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Kura Oncology(KURA) - 2024 Q1 - Quarterly Results
2024-05-02 20:10
Recent Highlights Exhibit 99.1 Kura Oncology Reports First Quarter 2024 Financial Results – Breakthrough Therapy Designation for ziftomenib in NPM1-mutant AML – – Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024 – – Positive preliminary combination data for ziftomenib in NPM1-mutant and KMT2A-rearranged AML – – First patient dosed with KO-2806 and cabozantinib in renal cell carcinoma – – $527 million in cash, cash equivalents and investments provide ru ...
Kura Oncology Receives Breakthrough Therapy Designation for Ziftomenib in NPM1-Mutant AML
Newsfilter· 2024-04-22 11:30
– Ziftomenib is the first investigational treatment to be granted Breakthrough Therapy Designation for NPM1-mutant AML – – Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024 – SAN DIEGO, April 22, 2024 (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, today announced that its investigational drug, ziftomenib, has been gra ...
Kura Oncology(KURA) - 2023 Q4 - Earnings Call Transcript
2024-02-28 03:19
Financial Data and Key Metrics Changes - Research and development (R&D) expenses for Q4 2023 were $32.5 million, up from $22.7 million in Q4 2022, while full-year R&D expenses increased to $115.2 million from $92.8 million year-over-year [21][22]. - Net loss for Q4 2023 was $42.8 million compared to a net loss of $33.1 million in Q4 2022, with a full-year net loss of $152.6 million versus $135.8 million in the prior year [22]. - As of December 31, 2023, cash, cash equivalents, and short-term investments totaled $424 million, down from $438 million a year earlier, but increased to approximately $570 million after a private placement in January 2024 [23]. Business Line Data and Key Metrics Changes - Ziftomenib demonstrated a 100% complete remission (CR) rate among five newly diagnosed patients with adverse risk acute myeloid leukemia (AML) and a 53% overall response rate (ORR) among 15 relapsed refractory patients [8][10]. - The company is advancing Ziftomenib in multiple studies, including KOMET-001 and KOMET-008, with plans to initiate a Phase 1b dose validation expansion by mid-2024 [14][25]. Market Data and Key Metrics Changes - The company is focusing on the NPM1 mutant and KMT2A rearranged AML markets, which represent significant unmet medical needs, particularly in pediatric populations [14][15]. - There is a growing interest in Ziftomenib among investigators, as evidenced by rapid enrollment in ongoing studies [13]. Company Strategy and Development Direction - The company aims to position Ziftomenib as a cornerstone therapy for acute leukemias driven by the Menin pathway, with plans to explore its use in solid tumors and other indications [16][78]. - Kura Oncology is also developing KO-2806, a next-generation Farnesyl Transferase Inhibitor, to enhance antitumor activity and address resistance mechanisms [17][19]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the safety and tolerability profile of Ziftomenib, highlighting its potential to become a preferred treatment option in the competitive AML market [62]. - The company anticipates completing enrollment in the KOMET-001 trial by mid-2024 and is preparing for pivotal studies based on the data generated [25][91]. Other Important Information - The company has initiated a proof-of-concept study for Ziftomenib in solid tumors and is making progress on a next-generation Menin inhibitor [16][78]. - Kura Oncology is actively engaging with global health authorities to expedite the development of its therapies [82]. Q&A Session Summary Question: Can you discuss your thoughts on the combinability of Ziftomenib with Ven/Aza? - Management confirmed that Ziftomenib is neither a CYP3A4 substrate nor an inhibitor, meaning no dose adjustment for Venetoclax is necessary when combined with Ziftomenib [29][32]. Question: What are the expectations for moving patients off Ziftomenib therapy? - Management indicated that patients are expected to remain on Ziftomenib until disease progression, with potential breaks only for transplant conditioning [72]. Question: Can you discuss the opportunity for Ziftomenib in combination with FLT3 inhibitors? - Management expressed confidence in the combinability of Ziftomenib with FLT3 inhibitors, citing preclinical data showing strong synergistic effects [58][63]. Question: When could Ziftomenib potentially move into pivotal development? - Management suggested that pivotal studies might not begin until early next year, with ongoing designs being developed based on current data [91]. Question: How does the company view the competitive landscape for menin inhibitors? - Management believes that Ziftomenib's safety and efficacy profile will differentiate it in the market, and they are focused on robust enrollment in ongoing studies [118].
Kura Oncology(KURA) - 2023 Q4 - Earnings Call Presentation
2024-02-28 01:36
KOMET-001 Phase 1/2 Study of Ziftomenib in Relapsed/Refractory AML Ziftomenib Demonstrates Optimal Pharmaceutical Properties • No dose adjustment of ziftomenib needed when administered with a CYP3A4 inhibitor (e.g., azoles) 10 • Rates of DS in KMT2A-r monotherapy patients were 38.5% at 200 mg and 37.5% at 600 mg; potential to mitigate in combination Fathi et al. EHA 2023 #LB2713 (preliminary data as of April 12, 2023) 11 40% of NPM1 patients achieved a CR during course of study High activity, durable respon ...
Kura Oncology(KURA) - 2023 Q4 - Annual Report
2024-02-27 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-37620 KURA ONCOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 61-1547851 (State or other jurisdiction of ...
Kura Oncology(KURA) - 2023 Q3 - Earnings Call Transcript
2023-11-03 20:12
Kura Oncology, Inc. (NASDAQ:KURA) Q3 2023 Earnings Conference Call November 2, 2023 4:30 PM ET Company Participants Pete De Spain - Head of Investor Relations Troy Wilson - President & Chief Executive Officer Tom Doyle - Senior Vice President of Finance & Accounting Conference Call Participants Jason Zemansky - Bank of America Peter Lawson - Barclays Roger Song - Jefferies Li Watsek - Cantor Fitzgerald Jeet Mukherjee - BTIG Phil Nadeau - TD Cowen Brad Canino - Stifel Operator Good afternoon, ladies and gent ...
Kura Oncology(KURA) - 2023 Q3 - Earnings Call Presentation
2023-11-03 01:38
Forecasted Milestones & Financial Highlights 32 | --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – November 2023 | | | | | * Optimum biologically active dose ** Cash, cash equivalents and short-term investments 2 All forward-looking statements contained in this presentation speak only as of the ...
Kura Oncology(KURA) - 2023 Q3 - Quarterly Report
2023-11-02 20:05
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 September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Indicate by check mark w ...
Kura Oncology(KURA) - 2023 Q2 - Quarterly Report
2023-08-09 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) 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 June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ (State or other jurisdiction ...
Kura Oncology(KURA) - 2023 Q2 - Earnings Call Transcript
2023-08-06 14:41
Financial Data and Key Metrics Changes - As of June 30, 2023, the company had cash, cash equivalents, and short-term investments of $477 million, an increase from $438 million as of December 31, 2022, which includes net proceeds of approximately $94 million from a public offering completed in June 2023 [15] - The net loss for the second quarter of 2023 was $37.2 million compared to a net loss of $34.8 million for the same period in 2022, with general and administrative expenses rising to $11.8 million from $11.1 million year-over-year [34] Business Line Data and Key Metrics Changes - The company reported a complete remission (CR) rate of 35% and an overall response rate of 45% in patients with NPM1-mutant acute myeloid leukemia (AML) treated with ziftomenib [3] - The median duration of response for all NPM1-mutant patients was 8.2 months, with a median follow-up of 8.8 months [9] Market Data and Key Metrics Changes - NPM1-mutant AML accounts for approximately 30% of new AML cases annually, representing a significant unmet medical need with no approved targeted therapies [4] - Head and neck cancer is the seventh most common cancer worldwide, with a significant unmet medical need for approved small molecule targeted therapies [5] Company Strategy and Development Direction - The company aims to establish ziftomenib as a foundational therapy that can be combined safely with various commonly used regimens, prioritizing combinations that represent the greatest unmet medical need and potential commercial value [142] - The company is evaluating the combination of tipifarnib and alpelisib in head and neck squamous cell carcinoma, with plans to initiate dose expansion in mid-2024 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the enrollment in the Phase 2 registration-directed trial of ziftomenib, noting that it continues to outperform projections due to strong interest and activity in patients who failed prior treatments [10][19] - Management believes that ziftomenib is well-positioned for the maintenance setting, with a favorable safety profile and no evidence of drug-induced myelosuppression [21][62] Other Important Information - The company plans to begin a post-transplant maintenance program for ziftomenib in the first quarter of 2024 [11] - The company has received FDA clearance for the investigational new drug application for KO-2806 for the treatment of advanced solid tumors, with plans to evaluate its safety and tolerability in a Phase 1 dose escalation study [14] Q&A Session Summary Question: Can you provide more details on enrollment progress for ziftomenib? - Management indicated that they anticipate full enrollment of 85 patients in the study by mid-next year, noting that enrollment is ahead of projections due to physician excitement and the data itself [37][90] Question: What are the expectations for initial data from the combination trial? - Management expects to have preliminary data from the COMET-007 study in the fourth quarter of 2023 or the first quarter of 2024, emphasizing the importance of gathering sufficient data before making meaningful conclusions [137][92] Question: How does the company view resistance mutations in the maintenance setting for ziftomenib? - Management does not believe resistance mutations will significantly impact the use of ziftomenib in the maintenance setting, citing a low rate of resistance mutations observed in their studies [61][62] Question: What is the strategic rationale for starting with renal cell carcinoma (RCC)? - Management explained that RCC is a more mature space with a clear understanding of the landscape, and they have conducted market research to inform their strategy [106] Question: Are there discussions with companies marketing approved drugs for combination therapies? - Management confirmed that they are exploring clinical collaboration or supply agreements to mitigate costs and expedite patient enrollment [121]