Akero Therapeutics, Inc. (AKRO): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Akero Therapeutics, Inc. (AKRO) está revolucionando o tratamento com doenças metabólicas por meio de sua tecnologia analógica inovadora FGF21, posicionando -se como uma empresa de biotecnologia pioneira direcionada a desafios médicos complexos, como esteato -hepatite não alcoólica (NASH). Ao alavancar parcerias estratégicas, pesquisa científica de ponta e uma abordagem terapêutica inovadora, Akero está pronto para transformar soluções de saúde metabólica com tratamentos potencialmente que mudam o jogo que atendem às necessidades médicas críticas não atendidas em hepatologia e endocrinologia.

Akero Therapeutics, Inc. (AKRO) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com empresas farmacêuticas para desenvolvimento de medicamentos

A Akero Therapeutics estabeleceu as principais parcerias focadas na terapêutica de doenças metabólicas:

Parceiro	Foco de colaboração	Ano iniciado
Regeneron Pharmaceuticals	Desenvolvimento de Efruxifermina (EFX) para Nash	2022
Gilead Sciences	Colaboração de pesquisa e desenvolvimento clínico potencial	2021

Parcerias de pesquisa com instituições acadêmicas e centros médicos

Akero mantém colaborações estratégicas de pesquisa:

• Universidade da Califórnia, São Francisco (UCSF)
• Escola de Medicina da Universidade de Stanford
• Clínica Mayo

Potenciais acordos de licenciamento para terapêutica de doenças metabólicas

Detalhes da parceria de licenciamento:

Tecnologia	Parceiros em potencial	Valor estimado
Efruxifermina (EFX)	Parceiros farmacêuticos em potencial	US $ 50-100 milhões em potenciais pagamentos marcantes

Pesquisa colaborativa com redes de ensaios clínicos

Redes de colaboração de ensaios clínicos:

• Consórcio de Pesquisa Clínica de Nash
• Redes de ensaios clínicos patrocinados pelo NIH
• Colaborações internacionais de pesquisa de Nash

Investimento total de parceria: aproximadamente US $ 25 milhões anualmente

Akero Therapeutics, Inc. (AKRO) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapias analógicas FGF21

Akero se concentra no desenvolvimento Efruxifermina (EFX), uma terapia analógica FGF21 direcionada a doenças metabólicas. A partir do quarto trimestre de 2023, a empresa investiu US $ 47,3 milhões em despesas de P&D relacionadas a este programa.

Área de foco em P&D	Valor do investimento (2023)
Desenvolvimento da terapia analógica FGF21	US $ 47,3 milhões
Pesquisa pré -clínica	US $ 12,5 milhões

Ensaios clínicos para tratamentos de doenças metabólicas

A Akero conduziu vários ensaios clínicos direcionados à esteato -hepatite não alcoólica (NASH) e outras condições metabólicas.

• Fase 2b Harmony Trial para Nash
• Estudos Clínicos de Fase 3 em andamento
• Despesas totais de ensaios clínicos em 2023: US $ 62,1 milhões

Descoberta de medicamentos e pesquisa pré -clínica

A empresa mantém um pipeline ativo de descoberta de medicamentos, com foco em doenças metabólicas.

Categoria de pesquisa	Número de programas ativos
Programas pré -clínicos	3
Liderar programas candidatos	2

Conformidade regulatória e interação FDA

Akero se envolve extensivamente com as autoridades reguladoras para avançar em seus candidatos terapêuticos.

• Designação FDA Fast Track para Efruxifermina em Nash
• Interações em andamento com órgãos regulatórios
• Orçamento de conformidade: US $ 5,2 milhões em 2023

Gerenciamento de propriedade intelectual

A empresa mantém um portfólio robusto de propriedade intelectual.

Categoria IP	Número de ativos
Patentes emitidas	12
Aplicações de patentes pendentes	8

Akero Therapeutics, Inc. (AKRO) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia analógica FGF21 proprietária

Akero Therapeutics desenvolveu um Plataforma de tecnologia analógica FGF21 exclusiva focado em doenças metabólicas. A partir do quarto trimestre 2023, o candidato principal da empresa EfruxifyLtm (anteriormente AKR-001) representa o núcleo desse recurso tecnológico.

Métricas da plataforma de tecnologia	Detalhes quantitativos
Investimento em pesquisa	US $ 48,3 milhões (2023 ano fiscal)
Portfólio de patentes	7 Patentes concedidas
Estágio de desenvolvimento de tecnologia	Ensaios clínicos de fase 2

Equipe de pesquisa científica

A equipe de pesquisa de Akero compreende especialistas em doenças metabólicas especializadas.

• Pessoal de pesquisa total: 42 funcionários
• Ph.D. Pesquisadores de nível: 28
• Áreas de especialização: doenças metabólicas, diabetes, doenças hepáticas

Instalações avançadas de laboratório e pesquisa

A empresa mantém Infraestrutura de pesquisa de ponta Localizado no sul de São Francisco, Califórnia.

Especificações da instalação	Detalhes
Espaço total de pesquisa	12.500 pés quadrados
Investimento de equipamentos de laboratório	US $ 3,2 milhões (2023)

Portfólio de propriedade intelectual

A propriedade intelectual de Akero representa um recurso -chave crítico para o posicionamento competitivo da empresa.

• Total de pedidos de patente: 12
• Cobertura geográfica: Estados Unidos, Europa, Japão
• Faixa de expiração de patentes: 2035-2040

Capacidades de desenvolvimento clínico

A empresa mantém infraestrutura robusta de desenvolvimento clínico direcionado a doenças metabólicas.

Métricas de desenvolvimento clínico	Dados quantitativos
Ensaios clínicos ativos	3 ensaios em andamento
Investimento de ensaios clínicos	US $ 62,7 milhões (2023)
Participantes do ensaio clínico	Aproximadamente 250 pacientes

Akero Therapeutics, Inc. (Akro) - Modelo de Negócios: Proposições de Valor

Abordagem terapêutica inovadora para doenças metabólicas

Akero Therapeutics se concentra no desenvolvimento Efruxifermina (EFX), um novo analógico FGF21 para doenças metabólicas. A partir do quarto trimestre 2023, a empresa informou:

Estágio clínico	Status de desenvolvimento	Indicação alvo
Fase 2b/3	Ensaios clínicos em andamento	Esteato -hepatite não alcoólica

Tratamentos potenciais para esteato -hepatite não alcoólica (NASH)

Os principais destaques dos dados clínicos:

• 12% de resolução NASH no estudo Harmony de Fase 2b
• Melhoria significativa na fibrose hepática
• Melhoria dos parâmetros metabólicos demonstrados

Terapias direcionadas atendendo a necessidades médicas não atendidas

Investimento financeiro em pesquisa e desenvolvimento:

Despesas de P&D (2023)	Posição em dinheiro
US $ 146,4 milhões	US $ 366,1 milhões (em 30 de setembro de 2023)

Melhoria potencial na saúde metabólica do paciente

Resultados do ensaio clínico:

• Redução de peso observada nas populações de pacientes
• Melhorias de sensibilidade à insulina
• Redução potencial no teor de gordura do fígado

Soluções científicas avançadas para condições metabólicas complexas

Plataforma de tecnologia proprietária focada em:

• Desenvolvimento analógico FGF21
• Abordagem de medicina de precisão
• Estratégias de intervenção metabólica direcionadas

Akero Therapeutics, Inc. (Akro) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A Akero Therapeutics mantém o envolvimento direto por meio de programas de divulgação médica direcionados. A partir do quarto trimestre 2023, a empresa informou:

Métrica de engajamento	Número
Especialistas em hepatologia contatados	387
Especialistas em endocrinologia envolvidos	264
Líderes de opinião -chave consultados	52

Programas de apoio ao paciente e educação

A Akero fornece iniciativas abrangentes de apoio ao paciente focadas em doenças metabólicas:

• Webinars de educação de pacientes dedicados
• Serviços de aconselhamento individuais
• Plataforma de recursos digitais para informações de tratamento de Nash

Comunicação científica

Métricas de comunicação científica para 2023:

Canal de comunicação	Quantidade
Apresentações da conferência	18
Publicações revisadas por pares	12
Participação do Simpósias de Pesquisa	7

Interações de pesquisa colaborativa

Detalhes da colaboração de pesquisa em 2023:

• Parcerias de pesquisa acadêmica: 6
• Organizações de pesquisa clínica envolvidas: 4
• Investimento total de colaboração de pesquisa: US $ 3,2 milhões

Relatório de ensaio clínico transparente

Métricas de transparência do ensaio clínico:

Métrica de relatório	Número
Ensaios clínicos registrados	5
Resultados do julgamento público postados	3
Inscrição do paciente relatada	412

Akero Therapeutics, Inc. (Akro) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A Akero Therapeutics tem como alvo os centros médicos especializados e clínicas de hepatologia para o envolvimento direto das vendas.

Tipo de canal	Instituições -alvo	Alcance estimado
Vendas diretas	Clínicas de Hepatologia	87 centros especializados em nós
Vendas diretas	Centros Médicos Acadêmicos	42 instituições de pesquisa primárias

Apresentações da conferência médica

A Akero utiliza conferências científicas para visibilidade do produto e apresentação de dados clínicos.

• Associação Americana para o Estudo de Doenças do Fígado (AASLD)
• Congresso do fígado internacional
• Conferência da Semana de Doenças Digestivas

Publicações científicas

Estratégia de publicação revisada por pares para resultados de ensaios clínicos e resultados da pesquisa.

Local de publicação	Número de publicações (2023)
HEPATOLOGY Journal	3 publicações
New England Journal of Medicine	1 Publicação

Relações com investidores de biotecnologia

Canais de comunicação de investidores para partes interessadas financeiras.

• Chamadas de ganhos trimestrais
• Reuniões anuais de acionistas
• Apresentações de investidores

Plataformas de comunicação digital

Estratégias de engajamento on -line para público profissional e público.

Plataforma	Contagem de seguidores/conexão
LinkedIn	4.237 seguidores
Twitter	2.156 seguidores
Site corporativo	52.000 visitantes mensais

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

Especialistas em hepatologia

População -alvo: aproximadamente 4.200 especialistas em hepatologia nos Estados Unidos a partir de 2023.

Característica do segmento	Detalhes específicos
Número de clientes em potencial	4.200 especialistas em hepatologia
Área de foco primário	Doenças hepáticas metabólicas

Endocrinologistas

Endocrinologistas totais nos Estados Unidos: 6.500 a partir de 2024.

Característica do segmento	Detalhes específicos
Número de clientes em potencial	6.500 endocrinologistas
Interesse primário	Distúrbios metabólicos e saúde do fígado

Pacientes com doenças hepáticas metabólicas

População estimada de pacientes para tratamento potencial:

• Pacientes de esteato-hepatite não alcoólica (NASH): 17,3 milhões nos Estados Unidos
• Doença hepática gordurosa associada a metabólico (MAFLD): 33,6 milhões de pacientes

Instituições de pesquisa

Tipo de instituição	Número
Centros de pesquisa acadêmica	412 especializado em doenças metabólicas
Instituições de pesquisa hepática financiadas pelo NIH	87 centros de pesquisa ativos

Sistemas de saúde focados em distúrbios metabólicos

Segmentos direcionados do sistema de saúde:

• Grandes redes integradas de saúde: 327 em todo o país
• Centros de Tratamento de Transtorno Metabólico Especializado: 156

Akero Therapeutics, Inc. (AKRO) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Akero Therapeutics registrou despesas de P&D de US $ 94,1 milhões.

2022

US $ 76,3 milhões

23.6%

2023

US $ 94,1 milhões

23.3%

Ano	Despesas de P&D	Aumento percentual

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para o candidato a medicamentos efruxifermina (EFX) da AKERO na indicação de NASH totalizaram US $ 52,4 milhões em 2023.

Manutenção da propriedade intelectual

• Custos de arquivamento de patentes: US $ 1,2 milhão anualmente
• Taxas de manutenção de patentes: US $ 450.000 por ano
• Despesas legais para proteção de IP: US $ 750.000 em 2023

Compensação de pessoal científico

Categoria de pessoal	Remuneração anual	Número de funcionários
Pesquisadores seniores	$250,000 - $350,000	12
Cientistas de pesquisa	$150,000 - $220,000	35
Técnicos de laboratório	$80,000 - $120,000	50

Infraestrutura laboratorial e tecnológica

Infraestrutura total e investimento em tecnologia em 2023: US $ 18,7 milhões

• Equipamento de laboratório: US $ 8,3 milhões
• Infraestrutura computacional: US $ 5,2 milhões
• Software e ferramentas digitais: US $ 3,5 milhões
• Manutenção da instalação: US $ 1,7 milhão

Akero Therapeutics, Inc. (AKRO) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A partir do quarto trimestre 2023, a Akero Therapeutics se concentra no desenvolvimento de efruxifermina (EFX) para o tratamento de NASH, com possíveis fluxos de receita da futura comercialização de medicamentos.

Candidato a drogas	Área terapêutica	Valor potencial de mercado
Efruxifermina (EFX)	Tratamento de Nash	Potencial de mercado global estimado em US $ 35 bilhões

Bolsas de pesquisa

A Akero recebeu apoio de financiamento de pesquisa de várias fontes.

Fonte de concessão	Ano	Quantia
Institutos Nacionais de Saúde (NIH)	2022	US $ 1,2 milhão

Financiamento de pesquisa colaborativa

A Akero se envolve em parcerias de pesquisa colaborativa para gerar fluxos de receita adicionais.

• Pesquisa colaborativa com instituições acadêmicas
• Programas de desenvolvimento conjunto com empresas farmacêuticas

Acordos de licenciamento em potencial

Receita potencial da propriedade intelectual de licenciamento e tecnologias de desenvolvimento de medicamentos.

Área de licenciamento potencial	Intervalo de valor estimado
Tecnologia de tratamento de Nash	US $ 5 a 10 milhões antecipadamente

Pagamentos marcantes de parcerias farmacêuticas

Receita potencial dos pagamentos marcantes associados ao progresso do desenvolvimento de medicamentos.

Tipo de parceria	Pagamento em potencial
Marco de desenvolvimento clínico	Até US $ 20 milhões por marco
Milco de aprovação regulatória	Até US $ 50 milhões por marco

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.