On October 30, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Deciphera Pharmaceuticals, OCT 30, 2023, View Source [SID1234636440]).
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"QINLOCK achieved another record quarter of product revenue with continued strength in commercial demand," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "With the positive results of the MOTION Phase 3 study of vimseltinib we reported earlier today, we are now one step closer to becoming a company with multiple approved products. We look forward to engaging with regulatory authorities to advance vimseltinib toward approval and deliver it to the TGCT patients in need of an effective and well tolerated treatment option."
Third Quarter 2023 Highlights and Upcoming Milestones
QINLOCK (ripretinib)
Recorded $41.8 million in QINLOCK net product revenue in the third quarter of 2023, including $32.7 million in U.S. net product revenue and $9.1 million in international net product revenue, an increase of 29% compared to net product revenue of $32.3 million in the third quarter of 2022. In addition, QINLOCK generated $1.5 million in collaboration revenue including royalties and supply revenue with Zai Lab, the Company’s partner in Greater China.
Successfully launched QINLOCK in Italy for the treatment of fourth-line gastrointestinal stromal tumor (GIST).
Initiated the INSIGHT Phase 3 study by opening the first sites for enrollment comparing QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.
Vimseltinib
Announced positive top-line results from the MOTION pivotal Phase 3 study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT). The study met its primary endpoint in the intent-to-treat (ITT) population demonstrating statistically significant and clinically meaningful improvements in objective response rate (ORR) at Week 25 compared to placebo. In the ITT population, the ORR at Week 25 was 40% for the vimseltinib arm and 0% for the placebo arm (p-value <0.0001). In addition, the study met all key secondary endpoints demonstrating statistically significant and clinically meaningful improvements in tumor volume score (TVS), range of motion (ROM), physical function, stiffness, quality of life, and pain compared to placebo. In the ITT population, the ORR by TVS at Week 25 was 67% for the vimseltinib arm and 0% for the placebo arm (p<0.0001). Treatment with vimseltinib also demonstrated an improvement in ROM at Week 25 of 18.4% vs. a 3.8% improvement for placebo (p=0.0077). Treatment with vimseltinib was well-tolerated in patients with TGCT and the safety profile was consistent with previously disclosed data. There was no evidence of cholestatic hepatotoxicity.
Announced updated results from the Phase 1/2 study of vimseltinib as of a June 27, 2023 cutoff date demonstrating strong clinical benefit with best overall response rates of 72% (Phase 1) and 64% (Phase 2 Cohort A), a favorable long-term safety profile with no evidence of cholestatic hepatotoxicity and increasing median treatment duration of 25.1 months (Phase 1) and 21.0 months (Phase 2 Cohort A). Results from the Phase 1 portion of the study are being presented in an oral presentation and results from Cohorts A and B of the Phase 2 portion of the study are being presented in two poster presentations at the Connective Tissue Oncology Society 2023 Annual Meeting in Dublin, Ireland on November 1-4, 2023.
Expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second quarter of 2024 and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the third quarter of 2024.
DCC-3116
Enrollment is ongoing in combination escalation cohorts evaluating the potential first-in-class ULK inhibitor, DCC-3116, in combination with binimetinib, trametinib, sotorasib, encorafenib/cetuximab, and QINLOCK, designed to select recommended Phase 2 combination dosing for potential expansion cohorts.
DCC-3084
Expects to submit an Investigational New Drug (IND) application to the FDA for its pan-RAF inhibitor, DCC-3084, by year end 2023.
DCC-3009
Expects to submit an IND application to the FDA for its pan-KIT inhibitor, DCC-3009, in the first half of 2024.
Third Quarter 2023 Financial Results
Revenue: Total revenue for the third quarter of 2023 was $43.3 million, which includes $41.8 million of net product revenue of QINLOCK and $1.5 million of collaboration revenue compared to $36.0 million of total revenue, including $32.3 million of net product revenue of QINLOCK and $3.7 million of collaboration revenue, for the same period in 2022.
Cost of Sales: Cost of sales were $1.3 million in the third quarter of 2023 compared to cost of sales of $3.3 million for the third quarter of 2022. In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
R&D Expenses: Research and development expenses for the third quarter of 2023 were $62.5 million, compared to $47.5 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs for QINLOCK and clinical study costs related to the Phase 1/2 study of DCC-3116. Non-cash, stock-based compensation was $5.0 million and $5.3 million for the third quarters of 2023 and 2022, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the third quarter of 2023 were $33.3 million, compared to $30.0 million for the same period in 2022. The increase was primarily due to an increase in professional, consulting, and other expenses as well as personnel-related costs. Non-cash, stock-based compensation was $6.1 million and $7.1 million for the third quarters of 2023 and 2022, respectively.
Net Loss: For the third quarter of 2023, Deciphera reported a net loss of $49.6 million, or $0.58 per share, compared with a net loss of $43.0 million, or $0.55 per share, for the same period in 2022.
Cash Position: As of September 30, 2023, cash, cash equivalents, and marketable securities were $376.9 million, compared to $389.4 million as of June 30, 2023. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestones received under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2026.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIc2885b197da74145bfc30deb5fb11858. A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors & News" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.