Kura Oncology, Inc.

Good day and welcome to the Cura Oncology 3Q conference call. Today's call is being recorded. I'll now turn the call over to Pete Despain. Please go ahead, sir.

Thank you, Paula. Good afternoon and welcome to Cura Oncology's third 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. Dr. Steven Dale, our chief medical officer, Kirsten Flowers, our chief commercial officer, and Kathy Ford, our chief operating officer, are also with us and available to answer questions. 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 Curo's filings with the SEC, which are available from the SEC or on the Curo Oncology website for information concerning risk factors that could affect the company. With that, I will now turn the call over to Dr. Troy Wilson, President and CEO of Curo Oncology.

Thank you, Pete, and thank you all for joining us this afternoon. I'm pleased by the progress our team has made over the past quarter, highlighted by accelerated enrollment in the Phase 1B expansion cohorts for KO539. Preclinical data highlighting the molecular mechanisms of activity for KO539 and its potential for synergistic combination with venetoclax. First clinical site activated in the Phase I-II trial of tipifarnib plus alpelisib in head and neck squamous cell carcinoma and ongoing IND enabling studies for KO2806. As an organization, we remain focused on our three main programs, our menin inhibitor, KO539 in acute leukemias, our farnesyl transferase inhibitor, tipifarnib and head and neck squamous cell carcinomas, and our next-generation farnesyl transferase inhibitor, KO2806, in solid tumors. We believe these programs have the potential to create significant value for patients, healthcare providers, and shareholders, and we believe we have the experience, leadership, and financial resources to deliver that value. Now, let's take a closer look at the progress within each of the programs, beginning with KO539. We've completed the phase 1A dose escalation study of 539, which demonstrated encouraging single-agent activity in an all-comer population of patients with relapsed and or refractory AML, including those with NPM1 mutations and KMT2A rearrangements. KO539 also showed a favorable safety and tolerability profile, notably with no evidence of QTC prolongation. We intend to conduct a comprehensive clinical development plan For KL539, both as a monotherapy and in combination. A key step is determination of a recommended phase 2 dose, which is the goal of our ongoing phase 1B study. We're currently enrolling two expansion cohorts, a lower dose of 200 milligrams and a higher dose of 600 milligrams, and each cohort is comprised of patients with NPM1 mutant or KMT2 rearranged relapsed and or refractory AML. The dose is being evaluated in a phase 1B, were selected based on the clinical activity, safety, and tolerability demonstrated in the Phase 1a study. We continue to be encouraged by the preliminary results from the Phase 1b study thus far, with evidence of activity at both doses and a favorable safety and tolerability profile. We're also encouraged by the enthusiasm of our investigators, with approximately half of an estimated 40 global sites now actively screening patients for enrollment in the study. We continue to aggressively add sites in the U.S. and Europe in anticipation of the Phase II portion of the study, and we maintain our enrollment guidance of 12 evaluable patients in each cohort of the Phase Ib study by the first quarter of 2022. Once enrolled, we will assess the patients in each cohort for safety and tolerability, pharmacokinetics, and efficacy to determine the recommended Phase II dose. The study protocol also gives us flexibility to enroll up to 30 patients in the selected cohort. This enables us to continue enrolling patients in the Phase 1b study at the recommended Phase 2 dose while we transition into a subsequent registration-directed portion of the study. Importantly, we believe data from all patients treated at the recommended Phase 2 dose have potential to contribute to the registrational patient population. Thus, our Phase 1b study not only helps us to refine selection of a recommended phase two dose, but it enables us to start our path toward registration while maintaining an aggressive development timeline for the program. We intend to provide a more comprehensive update on the phase one study, including results from the phase one A and the phase one B at a future medical meeting pending determination of the recommended phase two dose. Based on our progress, and the totality of the clinical and preclinical data to date, we continue to believe KO539 has potential to be both a first-in-class and a best-in-class Mennon inhibitor. As such, we're designing a development strategy that builds on the potential to register KO539 as a monotherapy, while giving us flexibility to get to larger opportunities in combination more quickly, including earlier lines of therapy. Efforts are already underway to support some of these additional development activities. For example, encouraging preclinical data has been generated through a research collaboration with Dr. Kapil Bala at MD Anderson, highlighting the molecular mechanisms of KO539 and its potential for synergistic activity in combination with venetoclax in KMT2 rearranged and NPM1 mutant AML models. These data have been accepted for presentation at the upcoming American Society of Hematology annual meeting. The abstract was published earlier today and is now available on the ASH website. We look forward to Dr. Bhalla's presentation next month and to sharing our progress with you as we continue to drive toward a recommended phase two dose for KO539 next quarter. Turning our attention now to farnesyl transferase, we continue to view farnesyl transferase inhibition as a potentially valuable therapeutic and commercial franchise one with potential to deliver multiple opportunities in oncology. For example, earlier today, an abstract was published with the final results from a Phase II study of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma. Although we paused continued development of tipifarnib in T-cell lymphoma in early 2020 to focus on our programs in head and neck squamous cell carcinoma and AML, the Phase II trial continued. The final results will be presented by Dr. Thomas Witzig hematologist at Mayo Clinic, and a studies lead investigator in an oral presentation at ASH. This abstract can also be found on the ASH website. The clinical benefit demonstrated in patients with certain subtypes of T-cell lymphoma, including an overall response rate of 56.3% and a median overall survival of 32.8 months in patients with angioimmunoblastic T-cell lymphoma, underscore the potential to target farnesyl transferase to drive clinical benefit in patients. As most of you know, our most advanced effort with tibifarnib is focused on patients with head and neck squamous cell carcinomas, or HNSCC, which carry mutations in the HRS gene. Tibifarnib has been awarded Breakthrough Therapy designation from FDA for the treatment of patients with recurrent or metastatic HRS mutant HNSCC. The Breakthrough Therapy designation was based upon data from our Phase II RUN-HN trial, which was published earlier this year in the Journal of Clinical Oncology. We continue to be motivated by these data and remain focused on our AIM-HN registration directed trial of tibifarnib as a monotherapy in patients with HRAS mutant HNSCC. In addition to addressing an urgent unmet need for patients, we believe the opportunity for tibifarnib in HRAS mutant HNSCC provides a beachhead to the development of rational combinations and the expansion to larger genetic subsets. Just last month, a review paper was published in the journal Cancers, highlighting the rationale and preclinical and clinical data that support the potential for farnesyl transferase inhibitors in combination regimens in squamous cell carcinomas. 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 potential 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 tipifarnib to as much as 50% of patients with HNSCC. This past quarter, we announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3 kinase alpha inhibitor alpelosib in patients with HNSCC. Alpelisib is approved to treat patients with PIK3CA mutant breast cancer, and it has demonstrated encouraging evidence of clinical activity in patients with HNSCC. We're now actively preparing for a Phase I-II study of tipifarnib in combination with alpelisib in 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 should allow us to identify a recommended phase two dose for the combination. We've now activated the first clinical site, and we're on track to begin dosing patients in the current trial by the end of this year. Meanwhile, through our own internal efforts and our network of academic collaborators, we've identified some exciting opportunities for farnesyl transferase inhibitors in combination with other targeted therapies in large solid tumor indications, opportunities that we believe represent significant potential value creation. Last quarter, we nominated KO2806 as the lead development candidate in our next-generation farnesyl transferase inhibitor program, a compound with improved potency, pharmacokinetic, and physical chemical properties relative to tippy farno. Our next-gen FTI program is designed to target innovative biology and to address large solid tumor indications of high unmet need through rational combinations with a focus on delaying the onset of drug resistance. We're very excited about this emerging opportunity, and we look forward to sharing more information in the months ahead. With that, I'll now turn the call over to Mark Grasso for a discussion of our financial results.