Kura Oncology, Inc.

Good day, and welcome to the Cura Oncology first quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Pete DeStain, Senior Vice President of Investor Relations. Please go ahead. Great.

Thank you, Ian. Good afternoon, and welcome to Cura Oncology's first quarter 2022 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. Stephen Dale, our Chief Medical Officer, 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 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. Despite what continues to be a challenging, broader market environment, we continue to operate from a position of strength here at Cura, armed with three independent drug development programs, a strong, experienced team, a well-designed clinical development strategy, and a cash runway through 2024. Now, as we approach a series of important catalysts, driven by completion of enrollment in the Phase 1B study of our MENIN inhibitor, Ziftimenib, and culminating in top-line data next quarter and a full data presentation in the fourth quarter. As mentioned, I'm pleased to report we recently completed enrollment of the patients in the Phase 1B portion of COMET001 required to identify a recommended Phase 2 dose for Ziftimenib. Recall the study was designed to enroll two expansion cohorts, 200 milligrams, and 600 milligrams, with each cohort comprised of patients with NPM1 mutant or KMT2A rearranged relapsed and or refractory acute myeloid leukemia. The goal of the Phase 1B is dose optimization consistent with FDA's guidance around Project Optimus, and the two doses were selected based on the encouraging clinical activity, safety profile, and tolerability demonstrated in the Phase 1A portion of the study. We're now assessing the patients in each expansion cohort for safety and tolerability, pharmacokinetics and exposure, as well as efficacy. We remain on track to identify the recommended Phase 2 dose for Ziftamenib and to report top-line data from the Phase 1b study in the third quarter with a more complete data set from COMET-001 reserved for presentation at a medical meeting in the fourth quarter. As a reminder, the study protocol gives us flexibility to enroll additional patients in the Phase 1b, enabling us to maintain momentum while we transition into a subsequent Phase 2 registration-directed portion of COMET001. 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 remain enthusiastic about the encouraging safety profile, tolerability, and clinical activity we are observing in the Phase 1b study as we continue to add sites in the U.S. and Europe in anticipation of the subsequent Phase 2 portion of COMET-001. We also intend to conduct a comprehensive development strategy that builds upon the potential to register zyptomenib as a monotherapy while giving us flexibility to access larger opportunities through combinations and in earlier lines. We look forward to sharing much more regarding our global development strategy for Ziftimenib later this year following identification of the recommended phase two dose. 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. One of the first examples of the use of FTIs as a targeted therapy was demonstration of the potential for tibifarnib to drive durable responses in recurrent and metastatic HRS mutant HNSCC, and our ongoing MHN registration-directed trial continues in that indication. More recently, we've begun efforts to build upon the initial monotherapy activity of tibifarnib with two goals. Number one, to drive deeper and more durable responses, and number two, to expand the potential patient population. Toward this end, we're pursuing the current HN trial to evaluate the combination of tipifarnib and dalpelicib, an inhibitor of PI3 kinase alpha, in selected HNSCC patient cohorts. By combining tipifarnib and dalpelicib, we believe we can achieve both goals. Our preclinical data suggests the combination has potential to provide meaningfully better antitumor activity relative to inhibiting either target alone, and by targeting both PIK3CA and HREF-dysregulated HNSCC, the combination has potential to increase the total addressable population for tibifarnib to as much as 50% of patients with HNSCC. In December, we dosed the first patient in our Phase I-II current HN trial of tibifarnib in combination with alpelicib in HNSCC. The initial cohort includes patients who have PIK3CA-dependent HNSCC. Screening has commenced in an HRAS overexpression cohort, and we expect to dose the first patient in this cohort by the third quarter. Our goal with the current HN trial is to identify a recommended Phase II dose and schedule for the combination and look for early signs of clinical activity. Our team is making excellent progress, and we look forward to providing an update. Beyond HNSCC, we're beginning to understand FTIs may represent an ideal combination partner for certain classes of targeted therapy in large solid tumor indications. The first of these emerging combination opportunities was highlighted last month in a late-breaking presentation at the American Association for Cancer Research annual meeting in New Orleans. The new findings were generated through a collaboration with NSERM, the French National Institute of Health and Medical Research. The presentation featured preclinical data supporting the potential for tipifarnib to prevent emergence of resistance to osimertinib in EGFR mutant non-small cell lung cancer. Several farnesylated targets were identified that appear to control the ability of lung cancer tumor cells to enter and exit a state that makes them tolerant to osimertinib. Using preclinical and vivo models of EGFR mutated lung tumors, co-treatment with tipifarnib durably prevented relapse to Osimertinib for up to six months with no evidence of toxicity. Collectively, these data strongly support the potential use of an FTI to prevent or delay the adaptive response to Osimertinib. We're preparing to initiate a phase one study of Tipifarnib in combination with Osimertinib in treatment naive locally advanced and or metastatic EGFR mutated non-small cell lung cancer and we expect to dose the first patient in that study, which we call the current lung trial, in the third quarter. We intend to perform initial clinical evaluation with tipifarnib and osimertinib, while in parallel advancing KO2806, the lead development candidate in our next generation FDI program, through IND-enabling studies. We remain on track to submit an IND application for KO2806 in the fourth quarter. With that, I'll now turn the call over to Tom