Kura Oncology’s Positive Earnings Call Highlights Progress and Prospects

Kura Oncology ((KURA)) has held its Q4 earnings call. Read on for the main highlights of the call.

Kura Oncology’s recent earnings call was marked by a positive sentiment, underscored by significant advancements in clinical trials, regulatory progress, and a robust financial position, despite increased expenses and ongoing net losses. The company’s strategic developments and financial health were key highlights that resonated with optimism for the future.

Positive Top-Line Results from KOMET-001

The Phase 2 registration-directed trial of ziftomenib in patients with relapsed/refractory NPM1-mutant Acute Myeloid Leukemia (AML) achieved its primary endpoint. The results were consistent with a targeted 20% to 30% complete remission/complete remission with partial hematologic recovery (CR/CRh) rate, and the safety profile aligned with previous reports, marking a significant milestone for Kura Oncology.

Regulatory Progress for Ziftomenib

Kura Oncology has made substantial regulatory progress with ziftomenib, aligning with both the FDA and EMA on potential pathways for accelerated approval in the US and Europe for frontline AML. The company plans to submit a New Drug Application (NDA) in the second quarter of 2025, setting the stage for potential market entry.

Strong Financial Position

As of December 31, 2024, Kura Oncology reported cash, cash equivalents, and short-term investments totaling $727.4 million. This strong financial footing is expected to fund the company’s operations into 2027, providing a solid foundation for ongoing and future projects.

Collaboration Revenue Boost

Kura Oncology experienced a significant boost in collaboration revenue, reporting $53.9 million for the fourth quarter of 2024 from its partnership with Kyowa Kirin. This marks a notable increase compared to the corresponding quarter of 2023, where no such revenue was recorded.

Future Prospects in Diabetes

Looking ahead, Kura Oncology plans to nominate a next-generation menin inhibitor development candidate for diabetes treatment in mid-2025. This decision is based on promising preclinical data, indicating potential expansion into new therapeutic areas.

Increased Operating Expenses

The company reported an increase in research and development expenses, which rose to $52.3 million in the fourth quarter of 2024 from $32.5 million in the same period of 2023. General and administrative expenses also increased to $24.1 million from $14.2 million, reflecting the company’s expanded operational activities.

Net Loss Despite Revenue Increase

Despite a revenue increase, Kura Oncology reported a net loss of $19.2 million for the fourth quarter of 2024. This is an improvement from the $42.8 million loss in the same quarter of the previous year, indicating progress toward profitability.

Long Timeline for Key Results

Kura Oncology anticipates top-line results for the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting for KOMET-017 by 2028. This long timeline reflects the complexity and rigor of ongoing clinical trials.

Forward-Looking Guidance

Kura Oncology’s forward-looking guidance highlights several key milestones for its ziftomenib program. The company plans to submit its first NDA for ziftomenib in Q2 2025, targeting relapsed/refractory NPM1-mutant AML. With alignment from regulatory bodies, Kura is preparing for the commercial launch of ziftomenib, aiming to establish it as a leading menin inhibitor in the market. Financially, the company is supported by a strong cash position, bolstered by a $330 million upfront payment from its Kyowa Kirin partnership.

In summary, Kura Oncology’s earnings call reflected a positive outlook, driven by clinical and regulatory advancements, a strong financial position, and strategic plans for future growth. Despite ongoing challenges, the company’s progress and forward-looking strategies offer a promising trajectory for stakeholders and investors.