Deciphera Pharmaceuticals, Inc.

Good morning, everyone, and welcome to the CIFRA Pharmaceuticals Second Quarter 2023 Financial Results 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 for joining us today to discuss the CIFRA's Second Quarter 2023 Financial Results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning 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, Margarita Duarte, Head of International, 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. made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples include our expectations for our preclinical and clinical programs, our commercialization of Kinloch and 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 as we provide an update from the second quarter, review our financial results, and look forward to the rest of the year. We've made tremendous progress so far in 2023 thanks to the exceptional work of our dedicated team at Decipherer. Our commercial business continues to drive strong results, highlighted by a record quarter for Kenlock, which generated over $38 million in Q2 revenue, an 18% increase over Q2 last year. We believe that we can significantly grow the Kenlock brand by expanding the label to include second line GIST patients with KIT exon 11 and 17 or 18 mutations. And we are pleased to announce today an important milestone toward that goal. The opening of the first sites for the phase three insight study. The compelling results of the exploratory analysis of circulating tumor DNA from the Intrigue phase three study of Kenlock and second line GIST patients were featured in an encore presentation at the 2023 ASCO Annual Meeting. These data continue to generate very positive feedback from physicians who are eager to enroll patients in the INSIGHT Study, which is designed to serve as the basis for a supplemental new drug application, or SNDA. We are also proud to announce today that we have initiated two new combination cohorts for DCC 3116, with Encurafenib and Cetuximab, and with Recretinib. On today's call, we will share a data update from the 3116 program, including data from both the phase one single agent escalation and the initial combination escalation cohorts. We're excited to generate additional data from this potential first in class program targeting the autophagy pathway. At the American Association of Cancer Research annual meeting in April, we presented eight posters on our early stage pipeline. including the first disclosure of our new pan-kit inhibitor, DCC3009, for which we expect to file an IND in the first half of 2024. The data we presented at AACR highlighted the sustained productivity of our kinase switch control research engine and its proven ability to generate product candidates with first and best-in-class potential. Now looking ahead, we are moving into an exciting second half of the year as we approach the top line readout for the pivotal phase three motion study of Vinsultinib in tenosynovial giant cell tumor and the IMD submission for DTC3084, our potential best-in-class pan-RAP inhibitor. Now I'd like to take a moment to recognize Dan Flynn, our founder and chief scientific officer, whose retirement was announced last week. On behalf of the entire Decipherit team, I want to thank him for his vision to found our company almost two decades ago, and his trailblazing innovations in switch control kinase inhibition, which have brought Decipherit to where it is today. It has been an honor working alongside Dan, and I wish him the very best in his retirement. We're excited to welcome Dr. Dash Danak as our new Chief Scientific Officer next month. Dash brings an exceptional background as a leader in drug discovery with over 30 years of experience. and joins DeCyphera from Insight Corporation, where he was most recently Executive Vice President and Chief Scientific Officer. On today's call, Dan Martin, our Chief Commercial Officer, will share insights on the U.S. commercial performance for the second quarter, and Margarita Duarte, our Head of International, will provide an update on Kenlock's ongoing fourth line just launched in Europe. Matt Sherman, our Chief Medical Officer, will provide an update on our R&D efforts, including data from the DCC 3116 Phase 1-2 study. Finally, Tucker Kelly, our Chief Financial Officer, will review the financial results from the second quarter. First, I'll turn the call over to Dan and Margarita to discuss our Q2 commercial performance.