What changed in this filing

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Item 1A. Risk Factors

2023-03-22 compared with 2022-03-22 · 449 added, 356 removed, 1233 unchanged (39% of the section changed)

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substantial degree of risk.

To date, we have focused primarily on developing XCART and researching additional drug candidates.

no products approved for commercial sale and have generated only limited revenue to date.

Due to capital constraints in 2021, we focused

solely on pre-clinical development efforts associated with our XCART technology.

Our primary focus is on advancing the XCART technology

through regulatory approval and commercialization and that we will continue to incur significant research and development and other expenses

related to our ongoing operations.

As a result, we have never been profitable and we may not achieve profitability in the foreseeable

future, if at all.

We have no products approved for commercial sale and have generated only limited revenue to date.

April 2022, we focused primarily on pre-clinical development efforts associated with our XCART technology.

With the licensing of the DNase

oncology platform from CLS in April 2022, our primary focus is now on advancing that technology via partnering opportunities or through

regulatory approval and commercialization.

We expect to continue to incur significant research and development and other expenses related

to our ongoing operations.

As a result, we have never been profitable and we may not achieve profitability in the foreseeable future,

Our ability to generate profits in the future will depend on a number of factors, including:

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to enter into collaborations, strategic alliances and licensing arrangements.

For example, on July 28, 2021, we completed a private placement

of our common stock, which resulted in gross proceeds of approximately $11.5 million before deducting the placement agent’s fees

and related offering expenses.

We do not currently have any committed external source of funds.

To the extent that we raise additional

capital through the sale of equity or convertible debt securities, equity interests will be diluted, and the terms of these securities

may include liquidation or other preferences that adversely affect the rights of our stockholders.

Debt financing, if available, may involve

agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making

capital expenditures or declaring dividends.

Such debt financing may also be secured by all or a portion of our assets.

We do not currently have any committed external source of

To the extent that we raise additional capital through the sale of equity or convertible debt securities, equity interests will

be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders.

Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions,

such as incurring additional debt, making capital expenditures or declaring dividends.

Such debt financing may also be secured by all

or a portion of our assets.

If we raise funds by selectively continuing to

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Our business is substantially dependent

on the success of XCART.

on the success of the DNase oncology platform.

Our business will substantially depend on the

successful clinical development, regulatory approval and commercialization of the XCART platform technology.

successful clinical development, regulatory approval and commercialization of the DNase oncology platform.

It will require substantial

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The clinical trials and

manufacturing and marketing of XCART and any other product candidates will be subject to extensive and rigorous review and regulation

by numerous government authorities in the United States, the European Union and other jurisdictions where we intend to test and, if approved,

market our product candidates.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate

through preclinical testing and clinical trials that the product candidate is safe and effective for use in each target indication and

potentially in specific patient populations.

This process can take many years and may include post-marketing studies and surveillance,

which would require the expenditure of substantial resources beyond the proceeds we have currently raised.

Of the large number of drugs

in development for approval in the United States and the European Union, only a small percentage successfully complete the FDA or EMA

regulatory-approval processes, as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite financing

or identify an academic collaboration partner to continue to fund our research, development and clinical programs, we cannot assure you

that XCART or any of our other product candidates will be successfully developed or commercialized.

manufacturing and marketing of DNase and any other product candidates will be subject to extensive and rigorous review and regulation

by numerous government authorities in the U.S., the European Union and other jurisdictions where we intend to test and, if approved, market

our product candidates.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through

preclinical testing and clinical trials that the product candidate is safe and effective for use in each target indication and potentially

in specific patient populations.

This process can take many years and may include post-marketing studies and surveillance, which would

require the expenditure of substantial resources beyond the proceeds we have currently raised.

Of the large number of drugs in development

for approval in the U.S.

and the European Union, only a small percentage successfully complete the FDA or European Medicines Agency regulatory-approval

processes, as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite financing or identify an academic

or strategic collaboration partner to continue to fund our research, development and clinical programs, we cannot assure you that DNase

or any of our other product candidates will be successfully developed or commercialized.

We are an early stage company in the business

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prevent us from achieving or maintaining market acceptance of our pharmaceutical products and impair our ability to generate revenues.

Clinical trials may fail to demonstrate

the safety and efficacy of our pharmaceutical drug candidates and could prevent or significantly delay regulatory approval.

Before receiving NDA or BLA approval to commercialize

a drug candidate, we must demonstrate to the FDA, with substantial evidence from well-controlled clinical trials, that the drug candidate

is both safe and effective or the biologic is safe, pure and potent.

If these trials or future clinical trials are unsuccessful, our business

and reputation could be harmed and our stock price could be adversely affected.

Clinical failure can occur at any stage of clinical

Clinical trials may produce negative or inconclusive results, and we or any of our current and future collaborators may decide,

or regulators may require us, to conduct additional clinical or preclinical testing.

We will be required to demonstrate with substantial

evidence through well-controlled clinical trials that our drug candidates are as safe and effective for use in a specific patient population

as the respective reference products before we can seek regulatory approvals for their commercial sale.

Success in early clinical trials

does not mean that future larger registration clinical trials will be successful because drug candidates in later-stage clinical trials

may fail to demonstrate equivalent safety and efficacy to the satisfaction of the FDA and foreign regulatory agencies despite having progressed

through initial clinical trials.

Drug candidates that have shown promising results in early clinical trials may still fail in subsequent

confirmatory clinical trials.

Similarly, the outcome of preclinical testing and early clinical trials may not be predictive of the success

of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

A number of companies in the

pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in advanced

clinical trials, even after obtaining promising results in earlier clinical trials.

In addition, the design of a clinical trial can

determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent

until the clinical trial is well advanced.

We may be unable to design and execute a clinical trial to support regulatory approval.

some instances, there can be significant variability in safety or efficacy results between different trials of the same drug candidate

due to numerous factors, including but not limited to, changes in trial protocols, differences in size and type of the patient populations,

adherence to the dosing regimen and the rate of dropout among clinical trial participants.

Because of these risks, our research and development

efforts, and those of our collaborative partners, may not result in any commercially viable products.

If a significant portion of these

development efforts is not successfully completed, or if required regulatory approvals are not obtained by us or our partners, or any

approved products are not commercially successful, we may not generate significant revenues or become profitable.

If we complete the necessary preclinical

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Suspend or withdraw regulatory approval or revoke a license;

Suspend any of our ongoing clinical trials;

Suspend or hold any of our ongoing clinical trials;

Refuse to approve pending applications or supplements to approved applications submitted by us;

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In the United States, no uniform policy of coverage

and reimbursement for products exists among third-party payors.

As a result, obtaining coverage and reimbursement approval of a product

from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting

scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage

and adequate reimbursement will be obtained.

Even if we obtain coverage for a given product, the resulting reimbursement payment rates

might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high.

Additionally,

third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of

our gene-modifying products.

Patients are unlikely to use our drug candidates unless coverage is provided and reimbursement is adequate

to cover a significant portion of the cost of our drug candidates.

There is significant uncertainty related to insurance coverage and

reimbursement of newly-approved products.

It is difficult to predict at this time what third-party payors will decide with respect to

the coverage and reimbursement for our drug candidates.

and reimbursement for products exists among third-party payors and their contracted pharmacy benefit managers that manage prescription

benefits for such payors.

As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party

payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness

data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.

Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain

profitability or may require co-payments that patients find unacceptably high.

Additionally, third-party payors and their pharmacy benefit

managers may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our gene-modifying

Patients are unlikely to use our drug candidates unless coverage is provided and reimbursement is adequate to cover a significant

portion of the cost of our drug candidates.

There is significant uncertainty related to insurance coverage and reimbursement of newly-approved

It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for

our drug candidates.

Moreover, increasing efforts by governmental and

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results of operations and prospects.

We may fail to obtain orphan drug designations

from the FDA for our drug candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with

orphan drug designation, including the potential for market exclusivity.

Under the Orphan Drug Act, the FDA may grant orphan

drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as one occurring in a patient population

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

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

In the United States,

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

tax advantages and user-fee waivers.

In addition, if a product that has orphan drug designation subsequently receives the first FDA approval

for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not

approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same indication for seven years,

except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer

is unable to assure sufficient product quantity.

We may seek to obtain orphan drug designation

for our active drug candidates for any qualifying indications they may be approved for in the future.

Even if we obtain such designations,

we may not be the first to obtain marketing approval of our drug candidate for the orphan-designated indication due to the uncertainties

associated with developing pharmaceutical products.

In addition, exclusive marketing rights in the United States may be limited if we

seek approval for an indication broader than the orphan-designated indication, or may be lost if the FDA later determines that the request

for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs

of patients with the rare disease or condition.

Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may

not effectively protect the product from competition because different drugs with different active moieties can be approved for the same

Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same active moiety for the

same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care.

drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory

review or approval process.

In addition, even if we seek orphan drug designation for our drug candidates, we may never receive such designations.

The market opportunities for our drug candidates

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therapy, which may adversely affect our business and results of operations.

Clinical trials may fail to demonstrate

the safety and efficacy of our pharmaceutical drug candidates and could prevent or significantly delay regulatory approval.

Before receiving NDA or BLA approval to commercialize

a drug candidate, we must demonstrate to the FDA, with substantial evidence from well-controlled clinical trials, that the drug candidate

is both safe and effective or the biologic is safe, pure and potent.

If these trials or future clinical trials are unsuccessful, our business

and reputation could be harmed and our stock price could be adversely affected.

Clinical failure can occur at any stage of clinical

Clinical trials may produce negative or inconclusive results, and we or any of our current and future collaborators may decide,

or regulators may require us, to conduct additional clinical or preclinical testing.

We will be required to demonstrate with substantial

evidence through well-controlled clinical trials that our drug candidates are as safe and effective for use in a specific patient population

as the respective reference products before we can seek regulatory approvals for their commercial sale.

Success in early clinical trials

does not mean that future larger registration clinical trials will be successful because drug candidates in later-stage clinical trials

may fail to demonstrate equivalent safety and efficacy to the satisfaction of the FDA and foreign regulatory agencies despite having progressed

through initial clinical trials.

Drug candidates that have shown promising results in early clinical trials may still fail in subsequent

confirmatory clinical trials.

Similarly, the outcome of preclinical testing and early clinical trials may not be predictive of the success

of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

A number of companies in the

pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in advanced

clinical trials, even after obtaining promising results in earlier clinical trials.

In addition, the design of a clinical trial can

determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent

until the clinical trial is well advanced.

We may be unable to design and execute a clinical trial to support regulatory approval.

some instances, there can be significant variability in safety or efficacy results between different trials of the same drug candidate

due to numerous factors, including but not limited to, changes in trial protocols, differences in size and type of the patient populations,

adherence to the dosing regimen and the rate of dropout among clinical trial participants.

Because of these risks, our research and development

efforts, and those of our collaborative partners, may not result in any commercially viable products.

If a significant portion of these

development efforts is not successfully completed, or if required regulatory approvals are not obtained by us or our partners, or any

approved products are not commercially successful, we may not generate significant revenues or become profitable.

We may fail to obtain orphan drug designations

from the FDA for our drug candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with

orphan drug designation, including the potential for market exclusivity.

Under the Orphan Drug Act, the FDA may grant orphan

drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as one occurring in a patient population

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

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

In the United States,

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

tax advantages and user-fee waivers.

In addition, if a product that has orphan drug designation subsequently receives the first FDA approval

for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not

approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same indication for seven years,

except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer

is unable to assure sufficient product quantity.

We may seek to obtain orphan drug designation

for our active drug candidates for any qualifying indications they may be approved for in the future.

Even if we obtain such designations,

we may not be the first to obtain marketing approval of our drug candidate for the orphan-designated indication due to the uncertainties

associated with developing pharmaceutical products.

In addition, exclusive marketing rights in the United States may be limited if we

seek approval for an indication broader than the orphan-designated indication, or may be lost if the FDA later determines that the request

for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs

of patients with the rare disease or condition.

Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may

not effectively protect the product from competition because different drugs with different active moieties can be approved for the same

Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same active moiety for the

same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care.

drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory

review or approval process.

In addition, even if we seek orphan drug designation for our drug candidates, we may never receive such designations.

Healthcare legislative reform measures may

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the effect that the ACA and any future measures to modify, repeal, replace or reaffirm the ACA have on our business.

We are not able to

provide any assurance that the continued healthcare reform debate will not result in legislation, regulation, litigation or executive

action by the President of the United States that is adverse to our business.

Additionally, the Inflation Reduction Act of 2022

may impact existing Medicare programs that cover prescription drugs.

In addition to other relevant provisions, the Inflation Reduction

Act of 2022 allow the Medicare program to directly negotiate the price of certain high-expenditure prescription drugs covered under Medicare

Parts B and D, starting in the year 2028 and 2026, respectively, by setting certain "maximum fair prices." Moreover, the Inflation

Reduction Act of 2022 requires manufacturers to pay rebates to the federal government if prices of certain drugs covered under the Medicare

program rise faster than the rate of inflation.

We will continue to evaluate the effects that the Inflation Reduction Act of 2022 will

have on our business.

We are not able to provide any assurance that

the continued healthcare reform debate will not result in legislation, regulation, litigation or executive action by the President of

the United States that is adverse to our business.

Laws and other reform and cost containment measures

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Risks Related to Our Reliance on Third-Parties

We may seek to establish additional collaborations

and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization

Our drug candidate development programs and the

potential commercialization of our drug candidates will require substantial additional cash to fund expenses.

For some of our drug candidates,

we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization

of those drug candidates.

We face significant competition in seeking appropriate

collaborators.

Whether we reach a definitive agreement for any additional collaborations 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 a number of factors.

Those factors may include the design or results of clinical trials, the likelihood of approval by FDA

or similar regulatory authorities outside the U.S., the potential market for the subject drug candidate, the costs and complexities of

manufacturing and delivering such drug candidate to patients, the potential of competing drugs, the existence of uncertainty with respect

to our ownership of technology (which can exist if there is a challenge to such ownership without regard to the merits of the challenge)

and industry and market conditions generally.

The collaborator may also consider alternative drug candidates or technologies for similar

indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for

our drug candidate.

The terms of any additional collaborations or other arrangements that we may establish may not be favorable to us.

We may also be restricted under existing collaboration

agreements from entering into future agreements on certain terms with potential collaborators.

Collaborations are complex and time-consuming

to negotiate and document.

In addition, there have been a significant number of recent business combinations among large pharmaceutical

companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate additional collaborations

on a timely basis on acceptable terms, or at all.

If we are unable to do so, we may have to curtail the development of the drug candidate

for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay

its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development

or commercialization activities at our own expense.

If we elect to increase our expenditures to fund development or commercialization

activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.

do not have sufficient funds, we may not be able to further develop our drug candidates or bring them to market and generate product revenue.

If conflicts arise between us and our collaborators

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impact our revenues.

We may seek to establish additional collaborations

and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization

Our drug candidate development programs and the

potential commercialization of our drug candidates will require substantial additional cash to fund expenses.

For some of our drug candidates,

we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization

of those drug candidates.

For our XCART technology, we intend to seek to leverage the manufacturing expertise and capability of an academic

or strategic collaborator during early development.

We face significant competition in seeking appropriate

collaborators.

Whether we reach a definitive agreement for any additional collaborations 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 a number of factors.

Those factors may include the design or results of clinical trials, the likelihood of approval by FDA

or similar regulatory authorities outside the United States, the potential market for the subject drug candidate, the costs and complexities

of manufacturing and delivering such drug candidate to patients, the potential of competing drugs, the existence of uncertainty with respect

to our ownership of technology (which can exist if there is a challenge to such ownership without regard to the merits of the challenge)

and industry and market conditions generally.

The collaborator may also consider alternative drug candidates or technologies for similar

indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for

our drug candidate.

The terms of any additional collaborations or other arrangements that we may establish may not be favorable to us.

We may also be restricted under existing collaboration

agreements from entering into future agreements on certain terms with potential collaborators.

Collaborations are complex and time-consuming

to negotiate and document.

In addition, there have been a significant number of recent business combinations among large pharmaceutical

companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate additional collaborations

on a timely basis, including for early XCART development, on acceptable terms, or at all.

If we are unable to do so, we may have to curtail

the development of the drug candidate for which we are seeking to collaborate, reduce or delay its development program or one or more

of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase

our expenditures and undertake development or commercialization activities at our own expense.

If we elect to increase our expenditures

to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to

us on acceptable terms, or at all.

If we do not have sufficient funds, we may not be able to further develop our drug candidates or bring

them to market and generate product revenue.

If we enter into one or more collaborations,

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Collaborators could terminate the arrangement or allow it to expire, which would delay the development and may increase the cost of developing our drug candidates.

Our contract manufacturers are subject to

significant regulation with respect to manufacturing our products.

The manufacturing facilities on which we rely may not continue to meet

regulatory requirements and have limited capacity.

We currently have relationships with a limited

number of suppliers for the manufacturing of our pharmaceutical products.

Each supplier may require licenses to manufacture components

if such processes are not owned by the supplier or in the public domain, and we may be unable to transfer or sublicense the intellectual

property rights we may have with respect to such activities.

All entities involved in the preparation of pharmaceutical

products for clinical studies or commercial sale, including our existing contract manufacturers for our drug candidates, are subject to

extensive regulation.

Components of a finished pharmaceutical product approved for commercial sale or used in late-stage clinical studies

must be manufactured in accordance with cGMP.

These regulations govern manufacturing processes and procedures (including record keeping)

and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved

Poor control of production processes can lead to the introduction of adventitious agents or other contaminants or to inadvertent

changes in the properties or stability of our pharmaceutical products that may not be detectable in final product testing.

manufacturers must supply all necessary documentation in support of an NDA or BLA on a timely basis and must adhere to the FDA’s

GLP and cGMP regulations enforced by the FDA through its facilities inspection program.

The facilities and quality systems of some or

all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of

regulatory approval of our pharmaceutical products or any of our other potential products.

In addition, the regulatory authorities may,

at any time, audit or inspect a manufacturing facility involved with the preparation of our pharmaceutical products or our other potential

products or the associated quality systems for compliance with the regulations applicable to the activities being conducted.

facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted.

The regulatory authorities also may, at any time

following approval of a product for sale, audit the manufacturing facilities of our third-party contractors.

If any such inspection or

audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations

occurs independent of such an inspection or audit, we, or the relevant regulatory authority, may require remedial measures that may be

costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical

study or commercial sales or the temporary or permanent closure of a facility.

Any such remedial measures imposed upon third parties with

whom we contract could materially harm our business.

If our third-party manufacturers fail to maintain

regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application

for a drug candidate or revocation of a pre-existing approval.

As a result, our business, financial condition and results of operations

may be materially harmed.

Additionally, if supply from one approved manufacturer

is interrupted, there could be a significant disruption in commercial supply.

The number of manufacturers with the necessary manufacturing

capabilities is limited.

In addition, an alternative manufacturer would need to be qualified through an NDA or BLA supplement which could

result in further delay.

The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial

Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial

timelines, which could materially harm our business and results of operations.

These factors could cause the delay of clinical

studies, regulatory submissions, required approvals or commercialization of our pharmaceutical products and/or cause us to incur higher

costs and prevent us from commercializing our products successfully.

Furthermore, if our suppliers fail to meet contractual requirements,

and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical studies

may be delayed or we could lose potential revenue, which could materially harm our business and results of operations.

We have no manufacturing, sales, marketing

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discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

Our contract manufacturers are subject to

significant regulation with respect to manufacturing our products.

The manufacturing facilities on which we rely may not continue to meet

regulatory requirements and have limited capacity.

We currently have relationships with a limited

number of suppliers for the manufacturing of our pharmaceutical products.

Each supplier may require licenses to manufacture components

if such processes are not owned by the supplier or in the public domain, and we may be unable to transfer or sublicense the intellectual

property rights we may have with respect to such activities.

All entities involved in the preparation of pharmaceutical

products for clinical studies or commercial sale, including our existing contract manufacturers for our drug candidates, are subject to

extensive regulation.

Components of a finished pharmaceutical product approved for commercial sale or used in late-stage clinical studies

must be manufactured in accordance with cGMP.

These regulations govern manufacturing processes and procedures (including record keeping)

and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved

Poor control of production processes can lead to the introduction of adventitious agents or other contaminants or to inadvertent

changes in the properties or stability of our pharmaceutical products that may not be detectable in final product testing.

manufacturers must supply all necessary documentation in support of an NDA or BLA on a timely basis and must adhere to the FDA’s

GLP and cGMP regulations enforced by the FDA through its facilities inspection program.

The facilities and quality systems of some or

all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of

regulatory approval of our pharmaceutical products or any of our other potential products.

In addition, the regulatory authorities may,

at any time, audit or inspect a manufacturing facility involved with the preparation of our pharmaceutical products or our other potential

products or the associated quality systems for compliance with the regulations applicable to the activities being conducted.

facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted.

The regulatory authorities also may, at any time

following approval of a product for sale, audit the manufacturing facilities of our third-party contractors.

If any such inspection or

audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations

occurs independent of such an inspection or audit, we, or the relevant regulatory authority, may require remedial measures that may be

costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical

study or commercial sales or the temporary or permanent closure of a facility.

Any such remedial measures imposed upon third parties with

whom we contract could materially harm our business.

If our third-party manufacturers fail to maintain

regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application

for a drug candidate or revocation of a pre-existing approval.

As a result, our business, financial condition and results of operations

may be materially harmed.

Additionally, if supply from one approved manufacturer

is interrupted, there could be a significant disruption in commercial supply.

The number of manufacturers with the necessary manufacturing

capabilities is limited.

In addition, an alternative manufacturer would need to be qualified through an NDA or BLA supplement which could

result in further delay.

The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial

Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial

timelines, which could materially harm our business and results of operations.

These factors could cause the delay of clinical

studies, regulatory submissions, required approvals or commercialization of our pharmaceutical products and/or cause us to incur higher

costs and prevent us from commercializing our products successfully.

Furthermore, if our suppliers fail to meet contractual requirements,

and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical studies

may be delayed or we could lose potential revenue, which could materially harm our business and results of operations.

Risks Related to Our Intellectual Property

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develop and commercialize the affected drug candidates, which could have a material adverse effect on our business.

We may be subject to claims that our employees,

consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees

have wrongfully used or disclosed alleged trade secrets of their former employers.

We employ individuals who were previously employed

at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We may be subject

to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual

property, including trade secrets or other proprietary information, of any of our employee’s former employers or other third parties.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages,

we may lose valuable intellectual property rights or personnel, which could adversely impact our business.

Even if we are successful in

defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims challenging

the inventorship or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees,

collaborators or other third parties have an ownership interest in our patents or other intellectual property.

We may have in the future

ownership disputes arising, for example, from conflicting obligations of consultants or others who are involved in developing our drug

Litigation may be necessary to defend against these and other claims challenging inventorship or ownership.

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.

Such an outcome could have a material adverse effect on our business.

if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management

and other employees.

Our inability to protect our confidential

information and trade secrets would harm our business and competitive position.

In addition to seeking patents for some of our

technology and products, 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 into 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 also enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

Any of these parties may breach the agreements and disclose our proprietary information, including

our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Enforcing a claim that a party illegally disclosed

or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.

In addition, some courts

both within and outside the United States may be less willing or unwilling to protect trade secrets.

If a competitor lawfully obtained

or independently developed any of our trade secrets, we would have no right to prevent such competitor from using that technology or information

to compete with us, which could harm our competitive position and our business.

We may be involved in lawsuits to protect

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the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

We may be subject to claims that our employees,

consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees

have wrongfully used or disclosed alleged trade secrets of their former employers.

We employ individuals who were previously employed

at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We may be subject

to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual

property, including trade secrets or other proprietary information, of any of our employee’s former employers or other third parties.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages,

we may lose valuable intellectual property rights or personnel, which could adversely impact our business.

Even if we are successful in

defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims challenging

the inventorship or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees,

collaborators or other third parties have an ownership interest in our patents or other intellectual property.

We may have in the future

ownership disputes arising, for example, from conflicting obligations of consultants or others who are involved in developing our drug

Litigation may be necessary to defend against these and other claims challenging inventorship or ownership.

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.

Such an outcome could have a material adverse effect on our business.

if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management

and other employees.

Our inability to protect our confidential

information and trade secrets would harm our business and competitive position.

In addition to seeking patents for some of our

technology and products, 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 into 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 also enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

Any of these parties may breach the agreements and disclose our proprietary information, including

our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Enforcing a claim that a party illegally disclosed

or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.

In addition, some courts

both within and outside the United States may be less willing or unwilling to protect trade secrets.

If a competitor lawfully obtained

or independently developed any of our trade secrets, we would have no right to prevent such competitor from using that technology or information

to compete with us, which could harm our competitive position and our business.

Obtaining and maintaining our patent protection

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Risks Related to Our Business Operations

We operate in an extremely competitive environment

and there can be no assurances that competing technologies would not harm our business development.

We are engaged in a rapidly-evolving field.

from numerous pharmaceutical companies is intense and expected to increase.

The large and rapidly-growing market for oncology treatments

is likely to attract new entrants.

Numerous biotechnology and pharmaceutical companies are focused on developing cancer treatments and

immuno-oncology technologies including CAR T.

Many, if not all, of these companies have greater financial and other resources and

development capabilities than we do.

Many of our competitors also have greater collective experience in undertaking preclinical and clinical

testing of products, obtaining regulatory approvals and manufacturing and marketing prescription pharmaceutical products.

no assurance that our under-development drug candidates will be more effective or achieve greater market acceptance than competitive products

or that our competitors will not succeed in developing products and technologies that are more effective than those being developed by

us or that would render our products and technologies less competitive or obsolete.

Additionally, there can be no assurance that the development

by others of new or improved drugs will not make our pharmaceutical products superfluous or obsolete.

Adverse developments affecting the financial

services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional

counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results

of operations.

Actual events involving limited liquidity, defaults,

non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the

financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other

similar risks, have in the past and may in the future lead to market-wide liquidity problems.

For example, on March 10, 2023, Silicon

Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal

Deposit Insurance Corporation (“FDIC”) as receiver.

Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp.

were each swept into receivership.

Although a statement by the Department of the Treasury, the Federal Reserve and the FDIC indicated

that all depositors of SVB would have access to all of their money after only one business day of closure, including funds held in uninsured

deposit accounts, borrowers under credit agreements, letters of credit and certain other financial instruments with SVB, Signature Bank

or any other financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder.

have substantially all of our cash on deposit with SVB, most of which would be uninsured by the FDIC, and we regularly maintain cash balances

that are not insured or are in excess of the FDIC’s insurance limit.

As of March 13, 2023, we had full access to our funds.

to have access to our funds on deposit could have material adverse impacts on our liquidity and our current and/or projected business

operations and financial condition and results of operations.

Although we are not a borrower or party to any such instruments with SVB,

Signature or any other financial institution currently in receivership, if any of our customers, suppliers or other parties with whom

we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution,

such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments

to us could be adversely affected.

In this regard, counterparties to SVB credit agreements and arrangements, and third parties such as

beneficiaries of letters of credit (among others), may experience direct impacts from the closure of SVB and uncertainty remains over

liquidity concerns in the broader financial services industry.

Similar impacts have occurred in the past, such as during the 2008-2010

financial crisis.

Inflation and rapid increases in interest rates

have led to a decline in the trading value of previously issued government securities with interest rates below current market interest

Although the U.S.

Department of Treasury, FDIC and Federal Reserve Board have announced a program to provide up to $25 billion

of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk

of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial

institutions for immediate liquidity may exceed the capacity of such program.

Additionally, there is no guarantee that the U.S.

of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other

banks or financial institutions, or that they would do so in a timely fashion.

Although we assess our banking relationships as

we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize

our current and projected future business operations could be significantly impaired by factors that affect the Company, or the financial

services industry or economy in general.

These factors could include, among others, events such as liquidity constraints or failures,

the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability

in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the

financial services industry.

These factors could involve financial institutions or financial services industry companies with which the

Company has financial or business relationships, but could also include factors involving financial markets or the financial services

industry generally.

The results of events or concerns that involve

one or more of these factors could include a variety of material and adverse impacts on our current and projected business operations

and our financial condition and results of operations.

These could include, but may not be limited to, delayed access to deposits or other

financial assets or the uninsured loss of deposits or other financial assets or the uninsured loss of deposits or other financial assets;

or the termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.

Investor concerns regarding the U.S.

or international

financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial

and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to

acquire financing on acceptable terms or at all.

Any decline in available funding or access to our cash and liquidity resources could,

among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations,

result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws.

of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above,

could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and

results of operations.

In addition, any further deterioration in the macroeconomic economy

or financial services industry could lead to losses or defaults by our customers or suppliers, which in turn, could have a material adverse

effect on our current and/or projected business operations and results of operations and financial condition.

For example, a customer

may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a supplier may

determine that it will no longer deal with us as a customer.

In addition, a customer or supplier could be adversely affected by any of

the liquidity or other risks that are described above as factors that could result in material adverse impacts on the Company, including

but not limited to delayed access or loss of access to uninsured deposits or loss of the ability to draw on existing credit facilities

involving a troubled or failed financial institution.

Any customer or supplier bankruptcy or insolvency, or the failure of any customer

to make payments when due, or any breach or default by a customer or supplier, or the loss of any significant supplier relationships,

could result in material losses to the Company and may have a material adverse impact on our business.

Our future success depends on our ability

12 unchanged sentences

to recruit or loss of the services of any executive, consultant or advisor may impede the progress of our research and development objectives.

Potential new accounting standards or legislative

actions may adversely impact our future financial position or results of operations.

Future changes in financial accounting standards

may cause adverse, unexpected fluctuations in the timing of the recognition of revenues or expenses, and may affect our financial position

or results of operations.

New standards may occur in the future and may cause us to be required to make changes in our accounting policies.

Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses.

Changing laws, regulations

and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 (or the Sarbanes-Oxley

Act), new SEC regulations, Public Company Accounting Oversight Board (or PCAOB) standards and Nasdaq rules, are creating uncertainty for

companies such as ours.

Insurance, accounting and auditing costs are high as a result of this uncertainty and other factors.

We have limited capital resources and currently

have only one full-time employee in our finance department.

We rely on outside consultants to supplement our internal expertise and are

committed to maintaining high standards of corporate governance and public disclosure.

As a result, we intend to invest all reasonably

necessary resources to comply with evolving standards, and this investment may result in increased general and administrative expenses

and a diversion of management time and attention from revenue-generating activities to compliance activities.

We will need to expand our organization

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

We operate in an extremely competitive environment

and there can be no assurances that competing technologies would not harm our business development.

We are engaged in a rapidly-evolving field.

from numerous pharmaceutical companies is intense and expected to increase.

The large and rapidly-growing market for oncology treatments

is likely to attract new entrants.

Numerous biotechnology and pharmaceutical companies are focused on developing cancer treatments and

immuno-oncology technologies.

Many, if not all, of these companies have greater financial and other resources and development capabilities

Many of our competitors also have greater collective experience in undertaking preclinical and clinical testing of products,

obtaining regulatory approvals and manufacturing and marketing prescription pharmaceutical products.

There can be no assurance that our

under-development drug candidates will be more effective or achieve greater market acceptance than competitive products or that our competitors

will not succeed in developing products and technologies that are more effective than those being developed by us or that would render

our products and technologies less competitive or obsolete.

Additionally, there can be no assurance that the development by others of

new or improved drugs will not make our pharmaceutical products superfluous or obsolete.

Potential new accounting standards or legislative

actions may adversely impact our future financial position or results of operations.

Future changes in financial accounting standards

may cause adverse, unexpected fluctuations in the timing of the recognition of revenues or expenses, and may affect our financial position

or results of operations.

New standards may occur in the future and may cause us to be required to make changes in our accounting policies.

Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses.

Changing laws, regulations

and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 (or the Sarbanes-Oxley

Act), new SEC regulations, Public Company Accounting Oversight Board (or PCAOB) standards and Nasdaq rules, are creating uncertainty for

companies such as ours.

Insurance, accounting and auditing costs are high as a result of this uncertainty and other factors.

We have limited capital resources and currently

have only one full-time employee in our finance department.

We rely on outside consultants to supplement our internal expertise and are

committed to maintaining high standards of corporate governance and public disclosure.

As a result, we intend to invest all reasonably

necessary resources to comply with evolving standards, and this investment may result in increased general and administrative expenses

and a diversion of management time and attention from revenue-generating activities to compliance activities.

Risks Related to Our Common Stock

We have, in the past, failed to satisfy

certain continued listing requirements on Nasdaq and could fail to satisfy those requirements again in the future, which could affect

the market price of our common stock and liquidity and reduce our ability to raise capital.

Our failure to meet the continued listing

requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

Failure to regain compliance with Nasdaq listing

rules could affect the market price of our Common Stock and liquidity and reduce our ability to raise capital.

Currently, our Common Stock trades on the Nasdaq

Capital Market.

If we fail to maintain compliance with any Nasdaq listing requirements, we could be delisted and our stock would be considered

a penny stock under regulations of the SEC.

The stock would therefore be subject to rules that impose additional sales practice requirements

on broker-dealers who sell our securities.

The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers

from effecting transactions in our common stock, which could severely limit the market liquidity of our common stock and your ability

to sell our securities in the secondary market.

An active, liquid and orderly market for

our common stock or purchase warrants may not develop.

Our common stock and purchase warrants trade on

An active trading market for our common stock or purchase warrants may never develop or be sustained.

If an active market for

our common stock or purchase warrants does not continue to develop or is not sustained, it may be difficult for investors to sell shares

or purchase warrants without depressing the market price, and investors may not be able to sell the shares or purchase warrants at all.

An inactive market may also impair our ability to raise capital by selling common stock or purchase warrants and may impair our ability

to acquire other businesses, applications or technologies using our common stock or purchase warrants as consideration, which, in turn,

could materially adversely affect our business.

On June 3, 2022, we received a written notification (the “Notice”) from the Listing Qualifications Department

of the NASDAQ Stock Market LLC (“Nasdaq”) notifying us that the closing bid price for our common stock had been below $1.00

for 30 consecutive business days and that we therefore were not in compliance with the minimum bid price requirement for continued inclusion

on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”).

The Notice has no immediate

effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, we had a period

of 180 calendar days from the date of the Notice to regain compliance with the Bid Price Requirement.

Accordingly, we had until November

30, 2022 (the "Compliance Date"), to regain compliance with the Bid Price Requirement.

On December 1, 2022, we received a letter

from Nasdaq informing us that although the Company’s common stock had not regained compliance with the minimum $1.00 bid price per

share requirement, Nasdaq had determined that we were eligible for an additional 180 calendar day period, or until May 29, 2023, to regain

Nasdaq’s determination was based on the Company meeting the continued listing requirement for market value of publicly

held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the bid price

requirement, and our written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse

stock split, if necessary.

If at any time before May 29, 2023, the closing

bid price of our common stock closes at or above $1.00 per share for a minimum of, subject to Nasdaq’s discretion, 10 consecutive

business days, Nasdaq will provide written notification that we have achieved compliance with the Bid Price Requirement.

We will continue to monitor the closing bid price

of our common stock and will consider our available options to resolve the deficiency and regain compliance with the Bid Price Requirement

within the allotted compliance period.

However, there can be no assurance that we will be able to regain compliance with the Bid Price

Requirement, or will otherwise be in compliance with other Nasdaq Listing Rules.

If we fail to regain compliance with the Nasdaq Listing

Rules, including the Bid Price Requirement, we could be delisted and our stock would be considered a penny stock under regulations of

the SEC, and would therefore be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities.

The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in

our common stock, which could severely limit the market liquidity of our common stock and stockholder’s ability to sell our securities

in the secondary market.

If our common stock were to be delisted from the NASDAQ Capital Market, the liquidity of our common stock

would be materially affected, which would decrease the attractiveness of our common stock to investors and result in a decline in the

market price of our common stock.

Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange.

The market price of our securities may be

7 unchanged sentences

Our securities could be subject to wide fluctuations in price in response to a variety of factors, including the following:

Adverse results or delays in pre-clinical or clinical studies;

Adverse results, delays, or holds in pre-clinical or clinical studies;

Inability to obtain additional funding;

16 unchanged sentences

Sales of our securities by us or our stockholders in the future;

Adverse economic conditions, including potential adverse effects of public health issues, such as the coronavirus outbreak, and geopolitical events, such as the Russian invasion of

Ukraine, and related sanctions and other economic disruptions or concerns, on economic activity generally;

Adverse economic conditions, including potential adverse effects of public health issues, such as the coronavirus outbreak, and geopolitical events, such as the Russian invasion of Ukraine, and related sanctions and other economic disruptions or concerns, on economic activity generally;

Trading volume of our securities.

We have entered into several agreements

with our stockholders.

We have in the past, and may continue to enter

into from time to time, agreements with our stockholders, which may result in conflicts of interest.

In addition, these arrangements may

not have been negotiated at arm’s length and may contain terms and conditions that are not in our best interest.

Our preferred stock has rights, preferences

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could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

An active, liquid and orderly market for

our common stock or purchase warrants may not develop.

Our common stock and purchase warrants trade on

An active trading market for our common stock or purchase warrants may never develop or be sustained.

If an active market for

our common stock or purchase warrants does not continue to develop or is not sustained, it may be difficult for investors to sell shares

or purchase warrants without depressing the market price, and investors may not be able to sell the shares or purchase warrants at all.

An inactive market may also impair our ability to raise capital by selling common stock or purchase warrants and may impair our ability

to acquire other businesses, applications or technologies using our common stock or purchase warrants as consideration, which, in turn,

could materially adversely affect our business.

We have entered into several agreements

with our stockholders.

We have in the past, and may continue to enter

into from time to time, agreements with our stockholders, which may result in conflicts of interest.

In addition, these arrangements may

not have been negotiated at arm’s length and may contain terms and conditions that are not in our best interest.

We do not intend to pay dividends on our

25 unchanged sentences

conflicts, terrorism or other geopolitical events, such as the Russian invasion of Ukraine, and related sanctions and other economic disruptions

For example, during March 2020, a global pandemic

was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus (COVID-19).

global spread of COVID-19 has created, and continues to create, significant volatility, uncertainty and economic disruption, including

significant volatility in the capital markets.

The extent to which the COVID-19 pandemic affects our business, operations, financial results

and the trading price of our common stock will depend on numerous evolving factors that we may not be able to accurately predict, including:

the duration and scope of the pandemic or possible resurgence of the pandemic or continued emergence of new strains of COVID-19;

the availability

of an effective vaccine and the speed with which it is administered to the public;

governmental and business actions that have been and

continue to be taken in response to the pandemic (including mitigation efforts such as stay at home and other social distancing orders)

and the impact of the pandemic on economic activity and actions taken in response (including stimulus efforts such as the Families First

Coronavirus Act and the Coronavirus Aid, Relief, and Economic Security Act).

The ultimate impact of the COVID-19 pandemic on our results

of operations and financial condition is dependent on future developments, including the duration of the pandemic and the related extent

of its severity, as well as its impact on macroeconomic conditions, which are uncertain and cannot be predicted at this time.

If the global

response to contain the COVID-19 pandemic escalates further or is unsuccessful, or if governmental decisions to ease pandemic related

restrictions are ineffective, premature or counterproductive, we could experience a material adverse effect on our business, financial

condition, results of operations and cash flows.

For example, the global pandemic related to the

rapidly growing outbreak of a novel strain of coronavirus (COVID-19) has created, and may continue to create, significant volatility,

uncertainty and economic disruption, including significant volatility in the capital markets.

The extent to which the COVID-19 pandemic

affects our business, operations, financial results and the trading price of our common stock will depend on numerous evolving factors

that we may not be able to accurately predict.

If the global response to contain the COVID-19 pandemic escalates further or is unsuccessful,

or if governmental decisions to ease pandemic related restrictions are ineffective, premature or counterproductive, we could experience

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

Additionally, the global economy and financial

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federal deferred tax value of the NOL carryforwards and the rules of utilization of federal NOL carryforwards.

The TCJA lowered the corporate

tax rate from 35% to 21% effective for our 2018 fiscal year.

For NOL carryforwards generated in years prior to 2018, there is no annual

limitation on the utilization, and the carryforward period remains at twenty years.

However, NOL carryforwards generated in years after

2017 will only be available to offset 80% of future taxable income in any single year but will not expire.

If our NOL carryforwards are limited, and we have

4 unchanged sentences

Tax reform may significantly affect the

Company and its stockholders.

Company and our stockholders.

Due to the potential for changes to tax laws and

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

What changed 10-K

Item 1A. Risk Factors