Kura Oncology, Inc.

afternoon ladies and gentlemen welcome to the Kira oncology third quarter 2024 financial results 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 also today's call is being recorded and if you should need any operator assistance during the call today please press star 0 now at this time I'll turn things over to mr. Pete to Spain Head of Investor Relations. Please go ahead, sir.

Great. Thank you both. Good afternoon and welcome to Cura Oncology's third quarter 2024 conference call. Joining me on the call are Dr. Troy Wilson, our President and Chief Executive Officer, and Tom Doyle, our Senior Vice President of Finance and Accounting. Dr. Molly Leone, our Executive Vice President of Clinical Development, is also with us and available to answer questions. 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 Kuro's filings with the SEC, which are available from the SEC or on the Kuro Oncology website for information concerning risk factors that could affect the company. With that, I'll now turn the call over to Troy.

Thank you, Pete, and thank you all for joining us. We continue to generate what we believe is a robust clinical data package to support the broad development of our menin inhibitor program, beginning with Ziftimenib. We believe Ziftimenib is well-positioned to transform the treatment of menin-dependent AML so that patients with cancer may lead better, longer lives. Earlier this week, two abstracts reporting preliminary data from our COMET007 combination trial of Ziftimenib were posted on the website of the American Society of Hematology. As of the June 21st data cutoff, the abstracts continue to support a potential best-in-class safety and tolerability profile for Zifdomenib, as well as robust and durable activity in combination with standards of care, including venetoclax plus azacitidine, as well as cytarabine plus donorubicin, commonly known as 7 plus 3. In the phase 1a dose escalation portion of the COMET007 study, ziftamenib combined with vaneza was well-tolerated and demonstrated promising activity in relapsed refractory patients. No DLTs or ziftamenib-induced QTC prolongation were reported. On-target differentiation syndrome was observed in 12% of patients, including 3 of 20 KMT2A rearranged patients, and all patients had resolution of DS with appropriate management. Encouraging clinical activity was observed at both 200 and 400 milligram dose levels, including activity in previously venetoclax-exposed NPM1 mutant and KMT2A rearranged patients. Updated results, including data from the 600 milligram cohorts, will be reported at ASH. In the AML frontline adverse risk population, we are very encouraged by the safety and tolerability profile, rates of complete response, and rates of MRD negativity. Notably, no events of differentiation syndrome were reported at 200 or 400 milligrams, including among KMT2A rearranged patients, suggesting Ziftamedib can be safely combined with induction chemotherapy. We're particularly encouraged by the fact that in the context of the very challenging 7 plus 3 adverse risk AML patient cohorts, 100% of the 15 NPM1 mutant AML patients and 84% of the 19 KMT2A rearranged patients remained on study as of the data cutoff, one year after study start. Here again, updated results, including data from the 600-milligram cohorts, will be presented at ASH. We look forward to sharing a more mature data set, including data from more than 100 patients with NPM1 mutant or KMT2A rearranged acute myeloid leukemia next month. In the meantime, I'm pleased to report that all four cohorts in the Phase Ia dose escalation portion of Comet 007 have cleared the highest dose and advanced into the Phase 1B expansion study at 600 milligrams. The Phase 1B expansion study includes multiple combination cohorts, most notably Zifdomenib plus Veneza in newly diagnosed NPM1 mutant or KMT2A rearranged AML, as well as Zifdomenib plus 7 plus 3 in newly diagnosed NPM1 mutant or KMT2A rearranged AML. removing the requirement for patients to have high-risk disease. Each combination cohort is enrolling independently, and we expect to enroll at least 20 patients per cohort. We believe the Phase 1b expansion study will continue to lay the groundwork for helping us to redefine the current standards of care for newly diagnosed patients with NPM1 mutant or KMT2A rearranged AML in both the fit and unfit populations. We anticipate sharing preliminary data from the phase 1B expansion study at a medical meeting in 2025. In addition to COMET007, we continue dosing patients in our ongoing COMET008 study of ziptomenib in combination with additional standards of care, including the FLIP3 inhibitor giltaritinib, as well as flagida and low-dose cytarabine. Roughly half of all patients with relapsed or refractory NPM1 mutant AML have co-occurring FLIP3 mutations, then the prognosis for these patients is poor. Preclinical data for Ziftimenib in combination with FLT3 inhibitors has shown strong synergistic effects compared to either single agent alone. When we look across the fit, unfit, and FLT3 mutant AML frontline populations, we believe a best-in-class safety and efficacy profile and optimal pharmaceutical properties could enable Ziftimenib to become a cornerstone of therapy for patients with acute leukemias. Ultimately, our mission is to develop Ziftimenib across the continuum of care for all eligible patients with acute leukemias whose disease is driven by the Menin pathway. A critical first step toward that mission is establishing Ziftimenib as the best-in-class Menin inhibitor for patients with relapsed and refractory NPM1 mutant AML. As a reminder, Ziftimenib is the first and only investigational therapy to be granted breakthrough therapy designation for treatment of relapsed and refractory NPM1 mutant AML. NPM1 mutant AML represents approximately 30% of new AML cases annually and is a disease of significant unmet need for which there is no approved targeted therapy. FDA awarded BTD based on data from our COMET001 trial, recognizing Zyptomenib's potential as an innovative medicine for patients with this devastating disease. Supporting data from the Phase I portion of COMET-001 were recently featured in a leading clinical oncology journal, The Lancet Oncology. We completed enrollment in the registration-directed portion of COMET-001 earlier this year, enrolling more than 85 NPM1 mutant patients in fewer than 16 months. We look forward to sharing top-line results from this pivotal study next year as we continue to work closely with FDA to expedite development and review of Ziptomenib as a monotherapy. Meanwhile, we've generated a growing body of preclinical data that supports opportunities for menin inhibitors beyond leukemias, including the potential for Ziptomenib in the treatment of certain solid tumors. Last month at the EORTC NCI AACR Symposium, on molecular targets and cancer therapeutics in Barcelona, we reported preclinical data supporting the combination of ziftamenib and imatinib for the treatment of advanced gastrointestinal stromal tumors, or GIST. The combination showed unexpectedly robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST patient-derived xenograft models, and in all cases, the combination was significantly superior to imatinib monotherapy. Mechanistically, the data reveal a kit-dependent mechanism with ziftamenib and imatinib combining to sharply reduce kit expression and or activity, effectively silencing both the ERK and AKT mTOR signaling pathways and driving robust cell cycle arrest in apoptosis. Given that imatinib is well-established as the frontline standard of care in patients with GIST and generic versions are available, we believe imatinib represents a promising combination partner for ziftamentib. In August, we received FDA clearance of our investigational new drug application for ziftamentib for treatment of advanced GIST. We're now prepared to initiate a proof-of-concept study evaluating ziftamentib and imatinib in patients with advanced GIST after imatinib failure in the first half of 2025. If successful, the potential opportunity in GIST appears to be agnostic to the mutational status of KIT ingest, suggesting an opportunity to explore the combination for nearly all patients, including those in the frontline setting. Earlier this year, we reported preclinical data supporting the potential therapeutic utility of menin inhibitors in the treatment of diabetes. We are advancing multiple next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases, and we expect to nominate the first of these next-generation development candidates in the first half of 2025. Now let's quickly turn our attention to our farnesyl transferase inhibitor programs. Despite the success of targeted therapies, a considerable need remains to drive enhanced anti-tumor activity while blunting the effects of innate and adaptive resistance. We're developing our next generation farnesyl transferase inhibitor, KO2806, to address this need. 2806 was designed to improve upon the potency pharmacokinetic, and physical chemical properties of earlier FTI drug candidates. We've generated a growing body of preclinical and clinical data that demonstrate the potential for KO2806 as a companion therapeutic to augment the antitumor activities of targeted therapies, including tyrosine kinase inhibitors, KRAS inhibitors, and PANRAS inhibitors. Late last year, we began dosing patients with KO2806 as a monotherapy in a phase one dose escalation trial that we call FIT-001. FIT-001 uses an innovative design that enabled us to begin dose escalation of KO-2806 in combination cohorts very early in the study, while continuing to dose escalate concurrently as a single agent. Earlier this year, we dosed the first patient with KO-2806 in combination with cabozantinib in clear cell renal cell carcinoma. And in August, we dosed the first patient in combination with adagraciv, in KRAS G12C mutated non-small cell lung cancer. As a reminder, the study of KO2806 and Adagrasiv is supported by a clinical collaboration and supply agreement with Mirati, now a Bristol-Myers Squibb company. If successful, we believe KO2806 could drive enhanced anti-tumor activity and become a combination partner to multiple targeted therapies in large solid tumor indications. Meanwhile, we continue to evaluate the combination of tipifarnib with the targeted therapy alpelicib in PIK3CA-dependent head and neck squamous cell carcinoma in a study we call CurrentHN. We believe there may be a meaningful opportunity to combine an FTI with a PI3 kinase alpha inhibitor and look forward to presenting preliminary clinical data from the CurrentHN trial at a medical meeting in the first half of 2025. With that, I'll now turn the call over to Tom for a discussion of our financial results.