Kura Oncology, Inc.

Stand by, your program is about to begin. Hello and welcome everyone joining today's second quarter 2025 Cura Oncology Inc. Financial Results Conference call. At this time all participants are in a listen-only mode. Later you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star and 1 on your telephone keypad. Please note this call is being recorded. I am standing by should you need any assistance. It is now my pleasure to turn the meeting over to Greg Mann, SVP of Investor Relations and Corporate Affairs. Please go ahead.

Thank you, Brittany. Good afternoon and welcome to Cura Oncology's second quarter 2025 conference call. Joining the call today 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, 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. Good afternoon and thank you all for joining us. At Cura, we're committed to transforming outcomes for patients with AML. Today, we'll provide updates on our global development progress for our lead programs of demented, regulatory status of our new drug application, preparations for commercialization with our partners at KiwaKiran, and advances in our pipeline including Mennon inhibitors for treatment of GIST and diabetes as well as barnesyl transferase inhibitors or FTIs for solid tumors. Starting with development, we were thrilled to present positive monotherapy data from the COMET001 trial at ASCO. Zipdementib showed promising results in relapsed or refractory NPM1 mutated AML, offering hope for this heavily pretreated population. We're also encouraged by Zipdementib's consistent safety and tolerability profile in this setting. We were pleased to announce FDA accepted our NDA for Zipdementib in adults with relapsed or refractory NPM1 mutant AML, granting priority review with a PDUFA target action date of November 30th, 2025. We're encouraged by the FDA's engagement and are focused on achieving a successful review outcome by our PDUFA date. In the frontline setting, we reported updated combination data for Zipdementib with intensive chemotherapy in newly diagnosed AML and EHA. These results highlight Zipdementib's potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Building upon the EHA data as well as emerging data for Zipdementib combined with Venetoclax, Anaseocytidine, or Venasa, which we plan to share later this year, we're accelerating development of Zipdementib in frontline AML. For this end, we are in study startup for the two Phase III frontline trials under the COMET 017 protocol. Along with the opportunity to treat FLIT3 mutant AML patients, these two Phase III trials could open up the opportunity to impact up to 50% of patients with AML. Molly will expand on our development activities for Zipdementib later in this call. On pre-commercial activities, we're actively preparing for potential approval by building commercial supply and quality systems, advancing pre-approval inspection readiness for CM&C and manufacturing, and recruiting and training our sales force as well as collaborating with our partner, Kyua Kirin, on launch planning. Brian will elaborate on our commercial readiness later in the call. Our partnership with Kyua Kirin continues to bolster the global development and commercialization of Zipdementib. We're aligned on advancing both relapsed refractory and frontline programs, and we value our shared commitment to bringing Zipdementib to patients. Beyond Mennon inhibitors, we're making strong progress with our fully owned next generation Farnesyl transferase inhibitor, KO2806. We're excited to announce three clinical abstracts from our FTI program have been accepted for presentation at the 2025 ESMO Congress. Molly will share more of the details on the upcoming presentations a bit later. We're also thrilled to welcome Greg Mann to our leadership team as our Senior Vice President Investor Relations and Corporate Affairs. Greg brings an extensive biotechnology and pharmaceutical experience with a proven track record of strategic communications and investor engagement, fostering strong relationships with analysts, investors, and key stakeholders. As of June 30th, 2025, CURRA had $630.7 million in cash, cash equivalents, and short-term investments. Under our Kioa-Kuren collaboration, we stand to receive up to $375 million in additional near-term milestones, including significant milestones tied to initiation of our Phase 3 frontline trials, as well as first commercial sale of Zipdementib in the relapsed refractory setting. As our data continues to demonstrate, we believe Zipdementib represents a potential -in-class Mennon inhibitor for AML and GIST. And with our cash reserve, our current cash reserves and anticipated milestones, we're well-funded to become the market leader, continue to advance our Zipdementib AML program through to commercialization in the frontline setting, and drive our pipeline to multiple value inflection points. With that overview, let's dive in, starting with Zipdementib. I'll turn it over to Molly to highlight our development activities. Molly?