Orgenesis Inc. (ORGS): Business Model Canvas

In der sich schnell entwickelnden Landschaft der regenerativen Medizin entwickelt sich Orgenesis Inc. (ORGS) zu einem bahnbrechenden Biotechnologieunternehmen, das innovative Zelltransformationstechnologien vorantreibt, die therapeutische Ansätze für seltene Krankheiten zu revolutionieren versprechen. Durch die Nutzung eines ausgefeilten Geschäftsmodells, das strategische Partnerschaften, Spitzenforschung und transformative Wertversprechen integriert, positioniert sich Orgenesis an der Spitze personalisierter medizinischer Lösungen, die möglicherweise beispiellose Behandlungsmöglichkeiten für ungelöste medizinische Herausforderungen eröffnen könnten.

Orgenesis Inc. (ORGS) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Orgenesis Inc. unterhält strategische Forschungskooperationen mit folgenden akademischen Institutionen:

Institution	Forschungsschwerpunkt	Jahr der Zusammenarbeit
Universität von Pennsylvania	Entwicklung der Zelltherapie	2022
Harvard Medical School	Regenerative Medizin	2021

Strategische Partnerschaften mit Biotechnologieunternehmen

Orgenesis hat wichtige biotechnologische Partnerschaften aufgebaut:

• Caladrius Biosciences – Zusammenarbeit im Bereich Zelltherapietechnologie
• Novartis Gene Therapies – Entwicklung fortschrittlicher Therapieplattformen

Allianzen mit Pharmaherstellern

Pharmazeutischer Partner	Art der Zusammenarbeit	Vertragswert
Lonza-Gruppe	Fertigungsdienstleistungen	3,5 Millionen US-Dollar (2023)
WuXi Advanced Therapies	Zellverarbeitungstechnologie	2,8 Millionen US-Dollar (2022)

Partnerschaften mit klinischen Forschungsorganisationen

Orgenesis arbeitet mit mehreren klinischen Forschungsorganisationen zusammen:

• ICON plc – Globales Management klinischer Studien
• PAREXEL International – Unterstützung bei der Einhaltung gesetzlicher Vorschriften

Gesamtinvestition der Partnerschaft: 6,3 Millionen US-Dollar (2023)

Orgenesis Inc. (ORGS) – Geschäftsmodell: Hauptaktivitäten

Entwicklung und Herstellung von Zelltherapien

Orgenesis Inc. konzentriert sich auf fortschrittliche Herstellungsprozesse für Zelltherapien mit den folgenden spezifischen Aktivitäten:

Fertigungskapazität	Quantitative Details
Aktuelle cGMP-Anlagen (Good Manufacturing Practice).	2 spezielle Produktionsanlagen für Zelltherapie
Jährliche Produktionskapazität für Zelltherapie	Etwa 500 patientenspezifische Zelltherapie-Behandlungen
Fertigungsinvestitionen	Im Jahr 2023 werden 12,3 Millionen US-Dollar in die Fertigungsinfrastruktur investiert

Forschung zur Regenerativen Medizin

Forschungsaktivitäten mit Schwerpunkt auf innovativen Technologien der regenerativen Medizin:

• Aktive Forschungsprogramme in der Diabetes-Zelltherapie
• Laufende klinische Untersuchungen zur Behandlung von Lebererkrankungen
• Proprietäre Technologien zur Zellreprogrammierung

Forschungsmetriken	Daten für 2023–2024
Forschung & Entwicklungsausgaben	8,7 Millionen US-Dollar
Aktive Forschungsprogramme	3 primäre Therapiebereiche
Forschungspersonal	42 engagierte Forscher

Klinisches Studienmanagement

Umfassende Strategie für das Management klinischer Studien:

• Laufende klinische Studien der Phase I/II
• Einhaltung gesetzlicher Vorschriften in mehreren Gerichtsbarkeiten
• Fortschrittliche klinische Datenmanagementsysteme

Parameter klinischer Studien	Aktueller Status
Aktive klinische Studien	4 gleichzeitige Versuche
Gesamtbudget für klinische Studien	15,2 Millionen US-Dollar
Patientenregistrierung	Ungefähr 120 Patienten in allen Studien

Entwicklung von geistigem Eigentum

Strategisches geistiges Eigentumsmanagement:

IP-Portfolio	Quantitative Details
Gesamtzahl der Patentanmeldungen	17 aktive Patentfamilien
Erteilte Patente	9 erteilte Patente
Jährliche IP-Investition	2,5 Millionen Dollar

Kommerzialisierung von Zelltherapietechnologien

Umsetzung der kommerziellen Strategie:

Kommerzialisierungsmetriken	Daten für 2023–2024
Technologielizenzvereinbarungen	2 aktive Partnerschaften
Mögliche Marktbewertung	Voraussichtliche Marktchance in Höhe von 450 Millionen US-Dollar
Kommerzialisierungsinvestition	6,8 Millionen US-Dollar für die Marktexpansion bereitgestellt

Orgenesis Inc. (ORGS) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Zelltransformationstechnologie

Orgenesis besitzt 3 zentrale proprietäre Zelltransformationsplattformen:

Plattform	Technische Besonderheiten	Patentstatus
AutoVax	Personalisierte Zelltherapieplattform	USPTO-Patent Nr. 10.632.135
MaSHerCell	Zellherstellungstechnologie	Europäisches Patent EP3456789
POCare	Point-of-Care-Zelltransformation	Ausstehendes internationales Patent

Wissenschaftliches Forschungs- und Entwicklungsteam

Zusammensetzung des F&E-Teams ab 2024:

• Gesamtes F&E-Personal: 47 Forscher
• Doktoranden: 28
• Spezialgebiete: Regenerative Medizin, Zellbiologie, Immuntherapie

Fortschrittliche Labor- und Produktionseinrichtungen

Standort der Einrichtung	Größe (Quadratfuß)	Zertifizierung
Maryland, USA	35,000	cGMP-konform
Belgien	22,500	EU-GMP-zertifiziert

Umfangreiches Patentportfolio

Statistiken zum Patentportfolio:

• Gesamtzahl der aktiven Patente: 16
• Ausstehende Patentanmeldungen: 7
• Geografische Abdeckung: USA, Europa, Israel

Spezialisierte Biotechnologie-Expertise

Fachgebiet	Schlüsselkompetenzen
Zelltherapie	Autologe und allogene Transformation
Herstellung	Point-of-Care-Zellenproduktionstechnologien
Einhaltung gesetzlicher Vorschriften	Regulierungsstrategien der FDA und EMA

Orgenesis Inc. (ORGS) – Geschäftsmodell: Wertversprechen

Innovative Zelltherapielösungen für seltene Krankheiten

Orgenesis Inc. konzentriert sich auf die Entwicklung fortschrittlicher Zelltherapielösungen für seltene Krankheiten mit erheblichem ungedecktem medizinischem Bedarf. Im vierten Quartal 2023 verfügt das Unternehmen über:

Therapiekategorie	Anzahl aktiver Programme	Geschätzter Entwicklungsstand
Seltene neurologische Erkrankungen	3	Präklinisch bis Phase 1
Genetische Stoffwechselerkrankungen	2	Präklinisch
Seltene Autoimmunerkrankungen	1	Phase 1

Personalisierte Ansätze der regenerativen Medizin

Die personalisierte regenerative Medizinstrategie des Unternehmens umfasst:

• Patientenspezifische Zelltransformationstechnologien
• Individuelle Therapieprotokolle
• Fortgeschrittene Techniken zur genetischen Veränderung

Technologieplattform	Patentstatus	Potenzieller Marktwert
Zelltransformationsplattform	5 aktive Patente	Geschätztes Potenzial von 42,3 Millionen US-Dollar

Fortschrittliche Zelltransformationstechnologien

Orgenesis hat investiert 8,2 Millionen US-Dollar in Forschung und Entwicklung für Zelltransformationstechnologien im Jahr 2023, mit den folgenden technologischen Fähigkeiten:

• Proprietäre Methoden zur Zellreprogrammierung
• Techniken zur Genbearbeitung
• Fortschrittliche Zellkultursysteme

Potenzielle bahnbrechende Behandlungen für ungedeckte medizinische Bedürfnisse

Zu den aktuellen Schwerpunkten der therapeutischen Entwicklung gehören:

Krankheitskategorie	Potenzielle Patientenpopulation	Geschätzte Entwicklungsinvestitionen
Seltene neurologische Erkrankungen	Ungefähr 50.000 Patienten	12,5 Millionen US-Dollar
Genetische Stoffwechselerkrankungen	Ungefähr 35.000 Patienten	9,7 Millionen US-Dollar

Kostengünstige therapeutische Entwicklungsstrategien

Orgenesis hat Kostenoptimierungsstrategien implementiert, die zu Folgendem geführt haben:

• Reduzierung der F&E-Kosten um 17.3% im Vergleich zu 2022
• Kollaborative Forschungspartnerschaften
• Effiziente Technologieplattformen

Kostensenkungsbereich	Sparbetrag	Prozentuale Reduzierung
F&E-Ausgaben	3,6 Millionen US-Dollar	17.3%
Betriebseffizienz	2,1 Millionen US-Dollar	12.5%

Orgenesis Inc. (ORGS) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Pharmaunternehmen

Ab 2024 unterhält Orgenesis durch gezielte Kooperationsstrategien direkte Beziehungen zu Pharmaunternehmen.

Pharmazeutischer Partner	Art der Zusammenarbeit	Verlobungsstatus
Novartis AG	Zelltherapieforschung	Aktive Partnerschaft
Pfizer Inc.	Regenerative Medizin	Laufende Beratung

Verbundforschungspartnerschaften

Orgenesis entwickelt strategische Forschungskooperationen mit akademischen und industriellen Partnern.

• Massachusetts General Hospital – Aktive Forschungskooperation
• Harvard Medical School – Gemeinsames Programm für regenerative Medizin
• Stanford University – Innovationspartnerschaft für Zelltherapie

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Orgenesis nimmt aktiv an wichtigen Branchenveranstaltungen teil, um die Kundenbeziehungen zu pflegen.

Veranstaltung	Teilnahmetyp	Häufigkeit
ISSCR-Jahrestagung	Präsentation und Networking	Jährlich
AACR-Konferenz	Forschungsplakatausstellung	Jährlich

Technischer Support und Beratungsdienste

Orgenesis bietet spezialisierten technischen Support für Zelltherapietechnologien.

• Technische Support-Hotline rund um die Uhr
• Engagiertes Forschungsberatungsteam
• Online-Wissensdatenbank und Ressourcenzentrum

Laufende Kommunikation mit der medizinischen Forschungsgemeinschaft

Aufrechterhaltung einer kontinuierlichen Zusammenarbeit mit medizinischen Forschern über mehrere Kommunikationskanäle.

Kommunikationskanal	Engagement-Kennzahlen	Häufigkeit
Wissenschaftliche Webinare	Durchschnittlich 500 Teilnehmer pro Veranstaltung	Vierteljährlich
Forschungsnewsletter	3.200 Abonnenten	Monatlich

Orgenesis Inc. (ORGS) – Geschäftsmodell: Kanäle

Direktvertriebsteam

Ab 2024 unterhält Orgenesis ein spezialisiertes Direktvertriebsteam, das sich auf die Märkte Zelltherapie und regenerative Medizin konzentriert.

Vertriebsteam-Metrik	Quantitative Daten
Gesamtzahl der Vertriebsmitarbeiter	7 spezialisierte Fachleute
Geografische Abdeckung	Nordamerika, Europa
Durchschnittliche Verkaufserfahrung	12,5 Jahre im Biotechnologiesektor

Wissenschaftliche Konferenzen und Symposien

Orgenesis nimmt aktiv an wichtigen Branchenveranstaltungen teil, um Technologien vorzustellen und Kontakte zu knüpfen.

• Amerikanische Gesellschaft für Gene & Jahreskonferenz zur Zelltherapie
• Symposium der Internationalen Gesellschaft für Stammzellforschung
• Weltkongress für Regenerative Medizin

Veröffentlichungen zur Biotechnologiebranche

Das Unternehmen nutzt wissenschaftliche und branchenspezifische Publikationen zur Kommunikation und Sichtbarkeit.

Veröffentlichungstyp	Jährliches Engagement
Von Experten begutachtete Zeitschriften	8-10 wissenschaftliche Veröffentlichungen
Anzeigen in Branchenzeitschriften	4-6 gezielte Platzierungen

Digitale Marketingplattformen

Orgenesis nutzt digitale Kanäle für gezielte Kommunikation und Markenbekanntheit.

• LinkedIn Professional Network
• Wissenschaftliche Forschungsplattformen
• Spezialisierte Biotechnologie-Webinare

Verbindungen zu akademischen und Forschungsnetzwerken

Strategische Partnerschaften mit Forschungseinrichtungen treiben die Technologieentwicklung und -vermarktung voran.

Netzwerkverbindungstyp	Anzahl aktiver Partnerschaften
Hochschulkooperationen in der Forschung	12 aktive institutionelle Partnerschaften
Forschungsstipendienkooperationen	5 laufende Forschungsfinanzierungsvereinbarungen

Orgenesis Inc. (ORGS) – Geschäftsmodell: Kundensegmente

Pharmazeutische Forschungsorganisationen

Wichtigstes Kundensegment mit spezifischem Forschungsbedarf:

Forschungsschwerpunkt	Potenzielles Engagement-Level	Jährliches Forschungsbudget
Entwicklung der Zelltherapie	Hoch	3,2 Millionen US-Dollar
Regenerative Medizin	Mittel	2,7 Millionen US-Dollar

Akademische medizinische Forschungseinrichtungen

Anvisierte institutionelle Segmente:

• Forschungsuniversitäten der Spitzenklasse
• Medizinische Forschungszentren
• Spezialisierte Abteilungen für regenerative Medizin

Institutionstyp	Anzahl potenzieller Kunden	Durchschnittliche Forschungsinvestition
Forschungsuniversitäten	87	1,5 Millionen Dollar
Medizinische Forschungszentren	42	2,3 Millionen US-Dollar

Biotechnologieunternehmen

Spezifische Marktsegmente der Biotechnologie:

• Gentherapie-Unternehmen
• Unternehmen für Zellmanipulationstechnologie
• Organisationen für fortgeschrittene therapeutische Entwicklung

Unternehmenskategorie	Potenzielle Marktgröße	Technologieinvestitionen
Gentherapie-Unternehmen	23	4,6 Millionen US-Dollar
Zellmanipulationsfirmen	15	3,9 Millionen US-Dollar

Auf Regenerative Medizin spezialisierte Gesundheitsdienstleister

Spezialisierte Gesundheitsmarktsegmente:

• Fortschrittliche Behandlungszentren
• Spezialisierte klinische Einrichtungen
• Kliniken für Regenerative Medizin

Anbietertyp	Anzahl potenzieller Kunden	Durchschnittliche Technologieinvestition
Fortgeschrittene Behandlungszentren	56	2,1 Millionen US-Dollar
Kliniken für Regenerative Medizin	34	1,8 Millionen US-Dollar

Sponsoren klinischer Studien

Aufschlüsselung des Marktes für klinische Forschung:

Sponsortyp	Anzahl aktiver Sponsoren	Durchschnittliches Testbudget
Pharmaunternehmen	42	5,3 Millionen US-Dollar
Staatliche Forschungsagenturen	18	3,7 Millionen US-Dollar

Orgenesis Inc. (ORGS) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Orgenesis Inc. Forschungs- und Entwicklungskosten in Höhe von 14,3 Millionen US-Dollar, was eine bedeutende Investition in wissenschaftliche Innovation und technologischen Fortschritt darstellt.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2023	14,3 Millionen US-Dollar	42.6%
2022	12,7 Millionen US-Dollar	38.9%

Investitionen in klinische Studien

Die Kosten für klinische Studien für Orgenesis beliefen sich im Jahr 2023 auf etwa 8,6 Millionen US-Dollar, wobei der Schwerpunkt auf der Zelltherapie und der regenerativen Medizinforschung lag.

• Klinische Studien der Phase I: 3,2 Millionen US-Dollar
• Klinische Studien der Phase II: 4,5 Millionen US-Dollar
• Präklinische Studien: 900.000 US-Dollar

Wartung der Fertigungsinfrastruktur

Die Herstellungs- und Wartungskosten für die Anlage beliefen sich im Jahr 2023 auf 5,7 Millionen US-Dollar, einschließlich Ausrüstungs-Upgrades und Betriebskosten.

Kostenkategorie	Betrag
Gerätewartung	2,3 Millionen US-Dollar
Betriebskosten der Anlage	3,4 Millionen US-Dollar

Schutz des geistigen Eigentums

Die Ausgaben für geistiges Eigentum und Patente beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

• Kosten für die Patentanmeldung: 650.000 US-Dollar
• Anwaltskosten für den Schutz des geistigen Eigentums: 550.000 US-Dollar

Personal- und wissenschaftliche Talentakquise

Die gesamten Personalkosten für 2023 beliefen sich auf 22,1 Millionen US-Dollar, einschließlich Gehältern, Sozialleistungen und Rekrutierungskosten für wissenschaftliches und technisches Personal.

Personalkategorie	Anzahl der Mitarbeiter	Gesamtvergütung
Wissenschaftliches Personal	87	12,6 Millionen US-Dollar
Forschungspersonal	65	9,5 Millionen US-Dollar

Orgenesis Inc. (ORGS) – Geschäftsmodell: Einnahmequellen

Lizenzierung von Zelltransformationstechnologien

Im vierten Quartal 2023 meldete Orgenesis Lizenzeinnahmen in Höhe von 1,2 Millionen US-Dollar aus Lizenzvereinbarungen für Zelltransformationstechnologie.

Kategorie „Technologie“.	Lizenzeinnahmen	Anzahl der Vereinbarungen
Zelltransformationsplattform	$850,000	3 aktive Lizenzen
Fortgeschrittene zelluläre Neuprogrammierung	$350,000	2 aktive Lizenzen

Vereinbarungen zur Forschungskooperation

Im Jahr 2023 erwirtschaftete Orgenesis 3,5 Millionen US-Dollar aus Forschungskooperationspartnerschaften.

• Pharmazeutische Forschungskooperationen: 2,1 Millionen US-Dollar
• Partnerschaften mit akademischen Institutionen: 1,4 Millionen US-Dollar

Potenzielle Verkäufe therapeutischer Produkte

Voraussichtlicher Umsatz mit therapeutischen Produkten für 2024: 4,7 Millionen US-Dollar

Produktkategorie	Prognostizierte Verkäufe
Zelltherapieprodukte	2,9 Millionen US-Dollar
Lösungen für die regenerative Medizin	1,8 Millionen US-Dollar

Zuschüsse und staatliche Forschungsförderung

Insgesamt im Jahr 2023 gesicherte Forschungsstipendien: 2,8 Millionen US-Dollar

• Zuschüsse der National Institutes of Health (NIH): 1,6 Millionen US-Dollar
• Forschungsförderung des Verteidigungsministeriums: 750.000 US-Dollar
• Forschungsstipendien auf Landesebene: 450.000 US-Dollar

Lizenzgebühren für geistiges Eigentum

Einnahmen aus Lizenzgebühren für geistiges Eigentum für 2023: 680.000 US-Dollar

IP-Kategorie	Lizenzeinnahmen	Patentzählung
Zelltransformationspatente	$420,000	12 aktive Patente
Mobilfunk-Reprogrammierungs-IP	$260,000	8 aktive Patente

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.