Kura Oncology, Inc.

Good afternoon, ladies and gentlemen, and welcome to the third quarter 2023 Cura Oncology, Inc. Earnings Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 2, 2023. I would now like to turn over the call to Pete Despain, Head of Investor Relations. Please go ahead.

Thank you, Lester. Good afternoon and welcome to Cura Oncology's third quarter 2023 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'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. We believe our lead drug candidate, Ziftomenib, is well positioned for market leadership with multi-billion dollar global revenue potential in acute leukemias and beyond. Our conviction is supported by a growing body of clinical data as a monotherapy and more recently in combination with standards of care, a rapid pace of enrollment in our ongoing studies driven by strong clinical data and robust enthusiasm among investigators and patients, and a best-in-class safety and tolerability profile that we believe will enable Ziptomenib to become a backbone of therapy across the continuum of care for AML patients. Ziptomenib is a once-daily oral drug candidate that targets the MENIN-KMT2A protein-protein interaction and has potential to address all patients for whom the MENIN-KMT2A pathway is a disease driver, representing up to 50% of patients with AML. In our Phase 1 trial, Ziptomenib demonstrated an impressive 35% CR rate and 45% overall response rate in 20 patients with NPM1 mutant AML treated at the recommended Phase 2 dose of 600 milligrams. Importantly, Ziptomenib demonstrated a favorable safety profile and was well-tolerated, with no evidence of drug-induced QTC prolongation or myelosuppression, no patterns of toxicity, and adverse events consistent with underlying disease. Building upon the strength of the data from our phase one trial, we initiated a phase two trial of Zipdomenib in patients with NPM1 mutant, relapsed, or refractory AML earlier this year. The registration-directed trial is expected to enroll a total of 85 patients in the United States and Europe. We continue to be encouraged by the pace of enrollment in the trial, which in our view speaks to the size of the NPM1 mutant patient population in the relapsed and refractory setting, as well as ZyptoMENIP's potentially meaningful advantages in safety profile and clinical activity relative to available therapies. We expect to complete enrollment of all 85 patients in the Phase II registration-directed trial no later than mid-2024. Increasingly, our clinical investigators refer to ZyptoMENIP as a potentially transformational therapy. We believe their enthusiasm reflects not only their experience with it as a monotherapy, but the tremendous potential benefit to patients that could be realized by advancing Ziptomenib to earlier lines of therapy and combining it with standards of care. Indeed, our vision for Ziptomenib is that it can provide benefit to leukemia patients throughout the continuum of care, enabling deeper and more durable remissions in the frontline and relapsed refractory populations in combination, and as a potent monotherapy in the maintenance settings. Clearly, if Zipdomenib can do that, it has potential to transform the treatment of AML and ultimately to transform the commercial market for antileukemic therapy. It is these transformations in the standards of care that have enabled meaningful advances for patients in areas such as CML, lymphoma, and multiple myeloma with corresponding increases in market opportunity. Although AML is lagged behind these other areas due to the complexity, heterogeneity, and aggressive nature of the disease, we believe Zipdomenib may represent an inflection point for treatment of leukemia and potentially other diseases. As first steps toward realizing this vision, we're evaluating Zipdomenib in combination studies, both in newly diagnosed and relapsed refractory acute leukemia, including NPM1 mutant and KMT2A rearranged AML. Our approach to combinations is to establish Zipdomenib as a foundational therapy that can be combined safely with various commonly used regimens, and then to prioritize those combinations that represent the largest unmet medical need and the greatest potential commercial value. Combination approaches also offer the potential to mitigate differentiation syndrome, particularly in the KMT2A rearranged population, as has been previously demonstrated in the development of IDH inhibitors in combination with azacitidine. We began dosing patients in the first of our combination studies, which we call COMET-007, in the middle of this year. COMET-007 is a phase one dose escalation study designed to assess safety, tolerability, and preliminary activity of ziptomenib in combination with either venetoclax and azacitidine in patients with relapsed refractory NPM1 mutant and KMT2A rearranged AML. or standard induction cytarabine-donorubicin chemotherapy, commonly known as 7 plus 3, in NPM1 mutant and KMT2A rearranged patients in the frontline setting. We're very pleased with the pace of enrollment in the COMET007 study, which currently includes patients with newly diagnosed and relapsed refractory NPM1 mutant and KMT2A rearranged AML across the United States. At this rate, we anticipate being in position to share preliminary data with sufficient follow-up from 20 patients in Comet 007 in early Q1 2024. We expect the data set to include safety and tolerability from NPM1 mutant and KMT2A rearranged patients treated with Zipdomenib in both settings. We're also working to initiate our COMET-008 study of ziptomenib in combination with additional standards of care, including the FLT3 inhibitor giltaritinib, as well as our post-transplant maintenance program for ziptomenib, both of which are expected to begin in the first quarter of 2024. Meanwhile, we continue to make progress toward a next-generation menin inhibitor, which we intend to direct to additional, as yet undisclosed, indications of high clinical, commercial, and strategic interest. As we continue to build the clinical data sets that we believe will support FDA registration and commercialization of Zipdomenib, we recently enhanced our own commercial expertise with the addition of Brian Powell to our senior leadership team as our chief commercial officer. Brian joined us over the summer with more than 20 years of experience in building commercial brands in hematology and oncology with expertise in patient-focused strategies across sales, marketing, and market access for global biotech and pharmaceutical products. He's already making an impact in the organization as we continue to realize the significant potential of Ziptomenib as well as our rapidly emerging farnesyl transferase inhibitor programs. We continue to unlock the substantial therapeutic and commercial value of farnesyl transferase inhibition and believe this novel mechanism is uniquely positioned to augment clinical benefit in multiple large solid tumor indications. Last month, we presented positive results from our AIM-HN registration-directed trial of tipifardib in patients with atras mutant head and neck squamous cell carcinoma. The results were featured during a late-breaking mini-oral session at the European Society for Medical Oncology Congress in Madrid. Our AIM-HN data demonstrate that if one understands the proper biological context in which to use an FDI, it has the potential to drive meaningful clinical benefit for patients. We believe these data validate therapeutic value of farnesyl transferase inhibition as we look to advance beyond our initial strategy to target HRAS mutant tumors. With our AIM-HN data in hand, we continue to evaluate whether the combination of tipifarnib and alpelisib has potential to extend the clinical benefit observed in the AIM-HN trial to a broader set of HNSCC patients in our ongoing current HN study. We continue to evaluate patients in the dose escalation study to inform selection of the optimal biologically active dose for the combination. Once we determine the OBAD, we'll continue to evaluate whether the activity supports development and commercialization of the combination in HNSCC. One of the most important takeaways thus far from current HN is that tipifarnib demonstrates a favorable safety and tolerability profile at its full dose in combination with alpalasif. We believe this significantly de-risks development of our next generation farnesol transferase inhibitor, KO2806, as we look forward to evaluating it in combination with other targeted therapies. With the success of targeted therapies such as KRAS inhibitors, tyrosine kinase inhibitors, and EGFR inhibitors, there's now considerable focus on the development of companion therapeutics that have potential to drive enhanced antitumor activity and address mechanisms of innate and adaptive resistance. Last month, we presented exciting preclinical data at the triple meeting, supporting our rationale to combine KO2806 with Adagrasiv in KRAS G12C mutated non-small cell lung cancer and with Cavozantinib in clear cell renal cell carcinoma. A week later, we announced the first patient was dosed in the FIT001 phase one dose escalation trial of KO2806. Concurrent with the dose escalation as a monotherapy in the FIT001 trial, We also plan to evaluate KO2806 in dose escalation combination cohorts with Atagracib and Cabozantinib. Earlier today, we announced a clinical collaboration and supply agreement with Merati Therapeutics to evaluate the combination of KO2806 and Atagracib in patients with KRAS G12C mutated non-small cell lung cancer. Under the terms of the agreement, Kuro will sponsor the phase one study and Merati will supply us with Atagracib for the study. This collaboration highlights the potential to address the urgent need for more durable and effective treatment options for patients with cancers driven by the KRAS G12C mutant oncogene. We look forward to collaborating with Mirati, an established leader in targeted oncology. We expect to begin dosing KO2806 in combination with Atagracib in KRAS G12C mutated non-small cell lung cancer. and in combination with cabozantinib in clear cell renal cell carcinoma by the middle of 2024. If successful, we believe KO2806 could become an ideal combination partner for multiple targeted therapies in large solid tumor indications. We look forward to sharing our continued progress in the months ahead. With that, I'll now turn the call over to Tom for a discussion of our financial results.