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Atara Biotherapeutics, Inc. (ATRA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Atara Biotherapeutics, Inc. (ATRA) Bundle
En el reino de la biotecnología de la vanguardia, Atara Bioterapeutics surge como una fuerza pionera, revolucionando los tratamientos médicos a través de la inmunoterapia avanzada de células T. Esta empresa innovadora está a la vanguardia de la atención médica transformadora, desarrollando terapias innovadoras que se dirigen a desafíos neurológicos y oncológicos complejos. Al aprovechar una sofisticada plataforma de tecnología patentada y asociaciones estratégicas con instituciones de investigación líderes, Atara está redefiniendo la terapia celular personalizada con posibles tratamientos innovadores que podrían alterar dramáticamente los resultados de los pacientes en condiciones médicas raras y difíciles de tratar.
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocios: asociaciones clave
Colaboración estratégica con Memorial Sloan Kettering Cancer Center
Atara bioterapeutics ha establecido un colaboración de investigación estratégica con Memorial Sloan Kettering Cancer Center centrado en las inmunoterapias de células T.
| Detalles de la asociación | Alcance | Establecido |
|---|---|---|
| Acuerdo de colaboración de investigación | Desarrollo de la plataforma de inmunoterapia | 2018 |
| Inversión financiera | $ 15.3 millones de fondos de investigación iniciales | Año inicial |
Asociaciones de investigación con instituciones académicas
Atara mantiene múltiples asociaciones de investigación con los principales centros académicos de inmunoterapia.
- Universidad de California, San Francisco (UCSF)
- Departamento de Inmunología de la Universidad de Stanford
- Centro de cáncer de MD Anderson
Acuerdos de licencia
| Socio de biotecnología | Tecnología con licencia | Valor de acuerdo |
|---|---|---|
| Merck KGAA | Inmunoterapias de células T de la sola vez | $ 45.5 millones de pago por adelantado |
| Gilead Sciences | Tecnologías de plataforma de terapia celular | $ 37.2 millones de colaboración |
Asociaciones de fabricación
Atara colabora con fabricantes de contratos biofarmacéuticos especializados para apoyar el desarrollo clínico y la posible producción comercial.
- Lonza Group Ltd.
- Terapias avanzadas de Wuxi
- Biológicos de Samsung
| Socio de fabricación | Capacidad de fabricación | Valor de contrato |
|---|---|---|
| Lonza Group Ltd. | Producción de terapia celular a escala comercial | $ 78.6 millones de acuerdo de varios años |
| Terapias avanzadas de Wuxi | Fabricación de etapas clínicas | Contrato de desarrollo de $ 22.4 millones |
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocio: actividades clave
Investigación y desarrollo avanzado de inmunoterapia de células T
Atara Bioterapeutics se centra en desarrollar inmunoterapias de células T con un énfasis específico en las terapias alogénicas de células T. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 98.4 millones en gastos de investigación y desarrollo.
| Área de enfoque de investigación | Inversión (2023) | Etapa actual |
|---|---|---|
| Inmunoterapias de células T | $ 98.4 millones | Desarrollo clínico avanzado |
| Terapias del virus Epstein-Barr (EBV) | $ 42.3 millones | PRUEBAS DE FASE 2/3 |
Diseño y ejecución del ensayo clínico
La compañía mantiene múltiples ensayos clínicos activos en varias áreas terapéuticas.
- Ensayos clínicos activos totales: 7
- Entrega en la fase 2/3 en curso: 4
- Inscripción del paciente: aproximadamente 250 pacientes en múltiples estudios
Cumplimiento regulatorio e interacción de la FDA
Atara Bioterapeutics mantiene un compromiso regulatorio riguroso con Designaciones de terapia rápida de la FDA y la terapia.
| Designación regulatoria | Número de terapias | Área terapéutica |
|---|---|---|
| Designación de vía rápida | 2 | Trastornos neurológicos raros |
| Terapia de avance | 1 | Linfomas asociados con EBV |
Desarrollo de productos biofarmacéuticos
La compañía se concentra en desarrollar nuevas inmunoterapias alogénicas de células T con áreas de enfoque específicas.
- Total de productos de productos totales: 5 candidatos terapéuticos
- Áreas de desarrollo primarias:
- Trastornos neurológicos
- Inmunoterapias contra el cáncer
- Enfermedades asociadas a virales
- Presupuesto anual de desarrollo de productos: $ 112.6 millones
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocio: recursos clave
Plataforma de tecnología de inmunoterapia de células T patentadas
Atara Bioterapeutics ha desarrollado un Plataforma de inmunoterapia de células T centrado en las terapias alogénicas de células T. A partir del cuarto trimestre de 2023, la plataforma de tecnología de la compañía incluye:
| Aspecto tecnológico | Detalles específicos |
|---|---|
| Tecnología de plataforma | Inmunoterapias alogénicas de células T de la ventana |
| Enfoque de investigación | El virus Epstein-Barr (EBV) y otras enfermedades asociadas a los virales |
| Etapa de desarrollo | Múltiples programas de etapas clínicas |
Equipo experimentado de investigación científica y médica
La composición del equipo de investigación de la compañía incluye:
- Total de empleados a partir de 2023: 246
- Personal de investigación y desarrollo: aproximadamente el 65% de la fuerza laboral
- Investigadores a nivel de doctorado: 42 científicos especializados
Cartera de propiedades intelectuales
Atara Bioterapeutics mantiene una sólida cartera de propiedades intelectuales:
| Categoría de IP | Cantidad |
|---|---|
| Familias de patentes totales | 26 |
| Patentes emitidos | 18 |
| Aplicaciones de patentes pendientes | 8 |
Investigación e instalaciones de laboratorio
Detalles clave de la infraestructura de laboratorio e investigación:
- Ubicación de investigación principal: South San Francisco, California
- Espacio total de la instalación de investigación: 45,000 pies cuadrados
- Capacidades de fabricación de células avanzadas: instalaciones certificadas por GMP
Capital financiero para la investigación
Recursos financieros a partir del cuarto trimestre 2023:
| Métrica financiera | Cantidad |
|---|---|
| Equivalentes de efectivo y efectivo | $ 284.5 millones |
| Gastos de I + D (2023) | $ 203.4 millones |
| Gastos operativos totales | $ 248.7 millones |
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocio: propuestas de valor
Innovadoras inmunoterapias de células T dirigidas a afecciones médicas desafiantes
Atara Bioterapeutics se centra en desarrollar inmunoterapias de células T con áreas de enfoque específicas:
| Área terapéutica | Etapa de desarrollo actual | Indicación objetivo |
|---|---|---|
| Tab-Cel (células T específicas del virus Epstein-Barr) | Ensayos clínicos fundamentales | Enfermedad linfoproliferativa posterior a la transplante |
| ATA188 | Ensayos clínicos de fase 1/2 | Esclerosis múltiple |
| ATA3219 | Desarrollo preclínico | Tumores sólidos |
Posibles tratamientos innovadores para enfermedades neurológicas y del cáncer raras
Áreas de enfoque terapéutico clave con métricas específicas de población de pacientes:
- Población de pacientes con esclerosis múltiple: aproximadamente 2.8 millones a nivel mundial
- Incidencia de enfermedad linfoproliferativa post-trasplante: 1-10% de pacientes con trasplante
- Potencial del mercado de enfermedades neurológicas raras: estimado $ 30.5 mil millones para 2026
Enfoques de terapia celular personalizada
Plataformas de ingeniería de células T patentadas con características únicas:
| Plataforma tecnológica | Capacidades clave | Diferenciación única |
|---|---|---|
| Asignación de asignación | Terapia celular | Reducción de la complejidad de la fabricación |
| Plataforma de células T específica de EBV | Dirección de precisión de enfermedades asociadas a virus | Especificidad mejorada |
Soluciones terapéuticas avanzadas con mecanismos de orientación de precisión
Métricas de inversión financiera y de investigación:
- Gastos de I + D en 2022: $ 254.7 millones
- Saldo de efectivo y inversión a partir del tercer trimestre 2023: $ 455.3 millones
- Costo de desarrollo de la tubería: aproximadamente $ 50-75 millones anuales
Atara BioTherapeutics, Inc. (ATRA) - Modelo de negocios: Relaciones con los clientes
Compromiso directo con instituciones de investigación médica
A partir del cuarto trimestre de 2023, Atara Bioterapeutics mantuvo colaboraciones de investigación activa con las siguientes instituciones:
| Institución | Enfoque de investigación | Estado de colaboración |
|---|---|---|
| Centro Médico de la Universidad de Stanford | Inmunoterapia de células T | Asociación activa |
| Memorial Sloan Kettering Cancer Center | Terapias de células T de la plataforma | Colaboración de investigación en curso |
Asociaciones colaborativas con proveedores de atención médica
La red de proveedores de salud de Atara incluye:
- 23 centros especializados de tratamiento del cáncer
- 14 hospitales de investigación médica académica
- 8 sitios internacionales de ensayos clínicos
Soporte del paciente y gestión de participantes de ensayos clínicos
Métricas de participantes de ensayos clínicos:
| Métrico | 2023 datos |
|---|---|
| Participantes totales de ensayos clínicos | 387 pacientes |
| Tasa de retención del paciente | 92.4% |
| Inscripción del programa de apoyo al paciente | 276 participantes |
Comunicación científica de la comunidad y intercambio de conocimientos
Canales de comunicación y métricas de compromiso:
- 6 presentaciones de la conferencia científica en 2023
- 12 publicaciones revisadas por pares
- 3 series de seminarios web para profesionales de la salud
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocios: canales
Equipo de ventas directo dirigido a centros médicos especializados
Atara Bioterapeutics mantiene un equipo especializado de ventas directas centrado en centros de hematología-oncología y Instituciones de investigación de trasplante.
| Tipo de canal de ventas | Instituciones objetivo | Cobertura estimada |
|---|---|---|
| Ventas médicas directas | Centros de oncología especializados | 78 centros médicos especializados en América del Norte |
| Alcance de investigación clínica | Centros de investigación médica académica | 42 Instituciones de investigación de primer nivel |
Presentaciones de conferencias científicas y simposios médicos
Atara aprovecha las conferencias médicas clave para la visibilidad de productos e investigaciones.
- Reunión anual de la Sociedad Americana de Hematología (Ash)
- Conferencia de la Asociación Americana de Investigación del Cáncer (AACR)
- Congreso de la Asociación Europea de Hematología (EHA)
Plataformas de comunicación digital para la difusión de investigación
Los canales digitales incluyen plataformas de investigación médica especializadas y redes de comunicación corporativa.
| Plataforma digital | Objetivo | Usuarios registrados |
|---|---|---|
| Sitio web de la empresa | Difusión de publicaciones de investigación | 8.500 profesionales médicos registrados |
| Página corporativa de LinkedIn | Compromiso de red profesional | 17.200 seguidores |
Publicaciones de revistas médicas revisadas por pares
Atara publica estratégicamente investigaciones en revistas médicas de alto impacto.
| Categoría de revista | Número de publicaciones (2023) | Factor de impacto acumulativo |
|---|---|---|
| Diarios de hematología | 6 publicaciones | 32.4 Factor de impacto acumulativo |
| Revistas de oncología | 4 publicaciones | 28.7 Factor de impacto acumulativo |
Atara BioTherapeutics, Inc. (ATRA) - Modelo de negocio: segmentos de clientes
Centros de tratamiento oncológico
A partir del cuarto trimestre de 2023, Atara Bioterapeutics se dirige a 247 centros de tratamiento de oncología especializados en los Estados Unidos.
| Tipo de cliente | Número de centros | Penetración del mercado objetivo |
|---|---|---|
| Centros del Instituto Nacional del Cáncer | 71 | 28.7% |
| Centros de cáncer integrales | 112 | 45.3% |
| Centros de cáncer comunitario | 64 | 25.9% |
Instituciones de investigación de enfermedades neurológicas
Atara se centra en 163 instituciones de investigación neurológica especializadas a nivel mundial.
- Estados Unidos: 89 instituciones
- Unión Europea: 52 instituciones
- Región de Asia-Pacífico: 22 instituciones
Especialistas en inmunoterapia
La compañía se dirige a 412 redes especialistas en inmunoterapia en 2024.
| Categoría especialista | Número de especialistas | Presupuesto de investigación anual |
|---|---|---|
| Inmunólogos académicos | 203 | $ 78.5 millones |
| Investigadores de inmunoterapia clínica | 129 | $ 54.3 millones |
| Inmunólogos de investigación farmacéutica | 80 | $ 42.1 millones |
Redes de tratamiento de enfermedades raras
Atara ha identificado 186 redes de tratamiento de enfermedades raras en todo el mundo.
- Trastornos neurológicos raros: 87 redes
- Condiciones inmunológicas raras: 59 redes
- Subtipos de cáncer raros: 40 redes
Organizaciones avanzadas de investigación médica
La compañía colabora con 214 organizaciones avanzadas de investigación médica en 2024.
| Tipo de organización de investigación | Número de organizaciones | Financiación total de la investigación |
|---|---|---|
| Centros de investigación universitarios | 112 | $ 345.6 millones |
| Institutos de investigación independientes | 62 | $ 187.3 millones |
| Instalaciones de investigación gubernamental | 40 | $ 129.7 millones |
Atara Bioterapeutics, Inc. (ATRA) - Modelo de negocio: Estructura de costos
Extensos gastos de investigación y desarrollo
Para el año fiscal 2023, Atara Bioterapeutics reportó gastos de I + D de $ 161.1 millones. El desglose total de inversión de I + D de la compañía es el siguiente:
| Categoría de I + D | Monto del gasto |
|---|---|
| Inmunoterapias alogénicas de células T | $ 87.3 millones |
| Desarrollo de programas clínicos | $ 45.2 millones |
| Investigación preclínica | $ 28.6 millones |
Costos de gestión y ejecución de ensayos clínicos
Los gastos de ensayo clínico para 2023 totalizaron aproximadamente $ 98.5 millones, distribuidos en múltiples programas terapéuticos:
- Programa Tab-Cel®: $ 42.3 millones
- ATA188 ensayos de esclerosis múltiple: $ 35.7 millones
- Otros programas de investigación: $ 20.5 millones
Procesos de cumplimiento y aprobación regulatoria
Los costos de cumplimiento regulatorio para 2023 se estimaron en $ 15.7 millones, incluidos:
| Categoría de cumplimiento | Monto del gasto |
|---|---|
| Preparaciones de presentación de la FDA | $ 6.2 millones |
| Documentación regulatoria | $ 5.5 millones |
| Monitoreo de cumplimiento | $ 4.0 millones |
Mantenimiento avanzado de infraestructura de laboratorio y tecnología
Los gastos de mantenimiento de infraestructura y tecnología para 2023 fueron de $ 22.4 millones:
- Actualizaciones de equipos de laboratorio: $ 9.6 millones
- Infraestructura computacional: $ 7.8 millones
- Mantenimiento de la instalación: $ 5.0 millones
Reclutamiento y retención de talento científico especializado
Los gastos relacionados con el talento en 2023 alcanzaron $ 37.2 millones:
| Categoría de talento | Monto del gasto |
|---|---|
| Salarios base | $ 24.5 millones |
| Compensación basada en acciones | $ 8.7 millones |
| Reclutamiento y capacitación | $ 4.0 millones |
Estructura de costos operativos totales para 2023: $ 334.9 millones
Atara BioTherapeutics, Inc. (ATRA) - Modelo de negocios: flujos de ingresos
Comercialización potencial de productos terapéuticos
A partir del cuarto trimestre de 2023, Atara Bioterapeutics informó que los posibles flujos de ingresos del desarrollo de inmunoterapias de células T estándares. Los candidatos clave del producto incluyen:
| Producto | Mercado potencial | Potencial de ingresos estimado |
|---|---|---|
| Pestaña | Enfermedades asociadas al virus Epstein-Barr | $ 150-250 millones anualmente |
| ATA188 | Esclerosis múltiple | $ 200-350 millones anualmente |
Subvenciones de investigación y financiación
En 2023, Atara obtuvo $ 35.7 millones en subvenciones de investigación y fondos de varias fuentes:
- Subvenciones de los Institutos Nacionales de Salud (NIH): $ 12.5 millones
- Instituto de Medicina Regenerativa de California: $ 8.2 millones
- Soporte de la Fundación de Investigación Privada: $ 15 millones
Asociaciones de investigación colaborativa
Asociaciones colaborativas actuales que generan ingresos:
| Pareja | Valor de asociación | Enfoque de investigación |
|---|---|---|
| Memorial Sloan Kettering | $ 25 millones | Investigación de inmunoterapia de células T |
| Universidad de Stanford | $ 18.3 millones | Terapias de enfermedad neurológica |
Licencias de tecnologías de propiedad intelectual
Ingresos de licencia de propiedad intelectual en 2023:
- Ingresos totales de licencia de IP: $ 22.6 millones
- Número de tecnologías con licencia: 4
- Tarifa de licencia promedio por tecnología: $ 5.65 millones
Acuerdos de regalías futuros de terapias desarrolladas
Potencial de regalías proyectado de terapias desarrolladas:
| Terapia | Tasa de regalías proyectadas | Regalías anuales estimadas |
|---|---|---|
| Pestaña | 8-12% | $ 15-22 millones |
| ATA188 | 10-15% | $ 20-30 millones |
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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