Deciphera Pharmaceuticals, Inc.

Good afternoon, everyone, and welcome to Decipher Pharmaceutical Second Quarter 2021 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Jen Robinson, Vice President of Investor Relations. Jen?

Thank you, Operator. Welcome, and thank you for joining us today to discuss Decipher's second quarter 2021 financial results. I'm Jen Robinson, Vice President, Investor Relations at Decipher. With me this afternoon to discuss the financial results and provide a general corporate update are Steve Herter, President and Chief Executive Officer, Dan Martin, Chief Commercial Officer, Matt Sherman, Chief Medical Officer, and Tucker Kelly, 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 reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our commercialization of Kinloch, and 2021 guidance. Forward-looking statements made on this call 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 made available on the company's website, www.decipher.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?

Thank you, Jen. During the first half of 2021, we continued to execute on our strategic priorities across the company, positioning us for a catalyst-rich second half of the year that will set the stage for the company's next phase of growth. As our Chief Commercial Officer, Dan Martin, will outline on today's call, our U.S. commercial organization has rapidly established Kinloch as the standard of care in fourth-line GIST, which has created a strong foundation for our future expansion into the second-line setting. In addition, we continue to publish key data updates from Kinloch studies, which underscore the broad clinical benefit this best-in-class medicine provides in GIST. Outside of the United States, we are making excellent progress with launches now underway in China and Hong Kong. As a reminder, an estimated 30,000 new patients are diagnosed with GIST in China each year, and we look forward to supporting our partner, XyLab, as they launch Kinloch in this important territory. In Europe, where our marketing authorization application is under review, we are building out an experienced commercial organization that is preparing for the expected approval by the European Medicines Agency in the fourth quarter of this year. This focused team will be well positioned to quickly deliver Kinloch to patients in early launch markets once the EMA approval is secured. Our next priority for Kinloch is moving this medicine into earlier lines of therapy for GIST. We have seen the significant difference Kinloch has been able to make in the lives of patients with fourth-line GIST and are eager to bring that life-changing impact to patients in earlier lines of treatment. We continue to expect to announce top line results from the ongoing phase three intrigue study in second line GIST in the fourth quarter of this year. In addition to Kinloch, we remain focused on advancing our growing pipeline of novel kinase inhibitors. In June, we treated the first patient in our phase one study of DCC3116. This phase one study is investigating the safety and tolerability of our first in class switch control ALK kinase inhibitor first as monotherapy in patients with solid tumors expressing a mutant RAS or RAF gene, and then in combination with a MEK inhibitor. We believe we have a leading position in the development of regulators of autophagy for cancer, an approach that holds tremendous potential to help a very large group of patients. As Matt Sherman, our chief medical officer, will discuss in more detail, we were pleased to announce today an exclusive licensing agreement with Sprint Bioscience, for a research stage program targeting VPS34, another important kinase in the autophagy pathway. This research program is complementary to DCC3116 and builds on our expertise in the science for regulating autophagy in cancer. We are also pleased with the progress we are making with our later stage clinical development programs. At the upcoming ESMO Congress, we look forward to presenting new data from the Phase 1-2 study of vimseltinib in patients with tenosynovial giant cell tumor, in addition to data from the platinum-resistant ovarian cancer cohort from the Phase 1-B2 study of ribastinib in combination with paclitaxel. We plan to finalize pivotal development studies for both programs in the second half of the year. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the U.S. Kenlock commercial results from Q2. Dan?