On May 5, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2020 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 5, 2020, View Source [SID1234557019]).

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"Work is underway across the company as we prepare for the potential approval and launch of ripretinib later this year," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We continue to make progress against our planned 2020 company milestones, including advancing our broad clinical-stage pipeline and completing enrollment in the ongoing, pivotal Phase 3 INTRIGUE study of ripretinib in second-line GIST."

Mr. Hoerter continued, "In these unprecedented times, we remain steadfast in our mission to bring important new medicines to patients for the treatment of cancer. Our employees have done a tremendous job adapting to the COVID-19 related challenges we are facing as a company, and as an industry, to carry out this mission. We are continuing to actively evaluate the potential impact of the pandemic on our business and proactively explore and implement mitigation measures."

COVID-19 Business Update

Deciphera is continuously assessing and adapting its business operations in an effort to mitigate interruption from the COVID-19 pandemic on its clinical programs, research efforts and other business activities and to ensure the well-being of its employees, as well as the physicians and patients participating in its clinical studies. At this stage of the COVID-19 pandemic, the operating environment remains fluid and uncertain. The full impact on the Company and its business is not known at this time, and the Company’s outlook assumes the COVID-19 impact on its business will be shorter-term over the next few months and not prolonged.

Clinical Trials and Research and Development Efforts

The Company is monitoring risks associated with potential interruptions to its clinical studies and is in frequent communication with clinical study sites and contract research organizations to address the individual circumstances at each site. At this stage, Deciphera can confirm previously announced milestone timing guidance:
Deciphera continues to believe that it will be able to achieve full enrollment in its Phase 3 INTRIGUE study in second-line gastrointestinal stromal tumor (GIST) patients in the second half of 2020.
The Company also continues to believe it will be able to present updated clinical data, select a recommended Phase 2 dose and open the expansion cohort for its DCC-3014 program in tenosynovial giant cell tumor patients in the second half of 2020. The Company also continues to expect to present updated clinical data from its rebastinib program in the second half of 2020.
The Company is continuing its discovery research, preclinical efforts and early development activities, and expects to file an IND for DCC-3116, its ULK kinase inhibitor, in the second half of 2020.
Drug Supply

Deciphera has commercial drug supply sufficient to support the potential launch of ripretinib in fourth-line GIST. Based on current inventories and supply plans, the Company does not anticipate any COVID-19-related supply interruptions to its clinical programs at this time.
Commercial Activities

In preparation for a potential launch of ripretinib, the Company has been preparing for the possible need to launch and promote using a virtual interaction model, if necessary.
Recent Program Highlights

Ripretinib
Today announced that two posters containing results from the Company’s pivotal Phase 3 INVICTUS study will be featured at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29-31, 2020 in a virtual format. The posters will be made available on-demand via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29, 2020 at 8:00 AM ET. Titles of the poster presentations can be found below:
"Quality of life (QoL) and self-reported function with ripretinib in ≥4th-line therapy for patients with gastrointestinal stromal tumors (GIST): Analyses from INVICTUS"
"Safety profile of ripretinib, including impact of alopecia and palmar-plantar erythrodysesthesia syndrome (PPES) on patient reported outcomes (PROs), in ≥4th-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS"
Today announced that a poster containing health economics and outcomes research regarding what constitutes meaningful change for patients in gastrointestinal-related cancer will be featured at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting, being held May 18-20, 2020 in a virtual format in a poster session on Tuesday, May 19, 2020 at 3:30-7:00 PM ET. The title of the poster presentation can be found below and a copy of the abstract can be found online here.
"Thresholds for meaningful change for the EQ-5D VAS and EORTC QLQ-C30 physical and role functioning scale in gastrointestinal-related cancer"
As previously announced, the New Drug Application (NDA) seeking approval for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib, is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020. The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review pilot program. Commercial preparations are currently underway to support the potential approval and launch of ripretinib.
Rebastinib
Today announced that the endometrial and ovarian cancer cohorts in Part 2 of the Phase 1b/2 study of rebastinib in combination with paclitaxel advanced into the second stage of the Simon two-stage design based on achievement of more than 4 responses in each cohort.
A poster containing data from the endometrial cancer cohort in Part 2 of the Company’s ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. The poster will be made available on-demand via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29 at 8:00 AM ET. The title of the poster presentation can be found below:
"An open-label, multicenter, phase 1b/2 study of rebastinib in combination with paclitaxel in a dose expansion cohort to assess safety and preliminary efficacy in patients with advanced or metastatic endometrial cancer"
Additional updates announced today from the Company’s rebastinib program include:
The addition of a carcinosarcoma cohort in Part 2 of the Phase 1b/2 study of rebastinib in combination with paclitaxel based on the clinical activity observed in Part 1 of the study.
In the Phase 1b/2 study of rebastinib in combination with carboplatin, Part 2 of the study is continuing to enroll patients with breast cancer, ovarian cancer, and mesothelioma at the recommended Phase 2 dose of 50 mg twice daily (BID), which was reduced from 100 mg BID based on the observed frequency of muscular weakness in preliminary data from the ongoing Part 2 portion of the study.
First Quarter 2020 Financial Results

Cash Position: As of March 31, 2020, cash, cash equivalents and marketable securities were $691.5 million, compared to $579.6 million as of December 31, 2019. The increase was primarily due to the Company’s follow-on public offering in February 2020 that raised net proceeds of $188.4 million. Deciphera expects its current cash, cash equivalents and marketable securities will enable the Company to fund its operating and capital expenditures into the second half of 2022.
R&D Expenses: Research and development expenses for the first quarter of 2020 were $51.4 million, compared to $35.8 million for the same period in 2019. The increase was primarily due to personnel costs, clinical trial costs related to ripretinib, DCC-3014, and rebastinib, and preclinical costs related to DCC-3116. Non-cash stock-based compensation was $3.3 million and $1.7 million for the first quarters of 2020 and 2019, respectively.
SG&A Expenses: Selling, general and administrative expenses for the first quarter of 2020 were $23.9 million, compared to $13.2 million for the same period in 2019. The increase was primarily a result of personnel costs as well as external spend associated with commercial readiness, increased expenses incurred in connection with our new headquarters that commenced in October 2019, and technology related costs to support the growth of the business. Non-cash stock-based compensation was $3.7 million and $4.5 million for the first quarters of 2020 and 2019, respectively.
Net Loss: For the first quarter of 2020, Deciphera reported a net loss of $72.8 million, or $1.36 per share, compared with a net loss of $47.4 million, or $1.25 per share, for the same period in 2019. The increase in net loss was primarily related to increases in R&D and SG&A expenses, as discussed above.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 5, 2020 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 5381739. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.