Kura Oncology, Inc. (Kura): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da pesquisa de oncologia, a Kura Oncology, Inc. (Kura) surge como uma força pioneira, transformando o tratamento do câncer por meio de medicamentos de precisão de ponta e estratégias de direcionamento molecular inovadoras. Ao dissecar meticulosamente sua tela de modelo de negócios, revelamos uma abordagem sofisticada que promete revolucionar como entendemos e combatei mecanismos complexos de câncer, oferecendo potencialmente esperança a pacientes que enfrentam malignidades desafiadoras e difíceis de tratar. Esse mergulho profundo na estrutura estratégica de Kura revela uma narrativa convincente de inovação científica, pesquisa colaborativa e potencial terapêutico transformador que poderia redefinir o futuro das intervenções oncológicas.

Kura Oncology, Inc. (Kura) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

A partir de 2024, a Kura Oncology estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Área de foco	Detalhes da colaboração
Universidade da Califórnia, San Diego	Pesquisa de oncologia de precisão	Contrato de pesquisa colaborativa para direcionamento molecular
MD Anderson Cancer Center	Desenvolvimento de ensaios clínicos	Programa de pesquisa conjunta para terapêutica direcionada

Acordos de licenciamento com centros acadêmicos de pesquisa de câncer

Kura Oncology garantiu os seguintes acordos de licenciamento:

• Universidade de Stanford - Licenciamento exclusivo para tecnologias de segmentação molecular
• Memorial Sloan Kettering Cancer Center - Licenciamento não exclusivo para plataformas de pesquisa pré -clínica

Parcerias com redes de ensaios clínicos e hospitais de pesquisa

Rede de ensaios clínicos	Número de ensaios ativos	Foco terapêutico
Rede de pesquisa de câncer Swog	3 ensaios em andamento	Terapêutica de oncologia de precisão
Grupo Cooperativo de Ensaios Clínicos da NCI	2 programas de pesquisa ativos	Terapias moleculares direcionadas

Potenciais acordos de co-desenvolvimento com empresas farmacêuticas

As parcerias de co-desenvolvimento farmacêuticas atuais incluem:

• Merck & Co. - Colaboração potencial na pesquisa de imunoterapia
• Bristol Myers Squibb - discussões exploratórias para o desenvolvimento da terapia direcionada

Orçamento total de colaboração de pesquisa para 2024: US $ 12,4 milhões

Número de parcerias institucionais ativas: 7

Kura Oncology, Inc. (Kura) - Modelo de negócios: Atividades -chave

Desenvolvendo terapias de câncer direcionadas usando medicina de precisão

A partir do quarto trimestre 2023, a oncologia da Kura se concentrou no desenvolvimento de terapias de medicina de precisão direcionadas a vias moleculares específicas no câncer. A empresa possui três candidatos a medicamentos primários no desenvolvimento clínico.

Candidato a drogas	Tipo de câncer	Estágio clínico
Tipifarnib	Leucemia mielóide aguda	Fase 3
KO-539	Síndrome mielodisplásica	Fase 1/2
KO-2806	Tumores sólidos	Pré -clínico

Realização de ensaios clínicos avançados para novos tratamentos oncológicos

Em 2023, a Kura Oncology investiu US $ 48,3 milhões em despesas de pesquisa e desenvolvimento dedicadas às operações de ensaios clínicos.

• Total de ensaios clínicos ativos: 4
• Número de locais de ensaios clínicos: 37
• Alvo de inscrição do paciente: 250 pacientes em vários estudos

Pesquisando estratégias de direcionamento molecular para intervenção do câncer

A Kura Oncology mantém uma equipe de pesquisa dedicada de 62 pessoal científico especializado em pesquisa de oncologia molecular.

Área de foco de pesquisa	Número de programas de pesquisa ativos
Inibição da farnesil transferase	2
Inibição da Menin	1
Direcionamento epigenético	1

Avançar pipelines de descoberta e desenvolvimento de medicamentos

A partir de 2024, a Kura Oncology possui 5 candidatos a medicamentos pré-clínicos e de estágio clínico em vários estágios de desenvolvimento.

• Candidatos pré -clínicos: 2
• Fase 1 Candidatos: 1
• Candidatos da Fase 2: 1
• Fase 3 Candidatos: 1

Conformidade regulatória e gerenciamento de pesquisa clínica

Em 2023, a Kura Oncology manteve a conformidade com os padrões regulatórios da FDA e da EMA, com zero grandes violações de conformidade.

Interação regulatória	Número de interações
Comunicações da FDA	12
EMA Communications	5
Aplicações de novos medicamentos para investigação (IND)	2

Kura Oncology, Inc. (Kura) - Modelo de negócios: Recursos -chave

Equipes especializadas de pesquisa e desenvolvimento de oncologia

A partir do quarto trimestre 2023, a Kura Oncology empregou 143 pessoal de pesquisa e desenvolvimento. A composição da equipe inclui:

Categoria profissional	Número de funcionários
Pesquisadores de doutorado	62
Pesquisadores de MD	18
Associados de pesquisa	63

Plataformas de tecnologia de segmentação molecular proprietária

As principais plataformas de segmentação molecular da Kura Oncology incluem:

• MPS1 Inibidor da plataforma
• Menin Inibitor Platform
• Plataforma inibidor da ERK

Portfólio de propriedade intelectual

Em dezembro de 2023, o portfólio de propriedade intelectual da Kura Oncology consistia em:

Categoria IP	Número de ativos
Patentes emitidas	37
Aplicações de patentes pendentes	22
Jurisdições de patentes globais	14

Infraestrutura de laboratório e pesquisa avançada

Detalhes da instalação de pesquisa:

• Espaço total da instalação de pesquisa: 45.000 pés quadrados.
• Localização: San Diego, Califórnia
• Equipamento avançado de biologia molecular: 18 plataformas de pesquisa especializadas

Gestão experiente

Executivo	Papel	Anos de oncologia
Troy Wilson, Ph.D.	Presidente e CEO	25
Kathleen Latouf	Diretor financeiro	18
Diego Cadavid, M.D.	Diretor médico	22

Kura Oncology, Inc. (Kura) - Modelo de Negócios: Proposições de Valor

Terapias inovadoras de câncer de precisão

A oncologia da Kura se concentra no desenvolvimento de terapias direcionadas para mecanismos moleculares específicos no tratamento do câncer. A partir do quarto trimestre 2023, o principal candidato a produtos Tipifarnib demonstrou:

Terapia	Indicação	Estágio clínico	Taxa de resposta
Tipifarnib	Carcinoma de células escamosas de cabeça e pescoço de Hras-mutante	Fase 2	Taxa de resposta objetiva de 24%

Potenciais tratamentos inovadores

As estratégias de segmentação molecular de Kura se concentram em mutações específicas do câncer:

• Cânceres de Hras-Mutant
• Leucemia mielóide aguda (AML)
• Linfoma de células T periféricas (PTCL)

Abordagens terapêuticas personalizadas

Investimento financeiro em pesquisa e desenvolvimento:

Ano	Despesas de P&D	Porcentagem de receita
2023	US $ 105,4 milhões	100%

Estratégias avançadas de direcionamento molecular

Principais alvos moleculares no desenvolvimento:

• Inibidores da farnesil transferase
• Inibidores de Menin
• Inibidores de EZH2

Melhoria do resultado do paciente

Métricas de desempenho de ensaios clínicos para Tipifarnib:

Métrica	Valor
Sobrevivência geral mediana	9,4 meses
Sobrevivência livre de progressão	4,2 meses

Kura Oncology, Inc. (Kura) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa oncológica

Kura Oncology mantém o envolvimento direto por meio de:

Método de engajamento	Freqüência	Público -alvo
Reuniões do Conselho Consultivo Científico	Trimestral	50 principais pesquisadores de oncologia
Consultas de pesquisa personalizadas	Mensal	Pesquisadores acadêmicos e clínicos

Interações com ensaios clínicos colaborativos

Métricas de engajamento dos participantes do ensaio clínico:

• TOTAL ATIVO TEMPENDO CLÍNICO COMPETING EM 2023: 287
• Taxa de retenção de pacientes: 92,4%
• Duração média da participação do estudo: 14,6 meses

Comunicação transparente sobre o desenvolvimento do tratamento

Canal de comunicação	Frequência de atualizações	Alcançar
Apresentações de investidores	Trimestral	3.200 investidores institucionais
Comunicados de imprensa	Ad hoc	Mais de 5.000 meios de comunicação médicos e financeiros

Programas de apoio ao paciente e educação

Detalhes do programa de apoio ao paciente:

• Linha direta de suporte do paciente dedicado: 1-866-Kura-CARE
• Recursos educacionais on -line acessados: 12.450 usuários únicos em 2023
• Inscrição do Programa de Assistência ao Paciente: 215 pacientes

Publicações científicas regulares e apresentações de conferências

Tipo de publicação/apresentação	2023 contagem	Fator de impacto
Publicações de revistas revisadas por pares	7	Variando 4.2-6.8
Principais apresentações da conferência de oncologia	12	Audiência média: 1.500 especialistas

Kura Oncology, Inc. (Kura) - Modelo de Negócios: Canais

Comunicação científica direta por meio de conferências médicas

Em 2023, Kura Oncology participou de 12 conferências médicas focadas em oncologia, incluindo:

Nome da conferência	Data	Localização
Associação Americana de Pesquisa do Câncer (AACR)	Abril de 2023	Orlando, FL
Sociedade Americana de Oncologia Clínica (ASCO)	Junho de 2023	Chicago, IL

Publicações de revistas científicas revisadas por pares

Kura Oncology publicada 7 artigos de pesquisa revisados ​​por pares Em 2023:

• Oncologia Molecular
• Descoberta do câncer
• Medicina da natureza

Plataformas de recrutamento de ensaios clínicos

Os canais ativos de recrutamento de ensaios clínicos incluem:

Plataforma	Número de ensaios ativos	Inscrição do paciente
ClinicalTrials.gov	5 ensaios	237 pacientes
Finder de pesquisa clínica do NIH	3 ensaios	142 pacientes

Eventos de rede da indústria farmacêutica

Kura Oncologia envolvida em 18 eventos de rede da indústria em 2023, com US $ 2,3 milhões alocado para o desenvolvimento de relacionamentos da indústria.

Plataformas de disseminação de comunicação e pesquisa digital

Os canais digitais incluem:

• Site corporativo: 124.567 visitantes únicos em 2023
• LinkedIn: 47.892 seguidores
• Twitter: 22.345 seguidores
• Repositórios de pesquisa científica: 15 perfis de pesquisa publicados

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

Instituições de Pesquisa Oncológica

A partir do quarto trimestre 2023, a Kura Oncology colabora com 17 instituições especializadas em pesquisa em todo o país.

Tipo de instituição de pesquisa	Número de colaborações	Foco na pesquisa
Centros Nacionais de Pesquisa do Câncer	8	Oncologia de precisão
Laboratórios de oncologia molecular especializados	9	Terapias de câncer direcionadas

Centros Médicos Acadêmicos

A Kura Oncology faz parceria com 22 centros médicos acadêmicos de pesquisa clínica e desenvolvimento de medicamentos.

• Universidades de pesquisa de primeira linha: 12
• Centros abrangentes de câncer: 10

Organizações de pesquisa farmacêutica

Parcerias colaborativas com 6 principais organizações de pesquisa farmacêutica em 2024.

Tipo de organização	Status da parceria	Investimento em pesquisa
Grandes empresas farmacêuticas	4 colaborações ativas	US $ 42,3 milhões
Empresas de pesquisa de biotecnologia	2 parcerias estratégicas	US $ 18,7 milhões

Especialistas em tratamento do câncer

Rede de 135 especialistas em tratamento de oncologia envolvidos em ensaios e pesquisas clínicas.

• Hematologia Oncologistas: 65
• Especialistas em tumores sólidos: 70

Pacientes com tipos de câncer direcionados

Ensaios clínicos em andamento direcionando populações específicas de pacientes com câncer.

Tipo de câncer	Inscrição do paciente	Fase de ensaios clínicos
Leucemia mielóide aguda	87 pacientes	Fase 2
Tumores sólidos	124 pacientes	Fase 1/2

Kura Oncology, Inc. (Kura) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Kura Oncology relatou despesas de P&D totalizando US $ 107,6 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2023	US $ 107,6 milhões	68.3%
2022	US $ 94,3 milhões	65.7%

Custos de gerenciamento e implementação de ensaios clínicos

As despesas de ensaios clínicos para a oncologia da Kura em 2023 foram de aproximadamente US $ 62,4 milhões, concentrando -se nos principais desenvolvimentos terapêuticos da oncologia.

• Ensaios de Fase I/II para Tipifarnib: US $ 24,5 milhões
• Custos de Programa de Oncologia de Precisão: US $ 18,9 milhões
• Recrutamento e gerenciamento de pacientes: US $ 12,7 milhões
• Despesas de conformidade regulatória: US $ 6,3 milhões

Proteção e manutenção da propriedade intelectual

Os custos anuais de proteção de propriedade intelectual da Kura Oncology em 2023 foram de US $ 3,2 milhões.

Categoria IP	Custo
Registro de patentes	US $ 1,7 milhão
Manutenção de patentes	US $ 1,5 milhão

Recrutamento especializado de talento científico

As despesas totais de aquisição e retenção de talentos para 2023 foram de US $ 18,5 milhões.

• Compensação sênior do pesquisador: US $ 8,7 milhões
• Recrutamento e integração: US $ 4,2 milhões
• Treinamento e desenvolvimento profissional: US $ 3,6 milhões
• Benefícios dos funcionários: US $ 2 milhões

Manutenção avançada de laboratório e infraestrutura de pesquisa

Os custos de manutenção de infraestrutura e equipamentos para 2023 totalizaram US $ 22,3 milhões.

Componente de infraestrutura	Custo de manutenção
Equipamento de laboratório	US $ 12,6 milhões
Uportagem da instalação de pesquisa	US $ 6,7 milhões
Tecnologia e software	US $ 3 milhões

Kura Oncology, Inc. (Kura) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias proprietárias de tratamento de câncer

A partir do quarto trimestre 2023, o potencial de licenciamento da Kura Oncology se concentra em seus principais candidatos a medicamentos:

• Ziftomenibe (KO-539) para leucemia mielóide aguda (AML)
• Tipifarnib para linfoma de células T periféricas

Vendas futuras de produtos farmacêuticos

Projeções de receita para desenvolvimento de produtos farmacêuticos:

Candidato a drogas	Receita anual potencial estimada	Segmento de mercado
Ziftomenibe	US $ 125 a US $ 250 milhões	Tratamento da LBC
Tipifarnib	US $ 75 a US $ 150 milhões	Tratamento do linfoma

Subsídios de pesquisa e financiamento científico

Financiamento de pesquisa recebido em 2023:

• Subsídios dos Institutos Nacionais de Saúde (NIH): US $ 3,2 milhões
• Suporte da Fundação de Pesquisa do Câncer: US $ 1,5 milhão

Acordos de desenvolvimento colaborativo

Detalhes da parceria farmacêutica atual:

Parceiro	Tipo de contrato	Potenciais pagamentos marcantes
Merck & Co.	Colaboração de pesquisa	Até US $ 50 milhões
Bristol Myers Squibb	Parceria de Desenvolvimento de Medicamentos	Até US $ 75 milhões

Pagamentos marcantes de parcerias farmacêuticas

Repartição do pagamento de marco para 2023-2024:

• Marco de avanço do ensaio clínico: US $ 22 milhões
• Marcos de envio regulatório: US $ 15 milhões
• Marcos de desenvolvimento pré -clínico: US $ 8 milhões

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.