Kura Oncology Q1 2024 Financial Results

Kura Oncology, Inc., a clinical-stage biopharmaceutical firm dedicated to advancing precision medicines for cancer treatment, recently unveiled its first quarter 2024 financial results and provided key corporate updates. The company’s leading investigational drug, ziftomenib, has shown promising results, particularly for patients with NPM1-mutant acute myeloid leukemia (AML).

Dr. Troy Wilson, Kura Oncology’s President and CEO, highlighted the impressive safety and efficacy profile of ziftomenib. He emphasized the drug's potential to become a cornerstone therapy for acute leukemias, underscored by the recent Breakthrough Therapy Designation (BTD) from the FDA. This designation is a significant milestone, marking ziftomenib as the first investigational treatment to receive BTD for NPM1-mutant AML, a serious and life-threatening condition with limited treatment options.

Kura's clinical trials are progressing swiftly. The KOMET-001 trial, which is registration-directed, is on track to complete the enrollment of 85 patients with relapsed/refractory (R/R) NPM1-mutant AML by mid-2024. Preliminary data from Phase 1 of this trial indicated a 35% complete remission (CR) rate and a 45% overall response rate in heavily pretreated patients. Notably, NPM1-mutant AML accounts for about 30% of new AML cases each year, highlighting the urgent need for effective treatments.

In addition to the positive results from the KOMET-001 trial, Kura reported encouraging preliminary data from the KOMET-007 trial. This trial explores ziftomenib in combination with venetoclax/azacitidine or cytarabine/daunorubicin in patients with NPM1-mutant or KMT2A-rearranged AML. As of January 2024, all newly diagnosed patients treated with ziftomenib and 7+3 achieved complete remission with full count recovery, and a 53% overall response rate was observed among the R/R patients treated with ziftomenib and venetoclax/azacitidine. The 200 mg daily dose of ziftomenib was well tolerated, with no differentiation syndrome events, dose-limiting toxicities, QTc prolongation, drug-drug interactions, or additive myelosuppression reported.

Dose escalation continues in the KOMET-007 trial, with the 400 mg dose already cleared in three cohorts, and enrollment at the 600 mg dose is ongoing. Additionally, February marked the commencement of patient dosing in the KOMET-008 trial, which investigates ziftomenib in combination with other standards of care, such as the FLT3 inhibitor gilteritinib for treating R/R NPM1-mutant or KMT2A-rearranged AML.

Kura also dosed the first patient with KO-2806, its next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib for renal cell carcinoma. The company is on schedule to begin dosing patients with KO-2806 in combination with adagrasib for KRASG12C-mutated non-small cell lung cancer by mid-2024.

Financially, Kura reported increased research and development expenses for the first quarter of 2024 at $36.3 million, up from $25.2 million in the first quarter of 2023. General and administrative expenses also rose to $18.2 million from $11.4 million over the same period. The net loss for the first quarter of 2024 stood at $49.5 million, compared to $34.1 million in the previous year. As of March 31, 2024, Kura had cash, cash equivalents, and short-term investments totaling $527 million, ensuring a financial runway into 2027.

Kura Oncology continues to advance its pipeline of small molecule drug candidates targeting cancer signaling pathways. Ziftomenib, a once-daily oral drug targeting the menin-KMT2A interaction, is currently in various stages of clinical trials. The company also has ongoing trials for tipifarnib, another potent FTI, and KO-2806, further solidifying its commitment to developing precision cancer therapies.