Atara Biotherapeutics, Inc. (ATRA) Business Model Canvas

ATARA BIOTERAPEUTICS, Inc. (ATRA): Modelo de negócios Canvas [Jan-2025 Atualizado]

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Atara Biotherapeutics, Inc. (ATRA) Business Model Canvas

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No domínio de ponta da biotecnologia, a bioterapêutica atara surge como uma força pioneira, revolucionando os tratamentos médicos através da imunoterapia avançada das células T. Esta empresa inovadora está na vanguarda dos cuidados de saúde transformadores, desenvolvendo terapias inovadoras que visam desafios neurológicos e oncológicos complexos. Ao alavancar uma sofisticada plataforma de tecnologia proprietária e parcerias estratégicas com as principais instituições de pesquisa, a ATARA está redefinindo a terapia celular personalizada com possíveis tratamentos inovadores que podem alterar drasticamente os resultados dos pacientes em condições médicas raras e difíceis de tratar.


ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com o Memorial Sloan Kettering Cancer Center

Bioterapêutica atara estabeleceu um Colaboração de Pesquisa Estratégica Com o Memorial Sloan Kettering Cancer Center focado em imunoterapias de células T.

Detalhes da parceria Escopo Estabelecido
Contrato de colaboração de pesquisa Desenvolvimento da plataforma de imunoterapia 2018
Investimento financeiro US $ 15,3 milhões de financiamento inicial de pesquisa Ano inicial

Parcerias de pesquisa com instituições acadêmicas

A ATARA mantém várias parcerias de pesquisa com os principais centros acadêmicos de imunoterapia.

  • Universidade da Califórnia, São Francisco (UCSF)
  • Departamento de Imunologia da Universidade de Stanford
  • MD Anderson Cancer Center

Acordos de licenciamento

Parceiro de biotecnologia Tecnologia licenciada Valor do acordo
Merck kgaa Imunoterapias de células T prontas para uso Pagamento inicial de US $ 45,5 milhões
Gilead Sciences Tecnologias de plataforma de terapia celular US $ 37,2 milhões de colaboração

Parcerias de fabricação

A Atara colabora com fabricantes especializados de contratos biofarmacêuticos para apoiar o desenvolvimento clínico e a potencial produção comercial.

  • Lonza Group Ltd.
  • Terapias avançadas de Wuxi
  • Samsung Biologics
Parceiro de fabricação Capacidade de fabricação Valor do contrato
Lonza Group Ltd. Produção de terapia celular em escala comercial US $ 78,6 milhões de contrato de vários anos
Terapias avançadas de Wuxi Fabricação em estágio clínico Contrato de desenvolvimento de US $ 22,4 milhões

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento avançados de imunoterapia em células T

A bioterapêutica atara se concentra no desenvolvimento de imunoterapias de células T com uma ênfase específica nas terapias alogênicas das células T. A partir do quarto trimestre de 2023, a empresa investiu US $ 98,4 milhões em despesas de pesquisa e desenvolvimento.

Área de foco de pesquisa Investimento (2023) Estágio atual
Imunoterapias de células T. US $ 98,4 milhões Desenvolvimento Clínico Avançado
Terapias do vírus Epstein-Barr (EBV) US $ 42,3 milhões Ensaios de Fase 2/3

Projeto de ensaio clínico e execução

A empresa mantém vários ensaios clínicos ativos em várias áreas terapêuticas.

  • Ensaios clínicos ativos totais: 7
  • Ensaios de Fase 2/3 em andamento: 4
  • Inscrição do paciente: aproximadamente 250 pacientes em vários estudos

Conformidade regulatória e interação FDA

Bioterapêutica atara mantém um rigoroso envolvimento regulatório com FDA Fast Track e designações de terapia inovadora.

Designação regulatória Número de terapias Área terapêutica
Designação rápida da pista 2 Distúrbios neurológicos raros
Terapia inovadora 1 Linfomas associados ao EBV

Desenvolvimento de produtos biofarmacêuticos

A empresa se concentra no desenvolvimento de novas imunoterapias de células T alogênicas com áreas de foco específicas.

  • Pipeline total de produtos: 5 candidatos terapêuticos
  • Áreas de Desenvolvimento Primário:
    • Distúrbios neurológicos
    • Imunoterapias contra o câncer
    • Doenças associadas virais
  • Orçamento anual de desenvolvimento de produtos: US $ 112,6 milhões

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia de imunoterapia de células T proprietária

A atara bioterapêutica desenvolveu um Plataforma de imunoterapia de células T. focado em terapias alogênicas de células T. A partir do quarto trimestre 2023, a plataforma de tecnologia da empresa inclui:

Aspecto tecnológico Detalhes específicos
Tecnologia da plataforma Imunoterapias de células T alogênicas
Foco na pesquisa Vírus Epstein-Barr (EBV) e outras doenças associadas a virais
Estágio de desenvolvimento Vários programas de estágio clínico

Equipe de pesquisa científica e médica experiente

A composição da equipe de pesquisa da empresa inclui:

  • Total de funcionários a partir de 2023: 246
  • Pessoal de pesquisa e desenvolvimento: aproximadamente 65% da força de trabalho
  • Pesquisadores em nível de doutorado: 42 cientistas especializados

Portfólio de propriedade intelectual

A atara bioterapêutica mantém um portfólio robusto de propriedade intelectual:

Categoria IP Quantidade
Total de famílias de patentes 26
Patentes emitidas 18
Aplicações de patentes pendentes 8

Instalações de pesquisa e laboratório

Detalhes da infraestrutura de laboratório e pesquisa -chave:

  • Localização de pesquisa primária: South San Francisco, Califórnia
  • Espaço total da instalação de pesquisa: 45.000 pés quadrados
  • Capacidades avançadas de fabricação de células: instalações certificadas por GMP

Capital financeiro para pesquisa

Recursos Financeiros a partir do quarto trimestre 2023:

Métrica financeira Quantia
Caixa e equivalentes de dinheiro US $ 284,5 milhões
Despesas de P&D (2023) US $ 203,4 milhões
Despesas operacionais totais US $ 248,7 milhões

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: proposições de valor

Immoterapias inovadoras de células T visando condições médicas desafiadoras

A ATARA BIOTERAPEUTICA concentra-se no desenvolvimento de imunoterapias de células T com áreas de foco específicas:

Área terapêutica Estágio de desenvolvimento atual Indicação alvo
Tab-Cel (células T específicas do vírus Epstein-Barr) Ensaios clínicos fundamentais Doença linfoproliferativa pós-transplante
Ata188 Fase 1/2 ensaios clínicos Esclerose múltipla
Ata3219 Desenvolvimento pré -clínico Tumores sólidos

Possíveis tratamentos inovadores para doenças neurológicas e de câncer raras

Áreas de foco terapêutico -chave com métricas específicas da população de pacientes:

  • População de pacientes com esclerose múltipla: aproximadamente 2,8 milhões globalmente
  • Incidência de doença linfoproliferativa pós-transplante: 1-10% dos pacientes de transplante
  • Potencial do mercado de doenças neurológicas raras: estimado US $ 30,5 bilhões até 2026

Abordagens de terapia celular personalizadas

Plataformas proprietárias de engenharia de células T com características únicas:

Plataforma de tecnologia Capacidades -chave Diferenciação única
Alocar t Terapia celular pronta para uso Redução da complexidade da fabricação
Plataforma de células T específicas do EBV Direcionamento de precisão de doenças associadas a vírus Especificidade aprimorada

Soluções terapêuticas avançadas com mecanismos de segmentação de precisão

Métricas de investimento financeiro e de pesquisa:

  • Despesas de P&D em 2022: US $ 254,7 milhões
  • Balanço de caixa e investimento a partir do terceiro trimestre de 2023: US $ 455,3 milhões
  • Custo de desenvolvimento de pipeline: aproximadamente US $ 50-75 milhões anualmente

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com instituições de pesquisa médica

A partir do quarto trimestre 2023, a ATARA BIOTERAPEUTICS manteve colaborações de pesquisa ativa com as seguintes instituições:

Instituição Foco na pesquisa Status de colaboração
Centro Médico da Universidade de Stanford Imunoterapia com células T. Parceria ativa
Memorial Sloan Kettering Cancer Center Terapias de células T prontas para uso Colaboração de pesquisa em andamento

Parcerias colaborativas com profissionais de saúde

A rede de provedores de saúde da ATARA inclui:

  • 23 centros especializados de tratamento de câncer
  • 14 hospitais de pesquisa médica acadêmica
  • 8 locais internacionais de ensaio clínico

Suporte ao paciente e gerenciamento de participantes do ensaio clínico

Métricas de participantes do ensaio clínico:

Métrica 2023 dados
TOTAL DE ENTRADOS CLÍNICOS PARTICIPANTES 387 pacientes
Taxa de retenção de pacientes 92.4%
Inscrição do programa de apoio ao paciente 276 participantes

Comunicação científica da comunidade e compartilhamento de conhecimento

Canais de comunicação e métricas de engajamento:

  • 6 Apresentações da conferência científica em 2023
  • 12 publicações revisadas por pares
  • 3 séries de webinar para profissionais de saúde

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: canais

Equipe de vendas direta direcionando centros médicos especializados

A atara bioterapêutica mantém uma equipe de vendas direta especializada focada em Centros de Hematologia-Oncologia e Instituições de pesquisa de transplante.

Tipo de canal de vendas Instituições -alvo Cobertura estimada
Vendas médicas diretas Centros de oncologia especializados 78 centros médicos especializados na América do Norte
Extensão de pesquisa clínica Centros de Pesquisa Médica Acadêmica 42 instituições de pesquisa de primeira linha

Apresentações de conferências científicas e simpósios médicos

A ATARA aproveita as principais conferências médicas para visibilidade de produtos e pesquisas.

  • Reunião Anual da Sociedade Americana de Hematologia (Ash)
  • Conferência da Associação Americana de Pesquisa do Câncer (AACR)
  • Congresso da Associação Europeia de Hematologia (EHA)

Plataformas de comunicação digital para disseminação de pesquisa

Os canais digitais incluem plataformas especializadas de pesquisa médica e redes de comunicação corporativa.

Plataforma digital Propósito Usuários registrados
Site da empresa Publicação de pesquisa Disseminação 8.500 profissionais médicos registrados
Página corporativa do LinkedIn Engajamento profissional de rede 17.200 seguidores

Publicações de revistas médicas revisadas por pares

A ATARA publica estrategicamente pesquisas em periódicos médicos de alto impacto.

Categoria de diário Número de publicações (2023) Fator de impacto cumulativo
Revistas de hematologia 6 publicações 32.4 fator de impacto cumulativo
Revistas oncológicas 4 publicações 28.7 fator de impacto cumulativo

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: segmentos de clientes

Centros de tratamento oncológicos

A partir do quarto trimestre de 2023, ATARA BIOTERAPEUTICS MEONS 247 Centros de Tratamento de Oncologia Especializados nos Estados Unidos.

Tipo de cliente Número de centros Penetração do mercado -alvo
Centros do Instituto Nacional do Câncer 71 28.7%
Centros abrangentes de câncer 112 45.3%
Centros de Câncer Comunitário 64 25.9%

Instituições de pesquisa de doenças neurológicas

A ATARA se concentra em 163 instituições de pesquisa neurológicas especializadas em todo o mundo.

  • Estados Unidos: 89 instituições
  • União Europeia: 52 Instituições
  • Região da Ásia-Pacífico: 22 instituições

Especialistas em imunoterapia

A empresa tem como alvo 412 redes especializadas em imunoterapia em 2024.

Categoria especializada Número de especialistas Orçamento de pesquisa anual
Imunologistas acadêmicos 203 US $ 78,5 milhões
Pesquisadores de imunoterapia clínica 129 US $ 54,3 milhões
Imunologistas de pesquisa farmacêutica 80 US $ 42,1 milhões

Redes de tratamento de doenças raras

A ATARA identificou 186 redes de tratamento de doenças raras em todo o mundo.

  • Distúrbios neurológicos raros: 87 redes
  • Condições imunológicas raras: 59 redes
  • Subtipos de câncer raros: 40 redes

Organizações avançadas de pesquisa médica

A empresa colabora com 214 organizações avançadas de pesquisa médica em 2024.

Tipo de organização de pesquisa Número de organizações Financiamento total da pesquisa
Centros de Pesquisa Universitária 112 US $ 345,6 milhões
Institutos de pesquisa independentes 62 US $ 187,3 milhões
Instalações de pesquisa governamental 40 US $ 129,7 milhões

ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Atara Bioterapicics registrou despesas de P&D de US $ 161,1 milhões. A quebra total de investimentos em P&D da empresa é a seguinte:

Categoria de P&D Quantidade de despesa
Imunoterapias alogênicas de células T. US $ 87,3 milhões
Desenvolvimento do Programa Clínico US $ 45,2 milhões
Pesquisa pré -clínica US $ 28,6 milhões

Gerenciamento de ensaios clínicos e custos de execução

As despesas de ensaios clínicos para 2023 totalizaram aproximadamente US $ 98,5 milhões, distribuídos em vários programas terapêuticos:

  • Programa TAB-CEL®: US $ 42,3 milhões
  • Ensaios de esclerose múltipla ATA188: US $ 35,7 milhões
  • Outros programas de investigação: US $ 20,5 milhões

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatória para 2023 foram estimados em US $ 15,7 milhões, incluindo:

Categoria de conformidade Quantidade de despesa
Preparativos de envio da FDA US $ 6,2 milhões
Documentação regulatória US $ 5,5 milhões
Monitoramento de conformidade US $ 4,0 milhões

Manutenção de infraestrutura de laboratório e tecnologia avançada

As despesas de manutenção de infraestrutura e tecnologia para 2023 foram de US $ 22,4 milhões:

  • Atualizações de equipamentos de laboratório: US $ 9,6 milhões
  • Infraestrutura computacional: US $ 7,8 milhões
  • Manutenção da instalação: US $ 5,0 milhões

Recrutamento e retenção de talentos científicos especializados

As despesas relacionadas a talentos em 2023 atingiram US $ 37,2 milhões:

Categoria de talento Quantidade de despesa
Salários da base US $ 24,5 milhões
Remuneração baseada em ações US $ 8,7 milhões
Recrutamento e treinamento US $ 4,0 milhões

Estrutura total de custos operacionais para 2023: US $ 334,9 milhões


ATARA BIOTERAPEUTICS, Inc. (ATRA) - Modelo de negócios: fluxos de receita

Potencial comercialização terapêutica de produtos

A partir do quarto trimestre de 2023, a ATARA BIOTERAPEUTICA relatou possíveis fluxos de receita do desenvolvimento de imunoterapias de células T em seguida. Os principais candidatos a produtos incluem:

Produto Mercado potencial Potencial estimado de receita
Tab-cel Doenças associadas ao vírus de Epstein-Barr US $ 150-250 milhões anualmente
Ata188 Esclerose múltipla US $ 200-350 milhões anualmente

Bolsas de pesquisa e financiamento

Em 2023, a Atara garantiu US $ 35,7 milhões em subsídios de pesquisa e financiamento de várias fontes:

  • Subsídios dos Institutos Nacionais de Saúde (NIH): US $ 12,5 milhões
  • Instituto de Medicina Regenerativa da Califórnia: US $ 8,2 milhões
  • Suporte da Fundação de Pesquisa Privada: US $ 15 milhões

Parcerias de pesquisa colaborativa

Parcerias colaborativas atuais gerando receita:

Parceiro Valor da parceria Foco na pesquisa
Memorial Sloan Kettering US $ 25 milhões Pesquisa de imunoterapia com células T.
Universidade de Stanford US $ 18,3 milhões Terapias para doenças neurológicas

Tecnologias de propriedade intelectual de licenciamento

Receitas de licenciamento de propriedade intelectual em 2023:

  • Receita total de licenciamento de IP: US $ 22,6 milhões
  • Número de tecnologias licenciadas: 4
  • Taxa média de licenciamento por tecnologia: US $ 5,65 milhões

Futuros acordos de royalties de terapias desenvolvidas

Potencial de royalties projetado de terapias desenvolvidas:

Terapia Taxa de royalties projetada Royalty anual estimada
Tab-cel 8-12% US $ 15-22 milhões
Ata188 10-15% US $ 20 a 30 milhões

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Value Propositions

You're looking at the core value Atara Biotherapeutics, Inc. is trying to deliver right now, which is heavily concentrated on getting their lead asset across the finish line in the US market. The entire financial structure, with cash on hand as of September 30, 2025, sitting at only $13.7 million, hinges on these propositions paying off, defintely.

Off-the-shelf, allogeneic T-cell therapy (Tab-cel) for rapid patient delivery

The primary value here is immediacy-getting the therapy to the patient from inventory, not custom-making it for each person. Atara Biotherapeutics claims to be the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.

  • Allogeneic T-cell therapies can be readily available for rapid delivery within days.
  • The platform does not require T-cell receptor or HLA gene editing.

Treatment for rare, high-unmet-need diseases like EBV+ PTLD

This is where the near-term financial trigger lies, tied to the FDA decision. The Biologics License Application (BLA) for tabelecleucel (tab-cel) for EBV+ PTLD has a Priority Review PDUFA target action date of January 10, 2026. If approved, Atara Biotherapeutics is eligible to receive a $40 million milestone payment from Pierre Fabre Laboratories. This is critical, as the company projects its Q3 2025 cash position, combined with this milestone, will provide significant runway.

Metric Data Point
FDA BLA Decision Date (Target) January 10, 2026
FDA Approval Milestone Payment $40 million
ORR (ALLELE Study) 50.7%
CR Rate (ALLELE Study) 28.0%
Prior EU Approval (EBVALLO) 2022

For patients, the value is clear: there are no FDA approved therapies in this treatment setting for patients who have received at least one prior therapy.

Potential for transformative therapies in autoimmune diseases and oncology

While the immediate focus is EBV+ PTLD, the underlying technology is positioned for broader application. The company is leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform for this purpose. Atara previously had CAR T projects like ATA3219 and ATA3431, which were discontinued in March 2025 to focus resources.

  • The platform forms the basis of a diverse portfolio targeting EBV-driven malignancies.
  • The platform has potential application for a wide range of disease-causing viral and non-viral targets.

Scalable manufacturing process capable of producing over a thousand doses per donor

The manufacturing value proposition addresses the scalability challenge inherent in cell therapy, though operational responsibility has shifted. The process is described as efficient and robust.

Manufacturing Capacity Potential Over a thousand doses from one healthy donor
Manufacturing Responsibility (as of late 2025) Transferred to Pierre Fabre Laboratories
Projected 2025 OpEx Reduction vs. 2024 At least 60%

The company's Q3 2025 net loss was $4.3 million, reflecting the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories.

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Customer Relationships

Atara Biotherapeutics, Inc. (ATRA) manages customer relationships across several distinct groups, reflecting its stage as a clinical-stage company transitioning toward commercialization for its lead asset.

Indirect relationship with end-users via commercial partner (Pierre Fabre)

The relationship with the ultimate end-users, patients receiving tab-cel (EBVALLO), is primarily mediated through the commercial partner, Pierre Fabre Laboratories. This structure dictates that Pierre Fabre handles the majority of commercialization activities upon regulatory approval. Atara remains eligible for significant financial upside from this relationship. Specifically, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. This milestone amount was adjusted from a previously expected $60 million following the January 2025 Complete Response Letter (CRL). Furthermore, Atara is entitled to double-digit tiered royalties as a percentage of net sales, plus additional milestones related to commercial sales of EBVALLO. The expanded global partnership, initiated in 2023, had an original structure allowing for potential payments up to USD 640 million plus royalties. Near-term payments from the initial agreement included approximately USD 30 million in cash upfront and initial inventory purchase at closing, alongside USD 100 million in potential regulatory milestones through BLA transfer. As of October 2025, Atara completed the transfer of regulatory activities, including BLA sponsorship, to Pierre Fabre Laboratories. Atara will continue to support Pierre Fabre Laboratories, at Pierre Fabre Laboratories expense, with certain regulatory activities related to the BLA.

Direct, high-touch engagement with regulatory agencies (FDA/EMA)

Direct engagement with the U.S. Food and Drug Administration (FDA) is critical and high-touch, focused on achieving marketing authorization for tab-cel. The BLA resubmission occurred in July 2025. The FDA granted the resubmitted BLA Priority Review status, setting a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. This followed an initial CRL issued in January 2025. The FDA lifted the clinical hold on active Investigational New Drug (IND) applications in May 2025. The FDA granted Atara a Type A meeting in the second quarter of 2025 to discuss the plan to address the issues raised in the CRL. The pivotal ALLELE study data supporting the BLA demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001). Tab-cel also holds Breakthrough Therapy Designation for rituximab-refractory EBV+ PTLD.

Collaborative support for clinical investigators and transplant centers

Support for clinical investigators and transplant centers centers on the data supporting the BLA and the ongoing, though reduced, clinical activities. The BLA data package covered more than 430 patients treated with tab-cel across multiple life-threatening diseases. The proposed indication is for adult and pediatric patients two years of age and older who have received at least one prior therapy. Following the discontinuation of the Car-T programs ATA3219 and ATA3431 in March 2025, the focus shifted. For the remaining ATA3219 program, initial clinical data for the Lupus Nephritis trial (NCT06429800) was expected in mid-2025.

Investor relations focused on milestone achievement and cost control

Investor communications heavily emphasize achieving the tab-cel milestone and rigorous cost control measures to extend the cash runway. Atara reported cash, cash equivalents and short-term investments of $13.7 million as of September 30, 2025, down from $22.3 million as of June 30, 2025. Net cash used in operating activities was $9.8 million for the third quarter of 2025. The company projects full-year 2025 operating expenses will decrease by at least 60% compared to 2024, with an earlier estimate projecting a reduction of approximately 65%. Significant workforce reductions were implemented, cutting headcount by 50% in January 2025 and another 50% in March 2025. In October 2025, a further reduction impacted approximately 29% of current employees, retaining about 15 employees. The company secured expected gross proceeds of $16 million from an offering in May 2025. The cash position as of June 30, 2025 ($22M) was projected to fund operations into the first quarter of 2026. The trailing Price-to-Earnings (P/E) Ratio as of November 26, 2025, was 6.82.

Here's a quick view of the financial context supporting these relationship strategies:

Metric Value/Amount Date/Period
Cash, Cash Equivalents, Short-Term Investments $13.7 million September 30, 2025
Net Cash Used in Operating Activities $9.8 million Q3 2025
Total Revenues $3.5 million Q3 2025
Net Loss per Share $0.32 Q3 2025
Projected Operating Expense Decrease (vs. 2024) at least 60% Full Year 2025
Contingent Milestone Payment (Pierre Fabre) $40 million Upon FDA Approval
FDA PDUFA Target Action Date January 10, 2026 Class 2 Resubmission

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Channels

You're looking at how Atara Biotherapeutics, Inc. (ATRA) gets its value propositions to its customers and stakeholders as of late 2025. It's a lean operation now, heavily reliant on its partner for commercialization, but still managing key regulatory and clinical fronts.

Pierre Fabre Laboratories' global commercial and distribution network

The primary channel for the lead asset, tabelecleucel (tab-cel or Ebvallo), is through the expanded global partnership with Pierre Fabre Laboratories. This arrangement grants Pierre Fabre the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets, building upon the existing European commercialization rights from October 2021.

Atara Biotherapeutics, Inc. completed the transfer of substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories in July 2025. The sponsorship of the Biologics License Application (BLA) remains with Atara Biotherapeutics, Inc., but Pierre Fabre Laboratories actively prepares for the potential U.S. launch.

Financial/Operational Metric Value Context/Date
Contingent Milestone Payment upon FDA BLA Approval $40 million Expected from Pierre Fabre Laboratories upon FDA approval of tab-cel BLA.
Royalty Structure Significant double-digit tiered royalties On net sales of EBVALLO from Pierre Fabre Medicament.
Upfront Cash Received (Dec 2023) Approximately USD 27 million Received upon closing of the expanded global partnership.
Total Potential Milestones (Original Agreement) Up to total of USD 640 million Under the agreement with Pierre Fabre Laboratories.

Direct regulatory submissions (BLA/MAA) to the FDA and EMA

The core channel for U.S. market access is the direct submission and ongoing management of the BLA for tabelecleucel (tab-cel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). Atara Biotherapeutics, Inc. maintains the sponsorship of this BLA.

The European Medicines Agency (EMA) approval for tab-cel was secured earlier, allowing for commercialization in the European Union, the United Kingdom, and Switzerland.

  • Phase 3 ALLELE clinical study for EBV+ PTLD restarted enrollment and treatment as of May 2025.
  • BLA resubmission accepted with Priority Review in July 2025.
  • Prescription Drug User Fee Act (PDUFA) target action date set for January 10, 2026.
  • The January 2025 Complete Response Letter (CRL) was related to third-party manufacturing facility observations, not efficacy or safety data.

Academic and clinical trial sites for pipeline asset development

This channel involves the network of academic and clinical trial sites necessary to advance the remaining pipeline assets, primarily ATA3219, despite the March 2025 discontinuation of all Car-T operations (which included ATA3219 and ATA3431). The clinical trial infrastructure remains a key operational channel.

Asset/Indication Trial Phase/Number Status/Data Expectation
ATA3219 for Relapsed/Refractory B-cell NHL Phase 1 (NCT06256484) Initial clinical data anticipated Q1 2025.
ATA3219 for Lupus Nephritis (LN) Phase 1 (NCT06429800) Initial clinical data expected mid-2025.
ATA3431 for B-cell malignancies Pre-clinical Allogeneic dual CAR T targeting CD19/CD20.

The company is working closely with its clinical trial sites to manage the restart of trials following the May 2025 lifting of the clinical hold. The clinical trial site network is essential for supporting the BLA review process.

Corporate communications for investor and public outreach

Investor and public outreach channels are critical for managing cash runway and communicating strategic shifts, especially following the workforce restructuring in October 2025. The company's financial reporting provides the hard numbers for this outreach.

  • Workforce reduction impacted approximately 29% of current employees in October 2025.
  • Retained employee count essential to executing strategic priorities is approximately 15 employees.
  • Anticipated full-year 2025 operating expenses decrease by at least 60% compared to 2024.

Here's the quick math from the Q3 2025 filing, which is the latest snapshot of the operating reality:

Financial Metric (Q3 2025) Amount (USD)
Cash, cash equivalents, and short-term investments (Sep 30, 2025) $13.7 million
Net cash used in operating activities (Q3 2025) $9.8 million
Total Revenues (Q3 2025) $3.5 million
Research and development expenses (Q3 2025) $2.9 million
General and administrative expenses (Q3 2025) $4.0 million

The Nasdaq: ATRA stock traded at $14.42 on November 12, 2025, with a volume of 25.45k shares reported that day. What this estimate hides is the reliance on the $40 million milestone to extend the cash runway beyond Q1 2026. Finance: draft 13-week cash view by Friday.

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Customer Segments

You're looking at the specific groups Atara Biotherapeutics, Inc. (ATRA) targets with its cell therapies, which is crucial for understanding their near-term revenue drivers and long-term pipeline potential.

Patients with Epstein-Barr virus positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)

This segment represents the immediate commercial opportunity for tabelecleucel (tab-cel, trademarked as EBVALLO in the EU) outside the US, as the US Biologics License Application (BLA) process is ongoing following a Complete Response Letter in January 2025.

  • Research suggests EBV causes approximately 50% of Post-Transplant Lymphoproliferative Disease (PTLD) cases.
  • The data package supporting the BLA included pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases.
  • Data from the ALLELE study showed an objective response rate (ORR) of 51.2% in relapsed/refractory EBV+ PTLD patients.
  • The estimated one-year overall survival rate (OS) for EBV+ PTLD patients in one study was 70.6%.

For the patients who respond to tab-cel in that study, the one-year OS was 85.7%, versus 0% for non-responders. That's a stark difference in outcomes.

Transplant centers and specialized hematology/oncology clinics

These institutions are the gatekeepers for prescribing and administering tab-cel, especially since the company has transitioned substantially all tab-cel activities to its partner, Pierre Fabre Medicament.

The operational focus for Atara Biotherapeutics, Inc. has shifted following a restructuring in October 2025, which reduced its workforce by approximately 29%, retaining only about 15 essential employees. This means the clinics are now primarily interacting with the commercial infrastructure of Pierre Fabre for tab-cel, while Atara focuses on its internal pipeline assets like ATA3219.

Metric/Segment Detail Latest Available Data Point Context/Relevance
US BLA Submission Status Path forward for resubmission being discussed with FDA following January 2025 CRL. Determines when US centers can prescribe.
EU Approval Status Tab-cel (EBVALLO) is approved by the EMA for use in PTLD. Defines established centers of use outside the US.
Atara Biotherapeutics Workforce (Post-Restructure) Approximately 15 essential employees retained as of October 2025. Indicates limited direct commercial/support presence for US centers.

Patients with serious autoimmune diseases (e.g., Lupus) targeted by the CAR T pipeline

This segment represents the future growth potential centered on the ATA3219 program, an allogeneic anti-CD19 CAR T-cell therapy, targeting B-cell driven autoimmune diseases.

  • ATA3219 is being investigated in Phase 1 for relapsed/refractory B-cell Non-Hodgkin's Lymphoma, with initial clinical data anticipated in Q1 2025.
  • For autoimmune indications, the Phase 1 study for subjects with lupus nephritis (LN), a form of Systemic Lupus Erythematosus (SLE), planned initiation in Q4 2024.
  • Initial clinical data for ATA3219 in lupus nephritis was expected in mid-2025.

The company is also advancing ATA3431, an allogeneic dual CAR T candidate targeting both CD19 and CD20 for B-cell malignancies, which could eventually address a broader patient population if successful.

Global pharmaceutical companies seeking licensing opportunities

This segment is currently defined by the existing, highly significant partnership with Pierre Fabre Medicament, which holds worldwide commercialization rights for tab-cel.

The financial relationship with Pierre Fabre provides a critical lifeline, as Atara Biotherapeutics, Inc. is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. The trailing twelve-month revenue as of September 30, 2025, was $152M, a figure heavily influenced by revenue recognition from this partnership, with Q1 2025 revenues hitting $98.1 million, up from $27.4 million in Q1 2024, largely due to the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025. Still, the cash position as of September 30, 2025, was tight at $13.7 million in cash, cash equivalents, and short-term investments.

Finance: draft 13-week cash view by Friday.

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Cost Structure

You're looking at a cost structure that has been aggressively streamlined, reflecting a major strategic shift focused on maximizing the value from the tab-cel program through the partnership with Pierre Fabre Laboratories. The entire cost base is being managed to stretch liquidity until the expected BLA approval milestone.

Atara Biotherapeutics, Inc. anticipates full-year 2025 operating expenses will decrease by at least 60% compared to 2024. Some reports indicated a projection of approximately 65% reduction for the full year 2025 versus 2024. This massive reduction is directly tied to the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories, alongside internal operational efficiencies implemented in the first half of the year.

The R&D and G&A lines show the most dramatic impact of this restructuring. Here's the quick math on the third quarter performance, which clearly illustrates the lean corporate structure Atara is operating under:

Expense Category Q3 2025 Amount Q3 2024 Amount
Research and Development (R&D) Expenses $2.9 million $43.9 million
General and Administrative (G&A) Expenses $4.0 million $10.4 million

The R&D spend for the third quarter 2025 was reported at $2.9 million. This minimal spend reflects the transfer of development activities. To be fair, the G&A costs for the third quarter 2025 settled at $4.0 million, supporting the narrative of a lean corporate structure focused on essential functions.

The costs associated with supporting the Tab-cel BLA transfer to Pierre Fabre are now largely shifted, but Atara Biotherapeutics, Inc. did incur initial costs that are now being offset or managed differently. Key elements of this cost structure shift include:

  • Pierre Fabre Laboratories agreed to reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer.
  • Substantially all tab-cel manufacturing, clinical, and regulatory activities were planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.
  • The company completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories in July 2025.
  • Pierre Fabre also assumed the costs related to remediation of the third-party manufacturing facility to support the BLA resubmission.

The company is now primarily focused on activities required to achieve potential BLA approval, which is contingent on the FDA PDUFA target action date of January 10, 2026. The cost structure is designed to preserve liquidity until this event, which unlocks a $40 million milestone payment from Pierre Fabre Laboratories. Finance: draft 13-week cash view by Friday.

Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Revenue Streams

You're looking at how Atara Biotherapeutics, Inc. brings in cash right now, and it's heavily tied to their partner, Pierre Fabre Medicament. The most significant near-term potential revenue is contingent on regulatory success for their lead asset, EBVALLO (tab-cel). Specifically, Atara Biotherapeutics, Inc. is eligible to receive a $40 million milestone payment immediately upon the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for tab-cel.

Beyond that approval trigger, the long-term revenue engine from this partnership is the royalties. Atara Biotherapeutics, Inc. is set to receive tiered double-digit royalties as a percentage of net sales of EBVALLO generated by Pierre Fabre Medicament in their commercial territories.

The revenue recognition pattern has shifted dramatically in 2025 due to the transfer of obligations. This is where you see large, non-recurring amounts hit the top line as performance obligations are satisfied. Here's a quick look at the reported revenue figures from the 2025 fiscal year so far, reflecting these transfers:

Revenue Component/Period Reported Amount
Total Revenues (Q1 2025) $98.1 million
Commercialization Revenue (Q3 2025) $3.45 million
Contingent FDA Approval Milestone (Potential) $40 million

That large Q1 2025 revenue figure of $98.1 million came primarily from revenue recognized as a result of completing certain performance obligations under the Pierre Fabre agreement when manufacturing responsibilities transferred on March 31, 2025. This was a one-time event tied to the asset transfer, so you shouldn't expect that magnitude of revenue from operations again unless another major transfer occurs.

For the third quarter of 2025, the revenue picture reflects the tail end of these transitions. Atara Biotherapeutics, Inc. posted total revenues of $3.45 million for Q3 2025. This is characterized as residual collaboration revenue, stemming from partner support activities, as substantially all operational activities and associated costs related to tab-cel have moved to Pierre Fabre Laboratories.

The current revenue streams can be summarized by their nature:

  • Contingent milestone payments, including the potential $40 million upon FDA approval of EBVALLO.
  • Long-term, variable income from double-digit tiered royalties on net sales.
  • Completed performance obligation revenue recognized in Q1 2025, totaling $98.1 million.
  • Residual collaboration revenue from ongoing partner support, which was $3.45 million in Q3 2025.

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