What changed in this filing

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Item 1A. Risk Factors

2020-09-10 compared with 2019-09-12 · 217 added, 173 removed, 649 unchanged (38% of the section changed)

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known to us or that we currently deem immaterial may also affect our business.

independent registered public accounting firm’s report states that there is a substantial doubt that we will be able to

continue as a going concern.

anticipate that our principal sources of liquidity as of June 30, 2019, together with the funds received under the Open Market

Sales Agreement SM , or the Sales Agreement, with Jefferies LLC, or Jefferies, as agent, during July and August 2019,

will only be sufficient to fund our activities into the first quarter of the Company’s fiscal year 2021.

As of June 30, 2019,

we had cash and cash equivalents, short-term bank deposits and restricted cash and long-term bank deposits of $24.8 million.

need to obtain additional funding by the first quarter of our fiscal year 2021 in order to continue to fund our operations, and

we cannot provide any assurance that we will be successful in doing so.

Our independent registered public accounting firm,

Kost Forer, Gabbay & Kassierer, a Member of Ernst & Young Global, has included an explanatory paragraph in their opinion

that accompanies our audited consolidated financial statements as of and for the year ended June 30, 2019, indicating that our

current liquidity position raises substantial doubt about our ability to continue as a going concern.

may need to raise additional financing to support the research, development and manufacturing of our cell therapy products and

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Although we were successful in raising

capital in the past, our current financial resources are limited and may not be sufficient to finance our operations until we

become profitable, if that ever happens.

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.

is likely that we will need to raise additional funds in the near future in order to satisfy our working capital and capital expenditure

requirements.

Therefore, we are dependent on our ability to sell our common stock for funds, receive grants, enter into collaborations

and licensing deals or to otherwise raise capital.

There can be no assurance that we will be able to obtain financing.

of our common stock in the future will result in dilution to existing stockholders and could adversely affect the market price

of our common stock.

Therefore, we are dependent on our ability to sell our common stock for funds, receive grants, potentially receive

milestone payments pursuant to the EIB 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 Agreement.

our common stock in the future will result in dilution to existing stockholders and could adversely affect the market price of

our common stock.

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

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

far, the products 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, and one Phase II clinical trial in IC.

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

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, and one Phase II clinical trial

In addition, we currently have an ongoing Phase II FDA study of PLX cells for the treatment of severe COVID-19 complicated

by ARDS and two Phase III multinational clinical trials with our PLX-PAD product candidate:

one in CLI, and the other in muscle

recovery following surgery for hip fracture.

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

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.

our cell therapy product candidates do not prove to be safe and effective in clinical trials, we will not obtain the required

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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 products.

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

cannot market and sell our cell therapy product candidates in the United States, Europe, or in other countries if we fail to obtain

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So far, we have successfully

conducted Phase I/II and Phase I clinical trials for our PLX-PAD product.

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 the 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.

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.

we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA, EMA, MOH and other regulatory

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on clinical hold;

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

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

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;

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third parties do not perform data collection and analysis in a timely or accurate manner;

● Third-party

clinical investigators 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;

● Inspections

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not currently part of the product candidate’s profile.

our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects

If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects

would be adversely affected.

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hip fracture or HCT.

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.

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.

cell therapy drug candidates represent new classes of therapy that the marketplace may not understand or accept.

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our product candidates at a commercial level.

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 market.

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.

result in a material adverse effect on our business.

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 market.

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.

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

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our products or even render our products obsolete.

We depend to a significant extent on certain key personnel, the loss of any of whom may materially and adversely affect our Company.

depend to a significant extent on certain key personnel, the loss of any of whom may materially and adversely affect our Company.

success depends to a significant extent on the continued services of certain highly qualified scientific and management personnel,

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on acceptable terms.

The loss of service of any of our key personnel could have a material adverse effect on our operations or

financial condition.

In the event of the loss of services of such personnel, no assurance can be given that we will be able to

obtain the services of adequate replacement personnel.

We do not maintain key person insurance on the lives of any of our officers

or employees.

loss of service of any of our key personnel could have a material adverse effect on our operations or financial condition.

the event of the loss of services of such personnel, no assurance can be given that we will be able to obtain the services of

adequate replacement personnel.

We do not maintain key person insurance on the lives of any of our officers or employees.

market for our products will be heavily dependent on third party reimbursement policies.

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actions that may impact our products;

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

● disruptions

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● competition.

addition, 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.

sales of our shares may cause the prevailing market price of our shares to decrease.

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.

sales of our common stock may cause dilution.

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

market price of our common stock.

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

existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution.

We may also issue

equity securities that provide for rights, preferences and privileges senior to those of our common stock.

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 stockholders of our company.

We are exposed to fluctuations in currency exchange rates.

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paid in NIS are employee salaries, subcontractors and material suppliers, fees for consultants and lease payments on our facilities.

During the year ended June 30, 2019, or fiscal year 2019, we entered into options contracts to hedge against some of the risk

During the year ended June 30, 2020, or the fiscal year 2020, 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.

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for the development and commercialization of our product candidates, and as a result may materially harm our business.

cash may be subject to a risk of loss and we may be exposed to fluctuations in the market values of our portfolio investments

and in interest rates.

Our cash may be subject to a risk of loss

and we may be exposed to fluctuations in the market values of our portfolio investments and in interest rates.

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

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control over financial reporting will continue to be effective in the future, which could result in our financial statements being

unreliable, government investigations or loss of investor confidence in our financial reports.

unreliable, government investigations or loss of investor confidence in our financial report.

to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to furnish an annual report by our management assessing the

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in our internal control over financial reporting identified by management.

In addition, our independent registered public accounting

firm must annually provide an opinion on the effectiveness of our internal control over financial reporting.

Management’s report

as of the end of fiscal year 2019 concluded that our internal control over financial reporting was effective.

In addition, our

registered independent public accounting firm provided an opinion that our internal control over financial reporting was effective

as of the end of fiscal year 2019.

There is, however, no assurance that we will be able to maintain such effective internal control

over financial reporting in the future.

Ineffective internal control over financial reporting can result in errors or other problems

in our financial statements.

In the future, if we or our registered independent public accounting firm are unable to assert that

our internal controls are effective, our investors could lose confidence in the accuracy and completeness of our financial reports,

which in turn could cause our stock price to decline.

Failure to maintain effective internal control over financial reporting

could also result in investigation or sanctions by regulatory authorities.

Management’s report as of the end of fiscal year 2020

concluded that our internal control over financial reporting was effective.

There is, however, no assurance that we will be able

to maintain such effective internal control over financial reporting in the future.

Ineffective internal control over financial

reporting can result in errors or other problems in our financial statements.

In the future, if we or our registered independent

public accounting firm are unable to assert that our internal controls are effective, our investors could lose confidence in the

accuracy and completeness of our financial report, which in turn could cause our stock price to decline.

Failure to maintain effective

internal control over financial reporting could also result in investigation or sanctions by regulatory authorities.

most of our officers and directors are located in non-U.S.

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portion of their assets are located outside the United States.

As a result, it may be difficult to enforce within the United States

any judgments obtained against our officers or directors, including judgments predicated upon the civil liability provisions of

the securities laws of the United States or any U.S.

a result, it may be difficult to enforce within the United States any judgments obtained against our officers or directors, including

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

we do not intend to pay any dividends on our common stock, investors seeking dividend income should not purchase shares of our

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contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product

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.

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 regulations.

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.

Our failure 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

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.

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

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.

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

Our failure 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.

third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under

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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 need to be replaced 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.

delays occur, which can materially impact our ability to meet our desired clinical development timelines.

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 need to be replaced 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

As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

may not be able to take advantage of the new regulatory pathways in the United States, Europe and Japan to shorten our time to

market our products.

regulatory pathways in United States, Europe and Japan may allow for early commercialization of our products and reducing the

time to market our products.

pathways in United States, Europe and Japan may allow for early commercialization of our products and thereby reducing the time

to market our products.

FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat

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be made available to a limited number of CLI patients in the United States who are unsuitable for revascularization and cannot

take part in the our ongoing Phase III clinical trial.

take part in our ongoing Phase III clinical trial .

In addition, the FDA has cleared

our EAP for the use of our PLX-PAD cells to treat ARDS caused by COVID-19 outside of our ongoing Phase II COVID-19 study in the

The EAP will include up to 100 patients with the resulting data being collected and evaluated alongside our existing clinical

trial in the U.S.

purpose of the EMA’s Adaptive Pathways Project is to shorten the time it takes for innovative medicines to reach patients

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expansion of the indications.

In Japan, a new law regarding regenerative therapies, including cell therapies, came into effect.

The new law allows for conditional, time-limited approval of products for marketing after limited proof of efficacy.

EMA selected our PLX-PAD cell program in CLI and in recovery following surgery for hip fracture for its Adaptive Pathways Project.

The EMA selected our PLX-PAD cell program in CLI and in recovery following surgery for hip fracture

for its Adaptive Pathways Project.

Japan, a regulation regarding regenerative therapies, including cell therapies.

This regulation allows for conditional, time-limited

approval of products for marketing after limited proof of efficacy.

addition, the PMDA approved the proposed quality and large-scale manufacturing methods for PLX-PAD and has cleared our PLX-PAD

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partnership with CHA for both the IC and CLI indications in Korea.

CHA will conduct PLX clinical trials in South Korea, and, following

approval, a joint venture equally owned by both parties will be established to market PLX products in South Korea.

Our PLX cells

are also being used in South Korean sites participating to our International IC study through our partnership with CHA.

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 or establish licensing or collaboration arrangements, these arrangements

may not be on favorable terms and may contain provisions that will restrict our ability to develop, test and market our product

Any failure to maintain or establish licensing or collaboration arrangements on favorable terms could adversely affect

our business prospects, financial condition or ability to develop and commercialize our product candidates.

CHA will conduct PLX clinical trials

in South Korea, and, following approval, a joint venture equally owned by both parties will be established to market PLX

products in South Korea.

Our PLX cells are also being used in South Korean sites participating to our International IC study through

our partnership with CHA.

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

arrangements necessary to develop and commercialize our product candidates.

if we are able to maintain or establish licensing or collaboration arrangements, these arrangements may not be on favorable terms

and may contain provisions that will restrict our ability to develop, test and market our product candidates.

Any failure to maintain

or establish licensing or collaboration arrangements on favorable terms could adversely affect our business prospects, financial

condition or ability to develop and commercialize our product candidates.

agreements with our collaborators and licensees may have provisions that give rise to disputes regarding the rights and obligations

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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.

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

condition, prospects, results of operations and reputation.

have limited experience in conducting Phase III trials.

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

though we conducted Phase I and Phase II trials and we are currently conducting Phase III for our PLX-PAD product, and Phase I

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.

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

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

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

will need to expand our experience and rely on consultants in order to obtain regulatory approvals for our therapeutic product

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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 for a drug.

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 for a drug.

orphan drug products are typically sold at a high price relative to other medications, the market may not be receptive to high

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

we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed

if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies

licensed to us.

We could be forced, including by court order, to cease commercializing the infringing technology or product.

we could be found liable for monetary damages.

A finding of infringement could prevent us from commercializing our product candidates

or force us to cease some of our business operations, which could materially harm our business.

For example, we are aware of issued

third party patents directed to placental stem cells and their use for therapy and in treating various diseases.

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.

addition, we could be found liable for monetary damages.

A finding of infringement could prevent us from commercializing our product

candidates or force us to cease some of our business operations, which could materially harm our business.

For example, we are

aware of issued third party patents directed to placental stem cells and their use for therapy and in treating various diseases.

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.

if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur

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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

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

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

COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our

business and operations.

recent outbreak of COVID-19 originated in Wuhan, China, in December 2019 and has since spread to approximately 200 countries,

including the United States, Israel and many European countries in which we operate.

On March 11, 2020, the World Health Organization

declared the outbreak a pandemic.

While COVID-19 is still spreading 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 the pandemic

and we are taking any necessary measures to respond to the situation in cooperation with the various stakeholders.

on guidelines provided by the Israeli Government, employers (including us) are also required to prepare and increase as much as

possible the capacity and arrangement for employees to work remotely.

In addition, COVID-19 infection of our workforce could result

in a temporary disruption in our business activities, including manufacturing and other functions.

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, though to date we have not experienced any such disruptions.

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 trials relating to CLI and 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 can no longer get to the clinic.

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 stock price fluctuated significantly, and such fluctuation may continue to occur.

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.

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.

impact of the use of our PLX cells in various COVID-19 related compassionate use programs, as well as our expected clinical trial,

if any, on our business and our results of operations cannot be predicted with certainty, as factors including, but not limited

to, the ultimate duration and scope of the compassionate use authorization, as well as the availability of our product internationally,

are not determinable at this time.

Our PLX cells may not be successful in treating complications associated with COVID-19.

Unresolved Staff Comments.

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