Kura Oncology, Inc.

Good day and thank you for standing by. And welcome to the second quarter 2021 Cura Oncology, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone or touchtone key. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Vice President of Investor Relations, Mr. Pete DeStein. Thank you. Please go ahead, sir.

Thank you, operator. Good afternoon and welcome to Cura Oncology's second quarter 2021 conference call. Joining me on the call are Dr. Troy Wilson, our President and Chief Executive Officer, and Dr. Mark Grasso, our Chief Financial Officer and Chief Business Officer. 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 Dr. Troy Wilson President and CEO of Cura Oncology.

Thank you, Pete, and thank you all for joining us this afternoon. I'm extremely proud of the progress our team has made across the pipeline over the past several months, underscoring our focus on operational execution. This progress is highlighted by the first patients dosed in the Phase Ib expansion cohorts with our Mennon inhibitor, KL539, a clinical collaboration with Novartis to evaluate Kipifarnib, in combination with the PI3 kinase alpha inhibitor Alpelisib in head and neck squamous cell carcinoma, and nomination of KO2806 as the lead development candidate in our next generation foreign cell transferase inhibitor program. Now let's take a closer look at the progress within each of our programs, beginning with our menin inhibitor, KO539. We continue to have strong conviction in KO539 and its potential to be both a first in class and a best-in-class menin inhibitor. This confidence is supported by the results from the Phase 1A dose escalation portion of COMET001, our Phase 1-2 clinical trial of KO539. These data showed promising single-agent activity in an all-comer population of patients with relapsed or refractory AML, including patients with NPM1 mutations and KMT2A rearrangements. We're also encouraged by the clinical activity observed in patients with other co-mutations, including a complete remission in a patient with a SETI2 RUNX1 mutation. We believe these patients may represent a potential third expansion cohort, a differentiating feature of our program. KO539 also demonstrated a favorable safety and tolerability profile with no evidence of QTC prolongation, another important differentiating feature of the program. Given the wide therapeutic window, KO539, demonstrated in the Phase 1A dose escalation portion of the study, we've now advanced to two Phase 1B expansion cohorts, a lower dose of 200 milligrams and a higher dose of 600 milligrams, each comprising NPM1 mutant and KMT2 rearranged relapsed and refractory AML patients. These two doses demonstrated preliminary evidence of activity and were determined to be safe and well-tolerated in the dose escalation portion of the study. The Phase 1b is designed to determine the lowest dose of KO539 that provides maximum biologic and clinical effect in keeping with guidance from FDA relating to targeted therapies in oncology, now known as Project Optimus. The first patient was dosed in the 600 milligram cohort of the Phase 1b in late June. We've now enrolled patients in each expansion cohort and have a queue of patients in screening. Approximately half of an estimated 20 U.S. sites are actively screening patients in the Phase 1b, with sites pending across five European countries, a demonstration of the strong execution of our clinical operations team. Our base case is that we should complete enrollment of the 12 evaluable patients in each cohort by the first quarter of 2022. We will then assess these patients for safety and tolerability, pharmacokinetics, and efficacy in order to determine the recommended Phase II dose. The study protocol gives us the flexibility to enroll up to 30 patients in the selected cohort. This enables us to continue enrolling patients in the Phase Ib at the recommended Phase II dose while we transition into the subsequent registration-directed portion of COMET-001. Importantly, we believe data from all patients treated at the recommended Phase II dose will contribute to the registrational patient population. Thus, our Phase Ib not only helps us to gather a more robust data set in our target populations and to refine the selection of a recommended Phase II dose, but it enables us to start our path toward registration and maintain an aggressive development timeline for the program. Although it's early and results are still preliminary, we're encouraged by observations of early signs of clinical activity in the Phase 1B. We intend to provide an update on both the Phase 1A and the Phase 1B at a future medical meeting pending determination of the recommended Phase 2 dose. In addition, we'll seek to provide qualitative updates on the progress of the Phase 1B in the months ahead as appropriate. In the meantime, we're preparing to conduct a comprehensive clinical development plan for KL539 pending determination of a recommended phase two dose. Additional development opportunities include combination studies, other genetic subtypes, pediatric development strategy, and other indications such as acute lymphocytic leukemia and myelodysplastic syndrome. Efforts are already underway to support some of these larger opportunities. For example, encouraging preclinical data has been generated through one of our research collaborations showing evidence of synergistic activity of KO539 in combination with venetoclax in KMT2 rearranged and NPM1 mutant AML models. We expect to have more to say regarding these data potentially later this year. Although our Mennon program continues to capture much of the attention, we remain just as excited about the opportunities for farnesyl transferase inhibition in oncology. The most advanced of these opportunities is focused on patients with head and neck squamous cell carcinomas, or HNSCC, that carry mutations in the HRAS gene. Earlier this year, tibifarnib was granted breakthrough therapy designation from FDA for the treatment of patients with recurrent or metastatic HRAS mutant HNSCC. The breakthrough therapy designation was based upon data from our Phase II RUN-HN trial, which was published a month later in the Journal of Clinical Oncology. We continue to be motivated by these data, by the BTD award from FDA, and the potential for tibifarnib to represent the first approved small molecule targeted therapy in HNSCC. As such, we remain focused on our AMHN registration-directed trial and bringing tibifarnib to market as quickly and as efficiently as possible. In addition to addressing an unmet need for patients, we believe the opportunity for tibifarnib and atres mutant HNSCC provides a beachhead to the development of rational combinations and expansion to larger genetic subsets. Among these potential combinations, we've identified, as a priority, the combination of tipifarnib and a PI3-kinase alpha inhibitor. 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 the potential to meaningfully to provide meaningfully better antitumor activity relative to inhibiting either target alone. We believe this combination has the potential to increase the total addressable population for tipifornib to as much as 50% of patients with HNSCC. Last month, we announced a clinical collaboration with Novartis to evaluate the combination of tipifornib and the PS3 kinase inhibitor alpelisib in patients with HNSCC. Alpelacib is approved to treat patients with PIK3CA mutant breast cancer, and it has demonstrated encouraging evidence of clinical activity in patients with HNSCC. Given the strong preclinical rationale and data, we look forward to evaluating the two drugs in combination. We're now actively preparing for a Phase 1-2 study of Tipifarnib in combination with Alpelacib and HNSCC, which we call the current trial. The initial cohort will include patients who have PIK3CA-dependent HNSCC. These patients can be identified using next-generation sequencing, which will allow us to identify a recommended Phase II dose and schedule for the combination. Under the terms of the collaboration agreement, we will sponsor the current trial and supply tipifarnib, and Novartis will supply alpelisib. We expect to initiate this study in the fourth quarter of 2021, and we look forward to sharing our progress with you. Meanwhile, through our own internal efforts and our network of academic collaborations, we've uncovered some exciting opportunities for farnesyl transferase inhibitors in combination with other targeted therapies. Last year, we initiated a discovery stage program to develop a next-generation farnesyl transferase inhibitor designed to target innovative biology and address large oncology indications of high unmet need through rational combinations. Our goal for this program was to deliver a drug candidate that has improved potency, pharmacokinetic, and physical chemical properties relative to tipifarnib. Our team identified multiple advanced lead compounds, and I'm pleased to report we've nominated one in particular, a compound we call KO2806, as our lead development candidate. We're now conducting IND-enabling studies and expect to submit an IND application for KO2806 by the end of 2022. We believe farnesyl transferase inhibition in oncology has the potential to deliver multiple opportunities for large indications, and we look forward to sharing an update with you as this story continues to evolve. With that, I'll now turn the call over to Mark Brasso for a discussion of our financial results.