Orgenesis Investigation

On 20 November 2024, European Commission President Ursula von der Leyen signed her declaration of interests.

Under her personal financial interests, the form says “NOT APPLICABLE”. The form excludes ordinary bank accounts, the family home, personal goods and some investments managed by third parties. The words mean that Ursula entered no personal asset under those reporting rules.

Her husband’s section contains far more information.

Heiko von der Leyen is Medical Director of Orgenesis Inc. He manages Orgenesis Germany GmbH. The form records options allowing him to buy 14,168 Orgenesis shares. It gives no strike price, grant date, vesting date or expiry date.

Heiko also owns and manages Visonamora Asset Management UG. The declaration says that company exists to acquire and manage assets and investments in German and foreign companies. It describes Visonamora as inactive.

His other declared roles place him inside healthcare consulting, clinical research, universities, pharmaceutical biotechnology and a gene and RNA therapy centre linked to Italy’s PNRR recovery programme.

One member of the household leads the European Commission. The other holds medical, corporate and equity-linked interests inside biotechnology and publicly supported research. Households do not live on separate lines.

(European Commission, Declaration of Interests of Ursula von der Leyen, signed 20 November 2024)

The SEC filings do not name Heiko as an executive officer or director. They place employee pay and options inside group totals.

Orgenesis completed a one-for-ten reverse share split on 20 September 2024. Ursula signed the declaration two months later. The option contract is needed to confirm whether the declared 14,168 options reflect the post-split quantity.

(Orgenesis, 2024 Form 10-K, employee options and reverse split)

Orgenesis acquired Koligo Therapeutics and its Kyslecel programme.

A surgeon removes a patient’s pancreas during a total pancreatectomy. The hospital sends the organ to a Koligo processing centre.

Workers break down the pancreatic tissue and isolate the insulin-producing islets. They formulate those cells as Kyslecel. The preparation then returns through the hospital system for infusion.

1. The surgeon removes the pancreas. The patient supplies the organ.
2. The organ leaves the hospital. A transport and custody system moves it to the processor.
3. Workers break down the organ. They separate the pancreatic islets from the surrounding tissue.
4. The cells become a product. Koligo formulates the isolated cells as Kyslecel.
5. Orgenesis earns revenue. Its accounts record cell-processing development and hospital-service income.

Orgenesis’s May 2024 investor presentation states: “Pancreatectomy is performed to remove the pain/inflammation-causing pancreas which is then transported to the Koligo processing center.” It continues: “The islets are isolated from the pancreas and formulated into Kyslecel.”

(Orgenesis, Investor Presentation, May 2024, p.19)

A company announcement about the Koligo acquisition said a forty-patient commercial pilot generated approximately $2 million in private sales revenue. This is an institutional self-description. It records how Orgenesis presented the commercial value of the programme.

(Orgenesis, Koligo Therapeutics acquisition announcement)

The 2024 accounts describe hospital services as “the sale or lease of products and the performance of processing services to our POCare hospitals or other medical providers”. They describe cell-process development and hospital services as the source of $1.020 million of the company’s $1.035 million revenue.

(Orgenesis, Form 10-K for the year ended 31 December 2024, filed 26 March 2026)

Kyslecel uses the patient’s own pancreas. Other transplant and research programmes use pancreases from dead donors. Those organs are scarce.

Doctors need cells, laboratories, trained staff, transport and processing capacity to treat sick patients. They compete against wealthy private companies, pharmaceutical firms and state-backed research programmes that can pay to turn the same human material into products, patents and political power.

The Orgenesis filings describe other programmes involving T cells taken from blood, immune cells taken from tumours, cells isolated from body fat, mesenchymal stem cells, induced pluripotent stem cells, dendritic cells, macrophages, extracellular vesicles and viruses used in treatment processes.

(Orgenesis, 2024 Form 10-K, therapies and patent sections)

The public record names the materials and the programmes. It does not supply the complete patient-level consent, custody, pricing, secondary-use, data-ownership or intellectual-property records.

The American public company began in Nevada on 5 June 2008. Its name was Business Outsourcing Services. It sold online bookkeeping services.

The 2009 registration statement records one employee, no subsidiaries, no patents and no biotechnology business. Guilbert Cuison and Jerome Golez controlled 69.6% of the company.

(Business Outsourcing Services, Form S-1, 2009)

On 28 June 2011, Oded Shvartz bought 317,912 restricted shares from Cuison and Golez for $3,973.90. The agreement also gave him an option over another 309,742 shares at $0.0125 each. If exercised, the position could reach 27.29%.

The filing identifies Shvartz as a citizen of Israel and Romania and president of Amraz Romania SRL. It says the option related to possible new business transactions and a new direction for the company.

(Oded Shvartz, Schedule 13D, filed 7 July 2011)

Amraz Romania formed part of a wider Israeli plastics and packaging group. Ampa Group says it owned Amraz with the Central Bottling Company, Coca-Cola Israel. A 2010 business report recorded two Amraz factories in Israel and a third in Romania.

Shvartz therefore ran the Romanian arm of an established Israeli industrial group when he bought shares and control-linked options in the Nevada bookkeeping company that became Orgenesis.

(Ampa Group, Amraz industrial holding) (Globes, Amraz sale report, 6 July 2010)

Later in 2011, the company changed its name to Orgenesis and completed a 35-for-one forward stock split.

(Orgenesis, Form 8-K, September 2011)

In 2012, Orgenesis created an Israeli subsidiary and obtained a worldwide exclusive licence to research connected to Tel Hashomer and Sheba Medical Center. The work concerned converting cells into insulin-producing cells. Vered Caplan became sole director. Sarah Ferber became chief scientific officer.

(Orgenesis, Form 8-K, 8 February 2012)

A tablet factory can make the same medicine for thousands of people. A patient-specific cell treatment starts with one person’s blood, tumour, fat, immune cells or pancreatic tissue.

The material must remain alive. Workers must track it. The laboratory must keep one patient’s cells separate from every other patient’s cells.

Orgenesis wants to place the factory beside the patient.

Its mobile laboratories are called OMPULs: Orgenesis Mobile Processing Units and Labs. The units sit inside or near hospitals. A central system controls production rules, quality checks, software, data and supplies.

(Orgenesis, 2024 Form 10-K, business model and POCare system)

The operating centre is Octomera LLC. Octomera turns scientific discoveries into repeatable production processes. It transfers those processes into hospitals and charges for development, equipment, processing and clinical services.

Regional partners prepare trials, seek approval and create clinical data. Orgenesis receives access to that data. It chooses which programmes to take into larger markets.

The company calls this “de-risking”.

Orgenesis generally seeks royalties of about 10% of net sales when a regional partner sells a product. It also seeks licence fees, service payments and hospital-processing income.

(Orgenesis, 2024 Form 10-K, regional partnerships, licences and royalties)

Hospitals provide patients, clinicians, buildings, medical records, emergency support and local regulatory access. Orgenesis provides the processing unit and the rules governing it.

The company’s website calls this “Design Global and Adapt Local”. The global company designs the system. The local medical institution changes its work to fit that design.

(Orgenesis, About Us, accessed 6 August 2026)

The OMPUL page advertises cloud-based batch monitoring and data collection. A local production event can therefore send patient-specific processing data into a central digital system.

The public pages do not name the cloud host. They do not explain who owns the data, who can train artificial-intelligence systems on it or what happens when a local company fails.

(Orgenesis, OMPUL technology page, accessed 6 August 2026)

The therapy pipeline

The stages and results come from company management. The HiCAR-T section reports data from 233 patients in Asia but provides no conventional trial table there.

(Orgenesis, 2024 Form 10-K, therapy pipeline)

The patent estate

The filing lists patents and applications covering cell vaccines, exosomes, automated cell-culture machines, tumour immune cells, stem cells, viruses, mobile processing units, fat-derived treatments and wound healing.

Some applications could remain in force into the 2040s if granted.

These assets are legal claims over ways of processing cells, training immune systems, moving human material and using medical data.

Much of the science began outside Orgenesis.

Tel Hashomer and Sheba supplied research on converting cells into insulin-producing cells. Columbia University supplied an exclusive cancer-treatment licence. The University of California entered a joint research agreement. Helmholtz Munich supplied patent rights, knowledge and human stem-cell materials.

Each agreement creates a route from public or academic research into private products, sublicences and royalties.

Columbia can receive 5% royalties on products using its patents. The University of California agreement can require up to 5% of sales or up to 20% of sublicensing revenue. Helmholtz can receive minimum royalties, sales royalties, service payments and part of sublicensing income.

(Orgenesis, 2024 Form 10-K, Note 12, university and research licences)

Governments also funded the machinery.

(Orgenesis, 2024 Form 10-K, grants and public programmes) (European Parliament, Written Question E-003749/2022)

The company calls grants “non-dilutive”. That means the government receives no shares for the money. The public accepts the financial risk. Existing shareholders keep their ownership.

The MIDA and Belgian projects use databases and artificial intelligence to select cells that meet clinical standards.

Public money funds the machinery. The machinery decides which human cells qualify.

Orgenesis reported $1.035 million in 2024 revenue.

The company once owned a conventional manufacturing business called Masthercell. It bought the company in 2015 for about $25 million. It sold Masthercell to Catalent in February 2020 and reported about $127 million in net proceeds.

(Orgenesis, completion of Masthercell sale, 11 February 2020)

The sale funded the distributed hospital model.

Orgenesis reported $36.025 million in revenue for 2022. Revenue fell to $530,000 in 2023. The company recorded a $64.918 million loss for 2023.

Management later admitted that it had failed to assess properly whether customers could pay for services already recorded as revenue.

(Orgenesis, 2024 Form 10-K, comparative financial statements and controls)

Customer A paid $492,000. Customer B paid $300,000. Customer D paid $150,000. The three unnamed customers paid $942,000 between them.

$942,000 divided by $1.035 million equals 91.0%.

Three unnamed United States customers therefore generated about 91% of Orgenesis’s 2024 revenue.

(Orgenesis, 2024 Form 10-K, revenue concentration table)

The same accounts report a $49.013 million net loss, $78,000 in unrestricted cash and $38.884 million in total liabilities at 31 December 2024.

The liquidity section reports approximately $65.8 million in outstanding debt. That figure uses calculated fair values for some loans. It is not the cash repayment total.

The accounts state that cell-process development and hospital services produced $1.020 million. Licence fees produced $15,000.

Orgenesis sold five OMPUL mobile processing units and related rights to Germfree for an adjusted price stated as up to $8.340 million. It reported receiving $6.720 million by year-end 2024.

Later financing gave lenders routes into shares, warrants, board rights and corporate control. An Alpha Prosperity structure could convert into as much as 80% of Orgenesis or Theracell, subject to the agreement’s terms.

(Orgenesis, 2024 Form 10-K, liquidity, asset and financing notes) (Orgenesis, Alpha Prosperity financing Form 8-K, 16 September 2025)

The company restated all three 2023 quarterly reports. It disclosed ineffective financial controls and no functioning audit committee at year-end. Its final 2024 annual report still contained the unfinished instruction “[COMPANY TO DESCRIBE LAWSUIT AND SETTLEMENT]”.

The public does not know who supplied about 91% of the revenue. The public does not know what each customer bought. The filings do not reveal whether the same person or company controlled a customer.

The customer letters do not remain attached to the same customer from one filing to the next. The company reordered the letters when customer size changed.

The 2024 annual report also contradicts itself. One section assigns Customer D $130,000 of 2023 revenue. The audited note assigns Customer D $280,000.

The audited-note customer figures total $650,000. The company reported only $530,000 of total 2023 revenue. The management table’s $130,000 figure produces the possible total.

This is a direct numerical defect in the annual report.

(Orgenesis, 2023 Form 10-K, customer table) (Orgenesis, 2024 Form 10-K, management table and Note 17)

Customer A’s $492,000 almost equals the complete external revenue of one segment. The filing does not identify which segment supplied the work.

The company names possible partners and institutions. It does not connect any of them to Customer A, B or D. CGT Global, Johns Hopkins, Kyslecel hospitals and Tissue Genesis customers remain leads, not identified customers.

(Orgenesis, 2024 Form 10-K, Note 4 and Note 17)

A parent company prepares group accounts by combining the companies it controls. When a court or liquidator takes a subsidiary away, the parent removes that company’s assets and debts from the group accounts.

Accountants call this deconsolidation.

If the failed company owes more than it owns, removing it can create an accounting gain for the parent.

(Orgenesis, 2024 Form 10-K, Notes 20 and 21)

Workers and suppliers made claims against local companies. Courts took control. The parent stopped combining the local debts with its own accounts. The group then recorded gains when net liabilities disappeared.

Equipment and rights moved too.

Orgenesis sold five OMPUL mobile laboratories and related intellectual property to Germfree. The original deal expected Germfree to lease the units back. Germfree later refused. The filed annual report left the instruction “[COMPANY TO DESCRIBE LAWSUIT AND SETTLEMENT]” inside the business section.

The final filing therefore contains an internal drafting instruction where the legal dispute should appear.

Two other transactions converted unpaid debts into medical property.

Broaden Bioscience owed Orgenesis $10.767 million for earlier work. Orgenesis had already decided the debt was unlikely to be collected. It then used the debt to reduce the price of Broaden’s CAR-T processes, algorithms, patents, knowledge, materials and approvals.

Theracell owed Orgenesis $10.324 million. Orgenesis used that debt to reduce the price of Theracell’s company shares, tumour-cell processes, lentivirus production, oncolytic-virus technology, kidney-treatment processes, extracellular-vesicle methods and wound-healing rights.

The unpaid service invoices became ownership of companies, medical processes and algorithms.

(Orgenesis, 2024 Form 10-K, Note 18 and Germfree transaction notes)

In September 2025, Theracell borrowed from Alpha Prosperity Fund SPC through a segregated portfolio in the Cayman Islands.

The initial loan was $1 million at 10% annual interest. The agreement added a credit facility of up to $10 million.

Alpha gained the right to convert debt into as much as 80% of Theracell or Orgenesis. It gained warrants over another 15% on a fully diluted basis. It also gained rights to more warrants and three Orgenesis board seats.

(Orgenesis, Alpha Prosperity financing Form 8-K, 16 September 2025)

By January 2026, Orgenesis had issued Alpha a warrant covering 3,289,490 shares for a total exercise price of $250,000.

(Orgenesis, Form 8-K, 26 January 2026)

The 2026 proxy calculates Alpha Portfolio P’s beneficial position at 89.09% after counting its conversion and warrant rights. Portfolio G held another 1,296,561 shares and warrants for 5,361,226 more.

Orgenesis had 9,799,538 ordinary shares outstanding. The board asked shareholders to increase the authorised total from 14,583,333 shares to 150 million.

Without the increase, Orgenesis could not issue every share promised through the financing structure.

(Orgenesis, 2026 proxy statement, beneficial ownership and share-authorisation proposal) (Orgenesis, Form 8-K, 2 June 2026)

Public grants helped build parts of the medical system. A Cayman fund now holds a route into corporate control.

The public-company shell remains. The economic power sits in debt, warrants and conversion rights.

The SEC currently places Orgenesis under SIC 2834: Pharmaceutical Preparations.

(SEC, Orgenesis company submissions record, CIK 0001460602)

The same SEC record shows that the company began as Business Outsourcing Service, Inc. The 2024 accounts describe revenue from cell-process development and hospital services. The investor presentation describes the transport of a removed pancreas to a processing centre.

“Pharmaceutical Preparations” does not tell an investor that the company transports human organs, extracts human cells and charges for processing and hospital services.

The code is an administrative category. It also helps determine which SEC office reviews the filings. The gap between the category and the physical business belongs in the regulatory record.

(SEC, Standard Industrial Classification code list)

The Orgenesis structure crossed companies, hospitals, universities and public programmes.

Its May 2024 investor map claimed relationships across the United States, Europe, Israel, South Korea, India, China, Saudi Arabia, the United Arab Emirates, Kuwait, Turkey and Panama. The map mixed owned companies, hospitals, research partners, patents and planned markets.

(Orgenesis, Investor Presentation, May 2024)

Orgenesis reported that more than 200 patients received its CAR-T system in Asia. It reported more than 1,750 treatments outside the United States using its system for extracting cells from human fat.

It reported more than eighty Kyslecel patients in the United States. These are the company’s own figures.

The companies did not all survive.

Workers in South Korea claimed unpaid salaries. The Korean company entered liquidation. Workers and suppliers in Belgium went unpaid. Two Belgian companies entered liquidation.

Employees in Israel claimed unpaid salaries. A trustee took control of Orgenesis Biotech Israel. The parent bought some of its equipment. Another Israeli company entered bankruptcy. The Australian company entered liquidation.

Koligo closed the Indiana facility that commercially processed human pancreases for Kyslecel.

By the end of 2024, Orgenesis claimed nineteen American patents, twenty-one foreign patents and dozens of pending applications across several countries.

The legal companies can fail. The research, equipment, databases, licences, patents and hospital relationships can move.

Workers, patients and public institutions remain where the damage happened.

(Orgenesis, 2024 Form 10-K, subsidiaries, grants, licences and liquidation notes) (European Parliament, Question E-003749/2022)

Unnamed hospitals and suppliers

The filing names very few hospitals despite describing a global hospital system.

Named or identifiable institutions include Sheba Medical Center, Wolfson Medical Center, Columbia University, UC Davis, an unnamed Spanish hospital, Kyslecel centres in the United States and unspecified Greek hospitals.

The investor map marks “leading clinical centers” in several countries without naming most of them.

Orgenesis also depends on a small number of suppliers for biological reagents, viruses, specialist equipment, disposable processing materials and contract manufacturing.

The company does not name most of those suppliers. It says many have no long-term supply contract.

The missing list would identify who makes the machines, enzymes, viral vectors, reagents and sterile kits. It would also identify the couriers, cold-chain services, cloud hosts and biological-waste companies.

(Orgenesis, 2024 Form 10-K, hospitals and supplier risks) (Orgenesis, Investor Presentation, May 2024)

The Orgenesis website opens with a promise: “Unlocking the Potential of Cell and Gene Therapy for All.”

It provides no complete treatment prices, eligibility rules, reimbursement terms or figures showing who received affordable care.

Later pages explain the income: long-term processing licences and royalties across the hospital network.

(Orgenesis, POCare Therapies, accessed 6 August 2026)

The website uses three words: available, accessible and affordable.

“Available” describes production machinery. “Accessible” means that an Orgenesis processing unit sits near a patient. “Affordable” describes lower manufacturing cost.

The technology page calls the same system “high-margin”. A margin is the gap between cost and price.

The website gives no figure showing whether a patient or public health service receives the saving.

(Orgenesis, About Us) (Orgenesis, POCare Technology)

The public pipeline also contains copied descriptions under unrelated products.

A patient cannot use that page to understand the products. An investor cannot use it to map the pipeline accurately.

(Orgenesis, Therapies Pipeline, captured 6 August 2026)

The investor page still called the 2023 annual filing the latest annual filing after the company filed its 2024 report in March 2026. The SEC-filings page displayed a Press Releases heading and no visible filing list.

The same investor page called the May 2024 Nasdaq-branded deck the latest corporate presentation after Nasdaq removed Orgenesis.

(Orgenesis, Investor Overview, captured 6 August 2026) (Orgenesis, SEC Filings page)

The deck claims: “Incoming revenues to date generated from co-development and Licensing of ORGS therapies $50M”.

It gives no period, entity list or accounting definition. Orgenesis reported $530,000 of revenue for 2023 and $1.035 million for 2024. The $50 million investor claim needs a bridge to the audited accounts.

The management page displays three people: Vered Caplan, Victor Miller and Heiko von der Leyen.

Heiko is one-third of the company’s displayed management team. The SEC filings do not disclose his individual pay or option contract.

(Orgenesis, Management Team, captured 6 August 2026)

The website’s disclaimer says: “The accuracy or completeness of the information is not warranted.”

The main pages make scientific and financial claims. The legal page withdraws responsibility for accuracy and completeness.

(Orgenesis, Disclaimer)

Central teams design the standards. Local hospitals supply bodies, clinicians, facilities and data. Public institutions absorb research and infrastructure costs. The company retains licences, platform control and royalty opportunities.

The Belgian workers can go unpaid. The Israeli company can close. The Korean subsidiary can liquidate. The parent can continue displaying the locations as proof of global reach.

The map survives the people.

The paperwork contains its own evidence of weak control.

The company filed its 2024 annual report fifteen months late. It had restated all three 2023 quarterly reports. Management found its financial controls ineffective. The company had no functioning audit committee at year-end.

The annual report contains an unfinished lawsuit instruction. A March 2026 filing contained bracketed template language and blanks. Major customers and critical suppliers remain unnamed.

The company website contains medically mismatched pipeline descriptions. Its investor portal failed to display current filings clearly.

These defects make the paperwork part of the investigation.

The Sheba dispute

The State of Israel and the Sheba research company sued Orgenesis Inc., Orgenesis Ltd., Sarah Ferber, Vered Caplan and another scientist.

The plaintiffs allege that Orgenesis used Sheba knowledge across cell therapy, the point-of-care platform, contract manufacturing, products and services. They seek 7% of sales, 24% of sublicensing revenue, financial statements and other payments.

Orgenesis disputes the claim.

A state hospital says its knowledge entered a private commercial platform without the full payments required by the licence.

(Orgenesis, 2024 Form 10-K, Note 22, Sheba litigation)

The Greek sales dispute

Ehud Almon sued Orgenesis companies and Vered Caplan over claimed fees or royalties connected to $896,000 of sales from an Octomera subsidiary to a Greek entity.

The filing does not name the Greek buyer. The court record may identify the product, subsidiary, intermediary, partnership and payment route.

Rights moved through a dissolved company

A January 2026 New York complaint concerns a joint venture with Theracell Advanced Biotechnology. The plaintiffs say rights moved to Texas Advanced Therapies LLC and then moved again after that company dissolved.

Orgenesis disputes that the dissolution transferred the rights. A court refused to keep the joint-venture agreement sealed and ordered its release.

The unsealed agreement may show how medical rights entered a company and who claimed them after dissolution.

(Orgenesis, 2024 Form 10-K, Note 22, legal proceedings)

In June 2024, the SEC told Orgenesis that staff had not reviewed and would not review a registration statement. The SEC reminded management that the company remained responsible for the accuracy and adequacy of its disclosures.

(SEC correspondence to Orgenesis, 11 June 2024)

The records place a series of functions inside one connected system.

Patients supply organs, tissue, cells and data. Hospitals provide surgery, clinical access and public infrastructure. Local doctors and scientists perform the physical work. Universities and public bodies supply research, licences and grants.

Orgenesis places its processing system between the body and the treatment. Its agreements can give the company licence fees, royalties, intellectual property, data access and commercial rights.

The patients supply the bodies. The public supplies hospitals and research money. Orgenesis collects patents, licences, data systems and commercial products.

Political power sits beside that system. Ursula von der Leyen leads the European Commission. Her husband holds medical and equity-linked interests inside Orgenesis and roles across biotechnology, research and public programmes.

Financial distress changes who controls the surviving value. Lenders receive conversion rights, warrants and board rights. Buyers receive equipment and intellectual property. Failed subsidiaries leave workers, suppliers and public institutions chasing debts.

Public visibility falls at the same time. Nasdaq removes the stock. OTC Markets restricts ordinary access. Annual and quarterly reports arrive late or remain absent.

Trafficking for organ removal divides tasks among different people and institutions. UNODC guidance tells investigators to examine recruiters, brokers, surgeons, laboratory workers, hospital administrators, transport, public officials and financial intermediaries.

The Orgenesis record contains many of those functions across state, medical and corporate institutions.

(UNODC, Background paper on trafficking in persons for organ removal, April 2024)