Kura Oncology, Inc. (KURA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la investigación de oncología, Kura Oncology, Inc. (Kura) emerge como una fuerza pionera, transformando el tratamiento del cáncer a través de medicina de precisión de vanguardia y estrategias innovadoras de focalización molecular. Al diseccionar meticulosamente su lienzo de modelo de negocio, revelamos un enfoque sofisticado que promete revolucionar cómo entendemos y combatemos los mecanismos de cáncer complejos, ofreciendo potencialmente esperanza a los pacientes que enfrentan malignas desafiantes y difíciles de tratar. Esta profunda inmersión en el marco estratégico de Kura revela una narración convincente de la innovación científica, la investigación colaborativa y el potencial terapéutico transformador que podría redefinir el futuro de las intervenciones oncológicas.

Kura Oncology, Inc. (Kura) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación farmacéutica

A partir de 2024, Kura Oncology ha establecido asociaciones estratégicas con las siguientes instituciones de investigación:

Institución	Área de enfoque	Detalles de colaboración
Universidad de California, San Diego	Investigación de oncología de precisión	Acuerdo de investigación colaborativa para la orientación molecular
Centro de cáncer de MD Anderson	Desarrollo de ensayos clínicos	Programa de investigación conjunta para terapias dirigidas

Acuerdos de licencia con Centros de Investigación Académica del Cáncer

Kura Oncology ha asegurado los siguientes acuerdos de licencia:

• Universidad de Stanford - Licencias exclusivas para tecnologías de orientación molecular
• Memorial Sloan Kettering Cancer Center - Licencias no exclusivas para plataformas de investigación preclínica

Asociaciones con redes de ensayos clínicos y hospitales de investigación

Red de ensayos clínicos	Número de pruebas activas	Enfoque terapéutico
Red de investigación sobre el cáncer SWOG	3 pruebas en curso	Terapéutica oncológica de precisión
Grupo cooperativo de ensayos clínicos de NCI	2 programas de investigación activos	Terapias moleculares dirigidas

Posibles acuerdos de desarrollo de co-desarrollo con compañías farmacéuticas

Las asociaciones de co-desarrollo farmacéuticas actuales incluyen:

• Merck & Co. - Colaboración potencial en la investigación de inmunoterapia
• Bristol Myers Squibb - Discusiones exploratorias para el desarrollo de la terapia dirigida

Presupuesto de colaboración de investigación total para 2024: $ 12.4 millones

Número de asociaciones institucionales activas: 7

Kura Oncology, Inc. (Kura) - Modelo de negocios: actividades clave

Desarrollo de terapias de cáncer dirigidas utilizando medicina de precisión

A partir del cuarto trimestre de 2023, Kura Oncology se ha centrado en el desarrollo de terapias de medicina de precisión dirigida a vías moleculares específicas en el cáncer. La compañía tiene 3 candidatos a medicamentos principales en desarrollo clínico.

Candidato a la droga	Tipo de cáncer	Estadio clínico
Tipifarnib	Leucemia mieloide aguda	Fase 3
KO-539	Síndrome mielodisplásico	Fase 1/2
KO-2806	Tumores sólidos	Preclínico

Realización de ensayos clínicos avanzados para nuevos tratamientos de oncología

En 2023, Kura Oncology invirtió $ 48.3 millones en gastos de investigación y desarrollo dedicados a operaciones de ensayos clínicos.

• Ensayos clínicos activos totales: 4
• Número de sitios de ensayos clínicos: 37
• Objetivo de inscripción de pacientes: 250 pacientes en múltiples estudios

Investigación de estrategias de orientación molecular para la intervención del cáncer

Kura Oncology mantiene un equipo de investigación dedicado de 62 personal científico especializado en investigación de oncología molecular.

Área de enfoque de investigación	Número de programas de investigación activos
Inhibición de farnesil transferasa	2
Inhibición de la menina	1
Orientación epigenética	1

Avance de las tuberías de descubrimiento y desarrollo de drogas

A partir de 2024, Kura Oncology tiene 5 candidatos a medicamentos preclínicos y clínicos en varias etapas de desarrollo.

• Candidatos preclínicos: 2
• Candidatos de fase 1: 1
• Candidatos de fase 2: 1
• Candidatos de fase 3: 1

Cumplimiento regulatorio y gestión de la investigación clínica

En 2023, Kura Oncology mantuvo el cumplimiento de las normas regulatorias de la FDA y EMA, con cero violaciones importantes de cumplimiento.

Interacción regulatoria	Número de interacciones
Comunicaciones de la FDA	12
Comunicaciones de EMA	5
Aplicaciones de nueva droga de investigación (IND)	2

Kura Oncology, Inc. (Kura) - Modelo de negocios: recursos clave

Equipos especializados de investigación y desarrollo de oncología

A partir del cuarto trimestre de 2023, Kura Oncology empleó a 143 personal de investigación y desarrollo. La composición del equipo incluye:

Categoría profesional	Número de empleados
Investigadores de doctorado	62
Investigadores de MD	18
Asociados de investigación	63

Plataformas de tecnología de orientación molecular patentada

Las plataformas de orientación molecular clave de Kura Oncology incluyen:

• Plataforma de inhibidores de MPS1
• Plataforma de inhibidores de la menina
• Plataforma inhibidor de ERK

Cartera de propiedades intelectuales

A diciembre de 2023, la cartera de propiedad intelectual de Kura Oncology consistía en:

Categoría de IP	Número de activos
Patentes emitidos	37
Aplicaciones de patentes pendientes	22
Jurisdicciones de patentes globales	14

Infraestructura avanzada de laboratorio e investigación

Detalles de la instalación de investigación:

• Espacio total de la instalación de investigación: 45,000 pies cuadrados.
• Ubicación: San Diego, California
• Equipo de biología molecular avanzada: 18 plataformas de investigación especializadas

Gestión experimentada

Ejecutivo	Role	Años en oncología
Troy Wilson, Ph.D.	Presidente y CEO	25
Kathleen latouf	Director financiero	18
Diego Cadavid, M.D.	Director médico	22

Kura Oncology, Inc. (Kura) - Modelo de negocio: propuestas de valor

Terapias innovadoras de cáncer de precisión

Kura Oncology se centra en el desarrollo de terapias dirigidas para mecanismos moleculares específicos en el tratamiento del cáncer. A partir del cuarto trimestre de 2023, el candidato principal del producto de la compañía, Tipifarnib, demostró:

Terapia	Indicación	Estadio clínico	Tasa de respuesta
Tipifarnib	Carcinoma de células escamosas de cabeza y cuello de cabeza y cuello	Fase 2	24% de tasa de respuesta objetiva

Posibles tratamientos innovadores

Las estrategias de orientación molecular de Kura se centran en mutaciones específicas de cáncer:

• Cánceres hras-mutantes
• Leucemia mieloide aguda (AML)
• Linfoma periférico de células T (PTCL)

Enfoques terapéuticos personalizados

Inversión financiera en investigación y desarrollo:

Año	Gastos de I + D	Porcentaje de ingresos
2023	$ 105.4 millones	100%

Estrategias de orientación molecular avanzada

Objetivos moleculares clave en el desarrollo:

• Inhibidores de farnesil transferasa
• Inhibidores de la menina
• Inhibidores de EZH2

Mejora del resultado del paciente

Métricas de rendimiento del ensayo clínico para tipifarnib:

Métrico	Valor
Mediana de supervivencia general	9.4 meses
Supervivencia libre de progresión	4.2 meses

Kura Oncology, Inc. (Kura) - Modelo de negocios: relaciones con los clientes

Comunidad directa de compromiso con la investigación de oncología

Kura Oncology mantiene la participación directa a través de:

Método de compromiso	Frecuencia	Público objetivo
Reuniones de la junta asesora científica	Trimestral	Los 50 principales investigadores de oncología
Consultas de investigación personalizadas	Mensual	Investigadores académicos y clínicos

Interacciones de participantes de ensayos clínicos colaborativos

Métricas de participación de los participantes del ensayo clínico:

• Participantes de ensayos clínicos activos totales en 2023: 287
• Tasa de retención del paciente: 92.4%
• Duración promedio de participación en el ensayo: 14.6 meses

Comunicación transparente sobre el desarrollo del tratamiento

Canal de comunicación	Frecuencia de actualizaciones	Alcanzar
Presentaciones de inversores	Trimestral	3.200 inversores institucionales
Comunicados de prensa	Ad-hoc	Más de 5,000 medios de comunicación médica y financiera

Programas de apoyo y educación del paciente

Detalles del programa de apoyo al paciente:

• Línea directa de apoyo al paciente dedicado: 1-866-Kura-Care
• Recursos educativos en línea accedidos: 12.450 usuarios únicos en 2023
• Inscripción del programa de asistencia al paciente: 215 pacientes

Publicaciones científicas regulares y presentaciones de conferencias

Tipo de publicación/presentación	2023 recuento	Factor de impacto
Publicaciones de revistas revisadas por pares	7	Ranging 4.2-6.8
Presentaciones principales de la conferencia de oncología	12	Audiencia promedio: 1.500 especialistas

Kura Oncology, Inc. (Kura) - Modelo de negocios: canales

Comunicación científica directa a través de conferencias médicas

En 2023, Kura Oncology participó en 12 Conferencias médicas centradas en la oncología, incluido:

Nombre de conferencia	Fecha	Ubicación
Asociación Americana para la Investigación del Cáncer (AACR)	Abril de 2023	Orlando, FL
Sociedad Americana de Oncología Clínica (ASCO)	Junio ​​de 2023	Chicago, IL

Publicaciones de revistas científicas revisadas por pares

Kura Oncology publicada 7 artículos de investigación revisados ​​por pares En 2023:

• Oncología molecular
• Descubrimiento de cáncer
• Medicina de la naturaleza

Plataformas de reclutamiento de ensayos clínicos

Los canales de reclutamiento de ensayos clínicos activos incluyen:

Plataforma	Número de pruebas activas	Inscripción del paciente
Clinicaltrials.gov	5 pruebas	237 pacientes
Buscador de investigación clínica de NIH	3 pruebas	142 pacientes

Eventos de redes de la industria farmacéutica

Kura Oncology participó en 18 eventos de redes de la industria en 2023, con $ 2.3 millones asignado para el desarrollo de la relación de la industria.

Plataformas de difusión de comunicación e investigación digital

Los canales digitales incluyen:

• Sitio web corporativo: 124,567 visitantes únicos en 2023
• LinkedIn: 47,892 seguidores
• Twitter: 22,345 seguidores
• Repositorios de investigación científica: 15 perfiles de investigación publicados

Kura Oncology, Inc. (Kura) - Modelo de negocios: segmentos de clientes

Instituciones de investigación de oncología

A partir del cuarto trimestre de 2023, Kura Oncology colabora con 17 instituciones de investigación de oncología especializada en todo el país.

Tipo de institución de investigación	Número de colaboraciones	Enfoque de investigación
Centros Nacionales de Investigación del Cáncer	8	Oncología de precisión
Laboratorios de oncología molecular especializadas	9	Terapias de cáncer dirigidas

Centros médicos académicos

Kura Oncology se asocia con 22 centros médicos académicos para la investigación clínica y el desarrollo de medicamentos.

• Universidades de investigación de primer nivel: 12
• Centros de cáncer integrales: 10

Organizaciones de investigación farmacéutica

Asociaciones colaborativas con 6 principales organizaciones de investigación farmacéutica en 2024.

Tipo de organización	Estado de asociación	Inversión de investigación
Grandes compañías farmacéuticas	4 colaboraciones activas	$ 42.3 millones
Firmas de investigación de biotecnología	2 asociaciones estratégicas	$ 18.7 millones

Especialistas en tratamiento contra el cáncer

Red de 135 especialistas en tratamiento de oncología involucrados en ensayos clínicos e investigación.

• Hematology Oncologists: 65
• Especialistas de tumor sólido: 70

Pacientes con tipos de cáncer seleccionados

Ensayos clínicos en curso dirigidos a poblaciones específicas de pacientes con cáncer.

Tipo de cáncer	Inscripción del paciente	Fase de ensayo clínico
Leucemia mieloide aguda	87 pacientes	Fase 2
Tumores sólidos	124 pacientes	Fase 1/2

Kura Oncology, Inc. (Kura) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Kura Oncology reportó gastos de I + D por un total de $ 107.6 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2023	$ 107.6 millones	68.3%
2022	$ 94.3 millones	65.7%

Costos de gestión e implementación de ensayos clínicos

Los gastos de ensayos clínicos para Kura Oncology en 2023 fueron de aproximadamente $ 62.4 millones, centrándose en desarrollos terapéuticos oncológicos clave.

• Pruebas de fase I/II para Tipifarnib: $ 24.5 millones
• Costos del programa de oncología de precisión: $ 18.9 millones
• Reclutamiento y gestión del paciente: $ 12.7 millones
• Gastos de cumplimiento regulatorio: $ 6.3 millones

Protección y mantenimiento de la propiedad intelectual

Los costos anuales de protección de la propiedad intelectual para Kura Oncology en 2023 fueron de $ 3.2 millones.

Categoría de IP	Costo
Presentación de patentes	$ 1.7 millones
Mantenimiento de patentes	$ 1.5 millones

Reclutamiento de talento científico especializado

Los gastos totales de adquisición y retención de talento para 2023 fueron de $ 18.5 millones.

• Compensación de investigadores senior: $ 8.7 millones
• Reclutamiento e incorporación: $ 4.2 millones
• Capacitación y desarrollo profesional: $ 3.6 millones
• Beneficios para empleados: $ 2 millones

Mantenimiento avanzado de infraestructura de laboratorio e investigación

Los costos de infraestructura y mantenimiento de equipos para 2023 totalizaron $ 22.3 millones.

Componente de infraestructura	Costo de mantenimiento
Equipo de laboratorio	$ 12.6 millones
Mantenimiento de la instalación de investigación	$ 6.7 millones
Tecnología y software	$ 3 millones

Kura Oncology, Inc. (Kura) - Modelo de negocios: flujos de ingresos

Licencias potenciales de tecnologías propietarias de tratamiento del cáncer

A partir del cuarto trimestre de 2023, el potencial de licencia de Kura Oncology se centra en sus candidatos clave de drogas:

• Ziftomenib (KO-539) para leucemia mieloide aguda (AML)
• Tipifarnib para linfoma periférico de células T

Ventas de productos farmacéuticos futuros

Proyecciones de ingresos para el desarrollo de productos farmacéuticos:

Candidato a la droga	Ingresos anuales potenciales estimados	Segmento de mercado
Ziffomenib	$ 125- $ 250 millones	Tratamiento con AML
Tipifarnib	$ 75- $ 150 millones	Tratamiento de linfoma

Subvenciones de investigación y financiación científica

Financiación de la investigación recibida en 2023:

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 3.2 millones
• Soporte de la Fundación de Investigación de Cáncer: $ 1.5 millones

Acuerdos de desarrollo colaborativo

Detalles actuales de la asociación farmacéutica:

Pareja	Tipo de acuerdo	Pagos potenciales de hitos
Merck & Co.	Colaboración de investigación	Hasta $ 50 millones
Bristol Myers Squibb	Asociación de desarrollo de drogas	Hasta $ 75 millones

Pagos de hitos de asociaciones farmacéuticas

Desglose de pago por hito para 2023-2024:

• Hitos de avance del ensayo clínico: $ 22 millones
• Hitos de presentación regulatoria: $ 15 millones
• Hitos de desarrollo preclínico: $ 8 millones

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.