89bio, Inc. (ETNB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, 89bio, Inc. (ETNB) emerge como un innovador innovador, posicionado estratégicamente para revolucionar los tratamientos de enfermedades metabólicas y hepáticas a través de su enfoque terapéutico basado en péptidos de vanguardia. Al aprovechar un modelo de negocio sofisticado que entrea en investigación científica avanzada, asociaciones estratégicas y medicina de precisión, la compañía está a punto de abordar las necesidades médicas no satisfechas críticas mientras potencialmente transforma los resultados de los pacientes en dominios de enfermedades complejos. Su propuesta de valor única combina excelencia científica, investigación dirigida y una estrategia integral que promete desbloquear nuevas fronteras en la innovación médica.

89bio, Inc. (ETNB) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

89bio ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año iniciado
Universidad de Stanford	Investigación de enfermedades metabólicas	2022
Universidad de California, San Francisco	Desarrollo terapéutico de la enfermedad hepática	2021

Asociaciones con centros de ensayos clínicos y hospitales de investigación

Las asociaciones actuales de ensayos clínicos incluyen:

• Clínica de mayonesa
• Hospital Mount Sinai
• Clínica de Cleveland

Organizaciones de investigación de contratos de biotecnología

Socio de CRO	Servicios proporcionados	Valor de contrato
IQVIA	Gestión de ensayos clínicos de fase 2/3	$ 4.2 millones
Parexel International	Apoyo para el desarrollo de drogas	$ 3.7 millones

Colaboración con fabricantes de dispositivos médicos

Asociaciones clave del fabricante de dispositivos médicos:

• Medtrónico
• Laboratorios de Abbott

Compromiso del cuerpo regulatorio

Interacciones regulatorias documentadas:

Cuerpo regulador	Tipo de interacción	Drogas/terapia
FDA	Aplicación de drogas de nueva investigación	Pegozafermina (tratamiento de la enfermedad hepática)
EMA	Procedimiento de asesoramiento científico	Enfermedad metabólica terapéutica

89bio, Inc. (ETNB) - Modelo de negocio: actividades clave

Desarrollo de terapias innovadoras basadas en péptidos

89BIO se centra en el desarrollo de terapias basadas en péptidos dirigidos a enfermedades metabólicas y cardiovasculares específicas. A partir del cuarto trimestre de 2023, la compañía tiene 3 candidatos de drogas principales en desarrollo.

Candidato a la droga	Área terapéutica	Etapa de desarrollo
Terapia con péptidos dirigidos a Nash	Enfermedad metabólica	Ensayo clínico de fase 2
Terapia con péptidos cardiovasculares	Enfermedad cardiovascular	Etapa preclínica
Péptido de trastorno metabólico	Trastorno metabólico	Etapa preclínica

Realización de investigaciones preclínicas y clínicas

La inversión de investigación para 2023 totalizaron $ 45.2 millones, dedicadas a avanzar en plataformas terapéuticas peptídicas.

• Presupuesto de investigación preclínica: $ 18.7 millones
• Gastos de investigación de ensayos clínicos: $ 26.5 millones
• Personal de investigación: 47 científicos e investigadores

Avanzar a los candidatos a los medicamentos a través de etapas de ensayos clínicos

La tubería de desarrollo clínico actual se centra en las indicaciones metabólicas y cardiovasculares.

Programa de drogas	Etapa actual	Línea de tiempo estimada
Terapia de péptidos para Nash	Fase 2	2024-2025
Terapia con péptidos cardiovasculares	IND Preparación	2025

Ingeniería molecular y descubrimiento de fármacos

Las inversiones de ingeniería molecular en 2023 alcanzaron $ 12.3 millones, centrándose en la optimización de péptidos y el nuevo diseño terapéutico.

• Plataforma de ingeniería péptidos patentada
• 5 programas de diseño molecular activo
• Solicitudes de patentes: 8 nuevas presentaciones en 2023

Desarrollo y protección de la propiedad intelectual

La cartera de propiedades intelectuales a partir de 2024 incluye 22 familias de patentes totales.

Categoría de IP	Número de patentes	Cobertura geográfica
Tecnología de péptidos	12 familias de patentes	EE. UU., EU, China
Composiciones terapéuticas	7 familias de patentes	Nosotros, EU
Mecanismos de administración de medicamentos	3 familias de patentes	A NOSOTROS

89bio, Inc. (ETNB) - Modelo de negocio: recursos clave

Instalaciones avanzadas de investigación de biotecnología

89bio opera una instalación de investigación ubicada en San Francisco, California, con aproximadamente 15,000 pies cuadrados de laboratorio dedicado y espacio de investigación.

Atributo de instalación	Especificación
Espacio total de investigación	15,000 pies cuadrados
Ubicación	San Francisco, CA
Inversión en equipos de investigación (2023)	$ 4.2 millones

Plataforma de ingeniería péptidos patentada

Características clave de la plataforma:

• Desarrollado a través de $ 37.5 millones en inversiones de investigación y desarrollo
• Se enfoca en intervenciones terapéuticas metabólicas y cardiovasculares
• Capaz de diseñar nuevas terapias peptídicas

Equipo científico y de gestión experimentado

Composición del equipo	Número
Total de empleados	62 (a partir del cuarto trimestre 2023)
Titulares de doctorado	28
Ejecutivos de gestión	7

Cartera de propiedades intelectuales

• Solicitudes de patentes totales: 16
• Patentes concedidas: 8
• Familias de patentes: 5
• Cobertura geográfica: Estados Unidos, Europa, Japón

Equipos y tecnologías de investigación especializadas

Categoría de equipo	Cantidad	Valor total
Sistemas de cromatografía líquida de alto rendimiento (HPLC)	4	$ 1.2 millones
Espectrómetros de masas	3	$ 1.5 millones
Laboratorios de cultivo celular	2	$850,000

89bio, Inc. (ETNB) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades metabólicas y hepáticas

89bio, Inc. se centra en el desarrollo de terapias dirigidas para enfermedades metabólicas y hepáticas, con un énfasis específico en su candidato de producto principal Pegozafermin (PEG-FGF21) para la esteatohepatitis no alcohólica (NASH).

Candidato al producto	Indicación objetivo	Etapa de desarrollo	Valor de mercado potencial
Pegozafermina	Nash	Fase 2B de ensayo clínico	Tamaño potencial del mercado de $ 35 mil millones

Posibles tratamientos innovadores con nuevas tecnologías de péptidos

89BIO aprovecha las tecnologías avanzadas de ingeniería de péptidos para desarrollar enfoques terapéuticos innovadores.

• Plataforma de modificación de péptidos patentados
• Tecnologías de péptidos de vida media extendida
• Estrategias de tratamiento de enfermedad metabólica mejorada

Terapias dirigidas con resultados mejorados del paciente

El enfoque terapéutico de la compañía se centra en la medicina de precisión con potencial para mejorar los resultados clínicos.

Enfoque terapéutico	Métricas clave de rendimiento
Intervención de enfermedades metabólicas	Reducción potencial de la grasa hepática en> 30%
Tratamiento de fibrosis	Mejora potencial en los marcadores de salud hepática

Abordar las necesidades médicas no satisfechas en áreas de enfermedades específicas

89BIO apunta a las necesidades médicas no satisfechas críticas en enfermedades metabólicas y hepáticas.

• Tratamiento de NASH con opciones terapéuticas actuales limitadas
• Intervenciones de trastorno metabólico
• Reducción potencial del riesgo cardiovascular

Enfoque de medicina de precisión para el desarrollo de medicamentos

La compañía emplea una sofisticada estrategia de medicina de precisión en el desarrollo de medicamentos.

Estrategia de desarrollo	Componentes tecnológicos clave
Ingeniería de péptidos	Técnicas avanzadas de modificación molecular
Diseño de ensayo clínico	Selección de población de pacientes dirigida

89bio, Inc. (ETNB) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

89BIO mantiene canales de comunicación directa con profesionales de la salud a través de programas de divulgación específicos. A partir del cuarto trimestre de 2023, la compañía reportó 247 interacciones especializadas con especialistas en hepatología y endocrinología.

Tipo de compromiso	Número de interacciones	Enfoque especializado
Consultas individuales	127	Hepatología
Informes médicos digitales	82	Endocrinología
Reuniones de asesoramiento clínico	38	Trastornos metabólicos

Conferencia científica y presentaciones de simposio médico

En 2023, 89bio participó en 14 conferencias médicas principales, presentando investigaciones sobre sus candidatos terapéuticos principales.

• Conferencia anual de la Asociación Americana de la Diabetes: 4 presentaciones
• Congreso internacional de hígado: 3 presentaciones
• Reunión anual de la sociedad endocrina: 5 presentaciones
• Cumbre de enfermedad metabólica: 2 presentaciones

Comunicación transparente del progreso del ensayo clínico

89BIO proporciona actualizaciones detalladas de ensayos clínicos a través de múltiples canales de comunicación. A diciembre de 2023, la compañía publicó 22 actualizaciones integrales de investigación en plataformas digitales.

Canal de comunicación	Número de actualizaciones	Alcanzar
Sitio web de la empresa	12	Comunidad médica global
Revistas revisadas por pares	6	Investigadores académicos
Plataformas de relaciones con los inversores	4	Partes interesadas financieras

Programas de apoyo y educación del paciente

89BIO desarrolló iniciativas específicas de apoyo al paciente que se centran en el manejo de enfermedades metabólicas. En 2023, la compañía llegó a aproximadamente 1,583 pacientes a través de recursos educativos.

• Portal de información del paciente digital
• Serie de seminarios web mensuales
• Guías de recursos para pacientes
• Comunidad de apoyo en línea

Plataformas digitales para la difusión de información médica

La compañía aprovecha múltiples plataformas digitales para distribuir información médica. Las métricas de participación digital para 2023 muestran 42,675 interacciones profesionales médicas únicas.

Plataforma digital	Interacciones únicas	Audiencia principal
Red profesional de LinkedIn	18,247	Profesionales de la salud
Portal de investigación de la empresa	14,328	Investigadores académicos
Seminarios web de información médica	10,100	Comunidad médica global

89bio, Inc. (ETNB) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

89bio, Inc. utiliza un enfoque de ventas directo dirigido a instituciones de salud especializadas que se centran en enfermedades hepáticas y metabólicas. A partir del cuarto trimestre de 2023, la compañía reportó 37 cuentas institucionales activas en los Estados Unidos.

Tipo de canal	Número de cuentas institucionales	Cobertura geográfica
Centros de hepatología	18	12 estados de EE. UU.
Clínicas de enfermedad metabólica	19	15 estados de EE. UU.

Asociaciones con distribuidores farmacéuticos

89bio ha establecido asociaciones de distribución estratégica para expandir el alcance del mercado.

• AmerisourceBergen: socio de distribución principal
• Cardinal Health: Red de distribución secundaria
• McKesson Corporation: distribución especializada de productos de enfermedad metabólica

Presentaciones de conferencia médica

En 2023, 89bio participó en 7 conferencias médicas principales, presentando datos clínicos para sus candidatos de productos principales.

Nombre de conferencia	Fecha	Enfoque de presentación
Congreso internacional de hígado de EASL	Abril de 2023	Terapéutica de la enfermedad hepática
Conferencia de la Asociación Americana de Diabetes	Junio ​​de 2023	Investigación de enfermedades metabólicas

Publicaciones científicas y revistas revisadas por pares

89bio publicó 5 artículos de investigación revisados ​​por pares en 2023, dirigidos a revistas de alto impacto en hepatología e investigación de enfermedades metabólicas.

• Revista de hepatología: 2 publicaciones
• Cuidado de diabetes: 1 publicación
• Revista de Investigación Clínica: 2 Publicaciones

Plataformas de comunicación digital

Métricas de participación digital para 89bio a diciembre de 2023:

Plataforma	Seguidores/suscriptores	Tasa de compromiso
LinkedIn	12,500	3.2%
Gorjeo	8,700	2.9%
Sitio web corporativo	45,000 visitantes mensuales	Tasa de conversión de 4.5%

89bio, Inc. (ETNB) - Modelo de negocio: segmentos de clientes

Especialistas en hepatología y enfermedad metabólica

Tamaño estimado del mercado objetivo: 15,000 especialistas en hepatología a nivel mundial a partir de 2023

Característica de segmento	Datos cuantitativos
Especialistas en hepatología global	15,000
Especialistas norteamericanos	4,500
Especialistas en europeos	5,200

Investigar hospitales y centros médicos

Instituciones de investigación potenciales totales en todo el mundo: 2.800

• Hospitales de investigación de los Estados Unidos: 1.100
• Centros de investigación europeos: 900
• Hospitales de investigación asiática: 600
• Resto del mundo: 200

Compañías farmacéuticas

Tipo de empresa	Número de socios potenciales
Grandes compañías farmacéuticas	25
Compañías farmacéuticas de tamaño mediano	50
Compañías de biotecnología	75

Grupos de pacientes con trastornos metabólicos específicos

Estimaciones de población de pacientes globales:

• Esteatohepatitis no alcohólica (NASH): 16,5 millones de pacientes
• Trastornos metabólicos: 23 millones de pacientes
• Popular población de pacientes objetivo: 6.2 millones

Instituciones académicas e de investigación

Región	Número de instituciones
América del norte	450
Europa	380
Asia-Pacífico	290
Resto del mundo	120

89bio, Inc. (ETNB) - Modelo de negocio: estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, 89bio, Inc. reportó gastos totales de investigación y desarrollo de $ 73.1 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Aumento porcentual
2022	$ 52.4 millones	39.5%
2023	$ 73.1 millones	39.5%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 89BIO, Inc. en 2023 totalizaron aproximadamente $ 45.3 millones, centrados en avanzar en sus candidatos de productos principales.

• Ensayos de fase 2 para Pegozamir (enfermedad hepática)
• Estudios en curso para NNV-4128 (enfermedades metabólicas)
• Costos de desarrollo preclínico

Protección de propiedad intelectual

La compañía invirtió $ 2.1 millones en protección de propiedad intelectual y mantenimiento de patentes durante 2023.

Categoría de IP	Gastos	Número de patentes
Presentación de patentes	$ 1.2 millones	17 patentes activas
Mantenimiento de patentes	$ 0.9 millones	12 patentes mantenidas

Adquisición de personal y talento

Los gastos totales relacionados con el personal para 89bio, Inc. en 2023 alcanzaron $ 38.6 millones, incluidos salarios, beneficios y costos de reclutamiento.

• Total de empleados: 184
• Compensación promedio por empleado: $ 210,000
• Costos de reclutamiento e incorporación: $ 1.5 millones

Mantenimiento de laboratorio y equipos

Los costos de mantenimiento de laboratorio y equipos para 2023 fueron de $ 12.4 millones, que cubren infraestructura científica especializada.

Categoría de equipo	Gasto de mantenimiento	Presupuesto de reemplazo
Instrumentos de investigación	$ 7.2 millones	$ 3.5 millones
Instalaciones de laboratorio	$ 5.2 millones	$ 2.1 millones

89bio, Inc. (ETNB) - Modelo de negocio: flujos de ingresos

Licencias potenciales de candidatos a drogas

A partir del cuarto trimestre de 2023, 89BIO tiene oportunidades de licencia potenciales para sus candidatos a drogas principales, que incluyen:

Candidato a la droga	Valor de licencia potencial	Etapa de desarrollo
Pegozafermina (Bio89-100)	$ 250 millones potencial por adelantado	Desarrollo de fase 3
Terapéutica de la enfermedad hepática	$ 150-200 millones de potencial estimado	Estadio clínico

Ventas de productos farmacéuticos futuros

Potencial de venta de productos farmacéuticos proyectados:

• Oportunidad de mercado estimada para el tratamiento de NASH: $ 35 mil millones para 2026
• Ingresos anuales potenciales de Pegozafermina: $ 500 millones a $ 1 mil millones

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
NIH Subvenciones de investigación	$ 2.5 millones	2023
Subvenciones SBIR/STTR	$ 1.8 millones	2023

Acuerdos de asociación estratégica

Flujos de ingresos de asociación estratégica actuales:

• Colaboración con compañías farmacéuticas: pagos potenciales de hitos
• Valor de acuerdo de asociación total: estimado de $ 300-400 millones

Pagos potenciales de hitos de colaboraciones

Tipo de hito	Rango de pago potencial	Condiciones
Hitos de desarrollo	$ 50-100 millones	Progresión del ensayo clínico
Hitos de aprobación regulatoria	$ 100-200 millones	Aprobación de la FDA/EMA
Hitos comerciales de lanzamiento	$ 150-250 millones	Primera venta comercial

89bio, Inc. (ETNB) - Canvas Business Model: Value Propositions

You're looking at the core reasons why 89bio, Inc. (ETNB) believes its lead candidate, pegozafermin, can capture significant value in the cardiometabolic and liver disease space. The value proposition centers on a dual indication strategy and a differentiated delivery profile.

Dual Efficacy: Treating Both Liver (MASH Fibrosis) and Cardiometabolic (SHTG) Diseases

Pegozafermin is engineered to address two distinct, yet often co-morbid, conditions: metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and severe hypertriglyceridemia (SHTG). This dual focus broadens the potential patient population and commercial reach.

The clinical development program reflects this strategy:

• Phase 3 ENLIGHTEN-Fibrosis targets non-cirrhotic MASH patients with fibrosis stages F2-F3.
• Phase 3 ENLIGHTEN-Cirrhosis targets compensated cirrhotic MASH patients with fibrosis stage F4.
• Phase 3 ENTRUST trial evaluates efficacy in patients with SHTG.

Potentially Best-in-Class: Differentiated Profile Among FGF21 Analogs for MASH/SHTG

89bio, Inc. (ETNB) positions pegozafermin as potentially best-in-class due to its underlying technology, which is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). This engineering aims to optimize biological activity through an extended half-life.

The differentiation is quantified in preclinical work:

Metric	Pegozafermin Profile	Comparison Point
Potency at FGFR1	Approximately 8-fold higher potency	Native FGF21
Tolerability	Differentiated profile	Resmetirom (which showed 41% adverse event rates in real-world use)

Convenient Dosing: Once-Weekly Subcutaneous Injection for Improved Patient Adherence

A key differentiator is the dosing flexibility designed to combat patient non-adherence, a common issue with chronic therapies. Pegozafermin's profile supports less frequent administration compared to some alternatives.

The Phase 3 ENLIGHTEN trials are designed to evaluate two specific dosing regimens:

• 30mg administered weekly (QW).
• 44mg administered every two weeks (Q2W).

This flexibility is intended to improve compliance in patients managing long-term conditions.

Fibrosis Regression: Demonstrated Ability to Regress Liver Fibrosis in MASH Patients

The value proposition is strongly supported by data from the Phase 2b ENLIVEN trial, which showed that pegozafermin has direct anti-fibrotic effects on the liver.

Key efficacy achievements from the Phase 2b trial include:

• Achieved both MASH resolution and fibrosis improvement.
• Improvement in FAST scores (Fibrosis, Attenuation, and Shadowing Test).
• Primary endpoint success included the proportion of participants achieving a ≥1 stage decrease in fibrosis stage with no worsening of MASH at week 24.

Addressing Unmet Need: Targeting Advanced MASH (F2-F4) and SHTG Patients with Limited Options

The target market size underscores the significant unmet need. The global MASH treatment market was valued at $7.87 billion in 2024 and is projected to reach $31.76 billion by 2033. Specifically, the stage 2-3 fibrosis segment is expected to grow at a 27.2% CAGR through 2033.

For SHTG, the global treatment market is expected to reach a market value of $2.67 billion by 2033, where current treatment options are noted as limited.

Financially, 89bio, Inc. (ETNB) was positioned with approximately $440 million in cash, cash equivalents, and marketable securities as of December 31, 2024, to advance these high-need programs toward expected topline data from the ENTRUST trial in the second half of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Relationships

You're looking at the relationships 89bio, Inc. maintained with its key stakeholders right up until the acquisition closed in late 2025. For a clinical-stage company, these relationships-with investigators, regulators, investors, and now, a strategic partner-are the lifeblood that funds and validates the science. Honestly, the relationship landscape shifted dramatically in Q4 2025.

High-Touch Clinical Engagement: Direct relationships with clinical investigators and sites

The core of 89bio's operational relationship was managing the global Phase 3 programs for pegozafermin. This required intense, direct engagement with clinical investigators and site staff to ensure protocol adherence and patient safety across multiple indications. The company was running three major global Phase 3 trials, which demands a high-touch approach to maintain momentum.

Here's a look at the status of those critical relationships as of mid-2025:

Trial Program	Indication	Enrollment Status (as of mid-2025)	Next Key Data Readout Expectation
ENTRUST	Severe Hypertriglyceridemia (SHTG)	Enrollment Completed	Topline data expected in Q1 2026 (updated from H2 2025)
ENLIGHTEN-Fibrosis	MASH with F2-F3 Fibrosis	Actively Enrolling Globally	Topline histology data expected in 1H 2027
ENLIGHTEN-Cirrhosis	MASH with F4 Cirrhosis	Actively Enrolling Globally	Topline histology data expected in 2028

Maintaining these sites meant managing the operational spend; for instance, Research and Development (R&D) expenses hit $103.9 million in Q2 2025, largely driven by advancing these Phase 3 MASH programs. That's the cost of keeping those clinical relationships active and on schedule.

Regulatory Dialogue: Continuous interaction with FDA and EMA for development pathway

The relationship with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) was centered on securing approval pathways. 89bio, Inc. had successfully aligned with both agencies on the Phase 3 ENLIGHTEN program design.

• Alignment secured for an accelerated approval pathway for both F2-F3 and compensated F4 MASH using histology cohorts.
• The trials were designed to continue for outcomes data to potentially support full approval across F2-F4 MASH.
• The company had obtained regulatory feedback on both clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings.

This alignment, established prior to 2025, was a major de-risking event that directly informed the structure of the ongoing clinical engagement.

Investor Relations: Managing expectations around Phase 3 readouts and acquisition

Investor relations in 2025 was a balancing act between communicating clinical progress and managing the financial runway, which culminated in the acquisition announcement. You had to manage expectations for data readouts that spanned from Q1 2026 through 2028.

Key financial metrics relevant to investor confidence leading up to the deal:

• Cash, cash equivalents, and marketable securities stood at $638.8 million as of March 31, 2025.
• This strengthened to $561.2 million by June 30, 2025, following a Q1 follow-on offering that generated gross proceeds of $287.5 million.
• The net loss for Q2 2025 was $111.5 million, reflecting the high cost of advancing late-stage trials.

The relationship shifted entirely on September 18, 2025, when Roche announced the definitive merger agreement. The offer was $14.50 per share in cash, representing a premium of approximately 52% to the 60-day VWAP as of September 17, 2025. By October 29, 2025, approximately 60.49% of shares were tendered, effectively securing the relationship transition.

Strategic Partner Management: Close collaboration with Roche on integration planning

This relationship became the defining one for 89bio, Inc. by late 2025. The merger agreement established a clear path for integration, moving from a partnership to full ownership.

The deal structure itself defines the post-acquisition relationship terms:

Deal Component	Value/Term	Condition/Date
Upfront Cash Payment	$14.50 per share	At closing (October 2025)
Contingent Value Right (CVR) - Max Value	Up to an aggregate of $6.00 per share	Upon achievement of certain milestones
CVR Milestone 1 (F4 MASH Sale)	$2.00 per share	First commercial sale in F4 MASH by March 31, 2030
CVR Milestone 2 (Sales Target)	$1.50 per share	Pegozafermin reaching annual net sales of at least $3.0 billion globally by December 31, 2033

The tender offer expired on October 29, 2025, and Roche intended to complete the acquisition via a second-step merger shortly thereafter, meaning the focus shifted to integrating 89bio's pipeline and manufacturing capabilities, including a commercial-scale production facility for which a non-recurring payment of $42.4 million was made in Q2 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Channels

Global Clinical Trial Sites: Primary channel for drug delivery and data collection.

89bio, Inc. is advancing pegozafermin through three global Phase 3 trials as of late 2025, which serve as the primary channel for gathering efficacy and safety data necessary for market access submissions.

• The Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG) completed enrollment, with topline 26-week data anticipated in the second half of 2025.
• The Phase 3 ENLIGHTEN program for metabolic dysfunction-associated steatohepatitis (MASH) continues to enroll patients globally across two studies: ENLIGHTEN-Fibrosis (non-cirrhotic F2-F3 MASH) initiated in March 2024, and ENLIGHTEN-Cirrhosis (compensated cirrhotic F4 MASH) initiated in May 2024.
• Data readouts for ENLIGHTEN-Fibrosis are expected in the first half of 2027, with ENLIGHTEN-Cirrhosis data expected in 2028.
• As of June 30, 2025, 89bio, Inc. reported cash, cash equivalents, and marketable securities of approximately $561.2 million to fund these ongoing global operations.

Regulatory Submissions: BLA/MAA filings to the FDA and EMA for market access.

The clinical trial channel directly feeds into the regulatory channel, with the goal of achieving marketing authorization. 89bio, Inc. obtained regulatory feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings are contingent upon positive clinical data from the Phase 3 programs. The company also completed construction of a commercial-scale production facility to support the BLA filing, with a remaining final milestone payment of $13.5 million due in 2026 upon facility completion.

Scientific Publications/Conferences: Disseminating clinical data to medical community.

Dissemination of data occurs through presentations at key medical and investor conferences, which is a critical channel for establishing scientific credibility and communicating progress to the financial community. Management participated in several investor conferences in the third quarter of 2025, including:

• Citi's 2025 Biopharma Back to School Conference on Wednesday, September 3, 2025.
• Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025.
• H.C. Wainwright 27th Annual Global Investment Conference starting Monday, September 8, 2025.

The company previously presented data from the Phase 2b ENLIVEN trial extension at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5 to 8, 2024.

Future Pharmaceutical Distribution: Leveraging Roche's global commercial infrastructure post-closing.

The future distribution channel is defined by the definitive merger agreement announced on September 17, 2025, where Roche agreed to acquire 89bio, Inc.. Upon closing, expected in the fourth quarter of 2025, 89bio, Inc. will be integrated into Roche's Pharmaceuticals Division, utilizing Roche's established global resources and infrastructure for commercialization.

The transaction terms define the financial structure underpinning this future channel:

Transaction Component	Amount/Value	Condition/Timing
Upfront Cash Per Share at Closing	$14.50 per share in cash	At closing of the tender offer
Aggregate Upfront Cash Payment	$2.4 billion	Based on outstanding shares at closing
Maximum Contingent Value Right (CVR) Per Share	Up to $6.00 per share in cash	Payable upon achievement of specified milestones
Total Potential Equity Value (Fully Diluted)	Up to approximately $3.5 billion	Includes upfront cash and maximum CVR payments
CVR Milestone 1: F4 MASH First Commercial Sale	$2.00 per share	By March 31, 2030
CVR Milestone 2: Global Net Sales of $3.0 Billion	$1.50 per share	By December 31, 2033
CVR Milestone 3: Global Net Sales of $4.0 Billion	$2.50 per share	By December 31, 2035

The company's Q2 2025 financial performance showed a net loss of $111.5 million for the three months ended June 30, 2025, with Research and Development Expenses at $103.9 million, reflecting the investment into these late-stage development and commercial readiness channels.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Segments

You're looking at the customer segments for 89bio, Inc. (ETNB) right after the definitive merger agreement with Roche was announced in September 2025. The focus shifts from a broad patient/physician base to the acquiring entity, Roche, as the primary customer for the asset, pegozafermin.

The customer segments are defined by the indications for pegozafermin and the strategic buyer.

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients: Specifically those with advanced fibrosis (F2-F4).
• Severe Hypertriglyceridemia (SHTG) Patients: Individuals with severely elevated triglyceride levels.
• Prescribing Physicians/Specialists: Hepatologists, endocrinologists, and cardiologists.
• Roche: The acquiring entity, which becomes the primary customer for the asset.

The MASH patient population represents a significant, growing market. The drug candidate, pegozafermin, is in Phase 3 trials targeting both non-cirrhotic (F2-F3) and cirrhotic (F4) MASH patients, with topline histology data expected in the first half of 2027 for F2-F3 and in 2028 for F4. MASH cases in the US are projected to rise by 82.6% to 19.53 million by 2039. For patients with Type 2 Diabetes, the prevalence of MASLD/MASH is almost 69%.

For Severe Hypertriglyceridemia (SHTG), defined as triglyceride levels $\ge \mathbf{500 \text{ mg/dL}}$, the patient base is smaller but carries an acute risk of pancreatitis. Approximately 3 million people live with SHTG in the U.S., with over 1 million considered high risk. SHTG is prevalent in approximately 1-2% of the U.S. population.

The transaction itself quantifies the value of these segments to the ultimate customer, Roche. Here's the quick math on the deal structure as of late 2025:

Customer/Segment Metric	Value/Amount
Total Potential Deal Value (Upfront + CVRs)	Up to $3.5 billion
Upfront Equity Value at Closing	Approximately $2.4 billion
Upfront Price Per Share	$14.50 per share in cash
Maximum CVR Payout	Up to an aggregate of $6.00 per share (or up to $1.1 billion total)
MASH Patient Projection (US, by 2039)	19.53 million cases
SHTG Patient Population (US Estimate)	Approximately 3 million people

The prescribing physicians-Hepatologists, endocrinologists, and cardiologists-are the gatekeepers who will write the prescriptions for pegozafermin, which is being tested for dosing every one or two weeks depending on the indication. Post-acquisition, these physicians will interact with Roche's commercial organization, which gains the asset after 89bio, Inc. (ETNB) reported cash, cash equivalents, and marketable securities of approximately $561.2 million as of June 30, 2025.

Roche, as the acquiring entity, is the final customer segment, purchasing the asset for its CVRM (Cardiovascular, Renal, and Metabolic Diseases) pipeline. The deal is expected to close in the fourth quarter of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Cost Structure

You're looking at the cost side of 89bio, Inc. (ETNB) as they push pegozafermin through late-stage trials and prepare for a potential acquisition by Roche. The costs are heavily weighted toward R&D, which is typical for a clinical-stage biopharma, but you can see clear investments in future commercial readiness, too.

The total Research and Development (R&D) spend for the first half of 2025 really shows the intensity of their current operations. For the six months ended June 30, 2025, the combined R&D expenses reached exactly $168.3 million. This number is the sum of the Q1 2025 R&D expense of $64.4 million and the Q2 2025 R&D expense of $103.9 million. That jump in Q2 is significant, reflecting escalating clinical activity.

Here is a breakdown of the key cost drivers based on the first half of 2025 reporting periods:

• The 1H 2025 R&D expense totaled $168.3 million.
• Net loss for Q2 2025 widened to $111.5 million, up from $48.0 million year-over-year.
• Cash, cash equivalents, and marketable securities stood at $561.2 million as of June 30, 2025.

Clinical trial costs are a massive component within that R&D figure. 89bio, Inc. is currently funding three global Phase 3 programs simultaneously. You need to keep an eye on the timelines for data readouts, as those often correlate with spending peaks and troughs. The ENTRUST trial for Severe Hypertriglyceridemia (SHTG) is expected to report topline data in the first quarter of 2026. The MASH trials, ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, are tracking for data in the first half of 2027 and 2028, respectively.

Manufacturing Costs show a clear commitment to commercial scale-up, even before final approval. In the second quarter of 2025 alone, R&D included a substantial $42.4 million non-recurring payment directly tied to the construction of the commercial-scale production facility for pegozafermin. This is a capital outlay to de-risk the supply chain for a future Biologics License Application (BLA). To be fair, the company noted that the remaining obligation for this facility is limited to one final milestone payment of $13.5 million, which is due in 2026.

General and Administrative (G&A) Expenses are steadily climbing as 89bio, Inc. scales its organization to support global Phase 3 execution and prepare for potential commercialization. For Q2 2025, G&A hit $11.9 million, up from $8.6 million in the prior year period. Similarly, Q1 2025 G&A was $11.5 million, an increase from $9.8 million in Q1 2024. This increase is defintely driven by higher personnel-related expenses, including stock-based compensation, reflecting a higher headcount across the board.

The Roche Acquisition represents a major, near-term financial event that will fundamentally change the cost structure post-close in Q4 2025. While the specific legal and financial advisory fees paid by 89bio, Inc. aren't itemized in the public filings, the deal terms themselves define the ultimate cost/value realization event. The upfront cash payment is set at $14.50 per share, equating to approximately $2.4 billion in equity value at the time of the announcement. Furthermore, shareholders are eligible for a non-tradeable Contingent Value Right (CVR) of up to $6.00 per share, bringing the total potential deal value up to $3.5 billion.

You can see the cost structure elements summarized here:

Cost Category	Specific Financial Data Point (Q1/Q2 2025)	Context/Driver
Research & Development (R&D)	$168.3 million (1H 2025 Total)	Phase 3 ENLIGHTEN (MASH) and ENTRUST (SHTG) trials advancement.
Manufacturing Investment	$42.4 million (Non-recurring payment in Q2 2025)	Cost of construction for commercial-scale production facility.
General & Administrative (G&A)	$11.9 million (Q2 2025)	Increased personnel costs and stock-based compensation due to higher headcount.
Clinical Trial Spending	Included in R&D, significant for three global Phase 3 trials.	Enrollment and execution across ENLIGHTEN and ENTRUST programs.
Acquisition Value (Roche)	Upfront: $14.50 per share (approx. $2.4 billion total equity value)	Defines the ultimate value realization event and shifts future costs to Roche.

The company is clearly spending heavily to get to the data readouts, which is the primary cost driver right now. Finance: draft 13-week cash view by Friday.

89bio, Inc. (ETNB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for 89bio, Inc. (ETNB) right at the cusp of its acquisition by Roche, which is a massive shift in the financial structure. Before the deal closed in October 2025, the company was entirely reliant on financing its clinical pipeline; after the close, the revenue stream becomes the acquisition consideration itself. Here's the quick math on what drove the top line before the finalization of the merger.

The primary financial events driving 89bio, Inc.'s capital base in 2025 were equity raises to fund its late-stage development programs, followed by the definitive acquisition agreement with Roche Holding AG.

The structure of the Roche transaction is the most significant element defining the revenue streams as of late 2025, as it essentially locks in the value derived from the pegozafermin asset.

Transaction Component	Upfront Value / Per Share Amount	Maximum Potential Value / Per Share Amount
Upfront Cash Payment	$14.50 per share in cash	N/A
Aggregate Upfront Equity Value	Approximately $2.4 billion	N/A
Contingent Value Right (CVR)	N/A	Up to $6.00 per share in cash
Total Headline Equity Value	N/A	Up to approximately $3.5 billion

The Contingent Value Rights (CVR) are key because they represent potential future revenue tied directly to the success of pegozafermin post-acquisition. These are non-tradeable rights granted to stockholders.

• Milestone 1: $2.00 per CVR upon first sale for F4 MASH by March 31, 2030.
• Milestone 2: $1.50 per CVR if global yearly sales reach at least $3.0 billion by December 31, 2033.
• Milestone 3: $2.50 per CVR if global yearly sales reach at least $4.0 billion by December 31, 2035.

Before the acquisition closed, 89bio, Inc. relied on equity financing to keep the lights on and fund its Phase 3 trials. This capital inflow was substantial, demonstrating investor confidence in the pipeline leading up to the deal announcement.

The company successfully executed a follow-on equity offering in the first quarter of 2025, which provided a critical cash infusion to support operations and clinical development.

• Equity Financing Gross Proceeds (Q1 2025): $287.5 million.
• Another earlier offering in early 2025 raised approximately $143.8 million in gross proceeds.

As a clinical-stage biopharmaceutical company, 89bio, Inc. had no product sales revenue in 2025, which is standard for a company advancing a lead candidate through late-stage trials. The cash balance at various points in 2025 was substantial, which would have generated minor interest income.

• Cash, cash equivalents, and marketable securities as of March 31, 2025: Approximately $638.8 million.
• Cash, cash equivalents, and marketable securities as of June 30, 2025: Approximately $561.2 million.

Interest income is generated from this balance, though it is a secondary, minor stream compared to the financing and acquisition proceeds. You can see the R&D expenses were high, reaching $103.9 million in Q2 2025 alone, which these financing events were designed to cover.