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

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

Overview

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.

Key Financial Performance

Collaboration Revenue $20.8 million for Q3 2025, compared to no revenue for Q3 2024. The increase is due to the partnership with Kyowa Kirin.

Research and Development Expenses $67.9 million for Q3 2025, compared to $41.7 million for Q3 2024. The increase is attributed to the advancement of clinical trials and development programs.

General and Administrative Expenses $32.8 million for Q3 2025, compared to $18.2 million for Q3 2024. The increase is due to expanded commercial preparations and organizational growth.

Net Loss $74.1 million for Q3 2025, compared to $54.4 million for Q3 2024. The increase is driven by higher R&D and administrative expenses.

Noncash Share-Based Compensation Expense $11 million for Q3 2025, compared to $8.3 million for Q3 2024. The increase reflects higher share-based compensation costs.

Cash, Cash Equivalents, and Short-Term Investments $549.7 million as of September 30, 2025, compared to $727.4 million as of December 31, 2024. On a pro forma basis, including milestone payments, the total is $609.7 million as of September 30, 2025. The decrease is due to operational expenses and investments in development programs.

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Operating Highlights

Ziftomenib: Significant progress in clinical pipeline and commercial launch preparations. FDA review for relapsed/refractory NPM1-mutated AML on track with a PDUFA target date of November 30, 2025. Positive clinical data from KOMET-001 study and other trials show high response rates and MRD negativity. Advanced into KOMET-017 Phase III trials targeting frontline settings with over 150 global sites. Commercial preparations are complete, including disease awareness campaigns and payer engagement.

Farnesyl Transferase Inhibitor (FTI) Portfolio: New clinical data presented showing potential to combine with targeted therapies like PI3-kinase alpha inhibitors and KRAS inhibitors. Trials like FIT-001 and KURRENT-HN show manageable safety profiles and robust antitumor activity. Represents a substantial commercial opportunity with potential to address over 200,000 patients annually in the U.S.

Commercial Launch Readiness: Teams are fully mobilized for ziftomenib launch. Disease awareness campaigns exceeded targets, and preapproval information exchanges with payers are complete. Limited distribution network and oncology account managers are prepared.

Partnership with Kyowa Kirin: Received $105 million in milestone payments in 2025, with $315 million more expected in near-term milestones. Partnership supports robust development and commercialization plans.

Financial Position: Pro forma cash of $609.7 million as of September 30, 2025, sufficient to fund operations through 2027. Collaboration with Kyowa Kirin provides additional financial resources.

R&D and Administrative Expenses: R&D expenses increased to $67.9 million in Q3 2025 from $41.7 million in Q3 2024. General and administrative expenses rose to $32.8 million from $18.2 million in the same period.

Dual Pipeline Strategy: Focus on menin inhibition and farnesyl transferase inhibition as key growth pillars. Strategy aims to address unmet needs in precision oncology and expand commercial opportunities.

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Risk or Challenges

Regulatory Review Risks: The FDA review of ziftomenib for treatment of relapsed and refractory NPM1-mutated AML is ongoing. Any delays or unfavorable outcomes in the regulatory process could adversely impact the company's plans for commercialization.

Clinical Trial Execution Risks: The success of the KOMET-017 Phase III trials and other ongoing studies is critical. Challenges in patient enrollment, site activation, or achieving desired clinical endpoints could delay or jeopardize the approval and commercialization of ziftomenib.

Commercial Launch Risks: The anticipated commercial launch of ziftomenib depends on successful FDA approval and market readiness. Any misalignment in the launch strategy, payer negotiations, or distribution network could hinder market penetration.

Financial Risks: The company reported a net loss of $74.1 million for Q3 2025, with increased R&D and administrative expenses. While current cash reserves are projected to fund operations through 2027, any unexpected financial pressures or delays in milestone payments could strain resources.

Competitive Pressures: Ziftomenib aims to become the menin inhibitor of choice, but competition in the precision oncology market could limit its market share. The success of alternative therapies could also impact its adoption.

Supply Chain and Manufacturing Risks: The readiness of the limited distribution network and manufacturing capabilities is critical for the ziftomenib launch. Any disruptions could delay product availability.

Strategic Execution Risks: The dual pipeline strategy involving menin inhibitors and farnesyl transferase inhibitors requires significant coordination and investment. Any missteps in prioritization or resource allocation could dilute focus and impact outcomes.

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Guidance & Outlook

Ziftomenib FDA Review and Approval: The FDA review of ziftomenib for relapsed and refractory NPM1-mutated AML is on track with a PDUFA target action date of November 30, 2025. The company is focused on achieving a successful review outcome.

Ziftomenib Development Plans: The company is advancing ziftomenib into frontline settings through the KOMET-017 Phase III trials, targeting newly diagnosed NPM1 mutant or KMT2A rearranged AML. These trials aim to support U.S. accelerated and full approvals with endpoints including MRD-negative complete response, event-free survival, and overall survival.

Ziftomenib Combination Studies: The company is conducting combination studies of ziftomenib with venetoclax and azacitidine, as well as with 7+3 induction chemotherapy and quizartinib for FLT3-ITD NPM1 mutant co-mutations. Preliminary Phase I data for the latter is expected in 2026.

Commercial Launch Preparations for Ziftomenib: The company is launch-ready for ziftomenib, with marketing, market access, patient support, and sales teams mobilized. Preapproval information exchanges with key payers are complete, and the distribution network is aligned for rapid access and uptake upon approval.

Farnesyl Transferase Inhibitor (FTI) Programs: The company plans to initiate expansion cohorts for darlafarnib and cabozantinib in advanced renal cell carcinoma in the first half of 2026. Updated dose escalation data and clinical data from combinations with KRAS G12C inhibitors are expected in 2026.

Financial Position and Milestones: The company has a strong financial position with $609.7 million in cash and expects to receive $315 million in near-term milestone payments, including a substantial payment upon ziftomenib's commercial launch. Financial resources are sufficient to fund operations through 2027.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:What do you foresee will be the makeup of account types that you are trying to penetrate for zifto launch? Are there any particular account types that you are focusing on? And also, are there any plans to include zifto in the NCCN guideline?

A:The expected account types are specialty hematologists, with a mix of large academic institutions (78%) and larger community oncology practices. Plans are to submit the KOMET-01 data to the NCCN for a listing within days of FDA approval.

Q:Can you just talk about what we should expect for the actual oral presentations versus what's in the abstract release yesterday?

A:The oral presentations will include more evaluable patients, evolution of responses across the patient population, new information about MRD negativity, longer follow-up, and general safety information.

Q:What does the new label from Syndax, which includes Tsad and the black box, mean for you and the space as you think about your own NPM1 launch and progression towards first line?

A:The black box warning indicates a serious risk, such as sudden cardiac death, with a frequency of 1 in 100 or more. The company believes their product has a differentiated and favorable benefit-risk profile, especially in the relapsed/refractory setting and potentially in the frontline setting. They emphasize the importance of safety and tolerability in differentiating their product.

Q:What kind of level of penetration or market share would you either expect or hope to achieve relative to your first-mover competitor in the space, at least in the near term in the relapsed/refractory setting?

A:The company has not provided specific market share penetration expectations but anticipates capturing a majority share due to the product's best-in-class profile, strong efficacy, safety, tolerability, and convenience of a once-daily oral medication.

Q:What other analyses or long-term outcomes are we expecting to see like durability? Will we have also subgroup insights?

A:The data will include longer follow-up, granularity around MRD negativity, durability, and subgroup insights such as FLT3 and IDH patients. The presentations will provide a comprehensive view of the data from a large patient pool.

Q:Is having a differentiated label enough to overcome the second mover advantage when you think about sort of prescriber inertia?

A:The company believes that physicians and patients are sophisticated and prioritize the best benefit-risk profile. They are confident that their superior benefit-risk profile and comprehensive development program will help overcome any second-mover disadvantage.

Q:Can you provide any sort of color in kind of what goes on in the joint launch meetings? How many people, what's the split between you and KK? Do you wait for the approval or hit the ground running?

A:The joint launch meetings involved field teams from both companies, including sales, market access, and medical teams. The teams were trained and certified to be ready for launch immediately upon FDA approval. The meeting was described as highly energetic and well-executed.

Q:What the label could look like? Is there any potential for the monitoring requirements, the differentiation syndrome to be different from other AML drugs?

A:The differentiation syndrome guidance has been consistent and does not require additional monitoring beyond what is typical for this patient population. However, the final label will be determined upon FDA approval.

Q:Could you maybe share some initial feedback from physicians on how they're viewing efficacy and tolerability versus competitor inhibitors in the space, the IPM1 space?

A:Physicians view efficacy as a baseline requirement, but safety, tolerability, combinability with other medications, and simplicity of dosing are key differentiators for ziftomenib. The product's once-daily dosing and strong safety profile are seen as significant advantages.

Q:Have you noticed or anticipate any changes in terms of cadence and discussions with the agency given the recent disruptions at FDA?

A:The company has not noticed any changes in discussions with the FDA and remains on track for the November 30 PDUFA date. Interactions with the agency have been described as open and constructive.

Q:Review of Unclear Management Responses

A:Management avoided directly answering the question about specific market share penetration expectations, stating they have not guided on this yet. Additionally, they did not provide a clear answer on potential differences in monitoring requirements for differentiation syndrome, deferring to the final label upon FDA approval.

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Earnings Word Cloud

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

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