Kura Oncology(KURA) - 2024 Q2 - Quarterly Results

Kura Oncology Reports Second Quarter 2024 Financial Results Kura Oncology reported Q2 2024 financial results, highlighting significant clinical pipeline advancements and a strong cash position Corporate Update and Pipeline Progress Kura Oncology advanced its clinical programs, completing KOMET-001 enrollment, expanding ziftomenib applications, and initiating KO-2806 studies, with key data readouts expected by early 2025 - Topline data from the registration-directed KOMET-001 trial of ziftomenib in R/R NPM1-mutant AML is expected in early 2025[1] - Ziftomenib was granted Breakthrough Therapy Designation by the FDA for the treatment of relapsed/refractory (R/R) NPM1-mutant AML[1][4] - The FDA has cleared the Investigational New Drug (IND) application for ziftomenib for the treatment of advanced gastrointestinal stromal tumors (GIST)[1][6] - The first patient has been dosed in the study of KO-2806, a next-generation FTI, in combination with adagrasib for KRASG12C-mutated non-small cell lung cancer (NSCLC)[1][8] Recent Highlights Kura Oncology achieved key milestones, including completing KOMET-001 enrollment, advancing KOMET-007, securing IND clearance for ziftomenib in GIST, and initiating KO-2806 dosing - Completed enrollment of 85 patients in the Phase 2 KOMET-001 registration-directed trial of ziftomenib in patients with R/R NPM1-mutant AML, with topline data expected in early 2025[3] - The Phase 1b expansion of the KOMET-007 combination study of ziftomenib is now open for enrollment, evaluating combinations with ven/aza and 7+3 in newly diagnosed AML[5] - The FDA cleared the IND application for ziftomenib to treat advanced gastrointestinal stromal tumors (GIST) in combination with imatinib, with a proof-of-concept study planned for the first half of 2025[6] - Preclinical data presented at the ADA Scientific Sessions showed ziftomenib induces insulin production and improves glycemic control, suggesting potential application in diabetes[7] Forecasted Milestones Kura Oncology anticipates key data readouts for KOMET-007 and KOMET-001 in late 2024/early 2025, alongside initiating a GIST study and advancing other pipeline candidates - Present updated data from the KOMET-007 trial (ziftomenib with ven/aza and 7+3) at a medical meeting in Q4 2024[10] - Report topline data from the KOMET-001 registration-directed trial of ziftomenib in R/R NPM1-mutant AML in early 2025[10] - Initiate a proof-of-concept study for ziftomenib and imatinib in advanced GIST in the first half of 2025[10] - Identify the maximum tolerated dose for KO-2806 as a monotherapy in the second half of 2024[11] - Present data from the KURRENT-HN trial of tipifarnib with alpelisib in HNSCC in the first half of 2025[11] Financial Results Kura Oncology reported an increased net loss of $50.8 million in Q2 2024 due to higher R&D expenses, maintaining a strong $491.5 million cash position projected into 2027 - Research and development expenses were $39.7 million in Q2 2024 compared to $28.2 million in Q2 2023[9] - General and administrative expenses were $16.7 million in Q2 2024 compared to $11.8 million in Q2 2023[9] - Net loss was $50.8 million in Q2 2024 compared to $37.2 million in Q2 2023[9] - As of June 30, 2024, cash, cash equivalents and short-term investments totaled $491.5 million, compared to $424.0 million as of December 31, 2023[9] - The company's current cash position is expected to fund operations into 2027[9] Statements of Operations Data Kura Oncology's net loss increased to $50.8 million in Q2 2024 and $100.4 million for the first six months, primarily driven by higher operating expenses, especially in R&D | (in thousands, except per share data) | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2024 | 2023 | 2024 | 2023 | | Research and development | $39,727 | $28,182 | $75,995 | $53,374 | | General and administrative | $16,677 | $11,821 | $34,861 | $23,195 | | Total operating expenses | $56,404 | $40,003 | $110,856 | $76,569 | | Net loss | $(50,837) | $(37,174) | $(100,362) | $(71,243) | | Net loss per share, basic and diluted | $(0.59) | $(0.53) | $(1.18) | $(1.03) | Balance Sheet Data Kura Oncology's cash, cash equivalents, and short-term investments significantly increased to $491.5 million as of June 30, 2024, bolstering total assets and stockholders' equity | (in thousands) | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $491,519 | $423,957 | | Working capital | $466,317 | $397,218 | | Total assets | $515,116 | $448,935 | | Stockholders' equity | $466,070 | $397,273 |