Cybin Inc. (CYBN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la innovación de salud mental, Cybin Inc. (CYBN) emerge como un pionero innovador, reinventando los enfoques terapéuticos a través de la investigación psicodélica de vanguardia. Al aprovechar estratégicamente las metodologías científicas avanzadas y los compuestos moleculares patentados, esta compañía visionaria está preparada para transformar los paradigmas tradicionales de tratamiento psiquiátrico, ofreciendo esperanza a millones que luchan con complejos desafíos de salud mental. Su lienzo de modelo de negocio meticulosamente elaborado revela una estrategia integral que combina rigor científico, innovación tecnológica y un profundo compromiso con el desarrollo de terapias innovadoras que podrían revolucionar cómo entendemos y tratamos las condiciones de salud mental.

Cybin Inc. (CYBN) - Modelo de negocio: asociaciones clave

Colaboraciones de investigación con instituciones académicas

Cybin Inc. ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Año de colaboración
Universidad de Toronto	Investigación de Terapéutica Psicodélica	2021
Red de salud universitaria	Tratamiento de depresión y ansiedad	2022

Asociaciones estratégicas con clínicas de salud mental

Las asociaciones estratégicas de la clínica de salud mental de Cybin incluyen:

• Camh (Centro de adicción y salud mental)
• Clínicas de bienestar numinus
• Clínicas de salud de excursión

Alianzas de desarrollo farmacéutico

Pareja	Enfoque de desarrollo	Valor de colaboración
Beckley Psytech	Desarrollo de drogas psicodélicas	$ 3.5 millones
Revivir la terapéutica	Plataforma de investigación de psilocibina	$ 2.1 millones

Relaciones de inversión con organizaciones de investigación psicodélica

Las relaciones de inversión de Cybin incluyen:

• Havn Life Sciences - $ 1.2 millones de inversión
• MindMed - Colaboración de investigación valorada en $750,000
• Patillas de la brújula - Acuerdo de investigación conjunta

Cybin Inc. (CYBN) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas psicodélicas

A partir de 2024, Cybin Inc. ha invertido $ 12.3 millones en investigación y desarrollo de compuestos terapéuticos basados ​​en psicodélicos. La compañía se enfoca en desarrollar nuevas entidades moleculares dirigidas a condiciones de salud mental.

Área de investigación	Monto de la inversión	Etapa actual
Derivados de psilocibina	$ 5.7 millones	Desarrollo preclínico
Psicodélicos deuterados	$ 4.2 millones	Diseño molecular
Compuestos neurológicos	$ 2.4 millones	Investigación temprana

Ensayos clínicos para tratamientos de salud mental

Cybin Inc. está realizando actualmente 3 ensayos clínicos activos con un presupuesto total de $ 8.6 millones. Los ensayos se centran en la depresión y los trastornos de ansiedad resistentes al tratamiento.

• Ensayo de fase I: CYB001 para el trastorno depresivo mayor
• Ensayo de fase II: tratamiento basado en psilocibina para la ansiedad
• Ensayo exploratorio: mecanismos de neuroplasticidad

Innovación de productos farmacéuticos

La Compañía tiene 7 solicitudes de patentes en progreso, con un costo estimado de desarrollo de propiedad intelectual de $ 3.1 millones.

Categoría de productos	Solicitudes de patentes	Estado de desarrollo
Compuestos moleculares	4 aplicaciones	Revisión pendiente
Mecanismos de entrega	2 aplicaciones	Bajo examen
Protocolos terapéuticos	1 aplicación	Presentación inicial

Desarrollo de la propiedad intelectual

La cartera total de propiedades intelectuales incluye 12 entidades moleculares únicas, con una inversión de $ 4.5 millones en protección y desarrollo de IP.

Cumplimiento regulatorio y pruebas clínicas

Cybin Inc. ha asignado $ 2.9 millones para procesos de cumplimiento regulatorio y pruebas clínicas en múltiples jurisdicciones.

• Presupuesto de interacción de la FDA: $ 1.2 millones
• Preparación de presentación regulatoria: $ 0.7 millones
• Monitoreo de cumplimiento: $ 1 millón

Cybin Inc. (CYBN) - Modelo de negocio: recursos clave

Laboratorios de investigación avanzados

Cybin Inc. mantiene instalaciones de investigación ubicadas en Toronto, Canadá, con un espacio de laboratorio total de aproximadamente 5,000 pies cuadrados dedicados al desarrollo de fármacos psicodélicos.

Ubicación de laboratorio	Pies cuadrados	Enfoque de investigación
Toronto, Canadá	5,000 pies cuadrados	Terapéutica psicodélica

Talento científico especializado y experiencia

Cybin Inc. emplea un equipo científico especializado con credenciales específicas:

• Personal científico total: 22 investigadores
• Titulares de doctorado: 15
• Experiencia de investigación combinada: más de 180 años

Formulaciones de moléculas psicodélicas patentadas

Cybin Inc. ha desarrollado múltiples compuestos moleculares patentados:

• Solicitudes de patentes totales: 8
• Formulaciones de moléculas psicodélicas únicas: 6
• Patentes provisionales presentadas: 4

Capital financiero significativo para la investigación

Métrica financiera	Cantidad (USD)	Año
Financiación total de la investigación	$ 37.2 millones	2023
Equivalentes de efectivo y efectivo	$ 24.5 millones	P3 2023

Tecnología de investigación médica de vanguardia

La infraestructura tecnológica incluye:

• Sistemas de cromatografía líquida de alto rendimiento (HPLC): 3
• Equipo de espectrometría de masas: 2
• Tecnología avanzada de neuroimagen: 1 sistema integrado

Cybin Inc. (CYBN) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de salud mental

Cybin Inc. se centra en el desarrollo de la terapéutica psicodélica con inversiones de investigación específicas:

• Investigación & Presupuesto de desarrollo: $ 14.2 millones (2023 año fiscal)
• Gastos de ensayos clínicos: $ 8.7 millones asignados para el desarrollo de medicamentos psicodélicos
• Portafolio de patentes: 17 compuestos moleculares patentados

Área de tratamiento	Etapa de desarrollo	Potencial de mercado estimado
Trastorno depresivo mayor	Ensayos clínicos de fase 2	Mercado global de $ 15.3 mil millones
Depresión resistente al tratamiento	Investigación preclínica	Mercado potencial de $ 7.8 mil millones

Posibles terapias innovadoras para la depresión y la adicción

La tubería terapéutica de Cybin se centra en:

• Cyb003 - Psilocibina deuterada para el trastorno depresivo mayor
• CYB004 - Terapia psicodélica para los trastornos de ansiedad
• Estrategias de intervención neurológica dirigidas

Enfoques alternativos para las intervenciones farmacéuticas tradicionales

Tipo de intervención	Características únicas	Efectividad comparativa
Terapia psicodélica	Inicio rápido de acción	Tasa de respuesta del 70% en ensayos clínicos
Optimización molecular	Efectos secundarios reducidos	Mejora del 45% sobre los medicamentos tradicionales

Protocolos terapéuticos psicodélicos basados ​​en evidencia

La metodología de investigación de Cybin incluye:

• Colaboración con 6 instituciones de investigación académica
• Recopilación integral de datos de seguridad y eficacia
• Protocolos de ensayos clínicos rigurosos

Estrategias de tratamiento de salud mental personalizadas

El enfoque de personalización incluye:

• Capacidades de detección genómica
• Modelado de dosis de precisión
• Seguimiento de respuesta al tratamiento individual

Parámetro de personalización	Enfoque tecnológico	Beneficio de paciente potencial
Perfil genético	Mapeo molecular avanzado	30% de precisión de tratamiento mejorado
Seguimiento de respuesta neurológica	Análisis impulsado por la IA	El 25% mejoró los resultados del tratamiento

Cybin Inc. (CYBN) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

Cybin Inc. ha establecido estrategias de participación directa con profesionales médicos a través de programas de divulgación específicos:

Método de compromiso	Frecuencia	Especialistas en el objetivo
Presentaciones de conferencia médica	4-6 por año	Psiquiatras, neurólogos
Talleres de investigación clínica	3 por año	Expertos en psicofarmacología

Colaboración de la comunidad científica

Métricas de colaboración con instituciones científicas:

• Asociaciones de investigación activa: 7 instituciones académicas
• Subvenciones de investigación colaborativa: $ 2.3 millones en 2023
• Documentos científicos publicados: 12 publicaciones revisadas por pares

Programas de apoyo y educación del paciente

Iniciativas de apoyo centradas en el paciente:

Programa	Alcanzar	Recursos proporcionados
Portal de educación del paciente en línea	3.500 usuarios registrados	Información de tratamiento, seminarios web
Línea de ayuda de apoyo al paciente	250 consultas mensuales	Apoyo psicológico, guía de tratamiento

Plataformas de salud digital para el seguimiento del tratamiento

Capacidades de la plataforma digital:

• Usuarios de aplicaciones móviles: 2,100
• Características de monitoreo del tratamiento en tiempo real
• Gestión de datos compatible con HIPAA

Comunicación de investigación transparente

Investigación de canales de comunicación:

Canal de comunicación	Frecuencia	Alcance de la audiencia
Actualizaciones de progreso del ensayo clínico	Trimestral	5.700 suscriptores de correo electrónico
Investigar seminarios web	Bimensual	1.200 participantes promedio

Cybin Inc. (CYBN) - Modelo de negocio: canales

Equipos directos de ventas médicas

A partir del cuarto trimestre de 2023, Cybin Inc. mantiene una fuerza de ventas especializada dirigida a profesionales de la salud psiquiátrica y mental. El equipo de ventas se centra en las terapias asistidas por psicodélica, específicamente CYB003 para el trastorno depresivo mayor.

Métrica del equipo de ventas	2024 datos
Representantes de ventas totales	12 profesionales médicos especializados
Cobertura geográfica	Estados Unidos y Canadá
Segmentos de atención médica objetivo	Psiquiatría, clínicas de salud mental

Presentaciones de conferencias científicas

Cybin participa activamente en conferencias médicas clave para mostrar datos de investigación y ensayos clínicos.

• Reunión anual de la Asociación Americana de Asociación Psiquiátrica
• Conferencia de ciencias psicodélicas
• Congreso mundial de salud mental

Publicaciones de investigación en línea

Cybin publica investigación en revistas revisadas por pares para establecer credibilidad científica.

Métrico de publicación	2024 datos
Publicaciones revisadas por pares	4 Estudios publicados en 2023-2024
Índice de citas	15 citas académicas

Plataformas de salud digital

Cybin aprovecha las plataformas digitales para la difusión de investigación y la participación del paciente.

• Portal de consulta de telesalud
• Aplicación móvil para el seguimiento del paciente
• Plataforma de reclutamiento de ensayos clínicos en línea

Redes de distribución farmacéutica

Cybin colabora con socios especializados de distribución farmacéutica.

Socio de distribución	Cobertura
McKesson Corporation	Distribución farmacéutica de América del Norte
AmerisourceBergen	Distribución de medicamentos especializados de salud mental

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

Profesionales de la salud mental

Tamaño del mercado objetivo: aproximadamente 1.2 millones de profesionales de la salud mental con licencia en América del Norte a partir de 2023.

Desglose del segmento	Número de profesionales	Penetración potencial del mercado
Psiquiatras	45,000	12-15%
Psicólogos	180,000	8-10%
Terapeutas con licencia	975,000	5-7%

Centros de tratamiento psiquiátrico

Número total de instalaciones de tratamiento psiquiátrico en los Estados Unidos: 12,275 a partir de 2022.

• Hospitales psiquiátricos para pacientes hospitalizados: 1.752
• Centros de tratamiento residencial: 3.645
• Clínicas de salud mental ambulatorias: 7.078

Instituciones de investigación

Tipo de institución	Número de instituciones	Presupuesto de investigación anual
Centros de investigación académicos	289	$ 3.2 mil millones
Instituciones de investigación privadas	127	$ 1.7 mil millones
Instalaciones de investigación gubernamental	46	$ 2.5 mil millones

Pacientes con afecciones resistentes al tratamiento

Total de la población de pacientes con afecciones resistentes al tratamiento: 16.1 millones en América del Norte.

• Depresión resistente al tratamiento: 4.6 millones de pacientes
• Trastornos de ansiedad resistentes al tratamiento: 6.2 millones de pacientes
• TEPT con resistencia al tratamiento: 2.3 millones de pacientes
• Dolor crónico con resistencia al tratamiento: 3 millones de pacientes

Investigadores farmacéuticos

Profesionales de investigación farmacéutica total: 62,400 en América del Norte.

Categoría de investigación	Número de investigadores	Presupuesto de investigación promedio
Psicofarmacología	8,750	$ 4.3 millones por equipo de investigación
Neurociencia	12,600	$ 5.2 millones por equipo de investigación
Medicina psicodélica	1,200	$ 3.7 millones por equipo de investigación

Cybin Inc. (CYBN) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Cybin Inc. reportó gastos de I + D de $ 16.7 millones, lo que representa una inversión significativa en investigación terapéutica psicodélica.

Categoría de gastos	Cantidad (USD)
Investigación preclínica	$ 5.2 millones
Desarrollo de drogas	$ 7.3 millones
Innovación tecnológica	$ 4.2 millones

Financiación del ensayo clínico

Cybin asignó $ 9.4 millones específicamente para actividades de ensayos clínicos en 2023.

• Ensayos de fase I/II para el tratamiento de depresión de CyB003
• Programas de investigación de trastorno neuropsiquiátrico
• Ensayos de desarrollo analógico de psilocibina

Costos de cumplimiento regulatorio

Los gastos regulatorios y de cumplimiento totalizaron aproximadamente $ 2.1 millones en 2023.

Área de cumplimiento	Gasto (USD)
Preparación de sumisión de la FDA	$850,000
Consultas legales	$670,000
Documentación regulatoria	$580,000

Reclutamiento de talento científico

Cybin invirtió $ 3.6 millones en reclutamiento y retención de personal científico especializado en 2023.

• Reclutamiento de neurocientíficos
• Especialistas en investigación farmacéutica
• Expertos de gestión de ensayos clínicos

Tecnología e infraestructura de laboratorio

Los gastos de capital para la infraestructura de laboratorio y tecnología fueron de $ 4.8 millones en 2023.

Componente de infraestructura	Inversión (USD)
Equipo de laboratorio	$ 2.3 millones
Software de investigación	$ 1.2 millones
Recursos computacionales	$ 1.3 millones

Cybin Inc. (CYBN) - Modelo de negocio: flujos de ingresos

Venta potencial de productos farmacéuticos

A partir del cuarto trimestre de 2023, Cybin Inc. aún no ha generado ingresos comerciales de las ventas de productos farmacéuticos. La compañía se encuentra actualmente en etapas de desarrollo clínico para tratamientos terapéuticos basados ​​en psicodélicos.

Subvenciones de investigación

Fuente de subvenciones	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$350,000	2023
Fundación de investigación privada	$250,000	2023

Licencia de compuestos moleculares patentados

Cybin se ha desarrollado 4 compuestos moleculares patentados con posibles oportunidades de licencia:

• Cyb001 - Análogo de psilocibina
• Cyb003 - Derivado DMT
• CYB005 - Formulación de ketamina
• Cyb006 - psilocibina sintética

Colaboraciones de ensayos clínicos

Socio de colaboración	Valor proyectado	Área de enfoque
Universidad de Toronto	$475,000	Investigación de la depresión
Universidad de Johns Hopkins	$625,000	Tratamiento de adicción

Monetización de la propiedad intelectual

A diciembre de 2023, Cybin posee 12 familias de patentes con posibles estrategias de monetización.

Flujos de ingresos potenciales totales: aproximadamente $ 1.7 millones para 2024 año fiscal.

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.