Kura Oncology Announces Q2 2024 Financial Results

Kura Oncology, Inc., a clinical-stage biopharmaceutical company, reported their second-quarter 2024 financial results and provided a comprehensive corporate update. Troy Wilson, President and CEO, highlighted significant accomplishments, notably the completion of patient enrollment in the KOMET-001 trial and the FDA granting Breakthrough Therapy Designation to ziftomenib for treating relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML).

Key Developments

Enrollment Completion in KOMET-001 Trial: In May 2024, Kura Oncology completed the enrollment of 85 patients in the Phase 2 segment of KOMET-001, a pivotal clinical trial for ziftomenib targeting patients with R/R NPM1-mutant AML. This form of AML comprises about 30% of new cases annually, representing a significant unmet medical need. Topline data from this trial is expected in early 2025.

Breakthrough Therapy Designation: In April 2024, ziftomenib received Breakthrough Therapy Designation from the FDA for treating R/R NPM1-mutant AML. This designation is given to drugs that show substantial improvement over existing therapies for serious or life-threatening conditions.

KOMET-007 Study Update: The Phase 1b expansion phase of the KOMET-007 study, which explores ziftomenib in combination with other treatments like venetoclax and azacitidine (ven/aza) and cytarabine plus daunorubicin (7+3), is now open for enrollment. The study aims to enroll around 100 patients across multiple cohorts. Updated data from this study will be presented in the fourth quarter of 2024.

IND Approval for GIST: The FDA has cleared Kura’s Investigational New Drug (IND) application for using ziftomenib in combination with imatinib to treat advanced gastrointestinal stromal tumors (GIST). Preclinical data suggest that ziftomenib has the potential to re-sensitize patients to imatinib, leading to deep, durable responses. A proof-of-concept study will commence in the first half of 2025.

Preclinical Diabetes Data: Preliminary data presented in June 2024 show that ziftomenib induces insulin production, improves insulin sensitivity, and lowers insulin resistance in a preclinical model of type 2 diabetes. These findings, presented at the American Diabetes Association (ADA) Scientific Sessions, demonstrate meaningful glycemic control.

KRASG12C-mutated NSCLC Study: The first patient has been dosed in a study of KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in combination with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC). This study builds on preclinical models suggesting that combining KO-2806 with adagrasib may enhance tumor regression and prolong antitumor responses. The study is supported by a collaboration agreement with Mirati, now part of Bristol Myers Squibb.

Financial Overview

For the second quarter of 2024, research and development expenses were $39.7 million, up from $28.2 million in the same quarter of 2023. General and administrative expenses rose to $16.7 million from $11.8 million. The net loss for this period was $50.8 million, compared to $37.2 million in the previous year. As of June 30, 2024, Kura Oncology had $491.5 million in cash, cash equivalents, and investments, providing a financial runway into 2027.

Upcoming Milestones

Kura Oncology has outlined several anticipated milestones:
- Presentation of updated KOMET-007 trial data in the fourth quarter of 2024.
- Reporting topline data from the KOMET-001 trial in early 2025.
- Presenting preclinical data on the potential use of ziftomenib in GIST in the second half of 2024.
- Initiating a proof-of-concept study for ziftomenib in GIST in the first half of 2025.
- Nominating a new menin inhibitor development candidate in early 2025.
- Identifying the maximum tolerated dose for KO-2806 as a monotherapy by the second half of 2024.
- Completing enrollment for expansion cohorts in the KURRENT-HN study and presenting data in early 2025.

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