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Item 1. Business

2024-09-18 compared with 2023-09-12 · 504 added, 571 removed, 337 unchanged (76% of the section changed)

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We are utilizing our technology in

the field of regenerative medicine and food tech and plan to utilize it in other industries and verticals that have a need for our mass

scale and cost-effective cell expansion platform.

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.

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.

We use our advanced cell-based

technology platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates for the treatment

of inflammatory, muscle injuries and hematologic conditions.

Our PLX cells are adherent stromal cells that are expanded using our 3D

Our PLX cells can be administered to patients off-the-shelf, without blood or tissue matching or additional manipulation

prior to administration.

PLX cells are believed to release a range of therapeutic proteins in response to the patient’s condition.

Our operations are focused

on the research, development and manufacturing of cells and cell-based products, conducting clinical studies and the business development

of cell therapeutics and cell-based technologies, such as our collaboration with Tnuva Food Industries – Agricultural Cooperative

in Israel Ltd., through its fully owned subsidiary, Tnuva Food-Tech Incubator (2019), Limited Partnership, or Tnuva, to use our technology

to establish a cultivated food platform, as well as the collaboration agreement we signed in 2022 with a leading European manufacturer

of active pharmaceutical ingredients, or APIs, to use our expansion technology, which aims to revolutionize the production of biologics

by enabling a cost-effective, sustainable and cruelty-free ingredient.

of inflammatory, muscle injuries, hematologic conditions and, most recently, we have also launched a novel immunotherapy platform.

cells are adherent stromal cells that are expanded using our 3D platform.

Our PLX cells can be administered to patients off-the-shelf,

without blood or tissue matching or additional manipulation prior to administration.

PLX cells are believed to release a range of therapeutic

proteins in response to the patient’s condition.

In the pharmaceutical area,

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is part of the NIH.

Pluri 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 its PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation

In the food tech field, we

established a new venture with Tnuva, Ever After Foods Ltd., or Ever After Foods, (previously Plurinuva Ltd.), which is incorporated under

the laws of the State of Israel.

Ever After Foods is developing cultivated meat products based on Pluri’s platform 3D cell expansion

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.

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.

Immunotherapy MAIT cells:

In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors

– a critical area in medicine where effective treatments are currently insufficient.

We believe that our MAIT cells, isolated from

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

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.

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.

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.

Scientific Background – Cell Therapy

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The characteristics and properties of cells vary as a function of tissue source and growth

The human placenta from which our PLX cells are derived provides a unique source of non-embryonic, adult cells and represents

an innovative approach in the cell therapy field.

The different factors that PLX cells release suggest that the cells can be used therapeutically

for a variety of ischemic, inflammatory, autoimmune and hematological deficiencies.

The human placenta, the source of our PLX and MAIT cells, provides a unique reservoir of stromal and immune cells representing

a groundbreaking approach in the field of cell therapy.

PLX, cells are placenta-derived,

mesenchymal-like adherent stromal cells that are expanded ex vivo.

The diverse factors released by PLX cells indicate their potential

therapeutic use across a range of ischemic, inflammatory, autoimmune and hematological conditions.

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 TCR, the MAIT cells minimizes 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, food, agricultural, and biologics.

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 implemented in the fields of regenerative medicine and food tech.

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

agtech and CDMO.

Our system utilizes a synthetic

scaffold to create an artificial 3D environment where cells can grow.

Our automated proprietary 3D, Current Good Manufacturing Practice,

or cGMP, approved process enables the large-scale monitored and controlled production of reproducible, high quality cell products and

scaffold to create a 3D environment where adherent or non-adherent cells can grow in a tissue like environment.

Our automated proprietary

3D, GMP, approved process enables the large-scale monitored and controlled production of reproducible, high quality cell products and

in mass quantities.

Additionally, our current manufacturing process, which has scaled up during the years, has demonstrated batch-to-batch

Additionally, our current manufacturing process, which has scaled up over the years, has demonstrated batch-to-batch

consistency, an important manufacturing challenge for biological products.

We developed a new cell manufacturing

process for industrial scale cell manufacturing called PluriMatrix, which we announced in April 2023, and which is built upon our platform

3D cell expansion technology, scaling high-quality cell production.

PluriMatrix is also used by Ever After Foods, for producing cultivated

Product Candidates

We believe that our technology

will continue to fuel medical research and develop pharmaceuticals, while also being used to potentially create novel cell-based solutions

for other innovative initiatives—such as food tech, cellular agriculture and biologics.

We aim to establish partnerships that leverage

our 3D cell-based technology to additional industries that require effective, mass cell production and will enable us to accelerate the

time to market.

Our primary objective is

to be the leading provider of allogeneic placenta-based cell therapy products that are true off-the-shelf products that do not require

any matching or additional manipulation prior to administration.

Currently, our PLX products are administered intramuscular, or IM, using

a standard needle and syringe.

Our first product candidate,

PLX-PAD, is composed of maternal mesenchymal stromal cell, or MSC, like cells originating from the placenta.

Our second product candidate,

PLX-R18, is composed of fetal MSC like cells originating from the placenta.

Modified PLX cells

As a platform technology

company, we are also developing additional product candidates, which are modified or induced PLX cells:

Induced PLX cells:

using cells from the placenta, induced with cytokines, to transiently alter their secretion profile.

Modified PLX cells using

CRISPR, or other gene editing technology:

CRISPR is a unique technology which allows precise gene editing of cells.

Using this technology,

we can initiate the next evolution in cell therapy by allowing the reprograming of cells for specific needs.

Our aim is to incorporate

the genetic engineering techniques into our cell manufacturing platform in order to develop large scale allogenic engineered PLX products

designed for specific indications.

We believe that using the

placenta as a unique cell source, combined with our innovative research, development and high-quality manufacturing capabilities, will

be the “engine” that drives this platform technology towards the successful development of additional PLX cell therapy products

and indications.

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

high-quality cell production.

We aim to establish partnerships

that leverage our 3D cell-based technology to additional industries that require effective, mass cell production and will enable us to

accelerate the time-to-market of our products.

Product Candidates - Pluri

PLX-PAD is composed of maternal

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

PLX-R18 is composed of fetal

MSC like cells originating from the placenta.

Allogeneic MAIT Cell Therapy Platform

MAIT cells are a distinct

type of unconventional immune T cells.

Their unique characteristics, including robust cytotoxic activity and low alloreactivity profile,

make them promising candidates for engineering and subsequent use in the treatment of solid tumors in the setting of allogeneic adoptive

cell therapy.

We believe that leveraging

the placenta as a unique source of cells, combined with our cutting-edge research, development and established high-quality manufacturing

capabilities, will serve as the driving force towards the successful development of a broader range of cell therapy products and applications.

Our Clinical Development Product Candidates

Orthopedic Indications .

Following U.S.

Food and Drug Administration, or FDA, and European Medicine Agency, or EMA, clearance, a multinational Phase III study

was conducted and completed in the United States, Europe and Israel.

The primary endpoint of this study was the Short Physical Performance

Battery, or SPPB, a test for lower limb performance and functional status.

We completed enrollment of 240 patients and the study was designed

to assess the efficacy at six months and a year, as well as safety for up to two years.

On July 13, 2022, we announced

topline results from our Phase III study of muscle regeneration following hip fracture surgery.

PLX-PAD was demonstrated to be an effective

accelerator of muscle strength and regeneration.

A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week

52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to

placebo (n=120).

The study did not meet the primary endpoint, which was the SPPB test at week 26.

On October 26, 2022, a 52-week follow

up of all patients was completed.

Our Phase III study protocol

and design was based on our phase I/II, randomized, double-blind, placebo-controlled study (n=20) to assess the safety and efficacy of

IM injections of allogeneic PLX-PAD cells for the regeneration of injured gluteal musculature after total hip replacement had been conducted

in Germany under the approval of Paul Ehrlich Institute, or PEI.

In this study, PLX-PAD cells or placebo were administered into the traumatized

gluteal muscle during total hip replacement surgery.

The study results met its primary efficacy endpoint, change in maximal voluntary

isometric contraction force of the gluteal muscle at six months after total hip replacement.

Patients treated with PLX-PAD had a significantly

greater improvement of maximal voluntary muscle contraction force than the placebo group (p=0.0067).

In addition, the study demonstrated

that PLX-PAD was safe and well tolerated by patients.

COVID-19 Complicated by

Acute Respiratory Distress Syndrome, or ARDS .

In May 2020, the FDA cleared our Investigational New Drug Application, or IND, for

a Phase II study of our PLX-PAD cells for treatment of severe COVID-19 cases complicated by ARDS and we initiated the study in June 2020.

study is a randomized, double-blind, placebo-controlled, multicenter, parallel-group intended to evaluate the efficacy and safety

of IM injections of PLX-PAD for the treatment of severe COVID-19 cases complicated by ARDS.

The primary endpoint is the number of ventilator

free days, or VFD, from day 1 through day 28 of the study.

Secondary efficacy endpoints include all-cause mortality, duration of mechanical

ventilation, intensive care unit, or ICU, free-days, and hospitalization free-days.

Safety and survival follow-up will be conducted until

In addition, the FDA has cleared our Expanded Access Program, or EAP, for the use of our PLX-PAD cells to treat ARDS caused

by COVID-19 outside of the Phase II COVID-19 complicated by ARDS study in the United States.

The EAP approval was for up to 100 patients.

In August 2020, the PEI cleared

our Phase II study in Germany titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy

and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19,” relating to the treatment of patients

hospitalized with severe cases of COVID-19 complicated by ARDS.

The primary efficacy endpoint of the study is the number of ventilator

free days during the 28-days from day one through day 28 of the study.

Secondary efficacy endpoints include all-cause mortality, duration

of mechanical ventilation, ICU free-days, and hospitalization free-days.

Safety and survival follow-up will be conducted until week 52.

We enrolled patients in Europe and Israel under this protocol.

On July 8, 2021, we announced

that we were bringing our COVID-19 complicated by ARDS Phase II studies in the United States, Europe and Israel to clinical readout.

The analysis was based on 89 patients enrolled.

On December 27, 2021, we

announced topline results for our COVID-19 studies based on 89 patients enrolled.

The studies did not meet the primary efficacy endpoint

of statistically significant improvement of VFD at 28 days.

Taking into consideration the baseline risk factors of the ARDS patients,

no differences in the safety profile were observed between PLX-PAD and placebo.

The U.S., Europe, and Israel studies are complete and

the clinical study reports have been submitted to the relevant regulatory agencies.

Recovery Following HCT .

This Phase I study of PLX-R18 in HCT was completed in the United States and Israel.

The study assessed the safety of PLX-R18 by assessing

adverse events, safety labs and vital signs in patients receiving different doses of PLX-R18.

One year follow up for all patients was

completed in September 2021 and the results of the study were announced on March 23, 2022.

PLX-R18 was well-tolerated with a favorable

safety profile.

Patients treated with PLX-R18 showed a mean increase in all three blood cell types compared to baseline with platelets

(p<0.001), hemoglobin (p=0.01) and neutrophils (p=0.15) levels increasing as early as 1 month following PLX-R18 administration and

enduring up to 12 months following treatment.

Additionally, the number of transfused units decreased from a mean monthly number of 5.09

for platelets and 2.91 for red blood cells at baseline to 0.55 for platelets (p=0.045) and 0 for red blood cells (p=0.0005) at 12 months.

Peripheral and Cardiovascular

We investigated the use of PLX-PAD cells for the treatment of peripheral arterial disease, or PAD, including intermittent

claudication, or IC, and CLI.

We completed two Phase I safety/dose-escalating clinical studies for CLI, one in the United States and

one in Germany.

These CLI studies demonstrated that no blood type or human leukocyte antigen matching is required, and that the administration

of PLX-PAD cells is safe, even if two doses are administered to a patient on two different occasions.

We completed a Phase II study in

IC which was conducted in the United States, Germany, South Korea and Israel.

A total of 172 patients were treated in this study.

administration of PLX-PAD cells was concluded to be safe and well tolerated.

We completed a pivotal Phase III study of PLX-PAD cells

in the treatment of CLI for patients with minor tissue loss (Rutherford Category 5) who are unsuitable for revascularization.

This multinational

Phase III study was conducted in the United States, Europe and Israel and enrolled 213 patients in total.

In December 2020, the independent

Data Monitoring Committee, or DMC, issued its recommendation letter following an interim analysis relating to the CLI Phase III study.

A clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined

as time to occurrence of major amputation of the index leg or death.

Based on the review, the DMC concluded that the CLI study was unlikely

to meet the primary endpoint by the time of the final analysis.

Following the DMC’s recommendation, we decided to terminate the

On July 11, 2023,

Both PLX-PAD and PLX-R18 products were tested

in clinical studies.

Studies were conducted in the United States, Europe and Israel

PLX-PAD was tested

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.

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.

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 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 USUHS to further advance the development of its PLX-R18 cell therapy as a potential novel

treatment for H-ARS.

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.

The period of performance

of this contract will be from July 1, 2023 through June 30, 2024, which may be extended for an additional two year period.

Before signing the contract,

we conducted several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with NIAID.

The NIH funded and conducted

a pilot study in non-human primates, or NHPs, to evaluate the therapeutic effect of PLX-R18 on hematological aspects of ARS.

we announced results of the NHPs pilot study for PLX-R18 as a treatment for ARS.

Although study size was not designed to show significance,

results showed a trend toward improved survival of PLX-R18 treated animals compared to control, placebo treated animals.

The study, conducted

and funded by the NIAID, was designed to assess the safety and efficacy of PLX-R18 following IM injection into irradiated and non-irradiated

Efficacy measures included survival as well as hematological parameters which are affected by exposure to high levels of radiation

as may occur in a nuclear accident or attack.

These data will help the design of a pivotal study to fulfill the requirements for a Biologics

License Application, or BLA, submission under the FDA’s Animal Rule regulatory pathway.

In October 2017, we announced

that the FDA granted us an orphan drug designation for our PLX-R18 cell therapy for the prevention and treatment of ARS.

In April 2018,

we announced that the FDA approved our Investigational New Drug, or IND, application for PLX-R18 cell therapy in the treatment of ARS.

The IND allows us to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.

2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD Armed Forces Radiobiology

Research Institute, part of the USUHS.

The studies were designed to evaluate PLX-R18 as a potential prophylactic countermeasure against

ARS administered prior to radiation exposure.

These animal studies demonstrate that PLX-R18, administered 24 hours before radiation exposure,

and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to

74% in the treated group.

In addition, the data show an increase in recovery of blood lineages and a favorable safety profile.

histopathological analysis and hematopoietic progenitor clonogenic assay of tissues collected show a significant increase in bone marrow

cell numbers and improved regenerative capability into all blood lineages.

Steroid-Refractory cGVHD .

In September 2017, we signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II clinical study

of PLX-PAD cell therapy for the treatment of Steroid-Refractory cGVHD.

This study is an investigator-initiated study.

As such, Tel Aviv

Sourasky Medical Center supports the study and is responsible for its design and implementation.

17 patients have been treated in this

study to date.

On June 6, 2024, NIAID

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

Prior to signing the contract

with NIAID, we conducted several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with NIAID and

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

Regulatory and Clinical Affairs Strategy

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Our Activities in the Food Tech Sector - Ever

On January 5, 2022, we signed

definitive collaboration agreements with Tnuva through the Subsidiary.

Under the definitive collaboration agreements, or the Joint Venture

Agreement, we established a new company, Ever After Foods, with the purpose of developing cultivated meat products of all types and kinds.

Ever After Foods is engaged in the development, manufacturing and commercialization of technology, know-how and products that will be

based on licensed products, or the Licensed Products, relating to the field of cultivated meat, or the Field.

Pursuant to the Joint Venture

Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Ever After Foods and the Subsidiary, pursuant to which Ever

After Foods issued on the closing date of the SPA, or the Closing Date, 187,500 ordinary shares, representing 15.79% of its share capital,

to Tnuva, as well as a warrant to purchase additional shares of Ever After Foods, in consideration of an aggregate of $7.5 million in

cash, which expired unexercised.

In December 2022, we reported

that our joint venture successfully completed proof of concept in its development of cultivated meat based on our cell-based technology

Ever After Foods is also using PluriMatrix for producing cultivated meat.

Technology Collaboration the Biologics

In September 2022, we entered

into a collaboration agreement, or API Collaboration, with a leading European manufacturer of APIs, among others, used to treat liver

diseases and gallstones.

As part of our collaboration, we utilize our platform to develop and manufacture a unique biologic API.

current source of this API is derived from animals that are sacrificed during the extraction process.

The joint goal of the collaboration

is to grow the specific cells needed for this API in our 3D cell expansion bioreactor systems which in return will secrete the biological

molecule without harming animals.

As of June 30, 2023, we recorded revenues of $270,000 related to API Collaboration.

We believe that proof of

concept with API derived from animals will open opportunities for us to serve additional API manufacturers in the rapidly growing biologics

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.

Ever After Foods’ Key

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.

By combining cutting-edge

technology, a talented team, and strategic partnerships, we believe that Ever After Foods is poised to revolutionize the food industry

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

Our Activities in the Ag-tech Sector

In January 2024, we announced

the launch of our cell-based coffee business activity through a new business vertical, PluriAgtech, leveraging Pluri’s 3D cell

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 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.

Intellectual Property

We understand that our success

will depend, in part, on maintaining our intellectual property, and therefore we are committed to protecting our technology and product

candidates with patents and other methods described below.

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 are the sole owner of

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applications includes the following claims:

proprietary 3D expansion methods for adherent cells including placental stromal

cells plant cells;

● composition

of matter claims covering the cells;

proprietary 3D expansion methods for cells in suspension including immune cells;

therapeutic and cosmetic use of PLX cells for the treatment of a variety of conditions;

● cell-culture,

harvest, thawing and formulation devices.

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

1 unchanged sentence

for manufacturing clinical-grade PLX cells in our facilities.

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, 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.

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,

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

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federal law and therefore only relevant to U.S.

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”

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.”

Our Patent Portfolio

Patent Name/ Int.

Jurisdictions

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PCT/IL2007/000380

Australia, Canada, China, Hong Kong, Europe, Israel, India, Japan, South Korea, Mexico, Russia,

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

March 23, 2027

2 unchanged sentences

United States

Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Mexico, Russia, 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

September 2, 2028

4 unchanged sentences

PCT/IL2009/000844

Europe, Israel

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

September 1, 2029

1 unchanged sentence

PCT/IL2009/000846

Australia, Canada, China, Europe, 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

1 unchanged sentence

PCT/IL2009/000845

United States, Europe, Israel

United States, Europe (Switzerland, Germany, France,

United Kingdom), Israel

September 1, 2029

6 unchanged sentences

United States, Israel

Australia, Canada, China, Hong Kong, Europe, Israel, Mexico, New Zealand, United States

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

Germany, Spain, France, United Kingdom, Italy, Belgium, Ireland, The Netherlands), Israel, Mexico, New Zealand, 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, Israel, India, South Korea, Mexico, Singapore, United

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

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

April 15, 2032

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United States

Europe, 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

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PCT/EP2011/058730

United States, Europe, Israel

United States, Europe (Belgium, Switzerland, Germany,

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

GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL

5 unchanged sentences

PCT/IB2013/058186

China, Hong Kong, Europe, Israel, Japan, South Korea, United States

Japan, Belgium, France, Italy, Switzerland, United

Kingdom, Germany, China, Hong Kong

August 31, 2033

1 unchanged sentence

PCT/IB2013/059808

Australia, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Russia, Singapore, United

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

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PCT/IB2016/051585

Israel, United States

March 21, 2036

1 unchanged sentence

PCT/IB2016/053310

Europe, United States, Israel

United States

METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS

PCT/IB2017/050868

Europe, Japan, Israel

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

Japan, Israel

February 16, 2037

1 unchanged sentence

PCT/IB2018/052806

Israel, United States

April 23, 2038

4 unchanged sentences

PCT/IB2018/055473

Israel, United States

July 23, 2038

4 unchanged sentences

PCT/IL2020/050477

Canada, Europe, Hong Kong, Israel, Japan, United States

United States

April 28, 2040

6 unchanged sentences

PCT/IB2019/055074

Israel, United States

Israel, United States, Singapore

June 18, 2039

11 unchanged sentences

PCT/IB2019/058429

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

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

United States

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,

Israel, Mexico

First Israeli application:

Other applications:

March 11, 2040

2 unchanged sentences

PCT/IL2020/050363

United States, Europe,

Canada, China, Israel, Australia

United States

March 26, 2040

8 unchanged sentences

PCT/IL2022/050937

Patent Cooperation Treaty, or PCT

Patent Cooperation Treaty, or PCT, United States

August 29, 2042

2 unchanged sentences

PCT/IL2023/050529

PCT, United States

PCT, Israel, South Korea, United States

A System For 3D

Cultivation of Plant Cells And Methods Of Use

United States

April 28, 2040

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

PCT/IL2024/050278

PCT, United States, Israel

March 18, 2044

GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT

T (MAIT) CELLS AND USES THEREOF

PCT/IL2024/050675

United States

GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT

T (MAIT) CELLS AND USES THEREOF

PCT/IL2024/050670

On January 8, 2022, we entered

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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, EP3103463, and 3091071), 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.

(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

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

In April 2016, the Subsidiary

entered into a licensing agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to obtain a key

patent in Japan to cover the treatment of ischemic diseases with placental cell therapy.

This license is subject to future single low-digit

royalties from sales of our product for treatment in the field of ischemic diseases in Japan, until expiry of the patent in 2023.

license is in addition to the grant of 13 patents to us by the Japanese Patent Office, which address 3D methods for expanding placental

and adipose cells, and specified cell therapies produced from placental tissue using these methods and bedside thawing devices.

in Japan expired in March 2023;

and therefore, the licensing agreement expired.

Research and Development

Foundational Research

Our initial technology, the

PluriX™ Bioreactor system, was invented at the Technion – Israel Institute of Technology’s Rappaport Faculty of Medicine,

in collaboration with researchers from the Weizmann Institute of Science.

This technology was acquired by us and has been further significantly

developed by our research and development teams over the ensuing years.

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.

Ongoing Collaborations

EIB Agreement

April 2020, we and our subsidiaries, Pluri Biotech Ltd.

and Pluristem GmbH, executed a finance agreement executed with the EIB, or the

EIB Finance Agreement, for non–dilutive funding of up to €50 million in the aggregate, payable in three tranches.

from the EIB Finance Agreement were intended to support our research and development in the EU to further advance our regenerative cell

therapy platform, and to bring the products in our pipeline to market.

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.

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As of June 30, 2024, the interest accrued

was in the amount of €1,665,000.

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

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 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.

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.

Charité Agreement

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

Pluri 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 will be from July 1, 2023 through

June 30, 2024, which may be extended for additional two years period.

If at any time during performance

of this contract, the contracting officer determines, in consultation with the Office of Laboratory Animal Welfare (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.

Fukushima Medical University

We signed a memorandum of

understanding for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center, or Fukushima.

of the collaboration is to develop our PLX-R18 cells for the treatment of ARS, and for morbidities following radiotherapy in cancer patients.

The collaboration will proceed alongside research supported by the NIH, which is studying PLX-R18 as a potential treatment for the hematologic

component of ARS.

The MOU for a collaboration with Fukushima will be renewed automatically on a yearly basis.

Each party is entitled

to terminate the agreement for convenience upon providing the other party 30 days prior notice.

CHA Agreement

On June 26, 2013, we entered

into an exclusive out-licensing and commercialization agreement, or the CHA Agreement, with CHA Biotech for conducting clinical studies

and commercialization of our PLX-PAD product candidate in South Korea in connection with two indications:

the treatment of CLI and IC.

We will continue to retain rights to our proprietary manufacturing technology and cell-related intellectual property.

The first clinical study

that was performed as part of the CHA Agreement was a Phase II study in IC.

Upon the first regulatory approval for a PLX product in South

Korea, if granted, for the specified indications, we and CHA will establish an equally owned joint venture with the purpose of commercializing

PLX cell products in South Korea.

Additionally, we will be able to use the data generated by CHA to pursue the development of PLX product

candidates outside of South Korea.

The term of the CHA Agreement

extends from June 24, 2013 until the later of the expiration, lapse, cancellation, abandonment or invalidation of the last valid patent

claim covering the development of the product indications.

The CHA Agreement contains customary termination provisions, including in

the event that the parties do not reach an agreement upon a development plan for conducting the clinical studies.

Upon termination of the CHA

Agreement, the license granted thereunder will terminate, and all rights included therein will revert to us, whereupon we will be free

to enter into agreements with any other third parties for the granting of a license in or outside South Korea or to deal in any other

manner with such rights as it shall see fit in our sole discretion.

The Phase III study of PLX-PAD

in CLI was conducted as a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative

Therapies, together with the Company and with the participation of additional third parties.

Our Phase III study of PLX-PAD

cell therapy in the treatment of muscle recovery following surgery for hip fracture is a collaborative project carried out by an international

consortium led by Charité, together with us and with the participation of additional third parties.

In October 2017, we entered

into a collaborative project, the nTRACK, carried out by an international consortium led by Leitat Technological Center.

The aim of this

project is to examine gold nano particles labeling of stem cells to enable assessment of cells’ in vivo persistence and distribution

in correlation to biological efficacy.

Under the project, PLX cells, labeled and non-labeled will be characterized and examined in animal

models for muscle injury.

All of our collaborative projects

under the Horizon 2020 program ended as of June 30, 2023.

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

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.

Horizon Europe - PROTO

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Center for Regenerative Therapies.

The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIA study for the treatment

of mild to moderate knee osteoarthritis.

Final approval of the grant is subject to completion of the consortium and Horizon Europe grant

agreements, or Horizon Europe.

The funds from the grant are expected to be allocated between us and other members of the consortium in

accordance with budget and work packages which will be determined by the consortium.

The Phase I/IIa study will

be carried out by Charité.

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

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Surgery will be carrying out the study.

Indiana University

In April 2018, NIAID awarded

a $2.5 million grant to Indiana University to conduct, together with us, studies of our PLX-R18 cell therapy in the treatment of ARS.

The goal of this project is to extend the PLX-R18 ARS studies to include examination of survival in pediatric and geriatric populations

as well as the ability of PLX-R18 to alleviate delayed effects of radiation in survivors.

The grant period ended during fiscal year 2023.

Chart Industries

In November 2018, we entered

into a license agreement with a subsidiary of Chart Industries, Inc., or Chart, regarding our thawing device for cell-based therapies.

Pursuant to the terms of the agreement, Chart obtained the exclusive rights to manufacture and market the thawing device in all territories

worldwide, excluding Greater China, and we are to receive royalties from sales of the product and supply of an agreed upon number of thawing

Royalties shall commence on the date of Chart’s first commercial sale of the thawing device.

As of the date of this annual

report, we have not received any royalties from Chart that relate to the sale of the thawing device.

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.

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 June 2020, we announced

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in the pharma, agriculture, and aquaculture industries.

CRISPR-IL is funded by the IIA with a total budget of approximately $10,000,000

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

5 unchanged sentences

program which ended on June 30, 2023, does not require us to pay royalties to the IIA.

United Arab Emirates-based Abu Dhabi Stem Cells

In August 2020, we signed

a non-binding MOU with the United Arab Emirates-based Abu Dhabi Stem Cells Center, a specialist healthcare center focused on cell therapy

and regenerative medicine.

The aim of the collaboration is to capitalize on each party’s respective areas of expertise in cell

The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential

activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions.

In-House Clinical Manufacturing

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to perform clinical cell manufacturing.

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

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.

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The site was also inspected

and approved by the MOH and we received a cGMP Certification and manufacturer-importer authorization.

We obtain the human placentas

used for our research and manufacturing activities from various hospitals in Israel after receiving a written informed consent by the

mother and pathogen clearance.

Any medical waste related to the use of placentas is treated in compliance with local environmental laws

and standards.

We have developed a serum-free

formulation to support the manufacturing of our cell therapy products.

This serum-free formulation was developed using our deep understanding

in cell therapy industrial scale production standards, and the quality methods designed to support implementation in Phase III development

and marketing.

Achieving this significant technological challenge is expected to provide us with large-scale, highly consistent production

capacity with operational independency from third party suppliers for standard serum, an expensive and quantity limited product.

is the first product candidate manufactured using the serum-free media.

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:

Process development and optimization;

Manufacturing from preclinical stages to commercial stages;

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.

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

In addition, the manufacturing conditions are specifically inspected by the MOH.

Union, the FDA and the European Medicines Agency, or 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.

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.

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.

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 cGMP 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, 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.

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 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 process.

Obtaining a Fast Track designation allows access for 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.

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.

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.

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.

In May 2015, we were selected

by the EMA for development of PLX-PAD cells via the EMA Adaptive Pathways Project.

Government Regulations - Food Tech

Regulators around the world

are in the process of developing a regulatory approval process for cultivated meat.

Although some companies have recently brought their

cultivated meat products to market in the United States, cultivated meat is not yet generally commercially available, but technologies

like the one being developed by Ever After Foods are anticipated to facilitate the imminent scaling up of cultivated meat production.

In general, cultivated meat production is subject to extensive regulatory laws and regulations in the United States and in other jurisdictions

such as Canada, Japan, the European Union and the United Kingdom.

The FDA and the U.S.

Department of Agriculture, or USDA, will be issuing

additional guidance and regulations applicable to cultivated meat.

Additional details are being developed at the FDA and the USDA, pursuant

to a Memorandum of Understanding, or MOU, published by the FDA and USDA on March 7, 2019 entitled the “Formal Agreement to Regulate

Cell-Cultured Food Products from Cell Lines of Livestock and Poultry.”

Under the MOU, which is expected

to affect Ever After Food’s future customers producing cultivated meat, the two agencies will operate under a joint regulatory framework

wherein the FDA will oversee cell collection, cell banks and cell growth and differentiation.

A transition from FDA to USDA oversight

will then occur during the cell harvest stage, at which point the USDA will oversee the production and labeling of cultivated meat.

USDA will be advancing new labeling requirements.

To the best of our knowledge, the regulatory approval details under development, including

the draft guidance on FDA premarket oversight, might apply to our business directly, but they are instructive as to the regulatory requirements

that our cultivated meat production customers are expected to face and their expectations of us, in the form of customer assurances, regarding

our products.

In the United States, companies

manufacturing cultivated meat products are subject to regulation by various government agencies, including the FDA, USDA, and the U.S.

Federal Trade Commission, or FTC.

Equivalent foreign regulatory authorities include the Canadian Food Inspection Agency, the Japanese

Food Safety Commission, the European Food Safety Authority and authorities of the EU member states, the State Food and Drug Administration

of China and the SFA.

These agencies, among other things, prescribe the requirements and establish the standards for food quality and

safety, and regulate various food technologies, including alternative meat product composition, ingredients, manufacturing, labeling and

other marketing and advertising to consumers.

We expect that federal, state and foreign regulators

will have the authority to inspect our customers’ facilities to evaluate compliance with applicable food safety requirements.

state and foreign regulatory authorities also require that certain nutrition and product information appear on the product labels of

our customers’ food products and, more generally, that such labels, marketing and advertising be truthful, non-misleading and not

deceptive to consumers.

As the cell-based agriculture

industry is still developing, and its regulatory framework is emerging and evolving, legislation and regulation may evolve to raise barriers

to our go-to-market strategies.

In addition to federal regulatory

requirements in the United States, certain states impose their own manufacturing and labeling requirements.

For example, states typically

require facility registration with the relevant state food safety agency, and those facilities are subject to state inspections as well

as federal inspections.

Further, states can impose state-specific labeling requirements.

In the United States, the USDA will be developing

new labeling requirements for foods under its jurisdiction produced through cell culture technology as noted in an Advance Notice of Proposed

Rulemaking, or ANPR, published in September 2021.

We are subject to labor and employment laws,

laws governing advertising, privacy laws, safety regulations and other laws, including consumer protection regulations that regulate

retailers or govern the promotion and sale of merchandise.

Our operations are subject to various laws and regulations relating to environmental

protection and worker health and safety matters.

We monitor changes in these laws and believe that we are in material compliance with

applicable laws.

Clinical Studies

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have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.

Government Regulations - Food Tech

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, or USDA, are in the process of developing guidance and regulations

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.

As of June 30, 2024, we employed

a total of 123 full-time employees and 11 part-time employees, of whom, 97 full-time employees and 9 part-time employees are engaged in

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

a total of 106 full-time employees and 12 part-time employees, of whom, 82 full-time employees and 9 part-time employees are engaged

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

Regenerative medicine:

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

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 such as Athersys Inc., Celularity Inc., Tigenix NV (acquired by Takeda), SanBio Inc.

Mesoblast Ltd.

Among other things, we expect to compete based upon our intellectual property 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.

Given the magnitude of the potential opportunity for cell therapy, we expect competition in this area to intensify.

Competitors in the cultivated

meat domain include both producers of consumer-end-products, as well as those developing inputs for the production process.

Foods competes with companies that include Upside Foods, Believer Meats, GOOD Meat, Mosa Meat, Aleph Farms, Stakeholder 3D and Gourmey.

We believe that our ability

to compete in the cultivated food field will derive from our experienced team, our unique 3D technology platform, and our industrial

scale in-house GMP, cell manufacturing facility, together with our partner, Tnuva, which has vast experience in the food industry.

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;

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.

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.

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.

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 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.

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.

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”, under the “Investors” and “Media” 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.

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:

Code of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist

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

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.

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.

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