Hepion Pharmaceuticals, Inc. (HEPA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la innovación farmacéutica, Hepion Pharmaceuticals surge como un faro de esperanza para pacientes que luchan contra enfermedades hepáticas complejas. Con un enfoque centrado en el láser en el desarrollo de la terapéutica innovadora, particularmente dirigida a la esteatohepatitis no alcohólica (NASH), esta compañía dinámica de biotecnología está siendo pionera en un viaje transformador a través de su lienzo de modelo de negocio meticulosamente elaborado. Al aprovechar la tecnología de inhibidores de CRF de vanguardia y las colaboraciones estratégicas, Hepion no solo está desarrollando medicamentos, sino reinventando el futuro del tratamiento de la enfermedad hepática, promulgando posibles avances que podrían revolucionar la atención al paciente y las intervenciones médicas.

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocios: asociaciones clave

Instituciones de investigación académica colaboración

Institución	Enfoque de colaboración	Área de investigación
Universidad de California, San Diego	Investigación de Nash	Desarrollo preclínico de fármacos
Clínica de mayonesa	Estudios de enfermedad hepática	Apoyo de ensayos clínicos

Socios estratégicos farmacéuticos

Partidos de colaboración de ensayos clínicos actuales:

• Medpace, Inc. - Organización de investigación por contrato
• Icon PLC - Servicios de investigación clínica global

Organizaciones de investigación por contrato (CRO)

Nombre de Cro	Valor de contrato	Fase de estudio
Medpacio	$ 3.2 millones	PRUEBAS DE NASH FASE 2
Ícono plc	$ 2.7 millones	Estudios preclínicos

Socios de licencia

Posibles socios de comercialización:

• Gilead Sciences - Licencias potenciales de tratamiento de enfermedad hepática
• Abbvie Inc. - discusiones de asociación terapéutica de Nash

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocio: actividades clave

Investigación y desarrollo de nuevas terapias para enfermedades hepáticas

A partir del cuarto trimestre de 2023, Hepion Pharmaceuticals ha invertido $ 12.3 millones En los esfuerzos de investigación y desarrollo centrados en la terapéutica de la enfermedad hepática.

Área de enfoque de I + D	Monto de la inversión	Etapa de investigación
Tubería de inhibidor de CRF	$ 7.5 millones	Ensayos clínicos de fase 2
Desarrollo del tratamiento de Nash	$ 4.8 millones	Investigación preclínica

Realización de ensayos clínicos para la tubería de inhibidores de CRF

La cartera de ensayos clínicos actuales incluye:

• 2 ensayos clínicos activos de fase 2
• Presupuesto total de ensayos clínicos de $ 9.2 millones para 2024
• Objetivo de inscripción de pacientes de 180 participantes

Desarrollo de tratamientos para la esteatohepatitis no alcohólica (NASH)

Métricas de desarrollo de tratamiento de Nash	Valores de 2024
Personal de investigación	12 investigadores especializados
Presupuesto de investigación anual	$ 5.6 millones
Posibles candidatos a drogas	3 en etapa preclínica

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Gastos de cumplimiento para 2024: $ 2.1 millones

• Reuniones de interacción de la FDA: 4 programados
• Equipo de preparación de documentación regulatoria: 6 profesionales

Gestión y protección de la propiedad intelectual

Categoría de IP	Número de activos	Costo de protección anual
Patentes activas	7	$ 1.3 millones
Solicitudes de patentes	3	$450,000

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocio: recursos clave

Plataforma de tecnología de inhibidores de CRF patentado

Tecnología de inhibidores de CRF (quinasa dependiente de ciclina) Representa un recurso crítico para Hepion Pharmaceuticals:

Atributo tecnológico	Detalles específicos
Enfoque tecnológico	Intervenciones terapéuticas de la enfermedad hepática
Estado de patente	Múltiples patentes emitidas que protegen la tecnología central
Etapa de desarrollo	Fases avanzadas de desarrollo preclínico y clínico

Experiencia científica e de investigación en terapéutica de enfermedades hepáticas

Las capacidades de investigación de Hepion incluyen:

• Equipo de investigación especializado con extensas antecedentes de hepatología
• Redes colaborativas con instituciones de investigación académica
• Experiencia en el desarrollo de tratamientos dirigidos de enfermedades hepáticas

Cartera de patentes para candidatos a drogas

Categoría de patente	Número de patentes	Alcance de protección
Tecnología de inhibidores de CRF básicos	7 patentes emitidas	Mercados farmacéuticos globales
Composiciones específicas de candidatos a drogas	3 solicitudes de patentes pendientes	Nuevas estructuras moleculares

Investigaciones y instalaciones de desarrollo

La infraestructura de I + D de Hepion incluye:

• Espacios de laboratorio dedicados en San Diego, California
• Equipo de investigación de biología molecular avanzada
• Capacidades de modelado computacional y diseño de fármacos

Grupo de talentos médicos y científicos especializados

Categoría profesional	Número de profesionales	Áreas de experiencia
Investigadores a nivel de doctorado	12 investigadores a tiempo completo	Hepatología, farmacología, biología molecular
Especialistas en desarrollo clínico	8 profesionales de investigación clínica	Diseño y gestión del ensayo clínico

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocio: propuestas de valor

Enfoque terapéutico innovador para el tratamiento de la enfermedad hepática

Hepion Pharmaceuticals se centra en el desarrollo de CRV431, un inhibidor de ciclofilina dirigido a la esteatohepatitis no alcohólica (NASH). Los datos del ensayo clínico a partir del cuarto trimestre de 2023 indican:

Parámetro clínico	Medición
Potencial de tratamiento CRV431	Reducción de la progresión de la fibrosis hepática
Estadio clínico	Ensayos clínicos de fase 2
Población de pacientes objetivo	Pacientes con Nash con fibrosis hepática

Posible avance en la gestión de Nash

Los objetivos terapéuticos clave incluyen:

• Mecanismo de inhibición de ciclofilina
• Reducción potencial de la inflamación hepática
• Mitigación de la progresión de la fibrosis

Desarrollo avanzado de fármacos de molécula pequeña

Investigación y desarrollo de métricas de inversión:

Métrica financiera	Cantidad
Gasto de I + D (2023)	$ 12.4 millones
Solicitudes de patentes	7 composiciones farmacéuticas activas

Opciones de tratamiento específicas para afecciones hepáticas complejas

Áreas de enfoque terapéutico:

• Esteatohepatitis no alcohólica (NASH)
• Fibrosis hepática
• Inflamación hepática

Reducción potencial de la progresión y complicaciones de la enfermedad hepática

Hitos de desarrollo clínico:

Etapa de desarrollo clínico	Estado
Ensayos clínicos de fase 2	Inscripción continua del paciente
Puntos finales clínicos anticipados	Regresión de fibrosis hepática

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Hepion Pharmaceuticals mantuvo la participación directa a través de 37 colaboraciones de investigación activa con instituciones académicas y médicas.

Tipo de compromiso	Número de colaboraciones	Enfoque de investigación
Asociaciones académicas	22	Investigación de enfermedades de Nash y hígado
Redes de investigación clínica	15	Ensayos clínicos CRN-001

Conferencia científica y presentaciones de simposio

En 2023, Hepion Pharmaceuticals presentó en 12 conferencias médicas internacionales, con 8 centrados en la hepatología y la investigación de la enfermedad hepática.

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

Comunicación transparente del progreso del ensayo clínico

Hepion reportó 4 ensayos clínicos activos a diciembre de 2023, con actualizaciones de progreso trimestrales compartidas a través de comunicaciones de inversores y publicaciones científicas.

Ensayo clínico	Inscripción del paciente	Estado actual
Prueba de Nash CRN-001	180 pacientes	Fase 2b activo

Colaboración con especialistas en hepatología

La compañía mantuvo relaciones profesionales con 64 especialistas en hepatología en América del Norte y Europa en 2023.

Interacciones del grupo de defensa del paciente

Hepion se dedicó a 7 organizaciones de defensa del paciente centradas en la enfermedad hepática y los trastornos metabólicos durante 2023.

• Fundación Americana de Hígado
• Programa de Educación Nash
• Fundación Fatty Liver

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

Hepion Pharmaceuticals ha publicado investigaciones en las siguientes revistas en 2023:

Nombre del diario	Número de publicaciones	Área de enfoque
Hepatología	3	Enfermedad de nash y hepático
Revista de hepatología	2	Investigación de hepatitis viral

Conferencias médicas y eventos de la industria

Detalles de participación de la conferencia para 2023:

Conferencia	Fecha	Tipo de presentación
Reunión de hígado de Aasld	Noviembre de 2023	Presentación oral
Congreso de hígado internacional	Abril de 2023	Póster

Comunicación directa con socios farmacéuticos

Canales de comunicación de socios:

• Comunicaciones directas por correo electrónico
• Reuniones de revisión de asociación trimestral
• Plataformas de intercambio de datos confidenciales

Plataformas de relaciones con los inversores

Métricas de comunicación de inversores para 2023:

Plataforma	Número de interacciones de los inversores	Llamadas de ganancias trimestrales
Seminarios web de inversores	4	4
Presentación de la SEC	12	N / A

Presentaciones de la agencia reguladora

Detalles de presentación regulatoria:

Agencia	Número de presentaciones	Tipo de envío
FDA	2	Protocolos de ensayos clínicos
EMA	1	Aplicación de drogas de nueva investigación

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

Especialistas médicos de hepatología

A partir de 2024, aproximadamente 3.500 especialistas en hepatología en los Estados Unidos. El tamaño del mercado objetivo estimado en $ 12.4 millones de participación anual potencial.

Categoría especialista	Número total	Penetración potencial del mercado
Hepatólogos certificados por la junta	3,500	65%
Especialistas del Centro Médico Académico	1,200	45%

Instituciones de investigación

Instituciones de investigación específicas centradas en la investigación de enfermedades hepáticas: 287 a nivel mundial.

• Centros de investigación de América del Norte: 124
• Instituciones de investigación europeas: 93
• Instalaciones de investigación asiática: 70

Compañías farmacéuticas

El mercado objetivo incluye 42 compañías farmacéuticas con programas de investigación de enfermedades hepáticas.

Tamaño de la empresa	Número de empresas	Interés potencial de colaboración
Grandes compañías farmacéuticas	12	Alto
Compañías farmacéuticas de tamaño mediano	18	Medio
Pequeñas empresas especializadas	12	Bajo

Pacientes con enfermedades hepáticas

Población total de pacientes direccionables: 4.5 millones en los Estados Unidos con enfermedades hepáticas crónicas.

• Enfermedad hepática grasa no alcohólica (NAFLD): 2.3 millones
• Hepatitis C: 900,000
• Cirrosis: 630,000
• Otras condiciones hepáticas: 670,000

Proveedores de atención médica centrados en los trastornos metabólicos

Proveedores de atención médica totales especializados en trastornos metabólicos: 8.700 en todo el país.

Tipo de proveedor	Proveedores totales	Tasa de compromiso potencial
Endocrinólogos	5,200	55%
Especialistas en enfermedades metabólicas	2,100	75%
Proveedores de práctica avanzada	1,400	40%

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Hepion Pharmaceuticals reportó gastos de I + D de $ 14.2 millones.

Año	Gastos de I + D
2022	$ 14.2 millones
2021	$ 16.9 millones

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para CRV431 (tratamiento con enfermedad hepática) fueron de aproximadamente $ 7.5 millones en 2022.

• Ensayos clínicos de fase 2 para indicación de NASH
• Programas de desarrollo clínico en curso

Costos de protección de propiedad intelectual

Los gastos de protección de patentes y marcas registradas fueron de aproximadamente $ 450,000 en 2022.

Gastos de cumplimiento regulatorio

Los costos de cumplimiento y envío regulatorio totalizaron aproximadamente $ 1.2 millones en 2022.

Costos de adquisición de personal y talento

Categoría de costos	Cantidad
Gastos totales de personal	$ 8.3 millones
Compensación ejecutiva	$ 2.1 millones
Compensación basada en acciones	$ 1.5 millones

Costos operativos totales para 2022: aproximadamente $ 31.6 millones

Hepion Pharmaceuticals, Inc. (HEPA) - Modelo de negocios: flujos de ingresos

Posibles acuerdos de licencia

A partir del cuarto trimestre de 2023, Hepion Pharmaceuticals no ha informado ningún acuerdos activos de licencia para su candidato principal al fármaco CRV431.

Comercialización futura de drogas

Candidato a la droga	Área terapéutica	Etapa de desarrollo actual	Valor de mercado potencial
CRV431	Esteatohepatitis no alcohólica (NASH)	Ensayos clínicos de fase 2	Mercado potencial de $ 35 mil millones para 2026

Subvenciones de investigación y financiación

Para el año fiscal 2023, Hepion Pharmaceuticals informó $ 3.2 millones en fondos de subvenciones de investigación y desarrollo.

Asociaciones farmacéuticas estratégicas

• No se informaron asociaciones farmacéuticas estratégicas activas en 2023
• Discusiones continuas con posibles colaboradores de investigación

Pagos potenciales de hitos

Tipo de hito	Rango de pago potencial	Probabilidad
Desarrollo preclínico	$ 1-3 millones	Medio
Iniciación de ensayos clínicos	$ 5-10 millones	Medio-alto

Ingresos totales para Hepion Pharmaceuticals en 2023: $ 4.7 millones

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.