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AliMcForever Bio and Introduction

 Ailíe Nic an tSaoir, is known online as AliMcForever , is an extremely educated, well spoken and talented  an Irish historian, writer, & independent researcher from Naas, Co. Kildare. who is not afraid to roar out and call a spade a spade in exposing corruption, wrongdoing and illegal activities in the Irish ad anywhere else, in politics, business,  government, banking, monetary and economic manipulation, and is in any way hesitant or afraid of naming names of any she finds in her detailed research in being involved in in politics, business,  government, banking, monetary and economic manipulation

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ACT TWO · THE MACHINERY

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)

A pancreatic islet is a small cluster of cells inside the pancreas. Some of those cells produce insulin. Islets are scarce because they come from human pancreatic tissue and because the isolation process can destroy part of the material.

Human islets support transplantation, diabetes research, drug testing, genetic research, stem-cell development and commercial product design.

(US National Institute of Diabetes and Digestive and Kidney Diseases, Pancreatic Islet Transplantation)

The same cells can become treatment, research material, genetic information or commercial intellectual property. Contracts decide who controls each form of value. Those contracts are not in the public record assembled here.

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.

ACT TWO · THE MACHINERY

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.

€3.999m

MIDA Biotech led a project using artificial intelligence and microfluidics to automate patient-specific stem-cell production.

€2m

A Belgian consortium built a CAR-T laboratory unit and an artificial-intelligence monitoring system.

up to €32m

Contemporary reports described possible support for Theracell and Orgenesis processing units in Greek hospitals.

€320m centre

A PNRR-funded gene and RNA therapy centre briefly included Heiko as Orgenesis Italy’s representative. The figure concerns the centre, not a direct payment to Orgenesis.

$299,000

An Israel-US public foundation funded work on insulin-producing cells. The grant becomes repayable from project sales.

(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.

ACT TWO · THE MACHINERY

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)

2024 revenue by operating segmentSegmentRevenueOctomera$533,000Therapies$525,000Internal transactions removed−$23,000Total$1.035 million

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)

https://orgenesis.com/about-us

• Global QA system
• Unified supply chain of reagents and disposables
• Centralized data management and IT solutions
• Automated processing systems
• Standardized training program
• OMPUL™ – identical processing environments

Process development focused on quality control (QC) & regulatory compliance - combined with custom closed loop and automated systems - integrated into localization of processing units which minimize logistic complexity and enables expedited scale out.

Minimized manual processing steps and isolated processing units enable parallel processing in a low-cost GMP mobile unit. Decentralized POCare™ platform enables reduction of logistic costs.

Orgenesis offers cost-effective scalable manufacturing capacities. The POCare™ platform is a unique globally harmonized and decentralized CGstandardized mobile processing units.

Regional POCare™ centers, enabling flexible T manufacturing infrastructure and offers cost-effective manufacturing capacities with ease for scalability and reproducibility. Watch the video to learn more.

Watch Video 

The POCare™ Platform overcomes conventional processing challenges by enabling high quality standards, sterile, scalable onsite processing of CGTs orchestrated by the POCare™ centers, servicing local hospitals and other customers. Manufacturing infrastructure is easily harmonized and reproducible using the OMPUL™, Orgenesis Mobile Processing Unit and Lab technology. It shortens implementation time from 18-24 to 3-6 months, offers a more cost-effective environment and enables local scalability by connecting additional OMPUL™.

Through Global Quality Harmonization standards aimed at ensuring quality comparability across the network and application of good practices (GxP) across all activities and throughout therapy lifecycles

By identifying and partnering with early-stage biotechnology developers, we bring development of promising new therapies in-house to create a pipeline of POCare Therapies.

We apply know-how in CGT development and production to build long-term opportunities via processing licenses and royalties at the POCare Network level.

Chief Executive Officer of Orgenesis Inc.

Chief Financial Officer of Orgenesis

Medical Director.

20271 Goldenrod Lane
Germantown, MD 20876
USA

• About Us
• Contact Us

• POCare Platform
• POCare Therapeutics
• POCare Technology
• POCare Network

• Overview
• Press Releases
• SEC Filings
• Investor Relations

 Orgenesis Investigation

Ursula von der Leyen leads the European Commission. Her husband, Heiko, is Medical Director of Orgenesis. The company transports and commercially processes human organs. This evidence file follows the signed declaration, the pancreas-processing system, the Nevada shell, public money, three unnamed customers, failed subsidiaries and the debt and warrants that can transfer control.

 
Live · EU action desk

1. Tell Parliament to remove this Commission.

https://alimcforever.com/i/

Find your MEP, edit the letter, translate it and send it. Nothing sends automatically.

Ireland's Great Hunger and the Irish Diaspora

Rebecca Abbott 

375,546 views Apr 12, 2020

Why did over a million people Irish people die of starvation and disease, and more than two million leave that country during roughly six years in the mid-1800s? The label "potato famine" doesn't begin to explain a crisis that was hundreds of years in the making, and one that happened in the midst of plenty. "Ireland's Great Hunger and The Irish Diaspora," narrated by actor Gabriel Byrne, explores the history, culture, and politics that lead to mass starvation, eviction, disease, and death in 19th century Ireland, and the lasting global legacy of that tragic event.

ACT ONE · THE SCENE

The signed form

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)

ACT TWO · THE MACHINERY

The hospital system

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”.

What de-risking means

A new treatment can consume years of work before anybody knows whether it will succeed.

Hospitals, universities, public programmes and regional companies pay part of that early cost. They supply patients, labour, facilities, approval work and clinical data.

Orgenesis keeps the option to commercialise the programmes that survive.

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)

Principal programmes in the 2024 annual reportProgrammeHuman material or methodTargetHiCAR-TGenetically engineered T cellsLeukaemia and B-cell lymphomaT-LOOPImmune cells extracted from tumoursSolid tumoursMDVACDendritic cells and macrophages loaded with cancer-cell materialSolid tumoursIntranasal immunotherapyCell-based treatment delivered through the noseGlioblastoma and drug deliveryKyslecelThe patient’s pancreatic islet cellsPancreatitis patients receiving pancreatic surgeryAutoSVFCells isolated from the patient’s fatLung injury and vascular disordersAutoVacPatient-specific immune-cell vaccineViral infections

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 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.

ACT TWO · THE PAPER TRAIL

Paperwork and disputes

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)

ACT THREE · THE PATTERN

The structure under investigation

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)

The investigation examines how states, public hospitals, corporations and cross-border programmes can move people, organs, cells and money while dividing legal responsibility among institutions.

The physical record establishes removal, transport and commercial processing of human pancreases. The missing record concerns consent, custody, pricing, secondary use and the distribution of resulting value.

Scarce human cells can serve patients, universities, pharmaceutical companies, private owners and state programmes. Wealth and institutional power decide who receives access and who owns the products, data and patents.

The declared household connection sits beside European grants, recovery programmes, regulation and publicly funded medical infrastructure. The missing record concerns meetings, screening, recusal, payment and influence.

Securities and accounting misconduct

The investigation examines restated reports, ineffective controls, anonymous revenue, drafting residue, overdue accounts, complex financing and transfers of equipment and rights.

Different regulators may each see one hospital, laboratory, company, grant or product. No public record assembled here shows one authority tracing the complete movement of organs, cells, data, equipment and money.

Delisting and missing reports weaken public visibility while creditors and purchasers obtain routes into shares, assets, intellectual property and control.

ACT THREE · THE RECORD

What the records establish

Established by the records

• Heiko von der Leyen holds Orgenesis roles and options over 14,168 shares.
• Orgenesis acquired a commercial system that transports removed pancreases and processes their cells.
• Three unnamed customers generated about 91% of 2024 revenue.
• The annual report contains a customer-table contradiction that exceeds total reported revenue.
• The company reported a $49.013 million loss and severe control weaknesses.
• Public and academic institutions supplied research, licences, grants and hospital infrastructure.
• Failed subsidiaries left workers and suppliers unpaid while deconsolidation produced accounting gains.
• Unpaid debts became price adjustments for medical companies, processes and algorithms.
• A Cayman lender obtained conversion, warrant and board rights capable of transferring control.
• The SEC classifies the company as Pharmaceutical Preparations.
• Nasdaq removed the shares, subsidiaries failed and 2025 reports remain missing.
• The current website contains stale Nasdaq branding, mismatched pipeline descriptions and an unexplained $50 million revenue claim.

• The structure connects political power, public medicine, human organs, private intellectual property and concentrated finance.
• Delisting, liquidation and asset transfers can move surviving value away from ordinary public scrutiny.
• The hospital system moves early cost, local labour and immediate medical risk towards public and regional institutions.
• Orgenesis keeps routes to licence fees, royalties, data, patents and control over the processing system.
• The structure warrants investigation for trafficking, organ harvesting, corruption, eugenic allocation, financial misconduct and regulatory evasion.

• The identities and contracts of the three principal customers.
• Complete patient consent, custody, pricing and secondary-use records.
• Complete grant, procurement, meeting and recusal records.
• Every hospital hosting an Orgenesis or Octomera processing unit.
• The five OMPUL serial numbers, locations, ownership and grant-funding history.
• The Germfree lawsuit and settlement omitted from the business section.
• The Broaden and Theracell valuation reports.
• The complete supplier, courier, data-hosting and contract-manufacturer lists.
• The unsealed Texas Advanced Therapies joint-venture agreement.
• Current beneficial ownership and asset registers.
• The missing 2025 annual and quarterly reports.

This evidence file uses preserved investigation records and links directly to the original sources.

Dialog- A private society ran four web properties. All Four disappeared or close after records were preserved.

 EVIDENCE RECORD · VERSION 004 · 6 AUGUST 2026 

https://alimcforever.com/orgenesis-investigation/

Orgenesis Investigation

This investigation concerns:

• suspected state-level human trafficking;
• organ harvesting and commercial extraction of human cells;
• eugenic and class-based control of scarce biological resources;
• corruption and political conflicts of interest;
• securities, accounting and disclosure misconduct;
• regulatory evasion;
• asset transfers designed to reduce scrutiny.

The record begins with a signed declaration of interests. It leads to human organs, hospital processing, a Nevada public company, state research, unnamed customers, missing accounts and companies operating across several countries.

The original records appear beside the findings.

VIDEO RECORD

The investigation, in full

The final video presents the public account. The records below provide the documents, figures and full investigation.

FINAL VIDEO

1. Ursula von der Leyen, Heiko von der Leyen and Orgenesis

11,325 views Aug 10, 2026 #UrsulaVonDerLeyen #EuropeanCommission #Orgenesis

Ursula von der Leyen leads the European Commission. Her husband, Heiko von der Leyen, is Medical Director of Orgenesis, a company that commercially processes human organs, cells and tissue.  This video follows the primary-source record connecting:  • Ursula von der Leyen’s declarations of interests; • Heiko von der Leyen’s role and financial interests in Orgenesis; • the EU’s COVID-19 vaccine procurement and missing Pfizer communications; • NextGenerationEU recovery funding; • Italy’s publicly funded gene-therapy programme; • Orgenesis Italy’s registered project inside that programme; • the European Parliament’s power to remove the Commission.  Read the evidence:  ORGENESIS INVESTIGATION https://alimcforever.com/orgenesis-in... FULL INTEL DESK https://alimcforever.com/i/ CONTACT YOUR MEP Find your representative, edit the letter, translate it and send it: https://alimcforever.com/eu/ Every major claim is linked to the underlying public record. Read the documents and draw your own conclusions.  Subscribe for primary-source public-interest journalism, accessible education and decolonial history.  #UrsulaVonDerLeyen #EuropeanCommission #Orgenesis

The Von Der Leyens & Orgenesis: Deep Investigation

ali mcforever

48.2K subscribers 

ACT TWO · THE MACHINERY

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)

ACT TWO · THE MACHINERY

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.

$1.335m gain

Employees claimed unpaid salaries. A court ordered liquidation. Orgenesis removed $708,000 of net liabilities and recorded a gain after currency effects.

$3.213m gain

Two companies could not pay staff or suppliers. Removing about $3.304 million of net liabilities produced a reported accounting gain.

$2.695m payable

Employees claimed unpaid salaries. A trustee took control. The parent bought some equipment and still recorded a large related-party payable to the failed company.

(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)

ACT TWO · THE MACHINERY

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.

ACT TWO · THE MACHINERY

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)

ACT TWO · THE MACHINERY

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)

State-hospital research entered a private worldwide licence. Later Israeli entities faced trusteeship, employee claims and bankruptcy.

Koligo processed pancreases in Kentucky. Maryland operations recorded cell-processing and hospital services. University licences connected Columbia and the University of California.

MIDA Biotech led an EU stem-cell project. A Belgian consortium received a Walloon grant. Belgian Orgenesis entities later entered liquidation.

Theracell entered a strategic public-investment route in Greece. Heiko briefly represented Orgenesis Italy inside a PNRR-linked gene and RNA therapy centre.

The accounts record liquidation or dissolution activity involving entities in both countries.

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)

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)

ACT TWO · THE PUBLIC SALES SURFACE

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.

Examples visible on 6 August 2026Product headingDescription shown beneath itCAR-NKText copied from the CD19/22 CAR-T product.SVF-COVRanpirnase genital-warts text.KyslecelThe same Ranpirnase genital-warts text.Cartil-S / ChondrosealLiver-cell-to-insulin-cell text.MSCKDThe same liver-to-insulin text.

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 Real Reason a Million Irish People Starved Was Never the Potato What They Never Taught You 

History Unburied 

224,760 views Oct 10, 2026

In December 1846, a Cork magistrate pushed open a cabin door in Skibbereen and found six people so starved he took them for corpses. That same winter, ships were leaving Irish harbours loaded with oats, calves, pork and butter. The same potato blight hit Belgium, the Netherlands and the Scottish Highlands, but only Ireland lost about a million people. So why did a million Irish people really die in the Great Famine?  This documentary follows the real reasons behind Ireland's Great Famine of 1845 to 1852, An Gorta Mór, the Great Hunger. The land and tenancy system and the absentee landlords. The Lumper potato that more than three million people lived on. Peel's Indian corn and the repeal of the Corn Laws. Lord John Russell's laissez-faire government and Charles Trevelyan's own words. The public works, the soup kitchens that fed three million people a day and were shut down anyway, and the Gregory clause, the quarter-acre clause that passed by 117 votes to 7. The workhouses, the evictions and clearances, the coffin ships to Grosse Île, the honest numbers on Irish food exports and grain imports, and the question people still argue about. Was the Irish Famine genocide, or a catastrophe made by policy?  If your school taught you the potato and nothing else, type quarter acre in the comments, and tell us where you're watching from. Did your family leave Ireland in the famine years? Share their story below, and subscribe to History Unburied for the documents, the names and the numbers behind history's most famous events.  Phytophthora started it, and a chain of decisions, every one of them on paper with names and dates beside it, turned it into a catastrophe. A quarter of an acre was the line Parliament drew in 1847 between a starving family and its next meal.

History Unburied

Notable 2024 Activities

On January 29, 2024, the Company and Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase Agreement (the “MM UPA”), pursuant to which the Company acquired all of the preferred units of Octomera LLC (“Octomera”) previously owned by MM (the “MM Acquisition”), and effective that date, reconsolidated Octomera into its accounts. The Company currently owns 100% of the equity interests of Octomera. The Company had previously, from June 30, 2023 (“date of deconsolidation”), deconsolidated Octomera from its consolidated financial statements.

On April 5, 2024, the Company entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”) with Griffin Fund 3 BIDCO, Inc., (“Germfree”), for the sale by the Company of five OMPULs to Germfree, which will be incorporated into Germfree’s lease fleet and leased back to the Company or to third-party lessees designated by the Company. On November 5, 2024, Germfree notified the Company of its intention not to lease any OMPULS back to the Company. Germfree confirmed that it has satisfied its obligations to the Company under the Purchase Agreement. On June 13, 2025 the Company and Germfree resolved all remaining differences between themselves.

On May 21, 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007,372 of outstanding principal and accrued interest was exchanged for an aggregate of 1,577,695 shares of common stock of the Company. On July 10, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience and Technology Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The process and algorithms developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable the Company to develop and sell treatments to third parties, which include Broaden’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals related thereto.

On July 12, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by the Company of the following assets (the “Assets”) owned by Theracell: 1) 50% of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and 2) Certain products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods, standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals.

On October 19, 2024, Mark Goodman resigned as a director of the Company, On October 28, 2024, the Board of Directors of the Company, following the recommendation of the Nominating and Corporate Governance Committee of the Board, elected Adam Pelavin, Jagannathan Bhalaji, and Santhosh Nagaraj to serve as members of the Board. On December 24, 2024, Jagannathan Bhalaji resigned as a director of the Company. On August 9, 2025, Yaron Adler and Adam Pelavin resigned as directors of the Company. On August 18, 2025, Santhosh Nagaraja resigned as a director of the Company.

On August 8, 2025, Mr. Victor Miller, the Chief Financial Officer, Treasurer and Secretary of the Company resigned. Vered Caplan assumed the role of the principal financial and accounting officer following his resignation.

On March 10, 2026, the Company appointed Douglas Karriker as its Chief Financial Officer, Treasurer and Secretary, effective March 10, 2026.

On November 8, 2024, the two Belgian subsidiaries of the Company, viz. Orgenesis Belgium SRL and Orgenesis Services SRL (“the Belgian subsidiaries”), petitioned the Liège Business Court in Belgium (“Court”) for allowing their judicial reorganization pursuant to Article XX.41 of the Belgian Code of Economic Law. The petition follows the current inability of the Belgian subsidiaries to pay employee payroll expenses and accounts payable. The Court ordered the liquidation of the two subsidiaries, which were deconsolidated from the Company’s accounts.

Revenue Model, Business Development and Licenses

Our POCare Platform is comprised of three enabling components: a multitude of licensed cell based POCare Therapies to be produced in closed, automated POCare Technology systems across a collaborative POCare Network. Our therapies include, but are not limited to, autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viral diseases, and tissue regeneration. We are establishing and positioning the business to bring point-of-care therapies to patients in a scalable way working directly with hospitals and through regional partners and organizations active in autologous cell therapy product development, including facilities in various countries in North America, Europe, Asia, the Middle East, and Australia. Our goal through the POCare Platform is to enable a rapid, globally harmonized pathway for these therapies to reach large numbers of patients at lowered costs through efficient, and decentralized production. Our POCare Network brings together industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies.

We are focused on technology in licensing and therapeutic collaborations, and we out-license therapies marketing rights and manufacturing rights to partners. In many cases, the partners are responsible for the preparation of clinical trials, local regulatory approvals and regional marketing activities. Such licensing includes exclusive or nonexclusive, sublicensable, royalty bearing rights and license to the Orgenesis Background IP as required to manufacture, distribute and market and sell Orgenesis products within the relevant territories. In consideration of the rights and the licenses so granted, we receive a royalty in the range of ten percent of the net sales generated by the partners and/or licensees or sublicensees (as applicable) with respect to the Orgenesis products.

Our business model of partnering with regional partners for initial clinical development of licensed POCare Therapies allows us to de-risk our clinical development plans. We have access to the development and clinical data generated by our partners based on which we can make informed decisions as to which of our assets have the most promising value for development in major markets such as the US and EU. Our goal is once we have proof of concept and clinical data from our regional partners, we can focus on developing such therapeutic products.

Further to revenues generated from out-licensing, we generate revenues from POCare Services and sales which is comprised of:

●R&D development services provided to out-licensing partners

We have signed POCare development services Master Services Agreements (“MSAs”) with our partners. In terms of the MSAs, we provide certain broadly defined development services that relate to our licensed therapies designed to develop or enhance the therapy with the objective of preparing it for clinical use. Such services, per therapy, include regulatory services, pre-clinical studies, intellectual property services, development services, and GMP process translation. We also provide support services to our customers.

●Hospital supply

Hospital services includes the sale or lease of products and the performance of processing services to our POCare hospitals or other medical providers. We either work directly with hospitals or receive payments through our regional partnerships.

●Cell process development revenue

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We provide cell process development services in some regions to third party customers. Those services are unique to the customers who retain the ownership of the intellectual property created through the process.

●POCare cell processing

We provide distributed cell processing services for third party customers at POCare Centers in close proximity to patients.

Our POCare revenue is as follows:

 Years Ended December 31, Revenue stream: 2024  2023   (in thousands) POCare development services $   $-Cell process development services and hospital services  1,020   515 License fees  15   15 Total $1,035  $530 

Liquidity

We do not currently have sufficient funds to service our operations and our expenses and other liquidity needs and require additional capital immediately, and our independent registered public accountants and management have expressed substantial doubt as to our ability to continue as a going concern.

As of December 31, 2024 and 2023, we had cash and cash equivalents of approximately $0.1 million and $0.8 million, respectively, and working capital deficits of approximately $26 million and $12 million, respectively. We continue to incur significant expenses in connection with operating as a public company. As of December 31, 2024 and 2023, we had accounts payable and accrued expenses of $12.8 million and $8.7 million, respectively.

We had approximately $65.8 million in outstanding debts as of December 31, 2024, inclusive of the calculated fair market value, and not the actual repayment amount, of our convertible loans, revolving line of credit, loans with related parties, and other debt obligations. In September 2025, we repaid $6.3 million of this outstanding debt.

We intend to continue to seek delays on certain payments and explore other ways of potentially reducing expenses with the goal of preserving cash until additional financing is secured. These efforts may not be successful or sufficient in amount or on a timely basis to meet our ongoing capital requirements. We continue to actively seek additional financing. In the absence of additional sources of liquidity, we do not have sufficient existing cash resources to meet operating and liquidity needs. However, there is no assurance that we will be able to timely secure such additional liquidity or be successful in raising additional funds or that such required funds, if available, will be available on acceptable terms or that they will not have a significant dilutive effect on our existing stockholders. In addition, we are unable to determine at this time whether any of these potential sources of liquidity will be adequate to support our operations or provide sufficient cash flows to us to meet our obligations as they become due and continue as a going concern. In the event we determine that additional sources of liquidity will not be available to us or will not allow us to meet our obligations as they become due, we may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. In addition, substantial doubt about our ability to continue as a going concern may cause investors or other financing sources to be unwilling to provide funding to us on commercially reasonable terms, if at all. If sufficient funds are not available, we will have to delay, reduce the scope of, or eliminate some or all of our business activities, which would adversely affect our business prospects and our ability to continue our operations..

Competition in the Cell Therapy Field

The biopharmaceutical industry is intensely competitive. There is continuous demand for innovation and speed, and as the cell-based therapies market evolves, there is always the risk that a competitor may be able to develop other compounds or drugs that are able to achieve similar or better results for indications. Potential competition includes major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions. Many of these competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations with established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Currently, we are not aware of any other companies pursuing a business model similar to what we are developing under our POCare Platform. However, our competitors in the CGT field who are significantly larger and better capitalized than us could undertake strategies similar to what we are pursuing and even develop them at a much more rapid rate. These potential competitors include the same multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions that are operating in the CGT field. In that respect, smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Intellectual Property

We will be able to protect our technology and products from unauthorized use by third parties only to the extent it is covered by valid and enforceable claims of our patents or is effectively maintained as trade secrets. Patents and other proprietary rights are thus an essential element of our business.

Our success will depend in part on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions, and improvements that are important to the development of our business. We also rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunities to develop and maintain our proprietary position.

In addition, we own or have exclusive rights to nineteen (19) United States patents, twenty one (21) foreign-issued patents, sixteen (16) pending patent applications in the United States, twenty seven (27) pending patent applications in foreign jurisdictions, including Australia, Brazil, Canada, China, Europe, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Korea, Panama, Russia, Singapore, and South Africa. These patents and patent applications relate, among others, to (1) dendritic cell based (whole cell) vaccines, and their use for treating cancer and viral diseases; (2) compositions comprising Ranpirnase and other ribonucleases and their use for treating viral diseases; (3) tumor infiltrating lymphocytes (TILs) and their use for treating cancer; (4) compositions comprising immune cells for treating COVID-19; (5) therapeutic compositions comprising exosomes, bioxomes, and redoxomes; (6) Sterile bio-processing system for culturing cells; (7) chimeric antigen receptors (CARs); (8) Mobile Processing Units; (9) Cell-delivery devices; and (10) skin diseases treatment and anti-aging compositions.

We have two granted U.S. patents and a pending U.S. patent application directed, among others, to dendritic cell-based (whole cell) vaccines, and their use for treating cancer and viral diseases. The granted U.S. patents will expire in 2037.

We have granted and pending U.S. patent applications directed, among others, to compositions comprising Ranpirnase and other ribonucleases for the treatment of viral diseases. Granted U.S. patents and if issued, any patents based on these applications will expire between 2024 and 2042. Counterpart granted patents and patents applications were filed in Australia, Canada, China, Europe, Hong Kong, Japan, Mexico, New Zealand, South Korea, Russian Federation, Singapore, and South Africa. If issued, any patents based on these applications will expire between 2035 and 2042. These expiration dates do not include any patent term extensions that might be available following the grant of marketing authorizations.

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We have pending U.S. patent applications directed, among others, to therapeutic compositions comprising exosomes, bioxomes, and redoxomes. If issued, any patents based on these applications will expire between 2029 and 2041. Counterpart patents applications were filed in, China, Europe, India, Israel, and Japan, . If issued, any patents based on these applications will expire in 2039 and 2041. These expiration dates do not include any patent term extensions that might be available following the grant of marketing authorizations.

We have a pending U.S. patent application directed, among others, to immune cell-based vaccines comprising antigens against Coronavirus Disease 2019 (COVID-19). A counterpart patent application was also filed in Europe. If issued, any patents based on these applications will expire in 2043, without including any patent term extensions that might be available following the grant of marketing authorizations.

We have granted U.S. patent and a pending U.S. patent application, directed, among others, to bioreactors for cell culture and automated devices for supporting cell therapies. The granted U.S. patents will expire in 2027. If issued, any patents based on pending applications will expire in 2041. Counterpart patent applications were filed in Israel, Japan, and Mexico. Patents were granted in Korea, China and Canada and will expire in 2027.

We have a pending U.S. patent application directed, among others, to tumor infiltrating lymphocytes (TILs) and their use for treating cancer. If issued, patents will expire in 2042, without including any patent term extension that might be available following the grant of marketing authorizations.

We have pending U.S. patent application directed, among others, to a sterile bio-processing system for culturing cells and methods for culturing cells, such as tumor infiltrating lymphocytes (TILs). Counterpart patent applications were filed in China and Europe. If issued, any patent based on this application would expire in 2044, without including any patent term extensions that might be available following the grant of marketing authorizations.

We have a pending U.S. patent application directed, among others, to compositions comprising mesenchymal stem cells, and their use for treating solid tumors. If issued, any patent based on this application would expire in 2040. Counterpart patent applications were filed in Europe, and Israel. If issued, any patents based on these applications would expire in 2040. These expiration dates do not include any patent term extensions that might be available following the grant of marketing authorizations.

We have a pending U.S. patent application directed, among others, to methods of treating cancer or CNS-related diseases by intranasal administration of an oncolytic virus. If converted into national phase applications and issued, any patents based on these applications will expire in 2043, without including any patent term extensions that might be available following the grant of marketing authorizations. A counterpart patent application was filed in Europe.

We have two pending U.S. patent applications and a pending European patent application, directed, among others, to chimeric antigen receptors (CARs), and their use for treating malignancies. Counterpart patent applications were filed in China and Hong-Kong. If issued, any patents based on the U.S. applications would expire in 2042 or 2043, without including any patent term extensions that might be available following the grant of marketing authorizations.

We have a pending U.S. patent application directed, among others, to a composition comprising topiramate and bioxome, redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles and its use for the treatment of a dermatological condition. If issued, any patents based on this application would expire in 2042, without including any patent term extensions that might be available following the grant of marketing authorizations.

We also own IP and related Extracellular Vesicle (“EV”) Technology pursuant to an EV purchase agreement (the “EV Agreement”). Pursuant to the EV Agreement, we received all of the rights in EV technology purchased. In addition, we received an exclusive worldwide license to use the EV IP technology for any purpose.

We have one U.S. patent application relating to hydrogel compositions (co-applicants).

We have two U.S. patent applications and two EP patent applications relating to adipose derived treatments (co-applicants).

The therapeutic efficacy of Ranpirnase and our other product candidates is unproven in humans, and we may not be able to successfully develop and commercialize Ranpirnase or any of our other product candidates.

Ranpirnase and our other product candidates are novel compounds and their potential benefit as antiviral drugs or immunotherapies is unproven. Ranpirnase and our other product candidates may not prove to be effective against the indications for which they are being designed to act and may not demonstrate in clinical trials any or all of the pharmacological effects that have been observed in preclinical studies. As a result, our clinical trial results may not be indicative of the results of future clinical trials.

Ranpirnase and our other product candidates may interact with human biological systems in unforeseen, ineffective or harmful ways. If Ranpirnase or any of our other product candidates is associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon the development of such product candidate or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Because of these and other risks described herein that are inherent in the development of novel therapeutic agents, we may never successfully develop or commercialize Ranpirnase or any of our other product candidates, in which case our business will be harmed.

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We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2024, we employed 77 employees. As our development and commercialization plans and strategies develop, we must add a significant number of additional managerial, operational, sales, marketing, financial, and other personnel. Future growth will impose significant added responsibilities on members of management, including:

●identifying, recruiting, integrating, maintaining, and motivating additional employees;●managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and●improving our operational, financial and management controls, reporting systems, and procedures.

Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. This lack of long-term experience working together may adversely impact our senior management team’s ability to effectively manage our business and growth.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, if at all. If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development, and commercialization goals.

We require additional capital to support our business, and this capital may not be available on acceptable terms or at all.

We intend to continue to make investments to support our business growth and require additional funds to respond to business challenges and to grow our POCare cell therapy business and to further the development of ATMPs. Accordingly, we will need to engage in equity or debt financings to secure additional funds.

Capital and credit market conditions, adverse events affecting our business or industry, the tightening of lending standards, rising interest rates, negative actions by regulatory authorities or rating agencies, the lack of liquidity in our common stock or other factors also could negatively impact our ability to obtain future financing on terms acceptable to us or at all. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, our ability to support our business growth and respond to business challenges could be significantly limited. In addition, the terms of any additional equity or debt issuances may adversely affect the value and price of our common stock, our results of operations, financial condition and cash flows.

If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new securities we issue could have rights, preferences and privileges superior to those of holders of our common stock. Any financing secured by us in the future could include restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.

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We conduct certain of our operations in Israel. Conditions in Israel, including the October 7, 2023 attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect certain of our operations.

Because we conduct certain operations in the State of Israel, some of our business and operations may be affected by economic, political, geopolitical and military conditions in Israel. In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Moreover, the clash between Israel and Hezbollah in Lebanon, may escalate in the future into a greater regional conflict.

Any hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners could adversely affect certain of our operations and results of operations and could make it more difficult for us to raise capital. The conflict in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. There have been travel advisories imposed relating to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be imposed in the future. Additionally, certain members of our management and employees are located and reside in Israel. Shelter-in-place and work-from-home measures, government-imposed restrictions on movement and travel and other precautions taken to address the ongoing conflict may temporarily disrupt our management and employees’ ability to effectively perform their daily tasks.

The Israel Defense Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions. Several of our employees are subject to military service in the IDF and have been, or may be, called to serve. It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.

It is currently not possible to predict the duration or severity of the ongoing conflict or its effects on our business, operations and financial conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt certain of our business and operations, among others.

Currency exchange fluctuations may impact the results of our operations.

The results of our operations are affected by fluctuations in currency exchange rates in both sourcing and selling locations. Our results of operations may still be impacted by foreign currency exchange rates, primarily, the euro-to-U.S. dollar exchange rate. In recent years, the euro-to-U.S. dollar exchange rate has been subject to substantial volatility which may continue, particularly in light of recent political events regarding the European Union, or EU. Because we do not hedge against all of our foreign currency exposure, our business will continue to be susceptible to foreign currency fluctuations.

We have entered into collaborations and joint ventures and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

We have entered into collaborations and joint ventures and may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners for which the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following:

●collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

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●collaborators may not perform their obligations as expected;●collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;●collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;●collaborators could fail to make timely regulatory submissions for a product candidate;●collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements;●collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;●product candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;●a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;●collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;●disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;●collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and●collaborators may own or co-own intellectual property covering our products that results from our collaborating with them and, in such cases, we would not have the exclusive right to commercialize such intellectual property.

As a result, if we enter into collaboration agreements and strategic partnerships or license our products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. The success of our existing and future collaboration arrangements and strategic partnerships, which include research and development services by our collaborators to improve our intellectual property, will depend heavily on the efforts and activities of our collaborators and may not be successful. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition, and results of operations.

Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product candidates, and we may not have control over a number of key elements relating to the development and commercialization of any such product candidate.

A key aspect of our strategy is to seek collaborations with partners, such as a large pharmaceutical organization, that are willing to further develop and commercialize a selected product candidate. To date, we have entered into a number of collaborative arrangements with cell therapy organizations. By entering into any such strategic collaborations, we may rely on our partner for financial resources and for development, regulatory and commercialization expertise. Our partner may fail to develop or effectively commercialize our product candidate because they:

●do not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as limited cash or human resources;●decide to pursue a competitive potential product developed outside of the collaboration;

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●cannot obtain the necessary regulatory approvals;●determine that the market opportunity is not attractive; or●cannot manufacture or obtain the necessary materials in sufficient quantities from multiple sources or at a reasonable cost.

We may not be able to enter into additional collaborations on acceptable terms, if at all. We face competition in our search for partners from other organizations worldwide, many of whom are larger and are able to offer more attractive deals in terms of financial commitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and support. If we are not successful in attracting a partner and entering into a collaboration on acceptable terms, we may not be able to complete development of or commercialize any product candidate. In such event, our ability to generate revenues and achieve or sustain profitability would be significantly hindered and we may not be able to continue operations as proposed, requiring us to modify our business plan, curtail various aspects of our operations or cease operations.

Our success depends on our ability to protect our intellectual property and our proprietary technologies.

 The Intelligence Playbook – alimcforever.com 

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Media & Mind

The Intelligence Playbook.

Coordinated comment campaigns are not new and they are not improvised. They are written down — in government training slides, leaked documents, declassified files, and decades of academic research. This is a document bank: the primary sources, the named tactics, and how to read them. Self-directed. No account, no opinion, no permission required.

https://alimcforever.com/media-and-mind/intelligence-playbook/

Format

Reference / document bank

Sources

Primary documents only

Use

Read in any order

Status

Evergreen

01JTRIG

02COINTELPRO

03Cognitive Infiltration

0410 Principles

05Manufactured Doubt

06The Tactics

07Why Some Topics Draw More

08In Comment Sections

09How to Spot It

10Document Bank

01 — The Source Document

JTRIG: revealed through the Snowden leaks (2013–2014)

In February 2014, Glenn Greenwald published a classified GCHQ training presentation from the Snowden archive in The Intercept. It was called “The Art of Deception: Training for a New Generation of Online Covert Operations” and it was classified SECRET//SI//REL TO USA, FVEY — shared across the Five Eyes intelligence alliance: the UK, US, Canada, Australia, and New Zealand.

JTRIG

What the unit was for, in its own words

Verified

The presentation came from a GCHQ unit called the Joint Threat Research Intelligence Group, or JTRIG. According to its own slides, JTRIG had two core purposes: injecting false material onto the internet to destroy the reputation of targets, and using social sciences to manipulate online conversations and activism to produce outcomes the government considered desirable. That is GCHQ’s own description of what they were doing.

The slides laid out what they called a “Disruption Operational Playbook” — infiltration operations, ruse operations, set piece operations, false flag operations, false rescue operations, disruption operations, and sting operations. They also named tools: UNDERPASS manipulated online polls; SLIPSTREAM inflated page-view counts; GESTATOR amplified approved YouTube content; SILVERLORD censored videos flagged as extremist; SPRING BISHOP found private Facebook photos; CHANGELING spoofed email addresses so messages appeared to come from someone else.

By early 2013, over 150 JTRIG staff were fully trained, and a separate initiative was rolling out a reduced version of the tradecraft to more than 500 other GCHQ analysts. “Targets” in these documents does not just mean terrorists or hostile nations: Greenwald pointed out that many techniques were discussed in the context of using them against people suspected but not charged with ordinary crimes, or engaged in online protest — people who had never been arrested or convicted of anything.

Greenwald, The Intercept — original report (2014)

EFF — full leaked presentation (PDF)

ACLU — JTRIG tools and techniques

Greenwald — follow-up on the named tools (2014)

02 — The Precedent

COINTELPRO: the FBI’s programme (1956–1971)

In 1956, the FBI set up COINTELPRO — Counter Intelligence Program. It was aimed at civil rights organisers, anti-war groups, and communist-affiliated organisations inside the United States. The Church Committee, the US Senate investigation that uncovered it, found the FBI started it partly out of frustration that the Supreme Court kept limiting what they could legally do to these groups. So they stopped doing things legally.

FBI

What it did, and how it surfaced

Verified

For fifteen years, COINTELPRO ran operations to damage people’s public image through surveillance and leaking personal information, manufacture conflicts between members of the same organisations, plant forged documents and anonymous letters to create distrust, and send agents into groups to encourage illegal activity that could then be used to discredit everyone involved.

Nobody outside the FBI knew any of this until 8 March 1971, when a group of activists broke into an FBI field office in Media, Pennsylvania, took the files, and posted them to journalists. The Senate formed the Church Committee to investigate. They spent sixteen months on it — 800 witnesses, 110,000 documents. The final report came out in April 1976 across six volumes and found that FBI domestic intelligence had violated both specific laws and constitutional rights.

US Senate — Church Committee summary

Church Committee — Book III, COINTELPRO (PDF)

Church Committee — “Intelligence Activities and the Rights of Americans” (PDF)

03 — The Academic Proposal

Cass Sunstein’s “cognitive infiltration” (2008)

In 2008, Cass Sunstein — who later became an adviser in the Obama administration — co-authored a paper proposing that governments should “cognitively infiltrate” groups that produce conspiracy theories by placing covert agents and people who appear to be independent advocates into online forums, chat rooms, and social networks.

2008

The argument, and the obvious problem

Verified

The argument was that conspiracy theorists suffer from a “crippled epistemology” — they only hear one set of voices — and the fix was to introduce “informational diversity” from the inside. Not by publicly debating them. By secretly placing people among them.

The obvious issue, which critics raised straight away, is that if people in those groups ever discovered the infiltration, it would confirm the exact conspiracy they already suspected. A paper proposing the government secretly place agents in people’s conversations to change what they think is a difficult thing to walk back once people find out about it.

Sunstein & Vermeule — full paper (PDF, archive.org)

David Coady — academic analysis (PDF)

04 — The Method, Named

The 10 Principles of Influence

The JTRIG “Art of Deception” presentation lists ten principles for manipulating targets online. These are what GCHQ trained its staff to use. The keystone is Flattery — and it maps directly onto the “I usually love your work, but…” pattern. Select any principle to read what the slides say it does.

Flattery

Compliment the target first; build connection before introducing doubt.

Read +

Social Compliance / Authority

Invoke expertise or institutional credibility to pressure conformity.

Read +

Herd

Make it look like everyone disagrees.

Read +

Consistency

Hold people to past statements.

Read +

Reciprocity

Give something first so the target feels obliged to respond.

Read +

Distraction

Redirect the conversation away from the core point.

Read +

Time

Create urgency or delay, whichever serves the operation.

Read +

Deception

Present false information as true.

Read +

Dishonesty

Misrepresent who you are, what you want, or who you work for.

Read +

Need and Greed

Exploit what the target wants.

Read +

05 — The Commercial Parallel

The Manufactured Doubt playbook

The comment patterns on political-education content follow the same logic as a strategy well-documented in the tobacco, fossil fuel, and pharmaceutical industries. It is called manufactured doubt, and it has four steps. The goal is never to win the argument — it is to create just enough hesitation in a casual viewer that they scroll on.

Step 1

Deny

“That is not what really happened.”

Step 2

Delay

“Where is your source for that?” — where the point is not to learn but to slow everything down.

Step 3

Dilute

“It is more nuanced than you are making it.”

Step 4

Discredit

“You are usually good, but this one is off.”

The Center for International Environmental Law traced this strategy from the tobacco industry’s response to cancer research in the 1950s through to the fossil fuel industry’s handling of climate science, and found the approach barely changed across decades and industries. You do not need to refute the content. You just need to make the audience hesitate.

CIEL — the oil-and-tobacco denial playbook

UICC — using Big Tobacco’s playbook

Center for Humane Technology — weaponizing uncertainty in tech

06 — The Specific Tactics

The tactics, and how to spot them

Five named tactics. Tap any one to open it. Each carries its own primary sources.

+

Concern Trolling

Opposing an idea while pretending to support it.

+

Sealioning

Relentless, polite demands for evidence designed to exhaust.

+

The “Both Sides” / “You Are Biased” Reframe

Shifting from “here is evidence” to “why are you not balanced?”

+

Swarm and Replace

Block one account, another appears — manufactured consensus.

+

False Flag Operations

Posting material and falsely attributing it to someone else.

07 — The Scale and the Frame

Why some topics draw more

Some political topics — particularly communism, socialism, and anti-capitalist analysis — attract more coordinated hostility than others. There are structural reasons, and they are on the record.

1956→

The historical frame

Verified

COINTELPRO was created in 1956 specifically to target communist-affiliated groups; the Church Committee confirmed this. Anti-communist disruption is where US domestic intelligence began, and a lot of the infrastructure built during the Cold War never fully dismantled. US international broadcasting, for instance, was explicitly designed to counter communist ideology — not just through news reporting but through direct ideological challenge — and that framing shaped institutions and professional cultures that are still around.

Church Committee — final report (PDF)

Texas National Security Review — Cold War media strategy

Dec 2025

The current framework: the Bondi / NSPM-7 memo

Verified

In December 2025, US Attorney General Pam Bondi issued a memorandum directing the FBI and all federal prosecutors to compile lists of groups engaged in what the administration defines as domestic terrorism. The memo was leaked by investigative journalist Ken Klippenstein and subsequently confirmed by the Department of Justice to Snopes. It identifies “anti-capitalism” and “anti-Americanism” as indicators of potential domestic terrorism, alongside opposition to immigration enforcement, “radical gender ideology,” and “hostility towards traditional views on family, religion, and morality.”

The memo directs the FBI to compile and update a list of these groups every 30 days, establish a cash reward system for tips from the public, and create cooperators to testify against members of targeted organisations. In February 2026, The Intercept reported that Attorney General Bondi confirmed to Congress that the list exists, while refusing to share it. There is now a formal framework within the US government under which discussing communism favourably sits alongside other views classified as indicators of potential domestic terrorism.

Ken Klippenstein — the leaked memo

Snopes — DOJ confirmation of the memo

Democracy Now — interview with Klippenstein

FIRE — legal analysis of the free-speech implications

The Hill — original reporting

The Intercept — Bondi confirms the list exists

2020

The industrial scale of it

Verified

On the platform side, research from the Oxford Internet Institute found that social media manipulation by political actors has become an industrial-scale problem. Their 2020 survey found organised manipulation campaigns in all 81 countries studied, up from 70 the previous year. Governments, PR firms, and political parties are producing misinformation at scale. The researchers found more than 65 private firms offering disinformation as a paid service, and documented nearly $60 million spent on hiring them since 2009.

Oxford Internet Institute — Industrialized Disinformation (2020)

Oxford OII — full report (PDF)

08 — How It Assembles

How it works in comment sections

The tactics above rarely appear alone. In practice they assemble into a sequence.

A seed account builds credibility first — normal posts, normal follows, a profile that looks like a real person. On Instagram this tends to be more developed than on TikTok, where the accounts are often blank. The account sits quietly until the creator publishes something about a sensitive topic.

Then the Flattery principle comes out: “I usually love your content, but…” — which, if you have read the JTRIG slides, is a trained influence technique designed to construct credibility for the commenter before they deliver the doubt. If the creator responds, the commenter shifts to sealioning — endless requests for sources, insistence on balance, reframing away from the original point. If the creator blocks instead, new accounts arrive, sometimes directly referencing the block. And throughout, coordinated engagement from other accounts in the network pushes the doubt-sowing comment higher in the algorithm so more casual viewers see it.

The operation does not need to convince anyone that the creator is wrong. It just needs enough casual scrollers to hesitate for a second before they move on.

09 — The Defence

How to spot it, as an audience member

These operations rely on audiences not knowing what they are looking at — which means that once you do know, a lot of the effect disappears.

✓

Check the commenter’s profile

Does the account have a life? Any pictures of their dog, complaints about the weather, opinions about food — or does it only appear in comment sections on specific political topics?

✓

Look for the template

“I usually love your work, but…” is a script. Genuine disagreement tends to be specific. Real people who disagree will usually say what they disagree with and bring their own evidence rather than offering vague doubt.

✓

Check whether the comment engages with actual evidence

Does the commenter reference a specific claim and offer counter-evidence — or do they say “this is not accurate” or “you need to do more research” without ever saying what is inaccurate or what research they mean?

✓

Notice the swarm

If blocking one account leads to another immediately saying “she is deleting comments,” that is coordination. Keep blocking them. Hold the line; let the debate occur elsewhere, among real adults who are respectful and genuine.

✓

Do not engage the sealion

Responding with evidence gives the troll more material to work with. The point is not to learn. Name the tactic if you want, and move on.

✓

Screenshot and document

Save comment patterns, account names, and timestamps. A single suspicious comment could be anything. Twenty using the same phrasing across different posts, from accounts created around the same time — that is a pattern, and patterns are evidence.

10 — The Document Bank

The primary sources, in full

The documents the playbook is built on. Read each one in place, or open the original. These are the actual files — government training slides, the Senate’s own report, the academic paper — not summaries of them.

Keystone document

The Art of Deception — GCHQ / JTRIG training presentation

Classified SECRET//SI//REL TO USA, FVEY · 52 pages · Snowden archive, via EFF

The training slides themselves. The “Disruption Operational Playbook,” the named tools, and the 10 Principles of Influence — including Flattery — in GCHQ’s own words.

Read in place

⤢

Open original at EFF

↗

Document

JTRIG Tools and Techniques

8 pages · via ACLU

The companion document listing the named tools — UNDERPASS, GESTATOR, SILVERLORD and the rest — and what each was built to do.

Read in place

⤢

Open original at ACLU

↗

Government report

Church Committee — Book III, COINTELPRO

US Senate, 1976 · 31 pages

The Senate’s own findings on the FBI’s domestic disruption programme — surveillance, forged documents, manufactured conflict, and the violation of constitutional rights.

Read in place

⤢

Open original (AARC)

↗

Academic paper

Sunstein & Vermeule — Conspiracy Theories / Cognitive Infiltration

2008 · 30 pages · via archive.org

The paper proposing governments “cognitively infiltrate” groups by placing covert agents and apparent independent advocates into online forums and networks.

Read in place

⤢

Open original (archive.org)

↗

The Core Insight

The “I usually love your work, but…” comment is a documented intelligence technique called the Flattery Principle. It is one of ten named principles for online influence and deception in classified GCHQ training. The flattery exists to make the doubt that follows feel credible — and once you know that, it stops working the same way.

This page is a reference compilation of primary and named sources. Verification chips reflect the status of each claim against the public record: VERIFIED indicates a primary or first-party source is linked. Documents in the Document Bank are the original files, linked at source; on-site hosted copies will replace these links once uploaded. Compiled from “The Intelligence Playbook,” alimcforever, March 2026. Read alongside the rest of Media & Mind.

ITEM 1A. RISK FACTORS

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

●Our management, as of December 31, 2024, and our independent registered public accounting firm, in its report on our financial statements as of and for the fiscal year ended December 31, 2024, have concluded that there is substantial doubt as to our ability to continue as a going concern.  ●Our POCare business has a limited operating history and an unproven business model and faces significant challenges as the cell therapy industry is rapidly evolving. Our prospects may be considered speculative and any failure to execute our business strategy could adversely impact our business.  ●We are not profitable as of December 31, 2024, have limited cash flow and, unless we increase revenues and take advantage of any commercial opportunities that arise to expand our POCare business, the perceived value of our company may decrease and our stock price could be affected accordingly.  ●Our research and development efforts on novel technology using cell-based therapy and our future success is highly dependent on the successful development of that technology.  ●We require additional capital to support our business, and this capital may not be available on acceptable terms or at all.  ●We have entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.  ●Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product candidates, and we may not have control over a number of key elements relating to the development and commercialization of any such product candidate.  ●Our success depends on our ability to protect our intellectual property and our proprietary technologies.  ●Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

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●Our success depends on our ability to develop and grow our paradigm-shifting decentralized approach to CGT therapies utilizing an automated and/or closed approach validated for compliant production at or near the patient care site (“Decentralized Cell Processing or DCP Platform”) and Octomera’s cell processing business.  ●Our success depends on our ability to develop and roll out our Decentralized Production Units and OMPULs.  ●If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.  ●We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurity and data storage risks.  ●There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.  ●Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.  ●Our product candidates are biologics, and the manufacture of our product candidates is complex, and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities.  ●Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.  ●We currently have no marketing and sales organization and have no experience in marketing therapeutic products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.  ●There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.  ●We face significant competition from other biotechnology and pharmaceutical companies, many of which have substantially greater financial, technical and other resources, and our operating results will suffer if we fail to compete effectively.  ●We are highly dependent on key personnel who would be difficult to replace, and our business plans will likely be harmed if we lose their services or cannot hire additional qualified personnel.  ●Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.  ●Third parties to whom we may license or transfer development and commercialization rights for products covered by intellectual property rights may not be successful in their efforts and, as a result, we may not receive future royalty or other milestone payments relating to those products or rights.  ●Conditions in Israel, including the October 7, 2023 attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect certain of our operations.

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●We have identified a material weakness in our internal control over financial reporting. Failure to achieve and maintain effective internal controls over financial reporting could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner, which could have an adverse impact on our business.  ●Our securities have been delisted from Nasdaq and currently trade on the OTC Expert Market, which could make it difficult to trade our common stock.  ●We have not been able, and may continue to be unable, to timely file periodic reports with the SEC.

Risk Factors

An investment in our common stock involves a number of very significant risks. You should carefully consider the following risks and uncertainties in addition to other information in this report in evaluating our company and its business before purchasing shares of our company’s common stock. Our business, operating results and financial condition could be seriously harmed due to any of the following risks. You could lose all or part of your investment due to any of these risks.

Risks Related to Our Company and POCare Business

We do not currently have sufficient funds to service our operations and our expenses and other liquidity needs and require additional capital immediately. Our management, as of December 31, 2024, and our independent registered public accounting firm, in its report on our financial statements as of and for the fiscal year ended December 31, 2024, have concluded that there is substantial doubt as to our ability to continue as a going concern.

We do not currently have sufficient funds to service our operations and our expenses and other liquidity needs beyond [DATE] and require additional capital immediately, and our independent registered public accountants and management have expressed substantial doubt as to our ability to continue as a going concern.

Our audited financial statements for the fiscal year ended December 31, 2024 were prepared assuming that we will continue as a going concern. The going concern basis of the presentation assumes that we will continue in operation for the foreseeable future and will be able to realize our assets and satisfy our liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from our inability to continue as a going concern. As of December 31, 2024, our management concluded that, based on expected operating losses and negative cash flows, there is substantial doubt about our ability to continue as a going concern for the twelve months after the date the financial statements were issued. Our ability to continue as a going concern is subject to our ability to raise additional capital through equity offerings or debt financings. However, we may not be able to secure additional financing in a timely manner or on favorable terms, if at all. If we cannot continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that our stockholders may lose some or all of their investment in us. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

We are reliant on Alpha Prosperity Fund SPC for our immediate capital needs and will require shareholder approval to receive up to an additional $2,750,000 upon the exercise of certain warrants, which we may not be able to obtain. We intend to continue to seek delays on certain payments and explore other ways of potentially reducing expenses with the goal of preserving cash until additional financing is secured. These efforts may not be successful or sufficient in amount or on a timely basis to meet our ongoing capital requirements. We continue to actively seek additional financing. In the absence of additional sources of liquidity, we do not have sufficient existing cash resources to meet operating and liquidity needs. However, there is no assurance that we will be able to timely secure such additional liquidity or be successful in raising additional funds or that such required funds, if available, will be available on acceptable terms or that they will not have a significant dilutive effect on our existing stockholders. In addition, we are unable to determine at this time whether any of these potential sources of liquidity will be adequate to support our operations or provide sufficient cash flows to us to meet our obligations as they become due and continue as a going concern. In the event we determine that additional sources of liquidity will not be available to us or will not allow us to meet our obligations as they become due, we may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. In addition, substantial doubt about our ability to continue as a going concern may cause investors or other financing sources to be unwilling to provide funding to us on commercially reasonable terms, if at all. If sufficient funds are not available, we will have to delay, reduce the scope of, or eliminate some or all of our business activities, which would adversely affect our business prospects and our ability to continue our operations.

25

Our POCare business has a limited operating history and an unproven business model and faces significant challenges as the cell therapy industry is rapidly evolving. Our prospects may be considered speculative and any failure to execute our business strategy could adversely impact our operations and the price of our common stock.

Our POCare business has a limited operating history and an unproven business model. Our plans to continue to grow our POCare cell therapy business and to further the development of ATMPs are subject to significant challenges, including having sufficient cash resources to support our operations. In addition, we may not be able to implement our POCare business or commence clinical trials or respond to competitive pressures due to other non-financial factors beyond our control. Our failure to effectively execute our business strategy could adversely affect our ability to successfully grow our POCare business and develop cell therapy product candidates, which could cause the value of your investment in our common stock to decline.

We are not profitable as of December 31, 2024, have limited cash flow and, unless we increase revenues and take advantage of any commercial opportunities that arise to expand our POCare business, the perceived value of our company may decrease and our stock price could be affected accordingly.

For the year ended December 31, 2024 and as of the date of this report, we assessed our financial condition and concluded that based on current and projected cash resources and commitments, there is a substantial doubt about our ability to continue as a going concern to meet our current operations for the next 12 months from the date of this report. Our auditor’s report for the year ended December 31, 2024 includes a going concern opinion on the matter. Management is unable to predict if and when we will be able to generate significant revenues or achieve profitability. Our plan regarding these matters is to continue improving the net results in our POCare business into fiscal year 2025. There can be no assurance that we will be successful in increasing revenues, improving our POCare results or that the perceived value of our company will increase. In the event that we are unable to generate significant revenues in our POCare business, our business and stock price could be adversely affected.

Our research and development programs are based on novel technologies and are inherently risky.

We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our cell therapy technology creates significant challenges with respect to product development and optimization, manufacturing, government regulation and approval, third-party reimbursement and market acceptance. For example, the FDA and EMA have relatively limited experience with the development and regulation of cell therapy products and, therefore, the pathway to marketing approval for our cell therapy product candidates may accordingly be more complex, lengthy and uncertain than for a more conventional product candidate. The indications of use for which we choose to pursue development may have clinical effectiveness endpoints that have not previously been reviewed or validated by the FDA or EMA, which may complicate or delay our effort to ultimately obtain FDA or EMA approval. Because this is a new approach to treating diseases, developing and commercializing our product candidates subjects us to a number of challenges, including:

●obtaining regulatory approval from the FDA, EMA and other regulatory authorities that have very limited experience with the commercial development of our technology for treating different diseases;●developing and deploying consistent and reliable processes for removing the cells from the patient engineering cells ex vivo and infusing the engineered cells back into the patient;●developing processes for the safe administration of these products, including long-term follow-up for all patients who receive our products;

26

●sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our products;●developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;●establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance; and●maintaining a system of post marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process.

Our efforts to overcome these challenges may not prove successful, and any product candidate we seek to develop may not be successfully developed or commercialized.

Kyslecel may not achieve patient or market acceptance, which could have a material adverse effect on our business.

Our commercialization strategy for Kyslecel relies on medical specialists, medical facilities and patients adopting TP-IAT with Kyslecel as an accepted treatment for chronic pancreatitis. However, medical specialists are historically slow to adopt new treatments, regardless of perceived merits, when older treatments continue to be supported by established providers. Overcoming such resistance often requires significant marketing expenditure or definitive product performance and/or pricing superiority. The cost of allocating resources for such requirements might severely impact the potential for profitability of Kyslecel.

There is no guarantee that physician or patient acceptance of TP-IAT with Kyslecel will be substantial. Further, there is no guarantee that Koligo will be able to achieve patient acceptance or obtain enough customers (clinical providers) to meet its sales objectives. If we do not meet our sales objectives, our business prospects and financial performance will be materially and adversely affected.

Further, we are partially reliant on published clinical trials and scientific research conducted by third parties to justify the patient benefit and safety of TP-IAT with Kyslecel and, as such, we rely, in part, on the accuracy and integrity of those third-parties to have reported the results and correctly collected and interpreted the data from all clinical trials conducted to date. If published data turn out to later be incorrect or incomplete, our business prospects and financial performance may be materially and adversely affected.

The REAL Reason the Irish Look Different From the English

 Sleepy UK History 

https://inltv.net/index.php/irish-historical-fight-for-a-true-independent-ireland

 In 1840's Ireland they called it Tumbling..men arrived with long iron crowbars, climbed onto the roof and pulled the Irish Family's Home down  https://www.facebook.com/share/19kBh2jQBB/   If your people came out of the west of Ireland in those years, there is a word you may never have heard for what was done to the house they left behind. They called it tumbling. It did not mean a family packed up and walked away. It meant men arrived with long iron crowbars, climbed onto the roof, and pulled the house down while the family stood in the lane and watched. The hired men who did it were known as the crowbar brigade, and they usually came with soldiers or police standing by. The point was never only to empty the house. The point was to make certain nobody could ever come back to it. A law had made it possible. The Poor Law of 1847 carried a clause saying that anyone applying for relief had to give up all but a quarter of an acre of land. To be fed, a family had to surrender the ground it lived on. And once the ground was gone, the house went with it. In the Kilrush union in County Clare alone, 2,890 houses were levelled across 1848 and 1849. A fifth of the entire population of that union was put out and their homes pulled down behind them. Between 1849 and 1854, more than a quarter of a million people in Ireland were evicted. Counting those who gave up and left before the crowbars ever arrived, the number who lost their holdings is reckoned closer to half a million. Not every family went far. Some dug a hole two or three feet into the earth, roofed it over with sticks and sods, and lived in that. Where any of the old walls were still standing, they built the shelter inside them, in the ruin of their own home. That one was called a scalpeen. A great many of the Irish names that later reached America belonged to people who had already lost a house long before they ever saw a ship. If your family came out of Clare, or Mayo, or Galway, the townland name handed down to you may be the last surviving piece of a house that stands nowhere now but in the record. A roof can be pulled down in an afternoon. The remembering of it has lasted the better part of two hundred years.

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Irish Republican Brotherhood

Introduction letter from Tomas O’Riain the President fo the Irish Brotherhood IRB

All of those IRB inspired movements resulted in the 1916 Rebellion and its aims so wonderfully expressed in the 1916 Proclamation. This was followed by the 1918 general election and the establishment of Dáil Éireann a parliament for all Ireland and by the War of Independence. The British couldn’t win so they sued for a truce which in turn led to representatives of Dáil Éireann engaging in ‘settlement’ talks with the British Government.

The final outcome was a British enforced settlement under Lloyd George Britain’s PM’s threat of waging ‘Immediate and terrible war’ on the Irish people.

An imposed divided country was the result with a six county apartheid British Statelet in the north and a Twenty-Six County British Dominion “Free State” in the south with a British created parliament and a British imposed constitution.

This led to a civil war which was really a British inspired counter revolution with British money, guns and even the ship that bombarded Dublin in 1916. They defeated the republicans and left us with what we have today, two failed corrupt disintegrating states.

Today’s Twenty-Six County state is rapidly choking in its own corruption and mismanagement. The Leinster House politicians capitulated to the demands of the corrupt bankers and bailed out their failed gambling orgy with the people’s money and resources.

The British created CORRUPT judicial system, at the behest of the thieving banks is busy destroying the fabric of Irish society by unlawfully ejecting people from their homes in their tens of thousands.

The parasitic politicians do nothing but pass more and more repressive legislation to wring every last hard earned penny out of the people’s pockets. They exercise power without responsibility. That cannot be allowed to continue. It breeds oppressive totalitarian corruption.

The resurgent IRB must unite the people into a peaceful but powerful mass movement and reclaim the country north and south from the corrupt onslaught of bankers, politicians, the judiciary and their supporting medias spin and propaganda merchants.

We must build the IRB into a powerful united people’s movement to turn the tide and reclaim Ireland for this and the future generations of her noble and ancient people. The GAA has a million members and so can we.

In response to this great need the Irish Republican Brotherhood is reorganising and opening new branches or Circles throughout Ireland and amongst the Irish Diaspora. Membership is open to all Irish people over the age of 16.

Tomas O’Riain IRB President

Éireann go Brách - Ireland Forever.

 Financial Dragnet: The Environmental Ledger – alimcforever

financial dragnet

Send the demand →

00Start

01Evidence

02Act

03Letters

04Essays

05Workers

06Press

07Rebuttals

08Methods

09Operator

FINANCIAL DRAGNET · THE ENVIRONMENTAL LEDGER · V1

The dragnet audits everyone except itself.

Estimated annual cost: 3 TWh of electricity, 14.7 billion litres of water, 1.4 million tonnes of CO₂. Estimated criminal proceeds intercepted: about 0.1%. Audited environmental disclosure found: none.

3 TWh · DERIVED ESTIMATE

14.7 BN L WATER · DERIVED ESTIMATE

1.4 MT CO₂ · DERIVED ESTIMATE

0.1% INTERCEPTED · PEER-REVIEWED

AUDITED DISCLOSURE · NONE FOUND

Send the demand →

Read the evidence

ACCURACY NOTE

The water figure is a central estimate of 14.7 billion litres a year: low case 4.5 billion, high case 30 billion. Do not lead with 30 billion without saying it is the top of the range. The frequently quoted 800 billion litres belongs to all US data centres in 2023, not to AML — it is scale context only → LBNL 2024 US Data Center Energy Usage Report. The 0.1% figure is criminal proceeds intercepted, never crimes or criminals → Pol, Policy Design and Practice.

FOUR NUMBERS

DERIVED ESTIMATE

3 TWh

electricity a year

Range 1 to 6 TWh. Three independent methods.

DERIVED ESTIMATE

14.7 bn L

water a year

1.1 bn direct cooling, 13.6 bn generating the power. Range 4.5 to 30 bn.

DERIVED ESTIMATE

1.4 Mt

CO₂ a year

3 TWh at the 2024 global grid average of 473 gCO₂/kWh.

PEER-REVIEWED

~0.1%

of criminal proceeds intercepted

About $3bn of an estimated $3tn a year. Up to 99.9% stays with criminals.

01

The finding

Financial institutions screen, score and retain transactions across a payment universe of about 3.4 to 3.6 trillion a year, and essentially all regulated customers are subject to identity checks and account-level monitoring. Records are kept for at least five years under international standards. Global spending on financial crime compliance is about $206.1 billion a year, roughly $3.33 a month for every working-age person alive.

That machine is physical. It is buildings, servers, cooling and power stations. The best defensible estimate of what it burns is 3 TWh of electricity, 14.7 billion litres of water and 1.4 million tonnes of CO₂ a year. It is an estimate because no measurement has been published.

What it catches: peer-reviewed analysis puts interception at about 0.1% of criminal proceeds, leaving up to 99.9% in criminal hands, at compliance costs more than a hundred times what is recovered.

→ McKinsey Global Payments Report · → LexisNexis Risk Solutions · → Pol, Policy Design and Practice

02

The missing ledger

A targeted public search found no audited workload-level energy, water or carbon disclosure for AML and KYC systems from any bank, regulator, cloud provider or AML vendor. Visa and Mastercard publish unusually detailed data-centre figures and neither says what share is compliance. The Payments Association wrote a framework in December 2024 naming “fraud detection software and compliance management systems” as an emissions category to measure, and published no numbers.

The honest formulation, and the one to defend in public: the surveillance system that logs and scores transactions on this scale does not itself keep an audited environmental ledger. Not “no figure exists anywhere” — that cannot be proved.

→ Payments Association Carbon Emissions Framework · → Computer Weekly on workload-level cloud reporting

03

What follows

The standard defence of surveillance is proportionality: intrusion justified by benefit. That is the right test, and it requires numbers on both sides. Right now there are reliable numbers on neither.

So the conclusion is not reform. Reform assumes the thing works and needs tuning. Stop the indiscriminate part. Audit what remains. Freeze the AI expansion until audited accounts exist. And investigate financial crime the way serious crime is supposed to be investigated: targeted, evidence-led, about suspects, under a legal process somebody can be held accountable to.

Send the demand →

Check the arithmetic

04 · CAMPAIGN OPERATORS

How the pressure works

This is the seven-part backbone for whoever runs the campaign. It is not homework for the audience. The public is asked to do exactly one thing, on the Act tab.

Layer A — operator infrastructure. Letter sets, the eight-question ledger, the tracker, coordinated request operations, the escalation ladder, the worker pack, the press pack.

Layer B — the public action. One short thing to copy, one place to send it, one place to log the answer. That is all the public is asked to do.

Every letter sent creates one of exactly three outcomes, and all three are useful: they answer and we publish data that has never been published; they refuse and the refusal becomes the story; they say nothing and we publish the silence, dated, alongside the institutions that did answer.

1

Publish the estimate and the missing ledger

Put the finding in public with the uncertainty stated honestly. The claim that lands is not “this is huge”. It is “no institution publishes a measurement of this, and here is the best defensible number anyone has produced”.

2

Send one identical eight-question demand to every named institution on the same day

Identical wording is the entire point. It makes answers comparable and non-answers visible. One question set sent to forty institutions produces a league table.

3

Equip the public for coordinated complaints and information requests at scale

Individually small. Arriving in volume, at the same time, about the same subject, they become an administrative fact institutions have to account for internally.

4

Maintain a public answer / refusal / silence tracker

The spine of the campaign. It converts scattered correspondence into a single visible scoreboard that journalists can read at a glance.

5

Open the worker route

Compliance staff, engineers, lawyers and civil servants can ask questions inside their organisations that no outsider can ask. Internal questions move faster than external ones.

6

Escalate non-response

Press coverage of the silence. Regulator submissions. Constituent pressure. Peaceful public meetings. Account switching where practical and safe. Support for civil-society litigation.

7

Hold the demands steady throughout

Audited environmental and effectiveness disclosure. A moratorium on expanding AI-driven financial surveillance while those audits do not exist. A sunset and repeal review of monitoring rules that cannot demonstrate proportionality.

BOUNDARIES, PERMANENTLY

No sabotage. No trespass. No property damage. No interference with infrastructure. No removal of confidential data. No threats. No harassment or doxxing of individual workers. The strength of this campaign is that it is entirely lawful and entirely documented.

Open the operator kit →

05

Six campaign demands

These are things we want to happen. None of them describes an obligation that already exists in law, and nobody should claim otherwise.

DEMAND 1

Publish an audited environmental account of AML/KYC workloads

Annual, independently assured: electricity; direct water with each facility's watershed named; indirect water; carbon on location-based and market-based bases; hardware and refresh cycle; data retained and retention periods; e-waste arising. For compliance workloads specifically, not buried in a firm-wide total.

DEMAND 2

Commission an independent cost-effectiveness and proportionality audit

By a body independent of the regulated firms and the vendors. Funds intercepted, frozen and confiscated as a proportion of estimated criminal proceeds; alert volumes, false positive rates and alert-to-outcome ratios; customers restricted, exited or refused on automated grounds and reversal rates; distribution of harms.

DEMAND 3

Impose an immediate moratorium on expanding AI-driven AML/KYC surveillance

No new deployment or scaling of machine-learning monitoring, behavioural scoring or automated adverse-media systems until the audits in demands 1 and 2 exist and are published. Maintaining existing systems is not expansion. Scaling them is.

DEMAND 4

Open a sunset and repeal review of indiscriminate monitoring and retention rules

Every rule requiring blanket monitoring, blanket reporting or multi-year retention about people who are not suspected of anything should carry an expiry date, and be re-authorised only on published evidence of proportionality.

DEMAND 5

Shift to targeted, evidence-led investigation under accountable legal process

Financial investigation directed at defined suspicion, authorised through a process that leaves an accountable record, and resourced properly. Move the money from monitoring populations to investigating suspects.

DEMAND 6

Establish a public reporting standard and an annual ledger

A single mandatory template so figures are comparable between institutions and across years, published in an open annual ledger alongside the effectiveness data. A metric that cannot be compared cannot be challenged.

One sentence version. Show us what it costs, show us what it catches, stop expanding it until you have, and stop watching people you have no reason to suspect.

06

Measured / Derived / Unknown / Demand

Four labels, used consistently across this site. They are what protect the argument.

MEASURED

Published by a named source. Global data-centre electricity (415 TWh, 2024). Water and carbon conversion factors. Visa's and Mastercard's own disclosures. Payment volumes. SAR and CTR volumes. UK funds denied. Compliance spending. Interception and confiscation rates. The five-year retention rule.

DERIVED

Arithmetic on measured inputs, formula shown. The 3 TWh figure and everything downstream of it: water, carbon, land, household and country comparisons. These are allocations of somebody else's total, not measurements of the dragnet.

UNKNOWN

No audited workload-level figure for AML/KYC energy, water or carbon from any bank, regulator, cloud provider or vendor. The split between transaction-triggered screening and always-on customer monitoring. Embodied carbon and materials in compliance hardware. Government-side compute across ~80 international bodies and 205 jurisdictions.

DEMAND

Something we want to happen. Not a fact, and not a legal obligation that already exists. Audited disclosure, an independent audit, a moratorium on AI expansion, a sunset review, targeted investigation, a public reporting standard.

Precision guardrails — the exact places this argument can be broken

Every figure on this site is labelled measured, derived or unknown. The electricity, water and carbon figures are derived allocations with an honest error bar of a factor of two either way, not measurements. The 0.1% figure is peer-reviewed and refers to criminal proceeds intercepted.

This site stores nothing. There is no analytics, no cookie, no account, no server. Letters are assembled in your browser and never leave it.

Not legal or financial advice · Compiled 4 August 2026 

We have a pending U.S. patent application and a pending EP patent application directed, among others, to Mobile Processing Units.

Government Regulation

Development Business

We are required to comply with the regulatory requirements of various local, state, national and international regulatory bodies having jurisdiction in the countries or localities where we manufacture products, where our OMPULs are established or where we plan to supply products. In particular, we are subject to laws and regulations concerning research and development, testing, manufacturing processes, equipment and facilities, including compliance with GMPs, labeling and distribution, import and export, facility registration or licensing, and product registration and listing. As a result, our facilities are subject to regulation in Israel and South Korea. We are also required to comply with environmental, health and safety laws and regulations, as discussed below. These regulatory requirements impact many aspects of our operations, including manufacturing, developing, labeling, packaging, storage, distribution, import and export and record keeping related to customers’ products. Noncompliance with any applicable regulatory requirements can result in government refusal to approve facilities for manufacturing products or products for commercialization.

Both of our products and our customers’ products must undergo pre-clinical and clinical evaluations relating to product safety and efficacy before they are approved as commercial therapeutic products. The regulatory authorities that have jurisdiction in the countries in which our and our customers’ products are intended to be marketed may delay or put on hold clinical trials, delay approval of a product or determine that the product is not approvable. The regulatory agencies can delay approval of a drug if our manufacturing facilities or OMPULs are not able to demonstrate compliance with cGTPs, pass other aspects of pre-approval inspections (i.e., compliance with filed submissions) or properly scale up to produce commercial supplies. The government authorities having jurisdiction in the countries in which our customers intend to market their products have the authority to withdraw product approval or suspend manufacture if there are significant problems with raw materials or supplies, quality control and assurance or the product is deemed adulterated or misbranded. In addition, if new legislation or regulations are enacted or existing legislation or regulations are amended or are interpreted or enforced differently, we may be required to obtain additional approvals or operate according to different manufacturing or operating standards or pay additional fees. This may require a change in our manufacturing techniques or additional capital investments in our facilities.

Certain products manufactured by us involve the use, storage and transportation of toxic and hazardous materials. Our operations are subject to extensive laws and regulations relating to the storage, handling, emission, transportation and discharge of materials into the environment and the maintenance of safe working conditions. We maintain environmental and industrial safety and health compliance programs and training at our facilities.

Prevailing legislation tends to hold companies primarily responsible for the proper disposal of their waste even after transfer to third party waste disposal facilities. Other future developments, such as increasingly strict environmental, health and safety laws and regulations, and enforcement policies, could result in substantial costs and liabilities to us and could subject the handling, manufacture, use, reuse or disposal of substances or pollutants at our facilities to more rigorous scrutiny than at present.

Our development operations involve the controlled use of hazardous materials and chemicals. Although we believe that our procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur significant additional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials or chemicals. As a result of any such contamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our contract manufacturing operations, which could materially harm our business, financial condition and results of operations.

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The costs associated with complying with the various applicable local, state, national and international regulations could be significant and the failure to comply with such legal requirements could have an adverse effect on our results of operations and financial condition. See “Risk Factors — Risks Related to Development and Regulatory Approval of Our Therapies and Product Candidates — Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.” for additional discussion of the costs associated with complying with the various regulations.

POCare Therapies Portfolio

Our therapeutic product portfolio pipeline is diverse and addresses various unmet clinical needs. It is predominantly comprised of personalized autologous cell therapies, implying that patients receive cells that originate from their own body, virtually eliminating the risk of an immune response and rejection and thus easing various regulatory hurdles. In addition, by leveraging our vast experience and proven track record in developing and optimizing cell processing, these selective therapies are adapted to be produced in closed, automated systems, reducing the need for health care provider in-house, high-grade and expensive cleanroom environments. The systems enable each stage of the manufacturing process (cell sorting, expansion, genetic modifications, quality control) to be optimized in order to substantially reduce the cost burden for patients and making the therapies widely accessible. Notably, some of our therapeutic pipeline is developed by researchers from our network and is subsequently out-licensed to the researcher for its territory and validated in multi-center clinical trials conducted across point of care partner sites leveraging the robustness of our POCare Network. Having access to a portfolio of therapeutics, for the most attractive products, the Company intends to than seek additional regulatory approvals and offer the products for sale to medical institutions globally within our network In exchange, the inventors will receive a royalty.

Regulatory Process in the United States

Our potential product candidates are subject to regulation as a biological product under the Public Health Service Act and the Food, Drug and Cosmetic Act. The FDA generally requires the following steps for pre-market approval or licensure of a new biological product:

●Pre-clinical laboratory and animal tests conducted in compliance with Good Laboratory Practice, or GLP, requirements to assess a drug’s biological activity and to identify potential safety problems, and to characterize and document the product’s chemistry, manufacturing controls, formulation, and stability;●Submission to the FDA of an Investigational New Drug, or IND, application, which must become effective before clinical testing in humans can start;●Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce biologic drug candidates into humans in clinical trials;●Conducting adequate and well-controlled clinical trials to establish the safety and efficacy of the product for its intended indication conducted in compliance with Good Clinical Practice, or GCP, requirements;●Compliance with current GMP regulations and standards;●Submission to the FDA of a Biologics License Application (“BLA”) for marketing that includes adequate results of pre-clinical testing and clinical trials;●The FDA reviews the marketing application in order to determine, among other things, whether the product is safe, effective and potent for its intended uses; and●Obtaining FDA approval of the BLA, including inspection and approval of the product manufacturing facility as compliant with GMP requirements, prior to any commercial sale or shipment of the pharmaceutical agent. The FDA may also require post marketing testing and surveillance of approved products or place other conditions on the approvals.

In 2024, the FDA’s regulatory landscape for cell and gene therapies (CGTs) continues to evolve with an increased emphasis on accelerated approval pathways and flexibility in clinical trial endpoints. The FDA’s Center for Biologics Evaluation and Research (CBER) is prioritizing fast-track approval options, particularly for rare diseases, through the use of surrogate or intermediate clinical endpoints supported by biomarker data and animal models. https://www.fda.gov/

20

Regulatory Process in Europe

In the European Union (“EU”) somatic cell and gene therapy products are called Advanced Therapy Medicinal Product (ATMPs). Since January 2022 the Clinical Trial Regulation (EU) 536/2014 regulates the application of medicinal products including ATMPs to humans immediately effective in all member states. In conjunction with Regulation 536/2014 the EU commission has released two delegated acts regulating manufacturing of investigational as well as marketed AMPs. For products that are regulated as an ATMP,

Regulation requires:

●Compliance with current GMP regulations and standards, as described in the delegated acts;●Filing a Clinical Trial Application (“CTA”);●in EU member states and EEA countries according to regulation 536/2014 via CTIS (Clinical Trial Information System) allowing a harmonized approval process among all member states (including multinational clinical trials);●Obtaining approval by ethic committees responsible for medical institutions;●Adequate and well-controlled clinical trials according to GCP standards protecting the well-being of a study participant and establishing the safety and efficacy of the product for its intended use;●Centralized submission procedure for ATMPs via EMA for Marketing Authorization; and●Review and approval of the Marketing Authorization Application.

Exemption from the centralized procedure was introduced into the ATMP Regulation to allow marketing of certain ATMPs in individual EU member states. The so-called “hospital exemption” can only be applied for custom-made ATMPs used in a hospital setting for a specific patient by a treating physician. In addition, a competent authority must authorize hospital exemption for ATMPs. Hospital exemption products must comply with the same national requirements concerning quality, traceability and pharmacovigilance that apply to authorized medicinal products. The “hospital exemption” has to be applied for individually in each EU member state according to national procedures and control measures.

In 2024, the European regulatory framework for cell and gene therapies (CGTs) continues to emphasize innovation while maintaining rigorous standards to ensure safety and efficacy. The European Medicines Agency (EMA) remains focused on adaptive pathways and flexibility in approving CGTs, particularly through mechanisms such as conditional marketing authorizations and adaptive licensing to expedite patient access while awaiting full clinical validation. https://core-reference.org/news-summaries/march-2024/

Clinical Trials

Typically, both in the U.S. and the EU, clinical testing involves a three-phase process, although the phases may overlap. In Phase I, clinical trials are conducted with a small number of healthy volunteers or patients and are designed to provide information about product safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial. Phase III clinical trials are generally large-scale, multi-center, comparative trials conducted with patients afflicted with a target disease in order to provide statistically valid proof of efficacy, as well as safety and potency. In some circumstances, the FDA or EMA may require Phase IV or post-marketing trials if it feels that additional information needs to be collected about the drug after it is on the market. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, as well as clinical trial investigators. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the testing based upon the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patient. Monitoring all aspects of the study to minimize risks is a continuing process. All adverse events must be reported to the FDA or EMA.

21

Human Capital Resources

As of December 31, 2024, we had an aggregate of 77 employees working at our company and Subsidiaries. In addition, we retain the services of outside consultants for various functions including clinical work, finance, accounting and business development services. Most of our senior management and professional employees have had prior experience in pharmaceutical or biotechnology companies. None of our employees are covered by collective bargaining agreements. We believe that we have good relations with our employees.

Compensation and Benefits

We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees. Biotechnology companies both large and small compete for a limited number of qualified applicants to fill specialized positions. To attract qualified applicants, we offer a total rewards package consisting of base salary and cash target bonus, a comprehensive benefit package and equity compensation to select employees. Bonus opportunity and equity compensation increase as a percentage of total compensation based on level of responsibility. Actual bonus payout is based on performance.

Diversity, Equity and Inclusion

Much of our success is rooted in the diversity of our teams and our commitment to inclusion. We value diversity at all levels. We believe that our business benefits from the different perspectives a diverse workforce brings, and we pride ourselves on having a strong, inclusive and positive culture based on our shared mission and values. This is reflected in our numbers with our total workforce being approximately 44% women, 14% ethnically diverse and 61% over the age of 40.

Environmental, Social and Governance

Our commitment to integrating sustainability across our organization begins with our Board of Directors, or the Board. The Nominating and Governance Committee of the Board has oversight of strategy and risk management related to Environmental, Social and Governance, or ESG. All employees are responsible for upholding our core values, including to communicate, collaborate, innovate and be respectful, as well as for adhering to our Code of Ethics and Business Conduct, including our policies on bribery, corruption, conflicts of interest and our whistleblower program. We encourage employees to come to us with observations and complaints, ensuring we understand the severity and frequency of an event in order to escalate and assess accordingly. Our Chief Compliance Officer strives to ensure accountability, objectivity, and compliance with our Code of Conduct. If a complaint is financial in nature, an Audit Committee member is notified concurrently, which triggers an investigation, action, and report.

We are committed to protecting the environment and attempt to mitigate any negative impact of our operations. We monitor resource use, improve efficiency, and at the same time, reduce our emissions and waste. We are systematically addressing the environmental impacts of the buildings we rent as we make improvements, including adding energy control systems and other energy efficiency measures. Waste in our own operation is minimized by our commitment to reduce both single-use plastics and operating paper-free, primarily in a digital environment. We have safety protocols in place for handling biohazardous waste in our labs, and we use third-party vendors for biohazardous waste and chemical disposal.

Corporate and Available Information

Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and all amendments to those reports are available free of charge though our website (http://www.orgenesis.com) as soon as practicable after such material is electronically filed with, or furnished to, the Securities and Exchange Commission (the “SEC”). Except as otherwise stated in these documents, the information contained on our website or available by hyperlink from our website is not incorporated by reference into this report or any other documents we file, with or furnish to, the SEC.

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During 2024 and 2025, we experienced significant changes in the trading status of our common stock. Following the delisting of our common stock from the Nasdaq Capital Market, our common stock began trading on the OTCQX operated by the OTC Markets Group, Inc. (“OTC Markets”) beginning on October 21, 2024. On June 3, 2025, following delays in our Exchange Act filings and the expiration of the applicable grace period, OTC Markets moved the trading of our common stock from OTCQX to the Pink Limited tier. On July 29, 2025, due to further delays in our Exchange Act filings, OTC Markets moved the trading of our common stock from OTC Pink Limited to the OTC Expert Market tier. As a result, public access to bid and ask prices and trading volume information became restricted, and most investors are not able to easily trade our common stock during this period. Despite these developments, our common stock remains tradable, with pricing information accessible to brokers and market makers. We are actively working to complete and file all required periodic reports to regain compliance with our Exchange Act reporting obligations. We intend to reapply for listing on the OTCQX Market as soon as we become current in our SEC filings. Our common stock is currently traded on the OTC Expert Market under the symbol “ORGS.”

As used in this Annual Report on Form 10-K and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars.