• Collaboration Revenue: $14.1 million for Q1 2025, compared to no revenue in Q1 2024.
• Research and Development Expenses: $56 million for Q1 2025, up from $36.3 million in Q1 2024.
• General and Administrative Expenses: $22.8 million for Q1 2025, compared to $18.2 million in Q1 2024.
• Net Loss: $57.4 million for Q1 2025, compared to $49.5 million in Q1 2024.
• Cash, Cash Equivalents, and Short-term Investments: $658.2 million as of March 31, 2025, compared to $727.4 million as of December 31, 2024.
• Pro Forma Cash Position: $703.2 million as of March 31, 2025, adjusted for a $45 million milestone payment.

• Warning! GuruFocus has detected 3 Warning Signs with KURA.

Release Date: May 01, 2025

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

Positive Points

• Kura Oncology Inc (NASDAQ:KURA) has submitted a New Drug Application (NDA) for ziftomenib, a menin inhibitor, for the treatment of relapsed or refractory NPM1-mutant acute myeloid leukemia (AML), marking a significant regulatory milestone.
• The company has achieved a $45 million milestone payment from its collaboration with Kyowa Kirin, enhancing its financial position.
• Kura Oncology Inc (NASDAQ:KURA) has a strong cash position with $703.2 million in cash, cash equivalents, and short-term investments, providing sufficient capital to fund its ziftomenib AML program through commercialization.
• The company is advancing its FTI program, with plans to share preliminary clinical data from multiple Phase 1 cohorts later this year, indicating potential for FTIs as combination therapies.
• Kura Oncology Inc (NASDAQ:KURA) has announced the appointment of Samir Vattompadam as Senior Vice President, Global Program Leadership, bringing over 20 years of experience in the biotech and pharmaceutical industry to the team.

Negative Points

• Research and development expenses increased to $56 million in Q1 2025 from $36.3 million in Q1 2024, indicating rising costs.
• The company reported a net loss of $57.4 million for Q1 2025, compared to a net loss of $49.5 million in Q1 2024, reflecting ongoing financial challenges.
• General and administrative expenses rose to $22.8 million in Q1 2025 from $18.2 million in the same period in 2024, suggesting increased operational costs.
• Despite progress, the competitive landscape for menin inhibitors in the relapsed/refractory AML setting remains challenging, with other companies also advancing in this space.
• The company faces potential uncertainties in the regulatory approval process, although it has not experienced any disruptions or delays so far.

Q & A Highlights

Q: Can you set expectations for the combo data coming later this year, especially the aza/ven cohort? What do you need to show to be competitive? A: We are primarily focused on safety in these preliminary data presentations. We want to establish the ability to safely combine ziftomenib with venetoclax in the frontline. We aim to demonstrate the combinability of ziftomenib without added toxicity or adverse events. We remain on track to start the study in the second half of 2025. - Mollie Leoni, Chief Medical Officer

Q: How have changes at the regulatory agency impacted the potential approval process and timelines for ziftomenib? A: We have not seen any impact from changes at the FDA. The agency has been responsive and collaborative. We requested priority review and expect to receive notification on the application acceptance and PDUFA date in the second quarter. - Troy Wilson, CEO

Q: What is your strategy for capturing market share in the NPM1 setting, given the competitive landscape? A: We emphasize safety, tolerability, and clinical activity. We believe ziftomenib will be competitive in the relapsed/refractory setting. We are working with Kyowa Kirin to bring resources and focus to compete for every patient, aiming for use in earlier lines of therapy and in combination. - Troy Wilson, CEO and Brian Powl, Chief Commercial Officer

Q: How do you envision the long-term development of KO-2806 in combination with VEGF TKIs in RCC? A: KO-2806 is seen as highly synergistic with current treatments, potentially offering deeper, longer, and higher response rates. We aim to augment current treatment paradigms, providing additional therapeutic options in RCC. - Mollie Leoni, Chief Medical Officer

Q: What are the gating steps before initiating the Phase 3 KOMET-017 trial, and how is the reception from trial investigators? A: We are in study startup, focusing on contracting, budgeting, and site initiation. Investigators are positive about ziftomenib, noting that patients feel the same or better on the therapy. We anticipate excitement to build as more data is shared. - Troy Wilson, CEO and Mollie Leoni, Chief Medical Officer

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