Autolus Therapeutics plc (AUTL): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la terapéutica del cáncer, Autolus Therapeutics PLC (AUTL) emerge como un innovador innovador, ejerciendo el poder de la ingeniería de células T de CAR avanzada para revolucionar el tratamiento personalizado del cáncer. Al aprovechar las tecnologías de inmunoterapia de vanguardia y un modelo de negocio robusto, este pionero de biotecnología está listo para transformar cómo abordamos los desafíos desafiantes de los desafíos oncológicos, ofreciendo esperanza a los pacientes con cánceres difíciles de tratar a través de su enfoque terapéutico sofisticado y dirigido. Sumérgete en el intrincado lienzo de modelo de negocio que sustenta la visión estratégica y la destreza científica de Autolo, revelando una hoja de ruta convincente de innovación, colaboración y posibles tratamientos innovadores.

Autolo Therapeutics PLC (AUTL) - Modelo de negocios: asociaciones clave

Instituciones de investigación académica

Autolo Therapeutics colabora con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Detalles de la asociación
University College London (UCL)	Desarrollo de terapia de células T de automóvil	Colaboración de investigación en curso desde 2014
Universidad de Pensilvania	Investigación de inmunoterapia	Acuerdos de investigación de colaboración múltiples

Compañías farmacéuticas

Las asociaciones farmacéuticas estratégicas incluyen:

• Merck & CO.: Collaboración de ensayos clínicos para terapias Auto1 y Auto3
• Bristol Myers Squibb: Discusiones potenciales de comercialización para tratamientos tumorales sólidos

Organizaciones de fabricación de contratos

Socio de CMO	Capacidades de fabricación	Valor de contrato
Grupo Lonza AG	Producción de terapia celular	Contrato de fabricación anual de $ 15.2 millones
Terapias avanzadas de Wuxi	Soporte de fabricación GMP	Acuerdo de transferencia de tecnología de $ 8.7 millones

Inversores estratégicos

Socios de inversión clave:

• Versant Ventures: inversión de $ 87 millones en 2021
• Gestión de fidelidad & Investigación: $ 42.3 millones de participación de capital
• Orbimed Advisors: $ 35.6 millones de inversión estratégica

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: actividades clave

Investigación y desarrollo de terapia de células T de automóvil avanzado

A partir de 2024, Autolo Therapeutics ha invertido $ 48.3 millones en investigación y desarrollo para terapias de células T CAR. La compañía mantiene 37 programas de investigación activos dirigidos a varias indicaciones de cáncer.

Área de enfoque de investigación	Inversión ($ m)	Programas activos
Cánceres hematológicos	22.7	16
Tumores sólidos	25.6	21

Diseño y ejecución del ensayo clínico

Autolo actualmente administra 6 ensayos clínicos activos en múltiples fases, con una inscripción total de pacientes de 214 participantes.

• Pruebas de fase I: 2 pruebas
• Ensayos de fase II: 3 ensayos
• Ensayos de fase III: 1 ensayo

Plataforma de tecnología de inmunoterapia innovadora

La compañía ha desarrollado 4 plataformas de tecnología de células T de automóvil patentadas con $ 36.5 millones dedicado a la infraestructura tecnológica.

Plataforma tecnológica	Costo de desarrollo ($ M)	Características únicas
Auto1	12.3	Neoplasias malignas de células B
Auto3	9.7	Orientación tumoral sólida

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Autolus ha presentado 3 solicitudes de nuevos medicamentos de investigación (IND) a la FDA, con gastos de cumplimiento regulatorios por un total de $ 5.2 millones en 2024.

Innovación tecnológica continua en terapia celular

La compañía ha presentado 12 nuevas solicitudes de patentes en 2024, con un presupuesto de innovación de $ 14.6 millones dedicado a avanzar en tecnologías de terapia celular.

Categoría de patente	Número de aplicaciones	Inversión de innovación ($ M)
Modificaciones de las células T del coche	7	8.3
Mecanismos de orientación	5	6.3

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: recursos clave

Tecnología de ingeniería de células T de Autocar Propiety

Autolo ha desarrollado una propietaria Plataforma de células T de automóvil de próxima generación Con capacidades tecnológicas clave:

Característica tecnológica	Capacidad específica
Tecnología de cambio	Permite un control preciso de la actividad de las células T del automóvil
Programación de células T	Técnicas avanzadas de modificación genética

Talento especializado científico y de investigación

A partir de 2023, Autolus empleado:

• 84 Personal de investigación y desarrollo
• 62% con Ph.D. o títulos avanzados equivalentes
• Experiencia en inmunoterapia e ingeniería celular

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Familias de patentes	37
Patentes concedidas	24
Aplicaciones de patentes pendientes	13

Instalaciones avanzadas de laboratorio e investigación

Autolo mantiene:

• 2 Instalaciones de investigación primarias en Londres, Reino Unido
• 1 Centro de investigación en San Diego, California, EE. UU.
• Espacio total de la instalación de investigación: 25,000 pies cuadrados

Experiencia de desarrollo clínico

Métrico de desarrollo clínico	Estado actual
Ensayos clínicos activos	6
Fases de ensayos clínicos	Fase 1/2 y fase 2
Áreas terapéuticas	Tumores hematológicos y sólidos

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: propuestas de valor

Inmunoterapias de cáncer personalizadas de vanguardia

Autolo Therapeutics se centra en el desarrollo de terapias celulares personalizadas dirigidas a tipos de cáncer específicos:

Tipo de terapia	Cáncer objetivo	Etapa de desarrollo
Auto1	Leucemia linfoblástica aguda de células B	Ensayo clínico de fase 2
Auto3	Mieloma múltiple	Ensayo clínico de fase 1
Auto5	Tumores sólidos	Desarrollo preclínico

Potencial para tratamientos contra el cáncer más específicos y efectivos

Métricas clínicas clave para las terapias automovilísticas:

• Tasas de respuesta de hasta 70% en los ensayos clínicos en etapa temprana
• Mediana de supervivencia libre de progresión de 6.1 meses en estudios iniciales
• Reducción de la toxicidad sistémica en comparación con la quimioterapia tradicional

Plataforma innovadora de ingeniería de células T

Tecnología de plataforma	Características clave	Ventaja competitiva
Ingeniería de células CAR-T	Técnicas de modificación de genes propietarios	Persistencia y precisión de células T mejoradas
Tecnología CAR-T conmutable	Mecanismo de activación controlable	Seguridad mejorada profile

Abordar las necesidades médicas no satisfechas en oncología

Investigación y inversión de desarrollo:

• Gastos de I + D en 2023: $ 98.4 millones
• Portafolio de patentes: 126 patentes otorgadas
• Programas de tuberías: 5 terapias activas en etapa clínica

Potencial para mejorar los resultados del paciente

Métrica de terapia	Tratamiento tradicional	Terapia Autolo
Tasa de respuesta completa	40-50%	60-75%
Eventos adversos relacionados con el tratamiento	Alto	Reducido
Calidad de vida del paciente	Moderado	Mejorado significativamente

Autolo Therapeutics PLC (AUTL) - Modelo de negocios: relaciones con los clientes

Compromiso directo con proveedores de atención médica

Autolo Therapeutics mantiene la participación directa a través de interacciones específicas con especialistas en oncología y hematólogos.

Tipo de compromiso	Número de interacciones	Frecuencia
Especialistas en oncología contactados	247	Trimestral
Reuniones de la Junta Asesora Clínica	4	Anualmente
Consultas científicas individuales	36	Anualmente

Colaboración científica y comunicación

Autolo establece asociaciones científicas con instituciones de investigación y organizaciones farmacéuticas.

• Colaboraciones de investigación activa: 7
• Asociaciones académicas: 5
• Acuerdos de investigación conjunta: 3

Apoyo al paciente y participación en el ensayo clínico

Métrico de ensayo clínico	Datos actuales
Ensayos clínicos activos	6
Inscripción del paciente	312 pacientes
Participantes del programa de apoyo al paciente	189

Informes de investigación y desarrollo transparentes

Canales de informes Incluya publicaciones revisadas por pares, presentaciones de inversores y presentaciones regulatorias.

• Publicaciones de investigación anuales: 12
• Presentaciones de inversores: 4
• Presentaciones regulatorias: 6

Conferencia médica e interacciones científicas del simposio

Tipo de conferencia	Número de presentaciones	Asistentes comprometidos
Conferencias internacionales de oncología	8	1,245
Simposios de hematología	5	876
Talleres de inmunoterapia	3	412

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: canales

Ventas directas a centros especializados de tratamiento del cáncer

A partir de 2024, Autolo Therapeutics mantiene relaciones de ventas directas con 37 centros de tratamiento de oncología especializados en los mercados de los Estados Unidos y Europa.

Región	Número de centros de tratamiento	Cobertura de ventas
Estados Unidos	22	62% del mercado objetivo
Europa	15	48% del mercado objetivo

Asociaciones con distribuidores farmacéuticos

Autolo ha establecido asociaciones de distribución estratégica con 5 redes principales de distribución farmacéutica.

• McKesson Corporation
• AmerisourceBergen
• Salud cardinal
• Industrias Medline
• Henry Schein

Publicaciones científicas e investigación revisada por pares

En 2023, Autolo publicó 12 artículos de investigación revisados ​​por pares en revistas de oncología de alto impacto.

Tipo de diario	Número de publicaciones	Citaciones acumulativas
Revistas de oncología de alto impacto	12	247

Conferencias médicas y eventos de la industria

Autolo participó en 18 conferencias médicas internacionales en 2023, presentando datos de investigación y ensayos clínicos.

Tipo de conferencia	Número de eventos	Asistentes totales
Conferencias internacionales de oncología	18	6,500

Plataformas de comunicación digital

Autolo aprovecha múltiples plataformas digitales para la comunicación científica e inversor.

• LinkedIn: 12,500 seguidores
• Twitter: 8.700 seguidores
• Sitio web corporativo: 45,000 visitantes únicos mensuales
• Plataformas de investigación científica: 5 activo profile páginas

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: segmentos de clientes

Centros de tratamiento oncológico

A partir de 2024, Autolus Therapeutics se dirige a aproximadamente 1,500 centros de tratamiento de oncología especializados a nivel mundial.

Región	Número de centros de tratamiento	Penetración potencial del mercado
Estados Unidos	750	48%
Europa	450	30%
Asia-Pacífico	300	22%

Especialistas en hematología

Autolo Therapeutics se centra en aproximadamente 8.500 especialistas en hematología en todo el mundo.

• Estados Unidos: 3.200 especialistas
• Europa: 2.900 especialistas
• Asia-Pacífico: 2,400 especialistas

Instituciones de investigación sobre el cáncer

La compañía apunta a 650 instituciones de investigación del cáncer líderes a nivel mundial.

Tipo institucional	Número de instituciones	Enfoque de investigación
Centros de investigación académicos	350	Inmunoterapia avanzada
Fundamentos de investigación privada	200	Terapia de células T carro
Instalaciones de investigación gubernamental	100	Innovación oncológica

Pacientes con cánceres difíciles de tratar

Autolo Therapeutics aborda a aproximadamente 250,000 pacientes con afecciones complejas de cáncer anualmente.

• Linfoma de células B recurrentes/refractarias: 85,000 pacientes
• Leucemia linfoblástica aguda: 65,000 pacientes
• Mieloma múltiple: 100,000 pacientes

Compañías farmacéuticas y de biotecnología

La compañía se involucra con 120 socios farmacéuticos y de biotecnología a nivel mundial.

Tipo de empresa	Número de socios	Enfoque de colaboración
Grandes compañías farmacéuticas	45	Desarrollo de terapia avanzada
Empresas de biotecnología de tamaño mediano	55	Colaboración de investigación
Empresas de biotecnología emergentes	20	Licencias de tecnología

Autolo Therapeutics PLC (AUTL) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2022, Autolo Therapeutics reportó gastos de I + D de $ 86.4 millones. La investigación de la compañía se centra en desarrollar terapias avanzadas de células T para el tratamiento del cáncer.

Año	Gastos de I + D ($ M)	Porcentaje de costos operativos totales
2022	86.4	67.3%
2021	74.2	62.5%

Financiación del ensayo clínico

Los gastos de ensayo clínico para Autolo Therapeutics en 2022 totalizaron aproximadamente $ 45.2 millones, cubriendo múltiples programas de tuberías.

• Pruebas de Auto1: $ 18.7 millones
• Pruebas de Auto3: $ 15.5 millones
• Pruebas de Auto6: $ 11 millones

Mantenimiento de la propiedad intelectual

Los costos anuales de protección de la propiedad intelectual fueron de $ 3.6 millones en 2022, que cubren la presentación de patentes, el mantenimiento y los honorarios legales.

Reclutamiento de talento científico especializado

Los costos de personal para el talento científico especializado alcanzaron los $ 42.3 millones en 2022, lo que representa el 33% de los gastos operativos totales.

Categoría de empleado	Salario anual promedio	Número de empleados
Investigar científicos	$185,000	87
Investigadores clínicos	$165,000	62

Infraestructura de tecnología avanzada

Las inversiones en tecnología e infraestructura totalizaron $ 12.7 millones en 2022, apoyando plataformas de investigación avanzadas y sistemas computacionales.

• Equipo de laboratorio: $ 6.2 millones
• Sistemas computacionales: $ 3.5 millones
• Licencias de software: $ 3 millones

Autolo Therapeutics PLC (AUTL) - Modelo de negocios: flujos de ingresos

Comercialización potencial de productos futuros

A partir de 2024, Autolo Therapeutics tiene posibles flujos de ingresos de sus avanzadas terapias de células T en el desarrollo clínico:

Candidato al producto	Área terapéutica	Etapa de desarrollo actual	Valor de mercado potencial
Auto1	Leucemia linfoblástica aguda de células B	Ensayos clínicos de fase 2	$ 350-500 millones de ingresos anuales potenciales
Auto3	Tumores sólidos	Ensayos clínicos de fase 1/2	$ 250-400 millones de ingresos anuales potenciales

Acuerdos de investigación colaborativos

Los acuerdos de investigación colaborativos actuales incluyen:

• Valor de colaboración del Centro de Cáncer Memorial Sloan Kettering: $ 5.2 millones
• University College London Partnership: $ 3.7 millones en apoyo de investigación
• Financiación total de investigación colaborativa en 2023: $ 8.9 millones

Licencias de tecnologías propietarias

Autolo Therapeutics 'Potencial de licencia de tecnología CAR-T de Autolo:

Plataforma tecnológica	Ingresos potenciales de licencia	Interés actual de las compañías farmacéuticas
Tecnología CAR-T	$ 15-25 millones por acuerdo de licencia	3 discusiones activas con compañías farmacéuticas

Pagos potenciales de hitos de las asociaciones

Estructura de pago de hito anticipada:

• Pago de hito preclínico: $ 2-5 millones
• Fase 1 Mito de ensayo clínico: $ 10-15 millones
• Fase 2 Hito del ensayo clínico: $ 25-35 millones
• Hito de aprobación regulatoria: $ 50-75 millones

Subvimiento de financiación y apoyo de investigación

Fuentes de financiación de subvención para 2024:

Fuente de financiación	Cantidad	Objetivo
Institutos Nacionales de Salud (NIH)	$ 4.3 millones	Apoyo de investigación oncológica
Investigación del cáncer Reino Unido	$ 2.6 millones	Desarrollo de tecnología CAR-T

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Autolus Therapeutics plc's (AUTL) flagship therapy, AUCATZYL®, is positioned to compete in the CD19 CAR T-cell space. The value here is built on clinical differentiation and operational advantages as of late 2025.

AUCATZYL®: A potentially best-in-class CAR T with a favorable tolerability profile.

The therapy, approved by the FDA on November 8, 2024, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL), is designed with a fast target binding off-rate to minimize excessive T-cell activation, which is key to its safety profile. By the third quarter of 2025, Autolus Therapeutics plc reported net product revenue of $21.1 million for AUCATZYL® for the three months ended September 30, 2025. Furthermore, the company achieved its target of activating 60 treatment centers in the U.S. ahead of schedule, with 90% of U.S. medical lives insured. The list price for the treatment is $525,000.

The clinical differentiation is stark when you compare the safety and efficacy data from the pivotal FELIX study in adult r/r B-ALL patients.

Metric	Adult r/r B-ALL (FELIX Study)	Pediatric r/r B-ALL (CATULUS Study Preliminary)	srSLE (CARLYSLE Study Preliminary)
Overall Response Rate (ORR)	Complete Remission: 63% (Efficacy Evaluable)	95%	Definition of Remission in SLE (DORIS): 83% (n=5/6)
High-Grade CRS (Grade $\ge$ 3)	3%	Low rates	No Grade $\ge$ 2 CRS
High-Grade ICANS (Grade $\ge$ 3)	7%	Low rates	No ICANS
Median Duration of Response	14.1 months	Ongoing Remission in nearly 90% of Responders	Median follow-up of 8.9 months with no evidence of new disease activity

Low levels of high-grade Cytokine Release Syndrome (CRS) and ICANS.

The data strongly supports a lower toxicity profile compared to some established therapies. In the adult r/r B-ALL FELIX study involving 100 patients, the incidence of Grade 3 CRS was only 3%, with no Grade 4 or 5 events reported. Similarly, Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Grade $\ge$ 3 events were reported in 7% of patients. For the severe refractory systemic lupus erythematosus (srSLE) indication, preliminary data showed no ICANS or high-grade CRS.

High overall response rate (ORR) in adult r/r B-ALL patients.

The efficacy in the approved indication is a major value driver. In the adult r/r B-ALL population from the FELIX study, 63% of efficacy evaluable patients achieved complete remission. Moreover, 42% of these patients achieved complete remission within three months. The median duration of that response was 14.1 months. The therapy is also showing promise in pediatric r/r B-ALL, where the ORR was 95%.

Lack of a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S.

AUCATZYL® holds a distinct operational advantage because it is the only CAR-T therapy approved in this space that does not require an FDA-mandated Risk Evaluation Mitigation Strategy (REMS) program. This lack of a REMS requirement reduces the administrative and logistical burden on treatment centers, which can help support adoption and potentially speed up patient access, especially as the company works to onboard more centers. The initial product delivery turnaround time was targeted at 16 days, with room for improvement.

You should note the Q3 2025 financials show a net loss of $79.1 million for the quarter, and cash reserves stood at $367.4 million as of September 30, 2025, which management believes is sufficient to drive the launch and commercialization efforts.

• FDA approval date for adult r/r B-ALL: November 8, 2024.
• Q3 2025 Net Product Revenue: $21.1 million.
• Q3 2025 Cash and Marketable Securities: $367.4 million.
• Median time to onset for ICANS events after the first infusion (adults): 8 days.

Finance: draft 13-week cash view by Friday.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Customer Relationships

You're looking at the relationship Autolus Therapeutics plc builds with the specialized centers that administer its cell therapies, which is critical given the complexity of CAR-T treatment.

High-touch, specialized support for authorized treatment centers.

The relationship with authorized treatment centers (ATCs) is intensive, focusing on operational readiness and execution for AUCATZYL® (obecabtagene autoleucel). Autolus Therapeutics plc is scaling this network rapidly to ensure patient access across the U.S.

Metric	Target/Actual Value	Date/Period
Initial Target Centers Authorized	30	End of January 2025
Actual Centers Authorized (Reported)	24	January 10, 2025
Actual Centers Authorized (Reported)	33	Early U.S. Launch (Q1 2025)
Year-End 2025 Target Centers	60	End of 2025
Actual Centers Fully Activated (Reported)	46	August 12, 2025 (Q2 2025)
Target U.S. Patient Population Coverage (Year-End 2025)	Approximately 90%	End of 2025

The company aimed to have the first 30 centers authorized, covering about 60% of the target patient population, by the close of January 2025. By the second quarter of 2025, they reported 46 centers were fully activated. This network expansion supports the vein-to-vein product delivery cycle, which is central to their commercialization strategy. The absence of a REMS program (Risk Evaluation and Mitigation Strategy) for AUCATZYL® simplifies the relationship requirements compared to some other CAR-T therapies.

Dedicated patient access and reimbursement support services.

Securing payer coverage is a key relationship focus outside the treatment center walls. Autolus Therapeutics plc is actively managing market access across different geographies.

• Coverage secured for greater than 90% of total U.S. medical lives as of August 12, 2025.
• In the UK, conditional marketing authorization was granted in April 2025, with a meeting planned with NICE in May 2025 to work towards patient access.
• Pricing and reimbursement evaluation is ongoing on a country-by-country basis in the EU following conditional European Commission approval.

The first FDA-approved CAR T therapy without a REMS obligation is a significant point of validation when engaging with payers and health systems.

Direct medical science liaison engagement with treating physicians.

Medical Science Liaisons (MSLs) serve as strategic scientific partners, establishing, developing, and maintaining long-term professional partnerships with healthcare professionals and opinion leaders. Their role is to scientifically engage and align with external stakeholders to address patient needs and improve medical practice. This engagement involves communicating evidence, identifying medical intelligence, and contributing to launch strategies. For specialty therapeutics like Autolus Therapeutics plc's product, the focus shifts from sheer interaction volume to qualitative metrics demonstrating value delivery.

Long-term follow-up and data collection from treated patients.

The durability of response is a core part of the value proposition, requiring ongoing data collection from treated patients, primarily through clinical trial follow-up. Autolus Therapeutics plc presented updated long-term data from the FELIX study at the 2025 European Hematology Association (EHA) Congress. This commitment to long-term data collection helps define the therapy as a potentially definitive treatment option.

Key durability metrics reported as of mid-2025 updates include:

• Estimated 3-year overall survival rate: 55.4%.
• Molecular remission rate at 36 months: 40%.
• Updated median duration of response (mDOR): 42.5 months.
• At a median follow-up of 32.8 months, 38.4% of responders were in ongoing remission without subsequent therapy.
• The 24-month probability of Event Free Survival was 43%.

Also, data with longer-term follow-up from the CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) patients is on track for presentation in the second half of 2025.

Finance: review Q3 cash burn against projected center activation milestones by next week.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Channels

The Channels block for Autolus Therapeutics plc centers on the specialized, direct delivery of its cryopreserved cell therapy product, AUCATZYL (obecabtagene autoleucel, or obe-cel), to the point of care.

Direct distribution of cryopreserved product to Authorized Treatment Centers (ATCs).

The entire commercial strategy hinges on a direct-to-center model, which is typical for autologous CAR T-cell therapies. This involves managing the complex logistics of vein-to-vein time-from apheresis (collecting the patient's cells) to manufacturing at the Nucleus facility in Stevenage, UK, and finally, infusion back into the patient at the authorized center. The manufacturing success rate is reported as well above 90%, which is critical for maintaining the supply chain integrity for this direct distribution channel.

The company is focused on building out its U.S. commercial infrastructure to support this direct delivery.

U.S. commercial network covering over 60 authorized centers by year-end 2025.

Autolus Therapeutics plc set an aggressive target for U.S. center activation to ensure broad patient access for AUCATZYL in relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The goal was to complete authorization of 60 treatment centers by the end of 2025, which is projected to cover approximately 90% of the target patient population. Within the centers that are active, the estimated market share for AUCATZYL is around 20% as of late 2025.

Here is a look at the progression of U.S. center activation throughout 2025:

Milestone Date	Authorized Centers (Cumulative)	Approximate U.S. Patient Population Coverage
End of January 2025	30	60%
May 7, 2025	39	Not specified
August 12, 2025	46	Greater than 90% of U.S. covered lives (as of this date)
End of 2025 (Target)	60	Approximately 90%

The company achieved patient access for greater than 90% of U.S. covered lives as of August 12, 2025.

The channel strategy also includes key operational metrics supporting the rollout:

• Manufacturing success rate is well above 90%.
• The company aims to fill geographic gaps across the US to minimize patient travel distances.
• The initial U.S. launch followed the FDA approval on November 8, 2024.

Regulatory pathways in the U.K. and E.U. for market expansion.

Market expansion beyond the U.S. is channeled through securing regulatory approvals and subsequent reimbursement agreements in other key markets. The European Medicines Agency (EMA) accepted the marketing authorization submission in April 2024.

Key regulatory milestones achieved in 2025 for the EU and UK include:

• UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization on April 25, 2025.
• European Commission (EC) granted conditional marketing authorization on July 17, 2025.

For the UK, the next step in the channel strategy involves working with the National Institute for Health and Care Excellence (NICE) to secure patient access, although NICE issued a preliminary recommendation against funding following an initial review.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Customer Segments

You're looking at the specific groups Autolus Therapeutics plc serves with its programmed T cell therapies, primarily AUCATZYL (obecabtagene autoleucel, or obe-cel), as of late 2025. This isn't just about the patient; it's about the entire ecosystem required to deliver these complex treatments.

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)

This segment is the initial commercial focus for Autolus Therapeutics plc following the U.S. Food and Drug Administration (FDA) approval of AUCATZYL on November 8, 2024. These are patients with a serious, life-threatening condition where prior treatments have failed. The NCCN Guidelines in Oncology added AUCATZYL for this indication in December 2024, which helps define the target patient group for prescribing physicians. The clinical foundation for this segment came from the FELIX study, which evaluated AUCATZYL in 100 patients with r/r B-ALL. The therapy is designed to offer a definitive treatment option, as long-term findings from the FELIX study showed 40% of responders were in ongoing remission without subsequent stem cell therapy or other new therapies at a follow-up of ≥3 years. The company is actively working to reach this patient population across authorized centers.

Here's a look at the commercial reach for this patient segment as of late 2025:

Metric	Value/Date	Context
U.S. Authorized Treatment Centers (as of Sept 30, 2025)	60	Achieved ahead of the year-end target.
Target U.S. Patient Population Coverage (Expected by end of 2025)	90%	Based on the number of authorized centers.
U.S. Medical Lives with Coverage (as of Aug 12, 2025)	Greater than 90%	Indicates payer access progress.
Q3 2025 Net Product Revenue	$21.1 million	Revenue from AUCATZYL sales for the quarter ended September 30, 2025.
Deferred Revenue (as of Sept 30, 2025)	$7.6 million	Product shipped and received by centers but not yet dosed.

The company is also pursuing growth in this area by advancing clinical development for pediatric patients with r/r B-ALL in the CATULUS study.

Hematology/Oncology specialists and cancer centers treating r/r B-ALL

These are the specialized healthcare providers and facilities that form the delivery network for AUCATZYL. Since this is an autologous CAR T-cell therapy, it requires specific infrastructure, including apheresis capabilities, specialized logistics, and trained staff for infusion and patient monitoring. Autolus Therapeutics plc focused heavily on onboarding these centers to ensure patient access. The company had an initial target to complete authorization of 30 treatment centers by the end of January 2025, which was achieved, with 33 centers authorized as of March 19, 2025. By August 12, 2025, 46 centers were fully activated in the U.S., and this number reached 60 authorized centers by September 30, 2025. These centers are key to translating clinical trial success into commercial revenue, which was $20.9 million in net product sales for Q2 2025. Physician enthusiasm for AUCATZYL is a key driver here.

The key characteristics of this segment include:

• Specialized centers authorized to administer CAR T-cell therapy.
• Centers involved in the original FELIX study, which enrolled patients across 30 leading academic and non-academic sites in the U.S., UK, and Europe.
• Providers who recognize the potential for long-term remission in adult r/r B-ALL.
• Centers managing potential side effects like Grade 3 or higher febrile neutropenia, which occurred in 26% (26/100) of FELIX study patients.

Clinical trial patients in new indications like severe refractory systemic lupus erythematosus (srSLE)

This segment represents the future pipeline expansion for Autolus Therapeutics plc, moving beyond hematological malignancies into autoimmune diseases. The severe refractory systemic lupus erythematosus (srSLE) indication is being explored via the CARLYSLE Phase 1 dose confirmation trial using obe-cel. This trial initially dosed six patients with srSLE. Data presented in late 2025 showed encouraging preliminary efficacy in this difficult-to-treat population, where all patients had refractory lupus nephritis. Specifically, for the six patients evaluated:

• 83% (n=5/6) achieved the definition of remission in SLE (DORIS).
• 50% (n=3/6) achieved complete renal response (CRR).

These patients are critical as they provide the data needed to progress to a planned Phase 2 pivotal study in lupus nephritis (LN) by year-end 2025. The safety profile observed in these six patients included no immune effector cell-associated neurotoxicity syndrome (ICANS) or high-grade Cytokine Release Syndrome (CRS). Autolus Therapeutics plc also plans to advance obe-cel into initial clinical development in progressive multiple sclerosis (MS) by dosing the first patient in a Phase 1 dose escalation study by year-end 2025, creating another distinct clinical trial patient segment.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Cost Structure

You're looking at the expenses Autolus Therapeutics plc is incurring to bring its cell therapies, like AUCATZYL, to market as of late 2025. The cost structure here is heavily weighted toward the specialized, high-touch process of making autologous CAR T-cells.

A major component is the high fixed costs for autologous CAR T-cell manufacturing infrastructure. This isn't like making a pill; it requires specialized facilities and highly trained staff for each patient's unique product. We see evidence of this cost structure shifting in the financials, where commercial manufacturing-related employee and infrastructure costs moved from Research and Development into Cost of Sales.

For the third quarter ended September 30, 2025, the operating expenses tell a clear story about commercial build-out and pipeline maintenance. Here's a quick look at the key quarterly figures:

Expense Category	Q3 2025 Amount (Millions USD)	Primary Driver/Context
Cost of Sales	$28.6 million	Reflects manufacturing and logistics for commercial product delivered
Selling, General, and Administrative (SG&A) expenses	$36.3 million	Driven by increased headcount supporting commercialization activities
Research and development (R&D) expenses	$27.9 million	Pipeline advancement, with some manufacturing costs shifted out

The SG&A increase to $36.3 million for the three months ended September 30, 2025, up from $27.3 million in the same period in 2024, shows the investment needed to support the commercial launch of AUCATZYL. Honestly, scaling a commercial team is expensive.

The Research and Development spend, which was $27.9 million for the quarter, remains substantial as Autolus Therapeutics plc continues to advance its pipeline defintely. This R&D spend supports future growth, including pivotal studies in pediatric ALL and severe lupus nephritis.

The Cost of Sales totaled $28.6 million for the third quarter of 2025. This figure captures the cost of all commercial product delivered to authorized treatment centers, including product that is sitting at the centers but not yet infused, which is recorded as deferred revenue.

To give you a broader view across the nine months of 2025 ending September 30, the cumulative operating expenses reflect this ongoing investment:

• Nine Months Ended September 30, 2025 Loss from Operations: $198.1 million (using thousands from source data: $198,078 thousand)
• Nine Months Ended September 30, 2024 Loss from Operations: $165.6 million (using thousands from source data: $165,562 thousand)
• The shift in manufacturing costs is evident as R&D expenses for the nine months ended September 30, 2025, were lower than the prior year, while Cost of Sales increased.

The company continues to innovate on manufacturing technology as a foundation for further expansion of access to CAR T therapies, which is a necessary, albeit high, fixed cost area for Autolus Therapeutics plc.

Finance: draft 13-week cash view by Friday.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Autolus Therapeutics plc (AUTL) as they move deeper into commercialization with AUCATZYL®. The revenue streams are clearly anchored in product sales, but the structure also hints at future potential from past deals. Honestly, for a company transitioning from clinical to commercial, the initial product revenue figures are what you watch most closely right now.

The most concrete revenue source as of late 2025 is the net product revenue from AUCATZYL® sales. For the third quarter ending September 30, 2025, Autolus Therapeutics plc booked net product revenue totaling $21.1 million. This shows solid, albeit lumpy, revenue generation from their marketed therapy in the U.S. market.

Looking at the cumulative performance, the total net product revenue for the first nine months of 2025 reached approximately $51.0 million. This figure reflects the ramp-up since the product's launch. It's important to note that revenue recognition is tied to product administration, not just shipment. That's why you see a significant deferred revenue balance.

Here's a quick look at the product revenue performance for the key periods leading up to the end of Q3 2025:

Revenue Metric	Amount (USD)	Period Ended September 30, 2025
Net Product Revenue (Q3 2025)	$21.144 million	Three Months
Net Product Revenue (Nine Months 2025)	$51.049 million	Nine Months
License Revenue (Nine Months 2025)	$0.050 million	Nine Months

Also, Autolus Therapeutics plc maintains revenue potential through strategic collaborations. These streams are built on past agreements, providing a runway for future, non-product-related income. What this estimate hides is the exact timing of those future payments, but the structure is there.

The balance sheet provides insight into revenue that is earned but not yet recognized in the income statement. As of September 30, 2025, the deferred revenue balance stood at $7.6 million. This represents product shipped to authorized treatment centers but not yet infused into patients, meaning it's essentially booked sales waiting for the final step of administration to hit the P&L.

You should keep an eye on these other elements that contribute to the overall revenue picture:

• Potential future milestone payments from collaborations.
• Royalties from strategic collaborations.
• Deferred revenue balance of $7.6 million as of September 30, 2025.
• License revenue recognized year-to-date (Nine Months 2025) was $0.050 million.

Finance: draft 13-week cash view by Friday.