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Item 1A. Risk Factors

2022-07-28 compared with 2021-08-10 · 910 added, 1058 removed, 1347 unchanged (59% of the section changed)

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and uncertainties described below are those that we currently believe may materially affect our business and results of operations.

Additional risks and uncertainties that we are unaware of or that we currently deem immaterial also may become important factors that

affect our business and results of operations.

Our shares of common stock involve a high degree of risk and should be purchased only

by investors who can afford a loss of their entire investment.

Prospective investors should carefully consider the following risk factors

concerning our business before making an investment.

risks and uncertainties that we are unaware of or that we currently deem immaterial also may become important factors that affect our

business and results of operations.

Our shares of common stock involve a high degree of risk and should be purchased only by investors

who can afford a loss of their entire investment.

Prospective investors should carefully consider the following risk factors concerning

our business before making an investment.

In addition, you should carefully consider

these risks when you read “forward-looking”

statements elsewhere in this Report.

these risks when you read “forward-looking” statements elsewhere in this Report.

These are statements that relate to our expectations

for future events and time periods.

Generally, the words “anticipate,”

“expect,”

“intend,”

Generally, the words “anticipate,” “expect,” “intend,” and similar

expressions identify forward-looking statements.

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Forward-Looking Statements and Associated Risks

We operate in a very competitive

and rapidly changing environment.

We operate in a competitive and rapidly changing

New risks emerge from time to time.

It is not possible for us to predict all of those risks, nor can

we assess the impact of all of those risks on our business or the extent to which any factor may cause actual results to differ materially

from those contained in any forward-looking statement.

The forward-looking statements in this Report are based on assumptions management

believes are reasonable.

However, due to the uncertainties associated with forward-looking statements, you should not place undue reliance

on any forward-looking statements.

Further, forward-looking statements speak only as of the date they are made, and unless required by

law, we expressly disclaim any obligation or undertaking to publicly update any of them in light of new information, future events, or

It is not possible for us to predict all of those risks, nor can we assess the impact

of all of those risks on our business or the extent to which any factor may cause actual results to differ materially from those contained

in any forward-looking statement.

The forward-looking statements in this Report are based on assumptions management believes are reasonable.

However, due to the uncertainties associated with forward-looking statements, you should not place undue reliance on any forward-looking

Further, forward-looking statements speak only as of the date they are made, and unless required by law, we expressly disclaim

any obligation or undertaking to publicly update any of them in light of new information, future events, or otherwise.

Summary of Risks Associated with Our Business

Our business is subject to numerous risks and uncertainties

that you should consider before investing in our company.

These risks are described more in more detail in the section titled “Risk

Factors”

Our business is subject to numerous risks and uncertainties that you

should consider before investing in our company.

These risks are described more in more detail in the section titled “Risk Factors”

in Item 1A of this Report.

These risks include, but are not limited to, the following:

We are a biotechnology company with limited resources, a limited operating history and have no products approved for clinical trials

or commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.

As a result of the clinical hold that has been placed on our IND by the FDA, it has taken and may continue to take considerable time

and expense to respond to the FDA, and no assurance can be given that the FDA will remove the clinical hold in which case our business

and prospects will likely suffer material adverse consequences.

The recent and ongoing COVID-19 pandemic has affected and could continue to affect our operations, as well as the business or operations

of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics

in regions where we or third parties on which we rely have significant business operations.

If we are unable to successfully raise additional capital in addition to our recent completed public offering, our future clinical

trials and product development could be limited, and our long-term viability may be threatened.

Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we

must prioritize development of certain product candidates.

We may expend our limited resources on programs that do not yield a successful

product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater

likelihood of success.

We are a biotechnology company with limited resources, a limited operating history and no products approved for clinical trials or commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.

As a result of the clinical hold that has been placed on our IND by the FDA, it has taken and may continue to take considerable time and expense to respond to the FDA, and no assurance can be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material adverse consequences.

We contract with Austrianova for the manufacture of our product candidates for preclinical studies and clinical trials, if allowed to proceed, and expect to continue to do so for commercialization.

This reliance on Austrianova increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties on which we rely, including Austrianova.

Our business could be impacted as a result of actions by activist shareholders, including as a result of a potential proxy contest for the election of directors at our 2022 annual meeting.

The recent and ongoing COVID-19 pandemic has affected and could continue to affect our operations, as well as the business or operations of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely have significant business operations.

If we are unable to successfully raise additional capital in addition to our recent completed public offering, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we must prioritize development of certain product candidates.

We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

We currently have no commercial revenue and may never become profitable.

Our ability to continue as a going concern.

If we are unable to obtain, or if there are delays in obtaining, required approval from the applicable regulatory agencies, we will

not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.

If allowed to proceed with our clinical development program, we intend to conduct clinical trials for certain of our product candidates

at sites outside of the U.S., and the U.S.

If we are unable to obtain, or if there are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.

If allowed to proceed with our clinical development program, we intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S., and the U.S.

regulatory agencies may not accept data from trials conducted in such locations.

Promising results in previous clinical trials of our encapsulated live cell and ifosfamide combination for advanced pancreatic cancer

may not be replicated in future clinical trials which could result in development delays or a failure to obtain marketing approval.

Promising results in previous clinical trials of our encapsulated live cell and ifosfamide combination for advanced pancreatic cancer may not be replicated in future clinical trials which could result in development delays or a failure to obtain marketing approval.

We may not be able to protect our intellectual property rights throughout the world.

We rely and expect to continue to rely heavily on third parties to conduct our preclinical studies, plan to rely on third parties

to conduct our and clinical trials, assuming they are allowed to proceed, and those third parties may not perform satisfactorily,

including failing to meet deadlines for the completion of such studies and trials.

We rely and expect to continue to rely heavily on third parties to

conduct our preclinical studies, plan to rely on third parties to conduct our and clinical trials, assuming they are allowed to proceed,

and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies and trials.

Our business could be impacted as a result of actions by activist shareholders, including as a result of a potential proxy contest for the election of directors at our annual meeting.

You may experience future dilution as a result of future equity offerings.

If we fail to comply with the continuing listing standards on Nasdaq, our securities could be delisted.

If we fail to comply with the continuing listing standards on Nasdaq, our securities could be delisted which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.

We may experience volatility in our stock price, which may adversely affect the trading price of our common stock.

We may not be able to meet the continued listing requirements for Nasdaq,

which could limit investors’

ability to make transactions in our securities and subject us to additional trading restrictions.

A large number of shares may be issued and subsequently sold upon the exercise of existing options and warrants.

We are a “smaller reporting company”

under the SEC’s disclosure rules and have elected to comply with the reduced

disclosure requirements applicable to smaller reporting companies.

We are a “smaller reporting company” under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.

Following the reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional

investors, and may not satisfy the investing requirements of those investors.

Consequently, the trading liquidity of our common stock

may not improve.

Risks Related to Our Financial Position, FDA

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We are a biotechnology company

with limited resources, a limited operating history and have no products approved for clinical trials or commercial sale, which may make

it difficult to evaluate our current business and predict our future success and viability.

We are a biotechnology company focused on

developing cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology

known as “Cell-in-a-Box ®

In recent years, we have devoted substantially all our resources to the

development of our product candidates for LAPC.

We have limited resources, a limited operating history, no products approved for

clinical trials or commercial sale and therefore have not produced any revenues.

We have generated significant operating losses

since our inception.

Our net losses for the years ended April 30, 2021 and 2020 were approximately $3.6 million and $3.8 million,

respectively.

As of April 30, 2021, we had an accumulated deficit of approximately $107 million.

Substantially all our losses have

resulted from expenses incurred relating to our research and development programs and from general and administrative expenses and

operating losses associated with our business.

We expect to continue to incur significant

expenses and operating losses for the foreseeable future.

We anticipate these losses will increase as we continue our research and

development of, and, if approved by the FDA, commence clinical trials for, our product candidates.

In addition to budgeted expenses,

we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our

with limited resources, a limited operating history, and no products approved for clinical trials or commercial sale, which may make it

difficult to evaluate our current business and predict our future success and viability.

We are a biotechnology company focused on developing

cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box ® .”

In recent years, we have devoted substantially all our resources to the development of our product candidates for LAPC.

We have limited

resources, a limited operating history, no products approved for clinical trials or commercial sale and therefore have not produced any

We have generated significant operating losses since our inception.

Our net losses for the years ended April 30, 2022, and 2021

were approximately $4.2 million and $3.6 million, respectively.

As of April 30, 2022, we had an accumulated deficit of approximately $112

Substantially all our losses have resulted from expenses incurred relating to our research and development programs and from

general and administrative expenses and operating losses associated with our business.

We expect to continue to incur significant expenses

and operating losses for the foreseeable future.

We anticipate these losses will increase as we continue our research and development

of, and, if approved by the FDA, commence clinical trials for, our product candidates.

In addition to budgeted expenses, we may encounter

unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We have no facilities to conduct fundamental research

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facility for the development of our product candidates.

Biotechnology product development is a

highly uncertain undertaking and involves a substantial degree of risk.

We have not commenced or completed clinical trials for any

of our product candidates, obtained marketing approval for any product candidates, manufactured a commercial scale product, or

arranged for a third party to do so on our behalf, or conducted sales and marketing activities necessary for successful product

commercialization.

Given the highly uncertain nature of biotechnology product development, we may never commence or complete

clinical trials for any of our product candidates, obtain marketing approval for any product candidates, manufacture a commercial

scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for

successful product commercialization.

Biotechnology product development is a highly

uncertain undertaking and involves a substantial degree of risk.

We have not commenced or completed clinical trials for any of our product

candidates, obtained marketing approval for any product candidates, manufactured a commercial scale product, or arranged for a third party

to do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization.

Given the highly

uncertain nature of biotechnology product development, we may never commence or complete clinical trials for any of our product candidates,

obtain marketing approval for any product candidates, manufacture a commercial scale product or arrange for a third party to do so on

our behalf, or conduct sales and marketing activities necessary for successful product commercialization.

Our limited operating history as a company makes

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and financial condition will suffer.

As a result of the clinical hold that

has been placed on our IND by the FDA, it has taken and may continue to take considerable time and expense to respond to the FDA and no

assurance can be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material

adverse consequences.

On October 1, 2020, we received

notice from the FDA that it had placed our IND for a planned Phase 2b clinical trial in LAPC on clinical hold.

As part of the clinical

hold process, the FDA has asked for additional information, tasks to be performed by us and new preclinical studies and assays.

taken and may continue to take a considerable period of time, the length of which is not certain at this time, for us to conduct such

tasks and preclinical studies and to generate and prepare the requested information.

In addition, the significant expense of such work

is likely to require us to raise additional capital.

As a result of the clinical hold that has

been placed on our IND by the FDA, it has taken and may continue to take considerable time and expense to respond to the FDA and no assurance

can be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material adverse consequences.

On October 1, 2020, we received notice from the

FDA that it had placed our IND for a planned Phase 2b clinical trial in LAPC on clinical hold.

As part of the clinical hold process, the

FDA has asked for additional information, tasks to be performed by us and new preclinical studies and assays.

It has taken and may continue

to take a considerable period of time, the length of which is not certain at this time, for us to conduct such tasks and preclinical studies

and to generate and prepare the requested information.

It is possible that the service providers that we will utilize for such work may

have considerable backlogs and/or are suffering from slowdowns as a result of COVID-19 and may not be able to perform such work for an

extended period of time.

Even if we are able to fully respond to the FDA’s requests, they may subsequently make additional requests

that we would need to fulfill prior to the lifting of the clinical hold and we may never be able to begin our clinical trial in LAPC,

obtain regulatory approval or successfully commercialize our product candidates.

An inability to conduct our clinical trial in LAPC as

a result of the clinical hold or otherwise, would likely force us to terminate our clinical development plans.

It is possible that we

will be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may never be lifted.

If the clinical

hold is not lifted or if the lifting takes an extended period of time, our business and prospects will likely suffer material adverse

consequences.

have considerable backlogs and/or are suffering from slowdowns as a result of COVID-19 and supply chain disruptions and may not be able

to perform such work for an extended period of time.

Even if we are able to fully respond to the FDA’s requests, they may subsequently

make additional requests that we would need to fulfill prior to the lifting of the clinical hold and we may never be able to begin our

clinical trial in LAPC, obtain regulatory approval or successfully commercialize our product candidates.

An inability to conduct our clinical

trial in LAPC as a result of the clinical hold or otherwise, would likely force us to terminate our clinical development plans.

possible that we will be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may never be lifted.

If the clinical hold is not lifted or if the lifting takes an extended period of time, our business and prospects will likely suffer material

adverse consequences.

We contract with Austrianova for the manufacture

of our product candidates for preclinical studies and clinical trials, if allowed to proceed, and expect to continue to do so for commercialization.

This reliance on Austrianova increases the risk that we will not have sufficient quantities of our product candidates or such quantities

at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not currently own or operate manufacturing

facilities to produce our encapsulated live cell product candidates for cancer, diabetes and malignant ascites.

We rely on and expect

to continue to rely on Austrianova to manufacture supplies of our product candidates for preclinical studies and clinical trials, if allowed

to proceed, as well as for commercial manufacture of our product candidates, and these must be maintained for us to receive marketing

approval for our product candidates.

Our encapsulated live cell product candidates

must be manufactured through complex, multi-step synthetic processes that are time-consuming and involve special conditions at certain

Biologics and drug substance manufacture requires high potency containment, and containment under aseptic conditions.

Any performance

failures on the part of our existing or future manufacturers could delay clinical development or marketing approval of our product candidates.

Moreover, the facilities that produce our Cell-in-a-Box ® capsules are unique to us and would not be replicable or replaceable

promptly, if at all, if those facilities become unavailable or are damaged or destroyed through an accident, natural disaster, labor disturbance

or otherwise.

If Austrianova should become unavailable to us

for any reason, we may incur additional cost or delay in identifying or qualifying a replacement manufacturer.

At this time, we are unaware

of any available substitute manufacturer other than Austrianova.

In addition, while we believe that our existing manufacturer, Austrianova,

can produce our product candidates, if approved, in commercial quantities, we may also need to identify a third-party manufacturer capable

of providing commercial quantities of our product candidates.

If we are unable to arrange for such a third-party manufacturing source

or fail to do so on commercially reasonable terms and in a timely manner, we may not be able to successfully produce and market our encapsulated

live cell and ifosfamide product or any other product candidate or may be delayed in doing so.

Even if we can establish such arrangements with

another third-party manufacturer, reliance on a new third-party manufacturer entails additional risks, including:

Reliance on the third party for regulatory compliance and quality assurance;

The possible breach of the manufacturing agreement by the third party;

The possible misappropriation of our proprietary information, including our trade secrets and know-how;

The possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

A new third-party manufacturer may not be able

to comply with cGMP standards or the requirements of a regulatory agency.

Our failure, or the failure of our third-party manufacturer,

to comply with these practices or requirements could result in sanctions being imposed on us, including additional clinical holds, fines,

injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates

or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product

Delays in the cGMP certification of the Austrianova

manufacturing facility in Bangkok, Thailand could affect its ability to manufacture encapsulated live cells on a timely basis and could

adversely affect supplies of our product candidates for clinical trials and to market.

Our product candidates that we may develop may

compete with other product candidates and products for access to manufacturing facilities.

There are a limited number of manufacturers

that operate under cGMP regulations and that might be capable of manufacturing products for us.

In addition, we expect to rely on Austrianova

to purchase from third-party suppliers the materials necessary to produce our product candidates for our clinical studies, if allowed

There are a small number of suppliers for certain equipment and raw materials that are used in the manufacture of our product

Such suppliers may not sell these raw materials to Austrianova at the times we need them or on commercially reasonable terms.

For example, there is from time to time a limited supply of acceptable cell media for production of our MCB.

We do not have any control

over the process or timing of the acquisition of these raw materials by Eurofins or Austrianova.

Moreover, we currently do not have any

agreements for the commercial production of these raw materials.

Austrianova from time to time has experienced significant supply chain

disruptions, some of which may be related to COVID-19, and we believe it is experiencing liquidity issues.

Any further significant delay

in the supply of a product candidate or the raw material components thereof our clinical trials, if allowed to proceed, due to the need

to replace a third-party supplier of these raw materials could considerably delay completion of our clinical studies, product testing

and potential regulatory approval of our product candidates.

If Eurofins, Austrianova or we are unable to purchase these raw materials

after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed

or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

Our current and anticipated future dependence

upon Austrianova and others for the manufacture of our product candidates may adversely affect our future profit margins and our ability

to commercialize any products that receive marketing approval on a timely and competitive basis.

Disruptions in the global economy and supply chains may have

a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties

on which we rely, including Austrianova.

The disruptions to the global economy in 2020, 2021 and into 2022 have

impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses.

a third-party supplier on whom we rely, from time to time has experienced significant supply chain disruptions, some of which may be related

to COVID-19, and we believe it may be experiencing liquidity issues.

Despite any actions we have undertaken to minimize the impacts from

disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain, inflationary pressures,

and delays our third parties face will not have a material adverse effect on our business, financial condition and results of operations.

Our business could be impacted as a result of actions by activist

shareholders, including as a result of a potential proxy contest for the election of directors at our annual meeting.

We recently received notice from Iroquois Capital

Management, LLC and certain of its affiliates nominating a slate of eight individuals for election to our Board of Directors for the 2022

annual meeting.

If a proxy contest or consent solicitation results from this notice, our business could be adversely affected because:

(i) responding to proxy contests and other actions by activist shareholders can be costly and time-consuming, which could disrupt our

operations and divert the attention of management and our employees;

(ii) perceived uncertainties as to our future direction could adversely

affect our relationships with customers, suppliers, investors, prospective and current team members and others, resulting in the loss

of potential business opportunities, or making it more difficult to attract and retain qualified personnel;

and (iii) if individuals are

elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our

strategic plan.

These actions could also cause our stock price to experience periods of volatility.

In addition, future proxy contests

and other actions by activist shareholders could require us to incur significant legal fees and solicitation expenses and require significant

time and attention by management and the Board of Directors and could materially and adversely affect our business and operating results.

We may also be subject, from time to time, to other legal and business challenges in the operation of our company due to actions instituted

by activist shareholders.

Responding to such actions could be costly and time-consuming.

The recent and ongoing COVID-19

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we rely have significant business operations.

Our business and its operations,

including, but not limited to, our proposed clinical development program, supply chain operations, research and development activities

and fundraising activities, has been and could continue to be adversely affected by the COVID-19 pandemic in areas where we have business

operations, including the U.S., India, Europe, Singapore and Thailand.

Also, this pandemic could cause significant disruption in the operations

of third parties upon whom we rely on to conduct the Company’s business.

Our business and its operations, including, but

not limited to, our proposed clinical development program, supply chain operations, research and development activities and fundraising

activities, has been and could continue to be adversely affected by the COVID-19 pandemic in areas where we have business operations,

including the U.S., India, Europe, Singapore and Thailand.

Also, this pandemic could cause significant disruption in the operations of

third parties upon whom we rely on to conduct the Company’s business.

In March 2020, the World Health Organization declared the

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The COVID-19 pandemic has had an impact upon our operations.

The effects of the executive

orders, the shelter-in-place orders and our work-from-home policies has and may continue to negatively impact productivity, disrupt our

business, and delay our proposed clinical development program and timeline, the magnitude of which will depend, in part, on the length

and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

These and similar,

and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place,

executive, and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business

operations could occur, related to COVID-19, could impact personnel at our third-party manufacturing facilities in Thailand, or the availability

or cost of materials we use or require to conduct our business, including product development, which would disrupt our supply chain.

of our suppliers and vendors of certain materials used in our operations and research and development activities are located in areas

that are subject to executive orders and shelter-in-place orders.

While many of these materials may be obtained from more than one supplier,

port closures and other restrictions resulting from the COVID-19 pandemic may disrupt our supply chain or limit our ability to obtain

sufficient materials to operate our business.

To date, we are aware of certain suppliers for our research and development activities that

have experienced operational delays directly related to the COVID-19 pandemic.

Depending upon the length of

the COVID-19 pandemic and whether the FDA lifts the clinical hold on our IND, we anticipate our planned clinical trial in LAPC may be

affected by the COVID-19 pandemic.

If COVID-19 continues to spread in the U.S.

and elsewhere, we may experience additional disruptions

that could adversely impact our business and proposed clinical trial, including:

(i) delays or difficulties in enrolling patients in our

Phase 2b clinical trial if the FDA allows us to go forward with such trial;

(ii) delays or difficulties in clinical site activation, including

difficulties in recruiting clinical site investigators and clinical site personnel;

(iii) delays in clinical sites receiving the supplies

and materials needed to conduct our clinical trial, including interruption in global shipping that may affect the transport of our clinical

trial product;

(iv) changes in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways

in which our clinical trial is to be conducted, which may result in unexpected costs, or to discontinue the clinical trial altogether,

if allowed to proceed;

(v) diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals

serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trial;

(vi) interruption of key clinical

trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments,

employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the

integrity of clinical trial data;

(vii) risk that participants enrolled in our proposed clinical trials will acquire COVID-19 while the

clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse

(viii) delays in necessary interactions with local regulators, ethics committees, and other important agencies and contractors

due to limitations in employee resources or forced furlough of government employees;

(ix) limitations in employee resources that would

otherwise be focused on the conduct of our clinical trial because of sickness of employees or their families or the desire of employees

to avoid contact with large groups of people;

(x) refusal of the FDA to accept data from clinical trials in affected geographies;

(xi) interruption or delays to our clinical trial activities.

The spread of COVID-19, which

has caused a widespread impact throughout the world, may materially affect us economically.

The potential economic impact brought about

by the COVID-19 pandemic, and the duration of such impact, is difficult to assess or predict.

The pandemic has resulted in significant

disruption of global financial markets, which could reduce our ability to access capital and negatively affect our future liquidity.

a recession or market correction resulting from the spread of COVID-19 and related government orders and restrictions could materially

affect our business and the value of our common stock.

The COVID-19 pandemic continues to evolve.

The ultimate impact of the COVID-19

pandemic and the mitigation efforts to address it is highly uncertain and subject to change.

We do not yet know the full extent of potential

delays or impacts on our business, our proposed clinical trial, healthcare systems or the global economy.

The effects of the executive orders, the shelter-in-place

orders and our work-from-home policies has and may continue to negatively impact productivity, disrupt our business, and delay our proposed

clinical development program and timeline, the magnitude of which will depend, in part, on the length and severity of the restrictions

and other limitations on our ability to conduct our business in the ordinary course.

These and similar, and perhaps more severe, disruptions

in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place, executive, and

similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could

occur, related to COVID-19, could impact personnel at our third-party manufacturing facilities in Thailand, or the availability or cost

of materials we use or require to conduct our business, including product development, which would disrupt our supply chain.

suppliers and vendors of certain materials used in our operations and research and development activities are located in areas that are

subject to executive orders and shelter-in-place orders.

While many of these materials may be obtained from more than one supplier, port

closures and other restrictions resulting from the COVID-19 pandemic may disrupt our supply chain or limit our ability to obtain sufficient

materials to operate our business.

To date, we are aware of certain suppliers for our research and development activities that have experienced

operational delays related to the COVID-19 pandemic.

Depending upon the length of COVID-19 and whether

the FDA lifts the clinical hold on our IND, we anticipate our planned clinical trial in LAPC may be affected by COVID-19.

continues to spread in the U.S.

and elsewhere, we may experience additional disruptions that could adversely impact our business and proposed

clinical trial, including:

(i) delays or difficulties in enrolling patients in our Phase 2b clinical trial if the FDA allows us to go

forward with such trial;

(ii) delays or difficulties in clinical site activation, including difficulties in recruiting clinical site investigators

and clinical site personnel;

(iii) delays in clinical sites receiving the supplies and materials needed to conduct our clinical trial,

including interruption in global shipping that may affect the transport of our clinical trial product;

(iv) changes in local regulations

as part of a response to COVID-19 which may require us to change the ways in which our clinical trial is to be conducted, which may result

in unexpected costs, or to discontinue the clinical trial altogether, if allowed to proceed;

(v) diversion of healthcare resources away

from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting

the conduct of our clinical trial;

(vi) interruption of key clinical trial activities, such as clinical trial site monitoring, due to

limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial

subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data;

(vii) risk that participants

enrolled in our proposed clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of

the clinical trial, including by increasing the number of observed adverse events;

(viii) delays in necessary interactions with local

regulators, ethics committees, and other important agencies and contractors due to limitations in employee resources or forced furlough

of government employees;

(ix) limitations in employee resources that would otherwise be focused on the conduct of our clinical trial because

of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

(x) refusal of the

FDA to accept data from clinical trials in affected geographies;

and (xi) interruption or delays to our clinical trial activities.

The spread of COVID-19, which has caused a widespread

impact throughout the world, may materially affect us economically.

The potential economic impact brought about COVID-19, and the duration

of such impact, is difficult to assess or predict.

The pandemic has resulted in significant disruption of global financial markets, which

could reduce our ability to access capital and negatively affect our future liquidity.

Also, a recession or market correction resulting

from the spread of COVID-19 and related government orders and restrictions could materially affect our business and the value of our common

COVID-19 continues to evolve.

The ultimate impact of COVID-19 and the mitigation efforts to address it is highly uncertain and

subject to change.

We do not yet know the full extent of potential delays or impacts on our business, our proposed clinical trial, healthcare

systems or the global economy.

If we are unable to successfully

raise additional capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

We have experienced negative

operating cash flows since our inception and have funded our operations primarily through sales of our equity securities.

to seek additional funds in the future through equity or debt financings, or strategic alliances with third parties, either alone or in

combination with equity financings to complete our product development initiatives.

These financings could result in substantial dilution

to the holders of our common stock or require contractual or other restrictions on our operations or on alternatives that may be available

If we raise additional funds by issuing debt securities, these debt securities could impose significant restrictions on our operations.

Any such required financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing

could have a material and adverse effect on our business, financial condition and results of operations, or threaten our ability to continue

as a going concern.

Our operating and capital requirements

during this fiscal year and thereafter will vary based on several factors, including whether the FDA allows us to commence our planned

clinical trial for LAPC, how quickly enrollment of patients in our such trial can be commenced, the duration of the clinical trial and

any change in the clinical development plans for our product candidates and the outcome, timing and cost of meeting regulatory requirements

established by the FDA and the EMA or other comparable foreign regulatory authorities.

The proceeds of this proposed offering will not

be sufficient to complete our planned Phase 2b clinical trial for LAPC if the clinical hold is lifted by the FDA.

Our present and future capital requirements will

be significant and will depend on many factors, including:

whether the FDA lifts

the clinical hold on our IND filing for LAPC;

the progress and results

of our development efforts for our product candidates;

the costs, timing and

outcome of regulatory review of our product candidates;

the costs and timing

of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any

intellectual property-related claims;

the effect of competing

technological and market developments;

market acceptance of

We have experienced negative operating cash flows

since our inception and have funded our operations primarily through sales of our equity securities.

We may need to seek additional funds

in the future through equity or debt financings, or strategic alliances with third parties, either alone or in combination with equity

financings to complete our product development initiatives.

These financings could result in substantial dilution to the holders of our

common stock or require contractual or other restrictions on our operations or on alternatives that may be available to us.

additional funds by issuing debt securities, these debt securities could impose significant restrictions on our operations.

Any such required

financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing could have

a material and adverse effect on our business, financial condition and results of operations, or threaten our ability to continue as a

going concern.

Our operating and capital requirements during

this fiscal year and thereafter will vary based on several factors, including whether we can complete the studies requested by the FDA

with respect to our IND filing, whether the FDA allows us to commence our planned clinical trial for LAPC, how quickly enrollment of patients

in our such trial can be commenced, the duration of the clinical trial and any change in the clinical development plans for our product

candidates and the outcome, timing and cost of meeting regulatory requirements established by the FDA and the EMA or other comparable

foreign regulatory authorities.

Our present and future capital requirements will be significant and

will depend on many factors, including:

our ability to complete the studies requested by the FDA with respect to our IND filing;

whether the FDA lifts the clinical hold on our IND filing for LAPC;

the progress and results of our development efforts for our product candidates;

the costs, timing and outcome of regulatory review of our product candidates;

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

the effect of competing technological and market developments;

market acceptance of our product candidates;

the rate of progress in establishing coverage and reimbursement arrangements with domestic and international commercial third-party payors and government payors;

the extent to which we acquire or in-license other products and technologies;

legal, accounting, insurance and other professional and business-related costs.

We may not be able to acquire additional funds

on acceptable terms, or at all.

If we are unable to raise adequate funds, we may have to liquidate some or all of our assets, or delay

or reduce the scope of or eliminate some or all of our development programs.

Further, if we do not have, or are not able to obtain, sufficient

funds, we may be required to delay planned and future clinical trials, including the pig study, and development or commercialization of

our product candidates.

the rate of progress

in establishing coverage and reimbursement arrangements with domestic and international commercial third-party payors and government

the extent to which

we acquire or in-license other products and technologies;

legal, accounting, insurance

and other professional and business-related costs.

We may not be able to acquire

additional funds on acceptable terms, or at all.

If we are unable to raise adequate funds, we may have to liquidate some or all of our

assets, or delay or reduce the scope of or eliminate some or all of our development programs.

Further, if we do not have, or are not able

to obtain, sufficient funds, we may be required to delay development or commercialization of our product candidates.

We also may have

to reduce the resources devoted to our product candidates or cease operations.

Any of these factors could harm our operating results.

Due to the significant resources required

for the development of our programs, and depending on our ability to access capital, we must prioritize development of certain product

We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on

product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

We seek to maintain a process

of prioritization and resource allocation to maintain an optimal balance between aggressively advancing lead programs and ensuring replenishment

of our portfolio.

Until such time, if ever, as the FDA lifts its clinical hold on ou r

I ND related to our planned Phase 2b clinical trial in LAPC, our Cell-in-a-Box ®

encapsulation technology is validated

in our planned Phase 2b clinical trial, and sufficient additional funding is available, we have halted spending on behalf of our other

development programs with respect to cannabinoids, malignant ascites fluid and diabetes.

Due to the significant resources

required for the development of our programs, we must focus our programs on specific diseases and decide which product candidates to pursue

and advance and the amount of resources to allocate to each.

Our decisions concerning the allocation of research, development, collaboration,

management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of any viable

commercial product and may divert resources away from better opportunities.

Similarly, our potential decisions to delay, terminate or

collaborate with third parties in respect of certain programs may subsequently also prove to be suboptimal and could cause us to miss

valuable opportunities.

We may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego

or delay pursuit of opportunities with other product candidates or other diseases that may later prove to have greater commercial potential

than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty

arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization

We also may have to reduce the resources devoted to our product candidates or cease operations.

Any of these factors

could harm our operating results.

Due to the significant resources required for the development

of our programs, and depending on our ability to access capital, we must prioritize development of certain product candidates.

expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates

or indications that may be more profitable or for which there is a greater likelihood of success.

We seek to maintain a process of prioritization

and resource allocation to maintain an optimal balance between aggressively advancing lead programs and ensuring replenishment of our

Until such time, if ever, as the FDA lifts its clinical hold on our IND related to our planned Phase 2b clinical trial in LAPC,

our Cell-in-a-Box ® encapsulation technology is validated in our planned Phase 2b clinical trial, and sufficient additional

funding is available, we have halted spending on behalf of our development program with respect to cannabinoids.

Due to the significant resources required for

the development of our programs, we must focus our programs on specific diseases and decide which product candidates to pursue and advance

and the amount of resources to allocate to each.

Our decisions concerning the allocation of research, development, collaboration, management

and financial resources toward particular product candidates or therapeutic areas may not lead to the development of any viable commercial

product and may divert resources away from better opportunities.

Similarly, our potential decisions to delay, terminate or collaborate

with third parties in respect of certain programs may subsequently also prove to be suboptimal and could cause us to miss valuable opportunities.

We may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of

opportunities with other product candidates or other diseases that may later prove to have greater commercial potential than those we

choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements

in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization

If we make incorrect determinations regarding the viability or market potential of any or all of our programs or product candidates

28 unchanged sentences

our product candidates that we may develop, in-license or acquire in the future.

We face substantial competition, which

may result in others discovering, developing or commercializing competing products before or more successfully than we do.

The development and commercialization

of new drug products is highly competitive.

We face substantial competition, which may result in others discovering,

developing or commercializing competing products before or more successfully than we do.

The development and commercialization of new drug

products is highly competitive.

We face competition with respect to our current product candidates.

We will face competition

with respect to any product candidates that we may seek to develop or commercialize in the future.

Such competition may arise from major

pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.

There are several large pharmaceutical

and biotechnology companies that currently market products or are pursuing the development of products for the treatment of the disease

indications for which we are developing our product candidates.

Some of these competitive products and therapies are based on scientific

approaches that are entirely different from our approach.

Potential competitors also include academic institutions, government agencies

and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements

for research, development, manufacturing and commercialization.

Specifically, there are numerous

companies developing or marketing therapies for cancer and diabetes, including many major pharmaceutical and biotechnology companies.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

We will face competition with respect

to any product candidates that we may seek to develop or commercialize in the future.

Such competition may arise from major pharmaceutical

companies, specialty pharmaceutical companies and biotechnology companies worldwide.

There are several large pharmaceutical and biotechnology

companies that currently market products or are pursuing the development of products for the treatment of the disease indications for

which we are developing our product candidates.

Some of these competitive products and therapies are based on scientific approaches that

are entirely different from our approach.

Potential competitors also include academic institutions, government agencies and other public

and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research,

development, manufacturing and commercialization.

Specifically, there are numerous companies developing

or marketing therapies for cancer, diabetes and malignant ascites, including many major pharmaceutical and biotechnology companies.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

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establishing a strong market position before we can enter the market.

Many of the companies against

which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research

and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved

products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology sectors may result in even more resources being

concentrated among a smaller number of our competitors.

Smaller and other early-stage companies may also prove to be significant competitors,

particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting

and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials,

as well as in acquiring technologies complementary to, or necessary for, our programs.

Many of the companies against which we are competing

or against which we may compete in the future have significantly greater financial resources and expertise in research and development,

manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we

Mergers and acquisitions in the pharmaceutical and biotechnology sectors may result in even more resources being concentrated among

a smaller number of our competitors.

Smaller and other early-stage companies may also prove to be significant competitors, particularly

through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining

qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well

as in acquiring technologies complementary to, or necessary for, our programs.

Our future revenues are unpredictable which

18 unchanged sentences

(i) the ability to obtain and retain customers;

(ii) our ability to attract new customers at a steady rate and maintain

customer satisfaction with products;

(ii) our ability to attract new customers at a steady rate and maintain customer

satisfaction with products;

(iii) our announcement or introduction of new products by us or our competitors;

(v) the level of use and consumer acceptance of its products;

(vi) the amount and timing of operating costs and capital

expenditures relating to expansion of the business, operations and infrastructure;

(iv) price competition;

the level of use and consumer acceptance of its products;

(vi) the amount and timing of operating costs and capital expenditures relating

to expansion of the business, operations and infrastructure;

(vii) governmental regulations;

(viii) general

economic conditions;

and (ix) the adverse impacts caused by COVID-19 discussed in more detail below.

(viii) general economic conditions;

delays or disruptions in our supply chain;

and (x) the adverse impacts caused by COVID-19 discussed in more detail below.

Additional Risks Related to Regulatory Matters

If we are unable to obtain, or if there

are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates

and our ability to generate revenue will be materially impaired.

Our product candidates must

obtain marketing approval from the FDA for commercialization in the U.S.

and from foreign regulatory agencies for commercialization in

countries outside the U.S.

The process of obtaining marketing approvals in the countries in which we intend to sell and distribute our

product candidates is expensive and can take many years if approval is obtained at all.

This process can vary substantially based upon

a variety of factors, including the type, complexity and novelty of the product candidates involved.

Failure to obtain marketing approval

for a product candidate will prevent us from commercializing that product candidate.

To date, we have not received approval to market

any of our product candidates from regulatory agencies in any jurisdiction.

We have no experience in filing and supporting the applications

necessary to gain marketing approvals and expect to rely on third-party contract research organizations to assist us in this process.

Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to the regulatory

agencies for each product candidate to establish the product candidate’s safety and efficacy.

Securing marketing approval also requires

the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory

Our product candidates may not

be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics

that may preclude our obtaining marketing approval or prevent or limit commercial use.

Regulatory agencies have substantial discretion

in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require

additional preclinical, clinical or other studies.

In addition, varying interpretations of the data obtained from preclinical and clinical

testing could delay, limit or prevent marketing approval of a product candidate.

Changes in marketing approval policies during the development

period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product

application, may also cause delays in or prevent the approval of an application.

New cancer drugs frequently are indicated only for patient

populations that have not responded to an existing therapy or have relapsed after such therapies.

If we experience delays in obtaining

approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed

and our ability to generate revenues will be materially impaired.

If allowed to proceed

with our clinical development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of

the U.S., and the U.S.

If we are unable to obtain, or if there are delays in obtaining,

required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates and our ability

to generate revenue will be materially impaired.

Our product candidates must obtain marketing approval

from the FDA for commercialization in the U.S.

and from foreign regulatory agencies for commercialization in countries outside the U.S.

The process of obtaining marketing approvals in the countries in which we intend to sell and distribute our product candidates is expensive

and can take many years if approval is obtained at all.

This process can vary substantially based upon a variety of factors, including

the type, complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate will

prevent us from commercializing that product candidate.

To date, we have not received approval to market any of our product candidates

from regulatory agencies in any jurisdiction.

We have no experience in filing and supporting the applications necessary to gain marketing

approvals and expect to rely on third-party contract research organizations to assist us in this process.

Securing marketing approval

requires the submission of extensive preclinical and clinical data and supporting information to the regulatory agencies for each product

candidate to establish the product candidate’s safety and efficacy.

Securing marketing approval also requires the submission of

information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory agencies.

Our product candidates may not be effective, may

be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may

preclude our obtaining marketing approval or prevent or limit commercial use.

Regulatory agencies have substantial discretion in the approval

process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical,

clinical or other studies.

In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay,

limit or prevent marketing approval of a product candidate.

Changes in marketing approval policies during the development period, changes

in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may

also cause delays in or prevent the approval of an application.

New cancer drugs frequently are indicated only for patient populations

that have not responded to an existing therapy or have relapsed after such therapies.

If we experience delays in obtaining approval or

if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability

to generate revenues will be materially impaired.

If allowed to proceed with our clinical

development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S., and the

regulatory agencies may not accept data from trials conducted in such locations.

Although the FDA may accept

data from clinical trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the regulatory

agencies outside of the U.S.

For example, the clinical trial must be well designed and conducted and performed by qualified investigators

in accordance with ethical principles.

The trial population must also adequately represent the population in the country in which the

clinical trial is being conducted.

Although the FDA may accept data from clinical

trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the regulatory agencies outside

For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance

with ethical principles.

The trial population must also adequately represent the population in the country in which the clinical trial

is being conducted.

The data must be applicable to the U.S.

population and medical practice in the U.S.

in ways that the

FDA deems clinically meaningful.

in ways that the FDA deems clinically

Generally, the patient population for any clinical trial conducted outside of the U.S.

must be representative

of the population for whom we intend to seek approval in the U.S.

In addition, while these clinical

trials are subject to the applicable local laws, the FDA acceptance of the data will be dependent upon its determination that the trials

also complied with all applicable U.S.

must be representative of the population

for whom we intend to seek approval in the U.S.

In addition, while these clinical trials are subject

to the applicable local laws, the FDA acceptance of the data will be dependent upon its determination that the trials also complied with

all applicable U.S.

laws and regulations.

There can be no assurance that the FDA will accept data from trials conducted

outside of the U.S.

If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the U.S.,

it would likely result in the need for additional trials that would be costly and time-consuming and delay or permanently halt the development

of our product candidate.

In addition, the conduct of

clinical trials outside the U.S.

There can be no assurance that the FDA will accept data from trials conducted outside of the

If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the U.S., it would likely

result in the need for additional trials that would be costly and time-consuming and delay or permanently halt the development of our

product candidate.

In addition, the conduct of clinical trials outside

could have a significant impact on us.

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future commercialization and marketing if regulatory approval is obtained.

If the FDA allows us to begin a clinical

trial by lifting its clinical hold on our IND, we have determined that the data contained in previous clinical trial reports using

the Cell-in-a-Box ®

If the FDA allows us to begin a clinical trial

by lifting its clinical hold on our IND, we have determined that the data contained in previous clinical trial reports using the Cell-in-a-Box ®

and its Associated Technologies are not enough to advance the program to a Phase 3 pivotal trial.

Therefore, we are designing a Phase 2b clinical trial that, if successful, we believe will provide the information necessary to plan

a Phase 3 pivotal trial.

Our determination to first conduct a Phase 2b clinical trial before conducting a pivotal Phase 3 clinical

trial will likely result in additional costs to us and resultant delays in the regulatory review process and any future

commercialization and marketing if regulatory approval is obtained.

The same is true to a greater extent if the FDA requires us to

commence a Phase 1 or other Phase 2 clinical trial instead of the planned Phase 2b clinical trial currently under clinical hold.

Therefore, we are designing a

Phase 2b clinical trial that, if successful, we believe will provide the information necessary to plan a Phase 3 pivotal trial.

Our determination

to first conduct a Phase 2b clinical trial before conducting a pivotal Phase 3 clinical trial will likely result in additional costs to

us and resultant delays in the regulatory review process and any future commercialization and marketing if regulatory approval is obtained.

The same is true to a greater extent if the FDA requires us to commence a Phase 1 or other Phase 2 clinical trial instead of the planned

Phase 2b clinical trial currently under clinical hold.

If we are unable to obtain, or if there

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from the FDA for commercialization in the U.S.

and from foreign regulatory agencies for commercialization in countries

outside the U.S.

The process of obtaining marketing approvals in the countries in which we intend to sell and distribute our product candidates

is expensive and can take several years if approval is obtained at all.

This process can vary substantially based upon a variety of factors,

including the type, complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate

will prevent us from commercializing that product candidate.

and from foreign regulatory agencies for commercialization in countries outside the U.S.

The process of obtaining marketing approvals in the countries in which we intend to sell and distribute our product candidates is expensive

and can take several years if approval is obtained at all.

This process can vary substantially based upon a variety of factors, including

the type, complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate will

prevent us from commercializing that product candidate.

To date, we have not received approval to market any of our product candidates

4 unchanged sentences

requires the submission of extensive preclinical and clinical data and supporting information to the regulatory agencies for each product

candidate to establish the product candidate’s safety and efficacy.

Securing marketing approval also requires the submission of

16 unchanged sentences

to generate revenues will be materially impaired.

Development of a biologic

involves a lengthy and expensive process with an uncertain outcome.

We may incur additional costs or experience delays in completing

or be unable to complete the development and commercialization of our product candidates.

Our Cell-in-a-Box ®

ifosfamide combination product candidate has not begun clinical development, and, like others’

candidates in a similar phase

of development, the risk of failure is high.

It is impossible to predict when or if this product candidate or any other product

candidate will prove effective or safe in humans or will receive regulatory approval.

Before obtaining marketing approval from

regulatory agencies for the sale of any product candidate, if allowed to proceed, we must complete preclinical development and then

conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans.

Clinical trials are

expensive, difficult to design and implement, can take several years to complete and are uncertain as to their outcome.

one or more clinical trials can occur at any stage of a clinical trial.

The clinical development of our product candidates is

susceptible to the risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy in a

clinical trial or across a broad population of patients, the occurrence of severe or medically or commercially unacceptable adverse

events, failure to comply with protocols or applicable regulatory requirements or determination by the regulatory agencies that a

drug or biologic product is not approvable.

It is possible that even if one or more of our product candidates has a beneficial

effect, that effect will not be detected during clinical evaluation because of one or more of a variety of factors, including the

size, duration, design, measurements, conduct or analysis of our clinical trials.

Conversely, because of the same factors, our

clinical trials if allowed to proceed, may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if

Similarly, in our clinical trials if allowed to proceed, we may fail to detect toxicity of, or intolerability caused by, our product candidates, or

mistakenly believe that our product candidates are toxic or not well tolerated when that is not, in fact, the case.

Development of a biologic involves a lengthy

and expensive process with an uncertain outcome.

We may incur additional costs or experience delays in completing or be unable to complete

the development and commercialization of our product candidates.

Our Cell-in-a-Box ® and ifosfamide

combination product candidate has not begun clinical development, and, like others’ candidates in a similar phase of development,

the risk of failure is high.

It is impossible to predict when or if this product candidate or any other product candidate will prove effective

or safe in humans or will receive regulatory approval.

Before obtaining marketing approval from regulatory agencies for the sale of any

product candidate, if allowed to proceed, we must complete preclinical development and then conduct extensive clinical trials to demonstrate

the safety and efficacy of our product candidates in humans.

Clinical trials are expensive, difficult to design and implement, can take

several years to complete and are uncertain as to their outcome.

A failure of one or more clinical trials can occur at any stage of a

clinical trial.

The clinical development of our product candidates is susceptible to the risk of failure inherent at any stage of drug

development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of

severe or medically or commercially unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements

or determination by the regulatory agencies that a drug or biologic product is not approvable.

It is possible that even if one or more

of our product candidates has a beneficial effect, that effect will not be detected during clinical evaluation because of one or more

of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials.

Conversely, because

of the same factors, our clinical trials if allowed to proceed, may indicate an apparent positive effect of a product candidate that is

greater than the actual positive effect, if any.

Similarly, in our clinical trials if allowed to proceed, we may fail to detect toxicity

of, or intolerability caused by, our product candidates, or mistakenly believe that our product candidates are toxic or not well tolerated

when that is not, in fact, the case.

The outcome of preclinical studies and early and

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the U.S., and it is possible that the FDA may not accept data from trials conducted in such locations or conducted nearly 20 years ago.

In support of our IND application to

commence a Phase 2b clinical trial in LAPC using genetically engineered live human cells encapsulated using our

Cell-in-a-Box ®

technology in combination with ifosfamide we are relying on a Phase 1/2 clinical trial and a Phase 2

clinical trial previously conducted using the same technology in combination with ifosfamide between 1998 and 1999 and between

1999 and 2000, respectively.

The Phase 1/2 clinical trial was carried out at the Division of Gastroenterology, University of

Rostock, Germany, and the Phase 2 clinical trial was carried out at four centers in two countries in Europe:

Berne, Switzerland, and

in Rostock, Munich and Berlin, Germany.

Although the FDA may accept data from

clinical trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the FDA.

risk that the FDA may not accept the data from the two previous trials.

In that case, we may be required to conduct a Phase 1 or a

Phase 1/2b clinical trial rather than the planned Phase 2b clinical trial in LAPC, currently under clinical hold.

This may result in

additional costs to us and resultant delays in the regulatory review process and any future commercialization and marketing if

regulatory approval is obtained.

It is not known whether the FDA would be likely to reject the use of such clinical data due to the

significant time that has elapsed since the earlier clinical trials were conducted or because the clinical trial material for our

proposed Phase 2b clinical trial is different from that used in the earlier clinical trials because of cloning the cells used in the

earlier trials and certain other modifications and improvements that have been made to the Cell-in-a-Box ®

since the time of the earlier trials.

In support of our IND application to commence

a Phase 2b clinical trial in LAPC using genetically -engineered live human cells encapsulated using our Cell-in-a-Box ® technology

in combination with ifosfamide we are relying on a Phase 1/2 clinical trial and a Phase 2 clinical trial previously conducted using the

same technology in combination with ifosfamide between 1998 and 1999 and between 1999 and 2000, respectively.

The Phase 1/2 clinical trial

was carried out at the Division of Gastroenterology, University of Rostock, Germany, and the Phase 2 clinical trial was carried out at

four centers in two countries in Europe:

Berne, Switzerland, and in Rostock, Munich and Berlin, Germany.

Although the FDA may accept data from clinical

trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the FDA.

There is a risk that the

FDA may not accept the data from the two previous trials.

In that case, we may be required to conduct a Phase 1 or a Phase 1/2b clinical

trial rather than the planned Phase 2b clinical trial in LAPC, currently under clinical hold.

This may result in additional costs to us

and resultant delays in the regulatory review process and any future commercialization and marketing if regulatory approval is obtained.

It is not known whether the FDA would be likely to reject the use of such clinical data due to the significant time that has elapsed since

the earlier clinical trials were conducted or because the clinical trial material for our proposed Phase 2b clinical trial is different

from that used in the earlier clinical trials because of cloning the cells used in the earlier trials and certain other modifications

and improvements that have been made to the Cell-in-a-Box ® technology since the time of the earlier trials.

We intend to conduct clinical trials for

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Obtain approval for indications or patient populations that are not as broad as we intended or desired;

Obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including “black-box”

Obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including “black-box” warnings;

Be subject to additional post-marketing testing or other requirements;

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or prevented.

We may experience numerous unforeseen events

during our clinical trials, if allowed to proceed, that could delay or prevent marketing approval of our product candidates,

We may experience numerous unforeseen events during

our clinical trials, if allowed to proceed, that could delay or prevent marketing approval of our product candidates, including:

Clinical trials of our product candidates may produce unfavorable or inconclusive results;

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The number of patients required for clinical trials of our product candidates may be larger than we anticipate, patient enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

Our third-party contractors, including those manufacturing our product candidates or components or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

Our third-party contractors, including those manufacturing our product candidates, components, or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

Regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

We may experience delays in reaching or may fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

Patients who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;

We may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of a product candidate;

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Competing clinical trials for the same patient population;

Clinicians’

and patients’

perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.

Clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.

Our inability to enroll enough patients for our

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If granted, accelerated approval is usually contingent

on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe

the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s clinical benefit, regulatory agencies

on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe

the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s clinical benefit, regulatory agencies

may withdraw their approval of the drug.

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and ten years in Europe.

The European exclusivity period can be reduced to six years

if a drug no longer meets the criteria for Orphan Drug designation or if the drug is sufficiently profitable so that market exclusivity

is no longer justified.

In Europe, a product must meet the orphan prevalence not only

when so designated but at marketing authorization.

The European exclusivity period can be reduced to six years if a drug no longer meets

the criteria for Orphan Drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

We have been granted Orphan Drug designation for

our pancreatic cancer therapy, including LAPC, in the U.S.

our pancreatic cancer therapy in the U.S.

and European Union.

Orphan Drug exclusivity may be lost if a regulatory agency

determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of

the drug to meet the needs of patients with the rare disease or condition.

Marketing exclusivity for a product designated as an Orphan

Drug may not effectively protect the product candidate from competition because different drugs can be approved for the same condition.

Even after an Orphan Drug is approved, the regulatory agency can subsequently approve a different drug for the same condition if they

conclude that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient

Orphan Drug exclusivity may be lost if a regulatory agency determines that

the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet

the needs of patients with the rare disease or condition.

Marketing exclusivity for a product designated as an Orphan Drug may not effectively

protect the product candidate from competition because different drugs can be approved for the same condition, and the same drug may be

approved for a different condition that may be used offlabel for an orphan indication.

Even after an Orphan Drug is approved and granted

exclusivity, the regulatory agency can subsequently approve the same drug in a different drug product for the same condition if they conclude

that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

A Fast Track by the FDA or similar designation

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or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

We do not currently have Fast Track

designation by the FDA or similar designation by another regulatory agency for any of our product candidates but intend to seek such

designation based upon the data generated from our clinical trials, if allowed to proceed and if successful.

If a drug or biologic

is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to

address unmet medical needs for this condition, the sponsor may apply for Fast Track designation by the FDA or similar designation

by another regulatory agency.

Regulatory agencies have broad discretion whether to grant this designation by the FDA or similar

designation by another regulatory agency.

Even if we believe a product candidate is eligible for this designation, we cannot assure

you that a regulatory agency would decide to grant it.

Even if we do receive Fast Track or similar designation, we may not

experience a faster development process, review or approval compared to conventional procedures adopted by a regulatory agency.

addition, a regulatory agency may withdraw Fast Track designation if it believes that the designation is no longer supported by data

from our clinical development program.

Many product candidates that have received Fast Track designation have failed to obtain

marketing approval.

We do not currently have Fast Track designation

by the FDA or similar designation by another regulatory agency for any of our product candidates but intend to seek such designation based

upon the data generated from our clinical trials, if allowed to proceed and if successful.

If a drug or biologic is intended for the treatment

of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical needs for this

condition, the sponsor may apply for Fast Track designation by the FDA or similar designation by another regulatory agency.

agencies have broad discretion whether to grant this designation by the FDA or similar designation by another regulatory agency.

if we believe a product candidate is eligible for this designation, we cannot assure you that a regulatory agency would decide to grant

Even if we do receive Fast Track or similar designation, we may not experience a faster development process, review or approval compared

to conventional procedures adopted by a regulatory agency.

In addition, a regulatory agency may withdraw Fast Track designation if it

believes that the designation is no longer supported by data from our clinical development program.

Many product candidates that have

received Fast Track designation have failed to obtain marketing approval.

A Breakthrough Therapy designation by the

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periodic inspections by regulatory agencies, requirements regarding the distribution of samples to physicians and recordkeeping.

In addition, regulatory agencies may impose

requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product

Regulatory agencies closely regulate the post-approval marketing and promotion of drugs and biologics to ensure the

products are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

impose stringent restrictions on manufacturers’

In addition, regulatory agencies may impose requirements

for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product candidate.

agencies tightly regulate the post-approval marketing and promotion of drugs and biologics to ensure the products are marketed only for

the approved indications and in accordance with the provisions of the approved labeling.

They also impose stringent restrictions on manufacturers’

communications regarding use of their products.

If we promote our product

candidates beyond their approved indications, we may be subject to enforcement action for off-label promotion.

Violations of the

laws relating to the promotion of prescription drugs or biologics may lead to investigations alleging violations of federal and

state healthcare fraud and abuse laws, as well as state consumer protection laws.

If we promote our product candidates beyond their approved indications, we may be subject

to enforcement action for off-label promotion.

Violations of the laws relating to the promotion of prescription drugs or biologics may

lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection

Also, later discovery of previously unknown adverse

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Requirements to conduct post-marketing studies or clinical trials;

Warning or untitled

letters or Form 483s;

Warning or untitled letters or Form 483s;

Withdrawal of the products from the market;

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also result in significant financial penalties.

Similarly, failure to comply with the Europe’s requirements regarding the protection

of personal information can also lead to significant penalties and sanctions.

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payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.

Our future arrangements with third-party payors and customers may expose us to broadly applicable federal and state fraud and abuse and

other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market,

sell and distribute any products for which we obtain marketing approval.

Restrictions under applicable healthcare laws and regulations

include the following:

Our future arrangements with third-party payors and customers may expose us to applicable federal and state fraud and abuse and other

healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell

and distribute any products for which we obtain marketing approval.

Restrictions under applicable healthcare laws and regulations include

the following:

The Anti-Kickback Statute prohibits, among other

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Some state laws require pharmaceutical companies

to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by

the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians

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restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs and biologics.

The Affordable Care Act was intended to

broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse,

add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health

industry and impose additional health policy reforms.

There have been significant ongoing judicial,

administrative, executive and legislative efforts to modify or eliminate the Affordable Care Act.

For example, the Tax Act, enacted on

December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section

5000A of the Internal Revenue Code, commonly referred to as the individual mandate.

The Trump administration issued executive orders which

sought to reduce burdens associated with the Affordable Care Act and modified how it was implemented.

Other legislative changes have been

proposed and adopted since passage of the Affordable Care Act.

The Budget Control Act of 2011, among other things, created the Joint Select

Committee on Deficit Reduction to recommend proposals in spending reductions to Congress.

The Joint Select Committee did not achieve its

targeted deficit reduction of an amount greater than $1.2 trillion for the fiscal years 2012 through 2021, triggering the legislation’s

automatic reductions to several government programs.

These reductions included aggregate reductions to Medicare payments to healthcare

providers of up to 2.0% per fiscal year, which went into effect in April 2013.

Subsequent litigation extended the 2% reduction, on average,

to 2030 unless additional Congressional action is taken.

However, pursuant to the Coronavirus Aid, Relief and Economic Security Act, or

CARES Act, and other legislation, the 2% Medicare sequester reductions have been suspended due to the COVID-19 pandemic.

On January 2,

2013, the American Taxpayer Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers,

including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government

to recover overpayments to providers from three to five years.

The Affordable Care Act has also been subject

to challenges in the courts.

On December 14, 2018, a Texas U.S.

District Court Judge ruled that the Affordable Care Act is unconstitutional

in its entirety because the “individual mandate”

was repealed by Congress.

On December 18, 2019, the Fifth Circuit U.S.

of Appeals held that the individual mandate is unconstitutional and remanded the case to the Texas District Court to reconsider its earlier

invalidation of the entire Affordable Care Act.

An appeal was taken to the U.S.

Supreme Court which heard oral arguments in the case on

November 10, 2020.

On June 17, 2021, the Supreme Court ruled that the plaintiffs lacked standing to challenge the law as they had not

alleged personal injury traceable to the allegedly unlawful conduct.

As a result, the Supreme Court did not rule on the constitutionality

of the ACA or any of its provisions.

Further changes to and under the Affordable Care

Act remain possible, although the new Biden administration has signaled that it plans to build on the Affordable Care Act and expand the

number of people who are eligible for subsidies under it.

President Biden indicated that he intends to undo changes to the Affordable

Care Act made by the Trump administration and would advocate for legislation to build on the Affordable Care Act, and has issued executive

orders to this effect.

It is unknown precisely what form any such changes or any law proposed to replace the Affordable Care Act would

take, and how or whether it may affect our business in the future.

We expect that changes or additions to the Affordable Care Act, the

Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug prices and changes stemming from other

healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have

a material adverse effect on the healthcare industry.

The Affordable Care Act was intended to broaden

access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency

requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional

health policy reforms.

We expect that the Affordable Care Act, as well

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strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the countries

of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.

In some countries, particularly the EEA countries

and the United Kingdom, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations

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effects or other unexpected properties of our encapsulated live cell plus ifosfamide product candidate or any of our other product candidates

may be identified during development that could delay or prevent the product candidates’

marketing approval.

may be identified during development that could delay or prevent the product candidates’ marketing approval.

Serious adverse events or undesirable side effects

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medical community necessary for commercial success and the market opportunity for the product candidate may be smaller than we anticipated.

We have never commercialized a drug or

biologic product.

Even if one of our product candidates is approved by a regulatory agency for marketing and sale, it may

nonetheless fail to gain sufficient market acceptance by physicians, patients, third party payors and others in the medical

For example, physicians are often reluctant to switch their patients from existing therapies even when new and

potentially more effective or convenient treatments enter the market.

Further, patients often acclimate to the therapy that they are

currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch

therapies due to lack of reimbursement for existing therapies.

We have never commercialized a drug or biologic

Even if one of our product candidates is approved by a regulatory agency for marketing and sale, it may nonetheless fail to gain

sufficient market acceptance by physicians, patients, third party payors and others in the medical community.

For example, physicians

are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments

enter the market.

Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their

physicians recommend switching products or they are required to switch therapies due to lack of reimbursement for existing therapies.

Efforts to educate the medical community and third-party

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Whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy;

Limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;

Our ability to offer the product for sale at competitive prices;

Our ability to establish and maintain pricing sufficient to realize a meaningful return on our investment;

The product’s convenience and ease of administration compared to alternative treatments;

The willingness of the target patient population to try, and of physicians to prescribe, the product;

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effects that were not previously identified, our ability to market the therapy could be compromised.

Clinical trials of our product candidates,

if allowed to proceed, will be conducted in carefully defined subsets of patients who have agreed to enter a clinical trial.

Consequently, it is possible that our clinical trials,

if allowed to proceed, may indicate an apparent positive effect of a product candidate that is

Clinical trials of our product candidates, if

allowed to proceed, will be conducted in carefully defined subsets of patients who have agreed to enter a clinical trial.

Consequently,

it is possible that our clinical trials, if allowed to proceed, may indicate an apparent positive effect of a product candidate that is

greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

If, following approval

of a product candidate, we or others discover that the product candidate is less effective than previously believed or causes

undesirable side effects that were not previously identified, any of the following adverse events could occur:

If, following approval of

a product candidate, we or others discover that the product candidate is less effective than previously believed or causes undesirable

side effects that were not previously identified, any of the following adverse events could occur:

A regulatory agency may withdraw its approval of the product candidate or seize the product candidate;

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We may be subject to fines, injunctions or the imposition of civil or criminal penalties;

A regulatory agency may require the addition of labeling statements, such as a “black box”

warning or a contraindication;

A regulatory agency may require the addition of labeling statements, such as a “black box” warning or a contraindication;

We may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution of our product candidate to patients;

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Risks Related to Our Dependence on Third Parties

We rely heavily on third parties to

conduct our preclinical studies and plan to rely on third parties to conduct our clinical trials, assuming they are allowed to

proceed, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such

studies and trials.

We currently rely heavily on

third parties to conduct our preclinical studies and plan to rely on third parties to conduct our clinical trials, assuming they are allowed

to proceed, including Austrianova in which we own an equity interest.

We expect to continue to rely heavily on third parties, such as

a CRO, a clinical data management organization, a medical institution, a clinical investigator and others to plan for and conduct our

clinical trials.

Our agreements with these third parties generally allow the third party to terminate our agreement with them at any time.

If we are required to enter alternative arrangements because of any such termination, the introduction of our product candidates to market

could be delayed.

Our reliance on these

third parties for research and development (“R&D”) activities will reduce our control over these activities but will

not relieve us of our responsibilities.

For example, we design our clinical trials and will remain responsible for ensuring that

each is conducted in accordance with the general investigational plan and protocol for the trial.

Moreover, regulatory agencies

require us to comply with current good manufacturing practices (“cGMP”) for conducting, recording and reporting the results of clinical

trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of

trial participants are protected.

Our reliance on third parties that we do not control does not relieve us of these responsibilities

and requirements.

We also are required to register ongoing clinical trials and post the results of completed clinical trials on a

government-sponsored database of regulatory agencies within specified timeframes.

Failure to do so can result in fines, adverse

publicity and civil and criminal sanctions.

Furthermore, these third parties

may also have relationships with other entities, some of which may be our competitors.

If these third parties do not successfully carry

out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of a regulatory

agency or our protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates

and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

We rely on numerous consultants

for a substantial portion of our R&D related to our product candidates.

If there are delays or failures to perform their obligations,

our product candidates would be adversely affected.

If our collaboration with these consultants is unsuccessful or is terminated, we would

need to identify new research and collaboration partners for our preclinical and clinical development.

If we are unsuccessful or significantly

delayed in identifying new collaboration and research partners, or unable to reach an agreement with such a partner on commercially reasonable

terms, development of our product candidates will suffer, and our business would be materially harmed.

In addition, if any of these

consultants change their strategic focus, or if external factors cause any one of them to divert resources from our collaboration, or

if any one of them independently develops products that compete directly or indirectly with our product candidates using resources or

information it acquires from our collaboration, our business and results of operations could suffer.

We rely heavily on third parties to conduct

our preclinical studies and plan to rely on third parties to conduct our clinical trials, assuming they are allowed to proceed, and those

third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies and trials.

We currently rely heavily on third parties to

conduct our preclinical studies and plan to rely on third parties to conduct our clinical trials, assuming they are allowed to proceed,

including Austrianova in which we own an equity interest.

We expect to continue to rely heavily on third parties, such as a CRO, a clinical

data management organization, a medical institution, a clinical investigator and others to plan for and conduct our clinical trials.

agreements with these third parties generally allow the third party to terminate our agreement with them at any time.

If we are required

to enter alternative arrangements because of any such termination, the introduction of our product candidates to market could be delayed.

Our reliance on these third parties for R&D

activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we design our clinical

trials and will remain responsible for ensuring that each is conducted in accordance with the general investigational plan and protocol

for the trial.

Moreover, regulatory agencies require us to comply with current good manufacturing practices (“cGMP”) for conducting,

recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the

rights, integrity and confidentiality of trial participants are protected.

Our reliance on third parties that we do not control does not

relieve us of these responsibilities and requirements.

We also are required to register ongoing clinical trials and post the results of

completed clinical trials on a government-sponsored database of regulatory agencies within specified timeframes.

Failure to do so can

result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, these third parties may also have

relationships with other entities, some of which may be our competitors.

If these third parties do not successfully carry out their contractual

duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of a regulatory agency or our protocols,

we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to,

or may be delayed in our efforts to, successfully commercialize our product candidates.

In addition, disruptions in the global economy and supply chains could

adversely affect the financial conditions of the third parties on which we rely, resulting in delays in preclinical studies and clinical

trials that could adversely affect our business, financial condition and results of operations.

For instance, Austrianova from time to

time has experienced significant supply chain delays, some of which may be related to COVID-19, and we believe it may be experiencing

liquidity issues.

We rely on numerous consultants for a substantial

portion of our R&D related to our product candidates.

If there are delays or failures to perform their obligations, our product candidates

would be adversely affected.

If our collaboration with these consultants is unsuccessful or is terminated, we would need to identify new

research and collaboration partners for our preclinical and clinical development.

If we are unsuccessful or significantly delayed in identifying

new collaboration and research partners, or unable to reach an agreement with such a partner on commercially reasonable terms, development

of our product candidates will suffer, and our business would be materially harmed.

In addition, if any of these consultants change

their strategic focus, or if external factors cause any one of them to divert resources from our collaboration, or if any one of them

independently develops products that compete directly or indirectly with our product candidates using resources or information it acquires

from our collaboration, our business and results of operations could suffer.

Future preclinical and clinical development

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Our ability to reach a definitive agreement for any collaboration will depend,

among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of several factors.

among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of several factors.

If we are unable to reach agreements with suitable

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Collaborators may not perform their obligations as expected;

Changes in the collaborators’

strategic focus or available funding, or external factors, such as an acquisition, may divert resources or create competing priorities;

Changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, may divert resources or create competing priorities;

Collaborators may delay discovery and preclinical development, provide insufficient funding for product development of targets selected by us, stop or abandon preclinical or clinical development of a product candidate or must repeat or conduct new preclinical and clinical development of a product candidate;

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We rely on Prof.

Günzburg, Dr.

Löhr for the development of our product candidates.

If they decide to terminate their relationship with us, we may not be

successful in the development of our product candidates.

Günzburg and Dr.

for the development of our product candidates.

If they decide to terminate their relationship with us, we may not be successful in the

development of our product candidates.

We rely on Prof.

Günzburg and Dr.

Brian Salmons, officers of Austrianova, and Dr.

Löhr, currently with the Karolinska Institute in Stockholm, Sweden, for the development

of our product candidates.

If they decide to terminate their relationship with us, we may not be successful in the development of our

product candidates.

Günzburg, Dr.

Salmons and Dr.

Löhr are involved in almost all our scientific endeavors underway and being planned by us.

These endeavors include preclinical

and clinical studies involving our cancer therapy for LAPC to be conducted in the U.S.

Günzburg and Dr.

Brian Salmons, officers

of Austrianova, for the development of our product candidates.

If they decide to terminate their relationship with us, we may not be successful

in the development of our product candidates.

Günzburg and Dr.

Salmons are involved

in almost all our scientific endeavors underway and being planned by us.

These endeavors include preclinical and clinical studies involving

our cancer therapy for LAPC to be conducted in the U.S.

and elsewhere on our behalf.

They also provide professional consulting services to us

through the respective consulting agreements we have entered with the consulting companies through which they provide services.

consulting agreements may be terminated for any reason at any time upon one party giving the other a written notice prior to the

effective date of the termination.

If that occurs, we may not be successful in the development of our product candidates which could

have a material adverse effect on us.

We contract with third parties for the

manufacture of our product candidates for preclinical studies and clinical trials, if allowed to proceed, and expect to continue to

do so for commercialization.

This reliance on third parties increases the risk that we will not have sufficient quantities of our

product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or

commercialization efforts.

We do not currently own or operate

manufacturing facilities to produce clinical quantities of our encapsulated live cell and ifosfamide product for pancreatic cancer

and other encapsulated product candidates and have limited personnel with manufacturing experience.

We currently rely on and expect

to continue to rely on third party contract manufacturers to manufacture supplies of our product candidates for preclinical studies

and clinical trials, if allowed to proceed, as well as for commercial manufacture of our product candidates, and these must be

maintained for us to receive marketing approval for our product candidates.

Our encapsulated live cell and ifosfamide product

and our other product candidates must be manufactured through complex, multi-step synthetic processes that are time-consuming and involve

special conditions at certain stages.

Biologics and drug substance manufacture requires high potency containment, and containment under

aseptic conditions.

Any performance failures on the part of our existing or future manufacturers could delay clinical development or marketing

approval of our product candidates.

Moreover, the facilities that produce our Cell-in-a-Box ®

capsules are unique to us

and would not be replicable or replaceable promptly, if at all, if those facilities become unavailable or are damaged or destroyed through

an accident, natural disaster, labor disturbance or otherwise.

If any of our manufacturer of CypCaps ™

should become unavailable to us for any reason, we may incur additional cost or delay in identifying or qualifying a replacement manufacturer.

In addition, while we believe that our existing manufacturer, Austrianova, can produce our product candidates, if approved, in commercial

quantities, we may also need to identify a third-party manufacturer capable of providing commercial quantities of our product candidates.

If we are unable to arrange for such a third-party manufacturing source or fail to do so on commercially reasonable terms and in a timely

manner, we may not be able to successfully produce and market our encapsulated live cell and ifosfamide product or any other product candidate

or may be delayed in doing so.

Even if we can establish such arrangements with

another third-party manufacturer, reliance on a new third-party manufacturer entails additional risks, including:

Reliance on the third party for regulatory compliance and quality assurance;

The possible breach of the manufacturing agreement by the third party;

The possible misappropriation of our proprietary information, including our trade secrets and know-how;

The possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

A new third-party manufacturer may not be

able to comply with cGMP standards or the requirements of a regulatory agency.

Our failure, or the failure of our third-party

manufacturer, to comply with these practices or requirements could result in sanctions being imposed on us, including additional

clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or

recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and

adversely affect supplies of our product candidates.

Delays in the cGMP certification of the Austrianova

manufacturing facility in Bangkok, Thailand could affect its ability to manufacture encapsulated live cells on a timely basis and could

adversely affect supplies of our product candidates for clinical trials and to market.

Our product candidates that we may develop may

compete with other product candidates and products for access to manufacturing facilities.

There are a limited number of manufacturers

that operate under cGMP regulations and that might be capable of manufacturing products for us.

In addition, we expect to rely on

Austrianova to purchase from third-party suppliers the materials necessary to produce our product candidates for our clinical

studies, if allowed to proceed.

There are a small number of suppliers for certain equipment and raw materials that are used in the

manufacture of our product candidates.

Such suppliers may not sell these raw materials to Austrianova at the times we need them or

on commercially reasonable terms.

For example, there is from time to time a limited supply of acceptable cell media for production

We do not have any control over the process or timing of the acquisition of these raw materials by Eurofins or

Moreover, we currently do not have any agreements for the commercial production of these raw materials.

Any significant

delay in the supply of a product candidate or the raw material components thereof our clinical trials, if allowed to proceed, due to

the need to replace a third-party supplier of these raw materials could considerably delay completion of our clinical studies,

product testing and potential regulatory approval of our product candidates.

If Eurofins, Austrianova or we are unable to purchase

these raw materials after regulatory approval has been obtained for our product candidates, the commercial launch of our product

candidates would be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the

sale of our product candidates.

Our current and anticipated future dependence

upon Austrianova and others for the manufacture of our product candidates may adversely affect our future profit margins and our ability

to commercialize any products that receive marketing approval on a timely and competitive basis.

The manufacture of our product

candidates is complex, and difficulties may be encountered in production.

If such difficulties are encountered or failure to meet

regulatory standards occurs, our ability to provide supply of our product candidates for clinical trials, if allowed to proceed, or

our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost

They also provide professional consulting services

to us through the respective consulting agreements we have entered with the consulting companies through which they provide services.

The consulting agreements may be terminated for any reason at any time upon one party giving the other a written notice prior to the effective

date of the termination.

If that occurs, we may not be successful in the development of our product candidates which could have a material

adverse effect on us.

The manufacture of our product candidates

is complex, and difficulties may be encountered in production.

If such difficulties are encountered or failure to meet regulatory standards

occurs, our ability to provide supply of our product candidates for clinical trials, if allowed to proceed, or our products for patients,

if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

The processes involved in manufacturing our product

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to build manufacturing facilities in a timely and cost-efficient manner.

In addition, the manufacturing process for

any products that we may develop is subject to FDA, EMA and foreign regulatory authority approval processes and continuous

oversight, and we will need to contract with manufacturers who can meet all applicable FDA, EMA and foreign regulatory authority

requirements, including complying with current good manufacturing processes, or on an ongoing basis.

If we or our third-party

manufacturers are unable to reliably produce products to specifications acceptable to the FDA, EMA or other regulatory authorities,

we may not obtain or maintain the approvals we need to commercialize such products.

Even if we obtain regulatory approval for any of

our product candidates, there is no assurance that either we or our third-party manufacturers will be able to manufacture the

approved product to specifications acceptable to the FDA, EMA or other regulatory authorities, to produce it in sufficient

quantities to meet the requirements for the potential launch of the product, or to meet potential future demand.

challenges could delay initiation and completion of clinical trials, require bridging clinical trials or the repetition of one or

more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts,

increase our cost of goods, and have an adverse effect on our business, prospects, financial condition, results of operations and

growth prospects.

In addition, the manufacturing process for any

products that we may develop is subject to FDA, EMA and foreign regulatory authority approval processes and continuous oversight, and

we will need to contract with manufacturers who can meet all applicable FDA, EMA and foreign regulatory authority requirements, including

complying with current good manufacturing processes, or on an ongoing basis.

If we or our third-party manufacturers are unable to reliably

produce products to specifications acceptable to the FDA, EMA or other regulatory authorities, we may not obtain or maintain the approvals

we need to commercialize such products.

Even if we obtain regulatory approval for any of our product candidates, there is no assurance

that either we or our third-party manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA,

EMA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product,

or to meet potential future demand.

Any of these challenges could delay initiation and completion of clinical trials, require bridging

clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate,

impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, prospects, financial condition,

results of operations and growth prospects.

Risks related to our Intellectual Property

We may not be able to protect our intellectual

property rights throughout the world.

prosecuting and defending patents or establishing other intellectual property rights to our product candidates in all countries throughout the

world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive

than those in the United States or non-existent.

We may not be able to protect our intellectual property rights

throughout the world.

Filing, prosecuting and defending patents or establishing

other intellectual property rights to our product candidates in all countries throughout the world would be prohibitively expensive, and

our intellectual property rights in some countries outside the United States can be less extensive than those in the United States or

non-existent.

For example, the Melligen cells are protected by patents only in the U.S.

and we are only pursuing patent protection for our pancreatic cancer product candidate in the U.S., Australia and Canada.

Many companies have encountered

significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of some countries

do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the infringement

of our patents or misappropriation of our intellectual property rights generally.

Proceedings to enforce our patent and other intellectual

property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of

our business, could put our patents or intellectual property rights at risk of being invalidated or interpreted narrowly and our patent

applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that

we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

countries, including European Union countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be

compelled under specified circumstances to grant licenses to third parties.

In those countries, we may have limited remedies

if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those

This could limit our ability to pursue strategic alternatives, including identifying and consummating transactions

with potential third-party partners, to further develop, obtain marketing approval for and/or commercialize our product candidates, and

consequently our potential revenue opportunities.

and Europe and we are only pursuing patent protection

for our pancreatic cancer product candidate in the U.S., Australia and Canada.

Many companies have encountered significant problems

in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of some countries do not favor the

enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our

patents or misappropriation of our intellectual property rights generally.

Proceedings to enforce our patent and other intellectual property

rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business,

could put our patents or intellectual property rights at risk of being invalidated or interpreted narrowly and our patent applications

at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate,

and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many countries, including European Union countries,

India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant

licenses to third parties.

In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a

license to a third party, which could materially diminish the value of those patents.

This could limit our ability to pursue strategic

alternatives, including identifying and consummating transactions with potential third-party partners, to further develop, obtain marketing

approval for and/or commercialize our product candidates, and consequently our potential revenue opportunities.

Our intellectual property and data and market

exclusivity may not be sufficient to block others from commercializing identical or competing products.

Our success depends in large part on our

ability to obtain and maintain both intellectual property rights and data and market exclusivity for our product candidates in order

to block others from commercializing identical or competing products.

Establishing intellectual property rights includes filing,

prosecuting, maintaining and enforcing patents that cover our product candidates and variations of our product candidates and

protecting our trade secrets and other proprietary information related to our product candidates from unauthorized use.

The foundational patents relating to the Cell-in-the-Box®

Our success depends in large part on our ability

to obtain and maintain both intellectual property rights and data and market exclusivity for our product candidates in order to block

others from commercializing identical or competing products.

Establishing intellectual property rights includes filing, prosecuting, maintaining

and enforcing patents that cover our product candidates and variations of our product candidates and protecting our trade secrets and

other proprietary information related to our product candidates from unauthorized use.

The foundational patents relating to the Cell-in-the-Box®

technology that were formerly licensed from Bavarian Nordic/GSF covering capsules encapsulating cells expressing cytochrome P450 and treatment

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if the company can demonstrate that the other biologic is clinically superior to first approved product.

Even if we are able to obtain patents and maintain

confidential information and trade secrets and obtain data and market exclusivity for our product candidates, our competitors may be able

to develop and obtain approval of identical or competing products.

Even if we are able to obtain patents, maintain

confidential information, trade secrets, obtain data, and market exclusivity for our product candidates, our competitors may be able to

develop and obtain approval of identical or competing products.

If we are unable to obtain and maintain

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Our patent portfolio relating

to the Cell-in-the-Box ®

technology was formerly licensed from Bavarian Nordic/GSF.

to the Cell-in-the-Box ® technology was formerly licensed from Bavarian Nordic/GSF.

The Bavarian Nordic/GSF patents covered

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product candidate for the treatment of cancer;

we have pending applications in the U.S., Australia, Canada and Europe relating to our

product candidate for the treatment of pancreatic cancer.

we have pending applications in the U.S., Australia and Canada and relating to our product

candidate for the treatment of pancreatic cancer.

If issued, such patents would expire in March 2038.

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and costs surrounding the prosecution of our owned or licensed patent applications and the enforcement or defense of our owned or licensed

On September 16, 2011, the Leahy-Smith America Invents Act (“Leahy-Smith Act”) was signed into law.

The Leahy-Smith

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In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole

or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue because our

patents do not cover the technology in question.

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We have licensed rights to intellectual property

from third parties to commercialize our product candidates, including our Cell-in-a-Box ®

Technology for LAPC and diabetes

from third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC and diabetes

and our COVID-19 diagnostic kits.

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patents that may be granted in the future.

If we are found to infringe a third party’s

intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our

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In addition, we could

be found liable for monetary damages, including treble damages and attorneys’

fees if we are found to have willfully infringed a

be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a

A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business

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entering confidentiality agreements with our employees and consultants;

however, we cannot be certain

that such agreements have been entered with all relevant parties.

however, we cannot be certain that such agreements have been entered

with all relevant parties.

Moreover, to the extent we enter such agreements,

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for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used

or disclosed trade secrets, or other confidential information of our employees’, consultants’

or independent contractors’

or disclosed trade secrets, or other confidential information of our employees’, consultants’ or independent contractors’

former employers, clients or other third parties.

We may also be subject to claims that former employers or other third parties

have an ownership interest in our patents.

We may also be subject to claims that former employers or other third parties have an

ownership interest in our patents.

Litigation may be necessary to defend against these claims.

There is no guarantee

of success in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose

valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property.

Even if we are

successful, litigation could result in substantial cost and be a distraction to our management and others working for us.

There is no guarantee of success in defending

these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property

rights, such as exclusive ownership of, or right to use, valuable intellectual property.

Even if we are successful, litigation could result

in substantial cost and be a distraction to our management and others working for us.

In addition, while it is our policy to require

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As discussed in Item 9A.

“Controls and Procedures,”

the senior management has identified material weaknesses in our internal controls over financial reporting and cannot assure you that

“Controls and Procedures,”

the senior management has identified a material weakness in our internal controls over financial reporting and cannot assure you that

additional material weaknesses will not be identified in the future.

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information which could have an adverse effect on the trading price of our securities.

Our success depends on additional states

legalizing medical Cannabis.

The success of our cannabis program may

depend on additional states legalizing medical Cannabis.

Continued development of the medical Cannabis

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Schedule I, II, III, IV or V substances.

Schedule I substances by definition have a high potential for abuse, have not currently

“accepted medical use”

in the U.S., lack accepted safety for use under medical supervision, and may not be prescribed, marketed

or sold in the U.S.

Schedule I substances by definition have a high potential for abuse, have not currently “accepted

medical use” in the U.S., lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in

Pharmaceutical products approved for use in the U.S.

may be listed as Schedule II, III, IV or V, with Schedule II

substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk

of abuse among such substances.

Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing

and procurement quotas, security requirements and criteria for importation.

In addition, dispensing of Schedule II drugs is further

For example, they may not be refilled without a new prescription.

While Cannabis is a Schedule I

controlled substance, products approved for medical use in the U.S.

that contain Cannabis or Cannabis extracts

must be placed in Schedules II - V, since approval by the FDA satisfies the “accepted medical use”

If we receive FDA approval for a product candidate involving Cannabis , the DEA will make a scheduling determination and place it

in a schedule other than Schedule I for it to be prescribed to patients in the U.S.

If approved by the FDA, we expect the product

candidates to be listed by the DEA as a Schedule II or III controlled substance.

Consequently, their manufacture, importation, exportation,

domestic distribution, storage, sale and legitimate use will be subject to a significant degree of regulation by the DEA.

The scheduling

process may take one or more years beyond FDA approval, thereby significantly delaying the launch of our product candidates involving

Furthermore, if the FDA, DEA or any foreign regulatory authority determines that our product candidates involving Cannabis

may have potential for abuse, it may require us to generate more clinical data than that which is currently anticipated, which could increase

the cost and/or delay the launch of such products.

may be listed as Schedule II, III, IV or V, with Schedule II substances

considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among

such substances.

Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement

quotas, security requirements and criteria for importation.

In addition, dispensing of Schedule II drugs is further restricted.

they may not be refilled without a new prescription.

While Cannabis is a Schedule I controlled

substance, products approved for medical use in the U.S.

that contain Cannabis or Cannabis extracts must be placed in Schedules

II - V, since approval by the FDA satisfies the “accepted medical use” requirement.

If we receive FDA approval for a product

candidate involving Cannabis , the DEA will make a scheduling determination and place it in a schedule other than Schedule I for

it to be prescribed to patients in the U.S.

If approved by the FDA, we expect the product candidates to be listed by the DEA as a Schedule

II or III controlled substance.

Consequently, their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate

use will be subject to a significant degree of regulation by the DEA.

The scheduling process may take one or more years beyond FDA approval,

thereby significantly delaying the launch of our product candidates involving Cannabis .

Furthermore, if the FDA, DEA or any foreign

regulatory authority determines that our product candidates involving Cannabis may have potential for abuse, it may require us

to generate more clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of such

Because one or more of our product candidates

contain active ingredients of Cannabis , which are Schedule I substances, to conduct preclinical studies and clinical

trials with these product candidates in the U.S.

prior to approval, each of our research sites must submit a research protocol to the

DEA and obtain and maintain a DEA researcher registration that will allow those sites to handle and dispense our product candidates and

to obtain the product from our manufacturer.

If the DEA delays or denies the grant of a research registration to one or more research

sites, the preclinical studies or clinical trials could be significantly delayed, and we could lose and be required to replace clinical

trial sites, resulting in additional costs.

contain active ingredients of Cannabis , which are Schedule I substances, to conduct preclinical studies and clinical trials with

these product candidates in the U.S.

prior to approval, each of our research sites must submit a research protocol to the DEA and obtain

and maintain a DEA researcher registration that will allow those sites to handle and dispense our product candidates and to obtain the

product from our manufacturer.

If the DEA delays or denies the grant of a research registration to one or more research sites, the preclinical

studies or clinical trials could be significantly delayed, and we could lose and be required to replace clinical trial sites, resulting

in additional costs.

Individual states have also established controlled

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they may separately schedule our product candidates involving Cannabis as well.

While some states automatically schedule a

drug based on federal action, other states schedule drugs through rulemaking or a legislative action.

While some states automatically schedule a drug

based on federal action, other states schedule drugs through rulemaking or a legislative action.

State scheduling may delay commercial

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products could limit our ability to market those products and decrease our ability to generate revenue.

The availability and extent of reimbursement

by governmental and private payors is essential for most patients to be able to afford expensive treatments.

Sales of our products,

if approved will depend substantially, both domestically and abroad, on the extent to which the costs of our products, if approved,

will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or

reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.

reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or

maintain pricing sufficient to realize a sufficient return on our investment.

The availability and extent of reimbursement by

governmental and private payors is essential for most patients to be able to afford expensive treatments.

Sales of our products, if approved

will depend substantially, both domestically and abroad, on the extent to which the costs of our products, if approved, will be paid by

health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health

administration authorities, private health coverage insurers and other third-party payors.

If reimbursement is not available, or is available

only to limited levels, we may not be able to successfully commercialize our product candidates.

Even if coverage is provided, the approved

reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on

our investment.

There is significant uncertainty related to the

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reasonable revenues and profits.

Moreover, increasing efforts by governmental

and third-party payors, in the U.S.

and abroad, to cap or reduce healthcare costs may cause such organizations to limit both

coverage and level of reimbursement for new products approved and, thus, they may not cover or provide adequate payment for our

product candidates.

We expect to experience pricing pressures with the sale of any of our products, if approved, due to the trend

toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other

treatments, has become very intense.

Because of this, increasingly high barriers are being erected to the entry of new products into

the healthcare market.

Moreover, increasing efforts by governmental and

third-party payors, in the U.S.

and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and

level of reimbursement for new products approved and, thus, they may not cover or provide adequate payment for our product candidates.

We expect to experience pricing pressures with the sale of any of our products, if approved, due to the trend toward managed healthcare,

the increasing influence of health maintenance organizations and additional legislative changes.

The downward pressure on healthcare costs

in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become very intense.

of this, increasingly high barriers are being erected to the entry of new products into the healthcare market.

In addition to CMS and private payors, professional

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The inability to commercialize any products that we may develop.

We currently do not have product liability

insurance because we do not have any products to market.

We will need such insurance for clinical trials, if allowed to proceed, and

for commercialization of our products, if approved.

We currently do not have product liability insurance

because we do not have any products to market.

We will need such insurance for clinical trials, if allowed to proceed, and for commercialization

of our products, if approved.

Product liability insurance coverage is increasingly expensive.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may

We may not be able to maintain insurance

coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

We incur increased costs because of operating

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We are subject to, among others, the

reporting requirements of the Exchange Act of 1934, as amended (“Exchange Act”), the Sarbanes-Oxley Act, the Dodd-Frank Wall

Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the Commission.

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increased our legal and financial compliance costs and made some activities more time-consuming and costlier.

The increased

costs have increased our net loss.

These rules and regulations may make it more difficult and more expensive

for us to maintain sufficient director and officer liability insurance coverage.

We cannot predict or estimate the amount or

timing of additional costs we may continue to incur to respond to these requirements.

The ongoing impact of these

requirements could also make it more difficult for us to attract and retain qualified persons to serve on our Board, our Board committees

or as executive officers.

The increased costs have

increased our net loss.

These rules and regulations may make it more difficult and more expensive for us to maintain sufficient director

and officer liability insurance coverage.

We cannot predict or estimate the amount or timing of additional costs we may continue to incur

to respond to these requirements.

The ongoing impact of these requirements could also make it more difficult for us to attract and retain

qualified persons to serve on our Board, our Board committees or as executive officers.

Risk Factors Related to Our Stock and Financial

We cannot predict the extent to which a

trading market for our common stock will develop or how liquid that market might become.

Our common stock has been approved for listing

on Nasdaq but is currently quoted on the OTC Link™

quotation platform of OTC Markets Group, Inc.

We cannot predict the extent to

which a trading market will develop or how liquid that market might become.

Accordingly, holders of our common stock may be required to

retain their shares for an indefinite period.

Market prices for our shares of common stock will

be influenced by several factors, including, but not limited to:

Our common stock is currently listed on Nasdaq.

Market prices for our shares of common stock will be influenced by several factors, including, but not limited to:

The issuance of new shares pursuant to future offering;

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General economic and other national and international conditions.

may experience future dilution as a result of future equity offerings.

to raise additional capital, we may in the future offer additional common stock or other securities convertible into or exchangeable for

our common stock at prices lower than that paid by existing investors.

Investors purchasing shares or other securities in the future

could have rights superior to existing shareholders.

The price per share at which we sell additional shares of our common stock, or securities

convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by existing

There has been no consistent active

trading market for our common stock, and public trading of our common stock ma y continue to fluctuate substantially.

There has never been a consistent active trading

market for our common stock, and trading has been limited and sporadic.

The Company’s OTCQB Market Symbol is PMCB, although as a

result of the recent reverse split of the Company’s common stock, until August 6, 2021, the Company’s OTCQB Market Symbol

has temporarily been “PMCBD.”

Although our common stock has been approved for listing on Nasdaq under

the symbol “PMCB,”

it has not yet commenced trading.

There is no assurance that the trading market

for our common stock will become more active or liquid.

Furthermore, there can be no assurance any market maker will be interested in

trading our stock.

Therefore, it may be difficult to sell your shares of common stock if you desire or need to sell them.

no assurances can be given that you will be able to readily sell your common stock at a price equal to or above the price you paid.

underwriter is not obligated to make a market in our securities, and even if they make a market, they can discontinue market making at

any time without notice.

Neither we nor the underwriter can provide any assurance that an active and liquid trading market in our securities

will develop or, if developed, that such market will continue.

Moreover, the trading price of our common

stock has fluctuated substantially over the past few years, and there remains a significant risk that our common stock price may continue

to fluctuate substantially in the future in response to various factors, including any material developments in the FDA approval process

for our proposed Phase 2b clinical trial, material variations in our periodic operating results, departures or additions of management

or other key personnel, announcements of acquisitions, mergers, share consolidations, or new technology or patents, new product developments,

significant litigation matters, gain or loss of significant licensees, significant capital transactions, substantial sales of our common

stock in our trading market, and general and specific market and economic conditions.

You may experience future dilution as a result of future equity

In order to raise additional capital, we may in

the future offer additional common stock or other securities convertible into or exchangeable for our common stock at prices lower than

that paid by existing investors.

Investors purchasing shares or other securities in the future could have rights superior to existing

shareholders.

The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into

common stock, in future transactions may be higher or lower than the price per share paid by existing investors.

We may not be able to meet the continued

listing requirements for Nasdaq or another nationally recognized stock exchange, which could limit investors’

ability to make transactions

listing requirements for Nasdaq or another nationally recognized stock exchange, which could limit investors’ ability to make transactions

in our securities and subject us to additional trading restrictions.

Our common stock has been approved for listing

on Nasdaq under the symbol “PMCB”

but has not yet commenced trading.

When our common stock is listed on Nasdaq,

in order to remain listed on Nasdaq, we will be required to meet the continued listing requirements of Nasdaq or any other U.S.

nationally recognized stock exchange to which we may apply and be approved for listing.

We may be unable to satisfy these continued

listing requirements, and there is no guarantee that our common stock will remain listed on Nasdaq or any other U.S.

or nationally

recognized stock exchange.

If, after listing, our common stock is delisted from Nasdaq or any other U.S.

or nationally recognized

stock exchange, we could face significant material adverse consequences, including:

In order to remain listed on Nasdaq, we will be

required to meet the continued listing requirements of Nasdaq or any other U.S.

or nationally recognized stock exchange to which we may

apply and be approved for listing.

We may be unable to satisfy these continued listing requirements, and there is no guarantee that our

common stock will remain listed on Nasdaq or any other U.S.

or nationally recognized stock exchange.

If, after listing, our common stock

is delisted from Nasdaq or any other U.S.

or nationally recognized stock exchange, we could face significant material adverse consequences,

a limited availability of market quotations for our common stock;

reduced liquidity with respect to the market for our common stock;

a determination that our common stock is a “penny stock,”

which will require brokers trading in our common stock to adhere to different rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;

a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to different rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;

a limited amount of news and analyst coverage;

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There can be no assurance that the market price

of our common stock will remain at the level required for continuing compliance with Nasdaq’s minimum bid requirement.

uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split.

of our common stock will remain at the level required for continuing compliance with Nasdaq’s minimum bid requirement.

uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split.

If the market

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such as negative financial or operational results, could adversely affect the market price of our common stock and jeopardize our ability

to maintain compliance with Nasdaq’s minimum bid price requirement.

There can be no assurance that we will be able to comply with

the continued listing standards of Nasdaq, a failure of which could result in a de-listing of our common stock .

Nasdaq requires that the trading price of its listed stocks remain

above one dollar in order for the stock to remain listed.

It is not uncommon for the market price of a company’s common stock to

decline in the period following a reverse stock split.

If the market price of our common stock declines following the effectuation of

the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split.

In any event,

other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, could

adversely affect the market price of our common stock and jeopardize our ability to maintain compliance with Nasdaq’s minimum bid

price requirement.

If a listed stock trades below one dollar for more than 30 consecutive trading days, then it is subject to delisting

In addition, to maintain a listing on Nasdaq, we must satisfy minimum financial and other continued listing requirements

and standards, including those regarding director independence and independent committee requirements, minimum stockholders’

and certain corporate governance requirements.

If we are unable to satisfy these requirements or standards, we could be subject to delisting.

This would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock

when you wish to do so.

In the event of a delisting, we can provide no assurance that any action we may take to restore our compliance

with the listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity

of our common stock, prevent our common stock from dropping below the minimum bid price requirement, or prevent future non-compliance

to maintain compliance with Nasdaq’s minimum bid price requirement.

There can be no assurance that we will be

able to comply with the continued listing standards of Nasdaq, a failure of which could result in a de-listing of our common stock .

Nasdaq requires that the trading price of its

listed stocks remain above one dollar in order for the stock to remain listed.

It is not uncommon for the market price of a company’s

common stock to decline in the period following a reverse stock split.

If the market price of our common stock declines following the

effectuation of the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split.

In any event, other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational

results, could adversely affect the market price of our common stock and jeopardize our ability to maintain compliance with Nasdaq’s

minimum bid price requirement.

If a listed stock trades below one dollar for more than 30 consecutive trading days, then it is subject

to delisting from Nasdaq.

In addition, to maintain a listing on Nasdaq, we must satisfy minimum financial and other continued listing

requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’

equity and certain corporate governance requirements.

If we are unable to satisfy these requirements or standards, we could be subject

to delisting.

This would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our

common stock when you wish to do so.

In the event of a delisting, we can provide no assurance that any action we may take to restore our

compliance with the listing requirements would allow our common stock to become listed again, stabilize the market price or improve the

liquidity of our common stock, prevent our common stock from dropping below the minimum bid price requirement, or prevent future non-compliance

with the listing requirements.

When our common stock is listed on Nasdaq, we will incur materially

Since our common stock is listed on Nasdaq, we will incur materially

increased costs and become subject to additional regulations and requirements.

When our common stock is listed on Nasdaq, as

a newly exchange-listed public company, we will incur material additional legal, accounting and other expenses, including payment of annual

exchange fees, to satisfy the continued listing standards for Nasdaq.

If our common stock is listed on Nasdaq, we must meet certain financial

and liquidity criteria to maintain our listing.

If we fail to meet any of Nasdaq’s listing standards, our common stock may be delisted.

In addition, our Board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits

of such listing.

A delisting of our common stock from Nasdaq may materially impair our stockholders’

ability to buy and sell our

common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

The delisting of our common stock could significantly impair our ability to raise capital and the value of your investment.

Since our common stock was recently listed on

Nasdaq, we will incur material legal, accounting and other expenses, including payment of annual exchange fees, to satisfy the continued

listing standards for Nasdaq.

If our common stock is listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain

If we fail to meet any of Nasdaq’s listing standards, our common stock may be delisted.

In addition, our Board may

determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.

of our common stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our common stock and could have

an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

The delisting of our common

stock could significantly impair our ability to raise capital and the value of your investment.

A large number of shares may be issued and subsequently sold

upon the exercise of existing options and warrants.

As of July 31, 2021, there were 42,333 shares of common stock issuable

under outstanding options and 2,981 shares issuable upon exercise of outstanding warrants at various exercise prices.

To the extent that

holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants, the market price of our

common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances of shares of common

stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further decline in the market

In addition, we will be issuing Common Warrants to purchase shares of common stock which are immediately exercisable.

The reverse stock split may decrease the liquidity of the shares

of our common stock .

The liquidity of the shares of our common stock may be affected adversely

by the reverse stock split given the reduced number of shares that will be outstanding following the reverse stock split, especially if

the market price of our common stock does not increase as a result of the reverse stock split.

In addition, the reverse stock split may

increase the number of shareholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such shareholders

to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

Following the reverse stock split, the resulting market price

of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of

those investors.

Consequen tl y, the trading liquidity of our common stock may not improve .

Although we believe that a higher market price of our common stock

may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a share

price that will attract new investors, including institutional investors.

In addition, there can be no assurance that the market price

of our common stock will satisfy the investing requirements of those investors.

As a result, the trading liquidity of our common stock

may not necessarily improve.

We may experience volatility in our stock

price, which may adversely affect the trading price of our common stock.

We have experienced significant volatility

from time to time in the market price of our shares of common stock.

Factors that may affect the market price include the

As of July 25, 2022, there were 769,129 shares

of common stock issuable under outstanding options and 9,890,847 shares issuable upon exercise of outstanding warrants at various exercise

To the extent that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants,

the market price of our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances

of shares of common stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further

decline in the market price.

In addition, we will be issuing Common Warrants to purchase shares of common stock which are immediately

We may experience volatility in our stock price, which may adversely

affect the trading price of our common stock.

We have experienced significant volatility from

time to time in the market price of our shares of common stock.

Factors that may affect the market price include the following:

Announcements of regulatory developments or technological innovations by us or our competitors;

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risk of loss because the price of our common stock may suffer greater declines due to the historical price volatility of our shares.

factors, some of which are beyond our control, that may cause our share price to fluctuate significantly include, but are not limited

factors, some of which are beyond our control, which may cause our share price to fluctuate significantly include, but are not limited

to, the following:

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Fluctuations in the stock market price and volume.

In addition, in recent years the stock

market in general, and the over-the-counter markets in particular, have experienced extreme price and volume fluctuations.

cases, these fluctuations are unrelated or disproportionate to the performance of the underlying company.

These market and industry

factors may materially and adversely affect our share price, regardless of our performance or whether we meet our business

In the past, class action litigation often has been brought against companies following periods of volatility in the

market price of those companies’

common stock.

If we become involved in this type of litigation in the future, it could

result in substantial costs and diversion of management attention and resources, which could have a material adverse effect on us

and the trading price of our common stock.

In addition, in recent years the stock market

in general, and the over-the-counter markets in particular, have experienced extreme price and volume fluctuations.

In some cases, these

fluctuations are unrelated or disproportionate to the performance of the underlying company.

These market and industry factors may materially

and adversely affect our share price, regardless of our performance or whether we meet our business objectives.

In the past, class action

litigation often has been brought against companies following periods of volatility in the market price of those companies’ common

If we become involved in this type of litigation in the future, it could result in substantial costs and diversion of management

attention and resources, which could have a material adverse effect on us and the trading price of our common stock.

We have no plans to pay dividends in the

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stock and do not anticipate paying such dividends in the foreseeable future.

We are a “smaller reporting company”

under the SEC’s

We are a “smaller reporting company” under the SEC’s

disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

We are a “smaller reporting company”

under the SEC’s

We are a “smaller reporting company” under the SEC’s

disclosure rules, meaning that we have either:

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a public float of less than $700 million.

As a smaller reporting company, we are permitted to comply with scaled-back

disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations regarding executive

compensation in our periodic reports and proxy statements.

We have elected to adopt the accommodations available to smaller reporting

Until we cease to be a smaller reporting company, the scaled-back disclosure in our SEC filings will result in less information

about our company being available than for other public companies.

If investors consider our common stock less attractive as a result

of our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading market

for our common stock and our share price may be more volatile.

As a smaller reporting company, we are permitted

to comply with scaled-back disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations

regarding executive compensation in our periodic reports and proxy statements.

We have elected to adopt the accommodations available to

smaller reporting companies.

Until we cease to be a smaller reporting company, the scaled-back disclosure in our SEC filings will result

in less information about our company being available than for other public companies.

If investors consider our common stock less attractive

as a result of our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading

market for our common stock and our share price may be more volatile.

As a non-accelerated filer, we are not required to comply with

the auditor attestation requirements of the Sarbanes-Oxley Act.

We are a non-accelerated filer under the Securities Exchange Act of

1934, as amended, or the Exchange Act, and we are not required to comply with the auditor attestation requirements of Section 404(b) of

the Sarbanes-Oxley Act of 2002.

Therefore, our internal controls over financial reporting will not receive the level of review provided

by the process relating to the auditor attestation included in annual reports of issuers that are subject to the auditor attestation requirements.

In addition, we cannot predict if investors will find our common stock less attractive because we are not required to comply with the

auditor attestation requirements.

If some investors find our common stock less attractive as a result, there may be a less active trading

market for our common stock and trading price for our common stock may be negatively affected.

We are a non-accelerated filer under the Securities

Exchange Act of 1934, as amended, or the Exchange Act, and we are not required to comply with the auditor attestation requirements of

Section 404(b) of the Sarbanes-Oxley Act of 2002.

Therefore, our internal controls over financial reporting will not receive the level

of review provided by the process relating to the auditor attestation included in annual reports of issuers that are subject to the auditor

attestation requirements.

In addition, we cannot predict if investors will find our common stock less attractive because we are not required

to comply with the auditor attestation requirements.

If some investors find our common stock less attractive as a result, there may be

a less active trading market for our common stock and trading price for our common stock may be negatively affected.

Risks Related to Employee and Tax Matters,

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We have a limited number of employees and

are highly dependent on our Chief Executive Officer, Chief Scientific Officer and Chief Financial Officer.

Our future success depends on

our ability to retain these officers and other key personnel and to attract, retain and motivate other needed qualified personnel.

We are an early-stage biotechnology company

with a limited operating history.

As of April 30, 2021, we had four full-time employees and eleven key consultants.

We are highly

dependent on the R&D, clinical and business development expertise of the principal members of our management, scientific and

clinical teams, specifically, on our Chief Executive Officer, Chief Scientific Officer and Chief Financial Officer.

Recruiting and

retaining qualified scientific, clinical, manufacturing and sales and marketing personnel will also be critical to our success.

loss of the services of our Chief Executive Officer, Chief Scientific Officer and Chief Financial Officer or other key

employees or consultants could severely impede the achievement of our R&D and commercialization of our product candidates and

seriously harm our ability to successfully implement our business strategy.

are highly dependent on our Chief Executive Officer and Chief Financial Officer.

Our future success depends on our ability to retain these

officers and other key personnel and to attract, retain and motivate other needed qualified personnel.

We are an early-stage biotechnology company with

a limited operating history.

As of April 30, 2022, we had 4 full-time employees and 23 consultants.

We are highly dependent on the R&D,

clinical and business development expertise of the principal members of our management, scientific and clinical teams, specifically, on

our Chief Executive Officer and Chief Financial Officer.

Recruiting and retaining qualified scientific, clinical, manufacturing and sales

and marketing personnel will also be critical to our success.

The loss of the services of our Chief Executive Officer and Chief Financial

Officer or other key employees or consultants could severely impede the achievement of our R&D and commercialization of our product

candidates and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and

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carryforwards and certain other tax attributes may be limited.

As of April 30, 2020,

we had federal net operating loss carryforwards of approximately $45 million, which will begin to expire in varying amounts beginning

As of April 30, 2022, we had federal net operating

loss carryforwards of approximately $62 million, which will begin to expire in varying amounts beginning in 2022.

Under Sections 382 and

383 of the United States Internal Revenue Code of 1986, as amended,

or the Code, and corresponding provisions of state law, if a corporation undergoes

an “ownership change,”

(generally defined as a greater than

50-percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year period),

the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset

its post-change taxable income or taxes may be limited.

We may have experienced ownership changes in

the past and could experience one or more ownership changes in the future, some of which are outside our control.

Our net operating loss

carryforwards may also be subject to limitation under state laws.

Further, our ability to utilize net operating loss carryforwards of

companies that we may acquire in the future may also be subject to limitations.

There is also a risk that due to tax law changes, such

as suspensions on the use of net operating loss carryforwards, or other unforeseen reasons, our ability to use our pre-change net operating

loss carryforwards and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation or

383 of the United States Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation

undergoes an “ownership change,” (generally defined as a greater than 50-percentage-point cumulative change (by value) in

the equity ownership of certain stockholders over a rolling three-year period), the corporation’s ability to use its pre-change

net operating loss carryforwards and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited.

We may have experienced ownership changes in the

past and could experience one or more ownership changes in the future, some of which are outside our control.

Our net operating loss carryforwards

may also be subject to limitation under state laws.

Further, our ability to utilize net operating loss carryforwards of companies that

we may acquire in the future may also be subject to limitations.

There is also a risk that due to tax law changes, such as suspensions

on the use of net operating loss carryforwards, or other unforeseen reasons, our ability to use our pre-change net operating loss carryforwards

and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation or expire.

We expect to expand our development and

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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