What changed in this filing

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Item 1. Business

2023-09-12 compared with 2022-09-21 · 569 added, 526 removed, 339 unchanged (76% of the section changed)

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of inflammatory, muscle injuries and hematologic conditions.

Our placental expanded, or PLX, 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.

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 recent collaboration with Tnuva Food Industries – Agricultural Cooperative

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.

We expect to demonstrate a

real-world impact and value from our cell-based technology platform, our current PLX pipeline and from other cell-based product candidates

that may be developed based on our platform.

Our business model for commercialization and revenue generation includes, but is not limited

to, licensing deals, joint ventures, partnerships, joint development agreements and direct sale of our products.

We are now completing a multinational

Phase III clinical study in muscle recovery following surgery for hip fracture, with sites in the United States, Europe and Israel.

the last year, we have completed a Phase II clinical study in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 and

a Phase I clinical study for incomplete recovery following bone marrow transplantation.

Additional areas of focus for clinical development

include an investigator-led Phase I/II Chronic Graft versus Host Disease, or cGVHD, study in Israel, and an Acute Radiation Syndrome,

or ARS, program under the U.S.

Food and Drug Administration, or FDA, animal rule.

We believe that each of these indications represents

a severe unmet medical need.

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.

In the pharmaceutical area,

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.

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, previously named Pluristem Ltd., 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.

In January 2022, the Subsidiary established an additional subsidiary, Plurinuva

Ltd., or Plurinuva, which is incorporated under the laws of Israel, which followed the execution of the collaboration agreement with Tnuva

On July 26, 2022, we completed

our legal entity name change from Pluristem Therapeutics Inc.

to Pluri Inc., by merging a wholly-owned

subsidiary with and into the Company, with us being the surviving corporation.

The name change reflects a broader strategy of leveraging

our 3D cell expansion technology to develop innovative cell-based products that can be harnessed for a range of fields beyond medicine,

providing solutions for various areas of life.

Effective July 26, 2022, our Nasdaq ticker symbol was changed to “PLUR.”

Scientific Background

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.

Scientific Background – Cell Therapy

Cell therapy is an established

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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 an uncontroversial 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.

PLX cells exhibit low immunogenicity,

thus do not require tissue matching prior to administration, which allows the development of ready-to-use / “off-the-shelf”

allogeneic products.

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.

Our Technology

Our PLX cells are adherent

stromal cells that are expanded using a proprietary three-dimensional, or 3D, process.

This system utilizes a synthetic scaffold to create

an artificial 3D environment where placental-derived stromal cells can grow.

Our automated proprietary 3D, cGMP approved, process enables

the large-scale monitored and controlled production of reproducible, high quality cell products and can manufacture a large number of

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

an important manufacturing challenge for biological products.

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 initiatives, including, but not limited

to, pharmaceuticals, climate change, food security and animal welfare.

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

consistent from batch to batch.

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 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 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

in mass quantities.

Additionally, our current manufacturing process, which has scaled up during 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

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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, agri-tech, and biologics.

We aim to establish partnerships that leverage our

3D cell-based technology to additional industries that require effective, mass cell production.

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.

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

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Our first product candidate,

PLX-PAD, is composed of maternal cells originating from the placenta.

PLX-PAD is used in a Phase III multinational clinical study in recovery

following surgery for hip fracture.

PLX-PAD is also under clinical

development in collaboration with Tel Aviv Sourasky Medical Center (Ichilov Hospital) through an investigator-initiated Phase I/II study

for the treatment of Steroid-Refractory cGVHD.

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 cells originating from the placenta.

We have completed our first

in human Phase I clinical study in incomplete hematopoietic recovery following hematopoietic cell transplantation, or HCT, in the United

States and Israel.

Through our collaboration

in the United States with the National Institutes of Health, or NIH, and the U.S.

Department of Defense, or DoD, we are also developing

a solution for ARS following or before exposure to massive radiation via the FDA Animal Rule regulatory pathway.

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

Modified PLX cells

In the last decade, we developed

an allogeneic platform based on cells originated from the fetal and maternal cell from the placenta, and by using this platform we can

produce large quantities of high-quality cells in automated and robust manufacturing process suitable for cGMP environment.

As a platform

technology company, we are currently developing additional product candidates, which are modified or induced 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:

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

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.

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Orthopedic Indications .

Following FDA and European Medicine Agency, or EMA, clearance, a multinational Phase III study is currently being conducted in the United

States, Europe and Israel.

The primary endpoint of this study is the Short Physical Performance Battery, or SPPB, a test for lower limb

performance and functional status.

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.

July 13, 2022, we announced topline results from our Phase III study of muscle regeneration following hip fracture surgery.

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).

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.

The study will continue to follow up with patients for up to 52 weeks for safety and other efficacy measures.

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 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.

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

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,

ICU free-days, and hospitalization free-days.

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

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.

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.

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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.

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.

patients in Europe and Israel under this protocol.

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.

analysis was based on 89 patients enrolled.

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.

study was recently completed,

and the second study conducted in Europe and Israel is planned for completion during the third calendar quarter of 2022.

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 .

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Peripheral and Cardiovascular

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

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.

IM 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 CLI study.

We have conducted

several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with the National Institute of Allergy

and Infectious Diseases, or the 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.

In 2017, we announced results of the NHPs pilot study for PLX-R18 as a treatment for

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 NHPs.

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.

We plan to continue the discussions

with the different government agencies with the goal of receiving their support for pivotal studies in NHPs as well as conducting the

safety studies required in order to file a BLA for this indication.

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,

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.

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 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.

In July 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 Uniformed Services

University of Health Sciences.

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 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.

Furthermore, 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.

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 .

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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 MOH, Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, and also the Ministry of Food and Drug Safety,

or MFDS, of South Korea.

Our Activities in the Food Tech Sector

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.

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, Plurinuva, with the purpose of developing cultivated

meat products of all types and kinds.

Plurinuva is intended to be 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

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 Plurinuva and the Subsidiary ,

pursuant to which Plurinuva 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 Plurinuva, in consideration of an aggregate of $7.5

million in cash.

In addition, pursuant to the SPA, in the event the Company decides to use its technology for the development of cultivated

milk or fish products, Tnuva shall also have the right, for a period of seven years following the Closing Date, to participate in the

formation of additional separate joint ventures for the development of those products.

The first warrant, or the

First Warrant, issued to Tnuva permits Tnuva to purchase up to 125,000 ordinary shares of Plurinuva at an exercise price of $40.00 per

share and has a term commencing on the Closing Date and ending at the earlier of (i) six months from the Closing Date, (ii) immediately

prior to and subject to the consummation of an initial public offering or acquisition of Plurinuva or (iii) the consummation of a financing

round with a non-affiliated investor.

In addition, on the six month anniversary of the Closing Date, and provided that the First Warrant

has not expired, Plurinuva shall issue to Tnuva a second warrant, or the Second Warrant, which will permit Tnuva to purchase up to a number

of ordinary shares of Plurinuva, or the then most senior securities issued by Plurinuva, in consideration for such amount equal to 200%

of the remaining balance of the aggregate purchase price of the First Warrant, provided that Tnuva exercises at least 62,500 ordinary

shares at a price per share of $40.00, or $2,500,000 in the aggregate, of the First Warrant.

The Second Warrant’s exercise price

per share equals $76.00.

The Second Warrant has a term commencing on the six months anniversary of the Closing Date and ending at the

earlier of (i) six months from its issuance, (ii) immediately prior to and subject to the consummation of an initial public offering or

acquisition of Plurinuva or (iii) the consummation of a financing round with a non-affiliated investor.

On August 23, 2022, the First

Warrant was extended for an additional 90-day period, so that the exercise period will end on November 22, 2022.

February 24, 2022, we announced the closing of the Joint Venture Agreement and the SPA, and on March 8, 2022, we announced the appointment

of Eyal Rosenthal as Chief Executive Officer of Plurinuva .

Prior to the Closing Date,

the Subsidiary and Plurinuva also executed a technology license agreement, or the License Agreement, and on the Closing Date, the Subsidiary

and Plurinuva executed a transitional services agreement, or the Services Agreement.

Pursuant to the License Agreement, the Subsidiary

granted Plurinuva an exclusive, royalty bearing, perpetual and irrevocable, worldwide, non-transferable (except under specific circumstances

specified thereunder), sublicensable license to its technology for the use in the development of the Licensed Products in the Field.

addition, Plurinuva granted the Subsidiary, pursuant to the License Agreement, an exclusive, perpetual and irrevocable, worldwide, sublicensable,

royalty-free, license to use, make, exploit and develop the improvements made by Plurinuva to the licensed technology outside of the Field.

In consideration for the license, Plurinuva agreed to pay the Subsidiary royalties from its future net sales in the mid-single digits.

Pursuant to the terms of the Services Agreement, the Subsidiary shall provide Plurinuva transitional services to support its development

efforts, for an initial term of eighteen months, subject to mutual extension for an additional six months.

Pursuant to the SPA, Tnuva

and Plurinuva agreed to enter into a commercialization agreement within twelve months pursuant to which Tnuva shall be granted exclusive

marketing, distribution and sale rights of the Licensed Products in Israel.

Tnuva’s exclusivity in the region will be subject to

achieving and maintaining specific milestones.

Plurinuva shall retain exclusive worldwide marketing, distribution, and sale rights for

the Licensed Products worldwide, except in Israel.

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

Intellectual Property

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We are the sole owner of

issued patents and approximately 64 pending patent applications in the United States, Europe, China, Japan and Israel, as well as in additional

countries worldwide, including countries in the Far East and South America (in calculating the number of issued patents, each European

patent validated in multiple jurisdictions was counted as a single patent).

142 issued patents and approximately 55 pending patent applications in the United States, Europe, China, Japan and Israel, as well as

in additional countries worldwide, including countries in the Far East and South America (in calculating the number of issued patents,

each European patent validated in multiple jurisdictions was counted as a single patent).

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.

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 expansion methods for 3D stromal cells and plant 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.

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.

Through our experience with

adherent stromal cell-based product development, we have developed expertise and know-how in this field and have established procedures

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.

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These agreements generally provide

for protection of confidential information, restrictions on the use of materials, and an obligation to assign to us inventions conceived

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.

In some 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.

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.

The expiration dates of these

patents, based on filing dates, range from 2027 to 2043.

Actual expiration dates will be determined according to extensions received based

on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L.

Actual expiration dates will be determined according to extensions received

based on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L.

98-417), commonly known as the “Hatch-Waxman”

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not infringe on any patents that may be issued to others.

See “Risk Factors - We must further protect and develop our technology

and products in order to become a profitable company.”

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

FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED MEDIA PRODUCED THEREBY FOR THERAPY

METHODS FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED

MEDIA PRODUCED THEREBY FOR THERAPY

PCT/IL2007/000380

China, Hong Kong

Australia, Canada, China, Hong Kong, Europe, Israel,

India, Japan, South Korea, Mexico, Russia, Singapore

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

March 23, 2027

CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

PCT/IL2008/001185

United States, Israel

Australia, Brazil, Canada, China, Europe, Hong Kong,

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

United States

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

September 2, 2028

OF TREATING INFLAMMATORY COLON DISEASES

METHODS OF TREATING INFLAMMATORY COLON DISEASES

PCT/IL2009/000527

United States, Israel, Russia

OF SELECTION OF CELLS FOR TRANSPLANTATION

METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION

PCT/IL2009/000844

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September 1, 2029

CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

PCT/IL2009/000846

Australia, Canada, China, Europe, Hong Kong, Israel,

India, Mexico, Russia, Singapore, United States

Australia, Canada, China, Europe, Hong Kong, Israel, India, Mexico, Singapore, United States

September 1, 2029

CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

PCT/IL2009/000845

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September 1, 2029

STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE DONORS AND USES THEREOF

ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE

DONORS AND USES THEREOF

PCT/IB2011/001413

United States

April 21, 2031

March 22, 2027

CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT

ADHERENT CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT

PCT/IB2010/003219

United States, Israel

Australia, Canada, China, Hong Kong, Europe, Israel,

Mexico, New Zealand, United States

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

November 29, 2030

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China, Israel

Australia, Canada, Europe, Israel, India, South Korea, Mexico, Singapore, United States

Australia, Canada, Europe, Israel, India, South Korea, Mexico, Singapore, United

April 15, 2032

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United States, Europe, Israel

GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL CELLS

CULTURED IN 3D

GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL

CELLS CULTURED IN 3D

PCT/IB2014/059114

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February 20, 2034

DEVICES AND METHODS FOR CULTURE OF CELLS

PCT/IB2013/058184

United States, Israel

August 31, 2033

METHODS FOR PREVENTION AND TREATMENT OF PREECLAMPSIA

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PCT/IB2013/059808

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

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

October 31, 2033

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March 3, 2035

METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING MUSCLE WASTING

METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING MUSCLE

WASTING DISORDERS

PCT/IB2015/059763

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December 18, 2035

USE OF ADHERENT STROMAL CELLS FOR ENHANCING HEMATOPOIESIS IN A SUBJECT

IN NEED THEREOF

USE OF ADHERENT STROMAL CELLS FOR ENHANCING HEMATOPOIESIS IN

A SUBJECT IN NEED THEREOF

PCT/IB2016/051585

United States, Israel

March 21, 2036

ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND USING

ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND

PCT/IB2016/053310

Europe, China, Israel

Europe, United States

Europe, United States, Israel

METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS

PCT/IB2017/050868

United States, Japan, Canada, Israel

Europe, Japan

Europe, Japan, Israel

February 16, 2037

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PCT/IB2018/050984

United States

February 18, 2038

6 unchanged sentences

June 25-July 3, 2038

DRUG CONTAINING HUMAN PLACENTA-ORIGIN MESENCHYMAL CELLS AND PROCESS FOR PRODUCING VEGF USING THE CELLS JP20030579842

March 28, 2023

METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS

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November 6, 2039

METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND SEQUELAE

METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND

SEQUELAE THEREOF

PCT/IL2021/050268

PCT, United States, Europe,

United States, Europe,

Israel, Mexico

2 unchanged sentences

March 11, 2041

METHODS AND COMPOSITIONS FOR AESTHETIC AND COSMETIC TREATMENT AND

STIMULATING HAIR GROWTH

METHODS AND COMPOSITIONS FOR AESTHETIC AND COSMETIC TREATMENT

AND STIMULATING HAIR GROWTH

PCT/IL2020/050363

United States, Europe,

Canada, China, Japan, Israel, Australia

Canada, China, Israel, Australia

March 26, 2040

1 unchanged sentence

September 23, 2040

METHODS AND COMPOSITIONS FOR

ENRICHMENT OF TARGET CELLS

PCT/IL2021/020514

United States, Israel

PLACENTAL CELL TREATMENT FOR CRITICAL LIMB ISCHEMIA PATIENT

SUBPOPULATIONS

PCT/IL2022/050937

Patent Cooperation Treaty, or PCT

August 29, 2042

SYSTEM AND METHODS FOR IMMUNE CELLS EXPANSION AND ACTIVATION

IN LARGE SCALE

PCT/IL2023/050529

PCT, United States

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.

(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

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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.

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.

In April 2016, the Subsidiary

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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 three dimensional methods for expanding

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

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

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

Collaborations and Ongoing Research and Development Plans

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.

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

During June 2021, we received

the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement.

The amount received is due to be repaid on

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

As of June 30, 2023, 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

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.

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.

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.

Department of Defense

In August 2017, we announced

that a pilot study of our PLX-R18 cell therapy was initiated by the DoD.

The study examined the effectiveness of PLX-R18 as a treatment

for ARS prior to, and within the first 24 hours of exposure to radiation.

In July 2019, we presented positive results from a series of

studies of our PLX-R18 cell therapy product conducted by the DoD.

NIAID Agreement

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.

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 an MOU for a collaboration with Fukushima Medical University,

Fukushima Global Medical Science Center.

The purpose 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.

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 for conducting clinical studies and commercialization

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

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

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.

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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.

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

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In October 2017, we entered

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

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

Horizon Europe

On September 6, 2022, we announced

that a €7.5 million non-dilutive grant from the European Union’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

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.

from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages

which will be determined by the consortium.

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.

Horizon Europe - PROTO

On September 6, 2022, we

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 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

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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.

Indiana University

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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

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

In February 2019, we entered

a collaboration with NASA’s Ames Research Center to evaluate the potential of our PLX cell therapies in preventing and treating

medical conditions caused during space missions.

Department of Defense

In August 2017, we announced

that a pilot study of our PLX-R18 cell therapy was initiated by the DoD.

The study examined the effectiveness of PLX-R18 as a treatment

for ARS prior to, and within the first 24 hours of exposure to radiation.

In July 2019, we presented positive results from a series of

studies of our PLX-R18 cell therapy product conducted by the DoD.

We are members of a large-scale

research initiative, the RESTORE project which has received funding of €1,000,000 (approximately $1,100,000) from the European Union’s

Horizon 2020 research and innovation program, to submit a full grant application for the development and advancement of transformative

therapeutics.

Currently, due to COVID-19, there is no open call for full proposal.

The members of the RESTORE project continue to collaborate

in attempt to collectively submit the grant application once such call is available.

In June 2020, we announced that we were selected as a member of the

CRISPR-IL consortium, a group funded by the IIA.

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 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

CRISPR-IL is 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 for extension of an additional 18 months, or

the Second Period, with additional budget from the IIA.

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.

In June 2020, we announced

that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA.

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.

CRISPR-IL is 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

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

In October 2021, we received

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period of eighteen months.

The CRISPR-IL consortium program does not require

us to pay royalties to the IIA.

The CRISPR-IL consortium

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

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and regenerative medicine.

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

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.

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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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

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

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We have developed a serum-free

formulation to support the manufacturing of cell therapy products.

formulation to support the manufacturing of our cell therapy products.

This serum-free formulation was developed using our deep understanding

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

Government Regulation

Government Regulation – Pharma

The development, manufacturing,

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

The FDA and the EMA 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 have similar

requirements for testing and marketing.

The process of obtaining these

approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time, resources

There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved, will be

reimbursed by public and private health insurance.

There are several stages every drug undergoes during

its development process.

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.

Governments in other countries may have similar requirements for testing and marketing.

The process of obtaining

these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time,

resources and money.

There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved,

will be reimbursed by public and private health insurance.

There are several stages every drug undergoes

during its development process.

Among these are:

Performance of nonclinical laboratory and animal studies to assess a drug’s biological activity 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 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.

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.

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 is unethical and field studies after an accidental or deliberate exposure are not feasible;

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 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

In the European Union, our

investigational cellular products are regulated under the Advanced Therapy Medicinal Product regulation, a regulation specific to cell

investigational cellular products are regulated under the Advanced Therapy Medicinal Products regulation, a regulation specific to cell

and tissue products.

Additionally, as of January 31, 2022, conducting clinical studies within EMA countries is subject to clinical trials

Additionally, as of January 31, 2022, the Clinical Trials Regulation harmonizes the submission, assessment and supervision

processes of clinical trials in the European Union.

This European Union regulation requires:

Filing a Central Clinical Trial Application utilizing the Clinical Trials Information System (CTIS) 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.

Other Regulations

In general, the approval procedure

varies among countries, and may involve additional preclinical testing and clinical studies.

The requirements and time required may differ

from those required for FDA or EMA approval.

Each country may impose certain procedures and requirements of its own.

Most countries other

than the United States, the European Union and Japan are willing to consider requests for marketing approval only after the product had

been approved for marketing by either the FDA, the EMA or the PMDA.

The decision regarding marketing approval is made following the submission

of a dossier that is thoroughly assessed and critically addressed.

In Japan, we have completed

the required regulatory interactions with the PMDA, prior to the submission of clinical study notification, in the framework of the new

regulations for regenerative therapy effective in November 2014, which promote expedited approval for regenerative therapies that are

being developed for seriously debilitating/life-threatening indications.

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

Typically, in the United States,

as well as in the European Union, clinical development involves a three-phase process, although the phases may overlap.

clinical studies are conducted in a small number of healthy volunteers, or patients in cases of ethical issues with using healthy volunteers

and are designed to provide information about product safety and to evaluate the pattern of drug distribution and metabolism within the

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.

Phase I, clinical studies are conducted in a small

number of healthy volunteers, or patients with the disease or condition.

These studies are designed to provide information about product

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

information on effectiveness.

Phase II clinical studies

are conducted in a homogenous group of patients afflicted with the specific target disease, to explore preliminary efficacy, optimal dosages

and confirm the safety profile.

In some cases, an initial study is conducted in patients to assess both preliminary efficacy and preliminary

safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II study.

Phase III clinical

studies 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, 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.

are conducted in a homogenous group of patients afflicted with the specific target disease, to explore preliminary efficacy, optimal

dosages and confirm the safety profile.

In some cases, an initial study is conducted in patients to assess both preliminary efficacy

and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II study.

Phase III clinical studies, sometimes known as pivotal studies, are generally large-scale, multi-center, controlled studies conducted

with a heterogeneous group of patients afflicted with the target disease, aiming to provide statistically significant support of 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.

During all phases of clinical

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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

research and development, manufacturing and clinical development.

As of August 30, 2022, we

employed a total of 129 full-time employees and 6 part-time employees, of whom, 102 full-time employees and 6 part-time employees are

engaged in research and development, manufacturing and clinical development.

The reduction in the number

of our employees was part of an efficiency and cost reduction plan we initiated in June 2022.

Our legacy product candidates have focused on

the regenerative medicine field.

The regenerative medicine field is characterized by intense competition, as global and local pharma

players are becoming more engaged in the cell therapy field based on the advancements made in clinical studies and due to the

favorable regenerative medicine legislation in certain regions.

We face competition from both allogeneic and autologous cell therapy

companies, academic, commercial and research institutions, pharmaceutical companies, biopharmaceutical companies, and governmental

Some of the clinical indications we currently have under development 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.

and Mesoblast Ltd.

Among other things, we expect

to compete based upon our intellectual property portfolio, our in-house manufacturing efficiencies and capabilities, and the 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.

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

More recently, through our collaboration with Tnuva and the establishment

of Plurinuva, we have begun to utilize our technology in the food tech field.

Competitors in the cultivated meat domain include both producers

of consumer-end-products, as well as those developing inputs for the production process.

Plurinuva competes with companies that include

Upside Foods, Future Meat, GOOD Meat, Mosa Meat, Aleph Farms, and Gourmey.

We believe that our ability to compete in the food tech 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 business.

Impact of COVID-19

In managing our ongoing global clinical studies, as well as our daily

operations, in the ongoing COVID-19 global pandemic, we are taking all necessary precautions for the safety and well-being of patients,

healthcare providers involved in our studies, and our employees.

We are continuing our operational and manufacturing activities, subject

to the directives of the MOH, with a dedicated team on site at our facilities.

In addition, the majority of our employees have been vaccinated

or recovered from COVID-19 and we are using remote work technologies that enable the mitigation of office staff while allowing other activities

to be conducted without the need for a physical presence in our facilities, if necessary.

The COVID-19 global pandemic caused delays in

enrollment of some of our clinical studies.

In addition, we are following the FDA and EMA guidelines regarding the management of clinical

studies during COVID-19.

However, the impact of the COVID-19 global pandemic is constantly evolving, and we may experience further impacts

on our daily operations, including the need for employees to potentially self-isolate based on potential exposure to the virus, difficulties

for our employees in travelling abroad, and delays in our ongoing research work with various hospitals and academic institutions.

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

Regenerative medicine:

The regenerative medicine

field is characterized by intense competition, as global and local pharma players are becoming more engaged in the cell therapy field

based on the advancements made in clinical studies and due to the favorable regenerative medicine legislation in certain regions.

face competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical

companies, biopharmaceutical companies, and governmental agencies.

Some of the clinical indications we currently have under development

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

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.

Available Information

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Information on our website is not incorporated by reference into this

Under the “SEC Filings” and “Financial Information” sections, under the “Investors & Media”

section 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.

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:

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

1 unchanged sentence

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