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]

Core Insights - Kura Oncology is advancing the use of farnesyl transferase inhibitors (FTIs) in combination with targeted therapies to overcome resistance mechanisms in cancer treatment [2][11] - Preliminary data from ongoing clinical trials indicate promising efficacy of darlifarnib, showing a 50% objective response rate and an 80% disease control rate in renal cell carcinoma when combined with cabozantinib [1][4] - The company is hosting a virtual investor event to discuss these findings and their implications for future cancer therapies [9][10] Clinical Data Highlights - Darlifarnib demonstrated a 50% objective response rate (ORR) and an 80% disease control rate (DCR) in renal cell carcinoma (RCC) patients in an ongoing dose-escalation trial [1][4] - The combination of tipifarnib and alpelisib showed a 47% ORR in heavily pretreated patients with PIK3CA-altered head and neck squamous cell carcinoma (HNSCC) [6][7] - The ongoing studies are assessing the optimal biologically active dose for combinations across various tumor types [6][4] Mechanism of Action - FTIs like darlifarnib block hyperactivated mTORC1 signaling in tumor endothelial cells, which is crucial for enhancing the efficacy of PI3Kα inhibitors [6][11] - The mechanism of FTIs addresses both innate and adaptive resistance pathways common in targeted oncology therapies [2][6] Future Directions - Kura Oncology plans to further evaluate darlifarnib in combination with PI3Kα inhibitors across different solid tumors [6][11] - A Phase 1b dose-expansion study is planned to determine the optimal dosing strategy for the combination therapies [6][4]

Company Overview - Kura Oncology is preparing for the FDA approval of ziftomenib, with a PDUFA date set for November 30, indicating confidence in obtaining a competitive label for relapsed/refractory NPM1-mutant AML [3]. Product Development - The company has received positive feedback from key opinion leaders (KOLs) regarding the efficacy, simplicity, compatibility, and safety of ziftomenib compared to competitors [3]. - Kura's commercial team is fully established and ready for market access and preapproval information exchanges [3]. Future Prospects - Kura Oncology is also advancing ziftomenib in combination with standard treatments for frontline indications, indicating a strategic focus on expanding its therapeutic applications [4].

Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML) [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the significance of FLT3 as a target [1] - The KOMET-007 clinical trial has commenced, focusing on ziftomenib's efficacy alongside cytarabine, daunorubicin, and quizartinib for newly diagnosed AML patients [1][2] Company Overview: Kura Oncology - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [4] - Ziftomenib, a menin inhibitor, is under development to address specific genetic drivers of acute myeloid leukemias [4] Company Overview: Kyowa Kirin - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5] - The company is committed to developing novel medicines and treatments for high unmet medical needs, including hematological diseases and rare diseases [5]

Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML), addressing a significant unmet need in patients with FLT3/NPM1 co-mutations [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the importance of targeting this genetic alteration [1] - The KOMET-007 clinical trial has commenced, focusing on the safety and efficacy of ziftomenib combined with standard chemotherapy and quizartinib for newly diagnosed AML patients [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company dedicated to developing precision medicines for cancer treatment, with a focus on small molecule drug candidates targeting cancer signaling pathways [4] - Kyowa Kirin is a global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation, aiming to develop novel therapies for high unmet medical needs [5] Clinical Development - Ziftomenib has received Breakthrough Therapy Designation from the FDA for treating adult patients with relapsed or refractory NPM1-mutated AML, indicating its potential significance in the treatment landscape [1] - The KOMET-007 trial will assess the combination of ziftomenib with intensive chemotherapy and quizartinib, with primary endpoints including complete remission and composite complete remission [2]