Kura Oncology Announces Q3 2024 Financial Results

Kura Oncology, Inc., a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, shared its financial results for the third quarter of 2024 and provided a corporate update. The company is advancing several clinical trials for its drug candidates, particularly the menin inhibitor ziftomenib, targeting acute myeloid leukemia (AML) and gastrointestinal stromal tumors (GIST), among others.

In a Phase 2 registration-directed trial (KOMET-001) of ziftomenib in relapsed/refractory (R/R) NPM1-mutant AML, Kura completed enrollment of 85 patients in May 2024. This trial aims to address the significant unmet need for therapies targeting this AML subset, which constitutes around 30% of new AML cases annually. Ziftomenib has received Breakthrough Therapy Designation (BTD) for this indication, and the Phase 1 results of the KOMET-001 trial were published in *The Lancet Oncology*. Topline results from this trial are anticipated in early 2025.

Additionally, initial data from a Phase 1a dose-escalation study of ziftomenib, combined with standard therapies for NPM1-m and KMT2A-rearranged (KMT2A-r) AML, will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2024. This study highlights ziftomenib’s potential safety, tolerability, and activity. Kura plans to present more extensive data from this study involving over 100 patients at ASH.

Kura is also progressing with the Phase 1b expansion study, where ziftomenib is being tested across multiple cohorts at a 600 mg dosage. The study includes ziftomenib combined with venetoclax and azacitidine (ven/aza) or cytarabine and daunorubicin (7+3) in newly diagnosed NPM1-m or KMT2A-r AML patients. Preliminary results from this study are expected at a medical meeting in 2025.

In the realm of GIST, Kura presented preclinical data at a symposium in Barcelona, showing that ziftomenib in combination with imatinib exhibits strong antitumor activity in both imatinib-sensitive and resistant GIST models. This combination outperformed imatinib alone, suggesting a promising therapeutic strategy for advanced GIST. The company plans to start a proof-of-concept study in the first half of 2025.

Kura has also initiated dosing in a study of KO-2806, a next-generation farnesyl transferase inhibitor, combined with adagrasib for KRASG12C-mutated non-small cell lung cancer (NSCLC). This combination aims to enhance tumor regression and antitumor responses, supported by a collaboration with Mirati, now part of Bristol Myers Squibb.

In other preclinical work, ziftomenib has shown potential in managing type 2 diabetes by inducing insulin production and improving insulin sensitivity. These findings were presented at the American Diabetes Association Scientific Sessions in June 2024. Kura plans to nominate a new menin inhibitor candidate for diabetes in the first half of 2025.

Financially, Kura reported research and development expenses of $41.7 million for the third quarter of 2024, compared to $29.3 million in the same period in 2023. General and administrative expenses were $18.2 million, up from $13.1 million the previous year. The net loss for Q3 2024 was $54.4 million, compared to $38.6 million in Q3 2023. As of September 30, 2024, Kura had $455.3 million in cash, cash equivalents, and short-term investments, expected to fund operations into 2027.

Upcoming milestones for Kura include presenting updated data from the KOMET-007 trial at ASH in December 2024, reporting topline results from the KOMET-001 trial in early 2025, and sharing preliminary data from the Phase 1b expansion portion of KOMET-007 in 2025. Other plans include initiating a proof-of-concept study for advanced GIST, nominating a new menin inhibitor for diabetes, and exploring combination therapies for renal cell carcinoma.