Kura Oncology, Inc.

Good day and thank you for standing by. Welcome to the Q4 2021 Cura Oncology Inc. Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touch-tone telephone. I would now like to turn the conference over to your host, Mr. Pete Despain, Senior Vice President of Investor Relations.

Thank you, Christian. Good afternoon and welcome to Cura Oncology's fourth quarter and full year 2021 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. Before I turn the call over to Dr. Wilson, I would 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 Cura 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 this afternoon. Although 2021 was a challenging year in many ways, We at Cura took the opportunity to invest in and optimize our discovery and development programs. We believe we've made significant advances in understanding the diseases we seek to target, as well as in learning how best to use our drug candidates to drive clinical benefit for patients. This past year was also one of deliberate focus on operational execution throughout the organization. Now, building on the tremendous efforts of our team, we approach a number of catalysts in the year ahead with significant momentum, resources, and enthusiasm. Our enthusiasm is supported by resumed enrollment in the COMET-001 Phase 1B expansion cohorts for our newly named MENIN inhibitor, Zifdomenib. The first several patients dosed in our Phase 1-2 combination trial of tipifarnib plus alpelisib in head and neck squamous cell carcinoma. an abstract supporting the therapeutic rationale for our next-generation farnesyl transferase inhibitor program accepted for presentation at AACR, and an expanded leadership team to support and advance our growth and execution. By mid-2022, we anticipate having three independent drug development programs to drive value in both solid and liquid tumors with meaningful data catalysts in the next 6 to 24 months. and as we approach these catalysts from a position of financial strength with an experienced team and organization and more than a half a billion in cash. Now let's take a closer look at the progress within each of our programs, beginning with our menin inhibitor, formerly known as KO539, Ziftimenib. Last month, we were pleased to receive FDA authorization to proceed with our COMET001 trial of Ziftimenib in patients with relapsed or refractory AML. the partial clinical hold was lifted following agreement with FDA on an enhanced mitigation strategy for differentiation syndrome. As we've discussed, differentiation syndrome is known to be an on-target effect associated with a number of therapeutic agents, including menin inhibitors, which may induce differentiation of leukemic blasts. Highlights of our enhanced mitigation strategy include heightened awareness, increased monitoring, and recommendations for aggressive, intervention, all to ensure physicians are fully informed and prepared to address future events should they occur. I'm very proud of our team for working so diligently with FDA and our site investigators over the holidays to resolve this issue, which speaks to our focus on operational execution. Screening for new patients began in earnest, and we're pleased to report that patient enrollment in the Phase 1B expansion cohorts has resumed. While we're excited to recruit new patients to our Phase 1B study, it's important to remember that patients already enrolled were eligible to remain on study during the partial clinical hold. And we continue to be encouraged by the safety and tolerability profile, as well as the clinical activity we're seeing with ZIFTA-MENET. Looking forward, we expect to complete enrollment of 24 patients in the Phase 1B study by the second quarter, after which we will assess the patients in each cohort for safety and tolerability, pharmacokinetics and exposure, as well as efficacy. Our goal is to identify the recommended Phase 2 dose and report top-line data from the Phase 1b by the third quarter with updated data from COMET-001 reserved for a medical meeting in the fourth quarter. Once we've identified the recommended Phase 2 dose, we plan to continue enrolling up to an additional 18 patients in the selected cohort of the Phase 1b study, enabling us to maintain momentum while we transition into the Phase 2 portion of Comet 001. We believe data from all patients treated at the recommended Phase 2 dose will have potential to contribute to the registrational patient population. Meanwhile, we continue to add sites in the United States and Europe in anticipation of the subsequent Phase 2 portion of Comet 001. We're also designing a comprehensive development strategy that builds on the potential to register Ziftimenib as a monotherapy while giving us flexibility to access larger opportunities, including earlier lines of therapy in combination more quickly. We expect to have much more to say regarding our global development strategy for Ziftimenib later this year. Now let's turn our attention to our farnesyl transferase inhibitor programs. We continue to view farnesyl transferase inhibition as a potentially valuable therapeutic and commercial franchise, one with potential to deliver multiple opportunities in oncology. Our most advanced effort is focused on patients with HRS mutant head and neck squamous cell carcinomas, or HNSCC, through our ongoing AMHN registration-directed trial of tibifarnabizum monotherapy. In addition, a growing body of preclinical and clinical data support the development of tipifarnib in combination regimens directed at larger genetic subsets. Among these potential combinations, we've prioritized the combination of tipifarnib and an inhibitor of PI3 kinase alpha. Our preclinical data suggests that HRAS and PI3 kinase alpha are codependent oncogenes in HNSCC, and that combining tipifarnib with a PI3 kinase alpha inhibitor has potential to provide meaningfully better anti-tumor activity relative to inhibiting either target alone. Furthermore, we believe this combination has potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC. Last year, we announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3 kinase alpha inhibitor alpelicib in patients with HNSCC. Alpelicib is approved to treat patients with PIK3CA mutant breast cancer, and it has demonstrated encouraging evidence of clinical activity in patients with PIK3CA-disregulated HNSCC. In December, we dosed the first patient in a phase 1-2 study of tipifarnib in combination with alpelosib in HNSCC, a study which we call the current trial, and we're pleased with the continued pace of enrollment. The initial cohort includes patients who have PIK3CA-dependent HNSCC, and we expect to initiate an HRAS overexpression cohort by the third quarter of this year. Our goal with the current trial is to identify a recommended phase 2 dose and schedule for the combination. Depending on our progress in the dose escalation, we may be in a position to provide preliminary data on safety, tolerability, and clinical activity of the combination in genetically enriched head and neck patients by year end. Meanwhile, through our own internal efforts and our network of academic collaborations, we've identified some exciting opportunities for farnesyl transferase inhibitors. opportunities we believe represent significant potential value creation. Last year, we nominated KO2806 as our lead development candidate in our next-generation farnesyl transferase inhibitor program. Based upon extensive preclinical work, KO2806 demonstrates improved potency, pharmacokinetic, and physiochemical properties relative to tipifarnib. KO2806 is designed to to target novel farnesylated proteins and address large solid tumor indications of high unmet need through combination regimens with a focus on delaying the onset of drug resistance. We were recently informed that an abstract from one of our academic collaborators supporting the first such opportunity in non-small cell lung cancer has been accepted for presentation at the upcoming American Association for Cancer Research annual meeting. We're excited about this emerging opportunity and look forward to sharing more detailed information in April. In the meantime, we are planning to perform initial clinical evaluation with tipifarnib in non-small cell lung cancer while continuing our IND enabling studies of KO2806. I believe each of our programs has potential to create significant value for patients, healthcare providers, and shareholders. And I believe we have the leadership, experience, and operational and financial resources to realize that value. Toward that end, we recently expanded our senior leadership team to help support and advance our mission. This expansion was driven by three key promotions. Dr. Molly Leone to Senior Vice President of Clinical Development, Pete to Spain to Senior Vice President of Investor Relations, Corporate Communications, Tom Doyle to Senior Vice President of Finance and Accounting. In addition, Nick Scolferato, our Senior Vice President of Regulatory Affairs, has also been added to our senior leadership team. We are intentional about cultivating talent within our organization. These additions to our senior leadership team reflect the significant contributions of Molly, Pete, Tom, and Nick, as well as our confidence in their ability to help lead us into the next exciting phase of growth. In connection with his promotion, Tom's also assumed the role of principal accounting officer from Mark Grasso, who recently stepped down as chief financial and chief business officer to pursue an opportunity closer to his family. I'd like to take this opportunity to thank Mark for his more than three years of service to Cura, during which he played an important role in ensuring our strong financial position. I respect his decision to be closer to his family and wish him well in his future endeavors. With that, I'll now turn the call over to Tom for a discussion of our financial results.