Deciphera Pharmaceuticals, Inc.

Good afternoon, everyone, and welcome to Decipher Pharmaceutical's third 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, Investor Relations. Jen?

Thank you, Operator. Welcome, and thank you for joining us today to discuss Deciphera's third quarter 2021 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, commercialization of Kinlaw, and 2021 and 2022 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 FDC 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. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Decipher. Steve?

Thank you, Jen, and good afternoon, everyone. During the third quarter, we made significant progress against our strategic priorities, including both expanding the reach of Kinloch for patients with GIST around the world and providing important new data updates for the next two product candidates advancing through the pipeline, and moving toward registration-directed studies. In the U.S., we have rapidly established Kinloch as the clear standard of care in fourth-line GIST, providing a strong foundation as we prepare to report top-line results from the Phase III Intrigue Study in second-line GIST later this quarter. At ESMO, we presented long-term follow-up from the Phase III Invictus Study, showing that Kinloch nearly tripled the overall survival benefit for patients in this setting. Based on the totality of the clinical data we have generated with Kinloch so far, we remain confident in the potential for Kinloch to fundamentally transform the treatment of this disease. Outside of the U.S., we continue our work to broaden the geographic reach of Kinloch. In September, we received a positive opinion from the EMA's CHMP, and we expect EU approval for Kinloch and fourth-line GIST later this quarter. In October, we were also pleased to announce the approval of Kinloch by Swiss Medic, Switzerland's regulatory agency. This marks the seventh approval worldwide for Kinloch and our first approval in continental Europe. We are excited to bring this important new medicine specifically designed for GIST to patients in Europe who are in need of a new treatment option. Beyond Europe, our partner Xilab continues to execute on its launch of Kinloch and fourth-line GIST in the China market. where an estimated 30,000 new patients are diagnosed with this disease each year. Building on the recent regulatory approvals in China and Hong Kong, Zai received approval for Kinloch in Taiwan last quarter. We look forward to working with Zai to provide Kinloch to just patients throughout greater China. Later on today's call, Matt Sherman, our chief medical officer, will review the highly encouraging data updates we provided for Vimseltinib and Ravastinib at the ESMO meeting in September. We were excited to present these new data updates and disclose our plans to move forward with pivotal Phase III studies for these novel product candidates. For rimseltinib, our potential best-in-class CSF1 receptor inhibitor, we expect to initiate the Phase III motion study in patients with tenosynovial giant cell tumor this quarter. And for ribastinib, our potential first-in-class Ti2 inhibitor, we expect to initiate a registration study next year. We are leaders in targeting autophagy in cancer, and our old inhibitor, DCC3116, is the first to enter the clinic in this important area of cancer research. In June, we initiated the phase one study of DCC3116, and we expect to present data from the dose escalation portion of this study next year. In October at the triple meeting, we highlighted exciting new preclinical data with 3116 in combination with EGFR inhibitors. For the first time, we described the upregulation of autophagy in non-small cell lung cancer preclinical models with osomertinib, the current standard of care for mutant EGFR non-small cell lung cancer, and the significant antitumor synergy seen with the combination of DCC3116 and osomertinib. These data and the growing literature underscore the broad applicability of targeting autophagy in cancer and the potential for DCC3116 to be combined with a number of targeted agents across a spectrum of solid and hematological malignancies. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the Kinloch commercial results from Q3. Dan?