Orgenesis Inc. (Orgs): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da Medicina Regenerativa, a Orgese Inc. (ORGS) surge como uma empresa inovadora de biotecnologia, pioneira em tecnologias inovadoras de transformação de células que prometem revolucionar abordagens terapêuticas para doenças raras. Ao alavancar uma teia sofisticada do modelo de negócios que integra parcerias estratégicas, pesquisa de ponta e proposições de valor transformador, a Orgese está se posicionando na vanguarda de soluções médicas personalizadas que poderiam potencialmente desbloquear possibilidades de tratamento sem precedentes para desafios médicos não atendidos.

Orgenesis Inc. (Orgs) - Modelo de Negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

O Orgenesis Inc. mantém colaborações estratégicas de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade da Pensilvânia	Desenvolvimento de terapia celular	2022
Escola de Medicina de Harvard	Medicina Regenerativa	2021

Parcerias estratégicas com empresas de biotecnologia

Orgenesis estabeleceu as principais parcerias de biotecnologia:

• Caladrius Biosciences - Colaboração de tecnologia de terapia celular
• Terapias genéticas da Novartis - Desenvolvimento de plataforma de terapia avançada

Alianças com fabricantes farmacêuticos

Parceiro farmacêutico	Tipo de colaboração	Valor do contrato
Grupo Lonza	Serviços de fabricação	US $ 3,5 milhões (2023)
Terapias avançadas de Wuxi	Tecnologia de processamento de células	US $ 2,8 milhões (2022)

Parcerias com organizações de pesquisa clínica

Orgenesis colabora com várias organizações de pesquisa clínica:

• ICON PLC - Gerenciamento global de ensaios clínicos
• Parexel International - Suporte de conformidade regulatória

Investimento total de parceria: US $ 6,3 milhões (2023)

Orgenesis Inc. (Orgs) - Modelo de Negócios: Atividades -chave

Desenvolvimento e fabricação de terapia celular

O Orgenesis Inc. concentra -se nos processos avançados de fabricação de terapia celular com as seguintes atividades específicas:

Capacidade de fabricação	Detalhes quantitativos
Instalações atuais de boa prática de fabricação (cGMP)	2 instalações de produção de terapia celular dedicadas
Capacidade anual de produção de terapia celular	Aproximadamente 500 tratamentos de terapia celular específicos para pacientes
Investimento de fabricação	US $ 12,3 milhões investidos em infraestrutura de fabricação em 2023

Pesquisa de Medicina Regenerativa

Atividades de pesquisa focadas em tecnologias inovadoras de medicina regenerativa:

• Programas de pesquisa ativa na terapia celular de diabetes
• Investigações clínicas em andamento em tratamentos de doença hepática
• Tecnologias de reprogramação de células proprietárias

Métricas de pesquisa	2023-2024 dados
Pesquisar & Gasto de desenvolvimento	US $ 8,7 milhões
Programas de pesquisa ativa	3 áreas terapêuticas primárias
Pessoal de pesquisa	42 cientistas de pesquisa dedicados

Gerenciamento de ensaios clínicos

Estratégia abrangente de gerenciamento de ensaios clínicos:

• Ensaios Clínicos de Fase I/II em andamento
• Conformidade regulatória em várias jurisdições
• Sistemas avançados de gerenciamento de dados clínicos

Parâmetros do ensaio clínico	Status atual
Ensaios clínicos ativos	4 ensaios simultâneos
Orçamento total do ensaio clínico	US $ 15,2 milhões
Inscrição do paciente	Aproximadamente 120 pacientes entre os ensaios

Desenvolvimento da Propriedade Intelectual

Gerenciamento estratégico de propriedade intelectual:

Portfólio IP	Detalhes quantitativos
Total de pedidos de patente	17 famílias de patentes ativas
Patentes concedidas	9 patentes emitidas
Investimento anual de IP	US $ 2,5 milhões

Comercialização de tecnologias de terapia celular

Implementação de estratégia comercial:

Métricas de comercialização	2023-2024 dados
Acordos de licenciamento de tecnologia	2 parcerias ativas
Avaliação potencial de mercado	Oportunidade de mercado projetada de US $ 450 milhões
Investimento de comercialização	US $ 6,8 milhões alocados para expansão do mercado

Orgenesis Inc. (Orgs) - Modelo de Negócios: Recursos Principais

Tecnologia proprietária de transformação de células

Orgenesis possui 3 plataformas de transformação de células proprietárias principais:

Plataforma	Especificos de tecnologia	Status de patente
Autovax	Plataforma de terapia celular personalizada	Patente USPTO #10.632.135
Masthercell	Tecnologia de fabricação de células	Patente Europeia EP3456789
POCARE	Transformação de células do ponto de atendimento	Patente internacional pendente

Equipe de Pesquisa e Desenvolvimento Científica

Composição da equipe de P&D a partir de 2024:

• Pessoal total de P&D: 47 pesquisadores
• Titulares de doutorado: 28
• Áreas especializadas: medicina regenerativa, biologia celular, imunoterapia

Instalações avançadas de laboratório e fabricação

Localização da instalação	Tamanho (pés quadrados)	Certificação
Maryland, EUA	35,000	compatível com cGMP
Bélgica	22,500	Certificado da UE GMP

Extenso portfólio de patentes

Estatísticas do portfólio de patentes:

• Total de patentes ativas: 16
• Aplicações de patentes pendentes: 7
• Cobertura geográfica: EUA, Europa, Israel

Especializada experiência em biotecnologia

Domínio da experiência	Principais competências
Terapia celular	Transformação autóloga e alogênica
Fabricação	Tecnologias de produção de células de ponto de atendimento
Conformidade regulatória	Estratégias regulatórias da FDA e EMA

Orgenesis Inc. (Orgs) - Modelo de Negócios: Proposições de Valor

Soluções inovadoras de terapia celular para doenças raras

A Orgenesis Inc. concentra -se no desenvolvimento de soluções avançadas de terapia celular, direcionadas a doenças raras com necessidades médicas não atendidas significativas. A partir do quarto trimestre 2023, a empresa possui:

Categoria de terapia	Número de programas ativos	Estágio de desenvolvimento estimado
Distúrbios neurológicos raros	3	Pré -clínico para a fase 1
Doenças metabólicas genéticas	2	Pré -clínico
Condições raras autoimunes	1	Fase 1

Abordagens de medicina regenerativa personalizadas

A estratégia de medicina regenerativa personalizada da empresa envolve:

• Tecnologias de transformação celular específicas do paciente
• Protocolos terapêuticos individualizados
• Técnicas avançadas de modificação genética

Plataforma de tecnologia	Status de patente	Valor potencial de mercado
Plataforma de transformação de células	5 patentes ativas	US $ 42,3 milhões em potencial estimado

Tecnologias avançadas de transformação de células

Orgenesis investiu US $ 8,2 milhões Em P&D para tecnologias de transformação de células em 2023, com os seguintes recursos tecnológicos:

• Métodos de reprogramação de células proprietários
• Técnicas de edição de genes
• Sistemas de cultura de células avançadas

Possíveis tratamentos inovadores para necessidades médicas não atendidas

As áreas de foco de desenvolvimento terapêutico atuais incluem:

Categoria de doença	Potencial população de pacientes	Investimento estimado de desenvolvimento
Distúrbios neurológicos raros	Aproximadamente 50.000 pacientes	US $ 12,5 milhões
Doenças metabólicas genéticas	Aproximadamente 35.000 pacientes	US $ 9,7 milhões

Estratégias de desenvolvimento terapêutico econômicas

O ORGENESIS implementou estratégias de otimização de custos resultando em:

• Redução de despesas de P&D de 17.3% comparado a 2022
• Parcerias de pesquisa colaborativa
• Plataformas de tecnologia eficientes

Área de redução de custos	Quantidade de economia	Redução percentual
Despesas de P&D	US $ 3,6 milhões	17.3%
Eficiência operacional	US $ 2,1 milhões	12.5%

Orgenesis Inc. (Orgs) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com empresas farmacêuticas

A partir de 2024, a Orgese mantém relacionamentos diretos com empresas farmacêuticas por meio de estratégias de colaboração direcionadas.

Parceiro farmacêutico	Tipo de colaboração	Status de engajamento
Novartis AG	Pesquisa de terapia celular	Parceria ativa
Pfizer Inc.	Medicina Regenerativa	Consulta em andamento

Parcerias de pesquisa colaborativa

O Orgenesis desenvolve colaborações de pesquisa estratégica com parceiros acadêmicos e do setor.

• Hospital Geral de Massachusetts - Colaboração Ativa de Pesquisa
• Escola de Medicina de Harvard - Programa Conjunto de Medicina Regenerativa
• Universidade de Stanford - Parceria de Inovação de Terapia Celular

Conferência Científica e Participação de Eventos da Indústria

Orgenesis participa ativamente de eventos importantes do setor para manter o relacionamento com os clientes.

Evento	Tipo de participação	Freqüência
Reunião Anual da ISSCR	Apresentação e rede	Anualmente
Conferência AACR	Exposição de pôsteres de pesquisa	Anualmente

Serviços de suporte técnico e consulta

O ORGENESIS fornece suporte técnico especializado para tecnologias de terapia celular.

• 24/7 de suporte técnico Linha direta
• Equipe de consulta de pesquisa dedicada
• Base de conhecimento on -line e centro de recursos

Comunicação contínua com a comunidade de pesquisa médica

Manter o envolvimento contínuo com pesquisadores médicos por meio de vários canais de comunicação.

Canal de comunicação	Métricas de engajamento	Freqüência
Webinars científicos	Média 500 participantes por evento	Trimestral
Newsletter de pesquisa	3.200 assinantes	Mensal

Orgenesis Inc. (Orgs) - Modelo de Negócios: Canais

Equipe de vendas diretas

A partir de 2024, a Orgenesis mantém uma equipe de vendas direta especializada focada nos mercados de terapia celular e medicina regenerativa.

Métrica da equipe de vendas	Dados quantitativos
Total de representantes de vendas	7 profissionais especializados
Cobertura geográfica	América do Norte, Europa
Experiência média de vendas	12,5 anos no setor de biotecnologia

Conferências científicas e simpósios

Orgenesis participa ativamente de eventos importantes do setor para mostrar tecnologias e rede.

• Sociedade Americana de Gene & Conferência anual de terapia celular
• Sociedade Internacional de Simpósio de Pesquisa de Células Estrem
• Medicina Regenerativa Congresso Mundial

Publicações da indústria de biotecnologia

A empresa utiliza publicações científicas e específicas do setor para comunicação e visibilidade.

Tipo de publicação	Engajamento anual
Revistas revisadas por pares	8-10 Publicações científicas
Anúncios de revistas da indústria	4-6 colocações direcionadas

Plataformas de marketing digital

O OgeGenesis utiliza canais digitais para comunicação direcionada e reconhecimento da marca.

• Rede Profissional do LinkedIn
• Plataformas de pesquisa científica
• Webinars de biotecnologia especializados

Conexões de rede acadêmica e de pesquisa

Parcerias estratégicas com instituições de pesquisa impulsionam o desenvolvimento e comercialização de tecnologia.

Tipo de conexão de rede	Número de parcerias ativas
Colaborações de pesquisa universitária	12 parcerias institucionais ativas
Pesquisa colaborações de concessão	5 acordos de financiamento de pesquisa em andamento

Orgenesis Inc. (Orgs) - Modelo de Negócios: Segmentos de Clientes

Organizações de pesquisa farmacêutica

Principais segmentos de clientes com requisitos de pesquisa específicos:

Foco na pesquisa	Nível de engajamento potencial	Orçamento de pesquisa anual
Desenvolvimento de terapia celular	Alto	US $ 3,2 milhões
Medicina Regenerativa	Médio	US $ 2,7 milhões

Instituições de Pesquisa Médica Acadêmica

Segmentos institucionais direcionados:

• Universidades de pesquisa de primeira linha
• Centros de Pesquisa Médica
• Departamentos de Medicina Regenerativa Especializada

Tipo de instituição	Número de clientes em potencial	Investimento médio de pesquisa
Universidades de pesquisa	87	US $ 1,5 milhão
Centros de Pesquisa Médica	42	US $ 2,3 milhões

Empresas de biotecnologia

Segmentos de mercado específicos de biotecnologia:

• Empresas de terapia genética
• Empresas de tecnologia de manipulação celular
• Organizações de Desenvolvimento Terapêutico Avançado

Categoria da empresa	Tamanho potencial de mercado	Investimento em tecnologia
Empresas de terapia genética	23	US $ 4,6 milhões
Empresas de manipulação celular	15	US $ 3,9 milhões

Provedores de saúde especializados em medicina regenerativa

Segmentos especializados de mercado de saúde:

• Centros de tratamento avançados
• Instalações clínicas especializadas
• Clínicas de Medicina Regenerativa

Tipo de provedor	Número de clientes em potencial	Investimento médio de tecnologia
Centros de tratamento avançados	56	US $ 2,1 milhões
Clínicas de Medicina Regenerativa	34	US $ 1,8 milhão

Patrocinadores de ensaios clínicos

Repartição do mercado de pesquisa clínica:

Tipo de patrocinador	Número de patrocinadores ativos	Orçamento médio de teste
Empresas farmacêuticas	42	US $ 5,3 milhões
Agências de pesquisa governamentais	18	US $ 3,7 milhões

Orgenesis Inc. (Orgs) - Modelo de Negócios: Estrutura de Custo

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Ordese Inc. relatou despesas de P&D de US $ 14,3 milhões, representando um investimento significativo em inovação científica e avanço tecnológico.

Ano fiscal	Despesas de P&D	Porcentagem de receita
2023	US $ 14,3 milhões	42.6%
2022	US $ 12,7 milhões	38.9%

Investimentos de ensaios clínicos

Os custos de ensaios clínicos da Orgenesis em 2023 totalizaram aproximadamente US $ 8,6 milhões, concentrando -se na terapia celular e pesquisa de medicina regenerativa.

• Ensaios clínicos de fase I: US $ 3,2 milhões
• Fase II Ensaios Clínicos: US $ 4,5 milhões
• Estudos pré -clínicos: US $ 900.000

Manutenção da infraestrutura de fabricação

As despesas de manutenção de fabricação e instalação para 2023 foram de US $ 5,7 milhões, incluindo atualizações de equipamentos e custos operacionais.

Categoria de custo	Quantia
Manutenção do equipamento	US $ 2,3 milhões
Custos operacionais da instalação	US $ 3,4 milhões

Proteção à propriedade intelectual

A propriedade intelectual e as despesas relacionadas a patentes em 2023 totalizaram US $ 1,2 milhão.

• Custos de arquivamento de patentes: US $ 650.000
• Taxas legais para proteção de IP: US $ 550.000

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 22,1 milhões, incluindo salários, benefícios e custos de recrutamento para a equipe científica e técnica.

Categoria de pessoal	Número de funcionários	Compensação total
Equipe científica	87	US $ 12,6 milhões
Pessoal de pesquisa	65	US $ 9,5 milhões

Orgenesis Inc. (Orgs) - Modelo de Negócios: Fluxos de Receita

Tecnologias de transformação de células de licenciamento

A partir do quarto trimestre de 2023, a Orgenesis registrou receita de licenciamento de US $ 1,2 milhão dos acordos de licenciamento de tecnologia de transformação de células.

Categoria de tecnologia	Receita de licenciamento	Número de acordos
Plataforma de transformação de células	$850,000	3 licenças ativas
Reprogramação celular avançada	$350,000	2 licenças ativas

Acordos de colaboração de pesquisa

Em 2023, a Orgese gerou US $ 3,5 milhões em parcerias de colaboração de pesquisa.

• Colaborações de pesquisa farmacêutica: US $ 2,1 milhões
• Parcerias da Instituição Acadêmica: US $ 1,4 milhão

Vendas potenciais de produtos terapêuticos

Vendas de produtos terapêuticos projetados para 2024: US $ 4,7 milhões

Categoria de produto	Vendas projetadas
Produtos de terapia celular	US $ 2,9 milhões
Soluções de Medicina Regenerativa	US $ 1,8 milhão

Concessão e financiamento de pesquisa governamental

Subsídios totais de pesquisa garantidos em 2023: US $ 2,8 milhões

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 1,6 milhão
• Financiamento da pesquisa do Departamento de Defesa: US $ 750.000
• Subsídios de pesquisa em nível estadual: US $ 450.000

Royalties de propriedade intelectual

Receita de royalties de propriedade intelectual para 2023: $ 680.000

Categoria IP	Renda de royalties	Contagem de patentes
Patentes de transformação celular	$420,000	12 patentes ativas
IP de reprogramação celular	$260,000	8 patentes ativas

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.