Deciphera Pharmaceuticals, Inc.

Welcome to the Cyphera Pharmaceuticals First Quarter 2021 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to hand the conference over to Jen Robinson, Vice President, Investor Relations.

You may begin. Thank you, Talanda. Welcome, and thank you for joining us today to discuss the Cyphera's First Quarter 2021 Financial Results. I'm Jen Robinson, Vice President, Investor Relations at DecipherUp. 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 10Q, 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.decipher.com. I will now turn the call over to Steve Herter, President and Chief Executive Officer of Decipher Us. Steve?

Thank you, Jen. It's been an exciting start to the year for Deciphera as we build upon all that we accomplished in 2020 and execute on our strategic priorities across the portfolio for 2021. We continue to make great progress against the three areas of focus for Kinloch this year, successfully launching Kinloch in the U.S., expanding the geographic reach of Kinloch by seeking regulatory approvals around the world, and moving Kinloch into earlier lines of therapy in GIST. Our successful launch of Kinloch in the U.S. demonstrates the significant unmet medical need in fourth-line GIST and the potential for Kinloch to offer a meaningful difference for patients in this setting. In a few minutes, Dan Martin, our Chief Commercial Officer, will outline our success in quickly establishing Kinloch as the standard of care in its approved indication. Our rapid penetration of this market and the very positive perceptions of Kinloch by GIST treaters create a solid foundation for our potential future expansion into the second-line setting. In the first quarter, we made important progress on our goal to expand the geographic reach of Kinloch. Our partner in Greater China, Xilab, received approval for Kinloch from both the China National Medical Products Administration and the Hong Kong Department of Health. An estimated 30,000 new patients are diagnosed with JIS in China each year, and we look forward to supporting XI as they launch Kinloch in China later this quarter. We expect to receive approval for Kinloch from the European Medicines Agency in the fourth quarter of this year. As we await action from the EMA, we are actively laying the groundwork for our commercial organization in Europe and building an experienced and focused team that will allow us to quickly deliver Kinloch to patients in key markets once approved. As the first drug specifically designed to treat GIST, we believe Kinloch has the potential to fundamentally alter the treatment of this disease. One of the key elements of our strategy to expand the use of Kinloch into earlier lines of treatment is our ongoing phase three study, Intrigue, in the second line setting. We expect to announce top line results for Intrigue in the fourth quarter of this year. And beyond the Intrigue study, we are pursuing additional opportunities to benefit patients with GIST by evaluating the use of Kinloch as a backbone of a treatment combination that seeks to address one of the potential mechanisms of resistance to KIT inhibition. reactivation of the MAP kinase pathway. Matt Sherman, our chief medical officer, will discuss in more detail later in the call our plan to initiate later this year a phase 1b2 study of Kinloch in combination with Benimetinib, an approved MEK inhibitor. Finally, we remain very excited about our expanding pipeline of kinase inhibitors beyond Kinloch. Throughout 2021, we expect to have significant clinical and regulatory updates that we believe have the potential to create significant value for shareholders as we continue to deliver on our mission of discovering, developing, and commercializing new medicines for patients with cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the U.S. Kenlock commercial results from Q1. Dan?