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Item 1A. Risk Factors

2022-09-21 compared with 2021-09-13 · 316 added, 473 removed, 483 unchanged (62% of the section changed)

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You should consider carefully the following information about these risks, together with the other information

contained in this Annual Report on Form 10-K before making an investment decision.

Our business, prospects, financial condition and results

of operations may be materially and adversely affected as a result of any of the following risks.

The value of our securities could decline

as a result of any of these risks.

contained in this Annual Report before making an investment decision.

Our business, prospects, financial condition and results of operations

may be materially and adversely affected as a result of any of the following risks.

The value of our securities could decline as a result

of any of these risks.

You could lose all or part of your investment in our securities.

Some of the statements in “Item

Risk Factors” are forward-looking statements.

Some of the statements in “Item 1A.

Factors” are forward-looking statements.

The following risk factors are not the only risk factors facing our Company.

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Summary of Risk Factors

Our business is subject to a number of risks,

including risks that may adversely affect our business, financial condition and results of operations.

These risks are discussed more

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

COVID-19 pandemic has caused interruptions and delays of our business plan and may have a significant adverse effect on our business;

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;

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;

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;

studies necessary to support the approval of our applications are often lengthy and expensive and require the enrollment of a large number

Suitable patients may be difficult to identify and enroll.

Any delay or failure of clinical trials could delay us from commercializing

our product candidates, which would materially and adversely affect our results of operations and the value of our business;

may not be able to successfully license our product candidates;

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;

may be subject, directly or indirectly, to applicable U.S.

federal and state anti-kickback, false claims laws, healthcare and security

laws and regulations, which could expose us to criminal sanctions civil penalties, contractual damages, reputational harm and diminished

profits and future earnings;

may be exposed to product liability and corporate claims and insurance may not be sufficient to cover these claims;

the United States and Europe, our business could be significantly and adversely affected by healthcare reform initiatives and/or other

legislation or judicial interpretations of existing or future healthcare laws and/or regulations;

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;

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;

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;

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, because a significant portion of our expenses in Israel are paid in NIS, and we anticipate receipt of additional funds in Euros

from the EIB Finance Agreement;

● restrictions

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

Our business is subject to

a number of risks, including risks that may adversely affect our business, financial condition and results of operations.

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;

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;

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;

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

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

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

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

recent increasing global inflation could affect our ability to

purchase materials needed for manufacturing and could increase the costs of our future product;

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

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.

Risk Related to Our Business

We may need to raise additional financing

to support the research, development and manufacturing of our cell therapy products in the future, but we cannot be sure we will be able

to support the research, development and manufacturing of our cell based products in the future, but we cannot be sure we will be able

to obtain additional financing on terms favorable to us when needed.

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

financial resources are limited, and are dependent, to a certain extent, on our achieving certain milestones, and may not be sufficient

to finance our operations until we become profitable, if that ever happens.

financial resources are limited, and may not be sufficient to finance our operations until we become profitable, if that ever happens.

It is likely that we will

need to raise additional funds in the future in order to satisfy our working capital and capital expenditure requirements.

we are dependent on our ability to sell our common shares for funds, receive grants, potentially receive milestone payments pursuant to

the EIB Finance Agreement, enter into collaborations and licensing deals or to otherwise raise capital.

There can be no assurance that

we will be able to obtain financing, including any funding under the EIB Finance Agreement.

Any sale of our common shares in the future

will result in dilution to existing shareholders and could adversely affect the market price of our common shares.

we are dependent on our ability to sell our common shares for funds, receive grants, enter into collaborations and licensing deals or

to otherwise raise capital.

Any sale of our common shares in the future could result in dilution to existing shareholders and could adversely

affect the market price of our common shares.

Also, we may not be able to

borrow or raise additional capital in the future to meet our needs or to otherwise provide the capital necessary to conduct the development

and commercialization of our potential cell therapy products, which could result in the loss of some or all of one’s investment

in our common shares.

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

on our ability to license and/or develop and commercialize our products based on our cell production technology, which is currently in

the development stage.

If we are unable to complete the development and commercialization of our cell therapy products successfully, our

likelihood of profitability will be limited severely .

on our ability to license and/or develop and commercialize our products based on our technology, which is currently in the development

If we are unable to complete the development and commercialization of our cell-based products successfully, or are unable to obtain

the necessary regulatory approvals, our likelihood of profitability will be limited severely .

We are engaged in the business

of developing cell therapy products.

We have not realized a profit from our operations to date and there is little likelihood that we

will 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 potential cell therapy products and/or licensing of our products, which will require additional research and

The clinical manufacturing process for cell

therapy products is complex and requires meeting high regulatory standards.

Any delay or problem in the clinical manufacturing of PLX

may result in a material adverse effect on our business.

Our manufacturing process,

controls, equipment and quality system for PLX-PAD have received approval from the FDA, EMA, Germany’s PEI, the MFDS and the PMDA.

However, the clinical manufacturing process is complex, and we have no experience in manufacturing our product candidates at a commercial

There can be no guarantee

that we will be able to successfully develop and manufacture our product candidates in a manner that is cost-effective or commercially

viable, or that our development and manufacturing capabilities might not take much longer than currently anticipated to be ready for the

In addition, if we fail to maintain regulatory approvals for our manufacturing facilities, we may suffer delays in our ability

to manufacture our product candidates.

This may result in a material adverse effect on our business.

If we are not able to successfully license

and/or develop and commercialize our cell therapy product candidates and obtain the necessary regulatory approvals, we may not generate

sufficient revenues to continue our business operations.

So far, the product candidates

we are developing have completed one Phase I/II clinical trial of Gluteal Musculature rehabilitation after total hip arthroplasty (efficacy,

ongoing for safety), two Phase I clinical trials for CLI, one Phase II clinical trial in IC and a multinational Phase III study in CLI.

In addition, we currently have two ongoing Phase II FDA studies of PLX cells for the treatment of COVID-19 complicated by ARDS and one

Phase III multinational clinical trial with our PLX-PAD product candidate in muscle recovery following surgery for hip fracture.

our second product candidate, PLX-R18, is currently in a Phase I study for recovery following HCT.

Our early stage cell therapy product

candidates may fail to perform as we expect.

Moreover, even if our cell therapy product candidates successfully perform as expected, in

later stages of development they may fail to show the desired safety and efficacy traits despite having progressed successfully through

pre-clinical or initial clinical testing.

We will need to devote significant additional research and development, financial resources

and personnel to develop commercially viable products and obtain the necessary regulatory approvals.

of developing cell-based products.

We have not realized a profit from our operations to date and there is little likelihood that we will

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.

If our cell therapy product

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to obtain such approvals, we may not generate sufficient revenues to continue our business operations.

Even if we obtain regulatory

approval of a product, that approval may be subject to limitations on the indicated uses for which it may be marketed.

Even after granting

regulatory approval, the FDA, the EMA, and regulatory agencies in other countries continue to regulate marketed products, manufacturers

and manufacturing facilities, which may create additional regulatory barriers and burdens.

Later discovery of previously unknown problems

with a product, manufacturer or facility, may result in restrictions on the product or manufacturer, including a withdrawal of the product

from the market.

Further, regulatory agencies

may establish additional regulations that could prevent or delay regulatory approval of our product candidates.

We have not generated significant or consistent revenues to date,

which raises doubts with respect to our ability to generate revenues in the future.

Even after granting regulatory

approval, the FDA, the EMA, and regulatory agencies in other countries continue to regulate marketed products, manufacturers and manufacturing

facilities, which may create additional regulatory barriers and burdens.

Later discovery of previously unknown problems with a product,

manufacturer or facility, may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.

We have not generated significant or consistent

revenues to date, which raises doubts with respect to our ability to generate revenues in the future.

We have a limited operating

history in our business of commercializing cell production technology.

Until we entered into the prior license agreement with United Therapeutics

Corporation which was terminated in December 2015, we did not generate any material revenues and we have not generated any material revenues

since that date.

It is not clear when we will generate revenues or whether we will experience further delays in recognizing revenues such

as if we experienced a clinical hold.

Our primary source of funds has been the sale of our common shares, government grants and funds

distributed pursuant to our EIB Finance Agreement.

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 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.

There is no assurance that we will ever be profitable.

If we encounter problems or delays in the

research and development of our potential cell therapy products, we may not be able to raise sufficient capital to finance our operations

during the period required to resolve such problems or delays.

Our cell therapy products

are currently in the development stage and we anticipate that we will continue to incur substantial operating expenses and incur net losses

until we have successfully completed all necessary research and clinical trials.

We, and any of our potential collaborators, may encounter

problems and delays relating to research and development, regulatory approval and intellectual property rights of our technology.

research and development programs may not be successful, and our cell culture technology may not facilitate the production of cells outside

the human body with the expected result.

Our cell therapy products may not prove to be safe and efficacious in clinical trials.

of these events occur, we may not have adequate resources to continue operations for the period required to resolve the issue delaying

commercialization and we may not be able to raise capital to finance our continued operation during the period required for resolution

of that issue.

Accordingly, we may be forced to discontinue or suspend our operations.

Because most of our officers and directors

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civil liability provisions of the securities laws of the United States or any U.S.

Risks Related to Development,

Clinical studies, and Regulatory Approval of Our Product Candidates

We cannot market and sell our cell therapy

product candidates in the United States, Europe, or in other countries if we fail to obtain the necessary regulatory approvals or licensure.

We cannot sell our cell therapy

product candidates until regulatory agencies grant marketing approval, or licensure.

The process of obtaining regulatory approval is lengthy,

expensive and uncertain.

It is likely to take at least several years to obtain the required regulatory approvals for our cell therapy

product candidates, or we may never gain the necessary approvals.

Any difficulties that we encounter

in obtaining regulatory approval may have a substantial adverse impact on our operations and cause our share price to decline significantly.

To obtain marketing approvals

in the United States and Europe for cell therapy product candidates we must, among other requirements, complete carefully controlled and

well-designed clinical trials sufficient to demonstrate to the FDA, the EMA and the PMDA that the cell therapy product candidates is safe

and effective for each disease for which we seek approval.

So far, we have successfully conducted Phase I/II and Phase I clinical trials

for our PLX-PAD product candidate.

Several factors could prevent completion or cause significant delay of these trials, including an inability

to enroll the required number of patients or failure to demonstrate adequately that cell therapy product candidates are safe and effective

for use in humans.

Negative or inconclusive results from or adverse medical events during a clinical trial could cause the clinical trial

to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful.

The FDA or EMA (or,

if we seek to conduct development efforts in Japan, the PMDA) can place a clinical trial on hold if, among other reasons, it finds that

patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury.

If safety concerns

develop, we, the FDA, the EMA or other regulatory bodies could stop our trials before completion.

While we may seek

partners for licensing deals, joint ventures, partnerships, and direct sale of our products in various industries, there is no guarantee

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.

Risks Related to Development, Clinical studies,

and Regulatory Approval of Our Product Candidates

If we are not able to conduct our clinical

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

The completion of our clinical

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

FDA, the EMA or the MOH does not grant permission to proceed or places additional trials on clinical hold;

do not enroll in our trials at the rate we expect, including as a result of COVID-19 pandemic;

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

regulators may ask to increase subject’s population in the clinical trials;

experience an unacceptable rate or severity of adverse side effects;

● Third party clinical

investigators and other related vendors do not perform our clinical trials on our anticipated schedule or consistent with the

clinical trial protocol, GCP and regulatory requirements, or other third parties do not perform data collection and analysis in a

timely or accurate manner;

● 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;

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 will

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

The completion of our future

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

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

places trials on clinical hold;

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

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

The regulators may ask to increase subject’s population in the clinical trials;

Subjects experience an unacceptable rate or severity of adverse side effects;

Third party clinical investigators and other related vendors may not

perform the clinical trials under the anticipated schedule or consistent with the clinical trial protocol, GCP and regulatory requirements.

Third party clinical investigators and other related vendors may declare bankruptcy or terminate their business unexpectedly, which most likely will result in further delays in our clinical trials’ anticipated schedule and cause additional expenditures;

Inspections of clinical trial sites by the FDA, EMA, MOH and other regulatory authorities find regulatory violations that require us to undertake corrective action, suspend or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications;

One or more IRBs suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trial.

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,

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

If our processing and storage facilities or our clinical

manufacturing facilities are damaged or destroyed, our business and prospects would be adversely affected.

If our processing and storage

facilities, our clinical manufacturing facility or the equipment in such facilities were to be damaged or destroyed, the loss of some

or all of the stored units of our cell therapy drug candidates would force us to delay or halt our clinical trial processes.

have one clinical manufacturing facility located in Haifa, Israel.

If these facilities or the equipment in them are significantly damaged

or destroyed, we may not be able to quickly or inexpensively replace our manufacturing capacity.

Favorable results from compassionate use

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patients with similar treatment needs.

There is no assurance that

we will obtain regulatory approval for PLX cells.

We will only obtain regulatory approval to commercialize a product candidate if we can

demonstrate to the satisfaction of the FDA, the EMA or other applicable regulatory authorities, in well-designed and conducted clinical

trials, that the product candidate is safe and effective and that the product candidate, including the cell production methodology, otherwise

meets the appropriate standards required for approval.

Clinical trials can be lengthy, complex and extremely expensive processes with

uncertain results.

A failure of one or more clinical trials may occur at any stage of testing.

Success in early clinical

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

We may not be able to secure and maintain research institutions

to conduct our clinical trials.

We rely on research institutions

to conduct our clinical trials.

Specifically, the limited number of centers experienced with cell therapy product candidates heightens

our dependence on such research institutions.

Our reliance upon research institutions, including hospitals and clinics, provides us with

less control over the timing and cost of clinical trials and the ability to recruit subjects.

If we are unable to reach agreements with

suitable research institutions on acceptable terms, or if any resulting agreement is terminated, we may be unable to quickly replace the

research institution with another qualified institution on acceptable terms.

We may not be able to secure and maintain suitable research

institutions to conduct our clinical trials.

Our product development programs are based on novel technologies

and are inherently risky.

We are subject to the

risks of failure inherent in the development of products based on new technologies.

The novel nature of our therapeutics creates

significant challenges in regard to product development and optimization, manufacturing, government regulation, third party

reimbursement and market acceptance.

For example, the FDA, the EMA and other countries’ regulatory authorities have relatively

limited experience with cell therapies.

Very few cell therapy products have been approved by regulatory authorities to date for

commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and

As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as

compared to the pathway for new conventional drugs.

There are very few drugs and limited therapies

that the FDA or EMA and other regulatory authorities have approved as treatments for some of the disease indications we are pursuing.

This could complicate and delay FDA, EMA or other countries’ regulatory authorities’ approval of our biologic drug candidates.

There are very few drugs and

limited therapies currently approved for the treatment of COVID-19, IC, ARS, muscle recovery following surgery for hip fracture or HCT.

As a result, the clinical efficacy endpoints, or the criteria to measure the intended results of treatment may be difficult to determine.

Despite our eligibility for certain accelerated pathways, this could increase the difficulty of our obtaining FDA, EMA or other countries’

regulatory authorities’ approval to market our products.

We are subject to the risks

of failure inherent in the development of products based on new technologies.

The novel nature of our therapeutics creates significant

challenges in regard to product development and optimization, manufacturing, government regulation, third party reimbursement and market

For example, the FDA, the EMA and other countries’ regulatory authorities have relatively limited experience with cell

Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to

regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthier.

As a result, the development

and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional

Our cell therapy drug candidates represent

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products will depend on a number of factors, including:

clinical safety and effectiveness of our cell therapy drug candidates and their perceived advantage over alternative treatment methods,

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

cost of our products and the reimbursement policies of government and private third party payers.

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

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

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

If the health care community

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

We have limited experience in conducting

Phase III trials.

If we fail in the conduct of such trials, our business will be materially harmed.

Even though we have conducted

Phase I, Phase II and Phase III trials, and we are currently conducting one Phase III trial for our PLX-PAD product candidate, two Phase

II studies of PLX cells for the treatment of severe COVID-19 complicated by ARDS, and a Phase I study for our PLX-R18 product, and have

recruited employees who are experienced in managing and conducting clinical trials, we have limited experience in this area.

We will need to expand our experience and

rely on consultants in order to obtain regulatory approvals for our therapeutic product candidates.

The failure to successfully conduct

clinical trials could materially harm our business.

Interim, “top-line,” and

preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available

or as additional analyses are conducted, and as the data are subject to audit and verification procedures, that could result in material

or as additional analyses are conducted, and as the data are subject to audit and verification procedures, which could result in material

changes in the final data.

From time to time, we may publish interim, “top-line,” or

preliminary data from our clinical studies.

Interim data from clinical trials that we may complete are subject to the risk that one or

more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

or “top-line” data also remain subject to audit and verification procedures that may result in the final data being

materially different from the preliminary data we previously published.

As a result, interim and preliminary data should be viewed with

caution until the final data are available.

Material adverse changes between preliminary, “top-line,” or interim

data and final data could significantly harm our business prospects.

From time to time, we may

publish interim, “top-line,” or preliminary data from our clinical studies.

Interim data from clinical trials that

we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues

and more patient data become available.

Preliminary or “top-line” data also remain subject to audit and verification

procedures that may result in the final data being materially different from the preliminary data we previously published.

interim and preliminary data should be viewed with caution until the final data are available.

Material adverse changes between preliminary, “top-line,” or

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

Union and other jurisdictions relating to the food tech industry.

Such laws and regulations may negatively impact its ability to expand

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.

Risk Related to Commercialization of Our Product

We may not successfully maintain our existing

exclusive out-licensing agreement with CHA, or establish new collaborative and licensing arrangements, which could adversely affect our

ability to develop and commercialize our product candidates.

We may not successfully establish new collaborations,

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

One of the elements of our

business strategy is to license our technology to other companies.

Our business strategy includes establishing collaborations and licensing

agreements with one or more pharmaceutical or biotechnology companies.

To date, we have a strategic partnership with CHA for both the

IC and CLI indications in Korea.

Notwithstanding, we may not be able to further establish or maintain such licensing and collaboration

arrangements necessary to develop and commercialize our product candidates.

Our business strategy includes development and in-house manufacturing

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

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

manufacturing needs for a variety of industries.

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

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

Notwithstanding,

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

our product candidates.

Even if we are able to maintain

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

The market for our products will be heavily dependent on third

party reimbursement policies.

The market for our cell therapy products will be heavily dependent

on third party reimbursement policies.

Our ability to successfully

commercialize our product candidates will depend on the extent to which government healthcare programs, as well as private health insurers,

health maintenance organizations and other third party payers will pay for our products and related treatments.

Reimbursement by third party payers depends on

a number of factors, including the payer’s determination that use of the product is safe and effective, not experimental or investigational,

medically necessary, appropriate for the specific patient and cost-effective.

Reimbursement in the United States or foreign

countries may not be available or maintained for any of our product candidates.

If we do not obtain approvals for adequate third

party reimbursements, we may not be able to establish or maintain price levels sufficient to realize an appropriate return on our investment

in product development.

Any limits on reimbursement from third party payers may reduce the demand for, or negatively affect the

price of, our products.

commercialize our cell therapy product candidates will depend on the extent to which government healthcare programs, as well as private

health insurers, health maintenance organizations and other third-party payers will pay for our products and related treatments.

Reimbursement by third party

payers depends on a number of factors, including the payer’s determination that use of the product is safe and effective, not experimental,

or investigational, medically necessary, appropriate for the specific patient and cost-effective.

Reimbursement in the United States

or foreign countries may not be available or maintained for any of our product candidates.

If we do not obtain approvals for adequate

third-party reimbursements, we may not be able to establish or maintain price levels sufficient to realize an appropriate return on our

investment in product development.

Any limits on reimbursement from third party payers may reduce the demand for, or negatively affect

the price of, our products.

The lack of reimbursement for these procedures by insurance payers has negatively affected the market for

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adverse effect on our ability to compete in the marketplace.

We must further protect and develop our technology and products

in order to become a profitable company.

If we do not complete the

development of our technology and products by the time our patents expire and create additional sufficient layers of patents or other

intellectual property rights, other companies may use the technology to develop competing products.

If this happens, we may lose our competitive

position and our business would likely suffer.

Furthermore, the scope of

our patents may not be sufficiently broad to offer meaningful protection.

In addition, our patents could be successfully challenged, invalidated

or circumvented so that our patent rights would not create an effective competitive barrier.

We also intend to seek patent protection

for any of our potential cell therapy products once we have completed their development.

We also rely on trade secrets and un-patentable

know-how that we seek to protect, in part, by confidentiality agreements with our employees, consultants, suppliers and licensees.

agreements may be breached, and we might not have adequate remedies for any breach.

If this were to occur, our business and competitive

position would likely suffer.

The patent approval process is complex,

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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.

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

as the NIS and the Euro, because 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, all of which subjects us to the risks of foreign currency fluctuations.

Our primary expenses paid

in NIS are employee salaries, and lease payments on our facilities.

During the fiscal year ended June 30, 2021, or Fiscal Year 2021, we

entered into options contracts to hedge against some of the risk of changes in future cash flows from payments of payroll and related

expenses and costs of operations denominated in NIS.

The dollar cost of our operations in Israel

will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the

dollar, which would harm our results of operations.

Since a considerable portion

of our expenses such as employees’ salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations

is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS

in relation to the dollar.

As a result, we are exposed to the risk that the NIS, after adjustment for inflation in Israel, will appreciate

in relation to the dollar.

In that event, the dollar cost of our operations in Israel will increase and our dollar-measured results of

operations will be adversely affected.

We cannot predict whether the NIS will appreciate against the dollar or vice versa in the future.

Any increase in the rate of inflation in Israel, unless the increase is offset on a timely basis by a devaluation of the NIS in relation

to the dollar, will increase labor and other costs, which will increase the dollar cost of our operations in Israel and harm our results

of operations.

The dollar cost of our loan from the EIB

will be subject to currency valuations of the U.S.

dollar and the Euro

Following the receipt of the

first tranche of the loan from the EIB, which was provided in Euros pursuant to the EIB Finance Agreement, we have established both a

cash asset and a liability in our financial statements.

If the Euro increases in value in relation to the U.S.

dollar, both the asset

and the liability of our loan from the EIB will increase, and if the Euro decreases in relation to the U.S.

dollar, both the asset and

liability will conversely decrease.

Since the tranche of the loan

received from the EIB and the accumulated interest are payable together in a single installment within five years from disbursement of

the tranche, and we are likely to use the cash received from the EIB to finance our operations, as time progress the cost basis of the

liability is expected to increase and the cash asset is expected to decrease.

Therefore, the effect of currency

fluctuations of the Euro in relation to the U.S.

dollar on the liability resulting from the loan from the EIB is expected to be greater

than the effect on the cash asset.

As part of our hedging strategy,

we may use currency transactions of options and forward contracts to minimize the risk of financial exposure from fluctuations in the

exchange rate of the U.S.

dollar against the Euro, but there are no guaranties that we will be able to offset some or all the losses if

the Euro inclines in value in relation to the U.S.

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, 2021.

we hold part 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 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.

The COVID-19 pandemic, or any other pandemic,

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

While COVID-19

is still spreading globally, and the final implications of the pandemic are difficult to estimate at this stage, it is clear that it has

affected the lives of a large portion of the global population.

At this time, the pandemic has caused states of emergency to be declared

in various countries, travel restrictions imposed globally, quarantines established in certain jurisdictions and various institutions

and companies being closed.

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.

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

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

Recent increasing

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.

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 have agreed to guaranty the loan and have also agreed to other 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.

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

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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 and the unstable military and political conditions of Israel may cause interruption or

suspension of our business operations without warning.

Our principal research and

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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.

In addition, 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.

Our internal computer systems, or those

used by our CROs or other contractors or consultants, may fail or suffer security breaches.

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

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

implementation of security measures, our internal computer systems and those of our current and future CROs and other contractors

and consultants are vulnerable to damage from computer viruses, cyber security incidents and unauthorized access.

While, to our

knowledge, we have not experienced any such material system failure or security breach to date, if such an event were to occur and

cause interruptions in our operations, it 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.

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.

Such data privacy laws, regulations and other obligations may require

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

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

Additionally, the privacy-

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

Several jurisdictions have

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

Privacy- and data

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

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

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

Unsuccessful compliance with certain European

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

collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation,

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.

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

prospects, results of operations and reputation.

Existing government programs and tax benefits may be terminated.

We have received certain Israeli

government approvals under certain programs and may in the future utilize certain tax benefits in Israel by virtue of these programs.

To remain eligible for such tax benefits, we must continue to meet certain conditions.

If we fail to comply with these conditions in the

future, the benefits we receive could be canceled and have to pay additional taxes.

We cannot guarantee that these programs and tax benefits

will be continued in the future, at their current levels or at all.

If these programs and tax benefits are ended, our business, financial

condition and results of operations could be materially adversely affected.

If we fail to obtain or maintain orphan

drug exclusivity for our products, our competitors may sell products to treat the same conditions and our potential future revenue will

Our business strategy focuses

on the development of drugs that are eligible for FDA and European Union orphan drug designation.

Under the Orphan Drug Act, the FDA may

designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer

than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation

that the cost of developing the drug will be recovered from sales in the United States.

In the European Union, the EMA’s Committee

for Orphan Medicinal Products, or COMP, grants orphan drug designation to promote the development of products that are intended for the

diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000

persons in the European Union Community.

Additionally, designation is granted for products intended for the diagnosis, prevention, or

treatment of a life threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely

that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug or biological

In the United States, orphan

drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages,

and user-fee waivers.

In addition, if a product receives the first FDA approval for the indication for which it has orphan designation,

the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug

for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the

product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity.

In the European Union, orphan

drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity

is granted following drug or biological product approval.

This period may be reduced to six years if the orphan drug designation criteria

are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Even if we obtain orphan drug

exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different

active moieties can be approved for the same condition.

Even with orphan drug exclusivity,

if a third party were to prepare or market a product which infringes upon our intellectual property, we may need to initiate litigation,

which may be costly, to enforce our rights against such party.

After an orphan drug is approved, the FDA can subsequently approve the

same drug with the same active moiety for the same condition if the FDA concludes that the later drug is safer, more effective, or makes

a major contribution to patient care.

Orphan drug designation on its own neither shortens the development time or regulatory review time

While orphan drug products are typically

sold at a high price relative to other medications, the market may not be receptive to high pricing of our products.

We develop our product candidates

to treat rare and ultra-rare diseases, a space where medications are usually sold at high prices compared with other medications.

Accordingly, even if regulatory

authorities approve our product candidates, the market may not be receptive to, and it may be difficult for us to achieve, a per-patient

per-year price high enough to allow us to realize a return on our investment.

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

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

Unresolved Staff

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