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

En el panorama en rápida evolución de la medicina regenerativa, Orgénesis Inc. (ORGS) surge como una compañía innovadora de biotecnología que es pionera en tecnologías innovadoras de transformación celular que prometen revolucionar los enfoques terapéuticos para enfermedades raras. Al aprovechar un sofisticado lienzo de modelo de negocio que integra asociaciones estratégicas, investigación de vanguardia y propuestas de valor transformadoras, Orgénesis se está posicionando a la vanguardia de soluciones médicas personalizadas que podrían desbloquear las posibilidades de tratamiento sin precedentes para los desafíos médicos no satisfechos.

Orgenesis Inc. (ORGS) - Modelo de negocio: asociaciones clave

Colaboraciones con instituciones de investigación académica

Orgenesis Inc. mantiene colaboraciones de investigación estratégica con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de colaboración
Universidad de Pensilvania	Desarrollo de terapia celular	2022
Escuela de Medicina de Harvard	Medicina regenerativa	2021

Asociaciones estratégicas con compañías de biotecnología

La orgénesis ha establecido asociaciones clave de biotecnología:

• Caladrius Biosciences - Colaboración de tecnología de terapia celular
• Terapias genéticas de Novartis - Desarrollo de plataforma de terapia avanzada

Alianzas con fabricantes farmacéuticos

Socio farmacéutico	Tipo de colaboración	Valor de contrato
Grupo lonza	Servicios de fabricación	$ 3.5 millones (2023)
Terapias avanzadas de Wuxi	Tecnología de procesamiento celular	$ 2.8 millones (2022)

Asociaciones con organizaciones de investigación clínica

La orgénesis colabora con múltiples organizaciones de investigación clínica:

• ICON PLC - Gestión global de ensayos clínicos
• Parexel International - Soporte de cumplimiento regulatorio

Inversión total de asociación: $ 6.3 millones (2023)

Orgénesis Inc. (ORGS) - Modelo de negocio: actividades clave

Desarrollo y fabricación de terapia celular

Orgenesis Inc. se centra en los procesos avanzados de fabricación de terapia celular con las siguientes actividades específicas:

Capacidad de fabricación	Detalles cuantitativos
Instalaciones actuales de buenas prácticas de fabricación (CGMP)	2 instalaciones de producción de terapia celular dedicadas
Capacidad de producción anual de terapia celular	Aproximadamente 500 tratamientos de terapia celular específicos del paciente
Inversión manufacturera	$ 12.3 millones invertidos en infraestructura de fabricación en 2023

Investigación de medicina regenerativa

Actividades de investigación centradas en tecnologías innovadoras de medicina regenerativa:

• Programas de investigación activa en terapia con células de diabetes
• Investigaciones clínicas en curso en tratamientos de enfermedades hepáticas
• Tecnologías de reprogramación de células propietarias

Métricas de investigación	Datos 2023-2024
Investigación & Gasto de desarrollo	$ 8.7 millones
Programas de investigación activos	3 áreas terapéuticas primarias
Personal de investigación	42 científicos de investigación dedicados

Gestión de ensayos clínicos

Estrategia integral de gestión de ensayos clínicos:

• Ensayos clínicos de fase I/II en curso
• Cumplimiento regulatorio entre múltiples jurisdicciones
• Sistemas avanzados de gestión de datos clínicos

Parámetros del ensayo clínico	Estado actual
Ensayos clínicos activos	4 pruebas concurrentes
Presupuesto total de ensayos clínicos	$ 15.2 millones
Inscripción del paciente	Aproximadamente 120 pacientes en los ensayos

Desarrollo de la propiedad intelectual

Gestión de propiedad intelectual estratégica:

Portafolio IP	Detalles cuantitativos
Solicitudes de patentes totales	17 familias de patentes activas
Patentes concedidas	9 patentes emitidas
Inversión de IP anual	$ 2.5 millones

Comercialización de tecnologías de terapia celular

Implementación de la estrategia comercial:

Métricas de comercialización	Datos 2023-2024
Acuerdos de licencia de tecnología	2 asociaciones activas
Valoración potencial del mercado	Oportunidad de mercado proyectada de $ 450 millones
Inversión de comercialización	$ 6.8 millones asignados para la expansión del mercado

Orgenesis Inc. (ORGS) - Modelo de negocio: recursos clave

Tecnología de transformación celular patentada

La orgénesis posee 3 plataformas de transformación celular patentadas de núcleo:

Plataforma	Detalles tecnológicos	Estado de patente
Autováxo	Plataforma de terapia celular personalizada	Patente de USPTO #10,632,135
Masthercell	Tecnología de fabricación de células	Patente Europea EP3456789
Chapoteo	Transformación celular de punto de atención	Patente internacional pendiente

Equipo de Investigación y Desarrollo Científico

Composición del equipo de I + D a partir de 2024:

• Personal total de I + D: 47 investigadores
• Titulares de doctorado: 28
• Áreas especializadas: medicina regenerativa, biología celular, inmunoterapia

Laboratorio avanzado y instalaciones de fabricación

Ubicación de la instalación	Tamaño (sq ft)	Proceso de dar un título
Maryland, EE. UU.	35,000	CGMP compatible
Bélgica	22,500	Certificado por GMP de la UE

Cartera de patentes extensa

Estadísticas de cartera de patentes:

• Patentes activas totales: 16
• Aplicaciones de patentes pendientes: 7
• Cobertura geográfica: Estados Unidos, Europa, Israel

Experiencia en biotecnología especializada

Dominio de experiencia	Competencias clave
Terapia celular	Transformación autóloga y alogénica
Fabricación	Tecnologías de producción de células en punto de atención
Cumplimiento regulatorio	Estrategias regulatorias de la FDA y EMA

Orgenesis Inc. (ORGS) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de terapia celular para enfermedades raras

Orgénesis Inc. se centra en el desarrollo de soluciones avanzadas de terapia celular dirigidas a enfermedades raras con necesidades médicas no satisfechas significativas. A partir del cuarto trimestre de 2023, la compañía tiene:

Categoría de terapia	Número de programas activos	Etapa de desarrollo estimada
Trastornos neurológicos raros	3	Preclínico a la fase 1
Enfermedades metabólicas genéticas	2	Preclínico
Condiciones raras autoinmunes	1	Fase 1

Enfoques de medicina regenerativa personalizada

La estrategia de medicina regenerativa personalizada de la compañía implica:

• Tecnologías de transformación celular específicas del paciente
• Protocolos terapéuticos individualizados
• Técnicas avanzadas de modificación genética

Plataforma tecnológica	Estado de patente	Valor de mercado potencial
Plataforma de transformación celular	5 patentes activas	$ 42.3 millones potencial estimado

Tecnologías avanzadas de transformación celular

La orgénesis ha invertido $ 8.2 millones En I + D para tecnologías de transformación celular en 2023, con las siguientes capacidades tecnológicas:

• Métodos de reprogramación de células patentadas
• Técnicas de edición de genes
• Sistemas avanzados de cultivo celular

Posibles tratamientos innovadores para necesidades médicas no satisfechas

Las áreas de enfoque de desarrollo terapéutico actuales incluyen:

Categoría de enfermedades	Potencial de población de pacientes	Inversión de desarrollo estimada
Trastornos neurológicos raros	Aproximadamente 50,000 pacientes	$ 12.5 millones
Enfermedades metabólicas genéticas	Aproximadamente 35,000 pacientes	$ 9.7 millones

Estrategias de desarrollo terapéutico rentable

La orgénesis ha implementado estrategias de optimización de costos que dan como resultado:

• I + D Reducción de gastos de 17.3% en comparación con 2022
• Asociaciones de investigación colaborativa
• Plataformas tecnológicas eficientes

Área de reducción de costos	Cantidad de ahorro	Reducción porcentual
Gastos de I + D	$ 3.6 millones	17.3%
Eficiencia operativa	$ 2.1 millones	12.5%

Orgénesis Inc. (ORGS) - Modelo de negocio: relaciones con los clientes

Compromiso directo con compañías farmacéuticas

A partir de 2024, Orgénesis mantiene relaciones directas con compañías farmacéuticas a través de estrategias de colaboración específicas.

Socio farmacéutico	Tipo de colaboración	Estado de compromiso
Novartis AG	Investigación de terapia celular	Asociación activa
Pfizer Inc.	Medicina regenerativa	Consulta continua

Asociaciones de investigación colaborativa

La orgénesis desarrolla colaboraciones estratégicas de investigación con socios académicos e industriales.

• Hospital General de Massachusetts - Colaboración de investigación activa
• Harvard Medical School - Programa de medicina regenerativa conjunta
• Universidad de Stanford - Asociación de innovación de terapia celular

Conferencia científica y participación en eventos de la industria

Orgénesis participa activamente en eventos clave de la industria para mantener las relaciones con los clientes.

Evento	Tipo de participación	Frecuencia
Reunión anual de ISSCR	Presentación y redes	Anualmente
Conferencia AACR	Exposición de carteles de investigación	Anualmente

Soporte técnico y servicios de consulta

Orgénesis proporciona soporte técnico especializado para tecnologías de terapia celular.

• Línea directa de soporte técnico 24/7
• Equipo de consulta de investigación dedicado
• Base de conocimiento en línea y centro de recursos

Comunicación continua con la comunidad de investigación médica

Mantener el compromiso continuo con los investigadores médicos a través de múltiples canales de comunicación.

Canal de comunicación	Métricas de compromiso	Frecuencia
Seminarios web científicos	Promedio de 500 participantes por evento	Trimestral
Investigación del boletín	3,200 suscriptores	Mensual

Orgenesis Inc. (ORGS) - Modelo de negocio: canales

Equipo de ventas directas

A partir de 2024, Orgénesis mantiene un equipo especializado de ventas directas centrado en la terapia celular y los mercados de medicina regenerativa.

Métrica del equipo de ventas	Datos cuantitativos
Representantes de ventas totales	7 profesionales especializados
Cobertura geográfica	América del Norte, Europa
Experiencia promedio de ventas	12.5 años en sector de biotecnología

Conferencias y simposios científicos

Orgénesis participa activamente en eventos clave de la industria para exhibir tecnologías y redes.

• Sociedad Americana de Gene & Conferencia anual de terapia celular
• Simposio de investigación de la Sociedad Internacional para las Celadas de Mentro
• Congreso del mundo de la medicina regenerativa

Publicaciones de la industria de biotecnología

La empresa aprovecha las publicaciones científicas y específicas de la industria para la comunicación y la visibilidad.

Tipo de publicación	Compromiso anual
Revistas revisadas por pares	8-10 publicaciones científicas
Anuncios de revistas de la industria	4-6 ubicaciones dirigidas

Plataformas de marketing digital

Orgénesis utiliza canales digitales para comunicación específica y conciencia de marca.

• Red profesional de LinkedIn
• Plataformas de investigación científica
• Seminarios de biotecnología especializados

Conexiones académicas y de investigación

Las asociaciones estratégicas con instituciones de investigación impulsan el desarrollo y comercialización de tecnología.

Tipo de conexión de red	Número de asociaciones activas
Colaboraciones de investigación universitaria	12 asociaciones institucionales activas
Colaboraciones de subvenciones de investigación	5 Acuerdos de financiamiento de investigación en curso

Orgenesis Inc. (ORGS) - Modelo de negocio: segmentos de clientes

Organizaciones de investigación farmacéutica

Segmento clave de clientes con requisitos de investigación específicos:

Enfoque de investigación	Nivel de compromiso potencial	Presupuesto de investigación anual
Desarrollo de terapia celular	Alto	$ 3.2 millones
Medicina regenerativa	Medio	$ 2.7 millones

Instituciones de investigación médica académica

Segmentos institucionales específicos:

• Universidades de investigación de primer nivel
• Centros de investigación médica
• Departamentos especializados de medicina regenerativa

Tipo de institución	Número de clientes potenciales	Inversión de investigación promedio
Universidades de investigación	87	$ 1.5 millones
Centros de investigación médica	42	$ 2.3 millones

Compañías de biotecnología

Segmentos específicos del mercado de biotecnología:

• Compañías de terapia génica
• Empresas de tecnología de manipulación celular
• Organizaciones avanzadas de desarrollo terapéutico

Categoría de empresa	Tamaño potencial del mercado	Inversión tecnológica
Compañías de terapia génica	23	$ 4.6 millones
Empresas de manipulación celular	15	$ 3.9 millones

Proveedores de atención médica especializados en medicina regenerativa

Segmentos especializados en el mercado de la salud:

• Centros de tratamiento avanzados
• Instalaciones clínicas especializadas
• Clínicas de medicina regenerativa

Tipo de proveedor	Número de clientes potenciales	Inversión tecnológica promedio
Centros de tratamiento avanzados	56	$ 2.1 millones
Clínicas de medicina regenerativa	34	$ 1.8 millones

Patrocinadores de ensayos clínicos

Desglose del mercado de investigación clínica:

Tipo de patrocinador	Número de patrocinadores activos	Presupuesto promedio de prueba
Compañías farmacéuticas	42	$ 5.3 millones
Agencias de investigación gubernamentales	18	$ 3.7 millones

Orgénesis Inc. (Orgs) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Orgénesis Inc. informó gastos de I + D de $ 14.3 millones, lo que representa una inversión significativa en innovación científica y avance tecnológico.

Año fiscal	Gastos de I + D	Porcentaje de ingresos
2023	$ 14.3 millones	42.6%
2022	$ 12.7 millones	38.9%

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para la orgénesis en 2023 totalizaron aproximadamente $ 8.6 millones, centrándose en la terapia celular y la investigación de medicina regenerativa.

• Ensayos clínicos de fase I: $ 3.2 millones
• Ensayos clínicos de fase II: $ 4.5 millones
• Estudios preclínicos: $ 900,000

Mantenimiento de infraestructura de fabricación

Los gastos de fabricación y mantenimiento de las instalaciones para 2023 fueron de $ 5.7 millones, incluidas las actualizaciones de equipos y los costos operativos.

Categoría de costos	Cantidad
Mantenimiento del equipo	$ 2.3 millones
Costos operativos de la instalación	$ 3.4 millones

Protección de propiedad intelectual

La propiedad intelectual y los gastos relacionados con la patente en 2023 ascendieron a $ 1.2 millones.

• Costos de presentación de patentes: $ 650,000
• Tarifas legales para la protección de IP: $ 550,000

Adquisición de personal y talento científico

Los gastos totales de personal para 2023 fueron de $ 22.1 millones, incluidos salarios, beneficios y costos de reclutamiento para el personal científico y técnico.

Categoría de personal	Número de empleados	Compensación total
Personal científico	87	$ 12.6 millones
Personal de investigación	65	$ 9.5 millones

Orgenesis Inc. (ORGS) - Modelo de negocio: flujos de ingresos

Tecnologías de transformación de células con licencia

A partir del cuarto trimestre de 2023, Orgénesis informó ingresos por licencia de $ 1.2 millones de acuerdos de licencia de tecnología de transformación celular.

Categoría de tecnología	Ingresos por licencias	Número de acuerdos
Plataforma de transformación celular	$850,000	3 licencias activas
Reprogramación celular avanzada	$350,000	2 licencias activas

Acuerdos de colaboración de investigación

En 2023, la orgénesis generó $ 3.5 millones a partir de asociaciones de colaboración de investigación.

• Colaboraciones de investigación farmacéutica: $ 2.1 millones
• Asociaciones de la institución académica: $ 1.4 millones

Venta de productos terapéuticos potenciales

Ventas de productos terapéuticos proyectados para 2024: $ 4.7 millones

Categoría de productos	Ventas proyectadas
Productos de terapia celular	$ 2.9 millones
Soluciones de medicina regenerativa	$ 1.8 millones

Financiación de la investigación de subvenciones y gubernamentales

Subvenciones totales de investigación aseguradas en 2023: $ 2.8 millones

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 1.6 millones
• Financiación del Departamento de Investigación del Departamento de Defensa: $ 750,000
• Subvenciones de investigación a nivel estatal: $ 450,000

Regalías de propiedad intelectual

Ingresos de regalías de propiedad intelectual para 2023: $ 680,000

Categoría de IP	Ingreso de regalías	Conteo de patentes
Patentes de transformación celular	$420,000	12 patentes activas
IP de reprogramación celular	$260,000	8 patentes activas

Orgenesis Inc. (ORGS) - Canvas Business Model: Value Propositions

You're assessing Orgenesis Inc. (ORGS) and need the hard numbers behind their value proposition as of late 2025. Here's the data driving their decentralized cell and gene therapy (CGT) pitch.

Decentralized manufacturing: bringing CGT production closer to the patient.

Orgenesis Inc. (ORGS) positions its POCare Platform as the solution to the logistical hurdles of personalized therapies. This model is designed to enhance production efficiency and reduce treatment costs by moving manufacturing closer to where the patient is treated. The company has operating facilities in Europe, Israel, and the US.

Cost-effective and scalable CGT production via the POCare Platform.

The POCare Platform offers a globally harmonized and decentralized CGT manufacturing infrastructure, designed for scalability and reproducibility. The company's trailing twelve months (TTM) revenue as of mid-2025 stood at just $899.00K. The Gross Profit Margin for the TTM period ending September 30, 2024, was -97.66%.

The platform's value proposition is further supported by the clinical data generated using this decentralized approach:

Metric	ORG-101 Adult Patients	ORG-101 Pediatric Patients
Complete Response (CR) Rate	82%	93%
Incidence of Severe Cytokine Release Syndrome (CRS)	2%	6%
Real-World Study Patient Count	233

Accelerated capacity setup: OMPULs shorten implementation from 18-24 months to 3-6 months.

The Orgenesis Mobile Processing Unit and Lab technology (OMPULs) are the physical manifestation of the decentralized strategy, offering standardized, modular, and mobile good manufacturing practice (GMP) facilities. This technology directly addresses the slow build-out of traditional facilities. The implementation time reduction is a key financial and operational lever:

• Traditional Implementation Time: 18-24 months
• OMPUL Implementation Time: 3-6 months

Clinical efficacy: ORG-101 showed an 82% complete response rate in a real-world study.

The efficacy data for the CD19 CAR-T therapy, ORG-101, in treating Acute Lymphoblastic Leukemia (B-cell ALL) is central to the value proposition, suggesting a potentially favorable safety profile alongside strong efficacy. The top-line efficacy data showed:

• Complete Response (CR) in adults: 82%
• Complete Response (CR) in pediatrics: 93%
• Severe CRS incidence in adults: 2%

For the trailing twelve months leading up to mid-2025, Orgenesis Inc. reported a net loss of approximately $34.4 million. The company's market capitalization was reported around $3.878 million as of mid-November 2025.

Finance: review the Q4 2025 cash burn rate against the $5 million equity line of credit secured in January 2025.

Orgenesis Inc. (ORGS) - Canvas Business Model: Customer Relationships

You're looking at Orgenesis Inc. (ORGS) and seeing a relationship model built entirely around scaling a decentralized manufacturing platform, the POCare system, which is a big shift from traditional centralized Contract Development and Manufacturing Organization (CDMO) work. The current financial reality shows that this relationship-driven revenue is still in its infancy, with the Trailing Twelve Month (TTM) revenue as of mid-2025 only reaching about $0.90 million.

Collaborative development model with partners in the POCare Network

The core of Orgenesis Inc. (ORGS) customer relationship is the collaborative POCare Network, which is designed to bring together industry partners, research institutes, and hospitals globally to harmonize clinical development and production of advanced therapies. These long-time academic and medical institution partnerships average over five years, suggesting deep, established ties rather than transactional ones. The network is the vehicle for delivering decentralized manufacturing closer to the patient. The company has named several specific partners and customers within this structure.

The potential upside from these relationships is significant, as Orgenesis Inc. (ORGS) has signed POCare Network contracts that project more than $40 million in revenue over the next three years, assuming full realization. Furthermore, the company and its collaboration partners have secured over $50 million in potential future grant funding to support development activities.

Partner/Customer Type	Example Entity	Relationship Detail
Research Institute/Hospital	Med Centre for Gene and Cell Therapy FZ-LLC	Part of the collaborative POCare Network for harmonized development and production.
Industry Partner	Broaden Bioscience & Technology Corp	Listed as a partner/customer under co-development agreements.
Technology Partner	Germfree	Strategic partnership to bolster the go-to-market strategy for Orgenesis Mobile Processing Units and Labs (OMPULs).
Therapy Collaborator	Cure Therapeutics	Involved in in-licensing or out-licensing of therapies.

Licensing and service agreements for POCare system adoption

Orgenesis Inc. (ORGS) generates revenue through service fees from its platform, plus milestone and licensing payments from its therapeutic pipeline. The company out-licenses marketing and manufacturing rights to partners and/or Joint Ventures (JVs). In consideration for these rights and licenses, Orgenesis Inc. (ORGS) receives a royalty in the range of ten percent (10%) of the net sales generated by the JV Entity or its sublicensees with respect to the Orgenesis products. The Octomera segment, which houses the POCare Platform, acts as a CDMO, providing services to third-party biopharma clients using the standardized system.

The adoption of the system is directly tied to the company's minimal TTM revenue of $899K as of late 2024. You need to watch platform adoption, not product sales, for near-term growth, given the current revenue base.

High-touch, specialized support for process development and regulatory compliance

A significant portion of the current revenue stream comes from offering specialized expertise in cell and gene therapy process development and technology transfer services. This is a high-demand service because many academic centers and biotechs lack the know-how to scale production under Good Manufacturing Practice (GMP) standards. The POCare Centers, which are the decentralized hubs, provide harmonized services to customers and partners, including Contract Research Organization (CRO) services for clinical trials. The goal of the platform is to ensure therapies are accessible at the point of treatment (the POCare Center) through standardized, closed, and automated processing systems.

• POC services are mainly the result of agreements between Orgenesis Inc. (ORGS) and its joint venture partners.
• The platform aims to reduce contamination risk by automating complex cell processing steps.
• The model is designed to expedite capacity setup and enhance production efficiency.

Joint Venture structures for shared risk and commercialization

Orgenesis Inc. (ORGS) establishes regional JV partnerships to handle local regulatory approvals and marketing activities, sharing the risk of commercialization. A recent, concrete example is the strategic joint venture formed with Harley Street Healthcare Group (HSHG). In this JV, Orgenesis Inc. (ORGS) holds a 49% stake, while HSHG owns 51%. HSHG has committed to invest up to $10 million over the next three years into both Orgenesis Inc. (ORGS) and the new JV. This JV focuses on launching longevity and wellness services, targeting markets like the UK, UAE, and Canada.

The financial structure of these JVs is critical, as Orgenesis Inc. (ORGS) receives a royalty in the range of 10% of net sales from the JV Entity. For the trailing twelve months leading up to mid-2025, the company reported a net loss of approximately $34.4 million against its minimal revenue, so sharing risk via JVs is a defintely necessary component of its strategy.

Finance: draft 13-week cash view by Friday.

Orgenesis Inc. (ORGS) - Canvas Business Model: Channels

You're looking at the channels Orgenesis Inc. (ORGS) uses to get its decentralized Point of Care (POCare) Platform and therapies to market as of late 2025. The reality is, the financial results from these channels are still small, reflecting the early stage of this disruptive model.

Direct sales and licensing of POCare Technology to hospitals and institutions.

This channel involves transferring the proprietary, automated, and closed-system POCare Technology to centers, ensuring they meet Good Manufacturing Practices (GMP) while maintaining central quality control. Revenue here comes from technology transfer fees and ongoing service fees. While the company aims for broad adoption, the Trailing Twelve Month (TTM) revenue as of mid-2025 was only approximately $0.90 million, showing this channel is in the early build-out phase. The company's U.S. Subsidiary, Orgenesis Maryland Inc., is currently focused on setting up and providing these POCare Services to the network.

POCare Network: a global foundation for development and distribution.

The POCare Network is the collaborative structure connecting patients, doctors, industry partners, research institutes, and hospitals globally. This network is key for harmonized, regulated clinical development and therapy distribution. Orgenesis applies its know-how to build long-term opportunities through processing licenses and royalties at this network level. The company's Belgian Subsidiary is focused on expanding this network in Europe.

• The network facilitates the distribution of licensed POCare Therapeutics.
• It brings together partners for standardized clinical development.
• Koligo Therapeutics, Inc., an Orgenesis subsidiary, uses the POCare network for US and international commercialization of its metabolic pipeline.

Joint Venture entities for commercializing Longevity & Wellness services in key regions.

Orgenesis Inc. has stated its intent to develop additional joint venture relationships as a way to produce demonstrable revenues. While specific, active Longevity & Wellness focused Joint Ventures with 2025 revenue figures aren't public, the strategy is clear: use JVs to scale commercialization in specific regions. The company secured an investment of up to $50 million in 2022 for its U.S.-based POCare Services subsidiary, Morgenesis LLC, which validates the decentralized model that JVs would leverage. Also, the company acquired Neurocords LLC in March 2025, which is part of its growth strategy across different business areas.

Clinical trial sites for pipeline therapy delivery.

The pipeline therapies are validated in multi-center clinical trials conducted across POCare partner sites, leveraging the network's robustness. The Belgian Subsidiary is specifically focused on the preparation of European clinical trials. The ORG-101 CAR-T therapy, for instance, achieved an 82% complete response rate in adults with Acute Lymphoblastic Leukemia during trials. The HiCAR-T therapy is listed as being in the IND enabling studies stage.

Here's a quick look at the financial context surrounding the execution of these channels as of late 2025:

Financial Metric (TTM as of mid-2025)	Amount	Context
Trailing Twelve Month Revenue	$0.90 million	Revenue generated from all commercial activities, including licensing and services.
Trailing Twelve Month Net Loss	$34.4 million	Reflects the high investment required to build out the decentralized manufacturing and network channels.
Recent Capital Raise (2025)	Up to $5 million	Flexible capital secured via an equity line to fund ongoing operations and channel development.
Gross Margin (Q3 2024)	-97.7%	Indicates significant cost of goods sold relative to minimal revenue from early-stage channel activity.

The clinical pipeline itself is a channel driver, as successful trials create the product that the POCare Network and technology sales are meant to support. For example, the ORG-101 therapy's 82% response rate is a key data point used to attract new partners to the network.

Finance: draft 13-week cash view by Friday.

Orgenesis Inc. (ORGS) - Canvas Business Model: Customer Segments

You're looking at Orgenesis Inc. (ORGS) and trying to map out exactly who they serve right now, late in 2025. The customer base is split across clinical adoption of their decentralized manufacturing platform, specialized service contracts, and a newer wellness venture. The quick math shows that while the current trailing twelve months (TTM) revenue as of mid-2025 is only about $0.90 million, the potential contract value and market size for their target segments are significantly larger.

Hospitals and medical centers seeking in-house CGT manufacturing capabilities

This segment is the core of the Octomera/POCare network adoption. These institutions partner with Orgenesis Inc. to deploy the closed and automated POCare technology systems for processing and producing cell and gene therapies near the patient. The company has signed POCare Network contracts that hold the potential to generate more than $40 million in revenue over the next three years if fully realized. The network currently consists of research institutes and hospitals utilizing this decentralized model.

Biotech and pharmaceutical companies needing CGT process development expertise

Orgenesis Inc. serves as a specialized partner, offering expertise in cell and gene therapy process development and technology transfer, often under Good Manufacturing Practice (GMP) standards. This service revenue is a significant component of the current, albeit small, revenue base. The broader U.S. cell & gene therapy contract research organizations market size was estimated at $2.09 billion in 2024 and is projected to reach $2.28 billion in 2025. Orgenesis Inc. is focused on providing the specialized know-how that many biotech firms lack for scaling production.

Patients with specific diseases (e.g., leukemia, spinal cord injuries)

This segment is served indirectly through the therapies in development and the acquisition of new platforms. For the ORG-101 CAR-T therapy targeting CD19+ Acute Lymphoblastic Leukemia (B-ALL), a real-world study demonstrated an 82% complete response rate in adults and a 93% complete response rate in pediatric patients. Furthermore, the March 2025 acquisition of Neurocords LLC assets targets Spinal Cord Injury (SCI) therapies, a global treatment market projected to reach $11.2 billion by 2031.

The key customer-facing metrics for these segments are summarized below:

Customer Segment Group	Key Metric/Data Point	Associated Value/Amount (2025 Data)
Hospitals/Medical Centers (POCare Network)	Potential Contract Revenue (Next 3 Years)	Over $40 million
Biotech/Pharma (Process Development Services)	U.S. CRO Market Projection for 2025	$2.28 billion
Patients (ORG-101 CAR-T Efficacy)	Pediatric Complete Response Rate	93%
Patients (Neurocords/SCI Market)	Projected SCI Market Size by 2031	$11.2 billion
Orgenesis Inc. (Overall TTM Revenue)	Trailing Twelve Months Revenue (mid-2025)	$899.00K

Global consumers for Longevity & Wellness services (via HSHG JV)

The joint venture with Harley Street Healthcare Group (HSHG) targets the Longevity & Wellness sector, utilizing Orgenesis Inc.'s know-how for disease prevention. This initiative involves an investment commitment of up to $10 million over 3 years. The JV expects to introduce services in key geographic markets including the UK, UAE, and Canada. This represents a strategic diversification away from the core oncology/regenerative medicine focus.

• HSHG JV Investment Commitment Period: 3 years.
• HSHG JV Maximum Investment: Up to $10 million.
• Targeted Initial Markets: UK, UAE, and Canada.
• Therapy Pipeline Support: Utilization of know-how developed for cancer treatment and disease prevention.

Finance: draft 13-week cash view by Friday.

Orgenesis Inc. (ORGS) - Canvas Business Model: Cost Structure

You're looking at the cost side of Orgenesis Inc. (ORGS) as of late 2025, and honestly, the numbers paint a clear picture of a company heavily invested in its platform while burning through capital. The cost structure is dominated by the necessary, but expensive, work to advance its technology and pipeline.

The most striking feature is the deeply negative profitability, which is typical for a pre-commercial, high-tech biotech, but the scale here is significant. The trailing twelve months (TTM) net loss, as of mid-2025, stood at approximately $34.4 million. This loss is the result of high operating expenses outpacing minimal revenue, which was only about $0.90 million for the TTM period ending mid-2025.

The margin profile is extremely challenging. For the third quarter of 2024, the gross margin was reported as deeply negative at -97.7%. Looking at the TTM figures that align with the mid-2025 loss, the Gross Margin was calculated at -97.66%. This indicates that the cost of revenue significantly exceeds the revenue generated from operations.

Here's a breakdown of the major cost components based on the latest available TTM data, which corresponds to the period leading up to mid-2025:

Cost Category	Trailing Twelve Months (TTM) Amount (Millions of US $)
Total Net Loss	$-34.41
Gross Profit	$-0.878
Operating Income (Loss)	$-25.87
Pretax Income (Loss)	$-35.35
Research and Development Expenses	$2.54
Selling, General, and Administrative (SG&A) Expenses	$0.96

The Research and Development (R&D) expenses are a core cost driver, essential for pipeline advancement, particularly for therapies like ORG-101 targeting CD19+ leukemia. The TTM R&D expense was $2.54 million. This investment supports the ongoing development and validation of the technology.

General and administrative (G&A) overhead, which is captured within the SG&A line item, was $0.96 million for the TTM period. This covers the fixed costs of running the corporate structure, separate from the direct costs of R&D or cost of revenue.

Costs related to the POCare Centers and OMPULs (Orgenesis Mobile Processing Unit and Lab technology) are embedded within R&D and capital expenditures, though specific deployment costs for 2025 aren't itemized in the latest summaries. The strategy, however, aims to reduce implementation time from 18-24 months down to 3-6 months, which should eventually lower the upfront capital and validation costs per unit deployed. The company has historically made significant investments in developing the OMPULs, with the majority of that development work reportedly completed.

You should keep an eye on cash burn, too. The TTM Free Cash Flow was negative at $-15.74 million. That's a lot of cash leaving the building every year just to keep the lights on and the labs running.

Finance: draft 13-week cash view by Friday.

Orgenesis Inc. (ORGS) - Canvas Business Model: Revenue Streams

You're looking at Orgenesis Inc. (ORGS) and seeing a company whose revenue streams are still heavily weighted toward platform adoption and support services, not yet from fully commercialized, high-volume cell and gene therapies (CGT). Honestly, the financial reality is that the revenue base is minimal right now, which is typical for a micro-cap biotech pivoting to a decentralized manufacturing model. The trailing twelve months (TTM) revenue as of mid-2025 was approximately $0.90 million.

The current income generation is built on supporting the adoption of the proprietary POCare Platform and related services. Here's how Orgenesis Inc. is bringing in cash as of late 2025:

• Licensing fees for the proprietary POCare Platform.
• Service fees from process development and regulatory support.
• Potential future royalties or sales from commercialized CGT products.
• Revenue from Longevity & Wellness services (via the HSHG Joint Venture).

The POCare Platform revenue is the core, coming from licensing the system and providing the necessary support to get hospitals and research centers operational. This is the Octomera segment focus: process development and optimization for decentralized manufacturing. The company is actively working to build out its network, which is key to scaling this revenue line. If onboarding takes 14+ days, churn risk rises, so execution here is critical.

For the CGT pipeline, the revenue is still prospective, tied to the Therapies segment, which focuses on developing and out-licensing advanced therapies. This is where the big potential royalties or sales would eventually land, but for now, it's R&D expense, not revenue. The company is also advancing its ORG-101 CAR-T therapy pipeline, with early data from the Phase 1/2 study in Greece expected in Q4 2025, which could be a major inflection point for future licensing value.

The Longevity & Wellness stream is a newer angle through the strategic joint venture (JV) with Harley Street Healthcare Group (HSHG), where Orgenesis Inc. holds a 49% stake. This JV targets markets like the UK, UAE, and Canada with services such as immune cell banking and longevity therapies under a Health-Wellness-as-a-Service (HWAAS) model. HSHG committed to invest up to $10 million over the next three years into both Orgenesis Inc. and the JV.

To give you a sense of the historical revenue mix before the full pivot, here's a look at the disaggregated revenue streams from a prior full fiscal year, which helps map the types of activities generating income:

Revenue Stream Type	Revenue (in thousands) - Year Ended Dec 31, 2022	Revenue (in thousands) - Year Ended Dec 31, 2021
POCare development services	$14,894	$32,192
Cell process development services and hospital services	$11,212	$3,310
POCare cell processing	$9,919	$0
Total Revenue	$36,025	$35,502

Note that the TTM revenue of $0.90 million as of mid-2025 is a stark contrast to the 2022 total of $36.03 million, reflecting the sale of the centralized manufacturing CDMO business (Masthercell) to focus on the POCare platform. That sale generated approximately $127 million in proceeds, which was used to accelerate the POC business.

Finance: draft 13-week cash view by Friday.