On August 3, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended June 30, 2021 and provided a corporate update (Press release, Deciphera Pharmaceuticals, AUG 3, 2021, View Source [SID1234585603]).

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"We made significant progress against our goals in the first half of the year and we look forward to carrying this momentum through the rest of 2021," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Building on the successful launch of QINLOCK for fourth-line GIST in the U.S., this best-in-class medicine has now been approved in China and Hong Kong and we expect approval from the European Medicines Agency later this year. In the fourth quarter, we look forward to reporting top-line data from the INTRIGUE Phase 3 study in second-line GIST. In addition, we expect to report updated data from the vimseltinib and rebastinib programs at the upcoming ESMO (Free ESMO Whitepaper) congress as well as finalize pivotal development plans for both programs later this year."

Mr. Hoerter continued, "We also recently achieved a key milestone treating the first patient in our Phase 1 trial of DCC-3116, a first-in-class ULK kinase inhibitor designed to address mutant RAS and RAF cancers through the inhibition of autophagy."

Second Quarter 2021 Highlights and Upcoming Milestones

QINLOCK (ripretinib)
Recorded $22.0 million in QINLOCK net product revenue in the second quarter of 2021, including $20.7 million in U.S. sales of QINLOCK and $1.3 million in ex-U.S. sales of QINLOCK.
Launched commercially in China, via our collaboration with Zai, for the treatment of adult patients with fourth-line GIST.
Presented data for QINLOCK patients undergoing intra-patient dose escalation after disease progression in the INVICTUS Phase 3 study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Expects to announce top-line results from the INTRIGUE Phase 3 study in the fourth quarter of 2021.
Expects potential approval from the European Medicines Agency (EMA) for QINLOCK in the fourth quarter of 2021.
Expects to initiate a Phase 1b/2 study of QINLOCK in combination with binimetinib, a commercially available MEK inhibitor, in post-imatinib GIST patients in the fourth quarter of 2021.
Vimseltinib
Expects to present updated data from the ongoing Phase 1/2 study in patients with TGCT at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September.
Plans to finalize the pivotal development plan for vimseltinib in patients with TGCT in the second half of 2021.
Rebastinib
Expects to present updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the platinum-resistant ovarian cancer cohort at the ESMO (Free ESMO Whitepaper) Congress 2021 in September.
Plans to finalize the pivotal development plan for rebastinib in combination with paclitaxel in the second half of 2021.
DCC-3116
Initiated the Phase 1 study of DCC-3116 in June 2021. The study is evaluating DCC-3116 as a single agent and in combination with trametinib in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Currently, expansion cohorts are planned in patients with advanced or metastatic pancreatic ductal adenocarcinoma with KRAS or BRAF mutations, non-small cell lung cancer with KRAS, NRAS, or BRAF mutations, colorectal cancer with KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF mutations.
Expects to present preclinical data on DCC-3116 in combination with approved, targeted oncology agents in multiple tumor models at an upcoming medical meeting in the second half of 2021.
Recent Corporate Updates

Today announced an agreement with Sprint Bioscience to exclusively in-license worldwide rights to a research-stage program targeting VPS34, a key kinase in the autophagy pathway, strengthening the company’s leading position in the development of regulators of autophagy for the potential treatment of cancer. VPS34 is involved in the endosomal trafficking of cellular cargo targeted for lysosomal degradation in cancer cells. Targeting VPS34 may provide an additional approach to regulating autophagy that is complementary to inhibition of ULK kinase by blocking VPS34-mediated immunosuppression in tumors.
Upcoming Scientific Congress Presentations

ESMO Congress 2021, September 16-21. The following will be e-poster presentations and will be available on-demand via the ESMO (Free ESMO Whitepaper) Congress 2021 website beginning on September 16 at 8:30 AM CEST / 2:30 AM EST.
QINLOCK
Ripretinib as ≥4th-line treatment in patients with advanced gastrointestinal stromal tumor: long-term update from the Phase 3 INVICTUS study.
Phase 1 study of ripretinib, a broad-spectrum KIT and PDGFRA inhibitor, in patients with KIT-mutated or KIT-amplified melanoma.
Vimseltinib
Safety and preliminary efficacy of vimseltinib in tenosynovial giant cell tumor (TGCT).
Rebastinib
A Phase 1b/2 study of rebastinib and paclitaxel in advanced/metastatic platinum-resistant ovarian cancer.
Second Quarter Financial Results

Revenue: Total revenue for the second quarter of 2021 was $23.6 million, which includes $22.0 million of net product revenue from sales of QINLOCK and $1.5 million of collaboration revenue comprised of commercial supply and royalty revenue under our license agreement with Zai Lab. Total revenue for the second quarter of 2020 was $7.1 million, which includes $4.8 million of net product revenue from sales of QINLOCK and $2.3 million of collaboration revenue.
Cost of Sales: Cost of sales was $1.3 million in the second quarter of 2021, which includes $0.4 million in cost of net product revenue for QINLOCK and $0.9 million in cost of collaboration revenue. Cost of sales was less than $0.1 million for the second quarter of 2020. Cost of net product sales is not expected to be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.
R&D Expenses: Research and development expenses for the second quarter were $60.0 million, compared to $46.1 million for the same period in 2020. The increase was primarily due to personnel and preclinical costs and an increase in clinical trial expenses related to our ongoing Phase 1/2 study of vimseltinib. Non-cash, stock-based compensation was $5.6 million and $5.3 million for the second quarters of 2021 and 2020, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the second quarter of 2021 were $32.8 million, compared to $29.9 million for the same period in 2020. The increase was primarily due to personnel costs as well as external spend related to professional fees, including those associated with establishing a targeted commercial infrastructure in key European markets to support a potential launch of QINLOCK in Europe, if approved. Non-cash, stock-based compensation was $6.8 million and $5.3 million for the first quarters of 2021 and 2020, respectively.
Net Loss: For the second quarter of 2021, Deciphera reported a net loss of $70.4 million, or $1.21 per share, compared with a net loss of $67.2 million, or $1.20 per share, for the same period in 2020. The increase in net loss was primarily a result of increased R&D expenses, as described above, partially offset by a full quarter of product sales during the second quarter of 2021.
Cash Position: As of June 30, 2021, cash, cash equivalents, and marketable securities were $451.0 million, compared to $502.2 million as of March 31, 2021. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product and royalty revenues, excluding any potential future milestone payments or other payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into the first half of 2023.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, August 3, 2021 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 9943767. 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.