Kura Oncology(US:KURA)2025-05-01 20:15Financial Position - As of March 31, 2025, Kura Oncology had cash, cash equivalents, and short-term investments totaling $658.2 million[99]. - The company had cash, cash equivalents, and short-term investments totaling $658.2 million as of March 31, 2025, which is expected to fund operations into 2027[127]. - The company had an accumulated deficit of $952.9 million and expects expenses to increase due to ongoing R&D activities[126]. - Total contractual obligations as of March 31, 2025, amounted to $38.9 million, with $4.5 million due within one year[134]. - The interest rate on the term loans was 9.90% as of March 31, 2025, with an end of term fee of approximately $1.5 million due at maturity[137]. Revenue and Financing - Kura Oncology received an upfront payment of $330.0 million from Kyowa Kirin for the global development and commercialization of ziftomenib[100]. - Collaboration revenue for the three months ended March 31, 2025, was $14.1 million, attributed to services performed under the Kyowa Agreement[116]. - The company has not generated any revenues from product sales and relies on collaboration and license agreements for funding[103]. - The company has not generated any revenues from product sales and does not expect to do so until regulatory approval is obtained[128]. - The ATM Facility allows the company to offer shares with an aggregate offering price of up to $150 million, although no shares have been sold under this facility yet[102]. - The company entered into a loan agreement providing for up to $125.0 million in term loans, of which $10.0 million was drawn from the initial tranche[124]. - The company anticipates significant additional financing will be required to continue operations, as indicated in the liquidity and capital resources section[120]. Research and Development - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed or refractory NPM1-mutant AML[84]. - The KOMET-001 trial achieved its primary endpoint of complete remission plus partial hematological recovery, demonstrating a favorable benefit-risk profile[84]. - Kura Oncology plans to initiate the KOMET-017-IC trial in the second half of 2025, evaluating ziftomenib with induction chemotherapy in newly diagnosed AML patients[91]. - The KOMET-017-NIC trial is set to evaluate ziftomenib in combination with venetoclax and azacitidine for patients unfit for intensive chemotherapy, expected to start in the second half of 2025[92]. - Kura Oncology is advancing KO-2806 in a Phase 1 trial, with preliminary data expected in the second half of 2025[96]. - The KURRENT-HN trial of tipifarnib in combination with alpelisib has completed enrollment, with data presentation anticipated in the second half of 2025[98]. - Kura Oncology is exploring ziftomenib for gastrointestinal stromal tumors, with the first patients dosed in the KOMET-015 trial[94]. Expenses - Research and development expenses increased to $55.973 million for the three months ended March 31, 2025, up from $36.268 million in the same period in 2024, reflecting a rise of $19.705 million[117]. - General and administrative expenses rose to $22.835 million for the three months ended March 31, 2025, compared to $18.184 million in the prior year, an increase of $4.651 million[118]. - Net cash used in operating activities for the three months ended March 31, 2025, was $71.9 million, an increase of $23.1 million compared to the same period in 2024[131]. Agreements and Milestones - A milestone payment of $45.0 million from Kyowa Kirin is expected in the second quarter of 2025 following the FDA's receipt of the NDA for ziftomenib[100]. - The Kyowa Agreement, established in November 2024, includes an upfront payment of $330 million and potential milestone payments of up to $933 million for the development of ziftomenib[121]. - The company may need to pay up to approximately $78.8 million in milestone payments if certain regulatory and commercial milestones are achieved[138]. - Under the Kyowa Agreement, the company will share equally in development costs and potential profits from the commercialization of ziftomenib in the U.S.[139]. Shareholder Information - In January 2024, the company completed a private placement, selling 1,376,813 shares at $17.25 per share, raising approximately $145.8 million in net proceeds[122]. - As of March 31, 2025, 559,424 pre-funded warrants from the private placement had been exercised, with 6,759,462 remaining outstanding[122].