Deciphera Pharmaceuticals, Inc.

Good morning, everyone, and welcome to Decipher of Pharmaceuticals' fourth quarter and full year 2022 financial results conference call. At this time, all participants 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, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, Please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jen Larson, Senior Vice President of Finance and Investor Relations. Please go ahead.

Operator, welcome and thank you for joining us today to discuss Decipher's fourth quarter and full year 2022 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 general corporate updates 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. 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 KMLOC, and 2023 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 annual report on Form 10-K, 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. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Decipher.

Thank you and good morning, everyone. Thank you for joining us today as we provide an update from the fourth quarter and full year 2022, review our financial results, and provide additional context on our strategic outlook and planned corporate milestones for 2023. 2022 was a year of exceptional execution for Deciphera. Global Kinloch product revenue grew 44% compared to 2021, driven by very strong performance in the U.S. as well as launches outside of the U.S. Kenlock is now approved for fourth-line gastrointestinal thermal tumor, or GIST, in 12 jurisdictions around the world. Last month, we outlined our key strategic priorities for the year, which will enable Decipher to continue its evolution toward being a fully integrated company with multiple approved medicines and capabilities ranging from international commercialization to early-stage discovery, all powered by our proprietary switch control kinase inhibitor platform. These priorities include expanding the market potential for Kenlock into earlier lines of GIST by initiating the INSIGHT Pivotal Phase III study of Kenlock versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 1718 in the second half of 2023. If successful, we believe the INSIGHT study has the potential to change practice in second-line KIT-driven GIST and to double the U.S. revenues for Kenlock. We were very pleased at the circulating tumor DNA or ctDNA data from our Phase III intrigue study of Kenlock in second-line GIST was selected for presentation at the ASCO Plenary Series session a few weeks ago. Matt Sherman, our Chief Medical Officer, will review the data later in the call and outline our plans for the new Phase III Insight Study. As we begin enrollment in the new Phase III Insight Study for Kenlock, we also expect to read out another pivotal trial, the Phase III Motion Study of imseltenib, our highly selective switch control kinase inhibitor of CSF1 receptor in patients with tenosynovial giant cell tumor, or TGCT, in the fourth quarter of this year. We have been very pleased with the pace of enrollment and are excited to announce today that we now expect to complete enrollment in the motion study in the first quarter and report top-line data in Q4 of this year. For DCC3116, our first-in-class inhibitor of the OLK12 kinases designed to inhibit autophagy, we expect to present updated data from the single-agent dose escalation portion of the Phase 1-2 study and initial combination data in the second half of 2023. Finally, we were very pleased to announce a clinical trial collaboration and supply agreement with Pfizer for a new combination dose escalation study of DCC3116 and incarafenib and cetuximab in colorectal cancer that we plan to initiate in the second half of this year. We look forward to presenting the preclinical data supporting this new combination cohort in the first half of this year, along with additional new preclinical data for DCC3116. We continue to complement these commercial and clinical stage advancements with investment in our research pipeline. Our discovery platform continues to drive new growth opportunities with potential first-in-class or best-in-class precision oncology agents, including DCC 3084, our newly nominated Pan-RAF clinical development candidate, for which we expect to present preclinical data in the first half of this year and to file an investigational new drug application in the second half of the year. DTC 3084 was discovered using the same proprietary switch control kinase inhibitor platform that has brought us Kinloch, Vimseltinib, and 3116, and we look forward to quickly advancing this program to the clinic. In addition, we plan to debut a new development candidate from our proprietary discovery engine in the coming months, as well as preclinical data from other research programs our team has been working on. Matt Sherman, our chief medical officer, will provide more detail about upcoming milestones for our pipeline programs on today's call. Ken Martin, our Chief Commercial Officer, will then share insights on the U.S. commercial performance for the quarter, and Margarita Duarte, our Head of International, will provide an update on Kinloch's ongoing fourth-line launch in Europe, which has sustained its strong momentum throughout 2022. We'll end with Tucker Kelly, our Chief Financial Officer, who will review highlights from the fourth quarter and full-year 2022 financial results and the recent highly successful follow-on equity offering that will allow us to continue to execute on our goals. First, I'll turn the call over to Matt Sherman to provide an update on our R&D efforts. Matt?