What changed in this filing

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Item 1A. Risk Factors

2023-09-12 compared with 2022-09-21 · 573 added, 543 removed, 256 unchanged (81% of the section changed)

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

the COVID-19 pandemic has caused interruptions and delays of our

business plan and may have a adverse effect on our business;

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 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;

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;

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;

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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;

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;

our business and market potential in the field of food-tech 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.

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.

Risk Related to Our Business

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our operations may be adversely affected or terminated.

It is highly likely that we

will need to raise significant additional capital in the future.

It is highly likely that

we will need to raise significant additional capital in the future.

Although we were successful in raising capital in the past, our current

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affect the market price of our common shares.

Also, we may not be able to

raise additional capital in the future to support the development and commercialization of our products, which could result in the loss

of some or all of one’s investment in our common shares.

Also, we may not be able

to raise additional capital in the future to support the development and commercialization of our products, which could result in the

loss of some or all of one’s investment in our common shares.

Our likelihood of profitability depends

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realize any profits in the short or medium term.

Any profitability in the future from our business will be dependent upon successful commercialization

of our cell-based products and/or licensing of our products, which will require additional research and development.

Any profitability in the future from our business will be dependent upon successful

commercialization of our cell-based products and/or licensing of our products, which will require additional research and development.

If our cell therapy product

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We have a limited operating

history in our business of commercializing cell production technology and we have not generate any material revenues to date.

clear when we will generate revenues or whether we will generate revenues in the future.

We cannot give assurances that we will be able

to generate any significant revenues or income in the future.

history in our business of commercializing cell-based products and cell technology and we have not generated material revenues to date.

It is not clear when we will generate material revenues or whether we will generate material revenues in the future.

We cannot give assurances

that we will be able to generate any significant revenues or income in the future.

There is no assurance that we will ever be profitable.

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we will be successful in doing so.

date, we have focused our efforts primarily in the regenerative medicine 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.

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

as we do not have experience in areas outside of the regenerative medicine 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 the cell based products.

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.

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;

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.

Our development costs may

increase if we have material delays in a clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial.

If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA, EMA,

MOH and other regulatory authorities.

The results of our clinical trials may not

support our product candidates’ claims or any additional claims we may seek for our product candidates and our clinical trials may

result in the discovery of adverse side effects.

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.

If we will be unable to conduct

clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA, EMA, MOH and other regulatory authorities.

The results of our clinical trials may

not support our product candidates’ claims or any additional claims we may seek for our product candidates and our clinical trials

may result in the discovery of adverse side effects.

Even if any clinical trial

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or foreign authorities will agree with our conclusions regarding the results of those trials.

The clinical trial process may fail to demonstrate

that our products or a product candidate is safe and effective for the proposed indicated use, which could cause us to stop seeking additional

clearances or approvals for our product candidates.

Any delay or termination of our clinical trials will delay the filing of our regulatory

submissions and, ultimately, our ability to commercialize a product candidate.

It is also possible that patients enrolled in clinical

trials will experience adverse side effects that are not currently part of the product candidate’s profile.

The clinical trial process may fail to

demonstrate that our products or a product candidate is safe and effective for the proposed indicated use, which could cause us to stop

seeking additional clearances or approvals for our product candidates.

Any delay or termination of our clinical trials will delay the

filing of our regulatory submissions and, ultimately, our ability to commercialize a product candidate.

It is also possible that patients

enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

Favorable results from compassionate use

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Even if early-stage clinical

trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for longer

periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities outside

the United States.

Even if we are able to obtain approval for our product candidates through an accelerated approval review program, we

may still be required to conduct clinical trials after such an approval.

If we are not successful in commercializing any of our lead product

candidates, or are significantly delayed in doing so, our business will be materially harmed.

trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for

longer periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities

outside the United States.

Even if we are able to obtain approval for our product candidates through an accelerated approval review program,

we may still be required to conduct clinical trials after such an approval.

If we are not successful in commercializing any of our lead

product candidates, or are significantly delayed in doing so, our business will be materially harmed.

Our product development programs are based on novel technologies

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and obtain regulatory approval for our cell therapy candidates, the market may not understand or accept them.

We are developing cell therapy

product candidates that represent novel treatments and will compete with a number of more conventional products and therapies manufactured

and marketed by others, including major pharmaceutical companies.

The degree of market acceptance of any of our developed 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.

We are developing cell

therapy product candidates that represent novel treatments and will compete with a number of more conventional products and therapies

manufactured and marketed by others, including major pharmaceutical companies.

The degree of market acceptance of any of our developed

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.

If the health care community

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interim data and final data could significantly harm our business prospects.

Risks Related to Our Food-Tech Business

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.

business prospects are difficult to predict due to its lack of operational history in the new and emerging food tech field, and its success

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

Because it has a limited operating history in the field of cultivated

meat and it is in the early stages of development, Plurinuva may not be able to evaluate its future prospects accurately.

prospects will be primarily dependent on its ability to successfully develop industrial scale cultivated meat technologies and processes,

and market these to its potential customers.

If Plurinuva is not able to successfully meet these challenges, its prospects, business,

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

addition, Plurinuva will be subject to changing laws, rules and regulations in the Israeli, United States, Asia Pacific, the European

Risks Related to Our Cultivated Food Business

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.

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

field, and its success will be dependent on its ability to meet a number of challenges.

Because it has a limited operating history in

the field of cultivated meat and it is in the early stages of development, Ever After Foods may not be able to evaluate its future prospects

Ever After Foods’ prospects will be primarily dependent on its ability to successfully develop industrial scale cultivated

meat technologies and processes, and market these to its potential customers.

If Ever After Foods is not able to successfully meet these

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

addition, Ever After Foods will be subject to changing laws, rules and regulations in the United States, Israeli, Asia Pacific, the European

Union and other jurisdictions relating to the food tech industry.

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its business and pursue business opportunities.

Plurinuva may also incur significant expenses to comply with the laws, regulations and

other obligations that will apply to it.

Plurinuva is primarily

focused on utilizing its technology for the development of cultivated meat , and it has limited data on the performance of our and its

technologies in the field of cultivated meat to date.

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

To date, Plurinuva

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.

Plurinuva’s current technologies are, in large part, based on our technologies and intellectual property.

We may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups and future growth, or

Plurinuva 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 Plurinuva to market industrial-scale cultivated meat manufacturing processes.

Plurinuva cannot guarantee that it will be successful in developing these technologies, based on its current roadmap , or at all.

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 Plurinuva's financial condition, results of operations and prospects.

Ever After Foods may also incur significant expenses to comply with the laws, regulations

and other obligations that will apply to it.

Ever After Foods

is primarily focused on utilizing its technology for the development of cultivated meat, and it has limited data on the performance of

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.

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

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.

Consumer trends

that we believe favor sales of products manufactured using our licensed technologies could change based on a number of possible factors,

including a shift in preference from animal-based protein products, economic factors and social trends.

A significant shift in consumer

demand away from products manufactured using our technologies could reduce our sales or our market share and the prestige of our brand,

which would harm our business and financial condition.

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

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

advertising and distribution of these products.

In addition, enforcement of existing laws and regulations, changes in legal requirements

and/or evolving interpretations of existing regulatory requirements may result in increased compliance costs and create other obligations,

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.

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.

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.

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

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

Risk Related to Commercialization of Our Product

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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 Korea and with Chart for the thawing device.

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

Notwithstanding,

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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.

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.

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 cell therapy products without infringing the proprietary rights of

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

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.

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.

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.

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

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

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.

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,

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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,

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

the amount of our cash resources and our ability to obtain additional funding;

changes in our revenues, expense levels or operating results;

entering into or terminating strategic relationships;

announcements of technical or product developments by us or our competitors;

market conditions for pharmaceutical and biotechnology shares in particular;

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

disputes concerning patents or proprietary rights;

new accounting pronouncements or regulatory rulings;

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

patent or proprietary rights developments;

regulatory actions that may impact our products;

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

disruptions in our manufacturing processes;

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.

The Nasdaq Stock Market

has established continued listing requirements, including a requirement to maintain a minimum closing bid price of at least $1.00 per

If a company trades for 30 consecutive business days below such minimum closing bid price, it will receive a deficiency notice

Assuming it is in compliance with the other continued listing requirements, Nasdaq would provide such company a period of

180 calendar days in which to regain compliance by maintaining a closing bid price at least $1.00 per share for a minimum of ten consecutive

business days.

If we are not able to regain compliance, there is a risk that our common shares may be delisted from Nasdaq.

As of the date of this

filing, our common shares are trading below $1.00 per share.

If the closing bid price of our common shares continues trading below $1.00 per share for

an aggregate of 30 consecutive business days, we will receive a deficiency notice from Nasdaq.

If, in such circumstance, we are not able

to regain compliance with the minimum bid price requirement within 180 days, our common shares will be subject to a delisting action by

A 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 shareholders:

the liquidity of our common shares;

the market price of our common shares;

the availability of information concerning the trading prices and volume of our common shares;

our ability to obtain financing or complete a strategic transaction;

the number of institutional and other investors that will consider investing in our common shares;

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

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.

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:

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

amount of our cash resources and our ability to obtain additional funding;

in our revenues, expense levels or operating results;

into or terminating strategic relationships;

● announcements

of technical or product developments by us or our competitors;

conditions for pharmaceutical and biotechnology shares in particular;

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

concerning patents or proprietary rights;

accounting pronouncements or regulatory rulings;

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

or proprietary rights developments;

actions that may impact our products;

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

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.

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

shareholders:

liquidity of our common shares;

market price of our common shares;

availability of information concerning the trading prices and volume of our common shares;

ability to obtain financing or complete a strategic transaction;

number of institutional and other investors that will consider investing in our common shares;

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.

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

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,

and we may be exposed to fluctuations in interest rates.

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, 2022.

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

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

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.

The ongoing COVID-19 pandemic, or any other

pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business and operations.

COVID-19 has had

and continues to have a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred;

chains have been disrupted;

facilities and production have been suspended;

and demand for certain goods and services, such as medical

services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen.

We are actively monitoring any

developments regarding the pandemic, and we are taking any necessary measures to respond to the situation in cooperation with the various

stakeholders.

COVID-19 infection

of our workforce could result in a temporary disruption in our business activities, including manufacturing and other functions.

on guidelines provided by the Israeli Government, we have increased as much as possible the capacity and arrangement for employees to

work remotely, and although the vast majority of our employees have been vaccinated and we have adopted hybrid working models to minimize

exposure, we cannot guaranty that there will be no infection and spread of the virus among our employees and staff.

The COVID-19 pandemic

is also affecting the United States, Israel and global economies and has affected, and may continue to affect, the conduct of our clinical

trials and may in the future affect our operations and those of third parties on which we rely, including by causing disruptions in our

raw material supply.

In that regard, to date we have experienced delays in enrolling patients in our various studies due to the COVID-19

In addition, the

COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals,

including with respect to our Phase III clinical trial related to muscle recovery following surgery for hip fracture.

The evolving COVID-19

pandemic has already impacted, and may continue to, directly or indirectly impact the pace of enrollment in our clinical trials as patients

may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical

trial staff may not be able to physically arrive to the clinical sites.

Additionally, such facilities and offices have been and may continue

to be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, thereby decreasing

availability, in whole or in part, for clinical trial services.

Additionally, the stock market has been unusually volatile during the

COVID-19 outbreak and such volatility may continue.

To date, during certain periods of the COVID-19 pandemic, our share price fluctuated

significantly, and such fluctuation may continue to occur.

The ultimate impact

of the COVID-19 pandemic is highly uncertain and subject to change.

We do not yet know the full extent of potential delays or impacts

on our business, financing or clinical trial activities, or on healthcare systems or the global economy as a whole if the pandemic continues

for an extended period of time or significantly worsens.

However, these effects could have a material impact on our liquidity, capital

resources, operations and business and those of the third parties on which we rely.

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

restrictions.

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.

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.

We have received royalty-bearing

1 unchanged sentence

The terms of the IIA’s grants limit our

ability to transfer know-how 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.

For more information,

Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital

Recent increasing

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.

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.

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

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

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 product candidates or cultivated meat products.

If we are not able to successfully manage any increases in inflation, our prospects,

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

Since 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 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.

The EIB Finance Agreement

contains certain limitations that we must adhere to such as the use of proceeds received from the EIB, the disposal of assets, substantive

changes in the nature of our business, our potential execution of mergers and acquisitions, changes in our holding structure, distributions

of future potential dividends and our engaging with other banks and financing entities for other loans.

Our 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.

Our 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.

Furthermore, 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.

In 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.

and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment.

Risk Related to Our Industry

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

Potential product liability claims could

adversely affect our future earnings and financial condition.

We face an inherent business

risk of exposure to product liability claims in the event that the use of our products results in adverse effects.

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 clinical 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.

We rely and will continue to rely on third

parties to conduct our clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected

deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.

We depend and will depend

upon independent investigators and collaborators, such as universities, medical institutions, CROs, vendors and strategic partners to

conduct our pre-clinical and clinical trials under agreements with us.

We negotiate budgets and contracts with CROs, vendors and study

sites which may result in delays to our development timelines and increased costs.

We rely heavily on these third parties over the course

of our clinical trials, and we control only certain aspects of their activities.

Nevertheless, we are responsible for ensuring that each

of our studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third

parties does not relieve us of our regulatory responsibilities.

We and these third parties are required to comply with current good clinical

practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product

candidates in clinical development.

Regulatory authorities enforce

these cGCPs through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of these third parties

fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA

or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.

We cannot assure that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the cGCP

In addition, any Phase III clinical trials which we may conduct must be conducted with biologic product produced under cGMP

and may require a large number of test patients.

Biologic products for commercial purposes must also be produced under cGMP.

or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to

repeat clinical trials, which would delay the regulatory approval process.

Moreover, our business may be implicated if any of these third

parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws and regulations.

Any third parties conducting

our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such third

parties, which in some instances may be limited, we cannot control whether or not they devote sufficient time and resources to our ongoing

pre-clinical, clinical and nonclinical programs.

These third parties may also have relationships with other commercial entities, including

our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect

their performance on our behalf.

If these third parties do not successfully carry out their contractual duties or obligations or meet

expected deadlines, if they declare bankruptcy or if they need to be replaced for whatever reason or if the quality or accuracy of the

clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other

reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory

approval of or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects for

our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding

third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus.

there is a natural transition period when a new third party commences work.

As a result, delays occur, which can materially impact our

ability to meet our desired clinical development timelines.

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 rely 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 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.

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 European Union and other jurisdictions relating

to the collection, use and security of personal information and data.

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.

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

market participants, including institutional investors and capital providers, are increasingly placing importance on the impact of their

investments and are thus focusing on corporate ESG practices, including the use of third-party benchmarks and scores to assess companies’

ESG profiles in making investment or voting decisions, and engaging with companies to encourage changes to their practices.

ESG ratings could lead to increased negative investor sentiment towards us or our industry.

If we do not comply with investor or stockholder

expectations and standards in connection with our ESG initiatives or are perceived to have not addressed ESG issues within our company,

our business and reputation could be negatively impacted and our share price could be materially and adversely affected, as well as our

access to and cost of capital.

we may, at times, engage in voluntary initiatives (such as voluntary disclosures, certifications, or goals, among others) or commitments

to improve the ESG profile of our company and/or products, such initiatives or achievements of such commitments may not have the desired

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.

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

information that we currently believe to be reasonable may subsequently be determined to be erroneous or be subject to misinterpretation.

Even if this is not the case, our current actions may subsequently be determined to be insufficient by various stakeholders, and we may

be subject to investor or regulator engagement on our ESG initiatives and disclosures, even if such initiatives are currently voluntary.

In addition, increasing ESG-related regulation, such as the SEC’s climate disclosure proposal, may also result in increased compliance

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.

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.

product liability claims could adversely affect our future earnings and financial condition.

face an inherent business risk of exposure to product liability claims in the event that the use of our products results in adverse effects.

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

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

Related to Our Dependence on Third Parties

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.

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.

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.

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.

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.

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.

rely 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.

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.

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 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.

security breaches or any material system failure events could result in a material disruption of our development programs and our business

For 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

5 unchanged sentences

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 European Union 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 European Union data protection law to non-European

Union entities under certain conditions, tightens existing European Union 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

European Union 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.

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

compliance with certain European privacy regulations could have an adverse effect on our business and reputation.

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

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.

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.

to these European privacy regulations and unsuccessful compliance may be onerous and adversely affect our business, financial condition,

prospects, results of operations and reputation.

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.

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

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.

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.

government may seek to hold our Company liable for successor

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

UNRESOLVED STAFF COMMENTS.

Not Applicable.

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

What changed 10-K

Item 1A. Risk Factors