taylor remains as senior advisor to the Company and a member of the Company’s Board of Directors.
First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, cash, cash equivalents and marketable securities were $262.3 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. Deciphera expects its current cash, cash equivalents and marketable securities will enable the Company to fund its operating, capital expenditures and debt service payments into the second half of 2020.
R&D Expenses: Research and development expenses for the first quarter of 2019 were $35.8 million, compared to $16.9 million for the same period in 2018. The increase was primarily due to an increase in spending on the ripretinib program of $10.7 million as a result of clinical trial costs related to the Phase 3 INTRIGUE study in second-line GIST, which the Company initiated in December 2018, and includes $5.3 million for comparator drug to be used in this trial. Expenses related to the rebastinib program increased $3.2 million, primarily due to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which the Company initiated in October 2018, and the second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin, which the Company initiated in January 2019. Personnel-related costs increased $3.7 million due primarily to increased headcount and stock-based compensation expense in research and development functions. Personnel-related costs for the first quarters of 2019 and 2018 included non-cash stock-based compensation expense of $1.7 million and $1.0 million, respectively. Facility-related and other costs included in unallocated expenses increased $1.7 million primarily due to increased costs incurred in connection with early-stage drug discovery programs and increased consulting fees.
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $13.2 million, compared to $5.0 million for the same period in 2018. The increase was primarily a result of increases in stock-based compensation expense and headcount in general and administrative functions. Non-cash stock-based compensation was $4.5 million and $1.1 million for the first quarters of 2019 and 2018, respectively. The increase in stock-based compensation expense was primarily related to the modification of stock options pursuant to the transition agreement with the Company’s former President and Chief Executive Officer and additional employee stock options. In addition, professional and consultant fees increased due to various advisory fees, including those related to commercialization preparedness.
Net Loss: For the first quarter of 2019, Deciphera reported a net loss of $47.4 million, or $1.25 per share, compared with a net loss of $21.4 million, or $0.66 per share, for the same period in 2018.