Kura Oncology(US:KURA)2025-11-04 12:30Product Development - Kura Oncology's lead product candidate, ziftomenib, is being developed for genetically defined subsets of acute leukemias, including AML and ALL, with a collaboration agreement with Kyowa Kirin for global commercialization[81] - The KOMET-001 trial for ziftomenib in relapsed or refractory NPM1-mutated AML showed a complete remission rate of 22%, exceeding the historical benchmark of 12%[88] - The overall response rate in the KOMET-001 trial was 33%, with a median duration of overall response of 4.6 months[88] - Ziftomenib received Breakthrough Therapy Designation from the FDA in April 2024, and a new drug application was submitted on March 31, 2025, with a PDUFA target action date of November 30, 2025[87] - The KOMET-007 trial is evaluating ziftomenib in combination with standard therapies for newly diagnosed AML, with preliminary data expected to be presented at the American Society for Hematology Annual Meeting in December 2025[95] - The KOMET-017 trials are assessing ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed NPM1-mutated AML, with topline results anticipated in 2028[98][99] - Kura Oncology is also exploring ziftomenib in combination with imatinib for gastrointestinal stromal tumors, with the KOMET-015 trial currently ongoing[102] - Darlifarnib, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 trial for safety and preliminary antitumor activity[104] - The combination of tipifarnib and alpelisib showed an ORR of 47% in heavily pretreated HNSCC patients[109] - The company anticipates presenting preliminary clinical data from the combination of darlifarnib and adagrasib in 2026[107] - The company expects to initiate Phase 1b expansion cohorts of darlifarnib and cabozantinib in advanced RCC in the first half of 2026[108] Financial Performance - Collaboration revenue for the three months ended September 30, 2025, was $20.8 million, with $20.3 million from the Kyowa License Agreement[129] - Research and development expenses increased by $26.2 million to $67.9 million for the three months ended September 30, 2025, compared to $41.7 million in the same period of 2024[128] - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $549.7 million[111] - The company received an upfront payment of $330 million under the Kyowa License Agreement and achieved $75 million in development milestone payments as of September 30, 2025[112] - Collaboration revenue for the nine months ended September 30, 2025, was $50.1 million, with $49.6 million from the Kyowa License Agreement[135] - Research and development expenses for the nine months ended September 30, 2025, totaled $186.7 million, an increase of $69.0 million compared to $117.7 million in 2024[136] - Ziftomenib-related costs increased to $107.9 million for the nine months ended September 30, 2025, up from $52.3 million in 2024, reflecting a change of $55.5 million[136] - The accumulated deficit as of September 30, 2025, was $1.1 billion, indicating ongoing operating losses since inception[144] - Net cash used in operating activities for the nine months ended September 30, 2025, was $181.3 million, an increase of $46.5 million from $134.8 million in 2024[149] - The company has milestone payment obligations of up to approximately $78.8 million contingent upon achieving certain regulatory and commercial milestones under in-license agreements[155] Strategic Partnerships and Agreements - Kura Oncology plans to advance its product candidates through internal development and strategic partnerships while maintaining significant development and commercial rights[85] - The company received an upfront payment of $330.0 million under the Kyowa License Agreement and is eligible for up to $933.0 million in additional milestone payments[139] - Under the Kyowa License Agreement, the company will share equally (50/50) with Kyowa Kirin all development costs for activities planned to be conducted prior to the end of 2028[156] Cash and Investments - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $549.7 million, expected to fund operations into 2027[145] - The company has borrowed $10.0 million under a loan agreement with a maturity date of November 2, 2027, with an end of term fee of approximately $1.5 million[142] - Net cash provided by investing activities for the nine months ended September 30, 2025, was $51.5 million, a significant increase from a net cash used of $6.6 million in 2024[150] Operational Risks and Considerations - The company has not generated any revenues from product sales and relies on equity and debt financings for operations[115] - The company expects general and administrative expenses to rise in future periods to support increased research and development and pre-commercial activities[133] - The company does not believe that a 10.0% change in interest rates would have a material effect on the fair value of its investment portfolio as of September 30, 2025[159] - The company is exposed to interest expense fluctuations through Term Loans, which bear interest at a rate that could be affected by changes in the prime rate[160] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the periods presented[161]