What changed in this filing

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Item 1A. Risk Factors

2023-03-29 compared with 2022-03-21 · 461 added, 377 removed, 1423 unchanged (37% of the section changed)

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we reported a net loss of $6,312,535 and $6,728,396, respectively.

As of December 31, 2021 and December 31, 2020, we had an accumulated

deficit of $37,082,164 and $30,353,768, respectively.

As of December 31, 2022 and 2021, we had an accumulated deficit of

$43,394,699 and $37,082,164, respectively.

do not expect to generate revenues for many years, if at all.

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operational, financial and management information systems and personnel.

independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates

the realization of assets and satisfaction of liabilities in the normal course of business.

The Company has no recurring source of revenue

and has experienced negative operating cash flows since inception, and management has stated that substantial doubt exists about the

Company’s ability to continue as a going concern.

As a result, our independent registered public accounting firm has included an

explanatory paragraph in their report that accompanies our audited consolidated financial statements as of and for the year ended December

31, 2022, with respect to this uncertainty.

This going concern opinion could materially limit our ability to raise additional funds through

the sale of equity securities in the future, and subsequent reports by our independent registered public accounting firm on our consolidated

financial statements may also include an explanatory paragraph with respect to our ability to continue as a going concern.

need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of

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product development programs or commercialization efforts.

expect that our existing cash resources as of December 31, 2021, combined with the proceeds from our registered direct equity offering

completed in March 2021, will provide sufficient working capital resources to fund our operations, including our clinical trial programs

with respect to the development of our lead anti-cancer clinical compound LB-100, through approximately September 30, 2022.

our existing cash resources will not be sufficient to complete development of and obtain regulatory approval for our lead product candidate,

and we will need to raise significant additional capital to help us do so.

The Company estimates that it will need to raise additional

capital to fund its operations, including its various clinical trial commitments, during the quarter ending September 30, 2022.

our operating plan might change as a result of many factors currently unknown to us, including possible additional clinical trials, and

we might need additional funds sooner than planned.

expect that our existing cash resources as of December 31, 2022 will provide sufficient working capital resources to fund our operations,

including our clinical trial programs with respect to the development of our lead anti-cancer clinical compound LB-100, through approximately

December 31, 2023.

Our existing cash resources will not be sufficient to complete development of and obtain regulatory approval for our

lead product candidate, and we will need to raise significant additional capital to help us do so.

The Company estimates that it will

need to raise additional capital to fund its operations, including its various clinical trial commitments, during the latter part of

the fiscal year ending December 31, 2023.

In addition, our operating plan might change as a result of many factors currently unknown

to us, including possible additional clinical trials, and we might need additional funds sooner than planned.

expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our lead

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unable to continue our operations at planned levels and might be forced to reduce our operations.

Tax Cuts and Jobs Act could adversely affect our business and financial condition.

1, “An Act to provide for reconciliation pursuant to title II and V of the concurrent resolution on the budget for fiscal year

2018,” informally entitled the Tax Cuts and Jobs Act (“Tax Act”) enacted on December 22, 2017, among other things,

contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to

a single rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted taxable income (except for certain small

businesses), limitation of the deduction for net operating losses carried forward from taxable years beginning after December 31, 2017

to 80% of current year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced

rates regardless of whether they are repatriated, elimination of U.S.

tax on foreign earnings (subject to certain important exceptions),

providing immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or

repealing many business deductions and credits (including reduction of tax credits under the Orphan Drug Act).

Notwithstanding the reduction

in the corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could be adversely

In addition, it is uncertain if and to what extent various states will conform to the Tax Act.

ability to use net operating losses to offset future taxable income might be subject to limitations.

of December 31, 2021, we had federal net operating loss, or NOL, carryforwards of approximately $6,723,000.

Our NOLs generated in tax

years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

tax laws, and

will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused and be unavailable to offset future

income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017 may be carried forward indefinitely,

but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will conform to the Tax Act,

or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

In addition, under Section

382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a corporation undergoes an

“ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership of its equity over

a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset

its post-change income might be limited.

December 31, 2022, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

$27,803,000 and $28,040,000, respectively.

Federal net operating losses from tax years preceding 2018, if not utilized earlier, expire

through 2038.

Federal net operating losses generated in a tax year beginning after 2017 have an indefinite carryforward period, but the

deductibility of such federal NOL’s may be limited.

state net operating loss carryovers include approximately $19,141,000 that were incurred in the State of New York and approximately $8,899,000

that were incurred in the State of California, which are subject to various restrictions and limitations.

addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a

corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership

of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change

tax attributes to offset its post-change income might be limited.

Related to the Development and Regulatory Approval of Our Product Candidates

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who are noncompliant or do not otherwise complete the trials;

with contract research organizations (each being a “CRO”) and/or with other vendors that handle our clinical trials.

with contract research organizations (each being a “CRO”) and/or with other vendors that handle

clinical trials.

might not be able to initiate or continue to support clinical trials of LB-100, our lead product candidate, for one or more indications,

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subjects on time, will need to be redesigned or will be completed on schedule, if at all.

There can be no assurance that the FDA will

not put clinical trials of our lead product candidate on hold in the future.

Clinical trials might be delayed, suspended or prematurely

terminated for a variety of reasons, such as:

There can be no assurance that the FDA or another

regulatory agency will not put clinical trials of our lead product candidate on hold in the future.

Clinical trials might be delayed,

suspended or prematurely terminated for a variety of reasons, such as:

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

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to demonstrate a benefit from using a product candidate;

in manufacturing or obtaining from one or more third parties sufficient quantities of a product candidate to start or to use in clinical

in manufacturing, obtaining, from one or more third parties, or qualifying sufficient quantities of a product candidate to start

or to use in clinical trials;

of adequate funding to continue a trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct

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associated with operating in foreign countries could materially adversely affect our product development.

might conduct future studies in countries outside of the U.S.

Consequently, we may be subject to risks related to operating in foreign

have entered into an agreement to conduct a clinical trial in Spain.

Consequently, we will also be subject to risks related to operating

in foreign countries.

Risks associated with conducting operations in foreign countries include:

regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;

stringent privacy requirements for data to be supplied to our operations in the U.S., but generated outside the U.S., e.g.

stringent privacy requirements for data to be supplied to our operations in the United States, but generated outside the United States,

, General Data Protection Regulation in the European Union;

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doing business or operating in another country;

uncertainty in countries where labor unrest is more common than in the U.S.;

uncertainty in countries where labor unrest is more common than in the United States;

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

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We cannot commercialize

our lead product candidate in the U.S.

without first obtaining regulatory approval for the product from the FDA.

Similarly, we cannot

commercialize our lead product candidate outside of the U.S.

without obtaining regulatory approval from one or more foreign regulatory

Before obtaining regulatory approvals for the commercial sale of our lead product candidate for a target indication, we

must demonstrate with substantial evidence gathered in preclinical studies and clinical trials, that the product candidate is safe and

effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate with respect

to such product candidate.

our lead product candidate in the United States without first obtaining regulatory approval for the product from the FDA.

we cannot commercialize our lead product candidate outside of the United States without obtaining regulatory approval from one or more

foreign regulatory authorities.

Before obtaining regulatory approvals for the commercial sale of our lead product candidate for a target

indication, we must demonstrate with substantial evidence gathered in preclinical studies and clinical trials, that the product candidate

is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate with

respect to such product candidate.

time required to obtain approval by the FDA and foreign regulatory authorities is unpredictable but typically takes many years following

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or additional studies, which might delay or prevent approval or our commercialization plans, or we might decide to abandon the development

If we were to obtain approval, regulatory authorities might approve our lead product candidate and any future product candidates

we might pursue for fewer or more limited indications than we request (including failing to approve the most commercially promising indications),

might grant approval contingent on the performance of costly post-marketing clinical trials, or might approve a product candidate with

a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

The FDA or a foreign regulatory authority might also require the manufacture of a new lead product candidate in accordance with

new or revised standards.

If we were to obtain approval, regulatory authorities might approve our lead product candidate and any future

product candidates we might pursue for fewer or more limited indications than we request (including failing to approve the most commercially

promising indications), might grant approval contingent on the performance of costly post-marketing clinical trials, or might approve

a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

we are unable to obtain regulatory approval for our lead product candidate in one or more jurisdictions, or if any approval contains

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to obtain regulatory approval in international jurisdictions would prevent our lead product candidate from being marketed abroad.

addition to regulations in the U.S., to market and sell our lead product candidate in the European Union, in the United Kingdom, in many

Asian countries and in other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory

requirements.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval

by one regulatory authority outside the U.S.

does not ensure approval by regulatory authorities in other countries or jurisdictions or

The regulatory approval process outside the U.S.

generally includes all of the risks associated with obtaining FDA approval

as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.

The approval procedure varies among

countries and can require additional data or involve additional testing.

The time required to obtain foreign approval may differ substantially

from that required to obtain FDA approval.

We might not be able to obtain approvals from regulatory authorities outside the U.S.

timely basis, if at all.

Clinical trials accepted in one country might not be accepted by regulatory authorities in other countries.

In addition, many countries outside the U.S.

require that a product be approved for reimbursement before it can be approved for sale

in that country.

A product candidate that has been approved for sale in a particular country might not receive reimbursement approval

in that country.

addition to regulations in the United States, to market and sell our lead product candidate in the European Union, in the United Kingdom,

in many Asian countries and in other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying

regulatory requirements.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions,

and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries

or jurisdictions or by the FDA.

The regulatory approval process outside the United States generally includes all of the risks associated

with obtaining FDA approval as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.

procedure varies among countries and can require additional data or involve additional testing.

The time required to obtain foreign approval

may differ substantially from that required to obtain FDA approval.

We might not be able to obtain approvals from regulatory authorities

outside the United States on a timely basis, if at all.

Clinical trials accepted in one country might not be accepted by regulatory authorities

in other countries.

In addition, many countries outside the United States require that a product be approved for reimbursement before

it can be approved for sale in that country.

A product candidate that has been approved for sale in a particular country might not receive

reimbursement approval in that country.

might not be able to file for regulatory approvals and might not receive necessary approvals to commercialize our intended product in

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occurrence of any event or penalty described above might inhibit our ability to successfully commercialize our intended product and generate

and promotion of any product candidate that obtains approval in the U.S.

is heavily scrutinized by the FDA, the Department of Justice,

the Office of Inspector General of Health and Human Services, state attorneys general, members of Congress and the public.

can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the

provisions of the approved label.

Additionally, advertising and promotion of any product candidate that obtains approval outside of the

is heavily scrutinized by foreign regulatory authorities.

Violations, including actual or alleged promotion of our intended product

for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions

by the FDA, as well as prosecution under the federal False Claims Act.

Any actual or alleged failure to comply with labeling and promotion

requirements can have a negative impact on our business.

and promotion of any product candidate that obtains approval in the United States is heavily scrutinized by the FDA, the Department of

Justice, the Office of Inspector General of Health and Human Services, state attorneys general, members of Congress and the public.

company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance

with the provisions of the approved label.

Additionally, advertising and promotion of any product candidate that obtains approval outside

of the United States is heavily scrutinized by foreign regulatory authorities.

Violations, including actual or alleged promotion of our

intended product for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal

sanctions by the FDA, as well as prosecution under the federal False Claims Act.

Any actual or alleged failure to comply with labeling

and promotion requirements can have a negative impact on our business.

Related to Our Dependence on Third Parties

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work is critical to our success.

The loss of members of our scientific personnel, or our inability to attract or retain other qualified

personnel or advisors, could significantly weaken our management, harm our ability to compete effectively and harm our business.

competition for qualified personnel in the pharmaceutical field is intense and, as a result, we might be unable to attract and retain

qualified personnel necessary for the development of our business.

Our inability to attract or retain qualified personnel or advisors in the future could significantly

weaken our management, harm our ability to compete effectively, and harm our business.

The competition for qualified personnel in the

pharmaceutical field is intense and, as a result, we might be unable to attract and retain qualified personnel necessary for the development

of our business.

September 2015, we entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which we engaged BioPharmaWorks to perform

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elects to terminate it.

Services under this Collaboration Agreement have been periodically suspended and resumed;

effective March 1,

2019, we and BioPharmaWorks agreed to resume services under this Collaboration Agreement, and the Collaboration Agreement is currently

The Collaboration Agreement is currently in effect.

Additionally,

we have hired Dr.

Miser as Chief Medical Officer.

For the foreseeable future, Dr.

Miser will be working with us on a half-time

We believe that this Collaboration Agreement with BioPharmaWorks and the hiring of Dr.

Miser mitigate, to a certain extent, our

reliance on the services of Dr.

Kovach, and would allow us the time to replace Dr.

we employ Dr.

Miser as Chief Medical Officer and promoted Eric J.

Forman to Vice President and Chief Operating Officer.

the foreseeable future, Dr.

Miser is working with us on a half-time basis.

We believe that this Collaboration Agreement with BioPharmaWorks

and the presence of Dr.

Miser and Mr.

Forman mitigate, to a certain extent, our reliance on the services of Dr.

Kovach, and would allow

us the time to replace Dr.

Kovach in the event that such a need arose.

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Lee Moffitt Cancer Center and Research Institute, Inc.;

a collaboration agreement with the Spanish Sarcoma Group;

a collaboration agreement

with the Spanish Sarcoma Group;

a cooperative research and development agreement with the National Cancer Institute;

a clinical research support agreement with City of Hope National Medical Center;

an agreement with Theradex Systems, Inc.;

a patent assignment

and exploitation agreement with Inserm Transfert SA;

an exclusive license agreement with Moffitt, a material cooperative research and

development agreement with the National Institutes of Health, a collaboration agreement with BioPharmaWorks;

and a consulting agreement

with NDA Consulting Corp.

Existing and future collaborators have significant discretion in determining the efforts and resources they

apply and might not perform their obligations as expected.

Potential third-party collaborators include biopharmaceutical, pharmaceutical

and biotechnology companies, academic institutions, government agencies and other entities.

Third-party collaborators may assist us in:

and a clinical research

support agreement with City of Hope National Medical Center.

Existing and future collaborators have significant discretion in determining

the efforts and resources they apply and might not perform their obligations as expected.

Potential third-party collaborators include

biopharmaceutical, pharmaceutical and biotechnology companies, academic institutions, government agencies and other entities.

collaborators may assist us in:

research, preclinical development, clinical trials and manufacturing;

and obtaining regulatory approvals;

commercializing any future product candidates.

seeking and obtaining regulatory

successfully commercializing

any future product candidates.

we are not able to establish further collaboration agreements, we might be required to undertake product development and commercialization

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cannot be certain we will be able to obtain patent protection to protect our product candidates and technology.

patents and patent applications are owned solely by our subsidiary Lixte Biotechnology, Inc., or jointly by Lixte Biotechnology, Inc.,

and one of our collaborators.

patents and patent applications are owned solely by our subsidiary Lixte Biotechnology, Inc., except in two instances jointly with one

of our collaborators.

patent prosecution process is expensive and time-consuming, and we might not be able to file or prosecute all necessary or desirable

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The degree of future protection for our proprietary rights is uncertain.

solely or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent

applications;

solely or jointly with our collaborators, might not have been the first to file patent applications for these inventions;

might independently develop identical, similar or alternative technologies;

or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent applications;

we, solely or jointly with

our collaborators, might not have been the first to file patent applications for these inventions;

others might independently

develop identical, similar or alternative technologies;

is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted

by any patents arising from our patent applications will be significantly narrower than expected;

might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;

court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability

we might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;

a court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability

and, therefore, conclude that one or more of our patents are unenforceable;

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or foreign laws;

court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could adversely

affect one or more of the patents’ the term, validity or enforceability;

court or patent office might determine that one or more patents issued to us in the future or under which we hold rights are invalid

or unenforceable;

might develop additional proprietary technologies that are not patentable and which might not be adequately protected through trade

secrets or know-how.

a court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could

adversely affect one or more of the patents’ the term, validity or enforceability;

a court or patent office

might determine that one or more patents issued to us in the future or under which we hold rights are invalid or unenforceable;

we might develop additional

proprietary technologies that are not patentable and which might not be adequately protected through trade secrets or know-how.

addition, we solely or jointly own patents or patent applications in jurisdictions having, or that might in the future have, geopolitical

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addition, disputes might arise regarding intellectual property subject to a license agreement, including:

scope of rights granted under the license agreement and other interpretation-related issues;

our technology, product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are

not subject to the licensing agreement;

diligence obligations under the license agreement and the activities that satisfy those obligations;

we are required to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;

ownership of inventions, data and know-how resulting from joint creation or use of intellectual property by our licensors and us.

rights granted under the license agreement and other interpretation-related issues;

whether our technology,

product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are not subject to

the licensing agreement;

our diligence obligations

under the license agreement and the activities that satisfy those obligations;

whether we are required

to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;

the ownership of inventions,

data and know-how resulting from joint creation or use of intellectual property by our licensors and us.

disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain

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first to invent the technology or that we were the first to file patent applications covering our technology, because:

patent applications in the United States are maintained in secrecy until the patents are issued;

applications in the United States are typically not published until 18 months after their earliest claimed priority date;

in the scientific literature often lag behind actual discoveries.

applications in the United States are maintained in secrecy until the patents are issued;

patent applications in

the United States are typically not published until 18 months after their earliest claimed priority date;

publications in the scientific

literature often lag behind actual discoveries.

competitors might have filed, and might in the future file, patent applications covering technology similar or identical to ours.

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might be subject to competition despite the existence of intellectual property we license or own.

We can give no assurances that our

intellectual property claims will be sufficient to prevent third parties from designing around patents we own or license and developing

and commercializing competitive products.

The existence of competitive products that avoid our intellectual property could materially

adversely affect our operating results and financial condition.

Furthermore, any actual or perceived limitations, in our intellectual

property might lessen the interest of third parties to partner, collaborate or otherwise transact with us, if third parties perceive

a higher than acceptable risk to commercialization of our intended products or future products.

We can give no assurance that our intellectual

property claims will be sufficient to prevent third parties from designing around patents we own or license and developing and commercializing

competitive products.

The existence of competitive products that avoid our intellectual property could materially adversely affect our

operating results and financial condition.

Furthermore, any actual or perceived limitations, in our intellectual property might lessen

the interest of third parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable

risk to commercialization of our intended products or future products.

approach includes filing patent applications covering combination therapy with known, studied and/or marketed drugs.

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we do not prevail in either type of litigation, we might be subject to:

monetary damages related to the legal expenses of the third party;

additional competition that might have a significant adverse effect on our intended-product pricing, market share, business operations,

financial condition, and the commercial viability of our intended products;

restructuring

our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical

trials, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

paying monetary

damages related to the legal expenses of the third party;

facing additional competition

that might have a significant adverse effect on our intended-product pricing, market share, business operations, financial condition,

and the commercial viability of our intended products;

restructuring our company

or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trials,

and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

third party might also challenge the validity, enforceability or scope of the intellectual property rights that we license or own, and

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issuance of patents, prosecution of patents, challenges to patent validity, and patent enforcement.

We can give no assurances that our

We can give no assurance that our

patents or those of our licensor(s) can be defended or will protect us against future intellectual property challenges, particularly

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following factors are important to our success:

patent protection for our product candidates;

others from infringing our intellectual property rights;

our patent rights and trade secrets.

receiving patent

protection for our product candidates;

preventing others from

infringing our intellectual property rights;

maintaining our patent

rights and trade secrets.

will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to

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of any product candidates for which we receive approval depends on a number of factors, including:

efficacy and safety of such product candidates as demonstrated in clinical trials;

clinical indications and patient populations for which the product candidate is approved;

by physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;

adoption of novel immunotherapies by physicians, hospitals and third-party payors;

potential and perceived advantages of product candidates over alternative treatments;

safety of product candidates seen in a broader patient group, including our use outside the approved indications;

restrictions on use together with other medications;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities;

timing of market introduction of our intended product as well as competitive products;

development of manufacturing and distribution processes for commercial scale manufacturing for our lead product candidate and any

future product candidates;

cost of treatment in relation to alternative treatments;

availability of coverage and adequate reimbursement from third-party payors and government authorities;

convenience and ease of administration;

effectiveness of our sales and marketing efforts and those of our collaborators.

and safety of such product candidates as demonstrated in clinical trials;

indications and patient populations for which the product candidate is approved;

acceptance by physicians,

major cancer treatment centers and patients of the drug as a safe and effective treatment;

the adoption of novel immunotherapies

by physicians, hospitals and third-party payors;

the potential and perceived

advantages of product candidates over alternative treatments;

the safety of product candidates

seen in a broader patient group, including our use outside the approved indications;

any restrictions on use

together with other medications;

the prevalence and severity

of any side effects;

product labeling or product

insert requirements of the FDA or other regulatory authorities;

the timing of market introduction

of our intended product as well as competitive products;

the development of manufacturing

and distribution processes for commercial scale manufacturing for our lead product candidate and any future product candidates;

the cost of treatment in

relation to alternative treatments;

the availability of coverage

and adequate reimbursement from third-party payors and government authorities;

relative convenience and

ease of administration;

the effectiveness of our

sales and marketing efforts and those of our collaborators.

our lead product candidate and any future product candidates are approved but fail to achieve market acceptance among physicians, patients,

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if we are able to commercialize our lead product candidate or any future product candidates, the products might not receive coverage

or adequate reimbursement from third-party payors in the U.S.

and in other countries in which we seek to commercialize our intended products,

which could harm our business.

or adequate reimbursement from third-party payors in the United States and in other countries in which we seek to commercialize our intended

products, which could harm our business.

ability to commercialize any product successfully will depend, in part, on the extent to which coverage and adequate reimbursement for

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by any future relaxation of laws that presently restrict imports of drugs from countries where they might be sold at lower prices than

No uniform policy for coverage and reimbursement exists in the U.S., and coverage and reimbursement can differ significantly

from payor to payor.

Third-party payors can rely upon Medicare coverage policy and payment limitations in setting their own reimbursement

policies, but also have their own methods and approval process apart from Medicare determinations.

Our inability to promptly obtain coverage

and profitable reimbursement rates from both government-funded and private payors for any approved product that we develop could have

a material adverse effect on our operating results, ability to raise capital needed to commercialize our intended product and overall

financial condition.

in the United States.

No uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can

differ significantly from payor to payor.

Third-party payors can rely upon Medicare coverage policy and payment limitations in setting

their own reimbursement policies, but also have their own methods and approval process apart from Medicare determinations.

Our inability

to promptly obtain coverage and profitable reimbursement rates from both government-funded and private payors for any approved product

that we develop could have a material adverse effect on our operating results, ability to raise capital needed to commercialize our intended

product and overall financial condition.

legislative measures aimed at reducing healthcare costs might have a material adverse effect on our business and results of operations.

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healthcare costs.

In both the U.S.

and certain international jurisdictions, there have been a number of legislative and regulatory changes

to the health care system that could impact our ability to sell our intended product profitably.

In particular, in 2010, the Affordable

Care Act (“ACA”) was enacted, which, among other things, subjected biologic products to potential competition by lower-cost

biosimilars, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated

for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by most manufacturers

under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled

in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs,

and provided incentives to programs that increase the federal government’s comparative effectiveness research.

Since its enactment,

there have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the current U.S.

administration

to repeal or repeal and replace certain aspects of the ACA.

On December 14, 2018, a U.S.

District Court Judge in the Northern District

of Texas, or the Texas District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and

therefore, because it was repealed as a part of the Tax Act, the remaining provisions of the ACA are invalid as well.

While the Texas

District Court Judge, as well as the Trump Administration and CMS, have stated that the ruling will have no immediate effect, it is unclear

how this decision, subsequent appeals and other efforts to repeal and replace the ACA will impact the ACA.

Until there is more certainty

concerning the future of the ACA, it will be difficult to predict its full impact and influence on our business.

addition, other legislative changes have been proposed and adopted in the U.S.

since the ACA was enacted.

In August 2011, the Budget

Control Act of 2011, among other things, created measures for spending reductions by Congress.

A Joint Select Committee on Deficit Reduction,

tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach

required goals, thereby triggering the legislation’s automatic reduction to several government programs.

This includes aggregate

reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in 2013, and will remain in effect through

2027 unless additional Congressional action is taken.

The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several

providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover

overpayments to providers from three to five years.

In both the United States and certain international jurisdictions, there have been a number of legislative and regulatory

changes to the health care system that could impact our ability to sell our intended product profitably.

In particular, in 2010, the

Affordable Care Act (“ACA”) was enacted, which, among other things, subjected biologic products to potential competition

by lower-cost biosimilars, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program

are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by

most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions

of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded

prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at

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costs of healthcare and/or impose price controls might adversely affect:

demand for our lead product candidate, if we obtain regulatory approval;

ability to receive or set a price that we believe is fair for our intended product;

ability to generate revenue and achieve or maintain profitability;

level of taxes that we are required to pay;

availability of capital.

for our lead product candidate, if we obtain regulatory approval;

to receive or set a price that we believe is fair for our intended product;

our ability to generate

revenue and achieve or maintain profitability;

the level of taxes that

we are required to pay;

the availability of capital.

expect that the ACA, as well as other healthcare reform measures that might be adopted in the future, might result in additional reductions

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that might affect our ability to operate include the following:

federal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, 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 might be made under a federal healthcare program such as Medicare and Medicaid;

civil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or

qui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,

healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully soliciting,

offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, 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 might be made under a federal healthcare program such as Medicare and Medicaid;

federal civil

and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or qui tam

actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,

to the federal government, including the Medicare and Medicaid programs, claims for payment or approval that are false or fraudulent

or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability

for executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and

willfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the

delivery of or payment for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and

Clinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect

to safeguarding the privacy, security and transmission of individually identifiable health information on entities subject to the

law, such as certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective

business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable

health information;

federal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical

supplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of value to physicians,

other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare

providers and their immediate family members and applicable group purchasing organizations;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, which might apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private

some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance

guidelines and the relevant compliance guidance promulgated by the federal government and might require drug manufacturers to report

information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures

or pricing information;

the federal Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability for executing a scheme

to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and willfully falsifying,

concealing or covering up a material fact or making any materially false statements in connection with the delivery of or payment

for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and Clinical Health Act

of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect to safeguarding the

privacy, security and transmission of individually identifiable health information on entities subject to the law, such as certain

healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective business associates

that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable health information;

the federal physician sunshine

requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical supplies, with certain exceptions,

to report annually to HHS information related to payments and other transfers of value to physicians, other healthcare providers,

and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate

family members and applicable group purchasing organizations;

analogous state and foreign

laws and regulations, such as state anti-kickback and false claims laws, which might apply to sales or marketing arrangements and

claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government and might require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or pricing

and certain state and local laws which require the registration of pharmaceutical sales representatives;

and foreign laws govern the privacy and security of health information in specified circumstances, many of which differ from each

other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

state and foreign laws

govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant

ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

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

demand for any product candidates or products that we might develop;

of clinical trial sites or entire clinical trial programs;

to our reputation and significant negative media attention;

of clinical trial participants;

costs to defend the related litigation;

monetary awards to trial subjects or patients;

of management and scientific resources from our business operations;

inability to commercialize any products that we might develop.

decreased demand

for any product candidates or products that we might develop;

termination of clinical

trial sites or entire clinical trial programs;

injury to our reputation

and significant negative media attention;

withdrawal of clinical

trial participants;

significant costs to defend

the related litigation;

substantial monetary awards

to trial subjects or patients;

loss of revenue;

diversion of management

and scientific resources from our business operations;

the inability to commercialize

any products that we might develop.

to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is customary

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and financial, research and technical resources than us.

Potential competitors in the U.S.

and worldwide are numerous and include pharmaceutical

and biotechnology companies, educational institutions and research foundations, many of which have substantially greater capital resources,

marketing experience, research and development staffs and facilities than ours.

Some of our competitors might develop and commercialize

products that compete directly with those incorporating our technology or might introduce products to market earlier than our intended

product or on a more cost-effective basis.

Our competitors compete with us in recruiting and retaining qualified scientific and management

personnel as well as in acquiring technologies complementary to our technology.

We might face competition with respect to product efficacy

and safety, ease of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory

approvals, availability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions

An inability to successfully complete our product development or commercializing our lead product candidate could result in

our having limited prospects for establishing market share or generating revenue.

Potential competitors in the United States and worldwide are numerous and include

pharmaceutical and biotechnology companies, educational institutions and research foundations, many of which have substantially greater

capital resources, marketing experience, research and development staffs and facilities than ours.

Some of our competitors might develop

and commercialize products that compete directly with those incorporating our technology or might introduce products to market earlier

than our intended product or on a more cost-effective basis.

Our competitors compete with us in recruiting and retaining qualified scientific

and management personnel as well as in acquiring technologies complementary to our technology.

We might face competition with respect

to product efficacy and safety, ease of use and adaptability to various modes of administration, acceptance by physicians, the timing

and scope of regulatory approvals, availability of resources, reimbursement coverage, price and patent position, including the potentially

dominant patent positions of others.

An inability to successfully complete our product development or commercializing our lead product

candidate could result in our having limited prospects for establishing market share or generating revenue.

of our competitors or potential competitors have significantly greater established presence in the market, financial resources and expertise

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Future growth would impose significant added responsibilities on members of management, including:

our clinical trials effectively;

recruiting, maintaining, motivating and integrating additional employees;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors

and other third parties;

our managerial, development, operational, information technology, and finance systems;

our facilities.

clinical trials effectively;

identifying, recruiting,

maintaining, motivating and integrating additional employees;

managing our internal development

efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial,

development, operational, information technology, and finance systems;

expanding our facilities.

our operations expand, we will likely also need to manage additional relationships with various strategic partners, suppliers and other

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markets and obtain necessary capital in order to properly capitalize and continue our operations.

market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have

serious adverse consequences on our business, financial condition and stock price.

global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity

and credit availability, declines in consumer confidence, declines in economic growth, inflationary pressures and interest rate changes,

increases in unemployment rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely

affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other

geopolitical events.

Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine,

may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or

others could exacerbate market and economic instability.

More recently, the closures of Silicon Valley Bank and Signature Bank and their

placement into receivership with the Federal Deposit Insurance Corporation (FDIC) created bank-specific and broader financial institution

liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the FDIC jointly released a statement

that depositors at Silicon Valley Bank and Signature Bank would have access to their funds, even those in excess of the standard FDIC

insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the

broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term

working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future credit and financial

market instability and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely

affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market

If the equity markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term

liquidity risk and also make any necessary equity financing more difficult, more costly and more dilutive.

Failure to secure any necessary

financing in a timely manner and on favorable terms could have a material adverse effect on our business plans and stock price and could

require us to delay or abandon clinical development plans.

In addition, there is a risk that one or more of our current service providers,

financial institutions, manufacturers and other partners may be adversely affected by the foregoing risks, which could directly affect

our ability to conduct our business plans on schedule and on budget.

Related to Owning our Securities

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stock or Warrants to fluctuate, in addition to the other risks mentioned in this “Risk Factors”, are:

of our common stock by our stockholders, executives, and directors and our stockholders;

and limitations in trading volumes of our shares of common stock;

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical

trials, and other business activities;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our

industry, including consolidation among competitors, customers or strategic partners;

outages or security breaches;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement,

enrollment or results of our clinical trials for our lead product candidate or any future clinical trials we might conduct;

in the development status of our lead product candidate;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical

and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our lead product candidate;

unanticipated

safety concerns related to the use of our lead product candidate;

to meet external expectations or management guidance;

in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

inability to enter into new markets or develop new products;

from existing technologies and products or new technologies and products that might emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which might be out of our control.

common stock by our stockholders, executives, and directors and our stockholders;

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business

and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry,

including consolidation among competitors, customers or strategic partners;

network outages or security

our ability to secure resources

and the necessary personnel to conduct clinical trials on our desired schedule;

commencement, enrollment

or results of our clinical trials for our lead product candidate or any future clinical trials we might conduct;

changes in the development

status of our lead product candidate;

any delays or adverse developments

or perceived adverse developments with respect to the FDA’s review of our planned preclinical and clinical trials;

any delay in our submission

for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our lead product

unanticipated safety concerns

related to the use of our lead product candidate;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new products;

reputational issues;

competition from existing

technologies and products or new technologies and products that might emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

general economic, political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which might be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

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even if unsuccessful, could be costly to defend and a distraction to management.

Company’s failure to meet the continued listing standards of Nasdaq could result in a delisting of its common stock.

In order to meet the continued

listing standards of the Nasdaq Capital Market (“Nasdaq”), the Company is required to meet various requirements, including

that it has stockholders’ equity of at least $2,500,000 and that its common stock have a minimum closing bid price of $1.00 per

If we fail to satisfy

the continued listing standards of Nasdaq in the future, Nasdaq may take steps to delist our common stock.

Such a delisting would

likely have a negative effect on the price of our common stock and would impair your ability to buy or sell our common stock when you

wish to do so.

A delisting would adversely affect the liquidity, trading volume and likely the price of our common stock, causing

the value of an investment in us to decrease, would adversely affect our ability to raise capital, and would have an adverse effect on

our business, financial condition and results of operations.

Related to the Company’s Common Stock

Company received a written notice from Nasdaq that it has failed to comply with certain listing requirements of The Nasdaq Stock Market,

which could result in the Company being delisted from The Nasdaq Stock Market.

June 24, 2022, the Company received an initial notification from Nasdaq related to its failure to maintain a minimum bid price of $1.00

per share for a period of 30 consecutive business days.

The Nasdaq Listing Rules provided the Company a compliance period of 180 calendar

days in which to regain compliance, which in the case of the initial notification was December 21, 2022.

As the Company did not regain

compliance with the minimum bid price requirement, the Company was afforded a second 180 calendar day compliance period to regain compliance

by letter dated December 22, 2022.

If at any time from the date of this second notice until June 19, 2023, the closing bid price of the

Company’s common stock is at least $1.00 per share for a minimum of ten consecutive business days, Nasdaq will provide the Company

with written confirmation of compliance and the matter will be closed.

If the Company does not regain compliance with the minimum bid

price requirement by the end of the second compliance period, the Company’s common stock and warrants will become subject to delisting.

order to achieve compliance with the minimum closing bid price per share requirement, the Company intends to file a proxy statement to

hold a special meeting of stockholders to seek approval to effect a reverse stock split of its issued and outstanding shares of common

However, there can be no assurance that the Company will be successful in this regard and will be able to regain compliance with

the minimum closing bid price requirement by June 19, 2023, in which case the Company anticipates Nasdaq would provide a notice to the

Company that its shares of common stock and warrants are subject to delisting, and the Company’s common shares and warrants would

then be delisted.

there can be no assurance that the market price per new share of the Company’s common stock after the reverse stock split will

remain unchanged or increase in proportion to the reduction in the number of old shares of the Company’s common stock outstanding

before the reverse stock split.

Even if the reverse stock split is approved by the Company’s stockholders, there can be no assurance

that the Company will be able to maintain compliance with the minimum bid price requirement in the future or will otherwise be able to

maintain compliance with other Nasdaq listing rules.

the Company is delisted from Nasdaq, its common stock and warrants may be eligible for trading on an over-the-counter market.

Company is not able to obtain a listing on another stock exchange or quotation service for its common stock and warrants, it may be extremely

difficult or impossible for stockholders to sell their shares of common stock and warrants.

Moreover, if the Company is delisted from

Nasdaq, but obtains a substitute listing for its common stock and warrants, it will likely be on a market with less liquidity, and therefore

experience potentially more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares of common

stock and warrants on any such substitute market in the quantities, at the times, or at the prices that could potentially be available

on a more liquid trading market.

As a result of these factors, if the Company’s common stock is delisted from Nasdaq, the value

and liquidity of the Company’s common stock and warrants would likely be significantly adversely affected.

A delisting of the Company’s

common stock from Nasdaq could also adversely affect the Company’s ability to obtain financing for its operations and/or could

result in a loss of confidence by investors, employees and/or business partners.

the Company implements a reverse stock split, liquidity of its common stock may be adversely effected.

indicated above, the Company intends to seek approval from its stockholders to effect a reverse stock split of the issued and outstanding

shares of its common stock in order to regain compliance with the Nasdaq $1.00 minimum bid price requirement.

The liquidity of the shares

of the Company’s common stock may be affected adversely by any reverse stock split given the reduced number of shares of the Company’s

common stock that will be outstanding following the reverse stock split, particularly if the market price of the Company’s common

stock does not increase as a result of the reverse stock split.

any reverse stock split, the resulting market price of the Company’s common stock may not attract new investors and may not satisfy

the investing requirements of those investors.

Although the Company believes that a higher market price of the Company’s common

stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a

share price that will attract new investors, including institutional investors.

In addition, there can be no assurance that the market

price of the Company’s common stock will satisfy the investing requirements of those investors.

As a result, the trading liquidity

of the Company’s common stock may not necessarily improve, or could decrease.

sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline.

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economy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults in recent years.

Our general business strategy might be adversely affected by any such economic downturns (including the current downturn related to the

current COVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic and market conditions.

these conditions continue to deteriorate or do not improve, it might make any necessary debt or equity financing more difficult to complete,

more costly, and more dilutive.

Failure to secure any necessary financing in a timely manner and on favorable terms could have a material

adverse effect on our growth strategy, financial performance, and share price and could require us to delay or abandon development or

commercialization plans.

Our general business strategy might be adversely affected by any such economic downturns (including the impact related to the recent

COVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic and market conditions.

If these conditions

continue to deteriorate or do not improve, it might make any necessary debt or equity financing more difficult to complete, more costly,

and more dilutive.

Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse

effect on our growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization

securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our

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and might also impair our ability to expand our business with existing customers and attract new customers.

certain of our stockholders control a significant number of shares of our common stock, they might have effective control over actions

requiring stockholder approval.

directors, executive officers and principal stockholders, and their respective affiliates, currently beneficially own approximately 23%

of our outstanding shares of common stock, based on 13,746,593 shares of common stock currently issued and outstanding.

This percentage

decreases to approximately 22% in the event that the shares of our Series A Preferred Stock are converted into shares of

common stock.

As a result, these stockholders, acting together, would have the ability to control the outcome of matters submitted to

our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all

of our assets.

In addition, these stockholders, acting together, would have the ability to control the management and affairs of our

Accordingly, this concentration of ownership might harm the market price of our common stock by:

deferring or preventing a change in corporate control;

a merger, consolidation, takeover or other business combination involving us;

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could

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rights and sinking fund provisions.

As of March 11, 2022, we have designated 350,000 shares of preferred stock as Series A Convertible

Preferred Stock, all of which are issued and outstanding.

The issuance of any preferred stock could materially adversely affect the rights

of the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future

holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve

control by the present management.

We have designated 350,000 shares of preferred stock as Series A Convertible Preferred Stock, all

of which are issued and outstanding.

The issuance of any preferred stock could materially adversely affect the rights of the holders

of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future holders of

preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve control

by the present management.

of our Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential

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the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:

the Board of Directors with the ability to alter the bylaws without stockholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon

at stockholder meetings;

that vacancies on the Board of Directors might be filled by a majority of directors in office, although less than a quorum.

reporting obligations of being a public company in the U.S.

are expensive and time-consuming, and our management will be required to

devote substantial time to compliance matters.

Board of Directors with the ability to alter the bylaws without stockholder approval;

place limitations on the

removal of directors;

establishing advance notice

requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon at stockholder

provide that vacancies

on the Board of Directors might be filled by a majority of directors in office, although less than a quorum.

reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required

to devote substantial time to compliance matters.

a publicly traded company we incur significant additional legal, accounting and other expenses.

The obligations of being a public company

require significant expenditures and will place significant demands on our management and other personnel, including costs

resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance

in the United States require significant expenditures and will place significant demands on our management and other personnel, including

costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance

practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing

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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