Kura Oncology, Inc. (KURA) Q1 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call presents a mixed picture: positive collaboration with Kyowa Kirin, strong cash position, and strategic developments. However, increased expenses and net losses are concerning. The Q&A reveals management's confidence but also highlights competitive pressures and lack of detailed differentiation strategy. The market cap suggests moderate volatility, leading to a neutral prediction.

Key Financial Performance

Collaboration Revenue $14.1 million (compared to $0 in Q1 2024) - This increase is due to the partnership with Kyowa Kirin, which began generating revenue in the current quarter.

Research and Development Expenses $56 million (up from $36.3 million in Q1 2024) - The increase is attributed to ongoing clinical trials and development activities.

General and Administrative Expenses $22.8 million (up from $18.2 million in Q1 2024) - This rise is likely due to increased operational costs associated with the company's growth.

Net Loss $57.4 million (compared to a net loss of $49.5 million in Q1 2024) - The increase in net loss is primarily due to higher expenses in R&D and G&A.

Cash, Cash Equivalents, and Short-term Investments $658.2 million (down from $727.4 million as of December 31, 2024) - The decrease is due to cash used in operations, although the adjusted pro forma figure is $703.2 million after accounting for the $45 million NDA milestone payment.

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Operating Highlights

NDA Submission for Ziftomenib: Kura submitted a New Drug Application (NDA) for ziftomenib as a monotherapy for relapsed or refractory NPM1-mutant AML.

Combination Therapy in GIST: First patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure were dosed with ziftomenib and imatinib.

FTI Program Progress: Kura continues to advance its FTI program and expects to share preliminary clinical data from multiple Phase 1 cohorts later this year.

Collaboration Revenue: Collaboration revenue from Kyowa Kirin partnership for Q1 2025 was $14.1 million, compared to no revenue in Q1 2024.

Cash Position: As of March 31, 2025, Kura had $703.2 million in cash, cash equivalents, and short-term investments, sufficient to fund operations into 2027.

Appointment of New SVP: Samir Vattompadam appointed as Senior Vice President, Global Program Leadership, bringing over 20 years of experience.

Partnership with Kyowa Kirin: Strategic partnership with Kyowa Kirin enhances development, commercial, and operational resources, providing financial stability.

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Risk or Challenges

Regulatory Risks: The company is closely monitoring the FDA review process for ziftomenib, with potential disruptions due to changes at Health and Human Services or the FDA, although no issues have been reported so far.

Competitive Pressures: Ziftomenib is the first investigational therapy targeting NPM1-mutant AML, but the company faces competition from other therapies in development for similar indications.

Supply Chain Challenges: The company has indicated that the impact from tariffs would be negligible, suggesting a low risk in supply chain disruptions.

Financial Risks: The company reported a net loss of $57.4 million for Q1 2025, which raises concerns about financial sustainability despite a strong cash position.

Market Dynamics: The company acknowledges a challenging market environment and is prepared to adapt to rapidly evolving situations.

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Guidance & Outlook

NDA Submission for Ziftomenib: Kura submitted a New Drug Application (NDA) for ziftomenib, targeting relapsed or refractory NPM1-mutant AML, with a priority review requested.

Clinical Data Presentations: Ziftomenib Phase 2 registrational data accepted for oral presentation at the 2025 ASCO Annual Meeting, with multiple updates anticipated throughout the year.

Leadership Appointment: Appointment of Samir Vattompadam as Senior Vice President, Global Program Leadership, to strengthen the leadership team.

Cash Position: Kura had a pro forma cash position of $703.2 million as of March 31, 2025, sufficient to fund operations into 2027.

Strategic Partnership: Collaboration with Kyowa Kirin enhances development, commercial, and operational resources, providing financial stability.

Revenue Expectations: Collaboration revenue from Kyowa Kirin for Q1 2025 was $14.1 million.

Future Milestones: Anticipated milestones include presenting full data for KOMET-001 in Q2 2025 and initiating two independent Phase 3 trials in the second half of 2025.

Financial Projections: Kura expects to receive an additional $375 million in near-term anticipated milestones.

Operating Expenses: Current cash resources are projected to support operations into 2027.

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Shareholder Return Plan

Cash Position: As of March 31, 2025, Kura had on a pro forma basis $703.2 million in cash, cash equivalents and short-term investments, adjusted for a $45 million milestone payment.

Anticipated Milestones: Kura expects to receive an additional $375 million in near-term anticipated milestones under the collaboration agreement with Kyowa Kirin.

Collaboration Revenue: Collaboration revenue from Kyowa Kirin partnership for Q1 2025 was $14.1 million.

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Key Q&A

Q:Can you maybe set the expectations for the combo data coming later this year, especially the aza/ven cohort? What do you need to show us to be competitive?

A:We’re always looking for safety as our first, second and third priorities. We want to establish the ability to safely combine ziftomenib with venetoclax in the frontline. We look forward to showing the combinability of ziftomenib with these agents.

Q:Can you discuss how the changes at the regulatory agency have impacted or not the potential approval process and timelines for ziftomenib?

A:We’re not seeing any impact at all. The agency has been responsive, collaborative, productive. We requested priority review and expect to receive notification from FDA in the second quarter.

Q:Can you help set expectations for the upcoming ASCO presentation of the KOMET-001 results?

A:The CR, CRh rate will be between 20% and 30%. The ASCO presentation will have a more fulsome data set compared to the abstract.

Q:What is Kyowa Kirin strategy to capture the share of the NPM1 market and overcome zifto second to market position?

A:It’s not obvious to us at the moment that we’ll be second to market. We submitted our NDA in March and requested priority review. We’re waiting to see where our competitors are in terms of their submission timelines.

Q:What patient segments do you think are going to be more responsive to the combination and the particular subgroups you are going to be focused on?

A:The combination should work regardless of the KIT mutation. We hope to move into the frontline setting as well.

Q:What are some of the gating steps before you’re able to initiate the trial in the second half?

A:We’re in study startup. There’s a lot that has to happen for a global Phase 3, including contracting and budgeting.

Q:What do you think is perhaps needed to pull clinicians who are perhaps familiar and comfortable with one agent over to zifto following a potential approval?

A:We think our objectives will be to appropriately communicate the risk benefit profile of our therapy relative to other competitors.

Q:How should we think about enrollment given you will soon have approved the drug?

A:There shouldn’t be a drag on enrollment in the frontline trials because that’s a patient population for which no menin inhibitor is approved.

Q:Review of Unclear Management Responses

A:Management avoided giving a direct answer regarding the specific points of differentiation that Kyowa Kirin will use to capture market share in the NPM1 market, and the exact gating steps before initiating the Phase 3 trial were not detailed.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

KURA Transcript

Kura Oncology, Inc. (KURA) Q3 2025 Earnings Call Transcript

Positive11-4

The earnings call highlights promising developments, particularly the FDA priority review for ziftomenib and its significant market potential. The Q&A further underscores strong confidence in product differentiation and launch readiness, despite management's evasiveness on market share expectations. The company's financials show a decrease in cash reserves due to investments, but this aligns with strategic growth. The overall sentiment is positive, with a potential stock price rise driven by the anticipated product launch and market expansion.

Kura Oncology, Inc. (KURA) Discusses On FTI Preclinical Program Review: Synergistic Combinations With Targeted Therapies Conference Transcript

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Kura Oncology, Inc. (KURA) Discusses On FTI Preclinical Program Review: Synergistic Combinations With Targeted Therapies Conference Transcript

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Kura Oncology, Inc. (KURA) Discusses On FTI Preclinical Program Review: Synergistic Combinations With Targeted Therapies Conference (Transcript)

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