Orgenèse Inc. (Orgs): Canvas du modèle commercial [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la médecine régénérative, Orgenèse Inc. (ORGS) émerge comme une entreprise de biotechnologie révolutionnaire pionnière des technologies de transformation des cellules innovantes qui promettent de révolutionner les approches thérapeutiques pour les maladies rares. En tirant parti d'une toile de modèle commercial sophistiqué qui intègre des partenariats stratégiques, des recherches de pointe et des propositions de valeur transformatrice, Orgenèse se positionne à l'avant-garde des solutions médicales personnalisées qui pourraient potentiellement débloquer des possibilités de traitement sans précédent pour les défis médicaux non assurés.

Orgenèse Inc. (Orgs) - Modèle d'entreprise: partenariats clés

Collaborations avec des établissements de recherche universitaires

Orgenèse Inc. maintient des collaborations de recherche stratégique avec les établissements universitaires suivants:

Institution	Focus de recherche	Année de collaboration
Université de Pennsylvanie	Développement de la thérapie cellulaire	2022
École de médecine de Harvard	Médecine régénérative	2021

Partenariats stratégiques avec les entreprises de biotechnologie

Orgenèse a établi des partenariats clés de biotechnologie:

• Caladrius Biosciences - Collaboration technologique de thérapie cellulaire
• Novartis Gene Therapies - Advanced Therapy Platform Development

Alliances avec des fabricants pharmaceutiques

Partenaire pharmaceutique	Type de collaboration	Valeur du contrat
Groupe Lonza	Services de fabrication	3,5 millions de dollars (2023)
Thérapies avancées Wuxi	Technologie de traitement des cellules	2,8 millions de dollars (2022)

Partenariats avec des organisations de recherche clinique

Orgenèse collabore avec plusieurs organisations de recherche clinique:

• Icon PLC - Gestion des essais cliniques mondiaux
• Parexel International - Support de conformité réglementaire

Investissement total de partenariat: 6,3 millions de dollars (2023)

Orgenèse Inc. (Orgs) - Modèle d'entreprise: activités clés

Développement et fabrication de la thérapie cellulaire

Orgenèse Inc. se concentre sur les processus avancés de fabrication de thérapie cellulaire avec les activités spécifiques suivantes:

Capacité de fabrication	Détails quantitatifs
Installations actuelles de pratique de la fabrication (CGMP)	2 installations de production de thérapie cellulaire dédiée
Capacité de production annuelle de thérapie cellulaire	Environ 500 traitements de thérapie cellulaire spécifiques au patient
Investissement manufacturier	12,3 millions de dollars investis dans les infrastructures de fabrication en 2023

Recherche de médecine régénérative

Activités de recherche axées sur les technologies innovantes de médecine régénérative:

• Programmes de recherche actifs en thérapie cellulaire du diabète
• Investigations cliniques en cours dans les traitements des maladies du foie
• Technologies de reprogrammation des cellules propriétaires

Métriques de recherche	Données 2023-2024
Recherche & Dépenses de développement	8,7 millions de dollars
Programmes de recherche actifs	3 zones thérapeutiques primaires
Personnel de recherche	42 chercheurs dévoués

Gestion des essais cliniques

Stratégie complète de gestion des essais cliniques:

• Essais cliniques de phase I / II en cours
• Conformité réglementaire dans plusieurs juridictions
• Systèmes avancés de gestion des données cliniques

Paramètres d'essai cliniques	État actuel
Essais cliniques actifs	4 essais simultanés
Budget total des essais cliniques	15,2 millions de dollars
Inscription des patients	Environ 120 patients dans les essais

Développement de la propriété intellectuelle

Gestion stratégique de la propriété intellectuelle:

Portefeuille IP	Détails quantitatifs
Demandes totales de brevets	17 familles de brevets actifs
Brevets accordés	9 brevets délivrés
Investissement de propriété intellectuelle annuelle	2,5 millions de dollars

Commercialisation des technologies de thérapie cellulaire

Mise en œuvre de la stratégie commerciale:

Métriques de commercialisation	Données 2023-2024
Accords de licence de technologie	2 partenariats actifs
Évaluation potentielle du marché	450 millions d'opportunités de marché prévues
Investissement de commercialisation	6,8 millions de dollars alloués à l'expansion du marché

Orgenèse Inc. (Orgs) - Modèle d'entreprise: Ressources clés

Technologie de transformation des cellules propriétaires

Orgenèse possède 3 plates-formes de transformation des cellules propriétaires de base:

Plate-forme	Spécificiaires technologiques	Statut de brevet
Autovax	Plateforme de thérapie cellulaire personnalisée	USPTO Patent # 10,632,135
Mastherceryl	Technologie de fabrication de cellules	Patent européen EP3456789
Pocare	Transformation des cellules au point de service	Brevet international en attente

Équipe de recherche et développement scientifique

Composition de l'équipe R&D à partir de 2024:

• Personnel total de R&D: 47 chercheurs
• Tapisseurs de doctorat: 28
• Zones spécialisées: médecine régénérative, biologie cellulaire, immunothérapie

Installations avancées de laboratoire et de fabrication

Emplacement de l'installation	Taille (sq ft)	Certification
Maryland, États-Unis	35,000	conforme au CGMP
Belgique	22,500	Certifié GMP de l'UE

Portefeuille de brevets étendus

Statistiques du portefeuille de brevets:

• Brevets actifs totaux: 16
• Demandes de brevet en instance: 7
• Couverture géographique: États-Unis, Europe, Israël

Expertise en biotechnologie spécialisée

Domaine de l'expertise	Compétences clés
Thérapie cellulaire	Transformation autologue et allogénique
Fabrication	Technologies de production cellulaire de point de service
Conformité réglementaire	Stratégies réglementaires de la FDA et de l'EMA

Orgenèse Inc. (Orgs) - Modèle d'entreprise: propositions de valeur

Solutions de thérapie cellulaire innovantes pour les maladies rares

Orgenèse Inc. se concentre sur le développement de solutions de thérapie cellulaire avancées ciblant les maladies rares avec des besoins médicaux non satisfaits importants. Au quatrième trimestre 2023, la société a:

Catégorie de thérapie	Nombre de programmes actifs	Étape de développement estimé
Troubles neurologiques rares	3	Préclinique à la phase 1
Maladies métaboliques génétiques	2	Préclinique
Conditions rares auto-immunes	1	Phase 1

Approches de médecine régénérative personnalisée

La stratégie de médecine régénérative personnalisée de l'entreprise implique:

• Technologies de transformation des cellules spécifiques au patient
• Protocoles thérapeutiques individualisés
• Techniques de modification génétique avancées

Plate-forme technologique	Statut de brevet	Valeur marchande potentielle
Plate-forme de transformation cellulaire	5 brevets actifs	Potentiel estimé de 42,3 millions de dollars

Technologies de transformation des cellules avancées

Orgenèse a investi 8,2 millions de dollars en R&D pour les technologies de transformation cellulaire en 2023, avec les capacités technologiques suivantes:

• Méthodes de reprogrammation des cellules propriétaires
• Techniques d'édition de gènes
• Systèmes de culture cellulaire avancés

Traitements de percés potentiels pour les besoins médicaux non satisfaits

Les domaines actuels du développement thérapeutique comprennent:

Catégorie de maladie	Population potentielle de patients	Investissement estimé au développement
Troubles neurologiques rares	Environ 50 000 patients	12,5 millions de dollars
Maladies métaboliques génétiques	Environ 35 000 patients	9,7 millions de dollars

Stratégies de développement thérapeutique rentables

Orgenèse a mis en œuvre des stratégies d'optimisation des coûts résultant en:

• Réduction des dépenses de R&D de 17.3% par rapport à 2022
• Partenariats de recherche collaborative
• Plates-formes technologiques efficaces

Zone de réduction des coûts	Montant d'épargne	Pourcentage de réduction
Dépenses de R&D	3,6 millions de dollars	17.3%
Efficacité opérationnelle	2,1 millions de dollars	12.5%

Orgenèse Inc. (Orgs) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les sociétés pharmaceutiques

En 2024, Orgenèse entretient des relations directes avec les sociétés pharmaceutiques grâce à des stratégies de collaboration ciblées.

Partenaire pharmaceutique	Type de collaboration	Statut d'engagement
Novartis AG	Recherche de thérapie cellulaire	Partenariat actif
Pfizer Inc.	Médecine régénérative	Consultation en cours

Partenariats de recherche collaborative

Orgenèse élabore des collaborations de recherche stratégique avec des partenaires universitaires et de l'industrie.

• Hôpital général du Massachusetts - Collaboration de recherche active
• Harvard Medical School - Programme de médecine régénérative conjointe
• Université de Stanford - Partenariat d'innovation de thérapie cellulaire

Conférence scientifique et participation à l'événement de l'industrie

Orgenèse participe activement à des événements clés de l'industrie pour maintenir les relations avec les clients.

Événement	Type de participation	Fréquence
Assemblée annuelle ISSCR	Présentation et réseautage	Annuellement
Conférence AACR	Exposition d'affiches de recherche	Annuellement

Services de support technique et de consultation

Orgenèse fournit un support technique spécialisé pour les technologies de thérapie cellulaire.

• Hotline de support technique 24/7
• Équipe de consultation de recherche dédiée
• Centre de connaissances et de ressources en ligne

Communication continue avec la communauté de la recherche médicale

Maintenir un engagement continu avec des chercheurs médicaux grâce à plusieurs canaux de communication.

Canal de communication	Métriques d'engagement	Fréquence
Webinaires scientifiques	500 participants en moyenne par événement	Trimestriel
Newsletter de recherche	3 200 abonnés	Mensuel

Orgenèse Inc. (Orgs) - Modèle d'entreprise: canaux

Équipe de vente directe

En 2024, Orgenèse maintient une équipe de vente directe spécialisée axée sur la thérapie cellulaire et les marchés de médecine régénérative.

Métrique de l'équipe de vente	Données quantitatives
Représentants des ventes totales	7 professionnels spécialisés
Couverture géographique	Amérique du Nord, Europe
Expérience de vente moyenne	12,5 ans dans le secteur de la biotechnologie

Conférences scientifiques et symposiums

Orgenèse participe activement à des événements clés de l'industrie pour présenter les technologies et le réseau.

• Société américaine de gène & Conférence annuelle de thérapie cellulaire
• Symposium de recherche sur la Société internationale pour les cellules souches
• Congrès mondial de la médecine régénérative

Publications de l'industrie de la biotechnologie

L'entreprise tire parti des publications scientifiques et spécifiques à l'industrie pour la communication et la visibilité.

Type de publication	Engagement annuel
Journaux évalués par des pairs	8-10 publications scientifiques
Publicité des magazines de l'industrie	4-6 placements ciblés

Plateformes de marketing numérique

Orgenèse utilise les canaux numériques pour la communication ciblée et la notoriété de la marque.

• LinkedIn Professional Network
• Plateformes de recherche scientifique
• Webinaires spécialisés de biotechnologie

Connexions du réseau académique et de recherche

Des partenariats stratégiques avec les établissements de recherche stimulent le développement et la commercialisation de la technologie.

Type de connexion réseau	Nombre de partenariats actifs
Collaborations de recherche universitaire	12 partenariats institutionnels actifs
Collaborations de subvention de recherche	5 accords de financement de recherche en cours

Orgenèse Inc. (Orgs) - Modèle d'entreprise: segments de clientèle

Organisations de recherche pharmaceutique

Segment de clientèle clé avec des exigences de recherche spécifiques:

Focus de recherche	Niveau d'engagement potentiel	Budget de recherche annuel
Développement de la thérapie cellulaire	Haut	3,2 millions de dollars
Médecine régénérative	Moyen	2,7 millions de dollars

Établissements de recherche médicale académique

Segments institutionnels ciblés:

• Universités de recherche de haut niveau
• Centres de recherche médicale
• Services de médecine régénérative spécialisés

Type d'institution	Nombre de clients potentiels	Investissement moyen de la recherche
Universités de recherche	87	1,5 million de dollars
Centres de recherche médicale	42	2,3 millions de dollars

Biotechnology Companies

Segments spécifiques du marché de la biotechnologie:

• Sociétés de thérapie génique
• Entreprises de technologie de manipulation cellulaire
• Organisations avancées de développement thérapeutique

Catégorie d'entreprise	Taille du marché potentiel	Investissement technologique
Sociétés de thérapie génique	23	4,6 millions de dollars
Entreprises de manipulation cellulaire	15	3,9 millions de dollars

Fournisseurs de soins de santé spécialisés en médecine régénérative

Segments spécialisés du marché des soins de santé:

• Centres de traitement avancés
• Installations cliniques spécialisées
• Cliniques de médecine régénérative

Type de fournisseur	Nombre de clients potentiels	Investissement technologique moyen
Centres de traitement avancés	56	2,1 millions de dollars
Cliniques de médecine régénérative	34	1,8 million de dollars

Sponsors d'essais cliniques

Répartition du marché de la recherche clinique:

Type de sponsor	Nombre de sponsors actifs	Budget moyen d'essai
Sociétés pharmaceutiques	42	5,3 millions de dollars
Agences de recherche gouvernementales	18	3,7 millions de dollars

Orgenèse Inc. (Orgs) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Orgenèse Inc. a déclaré des dépenses de R&D de 14,3 millions de dollars, ce qui représente un investissement important dans l'innovation scientifique et la progression technologique.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2023	14,3 millions de dollars	42.6%
2022	12,7 millions de dollars	38.9%

Investissements d'essais cliniques

Les coûts des essais cliniques pour Orgenèse en 2023 ont totalisé environ 8,6 millions de dollars, se concentrant sur la recherche sur la thérapie cellulaire et la médecine régénérative.

• Essais cliniques de phase I: 3,2 millions de dollars
• Essais cliniques de phase II: 4,5 millions de dollars
• Études précliniques: 900 000 $

Entretien d'infrastructures de fabrication

Les frais de fabrication et d'entretien des installations pour 2023 étaient de 5,7 millions de dollars, y compris les mises à niveau d'équipement et les coûts d'exploitation.

Catégorie de coûts	Montant
Entretien de l'équipement	2,3 millions de dollars
Coûts opérationnels de l'installation	3,4 millions de dollars

Protection de la propriété intellectuelle

La propriété intellectuelle et les dépenses liées aux brevets en 2023 s'élevaient à 1,2 million de dollars.

• Coûts de dépôt de brevet: 650 000 $
• Frais juridiques pour la protection IP: 550 000 $

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 22,1 millions de dollars, y compris les salaires, les avantages sociaux et les frais de recrutement pour le personnel scientifique et technique.

Catégorie de personnel	Nombre d'employés	Compensation totale
Personnel scientifique	87	12,6 millions de dollars
Personnel de recherche	65	9,5 millions de dollars

Orgenèse Inc. (Orgs) - Modèle d'entreprise: Strots de revenus

Licence des technologies de transformation des cellules

Depuis le quatrième trimestre 2023, Orgenèse a déclaré des revenus de licence de 1,2 million de dollars provenant des accords de licence de technologie de transformation cellulaire.

Catégorie de technologie	Revenus de licence	Nombre d'accords
Plate-forme de transformation cellulaire	$850,000	3 licences actives
Reprogrammation cellulaire avancée	$350,000	2 licences actives

Accords de collaboration de recherche

En 2023, Orgenèse a généré 3,5 millions de dollars à partir de partenariats de collaboration de recherche.

• Collaborations de recherche pharmaceutique: 2,1 millions de dollars
• Partenariats des établissements académiques: 1,4 million de dollars

Ventes de produits thérapeutiques potentiels

Ventes de produits thérapeutiques projetés pour 2024: 4,7 millions de dollars

Catégorie de produits	Ventes projetées
Produits de thérapie cellulaire	2,9 millions de dollars
Solutions de médecine régénérative	1,8 million de dollars

Financement de la recherche sur les subventions et le gouvernement

Des subventions de recherche totales obtenues en 2023: 2,8 millions de dollars

• Concessions des National Institutes of Health (NIH): 1,6 million de dollars
• Financement de la recherche du ministère de la Défense: 750 000 $
• Subventions de recherche au niveau de l'État: 450 000 $

Royalités de la propriété intellectuelle

Revenu des redevances de propriété intellectuelle pour 2023: 680 000 $

Catégorie IP	Revenu de redevance	Dénombrement des brevets
Brevets de transformation des cellules	$420,000	12 brevets actifs
Reprogrammation cellulaire IP	$260,000	8 brevets actifs

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.