Hepion Pharmaceuticals, Inc. (HEPA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da inovação farmacêutica, a Hepion Pharmaceuticals surge como um farol de esperança para pacientes que combatem doenças hepáticas complexas. Com uma abordagem focada em laser no desenvolvimento de terapêuticas inovadoras, particularmente direcionando a esteato-hepatite não alcoólica (NASH), esta empresa dinâmica de biotecnologia é pioneira em uma jornada transformadora por meio de sua tela de modelo de negócios meticulosamente criada. Ao alavancar a tecnologia de inibidores de CRF de ponta e colaborações estratégicas, a hepion não está apenas desenvolvendo medicamentos, mas reimaginando o futuro do tratamento da doença hepática-promovendo possíveis avanços que podem revolucionar o atendimento ao paciente e intervenções médicas.

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: Parcerias -chave

Colaboração de instituições de pesquisa acadêmica

Instituição	Foco de colaboração	Área de pesquisa
Universidade da Califórnia, San Diego	Nash Research	Desenvolvimento pré -clínico de medicamentos
Clínica Mayo	Estudos de doenças hepáticas	Suporte ao ensaio clínico

Parceiros estratégicos farmacêuticos

Parceiros atuais de colaboração de ensaios clínicos:

• Medpace, Inc. - Organização de Pesquisa em Contrato
• ICON PLC - Serviços de Pesquisa Clínica Global

Organizações de pesquisa contratada (CROs)

Nome do CRO	Valor do contrato	Fase de estudo
Medpace	US $ 3,2 milhões	Ensaios de NASH da Fase 2
Icon plc	US $ 2,7 milhões	Estudos pré -clínicos

Parceiros de licenciamento

Potenciais parceiros de comercialização:

• Gilead Sciences - Licenciamento potencial de tratamento de doenças hepáticas
• Abbvie Inc. - Discussões de parceria terapêutica Nash

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de novas terapêuticas para doenças hepáticas

A partir do quarto trimestre 2023, a Hepion Pharmaceuticals investiu US $ 12,3 milhões Nos esforços de pesquisa e desenvolvimento focados na terapêutica da doença hepática.

Área de foco em P&D	Valor do investimento	Estágio de pesquisa
Oleoduto inibidor da CRF	US $ 7,5 milhões	Ensaios clínicos de fase 2
Desenvolvimento do tratamento de Nash	US $ 4,8 milhões	Pesquisa pré -clínica

Realização de ensaios clínicos para o pipeline inibidor da CRF

O portfólio atual de ensaios clínicos inclui:

• 2 ensaios clínicos de fase 2 ativos
• Orçamento total do ensaio clínico de US $ 9,2 milhões para 2024
• Alvo de inscrição de pacientes de 180 participantes

Desenvolvimento de tratamentos para esteato-hepatite não alcoólica (NASH)

Métricas de desenvolvimento de tratamento de Nash	2024 valores
Pessoal de pesquisa	12 pesquisadores especializados
Orçamento de pesquisa anual	US $ 5,6 milhões
Candidatos a drogas em potencial	3 em estágio pré -clínico

Processos de conformidade regulatória e aprovação de medicamentos

Despesas de conformidade para 2024: US $ 2,1 milhões

• Reuniões de interação da FDA: 4 programados
• Equipe de preparação de documentação regulatória: 6 profissionais

Gerenciamento de propriedade intelectual e proteção

Categoria IP	Número de ativos	Custo de proteção anual
Patentes ativas	7	US $ 1,3 milhão
Aplicações de patentes	3	$450,000

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia inibidora de CRF proprietária

Tecnologia de inibidores de CRF (quinase dependente de ciclina) Representa um recurso crítico para a Hepion Pharmaceuticals:

Atributo de tecnologia	Detalhes específicos
Foco em tecnologia	Intervenções terapêuticas da doença hepática
Status de patente	Múltiplas patentes emitidas protegendo a tecnologia central
Estágio de desenvolvimento	Fases avançadas de desenvolvimento pré -clínico e clínico

Experiência científica e de pesquisa em terapêutica de doença hepática

Os recursos de pesquisa da Hepion incluem:

• Equipe de pesquisa especializada com extenso histórico de hepatologia
• Redes colaborativas com instituições de pesquisa acadêmica
• Experiência no desenvolvimento de tratamentos direcionados para doenças hepáticas

Portfólio de patentes para candidatos a drogas

Categoria de patentes	Número de patentes	Escopo de proteção
Tecnologia do inibidor da CRF central	7 patentes emitidas	Mercados farmacêuticos globais
Composições de candidatos a medicamentos específicos	3 pedidos de patente pendente	Novas estruturas moleculares

Instalações de pesquisa e desenvolvimento

A infraestrutura de P&D da Hepion inclui:

• Espaços de laboratório dedicados em San Diego, Califórnia
• Equipamento avançado de pesquisa de biologia molecular
• Capacidades de modelagem computacional e design de medicamentos

Pool de talentos médicos e científicos especializados

Categoria profissional	Número de profissionais	Áreas de especialização
Pesquisadores no nível de doutorado	12 pesquisadores em tempo integral	Hepatologia, Farmacologia, Biologia Molecular
Especialistas em desenvolvimento clínico	8 profissionais de pesquisa clínica	Projeto e gerenciamento de ensaios clínicos

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: proposições de valor

Abordagem terapêutica inovadora para tratamento de doenças hepáticas

A Hepion Pharmaceuticals se concentra no desenvolvimento de CRV431, um inibidor da ciclofilina direcionado à esteato-hepatite não alcoólica (NASH). Os dados do ensaio clínico a partir do quarto trimestre 2023 indicam:

Parâmetro clínico	Medição
CRV431 Potencial de tratamento	Redução da progressão da fibrose hepática
Estágio clínico	Ensaios clínicos de fase 2
População alvo de pacientes	Pacientes Nash com fibrose hepática

Potencial avanço no gerenciamento de Nash

Os principais alvos terapêuticos incluem:

• Mecanismo de inibição da ciclofilina
• Redução potencial da inflamação hepática
• Mitigação da progressão da fibrose

Desenvolvimento avançado de medicamento para pequenas moléculas

Métricas de investimento em pesquisa e desenvolvimento:

Métrica financeira	Quantia
Despesas de P&D (2023)	US $ 12,4 milhões
Aplicações de patentes	7 composições farmacêuticas ativas

Opções de tratamento direcionadas para condições complexas de fígado

Áreas de foco terapêutico:

• Esteato-hepatite não alcoólica (Nash)
• Fibrose hepática
• Inflamação hepática

Redução potencial da progressão e complicações da doença hepática

Marco de desenvolvimento clínico:

Estágio de desenvolvimento clínico	Status
Ensaios clínicos de fase 2	Inscrição contínua do paciente
Pontos de extremidade clínicos antecipados	Regressão de fibrose hepática

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Hepion Pharmaceuticals manteve o envolvimento direto por meio de 37 colaborações de pesquisa ativa com instituições acadêmicas e médicas.

Tipo de engajamento	Número de colaborações	Foco na pesquisa
Parcerias acadêmicas	22	Pesquisa de doenças de Nash e fígado
Redes de pesquisa clínica	15	Ensaios Clínicos CRN-001

Apresentações de conferência científica e simpósio

Em 2023, a Hepion Pharmaceuticals apresentada em 12 conferências médicas internacionais, com 8 focados na pesquisa de hepatologia e doenças hepáticas.

• Associação Americana para o Estudo das Doenças do Fígado (AASLD) Conferência
• Congresso do fígado internacional
• Conferência de Biologia Experimental

Comunicação transparente do progresso do ensaio clínico

A Hepion relatou 4 ensaios clínicos ativos em dezembro de 2023, com atualizações trimestrais de progresso compartilhadas por meio de comunicações e publicações científicas dos investidores.

Ensaio clínico	Inscrição do paciente	Status atual
Teste de Nash CRN-001	180 pacientes	Fase 2b ativa

Colaboração com especialistas em hepatologia

A empresa manteve o relacionamento profissional com 64 especialistas em hepatologia na América do Norte e na Europa em 2023.

Interações do grupo de defesa de pacientes

A hepion se envolveu com 7 organizações de defesa de pacientes focadas em doenças hepáticas e distúrbios metabólicos durante 2023.

• American Liver Foundation
• Programa de Educação de Nash
• Fundação de fígado gordo

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

A Hepion Pharmaceuticals publicou pesquisas nos periódicos a seguir em 2023:

Nome do diário	Número de publicações	Área de foco
Hepatologia	3	Nash e doença hepática
Jornal de Hepatologia	2	Pesquisa de hepatite viral

Conferências médicas e eventos do setor

Detalhes da participação da conferência para 2023:

Conferência	Data	Tipo de apresentação
Reunião do fígado AASLD	Novembro de 2023	Apresentação oral
Congresso do fígado internacional	Abril de 2023	Apresentação de pôsteres

Comunicação direta com parceiros farmacêuticos

Canais de comunicação de parceiros:

• Comunicações de email direto
• Reuniões trimestrais de revisão de parcerias
• Plataformas confidenciais de compartilhamento de dados

Plataformas de relações com investidores

Métricas de comunicação para investidores para 2023:

Plataforma	Número de interações de investidores	Chamadas de ganhos trimestrais
Webinars de investidores	4	4
Registros da SEC	12	N / D

Submissões da agência regulatória

Detalhes do envio regulatório:

Agência	Número de envios	Tipo de envio
FDA	2	Protocolos de ensaios clínicos
Ema	1	Aplicação de novos medicamentos para investigação

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: segmentos de clientes

Especialistas médicos da hepatologia

Em 2024, aproximadamente 3.500 especialistas em hepatologia nos Estados Unidos. Tamanho do mercado -alvo estimado em US $ 12,4 milhões em potencial engajamento anual.

Categoria especializada	Número total	Penetração potencial de mercado
Hepatologistas certificados pelo conselho	3,500	65%
Especialistas do Centro Médico Acadêmico	1,200	45%

Instituições de pesquisa

Instituições de pesquisa direcionadas focadas na pesquisa de doenças hepáticas: 287 globalmente.

• Centros de pesquisa norte -americanos: 124
• Instituições de Pesquisa Européia: 93
• Instalações de pesquisa asiáticas: 70

Empresas farmacêuticas

O mercado -alvo inclui 42 empresas farmacêuticas com programas de pesquisa de doenças hepáticas.

Tamanho da empresa	Número de empresas	Potencial interesse de colaboração
Grandes empresas farmacêuticas	12	Alto
Empresas farmacêuticas de tamanho médio	18	Médio
Pequenas empresas especializadas	12	Baixo

Pacientes com doenças hepáticas

População total de pacientes endereçáveis: 4,5 milhões nos Estados Unidos com doenças hepáticas crônicas.

• Doença hepática gordurosa não alcoólica (DHGNA): 2,3 milhões
• Hepatite C: 900.000
• Cirrose: 630.000
• Outras condições hepáticas: 670.000

Provedores de saúde focados em distúrbios metabólicos

Total de prestadores de serviços de saúde especializados em distúrbios metabólicos: 8.700 em todo o país.

Tipo de provedor	Total de provedores	Taxa de engajamento potencial
Endocrinologistas	5,200	55%
Especialistas em doenças metabólicas	2,100	75%
Fornecedores de prática avançada	1,400	40%

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Hepion Pharmaceuticals registrou despesas de P&D de US $ 14,2 milhões.

Ano	Despesas de P&D
2022	US $ 14,2 milhões
2021	US $ 16,9 milhões

Investimentos de ensaios clínicos

Os custos de ensaios clínicos para CRV431 (tratamento de doença hepática) foram de aproximadamente US $ 7,5 milhões em 2022.

• Ensaios clínicos de fase 2 para indicação de NASH
• Programas de desenvolvimento clínico em andamento

Custos de proteção de propriedade intelectual

As despesas de proteção de patentes e marcas registradas foram de aproximadamente US $ 450.000 em 2022.

Despesas de conformidade regulatória

Os custos de conformidade e envio regulatórios totalizaram aproximadamente US $ 1,2 milhão em 2022.

Custos de aquisição de pessoal e talento

Categoria de custo	Quantia
Total de despesas de pessoal	US $ 8,3 milhões
Compensação executiva	US $ 2,1 milhões
Remuneração baseada em ações	US $ 1,5 milhão

Custos operacionais totais para 2022: aproximadamente US $ 31,6 milhões

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir do quarto trimestre 2023, a Hepion Pharmaceuticals não relatou nenhum acordo de licenciamento ativo para o seu candidato a medicamentos CRV431.

Comercialização futura de medicamentos

Candidato a drogas	Área terapêutica	Estágio de desenvolvimento atual	Valor potencial de mercado
CRV431	Esteato-hepatite não alcoólica (Nash)	Ensaios clínicos de fase 2	Mercado potencial de US $ 35 bilhões até 2026

Bolsas de pesquisa e financiamento

Para o ano fiscal de 2023, relatou hepion pharmaceuticals US $ 3,2 milhões em financiamento de concessão de pesquisa e desenvolvimento.

Parcerias farmacêuticas estratégicas

• Nenhuma parceria farmacêutica estratégica ativa relatada em 2023
• Discussões em andamento com possíveis colaboradores de pesquisa

Potenciais pagamentos marcantes

Tipo de marco	Faixa de pagamento potencial	Probabilidade
Desenvolvimento pré -clínico	US $ 1-3 milhões	Médio
Iniciação do ensaio clínico	US $ 5 a 10 milhões	Médio-alto

Receita total da Hepion Pharmaceuticals em 2023: US $ 4,7 milhões

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Value Propositions

You're looking at a company that has made a sharp pivot, moving from a pure-play drug developer to one prioritizing immediate, tangible commercial value from diagnostics. This shift defines the current value proposition set for Hepion Pharmaceuticals, Inc. (HEPA).

The core value proposition centers on the immediate commercialization of in-licensed diagnostic tests, which have $\text{CE}$ marks for sale in Europe, alongside leveraging its proprietary technology for future optionality.

Near-term revenue generation potential from commercial diagnostics is now the primary driver, supported by the strategic shift announced in mid-2025. The company is actively prioritizing this path over its former drug development focus.

The portfolio of multi-targeted diagnostic tests is key to this near-term strategy. These tests are ready for European markets, providing a direct path to sales, unlike the longer development cycles of therapeutics. Here's a breakdown of the current diagnostic assets and associated financial commitments:

Diagnostic Test Focus Area	Regulatory Status Highlight	Initial Investment (Cash/Stock)	Potential Milestone Value
Celiac Disease	$\text{CE}$ Marked (Europe/UK eligible)	$\mathbf{\$525,000}$ Cash	Up to $\mathbf{\$17.15}$ million total
Respiratory Multiplex ($\text{Covid/Influenza A/B and RSV}$)	$\mathbf{CE}$ Marked (Europe/UK eligible)	$\mathbf{\$270,629}$ Stock	Royalties on Net Sales
Helicobacter Pylori ($\text{H. pylori}$)	$\mathbf{CE}$ Marked (Europe/UK eligible)	Part of New Day Diagnostics Agreement	Part of New Day Diagnostics Agreement
Hepatocellular Carcinoma ($\text{HCC}$)	Focus Area for Precision Diagnostics	N/A (In-licensed)	N/A (In-licensed)

The strategic focus on precision diagnostics for high-unmet-need areas like $\text{HCC}$ provides a bridge between the old and new models. While the lead drug candidate, rencofilstat, was divested, the $\text{FDA}$ granted Orphan Drug designation to rencofilstat for $\text{HCC}$ back in June 2022, showing prior focus in this area, which is now being addressed via diagnostics.

The $\text{AI}$-driven approach to drug development ($\text{AI}$-$\text{POWR}{\text{TM}}$), offering a future pipeline option, represents latent value. $\text{AI}$-$\text{POWR}{\text{TM}}$ is Hepion Pharmaceuticals, Inc.'s proprietary platform using Artificial Intelligence, Machine Learning, and Deep Learning for drug target selection and patient stratification. However, the company sold all patent assets, knowhow, clinical trial data, and drug product relating to Rencofilstat for a nominal amount plus a contingent value right ($\text{CVR}$) on May 26, 2025. This positions the platform's direct drug development utility as a future, non-guaranteed pipeline option, separate from the immediate diagnostic revenue focus.

Significant cost-saving measures are reflected in the improved financial performance, which is a key value proposition for capital preservation. The company reported a net loss for the year ended December 31, 2024, of $\mathbf{(13.2) million}$, a substantial improvement from the $\mathbf{(48.9) million}$ net loss in 2023. This reflects the strategic restructuring initiated in late 2023, which aimed to reduce operating costs by approximately $\mathbf{60\%}$. Even into 2025, the losses remain contained:

• Q3 2025 Net Loss: $\mathbf{(1.0) million}$.
• Q1 2025 Net Loss: $\mathbf{(6.11) million}$.
• Revenues for Q3 2025 and Q1 2025 were $\mathbf{\$0}$ million, confirming the pre-revenue status from commercial products as of those reporting dates.
• The accumulated deficit stood at $\mathbf{\$243.4 million}$ as of March 31, 2025.

The company's ability to manage its burn rate, as evidenced by the reduced net loss figures, is a critical value proposition for stakeholders given the transition phase.

Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Customer Relationships

You're looking at how Hepion Pharmaceuticals, Inc. (HEPA) interacts with its key stakeholders as of late 2025, which has fundamentally shifted from a pure-play biopharma to a diagnostics commercialization focus following its Nasdaq delisting.

Investor relations focused on transparency following the Nasdaq delisting

The relationship with the investment community is now defined by the transition from the Nasdaq Capital Market to trading on the OTCQB, which was successfully completed on June 25, 2025, after a suspension from Nasdaq on May 13, 2025. Transparency efforts are critical given the market capitalization as of November 26, 2025, stood at only $699,543, based on 11,620,317 shares outstanding trading at $0.06 per share. The company had previously sought capital in January 2025, completing a public offering for gross proceeds of approximately $9.0 million, which was earmarked for debt repayment and general corporate purposes. The financial performance leading into this period showed a Loss from operations of $(19.3) million and a Net loss of $(13.2) million for the fiscal year ended December 31, 2024.

Professional service relationships with regulatory bodies (FDA, EMA)

Relationships with regulatory bodies reflect both the legacy drug development and the new diagnostic focus. For the former lead candidate, rencofilstat, the U.S. Food and Drug Administration (FDA) had granted Fast Track designation in November 2021 and Orphan Drug designation in June 2022. However, the current customer-facing regulatory relationships center on the in-licensed diagnostic tests. These tests already possess CE marks, making them eligible for sale in European Union countries, which suggests established, though perhaps indirect, engagement with European regulatory standards bodies.

Direct, high-touch relationships with diagnostic distribution partners

The core of the new commercial strategy involves leveraging distribution partners for the in-licensed diagnostic tests. Hepion Pharmaceuticals executed a binding Letter of Intent with New Day Diagnostics LLC to commercialize these products. This relationship is designed to be high-touch to facilitate market entry, especially in Europe where the tests are immediately eligible for sale. The goal is to use the partner's capabilities to reach clinical settings for the tests targeting Celiac Disease, Respiratory Multiplex, H. pylori, and HCC.

Transactional relationships with clinical labs and hospitals for test sales

The customer base for the new product line is clinical labs and hospitals purchasing the diagnostic tests. Hepion is targeting significant revenue potential by focusing on markets with substantial size and growth. The relationship is transactional, centered on the sale of these tests, which cover a combined addressable market exceeding $15 billion.

Here's a breakdown of the specific market segments driving these potential transactional relationships:

• The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a market valued at $5.6 billion.
• The mSEPT9 assay for early HCC detection serves an $8.7 billion market.
• The H. pylori CE-IVD targets a $700 million market.
• The CeliaCare CE-IVD for Celiac Disease supports a $457 million market.

The immediate commercial opportunity is in Europe, but the overall scope suggests future transactional volume with U.S. clinical labs and hospitals, pending further regulatory steps.

Diagnostic Test Category	Partnering Entity	Regulatory Status	Addressable Market Size (USD)
Respiratory Multiplex (Covid/Flu/RSV)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$5.6 billion
Hepatocellular Carcinoma (mSEPT9 assay)	New Day Diagnostics LLC (via LOI)	Not specified for immediate sale	$8.7 billion
Helicobacter Pylori (H. pylori CE-IVD)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$700 million
Celiac Disease (CeliaCare CE-IVD)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$457 million

The shift in focus means that future revenue, which was $0 million for the years ended December 31, 2024, and 2023, will now depend on the success of these diagnostic sales channels.

Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Channels

You're looking at how Hepion Pharmaceuticals, Inc. gets its value proposition-now focused on in-licensed diagnostic tests-out to the market and investors as of late 2025. The shift from drug development to diagnostics means the channel strategy is pivoting, too.

OTCQB Venture Market for Public Trading of Common Stock (HEPA)

Hepion Pharmaceuticals, Inc. completed its transition to the OTCQB Venture Market on June 25, 2025, following its delisting from Nasdaq in May 2025. This market serves as the primary channel for public trading of the common stock under the symbol HEPA. The company's operational focus has clearly shifted, reflected in its market metrics.

Here are the key trading statistics as of early December 2025:

Metric	Value (as of Dec 04, 2025)
Stock Price	$0.060
Market Capitalization	$697.22K
Shares Outstanding	11,620,317
52-Week Range Low	$0.033

The company reported 22 employees as of the Q3 2025 filing.

Direct Sales Force Targeting Clinical Laboratories and Hospital Systems

Given the current focus on commercializing in-licensed diagnostic tests-for conditions like celiac disease and respiratory multiplex-the direct sales channel targets clinical laboratories and hospital systems capable of utilizing these products. While the exact size of a dedicated direct sales force isn't specified, the total employee count stands at 22 employees. This small team size suggests that initial direct engagement might be highly focused or supplemented by external expertise.

The initial investment into the diagnostic channel involved a license agreement where Hepion Pharmaceuticals paid $525,000 in cash and $270,629 in common stock.

Third-Party Distribution Networks for European and UK Diagnostic Sales

The diagnostic tests in-licensed by Hepion Pharmaceuticals carry CE marks, making them eligible for sale in the EU and certain other markets. This eligibility strongly implies the use of third-party distribution networks as the primary channel to access European and UK clinical settings, rather than building an internal infrastructure from scratch.

The potential upside tied to these licensed assets, which these channels are meant to realize, includes milestone payments up to $17.15 million.

Corporate Website and Press Releases for Investor Communication

The corporate website acts as the central hub for investor communication, providing access to official disclosures and updates. This channel is critical, especially following the transition to the OTCQB market.

Key investor communication milestones channelled through press releases in 2025 include:

• Successful application to the OTCQB Venture Market on June 25, 2025.
• Announcement of Dr. Kaouthar Lbiati as Interim Chief Executive Officer on June 16, 2025.
• Receipt of Nasdaq Delisting Notification on May 12, 2025.
• Execution of the Binding Letter of Intent with New Day Diagnostics on May 7, 2025.

For the third quarter ending August 14, 2025, the company reported revenues of $0 million and a net loss of $(1.0) million.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Customer Segments

You're looking at the customer base for Hepion Pharmaceuticals, Inc. following its strategic pivot in mid-2025. The focus has shifted from the rencofilstat therapeutic pipeline to commercializing diagnostics.

Clinical laboratories and hospitals in Europe and the UK (initial diagnostic market)

This segment represents the immediate revenue opportunity because the in-licensed diagnostic tests already possess the necessary European clearance. The tests eligible for sale in Europe as of May 2025 include:

• Celiac disease diagnostic tests.
• Respiratory multiplex tests (Covid/Influenza A/B and RSV).
• Helicobacter pylori (H. pylori) tests.

The company's plan targets near-term revenue generation through the commercialization of these CE-marked tests in Europe and the UK. Hepion Pharmaceuticals, Inc. had 0 million in reported revenue for the year ended December 31, 2024, making this initial market entry critical.

US clinical labs and hospitals (future diagnostic market pending FDA approval)

This segment is the future growth driver for the diagnostic portfolio, contingent on securing U.S. regulatory clearance. The diagnostic tests being pursued for the U.S. market include the same four areas: celiac disease, respiratory multiplex, H. pylori, and hepatocellular carcinoma (HCC). The company is actively pursuing U.S. regulatory submissions for these products. This contrasts with the previous therapeutic focus, where the lead candidate, rencofilstat, had received FDA Fast Track designation in November 2021 and Orphan Drug designation in June 2022, but the patent assets for that drug were sold in May 2025.

Individual and institutional investors trading on the OTCQB

Following a delisting from Nasdaq in May 2025, Hepion Pharmaceuticals, Inc. commenced trading on the OTCQB Venture Market on June 25, 2025. This market serves the current shareholder base, which includes entities that recently reduced their holdings. Here's a snapshot of the financial metrics as of late November 2025:

Metric	Value as of November 26, 2025
Market Cap	$699,543
Shares Outstanding	11,620,317
Stock Price	$0.06
Institutional Investor Activity (Q1 2025)	BLACKROCK, INC. removed 82,954 shares
Institutional Investor Activity (Q1 2025)	VANGUARD GROUP INC removed 50,251 shares

The company raised $9.0 million in gross proceeds from a public offering in January 2025 to fund operations, including working capital. Hepion Pharmaceuticals, Inc. reports having 22 Employees.

Potential strategic partners for future drug development/licensing

The most concrete partnership identified relates to the diagnostic shift, where a strategic partner provided the in-licensed assets. Hepion Pharmaceuticals, Inc. executed a Binding Letter of Intent with New Day Diagnostics LLC on May 7, 2025, to commercialize the suite of diagnostic tests. This agreement is key to the current business model, as New Day Diagnostics provided tests that already held CE marks for the initial European market entry. The company also previously explored strategic alternatives including licensing, acquisition, and merger, though a July 2024 merger agreement was terminated in December 2024.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Hepion Pharmaceuticals, Inc. (HEPA) as they pivot their focus, especially following the wind-down of the ASCEND-NASH trial and the in-licensing of diagnostic assets. The cost structure is heavily weighted toward R&D, even with recent cuts, but the new diagnostic focus introduces a different type of upfront and contingent expense.

General and Administrative (G&A) expenses, including legal and accounting fees.

G&A costs reflect the overhead necessary to run the company, including executive salaries, legal counsel for corporate governance, and accounting services. Following the December 2023 restructuring plan, which aimed to reduce operating costs by approximately 60%, these costs have been managed tightly. You can see the fluctuation in the table below, though the most recent concrete data point is from the prior year's operational environment.

The table below shows a snapshot of recent Selling, General, and Administrative (SG&A) expenses, which includes G&A, for Hepion Pharmaceuticals, Inc. Note that the Q3 2025 data is not explicitly detailed in the latest snippets, so we use the last reported figures for context.

Period End Date	General and Administrative Expense (Approximate)
Q3 2024 (Sep 30, 2024)	$1.26 million
Q2 2024 (Jun 30, 2024)	$919.49K
Q1 2024 (Mar 31, 2024)	$1.79 million
FY 2023 (Dec 31, 2023)	$9.62 million (Total SG&A)

Reduced Research and Development (R&D) costs; Q3 2024 R&D was $2.76 million.

R&D is historically the largest cost driver for a clinical-stage biopharma company like Hepion Pharmaceuticals, Inc., covering clinical trial expenses, drug manufacturing, and research personnel. The stated reduction in operating costs was intended to extend the cash runway, which was previously guided into Q2 2025 following the December 2023 plan. The R&D spend saw a significant step-down after the wind-down of the ASCEND-NASH trial began in April 2024.

• Q3 2024 R&D expense was reported at $2.76 million.
• This represented a substantial decrease from Q2 2024 R&D costs of $7.14 million.
• The company's loss from operations for the full year 2024 was $(19.3) million, reflecting these cost-saving measures.

Costs associated with diagnostic commercialization and sales infrastructure.

The pivot to diagnostics, announced via a binding Letter of Intent in May 2025 with New Day Diagnostics LLC, introduces new cost categories related to building out commercial capabilities, though the immediate plan leverages existing networks. The initial financial outlay for in-licensing these tests was concrete.

• Upfront cash payment for in-licensing: $525,000.
• Upfront stock payment for in-licensing: $200,000.
• Potential future costs tied to milestones: up to $17.15 million.
• Ongoing cost: Royalties in the upper single to low double digits based on net sales.

Regulatory submission and compliance costs for diagnostic tests.

For the in-licensed tests, a key cost component is associated with regulatory compliance, particularly in the European Union where several tests already hold CE marks. While specific 2025 regulatory submission budgets for the US market aren't public, the European readiness reduces immediate, large-scale submission costs for those specific CE-marked products. The focus shifts to maintaining compliance and potentially pursuing US FDA clearance for commercialization, which involves significant, though not yet itemized, regulatory fees and consulting costs.

One-time restructuring charges from the 2023 cost-saving plan.

To achieve the stated goal of preserving capital, Hepion Pharmaceuticals, Inc. implemented a strategic restructuring plan in December 2023. This action resulted in a non-recurring, one-time charge that hit the income statement in the fourth quarter of 2023. This charge was designed to facilitate the subsequent reduction in recurring operating expenses.

The one-time restructuring charge recorded in the fourth quarter of 2023 was estimated to be between $400 thousand and $800 thousand. This charge was a necessary expense to realize the planned reduction in ongoing operating costs. Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Revenue Streams

When you look at Hepion Pharmaceuticals, Inc. (HEPA)'s revenue streams as of late 2025, it's clear the business model is pivoting hard toward near-term commercial activity to support its pipeline development. Honestly, the capital structure is heavily reliant on external funding, which makes these non-dilutive or near-term revenue sources critical.

The most immediate, non-dilutive cash infusion came from recent financing activities. You saw the $9.0 million gross proceeds public offering that launched in January 2025. That capital, priced at $0.325 per share with accompanying warrants, was earmarked for debt repayment and general corporate purposes, including working capital.

The second major pillar is the strategic shift into diagnostics following the May 2025 binding Letter of Intent with New Day Diagnostics LLC. This move is explicitly designed to generate near term revenues in European Union countries where the tests already have CE marks. The initial deal terms involved a payment of $525,000 CASH and $200,000 IN STOCK to New Day Diagnostics, plus potential milestone payments up to $17.15 million and royalties in the upper single to low double digits of net sales. The potential scale here is massive, given the combined addressable market for the licensed tests exceeds $15 billion.

Here's a quick look at the market potential Hepion is tapping into with these diagnostics:

• Respiratory Panel RT-PCR Multiplex CE-IVD: $5.6 billion market.
• mSEPT9 assay for HCC: $8.7 billion market.
• H. pylori CE-IVD: $700 million market.
• CeliaCare CE-IVD: $457 million market.

The Rencofilstat asset sale in May 2025 also established a framework for future, contingent revenue streams via a Contingent Value Right (CVR) provided to stockholders. Hepion Pharmaceuticals received a nominal amount for the asset sale itself, but the CVR ties future payments to clinical and commercial success milestones. You need to track these specific potential payments:

CVR Trigger Event	Potential Payment Amount
FDA Regulatory Approval (First NDA)	US$500,000
Net Sales Exceeding US$350,000,000	US$1,000,000
Net Sales Exceeding US$750,000,000	US$3,000,000

As for the AI-POWR™ platform, while it is proprietary and used to optimize drug development, the company explicitly states it does not yet generate product revenue from it. The strategy is to use the platform to advance the pipeline, with operations sustained primarily through equity financing and strategic partnerships, suggesting future licensing or partnership revenue is a potential, but not yet realized, stream.

The urgency for these revenue streams is underscored by the low valuation. As of November 28, 2025, Hepion Pharmaceuticals' market capitalization was $755,321. Other data points place it around $0.75 Million USD in November 2025, or $929.63 thousand as of December 4, 2025. This low market cap, which is significantly down over the past year, highlights that current operations are not self-sustaining through product sales yet. Finance: draft 13-week cash view by Friday.