SAN DIEGO, Aug. 01, 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 it will report second quarter 2024 financial results after the close of U.S. financial markets on Thursday, August 8, 2024. Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate u ...

– Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases – "Despite the introduction of multiple options for the treatment of type 2 diabetes, a significant unmet need exists as a large proportion of patients do not achieve glycemic control," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are encouraged by these preclinical data for ziftomenib in diabetes, which demonstrate the potential for menin inhibitors t ...

– Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases – "Despite the introduction of multiple options for the treatment of type 2 diabetes, a significant unmet need exists as a large proportion of patients do not achieve glycemic control," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are encouraged by these preclinical data for ziftomenib in diabetes, which demonstrate the potential for menin inhibitors t ...

– Company enrolls 85 patients with R/R NPM1-mutant AML in fewer than 16 months – – Topline data expected in early 2025 – SAN DIEGO, May 14, 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 it has completed enrollment of 85 patients in the Phase 2 portion of KOMET- 001, a registration-directed clinical trial of the Company's menin inhibitor, ziftom ...

Financial Data and Key Metrics Changes - Research and development expenses for Q1 2024 were $36.3 million, up from $25.2 million in Q1 2023, primarily due to increased clinical trial costs related to ziftomenib and KO-2806 programs [28] - General and administrative expenses for Q1 2024 were $18.2 million compared to $11.4 million in Q1 2023 [51] - Net loss for Q1 2024 was $49.5 million, reflecting an increase from the previous year's loss [51] Business Line Data and Key Metrics Changes - Ziftomenib showed a 53% overall response rate among 15 relapsed refractory patients, with a 40% overall response rate among 10 patients who had prior venetoclax treatment [4] - The complete remission rate among nine menin inhibitor naive patients was 56% [4] - The company is on track to complete enrollment of 85 patients in the KOMET-001 trial by mid-2024 [10][23] Market Data and Key Metrics Changes - The FDA granted Breakthrough Therapy Designation for ziftomenib, indicating its potential as an innovative treatment for patients with NPM1-mutant AML [3] - The company is evaluating ziftomenib in combination with current standards of care, including venetoclax/azacitidine and cytarabine plus daunorubicin [23] Company Strategy and Development Direction - The company aims to identify the recommended Phase II dose of ziftomenib in combination with venetoclax and azacitidine by mid-2024 [10] - There is a focus on developing KO-2806 as a next-generation farnesyl transferase inhibitor, with plans to evaluate it in combination with other targeted therapies [26][50] - The company is also working towards an investigational new drug application for ziftomenib in solid tumor indications in the second half of 2024 [10][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing dialogue with the FDA and the potential for accelerated timelines due to the Breakthrough Therapy Designation [12][32] - The company is optimistic about the enrollment rates across different cohorts and believes that ziftomenib has the potential to be a best-in-class menin inhibitor [90] - Management highlighted the importance of safety and tolerability in ongoing trials, noting no significant toxicities reported thus far [47][74] Other Important Information - The company is preparing to share preclinical data supporting the use of ziftomenib in solid tumors at a medical meeting later this year [49] - The company is assessing the safety and tolerability of ziftomenib in post-transplant maintenance settings [78] Q&A Session Summary Question: What are the implications of ziftomenib receiving Breakthrough Therapy Designation? - Management indicated that the designation validates the unmet need for NPM1-mutant AML and may accelerate the approval process [54][91] Question: Can you provide details on the patients who have remained in the trial? - Management clarified that as of the January data cutoff, 16 of 20 patients remained in the study, with no significant toxicities reported [36][60] Question: What is the status of the post-transplant program? - The post-transplant program is in the hands of investigators and is currently in the study startup phase [120] Question: When can we expect data from the KOMET-001 study? - Management stated that data will be available after completing enrollment and cleaning the data, with no specific timeline provided yet [108] Question: Are there plans for additional studies with KO-2806? - Management confirmed that there is a rationale for combining KO-2806 with other drug candidates, and they are exploring various options [109][130]

SAN DIEGO, May 03, 2024 (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 that on May 1, 2024, the Compensation Committee of the Company's Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 67,950 shares of common stock to six (6) new employees under the Company's 20 ...

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, 2024 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) (State or other jurisdiction ...

Financial Performance - Kura Oncology reported a net loss of $49.5 million for Q1 2024, compared to a net loss of $34.1 million in Q1 2023, reflecting an increase in operating expenses [15]. - Research and development expenses for Q1 2024 were $36.3 million, up from $25.2 million in Q1 2023, while general and administrative expenses rose to $18.2 million from $11.4 million [8]. - As of March 31, 2024, Kura had cash, cash equivalents, and short-term investments totaling $527 million, an increase from $424 million as of December 31, 2023 [17]. - The company expects its cash reserves to fund operations into 2027 based on its current operating plan [8]. Clinical Trials and Developments - The company is on track to complete enrollment of 85 patients in the KOMET-001 trial of ziftomenib for NPM1-mutant R/R AML by mid-2024 [4]. - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed/refractory NPM1-mutant AML, based on data from the ongoing KOMET-001 trial [3]. - In the Phase 1 trial, ziftomenib demonstrated a 35% complete response rate and a 45% overall response rate in heavily pretreated patients with NPM1-mutant AML [4]. - Preliminary data from the KOMET-007 trial showed a 100% complete remission rate in newly diagnosed patients treated with ziftomenib in combination with standard therapies [4]. - Kura plans to initiate a Phase 1b expansion study of ziftomenib in combination with standards of care in the second half of 2024 [8]. - Kura is also advancing KO-2806, with the first patient dosed in a trial for renal cell carcinoma, and plans to dose the first patient in combination with adagrasib for KRASG12C-mutated non-small cell lung cancer by mid-2024 [5].

– 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 ...

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].