• Research and Development Expenses: $41.7 million for Q3 2024, up from $29.3 million in Q3 2023.
• General and Administrative Expenses: $18.2 million for Q3 2024, compared to $13.1 million in Q3 2023.
• Net Loss: $54.4 million for Q3 2024, compared to $38.6 million in Q3 2023.
• Noncash Share-Based Compensation Expense: $8.3 million for Q3 2024, compared to $7.1 million in Q3 2023.
• Cash, Cash Equivalents, and Short-Term Investments: $455.3 million as of September 30, 2024, up from $424 million as of December 31, 2023.

• Warning! GuruFocus has detected 1 Warning Sign with KURA.

Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Kura Oncology Inc (NASDAQ:KURA) reported promising preliminary data from their KOMET-007 trial, showing ziftomenib's potential best-in-class safety and tolerability profile.
• The company has advanced all four cohorts in the Phase Ia dose escalation portion of KOMET-007 to the Phase Ib expansion study, indicating positive progress in their clinical trials.
• Ziftomenib has been granted breakthrough therapy designation by the FDA for the treatment of relapsed and refractory NPM1 mutant AML, highlighting its potential as an innovative treatment.
• Kura Oncology Inc (NASDAQ:KURA) has a strong financial position with $455.3 million in cash, cash equivalents, and short-term investments, sufficient to fund operations into 2027.
• The company is exploring additional opportunities for ziftomenib beyond acute leukemias, including potential applications in solid tumors and diabetes, expanding its therapeutic scope.

Negative Points

• Research and development expenses increased significantly to $41.7 million in Q3 2024 from $29.3 million in Q3 2023, reflecting higher clinical trial costs.
• The net loss for Q3 2024 was $54.4 million, up from $38.6 million in Q3 2023, indicating increased financial pressure.
• There is uncertainty regarding the use of MRD negativity as a surrogate endpoint in accelerated trial designs, pending discussions with health authorities.
• The company faces challenges in establishing ziftomenib as the best-in-class menin inhibitor, with ongoing competition in the menin inhibitor space.
• Kura Oncology Inc (NASDAQ:KURA) is still in early stages of exploring the potential of menin inhibitors in diabetes and other metabolic diseases, which may delay market entry.

Q & A Highlights

Q: How are you thinking about the potential of using MRD negativity as part of the frontline endpoints? Is there any difference in the methodology used by you versus your peers? A: The base case scenario for frontline studies is using survival as the endpoint. There may be an opportunity to use MRD negativity as a surrogate endpoint in an accelerated design, but it's not yet approved by health authorities. We plan to discuss this with them soon. Regarding methodology, we plan to do a central analysis of samples to provide a uniform result on MRD negativity, as local tests can vary.

Q: For the 600 mg data that you'll present at ASH, what types of data might we see? A: We anticipate showing data on more than 100 patients, updating on their status with respect to response and duration of clinical benefit. We expect consistent activity across dose levels, with improved safety and tolerability at higher doses, which supports moving forward with the 600 mg dose in expansion cohorts.

Q: As we're starting to see longer-term data for ziftomenib and other menin inhibitors, how has that impacted your thinking on the opportunity for the class? A: The emerging data in the frontline setting is promising, with many patients remaining on therapy for extended periods. This suggests a significant opportunity to intercept patients early in their treatment journey, potentially keeping them on therapy for a year or more, which could significantly impact the disease and drive the commercial case.

Q: Regarding the combination updates at ASH, what should we be thinking in terms of benchmarking a win? Is safety still the focus? A: In the relapsed/refractory setting, safety and tolerability are the primary focus, with the ability to safely escalate doses being a strong sign of activity. In the frontline setting, we're comparing against the Vyxeos control arm, with a composite response rate of about 60% and overall survival of about 6 months. We're encouraged by the ability to escalate doses and the duration patients remain on therapy.

Q: What are your current thoughts on employing a strategy similar to a peer company using a European cooperative group for a frontline trial? A: Cooperative groups play an important role, especially for smaller indications. However, for major opportunities like 7+3 and ven/aza, we prefer company-sponsored studies to maintain control over design, timelines, and data interpretation. We will continue to use cooperative groups where appropriate for smaller indications.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.