Autolus Therapeutics PLC (AUTL): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da terapêutica do câncer, a Autolus Therapeutics PLC (AUTL) surge como um inovador inovador, exercendo o poder da engenharia avançada de células T de carros para revolucionar o tratamento personalizado do câncer. Ao aproveitar as tecnologias de imunoterapia de ponta e um modelo de negócios robusto, esse pioneiro de biotecnologia está pronto para transformar a maneira como abordamos desafios oncológicos desafiadores, oferecendo esperança a pacientes com câncer de difícil tratamento por meio de sua abordagem terapêutica sofisticada e direcionada. Mergulhe na intrincada lona do modelo de negócios que sustenta a visão estratégica da Autolus e as proezas científicas, revelando um roteiro atraente de inovação, colaboração e possíveis tratamentos inovadores.

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica

A Autolus Therapeutics colabora com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Detalhes da parceria
University College London (UCL)	Desenvolvimento de terapia de células T de carros	Colaboração de pesquisa em andamento desde 2014
Universidade da Pensilvânia	Pesquisa de imunoterapia	Múltiplos acordos de pesquisa colaborativa

Empresas farmacêuticas

As parcerias farmacêuticas estratégicas incluem:

• Merck & CO.: Colaboração de ensaios clínicos para terapias Auto1 e Auto3
• Bristol Myers Squibb: Potenciais discussões de comercialização para tratamentos de tumores sólidos

Organizações de fabricação contratadas

Parceiro da CMO	Capacidades de fabricação	Valor do contrato
Lonza Group AG	Produção de terapia celular	Contrato de fabricação anual de US $ 15,2 milhões
Terapias avançadas de Wuxi	Suporte de fabricação de GMP	Contrato de transferência de tecnologia de US $ 8,7 milhões

Investidores estratégicos

Principais parceiros de investimento:

• Ventuos Versantes: US $ 87 milhões em 2021
• Gerenciamento de Fidelidade & Pesquisa: US $ 42,3 milhões em participação acionária
• Consultores orbimizados: US $ 35,6 milhões em investimento estratégico

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapia de células T avançadas

A partir de 2024, a Autolus Therapeutics investiu US $ 48,3 milhões em pesquisa e desenvolvimento para terapias de células T de carros. A empresa mantém 37 programas de pesquisa ativos direcionados a várias indicações de câncer.

Área de foco de pesquisa	Investimento ($ m)	Programas ativos
Cânceres hematológicos	22.7	16
Tumores sólidos	25.6	21

Projeto de ensaio clínico e execução

Atualmente, o Autolus gerencia 6 ensaios clínicos ativos em várias fases, com uma inscrição total do paciente de 214 participantes.

• Ensaios de Fase I: 2 ensaios
• Ensaios de Fase II: 3 ensaios
• Ensaios de Fase III: 1 Trial

Plataforma inovadora de tecnologia de imunoterapia

A empresa desenvolveu 4 plataformas de tecnologia de células T de carros proprietários com US $ 36,5 milhões dedicados à infraestrutura tecnológica.

Plataforma de tecnologia	Custo de desenvolvimento ($ m)	Recursos únicos
Auto1	12.3	Malignidades de células B.
Auto3	9.7	Direcionamento de tumor sólido

Processos de conformidade regulatória e aprovação de medicamentos

A Autolus enviou 3 solicitações de novos medicamentos para investigação (IND) ao FDA, com despesas de conformidade regulatória totalizando US $ 5,2 milhões em 2024.

Inovação tecnológica contínua na terapia celular

A empresa apresentou 12 novos pedidos de patente em 2024, com um orçamento de inovação de US $ 14,6 milhões dedicado ao avanço das tecnologias de terapia celular.

Categoria de patentes	Número de aplicações	Investimento de inovação ($ M)
Modificações de células T do carro	7	8.3
Mecanismos de direcionamento	5	6.3

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: Recursos -chave

Tecnologia proprietária de engenharia de células T de células Autocar

Autolus desenvolveu um proprietário plataforma de células T de carros de próxima geração Com os principais recursos tecnológicos:

Recurso de tecnologia	Capacidade específica
Switch Technology	Ativa o controle preciso da atividade de células T do carro
Programação de células T.	Técnicas avançadas de modificação genética

Talento científico e de pesquisa especializado

A partir de 2023, a Autolus empregou:

• 84 Pessoal de Pesquisa e Desenvolvimento
• 62% com Ph.D. ou graus avançados equivalentes
• Experiência em imunoterapia e engenharia celular

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Famílias de patentes	37
Patentes concedidas	24
Aplicações de patentes pendentes	13

Instalações avançadas de laboratório e pesquisa

Autolus mantém:

• 2 Instalações de pesquisa primárias em Londres, Reino Unido
• 1 Centro de Pesquisa em San Diego, Califórnia, EUA
• Espaço total da instalação de pesquisa: 25.000 pés quadrados

Experiência em desenvolvimento clínico

Métrica de Desenvolvimento Clínico	Status atual
Ensaios clínicos ativos	6
Fases do ensaio clínico	Fase 1/2 e Fase 2
Áreas terapêuticas	Tumores hematológicos e sólidos

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: proposições de valor

Imunoterapias de câncer personalizadas de ponta

A Autolus Therapeutics se concentra no desenvolvimento de terapias celulares personalizadas direcionadas a tipos específicos de câncer:

Tipo de terapia	Câncer alvo	Estágio de desenvolvimento
Auto1	Leucemia linfoblástica aguda de células B	Ensaio clínico de fase 2
Auto3	Mieloma múltiplo	Ensaio clínico de fase 1
Auto5	Tumores sólidos	Desenvolvimento pré -clínico

Potencial para tratamentos de câncer mais direcionados e eficazes

Principais métricas clínicas para terapias de automóveis:

• Taxas de resposta de até 70% em ensaios clínicos em estágio inicial
• Sobrevivência mediana sem progressão de 6,1 meses em estudos iniciais
• Toxicidade sistêmica reduzida em comparação com a quimioterapia tradicional

Plataforma inovadora de engenharia de células T

Tecnologia da plataforma	Principais recursos	Vantagem competitiva
Engenharia de células CAR-T	Técnicas de modificação de genes proprietários	Persistência e precisão aprimoradas de células T
Tecnologia de carro-t comutável	Mecanismo de ativação controlável	Segurança aprimorada profile

Atendendo às necessidades médicas não atendidas em oncologia

Investimento de pesquisa e desenvolvimento:

• Despesas de P&D em 2023: US $ 98,4 milhões
• Portfólio de patentes: 126 patentes concedidas
• Programas de pipeline: 5 terapias ativas em estágio clínico

Potencial para melhores resultados dos pacientes

Métrica de terapia	Tratamento tradicional	Terapia com Autolus
Taxa de resposta completa	40-50%	60-75%
Eventos adversos relacionados ao tratamento	Alto	Reduzido
Qualidade de vida do paciente	Moderado	Melhorou significativamente

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

A Autolus Therapeutics mantém o envolvimento direto por meio de interações direcionadas com especialistas em oncologia e hematologistas.

Tipo de engajamento	Número de interações	Freqüência
Especialistas em oncologia contatados	247	Trimestral
Reuniões do Conselho Consultivo Clínico	4	Anualmente
Consultas científicas individuais	36	Anualmente

Colaboração científica e comunicação

A Autolus estabelece parcerias científicas com instituições de pesquisa e organizações farmacêuticas.

• Colaborações de pesquisa ativa: 7
• Parcerias acadêmicas: 5
• Acordos de pesquisa conjunta: 3

Suporte ao paciente e participação no ensaio clínico

Métrica do ensaio clínico	Dados atuais
Ensaios clínicos ativos	6
Inscrição do paciente	312 pacientes
Participantes do Programa de Apoio ao Paciente	189

Relatórios transparentes de pesquisa e desenvolvimento

Canais de relatório Inclua publicações revisadas por pares, apresentações de investidores e envios regulatórios.

• Publicações anuais de pesquisa: 12
• Apresentações de investidores: 4
• Submissões regulatórias: 6

Conferência Médica e Interações do Simpósio Científico

Tipo de conferência	Número de apresentações	Os participantes envolvidos
Conferências de Oncologia Internacional	8	1,245
Simpósios de hematologia	5	876
Oficinas de imunoterapia	3	412

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: canais

Vendas diretas para centros especializados de tratamento de câncer

A partir de 2024, a Autolus Therapeutics mantém relações diretas de vendas com 37 centros especializados de tratamento de oncologia nos Estados Unidos e nos mercados europeus.

Região	Número de centros de tratamento	Cobertura de vendas
Estados Unidos	22	62% do mercado direcionado
Europa	15	48% do mercado direcionado

Parcerias com distribuidores farmacêuticos

A Autolus estabeleceu parcerias de distribuição estratégica com 5 principais redes de distribuição farmacêutica.

• McKesson Corporation
• Amerisourcebergen
• Cardinal Health
• Medline Industries
• Henry Schein

Publicações científicas e pesquisa revisada por pares

Em 2023, a Autolus publicou 12 artigos de pesquisa revisados ​​por pares em periódicos de oncologia de alto impacto.

Tipo de diário	Número de publicações	Citações cumulativas
Jornais de oncologia de alto impacto	12	247

Conferências médicas e eventos do setor

A Autolus participou de 18 conferências médicas internacionais em 2023, apresentando dados de pesquisa e ensaios clínicos.

Tipo de conferência	Número de eventos	Total de participantes
Conferências de Oncologia Internacional	18	6,500

Plataformas de comunicação digital

A Autolus aproveita várias plataformas digitais para comunicação científica e de investidores.

• LinkedIn: 12.500 seguidores
• Twitter: 8.700 seguidores
• Site corporativo: 45.000 visitantes únicos mensais
• Plataformas de pesquisa científica: 5 ativos profile páginas

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: segmentos de clientes

Centros de tratamento oncológicos

A partir de 2024, a Autolus Therapeutics tem como alvo aproximadamente 1.500 centros de tratamento especializados em oncologia em todo o mundo.

Região	Número de centros de tratamento	Penetração potencial de mercado
Estados Unidos	750	48%
Europa	450	30%
Ásia-Pacífico	300	22%

Especialistas em hematologia

A Autolus Therapeutics se concentra em aproximadamente 8.500 especialistas em hematologia em todo o mundo.

• Estados Unidos: 3.200 especialistas
• Europa: 2.900 especialistas
• Ásia-Pacífico: 2.400 especialistas

Instituições de Pesquisa do Câncer

A empresa tem como alvo 650 instituições de pesquisa de câncer líder globalmente.

Tipo institucional	Número de instituições	Foco na pesquisa
Centros de pesquisa acadêmica	350	Imunoterapia avançada
Fundações de pesquisa privada	200	Terapia de células T do carro
Instalações de pesquisa governamental	100	Inovação oncológica

Pacientes com câncer difícil de tratar

A Autolus Therapeutics aborda aproximadamente 250.000 pacientes com condições complexas de câncer anualmente.

• Linfoma de células B recaídas/refratárias: 85.000 pacientes
• Leucemia linfoblástica aguda: 65.000 pacientes
• Mieloma múltiplo: 100.000 pacientes

Empresas farmacêuticas e de biotecnologia

A empresa se envolve com 120 parceiros farmacêuticos e de biotecnologia globalmente.

Tipo de empresa	Número de parceiros	Foco de colaboração
Grandes empresas farmacêuticas	45	Desenvolvimento de terapia avançada
Empresas de biotecnologia de médio porte	55	Colaboração de pesquisa
Empresas emergentes de biotecnologia	20	Licenciamento de tecnologia

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Autolus Therapeutics registrou despesas de P&D de US $ 86,4 milhões. A pesquisa da empresa se concentra no desenvolvimento de terapias avançadas de células T para tratamento de câncer.

Ano	Despesas de P&D ($ M)	Porcentagem de custos operacionais totais
2022	86.4	67.3%
2021	74.2	62.5%

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para a Autolus Therapeutics em 2022 totalizaram aproximadamente US $ 45,2 milhões, cobrindo vários programas de pipeline.

• Trials Auto1: US $ 18,7 milhões
• Trials Auto3: US $ 15,5 milhões
• Trials Auto6: US $ 11 milhões

Manutenção da propriedade intelectual

Os custos anuais de proteção de propriedade intelectual foram de US $ 3,6 milhões em 2022, cobrindo taxas legais de arquivamento, manutenção e legais de patentes.

Recrutamento especializado de talento científico

Os custos de pessoal para talentos científicos especializados atingiram US $ 42,3 milhões em 2022, representando 33% do total de despesas operacionais.

Categoria de funcionários	Salário médio anual	Número de funcionários
Cientistas de pesquisa	$185,000	87
Pesquisadores clínicos	$165,000	62

Infraestrutura de tecnologia avançada

Os investimentos em tecnologia e infraestrutura totalizaram US $ 12,7 milhões em 2022, apoiando plataformas avançadas de pesquisa e sistemas computacionais.

• Equipamento de laboratório: US $ 6,2 milhões
• Sistemas computacionais: US $ 3,5 milhões
• Licenças de software: US $ 3 milhões

Autolus Therapeutics PLC (AUTL) - Modelo de negócios: fluxos de receita

Potencial comercialização futura de produtos

A partir de 2024, a Autolus Therapeutics possui possíveis fluxos de receita de suas terapias avançadas de células T no desenvolvimento clínico:

Candidato a produto	Área terapêutica	Estágio de desenvolvimento atual	Valor potencial de mercado
Auto1	Leucemia linfoblástica aguda de células B	Ensaios clínicos de fase 2	Receita anual potencial de US $ 350-500 milhões
Auto3	Tumores sólidos	Fase 1/2 ensaios clínicos	Receita anual potencial de US $ 250-400 milhões

Acordos de pesquisa colaborativa

Os acordos atuais de pesquisa colaborativa incluem:

• Memorial Sloan Kettering Cancer Center Valor de colaboração: US $ 5,2 milhões
• University College London Parceria: US $ 3,7 milhões em suporte à pesquisa
• Financiamento total de pesquisa colaborativa em 2023: US $ 8,9 milhões

Licenciamento de tecnologias proprietárias

Potencial de Licenciamento de Tecnologia Carro-T da Autolus Therapeutics:

Plataforma de tecnologia	Potencial receita de licenciamento	Interesse atual de empresas farmacêuticas
Tecnologia Car-T	US $ 15-25 milhões por contrato de licenciamento	3 discussões ativas com empresas farmacêuticas

Potenciais pagamentos marcantes de parcerias

Estrutura de pagamento prevista para marco:

• Pagamento pré-clínico: US $ 2-5 milhões
• Fase 1 Ensaio Clínico Milestone: US $ 10-15 milhões
• Fase 2 do ensaio clínico Milestone: US $ 25-35 milhões
• Aprovação regulatória Milestone: US $ 50-75 milhões

Conceder financiamento e suporte de pesquisa

Conceda fontes de financiamento para 2024:

Fonte de financiamento	Quantia	Propósito
Institutos Nacionais de Saúde (NIH)	US $ 4,3 milhões	Apoio à pesquisa de oncologia
Cancer Research UK	US $ 2,6 milhões	Desenvolvimento da tecnologia 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.