Kura Oncology FY Conference Summary Company Overview - Kura Oncology (NasdaqGS: KURA) is a commercial-stage biopharmaceutical company focused on developing targeted therapies for liquid and solid tumors [2][3] Key Priorities for 2026 - Drive the launch of KOMZIFTI to achieve majority market share - Execute an aggressive development plan for ziftomenib (KOMZIFTI) throughout the treatment continuum, especially in frontline settings [2] Product Launch and Market Feedback - KOMZIFTI was approved in November of the previous year and has had a successful launch - Key opinion leaders (KOLs) have provided positive feedback on four differentiating factors: 1. Strong efficacy in relapsed refractory NPM1 mutant space 2. Differentiated safety profile 3. Combinability with other medications 4. Simplicity of once-daily dosing [5][6] Market Adoption and Payer Response - Rapid uptake from payers, with over 80% of private payers including KOMZIFTI in their policies within the first 90 days, exceeding benchmarks [9] Clinical Development Plans - Plans to move KOMZIFTI into earlier line settings, particularly frontline AML - Focus on the properties of ziftomenib and execution of clinical trials, with a goal of enrolling 1,300 patients in phase one studies [11][13] MRD Negativity and Patient Outcomes - Emphasis on achieving minimal residual disease (MRD) negativity as a key endpoint, with a benchmark of 45% MRD negativity after two cycles of intensive chemotherapy for NPM1 patients [23][25] - The goal is to demonstrate a clinically meaningful MRD negativity rate above 10%-15% [25] Combination Therapies and Future Studies - Ongoing studies include combinations of ziftomenib with other therapies, such as Venetoclax and azacitidine, showing an overall response rate (ORR) of almost 80% in relapsed refractory NPM1 settings [35] - Upcoming data updates expected in 2026, including frontline updates and combination studies with gilteritinib [31][39] Tipifarnib Development - Kura is also developing Tipifarnib for KRAS G12C mutant solid tumors, focusing on overcoming resistance mechanisms [51][66] - The combination of Tipifarnib with other therapies is being evaluated, with a focus on safety and tolerability [75][81] Safety Profile - The safety profile of Tipifarnib is reported to be favorable, with manageable adverse events primarily related to myelosuppression [79][81] Conclusion - Kura Oncology is positioned for significant growth in 2026 with a strong focus on the launch of KOMZIFTI and ongoing clinical trials for ziftomenib and Tipifarnib, aiming to address unmet needs in oncology [3][84]

Kura Oncology Conference Call Summary Company Overview - Kura Oncology (NasdaqGS: KURA) is focused on developing therapies for cancer, particularly acute myeloid leukemia (AML) and solid tumors. [1] - The company is in a strong cash position, financed through top-line results in frontline AML. [4] Key Product: KOMZIFTI - KOMZIFTI is Kura's first commercial product, launched for NPM1-mutated AML, with a focus on establishing market leadership. [2] - The product has shown over 21% of patients achieving a Complete Response (CR) or CR with partial hematologic recovery, with a median duration of response of five months. [5][6] - Feedback from clinicians has been positive, highlighting efficacy, safety, and ease of use as differentiating factors. [9][10] Market Potential - The total addressable market (TAM) for relapsed refractory NPM1 mutant AML is estimated to be between $350 million and $400 million. [15] - Kura aims to capture a significant share of this market, with a consensus sales estimate of $48 million for KOMZIFTI in 2026. [12][13] Clinical Trials and Development - Kura is conducting two Phase 3 trials (KOMET-017) for KOMZIFTI, targeting both intensive and non-intensive chemotherapy options. [17][18] - The trial design allows for rapid site engagement and aims to cover a broad patient population. [18] - Kura is also exploring combinations with other agents, such as Quizartinib and Gilteritinib, to enhance treatment efficacy. [31][32] Competitive Landscape - Kura acknowledges competition from other companies developing menin inhibitors, such as Johnson & Johnson and Sumitomo, but believes it has a competitive edge due to its advanced development and market strategy. [36][37] Financial Position - Kura reported a cash balance of over $650 million, with additional milestones of $180 million tied to Phase 3 trials. [55] - The company is positioned to maintain operations through key value inflection points without immediate need for additional financing. [56] Future Outlook - Kura plans to release further clinical data in 2026, which is expected to validate its treatment mechanisms and support ongoing development efforts. [53] - The company is also pursuing regulatory approval in the EU for KOMZIFTI, aiming to enhance its market presence. [16] Additional Insights - Kura is exploring the use of menin inhibitors for diabetes and cardiometabolic diseases, indicating a potential expansion of its therapeutic focus. [4] - The company is committed to developing combination therapies in oncology, recognizing that AML is not typically treated with monotherapy. [33]

Ziftomenib + Ven/Aza in Newly Diagnosed NPM1-m AML - In newly diagnosed NPM1-m AML patients, the combination of ziftomenib 600 mg QD with Ven/Aza resulted in a composite complete remission (CRc) rate of 86% (32/37), with a complete remission (CR) rate of 73% (27/37)[35] - Among CRc responders in newly diagnosed NPM1-m AML, 68% (17/25) achieved MRD negativity at a threshold of ≤01% and 44% (11/25) at a threshold of ≤001%[36] - In newly diagnosed NPM1-m AML, 68% (27/40) of patients remained alive and continued on study after a median follow-up of 261 weeks[40] Ziftomenib + Ven/Aza in R/R NPM1-m or KMT2A-r AML - In R/R NPM1-m AML patients, the combination of ziftomenib 600 mg with Ven/Aza resulted in an overall response rate (ORR) of 65% (31/48) and a CRc rate of 48% (23/48)[57] - In R/R KMT2A-r AML patients, the combination of ziftomenib 600 mg with Ven/Aza resulted in an ORR of 41% (13/32) and a CRc rate of 28% (9/32)[57] - Among R/R NPM1-m AML patients without prior venetoclax exposure, the CRc rate was 70% (16/23) and the ORR was 83% (19/23)[58] - Among R/R KMT2A-r AML patients without prior venetoclax exposure, the CRc rate was 60% (6/10) and the ORR was 70% (7/10)[58] - For R/R NPM1-m AML, the median duration of CRc was 399 weeks after a median follow-up of 274 weeks[61] - For R/R KMT2A-r AML, the median duration of CRc was 124 weeks after a median follow-up of 169 weeks[64]

Core Viewpoint - Kura Oncology is hosting a virtual analyst and investor event on December 8, 2025, to discuss data on the triplet combination of ziftomenib, venetoclax, and azacitidine for treating acute myeloid leukemia [1][2] Company Overview - Kura Oncology is a biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3] - The company has developed KOMZIFTI™, an FDA-approved oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia [3]