Kura Oncology, Inc. (KURA) Business Model Canvas

Kura Oncology, Inc. (KURA): Business Model Canvas [Dec-2025 Updated]

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You're looking at Kura Oncology, Inc. (KURA) right at a major inflection point, moving from a clinical-stage biotech to a commercial entity after its recent FDA approval for Komzifti. Honestly, this transition is where the rubber meets the road for any pharma play, and their Business Model Canvas tells a clear story of a high-stakes pivot. With a first-in-class menin inhibitor now on the market, the focus shifts from burning cash on trials-though R&D was $67.9 million in Q3 2025-to capturing revenue, supported by a pro forma cash position of $609.7 million as of Q3 2025 and near-term milestones worth about $315 million. Let's break down exactly how Kura Oncology, Inc. plans to execute this commercialization and pipeline build, so you can see the levers driving their next phase of growth.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Key Partnerships

You're looking at the structure Kura Oncology, Inc. has built around its key external relationships as of late 2025, especially following the KOMZIFTI approval. These partnerships are critical for funding development and getting the drug to market.

Global Development and Commercialization Partner: Kyowa Kirin Co., Ltd.

The collaboration with Kyowa Kirin Co., Ltd. is central to Kura Oncology, Inc.'s strategy for ziftomenib (Komzifti) in acute leukemias. This relationship has provided significant, non-dilutive funding milestones.

Kura Oncology, Inc. received an upfront payment of $330 million in December 2024 under the global strategic collaboration agreement. The progression of the ziftomenib program has triggered several subsequent payments:

  • NDA submission milestone payment earned: $45 million.
  • Milestone payment for first patient dosed in KOMET-017 (October 2025): $30 million.
  • Second milestone payment for first patient dosed in KOMET-017 (November 2025): $30 million.
  • Milestone triggered by first U.S. commercial sale of KOMZIFTI (December 2025): $135 million expected before year-end 2025.

The total potential payments for milestones under the agreement, including the opt-in for solid tumor indications, are up to $1.161 billion. This funding bolsters the balance sheet; as of September 30, 2025, Kura Oncology, Inc. had pro forma cash, cash equivalents, and short-term investments of $609.7 million, combined with anticipated collaboration funding.

Academic and Clinical Research Institutions

Kura Oncology, Inc. relies on external institutions to execute the pivotal trials required for regulatory approval and label expansion. The KOMET-017 protocol, evaluating ziftomenib in newly diagnosed AML, is a global, randomized, double-blind, placebo-controlled Phase 3 trial structure.

Key statistical and operational data points for these research partnerships include:

Trial/Data Point Metric/Value
KOMET-017 Trial Initiation Date September 29, 2025
KOMET-017 Global Enrollment Sites (Expected) Up to 200 sites worldwide
KOMET-001 R/R AML Complete Response Rate 21.4%
KOMET-001 R/R AML Median Duration of Response 5 months
FDA PDUFA Target Action Date (R/R AML NDA) November 30, 2025

Amer Zeidan, M.B.B.S., M.H.S., of Yale Cancer Center, serves as the lead investigator for KOMET-017.

Specialty Pharmacies and Distributors

Following the full FDA approval on November 13, 2025, commercial access is managed through specific channels. KOMZIFTI is commercially available to prescribers in the U.S. via this structure.

  • U.S. Availability Channel: Limited network of specialty pharmacies and distributors.
  • Clinical Endorsement: Included in the National Comprehensive Cancer Network (NCCN) Guidelines in Oncology as a Category 2A recommended treatment option.
  • Balance Sheet Health: The first sale triggered a milestone that contributed to a Current Ratio of 5.12 as of December 2025 data.

Contract Manufacturing Organizations (CMOs)

Kura Oncology, Inc. relies on Contract Manufacturing Organizations for the physical supply of drug substance and finished product for ziftomenib. The company's cash position, supported by collaboration funding, is expected to support the ziftomenib AML program through topline results from KOMET-017.

Specific financial terms or names of CMOs are not publicly detailed in the latest filings, but the manufacturing relationship is a necessary component of the commercial readiness activities.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Key Activities

You're preparing for the post-approval launch, so the focus shifts heavily to execution now that the initial hurdle is cleared. Here's the breakdown of Kura Oncology, Inc.'s key activities as of late 2025, grounded in the latest figures.

  • - Commercializing Komzifti (ziftomenib) in the U.S. market following November 2025 FDA approval.
  • - Conducting late-stage clinical trials, including Phase 3 KOMET-017 in frontline AML.
  • - Research and development (R&D) of pipeline candidates like KO-2806 and tipifarnib.
  • - Regulatory affairs and compliance for global drug approvals.
  • - Building a dedicated U.S. sales and market access team.

Commercialization and Market Access Execution

The primary activity is launching Komzifti (ziftomenib) following its full FDA approval on November 13, 2025, for adults with relapsed or refractory (R/R) NPM1-mutated Acute Myeloid Leukemia (AML). This established Kura Oncology, Inc. as a commercial-stage company. The current label covers an estimated U.S. market size of approximately $350-$400 million per year, targeting about 1,300 to 1,500 patients annually. The drug, the first and only once-daily, oral menin inhibitor for this indication, achieved a 21.4% complete response (CR) rate (CR + CR with partial hematologic recovery) in the pivotal KOMET-001 trial, with a median duration of response of 5 months. Furthermore, 88% of responding patients achieved CR/CRh within six months of starting treatment. The inclusion in the NCCN Guidelines as a Category 2A recommended treatment option is a key market access win.

The financial underpinning for this commercial push is solid, with Kura Oncology, Inc. reporting $549.7 million in cash, cash equivalents, and short-term investments as of September 30, 2025. Factoring in post-quarter milestones, the pro forma cash stood at $609.7 million, which management believes supports operating expenses into 2027 and the ziftomenib AML program through topline KOMET-017 results. Quarterly collaboration revenue from the Kyowa Kirin partnership for Q3 2025 was $20.8 million.

The operational build-out for this launch is largely complete, as the hiring and onboarding of the U.S. field sales team was reported as complete by August 2025, with pre-approval information exchange with key stakeholders ongoing.

The key financial metrics related to operating scale in Q3 2025 reflect this pre-commercial intensity:

Financial Metric (Q3 2025) Amount
Research and Development Expenses $67.9 million
General and Administrative Expenses $32.8 million
Net Loss $74.1 million
Noncash Share-Based Compensation Expense $11.0 million

Advancing Late-Stage and Pipeline Assets

The company is actively running the pivotal Phase 3 KOMET-017 trials, which began dosing the first patient in September/October 2025. These trials evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens for newly diagnosed AML, targeting NPM1-mutated or KMT2A-rearranged patients, representing settings for more than 50% of AML patients. The trials are expected to enroll patients at up to 200 sites worldwide. This activity triggered two $30 million milestone payments from Kyowa Kirin in October and November 2025.

R&D activities are also focused on the farnesyl transferase inhibitor (FTI) platform, with clinical data presented at ESMO 2025 (October 17-21, 2025). The potential commercial opportunity for KO-2806 combinations is substantial, estimated to address more than 200,000 incident patients annually in the U.S. alone.

Here's a snapshot of the latest clinical activity for the pipeline candidates:

  • - KO-2806 (Darlifarnib) Monotherapy: Tolerable dosing observed from 3 to 10 mg per day.
  • - KO-2806 + Cabozantinib (RCC): Objective Response Rate (ORR) ranged from 33% to 50%.
  • - Tipifarnib + Alpelisib (HNSCC): Achieved an ORR of 47% at a dose of 1,200 mg/day tipifarnib and 250 mg/day alpelisib.

Regulatory and Compliance Focus

Regulatory affairs centered on the New Drug Application (NDA) for ziftomenib, which had a PDUFA target action date of November 30, 2025. The successful achievement of full approval in November 2025 confirms the completion of this key activity for the initial indication. The receipt of $60 million in milestone payments in October and November 2025 is directly tied to achieving clinical regulatory milestones, specifically the first patient dosing in KOMET-017.

Finance: draft 13-week cash view by Friday.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Key Resources

You're looking at the core assets Kura Oncology, Inc. (KURA) is leaning on right now to drive value, especially after the recent regulatory win. Honestly, the balance sheet strength is a major resource, giving them breathing room.

The most immediate, tangible resource is the newly approved drug, Komzifti (ziftomenib). Kura Oncology, in partnership with Kyowa Kirin, secured U.S. Food and Drug Administration (FDA) approval for Komzifti on November 13, 2025. This makes it the first once-daily oral menin inhibitor approved for adults with relapsed or refractory acute myeloid leukemia (AML) carrying an NPM1 mutation. This approval officially establishes Kura Oncology as a commercial-stage company, a significant shift from its clinical-stage history.

Financially, the company holds a strong position as of the end of Q3 2025. Kura Oncology had cash, cash equivalents, and short-term investments totaling approximately $609.7 million on a pro forma basis as of September 30, 2025. This figure includes two $30 million milestone payments earned under the Kyowa Kirin collaboration in October and November 2025. Management believes this capital, combined with anticipated collaboration funding, is sufficient to fund current operating expenses into 2027 and support the ziftomenib AML program through topline results from the KOMET-017 trial.

The intellectual property (IP) portfolio is critical, underpinning both the menin inhibitor platform and the farnesyl transferase inhibitor (FTI) platform. Ziftomenib itself is designed to inhibit menin, blocking its interaction with the KMT2A protein complex. Furthermore, Kura Oncology is advancing its FTI program, with clinical data for agents like tipifarnib and darlifarnib presented at the 2025 ESMO Congress.

The clinical evidence supporting Komzifti is a core asset, primarily derived from the KOMET-001 pivotal trial. This data was the basis for the New Drug Application (NDA) and subsequent approval. The company has also made progress in building out its commercial capability; for instance, the hiring and onboarding of the U.S. field sales team was reported as complete by Q2 2025. The leadership teams possess the necessary oncology research and commercial expertise to execute the launch.

Here's a snapshot of the key efficacy data from the KOMET-001 trial in R/R NPM1-m AML patients, which is a major resource underpinning the drug's value proposition:

Metric Result/Value Context/Population
CR/CRh Rate 23% (or 21.4%) KOMET-001 Phase 2 cohort of 112 adults with R/R NPM1-m AML
Historical SOC CR/CRh Rate 12% Benchmark for statistical significance
Median Duration of Response Roughly five months (or 3.7 months median CR/CRh duration) For patients achieving CR/CRh
MRD-Negative Rate 63% (or 61%) of evaluable CR/CRh responders Assessed in the KOMET-001 trial

The company is also actively building out its pipeline assets, with KOMET-017 Phase 3 trials in frontline AML accelerating, including both intensive and non-intensive chemotherapy combinations.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Value Propositions

You're looking at the core value Kura Oncology, Inc. (KURA) is delivering to its customer segments-primarily oncologists and patients with high-need hematologic malignancies and solid tumors. The value proposition centers on first-in-class or best-in-class targeted therapies.

First and only FDA-approved menin inhibitor (Komzifti) for R/R NPM1-mutant AML

Kura Oncology, Inc. has successfully transitioned to a commercial-stage company with the full FDA approval of KOMZIFTI (ziftomenib) on November 13, 2025, for adults with relapsed or refractory (R/R) acute myeloid leukemia (AML) harboring an NPM1 mutation. This approval establishes KOMZIFTI as the first and only once-daily, oral menin inhibitor for this specific indication. Furthermore, the value is cemented by its rapid inclusion in the NCCN Guidelines in Oncology as a Category 2A recommended treatment option. This rapid guideline adoption signals strong clinical acceptance for a patient population historically facing poor outcomes.

Targeted, oral precision medicine for genetically defined acute leukemias

The value proposition is deeply rooted in precision medicine, targeting a specific genetic driver. NPM1 mutations are found in approximately 30% of all AML cases. KOMZIFTI offers a targeted, oral treatment option for a subset of these patients where treatment options have been limited, especially for those who relapse. The company is already looking to expand this value into the much larger frontline setting, with Phase 3 KOMET-017 trials investigating ziftomenib in combinations that target settings representing more than 50% of AML patients.

Here's a quick look at the initial commercial value proposition data for the R/R NPM1-mutant AML indication:

Metric Value/Amount
FDA Approval Date (Full) November 13, 2025
NCCN Guideline Status Category 2A Recommendation
Complete Response Rate (KOMET-001) 21.4%
Median Duration of Response (DOR) 5.0 months
Estimated Annual U.S. Market Size (R/R) $350-$400 million
Estimated Annual Eligible Patients (R/R) 1,300 to 1,500 patients
Price per 30-day Bottle (Estimated) $48,500

Potential for high complete remission rates and MRD-negativity in AML

While the initial approval is based on the KOMET-001 trial showing a 21.4% complete response rate, the future value proposition hinges on expanding efficacy across the continuum of care. The ongoing KOMET-017 Phase 3 trials are designed to evaluate KOMZIFTI in combination with intensive and non-intensive chemotherapy for newly diagnosed AML. This move aims to capture value earlier in the disease course, potentially leading to higher rates of durable remission and MRD-negativity (minimal residual disease-negativity) in a much larger patient pool. The company's pro forma cash position of $609.7 million as of September 30, 2025, is expected to support this ziftomenib AML program through topline results from KOMET-017.

Novel small molecule candidates addressing resistance mechanisms in solid tumors

Beyond AML, Kura Oncology, Inc. is creating value through its second strategic program focused on overcoming drug resistance in solid tumors. This involves their farnesyl transferase inhibitors (FTIs), specifically darlifarnib (KO-2806) and tipifarnib. Preliminary clinical data presented at the ESMO Congress 2025 highlighted the potential of these FTIs to enhance the anti-tumor activity of other targeted therapies, such as PI3Kα inhibitors and KRAS inhibitors, by addressing common resistance pathways. Tipifarnib is being investigated in a registration-enabling trial for PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC).

The value here is in the combination strategy, which addresses a major limitation of current precision medicines in solid tumors. You can see the pipeline focus:

  • Darlifarnib (KO-2806) in combination with cabozantinib and adagrasib.
  • Tipifarnib in combination with alpelisib for HNSCC.
  • FTIs are designed to address adaptive and innate resistance mechanisms.

This pipeline diversification provides a secondary, long-term value stream separate from the initial KOMZIFTI launch.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Customer Relationships

You're now moving Kura Oncology, Inc. from clinical success to commercial reality with Komzifti. The customer relationships here are highly specialized, focusing on a small, critically ill patient population and the specialized providers who treat them. It's all about high-touch support and access, which is key in oncology.

For the newly approved Komzifti (ziftomenib), Kura Oncology, Inc. has established dedicated support structures. The Medical Affairs and Market Access teams are reported as fully staffed to engage thought leaders and ensure patient access. This is crucial because the drug is initially available through a limited network of specialty pharmacies and distributors. One key partner announced is Onco360, one of the nation's leading independent specialty pharmacies.

Engagement with the medical community is intensive. Key Opinion Leaders (KOLs) are being engaged based on data presentations, such as those planned for the December 2025 American Society of Hematology (ASH) Annual Meeting. This high-touch approach is reinforced by the drug's immediate inclusion in the National Comprehensive Cancer Network® (NCCN) Guidelines as a Category 2A recommended treatment option as of November 25, 2025.

Here's a look at the commercial and financial milestones that shape these relationships:

Metric Category Data Point Value/Amount Date/Context
Komzifti Pricing (R/R AML) Price per 30-day supply $48,500 Late 2025 estimate
Komzifti Commercial Access Specialty Pharmacy Partner Announced Onco360 November 2025
Komzifti Guideline Status NCCN Recommendation Level Category 2A November 25, 2025
Financial Milestone (Kyowa Kirin) Payment Triggered by First U.S. Sale $135 million Expected by end of 2025
Cash Position Pro Forma Cash, Equivalents, and Short-Term Investments $609.7 million As of September 30, 2025 (adjusted)
Collaboration Funding Additional Near-Term Milestones Expected Up to $315 million Under Kyowa Kirin agreement

The relationship with investors is centered on transparently communicating the transition to commercialization. Kura Oncology, Inc. held a specific call regarding the FDA Approval on November 13, 2025. Following the first U.S. commercial sale on December 2, 2025, the company announced the triggering of the $135 million milestone payment from Kyowa Kirin, expected before year-end. This financial event, coupled with the cash position of $609.7 million as of September 30, 2025, is communicated to support operations into 2027.

You can expect Kura Oncology, Inc. to manage access through these specialty channels carefully. The current relapsed/refractory market size is estimated at $350-$400 million annually, based on a price of $48,500 per 30-day bottle and an average duration of five to six months. Anyway, the frontline potential is much larger, projected around $7 billion in U.S. annual sales.

The engagement strategy includes specific communication events:

  • Investor Event Presentation on September 8, 2025.
  • KOMZIFTI FDA Approval Call on November 13, 2025.
  • Virtual Investor Event on December 3, 2025, to discuss ASH 2025 data.
  • Two $30 million milestone payments received in October and November 2025 related to the KOMET-017 trial dosing.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Channels

You're looking at how Kura Oncology, Inc. plans to get its precision medicines, like KOMZIFTI (ziftomenib), to the specialists and patients who need them, especially now that the first product has gained U.S. approval in late 2025. This is a multi-pronged approach, blending internal execution with a major global partnership.

Direct U.S. sales force targeting hematology/oncology specialists and centers.

Kura Oncology has moved to establish its own dedicated commercial presence for the U.S. market, focusing on hematology/oncology centers where patients with relapsed or refractory NPM1-mutated Acute Myeloid Leukemia (AML) are treated. The company confirmed that the hiring and onboarding of this U.S. field sales team is now complete, signaling readiness for the launch of KOMZIFTI, which was approved by the FDA on November 13, 2025. To put the scale in perspective, as of September 30, 2025, Kura Oncology reported a total employee count of 192 individuals.

Limited network of specialty pharmacies and distributors for drug delivery.

For a specialized, high-touch oncology product, distribution relies on a focused network. Kura Oncology secured a key distribution channel in November 2025 by selecting Onco360 as a national specialty pharmacy partner for KOMZIFTI. Onco360 dispenses nationally through its network of pharmacies that hold URAC- and ACHC-accreditation, which speaks to the required quality standards for handling these therapies.

The commercialization activities are heavily supported by the financial structure of the Kyowa Kirin agreement, which provides the necessary capital runway. Here's a quick look at the major financial triggers related to the commercial launch and development:

Milestone Event Date Achieved/Announced (2025) Financial Impact to Kura Oncology
NDA Submission for Ziftomenib (R/R NPM1-m AML) Q1 2025 (March 31, 2025) $45 million milestone payment earned
First U.S. Commercial Sale of KOMZIFTI December 02, 2025 $135 million milestone payment triggered
First Patient Dosing in KOMET-017 (Frontline AML) October/November 2025 Two separate $30 million milestone payments received
Cash Position (Pro Forma) September 30, 2025 $609.7 million in cash, cash equivalents, and short-term investments

Global partner Kyowa Kirin for commercialization outside the U.S.

The international channel is entirely managed through the global strategic collaboration established with Kyowa Kirin in November 2024. Kyowa Kirin leads development, regulatory, and commercial strategy outside the U.S. Kura Oncology's direct financial benefit from this channel comes via tiered double-digit royalties on net product sales generated by Kyowa Kirin globally. The total potential value of this partnership, including milestones and an option for solid tumors, is up to $1.161 billion in payments to Kura Oncology.

Scientific publications and medical conferences (e.g., ASH, ESMO) for data dissemination.

Disseminating clinical data is a critical channel for building awareness and driving adoption among prescribing physicians. Kura Oncology actively presented data from its pipeline at major medical meetings throughout late 2025. Specifically, the company presented preliminary data from its farnesyl transferase inhibitor (FTI) programs at the 2025 European Society for Medical Oncology (ESMO) Congress, held from October 17 - 21, 2025. Furthermore, data on ziftomenib (KOMZIFTI) in combination with venetoclax/azacitidine were featured in two oral presentations at the American Society of Hematology (ASH) 2025 Annual Meeting on December 8, 2025. This scientific communication is key to establishing the clinical profile of their assets.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Kura Oncology, Inc. is targeting with ziftomenib, now branded as Komzifti following its FDA approval on November 13, 2025. The customer segments are sharply defined by specific genetic markers in Acute Myeloid Leukemia (AML).

Adult Patients with Relapsed/Refractory NPM1-mutant AML (R/R NPM1-m AML)

This is the initial, approved segment for Komzifti. NPM1 mutations are a key driver in AML, present in approximately 30% of all AML cases. For patients whose disease has relapsed or proven refractory to earlier treatments, options are severely limited.

The pivotal Phase 2 KOMET-001 trial supporting approval included 92 adult patients with R/R NPM1-m AML. These patients were heavily pre-treated, with a median of 2 prior lines of therapy, and 59% had prior exposure to venetoclax. The U.S. market size for this specific relapsed setting is estimated at approximately $350-$400 million per year, addressing an annual population of about 1,300 to 1,500 patients who relapse after frontline therapy.

The FDA granted Priority Review for this indication, with a PDUFA target action date of November 30, 2025. Early commercial acceptance is suggested by Komzifti's inclusion in the National Comprehensive Cancer Network (NCCN) Guidelines as a Category 2A recommended treatment option.

Patients with Newly Diagnosed AML (NPM1-m and KMT2A-r) in Frontline Trials

Kura Oncology, Inc. is aggressively pursuing the much larger frontline setting, which represents the long-term value driver. This segment includes patients with newly diagnosed AML harboring either the NPM1-mutation (about 30% of cases) or the KMT2A-rearranged mutation (about 5% to 10% of cases). The total addressable U.S. frontline population is estimated at roughly 11,000 individuals annually, representing a potential U.S. annual revenue exceeding $6.4 billion if Komzifti captures a meaningful share across combination regimens.

The development here centers on combination therapies, as shown in the Phase 2 KOMET-007 trial, which recruited up to 212 newly diagnosed NPM1-m and/or KMT2A-r AML patients. The company is advancing this by initiating two independent, global, randomized Phase 3 registration-enabling trials (KOMET-017-IC and KOMET-017-NIC) in the second half of 2025.

Here's a quick look at the patient population size potential for frontline AML:

Genetic Marker Approximate Percentage of De Novo AML Estimated Annual U.S. Patients (of 22,000 total)
NPM1-mutation 30% ~6,600
KMT2A-rearranged 5% to 10% ~1,100 to 2,200

Hematology/Oncology Specialists and Treating Physicians

These are the key prescribers and influencers. For the R/R indication, the customer base is concentrated in major cancer centers where patients with complex, relapsed hematologic malignancies are treated. The focus for these specialists is on the drug's clinical profile:

  • Complete Response (CR) plus CR with partial hematological recovery (CRh) rate of 23% in the pivotal R/R trial.
  • Minimal Residual Disease (MRD) negativity achieved in 63% of responders in the KOMET-001 trial.
  • A favorable safety profile, with only 3% of patients discontinuing due to treatment-related adverse events.
  • The drug is a once-daily, oral medication, which aids in outpatient management.

Global Pharmaceutical Partner Kyowa Kirin

Kyowa Kirin is a critical commercial and financial customer segment, as they hold the ex-U.S. rights for ziftomenib in AML. This partnership provides significant non-dilutive funding, which helps Kura Oncology, Inc. support its operations into 2027 without immediate financing concerns.

The financial relationship has already yielded substantial payments:

  • Upfront payment in December 2024: $330 million.
  • Milestone payment for NDA submission in Q1 2025: $45 million.
  • Two milestone payments for first patient dosing in KOMET-017 (Oct/Nov 2025): $30 million each, totaling $60 million.
  • Milestone payment for first U.S. commercial sale (Dec 2025): $135 million.

The total potential value of the collaboration is up to $1.2 billion in milestone payments. As of September 30, 2025, Kura Oncology, Inc. reported $501 million in cash and equivalents, bolstered by these anticipated collaboration payments.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Kura Oncology, Inc. (KURA) as they transition from a clinical-stage company to a commercial one following the November 13, 2025, FDA approval of KOMZIFTI (ziftomenib) for relapsed/refractory NPM1-mutated AML. The cost structure is heavily weighted toward advancing the pipeline, but commercial readiness is now a significant factor.

High Research and Development (R&D) costs for clinical trials and pipeline defintely remain a primary expense driver. This reflects the scale-up of late-stage studies, notably the two global, randomized, double-blind, placebo-controlled KOMET-017 Phase 3 trials evaluating ziftomenib in frontline AML settings. R&D expenses for the third quarter of 2025 reached $67.9 million, a notable increase from $41.7 million in the third quarter of 2024. This spending is crucial for generating data across the continuum of unmet need in AML and advancing the second strategic program involving FTIs like darlifarnib and tipifarnib. The initiation of patient dosing in KOMET-017 in September and October 2025 directly contributed to this quarterly spend level.

Sales, General, and Administrative (SG&A) costs are rising sharply, reflecting the necessary build-out for commercial launch readiness. General and administrative (G&A) expenses for Q3 2025 were reported at $32.8 million, up substantially from $18.2 million in the same period of 2024. This increase covers the hiring and onboarding of the commercial team in advance of KOMZIFTI's debut in real-world practice. The total operating expenses for the quarter hit $100.7 million, driving the net loss to $74.1 million for Q3 2025.

Manufacturing and supply chain expenses for Komzifti production are being managed through the Kyowa Kirin collaboration structure. This partnership significantly mitigates Kura Oncology's long-term cash burn rate related to commercialization. Specifically, for U.S. sales, the profit-sharing arrangement shifts half of the commercialization expense to Kyowa Kirin. Outside the United States, Kyowa Kirin covers all commercialization expenses for KOMZIFTI, while Kura Oncology collects milestones and royalties. The first U.S. commercial sale of KOMZIFTI in late 2025 triggered a $135 million milestone payment expected by the end of 2025, which helps offset these initial launch costs.

Here's a quick look at the key operating expense components and guidance as of late 2025:

Cost Component Q3 2025 Amount (USD Millions) Q3 2024 Amount (USD Millions) Context
Research and Development (R&D) Expense $67.9 $41.7 Phase 3 scale-up for ziftomenib (KOMET-017)
General and Administrative (G&A) Expense $32.8 $18.2 Pre-commercial activities and team build-out
Total Operating Expenses (R&D + G&A) $100.7 $59.9 Drove quarterly net loss of $74.1 million
2025 Total Operating Expenses Guidance $250 - $260 N/A Reduced guidance from previous $270 - $285 million range

The company's cash position as of September 30, 2025, was $549.7 million, which, when adjusted for the two $30 million milestone payments received in October and November 2025 from the KOMET-017 trial, brought the pro forma cash to $609.7 million. Management believes this cash, combined with anticipated collaboration funding, supports the ziftomenib AML program through topline results from KOMET-017 into 2027.

  • - High R&D spend driven by two global Phase 3 trials.
  • - G&A rising due to pre-commercialization efforts post-NDA acceptance.
  • - Manufacturing/supply chain costs partially offset by Kyowa Kirin profit-sharing.
  • - Non-cash share-based compensation expense in Q3 2025 was $11.0 million.
  • - Cash runway extends into 2027 based on current plans.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Revenue Streams

You're looking at Kura Oncology, Inc.'s revenue structure as of late 2025, right after a major regulatory win. This is where the partnership with Kyowa Kirin really starts paying off, moving beyond just research funding to actual commercial realization.

The most immediate new stream is tied directly to the U.S. launch of KOMZIFTI (ziftomenib). The first U.S. commercial sale, following the FDA approval on November 13, 2025, immediately triggered a significant cash event.

  • - Product sales revenue from U.S. commercialization of Komzifti (post-Nov 2025 approval): The first U.S. commercial sale triggered a $135 million milestone payment from Kyowa Kirin, which Kura Oncology expected to receive prior to year-end 2025.

The core of Kura Oncology, Inc.'s current financial inflow remains the collaboration with Kyowa Kirin. This covers cost-sharing, development milestones, and future sales participation.

Here's a breakdown of the collaboration's financial components:

Revenue Component Specific Amount/Detail
Upfront Collaboration Payment (Historical) $330 million
Q3 2025 Collaboration Revenue $20.8 million
Total Near-Term Milestones Anticipated Approximately $315 million
Total Milestones Received in 2025 (to early Dec) $105 million (from two $30 million clinical trial milestones plus the $135 million commercial sale milestone)
Total Potential Milestones (Original Deal) Up to $1.2 billion

The profit split on U.S. sales is 50/50 between Kura Oncology, Inc. and Kyowa Kirin, with Kura handling U.S. commercialization and sales reporting. This means half of the U.S. net profits flow back to Kura Oncology, Inc. after the initial milestone payments.

For territories outside the U.S., where Kyowa Kirin holds exclusive commercialization rights, Kura Oncology, Inc. secures passive income based on product performance.

  • - Potential future milestone payments, with approximately $315 million in near-term milestones anticipated.
  • - Tiered royalties on ex-U.S. sales of ziftomenib by Kyowa Kirin: These are structured as tiered double-digit royalties on sales.

The estimated annual U.S. market size for the currently approved indication (relapsed/refractory NPM1-mutated AML) is approximately $350-$400 million per year, based on an estimated price of $48,500 per 30-day bottle.

Finance: draft 13-week cash view by Friday.


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