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Item 1A. Risk Factors

2026-07-29 compared with 2025-08-11 · 1109 added, 928 removed, 1370 unchanged (60% of the section changed)

You should carefully consider these factors

that may affect future results, together with all the other information included in this Report in evaluating our business.

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

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.

You should carefully consider these factors that

may affect future results, together with all the other information included in this Report in evaluating our business.

The risks 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.

In addition, you should carefully consider these

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

These are statements that relate to our expectations

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Forward-Looking Statements and Associated Risks

We operate in a competitive and rapidly changing

We operate in a competitive and rapidly changing environment.

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.

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

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.

However, due to

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

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 in more detail in the section titled

“Risk Factors” in Item 1A of this Report.

Our business is subject to numerous risks and uncertainties

that you should consider before investing in our company.

These risks are described 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:

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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.

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.

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 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.

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

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

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

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

We are a “smaller reporting company” under the Commission’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.

Risks Related to Our Financial Position, FDA

Clinical Hold, Need for Additional Capital and Overall Business

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.

Risks Related to Our Financial Position, FDA Clinical

Hold, Need for Additional Capital and Overall Business

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.

We are a biotechnology company focused on developing

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We have generated significant operating losses since our inception.

Our net income attributable to common stockholders for the

year ended April 30, 2025 was approximately $23 million, mostly attributable to a gain on the related party investment of approximately

$21 million and fair value fluctuations of approximately $14 million, and for 2024 our net loss attributable to common stockholders was

approximately $17.2 million.

Our net loss attributable to common stockholders for the

year ended April 30, 2026 was approximately $23 million, mostly attributable to fair value fluctuations losses of approximately $14 million,

preferred stock and warrant issuance costs of $1.4 million, preferred stock accretion costs of $3.5 million and operating expenses of

approximately $6.8 million, net of a gain on the related party investment of approximately $2.1 million and for 2025 our net income attributable

to common stockholders was approximately $23 million.

As of April 30, 2026, we had an accumulated deficit of approximately $104 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.

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

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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.

Our limited operating history as a company makes

any assessment of our future success and viability subject to significant uncertainty.

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 any

assessment of our future success and viability subject to significant uncertainty.

We will encounter risks and difficulties frequently

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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

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 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.

Even if we are able to fully respond to the FDA’s requests, the agency 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

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.

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.

On October 1, 2020, we received notice from the FDA

that it had placed our IND for a planned 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.

Even if we are able to fully respond to the FDA’s requests, the agency 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.

As of the date of this Report, the clinical hold has remained in place for over five years since October 2020, and

we cannot predict whether or when it will be lifted.

government shutdowns, reductions in FDA

staffing and funding, or other disruptions to FDA operations could further delay the lifting of the clinical hold on our IND and materially

harm our business.

Our ability to advance our product candidates depends

entirely on the FDA’s willingness and capacity to engage with us, review our submissions, and ultimately lift the clinical hold

The FDA’s ability to perform these functions may be adversely affected by a variety of factors beyond our control, including

government shutdowns, reductions in federal agency funding and staffing, and policy changes affecting the FDA’s operations

and priorities.

In recent years, the U.S.

government has experienced multiple shutdowns during which the FDA was required to furlough

employees and suspend critical regulatory activities.

Additionally, beginning in 2025, the federal government has undertaken efforts to

reduce the federal workforce, including through voluntary termination programs, position eliminations, and involuntary terminations, which

may result in the loss of experienced FDA reviewers and support staff.

Any reduction in the FDA’s capacity to conduct timely reviews

of regulatory submissions, including our response to the clinical hold, could result in significant additional delays to our development

Furthermore, application of newly developed artificial

intelligence and other technologies by our competitors may increase the volume of regulatory submissions to the FDA, potentially straining

the agency’s review capacity and further extending review timelines for all applicants, including us.

Any such delays could have

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

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.

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

We do not currently own or operate manufacturing facilities

to produce our encapsulated live cell product candidates for cancer.

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 stages.

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

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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.

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

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live cell and ifosfamide product, if approved, 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:

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;

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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,

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

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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

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 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, 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

If 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, if approved, 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.

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.

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,

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 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, if approved, 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.

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

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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

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 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 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;

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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.

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

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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.

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

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

Cell-in-a-Box ® encapsulation technology is validated in our planned 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

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 our IND related to our planned clinical trial in LAPC, our Cell-in-a-Box ®

encapsulation technology is validated in our planned 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.

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adversely affected.

We currently have no commercial revenue

and may never become profitable.

Even if we can successfully achieve regulatory

approval for our product candidates, we do not know what the reimbursement status of our product candidates will be or when any of these

products will generate revenue for us, if at all.

We currently have no commercial revenue and

may never become profitable.

Even if we can successfully achieve regulatory approval

for our product candidates, we do not know what the reimbursement status of our product candidates will be or when any of these products

will generate revenue for us, if at all.

We have not generated, and do not expect to generate, any product revenue for the foreseeable

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uncertain and will depend, in part, on the rate of growth of our expenses.

Our ability to generate revenue from our product

candidates also depends on numerous additional factors, including our ability to:

Our ability to generate revenue from our product candidates

also depends on numerous additional factors, including our ability to:

successfully complete development activities, including the remaining preclinical studies and planned clinical trials for our product candidates;

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set a commercially viable price for any products for which we may receive approval.

We are unable to predict the timing or amount

of increased expenses, or when or if we will be able to achieve or maintain profitability.

Even if we can complete the processes described

above, we anticipate incurring significant costs associated with commercializing our product candidates.

We are unable to predict the timing or amount of increased

expenses, or when or if we will be able to achieve or maintain profitability.

Even if we can complete the processes described above, we

anticipate incurring significant costs associated with commercializing our product candidates.

To date, we have generated no revenue.

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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.

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

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which causes potential fluctuations in operating results.

Because of our limited operating history as a

biotech company;

we are currently unable to accurately forecast our revenues.

Future expense levels will likely be based largely on our

marketing and development plans and estimates of future revenue.

Any sales or operating results will likely generally depend on volume

and timing of orders, which may not occur and on our ability to fulfill such orders, which we may not be able to do.

We may be unable

to adjust spending in a timely manner to compensate for any unexpected revenue shortfall.

Accordingly, any significant shortfall in revenues

in relation to planned expenditures could have an immediate adverse effect on our business, prospects, financial condition and results

of operations.

Further, as a strategic response to changes in the competitive environment, we may from time to time make certain pricing,

service or marketing decisions that could have a material adverse effect on our business, prospects, financial condition and results of

We may experience significant fluctuations in

future operating results due to a variety of factors, many of which are outside of our control.

Factors that may affect operating results

Because of our limited operating history as a biotech

company, we are currently unable to accurately forecast our revenues.

Future expense levels will likely be based largely on our marketing

and development plans and estimates of future revenue.

Any sales or operating results will likely generally depend on volume and timing

of orders, which may not occur and on our ability to fulfill such orders, which we may not be able to do.

We may be unable to adjust spending

in a timely manner to compensate for any unexpected revenue shortfall.

Accordingly, any significant shortfall in revenues in relation

to planned expenditures could have an immediate adverse effect on our business, prospects, financial condition and results of operations.

Further, as a strategic response to changes in the competitive environment, we may from time to time make certain pricing, service or

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

We may experience significant fluctuations in future

operating results due to a variety of factors, many of which are outside of our control.

Factors that may affect operating results include:

(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;

(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;

(v) the level

of use and consumer acceptance of our 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;

delays or disruptions in our supply chain.

We may be unable to adequately protect our

information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal

data, damage our reputation, and subject us to significant financial and legal exposure.

We rely on information technology systems that

we or our third-party providers operate to process, transmit and store electronic information in our day-to-day operations.

and (ix) delays or

disruptions in our supply chain.

We may be unable to adequately protect our information

systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage

our reputation, and subject us to significant financial and legal exposure.

We rely on information technology systems that we

or our third-party providers operate to process, transmit and store electronic information in our day-to-day operations.

In connection

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availability.

A successful cyberattack could cause serious negative consequences for us, including, without limitation, the disruption

of operations, the misappropriation of confidential business information, including financial information, trade secrets, financial loss

and the disclosure of corporate strategic plans.

Although we devote resources to protect our information systems, we realize that cyberattacks

are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result in business,

legal, financial or reputational harm to us, or would have a material adverse effect on our results of operations and financial condition.

Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’

personal data could result in significant liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended

by HITECH), and international law (e.g., the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct

new studies and potentially disrupt our business.

In particular, threat actors are increasingly leveraging artificial intelligence technologies, including generative AI,

to enhance the sophistication and effectiveness of cyberattacks through techniques such as AI-generated phishing communications, deepfakes,

and advanced social engineering tactics that are more difficult to detect using traditional security measures.

A successful cyberattack

could cause serious negative consequences for us, including, without limitation, the disruption of operations, the misappropriation of

confidential business information, including financial information, trade secrets, financial loss and the disclosure of corporate strategic

Although we devote resources to protect our information systems, we realize that cyberattacks are a threat, and there can be no

assurance that our efforts will prevent information security breaches that would result in business, legal, financial or reputational

harm to us, or would have a material adverse effect on our results of operations and financial condition.

Any failure to prevent or mitigate

security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant

liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g.,

the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt

our business.

In addition, the computer systems of various third

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and correct for any such failures, deficiencies or breaches.

If we or our third-party providers fail to maintain or protect our information

technology systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to our information

technology systems, we or our third-party providers could have difficulty preventing, detecting and controlling such cyber-attacks and

any such attacks could result in losses described above as well as disputes with physicians, patients and our partners, regulatory sanctions

or penalties, increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which could have a material

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

Any failure by such third parties

to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly adverse consequences

If we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be exposed to litigation

and governmental investigations, which could lead to a potential disruption to our business.

Our cybersecurity risk management is led by a contracted third-party Information

Security Officer.

While this individual has substantial experience in cybersecurity, our reliance on a single contracted individual for

this critical function means that the departure, unavailability, or incapacitation of this individual could leave us without adequate

cybersecurity oversight for a period of time.

If we or our third-party providers fail to maintain or protect our information technology

systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to our information technology

systems, we or our third-party providers could have difficulty preventing, detecting and controlling such cyber-attacks and any such attacks

could result in losses described above as well as disputes with physicians, patients and our partners, regulatory sanctions or penalties,

increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which could have a material adverse effect

on our business, results of operations, financial condition, prospects and cash flows.

Any failure by such third parties to prevent or

mitigate security breaches or improper access to or disclosure of such information could have similarly adverse consequences for us.

we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be exposed to litigation and governmental

investigations, which could lead to a potential disruption to our business.

In addition, our cybersecurity insurance coverage may not

be adequate or sufficient to protect us from liabilities arising out of cybersecurity incidents, and such coverage may not continue to

be available on commercially reasonable terms or at all.

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.

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

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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,

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.

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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.,

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.

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Diminished protection of intellectual property in some countries.

Our plan to first pursue a clinical trial

before a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any 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 ®

Our plan to first pursue a clinical trial before

a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any 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 ®

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

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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

medically or commercially unacceptable or severe 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.

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

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 medically or

commercially unacceptable or severe 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

The design of a clinical trial can determine whether

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Therefore, the results of any ongoing or future clinical trials we conduct may not be successful.

We may experience significant delays in pursuing

any clinical trials, and any planned clinical trials may not begin on time, may require redesign, may not enroll sufficient healthy volunteers

We may experience significant delays in pursuing any

clinical trials, and any planned clinical trials may not begin on time, may require redesign, may not enroll sufficient healthy volunteers

or patients in a timely manner and may not be completed on schedule, if at all.

Our clinical trials may be delayed, suspended

or prematurely terminated because costs are greater than we anticipate or for a variety of other reasons, such as:

Our clinical trials may be delayed, suspended or prematurely

terminated because costs are greater than we anticipate or for a variety of other reasons, such as:

delay or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a trial design that we are able to execute;

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failure to initiate or delay of or inability to complete a clinical trial as a result of a clinical hold imposed by the FDA or comparable foreign regulatory authority due to observed safety findings or other reasons;

negative or inconclusive results in our clinical trials, and our decision to or regulators’ requirement that we conduct additional non-clinical studies, clinical trials or that we abandon one or more of our product development programs;

negative or inconclusive results in our clinical trials, and our decision to or regulators’ requirement that we conduct additional nonclinical studies, clinical trials or that we abandon one or more of our product development programs;

inability to manufacture sufficient quantities of a drug candidate of acceptable quality for use in clinical trials.

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the schedule for commencement or completion of any currently ongoing, planned or future clinical trials.

Many of the factors that cause, or lead to, a

delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for our product

If we experience delays in the commencement or

completion of, or suspension or termination of, any clinical trial for our drug candidates, the commercial prospects of the drug candidate

could be harmed, and our ability to generate product revenues from the drug candidate may be delayed or eliminated.

Many of the factors that cause, or lead to, a delay

in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for our product candidates.

If we experience delays in the commencement or completion

of, or suspension or termination of, any clinical trial for our drug candidates, the commercial prospects of the drug candidate could

be harmed, and our ability to generate product revenues from the drug candidate may be delayed or eliminated.

In addition, any delays

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could harm our business, financial condition, results of operations and prospects significantly.

We are seeking FDA approval to commence

clinical trials in the U.S.

of certain of our product candidates based on clinical data that was obtained in trials conducted outside

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 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 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:

We are seeking FDA approval to commence clinical

trials in the U.S.

of certain of our product candidates based on clinical data that was obtained in trials conducted outside 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 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 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

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

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.

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 clinical trial is different from that

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

Results in previous clinical trials of our

encapsulated live cell and ifosfamide combination for pancreatic cancer may not be replicated in future clinical trials which could result

in development delays or a failure to obtain marketing approval.

Results in the previous Phase 1/2 and Phase 2

clinical trials of the encapsulated live cell and ifosfamide combination product may not be predictive of similar results in future clinical

trials such as our planned clinical trial in LAPC, if allowed to proceed.

Results in previous clinical trials of our encapsulated

live cell and ifosfamide combination for pancreatic cancer may not be replicated in future clinical trials which could result in development

delays or a failure to obtain marketing approval.

Results in the previous Phase 1/2 and Phase 2 clinical

trials of the encapsulated live cell and ifosfamide combination product may not be predictive of similar results in future clinical trials

such as our planned clinical trial in LAPC, if allowed to proceed.

The previous Phase 1/2 and Phase 2 clinical trials had a relatively

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business could be substantially harmed.

The research, testing, manufacturing, labeling,

approval, sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDA in the U.S.

and by the respective regulatory agencies in other countries where regulations differ.

The research, testing, manufacturing, labeling, approval,

sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDA in the U.S.

the respective regulatory agencies in other countries where regulations differ.

We are not permitted to market our product candidates

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any drug candidates we may seek to develop in the future will ever obtain regulatory approval.

Our drug candidates could fail to receive, or

could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following:

Our drug candidates could fail to receive, or could

be delayed in receiving, regulatory approval for many reasons, including any one or more of the following:

the FDA or comparable foreign regulatory agencies may disagree with the design or implementation of our clinical trials;

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the change of the medical standard of care or the approval policies or regulations of the FDA or comparable foreign regulatory agencies may significantly change in a manner that renders our clinical data insufficient for approval.

The time and expense of the approval process,

as well as the unpredictability of future clinical trial results and other contributing factors, may result in our failure to obtain regulatory

The time and expense of the approval process, as well

as the unpredictability of future clinical trial results and other contributing factors, may result in our failure to obtain regulatory

approval to market, in one or more jurisdictions, for the product candidates we are currently developing or may seek to develop in the

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circumstances could materially harm the commercial prospects for our product candidates.

If we experience delays or difficulties

in the enrollment of patients in clinical trials, we may not achieve our clinical development timeline and our receipt of necessary regulatory

If we experience delays or difficulties in the

enrollment of patients in clinical trials, we may not achieve our clinical development timeline and our receipt of necessary regulatory

approvals could be delayed or prevented.

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or patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ drug

Patient enrollment is a significant factor in

the overall duration of a clinical trial and is affected by many factors, including:

Patient enrollment is a significant factor in the

overall duration of a clinical trial and is affected by many factors, including:

The size and nature of the patient population;

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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

clinical trials could result in significant delays or may require us to abandon one or more clinical trials altogether.

Enrollment delays

in our clinical trials may result in increased development costs for our product candidates, delay or halt the development of and approval

processes for our product candidates and jeopardize our ability to achieve our clinical development timeline and goals, including the

dates by which we will commence, complete and receive results from clinical trials.

Enrollment delays may also delay or jeopardize our

ability to commence sales and generate revenues from our product candidates., if approved Any of the foregoing could cause the value of

our company to decline and limit our ability to obtain additional financing, if needed.

Our inability to enroll enough patients for our clinical

trials could result in significant delays or may require us to abandon one or more clinical trials altogether.

Enrollment delays in our

clinical trials may result in increased development costs for our product candidates, delay or halt the development of and approval processes

for our product candidates and jeopardize our ability to achieve our clinical development timeline and goals, including the dates by which

we will commence, complete and receive results from clinical trials.

Enrollment delays may also delay or jeopardize our ability to commence

sales and generate revenues from our product candidates., if approved Any of the foregoing could cause the value of our company to decline

and limit our ability to obtain additional financing, if needed.

We may request priority review for our product

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We may be eligible for priority review designation

for our product candidates if the regulatory agencies determine such product candidates offer major advances in treatment of a serious

for our product candidates if the regulatory agencies determine that such product candidates offer major advances in treatment of a serious

disease or condition or provide a treatment for a serious disease or condition where no adequate therapy exists.

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priority review designation, see “Government Regulation – Fast Track, Breakthrough Therapy and Priority Review Designations.”

FDA has broad discretion with respect to whether

to grant priority review status to a product candidate, so even if we believe a product candidate is eligible for such designation or

status, FDA may decide not to grant it.

Thus, while FDA has granted priority review to other oncology products, our product candidates,

should we request priority review designation for them, may not receive such designation.

Moreover, even if one of our product candidates

is designated for priority review, such a designation does not change the standards for product approval and does not necessarily mean

a faster overall regulatory review process or necessarily confer any advantage with respect to approval compared to the standard FDA review

Receiving priority review from the regulatory

agencies does not guarantee approval within an accelerated timeline or thereafter.

In some instances, we believe we may be

able to secure approval from FDA to use accelerated development pathways.

If we are unable to obtain such approval, we may be required

to conduct additional preclinical studies or clinical trials beyond those that we contemplate which could increase the expense of obtaining

and delay the receipt of necessary marketing approvals.

We anticipate that we may seek an accelerated

approval pathway for certain of our product candidates.

FDA has broad discretion with respect to whether to

grant priority review status to a product candidate, so even if we believe a product candidate is eligible for such designation or status,

FDA may decide not to grant it.

Thus, while FDA has granted priority review to other oncology products, our product candidates, should

we request priority review designation for them, may not receive such designation.

Moreover, even if one of our product candidates is

designated for priority review, such a designation does not change the standards for product approval and does not necessarily mean a

faster overall regulatory review process or necessarily confer any advantage with respect to approval compared to the standard FDA review

Receiving priority review from the regulatory agencies

does not guarantee approval within an accelerated timeline or thereafter.

In some instances, we believe we may be able

to secure approval from FDA to use accelerated development pathways.

If we are unable to obtain such approval, we may be required to conduct

additional preclinical studies or clinical trials beyond those that we contemplate which could increase the expense of obtaining and delay

the receipt of necessary marketing approvals.

We anticipate that we may seek an accelerated approval

pathway for certain of our product candidates.

For a description of the accelerated approval pathway, see “Government Regulation

– Accelerated Approval Pathway.”

Prior to requesting accelerated approval, we

will seek feedback from the FDA and will otherwise evaluate our eligibility to use the accelerated approval pathway.

There can also

be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA or a BLA, as

applicable, for accelerated approval or any other form of designation or program intended to expedite the product development,

review or approval processes.

Similarly, there can be no assurance that after subsequent feedback from the FDA that we will continue

to pursue or apply for accelerated approval or any other form of designation or expedited program, even if we initially decide to do

Furthermore, if we decide to apply for accelerated approval or under another expedited regulatory designation (such as the

Breakthrough Therapy designation or Fast Track designation), there can be no assurance that such submission or application will be

accepted or that any expedited development, review or approval will be granted on a timely basis or at all.

The FDA could also

require us to conduct further studies prior to considering or granting our application or granting approval of any type and may

require us to have a confirmatory trial to verify the clinical benefit of the product underway and partially or fully enrolled

before granting approval.

We might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays,

or approval might not be granted because our submission is deemed incomplete by the FDA.

Even if we receive accelerated approval from the

FDA, we will be subject to rigorous post-marketing requirements, including the completion of confirmatory post-market clinical trials,

submission to the FDA of periodic progress reports on confirmatory trials, and submission to the FDA of all promotional materials prior

to their dissemination.

The FDA could seek to withdraw any product approval granted through the accelerated approval pathway for multiple

reasons, including if we fail to conduct any required post-market study with due diligence;

Prior to requesting accelerated approval, we will

seek feedback from the FDA and will otherwise evaluate our eligibility to use the accelerated approval pathway.

There can also be no assurance

that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA or a BLA, as applicable, for accelerated

approval or any other form of designation or program intended to expedite the product development, review or approval processes.

there can be no assurance that after subsequent feedback from the FDA that we will continue to pursue or apply for accelerated approval

or any other form of designation or expedited program, even if we initially decide to do so.

Furthermore, if we decide to apply for accelerated

approval or under another expedited regulatory designation (such as the Breakthrough Therapy designation or Fast Track designation), there

can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be

granted on a timely basis or at all.

The FDA could also require us to conduct further studies prior to considering or granting our application

or granting approval of any type and may require us to have a confirmatory trial to verify the clinical benefit of the product underway

and partially or fully enrolled before granting approval.

We might not be able to fulfill the FDA’s requirements in a timely manner,

which would cause delays, or approval might not be granted because our submission is deemed incomplete by the FDA.

Even if we receive accelerated approval from the FDA,

we will be subject to rigorous post-marketing requirements, including the completion of confirmatory post-market clinical trials, submission

to the FDA of periodic progress reports on confirmatory trials, and submission to the FDA of all promotional materials prior to their

dissemination.

The FDA could seek to withdraw any product approval granted through the accelerated approval pathway for multiple reasons,

including if we fail to conduct any required post-market study with due diligence;

a post-market study does not confirm the predicted

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procedures to withdraw any product for which we receive accelerated approval if our confirmatory trials fail to verify the purported clinical

A failure to obtain accelerated approval or any

other form of designation or program intended to expedite product development, review or approval for any of our product candidates that

we determine to seek accelerated approval or designation for would result in a longer time to commercialization of such product candidate,

A failure to obtain accelerated approval or any other

form of designation or program intended to expedite product development, review or approval for any of our product candidates that we

determine to seek accelerated approval or designation for would result in a longer time to commercialization of such product candidate,

could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

We currently have Orphan Drug designation

for our product candidate for the treatment of pancreatic cancer, and may seek Orphan Drug designation for additional product candidates,

We currently have Orphan Drug designation for

our product candidate for the treatment of pancreatic cancer, and may seek Orphan Drug designation for additional product candidates,

and we may be unsuccessful in obtaining or maintaining such designations.

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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

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.

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have received Fast Track designation have failed to obtain marketing approval.

A Breakthrough Therapy designation by the

FDA or similar designation by another regulatory agency, even if granted for any of our product candidates, may not lead to a faster development

A Breakthrough Therapy designation by the FDA

or similar designation by another regulatory agency, even if granted for any of our product candidates, may not lead to a faster development

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

We do not currently have Breakthrough Therapy

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

based upon the data we generate during our clinical trials, if successful.

For a description of Breakthrough Therapy designation, see

“Government Regulation – Fast Track, Breakthrough Therapy and Priority Review Designations.”

A Breakthrough Therapy or similar designation

is within the discretion of the FDA or other applicable regulatory agencies.

Accordingly, even if we believe, after completing early clinical

trials, that one of our product candidates meets the criteria for designation as a Breakthrough Therapy or other similar designation,

a regulatory agency may disagree and instead determine not to grant such designation.

In any event, the receipt of a Breakthrough Therapy

or other similar designation for a product candidate may not result in a faster development process, review or approval compared to drugs

or biologics considered for approval under conventional procedures of a regulatory agency and does not ensure the designated product’s

ultimate approval.

In addition, even if one or more of our product candidates receives Breakthrough Therapy designation or other similar

designations, a regulatory agency may later decide that such product candidates no longer meet the conditions for the designation.

Failure to obtain marketing approval in

international jurisdictions would prevent our product candidates from being marketed abroad.

We do not currently have Breakthrough Therapy designation

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

upon the data we generate during our clinical trials, if successful.

For a description of Breakthrough Therapy designation, see “Government

Regulation – Fast Track, Breakthrough Therapy and Priority Review Designations.”

A Breakthrough Therapy or similar designation is within

the discretion of the FDA or other applicable regulatory agencies.

Accordingly, even if we believe, after completing early clinical trials,

that one of our product candidates meets the criteria for designation as a Breakthrough Therapy or other similar designation, a regulatory

agency may disagree and instead determine not to grant such designation.

In any event, the receipt of a Breakthrough Therapy or other

similar designation for a product candidate may not result in a faster development process, review or approval compared to drugs or biologics

considered for approval under conventional procedures of a regulatory agency and does not ensure the designated product’s ultimate

In addition, even if one or more of our product candidates receives Breakthrough Therapy designation or other similar designations,

a regulatory agency may later decide that such product candidates no longer meet the conditions for the designation.

Failure to obtain marketing approval in international

jurisdictions would prevent our product candidates from being marketed abroad.

To market and sell our product candidates in Europe

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marketing approvals and may not receive necessary approvals to commercialize our product candidates in any market.

Any product candidate for which we obtain

marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions

or withdrawal from the market.

We may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated

problems with our products, when and if any of our product candidates are approved.

Any product candidate for which we obtain marketing

approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal

from the market.

We may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems

with our products, when and if any of our product candidates are approved.

Our product candidates and the activities associated

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criminal sanctions, substantial civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Although we do not currently have any products

on the market, upon commercialization of our drug candidates, if approved, we will be subject to additional healthcare statutory and regulatory

Although we do not currently have any products on

the market, upon commercialization of our drug candidates, if approved, we will be subject to additional healthcare statutory and regulatory

requirements and oversight by federal and state governments in the U.S.

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Restrictions under applicable healthcare laws and regulations include the following:

The Anti-Kickback Statute prohibits, among other

things, persons from knowingly and willfully soliciting, offering, receiving or providing any remuneration, directly or indirectly, in

cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation

of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

The False Claims Act imposes criminal and civil

penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for

payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the Federal

HIPAA imposes criminal and civil liability for

executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.

HIPAA, as amended

by HITECH and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding

the privacy, security and transmission of individually identifiable health information.

The Anti-Kickback Statute prohibits, among other things,

persons from knowingly and willfully soliciting, offering, receiving or providing any remuneration, directly or indirectly, in cash or

in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of,

any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

The False Claims Act imposes criminal and civil penalties

against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that

are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the Federal governments;

HIPAA imposes criminal and civil liability for executing

a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.

HIPAA, as amended by HITECH

and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy,

security and transmission of individually identifiable health information.

The Physician Payments Sunshine Act requires applicable

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or services reimbursed by non-governmental third-party payors, including private insurers.

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

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

and other healthcare providers or marketing expenditures.

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compliance efforts.

Efforts to ensure that our business arrangements

with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.

Efforts to ensure that our business arrangements with

third parties will comply with applicable healthcare laws and regulations will involve substantial costs.

It is possible that governmental

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sanctions, including exclusions from government funded healthcare programs.

Recently enacted and future legislation

could increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the

prices we may obtain.

All aspects of our business, including research

and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation

Recently enacted and future legislation could

increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices

we may obtain.

All aspects of our business, including research and

development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation

and regulation.

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Increased scrutiny by the U.S.

Congress of the

FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling

and post-marketing testing and other requirements.

Congress also must reauthorize the FDA’s user fee programs every five years and

often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA and industry

stakeholders as part of this periodic reauthorization process.

Congress most recently reauthorized the user fee programs in September

2022 without any substantive policy changes.

Congress of the FDA’s

approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing

testing and other requirements.

Congress also must reauthorize the FDA’s user fee programs every five years and often makes changes

to those programs in addition to policy or procedural changes that may be negotiated between the FDA and industry stakeholders as part

of this periodic reauthorization process.

Congress most recently reauthorized the user fee programs in September 2022 without any substantive

policy changes.

Among policy makers and payors in the U.S.

elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs,

improving quality and/or expanding access.

and elsewhere,

there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving

quality and/or expanding access.

In the U.S., the pharmaceutical industry has been a focus of these efforts and has been significantly

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industry in the U.S.

Further, over the past several years there has

been heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products,

which has resulted in several U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other

things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform

government program reimbursement methodologies for drug products.

The probability of success of these policies, many of which have been

subjected to legal challenge in the federal court system, and their potential impact on the U.S.

Further, over the past several years there has been

heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products, which

has resulted in several U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,

bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government

program reimbursement methodologies for drug products.

The probability of success of these policies, many of which have been subjected

to legal challenge in the federal court system, and their potential impact on the U.S.

prescription drug marketplace is unknown.

There are likely to be continued political and legal challenges associated with implementing these reforms as they are currently envisioned.

Additionally, on December 20, 2019, the Further

Consolidated Appropriations Act for 2020 was signed into law (P.L.

116-94) and includes a piece of bipartisan legislation called the Creating

and Restoring Equal Access to Equivalent Samples Act of 2019 (the “CREATES Act”).

The CREATES Act aims to address the concern

articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their

products, including by invoking the existence of a REMS for certain products, to deny generic product developers access to samples of

brand products.

Because generic product developers need samples of a reference listed drug, to conduct certain comparative testing required

by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products.

this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer

to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product

developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain

highly uncertain and its potential effects on any of our future commercial products are unknown.

are likely to be continued political and legal challenges associated with implementing these reforms as they are currently envisioned.

Additionally, on December 20, 2019, the Further Consolidated

Appropriations Act for 2020 was signed into law (P.L.

116-94) and includes a piece of bipartisan legislation called the Creating and Restoring

Equal Access to Equivalent Samples Act of 2019 (the “CREATES Act”).

The CREATES Act aims to address the concern articulated

by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products,

including by invoking the existence of a REMS for certain products, to deny generic product developers access to samples of brand products.

Because generic product developers need samples of a reference listed drug, to conduct certain comparative testing required by the FDA,

some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products.

To remedy this concern,

the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel

it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments

will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain

and its potential effects on any of our future commercial products are unknown.

In addition, many states have proposed or enacted

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once approved, or additional pricing pressures.

Even if we are able to commercialize any

of our drug candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare

Even if we are able to commercialize any of

our drug candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare

reform initiatives, which would harm our business.

The regulations that govern marketing approvals,

pricing, coverage and reimbursement for new drug and biological products vary widely from country to country.

Current and future legislation

may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries

require approval of the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing

approval is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing governmental control even

after initial approval is granted.

As a result, we may obtain marketing approval for a product in a particular country, but then be subject

to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues

we are able to generate from the sale of the product in that country.

Adverse pricing limitations may hinder our ability to recoup our

investment in one or more product candidates, even if our product candidates obtain marketing approval.

The regulations that govern marketing approvals, pricing,

coverage and reimbursement for new drug and biological products vary widely from country to country.

Current and future legislation may

change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries require

approval of the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing approval

is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial

approval is granted.

As a result, we may obtain marketing approval for a product in a particular country, but then be subject to price

regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we

are able to generate from the sale of the product in that country.

Adverse pricing limitations may hinder our ability to recoup our investment

in one or more product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize any product candidates

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prior authorization requirements.

Increasingly, third-party payors are requiring

that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for products.

cannot be sure that coverage will be available for any product candidate that we commercialize and, if coverage is available, what the

level of reimbursement will be.

Increasingly, third-party payors are requiring that

drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for products.

be sure that coverage will be available for any product candidate that we commercialize and, if coverage is available, what the level

of reimbursement will be.

Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing

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adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Further, there have been, and may continue to

be, legislative and regulatory proposals at the U.S.

federal and state levels and in foreign jurisdictions directed at broadening the

availability and containing or lowering the cost of healthcare.

The continuing efforts of the government, insurance companies, managed

care organizations and other third-party payors to contain or reduce costs of healthcare may adversely affect our ability to set prices

for our products that would allow us to achieve or sustain profitability.

In addition, governments may impose price controls on any of

our products that obtain marketing approval, which may adversely affect our future profitability.

Most recently, in August 2022, President Biden

signed into the law the Inflation Reduction Act of 2022, or the IRA.

Among other things, the IRA has multiple provisions that may impact

the prices of drug products that are both sold into the Medicare program and throughout the U.S.

Further, there have been, and may continue to be,

legislative and regulatory proposals at the U.S.

federal and state levels and in foreign jurisdictions directed at broadening the availability

and containing or lowering the cost of healthcare.

The continuing efforts of the government, insurance companies, managed care organizations

and other third-party payors to contain or reduce costs of healthcare may adversely affect our ability to set prices for our products

that would allow us to achieve or sustain profitability.

In addition, governments may impose price controls on any of our products that

obtain marketing approval, which may adversely affect our future profitability.

Most recently, in August 2022, President Biden signed

into the law the Inflation Reduction Act of 2022, or the IRA.

Among other things, the IRA has multiple provisions that may impact the

prices of drug products that are both sold into the Medicare program and throughout the U.S.

Starting in 2023, a manufacturer of drugs

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Risks Related to the Commercialization of Our Product Candidates

Serious adverse events or undesirable side

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

Serious adverse events or undesirable side 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.

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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

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.

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 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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the actual markets for our product candidates could be smaller than our estimates of the potential market opportunities.

If any of our product candidates receives

marketing approval and we or others later discover that the therapy is less effective than previously believed or causes undesirable side

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 provided informed consent to enter a clinical

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 could occur:

If any of our product candidates receives marketing

approval and we or others later discover that the therapy is less effective than previously believed or causes undesirable side 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 provided informed consent 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 could occur:

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

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Our reputation may suffer.

Any of these events could have a material and

adverse effect on our operations and business and could adversely impact our stock price.

Any of these events could have a material and adverse

effect on our operations and business and could adversely impact our stock price.

If we are unable to establish sales, marketing

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and experience than us.

We may not be able to license our encapsulated

live cell plus ifosfamide product candidate on reasonable terms, if at all.

We may not be able to license our encapsulated live

cell plus ifosfamide product candidate on reasonable terms, if at all.

If other product candidates are approved for smaller or easily

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could delay any product candidate launch.

We expect that we will commence the development

of these capabilities prior to receiving approval of any of our product candidates.

If the commercial launch of a product candidate for

which we recruit a sales force and establish marketing and distribution capabilities is delayed or does not occur for any reason, we could

have prematurely or unnecessarily incurred these commercialization costs.

Such a delay may be costly, and our investment could be lost

if we cannot retain or reposition our sales and marketing personnel.

We expect that we will commence the development of

these capabilities prior to receiving approval of any of our product candidates.

If the commercial launch of a product candidate for which

we recruit a sales force and establish marketing and distribution capabilities is delayed or does not occur for any reason, we could have

prematurely or unnecessarily incurred these commercialization costs.

Such a delay may be costly, and our investment could be lost if we

cannot retain or reposition our sales and marketing personnel.

In addition, we may not be able to hire or retain

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candidate independently.

We expect to seek one or more strategic partners

for commercialization of our product candidates outside the U.S.

Because of entering arrangements with third parties to perform sales,

marketing and distribution services, our product revenues or the profitability of these product revenues may be lower, perhaps substantially

lower, than if we were to directly market and sell products in those markets.

Furthermore, we may be unsuccessful in entering the necessary

arrangements with third parties or may be unable to do so on terms that are favorable to us.

In addition, we may have little or no control

over such third parties and any of them may fail to devote the necessary resources and attention to sell and market our product candidates

We expect to seek one or more strategic partners for

commercialization of our product candidates outside the U.S.

Because of entering arrangements with third parties to perform sales, marketing

and distribution services, our product revenues or the profitability of these product revenues may be lower, perhaps substantially lower,

than if we were to directly market and sell products in those markets.

Furthermore, we may be unsuccessful in entering the necessary arrangements

with third parties or may be unable to do so on terms that are favorable to us.

In addition, we may have little or no control over such

third parties and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively.

If we do not establish sales and marketing capabilities,

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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 contract research

organizations (“CROs”), clinical data management organizations, medical institutions (including academic medical centers),

clinical investigators 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.

Switching or adding third parties to conduct our studies involves substantial

cost and requires extensive management time and focus.

We may be forced to seek an engagement with a substitute or new third party and may

be unable to enter into arrangements with such third parties on commercially reasonable terms, or at all.

If we are required to enter

alternative arrangements because of any such termination, the development, marketing authorization, or 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 GCP 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.

Regulatory agencies enforce GCP requirements through periodic

inspections of trial sponsors, clinical investigators and trial sites.

If we or any of our contractors fail to comply with

applicable GCP regulations, the clinical data generated in the applicable trial may be deemed unreliable and regulatory agencies may

require us to perform additional clinical trials before approving a drug candidate for marketing, which we may not have sufficient

cash or other resources to support and which would delay our ability to generate revenue from future sales of such drug candidate.

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 contract research organizations

(“CROs”), clinical data management organizations, medical institutions (including academic medical centers), clinical investigators

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.

Switching or adding third parties to conduct our studies involves substantial cost and requires extensive

management time and focus.

We may be forced to seek an engagement with a substitute or new third party and may be unable to enter

into arrangements with such third parties on commercially reasonable terms, or at all.

If we are required to enter alternative arrangements

because of any such termination, the development, marketing authorization, or introduction of our product candidates to market could be

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

Moreover, regulatory agencies require us to comply with GCP 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.

agencies enforce GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites.

of our contractors fail to comply with applicable GCP regulations, the clinical data generated in the applicable trial may be deemed unreliable

and regulatory agencies may require us to perform additional clinical trials before approving a drug candidate for marketing, which we

may not have sufficient cash or other resources to support and which would delay our ability to generate revenue from future sales of

such drug candidate.

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, and we will be unable to control whether or not our contracted

third parties devote sufficient time and resources to our preclinical and clinical programs.

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

Failure to do so can result in fines, adverse publicity and civil and criminal

Furthermore, these third parties may also have relationships

with other entities, some of which may be our competitors, and we will be unable to control whether or not our contracted third parties

devote sufficient time and resources to our preclinical and clinical programs.

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.

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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.

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 business could be adversely affected.

For some of our product candidates, we may in

the future determine to collaborate with pharmaceutical and biotechnology companies for development of our product candidates.

significant competition in seeking appropriate collaborators.

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.

If we are unable to reach agreements with suitable

collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce

or delay its development program or one or more of our other development programs, delay our potential development schedule or increase

our expenditures and undertake preclinical and clinical development activities at our own expense.

If we fail to enter collaborations

and do not have sufficient funds or expertise to undertake the necessary development activities, we may not be able to further develop

our product candidates or continue to develop our product candidates and our business may be materially and adversely affected.

Future collaborations we may enter may involve

the following risks:

For some of our product candidates, we may in the

future determine to collaborate with pharmaceutical and biotechnology companies for development of our product candidates.

We face significant

competition in seeking appropriate collaborators.

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.

If we are unable to reach agreements with suitable collaborators

on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its

development program or one or more of our other development programs, delay our potential development schedule or increase our expenditures

and undertake preclinical and clinical development activities at our own expense.

If we fail to enter collaborations and do not have sufficient

funds or expertise to undertake the necessary development activities, we may not be able to further develop our product candidates or

continue to develop our product candidates and our business may be materially and adversely affected.

Future collaborations we may enter may involve the

following risks:

Collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

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Günzburg and Dr.

Salmons are involved

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

Salmons are involved in

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

These endeavors include preclinical and clinical studies involving

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adverse effect on us.

The manufacture of our product candidates

is complex, and difficulties may be encountered in production.

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

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could experience delays in our development efforts as we locate and qualify new third-party manufacturers.

In order to conduct planned or future clinical

trials of our product candidates, or supply commercial products, if approved, we will need to have them manufactured in small and large

Our manufacturing partners may be unable to successfully increase the manufacturing capacity for any of our product candidates

in a timely or cost-effective manner, or at all.

In order to conduct planned or future clinical trials

of our product candidates, or supply commercial products, if approved, we will need to have them manufactured in small and large quantities.

Our manufacturing partners may be unable to successfully increase the manufacturing capacity for any of our product candidates in a timely

or cost-effective manner, or at all.

In addition, quality issues may arise during scale-up activities.

If our manufacturing

partners are unable to successfully scale up the manufacture of our product candidates in sufficient quality and quantity, the development,

testing and potential clinical trials of that product candidate may be delayed or become infeasible, and regulatory approval or commercial

launch of any resulting product may be delayed or not obtained, which could significantly harm our business.

The same risks would apply

to our internal manufacturing facilities, should we in the future decide to build internal manufacturing capacity.

In addition, building

internal manufacturing capacity would carry significant risks in terms of being able to plan, design and execute on a complex project

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 other comparable foreign regulatory authority approval processes and continuous

oversight, and we will need to contract with manufacturers who can meet all applicable legal and regulatory requirements, including compliance

with cGMP, on an ongoing basis.

If our manufacturing partners are

unable to successfully scale up the manufacture of our product candidates in sufficient quality and quantity, the development, testing

and potential clinical trials of that product candidate may be delayed or become infeasible, and regulatory approval or commercial launch

of any resulting product may be delayed or not obtained, which could significantly harm our business.

The same risks would apply to our

internal manufacturing facilities, should we in the future decide to build internal manufacturing capacity.

In addition, building internal

manufacturing capacity would carry significant risks in terms of being able to plan, design and execute on a complex project 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 other comparable foreign regulatory authority approval processes and continuous oversight,

and we will need to contract with manufacturers who can meet all applicable legal and regulatory requirements, including compliance with

cGMP, on an ongoing basis.

If we or our third-party manufacturers are unable to reliably produce products to specifications acceptable

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and growth prospects.

Furthermore, our third-party manufacturers are

subject to inspection and approval by regulatory agencies before we can obtain regulatory approval and commercially launch of any of our

product candidates, and thereafter are subject to ongoing inspection from time to time.

Our failure, or the failure of our third-party

manufacturers, to comply with applicable regulations could result in enforcement actions, such as the issuance of inspectional observations

or notices of noncompliance, or sanctions being imposed on us, including clinical holds, injunctions, civil penalties, suspension or withdrawal

of approvals, seizures or recalls of products, operating restrictions or criminal prosecutions, any of which could significantly and adversely

Furthermore, our third-party manufacturers are subject

to inspection and approval by regulatory agencies before we can obtain regulatory approval and commercially launch of any of our product

candidates, and thereafter are subject to ongoing inspection from time to time.

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

to comply with applicable regulations could result in enforcement actions, such as the issuance of inspectional observations or notices

of noncompliance, or sanctions being imposed on us, including clinical holds, injunctions, civil penalties, suspension or withdrawal of

approvals, seizures or recalls of products, operating restrictions or criminal prosecutions, any of which could significantly and adversely

affect supplies of our products.

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Risks Related to our Intellectual Property

We may not be able to protect our intellectual property rights

throughout the world.

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

Filing, prosecuting and defending patents or establishing

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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.

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

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or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

Confidential know-how and trade secrets are only

protectable to the extent a third party utilizes the confidential know-how or trade secret in an unauthorized manner;

however, if a third

party is able to independently duplicate the technology, such as through reverse engineering, without access to or use of our confidential

know-how or trade secret, we would have no recourse.

In addition, data exclusivity that is provided

through the BPCIA in the U.S.

Confidential know-how and trade secrets are only protectable

to the extent a third party utilizes the confidential know-how or trade secret in an unauthorized manner;

however, if a third party is

able to independently duplicate the technology, such as through reverse engineering, without access to or use of our confidential know-how

or trade secret, we would have no recourse.

In addition, data exclusivity that is provided through

the BPCIA in the U.S.

and equivalents in foreign countries is limited in both time and scope.

The BPCIA bars the FDA from approving

biosimilar applications for 12 years after an innovator biological product receives initial marketing approval, however it does not bar

the FDA from approving an identical or similar product that is the subject of its own BLA.

Finally, upon the approval of the first BLA

for a biologic designated as an Orphan Drug for a specified indication, the sponsor of that BLA is entitled to 7 years of exclusive marketing

rights in the U.S.

for biologic for the particular indication unless the sponsor cannot assure the availability of sufficient quantities

to meet the needs of persons with the disease.

The BPCIA bars the FDA from approving biosimilar

applications for 12 years after an innovator biological product receives initial marketing approval, however it does not bar the FDA from

approving an identical or similar product that is the subject of its own BLA.

Finally, upon the approval of the first BLA for a biologic

designated as an Orphan Drug for a specified indication, the sponsor of that BLA is entitled to 7 years of exclusive marketing rights

for biologic for the particular indication unless the sponsor cannot assure the availability of sufficient quantities to meet

the needs of persons with the disease.

In Europe, this exclusivity is 10 years.

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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, 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

intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained

is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our

ability to successfully commercialize our technology and products may be impaired.

Our success depends in large part on our ability

to obtain and maintain patent protection in the U.S.

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 intellectual

property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not

sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability

to successfully commercialize our technology and products may be impaired.

Our success depends in large part on our ability to

obtain and maintain patent protection in the U.S.

and other countries with respect to our proprietary technology and products.

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If issued, such patents would expire in March 2038.

We cannot estimate the financial or other impact

of the expiration of the Bavarian Nordic/GSF patents or the failure of the USPTO or similar regulatory authorities in other countries

denying the claims we pursue in the U.S.

We cannot estimate the financial or other impact of

the expiration of the Bavarian Nordic/GSF patents or the failure of the USPTO or similar regulatory authorities in other countries denying

the claims we pursue in the U.S.

and other countries.

The patent prosecution and/or patent maintenance

process is expensive and time-consuming.

We may not be able to file and prosecute or maintain all necessary or desirable patent applications

or maintain the existing patents at a reasonable cost or in a timely manner.

The patent prosecution and/or patent maintenance process

is expensive and time-consuming.

We may not be able to file and prosecute or maintain all necessary or desirable patent applications or

maintain the existing patents at a reasonable cost or in a timely manner.

We may choose not to seek patent protection for certain innovations

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and preclinical development output before it is too late to obtain patent protection.

Moreover, in some circumstances, we do not have

the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that

Moreover, in some circumstances, we do not have the

right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that

we license from third parties.

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by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent is not conclusive as

to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices

The issuance of a patent is not conclusive as to its

inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices

Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated

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to exclude others from commercializing products similar or identical to ours.

The risks described elsewhere pertaining to our

patents and other intellectual property rights also apply to the intellectual property rights that we license, and any failure to obtain,

maintain and enforce these rights could have a material adverse effect on our business.

In some cases, we may not have control over the

prosecution, maintenance or enforcement of the patents that we license.

Moreover, our licensors may fail to take the steps that we believe

are necessary or desirable to obtain, maintain and enforce the licensed patents.

Any inability on our part to protect adequately our intellectual

property may have a material adverse effect on our business, operating results and financial position.

The risks described elsewhere pertaining to our patents

and other intellectual property rights also apply to the intellectual property rights that we license, and any failure to obtain, maintain

and enforce these rights could have a material adverse effect on our business.

In some cases, we may not have control over the prosecution,

maintenance or enforcement of the patents that we license.

Moreover, our licensors may fail to take the steps that we believe are necessary

or desirable to obtain, maintain and enforce the licensed patents.

Any inability on our part to protect adequately our intellectual property

may have a material adverse effect on our business, operating results and financial position.

If we do not obtain patent and/or data exclusivity for our product

candidates, our business may be materially harmed.

Our commercial success will largely depend on

our ability to obtain and maintain patent and other intellectual property protection and/or data exclusivity under the BPCIA in the U.S.

and other countries with respect to our proprietary technology, product candidates and our target indications.

If we are unable to obtain patents covering our

product candidates or obtain data and/or marketing exclusivity for our product candidates, our competitors may be able to take advantage

of our investment in development and clinical trials by referencing our clinical and preclinical data to obtain approval of competing

products, such as a biosimilar, earlier than might otherwise be the case.

Our commercial success will largely depend on our

ability to obtain and maintain patent and other intellectual property protection and/or data exclusivity under the BPCIA in the U.S.

other countries with respect to our proprietary technology, product candidates and our target indications.

If we are unable to obtain patents covering our product

candidates or obtain data and/or marketing exclusivity for our product candidates, our competitors may be able to take advantage of our

investment in development and clinical trials by referencing our clinical and preclinical data to obtain approval of competing products,

such as a biosimilar, earlier than might otherwise be the case.

Obtaining and maintaining our patent protection

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Our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity

fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent

Periodic maintenance fees, renewal fees, annuity fees

and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent

agencies outside of the U.S.

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or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Because competition in our industry is intense,

competitors may infringe or otherwise violate our issued patents, patents of our licensors or other intellectual property.

infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their

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.

An adverse result in any litigation proceeding could put one or more of the patents associated

with our business at risk of being invalidated or interpreted narrowly.

We may also elect to enter license agreements to settle patent

infringement claims or to resolve disputes prior to litigation, and any such license agreements may require us to pay royalties and other

fees that could be significant.

Furthermore, because of the substantial amount of discovery required in intellectual property litigation,

there is a risk that some of our confidential information could be compromised by disclosure.

Because competition in our industry is intense, competitors

may infringe or otherwise violate our issued patents, patents of our licensors or other intellectual property.

To counter infringement

or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

Any claims we assert against

perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents.

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.

An adverse result in any litigation proceeding could put one or more of the patents associated with our business

at risk of being invalidated or interpreted narrowly.

We may also elect to enter license agreements to settle patent infringement claims

or to resolve disputes prior to litigation, and any such license agreements may require us to pay royalties and other fees that could

be significant.

Furthermore, because of the substantial amount of discovery required in intellectual property litigation, there is a risk

that some of our confidential information could be compromised by disclosure.

If we breach any of our license or collaboration

agreements, it could compromise our development and commercialization efforts for our product candidates.

We have licensed rights to intellectual property

from third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC.

We have licensed rights to intellectual property from

third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC.

If we materially

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property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property,

including patent rights, which are important or necessary to the development of our products.

It may be necessary for us to use the patented

or proprietary technology of third parties to commercialize our products, in which case we would be required to obtain a license from

these third parties on commercially reasonable terms, or our business could be harmed, possibly materially.

A third party may hold intellectual property, including

patent rights, which are important or necessary to the development of our products.

It may be necessary for us to use the patented or

proprietary technology of third parties to commercialize our products, in which case we would be required to obtain a license from these

third parties on commercially reasonable terms, or our business could be harmed, possibly materially.

Although we believe that licenses

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adverse effect on the success of our business.

Our commercial success depends upon our ability,

and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies

Our commercial success depends upon our ability, and

the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies

without infringing the proprietary rights of third parties.

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of third parties could have a similar negative impact on our business.

We may not be successful in obtaining or

maintaining necessary rights for its development pipeline through acquisitions and licenses from third parties.

We may not be successful in obtaining or maintaining

necessary rights for its development pipeline through acquisitions and licenses from third parties.

Because our programs may involve additional product

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over us due to their size, cash resources and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be

a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual

property rights on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully obtain

rights to required third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

In addition, companies that perceive us to be a competitor

may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual property rights

on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully obtain rights to required

third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

If we are unable to protect the confidentiality

of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our

technology and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information,

to maintain our competitive position.

We seek to protect these trade secrets, in part, by entering non-disclosure and confidentiality

agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract

manufacturers, consultants, advisors and other third parties.

We seek to protect our confidential proprietary information, in part, by

entering confidentiality agreements with our employees and consultants;

however, we cannot be certain that such agreements have been entered

with all relevant parties.

In addition to seeking patents for some of our technology

and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to

maintain our competitive position.

We seek to protect these trade secrets, in part, by entering non-disclosure and confidentiality agreements

with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers,

consultants, advisors and other third parties.

We seek to protect our confidential proprietary information, in part, by entering confidentiality

agreements with our employees and consultants;

however, we cannot be certain that such agreements have been entered with all relevant

Moreover, to the extent we enter such agreements,

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competitive position would be harmed.

The majority of the technology that we license

and use for our product candidates is not protected by patents, but rather is based upon confidential know-how and trade secrets.

The majority of the technology that we license and

use for our product candidates is not protected by patents, but rather is based upon confidential know-how and trade secrets.

know-how and trade secrets are only protectable to the extent a third party utilizes the confidential know-how or trade secret in an unauthorized

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consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third

We employ individuals and use consultants and

independent contractors who were previously employed at other biotechnology or pharmaceutical companies.

Although we seek to ensure that

our employees and our consultants and independent contractors do not use the proprietary information or know-how of others in their work

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’

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 employ individuals and use consultants and independent

contractors who were previously employed at other biotechnology or pharmaceutical companies.

Although we seek to ensure that our employees

and our consultants and independent contractors do not use the proprietary information or know-how of others in their work 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’ 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.

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

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.

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in substantial cost and be a distraction to our management and others working for us.

In addition, while it is our policy to require

our employees, consultants and independent contractors who may be involved in the development of intellectual property to execute agreements

In addition, while it is our policy to require our

employees, consultants and independent contractors who may be involved in the development of intellectual property to execute agreements

assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops

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may be infringed or successfully challenged, resulting in harm to our business.

We expect to rely on trademarks as one means to

distinguish any of our drug candidates that are approved for marketing from the products of our competitors.

Once we select new trademarks

and apply to register them, our trademark applications may not be approved.

Third parties may oppose or attempt to cancel our trademark

applications or trademarks, or otherwise challenge our use of the trademarks.

If our trademarks are successfully challenged, we could

be forced to rebrand our drugs, which could result in loss of brand recognition and could require us to devote resources to advertising

and marketing new brands.

We expect to rely on trademarks as one means to distinguish

any of our drug candidates that are approved for marketing from the products of our competitors.

Once we select new trademarks and apply

to register them, our trademark applications may not be approved.

Third parties may oppose or attempt to cancel our trademark applications

or trademarks, or otherwise challenge our use of the trademarks.

If our trademarks are successfully challenged, we could be forced to

rebrand our drugs, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing

Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks.

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address all potential threats to our competitive advantage.

The degree of future protection afforded by our

intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business,

or permit us to maintain our competitive advantage.

The degree of future protection afforded by our intellectual

property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit

us to maintain our competitive advantage.

The following examples are illustrative:

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Risks Related to Our Business Model and Operations

Development of brand awareness is critical

to our success.

Development of brand awareness is critical to

For certain market segments that we plan to pursue,

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and time of the current senior management team.

Rapid advances in artificial intelligence by

our competitors and third parties may place us at a competitive disadvantage, and the use of AI technologies by our employees, consultants,

or service providers could expose us to additional risks.

We do not currently develop, deploy, or rely upon

artificial intelligence (“AI”) technologies in our drug discovery, preclinical development, or business operations.

many of our competitors and other companies in the biotechnology and pharmaceutical industries are increasingly using AI and machine learning

technologies to accelerate drug discovery, optimize clinical trial design, enhance manufacturing processes, and identify new therapeutic

If our competitors are able to leverage AI to develop competing therapies more quickly or cost-effectively than we can using

our current approaches, we may be placed at a significant competitive disadvantage.

Our failure to adopt AI technologies, or delays in

doing so, could impair our ability to compete effectively in an industry that is rapidly embracing these tools.

In addition, our employees, consultants, independent

contractors, or third-party service providers may use generative AI tools in the course of performing services for us, whether or not

authorized to do so.

Such use could result in the inadvertent disclosure or compromise of our confidential information, proprietary data,

trade secrets, or the personal data of clinical trial participants.

AI-generated content, analyses, or recommendations that are inaccurate,

biased, or otherwise deficient could lead to errors in our regulatory submissions, research activities, or business decision-making.

may have limited visibility into or control over third parties’ use of AI technologies in connection with services they provide

The regulatory landscape governing the use of AI is

rapidly evolving and increasingly fragmented across jurisdictions.

In the European Union, the Artificial Intelligence Act (the “AI

Act”) entered into force on August 1, 2024, with significant provisions scheduled to come into effect in August 2026.

imposes substantial obligations on providers and deployers of certain AI systems, including those used in healthcare settings, and non-compliance

can result in significant fines.

In the United States, multiple states have proposed or enacted legislation regulating AI use, governance,

and deployment in healthcare and other settings, creating a complex and uncertain regulatory patchwork.

If we adopt AI technologies in

the future, we may face significant compliance costs, regulatory uncertainty, and potential liability.

Even if we do not directly adopt

AI, evolving AI regulations could affect the third parties on which we rely or impose additional obligations on our industry.

Additionally,

threat actors are increasingly using AI to enhance the sophistication and effectiveness of cyberattacks, including through AI-generated

phishing, deepfakes, and other social engineering techniques, which may increase the cybersecurity risks we face.

may be unable to adequately protect our information systems from cyberattacks” above.

Any weakness in our internal controls could

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information which could have an adverse effect on the trading price of our securities.

The insurance coverage and reimbursement

status of newly approved products are uncertain.

Failure to obtain or maintain adequate coverage and reimbursement for new or current

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.

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

insurance coverage and reimbursement of newly approved products.

In the U.S., the principal decisions about reimbursement for new medicines

are typically made by the CMS, an agency within the HHS.

The insurance coverage and reimbursement status

of newly approved products are uncertain.

Failure to obtain or maintain adequate coverage and reimbursement for new or current 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.

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 insurance

coverage and reimbursement of newly approved products.

In the U.S., the principal decisions about reimbursement for new medicines are

typically made by the CMS, an agency within the HHS.

CMS decides whether and to what extent a new medicine will be covered and reimbursed

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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.

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.

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.

Because 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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our products.

Our employees, consultants and independent

contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,

which could subject us to significant liability and harm our reputation.

We are exposed to the risk of fraud and other

misconduct by those who work for us.

Misconduct by employees, consultants or independent contractors could include failures to comply

with the FCPA or with the DEA, the FDA or the EMA regulations or similar regulations of other foreign regulatory authorities or to provide

accurate information to the DEA, the FDA, the EMA or other foreign regulatory authorities.

In addition, misconduct could include failures

to comply with certain manufacturing standards, to comply with U.S.

federal and state healthcare fraud and abuse laws and regulations

and similar laws and regulations established and enforced by comparable foreign regulatory authorities, to report financial information

or data accurately or to disclose unauthorized activities to us.

Misconduct by those who work for us could also involve the improper use

of information obtained during our clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

have implemented and will enforce a Code of Business Conduct and Ethics, but it is not always possible to identify and deter misconduct

Our employees, consultants and independent contractors

may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could

subject us to significant liability and harm our reputation.

We are exposed to the risk of fraud and other misconduct

by those who work for us.

The precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged

risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with

such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting

our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant

fines or other sanctions.

Our transactions and relationships outside

Misconduct by employees, consultants or independent contractors could include failures to comply with the FCPA

or with the DEA, the FDA or the EMA regulations or similar regulations of other foreign regulatory authorities or to provide accurate

information to the DEA, the FDA, the EMA or other foreign regulatory authorities.

In addition, misconduct could include failures to comply

with certain manufacturing standards, to comply with U.S.

federal and state healthcare fraud and abuse laws and regulations and similar

laws and regulations established and enforced by comparable foreign regulatory authorities, to report financial information or data accurately

or to disclose unauthorized activities to us.

Misconduct by those who work for us could also involve the improper use of information obtained

during our clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

We have implemented and will

enforce a Code of Business Conduct and Ethics, but it is not always possible to identify and deter misconduct by those who work for us.

The precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or

in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions

could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

Our transactions and relationships outside the

will be subject to the FCPA and similar anti-bribery and anti-corruption laws.

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of the corporation and to devise and maintain an adequate system of internal accounting controls.

Compliance with these laws and regulations may

be costly and may limit our ability to expand into certain markets.

There is no certainty that all our employees, agents, contractors,

or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level

of complexity of these laws and regulations.

Violations of these laws and regulations could result in fines, criminal sanctions against

us, our officers, or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business

activities in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of our business.

Any such violations

could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our

brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results

and financial condition.

Compliance with these laws and regulations may be

costly and may limit our ability to expand into certain markets.

There is no certainty that all our employees, agents, contractors, or

collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of

complexity of these laws and regulations.

Violations of these laws and regulations could result in fines, criminal sanctions against us,

our officers, or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business activities

in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of our business.

Any such violations could

include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand,

our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results and financial

Product liability lawsuits against us could

cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability

exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially

sell any products that we may develop.

If we cannot successfully defend ourselves against claims that our product candidates or products

caused injuries, we will incur substantial liabilities.

We face an inherent risk of product liability exposure

related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any

products that we may develop.

If we cannot successfully defend ourselves against claims that our product candidates or products caused

injuries, we will incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims may result in:

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as a public company, and our management is required to devote substantial time to new compliance initiatives.

As a public company, we have incurred and are

continuing to incur significant legal, accounting and other expenses.

As a public company, we have incurred and are continuing

to incur significant legal, accounting and other expenses.

These expenses may increase.

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.

Our management and other personnel devote

a substantial amount of time to these compliance initiatives.

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.

Our management and other personnel devote a

substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations have substantially

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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:

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.

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

in our securities and subject us to additional trading restrictions.

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,

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

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 are not currently in compliance with the

continued listing requirements for Nasdaq, and if we are unable to regain compliance, our common stock could be delisted from 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.

In order to remain listed on Nasdaq, we are 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.

On December 1, 2025, we received a written notice (the “Notice”) from the Listing Qualifications

Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based on the closing bid price of our common stock for

the 30 consecutive business days preceding the date of the Notice, we were not in compliance with the minimum bid price requirement set

forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum

Bid Price Requirement”).

The Notice had no immediate effect on the listing or trading of our common stock, which continues to trade

on The Nasdaq Capital Market under the symbol “PMCB.” In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided

an initial compliance period of 180 calendar days, or until June 1, 2026, to regain compliance with the Minimum Bid Price Requirement.

On June 2, 2026, we received notice from Nasdaq that we were eligible for an additional 180 calendar day period, or until November 30,

2026, to regain compliance with the Minimum Bid Price Requirement.

There can be no assurance that we will regain compliance with the Minimum

Bid Price Requirement within the additional compliance period.

We may also be unable to satisfy other continued listing requirements in

the future, and there is no guarantee that our common stock will remain listed on Nasdaq or any other U.S.

or nationally recognized stock

To address this deficiency, our Board has approved,

and at our annual meeting of stockholders held on March 30, 2026, our stockholders approved, an amendment to our Articles of Incorporation,

as amended, to effect a reverse stock split of our common stock at a ratio of not less than 1-for-1.1 and not more than 1-for-100, with

the exact ratio, and whether and when to implement the reverse stock split, if at all, to be determined by our Board in its sole discretion.

Our Board has the authority, but not the obligation, to effect the reverse stock split and may abandon the amendment at any time before

it is filed with the Nevada Secretary of State, even though our stockholders have approved it.

There can be no assurance that our Board

will elect to effect the reverse stock split, that any reverse stock split will result in a sustained increase in the per share trading

price of our common stock sufficient for us to regain or maintain compliance with the Minimum Bid Price Requirement, or that our common

stock will not decline in price following any reverse stock split.

If we do not regain compliance with the Minimum Bid

Price Requirement or otherwise fail to satisfy Nasdaq’s other continued listing requirements, Nasdaq will notify us that our common

stock is subject to delisting, and we would be entitled to appeal that determination to a Nasdaq Hearings Panel, although there can be

no assurance that any such appeal would be successful.

If our common stock were delisted from Nasdaq, the established trading market for

our common stock would be eliminated, and we would likely be forced to seek to have our common stock quoted on the OTC Markets or another

quotation medium, which would likely reduce the liquidity and market price of our common stock, harm our reputation with employees, business

partners and existing and prospective investors, and impair our ability to raise additional capital on acceptable terms, or at all, when

If, after listing, our common stock is delisted from Nasdaq or any other U.S.

or nationally recognized stock exchange, we could

face significant additional material adverse consequences, including:

a limited availability of market quotations for our common stock;

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decreased ability to issue additional shares of our common stock or obtain additional financing in the future.

We may obtain additional capital through

the issuance of preferred stock, which may limit your rights as a holder of our common stock.

Nasdaq’s recently adopted minimum Market Value of Listed

Securities requirement of $5 million could result in the suspension and delisting of our common stock from Nasdaq.

On July 22, 2026, the SEC approved a new Nasdaq rule (Listing Rules

5450(a)(3) and 5550(a)(6)) requiring companies listed on the Nasdaq Global Market and Nasdaq Capital Market to maintain a minimum Market

Value of Listed Securities (“MVLS”) of at least $5 million.

Under the new rule, if a company’s MVLS remains below $5

million for 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination, and trading in the company’s securities

will be immediately suspended without any cure or compliance period.

This represents a significant departure from Nasdaq’s traditional

approach to continued listing deficiencies, which typically provides issuers with compliance periods to regain compliance while remaining

Although a Nasdaq Hearings Panel may, in its discretion, grant an exception of up to 180 calendar days from the Staff Delisting

Determination if a company demonstrates that it can satisfy Nasdaq’s initial listing standards, such relief is discretionary, and

the suspension from Nasdaq trading is not automatically stayed during any appeal.

As of the date of this Report, our MVLS may be at or near levels that

could implicate this new requirement.

Given our current stock price and the number of shares of our common stock outstanding, a sustained

decline in our stock price or other adverse market conditions could cause our MVLS to fall below $5 million for 30 consecutive business

days, triggering an immediate suspension and delisting from Nasdaq.

A delisting under this rule would have the same adverse consequences

described above, including reduced liquidity, limited market quotations, diminished analyst coverage, and impaired ability to raise capital.

Moreover, the lack of a cure period under this rule means that we would have limited time and recourse to address any such deficiency,

and any appeal to a Hearings Panel would require us to demonstrate compliance with Nasdaq’s more stringent initial listing standards.

Our outstanding Series C Convertible Preferred

Stock has dividend, liquidation, redemption, anti-dilution and voting rights that are senior to, or could dilute, the rights of holders

of our common stock, and we may issue additional shares of preferred stock, which may limit your rights as a holder of our common stock.

As of April 30, 2026, we had 4,766 shares of our Series

C Convertible Preferred Stock (the “Series C Preferred Stock”) outstanding, which we issued in August 2025 in a $7,000,000

private placement.

The Series C Preferred Stock has a stated value of $1,000 per share and an aggregate liquidation preference of approximately

$4.8 million as of April 30, 2026, which is senior to the rights of holders of our common stock upon any liquidation, dissolution or winding

up of the Company.

Holders of the Series C Preferred Stock are entitled to cumulative dividends of 7% per annum, compounded quarterly,

payable in cash, which rate increases to 15% per annum upon the occurrence of a Triggering Event (as defined in the applicable certificate

of designations).

Holders of the Series C Preferred Stock are also entitled to vote together with holders of our common stock as a single

class, on an as-converted basis, on all matters submitted to a vote of our common stockholders, and, upon the occurrence of a Triggering

Event, including our failure to pay amounts due when required, may require us to redeem their shares in cash at a premium.

dividend, liquidation, voting and redemption rights could reduce the amount of cash or other assets otherwise available for distribution

to, or dilute the voting power of, holders of our common stock.

We have previously issued other series of preferred

stock with senior terms.

In May 2023, we issued shares of our Series B Convertible Preferred Stock in a private placement, which carried

a 4% per annum dividend rate (increasing to 15% per annum upon a Triggering Event), an initial conversion price of $4.00 per share subject

to anti-dilution adjustment, and a right of holders to require redemption in cash at a premium upon a Triggering Event, although holders

of the Series B Convertible Preferred Stock had no voting rights except with respect to certain matters affecting their rights.

All outstanding

shares of our Series B Convertible Preferred Stock have been redeemed.

Without any stockholder vote or action, our Board

may designate and approve for issuance shares of our preferred stock.

The terms of any preferred stock may include priority claims to

assets and dividends and special voting rights which could limit the rights of the holders of our common stock.

The designation and issuance

of preferred stock favorable to current management or stockholders could make any possible takeover of us or the removal of our management

more difficult.

may designate and approve for issuance additional shares of our preferred stock.

The terms of any preferred stock may include priority

claims to assets and dividends and special voting rights which could limit the rights of the holders of our common stock.

The designation

and issuance of preferred stock favorable to current management or stockholders could make any possible takeover of us or the removal

of our management more difficult.

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.

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:

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Government regulation of drug pricing.

The price of our common stock is volatile,

which substantially increases the risk that our investors may not be able to sell their shares at or above the price that the investors

have paid for their shares.

Because of the price volatility in our shares,

we have observed since its inception, investors in our common stock may not be able to sell their shares when they desire to do so at

a price the investors desire to attain.

During the year ended April 30, 2025, shares of our common stock were quoted and traded at a high

of $2.42 per share and a low of $1.03 per share.

The inability to sell securities in a rapidly declining market may substantially increase

the risk of loss because the price of our common stock may suffer greater declines due to the historical price volatility of our shares.

Certain 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:

The price of our common stock is volatile, which

substantially increases the risk that our investors may not be able to sell their shares at or above the price that the investors have

paid for their shares.

Because of the price volatility in our shares, we

have observed since its inception, investors in our common stock may not be able to sell their shares when they desire to do so at a price

the investors desire to attain.

During the year ended April 30, 2026, shares of our common stock were quoted and traded at a high of $1.51

per share and a low of $0.63 per share.

The inability to sell securities in a rapidly declining market may substantially increase the

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, which may cause our share price to fluctuate significantly include, but are not limited

to, the following:

Variations in our quarterly operating results;

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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.

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.

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 stock.

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

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In addition, the terms of the certificate of designations

governing our Preferred Shares presently restricts our ability to pay dividends.

governing our Series C Preferred Stock presently restricts our ability to pay dividends.

We are a “smaller reporting company”

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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 Commission filings compared to other issuers, including with respect to disclosure

As a smaller reporting company, we are permitted to

comply with scaled-back disclosure obligations in our Commission filings compared to other issuers, including with respect to disclosure

obligations regarding executive compensation in our periodic reports and proxy statements.

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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.

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 Exchange

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trading price for our common stock may be negatively affected.

We face risks related to owning securities

issued by other public companies.

We own securities of other public companies, including

the Notes, the TNF Preferred Shares, the Femasys common stock, the Femasys Warrants and the TNF Warrants.

Discussion and Analysis of Financial Condition and Results of Operations – Femasys Transaction” and “– TNF Transaction”

for more information regarding these securities.

Defined terms used in this risk factor are defined in such section.

The Femasys Notes are convertible at a conversion

price of $1.18 per share.

To the extent we convert the Notes when the market price of the Femasys Shares is lower than the conversion

price, we may realize a loss equal to the difference between the conversion price and the market price.

Femasys may require us to convert

our Notes into Femasys Shares if the closing price of the Femasys Shares exceeds $2.36 per share for 10 consecutive trading days and the

daily dollar trading volume of the Femasys Shares exceeds one million dollars ($1,000,000) per day during the same period and certain

equity conditions described in the Notes are satisfied.

If we are forced to mandatorily convert the Notes, we may realize additional loss.

The TNF Preferred Shares are convertible at a

conversion price of $0.1832 per share.

To the extent we convert the TNF Preferred Shares when the market price of the TNF Common Shares

is lower than the conversion price, we may realize a loss equal to the difference between the conversion price and the market price.

The Femasys Series A Warrants are exercisable

at an exercise price of $1.18 per share.

We face risks related to owning securities issued

by other public companies.

We own securities of other public companies, the MyMD Pharmaceuticals Inc.

which subsequently changed its name to TNF Pharmaceuticals, Inc.

and then to Q/C Technologies,

(“QCLS”) QCLS Preferred Shares, the Femasys common stock, the Femasys Warrants and the QCLS Warrants.

Management’s Discussion and Analysis of Financial Condition and Results of Operations – Femasys Transaction” and

“– QCLS Transaction” for more information regarding these securities.

Defined terms used in this risk factor are defined

in such section.

The QCLS Series G Preferred Stock are convertible

at a conversion price of $3.3713 per share.

To the extent we convert the QCLS Series G Preferred Stock when the market price of the QCLS

Common Shares is lower than the conversion price, we may realize a loss equal to the difference between the conversion price and the market

The QCLS Series H Preferred Stock are convertible

at a conversion price of $3.3713 per share.

To the extent we convert the QCLS Series H Preferred Stock when the market price of the QCLS

Common Shares is lower than the conversion price, we may realize a loss equal to the difference between the conversion price and the market

The Femasys Series A Warrants are exercisable at an

exercise price of $1.18 per share.

In June 2026, Femasys completed a 20 to 1 reverse stock split, changing the conversion price to $23.60

The Femasys Series B Warrants expired on November 21, 2024.

There can be no assurance that the

Femasys Warrants will be in the money when exercisable, and as such they may expire worthless.

The TNF Warrants are exercisable at an exercise

There can be no assurance that the Femasys Warrants will be in

the money when exercisable, and as such they may expire worthless.

The QCLS Series G Warrants are exercisable at an exercise

price of $3.3713 per share.

There can be no assurance that the TNF Warrants will be in the money when exercisable, and as such they may

expire worthless.

There can be no assurance that the QCLS Series G Warrants will be in the money when exercisable, and as such

they may expire worthless.

The QCLS Series H Warrants are exercisable at an exercise price of $3.3713

There can be no assurance that the QCLS Series H Warrants will be in the money when exercisable, and as such they may expire

Our investments in securities of Femasys and QCLS

represent a substantial concentration of our total assets, and adverse developments affecting either company could materially and adversely

affect our financial condition.

Our ownership of securities of other companies

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Our purchases of securities

of other companies, including pursuant to the Femasys Transaction and the TNF Transaction (each as defined below), could give rise to

of other companies, including pursuant to the Femasys Transaction and the QCLS Transaction (each as defined below), could give rise to

a determination that we are or were an investment company subject to registration under the 1940 Act.

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

Risks Related to Employee and Tax Matters,

Managing Growth and Macroeconomic Conditions

We have experienced significant management

changes which could increase our control risks and have a material adverse effect on our ability to do business and our results of operations.

We have recently experienced a number of changes

in our management, including changes in our Chief Executive Officer and Board.

Risks Related to Employee and Tax Matters, Managing

Growth and Macroeconomic Conditions

We have experienced significant management changes

which could increase our control risks and have a material adverse effect on our ability to do business and our results of operations.

We have recently experienced a number of changes in

our management, including changes in our Chief Executive Officer and Board.

The magnitude of these changes and the short time interval

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Management attention may be diverted from regular business concerns by reorganizations.

We have a limited number of employees and

are highly dependent on our Chief Executive Officer and Chief Financial Officer.

We have a limited number of employees and 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, 2025, we had 2 full-time employees and numerous 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 Interim Chief Executive Officer and Chief Financial Officer.

We are an early-stage biotechnology company with a

limited operating history.

As of April 30, 2026, we had two full-time employees and relied on numerous 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 Interim 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

key employees and consultants may be difficult and may take an extended period because of the limited number of individuals in our industry

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 key

employees and consultants may be difficult and may take an extended period because of the limited number of individuals in our industry

with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product

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on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

We also experience competition for the hiring

of scientific and clinical personnel from universities and research institutions.

In addition, we rely on other consultants and advisors,

including scientific and clinical advisors, to assist us in formulating our discovery, preclinical and clinical development and commercialization

We also experience competition for the hiring of scientific

and clinical personnel from universities and research institutions.

In addition, we rely on other consultants and advisors, including

scientific and clinical advisors, to assist us in formulating our discovery, preclinical and clinical development and commercialization

Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory

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personnel, our ability to pursue our growth strategy will be limited.

Our ability to use our net operating loss

carryforwards and certain other tax attributes may be limited.

Our ability to use our net operating loss carryforwards

and certain other tax attributes may be limited.

As of April 30, 2026, we had federal net operating

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taxable income or taxes will be limited to approximately $36 million and $16 million for federal and state, respectively.

We 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

are 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

regulatory capabilities and potentially implement sales, marketing and distribution capabilities.

Thus, we may encounter difficulties

in managing our growth, which could disrupt our operations.

We expect to experience significant growth in

the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs and, if

any of our product candidates receive marketing approval, sales, marketing and distribution.

To manage our anticipated future growth,

we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit

and train additional qualified personnel.

Due to our limited financial resources and the limited experience of our management team in

managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and

We 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 are

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 regulatory

capabilities and potentially implement sales, marketing and distribution capabilities.

Thus, we may encounter difficulties in managing

our growth, which could disrupt our operations.

We expect to experience significant growth in the

number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs and, if any

of our product candidates receive marketing approval, sales, marketing and distribution.

To manage our anticipated future growth, we must

continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and

train additional qualified personnel.

The expansion of our operations may lead to significant costs and may divert our management and

business development resources.

Due to our limited financial resources and the limited experience of our management team in managing

a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train

additional qualified personnel.

The expansion of our operations may lead to significant costs and may divert our management and business

development resources.

Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Our business and operations would suffer

in the event of system failures.

Despite the implementation of security measures,

our internal computer systems and those of our third-party service providers on whom we rely on are vulnerable to damage from computer

viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

Furthermore, we have little

or no control over the security measures and computer systems of our third-party service providers.

While we and, to our knowledge, our

third-party service providers have not experienced any such system failure, accident or security breach to date, if such an event were

to occur and cause interruptions in our operations or the operations of our third-party service providers, it could result in a material

disruption of our drug development programs.

Our business and operations would suffer in

the event of system failures.

Despite the implementation of security measures, our

internal computer systems and those of our third-party service providers on whom we rely on are vulnerable to damage from computer viruses,

unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

Furthermore, we have little or no

control over the security measures and computer systems of our third-party service providers.

While we and, to our knowledge, our third-party

service providers have not experienced any such system failure, accident or security breach to date, if such an event were to occur and

cause interruptions in our operations or the operations of our third-party service providers, it could result in a material disruption

of our drug development programs.

If any disruptions occur, they could have a material adverse effect on our business.

Changes in U.S.

trade policy, tariffs, and geopolitical

conditions could disrupt our supply chain, increase our costs, and materially harm our business.

Our product candidates are manufactured exclusively

by Austrianova, which is based in Singapore.

We are dependent on the uninterrupted ability of Austrianova to source raw materials, manufacture

our product candidates, and ship finished products or materials to us and to clinical trial sites.

Changes in U.S.

trade policy, including

the imposition of new or increased tariffs on imports from Singapore or other countries in our supply chain, retaliatory trade measures

by foreign governments, export controls, sanctions, or other trade restrictions, could increase the cost of our product candidates, disrupt

or delay the supply of critical materials, and create uncertainty that impairs our ability to plan and budget for our clinical development

The current U.S.

trade policy environment is characterized by significant unpredictability, with tariff levels and trade agreements

subject to rapid change.

We may be unable to anticipate, plan for, or effectively mitigate the adverse effects of such measures on our

operations and costs.

In addition, geopolitical tensions, including regional

conflicts and evolving diplomatic relationships between the United States and countries in Asia, could further disrupt international trade,

logistics, and the operations of Austrianova and other third parties on which we rely.

Austrianova has from time to time experienced significant

supply chain delays, and we believe Austrianova may also be experiencing liquidity issues.

Geopolitical disruptions could exacerbate these

existing vulnerabilities and adversely affect Austrianova’s ability to perform its manufacturing obligations for us.

If Austrianova

is unable to manufacture our product candidates due to trade restrictions, supply chain disruptions, or other geopolitical factors, we

may not be able to locate a replacement manufacturer on acceptable terms, or at all, which would have a material adverse effect on our

business, financial condition, and results of operations.

Adverse macroeconomic conditions, including

inflation, rising interest rates, and tightening capital markets, could increase our operating costs and impair our ability to raise capital

on acceptable terms.

As a pre-revenue company that is dependent on external

financing to fund our operations and development programs, we are particularly vulnerable to adverse macroeconomic conditions.

inflation has increased, and may continue to increase, the costs of conducting preclinical studies, clinical trials, and regulatory compliance

activities, as well as the fees charged by our consultants, contract research organizations, and third-party manufacturers, including

Rising interest rates and volatility in the credit and financial markets may reduce the availability of capital and increase

the cost of any financing we may seek.

Tightening capital markets may also decrease investor appetite for investments in early-stage biotechnology

companies, making it more difficult for us to raise the additional capital we will need to complete our clinical development programs

and fund our ongoing operations.

In addition, macroeconomic uncertainty, including

geopolitical instability and trade policy developments, may adversely affect the financial condition and operations of the third parties

on which we rely, including Austrianova, our contract service providers, and potential future collaboration partners.

A deterioration

in general economic conditions could also result in declines in our stock price, which may further impair our ability to raise equity

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

We are subject to legal, regulatory, financial

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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