Deciphera Pharmaceuticals, Inc.

Good morning, everyone, and welcome to the Cypher Pharmaceuticals First Quarter 2023 Financial Results Conference Call. Later, we will conduct a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. 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 DeCyphera's first 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 that we make on this call that are not historical facts are forward-looking statements made pursuant to safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples include our expectations of our preclinical and clinical programs, our commercialization of Kinloch, and 2023 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 statement, 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.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 first quarter, review our financial results, and look forward to the rest of the year. We're off to an exciting start for this catalyst-rich year and have already achieved a number of critical milestones that advance our mission to discover, develop, and commercialize important new medicines to improve the lives of people with cancer. At the January ASCO plenary series session, we presented results from an exploratory analysis from the Intrigue Phase III clinical study of Kenlock using circulating tumor DNA, or CT DNA, from patients with gastrointestinal stromal tumor, or GIST, previously treated with imatinib. Based on these results, which showed a striking benefit for patients with mutations in KIT exon 11 and 1718 treated with Kenlock, We plan to initiate the INSIGHT Pivotal Phase 3 study of Kinloch in this patient population in the second half of the year. In March, we announced the FDA-granted Breakthrough Therapy designation for Kinloch for this population. This designation reflects the potential for Kinloch to offer substantial clinical benefit for this group of second-line GIST patients, and we believe it reflects the opportunity for Kinloch to become the future standard of care in this setting. The need for additional treatment options for GIST patients in the post-imatinib setting was further underscored by Kenlock's inclusion in the National Comprehensive Cancer Network, or NCCN, clinical practice guidelines in oncology as a preferred regimen for second-line GIST patients intolerant to sunitinib. In March, we completed enrollment in the MOTION Pivotal Phase III Study of Vimselfinib for the Treatment of Tenosynovial Giant Cell Tumor, or TGCT, and we expect to report top-line results from this study in the fourth quarter. Together, Kinloch and Vimselfinib have the potential to benefit thousands of patients around the world, with a peak worldwide sales potential of over $1 billion. We look forward to reporting the MOTION study results and initiating the INSIGHT study later this year. Most recently, at AHCR in April, we presented eight posters on our early-stage pipeline, the most comprehensive demonstration of Decipheris research in our company's history. These data 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. We presented new preclinical data on our ALK inhibitor, DCC3116, in combination with Repretinib in GIST models, and in combination with Incarapinib and Cetuximab in colorectal cancer models that strongly support two new dose escalation combination studies, which we expect to initiate in the second half of this year. We also presented the first preclinical data for DCC3084, a potential best-in-class PanRaf inhibitor that broadly inhibits Class I, II, and III BRAF mutations and BRAF fusions. We announced the nomination of our newest development candidate, DTC3009, a potential best-in-class pan-kit inhibitor, and we showcased our newly announced research program focused on GCN2 kinase, a key target in the integrated stress response pathway. These discovery, research, and early-stage clinical efforts complement our late-stage and commercial programs, which together form a deep pipeline of novel medicines and product candidates supporting our position as a leading, fully integrated oncology company. On today's call, Dan Martin, our Chief Commercial Officer, will share insights on the U.S. commercial performance for the first quarter, and Margarita Duarte, our Head of International, will provide an update on Kinloch's ongoing fourth-line gist launch in Europe. Finally, Tucker Kelly, our Chief Financial Officer, will review the financial results from the first quarter. But first, I'll turn the call over to Matt Sherman, our Chief Medical Officer, to discuss Deciphera's R&D efforts in greater detail. Matt?