Lyell Immunopharma, Inc. (Lyel): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da imunoterapia contra o câncer, a Lyell Immunopharma, Inc. (Lyel) emerge como um inovador inovador, empunhando tecnologias de engenharia de células T de ponta que prometem revolucionar o tratamento de tumores sólidos. Ao mapear estrategicamente sua tela de modelo de negócios, Lyell revela uma abordagem sofisticada para transformar a terapia celular personalizada do conceito teórico em potencial avanço clínico, se posicionando na vanguarda da pesquisa e desenvolvimento de imunoterapia com precisão.

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com Bristol Myers Squibb

Em dezembro de 2022, a Lyell Immunopharma entrou em uma colaboração estratégica com a Bristol Myers Squibb, focada no desenvolvimento da terapia de células T. A colaboração envolve:

Detalhes da parceria	Valor específico
Pagamento inicial	US $ 55 milhões
Potenciais pagamentos marcantes	Até US $ 2,16 bilhões
Foco na colaboração de pesquisa	Terapias de células T para tumores sólidos

Parcerias de pesquisa acadêmica

Lyell mantém parcerias de pesquisa com as principais instituições acadêmicas:

• Universidade de Stanford
• Universidade da Califórnia, São Francisco
• MD Anderson Cancer Center

Licenciamento de tecnologia farmacêutica

Lyell buscou possíveis acordos de licenciamento para tecnologias de imunoterapia com as seguintes características:

Categoria de tecnologia	Parceiros em potencial	Intervalo de valor estimado
Plataforma de engenharia de células T.	Empresas farmacêuticas não divulgadas	US $ 50-150 milhões em potencial valor de licenciamento
Tecnologia de células T semelhante à memória	Empresas de biotecnologia focadas em oncologia	US $ 75-225 milhões em potencial valor de colaboração

Colaborações do Centro de Tratamento do Câncer

Lyell estabeleceu colaborações de pesquisa com centros especializados de tratamento de câncer para avançar em ensaios clínicos e desenvolvimento de tecnologia.

• Memorial Sloan Kettering Cancer Center
• Instituto de Câncer Dana-Farber
• Fred Hutchinson Cancer Research Center

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapia de células T

A partir do quarto trimestre de 2023, a Lyell Immunopharma investiu US $ 45,2 milhões em pesquisa e desenvolvimento de terapia de células T. A empresa se concentra no desenvolvimento Terapias de células T da próxima geração direcionando tumores sólidos.

Categoria de pesquisa	Valor do investimento	Foco na pesquisa
Engenharia de células T.	US $ 22,7 milhões	Imunoterapias tumorais sólidas
Direcionamento molecular	US $ 15,3 milhões	Programação celular avançada
Otimização terapêutica	US $ 7,2 milhões	Melhorias de persistência e eficácia

Engenharia e Manufatura Avançada de Cells

Lyell opera a Facilidade de fabricação de células de 20.000 pés quadrados de 20.000 pés quadrados No sul de São Francisco, com uma capacidade de produção anual de 500 lotes de células terapêuticas.

• Investimento de fabricação: US $ 35,6 milhões em 2023
• Infraestrutura de produção compatível com GMP
• Tecnologias avançadas de engenharia celular

Projeto de ensaio clínico e execução

Em 2023, Lyell conduziu 4 ensaios clínicos ativos com um orçamento total de pesquisa de US $ 63,4 milhões.

Fase de teste	Número de ensaios	Inscrição total do paciente
Fase I.	2	76 pacientes
Fase II	2	124 pacientes

Inovação da plataforma de imunoterapia

Lyell se desenvolveu Tecnologias de programação de células T proprietárias com despesas de P&D de US $ 28,9 milhões em 2023.

Pesquisa pré -clínica e translacional

A empresa alocou US $ 18,7 milhões para pesquisas pré -clínicas em 2023, com foco em novas abordagens de imunoterapia.

• Pesquisa em Engenharia Molecular
• Identificação do alvo terapêutico
• Estudos de mecanismo imunológico

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: Recursos -chave

Tecnologia proprietária de engenharia de células T

Detalhes da plataforma de tecnologia:

Aspecto tecnológico	Parâmetros específicos
Abordagem de engenharia de células T.	Técnicas de modificação genética de precisão
Aplicações de patentes	7 Famílias de patentes ativas a partir de 2023
Investimento em desenvolvimento de tecnologia	US $ 24,3 milhões de despesas de P&D em 2022

Instalações avançadas de pesquisa e desenvolvimento

Especificações da instalação:

• Localização de pesquisa primária: South San Francisco, Califórnia
• Espaço total da instalação de pesquisa: 45.000 pés quadrados
• Laboratórios de Nível 2 e Nível 3 da Biossegurança

Portfólio de propriedade intelectual

Categoria IP	Quantidade
Patentes emitidas	12 patentes globais
Aplicações de patentes pendentes	18 APLICAÇÕES
Territórios de patentes	Estados Unidos, Europa, Japão

Equipe de liderança científica e médica experiente

Posição de liderança	Anos totais de experiência
Diretor executivo	22 anos em biotecnologia
Diretor científico	18 anos em pesquisa de imunoterapia
Membros da equipe de liderança total	7 executivos seniores

Capacidades especializadas de fabricação de células

Infraestrutura de fabricação:

• Instalações de produção celular certificadas por GMP
• Capacidade anual de produção: 5.000 unidades de terapia celular personalizadas
• Equipe de controle de qualidade: 22 pessoal especializado

Parâmetro de fabricação	Especificação
Investimento de fabricação	US $ 37,6 milhões em 2022
Equipamento de produção	3 unidades avançadas de processamento de células

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: proposições de valor

Terapias inovadoras de células T visando tumores sólidos

O Lyell Immunopharma se concentra no desenvolvimento de terapias avançadas de células T projetadas especificamente para tratamento de tumores sólidos. A partir do quarto trimestre 2023, a empresa tem 3 programas primários de terapia de células T no desenvolvimento clínico.

Programa de terapia	Estágio de desenvolvimento	Tipo de câncer alvo
Lyel-H1	Ensaio Clínico de Fase 1/2	Tumores sólidos
Lyel-H2	Desenvolvimento pré -clínico	Cânceres metastáticos
Lyel-H3	Estágio de pesquisa	Tumores sólidos avançados

Abordagens personalizadas de terapia celular

A estratégia de terapia celular personalizada da empresa envolve Engenharia de células T específicas do paciente.

• Plataforma de engenharia celular exclusiva
• Técnicas de modificação genética proprietária
• Projeto de tratamento individualizado

Soluções potenciais de tratamento de câncer

Lyell Immunopharma investiu US $ 48,3 milhões em despesas de P&D durante 2023, para desenvolver soluções inovadoras de tratamento de câncer.

Tecnologias avançadas de engenharia celular

Tecnologia	Recurso único	Impacto potencial
Plataforma de persistência das células T.	Sobrevivência aprimorada de células T.	Durabilidade de tratamento aprimorada
Sistema de modificação genética	Engenharia genética precisa	Eliminação de células cancerígenas direcionadas

Plataformas de imunoterapia de precisão

A abordagem de imunoterapia de precisão da empresa inclui 2 plataformas tecnológicas primárias com aplicações em potencial em vários tipos de câncer.

• Mecanismos de direcionamento molecular
• Programação de células imunológicas avançadas
• Otimização de resposta imune adaptativa

Lyell Immunopharma, Inc. (Lyel) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa oncológica

A partir do quarto trimestre 2023, a Lyell Immunopharma mantém estratégias de engajamento direto com aproximadamente 127 instituições de pesquisa de oncologia em todo o mundo.

Tipo de engajamento	Número de instituições	Alcance geográfico
Centros de pesquisa acadêmica	84	América do Norte, Europa
Centros abrangentes de câncer	43	Estados Unidos, Europa

Parcerias de ensaios clínicos colaborativos

Lyell Immunopharma estabeleceu 12 parcerias de ensaios clínicos ativos em vários domínios de pesquisa de oncologia.

• Ensaios de imuno-oncologia da Fase I/II: 5 parcerias
• Colaborações avançadas de terapia de células T: 4 parcerias
• Pesquisa de imunoterapia de precisão: 3 parcerias

Apresentações de conferência científica e simpósio

Tipo de conferência	Apresentações anuais	Alcance do público
Conferências de Oncologia Internacional	7	3.500+ pesquisadores
Simpósios de imunoterapia especializados	4	1.200+ especialistas

Programas de apoio ao paciente e educação

Lyell Immunopharma desenvolveu 3 iniciativas abrangentes de apoio ao paciente direcionando áreas de pesquisa de imunoterapia específicas.

• Webinars de informações do paciente: sessões trimestrais
• Recursos educacionais online: 12 guias de pesquisa detalhados
• Rede de suporte de participantes do ensaio clínico

Comunicação transparente do progresso da pesquisa

Os canais de comunicação incluem atualizações trimestrais de pesquisa e apresentações de investidores.

Canal de comunicação	Freqüência	Público
Apresentações de investidores	Trimestral	Investidores institucionais, partes interessadas de pesquisa
Relatórios de progresso da pesquisa	Semestral	Comunidade científica, parceiros em potencial

Lyell Immunopharma, Inc. (Lyel) - Modelo de Negócios: Canais

Comunicações científicas diretas

A partir do quarto trimestre 2023, a Lyell Immunopharma utilizou os seguintes canais diretos de comunicação científica:

Tipo de canal	Freqüência	Público -alvo
Comunicações da equipe de pesquisa direta	Semanalmente	Pesquisadores de imunoterapia
Reuniões do Conselho Consultivo Científico	Trimestral	Especialistas científicos externos

Apresentações da conferência médica

Lyell Immunopharma apresentado em 7 principais conferências científicas em 2023:

• Associação Americana de Pesquisa do Câncer (AACR)
• Sociedade de Imunoterapia do Câncer (SITC)
• Sociedade Europeia de Oncologia Médica (ESMO)

Publicações de revistas revisadas por pares

Jornal	Publicações em 2023	Fator de impacto
Biotecnologia da natureza	2	41.4
Célula	1	47.3

Plataformas de relações com investidores

Os canais de relações com investidores da Lyell Immunopharma incluem:

• Chamadas de ganhos trimestrais
• Reuniões anuais de acionistas
• Sec Comunicação de arquivamento
• Webinars de apresentação de investidores

Redes de comunicação científica digital

Plataforma	Seguidores/conexões	Propósito primário
LinkedIn	12,500	Networking profissional
Pesquisa	450 membros da pesquisa	Colaboração científica

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A Lyell Immunopharma tem como alvo instituições de oncologia acadêmica e focada na pesquisa com características específicas:

Tipo de instituição	Número de clientes em potencial	Foco na pesquisa
Centros de câncer designados por NCI	71	Terapias de células T.
Universidades de pesquisa de primeira linha	38	Desenvolvimento de imunoterapia

Empresas farmacêuticas

Os principais segmentos de clientes farmacêuticos incluem:

• Grandes empresas farmacêuticas com divisões de oncologia
• Empresas de biotecnologia de tamanho médio focadas em imunoterapias
• Empresas farmacêuticas focadas em oncologia emergentes

Tamanho da empresa	Contagem potencial de clientes	Faixa anual de orçamento de P&D
Grande farmacêutica (top 20)	20	$ 3b - $ 12b
Biotecnologia de tamanho médio	45	US $ 500M - US $ 2B

Centros de Tratamento do Câncer

Lyell tem como alvo instalações especializadas de tratamento de câncer:

Tipo central	Total nos Estados Unidos	Interesse potencial em terapias avançadas
Centros abrangentes de câncer	51	Alto
Centros de Câncer Comunitário	1,500	Médio

Laboratórios de Pesquisa Acadêmica

Segmentos de pesquisa acadêmica direcionados:

• Departamentos de pesquisa de imunologia
• Laboratórios focados em oncologia
• Unidades de pesquisa de terapia celular

Tipo de laboratório	Número estimado	Financiamento anual de pesquisa
Laboratórios de pesquisa de primeira linha	87	US $ 5m - US $ 50m

Investidores de biotecnologia

Segmentos de clientes focados em investimentos:

Tipo de investidor	Número de investidores em potencial	Intervalo de investimento médio
Empresas de capital de risco	62	US $ 10 milhões - US $ 100 milhões
Investidores de private equity	38	$ 50m - US $ 500 milhões

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: Estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Lyell Immunopharma registrou despesas de P&D de US $ 196,3 milhões, representando um investimento significativo em sua pesquisa científica e desenvolvimento tecnológico.

Ano fiscal	Despesas de P&D	Porcentagem de custos operacionais totais
2022	US $ 178,6 milhões	62.4%
2023	US $ 196,3 milhões	65.2%

Investimentos de ensaios clínicos

Os gastos com ensaios clínicos para Lyell Immunopharma em 2023 totalizaram aproximadamente US $ 87,5 milhões, focando na terapia celular e na pesquisa de imunoterapia.

• Ensaios clínicos de fase I: US $ 32,4 milhões
• Ensaios Clínicos de Fase II: US $ 41,6 milhões
• Estudos pré -clínicos: US $ 13,5 milhões

Manutenção da plataforma de tecnologia

Os custos de infraestrutura e manutenção de tecnologia para 2023 foram estimados em US $ 24,7 milhões.

Categoria de manutenção de tecnologia	Custo anual
Infraestrutura de TI	US $ 9,2 milhões
Licenciamento de software	US $ 6,5 milhões
Computação em nuvem	US $ 5,3 milhões
Segurança cibernética	US $ 3,7 milhões

Proteção à propriedade intelectual

As despesas de proteção da propriedade intelectual para 2023 foram de US $ 12,6 milhões.

• Arquivamento e manutenção de patentes: US $ 7,3 milhões
• Consulta legal: US $ 3,8 milhões
• Gerenciamento de portfólio de IP: US $ 1,5 milhão

Infraestrutura de fabricação

A infraestrutura de fabricação e os custos operacionais de 2023 totalizaram US $ 45,2 milhões.

Categoria de custo de fabricação	Custo anual
Manutenção da instalação	US $ 18,6 milhões
Depreciação do equipamento	US $ 14,3 milhões
Aquisição de matéria -prima	US $ 8,7 milhões
Controle de qualidade	US $ 3,6 milhões

Lyell Immunopharma, Inc. (Lyel) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir do quarto trimestre 2023, a Lyell Immunopharma não relatou receita específica de licenciamento. Nenhum contrato de licenciamento confirmado foi divulgado publicamente.

Financiamento de colaboração de pesquisa

Parceiro de colaboração	Valor de financiamento	Ano
Genentech	Pagamento antecipado de US $ 150 milhões	2022
Genentech	Potencial até US $ 3 bilhões em pagamentos marcantes	2022-FUTURA

Vendas futuras de produtos terapêuticos

Não há vendas atuais de produtos terapêuticos relatados a partir de 2024. Os produtos de Lyell permanecem em estágios de desenvolvimento clínico.

Pagamentos marcos de parcerias

• Genentech Collaboration potencial Milestone Payments: até US $ 3 bilhões
• Critérios específicos de realização de marcos não detalhados publicamente

Financiamento potencial de concessão

Não há valores específicos de financiamento relatados nas demonstrações financeiras recentes.

Métrica financeira	Quantia	Período
Receita total	US $ 30,7 milhões	Q3 2023
Perda líquida	US $ 45,2 milhões	Q3 2023

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Value Propositions

Lyell Immunopharma, Inc.'s value proposition centers on delivering next-generation CAR T-cell therapies engineered to overcome key limitations of current treatments, specifically targeting T-cell exhaustion and enhancing persistence, particularly in solid tumors.

The core technology is designed to create T cells with enhanced stemlike features, which is supported by their manufacturing process. The final drug product for LYL314 contained the desired CD62L-positive naïve T-cell phenotype with a median of 95%. Furthermore, LYL314 demonstrated robust expansion with a time to peak of 10 days in clinical settings. Lyell Immunopharma, Inc. is advancing these next-generation CAR T-cell product candidates, which are fully-armed with multiple technologies designed to address T-cell exhaustion and immune suppression within the hostile tumor microenvironment. The first Investigational New Drug (IND) application for a fully-armed solid tumor product candidate is expected in 2026.

The dual-targeting approach in the lead program, LYL314 (ronde-cel), is a key differentiator against antigen escape. This therapy targets both CD19 and CD20. Data from the Phase 1/2 trial in patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting showed compelling efficacy:

Metric	LYL314 (R/R LBCL, 3L+ Setting)	LYL314 (R/R LBCL, 3L+ Setting, Prior Data Point)
Overall Response Rate (ORR)	88% (N = 25)	94% (16/17 patients)
Complete Response (CR) Rate	72% (N = 25)	71% (12/17 patients by three months)
Durability of CR ($\ge$ 6 months)	71% of CR patients	N/A

For solid tumors, Lyell Immunopharma, Inc. is advancing LYL273, a guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate, which is also enhanced with CD19 CAR expression and controlled cytokine release. GCC expression is present on over 95% of metastatic colorectal cancer (mCRC) cases. The clinical activity observed in patients with refractory mCRC is a significant value driver:

• LYL273 showed a 67% overall response rate at the highest dose level studied to date in patients with refractory mCRC.
• The disease control rate reached 83% at the highest dose level.
• At Dose Level 2, the median progression-free survival was 7.8 months.
• The acquisition of global rights for LYL273 included an upfront payment of $40 million and 1.9 million shares.

Financially, Lyell Immunopharma, Inc. is positioned to support its pipeline advancement into 2027 through key clinical milestones, holding approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Research and development expenses for the third quarter ended September 30, 2025, were $28.2 million, contributing to a net loss of $38.8 million for that quarter.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Relationships

You're building a commercial-ready cell therapy operation, so the relationship with the clinical sites, investigators, and the FDA is everything right now. For Lyell Immunopharma, Inc., this means managing complex logistics and proving durability to key opinion leaders (KOLs) before the product hits the market.

High-touch, specialized support for autologous cell collection and delivery logistics centers around the LyFE Manufacturing Center™ in Bothell, Washington. This facility is designed for scale, with the capacity to manufacture more than 1,200 CAR T-cell doses at full capacity, supporting both ongoing pivotal trials and potential commercial launch. This manufacturing capability is a direct relationship touchpoint, ensuring the supply chain for autologous products is robust.

Direct engagement with clinical investigators and key opinion leaders (KOLs) is evidenced by the structure of their pivotal trials. The PiNACLE trial, a single-arm study for patients with relapsed and/or refractory (R/R) B-cell lymphomas in the third- or later-line (3L+) setting, is expected to enroll approximately 120 patients. Furthermore, the planned Phase 3 head-to-head trial, PiNACLE - H2H, in the second-line (2L) setting, is expected to enroll approximately 400 patients, split into 200 per arm. To guide this, Lyell Immunopharma formed an expert steering committee of lymphoma and cell therapy experts to collaborate on the design and conduct of PiNACLE - H2H.

Management of the regulatory relationship with the FDA has secured critical designations for their lead candidate, ronde-cel (LYL314). The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel for patients with R/R LBCL receiving treatment in the second-line (2L) setting. This designation, along with the prior Fast Track status, signals a close working relationship aimed at expedited review. The data from the 3L+ setting trial is targeted to form the basis of a Biologics License Application (BLA) submission to the FDA in 2027.

Scientific communication is a key way Lyell Immunopharma engages the broader medical customer base. They had two abstracts accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025, highlighting new clinical and translational data from the Phase 1/2 trial of ronde-cel. This direct scientific exchange builds credibility with prescribing physicians.

Building the commercial readiness team involved strategic hires in 2025 to align with late-stage clinical progress. The company appointed leaders with 'deep cell therapy expertise and highly relevant experience launching new medicines for patients' in June 2025. The addition of a new Board member brought 'experienced commercial leadership, including in cell therapy,' at the critical time as pivotal trials initiated.

Here's a quick look at the operational scale supporting these customer-facing activities as of late 2025:

Metric	Value/Status
LyFE Manufacturing Center Capacity (Doses/Year)	Over 1,200
PiNACLE Trial (3L+ LBCL) Expected Enrollment	Approximately 120 patients
PiNACLE - H2H Trial (2L LBCL) Expected Enrollment (Total)	Approximately 400 patients
FDA Designation for 2L LBCL	RMAT designation
Planned BLA Submission Year (3L+ Data)	2027
Key Scientific Presentation Date	December 2025 (ASH)

The focus on building out the executive and board structure shows a clear shift toward commercial readiness. For instance, personnel-related expenses in General and Administrative (G&A) increased due to higher headcount in Q1 2025, partly driven by these strategic additions.

You can see the relationship management is multi-faceted:

• Logistics: Ensuring the LyFE Center can deliver over 1,200 doses.
• Clinical: Initiating trials enrolling up to 400 patients in the 2L setting.
• Regulatory: Securing RMAT for the 2L indication.
• Scientific: Presenting data at the December 2025 ASH meeting.
• Commercial: Adding leaders with launch experience in 2025.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Channels

You're mapping out how Lyell Immunopharma, Inc. (LYEL) gets its product-or the promise of it-to the world, which, as a cell therapy company, is a complex dance between clinical sites and internal production. For late 2025, the channels are heavily weighted toward clinical execution and building the infrastructure for what comes next.

Specialized oncology treatment centers and hospitals (future commercialization)

The channel for future commercialization, which involves specialized oncology treatment centers and hospitals, is being built now through the readiness of the internal supply chain. Lyell Immunopharma, Inc. expects its manufacturing hub to provide drug supply not just for ongoing and planned pivotal trials but also through potential commercial launch. This readiness is a key indicator for future distribution channels.

The company's financial position as of September 30, 2025, with cash, cash equivalents, and marketable securities at approximately $320 million, is intended to support advancing the pipeline into 2027 through key clinical milestones, which directly underpins the timeline for establishing these commercial channels.

Clinical trial sites for patient enrollment and treatment delivery

Currently, the primary channel for patient access is the network of clinical trial sites supporting ongoing studies. Lyell Immunopharma, Inc. is actively enrolling patients in its pivotal trials. The company has noted that the number of qualified clinical investigators and clinical trial sites is limited, which can affect enrollment speed.

Key activities in late 2025 involved:

• Initiating the PiNACLE pivotal trial for LYL314 in the third- or later-line (3L+) setting.
• Remaining on track to initiate a pivotal trial in the second-line (2L) setting by early 2026.
• The Phase 1/2 trial for LYL314 included 36 patients in the efficacy evaluable population as of the April 15, 2025, cutoff date.

LyFE Manufacturing Center™ as the central production and supply chain hub

The LyFE Manufacturing Center™ in Bothell, Washington, is the core of Lyell Immunopharma, Inc.'s supply channel. This facility successfully completed technology transfer and received clearance from the FDA via an Investigational New Drug Amendment to begin manufacturing LYL314 clinical supply. This center was built at a cost of $65 million.

Here's a look at the manufacturing channel status and related financial actions as of mid-to-late 2025:

Metric	Value/Status	Date/Period Reference
Capacity	Over 1,000 CAR T-cell therapy doses per year	Q1 2025 Data
Facility Closure Cost	Expected aggregate expenses between $3.0 million to $4.0 million	Q1 2025 Actions
Facility Closure Workforce Reduction	Approximately 73 employees	Q1 2025 Actions
Total Assets	$408 million	September 30, 2025
Cash, Cash Equivalents, Marketable Securities	Approximately $320 million	September 30, 2025

Scientific publications and medical conferences for data dissemination

Dissemination of clinical and translational data is a critical channel for establishing credibility and informing the medical community about Lyell Immunopharma, Inc.'s progress. This is done through peer-reviewed publications and presentations at major medical meetings. The company reported revenue of only $15,000 for the third quarter ending September 30, 2025, underscoring that data dissemination, not product sales, is the current focus of this channel.

Key dissemination events through late 2025 included:

• Oral presentation of LYL314 data at the 18th International Conference on Malignant Lymphoma in June 2025.
• Presentation of an abstract on Stim-R™ technology at the American Association for Cancer Research Annual Meeting in 2025.
• Acceptance of two abstracts for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025.

The data presented at ASH is expected to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with R/R LBCL receiving treatment in the 3L+ setting.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Segments

You're looking at the core groups Lyell Immunopharma, Inc. (LYEL) needs to engage to bring its cell therapies to market. This isn't just about the patients; it's about the entire ecosystem that decides who gets treated and who pays for it.

Patients with relapsed or refractory (R/R) Large B-cell Lymphoma (LBCL) (2L/3L+)

This group represents the immediate, high-need population for ronde-cel (LYL314). The data from the ongoing trials show a clear potential to disrupt the current standard, where historical benchmarks like the SCHOLAR-1 study showed an objective response rate of only 26% and a complete remission rate of a mere 7% for refractory DLBCL patients. Lyell Immunopharma, Inc. (LYEL) is targeting this unmet need directly.

Here's a look at the clinical activity for LYL314 in this segment as of late 2025:

Patient Cohort / Trial Setting	Patient Count (N)	Median Follow-up	Overall Response Rate (ORR)	Complete Response (CR) Rate
PiNACLE (3L+ Pivotal Trial) - Efficacy Evaluable	25	9 months	88%	72%
Phase 1/2 (2L Setting) - Efficacy Evaluable	11	5 months	91%	64%
Primary Refractory (Subset of Efficacy Evaluable)	10	N/A	N/A	70%

The durability of response is also a key factor for this segment. In the 3L+ cohort, 71% ($\text{10/14}$) of patients who achieved a complete response were still in complete response at $\ge \text{6 months}$ of follow-up. Furthermore, the company is preparing for the next step in the 2L setting, with the $\text{PiNACLE - H2H}$ Phase 3 trial expected to enroll approximately 400 patients, with enrollment starting early 2026.

Patients with refractory metastatic Colorectal Cancer (mCRC)

This segment is targeted by LYL273, a novel GCC-targeted CAR T-cell product candidate for which Lyell Immunopharma, Inc. (LYEL) acquired exclusive global rights in November 2025. The biological rationale is strong, as the target receptor, GCC, is expressed on more than 95% of colorectal cancers. The U.S. patient burden is significant, with approximately 53,000 people expected to die from CRC in the U.S. in 2025.

Early clinical activity in the ongoing U.S. Phase 1 trial for refractory mCRC showed promise:

• Overall Response Rate (ORR) across both dose levels ($\text{N=12}$): 50%.
• Disease Control Rate (DCR): 83%.

Oncologists and hematologists specializing in cellular immunotherapy

These are the prescribers and administrators who need to trust the safety and efficacy profile of LYL314 and LYL273. The data presented at the ASH 67th Annual Meeting in December 2025 is critical for their adoption. For LYL314, the safety profile observed in 51 patients was described as manageable and appropriate for outpatient administration.

The financial health of Lyell Immunopharma, Inc. (LYEL) directly impacts the continuity of clinical supply and data generation that these specialists rely on:

• Cash, cash equivalents, and marketable securities as of September 30, 2025: Approximately $320 million.
• Projected cash runway: Sufficient to meet needs into 2027.
• Q2 2025 Financing: Gross proceeds of up to approximately $100 million from a private placement.
• Q3 2025 Financing: Completed a PIPE financing raising $57.8 million.

Payers and government health systems (future reimbursement)

Payers become a primary customer segment upon potential commercial launch. Lyell Immunopharma, Inc. (LYEL) is positioning its therapies to justify premium pricing by demonstrating superior outcomes over existing standards. The Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel in the third- or later-line setting is an early signal to payers regarding the drug's potential to address significant unmet needs.

The financial performance in the third quarter ended September 30, 2025, shows the investment required to reach this stage:

• Net Loss for Q3 2025: $38.8 million.
• Research and development (R&D) expenses for Q3 2025: $28.2 million.

The focus on durable responses, such as the 71% CR durability at $\ge \text{6 months}$ for LYL314 in 3L+ LBCL, is the core value proposition for securing favorable reimbursement terms from these entities.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for Lyell Immunopharma, Inc. as of late 2025. These costs are heavily weighted toward advancing their cell therapy pipeline, which is typical for a late-stage clinical company.

The primary cost drivers are centered on research, development, and maintaining the internal manufacturing capability. Here's a breakdown of the key financial figures from the third quarter ending September 30, 2025.

High Research and Development (R&D) expenses represent the single largest operational outlay, reflecting the commitment to clinical trials and platform technology refinement. For Q3 2025, GAAP R&D expenses were reported at $28.2 million, a notable decrease from $39.5 million in the same period last year.

This reduction in R&D spending was driven by specific cost-saving measures across key areas:

• Reduction in research activities, collaborations, and outside services: $4.4 million decrease.
• Decrease in personnel-related expenses: $4.2 million decrease.

The structure of these R&D costs directly relates to the clinical and manufacturing needs:

Cost Component Area	Financial Implication/Metric
Clinical Trial Execution Costs	R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes costs associated with clinical trials.
Pivotal/Phase 1 Trial Funding	Proceeds from a July 2025 private placement are intended to fund two pivotal-stage clinical trials of LYL314.
Manufacturing & Process Development Costs	R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes process development costs.
LyFE Center Capacity	The Lyell LyFE Manufacturing Center™ has commercial launch capability and can manufacture over 1,200 CAR T-cell doses at full capacity.

General and Administrative (G&A) expenses were $10.7 million for Q3 2025, down from $11.8 million in Q3 2024. This G&A reduction was mainly due to lower stock-based compensation expense and a decrease in outside services, specifically legal expenses.

A significant, non-recurring or milestone-based cost impacting the balance sheet was the upfront license payment for LYL273, which amounted to approximately $40 million.

The company's cash position is a key factor in managing these costs. Cash, cash equivalents, and marketable securities stood at approximately $320 million as of September 30, 2025, which, after the $40 million LYL273 payment, is expected to fund working capital and capital expenditures into 2027.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Revenue Streams

You're looking at the current and near-term revenue picture for Lyell Immunopharma, Inc. (LYEL) as of late 2025. For a company deep in late-stage clinical development, revenue is often minimal, coming from non-core activities until a product hits the market. The model here is clearly weighted toward future commercialization and potential upfront/milestone cash infusions.

The current, minimal revenue from product sales is quite small, reflecting the pre-commercial status of their pipeline. This is typical for a biotech firm focused on pivotal trials.

• Minimal current revenue from sales: $15,000 in Q3 2025.

The primary focus for significant revenue generation rests on their lead asset, ronde-cel (LYL314), which is advancing through pivotal trials for relapsed/refractory Large B-cell Lymphoma (LBCL). The path to commercial sales is clearly defined, though the revenue itself is still a few years out.

• Future commercial sales of LYL314 (ronde-cel) for LBCL.

Here's what the timeline looks like for LYL314:

Development Event	Targeted Timing	Indication Setting
Pivotal trial initiation (PiNACLE - H2H)	By early 2026	2L R/R LBCL
Biologics License Application (BLA) submission to the FDA	2027	3L+ R/R LBCL

Also on the pipeline is LYL273, which targets solid tumors, offering a diversification of potential future revenue streams beyond hematologic malignancies. This asset is currently in an earlier stage of development.

• Future commercial sales of LYL273 for mCRC and other solid tumors.

LYL273 is a GCC-targeted CAR T-cell product candidate. The receptor, GCC, is expressed on over 95% of colorectal cancers. Updated Phase 1 clinical data are expected in the first half of 2026.

Beyond product sales, Lyell Immunopharma, Inc. relies on non-operating income derived from its cash reserves. This interest income helps offset some operating burn, though it is sensitive to both the size of the cash balance and prevailing interest rates. You can see the cash balance has been managed, but interest income is a secondary, non-core revenue source.

Financial Metric	Amount (Q3 2025)
Interest income on cash and marketable securities	$3.3 million
Cash, cash equivalents and marketable securities (as of Sep 30, 2025)	Approximately $320 million

The company also has the potential for non-dilutive funding through strategic partnerships, which is a common revenue stream for clinical-stage biotechs. These deals typically involve an upfront payment and subsequent payments tied to development or regulatory achievements.

• Potential milestone payments from future licensing or collaboration agreements.

To be fair, while there was a recent report of Lyell Immunopharma, Inc. entering into an exclusive license agreement in November 2025, the specific dollar amounts for any milestone payments received or anticipated from that or other deals aren't detailed in the latest public filings, so we only list the potential for this type of revenue.

Finance: draft 13-week cash view by Friday.