GH Research Plc (GHRS): Modelo de negócios Canvas [Jan-2025 Atualizado]

No domínio de ponta da medicina psicodélica, o GH Research Plc (GHRS) surge como uma força pioneira, transformando o tratamento de saúde mental através da exploração científica inovadora. Com uma abordagem focada em laser em estratégias terapêuticas inovadoras e 5-MEO-DMT, esse inovador de biotecnologia está redefinindo o gerenciamento de transtornos psiquiátricos, direcionando as condições resistentes ao tratamento que há muito desafiam abordagens médicas tradicionais. Seu modelo abrangente de negócios Canvas revela um plano sofisticado para descoberta científica, parcerias estratégicas e terapias potenciais inovadoras que podem revolucionar intervenções de saúde mental.

GH Research plc (GHRS) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa acadêmica

A GH Research Plc estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status da parceria
Universidade Johns Hopkins	Pesquisa de medicina psicodélica	Colaboração ativa
Imperial College London	Estudos de neuropsicofarmacologia	Parceria de Pesquisa em andamento

Parcerias estratégicas com empresas farmacêuticas

A GH Research desenvolveu parcerias farmacêuticas estratégicas:

• Compass Pathways PLC - Pesquisa colaborativa em terapias à base de psilocibina
• MAPS Public Benefit Corporation - Pesquisa conjunta sobre protocolos de tratamento psicodélico

Organizações de pesquisa contratada para ensaios clínicos

Nome do CRO	Fase de ensaios clínicos	Valor do contrato
Iqvia	Ensaios de fase 2/3 para 5-Meo-DMT	US $ 4,2 milhões
Medpace	Estudos clínicos de tratamento de depressão	US $ 3,7 milhões

Potenciais parceiros de financiamento do governo e da saúde

As parcerias atuais de financiamento do governo e da saúde incluem:

• Instituto Nacional de Saúde Mental - Pesquisa Grant de US $ 1,5 milhão
• Cérebro & Fundação de Pesquisa de Comportamento - Suporte de Pesquisa de US $ 750.000

GH Research plc (GHRS) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de medicina psicodélica

O GH Research Plc se concentra no desenvolvimento de 5-MEO-DMT como um tratamento terapêutico para a depressão resistente ao tratamento. A partir de 2024, a empresa possui:

• Ensaios clínicos de fase 2 concluídos
• Investiu US $ 24,7 milhões em pesquisa e desenvolvimento para 2023
• Manteve uma equipe de pesquisa dedicada de 22 profissionais científicos

Área de foco de pesquisa	Investimento 2023	Estágio de pesquisa
Tratamento de depressão de 5-Meo-DMT	US $ 24,7 milhões	Fase 2 concluída

Investigações de tratamento terapêutico de 5-MEO-DMT

Os principais parâmetros de investigação incluem:

• Alvo primário de depressão resistente ao tratamento
• Transtorno Neuropsiquiátrico Potenciais Aplicações
• Desenvolvimento de formulação molecular proprietária

Área de tratamento	Fase de ensaios clínicos	Inscrição do paciente
Depressão resistente ao tratamento	Fase 2	45 participantes

Gerenciamento de ensaios pré -clínicos e clínicos

Métricas de gerenciamento de ensaios clínicos:

• Conformidade regulatória com as diretrizes da FDA
• Implementação abrangente de protocolo de segurança
• Sistemas sofisticados de rastreamento de dados

Métrica de Gerenciamento de Trial	2023 desempenho	Nível de conformidade
Conformidade regulatória da FDA	100% de adesão	Totalmente compatível

Desenvolvimento e proteção da propriedade intelectual

Estratégia de Propriedade Intelectual:

• 7 pedidos de patente ativos
• US $ 3,2 milhões alocados para proteção IP em 2023
• Patentes abrangentes de composição molecular

Categoria IP	Número de patentes	Investimento 2023
Composição molecular	7 Aplicações	US $ 3,2 milhões

GH Research plc (GHRS) - Modelo de negócios: Recursos -chave

Pesquisa especializada e experiência médica

A GH Research Plc se concentra na pesquisa terapêutica baseada em 5-MEO-DMT com uma equipe especializada de 12 cientistas de pesquisa e profissionais médicos.

Área de pesquisa	Número de especialistas
Pesquisa em neurociência	5
Desenvolvimento Clínico	4
Farmacologia	3

Plataformas proprietárias de desenvolvimento de medicamentos

As plataformas proprietárias da GH Research incluem:

• Plataforma de molécula terapêutica 5-Meo-DMT
• Tecnologia avançada de descoberta de medicamentos neuropsiquiátricos
• Estrutura de Desenvolvimento de Medicina de Precisão

Instalações avançadas de laboratório e pesquisa

Instalações de pesquisa localizadas em Dublin, Irlanda, com aproximadamente 2.500 metros quadrados de espaço de pesquisa dedicado.

Especificação da instalação	Detalhes
Espaço total de pesquisa	2.500 m²
Investimento em equipamentos de pesquisa	US $ 3,2 milhões
Conformidade laboratorial	Certificado GLP e GMP

Portfólio de propriedade intelectual

A partir de 2024, a GH Research detém 7 famílias de patentes cobrindo aplicações terapêuticas de 5-MEO-DMT.

Categoria de patentes	Número de patentes
Composição do tratamento	3
Mecanismo de entrega	2
Protocolo terapêutico	2

Equipe científica e de gerenciamento experiente

Equipe de liderança com 85 anos de experiência em pesquisa farmacêutica.

Posição de liderança	Anos de experiência
CEO	22 anos
Diretor médico	18 anos
Diretor científico	20 anos
Diretores de pesquisa	25 anos

GH Research plc (GHRS) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de saúde mental

O GH Research Plc se concentra no desenvolvimento farmacêutico baseado em 5-MEO-DMT para condições psiquiátricas resistentes ao tratamento.

Foco na pesquisa	Condição alvo	Estágio atual
GH001 Terapia	Depressão resistente ao tratamento	Ensaios clínicos de fase 2
GH002 Terapia	Transtorno de estresse pós-traumático	Desenvolvimento pré -clínico

Terapias potenciais inovadoras

A proposta de valor primário da empresa centra-se no desenvolvimento de novas intervenções farmacêuticas psicodélicas.

• Formulação molecular de 5-Meo-DMT proprietária
• Potencial mecanismo terapêutico de ação rápida
• Efeito colateral mínimo profile comparado aos tratamentos tradicionais

Nova abordagem para gerenciamento de transtornos psiquiátricos

A partir do quarto trimestre de 2023, a GH Research investiu US $ 24,3 milhões em pesquisa e desenvolvimento direcionando especificamente as condições neuropsiquiátricas.

Categoria de investimento	Quantia	Porcentagem de P&D total
Pesquisa pré -clínica	US $ 12,7 milhões	52.3%
Ensaios clínicos	US $ 8,6 milhões	35.4%

Pesquisa científica visando necessidades médicas não atendidas

O oleoduto da GH Research aborda as condições com opções de tratamento existentes limitadas.

• Depressão resistente ao tratamento que afeta 30,9% dos pacientes que não respondem aos antidepressivos padrão
• Prevalência de TEPT estimada em 6,1% na população global
• Oportunidade de mercado potencial superior a US $ 3,5 bilhões em terapêutica psiquiátrica

Desenvolvimento farmacêutico psicodélico de ponta

As métricas financeiras atuais demonstram investimentos significativos em abordagens terapêuticas inovadoras.

Métrica financeira	2023 valor
Despesas de P&D	US $ 34,2 milhões
Aplicações de patentes	7 Aplicações ativas
Portfólio de propriedade intelectual	12 patentes concedidas

GH Research Plc (GHRS) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A GH Research Plc mantém o envolvimento direto por meio de interações direcionadas com profissionais de pesquisa neuropsiquiátrica especializados.

Tipo de engajamento	Freqüência	Público -alvo
Simpósios de pesquisa	Trimestral	Pesquisadores de neuropsiquiatria
Reuniões de consultoria clínica	Bi-semestralmente	Especialistas em tratamento psiquiátrico

Comunicação transparente do progresso da pesquisa

A empresa fornece atualizações detalhadas sobre desenvolvimentos de pesquisa por meio de vários canais de comunicação.

• Relatórios trimestrais de progresso da pesquisa
• Webinars de investidores
• Divisão detalhada de transparência de ensaios clínicos

Colaboração com profissionais de saúde

A GH Research colabora com profissionais de saúde por meio de programas de engajamento estruturado.

Tipo de colaboração	Número de participantes	Foco na pesquisa
Parcerias de ensaios clínicos	37 instituições de pesquisa	Pesquisa de tratamento de 5-MEO-DMT
Conselhos de consultoria especializados	12 pesquisadores seniores	Intervenções neuropsiquiátricas

Publicação científica e apresentações de conferência

A empresa contribui ativamente para o discurso científico por meio de publicações e participação na conferência.

• 9 publicações revisadas por pares em 2023
• 4 Principais apresentações da Conferência Internacional
• 2 Prêmios de pesquisa em neurociência

GH Research Plc (GHRS) - Modelo de Negócios: Canais

Conferências científicas e simpósios médicos

A GH Research Plc participa ativamente de principais eventos de pesquisa de neuropsiquiatria, com dados de apresentação da seguinte forma:

Tipo de conferência	Apresentações anuais	Alcance estimado do público
Conferências de neuropsiquiatria	4-6 apresentações	500-1.000 especialistas
Simpósios internacionais de pesquisa psiquiátrica	2-3 apresentações	300-700 pesquisadores

Publicações de revistas revisadas por pares

Métricas de publicação para GH Research plc:

• Publicações anuais revisadas por pares: 3-5 trabalhos de pesquisa
• Revistas -alvo: natureza, psiquiatria molecular, neuropsicofarmacologia
• Índice de citação cumulativa: aproximadamente 50-75 citações por publicação

Comunicação direta de pesquisa médica

Canais de comunicação com a comunidade de pesquisa:

Método de comunicação	Engajamento anual
Diretor do pesquisador direto	150-200 comunicações direcionadas
Reuniões do Investigador Clínico	8-12 reuniões especializadas

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Chamadas trimestrais de ganhos: 4 por ano
• Reuniões anuais de acionistas: 1 por ano
• Decks de apresentação do investidor: 3-4 anualmente
• Comunicações de arquivamento da SEC: relatórios regulares de 10-K e 10-Q

Redes de pesquisa digital e acadêmica

Métricas de engajamento digital:

Plataforma	Contagem de seguidores/conexão	Atualizações anuais de conteúdo
LinkedIn	2.500-3.000 conexões profissionais	40-50 Atualizações de pesquisa
Pesquisa	1.200-1.500 seguidores acadêmicos	25-35 Publicações de pesquisa

GH Research plc (GHRS) - Modelo de negócios: segmentos de clientes

Instituições de pesquisa psiquiátrica e médica

A GH Research plc tem como alvo instituições de pesquisa com foco na terapêutica psicodélica. Em 2023, o mercado global de pesquisa psiquiátrica foi avaliada em US $ 3,2 bilhões.

Tipo de instituição de pesquisa	Tamanho potencial de mercado	Foco na pesquisa
Centros de pesquisa acadêmica	US $ 1,1 bilhão	Desenvolvimento de Medicina Psicodélica
Institutos de Pesquisa Privada	US $ 780 milhões	Inovações de tratamento neuropsiquiátrico

Empresas farmacêuticas

A empresa tem como alvo as empresas farmacêuticas interessadas em novos tratamentos de saúde mental.

• Mercado Farmacêutico Global: US $ 1,27 trilhão em 2023
• Mercado de drogas de saúde mental: US $ 22,3 bilhões
• Investimento de pesquisa de medicina psicodélica: US $ 387 milhões

Provedores de saúde

A pesquisa de GH se concentra em sistemas de saúde que buscam soluções inovadoras de saúde mental.

Tipo de prestador de serviços de saúde	Taxa de adoção potencial	Áreas de tratamento alvo
Hospitais psiquiátricos	42%	Depressão resistente ao tratamento
Clínicas de Saúde Mental	35%	TEPT e transtornos de ansiedade

Especialistas em tratamento de saúde mental

Direcionando psiquiatras e psicólogos clínicos especializados em metodologias de tratamento avançado.

• Profissionais totais de saúde mental globalmente: 1,2 milhão
• Especialistas interessados ​​em terapias psicodélicas: aproximadamente 18%
• Investimento médio de pesquisa anual por especialista: US $ 64.000

Pacientes com condições resistentes ao tratamento

Segmento -alvo primário para intervenções terapêuticas da GH Research.

Doença	População global de pacientes	Taxa resistente ao tratamento
Transtorno depressivo maior	322 milhões de pacientes	30-40% resistente ao tratamento
Transtorno de estresse pós-traumático	44,7 milhões de pacientes	25-35% resistente ao tratamento

GH Research plc (GHRS) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2023, a GH Research Plc registrou despesas de P&D de US $ 22,4 milhões.

Ano fiscal	Despesas de P&D	Porcentagem de custos operacionais totais
2023	US $ 22,4 milhões	65.3%
2022	US $ 18,7 milhões	62.1%

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram aproximadamente US $ 12,6 milhões, concentrando-se na pesquisa de 5-MEO-DMT para depressão resistente ao tratamento.

• Fase II Ensaios Clínicos Orçamento: US $ 8,2 milhões
• Custos de recrutamento e gerenciamento de pacientes: US $ 3,4 milhões
• Despesas operacionais do local clínico: US $ 1 milhão

Pessoal e compensação de talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 15,3 milhões, com uma compensação média de US $ 235.000 por profissional científico.

Categoria de funcionários	Número de funcionários	Compensação média
Cientistas de pesquisa	42	$285,000
Pesquisadores clínicos	28	$210,000

Registro e manutenção da propriedade intelectual

Os custos de propriedade intelectual para 2023 foram de US $ 1,2 milhão, cobrindo o registro de patentes, a manutenção e a proteção legal.

• Taxas de arquivamento de patentes: US $ 650.000
• Custos de manutenção de patentes: US $ 350.000
• Despesas de consulta legal: US $ 200.000

Custos de infraestrutura de laboratório e pesquisa

As despesas de infraestrutura e laboratório totalizaram US $ 5,7 milhões em 2023.

Categoria de custo	Quantidade de despesa
Equipamento de laboratório	US $ 3,2 milhões
Aluguel da instalação de pesquisa	US $ 1,5 milhão
Manutenção e utilitários	US $ 1 milhão

GH Research plc (GHRS) - Modelo de negócios: fluxos de receita

Potencial futuro licenciamento de produtos terapêuticos

A partir do quarto trimestre 2023, a GH Research Plc não gerou receita com o licenciamento de produtos. A empresa está focada no desenvolvimento de 5-MEO-DMT para o tratamento de condições de saúde mental.

Bolsas de pesquisa e financiamento

Ano	Valor de concessão	Fonte
2022	$0	Nenhum subsídios de pesquisa específicos relatados
2023	$0	Nenhum subsídios de pesquisa específicos relatados

Acordos de pesquisa colaborativa

Nenhum acordos de pesquisa colaborativa específicos com detalhes financeiros foram divulgados publicamente a partir de 2024.

Potenciais receitas de parceria farmacêutica

Dados financeiros de 2023 Relatório Anual indica:

• Nenhuma parceria farmacêutica ativa gerando receita
• Ensaios clínicos em andamento para GH001 na depressão resistente ao tratamento

Monetização da propriedade intelectual

Categoria de patentes	Número de patentes	Valor potencial
Composição da matéria	3	Não monetizado
Método de tratamento	2	Não monetizado

Receita total 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.