Summary of CURA Oncology's Conference Call Company Overview - CURA Oncology is preparing for significant presentations at ASCO and EHA, particularly focusing on Zifdomenib's pivotal trial results in NPM1 mutant AML [2][3] - The company has a strong financial position with over $700 million in capital and $375 million in near-term milestones [5][6] Key Highlights from ASCO and EHA - CURA will present full data from the COMMENT 001 registrational study at ASCO, with top-line results indicating a 23% complete response (CR) rate [7][8] - The company is optimistic about Zifdomenib's approval potential, citing competitive clinical activity and safety [8] - At EHA, CURA will provide updates on the COMMENT 007 trial, which involves intensive chemotherapy and Zifdomenib, and the COMET 015 study combining Zifdomenib with Imatinib in advanced GIST patients [4][19] Competitive Landscape - The menin inhibitor class is competitive, with CURA focusing on combination therapies to enhance efficacy [10][11] - The market for frontline therapy in AML is estimated to be between $5 billion to $10 billion, indicating potential for multiple competitors [13] Regulatory Considerations - The FDA will review both pivotal phase two and phase one data for Zifdomenib, focusing on response rates and safety [15][16] - The company is utilizing novel regulatory endpoints such as CR and MRD negative CR to potentially accelerate approval timelines [39][40] Safety and Efficacy - The differentiation syndrome associated with Zifdomenib is reportedly manageable, with physicians becoming more adept at early identification and intervention [17][18] - The company aims to demonstrate durability of response in patients, particularly in the context of intensive chemotherapy [24][26] Future Trials and Data - CURA is planning additional registrational trials, including maintenance settings and combinations with FLT3 inhibitors [45][46] - Updates on the ongoing trials, including the combination of Zifdomenib with other therapies, are expected in the second half of the year [54][55] Manufacturing and Supply Chain - CURA's intellectual property is based in the US, with minimal impact from pharmaceutical tariffs due to the nature of their products [55][56] Conclusion - CURA Oncology is well-positioned in the oncology market with promising data on Zifdomenib and a robust pipeline, while navigating competitive and regulatory challenges effectively [6][57]

Core Insights - Kura Oncology and Kyowa Kirin announced the acceptance of an abstract for the KOMET-001 trial of ziftomenib for R/R NPM1-m AML for oral presentation at the ASCO Annual Meeting in June 2025 [1][2] - Ziftomenib is the only investigational therapy with Breakthrough Therapy Designation from the FDA for treating R/R NPM1-m AML, which represents about 30% of AML cases [2][7] - The trial achieved its primary endpoint of complete remission and was well-tolerated with limited myelosuppression [2][3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational therapy [7] - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [8] Trial Details - The KOMET-001 trial is designed to assess the clinical activity, safety, and tolerability of ziftomenib in patients with R/R NPM1-m AML [2] - Positive topline results were previously announced, indicating a statistically significant primary endpoint achievement [2] - A trial-in-progress abstract for the KOMET-015 trial will also be presented at the ASCO Annual Meeting [3][4] Upcoming Events - Kura will host a virtual investor event on June 2, 2025, to discuss the trial results and provide insights from company management and investigators [5][6]

Core Insights - Kura Oncology and Kyowa Kirin announced that clinical data from the KOMET-007 trial of ziftomenib will be presented at the EHA2025 Congress, highlighting its potential as a treatment for acute myeloid leukemia (AML) patients with specific mutations [1][2][3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed or refractory NPM1-m AML [6][7] - Kyowa Kirin is a Japan-based global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation, focusing on high unmet medical needs in various therapeutic areas [8] Clinical Trial Details - The KOMET-007 trial is a multicenter Phase 1 study evaluating ziftomenib in combination with standard care treatments for newly diagnosed AML patients with NPM1-m or KMT2A-r mutations [2][3] - The upcoming oral presentation will include updated data from the Phase 1a and Phase 1b portions of the trial, specifically focusing on the combination of ziftomenib with the 7+3 chemotherapy regimen [2][4] Future Developments - The results from the KOMET-007 trial are expected to support the initiation of a pivotal Phase 3 trial, KOMET-017, aimed at further evaluating the combination treatment for AML patients [3][5] - Kura and Kyowa Kirin are also conducting additional clinical trials to assess ziftomenib in various combinations for both newly diagnosed and relapsed/refractory AML patients [7]

Summary of Conference Call Company Overview - The conference call discusses **Cura**, focusing on its clinical programs involving **menin inhibitors** and their applications in treating various cancers, particularly acute leukemia and gastrointestinal stromal tumors (GIST) [1][2][3]. Key Points and Arguments Menin Inhibitors - **Mechanism of Action**: Menin inhibitors are epigenetic regulators that affect gene expression, relevant in treating up to half of leukemia cases [2]. - **Clinical Applications**: Current trials include Zifdomenon in combination with imatinib for GIST, targeting the KIT gene, and exploring effects in diabetes by regulating pancreatic beta cell growth [3][4]. Upcoming Data and Competitive Landscape - The **ASCO meeting** is highlighted as a critical event for CURA, where data on cifdomenon pitavutal in relapsed/refractory AML will be presented [5]. - CURA aims to differentiate itself from competitors through superior safety and tolerability profiles, which are crucial for patient adherence to treatment [6][7]. Safety and Tolerability - ZiftoMenib is noted for its lack of clinically meaningful drug-drug interactions and dose-limiting toxicities, making it suitable for elderly patients who often have multiple comorbidities [10][11]. - The term "cruise medicine" is introduced, emphasizing the importance of maintaining patients' quality of life during treatment [13][15]. Regulatory Interactions - CURA submitted its **NDA** on March 31, with a request for priority review due to its breakthrough therapy designation, which could lead to a six-month review period [16][17]. - Positive interactions with the FDA are reported, with no disruptions noted in the review process [18][19]. Clinical Trial Insights - The **Frontline seven expansion cohort** is expected to yield new data, focusing on MRD negativity and event-free survival as primary endpoints [22][25]. - The historical context of relapse rates in AML is discussed, with a focus on improving response rates and delaying relapse through combination therapies [24][27]. Commercial Strategy - CURA's partnership with **Kyowa Kirin** is aimed at maximizing the value of Zifdomenib across various indications, including AML, GIST, and diabetes [58]. - The company plans to maintain a strong financial position without returning to equity markets, ensuring continued investment in its clinical programs [59]. Future Directions - Upcoming data presentations are anticipated for both frontline and relapsed/refractory settings, with a focus on the combination of ZiftoMenib with other therapies like venetoclax [52][53]. - The potential for ZiftoMenib to resensitize patients to venetoclax is noted, which could lead to improved complete response rates [50][51]. Additional Important Content - The call emphasizes the importance of patient-centric approaches in treatment, aiming to minimize toxicity and enhance quality of life [15][30]. - The competitive landscape is acknowledged, with CURA positioning itself against both menin inhibitors and other classes of therapies [54][56]. This summary encapsulates the critical insights from the conference call, focusing on CURA's strategic direction, clinical advancements, and regulatory interactions.

Company Overview - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [2] - The company's pipeline includes small molecule drug candidates targeting cancer signaling pathways [2] Key Products and Developments - Ziftomenib is the first investigational therapy to receive Breakthrough Therapy Designation from the U.S. FDA for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [2] - A global strategic collaboration with Kyowa Kirin Co., Ltd. was established in November 2024 to develop and commercialize ziftomenib for AML and other hematologic malignancies [2] - Enrollment in a Phase 2 registration-directed trial of ziftomenib for R/R NPM1-mutant AML has been completed, with a New Drug Application submitted in Q2 2025 [2] - KO-2806, a next-generation farnesyl transferase inhibitor, is in a Phase 1 dose-escalation trial for various solid tumors [2] - Tipifarnib is currently in a Phase 1/2 trial in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [2] Upcoming Events - Kura Oncology will participate in the Bank of America Securities 2025 Healthcare Conference, with a fireside chat scheduled for May 13, 2025 [1]

分组1 - Kura Oncology reported a quarterly loss of $0.66 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.51, and compared to a loss of $0.59 per share a year ago, indicating an earnings surprise of -29.41% [1] - The company posted revenues of $14.11 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 88.19%, and this is a significant increase from zero revenues a year ago [2] - Kura Oncology shares have declined approximately 24.7% since the beginning of the year, contrasting with the S&P 500's decline of -5.3% [3] 分组2 - The earnings outlook for Kura Oncology is mixed, with the current consensus EPS estimate for the coming quarter at -$0.62 on revenues of $41.42 million, and for the current fiscal year at -$1.66 on revenues of $193.66 million [7] - The Medical - Biomedical and Genetics industry, to which Kura Oncology belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Data and Key Metrics Changes - Collaboration revenue from the Kyowa Kirin partnership for Q1 2025 was $14.1 million compared to no revenue in Q1 2024 [20] - Research and development expenses for Q1 2025 were $56 million compared to $36.3 million for Q1 2024 [20] - General and administrative expenses for Q1 2025 were $22.8 million compared to $18.2 million for the same period in 2024 [20] - Net loss for Q1 2025 was $57.4 million compared to a net loss of $49.5 million for Q1 2024 [20] - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of $658.2 million compared to $727.4 million as of December 31, 2024 [21] Business Line Data and Key Metrics Changes - The Ziftamenib development program achieved its primary CRCRH endpoint in the Phase II trial for relapsed/refractory NPM1 mutant AML, with data to be presented at the 2025 ASCO Annual Meeting [11][12] - The company announced the first patients with advanced gastrointestinal stromal tumors (GIST) were dosed with the combination of Ziftamenib and imatinib [8] Market Data and Key Metrics Changes - The company is focusing on the NPM1 mutant AML market, which represents approximately 30% of new AML cases annually, indicating a significant unmet need [10] - The company is also targeting advanced GIST patients, where current treatment options are limited [15] Company Strategy and Development Direction - The company aims to commercialize Ziftamenib in acute myeloid leukemia (AML) and is preparing for multiple clinical data updates throughout the year [6][7] - The strategic partnership with Kyowa Kirin is expected to provide greater development, commercial, and operational resources, enhancing financial stability [19] - The company plans to initiate the COMMENT-seventeen Phase III trials in the second half of 2025, focusing on both intensive and non-intensive treatment regimens for AML [14][23] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential for Ziftamenib to impact patients with relapsed/refractory NPM1 mutant AML, citing a collaborative relationship with the FDA [10] - The company is monitoring the macro landscape and believes the impact from tariffs will be negligible [19] Other Important Information - The company has a strong cash position, with sufficient capital to fund the Ziftamenib AML program to commercialization and advance its pipeline [21] - The company is preparing for upcoming milestones, including presentations at major oncology meetings and the initiation of new trials [23] Q&A Session Summary Question: Expectations for combo data coming later this year - Management emphasized safety as the top priority for the combination data and confirmed they are on track to start the study in the second half of 2025 [26][29] Question: Impact of regulatory changes on approval process - Management stated there have been no disruptions from regulatory changes and they expect to receive notification from the FDA regarding the application review in the second quarter [33][36] Question: Market share strategy for NPM1 market - Management believes they are not necessarily second to market and are prepared to compete aggressively for patients [66][70] Question: Patient segments responsive to GIST combination - The combination approach is expected to be mutationally agnostic, potentially benefiting both imatinib-refractory and naive patients [74][75] Question: Enrollment timeline for pivotal trials - Management indicated that there should not be a drag on enrollment for frontline trials, as no menin inhibitor is currently approved for that patient population [114][116]

Financial Data and Key Metrics Changes - Collaboration revenue from the Kyowa Kirin partnership for Q1 2025 was $14.1 million compared to no revenue in Q1 2024 [19] - Research and development expenses for Q1 2025 were $56 million compared to $36.3 million for Q1 2024 [19] - General and administrative expenses for Q1 2025 were $22.8 million compared to $18.2 million for the same period in 2024 [19] - Net loss for Q1 2025 was $57.4 million compared to a net loss of $49.5 million for Q1 2024 [19] - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of $658.2 million compared to $727.4 million as of December 31, 2024 [20] Business Line Data and Key Metrics Changes - The Ziftomenib monotherapy Phase II registrational data were accepted for oral presentation at the 2025 ASCO Annual Meeting, indicating significant progress in the AML program [5][10] - The company announced the first patients with advanced gastrointestinal stromal tumors (GIST) were dosed with the combination of Ziftomenib and imatinib, marking a key milestone in the GIST program [6][14] Market Data and Key Metrics Changes - Approximately 30% of new AML cases annually are represented by NPM1 mutant AML, highlighting a significant unmet need in the market [9] - The company anticipates presenting preliminary clinical data from multiple Phase Ib expansion cohorts later this year, which will inform the market's understanding of Ziftomenib's potential [12][16] Company Strategy and Development Direction - The company aims to build a fully integrated organization and has appointed Sameer Vatompadam as Senior Vice President, Global Program Leadership to enhance its capabilities [6] - The strategic partnership with Kyowa Kirin is expected to provide greater development, commercial, and operational resources, as well as increased financial stability [18] - The company plans to initiate two independent Phase III registration enabling trials in frontline intensive and non-intensive AML in the second half of 2025 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Ziftomenib to impact patients with relapsed/refractory NPM1 mutant AML, citing a collaborative relationship with the FDA [9] - The company is prepared to adapt to the rapidly evolving macro landscape and believes the impact from tariffs would be negligible [18] Other Important Information - The company expects to present full data for the COMET-one trial in Q2 2025 at ASCO and anticipates sharing data from the FIT-one trial evaluating KO2806 in the second half of 2025 [22] - The company has received feedback from institutions and investigators that the design of the COMMIT-seventeen trial is attractive due to its simplified trial startup and conduct [13] Q&A Session Summary Question: Expectations for combo data coming later this year - Management emphasized safety as the top priority and is on track to start the study in the second half of 2025 [25][27] Question: Impact of regulatory changes on approval process - Management stated there has been no impact from regulatory changes and remains optimistic about the FDA's responsiveness [32][34] Question: Market share strategy for NPM1 market - Management believes they are not necessarily second to market and is focused on a competitive strategy to capture market share [64][66] Question: Patient segments responsive to GIST combination - Management indicated the approach is mutationally agnostic, allowing for use in both imatinib refractory and naive patients [72][74] Question: Enrollment timeline for pivotal trials - Management confirmed that there should not be a drag on enrollment for frontline trials due to the approval of Ziftomenib [112][113]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or 12730 High Bluff Drive, Suite 400, San Diego, CA 92130 (Address of principal executive offices) (Zip Code) (858) 500-8800 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File ...

Exhibit 99.1 Kura Oncology Reports First Quarter 2025 Financial Results – NDA submitted in 1Q 2025 for ziftomenib for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – – Data from Phase 1b/2 registration-directed trial of ziftomenib selected for oral presentation at ASCO Annual Meeting – – $45.0 million milestone payment earned for NDA submission under collaboration agreement with Kyowa Kirin – – First patients dosed in Phase 1 trial of ziftomenib plus imatinib in GIST ...