Cybin Inc. (CYBN): modelo de negócios [Jan-2025 Atualizado]

No cenário em rápida evolução da inovação em saúde mental, a Cybin Inc. (CYBN) surge como um pioneiro inovador, reimaginando as abordagens terapêuticas por meio de pesquisas psicodélicas de ponta. Ao alavancar estrategicamente metodologias científicas avançadas e compostos moleculares proprietários, esta empresa visionária está pronta para transformar os paradigmas tradicionais de tratamento psiquiátrico, oferecendo esperança a milhões de lutas com desafios complexos de saúde mental. Sua tela de modelo de negócios meticulosamente criada revela uma estratégia abrangente que combina rigor científico, inovação tecnológica e um profundo compromisso de desenvolver terapias inovadoras que podem revolucionar como entendemos e tratamos as condições de saúde mental.

Cybin Inc. (CYBN) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa com instituições acadêmicas

A Cybin Inc. estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade de Toronto	Pesquisa de terapêutica psicodélica	2021
Rede de Saúde da Universidade	Tratamento de depressão e ansiedade	2022

Parcerias estratégicas com clínicas de saúde mental

As parcerias da clínica estratégica de saúde mental da Cybin incluem:

• CAMH (Centro de dependência e Saúde Mental)
• Clínicas de bem -estar Numinus
• Clínicas de saúde de viagem de campo

Alianças de desenvolvimento farmacêutico

Parceiro	Foco de desenvolvimento	Valor de colaboração
Beckley Psytech	Desenvolvimento de medicamentos psicodélicos	US $ 3,5 milhões
Revive a terapêutica	Plataforma de pesquisa de psilocibina	US $ 2,1 milhões

Relações de investimento com organizações de pesquisa psicodélica

Os relacionamentos de investimento da Cybin incluem:

• Havn Life Sciences - US $ 1,2 milhão de investimento
• MindMed - Research Collaboration avaliado em $750,000
• Compass Pathways - Acordo de Pesquisa Conjunta

Cybin Inc. (CYBN) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas psicodélicas

A partir de 2024, a Cybin Inc. investiu US $ 12,3 milhões em pesquisa e desenvolvimento de compostos terapêuticos baseados em psicodélicos. A empresa se concentra no desenvolvimento de novas entidades moleculares direcionadas às condições de saúde mental.

Área de pesquisa	Valor do investimento	Estágio atual
Derivados de psilocibina	US $ 5,7 milhões	Desenvolvimento pré -clínico
Psicodélicos deuterados	US $ 4,2 milhões	Projeto molecular
Compostos neurológicos	US $ 2,4 milhões	Pesquisa antecipada

Ensaios clínicos para tratamentos de saúde mental

A Cybin Inc. está atualmente conduzindo 3 ensaios clínicos ativos com um orçamento total de US $ 8,6 milhões. Os ensaios se concentram em depressão resistente ao tratamento e transtornos de ansiedade.

• Ensaio de Fase I: CyB001 para transtorno depressivo maior
• Estudo de Fase II: Tratamento baseado em psilocibina para ansiedade
• Estudo exploratório: mecanismos de neuroplasticidade

Inovação de produtos farmacêuticos

A empresa possui 7 pedidos de patentes em andamento, com um custo estimado de desenvolvimento de propriedade intelectual de US $ 3,1 milhões.

Categoria de produto	Aplicações de patentes	Status de desenvolvimento
Compostos moleculares	4 APLICAÇÕES	Revisão pendente
Mecanismos de entrega	2 aplicações	Em exame
Protocolos terapêuticos	1 aplicação	Arquivamento inicial

Desenvolvimento da Propriedade Intelectual

O portfólio total de propriedades intelectuais inclui 12 entidades moleculares únicas, com um investimento de US $ 4,5 milhões em proteção e desenvolvimento de IP.

Conformidade regulatória e teste clínico

A Cybin Inc. alocou US $ 2,9 milhões para os processos de conformidade regulatória e testes clínicos em várias jurisdições.

• Orçamento de interação da FDA: US $ 1,2 milhão
• Preparação de submissão regulatória: US $ 0,7 milhão
• Monitoramento de conformidade: US $ 1 milhão

Cybin Inc. (CYBN) - Modelo de negócios: Recursos -chave

Laboratórios de Pesquisa Avançada

A Cybin Inc. mantém instalações de pesquisa localizadas em Toronto, Canadá, com um espaço total de laboratório de aproximadamente 5.000 pés quadrados dedicados ao desenvolvimento psicodélico de medicamentos.

Localização do laboratório	Metragem quadrada	Foco na pesquisa
Toronto, Canadá	5.000 pés quadrados	Terapêutica psicodélica

Talento científico especializado e experiência

A Cybin Inc. emprega uma equipe científica especializada com credenciais específicas:

• Pessoal científico total: 22 pesquisadores
• Titulares de doutorado: 15
• Experiência de pesquisa combinada: mais de 180 anos

Formulações de moléculas psicodélicas proprietárias

A Cybin Inc. desenvolveu vários compostos moleculares proprietários:

• Total de pedidos de patente: 8
• Formulações exclusivas da molécula psicodélica: 6
• Patentes provisórias arquivadas: 4

Capital financeiro significativo para pesquisa

Métrica financeira	Quantidade (USD)	Ano
Financiamento total da pesquisa	US $ 37,2 milhões	2023
Caixa e equivalentes de dinheiro	US $ 24,5 milhões	Q3 2023

Tecnologia de pesquisa médica de ponta

A infraestrutura tecnológica inclui:

• Sistemas de cromatografia líquida de alta eficiência (HPLC): 3
• Equipamento de espectrometria de massa: 2
• Tecnologia avançada de neuroimagem: 1 sistema integrado

Cybin Inc. (CYBN) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de saúde mental

A Cybin Inc. se concentra no desenvolvimento de terapêuticas psicodélicas com investimentos específicos de pesquisa:

• Pesquisar & Orçamento de desenvolvimento: US $ 14,2 milhões (2023 ano fiscal)
• Despesas de ensaios clínicos: US $ 8,7 milhões alocados para desenvolvimento psicodélico de medicamentos
• Portfólio de patentes: 17 compostos moleculares proprietários

Área de tratamento	Estágio de desenvolvimento	Potencial estimado de mercado
Transtorno depressivo maior	Ensaios clínicos de fase 2	US $ 15,3 bilhões no mercado global
Depressão resistente ao tratamento	Pesquisa pré -clínica	US $ 7,8 bilhões de mercado potencial

Terapias em potencial para depressão e dependência

O oleoduto terapêutico da Cybin se concentra em:

• Cyb003 - Psilocibina deuterada para transtorno depressivo maior
• CYB004 - Terapia psicodélica para transtornos de ansiedade
• Estratégias de intervenção neurológica direcionadas

Abordagens alternativas para intervenções farmacêuticas tradicionais

Tipo de intervenção	Características únicas	Eficácia comparativa
Terapia assistida psicodélica	Início rápido de ação	Taxa de resposta de 70% em ensaios clínicos
Otimização molecular	Efeitos colaterais reduzidos	45% de melhoria em relação aos medicamentos tradicionais

Protocolos terapêuticos psicodélicos baseados em evidências

A metodologia de pesquisa da Cybin inclui:

• Colaboração com 6 instituições de pesquisa acadêmica
• Coleta abrangente de dados de segurança e eficácia
• Protocolos rigorosos de ensaio clínico

Estratégias personalizadas de tratamento de saúde mental

A abordagem de personalização inclui:

• Capacidades de triagem genômica
• Modelagem de dosagem de precisão
• Rastreamento de resposta de tratamento individual

Parâmetro de personalização	Abordagem tecnológica	Benefício potencial do paciente
Perfil genético	Mapeamento molecular avançado	Precisão de tratamento aprimorada de 30%
Rastreamento de resposta neurológica	Análise orientada a IA	25% melhores resultados de tratamento

Cybin Inc. (CYBN) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com profissionais médicos

A Cybin Inc. estabeleceu estratégias de engajamento direto com profissionais médicos por meio de programas de extensão direcionados:

Método de engajamento	Freqüência	Especialistas -alvo
Apresentações da conferência médica	4-6 por ano	Psiquiatras, neurologistas
Oficinas de pesquisa clínica	3 por ano	Especialistas em Psicopharmacologia

Colaboração da comunidade científica

Métricas de colaboração com instituições científicas:

• Parcerias de pesquisa ativa: 7 instituições acadêmicas
• Subsídios de pesquisa colaborativa: US $ 2,3 milhões em 2023
• Artigos científicos publicados: 12 publicações revisadas por pares

Programas de apoio ao paciente e educação

Iniciativas de suporte focadas no paciente:

Programa	Alcançar	Recursos fornecidos
Portal de Educação de Pacientes Online	3.500 usuários registrados	Informações de tratamento, webinars
Helpline de apoio ao paciente	250 consultas mensais	Apoio psicológico, orientação de tratamento

Plataformas de saúde digital para rastreamento de tratamento

Recursos de plataforma digital:

• Usuários de aplicativos móveis: 2.100
• Recursos de monitoramento de tratamento em tempo real
• Gerenciamento de dados compatível com HIPAA

Comunicação de pesquisa transparente

Canais de comunicação de pesquisa:

Canal de comunicação	Freqüência	Alcance do público
Atualizações de progresso do ensaio clínico	Trimestral	5.700 assinantes de e -mail
Pesquisa on -line	Bimensal	1.200 participantes médios

Cybin Inc. (Cybn) - Modelo de Negócios: Canais

Equipes de vendas médicas diretas

A partir do quarto trimestre 2023, a Cybin Inc. mantém uma força de vendas especializada direcionada aos profissionais de saúde psiquiátrica e mental. A equipe de vendas se concentra em terapias assistidas por psicodélico, especificamente Cyb003 para o transtorno depressivo maior.

Métrica da equipe de vendas	2024 dados
Total de representantes de vendas	12 profissionais médicos especializados
Cobertura geográfica	Estados Unidos e Canadá
Segmentos de assistência médica -alvo	Psiquiatria, clínicas de saúde mental

Apresentações da conferência científica

A Cybin participa ativamente de conferências médicas importantes para mostrar dados de pesquisa e ensaios clínicos.

• Reunião Anual da Associação Psiquiátrica Americana
• Conferência de Ciência Psicodélica
• Congresso Mundial de Saúde Mental

Publicações de pesquisa on -line

A Cybin publica pesquisas em periódicos revisados ​​por pares para estabelecer credibilidade científica.

Métrica de publicação	2024 dados
Publicações revisadas por pares	4 Estudos publicados em 2023-2024
Índice de Citação	15 citações acadêmicas

Plataformas de saúde digital

A Cybin aproveita as plataformas digitais para disseminação de pesquisa e envolvimento do paciente.

• Portal de consulta de telessaúde proprietária
• Aplicativo móvel para rastreamento de pacientes
• Plataforma de recrutamento de ensaios clínicos online

Redes de distribuição farmacêutica

Cybin colabora com parceiros de distribuição farmacêutica especializados.

Parceiro de distribuição	Cobertura
McKesson Corporation	Distribuição farmacêutica norte -americana
Amerisourcebergen	Distribuição especializada de medicamentos para saúde mental

Cybin Inc. (CYBN) - Modelo de negócios: segmentos de clientes

Profissionais de saúde mental

Tamanho do mercado -alvo: aproximadamente 1,2 milhão de profissionais de saúde mental licenciados na América do Norte a partir de 2023.

Quebra de segmento	Número de profissionais	Penetração potencial de mercado
Psiquiatras	45,000	12-15%
Psicólogos	180,000	8-10%
Terapeutas licenciados	975,000	5-7%

Centros de tratamento psiquiátrico

Número total de instalações de tratamento psiquiátrico nos Estados Unidos: 12.275 a partir de 2022.

• Hospitais psiquiátricos de pacientes internados: 1.752
• Centros de Tratamento Residencial: 3.645
• Clínicas de saúde mental ambulatorial: 7.078

Instituições de pesquisa

Tipo de instituição	Número de instituições	Orçamento de pesquisa anual
Centros de pesquisa acadêmica	289	US $ 3,2 bilhões
Instituições de Pesquisa Privada	127	US $ 1,7 bilhão
Instalações de pesquisa governamental	46	US $ 2,5 bilhões

Pacientes com condições resistentes ao tratamento

População total de pacientes com condições resistentes ao tratamento: 16,1 milhões na América do Norte.

• Depressão resistente ao tratamento: 4,6 milhões de pacientes
• Transtornos de ansiedade resistentes ao tratamento: 6,2 milhões de pacientes
• TEPT com resistência ao tratamento: 2,3 milhões de pacientes
• Dor crônica com resistência ao tratamento: 3 milhões de pacientes

Pesquisadores farmacêuticos

Profissionais totais de pesquisa farmacêutica: 62.400 na América do Norte.

Categoria de pesquisa	Número de pesquisadores	Orçamento médio de pesquisa
Psicofarmacologia	8,750	US $ 4,3 milhões por equipe de pesquisa
Neurociência	12,600	US $ 5,2 milhões por equipe de pesquisa
Medicina psicodélica	1,200	US $ 3,7 milhões por equipe de pesquisa

Cybin Inc. (CYBN) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Cybin Inc. registrou despesas de P&D de US $ 16,7 milhões, representando um investimento significativo em pesquisa terapêutica psicodélica.

Categoria de despesa	Quantidade (USD)
Pesquisa pré -clínica	US $ 5,2 milhões
Desenvolvimento de medicamentos	US $ 7,3 milhões
Inovação tecnológica	US $ 4,2 milhões

Financiamento de ensaios clínicos

A Cybin alocou US $ 9,4 milhões especificamente para atividades de ensaios clínicos em 2023.

• Ensaios de Fase I/II para Tratamento de Depressão CYB003
• Programas de pesquisa de transtornos neuropsiquiátricos
• Ensaios de desenvolvimento analógico de psilocibina

Custos de conformidade regulatória

As despesas regulatórias e de conformidade totalizaram aproximadamente US $ 2,1 milhões em 2023.

Área de conformidade	Despesas (USD)
Preparação de envio da FDA	$850,000
Consultas legais	$670,000
Documentação regulatória	$580,000

Recrutamento de talentos científicos

A Cybin investiu US $ 3,6 milhões no recrutamento e retenção de pessoal científico especializado em 2023.

• Recrutamento de neurocientistas
• Especialistas em pesquisa farmacêutica
• Especialistas em gerenciamento de ensaios clínicos

Infraestrutura de tecnologia e laboratório

As despesas de capital para infraestrutura de laboratório e tecnologia foram de US $ 4,8 milhões em 2023.

Componente de infraestrutura	Investimento (USD)
Equipamento de laboratório	US $ 2,3 milhões
Software de pesquisa	US $ 1,2 milhão
Recursos computacionais	US $ 1,3 milhão

Cybin Inc. (CYBN) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos farmacêuticos

No quarto trimestre 2023, a Cybin Inc. ainda não gerou receita comercial com as vendas de produtos farmacêuticos. A empresa está atualmente em estágios de desenvolvimento clínico para tratamentos terapêuticos psicodélicos.

Bolsas de pesquisa

Fonte de concessão	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	$350,000	2023
Fundação de Pesquisa Privada	$250,000	2023

Licenciamento de compostos moleculares proprietários

A cybin se desenvolveu 4 compostos moleculares proprietários Com possíveis oportunidades de licenciamento:

• CYB001 - Analog da psilocibina
• CYB003 - Derivada DMT
• CYB005 - Formulação de cetamina
• Cyb006 - psilocibina sintética

Colaborações de ensaios clínicos

Parceiro de colaboração	Valor projetado	Área de foco
Universidade de Toronto	$475,000	Pesquisa de depressão
Universidade Johns Hopkins	$625,000	Tratamento de dependência

Monetização da propriedade intelectual

Em dezembro de 2023, a Cybin detém 12 famílias de patentes com possíveis estratégias de monetização.

Fluxos potenciais totais de receita: aproximadamente US $ 1,7 milhão para 2024 exercícios fiscais.

Cybin Inc. (CYBN) - Canvas Business Model: Value Propositions

You're looking at the core value Cybin Inc. (CYBN) is trying to deliver to the mental healthcare market, which is heavily reliant on daily medication with limited long-term success. The proposition here centers on durable, infrequent dosing for serious conditions.

For Major Depressive Disorder (MDD), the value centers on an intermittent treatment model built on the durability seen in Phase 2 data for CYB003. This aims to shift the paradigm from chronic daily use to a treatment regimen that provides sustained relief after just a few administrations.

The company is advancing its Phase 3 PARADIGM program for CYB003, which includes the APPROACH study enrolling 220 participants across approximately 45 U.S. clinical sites. The second pivotal study, EMBRACE, was set to initiate in Q4 2025, targeting 330 participants, with the PARADIGM program anticipating combined enrollment of approximately 550 patients. Topline data for APPROACH is expected in Q4 2026. The total addressable market for MDD is stated as >300 million people worldwide.

The value proposition is underpinned by the novel chemistry of its pipeline, specifically the deuterated molecules designed for optimized performance. CYB003 is a proprietary deuterated psilocin analog, and CYB004 is a deuterated N, N-dimethyltryptamine molecule.

CYB004 offers a differentiated delivery mechanism, utilizing an Intramuscular (IM) formulation designed for clinical and commercial scalability. This IM delivery is expected to result in a short-duration experience lasting approximately 90 minutes. The company's intellectual property (IP) portfolio supports this differentiation, with patent protection for the CYB004 IM formulation expected to provide exclusivity until 2040.

The strength of the IP portfolio as of June 2025 includes over 90 granted patents and over 230 pending applications, with CYB003 protection extending to 2041.

Cybin Inc. (CYBN) has secured an expedited regulatory pathway for its lead asset, CYB003. The molecule received FDA Breakthrough Therapy Designation (BTD) for the adjunctive treatment of MDD. This designation provides an expedited review pathway and increased access to FDA guidance throughout development.

The potential for rapid-onset and durable efficacy is demonstrated by the following Phase 2 data points, which inform the Phase 3 design:

Metric	Dose/Regimen	Time Point	Result
Response Rate (MDD)	Two doses of 16 mg CYB003	12 months	100%
Remission Rate (MDD)	Two doses of 16 mg CYB003	12 months	71%
Mean MADRS Change (MDD)	Two doses of 16 mg CYB003	12 months	Approximately -23 points
Remission Rate (MDD)	Two doses of 16 mg CYB003	4 months	75%

For Generalized Anxiety Disorder (GAD), CYB004 completed enrollment of its Phase 2 study participants, totaling 36 individuals, in September 2025. Topline data from this GAD study is expected in Q1 2026.

The company's financial position as of mid-2025 supports the advancement of these value drivers:

• Cash on hand totaled US$118.7 million as of June 30, 2025.
• Cash on hand totaled C$135 million as of March 31, 2025.
• Total assets grew to $210.8 million as of June 30, 2025.
• A recent financing agreement provided US$50 million in principal amount of convertible debentures.

Cybin Inc. (CYBN) - Canvas Business Model: Customer Relationships

You're navigating the complex landscape of late-stage clinical development, where relationships with investigators, regulators, and capital providers are just as critical as the science itself. For Cybin Inc., customer relationships are segmented across the clinical execution team, the future commercial ecosystem, the FDA, and the investment community.

High-touch, direct engagement with clinical investigators and sites

Direct engagement with clinical investigators is the engine driving the Phase 3 PARADIGM program for CYB003 in Major Depressive Disorder (MDD). This isn't a passive vendor relationship; it's a structured collaboration via the Strategic Clinical Site Partnership (SPA) program, designed to enhance efficiency and ensure protocol consistency. The initial SPA program kicked off with Segal Trials, a network based in South Florida with six research sites specializing in psychiatry and psychedelics research. By April 2025, this expanded to 18 U.S.-based SPA sites.

The two pivotal trials under PARADIGM have distinct site footprints, showing a scaling effort to gather robust data:

Trial Name	Indication	Target Enrollment	U.S. Sites (Approx.)	Total Sites (Approx.)
APPROACH	MDD (Phase 3)	220 participants	~30	45 U.S. and European sites
EMBRACE	MDD (Phase 3)	330 participants	Not specified	~60 across U.S., UK, Europe, and Australia

The company is actively leveraging the expertise of key clinical figures, such as Kimball A. Johnson, M.D., and Paul Thielking, to support trial execution. Honestly, having this level of site infrastructure in place is what allows Cybin Inc. to project filing a New Drug Application (NDA) as early as 2026.

Strategic collaboration with psychiatry practices for market access

Preparing for commercialization means building the bridge to the prescribing physician now. Cybin Inc. established a key relationship with Osmind, which is described as a leading service provider to psychiatry practices in the U.S.. This partnership is explicitly designed to accelerate commercial preparation for the clinical-stage pipeline.

The value of this relationship centers on Osmind's existing infrastructure:

• Access to over 800 psychiatry clinics in the U.S..
• Integration of point-of-care software.
• Access to real-world data capabilities.

The focus here is mapping the operational needs for interventional treatments, specifically in areas like pharmacy, fulfillment, patient access, and reimbursement. That's the defintely unglamorous but necessary work for a successful launch.

Formal regulatory communication via the BTD process

The relationship with the U.S. Food and Drug Administration (FDA) is formalized and highly advantageous for Cybin Inc.'s lead asset, CYB003. The company received Breakthrough Therapy Designation (BTD) from the FDA for the adjunctive treatment of MDD. This designation, secured in February 2024, is a significant acknowledgment of the unmet need and the promising Phase 2 data, which showed 71% remission rates at 12 months after two 16mg doses.

The BTD status directly impacts the relationship by:

• Providing an expedited review pathway.
• Offering enhanced FDA guidance throughout development.

This regulatory fast-track status is a core component of the strategy to potentially become one of the first companies to commercialize a psychedelic-derived therapy for MDD.

Investor relations to maintain capital access and confidence

Maintaining confidence with the investment community is crucial for funding multi-year Phase 3 trials. Cybin Inc. has been active in securing capital to support its pipeline advancement, including CYB003 and CYB004. As of June 30, 2025, the company reported cash of US$118.7 million, following a C$135 million cash position as of March 31, 2025.

Key recent financial relationship milestones include:

• A registered direct offering in October 2025, raising aggregate gross proceeds of US$175,009,911.45.
• The net proceeds from that offering are earmarked to repay outstanding unsecured convertible debentures held by High Trail Special Situations LLC.
• Prior to that, on June 30, 2025, the company completed a US$50,000,000 principal amount placement of unsecured convertible debentures with High Trail, part of a potential up to US$500,000,000 financing agreement.

The company has a history of capital activity, having raised funds over 7 funding rounds in total, with the largest being a $150M Post IPO round in March 2024. Cybin Inc. currently has a total of 12 investors, with 11 identified as institutional investors. This consistent access to capital, even while burning cash to advance trials, signals strong investor belief in the near-term catalysts. Finance: review the Q4 2025 cash burn rate against the new capital infusion by next Tuesday.

Cybin Inc. (CYBN) - Canvas Business Model: Channels

You're looking at how Cybin Inc. plans to get its breakthrough neuropsychiatric treatments, like CYB003 for Major Depressive Disorder (MDD) and CYB004 for Generalized Anxiety Disorder (GAD), from the lab bench to the patient's bedside. This is all about the pathways they are building now, well before final approval.

Multinational Clinical Trial Sites

The Phase 3 PARADIGM program for CYB003 is the core engine driving near-term value, requiring a broad network of clinical sites across multiple jurisdictions. This multinational approach helps with enrollment speed and provides data relevant to global regulatory bodies.

The two pivotal studies within PARADIGM show the scale of the current channel deployment:

Study Component	Indication	Target Enrollment	Site Count/Geography
APPROACH™	MDD (Adjunctive)	220 participants	Approximately 45 clinical sites across the United States
EMBRACE™	MDD (Adjunctive)	330 participants	Approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia

The EMBRACE study received approval to initiate in the United Kingdom, Ireland, Poland, Greece, and Australia.

Specialized Mental Health Clinics and Hospital Networks

For commercialization readiness, Cybin Inc. is using strategic partnerships to map out the future delivery system. The collaboration with Osmind is key here, focusing on operational infrastructure before a sales force is fully built out.

• Partnered with Osmind to accelerate commercial preparation.
• Osmind provides access to an extensive network of over 800 psychiatry clinics in the U.S..
• The partnership focuses on end-to-end mapping for pharmacy, fulfillment, patient access, and reimbursement workflows.

This network access is designed to support the commercialization of both the CYB003 and CYB004 programs.

Direct Regulatory Submissions

The regulatory pathway itself is a primary channel for market entry, leveraging designations to expedite review. Cybin Inc. is focused on direct submissions to the U.S. Food and Drug Administration (FDA) and international bodies.

• CYB003 has received FDA Breakthrough Therapy Designation (BTD) for MDD.
• BTD provides benefits including eligibility for Priority Review and Accelerated Approval.
• BTD also includes all Fast Track Designation features, such as Rolling Review for NDA.
• For a typical Biologics License Application (BLA) submission of 30 GB, the FDA targets an average total duration of 12 hours, including an average upload duration target of 6 hours.

Future Specialized Pharmaceutical Sales Force

While the immediate focus is on clinical execution and commercial preparation via Osmind, the long-term channel for post-approval distribution will involve a dedicated sales force. The company is advancing its proprietary drug delivery systems, such as the intramuscular formulation for CYB004, which is expected to have an experience lasting approximately 90 minutes. Specific financial commitments or headcount numbers for a future specialized sales force have not been publicly detailed as of late 2025, though commercial preparation is underway.

Finance: draft 13-week cash view by Friday.

Cybin Inc. (CYBN) - Canvas Business Model: Customer Segments

You're looking at the core groups Cybin Inc. (CYBN) needs to win over to turn its pipeline into a commercial success. This isn't just about patients; it's about the entire ecosystem that enables access to these novel treatments.

Patients with Major Depressive Disorder (MDD) refractory to current treatment

This is the primary focus for CYB003, the deuterated psilocin analog. The unmet need here is substantial, as the Treatment-Resistant Depression (TRD) market was valued at USD 2.16 billion in 2025, with projections showing growth to USD 3.14 billion by 2030. Globally, TRD impacts roughly 30% of the estimated 280 million people living with MDD. Specifically in the United States, TRD is anticipated to affect approximately 21 million adults. Cybin Inc. is targeting this group with its Phase 3 PARADIGM program, which leverages Phase 2 data showing a 71% remission rate after two doses of CYB003. The company's cash position as of June 30, 2025, was US$118.7 million, bolstered by a recent financing agreement of US$50 million in convertible debentures, providing runway to fund these trials.

The Phase 3 enrollment numbers show the scale of the immediate patient pool being engaged:

Study Component	Target Enrollment	Geographic Scope
APPROACH (Phase 3)	220 participants	U.S. and Europe (across 45 clinical sites as of August 2025)
EMBRACE (Phase 3)	330 participants	U.S., UK, Europe, and Australia (across approximately 60 clinical sites)

The total addressable market for MDD treatment is cited as >300 million people worldwide. If the Phase 3 trials proceed as planned, Cybin Inc. is aiming to submit a New Drug Application (NDA) to the FDA in 2027.

Patients with Generalized Anxiety Disorder (GAD)

CYB004 is the candidate for GAD, utilizing a deuterated DMT molecule. This patient group is also significant, and Cybin Inc. is using a differentiated delivery method-intramuscular-optimized for scalability. The Phase 2 trial for CYB004 allowed for the co-administration of antidepressants, which is a key consideration for this patient segment. Enrollment for this Phase 2 study was expected to be completed in August 2025, with topline data anticipated in the first quarter of 2026. The potential here is to use the GAD data to support dual indication development across both MDD and GAD.

Clinical Psychiatrists and mental health specialists who prescribe novel therapies

These prescribers are the direct channel to the patients. Cybin Inc. has been strategically preparing for commercialization by building out its infrastructure. A key action here is the partnership with Osmind, which provides access to over 800 psychiatry clinics in the U.S., along with point-of-care software. The focus for this segment is demonstrating that the therapy is not just effective in a trial setting but is workable in the real world. The Phase 2 CYB004 trial specifically allowed concomitant antidepressant/anxiolytic treatment, which speaks directly to the real-world prescribing patterns of these specialists.

• Phase 2 CYB004 study allowed concomitant antidepressant/anxiolytic treatment.
• Partnership with Osmind provides access to over 800 U.S. psychiatry clinics.
• The company holds over 90 granted patents, with protections extending to 2041 for CYB003 and 2040 for CYB004, offering exclusivity to attract prescribers.

Global regulatory agencies (FDA, EMA, MHRA) as key gatekeepers

Regulatory buy-in dictates market entry and reimbursement. Cybin Inc. has secured several critical designations that streamline this process. The FDA granted Breakthrough Therapy Designation for CYB003 in 2024. Furthermore, the company received European CTA approval and MHRA approval to commence the EMBRACE study in the UK, establishing a multinational regulatory footprint. The FDA end-of-Phase 2 meeting for CYB003 was expected in early 2024 to finalize the Phase 3 design. The company's operating expenses for Q2 2025 were $28.5 million, reflecting the significant investment required to satisfy these agencies' data requirements.

Key regulatory milestones and financial context include:

• FDA Breakthrough Therapy Designation secured for CYB003 in 2024.
• MHRA approval received for EMBRACE study initiation.
• Projected NDA submission to the FDA is set for 2027.
• Q2 2025 net loss was $33.7 million, showing the cost of regulatory progression.

Finance: draft 13-week cash view by Friday.

Cybin Inc. (CYBN) - Canvas Business Model: Cost Structure

The Cost Structure for Cybin Inc. is heavily weighted toward advancing its lead clinical candidates through late-stage trials, which drives significant operating expenses.

High Research and Development (R&D) expenses for Phase 3 trials

The progression of the CYB003 program into pivotal Phase 3 studies under the PARADIGM program is a primary cost driver. Analyst estimates have been increased to reflect this higher clinical trial activity.

• R&D expense estimates were increased by Canaccord Genuity to account for higher clinical trial activity around the Phase 3 PARADIGM program.
• The second pivotal study, EMBRACE, was planned to enroll 330 participants at approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia.
• The first pivotal study, APPROACH, expects to enroll 220 participants at approximately 45 U.S. clinical sites.

Historical planned spending for the EMBRACE study initiation, as of December 31, 2024, included an approximate remaining spend of $3,900 (likely in thousands of USD) by mid-2025, following an initial expected spend of approximately $5,484 (likely in thousands of USD) to initiate the study. That's a substantial upfront cost just to get the trial running.

Cash-based operating expenses totaled US$28.5 million for Q2 FY26

Operating costs have increased year-over-year, reflecting the ramp-up in clinical activities.

Metric	Q2 FY26 (Ended Sept 30, 2025)	Q2 FY25 (Year-over-Year Comparison)
Cash-based operating expenses (Research, G&A)	US$28.5 million	US$18.2 million
Cash flows used in operating activities	US$34.5 million	US$19.1 million

The net loss for the same quarter was US$33.7 million.

Intellectual property creation and maintenance costs

Costs are incurred to secure and defend the proprietary nature of Cybin Inc.'s molecules and delivery systems, which is crucial for long-term value capture.

• As of September 30, 2025, the intellectual property portfolio included 100+ granted patents and 250+ pending applications.
• The U.S. patent for the CYB003 program is expected to provide exclusivity until 2041.
• A U.S. patent covering the CYB004 program is expected to provide exclusivity until 2040.

Manufacturing and clinical supply chain costs (e.g., Thermo Fisher Scientific)

Securing manufacturing capacity for late-stage trials and potential commercialization is a fixed and variable cost component, formalized through key partnerships.

Cybin Inc. engaged Thermo Fisher Scientific to support the Phase 3 clinical supply and potential future U.S. commercial manufacturing of CYB003. This engagement covers both drug substance and drug product capsule production at Thermo Fisher's U.S. manufacturing sites, including Florence, South Carolina, and Cincinnati, Ohio.

You're looking at significant commitments to external Contract Development and Manufacturing Organization (CDMO) services to ensure supply for the pivotal program.

Cybin Inc. (CYBN) - Canvas Business Model: Revenue Streams

Cybin Inc. (CYBN) is currently pre-revenue, which is typical for a late-stage clinical biotech company focused on research and development.

The company's financial performance through the second quarter of fiscal year 2026 (ended September 30, 2025) reflects this pre-revenue status, characterized by net losses as operating expenses are driven by clinical trial execution.

Reporting Period End Date	Net Loss (USD/CAD)	Cash Balance (USD/CAD)
December 31, 2024 (Q3 FY2025)	C$10.5 million	C$136.3 million
March 31, 2025 (Q4 & FY2025)	C$31 million (Quarter) / C$113 million (Year)	C$135 million
June 30, 2025 (Q1 FY2026)	US$24.6 million	US$118.7 million
September 30, 2025 (Q2 FY2026)	US$33.7 million	US$83.8 million (before recent financing adjustment)

Future revenue streams are entirely dependent on the successful regulatory approval and subsequent commercial launch of its lead drug candidates, CYB003 and CYB004.

• Future product sales of CYB003 for Major Depressive Disorder (MDD) target a market of >300 million people worldwide.
• The overall psychedelic therapy market is projected to reach $5 billion by 2030.
• CYB003 Phase 2 data showed 71% remission rate after two doses of 16 mg.
• CYB004 Phase 2 study enrollment completion was expected in August 2025, with topline data readout anticipated in Q1 2026.

The company is also positioned to generate revenue through potential non-product sales mechanisms based on its intellectual property and development progress.

• Potential milestone payments from future licensing or co-development deals are a possible revenue source, though no specific amounts are publicly detailed as of late 2025.
• Cybin Inc. holds more than 90 granted patents and has over 230 pending applications.
• Intellectual property protection extends exclusivity until 2041 for CYB003 and 2040 for CYB004.
• A specific U.S. patent (No. 12,318,477) covers the CYB004 intramuscular formulation, which may support premium pricing.

The company has established commercial preparation partnerships, such as with Osmind, which has an 800-clinic network, to support future product distribution.