Core Insights - Kura Oncology, Inc. will report its third quarter 2024 financial results on November 7, 2024, after U.S. market close [1] - A conference call and webcast will be held at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [3] - The company's pipeline includes small molecule drug candidates targeting cancer signaling pathways, with ziftomenib being a key candidate for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [3] - Ziftomenib has received Breakthrough Therapy Designation and is currently in a Phase 2 registration-directed trial (KOMET-001) [3] - Kura is also evaluating KO-2806, a next-generation farnesyl transferase inhibitor, in a Phase 1 dose-escalation trial [3] - Tipifarnib is in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma [3]

Core Insights - Kura Oncology's menin inhibitor, ziftomenib, demonstrates strong and lasting antitumor activity when combined with imatinib in both imatinib-sensitive and resistant GIST models, indicating a promising therapeutic strategy for advanced gastrointestinal stromal tumors (GIST) [1][3][4] Group 1: Preclinical Data and Mechanism - Preclinical studies show that the combination of ziftomenib and imatinib significantly outperforms imatinib alone in patient-derived xenograft models of GIST [3] - The mechanism of action involves a synthetic lethal approach where ziftomenib targets an epigenetic vulnerability in GIST tumors, leading to reduced KIT expression and activity, and effectively silencing ERK and AKT/mTOR signaling pathways [3] Group 2: Clinical Development Plans - Kura Oncology plans to initiate a proof-of-concept study for ziftomenib in combination with imatinib in patients with advanced GIST who have failed imatinib treatment, expected to start in the first half of 2025 [1][4] - The FDA has cleared the Investigational New Drug (IND) application for ziftomenib, facilitating its clinical development for advanced GIST [4] Group 3: Background on GIST and Ziftomenib - GISTs are the most common form of sarcoma, primarily driven by KIT mutations, and while imatinib is the standard treatment, resistance often develops, necessitating new therapeutic options [5] - Ziftomenib is a selective oral menin inhibitor also being developed for acute myeloid leukemia (AML) and has received Breakthrough Therapy Designation from the FDA for this indication [6]

– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses – – Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 – SAN DIEGO, Aug. 08, 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 clearance by the U.S. Foo ...

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 Overview - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [7] - The company's lead investigational drug, ziftomenib (KO-539), is a menin inhibitor targeting relapsed or refractory NPM1-mutant acute myeloid leukemia (AML) [5][7] Clinical Trial Progress - Kura has completed enrollment of 85 patients in the Phase 2 portion of the KOMET-001 trial in under 16 months [1] - Topline data from the trial is expected to be reported in early 2025 [1][2] - The trial aims to assess the clinical activity, safety, and tolerability of ziftomenib, with a primary endpoint of complete response [2] Breakthrough Therapy Designation - Ziftomenib has received Breakthrough Therapy Designation from the FDA, which facilitates expedited review for its potential as an innovative treatment for R/R NPM1-mutant AML [2][5] - This designation underscores the urgent need for effective treatment options in AML, particularly for patients with NPM1 mutations, which account for approximately 30% of new AML cases annually [3][4] Market Need and Patient Prognosis - NPM1-mutant AML has a high unmet medical need, with no approved targeted therapies currently available [3][4] - Patients with R/R NPM1-mutant AML have poor survival outcomes, with only 30% overall survival at 12 months in the R/R setting [4] - The median overall survival for patients with NPM1-m AML is approximately 7.8 months in the second line, 5.3 months in the third line, and 3.5 months following the fourth line of treatment [4] Ziftomenib's Clinical Profile - In the Phase 1 study, ziftomenib demonstrated a favorable safety profile and a 35% complete remission rate at the recommended Phase 2 dose of 600 mg [5] - The drug is designed to be taken once daily and targets the menin-KMT2A/MLL protein-protein interaction [5][6]

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 ...