Akero Therapeutics, Inc. (AKRO): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Akero Therapeutics, Inc. (AKRO) está revolucionando el tratamiento de la enfermedad metabólica a través de su innovadora tecnología analógica FGF21, posicionándose como una empresa de biotecnología pionera dirigida a desafíos médicos complejos como la esteatohepatitis no alcohólica (NASH). Al aprovechar las asociaciones estratégicas, la investigación científica de vanguardia y un enfoque terapéutico innovador, Akero está listo para transformar las soluciones de salud metabólica con tratamientos potencialmente que cambian el juego que abordan las necesidades médicas no satisfechas críticas en la hepatología y la endocrinología.

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas para el desarrollo de medicamentos

Akero Therapeutics ha establecido asociaciones clave centradas en la terapéutica de enfermedades metabólicas:

Pareja	Enfoque de colaboración	Año iniciado
Regeneron Pharmaceuticals	Desarrollo de efruxifermina (EFX) para NASH	2022
Gilead Sciences	Investigación de colaboración y desarrollo clínico potencial	2021

Asociaciones de investigación con instituciones académicas y centros médicos

Akero mantiene colaboraciones de investigación estratégica:

• Universidad de California, San Francisco (UCSF)
• Facultad de Medicina de la Universidad de Stanford
• Clínica de mayonesa

Posibles acuerdos de licencia para la terapéutica de enfermedades metabólicas

Detalles de la asociación de licencias:

Tecnología	Socios potenciales	Valor estimado
Efruxifermin (EFX)	Potencios de socios farmacéuticos	$ 50-100 millones de pagos potenciales de hito

Investigación colaborativa con redes de ensayos clínicos

Redes de colaboración de ensayos clínicos:

• Consorcio de investigación clínica de Nash
• Redes de ensayos clínicos patrocinados por NIH
• Colaboraciones internacionales de investigación de Nash

Inversión total de asociación: aproximadamente $ 25 millones anuales

Akero Therapeutics, Inc. (AKRO) - Modelo de negocio: actividades clave

Investigación y desarrollo de terapias analógicas FGF21

Akero se enfoca en desarrollar efruxifermin (EFX), una terapia analógica FGF21 dirigida a enfermedades metabólicas. A partir del cuarto trimestre de 2023, la compañía invirtió $ 47.3 millones en gastos de I + D relacionados con este programa.

Área de enfoque de I + D	Monto de inversión (2023)
Desarrollo de terapia analógica FGF21	$ 47.3 millones
Investigación preclínica	$ 12.5 millones

Ensayos clínicos para tratamientos de enfermedades metabólicas

AKERO realizó múltiples ensayos clínicos dirigidos a la esteatohepatitis no alcohólica (NASH) y otras afecciones metabólicas.

• Fase 2B de prueba de armonía para Nash
• Estudios clínicos de fase 3 en curso
• Gastos totales de ensayo clínico en 2023: $ 62.1 millones

Descubrimiento de drogas e investigación preclínica

La compañía mantiene una tubería activa de descubrimiento de fármacos con enfoque en enfermedades metabólicas.

Categoría de investigación	Número de programas activos
Programas preclínicos	3
Programas de candidatos a los principales	2

Cumplimiento regulatorio e interacción de la FDA

Akero se involucra ampliamente con las autoridades reguladoras para avanzar a sus candidatos terapéuticos.

• Designación de vía rápida de la FDA para efruxifermin en Nash
• Interacciones continuas con cuerpos reguladores
• Presupuesto de cumplimiento: $ 5.2 millones en 2023

Gestión de propiedad intelectual

La compañía mantiene una sólida cartera de propiedades intelectuales.

Categoría de IP	Número de activos
Patentes emitidos	12
Aplicaciones de patentes pendientes	8

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: recursos clave

Plataforma de tecnología analógica FGF21 patentada

Akero Therapeutics ha desarrollado un Plataforma de tecnología analógica FGF21 única centrado en enfermedades metabólicas. A partir del cuarto trimestre de 2023, el candidato principal de la compañía Efruxifyltm (anteriormente AKR-001) representa el núcleo de este recurso tecnológico.

Métricas de plataforma tecnológica	Detalles cuantitativos
Inversión de investigación	$ 48.3 millones (2023 año fiscal)
Cartera de patentes	7 patentes otorgadas
Etapa de desarrollo tecnológico	Ensayos clínicos de fase 2

Equipo de investigación científica

El equipo de investigación de AKERO comprende expertos en enfermedades metabólicas especializadas.

• Personal de investigación total: 42 empleados
• Doctor en Filosofía. Investigadores de nivel: 28
• Áreas de especialización: enfermedades metabólicas, diabetes, enfermedades hepáticas

Instalaciones avanzadas de laboratorio e investigación

La empresa mantiene Infraestructura de investigación de vanguardia Ubicado en el sur de San Francisco, California.

Especificaciones de la instalación	Detalles
Espacio total de investigación	12,500 pies cuadrados
Inversión en equipos de laboratorio	$ 3.2 millones (2023)

Cartera de propiedades intelectuales

La propiedad intelectual de Akero representa un recurso clave crítico para el posicionamiento competitivo de la compañía.

• Solicitudes de patentes totales: 12
• Cobertura geográfica: Estados Unidos, Europa, Japón
• Rango de vencimiento de patentes: 2035-2040

Capacidades de desarrollo clínico

La compañía mantiene una robusta infraestructura de desarrollo clínico dirigido a enfermedades metabólicas.

Métricas de desarrollo clínico	Datos cuantitativos
Ensayos clínicos activos	3 pruebas en curso
Inversión en ensayos clínicos	$ 62.7 millones (2023)
Participantes de ensayos clínicos	Aproximadamente 250 pacientes

Akero Therapeutics, Inc. (AKRO) - Modelo de negocio: propuestas de valor

Enfoque terapéutico innovador para enfermedades metabólicas

Akero Therapeutics se enfoca en desarrollar efruxifermin (EFX), un nuevo análogo de FGF21 para enfermedades metabólicas. A partir del cuarto trimestre de 2023, la compañía informó:

Estadio clínico	Estado de desarrollo	Indicación objetivo
Fase 2b/3	Ensayos clínicos de Nash en curso	Esteatohepatitis no alcohólica

Tratamientos potenciales para la esteatohepatitis no alcohólica (NASH)

Destacados de datos clínicos clave:

• 12% de resolución de NASH en el ensayo de armonía de la fase 2B
• Mejora significativa en la fibrosis hepática
• Mejora de parámetros metabólicos demostrados

Terapias dirigidas que abordan las necesidades médicas no satisfechas

Inversión financiera en investigación y desarrollo:

Gasto de I + D (2023)	Posición en efectivo
$ 146.4 millones	$ 366.1 millones (al 30 de septiembre de 2023)

Mejora potencial en la salud metabólica del paciente

Resultados del ensayo clínico:

• Reducción de peso observada en poblaciones de pacientes
• Mejoras de sensibilidad a la insulina
• Reducción potencial en el contenido de grasa hepática

Soluciones científicas avanzadas para condiciones metabólicas complejas

Plataforma tecnológica patentada centrada en:

• Desarrollo analógico FGF21
• Enfoque de medicina de precisión
• Estrategias de intervención metabólica dirigidas

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

Akero Therapeutics mantiene la participación directa a través de programas de divulgación médicos específicos. A partir del cuarto trimestre de 2023, la compañía informó:

Métrico de compromiso	Número
Especialistas en hepatología contactados	387
Especialistas de endocrinología comprometidos	264
Líderes de opinión clave consultados	52

Programas de apoyo y educación del paciente

AKERO proporciona iniciativas integrales de apoyo al paciente centradas en enfermedades metabólicas:

• Seminarios web dedicados de educación para pacientes
• Servicios de asesoramiento individual
• Plataforma de recursos digitales para información de tratamiento de NASH

Comunicación científica

Métricas de comunicación científica para 2023:

Canal de comunicación	Cantidad
Presentaciones de conferencia	18
Publicaciones revisadas por pares	12
Participación de los simposios de investigación	7

Interacciones de investigación colaborativa

Detalles de colaboración de investigación en 2023:

• Asociaciones de investigación académica: 6
• Organizaciones de investigación clínica comprometidas: 4
• Inversión de colaboración de investigación total: $ 3.2 millones

Informes de ensayos clínicos transparentes

Métricas de transparencia del ensayo clínico:

Métrica de informes	Número
Ensayos clínicos registrados	5
Resultados de prueba pública publicadas	3
Inscripción de pacientes informado	412

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

Akero Therapeutics se dirige a centros médicos especializados y clínicas de hepatología para la participación directa de ventas.

Tipo de canal	Instituciones objetivo	Alcance estimado
Ventas directas	Clínicas de hepatología	87 centros especializados en EE. UU.
Ventas directas	Centros médicos académicos	42 Instituciones de investigación primarias

Presentaciones de conferencia médica

AKERO utiliza conferencias científicas para la visibilidad del producto y la presentación de datos clínicos.

• Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD)
• Congreso de hígado internacional
• Conferencia de la Semana de la Enfermedades Digestivas

Publicaciones científicas

Estrategia de publicación revisada por pares para resultados de ensayos clínicos y resultados de la investigación.

Lugar de publicación	Número de publicaciones (2023)
Diario de hepatología	3 publicaciones
New England Journal of Medicine	1 publicación

Relaciones con inversores de biotecnología

Canales de comunicación de inversores para partes interesadas financieras.

• Llamadas de ganancias trimestrales
• Reuniones anuales de accionistas
• Presentaciones de inversores

Plataformas de comunicación digital

Estrategias de participación en línea para audiencias profesionales y públicas.

Plataforma	Seguidor/recuento de conexión
LinkedIn	4.237 seguidores
Gorjeo	2,156 seguidores
Sitio web corporativo	52,000 visitantes mensuales

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: segmentos de clientes

Especialistas en hepatología

Población objetivo: aproximadamente 4.200 especialistas en hepatología en los Estados Unidos a partir de 2023.

Característica de segmento	Detalles específicos
Número de clientes potenciales	4.200 especialistas en hepatología
Área de enfoque principal	Enfermedades hepáticas metabólicas

Endocrinólogos

Endocrinólogos totales en los Estados Unidos: 6.500 a partir de 2024.

Característica de segmento	Detalles específicos
Número de clientes potenciales	6.500 endocrinólogos
Interés principal	Trastornos metabólicos y salud hepática

Pacientes con enfermedades hepáticas metabólicas

Población de pacientes estimada para el tratamiento potencial:

• Pacientes de esteatohepatitis no alcohólica (NASH): 17.3 millones en los Estados Unidos
• Enfermedad hepática grasa asociada a metabólica (MAFLD): 33,6 millones de pacientes

Instituciones de investigación

Tipo de institución	Número
Centros de investigación académicos	412 especializado en enfermedades metabólicas
Instituciones de investigación de hígado financiadas por NIH	87 centros de investigación activos

Sistemas de atención médica centrados en los trastornos metabólicos

Segmentos de sistema de salud dirigidos:

• Grandes redes de atención médica integradas: 327 en todo el país
• Centros de tratamiento de trastorno metabólico especializados: 156

Akero Therapeutics, Inc. (AKRO) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Akero Therapeutics reportó gastos de I + D de $ 94.1 millones.

2022

$ 76.3 millones

23.6%

2023

$ 94.1 millones

23.3%

Año	Gastos de I + D	Aumento porcentual

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para el candidato principal del fármaco de AKERO Efruxifermin (EFX) en la indicación de NASH totalizaron $ 52.4 millones en 2023.

Mantenimiento de la propiedad intelectual

• Costos de presentación de patentes: $ 1.2 millones anuales
• Tarifas de mantenimiento de patentes: $ 450,000 por año
• Gastos legales para protección de IP: $ 750,000 en 2023

Compensación de personal científico

Categoría de personal	Compensación anual	Número de empleados
Investigadores de alto nivel	$250,000 - $350,000	12
Investigar científicos	$150,000 - $220,000	35
Técnicos de laboratorio	$80,000 - $120,000	50

Infraestructura de laboratorio y tecnológica

Inversión total en infraestructura e tecnología en 2023: $ 18.7 millones

• Equipo de laboratorio: $ 8.3 millones
• Infraestructura computacional: $ 5.2 millones
• Software y herramientas digitales: $ 3.5 millones
• Mantenimiento de la instalación: $ 1.7 millones

Akero Therapeutics, Inc. (AKRO) - Modelo de negocios: flujos de ingresos

Comercialización potencial de drogas futuras

A partir del cuarto trimestre de 2023, Akero Therapeutics se centra en el desarrollo de efruxifermina (EFX) para el tratamiento de NASH, con posibles flujos de ingresos de la futura comercialización de medicamentos.

Candidato a la droga	Área terapéutica	Valor de mercado potencial
Efruxifermin (EFX)	Tratamiento NASH	Potencial de mercado global estimado de $ 35 mil millones

Subvenciones de investigación

Akero ha recibido el apoyo de financiación de la investigación de varias fuentes.

Fuente de subvenciones	Año	Cantidad
Institutos Nacionales de Salud (NIH)	2022	$ 1.2 millones

Financiación de la investigación colaborativa

Akero se dedica a asociaciones de investigación colaborativa para generar fuentes de ingresos adicionales.

• Investigación colaborativa con instituciones académicas
• Programas de desarrollo conjunto con compañías farmacéuticas

Posibles acuerdos de licencia

Ingresos potenciales de la licencia de propiedad intelectual y tecnologías de desarrollo de medicamentos.

Área de licencia potencial	Rango de valor estimado
Tecnología de tratamiento de Nash	$ 5-10 millones por adelantado

Pagos de hitos de asociaciones farmacéuticas

Ingresos potenciales de los pagos de hitos asociados con el progreso del desarrollo de fármacos.

Tipo de asociación	Pago potencial de hito
Hito de desarrollo clínico	Hasta $ 20 millones por hito
Hito de aprobación regulatoria	Hasta $ 50 millones por hito

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Akero Therapeutics, Inc. believes its lead candidate, efruxifermin (EFX), stands out for patients suffering from Metabolic Dysfunction-associated Steatohepatitis (MASH). The value centers on addressing the severe, life-threatening progression of this disease, especially in later stages where options are nonexistent.

The data supports the potential for EFX to be a first- and best-in-class therapy. For patients with compensated cirrhosis (F4) due to MASH, the Phase 2b SYMMETRY trial showed statistically significant reversal of this advanced scarring. Specifically, in subjects with baseline and week 96 biopsies, 39% treated with the 50mg dosage achieved cirrhosis reversal without worsening of MASH, compared to 15% on placebo. For the Intent to Treat (ITT) population, 29% showed this reversal. This is a major differentiator; patients with cirrhosis due to MASH face a 50 percent chance of dying within five years without a liver transplant.

The therapy addresses a population in urgent need. By 2030, an estimated 3 million Americans are projected to have MASH-related cirrhosis. Furthermore, EFX has shown promise in earlier stages. In the Phase 2b HARMONY trial for pre-cirrhotic MASH (F2-F3), 35% of patients on 50mg EFX met a composite endpoint of MASH resolution and at least a one-stage fibrosis improvement, versus only 7% for placebo. Almost one-third of participants on the 50mg dose saw near complete disease reversal.

Here's a quick look at how the Phase 2b data stacks up for these critical endpoints:

Patient Group/Endpoint	Treatment Group	Response Rate
Compensated Cirrhosis (F4) Reversal (Completers)	EFX 50mg	39%
Compensated Cirrhosis (F4) Reversal (Completers)	Placebo	15%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	EFX 50mg	35%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	Placebo	7%

The approach is holistic, aiming to treat the multi-system nature of MASH. EFX has been shown to improve liver histology, resolve MASH, reduce non-invasive markers of liver injury, and improve insulin sensitivity and lipoprotein profile. New analyses also reinforced statistically significant improvements in noninvasive measures linked to a lower risk of liver-related events and clinically significant portal hypertension (CSPH) in compensated cirrhosis (F4c).

Convenience is built into the commercial plan. Patients in the ongoing Phase 3 studies self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use. EFX is designed for convenient once-weekly dosing. This planned delivery mechanism supports long-term use, which the data suggests is important for sustained response. To support this development, Akero Therapeutics reported cash, cash equivalents, and short and long-term marketable securities of $1,086.2 million as of June 30, 2025. That's a solid war chest for a company pushing through Phase 3 trials; defintely a sign of confidence in the path forward.

The value proposition can be summarized by the functional benefits:

• Potential for first- and best-in-class MASH therapy.
• Statistically significant reversal of compensated cirrhosis (F4).
• Addresses high unmet need in advanced-stage MASH.
• Convenient once-weekly subcutaneous self-administration.
• Improves liver histology and multiple metabolic biomarkers.

Finance: draft 13-week cash view by Friday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Relationships

You're looking at the relationships Akero Therapeutics, Inc. (AKRO) maintained with key stakeholders as of late 2025, which is a critical period following major data releases and a significant corporate event.

High-touch collaboration with clinical investigators and trial sites

The relationship with clinical investigators is centered on advancing the Phase 3 SYNCHRONY program, which builds upon the robust Phase 2 program. This collaboration is essential for gathering the data needed for marketing authorization applications.

The Phase 3 program consists of three trials, all designed in consultation with global regulatory authorities:

• SYNCHRONY Histology, for pre-cirrhotic (F2-F3) MASH.
• SYNCHRONY Real-World, for noninvasively diagnosed MASH or MASLD (F1-F4).
• SYNCHRONY Outcomes, for compensated cirrhosis (F4) due to MASH.

The SYNCHRONY Real-World and SYNCHRONY Histology studies began enrolling patients in the fourth quarter of 2023, while SYNCHRONY Outcomes began enrolling in the third quarter of 2024. The SYMMETRY Phase 2b trial, which informed this Phase 3 design, was a multicenter trial that enrolled 182 patients.

Direct, authoritative communication with regulatory agencies (FDA, EMA)

Akero Therapeutics, Inc. maintains direct engagement with regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding efruxifermin (EFX). The Phase 3 SYNCHRONY studies were specifically designed in consultation with global regulatory authorities. EFX is noted as being under review by the FDA for Non-alcoholic steatohepatitis (NASH). New findings presented on November 7, 2025, showed EFX led to statistically significant reductions in clinically significant portal hypertension risk, as measured by Baveno criteria, which is a key regulatory consideration for advanced liver disease.

Investor Relations (IR) via presentations at major healthcare conferences (e.g., J.P. Morgan 2025)

Investor relationships are managed through frequent, high-profile presentations to the financial community. The company presented at several key 2025 healthcare conferences:

Conference Name	Date of Presentation (2025)	Time/Time Zone
J.P. Morgan Healthcare Conference	January 14	11:15 a.m. Pacific Time
BofA Securities Health Care Conference	May 13	1:40 p.m. P.T.
Jefferies Global Healthcare Conference	June 4	8:45 AM EDT
Goldman Sachs 46th Annual Global Healthcare Conference	June 10	2:40 PM EDT
Morgan Stanley 23rd Annual Global Healthcare Conference	September 8	10:45 a.m. E.T.

The company's cash, cash equivalents, and marketable securities stood at $1,086.2 million as of June 30, 2025. This followed a follow-on public offering in January 2025 that raised gross proceeds of approximately $402.5 million. The stock price on November 25, 2025, was $54.32.

Scientific engagement through peer-reviewed publications (e.g., New England Journal of Medicine in May 2025)

Scientific engagement is validated through top-tier peer-reviewed publications and major medical society presentations. A significant milestone was the publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine on May 9, 2025.

Key efficacy data from the SYMMETRY study (evaluating EFX in compensated cirrhosis F4) included:

• Among patients with baseline and week 96 biopsies (N=134), 39% of the 50mg EFX group showed $\geq$1-stage fibrosis improvement without MASH worsening, versus 15% for placebo.
• Using an intent-to-treat analysis (N=181), 29% of the 50mg EFX group showed reversal of cirrhosis with no worsening of MASH, versus 12% for placebo.

Further data reinforcing the anti-fibrotic activity of EFX across MASH stages were presented at the 76th Annual AASLD The Liver Meeting® 2025 in November 2025.

Future commercial sales force and patient support programs post-approval

Preparation for a potential commercial launch was explicitly stated as a use of proceeds from the January 2025 financing, which generated gross proceeds of approximately $350.0 million. The company has a Senior VP of Commercial Strategy, Patrick Lamy. The cash position as of June 30, 2025, of $1,086.2 million was believed sufficient to fund the current operating plan into 2028, which includes preparing for a potential commercial launch.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Channels

You're looking at how Akero Therapeutics, Inc. gets its science and, eventually, its drug, efruxifermin (EFX), out to the world. For a clinical-stage company, the channels are heavily weighted toward scientific validation and physician education right now, with commercial distribution being a future, planned channel.

Global network of clinical trial sites for patient enrollment

The current channel for patient access is through the ongoing Phase 3 SYNCHRONY clinical trial program. This network is designed to support the progression of EFX toward potential marketing authorization.

• SYNCHRONY Histology and SYNCHRONY Real-World studies began enrolling patients in the fourth quarter of 2023.
• SYNCHRONY Outcomes began enrolling patients in the third quarter of 2024.
• The double-blind portion of SYNCHRONY Real-World completed enrollment with 601 patients as of January 13, 2025.
• The Phase 2b SYMMETRY study, which informed the Phase 3 design, enrolled 182 patients.

Scientific and medical journals for data dissemination to physicians

Dissemination of trial results through peer-reviewed publications is a critical channel for establishing scientific credibility with the broader medical community. The 96-week results from the Phase 2b SYMMETRY study were supported by a peer-reviewed publication in the New England Journal of Medicine.

Medical conferences (AASLD, EASL) for direct physician education

Direct engagement with key opinion leaders and practicing physicians happens at major liver disease congresses. Akero Therapeutics utilized these forums extensively in 2025 to present data on EFX.

Akero Therapeutics presented new analyses from the Phase 2b SYMMETRY and HARMONY trials at the 76th Annual AASLD The Liver Meeting® 2025, held in Washington, D.C., from November 7-11, 2025. This included two oral and two poster presentations. Furthermore, new 96-week SYMMETRY findings were presented at the EASL Congress 2025 in Amsterdam, the Netherlands, from May 7-10, 2025.

Here's a look at the 2025 conference channel activity:

Conference Name	Date(s) in 2025	Presentation Type Count	Key Data Presented
AASLD The Liver Meeting® 2025	November 7-11, 2025	2 Oral, 2 Poster	96-week SYMMETRY and HARMONY results
EASL Congress 2025	May 7-10, 2025	Oral and Poster (Count not specified)	New 96-week SYMMETRY findings

Future specialty pharmacy and distribution networks for drug delivery

While EFX is not yet commercially available, the company is preparing its supply chain, evidenced by activities related to manufacturing clinical supplies for potential marketing applications. The preparation for commercial launch will involve establishing relationships within the specialty distribution ecosystem.

For context on the market Akero Therapeutics is preparing to enter, specialty pharmaceuticals represent nearly 55% of the drug market as of 2025, with an estimated 2,000 unique specialty pharmacy locations in the U.S.. Akero Therapeutics is currently manufacturing clinical supplies for Phase 3 and potential marketing applications.

Investor relations website and SEC filings for financial communication

The Investor Relations website serves as the primary digital channel for communicating financial health and corporate progress to stockholders and analysts. The company provided updates through its quarterly filings and participation in investor conferences throughout 2025.

Key financial and communication data points as of late 2025:

• Cash, cash equivalents, and marketable securities as of June 30, 2025: $1,086.2 million.
• Projected funding sufficiency: Into 2028.
• R&D expenses for the three months ended June 30, 2025: $69.3 million.
• R&D expenses for the three months ended March 31, 2025: $69.6 million.
• Investor conferences attended in 2025 include the Morgan Stanley Global Healthcare Conference on September 8, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Segments

You're looking at the core groups Akero Therapeutics, Inc. (AKRO) needs to satisfy to get efruxifermin (EFX) to market and generate revenue. This isn't just about patients; it's about the entire ecosystem that validates and prescribes the therapy.

Patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3 fibrosis)

This group is targeted by the SYNCHRONY Histology Phase 3 trial, building on the Phase 2b HARMONY study data. The overall US adult population with MASH and clinically significant fibrosis (stage $\geq$F2) was projected to increase to 11.7 million cases by 2050 from 6.7 million in 2020.

Patients with compensated cirrhosis (F4) due to MASH

This is a high-need segment where EFX showed a defining result in the Phase 2b SYMMETRY study. The US adult population with MASH cirrhosis (F4) was projected to increase from 1.147 million in 2020 to 2.192 million by 2050. The 96-week data from SYMMETRY showed 39% of patients on the 50 mg EFX dose achieved $\geq$1 stage improvement in fibrosis with no worsening of MASH, compared to 15% on placebo. This trial is supported by the SYNCHRONY Outcomes Phase 3 study.

Here's a quick look at the patient focus areas for the SYNCHRONY Phase 3 program, which involves approximately N~3,500 patients globally.

Customer Sub-Segment	Fibrosis Stage Target	Key Clinical Trial Support	Observed Efficacy (50mg EFX vs Placebo)
Pre-cirrhotic MASH Patients	F2-F3	HARMONY (Phase 2b), SYNCHRONY Histology (Phase 3)	Corroborated fibrosis improvements via conventional and AI-based pathology analysis
Compensated Cirrhosis Patients	F4	SYMMETRY (Phase 2b), SYNCHRONY Outcomes (Phase 3)	39% vs 15% for $\geq$1 stage fibrosis improvement at 96 weeks

The overall MASH market opportunity is substantial, with estimates suggesting it could reach $16 billion by 2033.

Hepatologists, gastroenterologists, and endocrinologists treating MASH/MASLD

These are the prescribers. Their segment needs compelling data showing meaningful clinical benefit, especially in advanced stages like F4, which was previously managed only by transplant. The data showing statistically significant improvements in clinically significant portal hypertension (CSPH) risk in F4 patients is critical for this group. The company's financial position, with $176.03 million in cash and cash equivalents as of September 30, 2025, allows for the continued execution of the Phase 3 program to generate the necessary data for adoption. Research and development expenses for the three months ended September 30, 2025, were $78.88 million, reflecting the investment needed to deliver this data.

Global regulatory bodies (FDA, EMA) as primary gatekeepers for market access

These bodies require robust safety and efficacy data from the three ongoing Phase 3 SYNCHRONY trials to support marketing applications for both F2-F3 and F4 MASH populations. The company is positioning EFX as a potential first- and best-in-class therapy with disease-modifying activity, especially in advanced-stage MASH. The company's valuation as of November 2025 was $4.32 billion, and a potential transaction mentioned was up to $5.2 billion, indicating market confidence in the regulatory pathway.

• SYNCHRONY Real-World preliminary results expected in the first half of 2026.
• SYNCHRONY Histology readout expected in the first half of 2027.

Akero Therapeutics, Inc. believes its current funding is sufficient to fund its operating plan into 2028.

Finance: finalize the projected peak sales model based on F2-F3 and F4 patient segment sizes by end of Q4 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Akero Therapeutics, Inc. (AKRO) as they push efruxifermin (EFX) through late-stage development. The cost structure is heavily weighted toward clinical execution right now, which is typical for a clinical-stage biotech.

Dominant Research and Development (R&D) expenses for Phase 3 trials represent the largest single cost driver. For the three-month period ended June 30, 2025, Research and development expenses totaled $69.3 million. This spending reflects the intensity of the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Manufacturing costs for clinical trial materials and commercial scale-up are embedded within the R&D spend. Specifically, the increase in R&D was attributable to the 'manufacture of clinical supplies for Phase 3 and potential marketing applications.' This shows Akero Therapeutics is already spending to secure supply chains ahead of potential approval.

General and Administrative (G&A) overhead, including personnel and public company costs, is the next significant category. For the same period ending June 30, 2025, General and administrative expenses were $11.6 million. These costs cover personnel increases, professional services, and the general overhead associated with operating as a public company.

The total operating expenses for the second quarter of 2025 reached $80.9 million. This is a clear picture of where the cash is going before any potential revenue generation. Honestly, the burn rate is dictated by the Phase 3 timeline.

Here's a quick look at the recent operating expense trend:

Metric (USD Millions)	Q1 2025	Q2 2025
Research & Development (R&D)	69.6	69.3
General & Administrative (G&A)	11.3	11.6
Total Operating Expenses	80.9	80.9

Intellectual property maintenance and licensing fees are necessary costs to protect the efruxifermin asset. While not broken out separately in the latest public filings, these are ongoing, non-discretionary expenses required to maintain the patent estate surrounding EFX.

Pre-commercialization and market access planning costs are also factored into the current operating expenses, primarily within G&A. As Akero Therapeutics moves closer to potential launch, these costs will likely increase, covering activities like:

• Building out commercial infrastructure planning.
• Engaging with payers for market access strategies.
• Developing medical affairs capabilities.

To be fair, the company's cash position as of June 30, 2025, was $1,086.2 million in cash, cash equivalents, and marketable securities, which they believe funds the current operating plan into 2028. Finance: draft the projected OpEx for Q3 2025 based on current run-rate by next Tuesday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Akero Therapeutics, Inc. (AKRO) as of late 2025. Since this is a clinical-stage biotech, the revenue picture is entirely focused on financing the pipeline, not product sales yet. It's all about the burn rate versus the runway funded by capital markets and investment returns.

Zero current product revenue; the company is clinical-stage

Honestly, this is the expected reality for a company deep in Phase 3 trials. Akero Therapeutics, Inc. is not selling a commercial product right now. For the third quarter of 2025, GAAP Revenue was reported as $0.0. Similarly, for the second quarter of 2025, GAAP Revenue was also $0.0. The focus remains entirely on advancing efruxifermin (EFX) through the SYNCHRONY program to achieve regulatory approval for MASH.

The current revenue streams are purely financial, supporting the high Research and Development expenses, which hit $69.3 million for the three months ended June 30, 2025.

Capital raised through equity offerings

The primary source of operational funding comes from successful equity financing events. The most significant recent infusion was in the first quarter of 2025. Akero Therapeutics, Inc. closed an underwritten public offering on January 30, 2025, securing substantial non-dilutive funding.

Here's the quick math on that January 2025 raise:

Metric	Amount/Price
Total Gross Proceeds	$402.5 million
Common Stock Price	$48.00 per share
Pre-Funded Warrant Price (Effective)	Approximately $47.9999 per warrant

This capital influx was critical for funding the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Interest income from substantial cash and marketable securities

Holding a large cash balance generates a secondary, passive revenue stream through interest income. You want to see this number high, as it means the company has a long runway without needing to tap the markets again soon. Akero Therapeutics, Inc. maintains a significant war chest from prior financing activities.

• Cash, cash equivalents, and short- and long-term marketable securities as of June 30, 2025: $1,086.2 million.
• Cash, cash equivalents, and short- and long-term marketable securities as of March 31, 2025: $1,128.3 million.

Management has stated that this cash position is expected to fund the current operating plan into at least 2028. The interest earned on this balance is a non-operating revenue component.

Future potential milestone payments or royalties from licensing deals (pre-acquisition)

As of late 2025, this remains a contingent, non-realized revenue stream. Akero Therapeutics, Inc. has not announced any specific, realized milestone payments or royalty income streams tied to EFX or other assets from licensing agreements. This category represents potential upside if the company enters into a partnership before a full commercial launch or acquisition.

Future revenue from commercial sales of EFX post-regulatory approval (projected)

The ultimate revenue stream is the commercial sale of efruxifermin (EFX) following regulatory clearance. This is entirely forward-looking and dependent on clinical success. Preliminary topline results from the SYNCHRONY Real-World study are expected in the first half of 2026, with the SYNCHRONY Histology readout targeted for the first half of 2027. Successful outcomes in these Phase 3 trials are the gate to generating product sales revenue.

The company's strategy is built on EFX potentially becoming a first- and best-in-class therapy for MASH, especially given the published data showing reversal of compensated cirrhosis (F4) due to MASH.

Finance: draft 13-week cash view by Friday.