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 Q4 2024 Cura Oncology, Inc. 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 1 on your telephone keypad. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Patty Bank, Investor Relations. Please go ahead.

Thank you, Angela. Good afternoon and welcome to Cura Oncology's fourth quarter and full year 2024 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 CURR's filings with the SEC, which are available from the SEC or on the CURR Oncology website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Patty, and thank you all for joining us. We're continuing the momentum generated in 2024 as we continue to make meaningful advancements across our pipeline. We're poised to submit our first NDA for Zyptomenib We're preparing to commercialize Ziftimenib as a potentially best-in-class menin inhibitor for patients with relapsed and or refractory NPM1 mutant AML, which serves as a first step to providing clinical benefit to patients across the treatment continuum. And we've delivered unprecedented development in regulatory pathways for Ziftimenib in frontline AML. Specifically, we've reached alignment with FDA on potential pathways for accelerated approval in the U.S. in both the intensive and non-intensive frontline settings, by allowing the trials to use MRD negative CR and CR as primary endpoints, respectively. We can now report we've also gained alignment with the European Medicines Agency, or EMA, on the COMET-017 protocol. We believe these advancements could meaningfully accelerate the development and commercialization of ziftaminoid frontline AML with top line results from the MRD negative CR accelerated endpoint in the intensive chemotherapy setting anticipated in 2028. As we look beyond Zifdomenib and AML, we're advancing a strong product candidate pipeline with clinical data updates expected throughout this year. And we're well financed and resourced to create significant value for patients and our stakeholders. So with that, let's turn to specific updates. Starting with our most recent news, earlier this month we announced positive top line results from COMET001, the phase two registration directed trial of Zifdomenib in patients with relapsed refractory NPM1 mutant AML. The trial achieved its primary endpoint, consistent with a targeted 20 to 30% CRCRH rate. The data have been submitted for presentation at ASCO. The benefit-risk profile for Zifdomenib is highly encouraging, and the safety profile was consistent with prior reports. As a reminder, Zifdomenib is the first and only investigational drug candidate to be granted breakthrough therapy designation, or BTD, for treatment of relastofractory NPM1 mutant AML. Facilitated by the BTD status of ZiptoMedib, we completed our pre-NDA meeting with FDA and anticipate submitting an NDA next quarter. We believe the combination of safety, tolerability, and clinical activity in a once-daily oral medication support a competitive profile in the relapsed refractory market, as well as advanced clinical development in those critical frontline indications. And speaking of the frontline AML indications, I'm going to turn it over to Molly to review the unmet need in this patient population as well as feedback we've received from regulatory agencies. We're excited to share these updates because we believe the frontline usage of MENIN inhibitors could be a transformative clinical and commercial opportunity with the U.S. market for MENIN inhibitors in frontline AML reaching over $7 billion annually. Molly, over to you.