On August 9, 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 second quarter ended June 30, 2023 and provided a corporate update (Press release, Deciphera Pharmaceuticals, AUG 9, 2023, View Source [SID1234634063]).
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"QINLOCK delivered record performance in the second quarter based on continued growth in the U.S. and around the world. Moving into a significant second half of 2023, we are looking forward to the top-line results from the MOTION study of vimseltinib in patients with tenosynovial giant cell tumor (TGCT), which has the potential to become our second approved medicine," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "Additionally, we have opened the first sites for INSIGHT, the pivotal Phase 3 study of QINLOCK versus sunitinib in second-line gastrointestinal stromal tumor (GIST) patients with mutations in KIT exon 11 and 17 or 18 and for additional combination cohorts of our ULK inhibitor DCC-3116, one in combination with QINLOCK and another in combination with encorafenib and cetuximab. We are on track to submit an Investigational New Drug application to the FDA for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the fourth quarter."
Mr. Hoerter continued, "We are proud of the significant progress across both our early-stage and late-stage programs that we have already achieved in the first half of 2023. In addition to the INTRIGUE Phase 3 ctDNA analysis presented at the ASCO (Free ASCO Whitepaper) Plenary Session in the first quarter, we also presented eight poster presentations at AACR (Free AACR Whitepaper) that showcased the depth and breadth of our kinase switch-control research engine along with the nomination of our newest development candidate, DCC-3009, a potential best-in-class pan-KIT inhibitor. At ASCO (Free ASCO Whitepaper) in June, we had one encore presentation of our INTRIGUE Phase 3 ctDNA analysis and three poster presentations, including overall survival and long-term safety data from the INTRIGUE Phase 3 study of QINLOCK. Finally, on behalf of everyone at Deciphera, I would like to thank Dan Flynn for his dedication to Deciphera’s founding vision of improving the lives of people with cancer, and for trailblazing the innovations that have made all these advancements possible. We are excited to build upon this foundation with Dash Dhanak as our new Chief Scientific Officer."
Second Quarter 2023 Highlights and Upcoming Milestones
QINLOCK (ripretinib)
Recorded $37.3 million in QINLOCK net product revenue in the second quarter of 2023, including $28.9 million in U.S. net product revenue and $8.4 million in international net product revenue, an increase of 18% compared to net product revenue of $31.5 million in the second quarter of 2022. In addition, QINLOCK generated $1.0 million in collaboration revenue driven by royalties for sales of QINLOCK by Zai Lab, the Company’s partner in Greater China.
Presented one encore presentation and three poster presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting featuring an update from the ASCO (Free ASCO Whitepaper) Plenary Series Session presenting circulating tumor DNA (ctDNA) analysis results from the INTRIGUE Phase 3 study of QINLOCK, updated overall survival (OS) and long-term safety results, and outcome data on patients without detectable ctDNA at baseline from the INTRIGUE Phase 3 study of QINLOCK in patients with advanced GIST previously treated with imatinib, and information on the study design for the upcoming INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations.
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.
Completed reimbursement negotiations process in Italy; launch expected shortly. Completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) in April 2023, which will enable broad access to fourth-line GIST patients in Canada.
Received regulatory approval for QINLOCK in Singapore in May 2023.
Vimseltinib
Expects to announce 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) in the fourth quarter of 2023.
Expects to present updated data from the Phase 1/2 study of vimseltinib in the fourth quarter of 2023.
DCC-3116
Presented preclinical data on combinations with DCC-3116, an investigational, orally administered, selective, and potent switch-control kinase inhibitor of ULK1/2-mediated autophagy, at the American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting 2023, including preclinical models in combination with QINLOCK in GIST models and with encorafenib and cetuximab in colorectal cancer (CRC) models.
Completed the Phase 1 single agent dose escalation (n=28) of DCC-3116 at doses from 50 mg – 300 mg BID; no maximum tolerated dose was reached with one dose limiting toxicity (DLT) observed (Grade 3 increased ALT at 100 mg BID) and no treatment-related serious adverse events observed.
As of August 4, 2023, combination dose escalations of DCC-3116 are ongoing with MEK inhibitors trametinib (n=11) and binimetinib (n=10), and with KRAS G12C inhibitor, sotorasib (n=6) in patients with advanced solid tumors. Evaluation of trametinib and binimetinib cohorts in combination with 50 mg QD of DCC-3116 is ongoing after dose reduction from 50 mg BID based on observed DLTs for the trametinib combination (Grade 3 skin rash and diarrhea in one patient and Grade 3 diarrhea in one patient) and the binimetinib combination (Grade 3 decreased ejection fraction in one patient and Grade 2 blurred vision in one patient).
Evaluation of sotorasib cohort in combination with 200 mg QD of DCC-3116 is ongoing; combination of sotorasib and DCC-3116 at 50 mg BID was well tolerated with no DLTs observed in three evaluable patients.
Initiated new combination escalation cohorts with the first site open for enrollment evaluating DCC-3116 (100 mg QD starting dose) in combination with QINLOCK in patients with GIST and in combination with encorafenib and cetuximab in patients with CRC. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the study and Pfizer will supply encorafenib at no cost.
DCC-3084
Presented preclinical data for DCC-3084, a pan-RAF inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated a potential best-in-class profile based on its inhibition of Class I, II, and III BRAF mutations, and BRAF fusions, and optimized pharmaceutical properties.
Expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for DCC-3084 in the fourth quarter of 2023.
DCC-3009
Presented preclinical data for DCC-3009, a potential best-in-class pan-KIT inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated its ability to potently and selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST models, spanning KIT exons 9, 11, 13, 14, 17, and 18.
Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024.
Kinase Switch-Control Research Engine
Presented new preclinical data in eight poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting 2023 from development candidates DCC-3116 (ULK), DCC-3084 (pan-RAF), DCC-3009 (pan-KIT) and research programs focused on GCN2 and PERK, novel targets in the integrated stress response pathway.
Corporate Update
Announced that the Company’s Founder, Executive Vice President, and Chief Scientific Officer, Daniel L. Flynn, Ph.D., will retire effective September 5, 2023, and will transition to a role as Senior Advisor to the Company. Dashyant Dhanak, Ph.D., has been appointed Executive Vice President and Chief Scientific Officer effective September 5, 2023. Dr. Dhanak brings over 30 years of experience in pharmaceutical research and discovery including most recently as Executive Vice President and Chief Scientific Officer at Incyte Corporation.
Announced that Ron Squarer has been appointed Chairperson of the Board of Directors. Mr. Squarer has over 30 years of experience in the pharmaceutical and biotechnology industry and joined Deciphera as a Director in December 2019. James A. Bristol, Ph.D., who has served as either Chairperson or Co-Chairperson since 2007, will remain a Board member of Deciphera.
Second Quarter 2023 Financial Results
Revenue: Total revenue for the second quarter of 2023 was $38.3 million, which includes $37.3 million of net product revenue of QINLOCK and $1.0 million of collaboration revenue compared to $32.5 million of total revenue, including $31.5 million of net product revenue of QINLOCK and $1.0 million of collaboration revenue, for the same period in 2022.
Cost of Sales: Cost of sales were $0.2 million in the second quarter of 2023 compared to cost of sales of $1.8 million for the second 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 second quarter of 2023 were $58.3 million, compared to $44.9 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs related to the Phase 1/2 study of DCC-3116, the MOTION Phase 3 study and Phase 1 /2 study of vimseltinib, and clinical study costs for QINLOCK. Non-cash, stock-based compensation was $5.7 million and $5.4 million for the second quarters of 2023 and 2022, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the second quarter of 2023 were $32.6 million, compared to $29.6 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 $7.1 million and $7.6 million for the second quarters of 2023 and 2022, respectively.
Net Loss: For the second quarter of 2023, Deciphera reported a net loss of $48.6 million, or $0.57 per share, compared with a net loss of $43.1 million, or $0.60 per share, for the same period in 2022.
Cash Position: As of June 30, 2023, cash, cash equivalents, and marketable securities were $389.4 million, compared to $426.3 million as of March 31, 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 milestone payments 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, August 9, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI74ff2d04fe8541f48da1cf0ad35339ae. 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.