NASDAQ: PLUR
Pluri Inc.CIK 0001158780 · SIC 2836 · Biological Products
We are a biotechnology company leveraging our proprietary 3D cell expansion platform, which is supported by an in-house, industrial-scale cell manufacturing facility and operates in accordance with Good Manufacturing Practice (“GMP”) standards on a self-declared basis. Our platform is designed to… About this business →
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Pluri prices $1.50/share offering of 1.2M shares plus pre-funded warrants; net proceeds $3.0M
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Latest financial statements
From 10-K filed Sep 10, 2026 (period ending Jun 30, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.
Consolidated Statements of Operations
Dollars in thousands
| Description | Year ended June 30, 2026 | Year ended June 30, 2025 |
|---|---|---|
| Revenues | 1,016 | 1,336 |
| Cost of revenues | (563) | (682) |
| Gross profit | 453 | 654 |
| Operating expenses: | ||
| Research and development expenses | (15,306) | (14,004) |
| Less: participation by the NIAID, the IIA (each, as defined below) and Horizon Europe | 214 | 1,153 |
| Research and development expenses, net | (15,092) | (12,851) |
| General and administrative expenses | (10,299) | (9,979) |
| Operating loss | (24,938) | (22,176) |
| Other financial income (expenses), net | 476 | (206) |
| Interest expense | (932) | (873) |
| Total financial income (expenses), net | (456) | (1,079) |
| Loss before taxes | (25,394) | (23,255) |
| Tax benefit | 25 | 5 |
| Net loss | (25,369) | (23,250) |
| Net loss attributed to non-controlling interests | (1,548) | (667) |
| Net loss attributed to shareholders | (23,821) | (22,583) |
| Loss per share: | ||
| Basic and diluted loss per share | (2.44) | (3.56) |
| Weighted average number of shares used in computing basic and diluted loss per share | 9,743,913 | 6,336,993 |
Consolidated Balance Sheets
Dollars in thousands
| Description | June 30, 2026 | June 30, 2025 |
|---|---|---|
| ASSETS | ||
| CURRENT ASSETS: | ||
| Cash and cash equivalents | 3,529 | 5,895 |
| Short-term bank deposits | 4,275 | 14,718 |
| Restricted cash | 29 | 422 |
| Customer receivables, net | 87 | 236 |
| Prepaid expenses and other current assets | 810 | 824 |
| Total current assets | 8,730 | 22,095 |
| LONG-TERM ASSETS: | ||
| Restricted bank deposits | 1,018 | 879 |
| Severance pay fund | 702 | 610 |
| Property and equipment, net | 1,566 | 1,823 |
| Advances for property and equipment | 861 | 420 |
| Intangible assets, net | 2,613 | 2,793 |
| Goodwill | 3,136 | 3,136 |
| Operating lease right-of-use asset | 6,164 | 6,900 |
| Other long-term assets | 88 | 27 |
| Total long-term assets | 16,148 | 16,588 |
| Total assets | 24,878 | 38,683 |
| LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) | ||
| CURRENT LIABILITIES | ||
| Trade payables | 702 | 866 |
| Accrued expenses | 928 | 1,178 |
| Operating lease liability | 996 | 659 |
| Accrued vacation and recuperation | 911 | 859 |
| Advances from customers | 68 | 148 |
| Loan from the European Investment Bank, or EIB | 27,431 | 27,289 |
| Other accounts payable | 1,683 | 1,329 |
| Total current liabilities | 32,719 | 32,328 |
| LONG-TERM LIABILITIES | ||
| Accrued severance pay | 678 | 703 |
| Operating lease liability | 6,487 | 6,102 |
| Deferred tax liabilities | 384 | 415 |
| Simple Agreement for Future Equity, or SAFE | 794 | - |
| Advance towards share subscription | 1,250 | - |
| Total long-term liabilities | 9,593 | 7,220 |
| COMMITMENTS AND CONTINGENCIES | 12 | |
| SHAREHOLDERS’ DEFICIT | ||
| Share capital: | ||
| Common shares, $0.00001 par value per share: authorized: 37,500,000 as of June 30, 2026 and 2025; issued and outstanding: 10,824,311 and 7,893,767 shares as of June 30, 2026 and 2025, respectively | * | * |
| Additional paid-in capital | 443,840 | 436,213 |
| Accumulated deficit | (466,876) | (443,055) |
| Total shareholders’ deficit | (23,036) | (6,842) |
| Non-controlling interests | 5,602 | 5,977 |
| Total deficit | (17,434) | (865) |
| Total liabilities and deficit | 24,878 | 38,683 |
Consolidated Statements of Cash Flows
Dollars in thousands
| Description | Year ended June 30 2026 | Year ended June 30 2025 |
|---|---|---|
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | (25,369) | (23,250) |
| Adjustments to reconcile loss to net cash used in operating activities: | ||
| Depreciation and amortization | 511 | 316 |
| Loss on property and equipment | 13 | - |
| Share-based compensation to employees, directors and non-employee consultants | 3,726 | 2,143 |
| Increase in fair value of simple agreement for future equity, or SAFE, liability | 80 | - |
| Decrease in fair value of warrant and pre-funded warrant liability | - | (556) |
| Decrease (increase) in customer receivable, net | 149 | (202) |
| Decrease (increase) in prepaid expenses, other current assets and other long-term assets | (47) | 1 |
| Decrease in trade payables | (77) | (235) |
| Increase in other accounts payable, accrued vacation and recuperation, deferred tax liabilities and accrued expenses | 124 | 377 |
| Increase (decrease) in advances from customers | (80) | 105 |
| Increase in operating lease right-of-use asset and liability, net | 1,458 | 834 |
| Decrease in interest receivable on short-term deposits and restricted bank deposits | 27 | 91 |
| Effect of exchange rate changes on cash, cash equivalents, deposits, restricted cash and restricted bank deposits | (128) | (1,055) |
| Increase in short-term interest payable and exchange rate differences related to the EIB loan, net | 142 | 3,262 |
| Decrease in accrued severance pay, net | (117) | (42) |
| Net cash used for operating activities | (19,588) | (18,211) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Purchase of property and equipment | (633) | (1,618) |
| Proceeds from sale of property and equipment | 18 | - |
| Proceeds from short-term deposits, net | 10,518 | 9,271 |
| Cash related to the Kokomodo Transaction (defined below) | - | 373 |
| Net cash provided by investing activities | 9,903 | 8,026 |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Issuance of common shares, pre-funded warrants and warrants, net of issuance costs | 5,074 | 9,580 |
| Proceeds from the advance towards share subscription | 1,250 | - |
| Issuance costs related to issuance of shares in the Kokomodo Transaction (defined below) | - | (47) |
| Proceeds from SAFE | 714 | - |
| Net cash provided by financing activities | 7,038 | 9,533 |
| EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 27 | 177 |
| Decrease in cash, cash equivalents, restricted cash and restricted bank deposits | (2,620) | (475) |
| Cash, cash equivalents, restricted cash and restricted bank deposits at the beginning of the period | 7,196 | 7,671 |
| Cash, cash equivalents, restricted cash and restricted bank deposits at the end of the period | 4,576 | 7,196 |
| Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets: | ||
| Cash and cash equivalents | 3,529 | 5,895 |
| Restricted cash | 29 | 422 |
| Long-term restricted bank deposits | 1,018 | 879 |
| Total cash, cash equivalents, restricted cash and restricted bank deposits | 4,576 | 7,196 |
| (a) Supplemental disclosure of non-cash activities: | ||
| Purchase of property and equipment on credit | 3 | 90 |
| The Kokomodo Transaction (defined below) | - | 4,686 |
| Lease liabilities arising from obtaining right-of-use assets | 250 | 1,080 |
Amounts as printed on the EDGAR/iXBRL face — Dollars in thousands. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗
About Pluri Inc.
Source: Item 1 (Business) from the 10-K filed September 10, 2026. Description as filed by the company with the SEC.
ITEM 1.
BUSINESS.
Overview
We are a biotechnology company
leveraging our proprietary 3D cell expansion platform, which is supported by an in-house, industrial-scale cell manufacturing facility
and operates in accordance with Good Manufacturing Practice (“GMP”) standards on a self-declared basis. Our platform is designed
to enable scalable, cost-efficient and reproducible expansion of human, plant and animal cells and supports cell-based products, services,
therapeutics and related technologies across two primary application areas: (i) Human Health and Longevity and (ii) Foodtech and Bio-Farming.
We were incorporated in Nevada
on May 11, 2001. Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”), which is incorporated under
the laws of the State of Israel.
In January 2020, Pluri Biotech
established a wholly owned subsidiary, Pluristem GmbH, which is incorporated under the laws of Germany.
In November 2021, Pluri Biotech
established a new subsidiary, Ever After Foods, which is incorporated under the laws of the State of Israel. Pluri Biotech holds approximately
69% of Ever After Foods’ issued and outstanding shares.
In March 2024 Pluri Biotech
established a wholly owned subsidiary, Coffeesai, which is incorporated under the laws of the State of Israel.
On April 28, 2025, the Company
completed an acquisition of approximately 79% of the equity in Kokomodo, which is currently held as majority owned Israeli subsidiary
of Pluri Biotech.
In November 2025, Pluri Biotech
established a wholly owned subsidiary, Cellav™, which is incorporated under the laws of the State of Israel.
Read full description ↓
Our operations are dedicated
to the research, development, manufacturing and commercialization of cell-based products, therapeutics and related technologies across
two primary application areas: (i) Human Health and Longevity and (ii) Foodtech and Bio-Farming, as set forth below:
Our proprietary 3D cell expansion
platform is the technological and manufacturing foundation for both business areas, designed to enable scalable, cost-efficient and reproducible
production of cell-based products. It uses a synthetic scaffold to create a 3D environment in which adherent or non-adherent cells can
grow in a tissue-like setting, and our automated manufacturing process is intended to support monitored, controlled and consistent production
of high-quality cell products at scale. We also developed PluriMatrix, an industrial-scale cell manufacturing system built on this platform,
to support commercially relevant cell production volumes.
HUMAN
HEALTH AND LONGEVITY
This key business application
includes our human-cell programs and services, comprised of cell therapy and immunotherapy product candidates, our PluriCDMO™ development
and manufacturing services, and our regenerative aesthetics, wellness and longevity activities conducted through Cellav™.
CELL
THERAPY
We use our proprietary 3D
cell expansion platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates and technologies.
Cell therapy is an established field within regenerative medicine, and the characteristics and properties of cells vary depending on tissue
source and growth conditions. The human placenta, the source of our PLX and MAIT cells, provides a reservoir of stromal and immune cells
that supports our development of both regenerative medicine and immunotherapy product candidates. Our PLX cells are placenta-derived,
mesenchymal-like adherent stromal cells expanded ex vivo using our 3D platform. They are designed to be administered off-the-shelf, without
blood or tissue matching or additional manipulation prior to administration, and are believed to release therapeutic proteins in response
to the patient’s condition. Our PLX product candidates include PLX-PAD, composed of maternal mesenchymal stromal cell, or MSC-like
cells, originating from the placenta, and PLX-R18, composed of fetal MSC-like cells originating from the placenta.
1
Our clinical development
activities currently include PLX-PAD and PLX-R18 product candidates, which have been tested in clinical studies in the United States,
Europe and Israel. PLX-PAD was tested for acute muscle injuries following hip fracture, acute respiratory distress syndrome due to COVID-19,
Graft versus Host Disease(“GvHD”), and peripheral artery disease, including intermittent claudication and critical limb ischemia.
PLX-PAD is also being developed for mild to moderate knee osteoarthritis as part of the PROTO program, an international collaboration
led by Charité Berlin Institute of Health Center for Regenerative Therapies (“Charité”), and the related clinical
study was approved by the Paul-Ehrlich-Institut (“PEI”) in June 2025. PLX-R18 was tested in a Phase I trial for incomplete
recovery following hematopoietic cell transplantation and was developed under the U.S. Food and Drug Administration’s (“FDA”)
Animal Rule regulatory pathway for Acute Radiation Syndrome (“ARS”), including prior work with the National Institute of Allergy
and Infectious Diseases (“NIAID”), the U.S. Department of Defense’s (“DoD”) Armed Forces Radiobiology
Research Institute (“AFRRI”) and the Uniformed Services University of the Health Sciences (“USUHS”). In April
2025, NIAID terminated its contract for the Government’s convenience, which we believe reflected broader federal budgetary and administrative
adjustments and was not related to performance issues on our part.
On December 20, 2023, we
entered into an agreement assigning the joint patent rights to develop Pluri’s PLX cells in the treatment of cocaine addiction to
Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), the commercial arm of Bar-Ilan University. Under the
agreement, Bar-Ilan University, through BIRAD, received the right to further develop and commercialize PLX cells as a cocaine anti-addiction
product, and we are entitled to 20% revenue sharing from future sales of the product for anti-addiction.
In March 2025, we entered
into an exclusive collaboration agreement with Hemafund, a Ukrainian umbilical cord blood bank with clinical and research laboratories
and facilities specializing in cell preservation and cryostorage. The collaboration aims to establish a strategic initiative for stockpiling,
local distribution and potential clinical advancement of our PLX-R18 cell therapy as a countermeasure for Hematopoietic ARS, (“H-ARS”),
in Ukraine. Such collaboration is currently not active.
Immunotherapy
In May 2024, we launched
a novel allogeneic immunotherapy platform utilizing placental MAIT cells designed to address solid tumors, an area where effective treatments
remain insufficient. MAIT cells are a distinct type of unconventional immune T cells with characteristics that include cytotoxic activity
and a low alloreactivity profile. We believe placental MAIT cells, together with our research, development and manufacturing capabilities,
may support the development of cell therapy products and applications, with potential advantages over conventional T cells. In October
2024, we announced IIA funding for our collaboration with BIRAD to support the continued development of MAIT cells for the treatment of
solid tumors, and in March 2026, the IIA approved a second year of funding for such collaboration.
Cell
Therapy Regulatory and Clinical Affairs Strategy
Our cell therapy development
strategy is to maintain open and frequent discussions with regulators, as appropriate, from preclinical development through more advanced
regulatory stages. We have applied this strategy in interactions with regulatory authorities, including the FDA, the European Medicines
Agency (“EMA”), Germany’s PEI and other European national competent authorities, the Israeli Ministry of Health (“MOH”),
Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) and the Ministry of Food and Drug Safety (“MFDS”)
of South Korea. Our current active cell therapy regulatory engagement is primarily focused on the PROTO program for PLX-PAD in mild to
moderate knee osteoarthritis, including the clinical study approved by Germany’s PEI in June 2025.
2
Cell
Therapy Collaborations
U.S.
Department of Defense
In August 2017, we announced
that a pilot study of our PLX-R18 cell therapy was initiated by the DoD. The study examined the effectiveness of PLX-R18 as a treatment
for ARS prior to, and within the first 24 hours of exposure to radiation. In July 2019, we presented positive results from a series of
studies of our PLX-R18 cell therapy product conducted by the DoD.
Charité
/ Horizon Europe PROTO Program
In September 2022, we announced
that a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program was awarded to PROTO, an international
collaboration led by Charité. The PROTO project is intended to support the development of novel interventional strategies for knee
osteoarthritis, including a Phase I clinical study of our PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis. Approximately
€500,000 (approximately $540,000) of the grant was allocated to us, and through June 30, 2026, we received approximately $449,000
in cash under the PROTO program.
In June 2025, the clinical
study was approved by Germany’s PEI, and the study was initiated in January 2026. The study is being conducted at Charité as
part of the PROTO consortium, under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health
Center of Regenerative Therapies, the Julius Wolff Institute and Center for Musculoskeletal Surgery.
In November 2025, we entered
into an agreement with Charité governing the execution of the Phase I study of PLX-PAD for the treatment of mild to moderate knee
osteoarthritis, and the allocation of rights in potential joint inventions arising from the study. Under the agreement, each party retains
ownership of its pre-existing intellectual property, while certain project results arising from the use of PLX-PAD in knee osteoarthritis
may be jointly owned by the parties. Subject to the terms of the agreement, Charité assigns or licenses to us certain rights in joint
results, joint inventions and related pseudonymized data necessary for the further development and commercialization of PLX-PAD for osteoarthritis.
If a regulatory-approved PLX-PAD-containing product for the treatment of osteoarthritis is commercialized, Charité is entitled to
receive a 2% royalty on net sales for a period of eight years from first commercial sale and may also be entitled to receive 4% of certain
license income received by us, excluding royalties on net sales.
3
Government
Regulation - Pharma
The development, manufacturing,
and future commercialization of our cell therapy product candidates are subject to the laws and regulations of governmental authorities
in the United States, the European Union, Israel, and other potential markets, including Japan and South Korea.
In the United States and
the European Union, the FDA and the EMA, respectively, must approve products prior to marketing. Furthermore, various governmental statutes
and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products
and their marketing. Governments in other countries may have similar requirements for testing and marketing.
The process of obtaining
these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time, resources
and money. There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved, will be
reimbursed by public and private health insurance.
There are several stages
every drug undergoes during its development process. Among these are:
●
Performance of nonclinical laboratory and animal studies to assess a drug’s biological activity, to
identify potential safety concerns, and to characterize and document the product’s chemistry, manufacturing controls, formulation,
and stability. In accordance with regulatory requirements, nonclinical safety and toxicity studies are conducted under Good Laboratory
Practice, requirements to ensure their quality and reliability;
●
The manufacture of the product according to GMP regulations and standards;
●
Conducting adequate and well-controlled human clinical studies in compliance with Good Clinical Practice
(“GCP”) to establish the safety and efficacy of the product for its intended indication; and
●
Potential post-marketing clinical testing and surveillance of the product after marketing approval, which
can result in additional conditions on the approvals or suspension of clinical use.
Approval of a drug for clinical
studies in humans and approval of marketing are sovereign decisions of states, made by national, or, in case of the European Union, international
regulatory competent authorities.
The Regulatory Process
in the United States:
In the United States, our
product candidates are subject to regulation as a biological product under the Public Health Service Act and the Federal Food, Drug and
Cosmetic Act. The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires
the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale:
●
Submission of an Investigational New Drug (“IND”) Application, which must become effective before
clinical testing in humans can begin;
●
Obtaining approval of Institutional Review Boards (“IRBs”) of research institutions or other
clinical sites to introduce the drug candidate into humans in clinical studies;
●
FDA may grant approval for EAP prior to the completion of clinical studies, in order to allow access for
the investigational drug, for patients that are excluded from the study;
4
●
FDA may grant
priority review status to expedite the Biologics License Application (“BLA”) review process. Obtaining a Fast Track designation
allows access to the request of priority review;
●
Submission of a BLA for marketing authorization of the product, which must include adequate results of pre-clinical
testing and clinical studies;
●
Submission of BLA with a proof of efficacy that is based only on animal studies is feasible in instances
where human efficacy studies cannot be conducted because the conduct of such studies would not be ethical or feasible (such as H-ARS).
In these cases, approval can be based on well controlled animal studies conducted under the FDA Animal Rule;
●
FDA review of the BLA in order to determine, among other things, whether the product is safe and effective
for its intended uses; and
●
FDA inspection and approval of
the product manufacturing facility at which the product will be manufactured.
Certain states, including
Florida and Utah, have enacted laws that authorize the administration or use of certain stem cell therapies that have not been approved
by the FDA, subject to specified eligibility, informed-consent, physician oversight, manufacturing, and other requirements. These laws
may provide a state-law pathway for the therapeutic use of qualifying stem cell products within those states; however, they do not constitute
FDA approval, nor do they authorize interstate commercial distribution, or establish a federal marketing authorization for any such product.
The Regulatory Process
in Europe:
In the European Union, our
investigational cellular products are regulated under the Advanced Therapy Medicinal Products regulation, a regulation specific to cell
and tissue products. Additionally, as of January 31, 2022, the Clinical Trials Regulation harmonizes the submission, assessment and supervision
processes of clinical trials in the European Union. This European Union regulation requires:
●
Filing a Central Clinical Trial Application utilizing the Clinical Trials Information System, and obtaining
an assessment and approval;
●
Obtaining approval of local and central ethics committees as required to test the investigational product
into humans in clinical studies
●
Conducting adequate and well-controlled clinical studies to establish the safety and efficacy of the investigational
product for its intended use; and
●
Since our investigational cellular
products are regulated under the Advanced Therapy Medicinal Product regulation, the application for marketing authorization to the EMA
is mandatory within the 28 member states of the European Union. The EMA is expected to review and approve the Marketing Authorization
Application.
Clinical
Studies
Typically, in the United
States, as well as in the European Union, clinical development involves a series of clinical studies from early, small scale, Phase I
studies to late-stage large, Phase III studies, although the phases may overlap. Phase I, clinical studies are conducted in a small
number of healthy volunteers, or patients with the disease or condition. These studies are designed to provide information about product
safety and dosage by gathering information on the interaction of the drug with the human body, its side effects as well as early preliminary
information on effectiveness.
5
Phase II clinical studies
are conducted in a homogenous group of patients afflicted with the specific target disease, to explore preliminary efficacy, optimal dosages
and confirm the safety profile. In some cases, an initial study is conducted in 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 study. Phase III clinical
studies, sometimes known as pivotal studies, are generally large-scale, multi-center, controlled studies conducted with a heterogeneous
group of patients afflicted with the target disease, aiming to provide statistically significant support for efficacy, as well as safety
and potency. The Phase III studies are considered confirmatory for establishing the efficacy and safety of the drug and are critical for
approval. In some circumstances, a regulatory agency may require Phase IV, or post-marketing studies in case additional information
needs to be collected after the drug is on the market.
During all phases of clinical
development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study
sites investigators to minimize risks and ensure high quality and integrity of the collected data. The sponsor of a clinical study is
required to submit an annual safety report to the relevant regulatory agencies, in which serious adverse events are reported, and to submit
in an expedited manner any individual serious adverse events that are suspected of being related to the tested drug and are unexpected
with its use. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that
have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.
Competition
- Regenerative medicine
The regenerative medicine
field is characterized by intense competition, as global and local pharma players are becoming more engaged in the cell therapy field
based on the advancements made in clinical studies and due to the favorable regenerative medicine legislation in certain regions. We face
competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical
companies, biopharmaceutical companies, and governmental agencies. Some of the clinical indications we currently have under development
are also being investigated in preclinical and clinical programs by others.
According to the Alliance
for Regenerative Medicine’s July 2026 Report, there were 1,806 active cell and gene therapy developers worldwide, including 1,031
developing cell therapies and 729 developing gene-modified cell therapies and cell-based immuno-oncology (GMCT and CBIO), with 1,712 ongoing
clinical trials in Phases I–III registered globally, of which 355 trials were in solid tumors (Source: ARM Q2 2026 Sector Snapshot
and Sector Data, July 2026 Report).
In the global market (excluding
China), while most allogeneic cell therapies remain in the preclinical stage, approximately 20 allogeneic Chimeric Antigen Receptor (“CAR”)-T
therapy products being studied for solid tumors have advanced into clinical stages. Notable examples include Adicet Bio’s allogeneic
CD70-CAR gamma-delta T cells, Poseida’s Allogenic MUC1-CAR Tscm cells, Fate’s allogeneic MICA/B-CAR T cells, and MD Anderson’s
TROP2-CAR NK cells (Source: GlobalData; Clinicaltrial.gov).
While there are hundreds
of companies in the regenerative medicine space globally, there are multiple participants in the cell therapy field based in the United
States, Europe, Japan, Korea, and Australia. Among other things, we expect to compete based upon our IP portfolio, our in-house manufacturing
efficiencies and capabilities, and the potential efficacy of our products. Our ability to compete successfully will depend on our continued
ability to attract and retain experienced and skilled executives, scientific and clinical development personnel, to identify and develop
viable cellular therapeutic candidates and exploit these products commercially and keep expanding and improving our unique technological
capabilities.
REGENERATIVE
AESTHETICS, WELLNESS AND LONGEVITY
In November 2025, we established
Cellav™, a wholly owned subsidiary focused on developing regenerative skin and hair solutions using our proprietary 3D cell expansion
technology. Cellav develops, manufactures and markets skin care and cosmetic products and cell-derived ingredients, including exosomes
and cell ingredients (human or plant-derived), conditioned media for integration into third-party formulations and for use in professional
and consumer skincare and haircare products. These products and ingredients are also offered as finished, ready-to-sell products, professional
kits or consumable products.
6
During calendar year 2026,
Cellav completed the development and U.S. cosmetic product listings of two professional regenerative aesthetic products, Regenativo+ and
Placento+, supporting a planned commercial launch in the United States. Cellav also completed the cosmetic regulatory registration and
notification process for Regenativo+ in the United Kingdom through the UK Cosmetic Product Notification portal, enabling commercial marketing
of the product in the UK. These regulatory and product-listing milestones support Cellav’s transition from product development toward
commercialization and its ongoing commercial discussions with distributors, clinic networks and strategic partners in the United States,
the United Kingdom and additional international markets. Collectively, these collaborations and regulatory milestones reflect continued
progress in applying our proprietary technology platform across multiple industries and in advancing selected subsidiaries toward potential
development, commercialization and distribution opportunities.
Government
Regulations - Aesthetic Products
Through Cellav, we develop
cosmetic and professional aesthetic products and ingredients that may be subject to applicable cosmetic product regulatory requirements
in the jurisdictions in which they are marketed or intended to be marketed. These requirements may include, as applicable, product safety
assessments, ingredient restrictions, labeling requirements, claims substantiation, product notification or registration, responsible-person
obligations, manufacturing practices, adverse-event reporting and post-market surveillance.
During calendar year 2026,
Cellav completed U.S. cosmetic product listings for its Regenativo+ and Placento+ products and completed the applicable cosmetic product
notification process for Regenativo+ in the United Kingdom through the UK Cosmetic Product Notification portal. Regenativo+ is a plant-derived
product, and Placento+ is a placenta-derived formulation; both products are intended for topical professional aesthetic use. Cellav is
pursuing commercialization opportunities for these products through discussions with distributors, aesthetic clinics and other potential
commercial partners in the United States, the United Kingdom and other international markets.
Competition
- Aesthetics, Wellness and Longevity
Through Cellav, we participate
in the competitive and rapidly evolving markets for aesthetics, wellness and longevity products, including skincare, aesthetics, consumer
health, biotechnology and regenerative products. We compete with established companies and emerging participants, including companies
developing or commercializing products based on exosomes, cell-derived ingredients, plant-derived ingredients, conditioned media, bioactive
formulations and other technologies. Competition in these markets is based on a range of factors, including product performance, scientific
support, product quality and safety, regulatory compliance, manufacturing capabilities and scale, distribution relationships, brand recognition,
customer experience and pricing. Our competitors include companies with greater financial, commercial, manufacturing, research and development,
regulatory and marketing resources, as well as direct-to-consumer brands and providers of aesthetic, wellness and longevity products and
services. The markets for aesthetics, wellness and longevity products are global and include significant activity in North America, Europe
and Asia. Participants in these markets include multinational consumer-products, pharmaceutical, biotechnology and medical-aesthetics
companies, as well as specialized skincare, wellness and direct-to-consumer brands, many of which are headquartered in the United States,
Europe and Asia. Competitive dynamics may vary by product category, applicable regulatory requirements, distribution channels and local
consumer preferences.
PLURICDMO™
In-House
Clinical Manufacturing
We maintain an in-house capability
for clinical cell manufacturing at our GMP-grade facility in Haifa, Israel, operational since February 2013 and previously approved for
the production of PLX-PAD and PLX-R18 for clinical use by multiple regulatory authorities, including the FDA, EMA, MFDS, PMDA, and the
MOH. The facility was approved by the MOH for a Phase III PLX-PAD trial and received GMP certification and manufacturer-importer
authorization, which remained valid through March 2023. In addition, the facility was inspected by a European Union Qualified Person in
December 2024, confirming compliance with current GMP requirements for the purposes of the PROTO clinical trial.
7
The facility continues to
operate in alignment with current GMP standards and principles under a self-declared compliance framework. We remain committed to maintaining
rigorous quality and regulatory practices consistent with applicable GMP principles.
In January 2024, we
launched a business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers cell therapy
development and manufacturing expertise to companies from early preclinical development, through late-stage clinical trials and commercialization,
with a mission to deliver high-quality, essential therapies to patients, as well as other services. Through PluriCDMO™, we have
entered into several commercial agreements with clients for development and manufacturing services.
Since 2024, our CDMO business
has offered manufacturing, process development and related services to pharmaceutical and biotechnology companies. PluriCDMO™ leverages
more than 15 years of our experience in GMP manufacturing, proprietary 3D cell expansion technologies, highly skilled team and flexible
4400 square meter purpose-built facilities to support cell therapy development and manufacturing from preclinical stages through clinical
trials and potential commercial supply, including on-site analytical testing, method development, gap assessment, method transfer and
validation, and support through audited third-party vendors.
In August 2026, Pluri Biotech
received ISO 13485:2016 certification for contract manufacturing services as a contract manufacturing organization for companies engaged
in the manufacturing and development of medical devices, further supporting PluriCDMO™’s quality infrastructure and enhancing
our ability to support customers operating in regulated life sciences environments. Our CDMO business may be subject to additional regulations, depending
on the services we provide to companies under such business division.
Competition
- CDMO
We compete in the cell therapy
CDMO services with several companies like Lonza Group AG, AGC Biologics A/S and Charles River Laboratories International, Inc. for outsourced
services from development to manufacturing in biotechnology and pharmaceutical cell-based products. The majority of our competitors are
large service providers with multiple offerings for different technologies, range of dosage form capabilities and medicine products. The
competition is driven by geographic location, technological capabilities, operational capacity, manufacturing expertise, and price.
While there are multiple
competitors that compete in the CDMO services arena, we have a few competitors that compete in advanced stages of cell therapy clinical
trials and can provide access to state-of-the-art manufacturing efficiency and capabilities. Our ability to compete successfully will
depend on our continued ability to attract and retain customers, support clinical development, identify new opportunities and keep expanding
our unique know-how, technology and manufacturing capabilities.
FOODTECH
AND BIOFARMING
We are involved in several
initiatives that apply our 3D cell expansion technology in the FoodTech and Biofarming market, including collaborations focused on bioactive
carrier and biostimulant delivery, sustainable vegetable production, and plant-cell activities in coffee and cacao through Coffeesai and
Kokomodo, respectively.
In October 2023, we entered
into a proof-of-concept (“POC”) collaboration with ICL Group Ltd. (“ICL”), a global specialty minerals company,
through its Open Innovation program, to evaluate the potential of our technology to enhance the delivery of biostimulants in agriculture.
The initial phase of the collaboration was focused on exploring the use of plant-derived bioactive compounds in combination with our proprietary
platform to improve crop resilience and yield under abiotic stress conditions. In December 2024 and March 2026, we signed amendments extending
the POC collaboration with ICL, reflecting continued mutual interest in further developing and validating the underlying technology for
agricultural applications.
8
In March 2024, we announced
an expansion of our intellectual property portfolio with a patent approval from the Israel Patent Office relating to our proprietary 3D
bioreactor technology for plant-cell cultivation. The patent has also been granted in the United States, and related patent applications
are pending in several additional jurisdictions.
In July 2024, we announced
the signing of a €1 million POC agreement with a leading international agriculture corporation (the “POC Party”) with
a goal to enhance the global sustainable vegetable supply. This strategic POC agreement is intended to boost the global vegetable product
supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture.
The result of the planned collaboration has the potential to minimize environmental impact and foster greater food security, as well as
to build a better agronomic and environmentally friendly infrastructure, bringing sustainable, high-quality solutions to the market. Pursuant
to this POC agreement, the POC Party will provide its know-how and other IP rights related to vegetable products while the Company will
provide its know-how and other IP rights related to its proprietary 3D cell expansion technology to develop a solution aimed at increasing
the global vegetable products supply. Currently, we are in discussions with the POC Party to evaluate potential opportunities for further
collaboration following the completion of Phase II.
Coffeesai
- In March 2024, we established Coffeesai Ltd., a wholly owned Israeli subsidiary focused on developing cultivated, cell-cultured coffee.
Coffeesai leverages our 3D cell expansion technology and controlled, scalable bioprocesses to develop cultivated coffee products intended
to address demand for sustainable, high-quality coffee production at scale, including challenges facing the traditional coffee industry
such as climate-related crop instability, supply chain disruptions and environmental impact. Coffeesai has been engaged in a POC project
relating to the development of a coffee beverage using its technology platform. Following the successful demonstration of the potential
application of Coffeesai’s technology to coffee production, current efforts are focused on optimizing the bioprocess and downstream
processing to further enhance the flavor and aroma characteristics of the resulting beverage.
Kokomodo
- On April 28, 2025, we completed the acquisition of approximately 79% of the equity in Kokomodo (held as a majority owned
subsidiary of our wholly owned subsidiary, Pluri Biotech). Kokomodo, an Israeli company, is an innovative agfood startup developing cellular
agriculture technology for the sustainable production of cacao. Instead of relying on traditional tropical farming, Kokomodo cultivates
real cacao directly from plant cells in controlled environments, such as bioreactors, making climate-resilient cacao accessible year-round
on a global scale. Founded in 2024, Kokomodo aims to transform the cacao industry, reducing environmental impact while ensuring a steady,
high-quality supply for chocolate and related products.
During fiscal year 2026,
Kokomodo continued the development of its cell-cultured cacao platform through research and industry collaborations. During that period,
Kokomodo collaborated with Cargill under a POC Co-Financing Instrument of the food innovation community of the European Institute of Innovation
and Technology (“EIT”), an EU body, to evaluate the functionality, sensory performance and scalability of its cell-cultured
cacao ingredients for potential food applications; participated as a consortium member in the COCO-AI project, a Horizon Europe-funded
initiative focused on advancing AI-enabled plant cell culture technologies for sustainable cocoa production; and collaborated with CSM
Ingredients S.r.l, a global ingredients research and production company focused on food and bakery ingredient solutions, through the Generate
Program 2025 in connection with the development of sustainable cacao ingredients for commercial applications.
Ever
After Foods - In 2022, we announced the establishment of a joint venture with Tnuva Food Industries - Agricultural Cooperative
in Israel Ltd. (“Tnuva”), Ever After Foods, incorporated under the laws of the State of Israel. The purpose of the joint venture
is to develop and commercialize scalable production technologies for cultivated meat, supporting the development of a wide range of cultivated
meat products by industry partners.
9
Leveraging Pluri’s
technology, Ever After Foods has advanced a business-to-business (“B2B”) platform intended to enable food producers to manufacture
cultivated protein products efficiently and at commercially relevant scale. Ever After Foods has demonstrated the production of muscle
and fat tissues from various animal cells and seeks to support cultivated meat and seafood production through its proprietary technology
platform and strategic collaborations.
In June 2024, Ever After
Foods entered into a share purchase agreement with Tnuva and certain other international strategic investors, pursuant to which Ever After
Foods issued and sold ordinary shares in a private placement offering for aggregate gross proceeds of $10 million. As part of the offering,
we invested $1.25 million. In addition, Pluri Biotech and Ever After Foods executed an Amended and Restated Technology License Agreement,
dated June 12, 2024, which amended the parties’ existing license agreement dated February 23, 2022, to expand the scope of the license
to include fish and seafood. Following the closing of that offering, Pluri Biotech held approximately 69% of Ever After Foods. This private
placement offering was intended to support Ever After Foods’ B2B technology platform and its development as a technology enabler
for cultivated protein production.
In February 2025, Ever After
Foods announced a strategic collaboration with Bühler Group (“Bühler”), a global provider of food processing technologies,
to jointly advance scalable cultivated meat production systems for the food industry. The collaboration is intended to combine Bühler’s
engineering and market access capabilities with Ever After Foods’ proprietary edible packed-bed (EPB™) bioreactor platform
to support commercial-scale cultivated meat production systems. The parties intend to develop and deploy manufacturing equipment that
enables food producers to produce cultivated meat at reduced cost and at volumes suitable for market entry.
On August 12, 2026, Ever
After Foods entered into a share purchase agreement to acquire Fishway BV, a Belgium-based biotechnology company engaged in development-stage
research relating to aquatic cell biology, cell lines and animal-component-free media for potential use in the cultivated protein industry
(the “Fishway Acquisition”). The Fishway Acquisition is intended to support Ever After Foods’ strategy by expanding
complementary research capabilities and establishing a corporate presence in Europe. The Fishway Acquisition closed on August 18, 2026,
and following its completion, our indirect ownership interest in Ever After Foods, held through Pluri Biotech, was reduced to approximately
58%, reflecting dilution to all Ever After Foods’ shareholders as a result of the Fishway Acquisition.
Government
Regulations - FoodTech
Regulators around the world
are in the process of developing or implementing a regulatory approval process for cultivated meat. Although some companies have recently
received regulatory approval for their cultivated meat products in the United States, Israel and Singapore cultivated meat is not yet
generally commercially available. However, technologies like the one being developed by Ever After Foods are anticipated to facilitate
the scaling up of cultivated meat production. In general, cultivated meat production is subject to extensive regulatory laws and regulations.
In the United States, the FDA and the U.S. Department of Agriculture (“USDA”), are in the process of developing guidance and
regulations applicable to cultivated meat.
In the cultivated plant-based
initiatives (e.g., coffee, cacao), we are working with an external regulatory consultant to evaluate the technical and scientific requirements
for determining whether our cultured coffee product is Generally Recognized as Safe (“GRAS”), under section 201(s) of the
Federal Food, Drug, and Cosmetic Act (“FDCA”), and FDA’s implementing regulations (21 C.F.R. § 170.30). If the
plant-based cultivated products (including all components) are determined to be GRAS in accordance with U.S. FDA requirements, it will
be exempt from the definition of “food additive” in section 201(s) of the FDCA and can therefore be lawfully marketed as a
food in the United States without the need to obtain a premarket authorization from the FDA.
10
Competition
- FoodTech
Our FoodTech operations operate
in a competitive and evolving industry that includes cultivated meat and cultivated protein companies, plant cell culture companies, bioprocess
equipment suppliers, bioreactor developers, scaffold technology providers, and established producers of plant-derived ingredients, flavors,
and other food products. Industry development is being driven by advances in biotechnology, increased focus on sustainability, and efforts
to develop more efficient and environmentally responsible alternatives to traditional agricultural and food-production methods.
Ever After Foods is developing
a proprietary technology platform designed to support natural cell growth for cultivated protein applications, including cultivated meat.
Unlike certain conventional approaches that adapt cells for growth in stirred-tank bioreactors, Ever After Foods’ technology is
designed to enable production at lower cost and greater scale. We believe that this technology, together with our capabilities in aquatic
cell biology and animal-component-free media development, experienced personnel, and strategic relationships with industry participants,
may provide us with a competitive advantage in the cultivated food market.
Our plant-based FoodTech
operations are advancing two principal product streams: cell-cultured coffee through Coffeesai and cell-cultured cacao and cocoa-derived
ingredients through Kokomodo. These businesses operate in distinct but related markets characterized by evolving technology, early-stage
commercialization, and growing demand for sustainable and resilient ingredient supply chains.
Coffeesai operates in the
emerging cell-cultured coffee market, which includes participants such as California Cultured, Inc., Food Brewer AG, Another Food Pte.
Ltd., and Atomo Foods, Inc., among others. We believe that Coffeesai’s integration of scale-up technology, proprietary bioprocessing
capabilities, and scientific expertise may support an efficient, cost-effective, and sustainable production model. We also believe that
potential partnerships across the coffee value chain may enhance Coffeesai’s ability to develop and commercialize its products.
Kokomodo operates in the
developing market for cell-cultured cacao and cocoa-derived ingredients. Participants in this market include Celleste Bio Ltd., California
Cultured, Inc., and Food Brewer AG, among others. These companies are seeking to develop alternatives or supplements to conventional cacao
cultivation in response to concerns relating to climate impact, supply volatility, and ethical sourcing. More broadly, competitors in
our plant-based Foodtech markets include companies focused on plant cell culture for specialty ingredients, as well as established producers
of plant-derived compounds and flavors, including DSM-Firmenich AG and Givaudan International SA.
We believe that our ability
to compete successfully across our Foodtech operations will depend on continued innovation, the performance and scalability of our production
systems, our ability to protect and improve our proprietary technologies, the availability of sufficient capital and strategic partnerships,
regulatory developments, and our ability to develop products that meet customer, consumer, and commercial requirements. We may face competition
from companies with greater financial resources, broader product portfolios, more established customer relationships, and greater manufacturing,
regulatory, and commercialization capabilities than we have.
Intellectual
Property
We recognize that our success
depends, in part, on securing our intellectual property, and therefore we are committed to protecting our technology and product candidates
through patents and other means, as outlined below.
We are the sole owner of
149 issued patents, and approximately 57 pending patent applications, including 5 applications that have been allowed but not yet granted,
in the United States, Europe, China, Japan and Israel, as well as in additional countries worldwide, including countries in the Far East
and South America (in calculating the number of issued patents, each European patent validated in multiple jurisdictions was counted as
a single patent).
11
Based
on the well-established understanding that the characteristics and therapeutic potential of a cell product are largely determined by their
source, the methods, and conditions used during their culture, our patent portfolio includes various types of claims that protect the
unique aspects of our technology.
Our
multi-national patent portfolio and pending applications include claims directed at:
●
our proprietary 3D cell expansion
methods for adherent cells, including placental stromal cells;
●
our proprietary 3D cell expansion methods for plant
cells;
●
our proprietary 3D cell expansion
methods for suspension cells, including immune cells;
●
composition of matter claims covering
the expanded cells;
●
therapeutic and cosmetic use of
PLX cells for a broad range of indications; and
●
devices and methods related to
cell-culture, harvesting, thawing and formulation, as well as cell therapies employing unmodified and engineered placenta-derived MAIT
cells for the treatment of various diseases.
Through
our development of adherent stromal cell-based products, we have built expertise and proprietary know-how, establishing robust procedures
for the manufacturing of clinical-grade PLX cells in our facilities. Leveraging this foundation, we have expanded our capabilities to
include the handling and expansion of suspension cells including immune cells, thereby broadening our platform in cellular therapies.
Certain elements of our manufacturing process are protected by issued patents and pending applications. In parallel, we safeguard proprietary
aspects of our technology, trade secrets and know-how, maintained through confidentiality agreements with our employees, consultants,
contractors, manufacturers and advisors. These agreements typically include provisions to protect confidential information, restrict material
use and require the assignment of inventions developed in the course of such engagement.
The
following table outlines our key patents and patent applications. It is not intended to represent a legal assessment of claims, scope,
enforceability or limitations. In certain instances, a jurisdiction may appear under both “pending” and “granted”
status within a single patent family, reflecting the existence of continuation or divisional applications filed in parallel with a granted
patent.
The
expiration dates of these patents, based on filing dates, range from 2027 to 2046. Actual expiration dates will be determined according
to extensions received based on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), commonly known as the
“Hatch-Waxman” Act, which permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining
FDA market approval. The Hatch-Waxman Act is based on a U.S. federal law and therefore only relevant to U.S. patents.
There
is a risk that our patents will be invalidated, and that our pending patent applications will not result in issued patents. We also cannot
be certain that we will not infringe on any patents that may be issued to others. See “Risk Factors – The patent approval
process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.”
12
Our
Patent Portfolio
Patent
Name/ Int. App. No.
Pending
Jurisdictions
Granted
Jurisdictions
Expiry
Date
METHODS FOR CELL EXPANSION AND USES OF CELLS
AND CONDITIONED MEDIA PRODUCED THEREBY FOR THERAPY PCT/IL2007/000380
Australia, Canada, China, Hong Kong, Europe (Spain, Germany,
France, Belgium, Switzerland, Czech Republic, Hungary, Ireland, Italy, The Netherlands, United Kingdom, Poland, Portugal, Denmark, Sweden,
Slovakia), Israel, India, Japan, South Korea, Mexico, Russia, Singapore
March 23, 2027
ADHERENT CELLS FROM PLACENTA TISSUE AND USE
THEREOF IN THERAPY PCT/IL2008/001185
United States
Israel, Japan, United States
September 2, 2028
METHODS OF TREATING INFLAMMATORY COLON DISEASES
PCT/IL2009/000527
United States, Israel
May 26, 2029
METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION
PCT/IL2009/000844
Israel
September 1, 2029
ADHERENT CELLS FROM PLACENTA TISSUE AND USE
THEREOF IN THERAPY PCT/IL2009/000846
Australia, Canada, China, Europe (Switzerland, Germany, France,
United Kingdom, Italy), Hong Kong, Israel, India, Mexico, Singapore, United States
September 1, 2029
ADHERENT CELLS FROM PLACENTA TISSUE AND USE
THEREOF IN THERAPY PCT/IL2009/000845
United States, Israel
September 1, 2029
ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS
OF MULTIPLE DONORS AND USES THEREOF PCT/IB2011/001413
Israel
April 21, 2031
ADHERENT CELLS FROM PLACENTA AND USE OF SAME
IN DISEASE TREATMENT PCT/IB2010/003219
Europe (Switzerland, Germany, France, Italy), Israel, United
States
November 29, 2030
METHODS AND SYSTEMS FOR HARVESTING ADHERENT
STROMAL CELLS PCT/IB2012/000933
Australia, Canada, Europe (Belgium, Switzerland, Germany, France,
United Kingdom, Ireland, Italy, The Netherlands), Israel, India, South Korea, Mexico, Singapore, United States
April 15, 2032
METHODS FOR TREATING RADIATION OR CHEMICAL
INJURY PCT/IB2012/000664
United States
Europe (Germany, United Kingdom), Hong Kong, Israel, Japan,
South Korea, United States
March 22, 2032
SKELETAL MUSCLE REGENERATION USING MESENCHYMAL
STEM CELLS PCT/EP2011/058730
United States
May 27, 2031
GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT
STROMAL CELLS CULTURED IN 3D PCT/IB2014/059114
Israel, United States
February 20, 2034
SYSTEMS AND METHODS FOR GROWING AND HARVESTING
CELLS PCT/IB2015/051559
Israel, United States
March 3, 2035
METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING
MUSCLE WASTING DISORDERS PCT/IB2015/059763
United States
December 18, 2035
ALTERED ADHERENT STROMAL CELLS AND METHODS
OF PRODUCING AND USING SAME PCT/IB2016/053310
United States
June 6, 2036
METHODS AND COMPOSITIONS FOR TREATING CANCERS
AND NEOPLASMS PCT/IB2017/050868
Israel
February 16, 2037
METHODS AND COMPOSITIONS FOR TREATING NEUROLOGICAL
DISORDERS PCT/IB2018/052806
Israel
April 23, 2038
13
METHODS FOR EXPANDING ADHERENT
STROMAL CELLS AND CELLS OBTAINED THEREBY PCT/IB2019/052569
Singapore, United States
March 28, 2039
METHODS AND COMPOSITIONS FOR FORMULATING AND
DISPENSING PHARMACEUTICAL FORMULATIONS PCT/IB2019/053115
United States
Israel
United States:
April 16, 2039
Israel:
April 26, 2038
MODULAR BIOREACTOR PCT/IB2019/058429
Europe, Hong Kong, South Korea (divisional application), Singapore,
United States
Israel, South Korea
October 3, 2039
METHODS AND COMPOSITIONS FOR TREATING VIRAL
INFECTIONS AND SEQUELAE THEREOF PCT/IL2021/050268
Israel
March 11, 2040
METHODS AND COMPOSITIONS FOR AESTHETIC AND
COSMETIC TREATMENT AND STIMULATING HAIR GROWTH PCT/IL2020/050363
United States
March 26, 2040
METHODS AND COMPOSITIONS FOR ENRICHMENT OF
TARGET CELLS PCT/IL2021/020514
United States, Israel
May 5, 2041
PLACENTAL CELL TREATMENT FOR CRITICAL LIMB
ISCHEMIA PATIENT SUBPOPULATIONS PCT/IL2022/050937
United States
August 29, 2042
SYSTEM AND METHODS FOR IMMUNE CELLS EXPANSION
AND ACTIVATION IN LARGE SCALE PCT/IL2023/050529
Israel, South Korea, Europe, China, India, Japan, Singapore,
Hong Kong, Australia
Israel, South Korea, Australia, United States, China, Japan
May 23, 2043
A SYSTEM FOR 3D CULTIVATION OF PLANT CELLS
AND METHODS OF USE PCT/IL2024/050278
United States, Australia, China, Hong Kong, Europe, India,
Japan, South Korea, Singapore, Brazil
Israel, United States
March 18,
2044
GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED
INVARIANT T (MAIT) CELLS AND USES THEREOF PCT/IL2024/050675
United States, China, Europe, Australia, Israel, India, Japan,
South Korea, Hong Kong
July 9, 2044
GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED
INVARIANT T (MAIT) CELLS AND USES THEREOF PCT/IL2024/050670
PCT, United States, China, Europe
July 9, 2044
PLACENTAL DERIVED MAIT CELLS
FOR CELLULAR THERAPY OF SOLID CANCER (PCT/IL2026/050122)
PCT
February 8, 2046
BIOFILM-DISRUPTING ENGINEERED
MAIT CELLS AND THERAPEUTIC USES THEREOF (US 63/902,066)
US Provisional
October 20, 2026
14
Employees
As
of June 30, 2026, we employed a total of 92 full-time employees and 21 part-time employees, of whom 73 full-time employees and 14 part-time
employees are engaged in cell research, development, and manufacturing including clinical and regulation affairs.
EIB
Financing Agreement
In
April 2020, we and our subsidiaries, Pluri Biotech and Pluristem GmbH, entered into a finance agreement with EIB, providing for non-dilutive
funding of up to €50 million, payable in three tranches (the “EIB Loan”). In June 2021, we received the first tranche
in the amount of €20 million, which represents the only amount disbursed under the EIB finance agreement, as the initial funding
period expired on December 31, 2022, and no additional funds were made available thereunder.
The €20 million loan
bears annual interest at a rate of 4% and was repayable on June 1, 2026, with interest payable together with the principal. As of June
30, 2026, accrued interest amounted to approximately €4.1 million. In addition to the interest, the EIB is entitled to royalty payments,
pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues from fiscal year 2024 through fiscal year 2030, at rates
of up to 2.3% on consolidated revenues below $350 million, 1.2% on consolidated revenues between $350 million and $500 million, and 0.2%
on consolidated revenues exceeding $500 million. As of June 30, 2026, accrued royalties amounted to $9 thousand. On April 21, 2026, we
received a notice from the EIB that the EIB is reserving its rights under the finance agreement while discussions with the EIB regarding
potential resolution of the EIB Loan remain ongoing. On May 28, 2026, the EIB confirmed to us that while the parties remain engaged in
constructive discussions, and without prejudice to any of the EIB’s rights and remedies, no enforcement action was contemplated
by the EIB.
On
August 17, 2026, we were notified by the EIB that its relevant committee had approved, subject to certain conditions, a proposed sale
of the EIB Loan not involving the Company as purchaser, on terms agreed with a third-party purchaser who may be a related party. The completion
of such sale remains subject to, among other things, execution of definitive legal documentation and completion of the EIB’s review
process and other conditions. If the proposed sale is completed, the Company intends to seek to reach an arrangement with the purchaser
regarding the settlement of the purchased loan, which may include the conversion of all or a portion of the outstanding loan amount into
equity of the Company. Any such arrangement would be subject to negotiation with the purchaser and the receipt of all required corporate
and other approvals. Until the proposed sale is finalized and any subsequent arrangement with the purchaser is agreed and approved, there
can be no assurance as to the outcome of these discussions or the timing or terms of any resolution, or that the EIB will continue to
refrain from exercising remedies available to it under the finance agreement, that any sale of the EIB Loan will be completed, that any
settlement or conversion arrangement will be entered into or consummated, or as to the timing, structure, accounting treatment or financial
statement impact of any such transaction.
Available
Information
Additional
information about us is available on our website at www.pluri-biotech.com. Information contained on, or accessible through, our website
is not incorporated by reference into, and should not be considered part of this Annual Report. Under the “Financial Reports”
and “SEC Filings” subsections of the “Investors” section on our website, our Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the
Securities Exchange Act of 1934, as amended (“the Exchange Act”), are available as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the SEC. Our reports filed with the SEC are also made available on the SEC’s
website at www.sec.gov. The following Corporate Governance documents are also posted on our website under the “Governance”
subsection of the “Investors” section: Trading Policy, Code of Business Conduct and Ethics, Anti Bribery and Corruption and
Anti Money Laundering and Terrorist Financing Compliance Policy, Clawback Policy and the Charters for each of the Committees of our Board
of Directors (the “Board”).
15