Kura Oncology, Inc. (KURA): History, Ownership, Mission, How It Works & Makes Money

Kura Oncology, Inc. (KURA): History, Ownership, Mission, How It Works & Makes Money

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Kura Oncology, Inc. (KURA) just hit a major inflection point, but are you positioned to understand what this transition means for its valuation and long-term strategy?

As of November 2025, the company's market capitalization stands at nearly $0.94 Billion USD, driven by the recent FDA approval of its lead drug, Komzifti (ziftomenib), for relapsed or refractory Acute Myeloid Leukemia (AML) with an NPM1 mutation, a critical step that shifts them from a purely clinical-stage entity to a commercial one.

This approval, coupled with a strong pro forma cash position of $609.7 Million as of Q3 2025, gives Kura Oncology the runway to execute on its mission of realizing the promise of precision medicines, but the next challenge is translating that clinical success into consistent revenue beyond the trailing twelve-month figure of $104 Million.

Let's defintely dig into the history and the unique business model that generates revenue through collaboration milestones, so you can map the near-term risks against the massive opportunity in the menin inhibitor space.

Kura Oncology, Inc. (KURA) History

You want the history of Kura Oncology, Inc. (KURA) to understand its current valuation and trajectory, and the direct takeaway is that the company's recent November 2025 FDA approval of Komzifti (ziftomenib) is the culmination of a decade-long pivot from its initial focus, transforming it into a commercial-stage entity with a strong cash runway.

The company's most significant strategic moves involved a 2015 reverse merger to go public quickly and a critical pipeline shift to menin inhibition, which now drives its multi-billion dollar market opportunity in Acute Myeloid Leukemia (AML).

Given Company's Founding Timeline

Year established

The original entity, Prior Kura, was incorporated in August 2014.

Original location

Kura Oncology is headquartered in San Diego, California.

Founding team members

The company was co-founded by Troy Wilson, Ph.D., J.D., who has served as President, CEO, and Chairman since its inception. Antonio Gualberto is also cited as a founder. Dr. Wilson's experience with pioneering small molecule inhibitors of the KRAS oncoprotein provided a strong foundation in precision oncology.

Initial capital/funding

While the exact seed capital isn't public, the company's first funding round occurred in January 2015. Kura Oncology has since raised a total funding of $63.4 million over four rounds, including a Post IPO round in January 2024 for $150 million. This capital strategy has been key to funding its clinical programs, including the pivotal KOMET-001 trial.

Given Company's Evolution Milestones

Year Key Event Significance
2014 Company Founded (Prior Kura) Established the initial focus on developing precision medicines for genetically defined cancers.
2015 Reverse Merger and IPO Became a public company, gaining financial flexibility and visibility to advance clinical programs.
2015 In-licensed Tipifarnib Expanded the pipeline with a clinical-stage farnesyl transferase inhibitor (FTI) for HRAS mutant cancers.
2021 Tipifarnib FDA Breakthrough Therapy Designation Received regulatory recognition for the FTI program, expediting development for HRAS mutant HNSCC.
Nov 2024 Kyowa Kirin Global Collaboration for Ziftomenib Secured a major strategic partner and non-dilutive capital, including up to $315 million in near-term milestones.
Nov 14, 2025 FDA Approval of Komzifti (ziftomenib) Transformed Kura from a clinical-stage to a commercial-stage company with its first approved product for R/R NPM1-mutant AML.

Given Company's Transformative Moments

The company's history is defintely marked by a series of high-stakes, transformative decisions that shifted its center of gravity from one drug class to another, a common but risky move in biotech.

  • The 2015 Reverse Merger: The decision to merge with Zeta Acquisition Corp. III, a public shell company, allowed Kura to bypass the traditional Initial Public Offering (IPO) process, securing public funding and liquidity much faster than a standard path. That's how you accelerate a biotech story.
  • The Strategic Pivot to Menin Inhibition: While Tipifarnib (an FTI) was the initial lead candidate, the launch and aggressive development of KO-539 (later ziftomenib), a menin inhibitor, became the primary value driver. This move targeted Acute Myeloid Leukemia (AML) with a specific genetic driver (NPM1-mutant and KMT2A-rearranged), a market opportunity estimated to be up to $3 billion annually in the U.S. alone.
  • The Kyowa Kirin Partnership: The November 2024 collaboration was a masterstroke, validating the ziftomenib program and providing a substantial financial buffer. This partnership, with anticipated milestone payments of $100 million to $150 million to be recognized in the 2025 fiscal year, gave the company a cash position of approximately $630.7 million as of Q2 2025, extending its cash runway into 2027. This financial strength allows them to focus on commercialization and new Phase 3 trials.
  • The Komzifti Approval and Commercial Transition: The November 2025 FDA approval of Komzifti for relapsed or refractory NPM1-mutated AML is the ultimate transformation. It moves Kura from a pure R&D expense model-Q2 2025 R&D was $62.8 million-to a commercial revenue model, fundamentally changing the risk profile. You can see a deeper dive into the financial implications here: Breaking Down Kura Oncology, Inc. (KURA) Financial Health: Key Insights for Investors

Kura Oncology, Inc. (KURA) Ownership Structure

Kura Oncology, Inc. is a publicly traded, clinical-stage biopharmaceutical company listed on the NASDAQ under the ticker KURA. The ownership is heavily concentrated in institutional hands, which is typical for a biotech firm advancing its pipeline, meaning strategic funds and asset managers drive most of the trading and governance decisions.

Given Company's Current Status

As of November 2025, Kura Oncology, Inc. is a public company (NASDAQ: KURA) that has just transitioned from a purely clinical-stage organization to one with a commercial product following the FDA approval of Komzifti (ziftomenib) on November 13, 2025. This approval, ahead of the November 30, 2025 PDUFA target action date, is a pivotal moment, shifting the company's focus to commercial launch and continued pipeline development. The company's financial position is strong, with pro forma cash, cash equivalents, and short-term investments totaling approximately $609.7 million as of September 30, 2025, providing a cash runway that is projected to extend into 2027.

You can get a deeper dive into the major players by reading Exploring Kura Oncology, Inc. (KURA) Investor Profile: Who's Buying and Why?

Given Company's Ownership Breakdown

The company's decision-making structure is primarily influenced by large institutional investors, including major asset managers and specialized healthcare funds. This institutional dominance, at nearly three-quarters of the outstanding shares, means that a small number of large shareholders hold significant voting power over corporate strategy and board appointments. Insiders, while holding a smaller percentage, still maintain a defintely meaningful stake, aligning management's interests with shareholder returns.

Shareholder Type Ownership, % Notes
Institutions (Funds, Asset Managers) 73.8% Includes major holders like BlackRock, Inc., Vanguard Group Inc, and specialized funds like BVF Inc/il.
Insiders (Executives and Directors) 6.40% This figure reflects the approximate ownership held by corporate insiders as of November 2025.
Retail and General Public 19.8% The remaining float available for individual investors. (Calculated: 100% - 73.8% - 6.40%)

Given Company's Leadership

The leadership team is a mix of seasoned executives with deep experience in oncology drug development, which is crucial as the company transitions into a commercial-stage entity following the recent FDA approval of Komzifti. This team is responsible for managing the cash position of over $600 million and executing the global launch strategy.

  • Troy Wilson, Ph.D., J.D.: President, Chief Executive Officer, and Chairman of the Board. He has led the company since its inception in 2014.
  • Mollie Leoni, M.D.: Chief Medical Officer, promoted in January 2025, overseeing clinical development, including the newly approved ziftomenib program.
  • Francis Burrows, Ph.D.: Chief Scientific Officer, promoted in January 2025, driving the company's translational research and pipeline innovation.
  • Heidi Henson, CPA: Chief Financial Officer and Secretary, managing the company's financial strategy and reporting.
  • Brian Powl: Chief Commercial Officer, leading the commercialization strategy for Komzifti.
  • Teresa Bair: Chief Legal Officer, responsible for legal and regulatory affairs.

Here's the quick math: The institutional interest is paramount, but the insider ownership is large enough to keep management focused on long-term clinical success. That's a good sign for stability.

Kura Oncology, Inc. (KURA) Mission and Values

Kura Oncology, Inc.'s core purpose transcends drug development; it is a commitment to realizing the full promise of precision medicine to significantly extend and improve the lives of cancer patients. This mission is driven by four clear core values that guide their scientific rigor and commercial execution.

Kura Oncology, Inc.'s Core Purpose

As a seasoned analyst, I look past the balance sheet to the cultural DNA, and Kura's is built on a very specific, patient-centric mandate. Their mission isn't just to find new drugs, but to find the right drugs for the right patients, which is what precision medicine is all about.

Official mission statement

The company's formal mission is direct and powerful:

  • Realize the promise of precision medicines.
  • Help patients with cancer lead better, longer lives.

This focus is why they invest heavily in understanding cancer biology, targeting molecular drivers of disease that have been previously untapped. For instance, their work on ziftomenib, which targets the menin-KMT2A interaction, is a direct result of this mission in action.

Vision statement

While a single, one-line vision statement isn't always published, Kura's actions and communications clearly map out their long-term aspiration: to be a leader in advancing precision oncology by conquering resistance and expanding the population of patients who benefit from targeted therapies.

  • Redefine patient outcomes by developing therapies for genetically defined cancers.
  • Pioneer new approaches to treat devastating diseases like acute leukemias and head and neck cancer.
  • Commit to overcoming treatment resistance, which is a key reason disease often returns.

The recent full FDA approval of KOMZIFTI (ziftomenib) in November 2025 for relapsed or refractory AML with a susceptible NPM1 mutation is a concrete step toward this vision, transforming Kura into a commercial-stage company. This milestone is defintely a proof point for their focused strategy. If you want to dive deeper into who is backing this vision, check out Exploring Kura Oncology, Inc. (KURA) Investor Profile: Who's Buying and Why?

Kura Oncology, Inc. Core Values

The company's culture is anchored by four core values that define how they operate, from the lab bench to the commercial launch team. These values ensure that the science is bold and the execution is excellent.

  • Work as one for patients: Collaboration is paramount because the patient impact is the common good.
  • Science-driven courageous innovators: They turn ideas into action and constantly seek to be better, measuring results against objectives.
  • Goal-focused and deliver with excellence: They use data to make tough decisions, doing things the right way, not the easy way.
  • Strive to bring out the best in each other and ourselves: They lead with trust, transparency, and respect, empowering the team to succeed.

This commitment to excellence is reflected in their latest financial results. For the third quarter of 2025, Kura reported revenue of $20.75 million, slightly exceeding analyst expectations, which shows their ability to execute on their goals even while reporting a wider loss per share of -$0.85 as they ramp up commercialization efforts. That's the cost of bold science and a commercial-stage transition.

Kura Oncology, Inc. slogan/tagline

The company's public-facing tagline summarizes their mission and vision in a concise, human-focused way.

  • The promise of precision oncology brought to life for patients.

Kura Oncology, Inc. (KURA) How It Works

Kura Oncology operates as a precision oncology company that designs and develops small molecule drug candidates to disrupt key cancer-driving signaling pathways, moving its lead asset, Komzifti (ziftomenib), from clinical trials to commercialization following its November 2025 FDA approval for acute myeloid leukemia (AML). The company creates value by identifying specific genetic mutations in cancer, developing targeted therapies against them, and then executing a dual-strategy of U.S. commercialization and global partnership to bring its medicines to market.

Kura Oncology, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
Komzifti (ziftomenib) Relapsed/Refractory NPM1-mutated Acute Myeloid Leukemia (AML) First-in-class, orally bioavailable menin inhibitor; targets a fundamental disease driver; approved by FDA in November 2025.
Ziftomenib (Pipeline) Frontline AML (NPM1-mutant and KMT2A-rearranged subsets) Being evaluated in Phase 3 trials (KOMET-017) in combination with intensive and non-intensive chemotherapy.
Darlifarnib (KO-2806) Solid Tumors (e.g., RCC, KRASG12C-mutant NSCLC) Next-generation Farnesyl Transferase Inhibitor (FTI); designed to enhance anti-tumor activity of targeted therapies by addressing resistance pathways.

Kura Oncology, Inc.'s Operational Framework

You need to see the machinery behind the drug. Kura Oncology's value creation is a focused, two-part process: deep research and strategic commercialization. The core of their operation is a high-cost, high-reward research and development (R&D) engine, which is now transitioning to a commercial sales and distribution model.

Here's the quick math on the R&D burn: Research and development expenses for the third quarter of 2025 were $67.9 million, showing a serious commitment to pipeline expansion and late-stage trials. General and administrative expenses also rose to $32.8 million in Q3 2025 as they built out the commercial infrastructure for Komzifti's launch.

  • Precision R&D: Focus on small molecule inhibitors that target specific oncogenic drivers like the menin-KMT2A interaction and the farnesyl transferase pathway.
  • Hybrid Revenue Model: Revenue comes from a mix of collaboration payments and, starting in late 2025, product sales. Trailing twelve months (TTM) revenue as of Q3 2025 was $104.03 million, mostly from collaboration milestones.
  • Strategic Partnership: The global strategic collaboration with Kyowa Kirin Co., Ltd. is critical. Kura Oncology handles U.S. development and commercialization, sharing profits and losses 50/50, while Kyowa Kirin manages ex-U.S. strategy, paying Kura double-digit royalties.
  • Clinical Acceleration: They are aggressively moving ziftomenib into the frontline AML setting with the KOMET-017 Phase 3 trials, which are fully funded through the collaboration.

They're building a commercial team while still running expensive, pivotal trials. Exploring Kura Oncology, Inc. (KURA) Investor Profile: Who's Buying and Why?

Kura Oncology, Inc.'s Strategic Advantages

Kura Oncology's market success hinges on a few clear, non-cliché differentiators that set them apart in the competitive oncology space.

  • First-Mover Advantage in Menin Inhibition: Komzifti's FDA approval in November 2025 for relapsed or refractory NPM1-mutated AML establishes Kura Oncology as a leader in this novel class of menin inhibitors, targeting a subset of AML that represents up to 50% of cases.
  • Differentiated Safety Profile: Komzifti carries no Boxed Warning for QTc prolongation, a heart rhythm issue sometimes seen with other targeted therapies, which gives it a key advantage in physician adoption.
  • Financial Stability and Runway: The company reported a pro forma cash, cash equivalents, and short-term investments balance of $609.7 million as of September 30, 2025. This strong cash position provides a runway into 2027, allowing them to fund multiple clinical programs without immediate capital raises.
  • De-risked Global Commercialization: The Kyowa Kirin partnership secures substantial non-dilutive funding, including anticipated milestone payments of $100-150 million in 2025, and provides immediate global reach and risk-sharing for ziftomenib.
  • Pipeline Diversification: Beyond the menin inhibitor program, the Farnesyl Transferase Inhibitor (FTI) platform (darlifarnib, tipifarnib) offers a second, distinct mechanism to address adaptive and innate resistance in solid tumors, providing a hedge against single-product risk.

The strong balance sheet buys them time to execute the commercial launch and get the Phase 3 data. That's the real edge.

Kura Oncology, Inc. (KURA) How It Makes Money

Kura Oncology, Inc. operates as a clinical-stage biopharmaceutical company, meaning its primary drug candidates are still in development, so it does not yet generate revenue from commercial product sales. Instead, the company makes money almost exclusively through strategic collaboration agreements, which provide upfront payments, milestone payments tied to clinical and regulatory progress, and research funding.

Kura Oncology's Revenue Breakdown

The company's revenue structure is typical for a biotech firm focused on late-stage clinical development. For the nine months ended September 30, 2025, Kura Oncology reported total revenue of approximately $50.1 million, all of which stemmed from its partnership with Kyowa Kirin. This revenue is the recognized portion of the licensing and collaboration fees.

Revenue Stream % of Total Growth Trend
Collaboration Revenue (Kyowa Kirin) 100% Increasing
Product Sales 0% Stable (at zero)

The 'Increasing' trend reflects the recognition of revenue from the significant Kyowa Kirin agreement, which was not a factor in prior years. For instance, Q3 2025 collaboration revenue was $20.8 million, up from zero in Q3 2024.

Business Economics

The economic fundamentals of Kura Oncology are defined by a high-risk, high-reward model common in oncology drug development. The primary value driver is the successful development and eventual commercialization of its lead candidate, ziftomenib, a menin inhibitor targeting certain acute myeloid leukemias (AML). The entire financial engine is currently a capital-intensive research and development (R&D) operation, funded by capital raises and partnership cash.

  • Value Creation Mechanism: The company creates value by advancing its proprietary small molecule drug candidates through clinical trials, which triggers substantial non-dilutive payments (milestones) from its collaboration partner, Kyowa Kirin.
  • Key Milestones: The collaboration agreement with Kyowa Kirin is the lifeblood right now. For example, Kura earned two separate $30 million clinical trial milestone payments in October and November 2025 for first patient dosing in the pivotal KOMET-017 trial for ziftomenib. Another $45 million milestone was earned in Q1 2025 for the New Drug Application (NDA) submission.
  • Pricing Strategy (Future): If ziftomenib receives FDA approval-the PDUFA target action date is November 30, 2025-the future revenue model will shift to include product sales and royalties on sales, which will be the real inflection point. The pricing for a first-in-class precision oncology drug for a high-unmet-need condition like AML is defintely expected to be premium.
  • Cost of Revenue: Currently, the cost of revenue is minimal or zero, as the revenue is purely from licensing and R&D reimbursement, not product manufacturing. The major cost is R&D.

You're betting on the pipeline, not current sales.

For a deeper dive into the company's core principles, you can review its Mission Statement, Vision, & Core Values of Kura Oncology, Inc. (KURA).

Kura Oncology's Financial Performance

The financial health of a clinical-stage biotech is gauged by its cash runway and its investment in the pipeline, not by profitability. The company is actively burning cash to fund its late-stage clinical trials for ziftomenib and other programs.

  • Net Loss: For the nine months ended September 30, 2025, the company reported a net loss of approximately $197.7 million, reflecting the heavy investment in R&D. The Q3 2025 net loss alone was $74.1 million.
  • Research & Development (R&D) Expenses: This is the key expense, representing the company's investment in its future. R&D expenses for Q3 2025 were $67.9 million, a significant increase from $41.7 million in Q3 2024, driven by the ziftomenib program.
  • Cash Position and Runway: As of September 30, 2025, Kura Oncology had a strong pro forma cash, cash equivalents, and short-term investments balance of approximately $609.7 million, after accounting for the recent milestone payments. This cash position is projected to fund current operating expenses into 2027.
  • General & Administrative (G&A) Expenses: G&A expenses also saw an increase, rising to $32.8 million in Q3 2025 from $18.2 million in Q3 2024, primarily due to pre-commercialization activities for ziftomenib.

Here's the quick math: the Q3 2025 cash burn rate (R&D + G&A) was about $100.7 million, which means the $609.7 million cash balance provides a comfortable cushion for the next 18-24 months, even before factoring in potential commercial revenue or additional milestones.

The immediate action for an investor is to watch the FDA decision on ziftomenib on November 30, 2025; that is the single biggest near-term risk and opportunity.

Kura Oncology, Inc. (KURA) Market Position & Future Outlook

Kura Oncology is at a critical commercial inflection point in November 2025, having recently secured FDA approval for its lead asset, Komzifti (ziftomenib), which transitions the company from a purely clinical-stage entity to a commercial-stage biopharmaceutical firm. The company is now poised to capture a significant share of the relapsed or refractory (R/R) Acute Myeloid Leukemia (AML) market, a segment with high unmet need, with the initial U.S. market opportunity for ziftomenib estimated at $350 million to $400 million annually. The strong balance sheet, with a pro forma cash position of $609.7 million as of September 30, 2025, provides a runway into 2027, enabling a focused commercial launch and continued pipeline expansion.

Competitive Landscape

Kura's primary competition lies within the highly specialized targeted therapy segment for AML, particularly the emerging class of menin inhibitors. While Syndax Pharmaceuticals was the first to market with a menin inhibitor for KMT2A-rearranged AML and slightly ahead for NPM1-mutated AML, Kura's Komzifti is positioned as the first and only once-daily, oral menin inhibitor for R/R NPM1-mutated AML, a key convenience and safety advantage.

Company Market Share, % (Targeted R/R AML) Key Advantage
Kura Oncology (Komzifti) <1% (Just Approved Nov 2025) First and only once-daily oral NPM1-m menin inhibitor; favorable safety profile (no QTc warning).
Syndax Pharmaceuticals (Revuforj) ~1.5% (Est. based on Q3 2025 sales) First-to-market menin inhibitor for KMT2A-r AML; established initial sales of $32.0 million in Q3 2025.
AbbVie/Roche (Venetoclax) ~25% (Est. BCL-2 inhibitor segment) Established BCL-2 inhibitor; standard-of-care backbone for many R/R AML combination therapies.

Opportunities & Challenges

The company's near-term trajectory is defined by its commercial launch and pipeline acceleration, but it must navigate intense competition and high operating costs. The collaboration with Kyowa Kirin is defintely a major de-risking factor.

Opportunities Risks
Commercial launch of Komzifti (ziftomenib) into a high-value, targeted R/R AML segment. Intense competition from Syndax Pharmaceuticals' Revuforj, which has a slight first-mover advantage and similar efficacy.
Expansion of ziftomenib into frontline AML with pivotal KOMET-017 Phase 3 trials, targeting over 50% of AML patients. Significant cash burn, with a Q3 2025 net loss of $74.1 million, requiring strong sales performance to offset R&D.
Potential for near-term non-dilutive funding from up to $315 million in expected milestone payments, including a substantial launch payment. Clinical or regulatory setbacks for the farnesyl transferase inhibitor (FTI) program (darlifarnib/tipifarnib) in solid tumors.

Industry Position

Kura Oncology is transitioning into a niche leader in precision oncology, specifically targeting the menin-KMT2A pathway, which drives a significant portion of acute leukemias. Its position is strengthened by a differentiated product profile and a strategic partnership.

  • Menin Inhibitor Pioneer: Kura is one of the two commercial-stage pioneers in this novel targeted therapy class, focusing on a genetically defined subset of AML.

  • Financial Stability: The company's cash position of $609.7 million as of Q3 2025, combined with the Kyowa Kirin partnership, provides a robust financial foundation to execute the commercial launch and fund the Phase 3 frontline trials into 2027.

  • Pipeline Diversification: Beyond AML, the FTI program (darlifarnib and tipifarnib) offers a second strategic pillar to address resistance in solid tumors, providing a hedge against single-product risk.

  • Analyst Consensus: Consensus analyst price targets have been raised to an average of $31.80, reflecting increased confidence post-approval.

For a detailed breakdown of the company's financial health and valuation metrics, you should read Breaking Down Kura Oncology, Inc. (KURA) Financial Health: Key Insights for Investors.

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