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Item 1. Business

2025-09-17 compared with 2024-09-18 · 525 added, 506 removed, 335 unchanged (75% of the section changed)

We are a biotechnology company,

with an advanced cell-based technology platform.

We have developed a unique three-dimensional, or 3D, technology platform for cell expansion

with an industrial scale in-house Good Manufacturing Practice, or GMP, cell manufacturing facility.

We are utilizing our technology in

the field of regenerative medicine, immunotherapy, food tech, CDMO, and agtech and plan to utilize it in industries and verticals that

have a need for our mass scale and cost-effective cell expansion platform via partnerships, joint ventures, licensing agreements and other

types of collaborations.

Our operations are focused

on the research, development and manufacturing of cell-based products and the business development of cell therapeutics and cell-based

technologies providing potential solutions for various industries.

leveraging our proprietary cell expansion platform to develop scalable, cell-based solutions across the healthcare, food, and agriculture

Through a collaborative network of ventures, we are advancing a diverse pipeline of products and services, including cultivated

food, regenerative medicine, and cell-based ingredients.

We have developed a unique three-dimensional (“3D”) technology platform

for cell expansion with an industrial-scale cell manufacturing facility operated in accordance with Good Manufacturing Practice (“GMP”)

standards, currently on a self-declared basis.

We are utilizing our technology across the fields of regenerative medicine, immunotherapy,

food tech, CDMO, and AgTech and plan to utilize it in industries and verticals that have a need for our mass scale and cost-effective

cell expansion platform via partnerships, joint ventures, licensing agreements and other types of collaborations.

We were incorporated in Nevada

on May 11, 2001.

has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, which is incorporated under the laws

of the State of Israel.

In January 2020, the Subsidiary established a wholly owned subsidiary, Pluristem GmbH, which is incorporated

under the laws of Germany, or the German Subsidiary.

In November 2021, the Subsidiary

established a new subsidiary, Ever After Foods Ltd., or Ever After Foods, which is incorporated under the laws of the State of Israel.

The Subsidiary holds approximately 69% of Ever After Foods issued and outstanding shares on a fully diluted basis.

In March 2024 the Subsidiary

established a wholly owned subsidiary, Coffeesai Ltd., or Coffeesai, which is incorporated under the laws of the State of Israel.

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.

Our operations are dedicated

to the research, development and manufacturing of cell-based products, as well as the commercialization of cell therapeutics and related

technologies aimed at delivering innovative solutions across a range of industries, as set forth below:

We use our advanced cell-based

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we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery

for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia, or CLI, Chronic Graft versus Host

Disease and a potential treatment for Hematopoietic Acute Radiation Syndrome, or H-ARS.

Some of these studies have been completed while

others are still ongoing.

We believe that each of these indications is a severe unmet medical need.

In July 2023, we announced

that we signed a three-year $4.2 million contract with the U.S.

National Institute of Allergy and Infectious Diseases, or NIAID, which

is part of the NIH.

Under such contract, we will collaborate with the U.S.

Department of Defense’s Armed Forces Radiobiology Research

Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the

development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters

and radiation exposure.

for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia (“CLI”), chronic Graft

versus Host Disease (“GvHD”), knee osteoarthritis and a potential treatment for Hematopoietic Acute Radiation Syndrome (“H-ARS”).

Some of these studies have been completed while others are still ongoing.

We believe that each of these indications is a severe unmet

medical need.

Immunotherapy MAIT cells:

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the human placenta, offer substantial potential benefits compared to conventional T cells.

MAIT cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various

chemokine receptors, which facilitate their migration directly to tumor sites.

Furthermore, unlike conventional autologous T cells typically

collected from peripheral blood, our MAIT cells are designed to be allogenic universal product.

Benefiting with very restricted T-cell

receptor, or TCR, the MAIT cells minimize their likelihood of inducing Graft versus Host Disease, or GvHD, a significant advantage over

other potential allogeneic products.

We are aiming to design the MAIT to potentially show better persistence in the body for a longer

duration, enhancing their therapeutic efficacy.

In April 2024, we unveiled

a novel method for expansion of immune cells using proprietary technology and announced we were granted a new U.S.

patent titled, “System

and Methods for Immune Cells Expansion and Activation in Large Scale.” This innovative approach ensures that the produced immune

cells retain their integrity, functionality, and therapeutic efficacy, thus offering a promising solution to meet the escalating demand

for advanced cell-based therapies for immune disorders and neurodegenerative diseases.

In January 2024, we launched

a new business division offering cell therapy manufacturing services as a CDMO:

PluriCDMO™ offers CDMO services

to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality,

essential therapies to patients.

We have signed several agreements with clients and are currently generating revenues from PluriCDMO™.

are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the agtech field, such as:

(a) cell-based

coffee business activity through our PluriAgtech business vertical, which is incorporated into our wholly owned subsidiary, Coffeesai

(b) an innovative proof-of-concept, or POC, collaboration with ICL Group Ltd., or ICL Group, a leading global specialty minerals company,

to revolutionize bio stimulant delivery and enhance yield sustainably, and (c) a strategic POC agreement with a leading international

agriculture corporation which 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.

In March 2024, we announced

an important expansion to our intellectual property, or IP portfolio with a new patent approval from the Israel Patent Office, that is

designed to reshape the agricultural technology landscape.

The patent represents a major breakthrough in our proprietary 3D bioreactor

technology, enabling efficient cultivation of plant cells across various applications, from sustainable agriculture to critical healthcare

Placental MAIT cells are

potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors,

which facilitate their migration directly to tumor sites.

Furthermore, unlike conventional autologous T cells typically collected from

peripheral blood, our MAIT cells are designed to be allogenic universal product.

Benefiting with very restricted T-cell receptor (“TCR”),

the MAIT cells minimize their likelihood of inducing GvHD, a significant advantage over other potential allogeneic products.

We are aiming

to design the MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.

In January 2024, we

launched a new business division offering cell therapy manufacturing services as a CDMO:

PluriCDMO™ offers CDMO

for cell therapy 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.

We have signed several agreements

with clients and are currently generating revenues from PluriCDMO™.

We are actively involved

in several initiatives leveraging Pluri’s 3D cell expansion technology in the AgTech field, including:

(a) an innovative proof-of-concept

(“POC”) collaboration with ICL Group Ltd.

(“ICL”), a leading global specialty minerals company, through its Open

Innovation program, to revolutionize bio stimulant delivery and enhance yield sustainably;

(b) a strategic POC agreement

with a leading international agriculture corporation aimed at boosting the global vegetable product supply, streamlining supply chains,

and promoting a more sustainable future for agriculture;

coffee and cacao through business activities operated via our subsidiaries in the plant-based vertical, Coffeesai and Kokomodo, respectively.

In 2024, we established Coffeesai

Ltd., an Israeli subsidiary focused on developing cultivated, cell-cultured coffee.

This initiative addresses key challenges facing the

traditional coffee industry, such as climate-related crop instability, supply chain disruptions, and environmental impact.

By leveraging

controlled, scalable bioprocess, Coffeesai aims to deliver consistent product quality, reduced resource consumption, and long-term cost

Coffeesai has successfully

demonstrated a POC coffee beverage, validating the potential of its technology.

Ongoing efforts are focused on enhancing flavor and aroma

profiles through bioprocess optimization and downstream refinement.

In parallel, Coffeesai is exploring research and development collaborations

aimed at accelerating development and commercialization with leading global coffee suppliers.

A third-party techno-economic assessment

has confirmed the cost-competitiveness of the platform at scale, supporting its commercial viability.

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

Kokomodo, an Israeli company, is an innovative agfood startup pioneering the sustainable production of cacao using cellular

agriculture technology.

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.

In 2022, we announced the

establishment of a joint venture with Tnuva, Ever After Foods, (previously Plurinuva Ltd.), which is incorporated under the laws of the

State of Israel, with the purpose of developing cultivated meat product of all kinds and types.

establishment of a joint venture with Tnuva - Ever After Foods, incorporated under the laws of the State of Israel.

The purpose of the

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.

Leveraging Pluri’s

innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business, or

B2B, version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues

for various animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat.

June 2024, we entered into a share purchase agreement, or the Agreement, by and among Ever After Foods, Tnuva, and certain other international

strategic investors, or, collectively, the Investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private

placement offering, or the Offering, for aggregate gross proceeds of $10 million.

innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business (“B2B”)

version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for

various animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat.

In June 2024, we entered

into a share purchase agreement (the “Agreement”) by and among Ever After Foods, Tnuva, and certain other international strategic

investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private placement offering (the “Offering”),

for aggregate gross proceeds of $10 million.

As part of the Offering, we invested $1.25 million.

In addition, the Subsidiary and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024,

or the Amended License.

The Amended License amended the parties’ existing license agreement dated as of February 23, 2022,

to expand the scope of the license to include fish and seafood.

$10 million funding round is intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology

Following the closing of the Offering, the Subsidiary holds approximately 69% of Ever After Foods.

In addition, Pluri Biotech and Ever

After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024 (the “Amended License”).

The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the scope of

the license to include fish and seafood.

The $10 million funding round

is intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler.

the closing of the Offering, our wholly owned subsidiary, Pluri Biotech, holds approximately 69% of Ever After Foods.

Scientific Background – Cell Therapy

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our MAIT cells are designed to be allogenic universal product.

Benefiting with very restricted TCR, the MAIT cells minimizes their likelihood

Benefiting with very restricted TCR, the MAIT cells minimize their likelihood

of inducing GvHD, a significant advantage over other potential allogeneic products.

We are designing the MAIT to potentially show better

persistence in the body for a longer duration, enhancing their therapeutic efficacy.

Our Technology

Our technology platform,

a patented and validated state-of-the-art 3D cell expansion system, aims to advance novel cell-based solutions for a range of industries,

including, but not limited to pharmaceuticals, foodtech, agtech, and CDMO.

Our method is uniquely accurate, scalable, cost-effective,

and consistent from batch to batch.

Our technology is currently being implemented in the fields of regenerative medicine, food tech,

Our patented and validated

3D cell expansion platform is a state-of-the-art system designed to enable novel cell-based solutions.

It delivers high accuracy, scalability,

cost-efficiency, and consistent batch-to-batch performance.

The platform is currently being applied in regenerative medicine, FoodTech,

AgTech, and CDMO.

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consistency, an important manufacturing challenge for biological products.

We developed a new cell manufacturing

process for industrial scale cell manufacturing called PluriMatrix, which is built upon our 3D cell expansion technology platform, scaling

high-quality cell production.

We developed PluriMatrix,

an industrial-scale cell manufacturing system built on our 3D cell expansion platform, designed to enable high-quality cell production

at commercially relevant volumes.

We aim to establish partnerships

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accelerate the time-to-market of our products.

Product Candidates - Pluri

Cell Therapy Product Candidates - Pluri

PLX-PAD is composed of maternal

mesenchymal stromal cell, or MSC, like cells originating from the placenta.

mesenchymal stromal cell (“MSC”) like cells originating from the placenta.

PLX-R18 is composed of fetal

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Our Clinical Development Product Candidates

Both PLX-PAD and PLX-R18 products were tested

in clinical studies.

Both PLX-PAD and PLX-R18

products were tested in clinical studies.

Studies were conducted in the United States, Europe and Israel.

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as a treatment for several indications:

acute muscle injuries following hip fracture, acute respiratory distress syndrome, or ARDS, due

to Coronavirus Disease, or COVID-19, GvHD, and peripheral artery disease, or PAD, including intermittent claudication, or IC, and critical

limb ischemia, or CLI.

acute muscle injuries following hip fracture, acute respiratory distress syndrome, due to Coronavirus

Disease (“COVID-19”), GvHD, and peripheral artery disease, including intermittent claudication, and critical limb ischemia

All clinical studies were completed.

In addition, PLX-PAD is being

developed for the treatment of mild to moderate knee osteoarthritis as part of the PROTO program, (Advanced PeRsOnalized Therapies for

Osteoarthritis), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies.

clinical study will be carried out by Charité and is pending regulatory approval.

developed for the treatment of mild to moderate knee osteoarthritis as part of the Advanced PeRsOnalized Therapies for Osteoarthritis

(“PROTO”) program, an international collaboration led by Charité Berlin Institute of Health Center for Regenerative

Therapies (“Charité”).

In June 2025, the clinical study was approved by the Paul-Ehrlich-Institut (“PEI”)

and the clinical study will be carried out by the Charité.

PLX-R18 was tested

in a Phase I trial for treatment of patients with incomplete recovery following hematopoietic cell transplantation, or HCT, in the United

States and Israel.

in a Phase I trial for treatment of patients with incomplete recovery following hematopoietic cell transplantation, in the United States

In addition, PLX-R18 is being

developed under the FDA’s Animal Rule regulatory pathway for Acute Radiation Syndrome, or ARS.

ARS On July 11, 2023,

we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH.

Pluri will collaborate with the U.S.

of Defense’s, or DoD’s, AFRRI, and the USUHS, to further advance the development of its PLX-R18 cell therapy as a potential

novel treatment for H-ARS.

H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure.

On June 6, 2024, NIAID

exercised its option for year two of the three-year $4.2 million contract.

developed under the FDA’s Animal Rule regulatory pathway for Acute Radiation Syndrome (“ARS”), and in November 2024,

we announced that we are evaluating our readiness to initiate mass production of PLX-R18 in light of heightened global nuclear threats.

Acute Radiation Syndrome:

On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH.

Pluri will collaborate with

Department of Defense’s (“DoD’s”), AFRRI, and the USUHS, to further advance the development of its PLX-R18

cell therapy as a potential novel treatment for H-ARS.

H-ARS is a deadly disease that can result from nuclear disasters and radiation

On June 6, 2024, NIAID exercised its option for year two of the three-year $4.2 million contract.

Prior to signing the contract

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DoD Armed Forces Radiobiology Research Institute, part of the USUHS.

On April 15, 2025, we received formal notice from NIAID that the

contract was being terminated for Government’s convenience, effective from the date of the notice.

We believe that the termination

reflects broader federal budgetary and administrative adjustments that have affected various health-related agencies, including the NIH.

The termination was not related to any performance issues on our part, and we received the funding for activities conducted up to the

effective date.

On January 8, 2022, we entered

into a definitive license agreement with Takeda Pharmaceuticals International AG (“Takeda”), a company based in Switzerland,

which operates in the field of adipose-derived cells, pursuant to which we granted Takeda a global, non-exclusive license to use several

of our patents (EP2591789 and EP3103463,), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing

its opposition with regards to said patents and paying us a lump sum of $200,000.

The license covers methods for expanding adherent stromal

cells and specified second medical uses.

On January 10, 2022, we entered

into a definitive license agreement with Novadip Biosciences (“Novadip”), a company based in Belgium, which operates in the

field of adipose-derived stem cells for cell therapy and cell-free therapy in respect of medical or cosmetic conditions, under which

we granted Novadip a global, non-exclusive, royalty free license to use two of our patents (EP2591789, EP3103463), limited to non-placental

cells and cell-derived therapies, sub-licensable only to Novadip’s customers.

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 via BIRAD will receive the right to further develop and commercialize PLX cells as a cocaine

anti-addiction product, and Pluri is 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 e stockpiling,

local distribution, and potential clinical advancement of our PLX-R18 cell therapy as a countermeasure for Hematopoietic Acute Radiation

Syndrome, or H-ARS, in Ukraine.

Regulatory and Clinical Affairs Strategy

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regulatory stages.

We utilize this strategy in working with the FDA, the EMA, Germany’s PEI as well as other European national

competent authorities, the Minister of Health, or MOH, Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, and also the

Ministry of Food and Drug Safety, or MFDS, of South Korea.

We utilize this strategy in working with the FDA, the European Medicines Agency (“EMA”), Germany’s

PEI as well as other European national competent authorities, the Israeli Minister of Health (“MOH”), Japan’s Pharmaceuticals

and Medical Devices Agency (“PMDA”) and also the Ministry of Food and Drug Safety (“MFDS”) of South Korea.

Our Activities in the Food Tech Sector - Ever

Ever After Foods is engaged

in the development and commercialization innovative cultivated meat products.

It leverages proprietary technology and expertise to create

sustainable, high-quality meat alternatives.

in the development and commercialization of innovative cultivated meat products, leveraging proprietary technology and expertise to create

sustainable, high-quality meat alternatives and to facilitate the production of cultivated meat and fish products by providing the necessary

technological infrastructure and support.

Ever After Foods’ key

and Development:

Ever After Foods is committed to advancing cultivated meat technology.

operations are:

Research and Development:

Ever After Foods is committed to advancing

cultivated meat technology.

Its R&D efforts focus on:

Optimizing bioreactor processes for efficient production.

- Enhancing the taste, texture, and nutritional value of cultivated

meat products.

It is dedicated to creating a diverse range of bioreactors with specialized scaffolds for cultivated meat production, emphasizing

efficient and sustainable production processes.

◾ Partnerships

and Collaborations:

It collaborates with industry leaders, gaining access to valuable expertise, resources, and market channels through

these strategic partnerships.

Enhancing the taste, texture, and nutritional value of cultivated meat

Product Development:

It is dedicated to creating a diverse range of

bioreactors with specialized scaffolds for cultivated meat production, emphasizing efficient and sustainable production processes.

Partnerships and Collaborations:

It collaborates with industry leaders,

gaining access to valuable expertise, resources, and market channels through these strategic partnerships.

By combining cutting-edge

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and offer consumers a sustainable and delicious alternative to traditional meat.

Our Activities in the Ag-tech Sector

In February 2025, Ever After

Foods announced entering into a strategic collaboration with Bühler Group (“Bühler”), a leading global provider

of food processing technologies, to jointly advance scalable cultivated meat production systems.

The collaboration aims to combine Bühler’s

engineering and market access capabilities with Ever After Foods’ proprietary edible packed-bed (EPB™) bioreactor platform

to deliver commercial-scale cultivated meat production systems specifically designed for the food industry.

The parties intend to develop

and deploy manufacturing equipment that enables food producers to efficiently produce cultivated meat at significantly reduced cost and

at volumes suitable for market entry.

The joint effort reflects a shared focus on addressing global food security challenges and supporting

the sustainable transition of protein systems.

Under the collaboration, Ever After Foods and Bühler plan to accelerate commercial

availability of tailored production systems that can support industry-wide adoption of cultivated meat technologies.

Our Activities in the AgTech Sector

In October 2023, we

entered into a POC collaboration with ICL, a global specialty minerals company, through its Open Innovation program, to evaluate the

potential of our technology for enhancing the delivery of biostimulants in agriculture.

The initial phase of the collaboration 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, we signed an agreement to extend the collaboration with ICL, which reflects

a continued mutual interest in further developing and validating the underlying technology for agricultural applications.

In January 2024, we announced

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expansion and addressing the ongoing global demand for sustainable, high-quality coffee at mass scale production.

We signed an innovative POC

collaboration with ICL Group, a leading global specialty minerals company, to revolutionize bio stimulant delivery and enhance yield

In March 2024, we announced

an important expansion to our IP portfolio with a new patent approval from the Israel Patent Office, that is designed to reshape the agricultural

technology landscape and enables efficient cultivation of plant cells across various applications, from sustainable agriculture to critical

healthcare solutions.

In March 2024, we

announced an important expansion to our intellectual property (“IP”) portfolio with a new patent approval from the

Israel Patent Office (“IPO”) that is designed to reshape the agricultural technology landscape.

The patent represents a

major breakthrough in our proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various

applications, from sustainable agriculture to critical healthcare solutions.

In July 2024, we announced

a €1 Million POC agreement to enhance global sustainable vegetable supply with a leading international agriculture corporation.

The 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 signing of a €1 million POC agreement with a leading international agriculture corporation.

The collaboration, which remains

ongoing, is focused on enhancing global sustainable vegetable production, improving supply chain efficiency, and addressing climate-related

This initiative aims to support a more resilient and environmentally sustainable agricultural system through natural, innovation-driven

Intellectual Property

We understand that our success

will depend, in part, on maintaining our IP, and therefore we are committed to protecting our technology and product candidates with patents

and other methods described below.

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

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Based on the well-established

understanding that the characteristics and therapeutic potential of a cell product are largely determined by the source of the cells

and by the methods and conditions used during their culturing, our patent portfolio includes different types of claims that protect the

various unique aspects of our technology.

Our multi-national portfolio of patent and patent

applications includes the following claims:

our proprietary 3D cell

expansion methods for adherent cells including placental stromal cells plant cells, and plant cells;

our proprietary 3D cell

expansion methods for cells in suspension including immune cells;

composition of matter claims

covering the cells;

the therapeutic and cosmetic

use of PLX cells for the treatment of a variety of conditions;

cell-culture, harvest,

thawing and formulation devices, cell therapy for a diverse array of diseases utilizing engineered MAIT cells derived from the placenta.

Through our experience with

the development of adherent stromal cell-based products, we have gained expertise and know-how in this field and have established procedures

for manufacturing clinical-grade PLX cells in our facilities.

Building on this foundation, we have expanded our expertise to include

the procedures for handling and expansion of cells in suspension including immune cells, broadening our capabilities in cellular therapies.

Certain aspects of our manufacturing process are covered by patents and patent applications.

In addition, specific aspects of our technology

are retained as know-how and trade secrets that are protected by our confidentiality agreements with our employees, consultants, contractors,

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

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 and 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;

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

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 generally provide for protection of confidential information, restrictions on the use of

materials, and obligations to assign to us inventions created during the course of performing services for us.

The following table sets

forth our key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope.

cases, a jurisdiction is listed as both pending and granted for a single patent family.

This is due to pending continuation or divisional

applications of the granted case.

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

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Our Patent Portfolio

Patent Name/ Int.

Jurisdictions

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PCT/IL2007/000380

Australia, Canada, China, Hong Kong, Europe (Spain,

Germany, France, Belgium, Switzerland, Czech Republic, Hungary, Ireland, Italy, The Netherlands), Israel, India, Japan, South Korea,

Mexico, Russia, Singapore

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

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United States

Brazil, Canada, China, Europe (Belgium, Austria, Spain,

Germany, Switzerland, France, Ireland, Italy, the Netherlands), Hong Kong, Israel, India, Japan, Mexico, Russia, United States, South

Brazil, Canada, China, Europe (Germany, Switzerland, France, Ireland, Italy, the Netherlands),

Hong Kong, Israel, India, Japan, Mexico, Russia, United States, South Korea

September 2, 2028

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PCT/IL2009/000527

United States, Israel, Russia

United States, Israel

METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION

PCT/IL2009/000844

Europe (Switzerland, Germany, France, United Kingdom),

September 1, 2029

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PCT/IL2009/000846

Australia, Canada, China, Europe (Switzerland, Germany,

France, United Kingdom, Italy), Hong Kong, Israel, India, Mexico, Singapore, United States

Australia, Canada, China, Europe (Switzerland, Germany, France, United Kingdom, Italy), Hong Kong,

Israel, India, Mexico, Singapore, United States

September 1, 2029

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PCT/IL2009/000845

United States, Europe (Switzerland, Germany, France,

United Kingdom), Israel

United States, Israel

September 1, 2029

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PCT/IB2010/003219

United States, Israel

Australia, Canada, China, Hong Kong, Europe (Switzerland,

Germany, Spain, France, United Kingdom, Italy, Belgium, Ireland, The Netherlands), Israel, Mexico, New Zealand, United States

Australia, Canada, China, Europe (Switzerland, Germany, France, United Kingdom, Italy), Israel,

Mexico, United States

November 29, 2030

METHODS AND SYSTEMS FOR HARVESTING ADHERENT

STROMAL CELLS

METHODS AND SYSTEMS FOR HARVESTING ADHERENT STROMAL CELLS

PCT/IB2012/000933

China, Israel

Australia, Canada, Europe (Belgium, Switzerland, Germany,

Spain, France, United Kingdom, Ireland, Italy, The Netherlands), Israel, India, South Korea, Mexico, Singapore, United States

Australia, Canada, Europe (Belgium, Switzerland, Germany, France, United Kingdom, Ireland, Italy,

The Netherlands), Israel, India, South Korea, Mexico, Singapore, United States

April 15, 2032

2 unchanged sentences

United States

Europe (Belgium, Switzerland, Germany, France, United

Kingdom, Ireland, The Netherlands), Hong Kong, Israel, Japan, South Korea, United States

Europe (Belgium, Switzerland, Germany, France, United Kingdom, Ireland, The Netherlands), Hong

Kong, Israel, Japan, South Korea, United States

March 22, 2032

1 unchanged sentence

PCT/EP2011/058730

United States, Europe (Belgium, Switzerland, Germany,

Spain, France, United Kingdom, Ireland, Italy, The Netherlands), Israel

United States

GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL

3 unchanged sentences

February 20, 2034

METHODS FOR PREVENTION AND TREATMENT OF PREECLAMPSIA

PCT/IB2013/058186

Japan, Belgium, France, Italy, Switzerland, United

Kingdom, Germany, China, Hong Kong

August 31, 2033

METHOD AND DEVICE FOR THAWING BIOLOGICAL MATERIAL

PCT/IB2013/059808

Australia, China, Europe (Belgium, Switzerland, Germany,

Spain, France, United Kingdom, Italy, The Netherlands), Hong Kong, Israel, India, Japan, South Korea, Russia, Singapore, United States

October 31, 2033

SYSTEMS AND METHODS FOR GROWING AND HARVESTING CELLS

7 unchanged sentences

December 18, 2035

USE OF ADHERENT STROMAL CELLS FOR ENHANCING HEMATOPOIESIS IN

A SUBJECT IN NEED THEREOF

PCT/IB2016/051585

Israel, United States

March 21, 2036

ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND

3 unchanged sentences

PCT/IB2017/050868

Europe (Switzerland, Germany, France, United Kingdom),

Japan, Israel

Europe (Switzerland, Germany, France, United Kingdom), Israel

February 16, 2037

2 unchanged sentences

April 23, 2038

METHODS AND COMPOSITIONS FOR TUMOR ASSESSMENT

PCT/IB2018/050984

February 18, 2038

METHODS AND COMPOSITIONS FOR TREATING ADDICTIONS

PCT/IB2018/055473

July 23, 2038

METHODS AND COMPOSITIONS FOR DETACHING ADHERENT CELLS

Germany 10 2018 115 360.0

June 25-July 3, 2038

METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS

4 unchanged sentences

PCT/IB2019/052569

Israel, Singapore, United States

Singapore, United States

March 28, 2039

METHODS AND COMPOSITIONS FOR TREATING SUBJECTS EXPOSED TO VESICANTS

AND OTHER CHEMICAL AGENTS

PCT/IB2019/055074

Israel, United States, Singapore

June 18, 2039

METHODS AND COMPOSITIONS FOR FORMULATING AND DISPENSING PHARMACEUTICAL

3 unchanged sentences

April 26, 2038

THERAPEUTIC DOSAGE REGIMENS COMPRISING ADHERENT STROMAL CELLS

PCT/IB2019/054828

Israel, United States

June 10, 2039

MODULAR BIOREACTOR

PCT/IB2019/058429

Europe, Israel, Hong Kong, South Korea, Singapore,

United States

Europe, Israel, Hong Kong, South Korea, Singapore, United States

Israel, South Korea

October 3, 2039

3 unchanged sentences

November 6, 2039

METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS

AND SEQUELAE THEREOF

METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND

SEQUELAE THEREOF

PCT/IL2021/050268

United States, Europe,

March 11, 2040

4 unchanged sentences

March 26, 2040

METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED

September 23, 2040

METHODS AND COMPOSITIONS FOR

5 unchanged sentences

PCT/IL2022/050937

Patent Cooperation Treaty, or PCT, United States

United States

August 29, 2042

2 unchanged sentences

PCT/IL2023/050529

PCT, Israel, South Korea, United States

A System For 3D

Cultivation of Plant Cells And Methods Of Use

United States

April 28, 2040

Israel, South Korea, Europe, China, India, Japan, Singapore, Hong

Kong, Australia

Israel, South Korea, Australia, United States

A SYSTEM FOR 3D CULTIVATION OF PLANT CELLS AND METHODS OF USE

PCT/IL2024/050278

PCT, United States, Israel

PCT, United States, Australia, China, Hong Kong, Europe, India,

Japan, South Korea, Singapore

March 18, 2044

2 unchanged sentences

PCT/IL2024/050675

United States

United States, China, Europe, Australia, Israel, India, Japan,

South Korea, Hong Kong

GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT

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PCT/IL2024/050670

On January 8, 2022, we entered

into a definitive license agreement with Takeda Pharmaceuticals International AG, or Takeda, a company based in Switzerland, which operates

in the field of adipose-derived cells, pursuant to which we granted Takeda a global, non-exclusive license to use several of our patents

(EP2591789 and EP3103463,), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing its opposition

with regards to said patents and paying us a lump sum of $200,000.

The license covers methods for expanding adherent stromal cells and

specified second medical uses.

On January 10, 2022, we entered

into a definitive license agreement with Novadip Biosciences, or Novadip, a company based in Belgium, which operates in the field of

adipose-derived stem cells for cell therapy and cell-free therapy in respect of medical or cosmetic conditions, under which we granted

Novadip a global, non-exclusive, royalty free license to use two of our patents (EP2591789, EP3103463), limited to non-placental cells

and cell-derived therapies, sub-licensable only to Novadip’s customers.

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 BIRAD–Research & Development Company Ltd., or Birad, the commercial arm of Bar-Ilan University.

agreement, Bar-Ilan University via Birad will receive the right to further develop and commercialize PLX cells as a cocaine anti-addiction

product, and Pluri is entitled to 20% revenue sharing from future sales of the product for anti-addiction.

PCT, United States

Ongoing Collaborations

EIB Agreement

In April 2020, we, the Subsidiary, and the German Subsidiary, together

with the European Investment Bank, or EIB, executed a finance agreement, or the EIB Finance Agreement, for non–dilutive funding

of up to €50 million in the aggregate, payable in three tranches.

The proceeds from the EIB Finance Agreement were intended to support

our research and development in Europe to further advance our regenerative cell therapy platform, and to bring the products in our pipeline

The term of the project was three years commencing on January 1, 2020.

EIB Finance Agreement

In April 2020, we and our

subsidiaries, Pluri Biotech and Pluristem GmbH, executed a finance agreement with EIB (the “EIB Finance Agreement”) for non-dilutive

funding of up to €50 million in the aggregate, payable in three tranches (the “EIB Loan”).

The proceeds from the EIB

Finance Agreement were intended to support our R&D in the European Union to further advance our regenerative cell therapy platform,

and to bring the products in our pipeline to market.

The initial funding period under the agreement was three years commencing on January

During June 2021, we received

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June 1, 2026, and bears annual interest of 4% to be paid together with the principal of the loan.

As of June 30, 2024, the interest accrued

was in the amount of €2.465 million.

In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated

to the amount disbursed from the EIB loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including its fiscal

year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between

$350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million.

As of June 30, 2024, the royalty accrued

was in the amount of €2,800.

As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant

to the EIB Finance Agreement.

The EIB Finance Agreement contains certain limitations that we must adhere to such as the use of proceeds

received from the EIB, the disposal of assets, substantive changes in the nature of our business, our potential execution of mergers

and acquisitions, changes in our holding structure, distributions of future potential dividends and our engaging with other banks and

financing entities for other loans.

We are currently in advanced discussions

with the EIB regarding a potential restructuring of the terms of the EIB Loan, which are currently focused on the new terms of the EIB

Loan, including an extension of the current maturity date of the EIB Loan.

However, there is no certainty as to the outcome of these

As of June 30, 2025, the interest accrued was in the amount of approximately €3.27 million.

In addition to the interest

payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues

beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues

below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding

$500 million.

As of June 30, 2025, we had an accrued royalty in the amount of $12 thousand.

Since the initial funding period under the

EIB Finance Agreement ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.

Charité Agreement

In July 2007, we entered

into a five-year collaborative research agreement with the Berlin-Brandenburg Center for Regenerative Therapies at Charité –

University Medicine Berlin, or Charité, which was extended from time to time through June 2027.

We and Charité are collaborating

on a variety of indications utilizing PLX cells.

According to the agreement, we will be the exclusive owner of the technology and any

products produced as a result of the collaboration.

Charité will receive between 1% to 2% royalties from net sales of new developments

that have been achieved during the joint development.

into a five-year collaborative research agreement with the Charité, which was extended from time to time through June 2027.

and Charité are collaborating on a variety of indications utilizing PLX cells.

According to the agreement, we will be the exclusive

owner of the technology and any products produced as a result of the collaboration.

Charité will receive between 1% to 2% royalties

from net sales of new developments that have been achieved during the joint development.

Department of Defense

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a three-year $4.2 million contract with the NIAID, which is part of the NIH.

We will collaborate with the U.S.

DoD’s AFRRI and USUHS

to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS.

H-ARS is a deadly disease that

can result from nuclear disasters and radiation exposure.

The period of performance of this contract was from July 1, 2023 through June

We agreed to collaborate with the U.S.

and USUHS to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS.

H-ARS is a deadly

disease that can result from nuclear disasters and radiation exposure.

The term of this contract was from July 1, 2023, through June

30, 2024, with an optional extension for an additional two-year period.

On June 6, 2024, the NIAID

exercised its option for year two of the three-year $4.2 million contract.

During the 12 months period from July 1, 2024 through June

30, 2025, the NIAID will provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo

studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.

If at any time during

performance of this contract, the contracting officer determines, in consultation with the Office of Laboratory Animal Welfare, or OLAW,

NIH, that we are not in compliance with any of the requirements and standards stated in the agreement, the contracting officer may immediately

suspend, in whole or in part, work and further payments under this contract until we correct the noncompliance.

If we fail to complete

corrective action within the period of time designated in the contracting officer’s written notice of suspension, the contracting

officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part.

exercised its option for year two of the three-year contract.

During the 12 months period from July 1, 2024, through June 30, 2025, the

NIAID was to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to

develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.

On April 15, 2025, Pluri

Biotech received a formal notice of termination from the NIAID, according to which, the contract was terminated for the Government’s

convenience, and such termination was effective as of April 15, 2025.

We believe that the termination of the contract may reflect broader

federal budgetary and administrative adjustments that have affected multiple health-related agencies, including the NIH.

As of the date

of this Annual Report, we received a total of $2.3 million in funding under the contract.

Horizon Europe - PROTO

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announced that a €7.5 million non-dilutive grant from the European Union, or EU’s, Horizon program has been awarded to PROTO,

(Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute of Health

Center for Regenerative Therapies.

The goal of the PROTO project is to utilize our PLX-PAD cells for the treatment of mild to moderate

knee osteoarthritis.

The clinical study will be

carried out by Charité.

We, together with an international consortium under the leadership of Professor Tobias Winkler, Principal

Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal

Surgery will be carrying out the study.

The initiation of the study is still pending regulatory approvals.

ICL Group – Open Innovation

In October 2023, we signed a POC collaboration with ICL Group Open

Innovation to pioneer advanced bioactive carriers and bio stimulants.

This partnership aims to leverage natural delivery mechanisms within

plants, boosting crop yields and fostering sustainability in agriculture.

Wilk Technologies

In May 2024, we announced

a strategic collaboration with Wilk Technologies Ltd.

a developer of authentic, cell cultured human and animal milk components, to develop

cultured human breast and animal milk products, by using components of breast milk for a unique medical food intended for the elderly

population on a commercial scale.

We expect to harness the unique properties of breast milk cells as solutions for a rapidly growing

elderly population.

an international collaboration led by Charité.

The goal of the PROTO project is to utilize our PLX-PAD cells for the treatment

of mild to moderate knee osteoarthritis.

In June 2025, the clinical

study was approved by the PEI.

The study is being conducted at Charité together with an international consortium and under the

leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius

Wolff Institute and Center for Musculoskeletal Surgery.

In October 2023, we

signed a POC collaboration with ICL, through its Open Innovation program, to pioneer advanced bioactive carriers and bio stimulants.

This partnership aims to leverage natural delivery mechanisms within plants, boosting crop yields and fostering sustainability in agriculture.

In December 2024, we signed an agreement to extend this collaboration, reflecting continued mutual interest in further developing and

validating the underlying technology for agricultural applications.

Undisclosed - Leading international agriculture

In July 2024, we announced a €1 million POC agreement with a leading

international agriculture corporation, or the POC Party, 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 the 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 to increase the global vegetable products supply.

The POC Party will pay the

Company in three installments, the first payable upon the effective date of the agreement, the second following completion of phase one

of the POC and the POC Party’s written notification of its decision to move to the next step, and the final installment occurring

upon the completion of phase two of the POC.

The POC Party may terminate upon 14 days’ written notice following the end of either

of the two phases of the POC.

In July 2024, we announced

the signing of a €1 million POC agreement with a leading international agriculture corporation (the “POC Party”) 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.

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.

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.

The POC Party is paying us

in three installments:

the first installment was made upon the effective date of the POC agreement;

the second installment was paid following

completion of Phase I of the POC and the POC Party’s written decision to proceed to the next phase;

and the final installment will

be payable upon completion of Phase II.

The POC Party may terminate the agreement with 14 days’ prior written notice following

the conclusion of either Phase I or Phase II.

In June 2020, we announced

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CRISPR-IL brings together the leading experts

in life science and computer science from academia, medicine, and industry, to develop Artificial Intelligence, or AI, based on end-to-end

genome-editing solutions.

These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications

in the pharma, agriculture, and aquaculture industries.

in life science and computer science from academia, medicine, and industry, to develop Artificial Intelligence (“AI”), based

on end-to-end genome-editing solutions.

These next-generation, multi-species genome editing products for human, plant, and animal DNA,

have applications in the pharma, agriculture, and aquaculture industries.

CRISPR-IL was funded by the IIA with a total budget of approximately

of which, an amount of approximately $480,000 was a direct grant allocated to us, for an initial period of 18 months, with a potential

for extension of an additional 18 months, or the Second Period, with additional budget from the IIA.

$10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for an initial period of 18 months, with

a potential for extension of an additional 18 months, with additional budget from the IIA.

In October 2021, we received

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In-House Clinical Manufacturing

We have the in-house capability

to perform clinical cell manufacturing.

Our state-of-the-art GMP grade manufacturing facility in Haifa has been in use since February

2013 for the main purpose of clinical grade, large-scale manufacturing.

The facility’s new automated manufacturing process and

products were approved for production of PLX-PAD for clinical use by the FDA, EMA, MFDS, PMDA and the MOH.

Our second product, PLX-R18,

was cleared by the FDA and the MOH for clinical use.

Furthermore, the site was inspected and approved by a European Union qualified person

(European accreditation body), approving that the site and production processes meet the current GMP for the purpose of manufacturing

clinical grade products.

The site was also inspected

and approved for a phase 3 PLX-PAD trial by the MOH, and we received a GMP Certification and manufacturer-importer authorization for

Since 2024, our CDMO has been

working with pharmaceutical and biotech companies to offer manufacturing and development services.

Based on 15 years of experience in

GMP manufacturing, our highly skilled team and utilizing our proprietary technologies and flexible 4400 square meter purpose-built facilities,

PluriCDMO™ can offer comprehensive manufacturing support from preclinical development, through clinical trials to commercial supply.

In January 2024, we announced that we are offering cell therapy

manufacturing services as a CDMO with the following key elements and services:

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

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.

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.

Since 2024, our CDMO has

been working with pharmaceutical and biotech companies to offer manufacturing, development and other services.

Based on over 15 years

of experience in GMP manufacturing, our highly skilled team and utilizing our proprietary technologies and flexible 4400 square meter

purpose-built facilities, PluriCDMO™ can offer comprehensive manufacturing support from preclinical development, through clinical

trials to commercial supply.

In January 2024, we

announced that we are offering cell therapy manufacturing services as a CDMO with the following key elements and services:

Process development and optimization;

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Analytical development and testing:

We offer a comprehensive range of on-site analytical capabilities, including methods development to meet characterization requirements, gap assessment, method transfer, and validation.

Additionally, we maintain well-established relationships with relevant audited vendors to further support our clients’ needs.

We offer a comprehensive range

of on-site analytical capabilities, including methods development to meet characterization requirements, gap assessment, method transfer,

and validation.

Additionally, we maintain well-established relationships with relevant audited vendors to further support our clients’

Government Regulation – Pharma

The development, manufacturing, and future marketing of our cell therapy

product candidates are subject to the laws and regulations of governmental authorities in the United States, Europe and Israel, as well

as other countries in which our products may be marketed in the future like Japan, and South Korea.

In addition, our manufacturing facility

was inspected by the MOH.

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 European Medicines Agency, or EMA, respectively, must approve products prior to marketing.

various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping

related to such products and their marketing.

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.

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Among these are:

Performance of nonclinical

laboratory and animal studies to assess a drug’s biological activity and 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, or GCP, to establish the safety and efficacy of

the product for its intended indication;

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.

Performance of nonclinical laboratory and animal studies to assess

a drug’s biological activity and 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;

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

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the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale:

Submission of an IND Application,

which must become effective before clinical testing in humans can begin;

Obtaining approval of Institutional

Review Boards, or IRBs, of research institutions or other clinical sites to introduce the drug candidate into humans in clinical

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;

FDA may grant priority

review status to expedite the BLA review process.

Obtaining a Fast Track designation allows access for the request of priority

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;

FDA inspection and approval

of the product manufacturing facility at which the product will be manufactured.

of an Investigational New Drug (“IND”) Application, which must become effective before clinical testing in humans can

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;

FDA may grant priority review status to expedite the BLA review

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;

FDA inspection and approval of the product manufacturing facility at

which the product will be manufactured.

The Regulatory Process in Europe

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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;

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 MAA.

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;

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 (“MAA”).

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 1

studies to late-stage large, Phase 3 studies, although the phases may overlap.

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

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These studies are designed to provide information about product

safety and dosage by gathering information on the drug interaction with the human body, its side effects as well as early preliminary

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.

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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 of efficacy,

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 profile 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.

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

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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 also

to submit in an expedited manner any individual serious adverse events that are suspected to be related to the tested drug and are unexpected

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.

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applicable to cultivated meat.

In the cultivated coffee space,

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, or GRAS, under section 201(s) of the Federal Food, Drug, and Cosmetic Act, or

FDCA, and FDA’s implementing regulations (21 C.F.R.

If the Coffeesai cultivated coffee product (including all of

its components) is 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.

Government Regulations-

Our CDMO business may be subject

to additional regulations, depending on the services we provide to companies under such

business division.

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, or GRAS, under section 201(s) of the Federal Food,

Drug, and Cosmetic Act, or FDCA, and FDA’s implementing regulations (21 C.F.R.

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.

Government Regulations- CDMO

Our CDMO business may be

subject to additional regulations, depending on the services we provide to companies under such business division.

As of June 30, 2025, we employed

a total of 127 full-time employees and 15 part-time employees, of whom 100 full-time employees and 11 part-time employees are engaged

in cell research, development, and manufacturing including clinical and regulation affairs, excluding Ever After Foods’ employees.

in cell research, development, and manufacturing including clinical and regulation affairs.

Regenerative medicine:

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are also being investigated in preclinical and clinical programs by others.

According to Alliance for

Regenerative Medicine Reports, as of June 30, 2023, there were a total of 1,197 developers of cell therapies, with 1,336 ongoing trials

registered globally.

74% of the total trials are focused on oncology research, and over 50% of the clinical trials are investigating CAR-T

therapy, with 157 trials focusing on solid tumors (Alliance for Regenerative Medicine Reports ARM).

According to GlobalData, clinicaltrial.gov,

in the global market excluding China, while most allogeneic cell therapies are still in the preclinical stage, approximately 20 allogeneic

CAR-T therapy products being studied for solid tumors have advanced into clinical stages, such as Adicet Bio’s allogeneic CD70-CAR

gamma-delta T cells, Artiva’s allogeneic HER2-NK cells, CiRA’s iPSC derived GPC3-CAR NK Cells, and Fate’s iPSC derived

HER2-CAR T cells, according to GlobalData;

to the Alliance for Regenerative Medicine’s July 2025 Report, there were a total of 2,096 cell-based therapies in development,

including 820 gene-modified and cellular immunotherapies, with 1,483 ongoing clinical trials registered globally, of which, 403 trials

were in solid tumors (Source:

ARM Report H1 2025 ).

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:

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.

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.

Ever After Foods operates

in a competitive landscape that includes both consumer-facing companies like Upside Foods, Believer Meats, and GOOD Meat, as well as B2B

players like Gelatex, Esco Aster, Ark Biotech, GEA and more.

Unlike traditional production technological approaches that rely on adapting

cells to grow in stirred tank bioreactors, Ever After Foods has a unique proprietary technology that is optimized for natural cell growth.

This allows EAF to produce cultivated meat at a significantly lower cost and on a larger scale.

Ever After Foods’ unique technology,

combined with an experienced team and strategic partnerships with industry leaders, provides us with a strong competitive advantage in

the cultivated food market.

in a competitive landscape that includes both consumer-facing companies like Upside Foods, Believer Meats, and GOOD Meat, as well as

B2B players like Gelatex, Esco Aster, Ark Biotech, GEA and more.

Unlike traditional technological production approaches that rely on

adapting cells to grow in stirred tank bioreactors, Ever After Foods has a unique proprietary technology that is optimized for natural

This allows Ever After Foods to produce cultivated meat at a significantly lower cost and on a larger scale.

Foods’ unique technology, combined with an experienced team and strategic partnerships with industry leaders, provides us with

a strong competitive advantage in the cultivated food market.

The AgTech industry continues

to evolve, driven by advancements in biotechnology, sustainability initiatives and transformation of traditional farming practices into

more efficient approaches.

Competitors in this domain include plant cellular companies producing natural ingredients from plant stem cell

culture such as California Cultured Inc.

and Ayana Bio LLC as well as plant-derived producers such as DSM Firmenich AG and Givaudan International

We believe that our ability to compete in the agtech space is derived from our technology platform capabilities and our innovative

developments.

Our ability to compete successfully will depend on our continued development of plant cellular products and our expansion

and improvement of our unique technological capabilities.

to evolve, driven by advancements in biotechnology, sustainability initiatives, and the transformation of traditional farming practices

into more efficient and environmentally responsible approaches.

Competitors in this domain include companies focused on plant cell culture

for specialty ingredients, such as California Cultured, Inc.

and Ayana Bio LLC, as well as established producers of plant-derived compounds

and flavors, including DSM Firmenich AG and Givaudan International SA.

We believe that our competitive positioning is derived from our

technology platform capabilities and our innovative developments.

We also believe that our ability to compete successfully will depend

on our continued innovation, the scalability of our production systems, and the consistent improvement of our unique technological capabilities.

As part of our AgTech operations,

we are currently advancing two principle product streams (which are also referred herein collectively as our plant-based vertical) -

cell-cultured coffee through Coffeesai, and cell-cultured cacao via Kokomodo, both leveraging our shared technological foundation and

competing in distinct markets with different dynamics.

Our proprietary 3D cell expansion platform, originally developed by our biotechnology

subsidiary, Pluri Biotech, enables efficient, high-volume, and consistent cultivation of plant cells in controlled environments.

that this platform provides meaningful advantages in scalability, cost-efficiency and product quality, positioning us to address critical

challenges in cellular agriculture that competitors often face in achieving industrial-scale production.

Coffeesai operates in the

emerging field of cell-cultured coffee, which currently includes a limited number of participants, such as California Cultured, Inc.,

Food Brewer AG, Another Food Pte.

Ltd., and Atomo Foods, Inc.

- each pursuing innovative approaches to sustainable coffee production.

Within this early-stage competitive landscape, we believe that Coffeesai differentiates itself through its integration of advanced scale-up

technology, proprietary bioprocessing expertise and deep scientific know-how, all of which contribute to an efficient, cost effective

and sustainable production model.

These capabilities, combined with potential partnerships across the coffee value chain, may offer Coffeesai

a strategic advantage in shaping the future of sustainable coffee.

Our cacao business, Kokomodo,

operates in a similarly dynamic and environment focused on cellular agriculture for cacao and cocoa-derived ingredients.

Current participants

in this space include Celleste Bio Ltd., California Cultured, Inc., and Food Brewer AG, all of which aim to develop alternatives to conventional

cacao cultivation in response to growing concerns about climate impact, supply volatility, and ethical sourcing.

Kokomodo seeks to differentiate

itself by leveraging the same advanced 3D cell expansion platform and bioprocess optimization strategies that underpin Coffeesai, enabling

the potential for consistent, large-scale production of high-quality cacao ingredients.

We believe that this combination of technological

innovation, process efficiency, and industrial scalability positions Kokomodo to play a significant role in the development of sustainable

solutions for the global chocolate industry.

We compete in the cell therapy

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The competition is driven

by geography location, relevant technologies, operational capacity, expertise in manufacturing techniques and price.

While there are multiple competitors

that compete in the CDMO services, 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.

by geographic location, technological capabilities, operational capacity, manufacturing expertise, and price.

While there are multiple

competitors that compete in the CDMO services, 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

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Available Information

Additional information

about us is contained on our Internet website at www.pluri-biotech.com.

Information on our website is not incorporated by reference

into this Annual Report.

Under the “Investors & ESG”- “Financial Reports” and “SEC Filings”

sections of our website, we make available free of charge 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, or the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish

it to, the SEC.

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, or 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 Investors & ESG” - Governance” section:

of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist Financing Compliance Policy,

Trading Policy, Clawback Policy and the Charters for each of the Committees of our Board of Directors, or the Board.

The following Corporate Governance documents are also posted on our website under the “Governance” subsection of the “Investors”

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”).

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business