Deciphera Pharmaceuticals, Inc.

Good afternoon, everyone, and welcome to the Decipher Pharmaceuticals Third Quarter 2020 Financial Results Conference Call. At this time, all lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, please press star 1 on your touch-tone keypad. Please be advised that today's call is being recorded. If you require any further assistance during the conference, please press star 0, and an operator will be happy to assist you. At this time, I would now like to turn the call over to Jen Robinson, Vice President, Investor Relations. Jen?

Thank you, Operator. Welcome, and thank you for joining us today to discuss Deciphera's third quarter 2020 financial results. I'm Jen Robinson, Vice President, Investor Relations at Deciphera. 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 2020 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.decyphera.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?

Thank you, Jen. Good afternoon, everyone, and thank you for joining us on today's call. This year has been an incredibly exciting one for Deciphera, a year in which we received regulatory approval for and launched our first medicine, Kinloch, and also made significant progress advancing our pipeline of new product candidates. That we were able to accomplish so much this year, in spite of the challenges of the pandemic, is a testament to the dedication and hard work of the team here at Deciphera and the investigators we work with around the world. We are well positioned for a strong finish to 2020 and eager to continue our mission in 2021. The third quarter marks the first full quarter of results from our ongoing launch of Kinloch in the United States. Kenlock, which was approved by the FDA in May of this year, was designed to address the broad spectrum of mutations that are one of the hallmarks of gastrointestinal stromal tumor, or GIST. In a moment, Dan Martin, our chief commercial officer, will share with you highlights from the launch and outline how we have been successful in establishing Kenlock as the standard of care in our approved indications. We are focused on exploring the full potential of Kinloch to benefit people with GIST, and on today's call, Matt Sherman, our Chief Medical Officer, will review recent data updates from the Kinloch Development Program, which reinforce the potential best-in-class profile of Kinloch in this disease. Our near-term focus for further clinical development remains in the second-line treatment setting, and we are on track to complete target enrollment by the end of this year in the Phase III INTRIG study, in which we are comparing Kenlock to sunitinib in the second line. We believe Kenlock has the potential to play an even broader role in the treatment of GIST, and we look forward to sharing with you our vision for further clinical development in the coming months. One of our goals this year was to expand access to Kenlock for people with GIST outside the United States. To that end, we announced today that we recently submitted a marketing authorization application, or MAA, to the European Medicines Agency. The submission was validated by the EMA last month, which signals the beginning of the formal review process. We look forward to working with the EMA to bring this potential new treatment option to patients in the European Union. We also announced today that we intend to establish a direct commercial presence in key markets in Europe to commercialize Canlock if approved. This nimble organization will be positioned for future expansion as we develop and seek approval for additional decipherer medicines in the coming years. In Europe, we believe the commercial opportunity in GIST is concentrated in the five largest markets, France, Germany, Italy, Spain, and the UK. Within these countries, the treatment of patients with GIST is often centralized at tertiary treatment centers, which we believe allows us to build an efficient and targeted commercial infrastructure. As we lay the building blocks in Europe, We continue to make strides for the commercialization of Kinloch in other areas of the world as well. Over the summer, we received approvals for Kinloch in both Canada and Australia. I am pleased to announce that we have recently entered into exclusive distribution agreements in both of these territories. And in China, our partner, Xilab, filed the new drug application for Kinloch in July, targeting a potential approval next year. We look forward to working with our partners around the world to bring Kinloch to patients with advanced GIST. Finally, we continue to advance multiple clinical stage programs that have the potential to be future approved medicines. Earlier this year, we presented initial compelling data with ribastinib in combination with paclitaxel in patients with heavily pretreated endometrial and ovarian cancers. And later this month, we are excited to present additional clinical data with TCC3014 in tenosynovial giant cell tumor. As our clinical stage pipeline comes into focus, our novel switch control kinase inhibitor discovery platform continues to provide opportunities for future growth. I'll now turn the call over to Dan Martin, our chief commercial officer, to discuss the exciting results for the first full quarter of Kenlock commercial sales. Dan?