Compass Pathways PLC (CMPs): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução do tratamento da saúde mental, o Compass Pathways PLC (CMPS) surge como um pioneiro inovador, reimaginando as abordagens terapêuticas por meio de seus inovadores protocolos de tratamento psicodélico. Ao aproveitar o potencial transformador da terapia com psilocibina, essa empresa visionária está desafiando os paradigmas tradicionais de saúde mental, oferecendo esperança a pacientes que lutam contra a depressão resistente ao tratamento e empurrando os limites da pesquisa médica. Seu modelo abrangente de negócios Canvas revela um plano estratégico que combina exploração científica de ponta, pesquisa colaborativa e uma abordagem centrada no paciente para revolucionar intervenções de saúde mental.

Compass Pathways plc (CMPs) - Modelo de negócios: parcerias -chave

Colaborações estratégicas com instituições de pesquisa em saúde mental

A Compass Pathways estabeleceu as principais parcerias com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Imperial College London	Pesquisa de terapia com psilocibina	2019
Johns Hopkins Center for Psychedelic Research	Estudos de depressão e saúde mental	2020
Universidade da Califórnia, São Francisco	Pesquisa neuropsiquiátrica	2021

Parcerias com empresas farmacêuticas para ensaios clínicos

A Compass Pathways colabora com empresas farmacêuticas para apoio aos ensaios clínicos:

• Parexel International Corporation - Gerenciamento de ensaios clínicos
• ICON PLC - Suporte da Organização de Pesquisa Clínica
• Medpace Holdings, Inc. - Coordenação de ensaios clínicos

Centros Médicos Acadêmicos de Pesquisa de Terapia com Psilocibina

Centro Médico	Foco na pesquisa	Fase de teste atual
Escola de Medicina da Universidade de Yale	Depressão resistente ao tratamento	Fase 2b
Centro Médico da Universidade de Stanford	Protocolos de terapia de psilocibina	Fase 2
Hospital Mount Sinai	Aplicações neuropsiquiátricas	Fase 2

Colaboração de órgãos regulatórios

Os caminhos da bússola se envolvem com as agências reguladoras para o desenvolvimento de medicamentos:

• Administração de Alimentos e Medicamentos dos EUA (FDA) - Processo de aprovação da terapia com psilocibina Comp360
• Agência Europeia de Medicamentos (EMA) - Conformidade regulatória de ensaios clínicos
• Agência regulatória de produtos de medicamentos e produtos de saúde (MHRA) no Reino Unido

Provedores de tratamento de saúde mental e médicos

Rede de provedores	Tipo de colaboração	Número de médicos participantes
Rede de cuidados de bússola	Desenvolvimento do protocolo de tratamento	127 médicos registrados
Associação Internacional de Profissionais de Saúde Mental	Colaboração de pesquisa	86 membros institucionais

Compass Pathways plc (CMPs) - Modelo de negócios: atividades -chave

Desenvolvendo terapias de saúde mental assistidas por psicodélico

As vias de bússola se concentram no desenvolvimento da terapia de psilocibina Comp360 para a depressão resistente ao tratamento (TRD). A partir do quarto trimestre 2023, a empresa possui:

• Ensaio clínico de fase 2B concluído com 233 pacientes
• Resultados estatisticamente significativos alcançados no tratamento da psilocibina
• Investiu US $ 62,4 milhões em pesquisa e desenvolvimento em 2022

Realização de ensaios clínicos para tratamento de psilocibina

Fase de ensaios clínicos	Contagem de pacientes	Investimento
Fase 2b TRD Trial	233 pacientes	US $ 15,3 milhões
Preparação de fase 3 em andamento	Estimado 400-500 pacientes	Projetado US $ 25 a 30 milhões

Pesquisando protocolos inovadores de intervenção em saúde mental

As prioridades de pesquisa da Compass Pathways incluem:

• Protocolos de tratamento de saúde mental
• Mecanismos de neuroplasticidade
• Aplicações terapêuticas de psilocibina

Conformidade regulatória e desenvolvimento de medicamentos

Os marcos regulatórios e as atividades de conformidade incluem:

• Designação de terapia sobre o FDA para Comp360
• Engajamento com órgãos regulatórios da EMA e FDA
• Conformidade com os padrões de fabricação de GMP

Avançar o entendimento científico da medicina psicodélica

Área de pesquisa	Parceiros colaborativos	Orçamento de pesquisa anual
Neurociência psicodélica	6 instituições de pesquisa acadêmica	US $ 8,7 milhões
Redes de pesquisa clínica	12 centros de pesquisa internacionais	US $ 5,2 milhões

Compass Pathways plc (CMPs) - Modelo de negócios: Recursos -chave

Protocolo de terapia com psilocibina comprayeary Comp360

Os caminhos da bússola se mantêm 1 patente primária para terapia com comp360 psilocibina, com 14 pedidos de patente adicionais em várias jurisdições globalmente.

Pesquisa avançada e instalações de teste clínico

Tipo de instalação	Quantidade	Propagação geográfica
Sites de pesquisa clínica	21	Reino Unido, Estados Unidos, Canadá, Holanda
Ensaios clínicos ativos	7	Foco primário de depressão resistente ao tratamento

Propriedade intelectual e portfólio de patentes

• Total de patentes: 15
• Jurisdições de patentes: Estados Unidos, União Europeia, Reino Unido
• Duração da proteção de patentes: até 2040

Equipe especializada de pesquisa científica e médica

Composição da equipe	Número
Pessoal de pesquisa total	48
Titulares de doutorado	32
Médicos médicos	16

Capital de risco significativo e financiamento de pesquisa

Total de financiamento levantado: US $ 116,5 milhões em dezembro de 2023

Fonte de financiamento	Quantia	Ano
Capital de risco	US $ 89,3 milhões	2021-2023
Bolsas de pesquisa	US $ 27,2 milhões	2020-2023

Compass Pathways plc (CMPs) - Modelo de negócios: proposições de valor

Abordagem terapêutica inovadora para depressão resistente ao tratamento

As vias de bússola se concentram na terapia de psilocibina Comp360, direcionando pacientes com depressão resistente ao tratamento (TRD). Os dados de ensaios clínicos do estudo de fase IIB mostram:

Métrica	Valor
Inscrição do paciente	233 pacientes
Taxa de resposta	37,0% na dose de 3 mg
Taxa de remissão	29,0% na dose de 25 mg

Potencial avanço nos paradigmas de tratamento de saúde mental

Diferestadores -chave do modelo terapêutico da Compass:

• Formulação de psilocibina sintética proprietária
• Protocolo de apoio psicológico padronizado
• Metodologia avançada de triagem de pacientes

Terapia personalizada e direcionada de assistência psicodélica

Investimento de desenvolvimento de terapia com comp360:

Ano	Despesas de P&D
2022	US $ 74,4 milhões
2023	US $ 89,2 milhões

Alternativa cientificamente validada aos tratamentos tradicionais

Destaques de pesquisa clínica:

• Publicado estudos revisados ​​por pares: 7 Publicações de pesquisa
• Múltiplos ensaios clínicos em andamento em diferentes condições de saúde mental
• Interações regulatórias com FDA e EMA

Atender às necessidades não atendidas de tratamento de saúde mental

Avaliação de Oportunidades de Mercado:

Segmento de depressão	Tamanho do mercado global
Depressão resistente ao tratamento	US $ 5,8 bilhões até 2026
Necessidade estimada do paciente não atendido	30-40% dos pacientes atuais de depressão

Compass Pathways plc (CMPs) - Modelo de negócios: relacionamentos com o cliente

Engajamento de pesquisa colaborativa com profissionais médicos

A Compass Pathways mantém parcerias de pesquisa com 28 locais clínicos na Europa e na América do Norte para ensaios de terapia de psilocibina.

Métricas de colaboração de pesquisa	2023 dados
Número de locais de pesquisa clínica	28
Países envolvidos	7
Total de pesquisadores envolvidos	186

Abordagem de desenvolvimento da terapia centrada no paciente

As vias de bússola se concentram na população de pacientes de depressão resistente ao tratamento (TRD).

• Demografia de paciente alvo: adultos com TRD
• Faixa etária: 18-65 anos
• Resistência ao tratamento anterior: mínimo 2 falhas antidepressivas

Comunicação transparente sobre protocolos de tratamento

Canal de comunicação	Frequência de engajamento
Atualizações de ensaios clínicos	Trimestral
Lançamentos de publicação científica	Bi-semestralmente
Apresentações de investidores/partes interessadas	4-6 vezes anualmente

Suporte clínico em andamento

As vias da bússola implementa protocolos estruturados de monitoramento de pacientes.

• Avaliações de triagem inicial
• Rastreamento pós-tratamento de 12 meses
• Ferramentas de avaliação de saúde mental padronizadas

Extensão educacional sobre terapia psicodélica

A Compass Pathways conduz iniciativas educacionais direcionadas para profissionais de saúde.

Engajamento educacional	2023 Estatísticas
Apresentações da conferência médica	12
Webinars profissionais	8
Publicações revisadas por pares	6

Compass Pathways plc (CMPs) - Modelo de negócios: canais

Engajamento direto com instituições de pesquisa médica

A Compass Pathways colabora com 22 locais de pesquisa na Europa e na América do Norte para ensaios clínicos.

Tipo de instituição de pesquisa	Número de parcerias
Centros Médicos Acadêmicos	12
Instalações de pesquisa psiquiátrica	7
Instituições de Pesquisa Privada	3

Apresentações da conferência científica

Os caminhos da bússola foram apresentados em 8 principais conferências de saúde mental em 2023.

• Reunião Anual da Associação Psiquiátrica Americana
• Congresso da Faculdade Europeia de Neuropsofarmacologia
• Congresso Internacional da Associação Psiquiátrica Mundial

Publicações de revistas médicas revisadas por pares

Em 2023, a Compass publicou 6 artigos de pesquisa revisados ​​por pares.

Categoria de diário	Número de publicações
Revistas de psiquiatria	4
Revistas de neurociência	2

Plataformas de recrutamento de ensaios clínicos

A Compass utiliza 3 plataformas primárias de recrutamento digital.

• ClinicalTrials.gov
• Pesquisa
• Registro de pacientes com bússola interna

Redes de comunicação em saúde digital

A Compass mantém canais de comunicação digital com 15.000 participantes potenciais de ensaios clínicos.

Canal digital	Número de conexões
Assinantes de newsletter por e -mail	8,500
Seguidores de mídia social	6,500

Compass Pathways plc (CMPs) - Modelo de negócios: segmentos de clientes

Pacientes de depressão resistentes ao tratamento

As vias da bússola têm como alvo pacientes com depressão resistente ao tratamento (TRD) que não responderam aos tratamentos antidepressivos tradicionais.

Métricas de segmento de pacientes	Dados estatísticos
População global de pacientes com TRD	100 milhões de indivíduos em todo o mundo
Porcentagem não respondendo a tratamentos padrão	30-40% dos pacientes com depressão
Custos de saúde anuais para TRD	US $ 84 bilhões globalmente

Profissionais de saúde mental

O Compass Pathways se concentra em psiquiatras, psicólogos e profissionais clínicos especializados em tratamento de saúde mental.

• Aproximadamente 414.000 psiquiatras globalmente
• Mais de 700.000 psicólogos na prática clínica
• Mercado -alvo de especialistas interessados ​​em tratamentos inovadores de depressão

Instituições de pesquisa acadêmica

A Compass colabora com os principais centros de pesquisa acadêmica que investigam terapias assistidas por psicodélico.

Categoria de instituição de pesquisa	Número de potenciais colaboradores
Universidades de pesquisa em saúde mental de primeira linha	50-75 instituições em todo o mundo
Centros de ensaios clínicos ativos	28 locais de pesquisa em ensaios de psilocibina Compass

Empresas farmacêuticas

A Compass tem como alvo as empresas farmacêuticas interessadas em abordagens inovadoras de tratamento de saúde mental.

• Valor de mercado farmacêutico global: US $ 1,3 trilhão
• Mercado de drogas de saúde mental: US $ 82,4 bilhões anualmente
• Oportunidades de parceria em potencial com grandes empresas farmacêuticas

Sistemas e prestadores de serviços de saúde

A Compass visa envolver os sistemas de saúde que buscam metodologias alternativas de tratamento de depressão.

Segmento do sistema de saúde	Alcance potencial do mercado
Sistemas Nacionais de Saúde	Mais de 40 países explorando tratamentos alternativos de saúde mental
Redes privadas de saúde	Mais de 5.000 organizações potenciais de prestadores de serviços de saúde
Centros de tratamento de saúde mental	2.300 instalações especializadas globalmente

Compass Pathways plc (CMPs) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa clínica e desenvolvimento

A Compass Pathways investiu US $ 49,4 milhões em despesas de pesquisa e desenvolvimento para o ano fiscal de 2022. O foco principal da empresa permanece na terapia de psilocibina Comp360 para a depressão resistente ao tratamento.

Ano	Despesas de P&D	Porcentagem de despesas totais
2021	US $ 39,7 milhões	68.5%
2022	US $ 49,4 milhões	72.3%

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatórios para os caminhos da bússola incluem:

• Taxas de interação e consulta da FDA
• Despesas de documentação do ensaio clínico
• Custos de preparação de submissão regulatória

Infraestrutura de pesquisa médica avançada

Redução de investimentos em infraestrutura para 2022:

Componente de infraestrutura	Custo anual
Equipamento de laboratório	US $ 3,2 milhões
Manutenção da instalação de pesquisa	US $ 1,8 milhão
Sistemas de tecnologia	US $ 2,5 milhões

Gerenciamento de propriedade intelectual

As despesas de propriedade intelectual de 2022 totalizaram aproximadamente US $ 1,5 milhão, cobrindo o arquivamento, manutenção e proteção legal das inovações de pesquisa.

Aquisição e retenção de talentos

Investimento de capital humano para 2022:

• Compensação total dos funcionários: US $ 22,3 milhões
• Salário médio para cientistas de pesquisa: US $ 145.000
• Compensação baseada em ações dos funcionários: US $ 8,6 milhões

Estrutura total de custo operacional para 2022: US $ 76,9 milhões

Compass Pathways plc (CMPs) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos farmacêuticos

A partir do quarto trimestre de 2023, a Compass Pathways registrou receita total de US $ 4,1 milhões, principalmente de atividades de pesquisa e desenvolvimento.

Candidato a produto	Mercado potencial	Potencial estimado de receita
Terapia com psilocibina comp360	Depressão resistente ao tratamento	US $ 500 milhões - US $ 1 bilhão
Terapia assistida psicodélica	Tratamentos de saúde mental	Mercado projetado de US $ 750 milhões

Bolsas de pesquisa e financiamento

Em 2023, os caminhos da Compass garantiram aproximadamente US $ 14,5 milhões em financiamento e subsídios de pesquisa.

• Institutos Nacionais de Saúde (NIH) Apoio à pesquisa
• Subsídios de fundação privada
• Financiamento de colaboração de pesquisa acadêmica

Propriedade intelectual de licenciamento

A Compass Pathways possui 25 famílias de patentes cobrindo vários aspectos das tecnologias terapêuticas psicodélicas.

Categoria de patentes	Número de patentes	Potencial receita de licenciamento
Composição da psilocibina	8 patentes	US $ 2-5 milhões anualmente
Protocolos terapêuticos	12 patentes	US $ 3-7 milhões anualmente

Parcerias de pesquisa colaborativa

As parcerias de pesquisa atuais avaliadas em aproximadamente US $ 18,3 milhões em 2023.

• Colaborações do Centro Médico Acadêmico
• Parcerias de pesquisa farmacêutica
• Instituições de pesquisa em saúde mental

Futuros royalties de tratamento terapêutico

Potencial de royalties projetados para terapia com comp360 psilocibina estimada em US $ 50-100 milhões anualmente após a comercialização bem-sucedida.

Área terapêutica	Porcentagem de royalties	Royalty anual estimada
Depressão resistente ao tratamento	5-8%	US $ 25-50 milhões
Outras aplicações de saúde mental	3-5%	US $ 25-50 milhões

COMPASS Pathways plc (CMPS) - Canvas Business Model: Value Propositions

You're looking at the core offering from COMPASS Pathways plc, which centers on delivering a novel, rapid-acting treatment for Treatment-Resistant Depression (TRD) using their investigational COMP360 synthesized psilocybin in conjunction with psychological support. This approach has gained significant regulatory traction, evidenced by the Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and the Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. The speed of effect is a key value driver; for instance, in the Phase 3 COMP005 trial, the clinical effect was observed as early as the day after administration.

The potential for a durable response from a single administration is a major differentiator from daily-dosed antidepressants. Data from an observational follow-up study on a single 25mg administration of COMP360 showed a median time to a depressive event of 92 days (n=252). Furthermore, for the subgroup that continued into the COMP004 long-term extension, this median time extended to 189 days (n=58). This contrasts with the primary endpoint data from the COMP005 Phase 3 trial, which demonstrated a highly statistically significant reduction in symptom severity at six weeks (mean difference of -3.6 points on the MADRS scale versus placebo; p<0.001).

Here's a quick look at the key efficacy and durability metrics we're seeing from COMPASS Pathways plc's data:

Metric	Value/Finding	Context/Timepoint
MADRS Reduction (25mg vs Placebo)	-3.6 points mean difference	6 weeks (Primary Endpoint COMP005)
Onset of Action	Day after administration	Observed in prior studies
Median Time to Depressive Event	92 days	Single 25mg administration (n=252)
Median Time to Depressive Event (Extension)	189 days	25mg subgroup in COMP004 extension (n=58)

This innovation directly addresses a significant unmet need for patients failed by existing antidepressants. TRD is generally defined as an inadequate response to two or more appropriate courses of approved medications. To put the scale in perspective, of the estimated 300 million people globally with Major Depressive Disorder (MDD), approximately one-third are estimated to develop TRD, representing a target population of around 100 million patients worldwide.

The value proposition is further cemented by an integrated care model combining the drug with specialized psychological support, which is critical for psychedelic-assisted therapy. COMPASS Pathways plc is actively exploring real-world implementation through collaborations, such as the one established with HealthPort to inform delivery in underserved communities, focusing on social determinants of health. From a financial standpoint, as of September 30, 2025, the company reported a cash position of $185.9 million, with an expected full-year 2025 net cash used in operating activities in the range of $120 million to $145 million. What this estimate hides is the variability from non-cash adjustments; for the third quarter of 2025, the net loss was $137.7 million, largely driven by a $101.3 million non-cash loss on warrant liabilities. Still, the current cash position is projected to be sufficient to fund operating expenses into 2027.

• Novel treatment for TRD with Breakthrough Therapy designation (US FDA).
• Single administration showing a mean MADRS difference of -3.6 points at 6 weeks (p<0.001).
• Durability potential: Median time to depressive event of 92 days from a single 25mg dose.
• Addresses a market where approximately one-third of MDD patients fail existing treatments.
• Integrated care model being tested via collaborations like the one with HealthPort.
• Cash position of $185.9 million as of September 30, 2025, funding runway into 2027.

COMPASS Pathways plc (CMPS) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so the relationship with the gatekeepers-the providers and regulators-is everything right now. Here's the quick math on how COMPASS Pathways plc is managing those critical connections as of late 2025.

High-touch, specialized engagement with certified treatment providers.

The relationship here is about building the delivery infrastructure before the product is even approved. COMPASS Pathways plc is actively establishing agreements with representative healthcare delivery centers to research scalable commercial rollout models for COMP360, assuming regulatory approval. These collaborations are key to understanding implementation challenges within different systems.

• Strategic collaboration established with HealthPort in April 2025 to inform potential delivery in underserved communities.
• Prior collaboration agreements include Hackensack Meridian Health and Greenbrook TMS (acquired by Neuronetics, Inc. in December 2024).
• The focus is on researching models for scalable, commercial COMP360 treatment delivery within various healthcare settings.

Direct communication with regulatory bodies like the FDA for rolling NDA submission.

Direct, data-driven dialogue with the U.S. Food and Drug Administration (FDA) is paramount for accelerating patient access. The company is moving aggressively on this front following positive trial results.

Regulatory Milestone/Event	Date/Timing	Trial Data Context
Positive Type B meeting with FDA	September 2025	Discussed NDA submission strategy for COMP360 in TRD, including potential rolling submission.
COMP005 6-week primary endpoint achieved	June 2025	First of two Phase 3 studies showing statistically significant improvement.
COMP006 Enrollment Completion	Prior to Q3 2025	Second Phase 3 trial completed enrollment ($\text{n}=585$).
Planned Data Disclosure (COMP006 Part A + COMP005 Part B)	Q1 2026	9-week data from COMP006 alongside 26-week data from COMP005.
Anticipated Final Gating Data (COMP006 Part B)	Early Q3 2026	26-week data from the second pivotal trial.
Targeted NDA Submission	Following Early Q3 2026 Data	Accelerated launch timing by 9-12 months projected.

Building trust through patient advocacy and rigorous, evidence-based research.

Trust is built on delivering on clinical promises. The company has successfully navigated two late-stage studies, which de-risks the program significantly for advocates and future prescribers.

• The COMP005 Phase 3 trial demonstrated a highly statistically significant result for the primary endpoint at 6 weeks.
• The COMP006 Phase 3 trial has 585 enrolled participants.
• The Phase 2b study showed a statistically significant ($\text{p}<0.001$) improvement after three weeks for patients receiving a single 25mg dose of COMP360 with psychological support.

Investor relations to secure ongoing financing for R&D.

Keeping the lights on and the trials funded requires constant, transparent communication with the capital markets. The company is managing its cash burn effectively to maintain its runway.

Financial Metric	Amount/Range	Date/Period
Cash and Cash Equivalents	\$185.9 million	September 30, 2025
Cash and Cash Equivalents	\$260.1 million	March 31, 2025
Gross Cash Proceeds Raised	\$150 million	January 2025
Expected Net Cash Used in Operating Activities	\$120 million to \$145 million	Full Year 2025 Guidance
Cash Runway Expectation	Sufficient into 2027	As of Q3 2025
Debt	\$31.3 million	September 30, 2025

The company is actively participating in investor conferences, such as those in December 2025, to keep the narrative current. They are defintely focused on demonstrating financial discipline to support the R&D pipeline.

Finance: draft 13-week cash view by Friday.

COMPASS Pathways plc (CMPS) - Canvas Business Model: Channels

The channels for COMPASS Pathways plc are currently split between the ongoing clinical development phase and the accelerated commercial readiness efforts for COMP360 in Treatment-Resistant Depression (TRD).

Global network of clinical trial sites for current drug development.

The current channel for data generation involves a global network of clinical trial sites. The pivotal Phase 3 program for TRD is the largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program ever conducted.

• Enrollment for the second Phase 3 trial, COMP006, has been completed with n=585 participants.
• The Phase 2 study for Post-Traumatic Stress Disorder (PTSD) involved n=22 participants in an open-label safety and tolerability study.
• The company is finalizing the design for a late-stage PTSD trial, with the first patients anticipated in Q1 2026.

Future network of certified treatment centers and clinics.

With commercial launch plans accelerated by 9-12 months, COMPASS Pathways plc is actively preparing the infrastructure for post-approval distribution. The strategy involves leveraging existing infrastructure where possible.

• Sites currently capable of administering SPRAVATO are expected to be able to deliver COMP360, as the physical infrastructure, staffing, and capabilities are largely transferable.
• A strategic collaboration with HealthPort, a multi-site comprehensive community health organization, is in place to inform the potential delivery of COMP360 in underserved communities, if FDA approved.

Direct-to-provider sales force for post-approval distribution.

Commercial preparation activities, including sales force structuring, are being pulled forward by several months. While specific sales force size post-approval isn't detailed, the overall company size provides context for the current operational scale.

• COMPASS Pathways plc had a total of 166 employees as of October 30, 2025.
• Commercial efforts are intensifying with a focus on targeting high-potential prescribers.

Scientific publications and medical conferences to reach prescribers.

Reaching prescribers and key opinion leaders is being executed through data dissemination at scientific forums and investor events.

• The Phase 2 PTSD study findings were published in the September 2025 issue of Journal of Psychopharmacology.
• Management participated in the Stifel 2025 Healthcare Conference on November 11, 2025.
• Management is scheduled to participate in Two Investor Conferences in December.

Here's a quick look at some channel-relevant operational and financial data as of late 2025:

Metric Category	Detail	Value/Date/Status
Clinical Trial Status (COMP006)	Enrollment Completion	Completed
Data Readout (COMP006 Part A)	Expected Timing	Q1 2026
Commercial Timeline	Acceleration	9-12 months
Financial Buffer	Cash Position (as of Sep 30, 2025)	$185.9 million
Financial Guidance (FY 2025)	Net Cash Used in Operating Activities	Expected range of $120 million to $145 million
Efficacy Data Point (COMP005)	6-Week Primary Endpoint MADRS Reduction	Mean difference of -3.6 (p<0.001)

COMPASS Pathways plc (CMPS) - Canvas Business Model: Customer Segments

You're looking at the core groups COMPASS Pathways plc targets as they push COMP360 toward commercialization. This isn't about future potential; this is about the patient populations and providers already engaged in their late-stage development and the financial entities that will ultimately cover the treatment.

Patients with Treatment-Resistant Depression (TRD)

The primary segment is patients with TRD, generally defined as those who haven't adequately responded to at least two or more appropriate courses of approved medications. Honestly, this represents a huge unmet need, as approximately one-third of patients with Major Depressive Disorder (MDD) fall into this category.

The clinical evidence base is built on these patients:

Trial Segment	Patient Count (n=)	Key Data Point
COMP005 Phase 3 (TRD)	258 participants dosed	Achieved 6-week primary endpoint with a mean difference of -3.6 (p<0.001) vs. placebo
COMP006 Phase 3 (TRD)	585 participants enrolled (as of late 2025)	Second pivotal trial, 26-week data expected in early Q3 2026

The company is accelerating commercial launch plans by 9-12 months based on these positive results in the TRD population.

Psychiatrists and specialized mental health clinicians

These are the professionals who administer the therapy and will be the gatekeepers for patient access post-approval. They are currently engaged through the clinical trial network and will be the target for specialized training programs.

• The COMP005 trial engaged clinical sites across 32 sites in the United States.
• The FDA granted Breakthrough Therapy Designation for COMP360 in TRD, signaling a high level of interest from regulators in novel treatment pathways for these specialists to adopt.

Training and establishing the necessary infrastructure within these clinics are key to the commercial strategy.

Healthcare systems and payers seeking innovative, cost-effective mental health solutions

This segment includes insurance providers and national health bodies that will determine reimbursement and formulary placement. Their focus is on the long-term economic impact of a treatment that offers rapid and durable responses.

From a financial stability perspective, which underpins future pricing and payer negotiations, COMPASS Pathways plc reported:

• Cash position of $185.9 million as of September 30, 2025.
• Expected full year 2025 net cash used in operating activities in the range of $120 million to $145 million.
• The current cash position is projected to fund operating expenses into 2027.

The successful completion of Phase 3 trials is the direct trigger for engaging these payers on value-based agreements.

Patients in earlier-stage trials for PTSD and anorexia nervosa

While TRD is the immediate focus, the pipeline extends to other serious mental health conditions. The company is actively designing a late-stage development program for Post-Traumatic Stress Disorder (PTSD) based on prior positive Phase 2a results.

The commitment to this segment is reflected in the ongoing R&D spend, with Research and development expenses at $27.3 million for the three months ended September 30, 2025.

COMPASS Pathways plc (CMPS) - Canvas Business Model: Cost Structure

You're looking at the core cash drains for COMPASS Pathways plc as they push their lead asset through late-stage trials and into commercial readiness. For a clinical-stage biotech, the cost structure is heavily weighted toward R&D, which is exactly what the numbers show.

High Research and Development (R&D) expenses are the biggest driver here, totaling $88.5 million for the nine months ended September 30, 2025. This figure reflects the significant investment needed to advance their COMP360 synthetic psilocybin treatment through pivotal Phase 3 clinical trials.

Here's a quick breakdown of the major operating cost components we see in the latest reporting periods:

Cost Category	Period Ended September 30, 2025 (3 Months)	Period Ended September 30, 2025 (9 Months)
Research and Development (R&D) Expenses	$27.3 million	$88.5 million
General and Administrative (G&A) Expenses	$13.2 million	Data not explicitly provided for 9 months, but Q3 is $13.2 million

Clinical trial costs, which are embedded within that R&D spend, cover everything from drug manufacturing for the trials to site management across the COMP005 and COMP006 studies. The increase in R&D year-over-year for the nine months was primarily due to development expenses associated with advancing those late-stage COMP360 phase 3 clinical trials.

General and administrative (G&A) costs for COMPASS Pathways plc, typical for a publicly traded biotech managing regulatory filings and investor relations, saw some fluctuation following a reorganization in late 2024. For the three months ended September 30, 2025, G&A expenses were reported at $13.2 million, down from $15.0 million in the same period of 2024. This decrease was largely due to lower personnel and facility expenses.

Looking at the overall cash burn, the company has provided guidance for the full year 2025 net cash used in operating activities expected to be in the range of $120 million to $145 million. This range includes the timing uncertainty related to the UK R&D tax credit, which is a factor to watch.

To give you a clearer picture of the quarterly G&A trend leading up to the September figure, consider these recent points:

• Three months ended March 31, 2025 G&A: $18.7 million
• Three months ended June 30, 2025 G&A: $12.6 million
• Three months ended September 30, 2025 G&A: $13.2 million

Finance: draft 13-week cash view by Friday.

COMPASS Pathways plc (CMPS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for COMPASS Pathways plc as of late 2025, and honestly, it's what you'd expect for a company deep in late-stage clinical trials. The core commercial product revenue stream is still theoretical.

• - $0 in commercial product revenue, as the company is pre-commercial.

The actual cash inflows right now come from non-sales activities, primarily from the capital markets and the bank account balances they maintain. Interest income is a direct result of holding significant cash and cash equivalents from prior financing rounds. Here's how that interest income stacked up through the first three quarters of 2025, based on their reported figures (in thousands of US dollars):

Period Ended	Interest Income (USD '000s)
Three Months Ended June 30, 2025	1,898
Six Months Ended June 30, 2025	4,284
Three Months Ended September 30, 2025	1,588
Nine Months Ended September 30, 2025	5,872

That interest income for the nine months ended September 30, 2025, was $5,872 thousand. To give you a sense of scale, that's up from $2,357 thousand for the same nine-month period in 2024. It's not the main event, but it helps offset burn a little.

The biggest non-operating cash inflow event in 2025 was the equity financing that closed around January 2025. This is crucial because it funds the ongoing Phase 3 trials. Here are the hard numbers from that January 2025 offering announcement:

• - Gross proceeds from the offering were expected to be approximately $150 million before deducting underwriting discounts and commissions and other estimated offering expenses.
• - The company could potentially receive up to approximately $353 million in additional gross proceeds if the accompanying ADS Warrants are fully exercised for cash.

You can see the impact of that financing on their balance sheet. Cash and cash equivalents stood at $260.1 million as of March 31, 2025, and then settled at $221.9 million as of June 30, 2025, before dropping further to $185.9 million as of September 30, 2025. That cash position is expected to fund operating expenses and capital expenditure requirements into 2027.

Finally, there's the potential for future, non-dilutive cash from the UK government. COMPASS Pathways plc has indicated that their full-year 2025 net cash used in operating activities guidance, which is a range of $120 million to $145 million, includes the amount receivable in respect of the R&D tax credit in the UK, though the timing for that receipt is uncertain. That tax credit is a future, non-guaranteed inflow that supports the overall cash runway projection.