Lyell Immunopharma, Inc. (LYEL): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la inmunoterapia contra el cáncer, Lyell Immunopharma, Inc. (Lyel) emerge como un innovador innovador, empuñando tecnologías de ingeniería de células T de vanguardia que prometen revolucionar el tratamiento tumoral sólido. Al mapear estratégicamente su lienzo de modelo de negocio, Lyell revela un enfoque sofisticado para transformar la terapia celular personalizada desde el concepto teórico hasta el posible avance clínico, posicionándose a la vanguardia de la investigación y el desarrollo de la inmunoterapia de precisión.

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: asociaciones clave

Colaboración estratégica con Bristol Myers Squibb

En diciembre de 2022, Lyell Immunopharma entró en una colaboración estratégica con Bristol Myers Squibb centrado en el desarrollo de la terapia con células T. La colaboración implica:

Detalle de la asociación	Valor específico
Pago por adelantado	$ 55 millones
Pagos potenciales de hitos	Hasta $ 2.16 mil millones
Enfoque de colaboración de investigación	Terapias de células T para tumores sólidos

Asociaciones de investigación académica

Lyell mantiene asociaciones de investigación con instituciones académicas clave:

• Universidad de Stanford
• Universidad de California, San Francisco
• Centro de cáncer de MD Anderson

Licencias de tecnología farmacéutica

Lyell ha seguido posibles acuerdos de licencia para tecnologías de inmunoterapia con las siguientes características:

Categoría de tecnología	Socios potenciales	Rango de valor estimado
Plataforma de ingeniería de células T	Compañías farmacéuticas no reveladas	Valor de licencia potencial de $ 50-150 millones
Tecnología de células T con forma de memoria	Firmas de biotecnología centradas en la oncología	$ 75-225 millones de valor potencial de colaboración

Colaboraciones del centro de tratamiento del cáncer

Lyell ha establecido colaboraciones de investigación con centros especializados de tratamiento del cáncer para avanzar en los ensayos clínicos y el desarrollo de la tecnología.

• Memorial Sloan Kettering Cancer Center
• Instituto del Cáncer Dana-Farber
• Fred Hutchinson Cancer Research Center

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: actividades clave

Investigación y desarrollo de terapia de células T

A partir del cuarto trimestre de 2023, Lyell Immunopharma invirtió $ 45.2 millones en investigación y desarrollo de terapia de células T. La compañía se enfoca en desarrollar Terapias de células T de próxima generación dirigido a tumores sólidos.

Categoría de investigación	Monto de la inversión	Enfoque de investigación
Ingeniería de células T	$ 22.7 millones	Inmunoterapias tumorales sólidas
Orientación molecular	$ 15.3 millones	Programación de células avanzadas
Optimización terapéutica	$ 7.2 millones	Mejoras de persistencia y eficacia

Ingeniería y fabricación de células avanzadas

Lyell opera un Instalación de fabricación de células de 20,000 pies cuadrados en el sur de San Francisco con una capacidad de producción anual de 500 lotes de células terapéuticas.

• Inversión de fabricación: $ 35.6 millones en 2023
• Infraestructura de producción compatible con GMP
• Tecnologías avanzadas de ingeniería celular

Diseño y ejecución del ensayo clínico

En 2023, Lyell realizó 4 ensayos clínicos activos con un presupuesto de investigación total de $ 63.4 millones.

Fase de prueba	Número de pruebas	Inscripción total del paciente
Fase I	2	76 pacientes
Fase II	2	124 pacientes

Innovación de la plataforma de inmunoterapia

Lyell se ha desarrollado Tecnologías de programación de células T patentadas con gastos de I + D de $ 28.9 millones en 2023.

Investigación preclínica y traslacional

La compañía asignó $ 18.7 millones a la investigación preclínica en 2023, centrándose en nuevos enfoques de inmunoterapia.

• Investigación de Ingeniería Molecular
• Identificación de objetivos terapéuticos
• Estudios de mecanismo inmunológico

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: recursos clave

Tecnología patentada de ingeniería de células T

Detalles de la plataforma de tecnología:

Aspecto tecnológico	Parámetros específicos
Enfoque de ingeniería de células T	Técnicas de modificación genética de precisión
Solicitudes de patentes	7 familias de patentes activas a partir de 2023
Inversión en desarrollo tecnológico	$ 24.3 millones de gastos de I + D en 2022

Investigaciones avanzadas y instalaciones de desarrollo

Especificaciones de la instalación:

• Ubicación de investigación principal: South San Francisco, California
• Espacio total de la instalación de investigación: 45,000 pies cuadrados
• Laboratorios de Nivel 2 de Nivel 3 de Bioseguridad

Cartera de propiedades intelectuales

Categoría de IP	Cantidad
Patentes emitidos	12 patentes globales
Aplicaciones de patentes pendientes	18 aplicaciones
Territorios de patentes	Estados Unidos, Europa, Japón

Equipo experimentado de liderazgo científico y médico

Posición de liderazgo	Total de años de experiencia
Director ejecutivo	22 años en biotecnología
Oficial científico	18 años en investigación de inmunoterapia
Miembros del equipo de liderazgo total	7 altos ejecutivos

Capacidades de fabricación de células especializadas

Infraestructura de fabricación:

• Instalaciones de producción celular certificadas por GMP
• Capacidad de producción anual: 5,000 unidades de terapia celular personalizadas
• Equipo de control de calidad: 22 personal especializado

Parámetro de fabricación	Especificación
Inversión manufacturera	$ 37.6 millones en 2022
Equipo de producción	3 unidades de procesamiento de células avanzadas

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocio: propuestas de valor

Terapias innovadoras de células T dirigidas a tumores sólidos

Lyell Immunopharma se centra en desarrollar terapias avanzadas de células T específicamente diseñadas para un tratamiento tumoral sólido. A partir del cuarto trimestre de 2023, la compañía tiene 3 programas primarios de terapia de células T en desarrollo clínico.

Programa de terapia	Etapa de desarrollo	Tipo de cáncer objetivo
Lyel-H1	Ensayo clínico de fase 1/2	Tumores sólidos
Lyel-H2	Desarrollo preclínico	Cánceres metastásicos
Lyel-H3	Etapa de investigación	Tumores sólidos avanzados

Enfoques de terapia celular personalizados

La estrategia de terapia celular personalizada de la compañía implica Ingeniería de células T específicas del paciente.

• Plataforma de ingeniería celular única
• Técnicas de modificación genética patentada
• Diseño de tratamiento individualizado

Posibles soluciones de tratamiento de cáncer de avance

Lyell Immunopharma ha invertido $ 48.3 millones en gastos de I + D durante 2023 para desarrollar soluciones innovadoras de tratamiento del cáncer.

Tecnologías avanzadas de ingeniería celular

Tecnología	Característica única	Impacto potencial
Plataforma de persistencia de células T	Supervivencia mejorada de células T	Mejor durabilidad del tratamiento
Sistema de modificación genética	Ingeniería genética precisa	Eliminación de células cancerosas dirigidas

Plataformas de inmunoterapia de precisión

El enfoque de inmunoterapia de precisión de la compañía incluye 2 plataformas tecnológicas primarias con posibles aplicaciones en múltiples tipos de cáncer.

• Mecanismos de orientación molecular
• Programación avanzada de células inmunes
• Optimización de respuesta inmune adaptativa

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: relaciones con los clientes

Comunidad directa de compromiso con la investigación de oncología

A partir del cuarto trimestre de 2023, Lyell Immunopharma mantiene estrategias de participación directa con aproximadamente 127 instituciones de investigación de oncología a nivel mundial.

Tipo de compromiso	Número de instituciones	Alcance geográfico
Centros de investigación académicos	84	América del Norte, Europa
Centros de cáncer integrales	43	Estados Unidos, Europa

Asociaciones de ensayos clínicos colaborativos

Lyell Immunopharma ha establecido 12 asociaciones de ensayos clínicos activos En múltiples dominios de investigación de oncología.

• Ensayos de inmuno-oncología de fase I/II: 5 asociaciones
• Colaboraciones avanzadas de terapia de células T: 4 asociaciones
• Investigación de inmunoterapia de precisión: 3 asociaciones

Conferencia científica y presentaciones de simposio

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias internacionales de oncología	7	Más de 3,500 investigadores
Simposios de inmunoterapia especializados	4	1,200+ especialistas

Programas de apoyo y educación del paciente

Lyell Immunopharma se ha desarrollado 3 Iniciativas integrales de apoyo al paciente dirigido a áreas específicas de investigación de inmunoterapia.

• Sebinarios web de información del paciente: sesiones trimestrales
• Recursos educativos en línea: 12 guías de investigación detalladas
• Red de apoyo para participantes de ensayos clínicos

Comunicación transparente del progreso de la investigación

Los canales de comunicación incluyen actualizaciones de investigación trimestrales y presentaciones de inversores.

Canal de comunicación	Frecuencia	Audiencia
Presentaciones de inversores	Trimestral	Inversores institucionales, partes interesadas de investigación
Informes de progreso de la investigación	Semestral	Comunidad científica, socios potenciales

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: canales

Comunicaciones científicas directas

A partir del cuarto trimestre de 2023, Lyell Immunopharma utilizó los siguientes canales de comunicación científica directa:

Tipo de canal	Frecuencia	Público objetivo
Comunicaciones del equipo de investigación directa	Semanalmente	Investigadores de inmunoterapia
Reuniones de la junta asesora científica	Trimestral	Expertos científicos externos

Presentaciones de conferencia médica

Lyell Immunopharma presentó a 7 principales conferencias científicas en 2023:

• Asociación Americana para la Investigación del Cáncer (AACR)
• Sociedad de Inmunoterapia de Cáncer (SITC)
• Sociedad Europea de Oncología Médica (ESMO)

Publicaciones de revistas revisadas por pares

Diario	Publicaciones en 2023	Factor de impacto
Biotecnología de la naturaleza	2	41.4
Celúla	1	47.3

Plataformas de relaciones con los inversores

Los canales de relaciones con los inversores de Lyell Immunopharma incluyen:

• Llamadas de ganancias trimestrales
• Reuniones anuales de accionistas
• SEC presentando comunicaciones
• Sebinarios web de presentación de inversores

Redes de comunicación científica digital

Plataforma	Seguidores/conexiones	Propósito principal
LinkedIn	12,500	Redes profesionales
Investigador	450 miembros de la investigación	Colaboración científica

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

Instituciones de investigación de oncología

Lyell Immunopharma se dirige a instituciones de oncología académica y centradas en la investigación con características específicas:

Tipo de institución	Número de clientes potenciales	Enfoque de investigación
Centros de cáncer designados por NCI	71	Terapias de células T
Universidades de investigación de primer nivel	38	Desarrollo de inmunoterapia

Compañías farmacéuticas

Los segmentos de clientes farmacéuticos clave incluyen:

• Grandes compañías farmacéuticas con divisiones de oncología
• Firmas de biotecnología de tamaño mediano que se centran en las inmunoterapias
• Compañías farmacéuticas centradas en la oncología emergente

Tamaño de la empresa	Recuento potencial de clientes	Rango anual de presupuesto de I + D
Pharma grande (Top 20)	20	$ 3B - $ 12B
Biotecnología de tamaño mediano	45	$ 500M - $ 2B

Centros de tratamiento del cáncer

Lyell se dirige a las instalaciones especializadas de tratamiento del cáncer:

Tipo central	Total en Estados Unidos	Interés potencial en terapias avanzadas
Centros de cáncer integrales	51	Alto
Centros de cáncer comunitario	1,500	Medio

Laboratorios de investigación académica

Segmentos de investigación académica dirigidos:

• Departamentos de investigación de inmunología
• Laboratorios centrados en oncología
• Unidades de investigación de terapia celular

Tipo de laboratorio	Número estimado	Financiación anual de investigación
Laboratorios de investigación de primer nivel	87	$ 5M - $ 50M

Inversores de biotecnología

Segmentos de clientes centrados en la inversión:

Tipo de inversor	Número de inversores potenciales	Rango de inversión promedio
Empresas de capital de riesgo	62	$ 10M - $ 100M
Inversores de capital privado	38	$ 50M - $ 500M

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Lyell Immunopharma reportó gastos de I + D de $ 196.3 millones, lo que representa una inversión significativa en su investigación científica y desarrollo tecnológico.

Año fiscal	Gastos de I + D	Porcentaje de costos operativos totales
2022	$ 178.6 millones	62.4%
2023	$ 196.3 millones	65.2%

Inversiones de ensayos clínicos

Los gastos de ensayos clínicos para la inmunopharma de Lyell en 2023 totalizaron aproximadamente $ 87.5 millones, centrándose en la terapia celular y la investigación de inmunoterapia.

• Ensayos clínicos de fase I: $ 32.4 millones
• Ensayos clínicos de fase II: $ 41.6 millones
• Estudios preclínicos: $ 13.5 millones

Mantenimiento de la plataforma de tecnología

Los costos de infraestructura y mantenimiento de tecnología para 2023 se estimaron en $ 24.7 millones.

Categoría de mantenimiento de tecnología	Costo anual
Infraestructura	$ 9.2 millones
Licencia de software	$ 6.5 millones
Computación en la nube	$ 5.3 millones
Ciberseguridad	$ 3.7 millones

Protección de propiedad intelectual

Los gastos de protección de la propiedad intelectual para 2023 fueron de $ 12.6 millones.

• Presentación y mantenimiento de patentes: $ 7.3 millones
• Consulta legal: $ 3.8 millones
• Gestión de cartera de IP: $ 1.5 millones

Infraestructura de fabricación

La infraestructura de fabricación y los costos operativos para 2023 ascendieron a $ 45.2 millones.

Categoría de costos de fabricación	Costo anual
Mantenimiento de la instalación	$ 18.6 millones
Depreciación del equipo	$ 14.3 millones
Adquisición de materia prima	$ 8.7 millones
Control de calidad	$ 3.6 millones

Lyell Immunopharma, Inc. (Lyel) - Modelo de negocios: flujos de ingresos

Posibles acuerdos de licencia

A partir del cuarto trimestre de 2023, Lyell Immunopharma no ha informado de ingresos específicos de licencia. No se han revelado públicamente los acuerdos de licencia confirmados.

Financiación de la colaboración de investigación

Socio de colaboración	Monto de financiación	Año
Genentech	Pago por adelantado de $ 150 millones	2022
Genentech	Potencial de hasta $ 3 mil millones en pagos por hitos	2022-futuro

Venta de productos terapéuticos futuros

No se informaron ventas de productos terapéuticos actuales a partir de 2024. Los productos de Lyell permanecen en etapas de desarrollo clínico.

Pagos de hitos de las asociaciones

• Pagos de hitos potenciales de colaboración de Genentech: hasta $ 3 mil millones
• Criterios de logro de hito específicos no detallados públicamente

Financiación potencial de la subvención

No se informaron montos de financiación de subvenciones específicos en los estados financieros recientes.

Métrica financiera	Cantidad	Período
Ingresos totales	$ 30.7 millones	P3 2023
Pérdida neta	$ 45.2 millones	P3 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.