Deciphera Pharmaceuticals, Inc.

Good morning, everyone, and welcome to the Decipher Our Pharmaceuticals Motion Top Line Data and Third Quarter 2023 Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Jen Larson, Senior Vice President of Finance and Investor Relations. Jen?

Thank you, Operator. Welcome, and thank you all for joining us today. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning to discuss the VINCEL Team of Data and our third quarter financial results and to provide a general corporate update are Steve Herter, President and Chief Executive Officer, Matt Sherman, Chief Medical Officer, Dan Martin, Chief Commercial Officer, Margarita Duarte, Head of International, and Tucker Kelly, our Chief Financial Officer. Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements. made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples include our expectations of our pre-clinical and clinical programs, including themselves in it, our commercialization of Kinloch, and corporate guidance. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10-Q, as well as our other SEC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?

Thank you, Jen, and good morning, everyone. Thank you for joining us today. We're thrilled to host this morning's call to review the exceptional top-line results from the Pivotal Motion Phase 3 study of Vimseltinib and TGCT that we announced earlier today, as well as compelling updated data from the Vimseltinib Phase 1-2 study. This morning, we also announced our third quarter financial results, showcasing record Kenlock sales. The motion study was a resounding success, achieving its primary and all key secondary endpoints, showing that Vimseltinib has the potential to offer substantial benefit to TGCT patients across a wide range of clinical measures and patient-reported outcomes with a favorable safety profile. Based on the totality of the data, we believe Vimseltinib offers an exceptional clinical profile for people who suffer from TGCT, a chronic debilitating condition with significant unmet medical needs. In addition, we announced updated data today from the Vimsaltinib Phase 1-2 study in TGCT, highlighting that treatment over much longer periods of time can deliver even greater benefits for patients. After another year of follow-up, we now see median treatment duration extending to approximately two years, with the longest patient on treatment for almost four years. We look forward to engaging with regulatory authorities as we prepare to submit an NDA in the U.S. in the second quarter of next year and an MAA in the EU shortly thereafter. Today represents a significant step in our journey to become a fully integrated, self-sustaining biotechnology company. Together, Ken Locke and himself and I have the potential to benefit thousands of patients around the world and generate more than $1 billion in peak global revenue. Bolstering our view of Kenlock's potential, we are also very excited to report another record quarter for Kenlock, with Q3 net product revenue increasing 29% year-over-year and 12% quarter-over-quarter. Dan Martin, our Chief Commercial Officer, will discuss the factors driving the strong U.S. commercial performance over the last two quarters, which we believe are the results of continued focused execution in our fourth-line business as well as increased unpromoted use of Kenlock and earlier lines of GIST based on physician decision. Margarita Duarte, our head of international, will then share more details about Kenlock's strong international performance and our dedication to expanding access to Kenlock to patients around the world. We also remain focused on advancing our deep pipeline of product candidates with first in class and best in class potential. and expect to file the IND for DCC3084, our pan-RAF inhibitor, later this quarter, and we are on track to file the IND for DCC3009, our pan-KIT inhibitor, in the first half of next year. Meanwhile, our potential first-in-class ALK inhibitor, DCC3116, is being studied in multiple combination cohorts as we seek to generate proof-of-concept data to validate a novel approach to treating a wide range of cancers. Before I hand it over to Matt Sherman to discuss the motion and Phase 1-2 study results, I'd like to take a moment to thank the patients who participated in these clinical studies, along with their caregivers and families. Their commitment and resilience have inspired us to deliver on the potential for a new standard of care treatment for TGCT. We're also grateful for the hard work of the investigators, study teams, and healthcare professionals who have participated in the Vimseltinib development program. With that, I'll now turn the call over to Matt.