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]

Financial Data and Key Metrics Changes - Kura Oncology reported net product revenue of $2.1 million from Komzifti sales in Q4 2025, compared to none in Q4 2024 [16] - Collaboration revenue from the partnership with Kyowa Kirin was $15.2 million, down from $53.9 million in the same period in 2024 [16] - Research and development expenses increased to $64.4 million from $52.3 million in Q4 2024, driven by ziftomenib combination trials [16] - Sales, general, and administrative expenses rose to $39.1 million from $24.1 million in Q4 2024, attributed to the commercial launch of Komzifti [17] - The net loss for Q4 2025 was $81 million, compared to a net loss of $19.2 million in Q4 2024 [17] - Cash equivalents and short-term investments as of December 31, 2025, were $667.2 million, down from $727.4 million at the end of 2024 [17] Business Line Data and Key Metrics Changes - Komzifti generated $2.1 million in net product revenue shortly after its launch, indicating a strong start [3] - The initial U.S. market for NPM1-mutated relapse refractory AML is estimated at approximately $350 million to $400 million annually [10] - Kura anticipates a total U.S. opportunity across relapsed refractory and frontline AML of approximately $7 billion [4] Market Data and Key Metrics Changes - Prescription trends for Komzifti are strong, with positive feedback from physicians and pharmacists regarding its clinical activity and ease of use [7] - Approximately 84% of private payers established coverage for Komzifti within 90 days of approval, surpassing industry benchmarks [9] - Certain blue plans are requiring patients to use Komzifti before allowing coverage for other approved menin inhibitors, indicating a competitive advantage [9] Company Strategy and Development Direction - Kura's strategy focuses on executing commercially, expanding development of ziftomenib across the AML treatment continuum, and advancing a pipeline with meaningful catalysts in 2026 [5] - The company aims to position ziftomenib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens [4] - Kura is advancing a focused solid tumor strategy alongside its AML initiatives [4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early launch of Komzifti and its potential to establish leadership in the menin inhibitor class [6] - The company is focused on quarter-over-quarter growth, net revenue, and new patient starts, with plans to provide additional metrics to track progress [10] - Management highlighted the importance of combination therapies in driving better outcomes for patients and gaining market share [42] Other Important Information - Komzifti is now listed in the FDA's Orange Book with patent protection through July 2044, enhancing the long-term value of the franchise [4] - Kura expects to provide guidance for collaboration revenue of $45 million to $55 million in 2026, with anticipated milestones of $180 million under the collaboration agreement with Kyowa Kirin [18] Q&A Session Summary Question: Can you provide more information about the step editing policy from payers? - Management noted that some payers are recommending Komzifti before other menin inhibitors based on its differentiated profile, particularly its cost predictability and safety [25][26] Question: Can you comment on patient demand versus revenue generation? - Management indicated that the launch has been strong, with positive feedback from physicians and expectations for increased patient demand as more data becomes available [33] Question: What do you see as the biggest hurdle for Komzifti to gain market share in 2026? - Management identified the need to get incident patients onto therapy as a key challenge, with no significant payer hurdles reported [40] Question: How do you plan to maximize the FLT3 opportunity? - Management emphasized the importance of combining ziftomenib with FLT3 inhibitors to capture a significant portion of the AML market, as FLT3 mutations represent a large patient population [64] Question: What are the expectations for duration of therapy with Komzifti? - Management stated that while it is early to provide specific data, they expect patients to be treated for up to six months, with ongoing assessments of treatment duration as more data becomes available [87]

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 has received FDA approval for ziftomenib, marking a significant milestone for the company in its oncology portfolio [1]. Group 1: Company Overview - The conference call is led by Greg Mann, Senior Vice President of Investor Relations and Corporate Affairs at Kura Oncology [1]. - Key executives participating in the call include Dr. Troy Wilson (President and CEO), Dr. Mollie Leoni (Chief Medical Officer), and Brian Powl (Chief Commercial Officer) [2]. Group 2: FDA Approval Details - The call is focused on discussing the FDA approval of ziftomenib, with supporting materials available on the company's website [1]. - Dr. Eunice Wang, a notable expert in leukemia, is a guest speaker for the call, indicating the importance of the approval in the context of leukemia treatment [2].

Core Insights - Kura Oncology's ziftomenib is under FDA Priority Review for adults with relapsed/refractory NPM1-m acute myeloid leukemia (AML), with a target action date of November 30, 2025 [1] - The KOMET 017 Phase 3 trials for ziftomenib are accelerating, targeting over 50% of AML patients by evaluating its combination with intensive and non-intensive chemotherapy [1][5] - The company reported a net loss of $74.1 million for Q3 2025, an increase from a net loss of $54.4 million in Q3 2024, with significant increases in research and development expenses [7][16] Company Updates - Kura Oncology is advancing its ziftomenib program and broader precision oncology pipeline, supported by a strong balance sheet and collaboration with Kyowa Kirin [2] - The first patient was dosed in the KOMET-017 trial in September 2025, which includes two global, randomized, double-blind, placebo-controlled trials [5] - Preliminary clinical data from ziftomenib in combination with venetoclax/azacitidine will be presented at the 2025 ASH Annual Meeting [5][9] Financial Performance - Collaboration revenue for Q3 2025 was $20.8 million, compared to no revenue in Q3 2024 [7][16] - Research and development expenses rose to $67.9 million in Q3 2025 from $41.7 million in Q3 2024 [7][16] - As of September 30, 2025, the company had pro forma cash and equivalents of $609.7 million, expected to support operations into 2027 [7][18]

Core Insights - Kura Oncology has received a $30 million milestone payment from Kyowa Kirin for the dosing of the first patient in the second Phase 3 trial of ziftomenib, bringing total milestone payments received to $105 million, with expectations of up to $315 million in additional near-term milestones [1][2]. Group 1: Company Overview - Kura Oncology is a clinical-stage 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 is developing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemia (AML), and is pioneering advancements in menin inhibition for both acute leukemias and solid tumors [3]. Group 2: Clinical Trials - The KOMET-017 trial consists of two independent, global, randomized double-blind, placebo-controlled Phase 3 trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML [2]. - Kura believes that KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings [2].

Core Insights - Kura Oncology and Kyowa Kirin announced that results from the KOMET-007 trial of ziftomenib will be presented at the ASH 2025 Annual Meeting on December 8, 2025 [1][2] Group 1: Trial Details - KOMET-007 is a Phase 1a/b study assessing ziftomenib in combination with standard chemotherapies for adults with NPM1-mutated or KMT2A-rearranged acute myeloid leukemia (AML) [2] - The upcoming presentations will include data on newly diagnosed adults with NPM1-m AML and updated results for relapsed or refractory cases treated with ziftomenib combined with venetoclax and azacitidine [2][3] Group 2: Presentation Information - Two oral presentations will take place on December 8, 2025, focusing on the safety and clinical activity results from the KOMET-007 trial [5] - The presentations will provide more mature data, including additional response-evaluable patients and expanded safety summaries [3] Group 3: Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [6] - Ziftomenib is a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias, with ongoing efforts to advance menin inhibition in various cancer types [6]

Core Insights - Kura Oncology, Inc. will report its third quarter 2025 financial results on November 4, 2025, before U.S. markets open [1] - A conference call and webcast will be held at 8:00 a.m. ET / 5:00 a.m. PT to discuss the financial results and provide a corporate update [1] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [3] - The company's pipeline includes small molecule drug candidates targeting cancer signaling pathways, specifically for hematologic malignancies and solid tumors [3] - Kura is developing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias, and is advancing menin inhibition for acute leukemias and solid tumors [3]

Core Insights - Kura Oncology has received a $30 million milestone payment following the dosing of the first patient in the KOMET-017 Phase 3 clinical trials for ziftomenib, an investigational oral menin inhibitor [1] - The KOMET-017 trials are designed to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia [2] - Kura Oncology is focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company dedicated to developing precision medicines for cancer treatment [3] - The company is advancing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias, and is also exploring farnesyl transferase inhibition for solid tumors [3]