Kura Oncology, Inc.

Good day, everybody. My name is Dani, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology Third Quarter 2025 conference call. All lines have been placed on mute to prevent any background noises. 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 have joined via the webinar, please use the raised 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 from Cura Oncology. Thank you.

Thank you, Danny. Good morning and welcome to Cura Oncology's third quarter 2025 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Tom Doyle, Senior Vice President, Finance and Accounting. Dr. Molly Leone, Chief Medical Officer, and Brian Powell, Chief Commercial Officer, are also on the call and available to answer questions. 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 morning, and thank you all for joining our third quarter financial results conference call. Over the past quarter, we've continued to significantly advance both our clinical pipeline as well as preparations for the anticipated commercial launch of Zifto-Menib, our once-daily investigational menin inhibitor for acute myeloid leukemia. I'll begin with an update on Zifto, followed by brief remarks on our commercial readiness and our farnesyl transferase inhibitor program. The FDA review of Ziftimenib for treatment of patients with relapsed and refractory NPM1 mutated AML remains on track, with a PDUFA target action date of November 30, 2025. Communication with FDA continues to be open and constructive, and we remain focused on achieving a successful review outcome. Based on clinical data from the COMET-001 study, which has been presented at major medical meetings and published in the Journal of Clinical Oncology in September, we're confident Ziftamidib has a differentiated and favorable benefit-risk profile, and if approved, Ziftamidib could potentially reset the commercial landscape and become the menin inhibitor of choice for eligible patients. Although while the regulatory review process for Zifdomenib progresses, our clinical team continues to execute on a strategic development plan targeted at addressing the large unmet need beyond the relapsed refractory setting, where we believe Zifdomenib's benefit-risk profile will be even more competitive and more impactful for patients. At EHA earlier this year, we reported updated combination data for ziftamenib with 7 plus 3 intensive chemotherapy in newly diagnosed NPM1 mutant and KMT2A rearranged AML. These data were very encouraging, showing high rates of complete remission and MRD negativity. in over 70 patients across the combination cohorts, with a safety profile consistent with what is expected in patients treated with 7 plus 3 alone. These results highlight ziftaminib's potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Yesterday, we announced acceptance of two oral presentations at ASH, which will feature data on ziftaminib in combination with venetoclax and azacitidine chemotherapy. Both abstracts, one in the newly diagnosed setting and the second in the relapsed refractory setting, reported high response rates and MRD negativity with a safety profile consistent with previous reports. The abstracts used data cutoff of June 25, 2025, and updated results reflecting additional follow-up will be reported in the oral presentations next month. We plan to host a virtual investor and analyst event to discuss these ASH presentations on Monday, December 8th at 12.30 p.m. Eastern Time. Details will be available on our website. Encouraged by these positive results, we've advanced rapidly into our Comet 017 Frontline Phase 3 trials. COMET017 comprises two randomized, double-blind, placebo-controlled trials to evaluate ziptomenib in combination with both intensive 7 plus 3 and non-intensive Veneza chemotherapy regimens in patients with newly diagnosed NPM1 mutant or KMT2A rearranged AML. The program aims to advance sift amenib to the frontline setting with potential to treat patients earlier in their disease course when the opportunity to alter its trajectory is greatest. We're targeting enrollment at over 150 global sites with a large proportion in the U.S. Each COMET-017 trial includes dual primary endpoints to support potential U.S. accelerated and full approvals. The intensive chemotherapy combination study evaluates MRD negative complete response, or CR, and event-free survival. The non-intensive chemotherapy combination study assesses CR and overall survival. Site activation is accelerating. In each of these companies sponsored registrational trials and patient enrollment is progressing well. Continuing this momentum, last month we opened a trial cohort to assess Ziftimidib combined with 7 plus 3 induction chemotherapy and Quisartinib, an approved FLT3 inhibitor in patients with newly diagnosed AML harboring FLT3 ITD and PM1 mutant co-mutations. FLT3 mutations represent one of the most common and challenging genetic mutations in AML with limited durable treatment options. Our preclinical studies suggest Ziftimenib and Quisartinib synergize to enhance activity without undue toxicity. Note, this effort also builds on our clinical experience with the combination of ziftamenib and giltaritinib in the relapsed refractory NPM1 mutant setting. Enrollment in that trial has been robust, and we intend to present preliminary Phase I data at a major medical meeting next year. With these studies now underway, ziftamenib development is active in all three major frontline settings, collectively representing up to 50% of incident AML cases in the U.S., Turning now to commercial preparations, our teams are launch ready and confident in our execution plan. Across the commercial organization from marketing, market access, as well as patient support and sales analytics, field operations and sales, our teams are fully mobilized and prepared to execute as soon as Zip2Mentive is approved. Our disease awareness campaigns have exceeded their targets. Our pre-approval information exchanges with key payers and other market decision makers are complete, offering us confidence that we will facilitate rapid access and uptake. Our limited distribution network is fully aligned and ready to support product upon approval. And our team of experienced oncology account managers is already engaged in profiling target accounts. In early October, we and our partner, Kyokuren, held a joint launch readiness meeting where our two field teams of Kura and Kyokuren, what we fondly call 1K, completed their training and pre-certification. The excitement and alignment across both organizations is palpable, and the 1K team stands ready to deliver upon approval. Turning now to our farnesyl transferase inhibitor portfolio, last month we presented new clinical data highlighting the potential of FTIs to safely combine with major classes of targeted therapies, including PI3 kinase alpha inhibitors, KRAS inhibitors, and anti-angiogenic tyrosine kinase inhibitors, to overcome resistance pathways and enhance antitumor activity. In our FIT-001 Phase I trial evaluating darlafarnib, our next-generation FTI, in combination with cabozantinib in patients with renal cell carcinoma, we observed a manageable safety profile across multiple dose levels of each agent, including at the full labeled dose of cabozantinib. Antitumor activity was seen across all dose combinations, including in patients with prior exposure to cabozantinib. The objective response rate, or ORR, was 33% to 50% in clear cell renal cell carcinoma and 17% to 50% in patients with prior cabozantinib exposure. The current HN trial evaluates tipifarnib, our first-generation FTI, with alpelicib in patients with PIK3CA-dependent head and neck squamous cell carcinoma. This combination also demonstrated a manageable safety profile and robust antitumor activity in a heavily pretreated patient population where meaningful benefit would not be expected from either agent alone. An ORR of 47% was observed at a dose of tipifarnib of 1,200 milligrams per day and dalpelicib at 250 milligrams per day. We see tremendous promise in darlafarnib and the broader potential of farnesyl transferase inhibition as a differentiated mechanism to extend the reach of precision oncology. With the potential to enhance activity of PI3 kinase alpha inhibitors, KRAS inhibitors, and TKIs, darlafarnib represents a very substantial commercial opportunity with the potential to address more than 200,000 incident patients annually in the US alone. We view our FTI platform as a strategically important pillar of growth that complements our leadership in menin inhibition. Our dual pipeline strategy positions Cura with two clinically validated mechanisms that address some of the most pressing needs in precision oncology. We expect to have more to share regarding our FDI clinical development plans and business development strategy in 2026, supported by a steady cadence of data presentations at medical meetings throughout the year. Kuro remains in a strong financial position to execute across our pipeline, advance the development of Zip2Mentib, and support our commercialization activities. Our partnership with Kyowa Kirin has enabled us to invest in a robust, expansive, and accelerated development plan for Zip2Mentib. We recently received two $30 million milestone payments. payable for the first patients dosed in the two Comet 017 Phase 3 trials, which brings the total milestones received this year to $105 million. We expect approximately $315 million more in near-term milestone payments, including a substantial milestone payment associated with commercial launch of Ziftamenib. This is consistent with the $420 million in near-term milestones we announced at the inception of the partnership with Kyokuren last November. We reported pro forma cash of $609.7 million for the period. This figure includes milestone payments received in October and November 2025 and reflects a strong capital position to advance our pipeline through key clinical and regulatory milestones. I'll now turn it over to Tom, who will review the third quarter financial results.