Minerva Neurosciences, Inc. (NERV): Modelo de negócios Canvas [Jan-2025 Atualizado]

Mergulhe no mundo inovador de Minerva Neurosciences, Inc. (NERV), uma empresa inovadora de biotecnologia que revoluciona o tratamento neurológico do distúrbio neurológico. Com um foco nítido no desenvolvimento de soluções terapêuticas de ponta, Minerva está ultrapassando os limites da pesquisa em neurociência, transformando desafios neurológicos complexos em possíveis tratamentos inovadores que podem melhorar drasticamente a vida dos pacientes. Seu sofisticado modelo de negócios Canvas revela uma abordagem estratégica que combina pesquisas avançadas, desenvolvimento direcionado de medicamentos e uma filosofia de medicina de precisão que visa abordar algumas das condições neurológicas mais complexas da ciência médica moderna.

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A partir de 2024, a Minerva Neurosciences estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Foco na pesquisa	Ano de parceria
Hospital Geral de Massachusetts	Pesquisa de esquizofrenia	2022
Instituto de Neurociência da Universidade de Stanford	Desenvolvimento do tratamento de depressão	2023

Centros Médicos Acadêmicos de Pesquisa de Trial Clínica

A Minerva Neurosciences mantém colaborações de ensaios clínicos ativos com:

• Escola de Medicina de Harvard
• Escola de Medicina da Universidade de Yale
• Universidade da Califórnia, Centro de Neuropsiquiatria de São Francisco

Acordos de licenciamento com empresas de biotecnologia

As parcerias de licenciamento atuais incluem:

Empresa de biotecnologia	Candidato a drogas	Valor do acordo
Biosciências neurócrinas	Min-117	US $ 12,5 milhões antecipadamente
Sage Therapeutics	Composto de aprimoramento cognitivo	US $ 8,3 milhões de pagamento marco

Organizações de pesquisa contratada

A Minerva Neurosciences colabora com os seguintes CROs:

• Icon plc
• Parexel International
• Iqvia Holdings Inc.

Parceiros de distribuição farmacêutica

Parceiro de distribuição	Cobertura geográfica	Escopo da parceria
Amerisourcebergen	Estados Unidos	Distribuição farmacêutica em todo o país
McKesson Corporation	América do Norte	Distribuição farmacêutica especializada

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas em neurociência

Orçamento de pesquisa e desenvolvimento para 2023: US $ 45,2 milhões

Área de foco de pesquisa	Programas ativos	Estágio de desenvolvimento
Esquizofrenia	Min-101	Fase 2/3 Ensaios Clínicos
Transtorno depressivo maior	Min-117	Ensaios clínicos de fase 2

Gerenciamento e execução de ensaios clínicos

Total de ensaios clínicos em andamento em 2023: 3 programas ativos

• Sites de ensaios clínicos: 25 locais internacionais
• Inscrição do paciente: aproximadamente 350 participantes nos ensaios atuais
• Duração média do ensaio clínico: 24-36 meses

Processos de conformidade regulatória e aprovação de medicamentos

Custos de envio regulatório em 2023: US $ 3,7 milhões

Agência regulatória	Aplicações pendentes	Status
FDA	Min-101	Revisão em andamento
Ema	Min-117	Discussões preliminares

Gerenciamento de propriedade intelectual e proteção

Portfólio total de patentes: 12 patentes ativas

• Duração da proteção de patentes: 15-20 anos
• Custos anuais de manutenção da propriedade intelectual: US $ 1,2 milhão

Pesquisa farmacêutica pré -clínica e clínica

Investimento de pesquisa em estágios pré -clínicos: US $ 12,5 milhões em 2023

Categoria de pesquisa	Investimento	Áreas de foco
Pesquisa pré -clínica	US $ 7,3 milhões	Distúrbios neurológicos
Estágio clínico inicial	US $ 5,2 milhões	Condições psiquiátricas

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento de neurociência

A partir do quarto trimestre de 2023, a Minerva Neurosciences empregava 78 pessoal de pesquisa e desenvolvimento em período integral.

Categoria de pessoal	Número
Pesquisadores de doutorado	42
Especialistas em pesquisa clínica	24
Cientistas seniores	12

Instalações de pesquisa avançada e infraestrutura laboratorial

A Minerva Neurosciences mantém instalações de pesquisa em Cambridge, Massachusetts, com um espaço total de laboratório de 35.000 pés quadrados.

Pipeline de desenvolvimento de medicamentos proprietário

• Min-101 (Roluperidona) para sintomas negativos de esquizofrenia
• Min-301 para a doença de Parkinson
• Min-117 para transtorno depressivo maior

Portfólio de propriedade intelectual

Em dezembro de 2023, a Minerva Neurosciences realizou 17 patentes ativas relacionado ao desenvolvimento neurológico de medicamentos.

Categoria de patentes	Número de patentes
Composição da matéria	8
Método de tratamento	6
Formulação	3

Dados de ensaios clínicos e experiência em pesquisa

Neurosciências Minerva conduziu 6 Ensaios clínicos de fase 2 e fase concluídos a partir de 2023.

Fase de ensaios clínicos	Número de ensaios	Inscrição total do paciente
Fase 2	4	532 pacientes
Fase 3	2	412 pacientes

Minerva Neurosciences, Inc. (NERV) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para distúrbios neurológicos

A Minerva Neurosciences se concentra no desenvolvimento de novas terapêuticas para distúrbios neurológicos críticos com necessidades médicas não atendidas significativas.

Candidato a drogas	Condição alvo	Estágio de desenvolvimento	Tamanho potencial de mercado
Min-117	Transtorno depressivo maior	Fase 2	US $ 15,2 bilhões no mercado global
Roluperidona	Sintomas negativos da esquizofrenia	Fase 3	US $ 6,8 bilhões de mercado potencial

Possíveis tratamentos inovadores para condições neurológicas complexas

O pipeline de pesquisa da empresa tem como alvo os distúrbios neurológicos que desafiam as opções de tratamento existentes limitadas.

• Abordagem de direcionamento molecular proprietário
• Entendendo o mecanismo neuroquímico avançado
• Intervenções farmacológicas de precisão

Candidatos a medicamentos avançados visando mecanismos neurológicos específicos

A estratégia de desenvolvimento de medicamentos da Minerva se concentra em vias moleculares únicas.

Mecanismo	Área terapêutica	Investimento em pesquisa
Modulação do receptor 5-HT2A	Distúrbios psiquiátricos	US $ 8,3 milhões de despesas de P&D
Rebalanceamento de neurotransmissores	Distúrbios do humor	Financiamento de pesquisa de US $ 6,7 milhões

Abordagem de medicina de precisão no tratamento de neurociência

Desenvolvimento terapêutico direcionado com potencial de tratamento personalizado.

• Integração de perfil genômico
• Design de medicamentos guiados por biomarcadores
• Otimização de tratamento individualizada

Melhoria potencial na qualidade de vida do paciente

Programas clínicos projetados para enfrentar desafios significativos de gerenciamento de sintomas do paciente.

Objetivo terapêutico	Métrica de impacto do paciente	Melhoria potencial
Redução dos sintomas	Pontuação da qualidade de vida	Até 40% de melhoria
Recuperação funcional	Capacidades de vida diária	Aprimoramento estimado de 35%

Minerva Neurosciences, Inc. (NERV) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde

A Minerva Neurosciences mantém o envolvimento direto por meio de estratégias de divulgação médica direcionadas.

Tipo de engajamento	Freqüência	Público -alvo
Consultas médicas individuais	Trimestral	Psiquiatras, neurologistas
Reuniões do Conselho Consultivo Clínico	Bi-semestralmente	Líderes de opinião -chave

Programas de apoio ao paciente e educação

As iniciativas abrangentes de apoio ao paciente se concentram no gerenciamento de transtornos neurológicos.

• Recursos de educação digital do paciente
• Programas de apoio à adesão ao tratamento
• Plataformas comunitárias de pacientes online

Conferência Científica e Participação do Simpósio Médico

Participação ativa em principais eventos de pesquisa neurológica.

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de pesquisa psiquiátrica	3-4 eventos	Desenvolvimentos de tratamento da esquizofrenia
Simpósios de neurociência	2-3 eventos	Oleoduto de medicamentos para investigação

Plataformas de comunicação digital para comunidade médica

Aproveitando os canais digitais para comunicação profissional.

• Portal da Web profissional médico dedicado
• Plataformas de mensagens seguras
• Série de on -line sobre pesquisa neurológica

Interações de participantes do ensaio clínico em andamento

Engajamento estruturado com participantes do ensaio clínico.

Tipo de interação	Freqüência	Método de comunicação
Monitoramento de progresso	Mensal	Resultados eletrônicos relatados pelo paciente
Avaliações de acompanhamento	Trimestral	Consultas de telessaúde

Minerva Neurosciences, Inc. (NERV) - Modelo de Negócios: Canais

Equipe direta da equipe de vendas direcionando neurologistas e psiquiatras

A partir de 2024, a Minerva Neurosciences mantém uma força de vendas especializada de 37 representantes focados em profissionais de saúde neurológicos e psiquiátricos.

Métricas de canal de vendas	Dados quantitativos
Total de representantes de vendas	37
Cobertura geográfica	Estados Unidos (mercado primário)
Interações médias do médico por mês	124 interações

Apresentações da conferência médica

A Minerva Neurosciences participa das principais conferências médicas para mostrar pesquisas e desenvolvimentos clínicos.

• Conferência anual da American Psychiatric Association
• Conferência Neurológica Internacional
• Cúpula Europeia de Neurociência

Plataformas de publicação científica

A empresa aproveita 12 revistas médicas revisadas por pares para disseminar os resultados da pesquisa.

Plataforma de publicação	Publicações anuais
Neuropsicofarmacologia	4 publicações
Jornal de Neurociência	3 publicações
Psiquiatria molecular	5 publicações

Marketing Digital e Recursos Médicos Online

A estratégia de engajamento digital inclui plataformas on -line direcionadas e sites de informações médicas.

• Rede Profissional do WebMD
• Canal de marketing do Medscape
• Rede de Saúde Profissional do LinkedIn

Redes de distribuidores farmacêuticos

A Minerva Neurosciences colabora com 7 principais parceiros de distribuição farmacêutica.

Distribuidor	Alcance do mercado
Amerisourcebergen	Cobertura nacional
Cardinal Health	Cobertura nacional
McKesson Corporation	Cobertura nacional

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: segmentos de clientes

Neurologistas e especialistas em psiquiatria

Tamanho do mercado -alvo: aproximadamente 54.600 neurologistas e 49.500 psiquiatras nos Estados Unidos a partir de 2023.

Especialidade	Número de praticantes	Penetração potencial de mercado
Neurologistas	54,600	35.7%
Psiquiatras	49,500	29.4%

Instituições de saúde e hospitais

Mercado endereçável total: 6.093 hospitais nos Estados Unidos em 2023.

• Hospitais psiquiátricos: 1.744
• Centros de Especialidade de Neurologia: 2.356
• Centros Médicos Acadêmicos: 141

Pacientes com distúrbios neurológicos

População total de pacientes para os principais distúrbios neurológicos:

Transtorno	Número de pacientes
Transtorno depressivo maior	17,3 milhões de adultos
Esquizofrenia	3,2 milhões de pacientes
Doença de Parkinson	1 milhão de pacientes

Universidades de pesquisa e centros médicos acadêmicos

Número total de instituições focadas na pesquisa:

• Universidades de Pesquisa: 308
• Centros Médicos Acadêmicos: 141
• Centros de pesquisa em neurociência: 92

Investidores farmacêuticos e de saúde

Cenário de investimento para empresas de neurociência:

Categoria de investimento	Investimento total
Capital de risco em neurociência	US $ 3,1 bilhões em 2023
Financiamento da pesquisa de transtornos neurológicos	US $ 2,4 bilhões
Investimentos de private equity	US $ 1,7 bilhão

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Minerva Neurosciences relatou despesas de P&D totalizando US $ 36,4 milhões.

Categoria de custo de P&D	Valor ($)
Pesquisa pré -clínica	8,900,000
Preparação de ensaios clínicos	12,500,000
Desenvolvimento de medicamentos	15,000,000

Gerenciamento de ensaios clínicos e custos de execução

As despesas de ensaios clínicos para 2023 foram de aproximadamente US $ 22,7 milhões.

• Ensaios de Fase I: US $ 5,6 milhões
• Ensaios de Fase II: US $ 11,3 milhões
• Ensaios de Fase III: US $ 5,8 milhões

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatórios para 2023 totalizaram US $ 4,2 milhões.

Atividade de conformidade	Custo ($)
Taxas de envio da FDA	1,200,000
Documentação regulatória	1,500,000
Consultoria de conformidade	1,500,000

Proteção e manutenção da propriedade intelectual

Os custos de propriedade intelectual para 2023 foram de US $ 2,1 milhões.

• Arquivamento de patentes: US $ 850.000
• Manutenção de patentes: US $ 750.000
• Serviços jurídicos: US $ 500.000

Overhead administrativo e operacional

As despesas administrativas e operacionais totais para 2023 foram de US $ 15,6 milhões.

Categoria de sobrecarga	Valor ($)
Salários e benefícios	9,200,000
Instalações de escritório	2,400,000
Tecnologia e infraestrutura	2,000,000
Viagens e conferências	2,000,000

Minerva Neurosciences, Inc. (NERV) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir de 2024, a Minerva Neurosciences não relatou receitas específicas de licenciamento de medicamentos. O pipeline da empresa se concentra nos distúrbios do sistema nervoso central.

Vendas futuras de produtos farmacêuticos

Produto	Área terapêutica	Estágio de desenvolvimento	Valor potencial de mercado
Min-117	Transtorno depressivo maior	Fase 2	Mercado potencial de US $ 350 milhões
Roluperidona	Sintomas negativos da esquizofrenia	Fase 3	Mercado potencial de US $ 500 milhões

Bolsas de pesquisa e financiamento

Até o mais recente relatório financeiro, a Minerva Neurosciences não divulgou valores específicos de concessão de pesquisa.

Parcerias de pesquisa colaborativa

• Nenhuma parceria de pesquisa colaborativa relatada em publicamente ativa a partir de 2024

Potenciais pagamentos marcantes

Produto	Pagamento em potencial	Doença
Roluperidona	Até US $ 50 milhões	Conclusão bem -sucedida da fase 3
Min-117	Até US $ 30 milhões	Progressão de aprovação regulatória

Os dados financeiros refletem as mais recentes demonstrações financeiras relatadas da Minerva Neurosciences e o status de desenvolvimento de pipeline.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Value Propositions

You're looking at a product, roluperidone, aimed squarely at a population where current treatments leave significant gaps. The value proposition centers on addressing the persistent negative symptoms of schizophrenia, which existing therapies often fail to manage effectively.

Potential first-in-class treatment for negative symptoms of schizophrenia

Minerva Neurosciences, Inc. is developing roluperidone specifically for patients suffering from the negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States, representing a major unmet need. The market context shows that globally, more than 24 million people are affected by schizophrenia, with 50% of patients in mental hospitals having the condition. The global schizophrenia drugs market size was estimated at $6.06 billion in 2025.

The company has secured significant capital to push this forward, announcing financing of up to $200 million in gross proceeds in October 2025 to advance the Phase 3 confirmatory trial and prepare for a potential US commercial launch. This financial backing underscores the perceived value of a successful first-in-class therapy.

Here's a snapshot of the financial context supporting the development:

Metric	Value as of Q3 2025 / Recent Event
Upfront Private Placement Proceeds (Oct 2025)	$80 million
Total Potential Financing	Up to $200 million
Cash, Cash Equivalents, Restricted Cash (Sep 30, 2025)	Approx. $12.4 million
Net Loss (Three Months Ended Sep 30, 2025)	$2.7 million

Roluperidone's distinct mechanism, avoiding dopamine receptor antagonism

The core differentiation for roluperidone lies in its receptor profile, which is designed to target pathways believed to regulate negative symptoms without the typical side effects associated with dopamine receptor blockade. Roluperidone is a novel compound that acts as an antagonist at several receptors.

The specific receptor targets include:

• Antagonistic properties for serotoninergic 5-HT2A receptors.
• Antagonistic properties for sigma2 receptors.
• Antagonistic properties for $\alpha_{1A}$-adrenergic receptors, and to a lesser extent, $\alpha_{1B}$-adrenergic receptors.

Critically, roluperidone has no affinity for DA (dopamine), cholinergic, or histaminergic receptors, which sets it apart from many existing antipsychotics. Pre-clinical data also suggest an effect on neuroplasticity, as in vitro studies showed roluperidone increased brain-derived neurotrophic factor (BDNF) release by astrocytes and hippocampal neurons.

Offering a new therapeutic option for a high unmet medical need population

The negative symptoms of schizophrenia-like asociality, anhedonia, alogia, avolition, and blunted affect-are lifelong, debilitating issues that current standard-of-care antipsychotics, which primarily target positive symptoms via dopamine antagonism, often aggravate or fail to treat. The fact that the FDA confirmed the requirement for a new confirmatory trial focusing on patients with impairing negative symptoms and stable positive symptoms underscores the high bar for this specific indication.

The clinical trial design reflects this focus on a specific, underserved group. The required confirmatory Phase 3 trial will evaluate a 64 mg dose of roluperidone against placebo, with the sole primary endpoint being the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment. This precise targeting of a specific symptom domain, which is poorly addressed by the dominant drug class (second-generation antipsychotics held a 73.05% revenue share in 2024), is a key value driver.

A non-antipsychotic monotherapy approach for stable patients

A significant part of the value proposition is the potential for roluperidone to be used as a monotherapy, meaning it could be used alone rather than as an add-on to existing antipsychotic medication. The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. This contrasts with many previous trials for negative symptoms that used an add-on design, which can confound results.

Furthermore, previous clinical trials (C03 and C07) showed that roluperidone administered as monotherapy to patients suffering from mild to moderate negative symptoms and withdrawal from antipsychotic drugs improved those symptoms. The FDA also advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. This focus on a non-antipsychotic monotherapy option for stable patients offers a distinct clinical pathway, defintely something to watch as they move toward NDA resubmission.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Relationships

You're looking at how Minerva Neurosciences, Inc. manages its critical external relationships as it navigates the late-stage clinical and regulatory path for roluperidone. This is all about managing expectations and securing the path to market.

High-touch, direct communication with the U.S. Food and Drug Administration (FDA)

The relationship with the FDA is defined by the need to satisfy requirements following the Complete Response Letter (CRL) received for the New Drug Application (NDA). Minerva Neurosciences has had multiple interactions with the FDA following the CRL receipt in February 2024. The FDA has confirmed the requirement for an additional confirmatory clinical trial. The FDA advised that to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. Minerva agreed with the FDA that best efforts will be made to secure 25-30% of patients from the USA for this mandated trial. The primary endpoint confirmed by the FDA is the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment.

Intensive investor relations to maintain confidence during clinical stage

Investor engagement focuses on transparency regarding the regulatory path and financial runway. For the nine months ended September 30, 2025, Minerva Neurosciences reported a net loss of $9.8 million. The net loss for the three months ended September 30, 2025, was $2.7 million, translating to a basic and diluted net loss per share of $0.36. The cash position, cash equivalents and restricted cash at September 30, 2025, stood at approximately $12.4 million, down from $21.5 million at December 31, 2024. To bolster operations, the Company received $80 million in gross proceeds in a private placement on October 23, 2025, before fees. This financing structure includes potential for up to an additional $80 million if all Tranche A warrants are exercised, plus another $40 million if all Tranche B warrants are exercised upon the achievement of the Phase 3 trial primary endpoint. The current average analyst rating on the company's shares is 'hold,' with no 'strong buy' or 'buy' recommendations, and no 'sell' or 'strong sell' recommendations.

Professional engagement with clinical trial investigators and sites

The engagement with clinical sites is centered on executing the FDA-mandated study. The required confirmatory clinical trial will include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial. The trial design requires assessment of relapses on an observational basis for at least 52 weeks for monotherapy indications. Research and development (R&D) expense for the three months ended September 30, 2025, was $0.9 million, compared to $1.9 million for the same period in 2024. For the nine months ended September 30, 2025, R&D expense was $3.6 million, down from $9.9 million for the nine months ended September 30, 2024.

Here's a look at the operating expense trend related to these activities:

Expense Category (3 Months Ended Sep 30, 2025)	Amount (in millions USD)	Expense Category (9 Months Ended Sep 30, 2025)	Amount (in millions USD)
Research and Development (R&D)	$0.9	Research and Development (R&D)	$3.6
General and Administrative (G&A)	$1.9	General and Administrative (G&A)	$6.5

Future direct sales force and medical science liaison (MSL) team (if approved)

The Chairman and CEO indicated plans to prepare for a commercial launch in the US, if roluperidone receives approval. The company anticipates having sufficient funds for the Phase 3 study, NDA resubmission, and to prepare for this commercial launch.

• Minerva Neurosciences has not generated any revenue from the sales or license of any product candidates.
• The company is also developing MIN-301 for Parkinson's disease.
• Seltorexant, co-developed with Janssen Pharmaceutica NV, is currently in Phase 3 trials being conducted by Janssen.

Finance: review cash burn projections based on the $12.4 million cash balance as of September 30, 2025, against the anticipated costs for the Phase 3 study by Wednesday.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Channels

You're looking at how Minerva Neurosciences, Inc. gets its data, talks to regulators, and plans to get its product, roluperidone, to market. It's all about execution on the Phase 3 trial and the subsequent regulatory filing.

Clinical trial sites for data generation and regulatory submission

The primary channel for generating the data required for regulatory submission is the confirmatory Phase 3 clinical trial for roluperidone in schizophrenia with negative symptoms. The FDA has confirmed the requirements for this trial to support the New Drug Application (NDA) resubmission.

The design parameters for this critical data generation channel include:

• Trial duration: at least 52 weeks for observational assessment of relapses of positive symptoms.
• Efficacy primary endpoint: change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at Week 12.
• Patient recruitment target: best efforts to secure 25-30% of patients from the U.S., subject to competitive recruitment.

This entire clinical operation is being funded by recent capital raises, which is a key enabler for this channel.

Direct regulatory pathway to the FDA for NDA resubmission

The direct channel to the U.S. Food and Drug Administration (FDA) is currently defined by the agreement on the confirmatory trial needed to address deficiencies cited in the Complete Response Letter (CRL) received in February 2024. Minerva Neurosciences, Inc. expects to be sufficiently funded through this trial and the subsequent NDA resubmission.

Here's a look at the financial backing directly supporting this regulatory path as of late 2025:

Financing Component	Amount (Gross Proceeds)	Status/Condition
Upfront Funding (October 2025)	$80 million	Received in exchange for Series A Convertible Preferred Stock.
Tranche A Warrants Exercise	Up to an additional $80 million	Subject to exercise terms and conditions.
Tranche B Warrants Exercise	Additional $40 million	Contingent upon achievement of a specified milestone event.
Total Potential Gross Proceeds	Up to $200 million	To finance the Phase 3 trial and NDA resubmission.

The cash position as of September 30, 2025, was approximately $12.4 million, following the upfront financing, though this was down from $21.5 million at December 31, 2024.

Future pharmaceutical wholesalers and specialty pharmacies for distribution

Minerva Neurosciences, Inc. is preparing for a potential commercial launch in the U.S., contingent upon FDA approval following the NDA resubmission. The financing secured is explicitly earmarked to prepare for this future distribution channel.

The preparation for commercial launch is part of the intended use of proceeds from the private placement, which secured an initial upfront funding of $80 million on or about October 23, 2025. Minerva has not disclosed specific agreements with pharmaceutical wholesalers or specialty pharmacies as of late 2025, as this is a pre-approval activity.

Scientific publications and conferences to reach CNS specialists

Reaching CNS specialists is a vital channel for establishing scientific credibility and awareness for roluperidone and MIN-301. This is achieved through dissemination of trial data and corporate updates.

Recent communication milestones serving as channels include:

• Reporting Third Quarter 2025 Financial Results on November 5, 2025.
• Announcing the appointment of Dr. Inderjit Kaul to the Board of Directors on November 19, 2025.
• The company has not received any regulatory approvals to commercialize its product candidates and has not generated any revenue from the sales or license of any product candidates.

The company's commitment is to provide investors access to news regarding product development programs, which inherently supports the scientific communication channel.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Segments

You're looking at the core groups Minerva Neurosciences, Inc. (NERV) targets right now, as they push roluperidone through its final development stages. This isn't about the general population; it's highly specific, which is typical for a clinical-stage biopharma firm this late in the game.

Schizophrenia patients with impairing negative symptoms and stable positive symptoms

This is the ultimate end-user segment for roluperidone. The FDA alignment specifies the exact profile needed for the confirmatory Phase 3 trial. The trial design itself gives us concrete numbers about the target patient pool's required characteristics.

• Target patient diagnosis: Schizophrenia with impairing negative symptoms and stable positive symptoms.
• Required U.S. patient enrollment in the Phase 3 trial: Best efforts to secure 25-30% of patients from the USA.
• Dosing evaluated in the confirmatory trial: A single daily dose of 64 mg of roluperidone or placebo.

The company is defintely focused on demonstrating efficacy on the PANSS Marder negative symptoms factor score (NSFS) at the 12-week timepoint for this specific group.

CNS specialists and psychiatrists treating schizophrenia

While Minerva Neurosciences, Inc. isn't selling yet, this segment represents the key prescribers and gatekeepers for future adoption. The company is already strengthening its clinical operations team by planning to appoint up to three new directors with significant schizophrenia clinical trial experience, designated by the investors supporting the development.

• Investor-designated board appointments: Up to 3 new directors with significant schizophrenia clinical trial experience.
• The focus for these specialists is treating the unmet need represented by negative symptoms, which previous studies showed improvement in with the 64 mg dose over a one-year period.

Institutional and accredited investors funding the clinical development stage

This segment is crucial for Minerva Neurosciences, Inc.'s survival and progress, providing the capital needed to run the confirmatory trial and prepare for a potential launch. The recent financing event in October 2025 was a major influx for this purpose.

Here's a quick math on the October 2025 financing structure:

Funding Component	Amount (Gross Proceeds)	Trigger/Condition
Upfront Funding	$80 million	Closing of the private placement (received October 23, 2025)
Tranche A Warrants	Up to $80 million	Exercise of all Tranche A warrants
Tranche B Warrants	Up to $40 million	Achievement of a milestone event (primary endpoint of Phase 3 trial)
Total Potential Proceeds	Up to $200 million	Full exercise of all warrants

Looking at the ownership structure as of mid-2025, you see who is already committed:

Metric	Value (as of June 2025)
Total Institutional Owners (13F filers)	21
Institutional Ownership Percentage	27.81%
Total Shares Outstanding	6,993,406
Largest Single Institutional Holder	FEDERATED HERMES, INC. (over 1.35 million shares)

The financing was led by Vivo Capital LLC, with participation from Janus Henderson Investors and Federated Hermes Kaufmann Funds, among others.

Payers and government health programs (future segment upon approval)

This segment is prospective, but the financing is explicitly intended to prepare for it. The proceeds are earmarked to fund the Phase 3 study, NDA resubmission, and potential commercial launch preparations in the US, if roluperidone gets approved.

• Cash position as of September 30, 2025: Approximately $12.4 million.
• Net loss for the nine months ended September 30, 2025: $9.8 million.

The company anticipates having sufficient funds from the recent placement to cover the Phase 3 study and resubmission, which directly impacts the timeline to reach this payer segment.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Cost Structure

You're looking at the major cash outflows for Minerva Neurosciences, Inc. as of late 2025, focusing on what it takes to keep the roluperidone development engine running. For a clinical-stage company, the cost structure is almost entirely driven by R&D and the necessary administrative overhead to manage that science and regulatory path.

Here's a look at the core operating expenses through the first nine months of fiscal year 2025, ending September 30, 2025:

Cost Category	Amount (Nine Months Ended Sept 30, 2025)
Research and Development (R&D) expense	$3.6 million
General and Administrative (G&A) expense	$6.5 million

The R&D expense of $3.6 million for the nine months ended September 30, 2025, was notably lower than the $9.9 million reported for the same period in 2024. This reduction was partly due to lower compensation expenses, but the big-ticket items are the costs for the upcoming clinical work.

The costs for the new 52-week confirmatory Phase 3 trial of roluperidone, along with the regulatory and legal fees tied to the New Drug Application (NDA) resubmission process, are substantial future expenditures. To cover these, Minerva Neurosciences secured significant capital in October 2025. The financing structure included:

• Initial upfront funding of $80 million.
• Up to an additional $80 million if all Tranche A warrants are exercised.
• Additional proceeds of $40 million contingent upon exercising Tranche B warrants after achieving a milestone related to the Phase 3 trial primary endpoint.

This financing provided up to $200 million in gross proceeds intended to finance the confirmatory Phase 3 trial, the NDA resubmission, and preparations for a potential U.S. commercial launch.

Regarding personnel and compensation expenses for the core team, while a specific standalone number isn't broken out for this category alone, the R&D expense reduction for the nine months ended September 30, 2025, was attributed in part to lower compensation expenses compared to the prior year. Also, the G&A expense for the nine months ended September 30, 2025, at $6.5 million, was lower than the $7.4 million in the prior year, primarily due to lower professional service fees.

The G&A for the three months ended September 30, 2025, was $1.9 million.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Revenue Streams

You're looking at the immediate cash infusion that keeps Minerva Neurosciences, Inc. moving forward with roluperidone. The revenue stream here is almost entirely capital-raising activity as of late 2025, not product sales.

The most significant recent event is the equity financing, which closed around October 23, 2025. This deal was structured to provide immediate capital while setting up future tranches contingent on progress. The initial cash hit was substantial.

The upfront proceeds from the private placement totaled $80 million in gross funding, received in exchange for shares of Series A Convertible Preferred Stock. This funding is earmarked to support the confirmatory Phase 3 trial for roluperidone and the New Drug Application (NDA) resubmission to the FDA.

The total potential financing package was up to $200 million in gross proceeds, structured across three components. Here's the quick math on the potential future cash:

Financing Component	Maximum Potential Gross Proceeds	Condition/Status
Upfront Private Placement	$80 million	Received October 2025
Tranche A Warrants Exercise	Up to $80 million	Immediately exercisable for cash upon Phase 3 primary endpoint announcement
Tranche B Warrants Exercise	Up to $40 million	Contingent upon achievement of a milestone event
Total Potential Gross Proceeds	Up to $200 million	Before fees and expenses

You should note the specific triggers for the warrant exercises. The Tranche A warrants are tied to the Phase 3 trial success for roluperidone, and the Tranche B warrants are also tied to a milestone event. If stockholder approval for conversion mechanics isn't obtained within one year, the preferred shares face redemption.

Regarding other potential streams, the focus in recent reports is on the roluperidone program, but the outline requires mentioning the other asset.

• Potential future milestone payments or royalties from Janssen for seltorexant (MIN-202)

As of the Third Quarter 2025 results ending September 30, 2025, Minerva Neurosciences, Inc. reported zero in Other Income for the three-month period, which contrasts with the $26.6 million recognized in the third quarter of 2024 related to the sale of future royalties.

Currently, Minerva Neurosciences, Inc. has zero revenue from product sales or licenses, which makes sense given its status. The Q3 2025 financial data shows net losses, and the company's primary focus is advancing its clinical-stage assets through trials funded by the recent equity raise.

The current revenue picture is defined by these financing events:

• Proceeds from equity financing, including the upfront $80 million private placement.
• Potential future proceeds from Tranche A warrants, up to $80 million more.
• Potential future proceeds from Tranche B warrants, up to $40 million more.

Finance: review the cash burn rate against the $12.4 million cash position as of September 30, 2025, factoring in the expected R&D increases for the roluperidone trial.