Investors in Kura Oncology, Inc. (KURA) need to pay close attention to the stock based on moves in the options market lately. That is because the July 18, 2025 $2.50 Put had some of the highest implied volatility of all equity options today.What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could al ...

Kura Oncology (KURA) FY Conference June 10, 2025 11:20 AM ET Speaker0 Thanks Speaker1 everyone for joining us. I'm Andrea Newkirk, one of the biotech analysts here at Goldman Sachs and I'm really pleased to be joined by Troy Wilson, President and CEO of Cura Oncology. Thanks so much Troy for joining us. Speaker0 My pleasure. Thank you for the chance to participate. Speaker1 Yeah, of course. Well maybe I will open it up to you for some high level remarks on the company, the overview of your clinical programs ...

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]

Summary of Kura Oncology Conference Call Company Overview - **Company**: Kura Oncology - **Event**: Jefferies Global Healthcare Conference 2025 - **Key Participants**: CEO Troy, Commercial Officer Brian, CMO Molly Industry Focus - **Industry**: Oncology, specifically Acute Myeloid Leukemia (AML) and Menin inhibitors Key Highlights from the Call 1. **Positive Trial Results**: Kura Oncology reported two positive trials indicating that their mechanism works in AML, suggesting that their drugs are likely approvable [4][10] 2. **Clinical Data**: - Phase 2 trial showed a 23% complete response (CR) rate and a median overall survival of 16.4 months for responders, compared to typical survival of 3 months in relapsed refractory leukemia [5] - Zifdomenib demonstrated consistent activity regardless of prior treatments or therapy lines [6] 3. **Safety Profile**: - No myelosuppression differentiation syndrome was reported, and QT prolongation was not clinically meaningful [7][8] - Once-daily oral dosing was highlighted as a convenience factor for patients and physicians [8][15] 4. **Regulatory Milestones**: - Kura has a PDUFA date set for November 30, indicating a priority review status [10][12] - The company is preparing for a significant data presentation at EHA on June 12 [9] 5. **Market Opportunity**: - Approximately 20,000 AML patients are diagnosed annually, with an estimated 10,000 potentially eligible for Menin inhibitors [52] - The potential market size for Kura's product in AML is estimated between $5 billion to $10 billion, with Kura aiming to capture around $3 billion [53] 6. **Combination Therapies**: - Kura is exploring combination therapies, including a study combining Zifdomenib with Imatinib for GIST, which could enhance treatment durability [56][59] - The company is also investigating combinations in breast cancer and other solid tumors [60][61] 7. **Pipeline and Funding**: - Kura has $703 million in cash and is eligible for an additional $375 million in near-term milestones, ensuring funding through the AML program [67] - The company is focused on advancing its pipeline, including FTI programs and diabetes treatments [67] Additional Insights - **Physician Feedback**: Physicians are excited about the introduction of Menin inhibitors, indicating a competitive landscape but also a growing acceptance of new therapies [21][22] - **Regulatory Environment**: Kura does not anticipate changes in FDA perspectives that would affect their accelerated approval pathway [33][36] - **Operational Efficiency**: Kura is combining two phase three trials under a single protocol to streamline operations and enhance patient eligibility [39][40] This summary encapsulates the critical points discussed during the conference call, highlighting Kura Oncology's advancements, market potential, and strategic direction in the oncology space.

Financial Data and Key Metrics Changes - The FDA has accepted the new drug application for Ziftamenib based on positive results from the COMET-one trial, with a PDUFA target action date of November 30, 2025 [5][39]. - The company reported having over $700 million on the balance sheet as of the end of the first quarter, with potential to earn an additional $375 million in near-term milestones [46]. Business Line Data and Key Metrics Changes - The COMET-one trial demonstrated a 35% overall response rate and a 25% complete remission with and without hematologic recovery (CRCRH) rate in patients treated with Ziftamenib [14][22]. - Among the 92 patients in the phase two portion of the study, the CRCRH rate was 23%, significantly superior to the historical 12% rate with conventional chemotherapy [14][22]. Market Data and Key Metrics Changes - The company is targeting the relapsed refractory acute myeloid leukemia (AML) patient population, where there is a high unmet medical need, with 20% being primary refractory and 50% relapsing within one year [39]. - Physicians have expressed positive feedback regarding Ziftamenib's overall survival among responders, which is longer than expected in this patient population [36]. Company Strategy and Development Direction - The company is pursuing an aggressive development and commercialization strategy for Ziftamenib, aiming to treat up to 50% of AML patients who may benefit from menin inhibitor therapy [5][25]. - A comprehensive development strategy is in place to address patients in both frontline and relapsed refractory settings, utilizing both company-sponsored and investigator-initiated studies [25][28]. Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of Ziftamenib's favorable safety profile, which positions it as a potentially best-in-class menin inhibitor for AML [44]. - The company is focused on supporting the FDA review process and preparing for a potential launch in the fourth quarter of 2025 [44][46]. Other Important Information - The COMET-one study showed that Ziftamenib was well tolerated, with low rates of myelosuppression and no clinically significant QTc prolongation [19][22]. - The differentiation syndrome was observed in 23% of patients, but with effective management strategies, the majority of patients continued therapy [21][80]. Q&A Session Summary Question: Can you talk about predicting patient responses to Ziftamenib? - Management indicated that currently, there is no clear way to predict which patients will respond to Ziftamenib, although some patients with IDH1 co-mutations appeared to respond better [50][53]. Question: What are the plans for commercial launch preparation? - The company is building out its capabilities to ensure product availability upon approval, learning from the market experience of other menin inhibitors [56][60]. Question: How are physicians managing differentiation syndrome? - Experienced investigators have implemented early recognition and mitigation strategies for differentiation syndrome, leading to better management and patient retention in studies [78][80]. Question: What differentiates Ziftamenib from other products in the market? - Convenience and safety are highlighted as key differentiators, with Ziftamenib being a once-daily oral medication that does not require extensive monitoring [86][90]. Question: What is the expected average duration of therapy for Ziftamenib? - The expected duration of therapy is approximately six months, based on the time needed for patients to achieve a response and the duration of that response [94][97]. Question: Why might FLT3 ITD patients have a lower response rate? - The lower response rate in FLT3 ITD patients may be due to their heavily pretreated status and the development of resistance to multiple therapies [100][101].

Core Insights - Kura Oncology and Kyowa Kirin announced positive pivotal results from the KOMET-001 Phase 2 trial of ziftomenib for relapsed/refractory NPM1-mutant AML patients, with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% [1][3][2] - The trial demonstrated consistent efficacy across various pre-specified subgroups, indicating the potential of ziftomenib as a treatment option for heavily pre-treated patients [1][4][2] - Ziftomenib has a favorable safety profile, with limited myelosuppression and a low discontinuation rate due to treatment-related adverse events [1][5][7] 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 R/R NPM1-m AML [9] - The company has a strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib, with ongoing clinical trials evaluating its efficacy in combination with current standards of care [9][10] Clinical Trial Details - The KOMET-001 Phase 2 trial included 92 adult patients with a median age of 69, with 33% having received three or more prior lines of therapy [2][3] - Among the patients achieving CR/CRh, 63% were minimal residual disease (MRD)-negative, highlighting the treatment's potential effectiveness [3][4] Safety and Tolerability - The safety profile of ziftomenib showed that treatment-related adverse events led to discontinuation in only 3% of patients, with differentiation syndrome being the most common adverse event [5][6][7] - The absence of clinically significant QTc prolongation and effective management of differentiation syndrome further support ziftomenib's favorable benefit-risk profile [7][6] Future Outlook - The FDA has set a PDUFA target action date of November 30, 2025, for the New Drug Application (NDA) of ziftomenib, indicating a potential first approval for a once-daily oral menin inhibitor for this patient population [1][2] - Kura Oncology is hosting a virtual investor event to discuss the trial results and future plans for ziftomenib [8]

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]

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]