Kura Oncology, Inc.

Please stand by, your program is about to begin. If you need assistance during your conference today, please press star zero. Good day, everyone, and welcome to today's first quarter 2025 Cura Oncology Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. Please note this call may be recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Apoorva Chollui. Please go ahead.

Thank you, operator. Good afternoon and welcome to Cura Oncology's first quarter 2025 conference call. Joining me on the call are Dr. Troy Wilson, President and Chief Executive Officer, Dr. Molly Leone, Chief Medical Officer, Brian Powell, Chief Commercial Officer, and Tom Doyle, Senior Vice President of Finance and Accounting. Before I turn the call over to Dr. Wilson, I'd like to 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 could 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 Cora Oncology website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Apoorva. Good afternoon, and thank you all for joining us. Over the past quarter, we've made substantial progress executing against our pipeline. We've achieved important clinical and regulatory milestones, which have clinically and financially de-risked our preparations to commercialize Ziftimidib in acute myeloid leukemia or AML, including the recent NDA submission for Ziftimidib as a monotherapy in relapsed or refractory NPM1 mutant AML. The Ziftimidib monotherapy phase two registrational data were accepted for oral presentation at the 2025 ASCO annual meeting, which will be the first of multiple clinical data updates we anticipate presenting at major oncology medical meetings throughout this year. Earlier this week, we announced the first patients with advanced gastrointestinal stromal tumors, or GIST, after imatinib failure were dosed with the combination of Ziftimenib and imatinib. Our FTI program continues to advance, and we expect to share preliminary clinical data from multiple Phase I cohorts later this year, evidencing the potential of FTIs as combination therapies. As we continue to build CURA into a fully integrated organization, we're pleased to announce the appointment of Sameer Vattompadam to our leadership team as Senior Vice President, Global Program Leadership. Sameer joins CURA with more than 20 years of experience in the biotech and pharmaceutical industry, including extensive leadership of global program teams which have driven the development and commercialization of 16 novel medicines and indications across 13 diseases. primarily in oncology and hematology. As adjusted for the $45 million milestone payment under our collaboration agreement with Kilicurin, upon receipt by FDA of the NDA submission for Zifdometib, Cura had on a pro forma basis $703.2 million in cash, cash equivalents, and short-term investments as of March 31st, 2025. Accounting for the $45 million milestone payment, we stand to receive an additional $375 million in near-term anticipated milestones. This strong cash position provides sufficient capital to fund our ZIFTA-MENIP AML program to commercialization in the frontline setting, as well as advance our pipeline to multiple value inflection points. With that overview, let's now dive in, starting with ZIFTA-MENIP. On March 31st, we submitted our new drug application, or NDA, for Ziftimenib, our once-daily oral investigational menin inhibitor. As a reminder, Ziftimenib is the first and only investigational therapy to be granted breakthrough therapy designation for treatment of relapsed or refractory NPM1 mutant AML. There are no FDA-approved therapies targeting NPM1 mutant AML, which represents approximately 30% of new AML cases annually and is a disease of significant unmet need. Priority review was requested, which if granted, would provide a target FDA review period of six months from FDA, from NDA acceptance. FDA has been a collaborative and supportive partner. And although it's early days in our review cycle, we've not experienced any disruptions or delays due to the changes underway at Health and Human Services or FDA. We look forward to continuing to work closely with the agency throughout the review process and are optimistic about the potential for ZiftaMedib to impact patients with relapsed refractory and PM1 mutant AML. With that introduction, I'd like to turn it over to Molly to walk through updates to our development pipeline and programs. Molly?