Medicinova, Inc. (MNOV): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem dinâmica da inovação biofarmacêutica, a Medicinova, Inc. (MNOV) surge como uma força pioneira, navegando estrategicamente no complexo terreno da terapêutica neurológica e inflamatória. Ao alavancar pesquisas de ponta, parcerias estratégicas e uma abordagem focada em laser às necessidades médicas não atendidas, esta empresa está redefinindo os limites do desenvolvimento farmacêutico. Sua tela de modelo de negócios meticulosamente criada revela um projeto sofisticado para transformar o potencial científico em soluções médicas inovadoras, promissor esperança para pacientes e investidores no mundo desafiador da descoberta e desenvolvimento de drogas.

Medicinova, Inc. (MNOV) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa estratégica com instituições acadêmicas

A Medicinova estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade da Califórnia, San Diego	Pesquisa em transtorno neurológico	2019
Universidade Johns Hopkins	Estudos de doenças inflamatórias	2020

Parcerias de desenvolvimento farmacêutico com organizações de pesquisa contratada

A Medicinova colabora com organizações especializadas de pesquisa de contratos (CROs):

• ICON PLC - Fase II/III de gerenciamento de ensaios clínicos
• Parexel International - Suporte ao Desenvolvimento de Medicamentos
• IQVIA - Pesquisa Clínica e Suporte Regulatório

Acordos de licenciamento com empresas de biotecnologia

Parcerias de licenciamento ativo incluem:

Empresa parceira	Candidato a drogas	Termos de licenciamento
Kyorin Pharmaceutical Co.	MN-166 (Ibudilast)	Direitos exclusivos para tratamento com ALS
Nuvelution pharma	MN-001 (Tipelukast)	Acordo de Desenvolvimento Colaborativo

Potenciais joint ventures no desenvolvimento de medicamentos

Discussões potenciais de joint venture atuais:

• Desenvolvimento do tratamento para transtornos neurológicos
• Pesquisa terapêutica de doenças inflamatórias
• Innovação de drogas para doenças respiratórias

Parcerias no local do ensaio clínico com centros médicos

Parcerias de local de ensaio clínico ativo:

Centro Médico	Foco no teste	Status atual
Clínica Mayo	Ensaios clínicos da ALS	Fase II/III em andamento
Centro Médico da Universidade de Stanford	Pesquisa progressiva de esclerose múltipla	Fase de recrutamento

Medicinova, Inc. (MNOV) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Biofarmacêutico

O Medicinova se concentra no desenvolvimento de tratamentos terapêuticos inovadores principalmente em neurologia e doenças inflamatórias. A partir de 2024, a empresa tem 4 candidatos a drogas primárias em vários estágios de desenvolvimento.

Candidato a drogas	Área terapêutica	Estágio de desenvolvimento
MN-166 (Ibudilast)	Distúrbios neurológicos	Ensaios Clínicos de Fase II/III
MN-001 (Tipelukast)	Doenças inflamatórias	Ensaios clínicos de fase II

Descoberta de medicamentos e testes pré -clínicos

A empresa investe significativamente nos processos de desenvolvimento de medicamentos em estágio inicial.

• Despesas anuais de P&D: US $ 12,5 milhões (2023 ano fiscal)
• Orçamento de pesquisa pré -clínica: aproximadamente US $ 3,2 milhões
• Número de programas de pesquisa ativos: 3-4 candidatos a medicamentos

Gerenciamento de ensaios clínicos

O Medicinova mantém ensaios clínicos ativos em várias áreas terapêuticas.

Foco no ensaio clínico	Número de ensaios ativos	Inscrição estimada do paciente
Distúrbios neurológicos	2 ensaios	Aproximadamente 250 pacientes
Condições inflamatórias	1 Trial	Aproximadamente 150 pacientes

Processos de envio e aprovação regulatórios

O Medicinova se envolve ativamente com agências reguladoras para aprovações de drogas.

• Interações da FDA: consultas regulatórias trimestrais
• IND ativo (novo medicamento investigacional) Aplicações: 2
• Orçamento de conformidade regulatória: US $ 1,5 milhão anualmente

Gerenciamento de propriedade intelectual e proteção

A empresa mantém uma estratégia de propriedade intelectual robusta.

Categoria IP	Número de patentes	Faixa de expiração da patente
Patentes emitidas	12	2030-2040
Aplicações de patentes pendentes	5	Ainda não determinado

Medicinova, Inc. (MNOV) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa farmacêutica

A partir de 2024, a Medicinova mantém uma equipe de pesquisa de 35 cientistas e pesquisadores especializados. A composição da equipe inclui:

• 12 Ph.D. pesquisadores de nível
• 8 médicos especializados em desenvolvimento de medicamentos
• 15 Associados de pesquisa e técnicos de laboratório

Tecnologias proprietárias de desenvolvimento de medicamentos

Plataforma de tecnologia	Foco específico	Estágio de desenvolvimento atual
MN-166 (Ibudilast)	Neuroinflamação e neuroproteção	Fase 2/3 Ensaios Clínicos
MN-001 (Tipelukast)	Doenças inflamatórias e fibróticas	Desenvolvimento Clínico de Fase 2

Portfólio de patentes para terapêutica inovadora

O portfólio de patentes da Medicinova consiste em:

• 17 patentes ativas
• 9 pedidos de patente pendente
• Cobertura de propriedade intelectual nos Estados Unidos, Europa e Japão

Capital financeiro para pesquisa em andamento

Métrica financeira	Valor (a partir do quarto trimestre 2023)
Caixa e equivalentes de dinheiro	US $ 48,3 milhões
Despesas de pesquisa e desenvolvimento	US $ 22,7 milhões anualmente

Infraestrutura de laboratório e pesquisa avançada

Instalações de pesquisa:

• 2 centros de pesquisa primários localizados na Califórnia
• Espaço total da instalação de pesquisa: 12.500 pés quadrados
• Equipamentos de laboratório avançados avaliados em aproximadamente US $ 3,6 milhões

Medicinova, Inc. (MNOV) - Modelo de negócios: proposições de valor

Soluções terapêuticas inovadoras para doenças neurológicas e inflamatórias

O Medicinova se concentra no desenvolvimento de soluções terapêuticas com candidatos específicos de produtos:

Candidato a produto	Área da doença	Estágio de desenvolvimento atual
MN-166 (Ibudilast)	Esclerose múltipla	Fase 2/3 Ensaios Clínicos
MN-166 (Ibudilast)	Esclerose múltipla progressiva	Desenvolvimento Clínico
MN-166	ALS (esclerose lateral amiotrófica)	Ensaios clínicos de fase 2

Tratamentos em potencial com novos mecanismos de ação

Principais mecanismos de ação para candidatos a medicamentos primários:

• Inibição da fosfodiesterase
• Inibição do fator inibidor da migração de macrófagos (MIF)
• Redução de neuroinflamação

Concentre -se nas necessidades médicas não atendidas em desafiar áreas de doenças

Análise de oportunidades de mercado para áreas de doenças -alvo:

Doença	Prevalência global	Necessidades de tratamento não atendidas
Esclerose múltipla	2,8 milhões de pacientes em todo o mundo	Tratamentos eficazes de MS limitados eficazes
ALS	Aproximadamente 450.000 pacientes globalmente	Sem tratamentos curativos disponíveis

Desenvolvimento de terapias direcionadas e potencialmente mais eficazes

Investimento de pesquisa e desenvolvimento:

Ano fiscal	Despesas de P&D
2022	US $ 14,3 milhões
2023	US $ 16,7 milhões

Potencial para tratamentos inovadores com resultados aprimorados do paciente

Métricas de desempenho de ensaios clínicos:

• Estudo MN-166 Fase 2 ALS: Demonstrado potenciais efeitos neurprotetores
• Pesquisa de esclerose múltipla: Direcionar mecanismos de neuroinflamação
• Desenvolvimento de medicamentos proprietários: 5 programas de investigação ativos

Medicinova, Inc. (MNOV) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com profissionais médicos

O Medicinova mantém canais de comunicação direta com profissionais médicos por meio de:

• Extensão direcionada para neurologistas e pulmonologistas
• Reuniões individuais do conselho consultivo médico
• Compartilhamento de informações de ensaios clínicos personalizados

Método de engajamento	Freqüência	Especialistas -alvo
Consultas médicas diretas	Trimestral	Neurologistas, pulmonologistas
Reuniões de colaboração de pesquisa	Bi-semestralmente	Pesquisadores acadêmicos

Participação do Simpósio de Conferência Científica e Pesquisa

O Medicinova participa ativamente de eventos importantes de pesquisa médica:

• Reunião Anual da Associação Neurológica Americana
• Simpósio Internacional de Pesquisa Pulmonar
• Doenças raras e conferência de desenvolvimento de medicamentos órfãos

Comunicação transparente sobre o progresso do ensaio clínico

Canais de comunicação para atualizações de ensaios clínicos:

• Atualizações trimestrais de investidores e pesquisas
• Sec Divulgações de arquivamento
• Comunicamentos de imprensa documentando marcos de julgamento

Tipo de comunicação	Freqüência	Plataforma de relatório
Ligações de investidores	Trimestral	Webcast de ganhos
Atualizações de ensaios clínicos	À medida que os marcos ocorrem	Site da empresa, registros da SEC

Abordagem de desenvolvimento de medicamentos focados no paciente

Estratégias de envolvimento do paciente:

• Colaborações do Grupo de Pacientes com doenças raras
• Rastreamento de resultados relatado pelo paciente
• Programas de acessibilidade de ensaios clínicos

Educação médica em andamento e apoio à pesquisa

Iniciativas de pesquisa e apoio educacional:

• Subsídios de pesquisa para estudos neurológicos
• Programas de patrocínio de irmandade
• Suporte de publicação científica

Programa de suporte	Orçamento anual	Área de foco
Bolsas de pesquisa	$500,000	Distúrbios neurológicos
Patrocínio da Irmandade	$250,000	Pesquisa de doenças raras

Medicinova, Inc. (MNOV) - Modelo de negócios: canais

Comunicação direta com distribuidores farmacêuticos

A Medicinova utiliza canais de distribuição farmacêutica direcionada, com foco específico em parceiros em potencial para seus principais candidatos a medicamentos.

Canal de distribuição	Mercado -alvo	Status atual
Representantes de vendas diretas	Mercados de Neurologia/Respiratório	Engajamento ativo
Parcerias de licenciamento	Empresas farmacêuticas globais	Discussões em andamento

Apresentações da conferência médica

O Medicinova participa ativamente de conferências científicas para mostrar os resultados da pesquisa.

• Reunião Anual da Academia Americana de Neurologia
• Conferência Internacional da Sociedade Respiratória
• Convenção da Organização de Inovação de Biotecnologia (BIO)

Plataformas de publicação científica

A empresa aproveita os periódicos científicos revisados ​​por pares para disseminação de pesquisa.

Plataforma de publicação	Número de publicações (2023)	Fator de impacto
Biotecnologia da natureza	2	41.4
A neurologia da Lancet	1	38.5

Comunicações de Relações com Investidores

O Medicinova mantém a comunicação transparente com os investidores por meio de vários canais.

• Chamadas de ganhos trimestrais
• Reuniões anuais de acionistas
• Registros da SEC
• Webinars de apresentação de investidores

Redes de comunicação científica digital e online

As plataformas digitais permitem engajamento científico e profissional mais amplo.

Plataforma digital	Contagem de seguidores	Taxa de engajamento
LinkedIn	3,427	4.2%
Pesquisa	287	3.8%

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

Mercados de tratamento de doenças neurológicas

A Medicinova tem como alvo os mercados de tratamento de doenças neurológicas com áreas de foco específicas:

Categoria de doença	Tamanho do mercado (2024)	População -alvo
Esclerose múltipla	US $ 23,4 bilhões	Aproximadamente 2,8 milhões de pacientes globalmente
ALS (esclerose lateral amiotrófica)	US $ 1,2 bilhão	Cerca de 30.000 pacientes nos Estados Unidos

Especialistas em tratamento de doenças inflamatórias

Principais segmentos de mercado de doenças inflamatórias:

• Especialistas agudos da síndrome do desconforto respiratório (ARDS)
• Pesquisadores de transtornos inflamatórios pulmonares
• Profissionais médicos de cuidados intensivos

Provedores de saúde

Tipo de provedor	Alcance potencial do mercado	Volume anual de tratamento
Clínicas neurológicas	4.500 centros especializados	1,2 milhão de consultas de pacientes
Departamentos de neurologia hospitalar	2.300 grandes hospitais	850.000 tratamentos para pacientes

Instituições de pesquisa

O Medicinova colabora com instituições de pesquisa com foco em:

• Centros Médicos Acadêmicos
• Universidades de Pesquisa em Neurociência
• Laboratórios de Pesquisa Farmacêutica

Empresas farmacêuticas e de biotecnologia

Tipo de empresa	Oportunidades de colaboração em potencial	Potencial de mercado
Grandes empresas farmacêuticas	Parcerias de desenvolvimento de medicamentos	Mercado colaborativo de US $ 50 bilhões
Empresas de pesquisa de biotecnologia	Pesquisa de tratamento inovador	Mercado potencial de US $ 35 bilhões

Medicinova, Inc. (MNOV) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Medicinova registrou despesas de P&D de US $ 14,3 milhões. As principais áreas de foco da empresa incluem:

• MN-166 (ibudilast) para esclerose múltipla progressiva
• MN-001 para doenças inflamatórias e fibróticas

Custos de implementação de ensaios clínicos

Ensaio clínico	Custo anual estimado
Trial MN-166 Progressive MS	US $ 7,2 milhões
Ensaios relacionados ao CoVID-19	US $ 3,5 milhões

Proteção à propriedade intelectual

Custos anuais de propriedade intelectual e manutenção de patentes: US $ 450.000

Investimentos de conformidade regulatória

As despesas regulatórias de conformidade e envio para 2023: US $ 1,8 milhão

Overhead administrativo e operacional

Categoria de despesa	Custo anual
Despesas de pessoal	US $ 6,5 milhões
Custos de escritório e instalação	US $ 1,2 milhão
Tecnologia e infraestrutura	$750,000

Custos operacionais totais para 2023: US $ 36,5 milhões

Medicinova, Inc. (MNOV) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir de 2024, a Medicinova possui acordos de licenciamento em potencial para os seguintes ativos -chave:

Candidato a drogas	Licenciado potencial	Valor potencial estimado
MN-166 (Ibudilast)	Empresas farmacêuticas não divulgadas	Potencial inicial de US $ 5 a 10 milhões
MN-001	Potenciais parceiros de doenças respiratórias	Potencial de licenciamento de US $ 3-7 milhões

Comercialização futura do produto

Os fluxos de receita potenciais da comercialização de produtos incluem:

• MN-166 para esclerose múltipla progressiva
• MN-166 para tratamento com ALS
• MN-001 para IPF e Nash

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	US $ 2,1 milhões	2023
Departamento de Defesa	US $ 1,5 milhão	2023

Parcerias de pesquisa colaborativa

Detalhes financeiros da colaboração de pesquisa atual:

• Parcerias do Centro Médico Acadêmico avaliadas em aproximadamente US $ 750.000 anualmente
• Colaborações de pesquisa farmacêutica estimadas em US $ 1,2 milhão por projeto

Potenciais pagamentos marcantes de parcerias farmacêuticas

Candidato a drogas	Faixa de pagamento em potencial	Evento de gatilho
MN-166	US $ 10-25 milhões	Fase III iniciação de ensaios clínicos
MN-001	US $ 5-15 milhões	Conclusão bem -sucedida da 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.