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]

Kura Oncology (KURA) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Speaker0 Please standby. Your program is about to begin. If you need assistance during your conference today, please press 0. Good day everyone and welcome to today's First Quarter twenty twenty five CURA Oncology Financial Results Conference Call. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any t ...

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 ...

– 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 – – $703.2 million in pro forma cash, together with anticipated collabor ...

– Phase 1 dose-escalation study to evaluate ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure – – Combination of ziftomenib and imatinib shows robust and durable antitumor activity in imatinib-sensitive and imatinib-resistant GIST preclinical models – SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, toda ...

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 ...