What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-09-21 compared with 2021-09-13 · 448 added, 366 removed, 417 unchanged (66% of the section changed)

Our Current Business

We are a biotechnology company

focused in the field of regenerative medicine, and a leading developer of placenta-based cell therapy product candidates for the treatment

of multiple inflammatory, muscle injuries and hematologic conditions.

Our operations are focused on the research, development, manufacturing,

conducting clinical trials and business development of cell therapeutics and related technologies.

Placental expanded, or PLX,

cells are derived from a class of placental cells that are harvested from donated placenta at the time of full term healthy delivery of

The cells are grown using our proprietary three-dimensional expansion technology and can be administered to patients off the-shelf,

without blood or tissue matching prior to administration.

PLX cells are believed to release a range of therapeutic proteins in response

to the patient’s condition, such as inflammation, muscle trauma, hematological disorders and radiation damage.

We are conducting several

multinational clinical studies which consist of a Phase III clinical study in muscle recovery following surgery for hip fracture and two

Phase II clinical studies in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 in the United States, Europe and Israel.

In addition, we are focusing on other clinical programs in the hematological field such as a Phase I clinical study for incomplete recovery

following bone marrow transplantation in the United States and Israel, an investigator-led Phase I/II Chronic Graft versus Host Disease,

or cGVHD, study in Israel, and Acute Radiation Syndrome, or ARS, under the U.S.

with an advanced cell-based technology platform.

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

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

We are utilizing our technology in

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

scale and cost-effective cell expansion platform.

We use our advanced cell-based

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

of inflammatory, muscle injuries and hematologic conditions.

Our 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 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

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.

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

Our manufacturing facility

complies with the European, Japanese, Israeli, South Korean and the FDA’s current Good Manufacturing Practice, or cGMP, requirements

and has been inspected and approved by the European and Israeli regulators for production of PLX-PAD for late stage trials.

been granted manufacturer/importer authorization and cGMP Certification by the Israeli Ministry of Health, or MOH.

If we obtain FDA and

other regulatory approvals to market PLX cells, we expect to have in-house production capacity to grow PLX cells in commercial quantities.

Our goal is to make significant

progress with our clinical pipeline and our clinical studies in order to ultimately bring innovative, potent therapies to patients who

need new treatment options.

We expect to demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale

manufacturing capacity.

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

joint ventures with pharmaceutical companies, direct sale of our products, and partnerships.

We believe that each of these indications represents

a severe unmet medical need.

We were incorporated in Nevada

in 2001, and we have a wholly owned subsidiary in Israel called Pluristem Ltd., or the Israeli Subsidiary, and a wholly owned subsidiary

in Germany called Pluristem GmbH.

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

Cell therapy is an emerging

Cell therapy is an established

field within the regenerative medicine area.

4 unchanged sentences

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

PLX cells do not require tissue matching

prior to administration, which allows the development of ready-to-use / “off-the-shelf” allogeneic products.

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.

Our Technology

We develop, and intend to

commercialize, cell therapy production technologies and products that are derived from the human placenta after a full-term delivery of

a healthy baby.

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

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 PLX doses.

Additionally, our current manufacturing process, which has scaled up as compared

to previous years, has demonstrated batch-to-batch consistency, an important manufacturing challenge for biological products.

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 is currently implemented in the fields of regenerative medicine and food-tech.

Product Candidates

We believe that our technology

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

for other innovative initiatives—such as food-tech, 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

1 unchanged sentence

matching or additional manipulation prior to administration.

From the physician’s and patient’s perspective, we believe that

our PLX products are comparable to any other product delivered in a vial.

Currently, our PLX products are administered intramuscular,

or IM, using a standard needle and syringe.

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

a standard needle and syringe.

Our first product candidate,

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

PLX-PAD is currently being used in a Phase III multinational clinical

study in recovery following surgery for hip fracture, and in two Phase II clinical studies in ARDS associated with COVID-19 in the United

States, Europe and Israel.

We have also conducted a pivotal

Phase III multinational clinical study in the use of PLX-PAD for the treatment of Critical Limb Ischemia, or CLI, which we terminated

in December 2020, and in a Phase II multinational clinical study in Intermittent Claudication, or IC.

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 study, and used

in a Phase I/II for the treatment of Steroid-Refractory cGVHD.

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.

Our second product candidate,

PLX-R18, is composed of fetal cells originated from the placenta.

We have completed enrollment in our first in human

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

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

5 unchanged sentences

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 suitable for cGMP environment.

As a platform technology

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

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:

Induced PLX cells:

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

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

Modified PLX cells using CRISPR,

CRISPR is a unique technology that opens the door for precise gene editing of cells.

Using such technology 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

or other gene editing technology:

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

Using this technology, we

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

Our aim is to incorporate the

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

designed for specific indications.

We believe that using the

6 unchanged sentences

States, Europe and Israel.

The primary endpoint of this study is the Short Physical Performance Battery (SPPB), a test for lower leg performance

and functional status.

The study is planned to include 240 patients and will assess efficacy at six months and a year, as well as safety

for up to two years.

Currently, over 95% of the study patients have been enrolled in this study.

The primary endpoint of this study is 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).

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

16 unchanged sentences

of severe COVID-19 cases complicated by ARDS.

The primary endpoint is the number of ventilator free days during the 28-days following

Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, ICU free-days, and hospitalization

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.

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.

9 unchanged sentences

patients in Europe and Israel under this protocol.

July 8, 2021, we announced that we are bringing our COVID-19 complicated by ARDS Phase II studies in the United States, Europe and Israel

to clinical readout.

The analysis will be based on 89 patients enrolled.

We expect to announce the topline results of the readout during

the fourth quarter of 2021.

We also announced that we will not pursue the previously announced plans in December 2020 to expand our COVID-19

program in Mexico in collaboration with Innovare R&D SA de CV.

Following HCT .

This Phase I study of PLX-R18 in HCT, has completed enrollment of 21 patients in the United States and Israel.

study is designed to assess the safety of PLX-R18 by assessing adverse events, safety labs and vital signs in patients receiving different

doses of PLX-R18.

We expect to complete one year follow up for all patients in September 2021.

In April 2021, we announced topline

results of this study.

The 21 patients enrolled in the United States and Israel were at least three months after the HCT procedure (median:

236 days) and had low blood counts in at least one blood cell lineage.

They were assigned to one of three treatment arms:

cells/kg, two million cells/kg or four million cells/kg.

Each patient received two treatments of the assigned dose.

Data from the six-month follow-up

were available for 14 of the 21 treated patients and demonstrated that (i) PLX-R18 was well-tolerated with a favorable safety profile;

(ii) statistically significant improvement from baseline counts was observed in all cohorts for hemoglobin and platelet counts (p<0.05)

and the patients in the high dose arm (4 million cells/kg) exhibited statistically significant improvements in all three blood cell lineages

(iii) approximately 60% of patients exhibited improvements in all three blood cell lineages:

hemoglobin, neutrophil and platelet

counts that are above the initial criteria for inclusion in the study and (iv) 13 patients were transfusion dependent at baseline;

of those became transfusion independent at 6 month follow-up and no patients who were transfusion independent at baseline became transfusion

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.

Recovery Following HCT .

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

The study assessed the safety of PLX-R18 by assessing

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

One year follow up for all patients was

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

PLX-R18 was well-tolerated with a favorable

safety profile.

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

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

enduring up to 12 months following treatment.

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

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

Peripheral and Cardiovascular

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

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

6 unchanged sentences

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 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 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 BLA for this indication.

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.

In October 2017, we announced

4 unchanged sentences

have been acutely exposed to high dose radiation due to nuclear attack or accident.

In December 2015, we

also signed a memorandum of understanding, or MOU, for a collaboration with Fukushima Medical University, Fukushima Global Medical Science

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.

In June 2018, we reported positive animal data from studies conducted in collaboration with Fukushima Medical University

evaluating PLX-R18 cells as a treatment for radiation damage to the gastrointestinal, or GI, tract and bone marrow.

Data from these studies

showed that PLX-R18 cells significantly increased survival rates, preserved GI stem cells activity that enhance the recovery of the GI

system and prevented severe damage to the intestinal lining, suggesting PLX-R18 potential as a multi-organ therapy for ARS.

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 addition, the data shows 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.

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 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.

Steroid-Refractory cGVHD .

4 unchanged sentences

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

13 patients have been treated in this

study to date.

Regulatory and Clinical Affairs Strategy

5 unchanged sentences

or MFDS, of South Korea.

Our Activities in the Food Tech Sector

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

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.

Intellectual Property

6 unchanged sentences

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

In April 2016, the Israeli

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

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

This license is subject to future

single low-digit royalties from sales of our product for treatment in the field of ischemic diseases in Japan, until expiry of the patent

This 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.

In February 2017, the Israeli

Subsidiary signed an agreement with founders of a certain patent for a five-year option to purchase a certain patent for an amount of

The agreement includes yearly payments of €75,000, €75,000 and €100,000 in February 2017, 2018 and 2019,

respectively, which have been paid.

We are entitled to terminate the agreement for convenience upon providing the founders 30 days prior

In April 2019, we filed a

provisional patent application titled “Methods and Compositions for Producing Cannabinoids,” which covers the use of

our state-of-the-art, proprietary 3D cell culturing technology for the potential manufacturing of cannabinoid-producing cells.

2020, we filed a Patent Cooperation Treaty, or PCT, application with respect to the technology.

In June 2021, national or regional phase

applications of the PCT were filed in the United States, Europe, Japan, Canada, and Israel.

In March 2020, we filed a

provisional patent application titled “Methods and Compositions for Treating Viral Infections and Sequelae Thereof,”

which covers the use of placental adherent stromal cells for treating coronavirus infections and sequelae thereof.

In May 2020, a related

Israeli patent application was filed, which was allowed in March 2021.

In March 2021, a PCT application as well as national applications

were filed in the United States and Israel.

In June 2021, national or regional phase applications of the PCT were filed in Europe and

Based on the well-established

4 unchanged sentences

applications includes the following claims:

proprietary expansion methods for 3D stromal cells;

● composition

of matter claims covering the cells;

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

● cell-culture,

harvest, and thawing devices.

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.

Through our experience with

19 unchanged sentences

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

Act, that permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining FDA market approval.

Act, which permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining FDA market approval.

Hatch-Waxman Act is based on a U.S.

7 unchanged sentences

Our Patent Portfolio

Patent Name/ Int.

Pending Jurisdictions

Granted Jurisdictions

METHODS FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED MEDIA

PRODUCED THEREBY FOR THERAPY

Jurisdictions

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, Singapore

March 23, 2027

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

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

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

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

September 2, 2028

METHODS OF TREATING INFLAMMATORY COLON DISEASES

OF TREATING INFLAMMATORY COLON DISEASES

PCT/IL2009/000527

United States, Israel, Russia

METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION

OF SELECTION OF CELLS FOR TRANSPLANTATION

PCT/IL2009/000844

1 unchanged sentence

September 1, 2029

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

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, Russia, Singapore, United States

September 1, 2029

ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY

PCT/IL2009/000845

1 unchanged sentence

September 1, 2029

ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE DONORS

AND USES THEREOF

STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE DONORS AND USES THEREOF

PCT/IB2011/001413

2 unchanged sentences

March 22, 2027

ADHERENT CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT

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

27 unchanged sentences

PCT/IB2013/059808

Australia, 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 States

October 31, 2033

10 unchanged sentences

PCT/IB2016/051585

United States, China, Israel

United States, Israel

March 21, 2036

2 unchanged sentences

Europe, China, Israel

United States

Europe, United States

METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS

PCT/IB2017/050868

United States, Japan, Canada, Australia, Israel

United States, Japan, Canada, Israel

Europe, Japan

February 16, 2037

5 unchanged sentences

PCT/IB2018/050984

United States, Israel

United States

February 18, 2038

9 unchanged sentences

METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS

PCT, Canada, Europe, Israel, Japan, United States

PCT/IL2020/050477

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

April 28, 2040

20 unchanged sentences

PCT/IB2019/058429

Europe, Israel, South Korea, Singapore, United States

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

October 3, 2039

13 unchanged sentences

PCT/IL2020/050363

PCT, United States, Europe,

United States, Europe,

Canada, China, Japan, Israel, Australia

2 unchanged sentences

September 23, 2040

On January 8, 2022, we entered

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

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

(EP2591789, EP3103463, and 3091071), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing its

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

The license covers methods for expanding adherent stromal

cells and specified second medical uses.

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.

In April 2016, the Subsidiary

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

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

This license is subject to future single low-digit

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

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

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

Research and Development

Foundational Research

Our initial technology, the PluriX™ Bioreactor system, was invented

at the Technion – Israel Institute of Technology’s Rappaport Faculty of Medicine, in collaboration with researchers from the

Weizmann Institute of Science.

This technology was acquired by us and has been further significantly developed by our research and development

teams over the ensuing years.

Our initial technology, the

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

in collaboration with researchers from the Weizmann Institute of Science.

This technology was acquired by us and has been further significantly

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

Collaborations and Ongoing Research and Development Plans

10 unchanged sentences

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 Pluristem’s

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.

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 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.

CHA Agreement

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:

the treatment

of CLI and IC.

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

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

Upon the first regulatory approval for

a PLX product in South Korea, if granted, for the specified indications, we and CHA will establish an equally owned joint venture with

the purpose of commercializing PLX cell products in South Korea.

Additionally, we will be able to use the data generated by CHA to pursue

the development of PLX product candidates outside of South Korea.

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:

the treatment of CLI and IC.

We will continue to retain

rights to our proprietary manufacturing technology and cell-related intellectual property.

The first clinical study that

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

Upon the first regulatory approval for a PLX product in South Korea,

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

PLX cell products in South Korea.

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

candidates outside of South Korea.

The term of the CHA Agreement

19 unchanged sentences

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.

The Phase I/IIa study will

be carried out by Charité.

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

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

Indiana University

3 unchanged sentences

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

Thermo Fisher

In July 2018, we entered into

a strategic collaboration agreement with Thermo Fisher Scientific Inc., or Thermo Fisher, with the aim of advancing the fundamental knowledge

of cell therapy industrialization and to improve quality control of the end-to-end supply chain.

The collaboration enables us to combine

Thermo Fisher’s experience in cell therapy development and bioproduction scaleup with our expertise in cell therapy manufacturing,

clinical development, and quality control.

Chart Industries

21 unchanged sentences

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 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 is 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 August 2021, we submitted

an additional budget for the Second Period.

The CRISPR-IL consortium program does not require us to pay royalties to the IIA.

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.

In October 2021, we received

approval for an additional grant of approximately $583,000 from the IIA pursuant to the CRISPR-IL consortium program, for an additional

period of eighteen months.

The CRISPR-IL consortium program does not require

us to pay royalties to the IIA.

United Arab Emirates-based Abu Dhabi Stem Cells

4 unchanged sentences

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, including COVID-19.

We plan to continue to collaborate

with universities, academic institutions, and corporate partners worldwide to fully leverage our expertise and explore the use of our

cells in other indications.

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

In-House Clinical Manufacturing

1 unchanged sentence

to perform clinical cell manufacturing.

Our state-of-the-art Good Manufacturing Practice, or GMP, grade manufacturing facility in Haifa

has been in use since February 2013 for the main purpose of clinical grade, large-scale manufacturing.

The facility’s new automated

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

second product, PLX-R18, was cleared by the FDA and the MOH for clinical use.

Furthermore, the site was inspected and approved by an European

Union qualified person (European accreditation body), approving that the site and production processes meet the current GMP for the purpose

of manufacturing clinical grade products.

The site was also inspected and approved by the MOH and we received

a cGMP Certification and manufacturer-importer authorization.

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

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

The facility’s new automated manufacturing process and products

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

Our second product, PLX-R18, was cleared

by the FDA and the MOH for clinical use.

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

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

The site was also inspected

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

We obtain the human placentas

3 unchanged sentences

and standards.

In June 2019, we announced

that we developed a serum-free formulation to support the manufacturing of cell therapy products.

This serum-free formulation was developed

using our deep understanding in cell therapy industrial scale production standards, and the quality methods designed to support implementation

in Phase III development and marketing.

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

highly consistent production capacity with operational independency from third party suppliers for standard serum, an expensive and quantity

limited product.

PLX-R18 is the first product candidate manufactured using the serum-free media.

We have developed a serum-free

formulation to support the manufacturing of cell therapy products.

This serum-free formulation was developed using our deep understanding

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

and marketing.

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

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

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

Government Regulation

16 unchanged sentences

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;

manufacture of the product according to GMP regulations and standards;

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;

post-marketing clinical testing and surveillance of the product after marketing approval, which can result in additional conditions on

the approvals or suspension of clinical use.

Performance of nonclinical laboratory and animal studies to assess a drug’s biological activity and to identify potential safety concerns, and to characterize and document the product’s chemistry, manufacturing controls, formulation, and stability.

In accordance with regulatory requirements, nonclinical safety and toxicity studies are conducted under Good Laboratory Practice, requirements to ensure their quality and reliability;

The manufacture of the product according to GMP regulations and standards;

Conducting adequate and well-controlled human clinical studies in compliance with Good Clinical Practice, or GCP, to establish the safety and efficacy of the product for its intended indication;

Potential post-marketing clinical testing and surveillance of the product after marketing approval, which can result in additional conditions on the approvals or suspension of clinical use.

Approval of a drug for clinical

studies in humans and approval of marketing are sovereign decisions of states, made by national,

or, in case of the European Union, international regulatory competent authorities.

studies in humans and approval of marketing are sovereign decisions of states, made by national, or, in case of the European Union, international

regulatory competent authorities.

The Regulatory Process in the United States

3 unchanged sentences

The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires

the following steps prior to approving a new biological product for use either for clinical studies

or for commercial sale:

of an IND Application, which must become effective before clinical testing in humans can begin;

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

humans in clinical studies;

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;

may grant priority review status to expedite the BLA review process.

Obtaining a Fast Track designation allows access for

the request of priority review;

of a BLA for marketing authorization of the product, which must include adequate results of pre-clinical testing and clinical studies;

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;

review of the BLA in order to determine, among other things, whether the product is safe and effective for its intended uses;

inspection and approval of the product manufacturing facility at which the product will be manufactured.

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

Submission of an IND Application, which must become effective before clinical testing in humans can begin;

Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce the drug candidate into humans in clinical studies;

FDA may grant approval for EAP prior to the completion of clinical studies, in order to allow access for the investigational drug, for patients that are excluded from the study;

FDA may grant priority review status to expedite the BLA review process.

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

Submission of a BLA for marketing authorization of the product, which must include adequate results of pre-clinical testing and clinical studies;

Submission of BLA with a proof of efficacy that is based only on animal studies is feasible in instances where human efficacy studies cannot be conducted because the conduct of such studies 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.

The Regulatory Process in Europe

2 unchanged sentences

and tissue products.

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

This European Union regulation requires:

a Clinical Trial Application for each European country involved in the clinical study.

The application may be filed via a centralized

procedure, which makes it possible to obtain a coordinated assessment of an application for a clinical study that is to take place in

several European countries;

approval of affiliated ethics committees to test the investigational product into humans in clinical studies;

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 (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.

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.

In May 2015, we were selected by the

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

Other Regulations

19 unchanged sentences

Phase II clinical studies

are conducted with 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.

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.

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 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

5 unchanged sentences

with its use.

An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study

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

An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that

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

As of June 30, 2022, we employed

a total of 153 full-time employees and nine part-time employees, of whom, 129 full-time employees and nine part-time employees are engaged

in research and development, manufacturing and clinical development.

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 new favorable regenerative medicine legislation in certain regions.

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

companies, biopharmaceutical companies, and governmental agencies.

Some of the clinical indications we currently have under development

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

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

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 intensify.

a total of 154 full-time employees and 5 part-time employees, of whom, 128 full-time employees and 5 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

5 unchanged sentences

In addition, the majority of our employees have been vaccinated

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.

The COVID-19 global pandemic caused delays in enrollment of some of our clinical studies.

Despite these impacts, we currently hold supplies of PLX cells in inventory in Israel, and in secure storage facilities in Europe and

In addition, we are following the FDA and EMA guidelines regarding the management of clinical studies during COVID-19.

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 clinical trials and our ongoing research work with various hospitals and academic institutions.

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.

Available Information

Additional information about

us is contained on our Internet website at www.pluristem.com.

Information on our website is not incorporated by reference into this report.

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,

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

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.

2 unchanged sentences

are also posted on our website:

Code of Business Conduct and Ethics, Trading Policy and the Charters for each of the Committees of our

Board of Directors, or the Board.

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

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

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