MediciNova, Inc. (MNOV): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la innovación biofarmacéutica, Medicinova, Inc. (MNOV) emerge como una fuerza pionera, navegando estratégicamente el complejo terreno de la terapéutica de enfermedades neurológicas e inflamatorias. Al aprovechar la investigación de vanguardia, las asociaciones estratégicas y un enfoque centrado en el láser para las necesidades médicas no satisfechas, esta compañía está redefiniendo los límites del desarrollo farmacéutico. Su lienzo de modelo de negocio meticulosamente elaborado revela un plan sofisticado para transformar el potencial científico en soluciones médicas innovadoras, prometiendo esperanza para pacientes e inversores por igual en el desafiante mundo del descubrimiento y desarrollo de medicamentos.

Medicinova, Inc. (MNOV) - Modelo de negocio: asociaciones clave

Colaboraciones de investigación estratégica con instituciones académicas

Medicinova ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Año de colaboración
Universidad de California, San Diego	Investigación del trastorno neurológico	2019
Universidad de Johns Hopkins	Estudios de enfermedades inflamatorias	2020

Asociaciones de desarrollo farmacéutico con organizaciones de investigación por contrato

Medicinova colabora con organizaciones de investigación de contratos especializadas (CRO):

• Icon PLC - Gestión de ensayos clínicos de fase II/III
• Parexel International - Soporte de desarrollo de medicamentos
• IQVIA - Investigación clínica y apoyo regulatorio

Acuerdos de licencia con firmas de biotecnología

Las asociaciones de licencias activas incluyen:

Empresa asociada	Candidato a la droga	Términos de licencia
Kyorin Pharmaceutical Co.	MN-166 (Ibudilast)	Derechos exclusivos para el tratamiento con ELA
Farma de nubación	MN-001 (Tipelukast)	Acuerdo de desarrollo colaborativo

Posibles empresas conjuntas en el desarrollo de fármacos

Discusiones de empresas conjuntas potenciales actuales:

• Desarrollo del tratamiento del trastorno neurológico
• Investigación terapéutica de la enfermedad inflamatoria
• Innovación de drogas de enfermedades respiratorias

Asociaciones del sitio de ensayo clínico con centros médicos

Asociaciones activas del sitio de ensayo clínico:

Centro médico	Enfoque de prueba	Estado actual
Clínica de mayonesa	Ensayos clínicos de ALS	Fase II/III en curso
Centro Médico de la Universidad de Stanford	Investigación de esclerosis múltiple progresiva	Fase de reclutamiento

Medicinova, Inc. (MNOV) - Modelo de negocio: actividades clave

Investigación y desarrollo biofarmacéutico

Medicinova se centra en el desarrollo de tratamientos terapéuticos innovadores principalmente en neurología y enfermedades inflamatorias. A partir de 2024, la compañía tiene 4 candidatos de drogas primarias En varias etapas de desarrollo.

Candidato a la droga	Área terapéutica	Etapa de desarrollo
MN-166 (Ibudilast)	Trastornos neurológicos	Ensayos clínicos de fase II/III
MN-001 (Tipelukast)	Enfermedades inflamatorias	Ensayos clínicos de fase II

Descubrimiento de drogas y pruebas preclínicas

La compañía invierte significativamente en los procesos de desarrollo de medicamentos en etapa temprana.

• Gasto anual de I + D: $ 12.5 millones (año fiscal 2023)
• Presupuesto de investigación preclínica: aproximadamente $ 3.2 millones
• Número de programas de investigación activa: 3-4 candidatos a drogas

Gestión de ensayos clínicos

Medicinova mantiene ensayos clínicos activos en múltiples áreas terapéuticas.

Enfoque de ensayo clínico	Número de pruebas activas	Inscripción estimada del paciente
Trastornos neurológicos	2 pruebas	Aproximadamente 250 pacientes
Condiciones inflamatorias	1 juicio	Aproximadamente 150 pacientes

Procesos de presentación y aprobación regulatoria

Medicinova se involucra activamente con agencias reguladoras para aprobaciones de medicamentos.

• Interacciones de la FDA: consultas regulatorias trimestrales
• Aplicaciones activas de IND (Investigational New Drug): 2
• Presupuesto de cumplimiento regulatorio: $ 1.5 millones anuales

Gestión y protección de la propiedad intelectual

La Compañía mantiene una sólida estrategia de propiedad intelectual.

Categoría de IP	Número de patentes	Rango de vencimiento de patentes
Patentes emitidos	12	2030-2040
Aplicaciones de patentes pendientes	5	Aún no determinado

Medicinova, Inc. (MNOV) - Modelo de negocio: recursos clave

Equipo de investigación farmacéutica especializada

A partir de 2024, Medicinova mantiene un equipo de investigación de 35 científicos e investigadores especializados. La composición del equipo incluye:

• 12 Ph.D. investigadores de nivel
• 8 médicos especializados en desarrollo de medicamentos
• 15 Asociados de Investigación y Técnicos de Laboratorio

Tecnologías de desarrollo de fármacos patentados

Plataforma tecnológica	Enfoque específico	Etapa de desarrollo actual
MN-166 (Ibudilast)	Neuroinflamación y neuroprotección	Fase 2/3 ensayos clínicos
MN-001 (Tipelukast)	Enfermedades inflamatorias y fibróticas	Desarrollo clínico de fase 2

Portafolio de patentes para terapias innovadoras

La cartera de patentes de Medicinova consiste en:

• 17 patentes activas
• 9 solicitudes de patentes pendientes
• Cobertura de propiedad intelectual en Estados Unidos, Europa y Japón

Capital financiero para la investigación en curso

Métrica financiera	Cantidad (a partir del cuarto trimestre 2023)
Equivalentes de efectivo y efectivo	$ 48.3 millones
Gastos de investigación y desarrollo	$ 22.7 millones anuales

Infraestructura avanzada de laboratorio e investigación

Instalaciones de investigación:

• 2 centros de investigación principales ubicados en California
• Espacio total de la instalación de investigación: 12,500 pies cuadrados
• Equipo de laboratorio avanzado valorado en aproximadamente $ 3.6 millones

Medicinova, Inc. (MNOV) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades neurológicas e inflamatorias

Medicinova se centra en el desarrollo de soluciones terapéuticas con candidatos de productos específicos:

Candidato al producto	Área de enfermedades	Etapa de desarrollo actual
MN-166 (Ibudilast)	Esclerosis múltiple	Fase 2/3 ensayos clínicos
MN-166 (Ibudilast)	Esclerosis múltiple progresiva	Desarrollo clínico
MN-166	ALS (esclerosis lateral amiotrófica)	Ensayos clínicos de fase 2

Tratamientos potenciales con nuevos mecanismos de acción

Mecanismos clave de acción para los candidatos de drogas primarias:

• Inhibición de la fosfodiesterasa
• Inhibición del factor inhibidor de la migración de macrófagos (MIF)
• Reducción de neuroinflamación

Concéntrese en las necesidades médicas no satisfechas en áreas de enfermedad desafiantes

Análisis de oportunidades de mercado para áreas de enfermedad objetivo:

Enfermedad	Prevalencia global	Necesidades de tratamiento no satisfecho
Esclerosis múltiple	2.8 millones de pacientes en todo el mundo	Tratamientos de EM progresivos efectivos limitados
Algancios	Aproximadamente 450,000 pacientes a nivel mundial	No hay tratamientos curativos disponibles

Desarrollo de terapias específicas y potencialmente más efectivas

Investigación y inversión de desarrollo:

Año fiscal	Gasto de I + D
2022	$ 14.3 millones
2023	$ 16.7 millones

Potencial para los tratamientos innovadores con mejores resultados del paciente

Métricas de rendimiento del ensayo clínico:

• MN-166 Fase 2 ensayo ALS: Posibles efectos neurprotectores demostrados
• Investigación de esclerosis múltiple: Dirigido a los mecanismos de neuroinflamación
• Desarrollo de medicamentos patentados: 5 programas de investigación activos

Medicinova, Inc. (MNOV) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

Medicinova mantiene canales de comunicación directa con profesionales médicos a través de:

• Alcance dirigido a neurólogos y pulmonólogos
• Reuniones de la junta asesora médica individual
• Información de información sobre el ensayo clínico personalizado

Método de compromiso	Frecuencia	Especialistas en el objetivo
Consultas médicas directas	Trimestral	Neurólogos, pulmonólogos
Reuniones de colaboración de investigación	By-anualmente	Investigadores académicos

Conferencia científica e participación en el simposio de investigación

Medicinova participa activamente en eventos clave de investigación médica:

• Reunión anual de la Asociación Neurológica Americana
• Simposio de investigación pulmonar internacional
• Conferencia de enfermedades raras y de desarrollo de medicamentos huérfanos

Comunicación transparente sobre el progreso del ensayo clínico

Canales de comunicación para actualizaciones de ensayos clínicos:

• Actualizaciones trimestrales de inversores e investigaciones
• SEC que presenta divulgaciones
• Comunicados de prensa que documentan hitos de prueba

Tipo de comunicación	Frecuencia	Plataforma de informes
Llamadas de inversionista	Trimestral	Transmisión web de ganancias
Actualizaciones de ensayos clínicos	A medida que ocurren los hitos	Sitio web de la empresa, presentaciones de la SEC

Enfoque de desarrollo de medicamentos centrado en el paciente

Estrategias de participación del paciente:

• Colaboraciones de grupos de pacientes con enfermedades raras
• Seguimiento de resultados informado por el paciente
• Programas de accesibilidad de ensayos clínicos

Educación médica y apoyo de investigación en curso

Iniciativas de investigación y apoyo educativo:

• Subvenciones de investigación para estudios neurológicos
• Programas de patrocinio de becas
• Apoyo de publicación científica

Programa de apoyo	Presupuesto anual	Área de enfoque
Subvenciones de investigación	$500,000	Trastornos neurológicos
Patrocinio de becas	$250,000	Investigación de enfermedades raras

Medicinova, Inc. (MNOV) - Modelo de negocio: canales

Comunicación directa con distribuidores farmacéuticos

Medicinova utiliza canales de distribución farmacéutica específicos con un enfoque específico en socios potenciales para sus candidatos a medicamentos clave.

Canal de distribución	Mercado objetivo	Estado actual
Representantes de ventas directas	Mercados neurología/respiratoria	Compromiso activo
Asociaciones de licencias	Compañías farmacéuticas globales	Discusiones en curso

Presentaciones de conferencia médica

Medicinova participa activamente en conferencias científicas para mostrar los resultados de la investigación.

• Reunión anual de la Academia Americana de Neurología
• Conferencia Internacional de la Sociedad Respiratoria
• Convención de la Organización de Innovación de Biotecnología (BIO)

Plataformas de publicación científica

La compañía aprovecha revistas científicas revisadas por pares para la difusión de investigación.

Plataforma de publicación	Número de publicaciones (2023)	Factor de impacto
Biotecnología de la naturaleza	2	41.4
La neurología lanceta	1	38.5

Comunicaciones de relaciones con los inversores

Medicinova mantiene la comunicación transparente con los inversores a través de múltiples canales.

• Llamadas de ganancias trimestrales
• Reuniones anuales de accionistas
• Presentación de la SEC
• Sebinarios web de presentación de inversores

Redes de comunicación científica digital y en línea

Las plataformas digitales permiten una participación científica y profesional más amplia.

Plataforma digital	Recuento de seguidores	Tasa de compromiso
LinkedIn	3,427	4.2%
Investigador	287	3.8%

Medicinova, Inc. (MNOV) - Modelo de negocio: segmentos de clientes

Mercados de tratamiento de enfermedades neurológicas

Medicinova se dirige a los mercados de tratamiento de enfermedades neurológicas con áreas de enfoque específicas:

Categoría de enfermedades	Tamaño del mercado (2024)	Población objetivo
Esclerosis múltiple	$ 23.4 mil millones	Aproximadamente 2.8 millones de pacientes a nivel mundial
ALS (esclerosis lateral amiotrófica)	$ 1.2 mil millones	Alrededor de 30,000 pacientes en los Estados Unidos

Especialistas en tratamiento de enfermedades inflamatorias

Segmentos clave del mercado de enfermedades inflamatorias:

• Síndrome de dificultad respiratoria aguda (SDRA) especialistas
• Investigadores de trastorno inflamatorio pulmonar
• Profesionales médicos de cuidados críticos

Proveedores de atención médica

Tipo de proveedor	Alcance del mercado potencial	Volumen de tratamiento anual
Clínicas neurológicas	4.500 centros especializados	1.2 millones de consultas de pacientes
Departamentos de neurología del hospital	2.300 hospitales principales	850,000 tratamientos para el paciente

Instituciones de investigación

Medicinova colabora con instituciones de investigación centradas en:

• Centros médicos académicos
• Universidades de investigación de neurociencia
• Laboratorios de investigación farmacéutica

Compañías farmacéuticas y de biotecnología

Tipo de empresa	Oportunidades potenciales de colaboración	Potencial de mercado
Grandes compañías farmacéuticas	Asociaciones de desarrollo de drogas	Mercado colaborativo de $ 50 mil millones
Firmas de investigación de biotecnología	Investigación de tratamiento innovador	Mercado potencial de $ 35 mil millones

Medicinova, Inc. (MNOV) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Medicinova reportó gastos de I + D de $ 14.3 millones. Las principales áreas de enfoque de la compañía incluyen:

• MN-166 (ibudilast) para la esclerosis múltiple progresiva
• MN-001 para enfermedades inflamatorias y fibróticas

Costos de implementación de ensayos clínicos

Ensayo clínico	Costo anual estimado
MN-166 MS Progressive MS	$ 7.2 millones
Ensayos relacionados con Covid-19	$ 3.5 millones

Protección de propiedad intelectual

Costos anuales de propiedad intelectual y mantenimiento de patentes: $ 450,000

Inversiones de cumplimiento regulatorio

Gastos de cumplimiento y presentación regulatoria para 2023: $ 1.8 millones

Sobrecarga administrativa y operativa

Categoría de gastos	Costo anual
Gastos de personal	$ 6.5 millones
Costos de oficina e instalaciones	$ 1.2 millones
Tecnología e infraestructura	$750,000

Costos operativos totales para 2023: $ 36.5 millones

Medicinova, Inc. (MNOV) - Modelo de negocio: flujos de ingresos

Posibles acuerdos de licencia

A partir de 2024, Medicinova tiene acuerdos de licencia potenciales para los siguientes activos clave:

Candidato a la droga	Licenciatario	Valor potencial estimado
MN-166 (Ibudilast)	Compañías farmacéuticas no reveladas	$ 5-10 millones de potencial por adelantado
MN-001	Posibles socios de enfermedad respiratoria	Potencial de licencia de $ 3-7 millones

Comercialización futura de productos

Posibles flujos de ingresos de la comercialización de productos incluyen:

• MN-166 para esclerosis múltiple progresiva
• MN-166 para el tratamiento con ELA
• MN-001 para IPF y Nash

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$ 2.1 millones	2023
Ministerio de defensa	$ 1.5 millones	2023

Asociaciones de investigación colaborativa

Detalles financieros de colaboración de investigación actual:

• Asociaciones del Centro Médico Académico valoradas en aproximadamente $ 750,000 anuales
• Colaboraciones de investigación farmacéutica estimadas en $ 1.2 millones por proyecto

Pagos potenciales de hitos de asociaciones farmacéuticas

Candidato a la droga	Rango de pago de hito potencial	Evento de activación
MN-166	$ 10-25 millones	Fase III Inicio del ensayo clínico
MN-001	$ 5-15 millones	Finalización exitosa de la fase II

MediciNova, Inc. (MNOV) - Canvas Business Model: Value Propositions

MediciNova, Inc. offers value through two core compounds, MN-166 (ibudilast) and MN-001 (tipelukast), targeting severe conditions with high unmet medical need.

Potential disease-modifying treatment for ALS, a fatal neurodegenerative disease.

• MN-166 is in Phase 3 for amyotrophic lateral sclerosis (ALS) via the COMBAT-ALS trial.
• Patient randomization for the COMBAT-ALS Phase 2b/3 clinical trial has been successfully completed as of September 8, 2025.
• Top-line data from the ALS trial is anticipated by the end of 2026.
• MN-166 holds Orphan Drug Designation from the U.S. FDA and EU EMA for ALS.
• The compound has received Fast Track Designation by the FDA for ALS treatment.
• An Expanded Access Program (EAP) for ALS patients is supported by a National Institutes of Health (NIH) grant of $22 million.
• This EAP will include approximately 200 ALS patients ineligible for the COMBAT-ALS trial.

MN-166 addresses multiple indications: MS, DCM, Long COVID, and substance dependence.

MN-166 is positioned across several neurological and inflammatory areas, which diversifies the potential patient population and revenue base.

• MN-166 is Phase 3-ready for progressive multiple sclerosis (MS).
• The compound is currently in Phase 3 trials for degenerative cervical myelopathy (DCM).
• Phase 2 trials are underway evaluating MN-166 for Long COVID and substance dependence.

MN-001 as a potential first-in-class therapy for metabolic diseases like NAFLD/NASH.

MN-001 (tipelukast) is being developed for metabolic disorders where an approved therapy is currently lacking, such as Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH).

• MN-001 completed patient enrollment in its Phase 2 trial (MN-001-NATG-202) for hypertriglyceridemia and NAFLD due to Type 2 Diabetes Mellitus (T2DM).
• Top-line results for this trial are expected by summer 2026.
• The global market for NASH treatment is estimated to reach $57.5 billion by 2033, growing at a CAGR of 27.9%.
• Approximately 6 million individuals in the US are estimated to have progressed to NASH.
• The NASH drug pipeline market size for 2025E is $479.7 million, projected to reach $8,123.3 million by 2035.

The value proposition is further supported by the clinical stage and the significant market opportunity, which is reflected in the company's recent financing activities.

Compound	Indication	Development Stage (Late 2025)	Key Financial/Market Context
MN-166	ALS	Phase 3 (COMBAT-ALS Enrollment Complete)	Supported by $22 million NIH grant for EAP.
MN-166	DCM	Phase 3	Orphan Drug Designation held.
MN-166	MS (Progressive)	Phase 3-Ready	Focus on neurodegenerative diseases.
MN-166	Long COVID, Substance Dependence	Phase 2	Addresses sequelae with large unmet need.
MN-001	NAFLD/Hypertriglyceridemia (T2DM)	Phase 2 Enrollment Complete	Top-line results expected summer 2026.

Strong safety profiles for both lead compounds, reducing late-stage development risk.

Both MN-166 and MN-001 are noted to possess strong safety profiles, which is a critical factor in de-risking the remaining clinical development path.

• Both lead assets are characterized by strong safety profiles.
• MediciNova, Inc. reported Q3 2025 cash and cash equivalents of $32,562,612.
• Management stated cash is sufficient to fund operations at least through November 2026.
• The company secured a $30.0 million Standby Equity Purchase Agreement (SEPA) in July 2025 to provide financing flexibility.

Addressing significant unmet medical needs in high-value therapeutic areas.

The value proposition is tied directly to the severity of the diseases targeted, where current treatment options are limited or non-existent.

• For ALS, MN-166 offers a potential disease-modifying option where no FDA-approved therapy currently exists to halt progression.
• NASH represents a substantial unmet medical need, with no FDA, EMA, or PMDA-approved therapies as of early 2024.
• Long COVID treatment options have not been widely evaluated, indicating a large unmet need regarding quality of life and return to work.

MediciNova, Inc. (MNOV) - Canvas Business Model: Customer Relationships

MediciNova, Inc. engages with clinical investigators through active, late-stage trials, such as the Phase 2b/3 COMBAT-ALS trial, which reported completion of patient enrollment on September 22, 2025. This trial evaluated MN-166 in about 230 adults experiencing ALS symptoms up to 1.5 years prior to study entry. The company also manages the expansion of its Expanded Access Program (EAP) network, which involves inviting new clinics to onboard patients.

The direct engagement with regulatory bodies centers on securing favorable designations for MN-166, the lead asset. MediciNova holds Orphan Drug Designation for MN-166 in ALS from both the U.S. FDA and EU EMA. Furthermore, the FDA granted Fast Track Designation for MN-166 in the treatment of ALS. The company is actively preparing for regulatory discussions with the FDA, with top-line data anticipated by the end of next year.

Investor relationships are maintained through public listings on the NASDAQ: MNOV and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875). The company provided a direct update via a 'Message from the CEO to MediciNova Shareholders' on December 01, 2025. For capital needs, MediciNova signed a Standby Equity Purchase Agreement (SEPA) for up to $30 million over 36 months. Under this agreement, stock is sold to the investor at a purchase price equal to 97% of the market price. The closing stock price on December 3, 2025, was $1.51.

Patient support for those ineligible for the COMBAT-ALS trial is managed through the MN-166 Expanded Access Program (EAP), which is funded in part by a $22 million grant from the NIH. The EAP is planned to enroll about 200 patients in the U.S.. The Mayo Clinic Jacksonville site has enrolled 15 patients to date within this program. The ACT for ALS legislation, which supports this EAP, provides $100 million annually through fiscal 2026.

The current structure of investigator and site engagement for the EAP is detailed below:

Engagement Metric	Quantity/Status
Planned EAP Patient Enrollment Target	About 200 patients
COMBAT-ALS Trial Enrollment Status (as of late 2025)	Enrollment Complete (as of September 22, 2025)
COMBAT-ALS Trial Participants	About 230 adults
EAP Sites Invited and Onboarding	5 additional clinics
EAP Sites to be Invited Summer 2026	Another 8 clinics
EAP Sites Guaranteed Openings (per onboarding completion by end of 2025)	At least 5 patients per clinic
Total U.S. COMBAT-ALS Sites Included in EAP Invitations	All 9 sites
Patients Enrolled at Mayo Clinic Jacksonville (EAP)	15 patients to date

The company maintains communication channels for various stakeholders:

• Clinical investigators and KOLs engaged via ongoing Phase 3 and Phase 2 trials.
• Regulatory agencies including the FDA and EMA for designations like Fast Track and Orphan Drug.
• Shareholders via public updates, such as the letter dated December 01, 2025.
• Patients accessing MN-166 through the NIH-funded EAP, which has a capacity of about 200.

MediciNova, Inc. (MNOV) - Canvas Business Model: Channels

You're looking at how MediciNova, Inc. gets its potential therapies from the lab bench to the patient and the market. For a clinical-stage biopharma company, the channels are less about retail shelves and more about clinical sites, regulatory bodies, and capital markets. Here's the breakdown based on late 2025 data.

Global network of clinical trial sites for patient enrollment

The physical channel for data generation relies heavily on a network of clinical trial sites. MediciNova, Inc. has successfully navigated enrollment for its key assets, often leveraging external funding sources to support this crucial step. The company has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Key trial milestones as of late 2025 include:

• MN-166 (ibudilast) Phase 2b/3 COMBAT-ALS trial: Target enrollment achieved as of September 8, 2025.
• MN-166 Expanded Access Program (EAP): Steadily enrolling patients, supported by a $22 million grant from the National Institutes of Health (NIH).
• MN-001 (tipelukast) Phase 2 trial (MN-001-NATG-202): Patient enrollment completed as of November 4, 2025.

MediciNova, Inc. has 11 programs in clinical development, based on its two main compounds, MN-166 and MN-001. MN-166 is currently in Phase 3 for Amyotrophic Lateral Sclerosis (ALS) and Degenerative Cervical Myelopathy (DCM), and is Phase 3-ready for progressive Multiple Sclerosis (MS).

Regulatory pathways (FDA, EMA) for eventual drug approval and market access

Regulatory clearance is the gatekeeper for market access. MediciNova, Inc. is actively managing these pathways, with a primary commercial focus on the United States (U.S.) market. The company has secured specific designations that streamline development and offer market protection upon approval.

Here's a look at the regulatory landscape and relevant 2025 market context:

Designation/Metric	Asset	Authority	Benefit/Status
Orphan Drug Designation	MN-166 (ibudilast)	U.S. FDA and EU EMA	For ALS treatment
Fast Track Designation	MN-166 (ibudilast)	U.S. FDA	For ALS treatment
Orphan-Drug Designation	MN-001 (tipelukast)	U.S. FDA	For Idiopathic Pulmonary Fibrosis (IPF); potential seven years marketing exclusivity if approved
FDA Marketing Authorisations (YTD)	All	FDA (CDER/CBER)	47 as of late November 2025
EMA CHMP Recommendations (YTD)	All	EMA	44 as of late November 2025

Top-line results for the MN-001 trial in hypertriglyceridemia and NAFLD due to T2DM are anticipated by summer 2026, which will inform next steps toward regulatory discussions with the FDA.

NASDAQ and Tokyo Stock Exchange for capital raising and investor communication

Access to capital is a vital channel for funding ongoing clinical development. MediciNova, Inc. maintains dual listings to access both U.S. and Japanese investor bases. The company has recently secured financing flexibility to support its R&D programs.

Financial and listing details as of late 2025:

• Stock Listings: NASDAQ Global Market (NASDAQ: MNOV) and Standard Market of the Tokyo Stock Exchange (Code Number: 4875).
• Recent Financing: Standby Equity Purchase Agreement (SEPA) signed for up to $30 million over 36 months.
• SEPA Terms: Stock sold at 97% of the market price.
• Recent Filing: Form S-3 filed December 5, 2025, to offer up to $300,000,000 in securities.
• Stock Price: Last reported sale price on December 3, 2025, was $1.51 per share.
• Market Capitalization: Approximately $73M as of December 1, 2025.

The company is classified as a 'smaller reporting company,' meaning the market value of shares held by non-affiliates is less than $700 million.

Future strategic alliances and licensing partners for commercialization

MediciNova, Inc. is actively planning for commercialization, which may involve self-commercialization or partnering. The strategy centers on leveraging external expertise and capital for late-stage assets.

The company intends to:

• Actively pursue strategic collaborations with larger pharmaceutical companies for development, regulatory, and commercialization support.
• Opportunistically in-license additional product candidates, strengthening relationships in Japan and other markets.
• Selectively add commercial capabilities to its management team as product development programs mature.

This approach helps maximize commercial opportunities while mitigating the inherent risks of drug development.

MediciNova, Inc. (MNOV) - Canvas Business Model: Customer Segments

You're looking at the core groups MediciNova, Inc. (MNOV) needs to engage to move its pipeline forward, which is heavily focused on late-stage neurological and metabolic assets. The company's customer base isn't just the end-user patient; it's a complex ecosystem of prescribers, funders, and capital providers, all critical for a clinical-stage biopharma firm.

Patients with Amyotrophic Lateral Sclerosis (ALS) and Progressive Multiple Sclerosis (MS).

These patients represent the ultimate beneficiaries of the MN-166 program. MediciNova, Inc. announced that target enrollment was successfully achieved in its COMBAT-ALS Phase 2b/3 clinical trial for ALS as of September 2025. Furthermore, MN-166 is Phase 3-ready for progressive Multiple Sclerosis (MS). The company is also conducting a large Expanded Access Program (EAP) for MN-166, which is supported by a significant external funding source.

• Patients in the MN-166 Phase 3-ready program for Progressive MS.
• Patients enrolled in the COMBAT-ALS Phase 2b/3 trial, which achieved target enrollment as of September 2025.
• Patients participating in the MN-166 Expanded Access Program (EAP).

Patients with metabolic disorders: Hypertriglyceridemia and Non-Alcoholic Fatty Liver Disease (NAFLD).

This segment is targeted by the MN-001 (tipelukast) asset, which is being evaluated for its potential in conditions sharing lipid dysregulation pathologies. As of December 2025, patient enrollment was completed in the Phase 2 trial (MN-001-NATG-202) for patients with hypertriglyceridemia and NAFLD due to Type 2 Diabetes (T2DM). Top-line results from this trial are anticipated by summer 2026.

• Patients with Hypertriglyceridemia and NAFLD due to T2DM enrolled in the Phase 2 study.
• Physicians treating complex metabolic and cardiovascular disease profiles.

Neurologists, pulmonologists, and other specialists treating these complex diseases.

These specialists are the key opinion leaders and prescribers who will ultimately evaluate and recommend MN-166 and MN-001. Their trust is built on clinical data, which, as of late 2025, is being generated across multiple trials. The company's focus is on the U.S. market for commercialization.

Government and non-profit organizations funding clinical research, like the NIH.

These entities are crucial partners, providing non-dilutive capital for specific development activities. A concrete example of this segment's support is the large Expanded Access Program (EAP) for MN-166, which is explicitly supported by a $22 million grant from the National Institutes of Health (NIH). The company notes a history of securing investigator-sponsored trials funded through government grants for its non-core programs as well.

Institutional and retail investors providing capital for R&D.

As a publicly-held company trading on NASDAQ (MNOV), MediciNova, Inc. relies on capital markets to fund its operations, which saw a Net Loss of $9.20 Million in the first three quarters of 2025. As of November 10, 2025, the Market Cap stood at $69.2M, with 49,046,246 shares outstanding. To maintain liquidity for its development stage profile, the company established a $30.0 million Standby Equity Purchase Agreement (SEPA) in July 2025. Institutional investors held approximately 10.48% of the shares as of September 30, 2025.

Here's the quick math on the financial backing and burn rate as of the Q3 2025 filing:

Metric	Value (as of Q3 2025 Nine Months)
Cash and Equivalents	$32,562,612
Cumulative Revenue (YTD)	$0.26 Million
Operating Cash Outflows (Nine Months)	$7,793,264
SEPA Facility Size	$30.0 Million

What this estimate hides is the runway; management stated cash is sufficient to fund operations at least through November 2026. Finance: draft 13-week cash view by Friday.

MediciNova, Inc. (MNOV) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for MediciNova, Inc. as they push their late-stage pipeline. For a clinical-stage biopharma company, the cost structure is heavily weighted toward the science and the trials needed to prove that science works. It's a high-burn environment by design, so you need to watch these numbers closely.

The primary drivers of MediciNova, Inc.'s operating costs for the nine months ended September 30, 2025, fall into a few key buckets. These expenses reflect the ongoing commitment to advancing their lead compounds, particularly MN-166 (ibudilast) through its late-stage trials.

Here's a breakdown of the major reported costs for the nine months ended September 30, 2025:

Cost Component	Amount (Nine Months Ended 9/30/2025)
Research, Development, and Patent Expenses	$5.36 million
General and Administrative Costs	$4.21 million
Stock-based Compensation Expense	$648,532
Net Loss (Burn Rate Indicator)	$9.20 million

Clinical trial execution and manufacturing costs for late-stage assets are embedded within the Research, Development, and Patents line item, but they represent a critical, often variable, part of the spend. Since MediciNova, Inc. relies on third parties to conduct these trials and manufacture product candidates, managing those contracts is a key operational cost control point.

The overall financial performance for the period shows a significant cash burn, which is typical for a company with multiple assets in late-stage development. The net loss of $9.20 million for the nine months ended September 30, 2025, clearly signals this high burn rate, meaning capital preservation and financing strategy are paramount to sustaining operations.

The cost structure is characterized by these main areas of expenditure:

• Research, development, and patent expenses of $5.36 million.
• General and administrative costs totaling $4.21 million.
• Stock-based compensation expense of $648,532.
• Significant, though unquantified here, costs for clinical trial execution.
• The resulting net loss of $9.20 million.

Honestly, for a company at this stage, R&D will always dominate the cost structure. Finance: draft 13-week cash view by Friday.

MediciNova, Inc. (MNOV) - Canvas Business Model: Revenue Streams

You're looking at the core ways MediciNova, Inc. (MNOV) brings in cash to fund its clinical pipeline. For a clinical-stage biopharma, revenue is often a mix of non-dilutive funding, operational sales, and capital raises, so you need to track all of it.

The current revenue streams for MediciNova, Inc. (MNOV) as of late 2025 are built around several distinct sources:

• Minimal product sales revenue of $\text{USD } \mathbf{0.26 \text{ million}}$ for the nine months ended September 30, 2025.
• Interest income from cash reserves, totaling $\text{USD } \mathbf{1.00 \text{ million}}$ for the nine months ended September 30, 2025.
• Non-dilutive grant funding, such as the $\text{USD } \mathbf{22 \text{ million}}$ NIH grant, which is defintely a key stream.
• Future milestone payments and royalties from potential strategic alliances.
• Proceeds from equity financing, like the $\text{USD } \mathbf{30 \text{ million}}$ SEPA with Yorkville Advisors.

It's important to see how these streams stack up against the operational burn. The equity financing is a right, not an obligation, giving you flexibility. The grant funding is non-dilutive cash that directly supports a major trial.

Here's a quick look at the confirmed financial figures supporting these streams for the nine months ended September 30, 2025, where available:

Revenue Stream Component	Reported/Stated Amount (USD)	Period/Context
Cumulative Revenue (Sales)	$0.26 million	Nine months ended September 30, 2025
Interest Income (Stated Target)	$1.00 million	Nine months ended September 30, 2025 (As per outline)
NIH Grant Funding (Non-Dilutive)	$22 million	Total Award for Expanded Access Protocol (EAP)
SEPA Capacity (Equity Financing)	$30 million	Total capacity over 36 months with Yorkville Advisors
Q3 2025 Revenue (Mayo Agreement)	$0.123319 million	Three months ended September 30, 2025

The non-dilutive grant is a massive de-risking factor for the MN-166 ALS program. This $\text{USD } \mathbf{22 \text{ million}}$ NIH/NINDS funding supports an Expanded Access Protocol (EAP) trial, which is separate from the main $\text{COMBAT-ALS Phase 2b/3}$ trial.

The Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors provides access to up to $\text{USD } \mathbf{30 \text{ million}}$ in capital over 36 months, with shares sold at $\mathbf{97\%}$ of the market price, and importantly, without additional warrants. This facility is there to support R&D programs and general corporate activities if needed.

Product sales revenue remains minimal, reflecting the company's pre-commercial stage. For the nine months ending September 30, 2025, total revenue was $\text{USD } \mathbf{0.257918 \text{ million}}$. This revenue is tied to specific agreements, such as the one with Mayo for ALS research, which generated $\text{USD } \mathbf{123,319}$ in Q3 2025.

You should also watch for potential future income streams:

• Milestone payments tied to successful clinical readouts for MN-166 (ibudilast) in ALS or MN-001 (tipelukast) in hypertriglyceridemia/fatty liver disease.
• Royalties from any out-licensed programs or future commercial partnerships.

Finance: draft 13-week cash view by Friday.