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]

Financial Position - As of March 31, 2025, Kura Oncology had cash, cash equivalents, and short-term investments totaling $658.2 million[99]. - The company had cash, cash equivalents, and short-term investments totaling $658.2 million as of March 31, 2025, which is expected to fund operations into 2027[127]. - The company had an accumulated deficit of $952.9 million and expects expenses to increase due to ongoing R&D activities[126]. - Total contractual obligations as of March 31, 2025, amounted to $38.9 million, with $4.5 million due within one year[134]. - The interest rate on the term loans was 9.90% as of March 31, 2025, with an end of term fee of approximately $1.5 million due at maturity[137]. Revenue and Financing - Kura Oncology received an upfront payment of $330.0 million from Kyowa Kirin for the global development and commercialization of ziftomenib[100]. - Collaboration revenue for the three months ended March 31, 2025, was $14.1 million, attributed to services performed under the Kyowa Agreement[116]. - The company has not generated any revenues from product sales and relies on collaboration and license agreements for funding[103]. - The company has not generated any revenues from product sales and does not expect to do so until regulatory approval is obtained[128]. - The ATM Facility allows the company to offer shares with an aggregate offering price of up to $150 million, although no shares have been sold under this facility yet[102]. - The company entered into a loan agreement providing for up to $125.0 million in term loans, of which $10.0 million was drawn from the initial tranche[124]. - The company anticipates significant additional financing will be required to continue operations, as indicated in the liquidity and capital resources section[120]. Research and Development - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed or refractory NPM1-mutant AML[84]. - The KOMET-001 trial achieved its primary endpoint of complete remission plus partial hematological recovery, demonstrating a favorable benefit-risk profile[84]. - Kura Oncology plans to initiate the KOMET-017-IC trial in the second half of 2025, evaluating ziftomenib with induction chemotherapy in newly diagnosed AML patients[91]. - The KOMET-017-NIC trial is set to evaluate ziftomenib in combination with venetoclax and azacitidine for patients unfit for intensive chemotherapy, expected to start in the second half of 2025[92]. - Kura Oncology is advancing KO-2806 in a Phase 1 trial, with preliminary data expected in the second half of 2025[96]. - The KURRENT-HN trial of tipifarnib in combination with alpelisib has completed enrollment, with data presentation anticipated in the second half of 2025[98]. - Kura Oncology is exploring ziftomenib for gastrointestinal stromal tumors, with the first patients dosed in the KOMET-015 trial[94]. Expenses - Research and development expenses increased to $55.973 million for the three months ended March 31, 2025, up from $36.268 million in the same period in 2024, reflecting a rise of $19.705 million[117]. - General and administrative expenses rose to $22.835 million for the three months ended March 31, 2025, compared to $18.184 million in the prior year, an increase of $4.651 million[118]. - Net cash used in operating activities for the three months ended March 31, 2025, was $71.9 million, an increase of $23.1 million compared to the same period in 2024[131]. Agreements and Milestones - A milestone payment of $45.0 million from Kyowa Kirin is expected in the second quarter of 2025 following the FDA's receipt of the NDA for ziftomenib[100]. - The Kyowa Agreement, established in November 2024, includes an upfront payment of $330 million and potential milestone payments of up to $933 million for the development of ziftomenib[121]. - The company may need to pay up to approximately $78.8 million in milestone payments if certain regulatory and commercial milestones are achieved[138]. - Under the Kyowa Agreement, the company will share equally in development costs and potential profits from the commercialization of ziftomenib in the U.S.[139]. Shareholder Information - In January 2024, the company completed a private placement, selling 1,376,813 shares at $17.25 per share, raising approximately $145.8 million in net proceeds[122]. - As of March 31, 2025, 559,424 pre-funded warrants from the private placement had been exercised, with 6,759,462 remaining outstanding[122].

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 ...

Core Viewpoint - Kura Oncology has submitted its first New Drug Application (NDA) for ziftomenib to the FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, marking a significant milestone for the company [2][5]. Company Updates - The NDA submission for ziftomenib occurred on March 31, 2025, with a 60-day filing review period expected from the FDA, potentially leading to a six-month review if Priority Review is granted [5]. - Kura Oncology is preparing for two Phase 3 studies in the frontline setting and anticipates multiple clinical data readouts throughout the year [2][4]. - The first patients have been dosed in the Phase 1 trial of ziftomenib in combination with imatinib for gastrointestinal stromal tumors (GIST) [1][6]. Financial Highlights - Collaboration revenue from the partnership with Kyowa Kirin for Q1 2025 was $14.1 million, compared to no revenue in Q1 2024 [9]. - Research and development expenses for Q1 2025 were $56.0 million, up from $36.3 million in Q1 2024, while general and administrative expenses increased to $22.8 million from $18.2 million [9]. - The net loss for Q1 2025 was $57.4 million, compared to a net loss of $49.5 million in Q1 2024, with cash, cash equivalents, and short-term investments totaling $658.2 million as of March 31, 2025 [9][16]. Milestones and Future Plans - Kura expects to present data from the KOMET-001 Phase 1b/2 trial at the ASCO and EHA meetings in the second quarter of 2025 [9]. - The company plans to initiate two independent Phase 3 registration-enabling trials in the second half of 2025 [9][13]. - Kura anticipates receiving up to $375 million in additional milestone payments from Kyowa Kirin, following the $45 million milestone payment triggered by the NDA submission [4][5].

Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]

SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced it will report first quarter 2025 financial results after the close of U.S. financial markets on Thursday, May 1, 2025. Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate up ...