Kura Oncology, Inc.

Greetings and welcome to Cora Oncology's fourth quarter 2022 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Pete Despain. Thank you. You may begin.

Thank you, Rob. Good afternoon and welcome to Cura Oncology's fourth quarter and full year 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. Let's jump right in. In December, we were proud to report updated data from our Phase I trial of Ziftomenib at the American Society of Hematology annual meeting. Ziftomenib is our once-daily oral drug candidate targeting the MEN and KMT2A protein-protein interaction for treatment of genetically defined AML patients with high unmet need. The data at ASH highlighted the encouraging safety profile and clinical activity of Ziftomenib in patients with relapsed refractory AMLs. Notably, the data included a 30% complete response rate with full count recovery among 20 patients with NPM1 mutant AML treated at the 600 milligram dose. To our knowledge, this represents one of the highest response rates reported to date for targeted therapies in a relapsed refractory setting. A median duration of response had not been reached as of the ASH data cutoff on October 24th. In addition to the strong observed clinical activity, Zifdomenib demonstrated a favorable safety profile and encouraging tolerability, which resulted in designation of 600 milligrams once daily dosing as the recommended Phase II dose and schedule following a positive Type C meeting with FDA. Building on the momentum of our Phase I data and FDA interactions, we recently announced the first patients dosed in our Phase II registration-directed trial of Zifdomenib in NPM1 mutant, relapsed, or refractory AML. We expect to enroll a total of 85 patients in the United States and Europe. The primary endpoint is CR or CRH, and key secondary endpoints include duration of response, transfusion independence, safety, and tolerability. Dosing the first patients in our registration-directed trial of Zifdomenib marks a significant milestone for our Mennon program and is a testament to the hard work and dedication of our team. The speed with which we've begun enrolling patients in the trial also speaks to the significant interest in Zipdomenib among investigators. NPM1 mutant AML accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy yet exists. Although untreated NPM1 mutant AML may pretend a more favorable prognosis upon initial diagnosis, The risk of relapse remains high, and survival outcomes are poor after initial chemotherapy, particularly when other poor-risk mutations, such as IDH1 or 2 or FLT3, are also present. Notably, in our Phase I trial for Ziftamenib, two-thirds of NPM1 mutant AML patients who achieved a CR at 600 milligrams had either IDH and or FLT3 co-mutations, all of whom had failed prior treatment with IDH and or FLT3 inhibitors. An additional NPM1 mutant patient who entered the trial with multiple co-mutations, including DNMT3A, following two prior stem cell transplants, also achieved a CR with no evidence of minimal residual disease and remains unzipped amenib for more than 31 cycles as of the October 24th data cutoff. In addition to impressive activity as a monotherapy in patients with NPM1 mutations, We believe Zyptomenib is well-positioned for future combination strategies. Our conviction is supported by several key competitive advantages, including no evidence of drug-induced QTC prolongation, no predicted adverse drug-drug interactions, and oral daily dosing that should enable convenient administration with standards of care. Our team is working diligently to initiate the COMET007 and COMET008 trials to evaluate Ziptomenib in combination with current standards of care in earlier lines and across multiple patient populations, including NPM1 mutant and KMT2A rearranged AML. We've designed these phase one studies to assess the safety, tolerability, and therapeutic activity of Ziptomenib in combination with key regimens, such as venetoclax and azacitidine, giltaritinib, and 7 plus 3. Our approach is to establish a foundation where ziftamenib can be combined safely with various commonly used regimens and then prioritize those combinations that represent the largest populations and greatest potential commercial value, primarily venetoclax and FLT3-containing regimens. In particular, we believe ZiptoMenib has potential to combine more safely and effectively with FLT3 inhibitors relative to other menin inhibitors in development. Notably, up to half of NPM1 mutant AML patients also exhibit commutations in the FLT3 gene. We also believe that rational combination approaches will help to mitigate differentiation syndrome in the KMT2A rearranged population. as has previously been demonstrated in the development of IDH inhibitors in combination with azacitidine. We're very excited about the potential for our combination studies to further unlock the value of Zipdomenib for patients with acute leukemias. We anticipate initiating the first of these studies, COMET007, in the first half of 2023. We continue to have strong conviction in Ziptomenib and its potential to be the best-in-class MEN inhibitor, and we continue to prioritize investment in the program, including significant investments in NDA preparedness as well as combination studies. We look forward to sharing further updates on the program as the year progresses, including presentation of a more mature dataset from our Phase 1 trial of Ziptomenib in NPM1 mutant AML at a medical meeting in mid-2023. Now, let's turn our attention to our farnesyl transferase inhibitor programs. Over the past several years, we've pioneered the development of FTIs as combination agents to delay or prevent emergence of resistance to certain classes of targeted therapies in large solid tumor indications. Our preclinical data is supportive of FTIs in combination with a growing number of targeted therapies, including EGFR inhibitors and piatric kinase alpha inhibitors as well as tyrosine kinase inhibitors in renal cell carcinoma and KRAS G12C inhibitors in lung cancer. Our next-generation farnesyl transferase inhibitor, KO2806, was developed with these applications in mind. KO2806 was designed to improve upon potency, pharmacokinetic, and physical chemical properties of earlier FDI drug candidates. Last month, we were pleased to announce FDA clearance of the investigational new drug application for KO2806 for treatment of advanced solid tumors. We intend to evaluate safety, tolerability, and preliminary anti-tumor activity of KO2806 in a phase one dose escalation trial, which we're calling FIT001, as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. Clearance of the IND for KO2806 marks an important next step for this program, and we look forward to starting FIT001 in the third quarter. Meanwhile, we continue to evaluate tipifarnib in combination with the PI3 kinase alpha inhibitor alpelosib to address larger genetic subsets of HNSCC patients. In October, we reported the first demonstration that the combination of tipifarnib and alpelosib can induce a durable clinical response in a PIK3CA-dependent HNSCC at the EORTC NCI AACR Molecular Targets and Cancer Therapeutics Symposium. Notably, a patient with stage 3 squamous cell carcinoma of the tonsil with a PIK3CA mutation has achieved a durable partial response in our current HN trial and has continued on study for more than 27 weeks as of the September 14th data cutoff. Treatment-related adverse events in current HN are consistent with the known safety profiles of each drug and are manageable, with no dose-limiting toxicities reported to date. Our team is now focusing its efforts on identifying a recommended Phase II dose and schedule for the combination, with a goal of determining the optimal biologically active dose in mid-2023. In an ongoing effort to prioritize those programs with highest potential, To create value for patients, healthcare providers, and shareholders, we've decided to close our current lung trial and discontinue further development of Tipifarnib in combination with Osimertinib. We believe taking this disciplined approach enables us to enhance our focus on those development programs with the highest potential value, namely, Zifdomenib and KO2806, while maintaining a strong cash position. Finally, in support of our ongoing corporate development strategy, we were pleased to announce a $25 million equity investment from Bristol-Myers Squibb in the fourth quarter. The equity investment from BMS strengthens the relationship between our organizations and provides us with key insights and expertise. We're pleased to have the confidence of the BMS team and excited to work with them to deliver innovative science with the potential to benefit patients. With that, I'll now turn the call over to Tom for a discussion of our financial results.