Minerva Neurosciences, Inc. (NERV): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Sumérgete en el innovador mundo de Minerva Neurosciences, Inc. (NERV), una innovadora compañía de biotecnología que revoluciona el tratamiento del trastorno neurológico. Con un enfoque afilado en el desarrollo de soluciones terapéuticas de vanguardia, Minerva está empujando los límites de la investigación de neurociencia, transformando desafíos neurológicos complejos en posibles tratamientos innovadores que podrían mejorar dramáticamente la vida de los pacientes. Su sofisticado lienzo de modelo de negocio revela un enfoque estratégico que combina investigación avanzada, desarrollo de medicamentos dirigidos y una filosofía de medicina de precisión destinada a abordar algunas de las condiciones neurológicas más intrincadas en la ciencia médica moderna.

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

A partir de 2024, Minerva Neurosciences ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Enfoque de investigación	Año de asociación
Hospital General de Massachusetts	Investigación de esquizofrenia	2022
Instituto de Neurociencia de la Universidad de Stanford	Desarrollo del tratamiento de depresión	2023

Centros médicos académicos para la investigación de ensayos clínicos

Minerva Neurosciences mantiene colaboraciones activas de ensayos clínicos con:

• Escuela de Medicina de Harvard
• Facultad de Medicina de la Universidad de Yale
• Universidad de California, Centro de Neuropsiquiatría de San Francisco

Acuerdos de licencia con firmas de biotecnología

Las asociaciones actuales de licencia incluyen:

Firma de biotecnología	Candidato a la droga	Valor de acuerdo
Biosciencias neurocrinas	Min-117	$ 12.5 millones por adelantado
Terapéutica de Sabio	Compuesto de mejora cognitiva	Pago por hito de $ 8.3 millones

Organizaciones de investigación por contrato

Minerva Neurosciences colabora con los siguientes CRO:

• Ícono plc
• Parexel International
• IQVIA Holdings Inc.

Socios de distribución farmacéutica

Socio de distribución	Cobertura geográfica	Alcance de la asociación
AmerisourceBergen	Estados Unidos	Distribución farmacéutica a nivel nacional
McKesson Corporation	América del norte	Distribución farmacéutica especializada

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas de neurociencia

Presupuesto de investigación y desarrollo para 2023: $ 45.2 millones

Área de enfoque de investigación	Programas activos	Etapa de desarrollo
Esquizofrenia	Min-101	Fase 2/3 ensayos clínicos
Trastorno depresivo mayor	Min-117	Ensayos clínicos de fase 2

Gestión y ejecución del ensayo clínico

Ensayos clínicos en curso total a partir de 2023: 3 programas activos

• Sitios de ensayos clínicos: 25 ubicaciones internacionales
• Inscripción del paciente: aproximadamente 350 participantes en los ensayos actuales
• Duración promedio del ensayo clínico: 24-36 meses

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Costos de presentación regulatoria en 2023: $ 3.7 millones

Agencia reguladora	Aplicaciones pendientes	Estado
FDA	Min-101	Revisión continua
EMA	Min-117	Discusiones preliminares

Gestión y protección de la propiedad intelectual

Portafolio de patentes totales: 12 patentes activas

• Duración de protección de patentes: 15-20 años
• Costos anuales de mantenimiento de propiedad intelectual: $ 1.2 millones

Investigación farmacéutica preclínica y clínica en etapa clínica

Inversión de investigación en etapas preclínicas: $ 12.5 millones en 2023

Categoría de investigación	Inversión	Áreas de enfoque
Investigación preclínica	$ 7.3 millones	Trastornos neurológicos
Etapa clínica temprana	$ 5.2 millones	Condiciones psiquiátricas

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: recursos clave

Equipo de Investigación y Desarrollo de Neurociencia Especializada

A partir del cuarto trimestre de 2023, Minerva Neurosciences empleó a 78 personal de investigación y desarrollo a tiempo completo.

Categoría de personal	Número
Investigadores de doctorado	42
Especialistas en investigación clínica	24
Científicos superiores	12

Instalaciones de investigación avanzadas e infraestructura de laboratorio

Minerva Neurosciences mantiene instalaciones de investigación en Cambridge, Massachusetts, con un espacio de laboratorio total de 35,000 pies cuadrados.

Propietario de desarrollo de fármacos

• Min-101 (roluperidona) para síntomas negativos de esquizofrenia
• Min-301 para la enfermedad de Parkinson
• Min-117 para el trastorno depresivo mayor

Cartera de propiedades intelectuales

A diciembre de 2023, Minerva Neurociences sostenía 17 patentes activas relacionado con el desarrollo de fármacos neurológicos.

Categoría de patente	Número de patentes
Composición de la materia	8
Método de tratamiento	6
Formulación	3

Datos de ensayos clínicos y experiencia en investigación

Minerva Neurosciences ha realizado 6 ensayos clínicos de fase 2 y fase 3 a partir de 2023.

Fase de ensayo clínico	Número de pruebas	Inscripción total del paciente
Fase 2	4	532 pacientes
Fase 3	2	412 pacientes

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para trastornos neurológicos

Minerva Neurosciences se centra en el desarrollo de nuevas terapias para trastornos neurológicos críticos con importantes necesidades médicas no satisfechas.

Candidato a la droga	Condición objetivo	Etapa de desarrollo	Tamaño potencial del mercado
Min-117	Trastorno depresivo mayor	Fase 2	Mercado global de $ 15.2 mil millones
Roluperidona	Síntomas negativos de la esquizofrenia	Fase 3	Mercado potencial de $ 6.8 mil millones

Posibles tratamientos innovadores para afecciones neurológicas complejas

La tubería de investigación de la compañía se dirige a trastornos neurológicos desafiantes con opciones de tratamiento existentes limitadas.

• Enfoque de orientación molecular patentada
• Comprensión de mecanismo neuroquímico avanzado
• Intervenciones farmacológicas de precisión

Candidatos a medicamentos avanzados dirigidos a mecanismos neurológicos específicos

La estrategia de desarrollo de fármacos de Minerva se centra en vías moleculares únicas.

Mecanismo	Área terapéutica	Inversión de investigación
Modulación del receptor 5-HT2A	Trastornos psiquiátricos	Gastos de I + D de $ 8,3 millones
Neurotransmisor reequilibrio	Trastornos del estado de ánimo	$ 6.7 millones de fondos de investigación

Enfoque de medicina de precisión en el tratamiento de neurociencia

Desarrollo terapéutico dirigido con potencial de tratamiento personalizado.

• Integración de perfiles genómicos
• Diseño de fármacos guiado por biomarcadores
• Optimización de tratamiento individualizada

Mejora potencial en la calidad de vida del paciente

Programas clínicos diseñados para abordar los importantes desafíos de manejo de síntomas del paciente.

Meta terapéutica	Métrica de impacto del paciente	Mejora potencial
Reducción de síntomas	Puntuación de calidad de vida	Hasta el 40% de mejora
Recuperación funcional	Capacidades de vida diaria	Mejora estimada del 35%

Minerva Neurosciences, Inc. (NERV) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

Minerva Neurosciences mantiene la participación directa a través de estrategias de divulgación médica específicas.

Tipo de compromiso	Frecuencia	Público objetivo
Consultas médicas individuales	Trimestral	Psiquiatras, neurólogos
Reuniones de la Junta Asesora Clínica	By-anualmente	Líderes de opinión clave

Programas de apoyo y educación del paciente

Las iniciativas integrales de apoyo al paciente se centran en el manejo del trastorno neurológico.

• Recursos de educación de pacientes digitales
• Programas de apoyo a la adherencia al tratamiento
• Plataformas comunitarias de pacientes en línea

Conferencia científica y participación del simposio médico

Participación activa en eventos clave de investigación neurológica.

Tipo de conferencia	Participación anual	Enfoque de presentación
Conferencias de investigación psiquiátrica	3-4 eventos	Desarrollos de tratamiento de esquizofrenia
Simposios de neurociencia	2-3 eventos	Tubería de drogas de investigación

Plataformas de comunicación digital para comunidad médica

Aprovechando los canales digitales para la comunicación profesional.

• Portal web de profesional médico dedicado
• Plataformas de mensajería seguras
• Serie de seminarios web sobre investigación neurológica

Interacciones participantes de ensayos clínicos en curso

Compromiso estructurado con participantes de ensayos clínicos.

Tipo de interacción	Frecuencia	Método de comunicación
Monitoreo de progreso	Mensual	Resultados electrónicos informados por el paciente
Evaluaciones de seguimiento	Trimestral	Consultas de telesalud

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: canales

Equipo de ventas directo dirigido a neurólogos y psiquiatras

A partir de 2024, Minerva Neurosciences mantiene una fuerza de ventas especializada de 37 representantes centrados en profesionales de la salud neurológica y psiquiátrica.

Métricas de canales de ventas	Datos cuantitativos
Representantes de ventas totales	37
Cobertura geográfica	Estados Unidos (mercado primario)
Interacciones médicas promedio por mes	124 interacciones

Presentaciones de conferencia médica

Minerva Neurosciences participa en conferencias médicas clave para mostrar investigaciones y desarrollos clínicos.

• Conferencia anual de la Asociación Americana de Psiquiatría
• Conferencia neurológica internacional
• Cumbre europea de neurociencia

Plataformas de publicación científica

La compañía aprovecha 12 revistas médicas revisadas por pares para difundir los hallazgos de la investigación.

Plataforma de publicación	Publicaciones anuales
Neuropsicofarmacología	4 publicaciones
Revista de Neurociencia	3 publicaciones
Psiquiatría molecular	5 publicaciones

Marketing digital y recursos médicos en línea

La estrategia de participación digital incluye plataformas en línea específicas y sitios web de información médica.

• Red profesional webmd
• Canal de marketing de Medscape
• Red de atención médica profesional de LinkedIn

Redes de distribuidores farmacéuticos

Minerva Neurosciences colabora con 7 principales socios de distribución farmacéutica.

Distribuidor	Alcance del mercado
AmerisourceBergen	Cobertura nacional
Salud cardinal	Cobertura nacional
McKesson Corporation	Cobertura nacional

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

Neurólogos y especialistas en psiquiatría

Tamaño del mercado objetivo: aproximadamente 54,600 neurólogos y 49,500 psiquiatras en los Estados Unidos a partir de 2023.

Especialidad	Número de practicantes	Penetración potencial del mercado
Neurólogos	54,600	35.7%
Psiquiatras	49,500	29.4%

Instituciones y hospitales de atención médica

Mercado total direccionable: 6.093 hospitales en los Estados Unidos en 2023.

• Hospitales psiquiátricos: 1.744
• Centros de especialidad de neurología: 2,356
• Centros médicos académicos: 141

Pacientes con trastornos neurológicos

Población total de pacientes para trastornos neurológicos clave:

Trastorno	Número de pacientes
Trastorno depresivo mayor	17.3 millones de adultos
Esquizofrenia	3.2 millones de pacientes
Enfermedad de Parkinson	1 millón de pacientes

Universidades de investigación y centros médicos académicos

Número total de instituciones centradas en la investigación:

• Universidades de investigación: 308
• Centros médicos académicos: 141
• Centros de investigación de neurociencia: 92

Inversores farmacéuticos y de atención médica

Panorama de inversiones para empresas de neurociencia:

Categoría de inversión	Inversión total
Capital de riesgo de neurociencia	$ 3.1 mil millones en 2023
Financiación de la investigación del trastorno neurológico	$ 2.4 mil millones
Inversiones de capital privado	$ 1.7 mil millones

Minerva Neurosciences, Inc. (NERV) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Minerva Neurosciences informó que los gastos de I + D por un total de $ 36.4 millones.

Categoría de costos de I + D	Monto ($)
Investigación preclínica	8,900,000
Preparación de ensayos clínicos	12,500,000
Desarrollo de drogas	15,000,000

Costos de gestión y ejecución de ensayos clínicos

Los gastos de ensayo clínico para 2023 fueron de aproximadamente $ 22.7 millones.

• Pruebas de fase I: $ 5.6 millones
• Pruebas de fase II: $ 11.3 millones
• Pruebas de fase III: $ 5.8 millones

Procesos de cumplimiento y aprobación regulatoria

Los costos de cumplimiento regulatorio para 2023 ascendieron a $ 4.2 millones.

Actividad de cumplimiento	Costo ($)
Tarifas de presentación de la FDA	1,200,000
Documentación regulatoria	1,500,000
Consultoría de cumplimiento	1,500,000

Protección y mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 2.1 millones.

• Presentación de patentes: $ 850,000
• Mantenimiento de patentes: $ 750,000
• Servicios legales: $ 500,000

Sobrecarga administrativa y operativa

Los gastos administrativos y operativos totales para 2023 fueron de $ 15.6 millones.

Categoría de gastos generales	Monto ($)
Salarios y beneficios	9,200,000
Instalaciones de oficina	2,400,000
Tecnología e infraestructura	2,000,000
Viajes y conferencias	2,000,000

Minerva Neurosciences, Inc. (NERV) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir de 2024, Minerva Neurosciences no ha informado ingresos específicos de licencias de medicamentos. La tubería de la compañía se centra en los trastornos del sistema nervioso central.

Ventas de productos farmacéuticos futuros

Producto	Área terapéutica	Etapa de desarrollo	Valor de mercado potencial
Min-117	Trastorno depresivo mayor	Fase 2	Mercado potencial de $ 350 millones
Roluperidona	Síntomas negativos de la esquizofrenia	Fase 3	Mercado potencial de $ 500 millones

Subvenciones de investigación y financiación

A partir del último informe financiero, Minerva Neurosciences no ha revelado montos específicos de subvenciones de investigación.

Asociaciones de investigación colaborativa

• No hay asociaciones de investigación colaborativas activas informadas públicamente a partir de 2024

Pagos potenciales de hitos

Producto	Pago potencial de hito	Condición
Roluperidona	Hasta $ 50 millones	Finalización exitosa de la fase 3
Min-117	Hasta $ 30 millones	Progresión de aprobación regulatoria

Los datos financieros reflejan los últimos estados financieros informados de Minerva Neurosciences y el estado de desarrollo de la tubería.

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.