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Kura Oncology (KURA) Earnings Call Presentation
2025-06-19 11:58
2025 EHA ANALYST AND INVESTOR EVENT Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer June 18, 2025 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, KO-2806 and tipifarnib, expectations regarding the relative benefits of our product candidates ve ...
Kura Oncology and Kyowa Kirin Report Positive Updated Combination Data for Ziftomenib in Newly Diagnosed AML at 2025 European Hematology Association Congress
GlobeNewswire News Room· 2025-06-12 11:30
Core Insights - The KOMET-007 trial demonstrated encouraging clinical activity for ziftomenib in combination with 7+3 for newly diagnosed NPM1-m and KMT2A-r AML patients, showing high rates of complete remission and minimal residual disease negativity [1][2][4] Group 1: Clinical Data - In the KOMET-007 trial, 93% (41/44) of NPM1-m patients and 89% (24/27) of KMT2A-r patients achieved complete remission composite (CRc) [1] - Among responding patients, 71% (24/34) of NPM1-m and 88% (14/16) of KMT2A-r patients achieved measurable residual disease (MRD) negativity [1] - The median follow-up times were 24.9 weeks for NPM1-m patients and 15.7 weeks for KMT2A-r patients, with 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remaining alive [3] Group 2: Safety and Tolerability - The safety profile of ziftomenib was consistent with previous data, with Grade 3 adverse events occurring in over 10% of patients, including febrile neutropenia (15%) and decreased platelet count (15%) [4] - No dose-limiting toxicities or additive myelosuppression were observed, indicating a favorable safety profile for ziftomenib [4] Group 3: Future Developments - Kura Oncology plans to initiate the KOMET-017-IC and NIC Phase 3 studies in the second half of 2025 to further evaluate ziftomenib's efficacy in AML treatment [1][5] - A virtual investor event is scheduled for June 18, 2025, to discuss the results and broader development plans for ziftomenib [6] Group 4: Company Background - Kura Oncology is focused on developing precision medicines for cancer, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML [7] - Kyowa Kirin, a partner in the development of ziftomenib, has a long history in drug discovery and biotechnology innovation, aiming to address high unmet medical needs [9]
KURA Stock Rises More Than 15% This Past Week: Here's Why
ZACKS· 2025-06-06 16:56
Core Insights - Kura Oncology's shares have increased by 15.5% over the past week, contrasting with a 0.1% decline in the industry [1] - The FDA has accepted Kura's new drug application (NDA) for ziftomenib, aimed at treating adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation [1][9] - A decision from the FDA regarding the NDA is anticipated on November 30, 2025, following a priority review [1] Company Developments - Ziftomenib is positioned to be the first menin inhibitor approved for treating R/R NPM1-mutant AML if the FDA grants approval [2] - The NDA submission was based on the phase II KOMET-001 study, which achieved its primary endpoint of complete remission and demonstrated statistically significant results [7] - Kura has entered into a partnership with Kyowa Kirin for the development and commercialization of ziftomenib, which triggered a $45 million milestone payment upon NDA submission [6][9] Clinical Pipeline - Ziftomenib is also being explored in combination with imatinib for advanced gastrointestinal stromal tumors after imatinib failure [10] - Kura is developing KO-2806, a next-generation farnesyl transferase inhibitor, for various solid tumors, and another FTI, tipifarnib, in combination with alpelisib for head and neck squamous cell carcinoma [11] - Data from these studies are expected to be presented later in 2025, which may further influence Kura's stock performance [12]
Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML
Globenewswire· 2025-06-01 23:00
Core Viewpoint - Kura Oncology and Kyowa Kirin have announced the acceptance of a New Drug Application (NDA) for ziftomenib by the FDA, targeting adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, with a PDUFA target action date set for November 30, 2025 [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline of small molecule drug candidates [7] - Kyowa Kirin is a Japan-based global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation [8] Drug Development - Ziftomenib is an investigational menin inhibitor that has received Breakthrough Therapy Designation (BTD), Fast Track, and Orphan Drug Designations from the FDA for the treatment of adult patients with R/R AML with an NPM1 mutation [3][6] - The NDA is based on positive results from the Phase 2 KOMET-001 trial, which achieved its primary endpoint of complete remission and demonstrated a favorable safety profile with limited myelosuppression [2][3] Clinical Trial Insights - The KOMET-001 trial is designed to assess the clinical activity, safety, and tolerability of ziftomenib, and full data analyses will be presented at the 2025 ASCO Annual Meeting and the 2025 EHA Congress [3][4] - Adult patients with R/R NPM1-m AML have a poor prognosis, with only 30% overall survival at 12 months in the relapsed setting, highlighting the urgent need for innovative treatment options [4][5] Market Potential - There are currently no FDA-approved therapies specifically targeting NPM1-m AML, indicating a significant market opportunity for ziftomenib if approved [5][6]
Kura Oncology and Kyowa Kirin Announce Pivotal Monotherapy Data for Ziftomenib in Oral Presentation at the 2025 ASCO Annual Meeting
Globenewswire· 2025-05-22 21:30
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]
Kura Oncology Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-01 20:05
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].
Kura Oncology Announces First Patients Dosed in Phase 1 Combination Trial of Ziftomenib for the Treatment of Advanced GIST
Globenewswire· 2025-04-28 11:30
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]