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Item 1A. Risk Factors

2024-09-18 compared with 2023-09-12 · 686 added, 524 removed, 305 unchanged (80% of the section changed)

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are discussed more fully below and include, but are not limited to, risks related to:

we have a history of losses and have not generated significant

revenues to date.

We expect to experience future losses and do not foresee generating significant or steady revenues in the immediate

we may need to raise additional capital to meet our business

requirements in the future, and such capital raising may be costly or difficult to obtain and could dilute our shareholders’

ownership interests, and such offers or availability for sale of a substantial number of our common shares may cause the price of

our publicly traded shares to decline;

we may become subject to claims by much larger and better

funded competitors enforcing their intellectual property rights against us or seeking to invalidate our intellectual property or

our rights thereto;

there are inherent risks in the manufacturing of our product

candidates, including meeting relevant high regulatory standards, the failure of which could materially and adversely affect our

results of operations and the value of our business;

if we are unable to obtain and maintain intellectual property

protection covering our products and technology, others may be able to utilize our intellectual property, which would adversely affect

our business;

we are an international business, and we are exposed to

various global and local risks that could have a material adverse effect on our financial condition and results of operations;

the market prices of our common shares are subject to fluctuation

and have been and may continue to be volatile, which could result in substantial losses for investors;

we anticipate being subject to fluctuations in currency

exchange rates because a significant portion of our business is conducted outside the United States and we are exposed to currency

exchange fluctuations in other currencies such as the New Israeli Shekel, or NIS, and the Euro;

restrictions and covenants contained in the EIB Finance Agreement may restrict our ability to conduct certain strategic initiatives;

limitations we may face relating to the grants we have

received from the IIA may impact our plans and future decisions;

if there are significant shifts in the political, economic and military conditions in Israel and its neighboring countries, it could have a material adverse effect on our business relationships and profitability;

it may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers;

cybersecurity incidents may have an adverse impact on our business and operations;

recent increasing global inflation could affect our ability to purchase materials needed for manufacturing and could increase the costs of our future product;

we have a limited operating history in the field of food tech to date and our prospects will be dependent on our ability to meet a number of challenges;

there are risks relating to our food-tech endeavors, including changes in consumer preferences and governmental regulations relating to cultivated meat;

our business and market potential in the field of cultivated food are unproven, and we have limited insight into trends that may emerge and affect our business;

the research and development associated with technologies for cultivated meat manufacturing is a lengthy and complex process;

we could fail to maintain the listing of our common shares on Nasdaq, which could harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction.

we have a history of losses

and have not generated significant revenues to date.

We expect to experience future losses and do not foresee generating significant

or steady revenues in the immediate future;

we may need to raise additional

capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and could

dilute our shareholders’ ownership interests, and such offers or availability for sale of a substantial number of our common

shares may cause the price of our publicly traded shares to decline;

we may become subject to claims by much larger and better funded competitors

enforcing their IP rights against us or seeking to invalidate our IP or our rights thereto;

there are inherent risks

in the manufacturing of our product candidates, including meeting relevant high regulatory standards, the failure of which could

materially and adversely affect our results of operations and the value of our business;

if we are unable to obtain and maintain IP protection covering our

products and technology, others may be able to utilize our IP, which would adversely affect our business;

we are an international

business, and we are exposed to various global and local risks that could have a material adverse effect on our financial condition

and results of operations;

the market prices of our

common shares are subject to fluctuation and have been and may continue to be volatile, which could result in substantial losses

for investors;

we anticipate being subject

to fluctuations in currency exchange rates because a significant portion of our business is conducted outside the United States and

we are exposed to currency exchange fluctuations in other currencies such as the New Israeli Shekel, or NIS, and the Euro;

restrictions contained

in the EIB Finance Agreement may restrict our ability to conduct certain strategic initiatives;

limitations we may face

relating to the grants we have received from the IIA may impact our plans and future decisions;

if there are significant

shifts in the political, economic and military conditions in Israel and its neighboring countries, it could have a material adverse

effect on our business relationships and profitability;

it may be difficult for

investors in the United States to enforce any judgments obtained against us or some of our directors or officers;

cybersecurity incidents

may have an adverse impact on our business and operations;

recent increasing global

inflation could affect our ability to purchase materials needed for manufacturing and could increase the costs of our future product;

have a limited operating history in the field of food tech agtech and CDMO to date and our prospects

will be dependent on our ability to meet a number of challenges;

there are risks relating to our CDMO business,

including financial risks associated with contracts that could be terminated, changed or delayed, risk related to products that might

not gain market approval and risk related to providing timely services to customers in a highly competitive industry in which we

there are risks relating

to our food-tech endeavors, including changes in consumer preferences and governmental regulations relating to cultivated meat;

our business and market

potential in the field of cultivated food and cell-based coffee technology are unproven, and we have limited insight into trends

that may emerge and affect our business;

the research and development

associated with technologies for cultivated meat manufacturing is a lengthy and complex process;

we could fail to maintain

the listing of our common shares on Nasdaq, which could harm the liquidity of our shares and our ability to raise capital or complete

a strategic transaction.

Risk Related to Our Business

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we will be successful in doing so.

date, we have focused our efforts primarily in the regenerative medicine field and in the Food Tech field, but we may seek partners for

licensing deals, joint ventures, partnerships, and direct sale of our products or use of our technology in various industries.

deals, joint ventures and partnerships in new fields involve numerous risks, including the potential integration of our technology and

products in various new ways, which may or may not be successful.

Such projects may require significant funds, time and attention of management

and other key personnel.

In addition, as we do not have experience in areas outside of the regenerative medicine field and limited experience

in Food Tech field, we may lack the personnel to properly lead such initiatives.

There can be no assurance that we will be successful

in finding the relevant partners to fund and market our cell-based products.

date, we have focused our efforts primarily in the regenerative medicine field, in the food tech field, in the CDMO field, and in the

agriculture field, but we may seek partners for licensing deals, joint ventures, partnerships, and direct sale of our products or

use of our technology in various industries.

Licensing deals, joint ventures and partnerships in new fields involve numerous risks,

including the potential integration of our technology and products in various new ways, which may or may not be successful.

projects may require significant funds, time and attention of management and other key personnel.

In addition, as we do not have

experience in areas outside of the regenerative medicine field and limited experience in the food tech, CDMO and agriculture fields,

we may lack the personnel to properly lead such initiatives.

There can be no assurance that we will be successful in finding the

relevant partners to fund and market our cell-based products.

Risks Related to Development, Clinical studies,

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clinical trials may be delayed or terminated for many reasons, such as:

The FDA, the EMA or the MOH does not grant permission to

proceed or places trials on clinical hold;

Subjects do not enroll in our trials at the rate we expect;

Government actions, such as those enacted during the ongoing

COVID-19 pandemic, which limit the general populations movement;

The regulators may ask to increase subject’s population

in the clinical trials;

Subjects experience an unacceptable rate or severity of

adverse side effects;

Third party clinical investigators and other related vendors

may not perform the clinical trials under the anticipated schedule or consistent with the clinical trial protocol, GCP and regulatory

requirements;

Third party clinical investigators and other related vendors

may declare bankruptcy or terminate their business unexpectedly, which most likely will result in further delays in our clinical

trials’ anticipated schedule and cause additional expenditures;

Inspections of clinical trial sites by the FDA, EMA, MOH

and other regulatory authorities find regulatory violations that require us to undertake corrective action, suspend or terminate

one or more sites, or prohibit us from using some or all of the data in support of our marketing applications;

One or more IRBs suspends or terminates the trial at an

investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trial.

The FDA, the EMA or the

MOH does not grant permission to proceed or places trials on clinical hold;

Subjects do not enroll

in our trials at the rate we expect;

Government actions, such

as those enacted during the ongoing COVID-19 pandemic, which limit the general populations movement;

The regulators may ask

to increase subject’s population in the clinical trials;

Subjects experience an

unacceptable rate or severity of adverse side effects;

Third party clinical investigators

and other related vendors may not perform the clinical trials under the anticipated schedule or consistent with the clinical trial

protocol, GCP and regulatory requirements;

Third party clinical investigators

and other related vendors may declare bankruptcy or terminate their business unexpectedly, which most likely will result in further

delays in our clinical trials’ anticipated schedule and cause additional expenditures;

Inspections of clinical

trial sites by the FDA, EMA, MOH and other regulatory authorities find regulatory violations that require us to undertake corrective

action, suspend or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications;

One or more IRBs suspends

or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the

If we will be unable to conduct

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and potential products will depend on a number of factors, including:

the clinical safety and effectiveness of our cell therapy

drug candidates and their perceived advantage over alternative treatment methods, if any;

adverse events involving our cell therapy product candidates

or the products or product candidates of others that are cell-based;

the cost of our products and the reimbursement policies

of government and private third-party payers.

the clinical safety and

effectiveness of our cell therapy drug candidates and their perceived advantage over alternative treatment methods, if any;

adverse events involving

our cell therapy product candidates or the products or product candidates of others that are cell-based;

the cost of our products

and the reimbursement policies of government and private third-party payers.

If the health care community

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Ever After Foods

has a limited operating history in the field of cultivated meat to date and its prospects will be dependent on its ability to meet a

number of challenges.

has a limited operating history in the field of cultivated or cultured meat (hereinafter, “cultivated meat”) to date and

its prospects will be dependent on its ability to meet a number of challenges.

After Foods’ business prospects are difficult to predict due to its lack of operational history in the new and emerging food tech

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our and its technologies in the field of cultivated meat to date.

After Foods does not currently have any products or technologies approved for sale and it is still in the early stages of development.

To date, Ever After Foods has limited data on the ability of our and its technologies to successfully manufacture cultivated meat, towards

which they have devoted substantial resources to date.

Ever After Foods’ current technologies are, in large part, based on our technologies

and intellectual property.

It may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups

and future growth, or at all.

Ever After Foods expects that a substantial portion of its efforts and expenditures over the next

few years will be devoted to the development of technologies designed to enable Ever After Foods to market industrial scale cultivated

meat manufacturing processes.

Ever After Foods cannot guarantee that it will be successful in developing these technologies, based

on its current roadmap, or at all.

If Ever After Foods is able to successfully develop its cultivated meat technologies, it cannot ensure

that it will obtain regulatory approval or that, following approval, upon commercialization its technologies will achieve market acceptance.

Any such delay or failure could materially and adversely affect Ever After Foods’ financial condition, results of operations and prospects.

Ever After Foods does not currently have any products or technologies approved

for sale and it is still in the early stages of development.

To date, Ever After Foods has limited data on the ability of our and its

technologies to successfully manufacture cultivated meat, towards which they have devoted substantial resources to date.

Ever After Foods’

current technologies are, in large part, based on our technologies and IP.

It may not be successful in developing its technologies in

a manner sufficient to support its expected scale-ups and future growth, or at all.

Ever After Foods expects that a substantial portion

of its efforts and expenditures over the next few years will be devoted to the development of technologies designed to enable Ever After

Foods to market industrial scale cultivated meat manufacturing processes.

Ever After Foods cannot guarantee that it will be successful

in developing these technologies, based on its current roadmap, or at all.

If Ever After Foods is able to successfully develop its cultivated

meat technologies, it cannot ensure that it will obtain regulatory approval or that, following approval, upon commercialization its technologies

will achieve market acceptance.

Any such delay or failure could materially and adversely affect Ever After Foods’ financial condition,

results of operations and prospects.

Consumer preferences

for alternative proteins in general, and more specifically cultured meats, are difficult to predict and may change, and, if we are unable

to respond quickly to new trends, Ever After Food’s business may be adversely affected.

After Food’s business is focused on the development and marketing of licensable cultured meat manufacturing technologies.

demand for the cultured meats manufactured using these technologies could change based on a number of possible factors, including dietary

for alternative proteins in general, and more specifically cultivated meats, are difficult to predict and may change, and, if we are unable

to respond quickly to new trends, Ever After Foods’ business may be adversely affected.

After Foods’ business is focused on the development and marketing of licensable cultivated meat manufacturing technologies.

demand for the cultivated meats manufactured using these technologies could change based on a number of possible factors, including dietary

habits and nutritional values, concerns regarding the health effects of ingredients and shifts in preference for various product attributes.

If consumer demand for such products decreases, Ever After Food’s business and financial condition would suffer.

If consumer demand for such products decreases, Ever After Foods’ business and financial condition would suffer.

Consumer trends

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We expect that

products utilizing Ever After Food’s technologies will be subject to regulations that could adversely affect its business and results

of operations.

manufacture and marketing of food products is highly regulated.

Ever After Foods, its suppliers and licensees, may be subject to a variety

of laws and regulations.

These laws and regulations apply to many aspects of Ever After Food’s business, including the manufacture,

composition and ingredients, packaging, labeling, distribution, advertising, sale, quality and safety of food products, as well as the

health and safety of our employees and the protection of the environment.

the reasons discussed below, we ourselves do not expect to be directly regulated by the FDA for United States compliance purposes but

will apply the FDA’s food contact substance standards or analogous foreign regulations.

From a regulatory perspective, in the United

States, we expect companies manufacturing finished cultured meat products to be subject to regulation by various government agencies,

including the FDA, the USDA, the FTC, Occupational Safety and Health Administration and the Environmental Protection Agency, as well as the

requirements of various state and local agencies and laws, such as the California Safe Drinking Water and Toxic Enforcement Act of

We likewise expect these products to be regulated by equivalent agencies outside the United States by various international regulatory

the manufacturer of technology used to produce cultured meat, and consistent with the Federal Food, Drug and Cosmetic Act, Federal Meat

Inspection Act, and Poultry Products Inspection Act, we believe we will not be directly regulated by the FDA or USDA.

Rather, we believe

the regulatory obligation falls on our customers — cultured meat producers — to ensure that all food produced using our technology

is wholesome and not adulterated.

Consistent with food industry norms, we expect that our customers will therefore request assurances

from us that our products are suitable for their intended use from an FDA regulatory perspective.

manufacturing of cultured meat is expected to be subject to extensive regulations internationally, with products subject to numerous

products utilizing Ever After Foods’ technologies will be subject to regulations that could adversely affect Ever After Foods’

business and operations.

manufacture, distribution and marketing of food products is highly regulated.

Ever After Foods and its suppliers and licensees, may be

subject to a variety of laws and regulations.

These laws and regulations apply to many aspects of Ever After Foods’ business, including

the manufacture, composition and ingredients, packaging, labeling, distribution, advertising, sale, quality and safety of food products

and food contact substances (including some manufacturing equipment), as well as the health and safety of our employees and the protection

of the environment.

applicable, the manufacturing equipment that will be manufactured by Ever After Foods will comply with the FDA’s regulatory requirements

for food contact substances and analogous foreign regulations.

Ever After Foods will also ensure that the edible scaffolds and any other

production materials it sells to its customers comply with applicable FDA standards.

From a regulatory perspective, in the United States,

we expect companies manufacturing finished cultivated meat products ( i.e., the companies that will license Ever After Foods’ manufacturing

technologies) to be subject to regulation by various government agencies, including the FDA, the USDA, the FTC, the Occupational Safety

and Health Administration and the Environmental Protection Agency, as well as the requirements of various state and local agencies

and laws, such as the California Safe Drinking Water and Toxic Enforcement Act of 1986.

We likewise expect these products to be regulated

by equivalent agencies outside the United States by various international regulatory bodies.

as noted above, Ever After Foods will ensure that the products it sells to its customers (including manufacturing equipment and scaffolds)

comply with applicable FDA and USDA standards, we believe that our customers, as entities engaged in the manufacture, distribution, and

sale of cultivated meat products, will bear primary legal responsibility for ensuring that all finished foods produced using our technology

is wholesome and not adulterated and otherwise in compliance with applicable laws and regulations.

Consistent with food industry norms,

we expect that our customers will therefore request assurances from us that our products are suitable for their intended use under applicable

legal requirements.

manufacturing of cultivated meat is expected to be subject to extensive regulations internationally, with products subject to numerous

food safety and other laws and regulations relating to the sourcing, manufacturing, composition and ingredients, storing, labeling, marketing,

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financial or otherwise, that could adversely affect our business, financial condition or operating results.

In addition, we could be

adversely affected by violations of the U.S.

Foreign Corrupt Practices Act, or FCPA, and similar worldwide anti-bribery laws, which generally

prohibit companies and their intermediaries from making improper payments to officials or other third parties for the purpose of obtaining

or retaining business.

While our policies mandate compliance with anti-bribery laws, our internal control policies and procedures may

not protect us from reckless or criminal acts committed by our employees, contractors or agents.

In addition, we could be adversely

affected by violations of the U.S.

Foreign Corrupt Practices Act, or FCPA, and similar worldwide anti-bribery laws, which generally prohibit

companies and their intermediaries from making payments to foreign government officials for the purpose of obtaining or retaining business,

and require companies both to keep accurate books and records and to devise and maintain an adequate system of internal accounting controls.

While our policies mandate compliance with anti-bribery laws, including the FCPA, our internal control policies and procedures may not

protect us from reckless or criminal acts committed by our employees, contractors or agents.

Violations of these laws, or allegations

of such violations, could disrupt our business and adversely impact our results of operations, cash flows and financial condition.

of such violations, could result in government investigations, the assessment of fines and penalties, reputational damage, disruption

to our business, and adverse impacts on our results of operations, cash flows and financial condition.

Any changes in,

or changes in the interpretation of, applicable laws, regulations or policies of the USDA, state regulators or similar foreign regulatory

authorities that relate to the use of the word “meat” or other similar words in connection with cultured meat products could

adversely affect our business, prospects, results of operations or financial condition.

authorities that relate to the use of the terms “meat” or “poultry” or other similar terms in connection with

cultivated meat products could adversely affect our business, prospects, results of operations or financial condition.

USDA, state regulators or similar foreign regulatory authorities, such as Health Canada or the Canadian Food Inspection Agency, or CFIA,

or authorities of the EU or the EU member states ( e.g., European Food Safety Authority, or EFSA), could take action to impact

our ability to use the term “meat” or similar words, such as “beef”, to describe the product.

In addition, a food

may be deemed misbranded if its labeling is false or misleading in any particular way, and the USDA, CFIA, EFSA or other regulators could

interpret the use of the term “meat” or any similar phrase(s) to describe our cultured meat products as false or misleading

or likely to create an erroneous impression regarding their composition.

In the U.S., the USDA will develop new labeling requirements

or authorities of the EU or the EU member states ( e.g., European Food Safety Authority, or EFSA), could take action that impacts

our customers’ ability to use the term “meat” or “poultry” or similar words, such as “beef”

or “chicken” , to describe their finished products.

In addition, a food may be deemed misbranded if its labeling is false

or misleading in any particular way, and the USDA, CFIA, EFSA or other regulators could interpret the use of the terms “meat”

or “poultry” or any similar phrase(s) to describe our customers’ cultivated meat products as false or misleading or

likely to create an erroneous impression regarding their composition.

In the U.S., the USDA intends to issue new labeling requirements

for foods under its jurisdiction produced through cell culture technology as noted in an ANPR published in September 2021.

Our various new lines of business, including

our cell-based coffee business vertical, PluriAgtech, and Ever After Foods, are new businesses with limited operating activity to date,

and their success is dependent on the ability to deliver a high-quality product while overcoming multiple challenges.

The success of our various

new lines of business is difficult to predict due to our lack of operational history in these industries, and we will be dependent on

our ability to meet a number of challenges.

Because our new lines of business have a limited operating history, these lines of business

may not be able to deliver a successful high-quality product at the scale production they aim to deliver.

The success of these lines of

business will be primarily, but not only, dependent on their ability to develop manufacturing solutions, and leveraging Pluri’s

3D cell expansion technology to create compelling products.

If our businesses will not be able to successfully meet these challenges,

and our prospects, business, financial condition and results of operations could be adversely impacted.

In addition, certain of our

lines of business, such PluriAgtech, Ever After Foods and Coffeesai, will be subject to changing laws, rules and regulations in the United

States, Israel, Asia Pacific, the European Union and other jurisdictions.

Such laws and regulations may negatively impact their ability

to expand their businesses and pursue business opportunities.

Our subsidiaries may also incur significant expenses to comply with the

laws, regulations and other obligations that will apply to them.

We may need to

raise additional financing to support PluriAgtech’s and Coffeesai’s business verticals and the research, development and manufacturing

of their respective products.

If we are unable to obtain additional financing to meet their needs, their operations may be adversely affected

or terminated .

It is highly likely that we

will need to raise significant additional capital from investors in the future to finance PluriAgtech’s and Coffeesai’s business

vertical operations.

Our current capital may not be sufficient to finance PluriAgtech’s and Coffeesai’s operations until we

are able to complete the development of a high-quality coffee, if that ever happens.

If we are not able to find investors and obtain additional

financing, PluriAgtech’s and Coffeesai’s operations may be adversely affected or terminated.

products utilizing our 3D cell expansion technology may be subject to regulations that could adversely affect its business and results

of operations.

In the cultivated coffee space,

we are working with an external regulatory consultant to evaluate the technical and scientific requirements for determining whether the

cultured coffee product is GRAS under section 201(s) of the FDCA and FDA’s implementing regulations (21 C.F.R.

the Coffeesai cultivated coffee product (including all of its components) is determined to be GRAS in accordance with FDA requirements,

it will be exempt from the definition of “food additive” in section 201(s) of the FDCA, and may therefore be lawfully marketed

as a food in the U.S.

without the need to obtain a premarket authorization from FDA.

However, if the Coffeesai cultivated coffee product

(including any of its components) is not determined to be GRAS, it or the particular non-GRAS component would be considered a “food

additive” under section 201(s) of the FDCA;

this, in turn, would mean that the ingredient could only be lawfully marketed in the

United States.

if it was authorized for its intended use under a food additive regulation and otherwise complied with other food safety,

facility registration, and labeling requirements.

If Coffeesai determines that the product is not authorized for its intended use under

an existing food additive regulation, Coffeesai may need to submit a food additive petition to request that FDA issue a new food additive

regulation authorizing the ingredient for its intended use.

Additionally, before marketing

the cultivated coffee product in the Unites States, Coffeesai will also need to ensure that the product is labeled in accordance with

applicable FDA food labeling requirements established under section 403 of the FDCA and FDA’s implementing regulations (21 C.F.R.

Part 101), manufactured at an FDA-registered food facility pursuant to section 415 of the FDCA and FDA’s implementing regulations

Part 1, Subpart H), and manufactured in accordance with all applicable FDA food safety requirements including, but not limited

to, FDA’s Hazard Analysis and Preventive Controls and Current Good Manufacturing Practice requirements (21 C.F.R.

FDA regulatory requirements may apply if Coffeesai plans to import the cultivated coffee product into the United States, including requirements

for submitting prior notice of imported foods to FDA (21 C.F.R.

Part 1, Subpart I) and complying with Foreign Supplier Verification requirements

Part 1, Subpart L) as applicable.

Risk Related to Commercialization of Our Product

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joint ventures or licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates.

One of the elements of our

business strategy is to license our technology to other companies.

Our business strategy includes development and in-house manufacturing

of innovative new cell- based products and solutions powered by our 3D cell expansion technology platforms and establishing joint ventures

and partnerships that leverage our cell expansion technology and cell-based product portfolio to expand product pipelines and meet cell-based

manufacturing needs for a variety of industries.

To date, we have a strategic partnership with Tnuva to use our technology to establish

a cultivated food platform, with CHA for both the IC and CLI indications in South Korea and with Chart for the thawing device.

Notwithstanding,

we may not be able to further establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize

our product candidates.

One of the elements of our business strategy is to collaborate with

partners and to license our technology to other companies.

Our business strategy includes development and in-house manufacturing of innovative

new cell- based products and solutions powered by our 3D cell expansion technology platforms and establishing joint ventures and partnerships

that leverage our cell expansion technology and cell-based product portfolio to expand product pipelines and meet cell-based manufacturing

needs for a variety of industries.

To date, we have established Ever After Foods, a strategic partnership with Tnuva, with ICL Group for

advanced bioactive carriers and bio stimulants, with Wilk Technologies to develop cultured human breast and animal milk products and with

an undisclosed - leading international agriculture corporation to enhance the global sustainable vegetable supply.

Notwithstanding, we may not

be able to further establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize our product

Even if we are able to maintain

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our product candidates.

Our agreements with our collaborators

and licensees may have provisions that give rise to disputes regarding the rights and obligations of the parties.

These and other possible

disagreements could lead to termination of the agreement or delays in collaborative research, development, supply, or commercialization

of certain product candidates, or could require or result in litigation or arbitration.

Moreover, disagreements could arise with our

collaborators over rights to intellectual property or our rights to share in any of the future revenues of products developed by our

collaborators.

These kinds of disagreements could result in costly and time-consuming litigation.

Any such conflicts with our collaborators

could reduce our ability to obtain future collaboration agreements and could have a negative impact on our relationship with existing

collaborators.

Our agreements with our collaborators and licensees may have provisions

that give rise to disputes regarding the rights and obligations of the parties.

These and other possible disagreements could lead to termination

of the agreement or delays in collaborative research, development, supply, or commercialization of certain product candidates, or could

require or result in litigation or arbitration.

Moreover, disagreements could arise with our collaborators over rights to IP or our rights

to share in any of the future revenues of products developed by our collaborators.

These kinds of disagreements could result in costly

and time-consuming litigation.

Any such conflicts with our collaborators could reduce our ability to obtain future collaboration agreements

and could have a negative impact on our relationship with existing collaborators.

The market for our cell therapy products will be heavily dependent

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ability to develop and protect our technology and our cell therapy products.

If our patents and proprietary rights agreements do not

provide sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer.

If our patents and proprietary rights agreements do not provide

sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer.

Our success will also depend

in part on our ability to develop our technology and commercialize our products without infringing the proprietary rights of others.

We have not conducted full freedom of use patent searches and no assurance can be given that patents do not exist or could not be filed

which would have an adverse effect on our ability to develop our technology or maintain our competitive position with respect to our

potential cell therapy products.

If our technology components, devices, designs, products, processes or other subject matter are claimed

under other existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject

to infringement actions.

In such event, we may challenge the validity of such patents or other proprietary rights, or we may be required

to obtain licenses from such companies in order to develop, manufacture or market our technology or products.

There can be no assurances

that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms.

Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing

our proposed products or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which

could have a material adverse effect on our business, financial condition and results of operations.

If we are required to defend ourselves

against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred

regardless of whether we are successful.

have not conducted full freedom of use patent searches and no assurance can be given that patents do not exist or could not be filed which

would have an adverse effect on our ability to develop our technology or maintain our competitive position with respect to our potential

cell therapy products.

If our technology components, devices, designs, products, processes or other subject matter are claimed under other

existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement

In such event, we may challenge the validity of such patents or other proprietary rights, or we may be required to obtain licenses

from such companies in order to develop, manufacture or market our technology or products.

There can be no assurances that we would be

able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms.

Furthermore, the

failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed products

or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which could have a material

adverse effect on our business, financial condition and results of operations.

If we are required to defend ourselves against charges

of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether

we are successful.

Such proceedings are typically protracted with no certainty of success.

An adverse outcome could

subject us to significant liabilities to third parties and force us to curtail or cease our development of our technology and the commercialization

our potential cell therapy products.

We have built the ability

to manufacture clinical grade adherent stromal cells in-house.

Through our experience with adherent stromal cell-based product development,

we have developed expertise and know-how in this field.

To protect these expertise and know-how, our policies require confidentiality

agreements with our employees, consultants, contractors, manufacturers and advisors.

These agreements generally provide for protection

of confidential information, restrictions on the use of materials and assignment of inventions conceived during the course of performance

These agreements might not effectively prevent disclosure of our confidential information.

An adverse outcome could subject us to significant

liabilities to third parties and force us to curtail or cease our development of our technology and the commercialization our potential

cell therapy products.

We have built the ability to manufacture clinical grade adherent stromal

cells in-house.

Through our experience with adherent stromal cell-based product development, we have developed expertise and know-how

in this field.

We also have built the ability to grow on a large scale various immune cells including engineered placental MAIT cells

for use in cell therapy.

Additionally, we have built the ability to grow on a large scale plant cells for various agtech uses.

these expertise and know-how, our policies require confidentiality agreements with our employees, consultants, contractors, manufacturers

and advisors.

These agreements generally provide for protection of confidential information, restrictions on the use of materials and

assignment of inventions conceived during the course of performance for us.

These agreements might not effectively prevent disclosure

of our confidential information.

Third parties may initiate legal proceedings

alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material

adverse effect on our business.

alleging that we are infringing their IP rights, the outcome of which would be uncertain and could have a material adverse effect on our

Our commercial success depends

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to third parties.

We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property

rights with respect to our products and technology, including interference proceedings before the U.S.

We may become party to, or threatened with, future adversarial proceedings or litigation regarding IP rights with respect

to our products and technology, including interference proceedings before the U.S.

Patent and Trademark Office.

parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

If we are found

to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue

developing and marketing our products and technology.

However, we may not be able to obtain any required license on commercially reasonable

terms or at all.

Third parties may assert

infringement claims against us based on existing patents or patents that may be granted in the future.

If we are found to infringe a third

party’s IP rights, we could be required to obtain a license from such third party to continue developing and marketing our products

and technology.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain

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We may need to seek a license for one or more of these patents.

assurances can be given that such a license will be available on commercially reasonable terms, if at all.

Claims that we have misappropriated

the confidential information or trade secrets of third parties could have a similar negative impact on our business.

Even if resolved in our favor,

litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract

our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results

of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be

negative, it could have a substantial adverse effect on the price of our common shares.

Such litigation or proceedings could substantially

increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution

We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings.

competitors are able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material

adverse effect on our ability to compete in the marketplace.

patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be

patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions

and has in recent years been the subject of much litigation.

As a result, the issuance, scope, validity, enforceability and commercial

value of our and any future licensors’ patent rights are highly uncertain.

Our pending and future patent applications may not result

in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive

technologies and products.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries

may diminish the value of our patents or narrow the scope of our patent protection.

The laws of foreign countries may not protect our

rights to the same extent as the laws of the United States and we may not be able to obtain meaningful patent protection for any of our

commercial products either in or outside the United States.

assurance can be given that the scope of any patent protection granted will exclude competitors or provide us with competitive advantages,

that any of the patents that have been or may be issued to us will be held valid if subsequently challenged, or that other parties will

not claim rights to or ownership of our patents or other proprietary rights that we hold.

Furthermore, there can be no assurance that

others have not developed or will not develop similar products, duplicate any of our technology or products or design around any patents

that have been or may be issued to us or any future licensors.

Since patent applications in the United States and in Europe are not publicly

disclosed until patents are issued, there can be no assurance that others did not first file applications for products covered by our

pending patent applications, nor can we be certain that we will not infringe any patents that may be issued to others.

Related to Our Common Shares

price of our common shares may fluctuate significantly.

market for our common shares may fluctuate significantly.

A number of events and factors may have an adverse impact on the market price

of our common shares, such as:

No assurances

can be given that such a license will be available on commercially reasonable terms, if at all.

Claims that we have misappropriated the

confidential information or trade secrets of third parties could have a similar negative impact on our business.

Even if resolved in our favor, litigation or other legal proceedings

relating to IP claims may cause us to incur significant expenses and could distract our technical and management personnel from their

normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings

or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect

on the price of our common shares.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources

available for development activities or any future sales, marketing or distribution activities.

We may not have sufficient financial or

other resources to adequately conduct such litigation or proceedings.

Some of our competitors are able to sustain the costs of such litigation

or proceedings more effectively than we can because of their greater financial resources.

Uncertainties resulting from the initiation

and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

The patent approval process is complex, and we cannot be

sure that our pending patent applications or future patent applications will be approved.

The patent position of biotechnology

and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been

the subject of much litigation.

As a result, the issuance, scope, validity, enforceability and commercial value of our and any future

licensors’ patent rights are highly uncertain.

Our pending and future patent applications may not result in patents being issued

which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value

of our patents or narrow the scope of our patent protection.

The laws of foreign countries may not protect our rights to the same extent

as the laws of the United States and we may not be able to obtain meaningful patent protection for any of our commercial products either

in or outside the United States.

No assurance can be given

that the scope of any patent protection granted will exclude competitors or provide us with competitive advantages, that any of the patents

that have been or may be issued to us will be held valid if subsequently challenged, or that other parties will not claim rights to or

ownership of our patents or other proprietary rights that we hold.

Furthermore, there can be no assurance that others have not developed

or will not develop similar products, duplicate any of our technology or products or design around any patents that have been or may be

issued to us or any future licensors.

Since patent applications in the United States and in Europe are not publicly disclosed until patents

are issued, there can be no assurance that others did not first file applications for products covered by our pending patent applications,

nor can we be certain that we will not infringe any patents that may be issued to others.

Risk Related to Our Common

The price of our common shares may fluctuate significantly.

The market for our common

shares may fluctuate significantly.

A number of events and factors may have an adverse impact on the market price of our common shares,

of our clinical trials or adverse events associated with our products;

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conditions for pharmaceutical and biotechnology shares in particular;

in laws and governmental regulations, including changes in tax, healthcare, competition and

in laws and governmental regulations, including changes in tax, healthcare, competition and patent laws;

concerning patents or proprietary rights;

accounting pronouncements or regulatory rulings;

announcements regarding medical advances in the treatment of the disease states that we are

announcements regarding medical advances in the treatment of the disease states that we are targeting;

or proprietary rights developments;

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sales of our common shares, or the perception of such sales;

● disruptions

in our manufacturing processes;

addition, a global pandemic, such as the COVID-19 pandemic and a market downturn in general and/or in the biopharmaceutical sector in

particular, may adversely affect the market price of our securities, which may not necessarily reflect the actual or perceived value

of our Company.

could fail to maintain the listing of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability

to raise capital or complete a strategic transaction.

April 19, 2023, we received a letter, or Notice, from Nasdaq, advising us that for 30 consecutive trading days preceding the date of

the Notice, the bid price of our common shares had closed below the $1.00 per share minimum required for continued listing on Nasdaq

pursuant to Nasdaq Listing Rule 5450(a)(1), or MBPR.

The Notice had no effect on the listing of our common shares , and our common shares

continue to trade on Nasdaq under the symbol “PLUR”.

Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar days period following the date of the Notice the closing bid price of our

common shares is at or above $1.00 for a minimum of 10 consecutive business days, we will regain compliance with the MBPR and our common

shares will continue to be eligible for listing on Nasdaq, absent noncompliance with any other requirement for continued listing.

compliance period, or Compliance Period, to comply with the MBPR will expire on October 16, 2023.

we do not regain compliance with the MBPR by the end of the Compliance Period, then under Nasdaq Listing Rule 5810(c)(3)(A)(i) we may

transfer to The Nasdaq Capital Market, provided that we meet the applicable market value of publicly held shares requirement for continued

listing as well as all other standards for initial listing of our common shares on the Nasdaq Capital Market (other than the MBPR) and

notify Nasdaq of our intention to cure the deficiency.

Following a transfer to The Nasdaq Capital Market, we may be afforded an additional

180-days to regain compliance with the MBPR.

of the date of this filing, our common shares are trading below $1.00 per share.

If we do not regain compliance with the MBPR by the

end of the Compliance Period (or the Compliance Period as may be extended), our common shares will be subject to delisting.

● competition.

In addition, a global pandemic,

such as the COVID-19 pandemic and a market downturn in general and/or in the biopharmaceutical sector in particular, may adversely affect

the market price of our securities, which may not necessarily reflect the actual or perceived value of our Company.

We could fail to maintain the listing

of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a

strategic transaction.

On May 28, 2024, we received

a deficiency letter, or the Nasdaq Letter, from the Listing Qualifications Department of Nasdaq, notifying us that we were not in compliance

with Nasdaq Listing Rule 5550(b)(1), which requires us to maintain a minimum of $2.5 million in stockholders’ equity for continued

listing on The Nasdaq Capital Market, or the Stockholders’ Equity Requirement, nor were we in compliance with either of the alternative

listing standards, a market value of listed securities of at least $35 million or net income of $0.5 million from continuing operations

in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

Pursuant to the Nasdaq Letter,

on July 11, 2024, we submitted a plan to Nasdaq to regain compliance, or the Compliance Plan.

Based on the Compliance Plan, Nasdaq has

determined to grant us an extension of time to regain compliance with the Stockholders’ Equity Requirement until November 24, 2024.

If we fail to evidence compliance by the required deadline, we may be subject to delisting.

At that time, we may appeal Staff’s

determination to a Hearings Panel.

we do not regain compliance with the Stockholders’ Equity Requirement, our common shares will be subject to delisting.

from Nasdaq would likely result in a reduction in some or all of the following, each of which could have a material adverse effect on

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number of market markers or broker-dealers for our common shares.

intend to monitor the closing bid price of our common shares and may, if appropriate, consider implementing available options to regain

compliance with the MBPR under the Nasdaq Listing Rules, including initiating a reverse stock split.

sales of our common shares may cause dilution.

sales of our common shares, or the perception that such sales may occur, could cause immediate dilution and adversely affect the market

price of our common shares.

If we raise additional capital by issuing equity securities, the percentage ownership of our existing shareholders

may be reduced, and accordingly these shareholders may experience substantial dilution.

We may also issue equity securities that provide

for rights, preferences and privileges senior to those of our common shares.

Given our need for cash and that equity raising is the most

common type of fundraising for companies like ours, the risk of dilution is particularly significant for shareholders of our company.

Related to Foreign Exchange Rates

are exposed to fluctuations in currency exchange rates.

significant portion of our business is conducted outside the United States.

Therefore, we are exposed to currency exchange fluctuations

in other currencies such as the NIS and the Euro.

A significant portion of our expenses in Israel are paid in NIS, and we have also received

€20 million pursuant to the EIB Finance Agreement, that bears 4% annual interest.

All of these factors subject us to the risks of

foreign currency fluctuations.

intend to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq.

there can be no assurance we will ultimately regain compliance with all applicable requirements for continued listing.

Future sales of our common shares may cause dilution.

Future sales of our common

shares, or the perception that such sales may occur, could cause immediate dilution and adversely affect the market price of our common

If we raise additional capital by issuing equity securities, the percentage ownership of our existing shareholders may be reduced,

and accordingly these shareholders may experience substantial dilution.

We may also issue equity securities that provide for rights, preferences

and privileges senior to those of our common shares.

Given our need for cash and that equity raising is the most common type of fundraising

for companies like ours, the risk of dilution is particularly significant for shareholders of our company.

Risks Related to Foreign Exchange Rates

We are exposed to fluctuations in currency exchange rates.

A significant portion of our

business is conducted outside the United States.

Therefore, we are exposed to currency exchange fluctuations in other currencies such

as the NIS and the Euro.

A significant portion of our expenses in Israel are paid in NIS, and we have also received €20 million pursuant

to the EIB Finance Agreement, that bears 4% annual interest.

All of these factors subject us to the risks of foreign currency fluctuations.

Our primary expenses paid in NIS are employee salaries, and lease payments on our facilities.

to time, we may apply a hedging strategy by using options and forward contracts to protect ourselves against some of the risks of currency

exchange fluctuations and we are actively monitoring the exchange rate differences of the NIS, Euro and U.S.

however, we are

still exposed to potential losses from currency exchange fluctuation.

cash may be subject to a risk of loss.

assets include a significant component of cash and cash equivalents and bank deposits.

We adhere to an investment policy set

by our investment committee which aims to preserve our financial assets, maintain adequate liquidity and maximize returns.

that our cash is held in institutions whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected

in our consolidated financial statements as of June 30, 2023.

From time to time, we may apply a hedging

strategy by using options and forward contracts to protect ourselves against some of the risks of currency exchange fluctuations and we

are actively monitoring the exchange rate differences of the NIS, Euro and U.S.

however, we are still exposed to potential losses

from currency exchange fluctuation.

Our cash may be subject to a risk of loss.

Our assets include a significant

component of cash and cash equivalents and bank deposits.

We adhere to an investment policy set by our investment committee which

aims to preserve our financial assets, maintain adequate liquidity and maximize returns.

We believe that our cash is held in institutions

whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected in our consolidated financial statements

as of June 30, 2024.

Currently, we hold most of our cash assets in bank deposits in Israel.

However, nearly all of our cash and bank deposits are not insured by the Federal Deposit Insurance Corporation, or the FDIC, or

similar governmental deposit insurance outside the United States.

Therefore, our cash and any bank deposits that we now hold or

may acquire in the future may be subject to risks, including the risk of loss or of reduced value or liquidity, particularly in light

of the increased volatility and worldwide pressures in the financial and banking sectors.

we received grants from the IIA, we are subject to on-going restrictions.

However, nearly all of our cash and bank deposits

are not insured by the Federal Deposit Insurance Corporation, or the FDIC, or similar governmental deposit insurance outside the

United States.

Therefore, our cash and any bank deposits that we now hold or may acquire in the future may be subject to risks, including

the risk of loss or of reduced value or liquidity, particularly in light of the increased volatility and worldwide pressures in the financial

and banking sectors.

Risk Related to Our Industries

The trend towards consolidation in the pharmaceutical and biotechnology

industries may adversely affect us.

There is a trend towards consolidation

in the pharmaceutical and biotechnology industries.

This consolidation trend may result in the remaining companies having greater financial

resources and technical discovery capabilities, thus intensifying competition in these industries.

This trend may also result in fewer

potential collaborators or licensees for our therapeutic product candidates.

Also, if a consolidating company is already doing business

with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.

This trend may adversely affect

our ability to enter into license agreements or agreements for the development and commercialization of our product candidates, and as

a result may materially harm our business.

If we do not keep pace with our competitors

and with technological and market changes, our technology and products may become obsolete, and our business may suffer.

The cellular therapeutics

industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid and intense.

We have faced,

and will continue to face, intense competition from biotechnology, pharmaceutical and biopharmaceutical companies, academic and research

institutions and governmental agencies engaged in cellular therapeutic and drug discovery activities or funding, both in the United States

and internationally.

Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target

the same diseases and conditions that we target in our clinical and pre-clinical programs.

Some of our competitors have

greater resources, more product candidates and have developed product candidates and processes that directly compete with our products.

Our competitors may have developed, or could develop in the future, new products that compete with our products or even render our products

Moreover, the alternative

protein market is highly competitive, with numerous brands vying for limited space in retail, foodservice, and consumer preference.

succeed, Ever After Foods’ cultured meat products must excel in costs, taste, ingredients, marketing and branding.

Generally, the

food industry is dominated by multinational corporations with substantially greater resources and operations than Ever After Foods.

cannot be certain that Ever After Foods will successfully compete with larger competitors that have greater financial, marketing, sales,

manufacturing, distributing and technical resources.

Conventional food companies may acquire Ever After Foods’ competitors or launch

their own competing products, and they may be able to use their resources and scale to respond to competitive pressures and changes in

consumer preferences by introducing new products, reducing prices or increasing promotional activities, among other things.

pressures or other factors could prevent Ever After Foods from acquiring market share or cause us to lose market share, which may require

Ever After Foods to lower prices, or increase marketing and advertising expenditures, either of which would adversely affect its margins

and could result in a decrease in its operating results and profitability.

We cannot assure that we will be able to maintain a competitive

position or compete successfully against such sources of competition.

Potential product liability claims could

adversely affect our future earnings and financial condition.

We face an inherent business

risk of exposure to product liability and CDMO service claims in the event that the use of our products or CDMO services results in adverse

We may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms.

Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.

Risk Related to Our Dependence on Third Parties

We are dependent upon third party suppliers

for raw materials needed to manufacture PLX;

if any of these third parties fails or is unable to perform in a timely manner, our ability

to manufacture and deliver will be compromised.

In addition to the placenta

used in the clinical manufacturing process of PLX, we require certain raw materials.

These items must be manufactured and supplied to

us in sufficient quantities and in compliance with current GMP.

To meet these requirements, we have entered into supply agreements with

firms that manufacture these raw materials to current GMP standards.

Our requirements for these items are expected to increase if and

when we transition to the manufacture of commercial quantities of our cell-based drug candidates.

In addition, as we proceed

with our trial efforts, we must be able to continuously demonstrate to the FDA, EMA and other regulatory authorities that we can manufacture

our cell therapy product candidates with consistent characteristics.

Accordingly, we are materially dependent on these suppliers for supply

of current GMP-grade materials of consistent quality.

Our ability to complete ongoing clinical trials may be negatively affected in the

event that we are forced to seek and validate a replacement source for any of these critical materials.

We intend to decrease our

dependency in third party suppliers for raw materials.

To that effect we have developed a serum-free formulation which is expected 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 with operational

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

There can be no guarantee that

we will successfully implement the use of our serum-free formulation to support the manufacturing of cell therapy products or any other

future product candidates, if any, that we seek to produce using such formulation, or that such implementation of the serum-free formulation

will decrease our dependency on third party suppliers for raw materials.

With respect to CAR/TCR-MAIT products for

immune-oncology, we are dependent upon third party suppliers for the construct of Chimeric Antigen Receptor, or CAR, or TCR, needed to

manufacture the final product;

if these third parties fail or are unable to perform in a timely manner, our ability to manufacture and

deliver the final product will be compromised.

In addition to the placenta

used in the manufacturing process of extracting MAIT cells, the construct of CAR or TCR is needed for the manufacturing of the final product.

The final product would be allogeneic placental derived MAIT cells transduced with CAR or TCR construct.

The construct must be manufactured

and supplied to us in sufficient quantities and in compliance with current GMP by a third party.

To meet these requirements, we have started

discussions with potential partners and manufacturers that obtain IP rights for these constructs, engaging in feasibility tests to ensure

compliance with our MAIT cells and requirements.

In addition to ensuring a

proper partner or supplier to manufacture the construct, we must succeed in incorporating the construct into the MAIT cells to create

a sufficient number of final products, i.e CAR or TCR-MAIT products.

As a first POC, the final product will be tested for efficacy and

safety in pre-clinical setting and the process development will be finalized to allow pre-IND readiness and proceed to clinical development.

If these potential partners

and manufactures fail to deliver sufficient construct in a timely manner and in compliance with current GMP, our ability to incorporate

the construct in the MAIT cells to create sufficient number of final products will be compromised.

A cybersecurity incident, other technology disruptions

or failure to comply with laws and regulations relating to privacy and the protection of data relating to individuals could negatively

impact our business and our reputation.

We have relied on and utilize

services provided by third parties in connection with our clinical trials, which services involve the collection, use, storage and analysis

of personal health information.

While we receive assurances from these vendors that their services are compliant with the Health Insurance

Portability and Accountability Act, or HIPAA, and other applicable privacy laws, there can be no assurance that such third parties will

comply with applicable laws or regulations.

Non-compliance by such vendors may result in liability for us which would have a material

adverse effect on our business, financial conditions and results of operations.

During November 2021, we experienced

a cybersecurity incident in which one or more third parties were able to impersonate one of our vendors by using a falsified email domain

account and asked to make a payment to a false bank account.

As a result of this incident, the third parties managed to extract a sum

of approximately $616,000 from us.

Following the incident, we hired the services of a cybersecurity investigation firm to fully access

the incident and notified the appropriate government authorities, including the banks involved in the transaction.

During February 2022,

with the assistance of local and global law enforcement agencies, we were able to recover an amount of approximately $412,000 from the

false bank account.

Together with the reimbursement received from our insurance company, we were able to recover the full amount lost.

The cybersecurity incident

has not had any material effect on our ability to meet our financial obligations, including our ability to carry out our operations and

business activities, and our investigation has confirmed that, other than the funds referenced above, none of our information or data

was stolen or damaged.

Nonetheless, despite the implementation of security measures, including the steps we have taken following the November

2021 cybersecurity incident, our internal computer systems and those of our current and future clinical research organization or CROs

and other contractors and consultants may not prevent future incidents of a similar nature or other cyber-attacks.

We are constantly exploring

new and advanced security protection measures to prevent future cybersecurity incidents.

“Cybersecurity”, for

additional information.

Future security breaches or

any material system failure events could result in a material disruption of our development programs and our business operations.

example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts

and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security breach were to result

in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could

incur liability and the further development and commercialization of our product candidates could be delayed.

addition, we are subject to laws, rules and regulations in the Israeli, United States, the EU and other jurisdictions relating to the

collection, use and security of personal information and data.

Such data privacy laws, regulations and other obligations may require us

to change our business practices and may negatively impact our ability to expand our business and pursue business opportunities.

incur significant expenses to comply with the laws, regulations and other obligations that apply to us.

Additionally, the privacy- and

data protection-related laws, rules and regulations applicable to us are subject to significant change.

Several jurisdictions have passed

new laws and regulations in this area, and other jurisdictions are considering imposing additional restrictions.

Privacy- and data protection-related

laws and regulations also may be interpreted and enforced inconsistently over time and from jurisdiction to jurisdiction.

Any actual or

perceived inability to comply with applicable privacy or data protection laws, regulations, or other obligations could result in significant

cost and liability, litigation or governmental investigations, damage our reputation, and adversely affect our business.

Unsuccessful compliance with certain European

privacy regulations could have an adverse effect on our business and reputation.

The collection and use of

personal health data in the EU is governed by the provisions of the General Data Protection Regulation, or GDPR.

This directive imposes

several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals,

notification of data processing obligations to the competent national data protection authorities and the security and confidentiality

of the personal data.

The GPDR also extends the geographical scope of EU data protection law to non-EU entities under certain conditions,

tightens existing EU data protection principles and creates new obligations for companies and new rights for individuals.

Failure to comply

with the requirements of the GDPR and the related national data protection laws of the EU member States may result in fines and other

administrative penalties.

There may be circumstances under which a failure to comply with GDPR, or the exercise of individual rights under

the GDPR, would limit our ability to utilize clinical trial data collected on certain subjects.

The GDPR regulations impose additional

responsibility and liability in relation to personal data that we process, and we intend to put in place additional mechanisms ensuring

compliance with these and/or new data protection rules.

Changes to these European

privacy regulations and unsuccessful compliance may be onerous and adversely affect our business, financial condition, prospects, results

of operations and reputation.

We may be exposed to liabilities under the Foreign Corrupt Practices

Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business.

We are subject to the Foreign

Corrupt Practice Act, or FCPA, and other laws that prohibit U.S.

companies or their agents and employees from providing anything of value

to a foreign official or political party for the purposes of influencing any act or decision of these individuals in their official capacity

to help obtain or retain business, direct business to any person or corporate entity or obtain any unfair advantage.

We have operations

and agreements with third parties.

Our international activities create the risk of unauthorized and illegal payments or offers of payments

by our employees or consultants, even though they may not always be subject to our control.

We discourage these practices by our employees

and consultants.

However, our existing safeguards and any future improvements may prove to be less than effective, and our employees or

consultants, may engage in conduct for which we might be held responsible for Any failure by us to adopt appropriate compliance procedures

and ensure that our employees and consultants comply with the FCPA and applicable laws and regulations in foreign jurisdictions could

result in substantial penalties or restrictions on our ability to conduct business in certain foreign jurisdictions.

Violations of the FCPA may

result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business,

operating results, and financial condition.

In addition, the U.S.

government may seek to hold our Company liable for successor liability

FCPA violations committed by companies in which we invest or that we acquire.

Since we received grants from the IIA, we are subject to on-going

restrictions.

We have received royalty-bearing

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The terms of the IIA’s grants limit our

ability to transfer know-how developed under an approved research and development program, and/or the manufacturing of products developed

under an approved research and development program, outside of Israel, regardless of whether the royalties are fully paid.

Any non-Israeli

citizen, resident or entity that, among other things, becomes a holder of 5% or more of our share capital or voting rights, is entitled

to appoint one or more of our directors or our Chief Executive Officer, or CEO, serves as a director of our Company or as our CEO is generally

required to notify the same to the IIA and to undertake to observe the law governing the grant programs of the IIA, the principal restrictions

of which are the transferability limits described above.

To the extent a company wishes to transfer its IIA-supported know-how outside

of Israel - the IIA acts under the Law for the Encouragement of Research, Development and Technological Innovation in the Industry 1984

and the related IIA rules and regulations, it must be preapproved by the IIA and the company may be required to pay an additional payment

The minimum amount of the payment is the total sum of grants received plus interest and the maximum amount shall be no higher

than six times the total sum of grants received plus interest.

In the case that the IIA-supported company retains its research and development

center in Israel for at least three consecutive years, following the year of transferring the IIA-supported know-how outside of Israel,

while maintaining at least 75% of its research and development employees in Israel – the payment will be limited to three times

the total sum of grants received plus interest.

ability to transfer know-how developed under an approved research and development program (by way of sale and/or granting a license to

use the IP), and/or the manufacturing of products developed under an approved research and development program, outside of Israel, regardless

of whether the royalties are fully paid.

Any non-Israeli citizen, resident or entity that, among other things, becomes a holder of 5%

or more of our share capital or voting rights, is entitled to appoint one or more of our directors or our Chief Executive Officer, or

CEO, serves as a director of our Company or as our CEO is generally required to notify the same to the IIA and to undertake to observe

the law governing the grant programs of the IIA, the principal restrictions of which are the transferability limits described above.

the extent a company wishes to transfer its IIA-supported know-how outside of Israel (by way of sale and/or granting a license to use

the IP) – the IIA acts under the Law for the Encouragement of research, Development and Technological Innovation in the Industry

1984 and the related IIA rules and regulations, it must be preapproved by the IIA and the company may be required to pay an additional

payment to the IIA.

The minimum amount of the payment is the total sum of grants received plus interest and the maximum amount shall be

no higher than six times the total sum of grants received plus interest.

In the case that the IIA-supported company sells the IP but retains

its research and development center in Israel for at least three consecutive years, following the year of transferring the IIA-supported

know-how outside of Israel, while maintaining at least 75% of its research and development employees in Israel – the payment will

be limited to three times the total sum of grants received plus interest.

For more information, see “Item 7.

Management’s Discussion and Analysis of

Financial Condition and Results of Operations - Liquidity and Capital Resources.”

global inflation may adversely affect our business results.

could affect our ability to purchase materials needed to support our research, development and operational activities, which in turn

could result in higher burn rate and a higher end price of our future products.

As a result, we may not be able to effectively develop

our cell-based product candidates or cultivated meat products.

If we are not able to successfully manage inflation, our prospects, business,

financial condition, and results of operations could be adversely impacted.

Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.”

Recent global inflation

may adversely affect our business results.

could affect our ability to purchase materials needed to support our research, development and operational activities, which in turn could

result in higher burn rate and a higher end price of our future products.

As a result, we may not be able to effectively develop our cell-based

product candidates or cultivated meat products.

If we are not able to successfully manage inflation, our prospects, business, financial

condition, and results of operations could be adversely impacted.

Non-compliance

with environmental, social, and governance, or ESG, practices could harm our reputation, or otherwise adversely impact our business,

while increased attention to ESG initiatives could increase our costs.

with environmental, social, and governance, or ESG, practices could harm our reputation, or otherwise adversely impact our business, while

increased attention to ESG initiatives could increase our costs.

across industries are facing increasing scrutiny from a variety of stakeholders related to their ESG and sustainability practices.

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effect and may be costly.

addition, we may commit to certain initiatives or goals but not ultimately achieve such commitments or goals due to factors that are

both within or outside of our control.

addition, we may commit to certain initiatives or goals but not ultimately achieve such commitments or goals due to factors that are both

within or outside of our control.

Moreover, actions or statements that we may take based on expectations, assumptions, or third-party

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costs or scrutiny.

around a company’s management of ESG matters continues to evolve rapidly, in many instances due to factors that are out of our

To the extent ESG matters negatively impact our reputation, it may also impede our ability to compete as effectively to

attract and retain employees or customers, which may adversely impact our operations.

we have signed the EIB Finance Agreement, we agreed to guaranty the loan as well as agreed to limitations that require us to notify the

European Investment Bank, or EIB, and in some cases obtain their approval, before we engage with other banks for additional sources of

funding or with potential partners for certain strategic activities.

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.

principal research and development and manufacturing facilities are located in Israel and the unstable military and political conditions

of Israel may cause interruption or suspension of our business operations without warning.

principal research and development and manufacturing facilities are located in Israel.

As a result, we are directly influenced by the

political, economic, and military conditions affecting Israel.

Since the establishment of the State of Israel in 1948, a number of armed

conflicts have taken place between Israel and its Arab neighbors.

During June 2021, July and August 2014 and November 2012, Israel was

engaged in an armed conflict with a militia group and political party which controls the Gaza Strip, and during the summer of 2006, Israel

was engaged in an armed conflict with Hezbollah, a Lebanese Islamist Shiite militia group and political party.

These conflicts involved

missile strikes against civilian targets in various parts of Israel, including areas in which our employees and some of our consultants

are located, and negatively affected business conditions in Israel.

We cannot predict if or when armed conflict will take place and the

duration of each conflict.

certain of our employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called

up for active military duty at any time.

All Israeli male citizens who have served in the army are required to perform reserve duty until

they are between 40 and 49 years old, depending upon the nature of their military service.

addition, Israeli-based companies and companies doing business with Israel, have been the subject of an economic boycott by members of

the Arab League and certain other predominantly Muslim countries since Israel’s establishment.

Although Israel has entered into

various agreements with certain Arab countries and the Palestinian Authority, and various declarations have been signed in connection

with efforts to resolve some of the economic and political problems in the Middle East, we cannot predict whether or in what manner these

problems will be resolved.

Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing

the level of foreign and local investment.

Israeli government is currently pursuing extensive changes to Israel’s judicial system.

In response to the foregoing developments,

individuals, organizations and institutions, both within and outside of Israel, have voiced concerns that the proposed changes may negatively

impact the business environment in Israel including due to reluctance of foreign investors to invest or conduct business in Israel, as

well as to increased currency fluctuations, downgrades in credit rating, increased interest rates, increased volatility in securities

markets, and other changes in macroeconomic conditions.

Such proposed changes may also adversely affect the labor market in Israel or

lead to political instability or civil unrest.

Related to Our Industry

trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.

is a trend towards consolidation in the pharmaceutical and biotechnology industries.

This consolidation trend may result in the remaining

companies having greater financial resources and technical discovery capabilities, thus intensifying competition in these industries.

This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates.

Also, if a consolidating

company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.

This trend may adversely affect our ability to enter into license agreements or agreements for the development and commercialization

of our product candidates, and as a result may materially harm our business.

we do not keep pace with our competitors and with technological and market changes, our technology and products may become obsolete,

and our business may suffer.

cellular therapeutics industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid

We have faced, and will continue to face, intense competition from biotechnology, pharmaceutical and biopharmaceutical companies,

academic and research institutions and governmental agencies engaged in cellular therapeutic and drug discovery activities or funding,

both in the United States and internationally.

Some of these competitors are pursuing the development of cellular therapeutics, drugs

and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs.

of our competitors have greater resources, more product candidates and have developed product candidates and processes that directly

compete with our products.

Our competitors may have developed, or could develop in the future, new products that compete with our products

or even render our products obsolete.

Moreover, the alternative

protein market is highly competitive, with numerous brands vying for limited space in retail, foodservice, and consumer preference.

succeed, Ever After Food’s cultured meat products must excel in costs, taste, ingredients, marketing and branding.