Kura Oncology, Inc.

Good day, everyone. My name is Abigail, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology's Q4 and FY 2025 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application. To allow everybody the opportunity to participate, we ask that you please limit yourself to one question and then re-enter the queue for any follow-ups. At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Cura Oncology. Please go ahead.

Thank you, Abigail. Good morning and welcome to Cura Oncology's fourth quarter 2025 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Brian Powell, Chief Commercial Officer, Dr. Molly Leone, Chief Medical Officer, and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Cura's filings with the SEC, which are available from the SEC or on the Cura Oncology website, for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Greg, and good morning, everyone. 2025 was a defining year for Cura, marked by FDA approval of ComSifty and initiation of a successful commercial launch. As we enter 2026, our priorities are clear. Execute commercially, move aggressively into frontline AML and combinations, and build long-term leadership in men and innovation while advancing a data-rich pipeline. ComSifty generated $2.1 million in net product revenue in the final weeks of 2025. Although it's early, the launch is off to a strong start. Feedback from physicians, pharmacists, and payers has been consistent. Comsifty delivers meaningful efficacy with differentiated safety, simplicity, and combinability with concomitant medications. In medically complex AML patients, that matters. We believe leadership in relapsed and refractory NPM1 mutant AML will be determined by preference, not by who enters the market first. Importantly, Comsifty is now listed in the FDA's Orange Book with patent protection through July 2044. That runway strengthens the long-term value of the franchise, particularly as we expand into frontline AML and combination settings. Our strategy extends well beyond the initial approval. Enrollment is underway in our Pivotal Comet 017 frontline trials, and 2026 will bring important data in both the frontline and relapse refractory settings. We're positioning Zip2Mentib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens. Across relapsed refractory and frontline AML, we estimate the total U.S. opportunity at approximately $7 billion. Beyond AML, we're advancing a focused solid tumor strategy. Our ziftamidib combination with imatinib in gastrointestinal stromal tumors, or GIST, is progressing in dose escalation, and our next-generation MENIN programs are advancing. Darlifarnib, our farnesyl transferase inhibitor, is designed to address resistance mechanisms across multiple oncogenic pathways. Its combination flexibility, including with cabozantinib, KRAS inhibitors, and PI3 kinase inhibitors, gives it potential to impact more than 200,000 patients annually in the U.S. We expect multiple clinical updates this year. In short, we're executing commercially, expanding development of Zip2Mentib across the AML treatment continuum, and advancing a pipeline with meaningful catalysts in 2026. With that, I'll turn it over to Brian.