GH Research PLC (GHRS): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

En el reino de vanguardia de la medicina psicodélica, GH Research Plc (GHRS) surge como una fuerza pionera, transformando el tratamiento de salud mental a través de una exploración científica innovadora. Con un enfoque centrado en el láser en las estrategias terapéuticas innovadoras de 5-MEO-DMT, este innovador de biotecnología está redefiniendo el manejo del trastorno psiquiátrico al dirigirse a afecciones resistentes al tratamiento que han desafiado durante mucho tiempo los enfoques médicos tradicionales. Su lienzo de modelo de negocio integral revela un plan sofisticado para el descubrimiento científico, las asociaciones estratégicas y las posibles terapias innovadoras que podrían revolucionar las intervenciones de salud mental.

GH Research PLC (GHRS) - Modelo de negocios: asociaciones clave

Colaboración con instituciones de investigación académica

GH Research Plc ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de asociación
Universidad de Johns Hopkins	Investigación de medicina psicodélica	Colaboración activa
Imperial College London	Estudios de neuropsicofarmacología	Asociación de investigación en curso

Asociaciones estratégicas con compañías farmacéuticas

GH Research ha desarrollado asociaciones farmacéuticas estratégicas:

• Compass Pathways PLC - Investigación colaborativa en terapias basadas en psilocibinas
• Maps Public Benefit Corporation - Investigación conjunta sobre protocolos de tratamiento psicodélico

Organizaciones de investigación por contrato para ensayos clínicos

Nombre de Cro	Fase de ensayo clínico	Valor de contrato
IQVIA	Ensayos de fase 2/3 para 5-MEO-DMT	$ 4.2 millones
Medpacio	Estudios clínicos de tratamiento de depresión	$ 3.7 millones

Potencios del gobierno y socios de financiación de la salud

Las asociaciones actuales de financiación gubernamental y de atención médica incluyen:

• Instituto Nacional de Salud Mental - Subvención de investigación de $ 1.5 millones
• Cerebro & Fundación de Investigación del Comportamiento - Soporte de investigación de $ 750,000

GH Research Plc (GHRS) - Modelo de negocio: actividades clave

Investigación y desarrollo de la medicina psicodélica

GH Research PLC se centra en desarrollar 5-MeO-DMT como un tratamiento terapéutico para la depresión resistente al tratamiento. A partir de 2024, la compañía tiene:

• Ensayos clínicos de fase 2 completados
• Invirtió $ 24.7 millones en investigación y desarrollo para 2023
• Mantuvo un equipo de investigación dedicado de 22 profesionales científicos

Área de enfoque de investigación	Inversión 2023	Etapa de investigación
Tratamiento de depresión de 5-MEO-DMT	$ 24.7 millones	Fase 2 completada

Investigaciones de tratamiento terapéutico 5-MEO-DMT

Los parámetros de investigación clave incluyen:

• Objetivo primario de depresión resistente al tratamiento
• Aplicaciones potenciales de trastorno neuropsiquiátrico
• Desarrollo de formulación molecular patentada

Área de tratamiento	Fase de ensayo clínico	Inscripción del paciente
Depresión resistente al tratamiento	Fase 2	45 participantes

Gestión de ensayos preclínicos y clínicos

Métricas de gestión de ensayos clínicos:

• Cumplimiento regulatorio de las directrices de la FDA
• Implementación integral del protocolo de seguridad
• Sistemas de seguimiento de datos sofisticados

Métrico de gestión de ensayos	2023 rendimiento	Nivel de cumplimiento
Cumplimiento regulatorio de la FDA	100% de adherencia	Totalmente cumplido

Desarrollo y protección de la propiedad intelectual

Estrategia de propiedad intelectual:

• 7 solicitudes de patentes activas
• $ 3.2 millones asignados para protección de IP en 2023
• Patentes integrales de composición molecular

Categoría de IP	Número de patentes	Inversión 2023
Composición molecular	7 aplicaciones	$ 3.2 millones

GH Research PLC (GHRS) - Modelo de negocios: recursos clave

Investigación especializada y experiencia médica

GH Research PLC se centra en la investigación terapéutica basada en 5-MEO-DMT con un equipo especializado de 12 científicos de investigación y profesionales médicos.

Área de investigación	Número de especialistas
Investigación de neurociencia	5
Desarrollo clínico	4
Farmacología	3

Plataformas de desarrollo de fármacos patentados

Las plataformas patentadas de GH Research incluyen:

• Plataforma de moléculas terapéuticas 5-MEO-DMT
• Tecnología avanzada de descubrimiento de fármacos neuropsiquiátricos
• Marco de desarrollo de medicina de precisión

Instalaciones avanzadas de laboratorio e investigación

Instalaciones de investigación ubicadas en Dublín, Irlanda con aproximadamente 2,500 metros cuadrados de espacio de investigación dedicado.

Especificación de la instalación	Detalles
Espacio total de investigación	2.500 m²
Inversión en equipos de investigación	$ 3.2 millones
Cumplimiento de laboratorio	Certificado por GLP y GMP

Cartera de propiedades intelectuales

A partir de 2024, GH Research posee 7 familias de patentes que cubren aplicaciones terapéuticas 5-MEO-DMT.

Categoría de patente	Número de patentes
Composición del tratamiento	3
Mecanismo de entrega	2
Protocolo terapéutico	2

Equipo científico y de gestión experimentado

Equipo de liderazgo con 85 años acumulativos de experiencia en investigación farmacéutica.

Posición de liderazgo	Años de experiencia
CEO	22 años
Director médico	18 años
Oficial científico	20 años
Directores de investigación	25 años

GH Research PLC (GHRS) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de salud mental

GH Research PLC se centra en el desarrollo farmacéutico basado en 5-MEO-DMT para afecciones psiquiátricas resistentes al tratamiento.

Enfoque de investigación	Condición objetivo	Etapa actual
Terapia GH001	Depresión resistente al tratamiento	Ensayos clínicos de fase 2
Terapia GH002	Trastorno de estrés postraumático	Desarrollo preclínico

Posibles terapias innovadoras

La propuesta de valor principal de la compañía se centra en el desarrollo de nuevas intervenciones farmacéuticas basadas en psicodélicas.

• Formulación molecular de 5-MEO-DMT
• Mecanismo terapéutico potencial de acción rápida
• Efecto secundario mínimo profile en comparación con los tratamientos tradicionales

Enfoque novedoso para el manejo del trastorno psiquiátrico

A partir del cuarto trimestre de 2023, la investigación de GH ha invertido $ 24.3 millones en investigación y desarrollo específicamente dirigido a condiciones neuropsiquiátricas.

Categoría de inversión	Cantidad	Porcentaje de I + D total
Investigación preclínica	$ 12.7 millones	52.3%
Ensayos clínicos	$ 8.6 millones	35.4%

Investigación científica dirigida a las necesidades médicas no satisfechas

La tubería de GH Research aborda las condiciones con opciones de tratamiento existentes limitadas.

• Depresión resistente al tratamiento que afecta al 30.9% de los pacientes que no responden a los antidepresivos estándar
• La prevalencia de TEPT estimada en 6.1% en la población global
• Oportunidad de mercado potencial superior a $ 3.5 mil millones en terapéutica psiquiátrica

Desarrollo farmacéutico psicodélico de vanguardia

Las métricas financieras actuales demuestran una inversión significativa en enfoques terapéuticos innovadores.

Métrica financiera	Valor 2023
Gasto de I + D	$ 34.2 millones
Solicitudes de patentes	7 aplicaciones activas
Cartera de propiedades intelectuales	12 patentes otorgadas

GH Research PLC (GHRS) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

GH Research PLC mantiene la participación directa a través de interacciones específicas con profesionales de investigación neuropsiquiátrica especializados.

Tipo de compromiso	Frecuencia	Público objetivo
Simposios de investigación	Trimestral	Investigadores de neuropsiquiatría
Reuniones de asesoramiento clínico	By-anualmente	Especialistas en tratamiento psiquiátrico

Comunicación transparente del progreso de la investigación

La compañía proporciona actualizaciones detalladas sobre desarrollos de investigación a través de múltiples canales de comunicación.

• Informes de progreso de investigación trimestral
• Seminarios web de inversores
• Divulgaciones detalladas de transparencia de ensayos clínicos

Colaboración con profesionales de la salud

GH Research colabora con profesionales de la salud a través de programas de participación estructurados.

Tipo de colaboración	Número de participantes	Enfoque de investigación
Asociaciones de ensayos clínicos	37 instituciones de investigación	Investigación de tratamiento de 5-MEO-DMT
Juntas de asesoramiento de expertos	12 investigadores senior	Intervenciones neuropsiquiátricas

Publicación científica y presentaciones de conferencias

La Compañía contribuye activamente al discurso científico a través de publicaciones y participación de conferencias.

• 9 publicaciones revisadas por pares en 2023
• 4 Presentaciones de conferencias internacionales importantes
• 2 Premios de investigación de neurociencia

GH Research PLC (GHRS) - Modelo de negocios: canales

Conferencias científicas y simposios médicos

GH Research PLC participa activamente en eventos clave de investigación en neuropsiquiatría, con datos de presentación de la siguiente manera:

Tipo de conferencia	Presentaciones anuales	Alcance de audiencia estimado
Conferencias de neuropsiquiatría	4-6 Presentaciones	500-1,000 especialistas
Simposios de investigación psiquiátrica internacional	2-3 presentaciones	300-700 investigadores

Publicaciones de revistas revisadas por pares

Métricas de publicación para GH Research plc:

• Publicaciones anuales revisadas por pares: 3-5 trabajos de investigación
• Revistas objetivo: naturaleza, psiquiatría molecular, neuropsicofarmacología
• Índice de citas acumulativas: aproximadamente 50-75 citas por publicación

Comunicación directa de investigación médica

Canales de comunicación con comunidad de investigación:

Método de comunicación	Compromiso anual
Alcance directo del investigador	150-200 comunicaciones dirigidas
Reuniones de investigadores clínicos	8-12 reuniones especializadas

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Llamadas de ganancias trimestrales: 4 por año
• Reuniones anuales de accionistas: 1 por año
• Macetas de presentación del inversor: 3-4 anualmente
• Comunicaciones de presentación de la SEC: informes regulares de 10-K y 10-Q

Redes de investigación digital y académica

Métricas de compromiso digital:

Plataforma	Seguidor/recuento de conexión	Actualizaciones anuales de contenido
LinkedIn	2,500-3,000 conexiones profesionales	40-50 actualizaciones de investigación
Investigador	1.200-1,500 seguidores académicos	25-35 publicaciones de investigación

GH Research Plc (GHRS) - Modelo de negocio: segmentos de clientes

Instituciones de investigación psiquiátrica y médica

GH Research PLC se dirige a instituciones de investigación que se centran en la terapéutica psicodélica. A partir de 2023, el mercado global de investigación psiquiátrica se valoró en $ 3.2 mil millones.

Tipo de institución de investigación	Tamaño potencial del mercado	Enfoque de investigación
Centros de investigación académicos	$ 1.1 mil millones	Desarrollo de medicina psicodélica
Institutos de Investigación Privada	$ 780 millones	Innovaciones de tratamiento neuropsiquiátrico

Compañías farmacéuticas

La compañía se dirige a empresas farmacéuticas interesadas en nuevos tratamientos de salud mental.

• Mercado farmacéutico global: $ 1.27 billones en 2023
• Mercado de drogas de salud mental: $ 22.3 mil millones
• Inversión de investigación de medicina psicodélica: $ 387 millones

Proveedores de atención médica

GH Research se centra en los sistemas de salud que buscan soluciones innovadoras de salud mental.

Tipo de proveedor de atención médica	Tasa de adopción potencial	Áreas de tratamiento objetivo
Hospitales psiquiátricos	42%	Depresión resistente al tratamiento
Clínicas de salud mental	35%	TEPT y trastornos de ansiedad

Especialistas en tratamiento de salud mental

Dirigido a psiquiatras y psicólogos clínicos especializados en metodologías de tratamiento avanzadas.

• Profesionales totales de salud mental a nivel mundial: 1.2 millones
• Especialistas interesados ​​en terapias psicodélicas: aproximadamente el 18%
• Inversión de investigación anual promedio por especialista: $ 64,000

Pacientes con afecciones resistentes al tratamiento

Segmento objetivo primario para las intervenciones terapéuticas de GH Research.

Condición	Población de pacientes global	Tasa resistente al tratamiento
Trastorno depresivo mayor	322 millones de pacientes	30-40% resistente al tratamiento
Trastorno de estrés postraumático	44.7 millones de pacientes	25-35% resistente al tratamiento

GH Research Plc (GHRS) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2023, GH Research Plc reportó gastos de I + D de $ 22.4 millones.

Año fiscal	Gastos de I + D	Porcentaje de costos operativos totales
2023	$ 22.4 millones	65.3%
2022	$ 18.7 millones	62.1%

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron aproximadamente $ 12.6 millones, centrándose en la investigación de 5-MEO-DMT para la depresión resistente al tratamiento.

• Presupuesto de ensayos clínicos de fase II: $ 8.2 millones
• Costos de reclutamiento y gestión del paciente: $ 3.4 millones
• Gastos operativos del sitio clínico: $ 1 millón

Personal y compensación de talento científico

Los gastos totales de personal para 2023 fueron de $ 15.3 millones, con una compensación promedio de $ 235,000 por profesional científico.

Categoría de empleado	Número de empleados	Compensación promedio
Investigar científicos	42	$285,000
Investigadores clínicos	28	$210,000

Registro y mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 1.2 millones, que cubren la presentación de patentes, el mantenimiento y la protección legal.

• Tarifas de presentación de patentes: $ 650,000
• Costos de mantenimiento de patentes: $ 350,000
• Gastos de consulta legal: $ 200,000

Costos de infraestructura de laboratorio e investigación

Los gastos de infraestructura y laboratorio totalizaron $ 5.7 millones en 2023.

Categoría de costos	Monto del gasto
Equipo de laboratorio	$ 3.2 millones
Investigación de la instalación de alquiler	$ 1.5 millones
Mantenimiento y servicios públicos	$ 1 millón

GH Research Plc (GHRS) - Modelo de negocio: flujos de ingresos

Licencias potenciales de productos terapéuticos futuros

A partir del cuarto trimestre de 2023, GH Research PLC no ha generado ningún ingreso a partir de la licencia de productos. La compañía se centra en desarrollar 5-MEO-DMT para el tratamiento de afecciones de salud mental.

Subvenciones de investigación y financiación

Año	Monto de subvención	Fuente
2022	$0	No se informaron subvenciones de investigación específicas
2023	$0	No se informaron subvenciones de investigación específicas

Acuerdos de investigación colaborativos

No se han divulgado públicamente acuerdos de investigación colaborativos específicos con detalles financieros a partir de 2024.

Ingresos potenciales de asociación farmacéutica

Los datos financieros del informe anual de 2023 indican:

• No hay asociaciones farmacéuticas activas que generen ingresos
• Ensayos clínicos en curso para GH001 en depresión resistente al tratamiento

Monetización de la propiedad intelectual

Categoría de patente	Número de patentes	Valor potencial
Composición de la materia	3	No monetizado
Método de tratamiento	2	No monetizado

Ingresos totales para 2023: $ 0

GH Research PLC (GHRS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why GH Research PLC's lead asset, GH001, is positioned to disrupt the Treatment-Resistant Depression (TRD) space. The value here isn't just incremental improvement; it's about a fundamental shift in how severe depression is managed.

Ultra-rapid onset of action for severe depression symptoms.

The speed of effect is a major differentiator from conventional antidepressants that often take weeks to show clinical benefit. In the Phase 2b trial (GH001-TRD-201), patients treated with GH001 showed a highly significant reduction in depressive symptoms very quickly. The primary endpoint was met with a placebo-adjusted reduction from baseline of -15.5 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8. This rapid effect was also seen in a prior Phase 2 part of a trial where 87.5% of patients with TRD achieved ultra-rapid remission.

High and durable remission rate, with 73% remission at 6 months for TRD.

Efficacy isn't just fast; it's sustained. The Open-Label Extension (OLE) analysis of the Phase 2b trial confirmed that the treatment effect endures. Specifically, 73.0% of patients who completed the 6-month OLE achieved remission (MADRS $\le$10). To be fair, the initial Day 8 remission rate in the double-blind portion was 57.7% versus 0% for placebo. What's more, 90% of those who achieved remission at Day 8 were still in remission at month 6.

Potential for a single-day, infrequent treatment regimen.

This value proposition addresses the burden of chronic medication adherence and frequent clinic visits. The treatment is designed around an Individualized Dosing Regimen (IDR) administered on a single day, consisting of up to 3 increasing doses (6 mg, 12 mg, and 18 mg). The long-term data supports infrequent re-treatment; most patients (60.3%) in the 6-month period received only 1-4 GH001 treatments. The treatment was associated with short clinic visits, potentially only 1-3 hours long. The safety profile supported this, with almost all patients (97.4%) being discharge ready within an hour of the last dose.

The key efficacy and durability metrics from the Phase 2b trial are summarized below:

Metric	GH001 Result	Comparator/Context
MADRS Reduction (Day 8, Placebo-Adjusted)	-15.5 points	p<0.0001
Remission Rate (Day 8)	57.5%	vs 0% for Placebo
Remission Rate (6 Months, OLE Completers)	73%	Infrequent treatment visits
Treatments Received (6 Months)	Median of 1-4 treatments	For the majority of patients

Novel, proprietary inhalation delivery method (GH001).

GH001 utilizes a novel delivery system for mebufotenin (synthetic 5-methoxy-N,N-dimethyltryptamine or 5-MeO-DMT). The drug is formulated for administration via a proprietary inhalation approach. This method is critical because mebufotenin is not orally active due to significant first-pass metabolism. The inhalation delivery is fast-acting, with a minimal median psychoactive effect duration of only 11 minutes per dose reported. The company is advancing a Phase 1 trial to bridge clinical data to a commercially available device.

Practice-changing treatment for Treatment-Resistant Depression (TRD).

The combination of rapid, profound effect, high durability, and infrequent dosing positions GH001 as a potential paradigm shift. The data suggests it could change the way TRD is treated today. The company's financial position as of September 30, 2025, stood at $293.9 million in cash, cash equivalents, and marketable securities, supporting the advancement toward initiating the global pivotal program in 2026.

The key attributes supporting this claim include:

• Rapid MADRS improvement of -15.5 points placebo-adjusted by Day 8.
• Sustained remission of 73% at 6 months.
• No mandated psychotherapeutic intervention required.
• Well-tolerated with no treatment related serious adverse events across the 6-month trial duration.

Finance: draft 13-week cash view by Friday.

GH Research PLC (GHRS) - Canvas Business Model: Customer Relationships

You're managing the relationships that keep GH Research PLC moving from clinical data to potential market readiness. This isn't just about selling; it's about deep scientific collaboration and rigorous regulatory navigation.

High-touch, collaborative relationships with clinical investigators and sites

The relationship with clinical investigators centers on the data generated from the GH001 program. The full dataset from the Phase 2b trial in treatment-resistant depression (TRD), GH001-TRD-201, was reported in July 2025, providing the core evidence for these collaborations.

The performance metrics from the key trials define the collaborative success:

Metric	Trial/Phase	Value/Rate
Placebo-Adjusted MADRS Reduction (Day 8)	Phase 2b TRD (GH001-TRD-201)	-15.5 points
Remission Rate (Day 8)	Phase 2b TRD (GH001-TRD-201)	57.5%
Remission Rate (6 Months, OLE)	Phase 2b TRD Open-Label Extension	73%
Remission Maintenance (Day 8 to Month 6)	Phase 2b TRD	90%

The Open-Label Extension (OLE) analysis confirms this sustained efficacy, showing a 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapy. Also, the Phase 1 clinical pharmacology trial (GH001-HV-106) evaluating the proprietary aerosol delivery device is ongoing in the United Kingdom, requiring close coordination with that site.

Direct, formal engagement with regulatory bodies like the FDA

Formal engagement with the U.S. Food and Drug Administration (FDA) is critical, specifically regarding the Investigational New Drug Application (IND) clinical hold for GH001. Engagement on the complete response submission is ongoing as of November 2025.

Key points of the ongoing regulatory dialogue include:

• The company submitted its complete response to the IND clinical hold in June 2025.
• Only one hold topic remains outstanding as of July 2025.
• The remaining issue relates to respiratory tract histology findings in rats, which GH Research PLC believes are rat-specific based on scientific evidence.
• There are no additional requests outstanding related to dog toxicology or device issues.
• GH Research PLC plans to submit an IND application for its second product candidate, GH002, in Q4 2025.

The initiation of the global pivotal program for GH001 remains on track for 2026, contingent on resolving this final FDA topic.

Investor relations and communication with the financial community

GH Research PLC maintains active communication with stockholders and potential investors, highlighted by public reporting and conference participation. The company reported its Third Quarter 2025 Financial Results in November 2025 and its Second Quarter 2025 Financial Results in August 2025.

Financial standing directly impacts investor confidence. As of June 30, 2025, cash, cash equivalents and marketable securities stood at $308.7 million. The company also participated in the Stifel 2025 Healthcare Conference in New York from November 11-13, 2025, where they conducted one-on-one investor meetings.

Scientific communication via conferences (ECNP, ASCP) and publications

Disseminating clinical findings to the scientific community is a core relationship activity. GH Research PLC announced the acceptance of presentations at major 2025 meetings.

Scientific engagement highlights for 2025 include:

• Presentation acceptance at the 2025 ECNP Congress in Amsterdam (October 11 - 14), featuring a Novel Therapies Symposium Presentation and posters.
• Presentation acceptance at the ASCP 2025 Annual Meeting in Arizona (May 27 - 30), including a Pharmaceutical Pipeline Presentation.

The ECNP presentation included long-term data for GH001 in TRD patients, reinforcing the data shared with the FDA.

GH Research PLC (GHRS) - Canvas Business Model: Channels

You're hiring before product-market fit, so every interaction point, from the lab bench to the investor call, has to be precise. Here's how GH Research PLC moves its science and capital.

Global clinical trial sites for product development and testing

The channel for product development centers on clinical trials across various jurisdictions. The global pivotal program for GH001 is on track for initiation in 2026. Currently, a Phase 1 clinical pharmacology trial (GH001-HV-106) evaluating the proprietary aerosol delivery device is ongoing in the United Kingdom.

Key data points from completed trials, which inform site selection and protocol design for future phases, include:

Trial/Data Point	Indication/Measure	Result/Metric
Phase 2b (GH001-TRD-201) Primary Endpoint	MADRS Reduction (Day 8 vs. Placebo)	Placebo-adjusted reduction of -15.5 points (p<0.0001)
Phase 2b Open-Label Extension (OLE) Remission	Remission Rate at 6 Months	73%
Phase 2b Remission Rate	Remission at Day 8	57.5%
Remission Maintenance	Maintained remission at 6 Months (of Day 8 remitters)	90%

Scientific and medical conferences for data dissemination

Dissemination of clinical data occurs through presentations and posters at major scientific meetings. GH Research PLC actively presented data throughout 2025, focusing on its lead candidate, GH001.

• American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Arizona, May 27 - 30, 2025: Included a Pharmaceutical Pipeline Presentation.
• International Society for Bipolar Disorders (ISBD) Annual Conference in Chiba, Japan, September 17 - 19, 2025: Accepted poster presentation.
• 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, October 11-14, 2025: Included a Novel Therapies Symposium Presentation on long-term data.

Regulatory submissions (INDs, NDAs) to the FDA and other agencies

The primary channel for regulatory interaction involves submissions to the U.S. Food and Drug Administration (FDA) concerning the Investigational New Drug (IND) applications for its product candidates.

For GH001, the company submitted its complete response to the clinical hold on its IND in June 2025. This submission was ahead of schedule. The FDA response indicated only one remaining topic, concerning respiratory tract histology findings in rats, which GH Research PLC believes are rat-specific. There are no remaining device-related issues.

For the second candidate, GH002, GH Research PLC plans to submit an IND application to the FDA in Q4 2025.

Investor presentations and press releases for capital markets

Capital markets communication is managed through financial reporting, corporate presentations, and conference participation. As of September 30, 2025, GH Research PLC reported cash, cash equivalents, and marketable securities of $293.9 million.

Key financial metrics from the Third Quarter 2025 results include:

• Net loss for the quarter: $14.0 million (or $0.23 loss per share).
• R&D expenses for the quarter: $10.6 million.
• General & Administrative (G&A) expenses for the quarter: $6.0 million.

The company held investor meetings and participated in the Stifel 2025 Healthcare Conference in New York from November 11-13, 2025. A Corporate Presentation was released on November 06, 2025. To be fair, the stock surged 90% over the six months leading up to July 2025, when its market cap was reported at $1.04 billion. Finance: draft 13-week cash view by Friday.

GH Research PLC (GHRS) - Canvas Business Model: Customer Segments

Patients with Treatment-Resistant Depression (TRD), the primary focus.

GH Research PLC's lead candidate, GH001, is specifically targeting patients with Treatment-Resistant Depression (TRD), defined as depression not responding to at least two adequate antidepressant therapies. The potential patient pool in the US alone was estimated to be 2.8 million adults in 2021. The US TRD treatment market was valued at USD 873.2 million in 2022, while the global market across seven major regions reached USD 3,494.7 Million in 2024.

The clinical data from the Phase 2b trial (GH001-TRD-201) provides concrete numbers on the segment's response profile:

Metric	GH001 Group Data	Comparison/Context
Phase 2b Trial Enrollment (TRD)	Approx. 80 patients	Trial completed double-blind phase in 2024
MADRS Reduction (Day 8, Placebo-Adjusted)	-15.5 points	Clinically and statistically significant (p<0.0001)
Remission Rate (Day 8)	57.5%	Compared to 0% in the placebo group
Remission Rate (6 Months OLE)	73%	With infrequent treatment visits
6-Month Remission Rate (for Day 8 Responders)	91.7%	Patients in remission on Day 8 maintained remission at 6 months
Estimated Treatment Visits (6 Months)	Approx. 4 visits	Compared to 23 visits assumed for Spravato®

Patients with Postpartum Depression (PPD) and Bipolar II Depression (secondary).

GH Research PLC has also advanced GH001 into earlier-stage trials for these secondary indications, suggesting these patient populations are key to future expansion. The company has completed Phase 2 open-label trials in both indications.

• Phase 2 open-label trials completed for Postpartum Depression (PPD).
• Phase 2 open-label trials completed for Bipolar II Disorder (BD).
• Positive results from Phase 2a trials in PPD and Bipolar II indicate potential broad applications.

Psychiatrists and mental health specialists who treat severe depression.

This group represents the prescribers and gatekeepers for novel therapies like GH001. The overall Psychiatrists market size in 2024 was $195.22 billion, projected to grow to $215.02 billion in 2025 at a compound annual growth rate (CAGR) of 10.1%. North America was the largest region in this market in 2024. These specialists are the direct target for education on the ultra-rapid onset and durable effects demonstrated by GH001.

Healthcare payers and government agencies (future commercial segment).

This segment becomes critical upon potential commercialization, as payers determine formulary access and reimbursement rates. The company is preparing for its global pivotal program initiation in 2026, which directly precedes commercial launch discussions with payers. As of September 30, 2025, GH Research PLC held $293.9 million in cash, cash equivalents and marketable securities, supporting the R&D required to reach this commercial stage, while reporting a net loss of $14.0 million for the quarter ended September 30, 2025.

GH Research PLC (GHRS) - Canvas Business Model: Cost Structure

You're looking at the operational burn rate for GH Research PLC as of late 2025, which is heavily weighted toward advancing its clinical pipeline.

The most recent reported figures, covering the quarter ended September 30, 2025, give us a clear picture of where the cash is going right now. Honestly, for a company at this stage, the cost structure is almost entirely driven by R&D.

Cost Category	Q3 2025 Amount (Millions USD)	Comparative Context
Heavy Research and Development (R&D) Expenses	$10.6 million	Up from $8.4 million in Q3 2024
General and Administrative (G&A) Expenses	$6.0 million	Up from $4.2 million in Q3 2024
Net Loss for the Quarter	$14.0 million	Compared to $12.1 million in Q3 2024
Cash, Cash Equivalents, and Marketable Securities	$293.9 million	As of September 30, 2025

The R&D spend increase in Q3 2025 was primarily fueled by technical development activities and employee costs, though this was partly offset by a decrease in clinical development expenses for that specific quarter. The G&A rise reflects higher professional fees and employee expenses too.

Here's the quick math: R&D made up about 63.5% of the total operating expenses ($10.6M / ($10.6M + $6.0M)) for the quarter. That's where the focus defintely is.

The specific components driving these costs include:

• Clinical trial costs, including CRO fees and site payments.
• Employee expenses for scientific, technical, and professional staff.
• Regulatory and professional fees for IND submissions and legal work.

What this estimate hides is the exact split between CRO fees versus site payments within that clinical development bucket, as the search results only give the aggregate R&D number.

The cost drivers within the R&D spend for the quarter ended September 30, 2025, were:

• Increased expenses relating to technical development activities.
• Increased employee expenses.
• A decrease in clinical development expenses.

The G&A increase for the quarter ended September 30, 2025, was driven by:

• An increase in professional fees.
• An increase in employee expenses.

Finance: draft 13-week cash view by Friday.

GH Research PLC (GHRS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for GH Research PLC (GHRS) as of late 2025, and honestly, it's what you'd expect for a clinical-stage company deep in development. There's no product revenue right now; GH Research PLC is pre-commercial, focused entirely on getting its lead candidate, GH001, through the final stages of regulatory review and into pivotal trials. That means the current financial lifeblood comes from outside the lab-to-market pipeline.

The primary, most significant cash inflow you see is from equity financing. This is how GH Research PLC funds its operations while waiting for a marketable product. A major example of this was the underwritten public offering that closed in early 2025. This inflow was crucial for maintaining the large cash buffer needed for ongoing research and development expenses, which hit $10.6 million in the third quarter of 2025 alone. You need to track these capital raises closely.

Here's a quick look at that key financing event:

Financing Event Detail	Amount/Value
Offering Date (Pricing)	February 2025
Shares Offered	10,000,000 ordinary shares
Public Offering Price Per Share	$15.00
Total Gross Proceeds	Approximately $150.0 million
Underwriters Option (Max Additional)	Up to 1,500,000 ordinary shares

Next up, you have interest income. Since GH Research PLC is sitting on a substantial balance of unspent capital, the interest earned on those holdings is a reliable, albeit secondary, revenue component. This income is generated from their large holdings of cash, cash equivalents, and marketable securities, which are primarily investment-grade bonds and money market funds. It's not product revenue, but it helps offset the net losses, which were $14.0 million for the quarter ended September 30, 2025.

The cash position itself is the key metric here, showing the runway provided by past financing. As of September 30, 2025, the balance was $293.9 million. That's a significant increase from the $182.6 million reported at the end of 2024. You should definitely keep an eye on this burn rate versus the cash on hand.

• Cash, cash equivalents and marketable securities as of September 30, 2025: $293.9 million.
• Cash, cash equivalents and marketable securities as of June 30, 2025: $308.7 million.
• Cash, cash equivalents and marketable securities as of March 31, 2025: $315.3 million.

Looking forward, the potential revenue streams are entirely contingent on clinical and regulatory success. You should be watching for two main future possibilities. First, there are potential milestone payments that could come from any existing or future licensing or collaboration deals that GH Research PLC might strike for its pipeline assets, though no specific amounts are public right now. Second, and most important, is the eventual revenue from product sales, which is contingent on successful regulatory approval. GH Research PLC continues to work on its Investigational New Drug (IND) application response with the FDA, and the company expects to initiate its global pivotal program in 2026. That 2026 timeline sets the stage for any potential commercial revenue post-approval, which is definitely not expected before 2027.