|
Orgenesis Inc. (ORGS): Business Model Canvas [Dec-2025 Updated] |
Fully Editable: Tailor To Your Needs In Excel Or Sheets
Professional Design: Trusted, Industry-Standard Templates
Investor-Approved Valuation Models
MAC/PC Compatible, Fully Unlocked
No Expertise Is Needed; Easy To Follow
Orgenesis Inc. (ORGS) Bundle
You're looking at Orgenesis Inc., a biotech company making a high-stakes bet on decentralized cell and gene therapy manufacturing, which is a defintely disruptive model but comes with a tiny revenue base and a massive cash burn right now. Honestly, when you see a trailing twelve-month revenue of just $0.90 million as of mid-2025, paired with a Q3 2024 gross margin sinking to -97.7%, you have to ask if the promise of bringing production closer to the patient via their OMPULs is worth the $34.4 million net loss they posted over the same period. I've spent two decades mapping these high-growth, high-cash-burn plays, and this one is particularly fascinating; dive below to see the full nine blocks of their Business Model Canvas to understand the real mechanics behind this aggressive strategy.
Orgenesis Inc. (ORGS) - Canvas Business Model: Key Partnerships
You're mapping out Orgenesis Inc.'s strategic alliances, which are central to its decentralized manufacturing model. These partnerships are how the company scales its POCare Platform without massive capital expenditure on its own facilities everywhere. Here's the breakdown of the most significant relationships as of late 2025.
Academic and Medical Collaborations
The POCare Network is the foundation, linking academia, research, and hospitals globally to enable therapy development and distribution right at the point of care. This network is key to validating the decentralized approach.
- Development and Service Centers are established in the United States, Belgium, Israel, and South Korea.
- The business is positioning itself via regional Joint Ventures (JVs) across North America, Europe, Asia, the Middle East, and Australia.
- The Maryland POCare Center, a joint project with Johns Hopkins University, is a planned 7,000 square-foot facility.
- The Maryland Center received funding in part from a $5 million grant from the state of Maryland.
- The company has a history of collaboration with University of California, Davis, dating back to a January 2020 agreement.
Strategic Joint Ventures and Equity Financing
Orgenesis Inc. uses JVs to enter new markets and secures financing through strategic equity investments. The structure of the Longevity & Wellness JV with Harley Street Healthcare Group (HSHG) shows a clear division of responsibility and investment.
The stock price as of October 31, 2025, closed at $0.15, which you should keep in mind when looking at these commitments.
| Partner/Instrument | Nature of Relationship | Stated Financial Commitment/Stake | Key Date/Term |
|---|---|---|---|
| Harley Street Healthcare Group (HSHG) JV | Longevity & Wellness Services JV | 49% ownership for Orgenesis Inc. (initial) | JV established in August 2024. |
| HSHG Investment | Investment in Orgenesis common stock | Committed to invest $5 million (completed by end of December 2024) | Option for an additional $5 million by the end of 2025. |
| HSHG Investment Total | Total investment commitment | Up to $10 million over three years into Orgenesis and the JV | Agreement signed August 2024. |
| Williamsburg Venture Holdings | Equity Line of Credit | Secured a $5 million equity investment | Investment closed on January 29, 2025. |
Technology and Platform Partners
Orgenesis Inc. relies on technology partners to build out its proprietary systems, which are designed to be closed, automated, and Good Manufacturing Practice (GMP) compliant for point-of-care use. The company's core technology is the POCare Platform, which includes the automated Prodigy® platform.
The company's trailing twelve-month revenue as of September 30, 2024, was $899K, and its market capitalization as of November 21, 2025, was reported at $4.93 million. Revenue generation is tied to licensing and service fees for these POCare systems.
Finance: review the cash burn rate against the HSHG $5 million option for year-end 2025.
Orgenesis Inc. (ORGS) - Canvas Business Model: Key Activities
You're looking at the core things Orgenesis Inc. is actively doing to drive value, which is critical when assessing a high-risk biotech play like this. These activities are where the cash is being spent and where the potential breakthroughs-or setbacks-will show up.
The company's focus is split between advancing its own pipeline and monetizing its decentralized manufacturing technology through services and partnerships. Here's the quick math on what those key activities look like right now, based on late 2025 visibility.
Developing and Advancing the Clinical Cell and Gene Therapy (CGT) Pipeline (e.g., ORG-101)
The pipeline activity centers heavily on ORG-101, their CD19 CAR-T therapy. The data coming out of the real-world study is definitely the headline here, showing strong initial efficacy and a potentially better safety profile than the established competition.
The key results you need to track for ORG-101 are:
- Complete Response Rate (CR) in adults: 82%.
- Complete Response Rate (CR) in pediatric patients: 93%.
- Incidence of severe Cytokine Release Syndrome (CRS) in adults: 2%.
- Incidence of severe Cytokine Release Syndrome (CRS) in pediatric patients: 6%.
The next major operational milestone was the expected trial readout for the Phase 1/2 study, slated for Q4 2025. Also, remember that the company is working to adapt manufacturing methods as candidates move through trials, which always carries a risk of altering performance.
Manufacturing and Deploying OMPULs (Mobile Processing Units and Labs)
This is the infrastructure play-getting their Orgenesis Mobile Processing Units and Labs (OMPULs) out into the world via the POCare Network. The main value proposition here is speed and cost reduction compared to traditional centralized manufacturing.
Here's how the deployment metrics stack up against the old way of doing things:
| Metric | OMPUL/POCare Deployment | Conventional CGT Production |
| Implementation Timeframe | 3 to 6 months | 18-24 months |
| Patient Proximity | Within 6 hours or less of patients | Implied longer travel/logistics |
The goal is to use these mobile units to create POCare Hubs, standardizing the best science globally while enabling local scalability by connecting additional OMPULs.
Providing Process Development and Regulatory Support Services for CGTs
This activity feeds the revenue stream through licensing and service fees for the POCare systems and associated support. While the company is focused on its own pipeline, these services provide the necessary cash flow to keep the lights on, though the TTM revenue figures show the scale of the challenge.
You should note the revenue context:
- Trailing Twelve Month (TTM) Revenue as of September 30, 2024: $899K.
- The company operates two segments: Octomera (for POCare Services) and Therapies.
The management is definitely counting on the expansion of the POCare Network to drive a meaningful ramp-up in service revenue, especially given the persistent losses.
Integrating Acquired Neurocords Assets for Spinal Cord Injury Therapies
The integration of Neurocords assets is a strategic move to expand the therapeutic portfolio into spinal cord injury (SCI) therapies, leveraging their iPSC differentiation technology with Orgenesis' MIDA Technology for an autologous neural cell production platform. This is a clear diversification effort.
Key transaction details include:
- Acquisition of certain Neurocords LLC assets completed on March 6, 2025.
- Total consideration involved issuing 1,200,000 shares of common stock.
- The reported value of the asset purchase was $5.7 million.
The market you are targeting here is substantial; the global SCI treatment market was valued at $7.5 billion in 2023 and is projected to hit $11.2 billion by 2031. You'll want to watch for commercialization updates from this integrated asset, which were anticipated in the second half of 2025.
Finance: draft 13-week cash view by Friday.
Orgenesis Inc. (ORGS) - Canvas Business Model: Key Resources
You're looking at the core assets Orgenesis Inc. (ORGS) is banking on to make its decentralized cell and gene therapy (CGT) vision a reality. These aren't just ideas; they are tangible platforms, clinical data, and established networks that form the foundation of their business, even as the company navigates a tight financial spot, reporting a trailing twelve months (TTM) revenue of only $899.00K as of mid-2025.
Proprietary POCare Platform (closed, automated, decentralized CGT manufacturing)
The centerpiece is the POCare Platform, which is their unique infrastructure for manufacturing CGTs right near the patient. This system is designed to be closed and automated, which is key for maintaining high quality standards in a decentralized setting. The technology, specifically using the Orgenesis Mobile Processing Unit and Lab (OMPUL™), is a resource that drastically cuts down on setup time. Honestly, the platform shortens the implementation time for a new manufacturing site from the industry standard of 18-24 months down to 3-6 months. This speed is a critical resource for quickly scaling their decentralized model.
The company is investing in this platform, evidenced by the strategic capital secured in January 2025: an equity line of credit of up to $5 million explicitly earmarked to accelerate the rollout of this decentralized CGT platform. Furthermore, the potential future value tied to this platform's adoption is significant, with signed POCare Network contracts that could generate more than $40 million in revenue over the next three years if fully realized.
Clinical-stage therapeutic pipeline assets (e.g., ORG-101 CAR-T)
The pipeline assets represent the therapeutic value Orgenesis aims to process using its technology. The most concrete data comes from the ORG-101 CD19 CAR-T therapy, which targets relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). This asset is a resource because it has generated compelling, real-world clinical results from a study involving 233 patients. The efficacy data shows a complete response (CR) rate of 82% in adult patients and 93% in pediatric patients. Crucially for a cell therapy, the safety profile appears favorable, with the incidence of severe Cytokine Release Syndrome (CRS) reported at only 2% in adults and 6% in pediatric patients.
The company also expanded its therapeutic resource base in March 2025 by acquiring certain assets from Neurocords LLC, a move that cost $5.7 million. This acquisition specifically broadens the pipeline into regenerative medicine for spinal cord injuries.
Here are the key metrics for the lead immuno-oncology asset:
| Asset/Metric | Indication | Patient Cohort | Complete Response (CR) Rate | Severe CRS Incidence |
| ORG-101 (CD19 CAR-T) | B-cell ALL | Adults | 82% | 2% |
| ORG-101 (CD19 CAR-T) | B-cell ALL | Pediatrics | 93% | 6% |
Global POCare Network of affiliated hospitals and research centers
The network is the distribution and implementation arm of the POCare Platform, turning decentralized manufacturing into a reality. This ecosystem of partners is a vital intangible resource for global harmonization and clinical research. The company maintains development and service centers in four key geographic locations: the United States, Belgium, Israel, and South Korea. The depth of these relationships is also a factor; Orgenesis Inc. has long-time academic partnerships that average over five years.
The network's commitment is to a common vision of harmonized, regulated clinical development and production. This structure is designed to decrease clinical research costs by leveraging a vast network for trials.
Intellectual property and patents for CGT processing technology
The intellectual property (IP) portfolio, which includes patents, trade secrets, and know-how, is the legal moat protecting the proprietary technology. Orgenesis Inc. is actively focused on maintaining, protecting, and expanding this portfolio. While the exact number of granted patents as of late 2025 isn't explicitly stated in the latest filings, the continuous focus on IP protection is a stated operational priority to support the unique decentralized approach.
The human capital supporting these resources is also noteworthy; as of late 2024, Orgenesis Inc. reported 146 total employees.
- IP focus: Maintaining, protecting, and expanding portfolio.
- Legal representation for IP matters is handled by Pearl Cohen.
- The POCare Platform relies on proprietary CAR constructs within the ORG-101 therapy.
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.
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.