Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Kura Oncology Inc (KURA, Financial) received breakthrough therapy designation from the FDA for ziftomenib, highlighting its potential as an innovative treatment for NPM1 mutant acute myeloid leukemia.
- The company completed enrollment in the KOMET-001 trial ahead of schedule, demonstrating strong execution and interest in ziftomenib.
- Ziftomenib showed encouraging safety and tolerability in the KOMET-007 trial, with no differentiation syndrome events or dose-limiting toxicities reported.
- Kura Oncology Inc (KURA) has a robust pipeline with multiple ongoing trials, including the KOMET-008 study and a new proof-of-concept study for gastrointestinal stromal tumors.
- The company has a strong financial position with $491.5 million in cash and investments, sufficient to fund operations into 2027.
Negative Points
- Research and development expenses increased significantly, from $28.2 million in Q2 2023 to $39.7 million in Q2 2024, primarily due to clinical trial costs.
- The net loss for Q2 2024 was $50.8 million, up from $37.2 million in the same period last year, indicating increased financial pressure.
- There is uncertainty regarding the regulatory process for ziftomenib, with potential risks of delays or challenges in securing approvals.
- The company faces competition from other Menin inhibitors, which could impact its market position and future revenue potential.
- Enrollment dynamics for the KOMET-008 study are still ramping up, which could delay data readouts and subsequent development timelines.
Q & A Highlights
Q: Can you provide details on the patient distribution in the KOMET-007 expansion cohort and the gating steps for the GIST proof-of-concept study?
A: We have dosed over 100 patients in the KOMET-007 study, with a minimum of 72 patients required across four genetically driven cohorts at three different doses. Enrollment has been robust, and we expect a meaningful update later this year. For the GIST study, we are in the study startup phase, working with leading KOLs to design the study. Success would be indicated by reversing progression in patients who have failed imatinib, aiming for durable responses.
Q: How are you preparing for regulatory interactions with the KOMET-001 study fully enrolled, and can you provide insights on the ziftomenib dose levels in KOMET-007?
A: We are actively engaging with the FDA and preparing NDA submission modules. We are not planning to use accelerated approval pathways but will leverage breakthrough therapy designation interactions. For KOMET-007, the safety and tolerability are consistent across doses, and we see enhanced activity at 600 mg, which we plan to use in expansion cohorts.
Q: How should we benchmark success for activity in the expansion cohort of KOMET-007, and what are your expectations for duration of response and MRD negativity rates?
A: We expect higher response rates and better outcomes in frontline populations. The safety and tolerability observed are encouraging, and we will provide a comprehensive update at the end of the year. Physicians will focus on depth and durability of response, and the ability to maintain patients in response.
Q: What are the plans for the expansion cohort data release versus potential pivotal plans for standard of care combinations, and how should we think about the combination pivotal plan?
A: We are preparing at risk for combination pivotals, aiming to start in the first half of next year. We are optimistic about the opportunities in fit, unfit, and FLT3 populations. The pivotal plans will be informed by safety, tolerability, and dose definition data.
Q: Can you elaborate on the diabetes data and how ziftomenib compares to existing Menin inhibitor data?
A: The preclinical data for ziftomenib shows meaningful glycemic control and beta cell proliferation. We have tested competitor compounds and found ziftomenib's safety and activity to be favorable. We plan to advance next-generation Menin inhibitors for diabetes, focusing on safety.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
