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Item 1A. Risk Factors

2024-03-28 compared with 2023-03-02 · 1252 added, 1264 removed, 49 unchanged (98% of the section changed)

Summary of Risk Factors

Below is a summary of the principal factors that

make an investment in our common stock speculative or risky.

This summary does not address all of the risks that we face.

Additional discussion

of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors”

and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making

an investment decision regarding our common stock.

We have incurred significant

losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.

ability to successfully engage with, and satisfactorily

respond to, requests for additional information from the FDA concerning the clinical hold

on our investigational new drug application for XPro and the timing and outcomes of such

interactions, including our plans to engage the FDA in order to lift the clinical hold.

will require additional capital to fund our operations and if we fail to obtain necessary

financing, we will not be able to complete the development and commercialization of our product

have a substantial amount of debt, and we may be unable to make required payments of interest

and principal as they become due.

We are significantly dependent

on the success of our DN-TNF product platform and Natural Killer Cell Priming Platform (INKmune) and our product candidates based

on these platforms.

We need to attract and

retain highly skilled personnel;

of Risk Factors

is a summary of the principal factors that make an investment in our common stock speculative or risky.

This summary does not address

all of the risks that we face.

Additional discussion of the risks summarized in this risk factor summary, and other risks that we face,

can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in

this Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

We will require additional capital to finance our operations to continue as a going concern, which may not be available to us on acceptable terms, if at all.

As a result, we may not complete the development and commercialization of our product candidates or develop new product candidates and have substantial doubt about our ability to continue as a going concern.

ability to successfully engage with, and satisfactorily respond to, requests for information

from the FDA in the future.

will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete

the development and commercialization of our product candidates.

have a substantial amount of debt, and we may be unable to make required payments of interest and principal as they become due.

are significantly dependent on the success of our DN-TNF product platform and Natural Killer Cell Priming Platform (INKmune) and

our product candidates based on these platforms.

need to attract and retain highly skilled personnel;

we may be unable to effectively manage growth with our limited resources.

We depend upon our senior

management and key consultants and their loss or unavailability could put us at a competitive disadvantage.

The biotechnology and immunotherapy

industries are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with

more substantial enterprises.

We can provide no assurance

that our clinical product candidates will obtain regulatory approval or that the results of clinical studies will be favorable.

Drug discovery and development

is a complex, time-consuming and expensive process with a high rate of failure.

depend upon our senior management and key consultants and their loss or unavailability could put us at a competitive disadvantage.

biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with more substantial enterprises.

can provide no assurance that our clinical product candidates will obtain regulatory approval or that the results of clinical studies

will be favorable.

discovery and development is a complex, time-consuming and expensive process with a high rate of failure.

may face legal claims;

legal disputes are expensive, and we may not be able to afford the

We can provide no assurance of the successful and timely development of new products.

We must comply with significant government regulations.

We rely upon patents to protect our technology.

legal disputes are expensive, and we may not be able to afford the costs.

can provide no assurance of the successful and timely development of new products.

must comply with significant government regulations.

rely upon patents to protect our technology.

We may be unable to protect our intellectual property rights.

The price of our common stock may be volatile.

The market prices for our common stock may be adversely impacted by future events.

A limited public trading market may cause volatility in the price of our common stock.

Our Rights Agreement contains anti-takeover provisions that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

You should carefully consider the risks described

below as well as other information provided to you in this document, including information in the section of this document entitled “Information

Regarding Forward Looking Statements.” If any of the following risks actually occur, the Company’s business, financial condition

or results of operations could be materially adversely affected, the value of the Company’s Common Stock could decline, and you

may lose all or part of your investment.

RISKS RELATED TO OUR BUSINESS

We will need additional capital.

If additional

capital is not available or is available at unattractive terms, we may be forced to delay, reduce the scope of or eliminate our research

and development programs, reduce our commercialization efforts or curtail our operations.

As of December

31, 2022, we had cash and cash equivalents of $52.2 million and we had $15 million of outstanding debt.

In order to develop and

bring our product candidates to market, we must commit substantial resources to costly and time-consuming research, preclinical and clinical

trials and marketing activities.

We anticipate that our existing cash and cash equivalents will enable us to maintain our current operations

for at least the next twelve months.

We anticipate using our cash and cash equivalents to fund further research and development with respect

to our lead product candidates.

We may, however, need to raise additional funding sooner if our business or operations change in a manner

that consumes available resources more rapidly than we anticipate.

Our requirements for additional capital will depend on many factors,

successful commercialization of our product candidates;

the time and costs involved in obtaining regulatory approval for our product candidates;

costs associated with protecting our intellectual property rights;

development of marketing and sales capabilities;

payments received under future collaborative agreements, if any;

market acceptance of our products, if any.

Issuances of additional

debt or equity securities could impact the rights of the holders of our common stock and will dilute their ownership percentage.

the establishment of other funding facilities may impose restrictions on our operations.

These restrictions could include limitations

on additional borrowing and specific restrictions on the use of our assets, as well as prohibitions on our ability to create liens, pay

dividends, redeem our stock or make investments.

We may also raise additional capital by pursuing opportunities for the licensing

or sale of certain intellectual property and other assets.

We cannot offer assurances, however, that any strategic collaboration,

sales of securities or sales or licenses of assets will be available to us on a timely basis or on acceptable terms, if at all.

be required to enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would

have sought to develop independently, and any such relationships may not be on terms as commercially favorable to us as might otherwise

In the event that sufficient

additional funds are not obtained through strategic collaboration opportunities, sales of securities, funding facilities, licensing arrangements,

borrowing arrangements and/or asset sales on a timely basis, we may be required to reduce expenses through the delay, reduction or curtailment

of our projects, or further reduction of costs for facilities and administration.

We cannot provide assurances

that changed or unexpected circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.

There can be no assurances that we will be able to raise additional capital in sufficient amounts or on favorable terms, or at all.

we are unable to raise adequate additional capital when required or in sufficient amounts or on terms acceptable to us, we may have to

delay, scale back or discontinue one or more product development programs, curtail our commercialization activities, significantly reduce

expenses, sell assets (potentially at a loss), enter into relationships with third parties to develop or commercialize products or technologies

that we otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue an acquisition of our

company at a price that may result in up to a total loss on investment for our stockholders, file for bankruptcy or seek other protection

from creditors, or liquidate all of our assets.

To fund our operations

and service our debt, we will be required to generate a significant amount of cash.

Our ability to generate cash depends on a number of

factors, some of which are beyond our control, and any failure to meet our debt obligations would have a material adverse effect on our

business, financial condition, cash flows and results of operations and could cause the market value of our common stock to decline.

Prevailing economic conditions

and financial, business and other factors, many of which are beyond our control, may affect our ability to make payments on our debt.

If we do not generate sufficient cash flow to satisfy our debt obligations, we may have to undertake alternative financing plans, such

as refinancing or restructuring our debt, selling assets, reducing or delaying capital investments or seeking to raise additional capital.

price of our common stock may be volatile.

market prices for our common stock may be adversely impacted by future events.

limited public trading market may cause volatility in the price of our common stock.

Rights Agreement contains anti-takeover provisions that could discourage, delay or prevent a change in control, which may cause our

stock price to decline.

should carefully consider the risks described below as well as other information provided to you in this document, including information

in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks

actually occur, the Company’s business, financial condition or results of operations could be materially adversely affected, the

value of the Company’s Common Stock could decline, and you may lose all or part of your investment.

RELATED TO OUR BUSINESS

There is doubt about our ability to continue

as a going concern.

As of December 31, 2023, the

Company had an accumulated deficit of $121,022,000.

Losses have principally occurred as a result of the substantial resources required

for research and development of the Company’s product candidates which included the general and administrative expenses associated

with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products

are commercialized.

These factors raise substantial doubt about the Company’s ability to continue as a going concern for the 12

months from the issuance date of these financial statements.

These financial statements do not include any adjustments to reflect the

possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result

from the outcome of these uncertainties.

Management intends to pursue additional funding and implement its strategic plan to allow the

opportunity for the Company to continue as a going concern, however, there cannot be any assurance that we will be successful in doing

The opinion of our independent registered public accounts on our audited financial statements for the year ended December 31, 2023,

contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

There is no assurance that

we will be successful in raising the additional funds needed to fund our business plan.

If we are not able to raise sufficient capital

in the near future, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer

all or substantially all of our remaining assets.

fund our operations and service our debt, we will be required to generate a significant amount of cash.

Our ability to generate cash

depends on a number of factors, some of which are beyond our control, and any failure to meet our debt obligations would have a material

adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common

stock to decline.

economic conditions and financial, business and other factors, many of which are beyond our control, may affect our ability to make payments

If we do not generate sufficient cash flow to satisfy our debt obligations, we may have to undertake alternative financing

plans, such as refinancing or restructuring our debt, selling assets, reducing or delaying capital investments or seeking to raise additional

Alternatively, we may also attempt to refinance certain of our debt, for example, to extend maturities.

Our ability to restructure or

refinance our debt will depend on the capital markets and our financial condition at such time.

Our ability to restructure

or refinance our debt will depend on the capital markets and our financial condition at such time.

If we are unable to access the capital

7 unchanged sentences

stock and/or debt securities to decline.

Our ability to continue

to reduce our indebtedness will depend upon factors including our future operating performance, our ability to access the capital markets

to refinance existing debt and prevailing economic conditions and financial, business and other factors, many of which are beyond our

ability to continue to reduce our indebtedness will depend upon factors including our future operating performance, our ability to access

the capital markets to refinance existing debt and prevailing economic conditions and financial, business and other factors, many of

which are beyond our control.

We can provide no assurance of the amount by which we will reduce our debt, if at all.

In addition, servicing our debt will result

in a reduction in the amount of our cash flow available for other purposes, including operating costs and research and development costs.

Our debt agreement contains covenant restrictions that may limit

our ability to operate our business.

The terms of our debt agreement

contains, and any of our other future debt agreements may contain, covenant restrictions that limit our ability to operate our business,

including restrictions on our ability to, among other things, incur additional debt or issue guarantees, create liens, repurchase stock,

or make other restricted payments, and make certain voluntary prepayments of specified debt.

As a result of these covenants, our ability

to respond to changes in business and economic conditions and engage in beneficial transactions, including to obtain additional financing

as needed, may be restricted.

Furthermore, our failure to comply with our debt covenants could result in a default under our debt agreements,

which could permit the holders to accelerate our obligation to repay the debt.

If any of our debt is accelerated, we may not have sufficient

funds available to repay it.

The Company violated certain non-financial debt covenants during 2022 and obtained a waiver from its lender

for the violations during February 2023.

The FDA has placed

a clinical hold on XPro.

If the FDA does not remove the clinical hold on a timely basis, or at all, our development timelines and

our business may be adversely affected, and our stock price may decline.

previously announced by the Company in a press release dated on May 23, 2022, the FDA placed a full clinical hold on XPro, requesting

additional information around the Company’s chemistry manufacturing and controls for the treatment.

The Company is working

with the regulatory body to have the current hold removed as soon as possible, but it is not yet clear when the hold will be lifted.

If the FDA does not lift the clinical hold in a timely manner, or at all, our long-term development

timeline for XPro and our business, financial condition or results of operations, may be

adversely affected.

The trial for XPro in Alzheimer’s disease is currently open in Australia and Canada.

We face intense competition in the markets

targeted by our lead product candidates.

Many of our competitors have substantially greater resources than we do, and we expect that all

of our product candidates under development will face intense competition from existing or future drugs.

We expect that all of our product candidates under

development, if approved, will face intense competition from existing and future drugs marketed by large companies.

These competitors

may successfully market products that compete with our products, successfully identify drug candidates or develop products earlier than

we do, or develop products that are more effective, have fewer side effects or cost less than our products, if any.

Additionally, if a competitor receives FDA approval

before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate may be precluded or delayed

due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering its newly-approved drug

Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates can extend up to

three and one-half years.

In addition, servicing

our debt will result in a reduction in the amount of our cash flow available for other purposes, including operating costs and research

and development costs.

debt agreement contains covenant restrictions that may limit our ability to operate our business.

terms of our debt agreement contains, and any of our other future debt agreements may contain, covenant restrictions that limit our ability

to operate our business, including restrictions on our ability to, among other things, incur additional debt or issue guarantees, create

liens, repurchase stock, or make other restricted payments, and make certain voluntary prepayments of specified debt.

As a result of

these covenants, our ability to respond to changes in business and economic conditions and engage in beneficial transactions, including

to obtain additional financing as needed, may be restricted.

Furthermore, our failure to comply with our debt covenants could result

in a default under our debt agreements, which could permit the holders to accelerate our obligation to repay the debt.

If any of our

debt is accelerated, we may not have sufficient funds available to repay it.

face intense competition in the markets targeted by our lead product candidates.

Many of our competitors have substantially greater resources

than we do, and we expect that all of our product candidates under development will face intense competition from existing or future

expect that our product candidates under development, if approved, will face intense competition from existing and future drugs marketed

by large companies.

These competitors may successfully market products that compete with our products, successfully identify drug candidates

or develop products earlier than we do, or develop products that are more effective, have fewer side effects or cost less than our products,

Additionally,

if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our

product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor

of patents covering its newly-approved drug product.

Periods of non-patent exclusivity for new versions of existing drugs such as our

current product candidates can extend up to three and one-half years.

See “Business — Government Regulation.”

These competitive factors could require us to

conduct substantial new research and development activities to establish new product targets, which would be costly and time consuming.

These activities would adversely affect our ability to commercialize products and achieve revenue and profits.

Competition and technological change may

make our product candidates and technologies less attractive or obsolete.

We compete with established pharmaceutical and

biotechnology companies that are pursuing other forms of treatment for the same indications we are pursuing and that have greater financial

and other resources.

Other companies may succeed in developing products earlier than us, obtaining FDA approval for products more rapidly,

or developing products that are more effective than our product candidates.

Research and development by others may render our technology

or product candidates obsolete or noncompetitive, or result in treatments or cures superior to any therapy we develop.

We face competition

from companies that internally develop competing technology or acquire competing technology from universities and other research institutions.

As these companies develop their technologies, they may develop competitive positions that may prevent, make futile, or limit our product

commercialization efforts, which would result in a decrease in the revenue we would be able to derive from the sale of any products.

There can be no assurance that any of our product

candidates will be accepted by the marketplace as readily as these or other competing treatments.

Furthermore, if our competitors’

products are approved before ours, it could be more difficult for us to obtain approval from the FDA.

Even if our products are successfully

developed and approved for use by all governing regulatory bodies, there can be no assurance that physicians and patients will accept

our product(s) as a treatment of choice.

Furthermore, the pharmaceutical research industry

is diverse, complex, and rapidly changing.

By its nature, the business risks associated therewith are numerous and significant.

of competition, intellectual property disputes, market acceptance, and FDA regulations preclude us from forecasting revenues or income

with certainty or even confidence.

If we fail to protect our intellectual property

rights, our ability to pursue the development of our technologies and products would be negatively affected.

Our success will depend, in part, on our ability

to obtain patents and maintain adequate protection of our technologies and products.

If we do not adequately protect our intellectual

property, competitors may be able to use our technologies to produce and market drugs in direct competition with us and erode our competitive

Some foreign countries lack rules and methods for defending intellectual property rights and do not protect proprietary rights

to the same extent as the United States.

Many companies have had difficulty protecting their proprietary rights in these foreign countries.

competitive factors could require us to conduct substantial new research and development activities to establish new product targets,

which would be costly and time-consuming.

These activities would adversely affect our ability to commercialize products and achieve revenue

and technological change may make our product candidates and technologies less attractive or obsolete.

compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same indications

we are pursuing and that have greater financial and other resources.

Other companies may succeed in developing products earlier than

us, obtaining FDA approval for products more rapidly, or developing products that are more effective than our product candidates.

and development by others may render our technology or product candidates obsolete or noncompetitive or result in treatments or cures

superior to any therapy we develop.

We face competition from companies that internally develop competing technology or acquire competing

technology from universities and other research institutions.

As these companies develop their technologies, they may develop competitive

positions that may prevent, make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue

we would be able to derive from the sale of any products.

can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or other competing treatments.

Furthermore, if our competitors’ products are approved before ours, it could be more difficult for us to obtain approval from the

Even if our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance

that physicians and patients will accept our product(s) as a treatment of choice.

the pharmaceutical research industry is diverse, complex, and rapidly changing.

By its nature, the business risks associated therewith

are numerous and significant.

The effects of competition, intellectual property disputes, market acceptance, and FDA regulations preclude

us from forecasting revenues or income with certainty or even confidence.

we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be

negatively affected.

success will depend, in part, on our ability to obtain patents and maintain adequate protection of our technologies and products.

we do not adequately protect our intellectual property, competitors may be able to use our technologies to produce and market drugs in

direct competition with us and erode our competitive advantage.

Some foreign countries lack rules and methods for defending intellectual

property rights and do not protect proprietary rights to the same extent as the United States.

Many companies have had difficulty protecting

their proprietary rights in these foreign countries.

We may not be able to prevent misappropriation of our proprietary rights.

We have received, and are currently seeking, patent

protection for numerous compounds and methods of treating diseases.

However, the patent process is subject to numerous risks and uncertainties,

and there can be no assurance that we will be successful in protecting our products by obtaining and defending patents.

These risks and

uncertainties include the following:

patents that may be issued or licensed may be challenged, invalidated, or circumvented, or otherwise

may not provide any competitive advantage;

our competitors, many of which have substantially greater resources than us and many of which

have made significant investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere

with, or eliminate our ability to make, use, and sell our potential products either in the United States or in international markets;

there may be significant pressure on the United States government and other international governmental bodies to limit the scope of patent

protection both inside and outside the United States for treatments that prove successful as a matter of public policy regarding worldwide

health concerns;

countries other than the United States may have less restrictive patent laws than those upheld by United States courts,

allowing foreign competitors the ability to exploit these laws to create, develop, and market competing products.

Moreover, any patents issued to us may not provide

us with meaningful protection, or others may challenge, circumvent or narrow our patents.

Third parties may also independently develop

products similar to our products, duplicate our unpatented products or design around any patents on products we develop.

Additionally,

extensive time is required for development, testing and regulatory review of a potential product.

While extensions of patent term due

to regulatory delays may be available, it is possible that, before any of our product candidates can be commercialized, any related patent,

even with an extension, may expire or remain in force for only a short period following commercialization, thereby reducing any advantages

of the patent.

In addition, the United States Patent and Trademark

Office (the “USPTO”) and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical

and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the

patent application, thereby limiting the scope of protection against competitive challenges.

Thus, even if we or our licensors are able

to obtain patents, the patents may be substantially narrower than anticipated.

Our success depends on patent applications that

are licensed exclusively to us and other patents to which we may obtain assignment or licenses.

We may not be aware, however, of all patents,

published applications or published literature that may affect our business either by blocking our ability to commercialize our product

candidates, by preventing the patentability of our product candidates to us or our licensors, or by covering the same or similar technologies

that may invalidate our patents, limit the scope of our future patent claims or adversely affect our ability to market our product candidates.

In addition to patents, we rely on a combination

of trade secrets, confidentiality, nondisclosure and other contractual provisions, and security measures to protect our confidential and

proprietary information.

These measures may not adequately protect our trade secrets or other proprietary information.

If they do not

adequately protect our rights, third parties could use our technology, and we could lose any competitive advantage we may have.

others may independently develop similar proprietary information or techniques or otherwise gain access to our trade secrets, which could

impair any competitive advantage we may have.

Patent protection and other intellectual property

protection is crucial to the success of our business and prospects, and there is a substantial risk that such protections will prove inadequate.

We license our patents from others.

owners do not properly maintain or enforce the intellectual property underlying such licenses, our competitive position and business prospects

could be harmed.

have received, and are currently seeking, patent protection for numerous compounds and methods of treating diseases.

However, the patent

process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our products

by obtaining and defending patents.

These risks and uncertainties include the following:

patents that may be issued or licensed may be

challenged, invalidated, or circumvented, or otherwise may not provide any competitive advantage;

our competitors, many of which have

substantially greater resources than us and many of which have made significant investments in competing technologies, may seek, or may

already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products

either in the United States or in international markets;

there may be significant pressure on the United States government and other

international governmental bodies to limit the scope of patent protection both inside and outside the United States for treatments that

prove successful as a matter of public policy regarding worldwide health concerns;

countries other than the United States may have less

restrictive patent laws than those upheld by United States courts, allowing foreign competitors the ability to exploit these laws to

create, develop, and market competing products.

any patents issued to us may not provide us with meaningful protection, or others may challenge, circumvent or narrow our patents.

parties may also independently develop products similar to our products, duplicate our unpatented products or design around any patents

on products we develop.

Additionally, extensive time is required for development, testing and regulatory review of a potential product.

While extensions of patent term due to regulatory delays may be available, it is possible that, before any of our product candidates

can be commercialized, any related patent, even with an extension, may expire or remain in force for only a short period following commercialization,

thereby reducing any advantages of the patent.

addition, the United States Patent and Trademark Office (the “USPTO”) and patent offices in other jurisdictions have often

required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially

to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive

Thus, even if we or our licensors are able to obtain patents, the patents may be substantially narrower than anticipated.

Our success depends on patent

applications that are licensed exclusively to us and other patents to which we may obtain assignment or licenses.

We may not be aware,

however, of all patents, published applications or published literature that may affect our business either by blocking our ability to

commercialize our product candidates, by preventing the patentability of our product candidates to us or our licensors, or by covering

the same or similar technologies that may invalidate our patents, limit the scope of our future patent claims or adversely affect our

ability to market our product candidates.

addition to patents, we rely on a combination of trade secrets, confidentiality, nondisclosure and other contractual provisions, and

security measures to protect our confidential and proprietary information.

These measures may not adequately protect our trade secrets

or other proprietary information.

If they do not adequately protect our rights, third parties could use our technology, and we could

lose any competitive advantage we may have.

In addition, others may independently develop similar proprietary information or techniques

or otherwise gain access to our trade secrets, which could impair any competitive advantage we may have.

protection and other intellectual property protection is crucial to the success of our business and prospects, and there is a substantial

risk that such protections will prove inadequate.

working with research collaborators patent rights may be jointly owned by different parties.

of our licensors may have relied on third-party consultants or collaborators such that our licensors are not the sole and exclusive owners

of the patents we in-licensed.

If other third parties have ownership rights to our in-licensed patents, the license granted to us for

such jointly owned patents may not be valid.

Absent an agreement, each joint owner can independently sell, license, or otherwise exploit

the jointly owned patent without the approval of the other joint owner(s) and without having to account to each other for their revenues.

Without the cooperation of all joint owners, none can grant an exclusive license to a third party.

Further, a jointly owned patent cannot

be enforced unless all of the owners join in the lawsuit.

If a co-owner refuses to participate, the lawsuit cannot proceed.

our in-licensed patents from Xencor show joint ownership between Xencor and a third party.

Xencor provided representations and warrants

as to its ability to grant the rights provided in the license.

In addition, Xencor is required to indemnify us as to any breach of its

representations, warranties and covenants made in the agreement.

our rights to current or future in-licensed patents and patent applications may be dependent, in part, on inter-institutional or other

operating agreements between the joint owners of such in-licensed patents and patent applications.

If one or more of such joint owners

breaches such inter-institutional or operating agreements, our rights to such in-licensed patents and patent applications may be adversely

Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results

of operations, and prospects.

property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain

reporting requirements and a preference for U.S.-based companies.

Compliance with such regulations may limit our exclusive rights and

limit our ability to contract with non-U.S.

manufacturers.

in-licensed patents (i.e.

those from the University of Pittsburgh) were supported through the use of U.S.

government funding.

to the Bayh-Dole Act of 1980, the U.S.

government has certain rights in inventions developed with government funding.

rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive

licenses to any of these inventions to a third party if it determines that:

(1) adequate steps have not been taken to commercialize the

(2) government action is necessary to meet public health or safety needs;

or (3) government action is necessary to meet requirements

for public use under federal regulations (also referred to as march-in rights).

government exercised its march-in rights

in our current or future intellectual property rights that are generated through the use of U.S.

government funding or grants, we could

be forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can

be no assurance that we would receive compensation from the U.S.

government for the exercise of such rights.

government also

has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to

file an application to register the intellectual property within specified time limits.

Intellectual property generated under a government

funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources.

In addition, the U.S.

government requires that any products embodying any of these inventions or produced through the use of any of these

inventions be manufactured substantially in the United States.

This preference for U.S.

industry may be waived by the federal agency

that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have

been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States

or that under the circumstances domestic manufacture is not commercially feasible.

This preference for U.S.

industry may limit our ability

to contract with non-U.S.

product manufacturers for products covered by such intellectual property.

license our patents from others.

If such owners do not properly maintain or enforce the intellectual property underlying such licenses,

our competitive position and business prospects could be harmed.

Our licensors may also seek to terminate our license.

We are a party to a number of licenses that give

us rights to third-party intellectual property that is necessary or useful to our business.

To this end, we are dependent on our licenses

with Xencor, Inc., Immune Ventures, LLC and the University of Pittsburgh.

Our success will depend in part on the ability of our licensors

to obtain, maintain and enforce our licensed intellectual property.

Our licensors may not successfully prosecute any applications for

or maintain intellectual property to which we have licenses, may determine not to pursue litigation against other companies that are infringing

such intellectual property, or may pursue such litigation less aggressively than we would.

Without protection for the intellectual property

we license, other companies might be able to offer similar products for sale, which could adversely affect our competitive business position

and harm our business prospects.

If we lose any of our right to use third-party intellectual property, it could adversely affect our ability

to commercialize our technologies, products or services, as well as harm our competitive business position and our business prospects.

We are dependent on our licensing agreement

with Xencor, and the termination of this agreement could a have an adverse effect on our business.

On October 3, 2017, the Company entered into a license agreement with

Xencor, Inc., which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor.

to the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed

know-how and licensed materials to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates

Xencor’s proprietary protein known as XPro that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants

of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients,

in any dosage or formulation.

If we breach this Agreement Xencor may be able to terminate it and as a result of this terminate our business

could be negatively impacted.

Our officers and Directors own the company

that we license our INKmune patent from.

On October 29, 2015, we entered into an exclusive

license agreement with Immune Ventures, LLC (Immune Ventures).

The license agreement relates to our natural killer program, INKmune.

Ventures is owned by our RJ Tesi, our CEO and Chairman of the Board of Directors, David Moss, our Chief Financial Officer and Treasurer

and Mark Lowdell, our Chief Scientific Officer.

Because our officers and directors also own Immune Ventures there may be an inherent conflict

of interest which could result in unanticipated actions that adversely affect us.

We have a limited operating history and

expect to incur significant additional operating losses.

We are an early-stage company formed in September 2015 and have only a limited operating history.

are a party to a number of licenses that give us rights to third-party intellectual property that is necessary or useful to our business.

To this end, we are dependent on our licenses with Xencor, Inc., Immune Ventures, LLC and the University of Pittsburgh.

Our success will

depend in part on the ability of our licensors to obtain, maintain and enforce our licensed intellectual property.

Our licensors may

not successfully prosecute any applications for or maintain intellectual property to which we have licenses, may determine not to pursue

litigation against other companies that are infringing such intellectual property, or may pursue such litigation less aggressively than

Without protection for the intellectual property we license, other companies might be able to offer similar products for sale,

which could adversely affect our competitive business position and harm our business prospects.

If we lose any of our right to use third-party

intellectual property, it could adversely affect our ability to commercialize our technologies, products or services, as well as harm

our competitive business position and our business prospects.

are dependent on our licensing agreement with Xencor, and the termination of this agreement could have an adverse effect on our business.

October 3, 2017, the Company entered into a license agreement with Xencor, Inc., which has discovered and developed a proprietary biological

molecule that inhibits soluble tumor necrosis factor.

Pursuant to the license agreement, Xencor granted the Company an exclusive worldwide,

royalty-bearing license in licensed patent rights, licensed know-how and licensed materials to make, develop, use, sell and import any

pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as XPro that inhibits soluble

tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis

factor) alone or in combination with one or more active ingredients, in any dosage or formulation.

If we breach this Agreement, Xencor

may be able to terminate it, which could be negatively impact our business.

officers and Directors own the company that we license our INKmune patent from.

October 29, 2015, we entered into an exclusive license agreement with Immune Ventures, LLC (Immune Ventures).

The license agreement relates

to our natural killer program, INKmune.

Immune Ventures is owned by our RJ Tesi, our CEO and Chairman of the Board of Directors, David

Moss, our Chief Financial Officer and Treasurer and Mark Lowdell, our Chief Scientific Officer.

Because our officers and directors also

own Immune Ventures there may be an inherent conflict of interest which could result in unanticipated actions that adversely affect us.

have a limited operating history and expect to incur significant additional operating losses.

are an early-stage company formed in September 2015 and have only a limited operating history.

Therefore, there is limited historical

6 unchanged sentences

Our ability to generate material revenue and achieve

profitability will depend on, among other things, successful completion of the preclinical and clinical development of our product candidate;

profitability will depend on, among other things, successful completion of the preclinical and clinical development of our product candidate(s);

obtaining necessary regulatory approvals from the FDA and international regulatory agencies;

4 unchanged sentences

our business, prospects, and results of operations may be materially adversely affected.

INKmune represents a novel approach to cancer

treatment that creates significant challenges for us.

We believe INKmune represents a novel approach

to cancer treatment.

Advancing this novel therapy creates significant challenges for us, including:

Educating medical personnel regarding the potential side effect profile of INKmune;

Sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

Obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of immunotherapies for cancer;

Establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.

Even if we are able to commercialize any

product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement

practices or healthcare reform initiatives that could harm our business.

The commercial success of our product candidates

will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health

maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration

authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors.

If reimbursement is not available,

or is available only to limited levels, we may not be able to successfully commercialize our product candidates.

Even if coverage is provided,

the approved reimbursement amount may not be high enough to allow us to establish and maintain pricing sufficient to realize a meaningful

return on our investment.

There is significant uncertainty related to third-party

payor coverage and reimbursement of newly approved drugs.

Marketing approvals, pricing and reimbursement for new drug products vary widely

from country to country.

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

In many countries, the

pricing review period begins after marketing or product licensing approval is granted.

represents a novel approach to cancer treatment that creates significant challenges for us.

believe INKmune represents a novel approach to cancer treatment.

Advancing this novel therapy creates significant challenges for us,

medical personnel regarding the potential side effect profile of INKmune;

clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of immunotherapies

sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.

if we are able to commercialize any product candidate that we develop, the product may become subject to unfavorable pricing regulations,

third-party payor reimbursement practices or healthcare reform initiatives that could harm our business.

commercial success of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs

of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations,

or reimbursed by government health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other

third-party payors.

If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize

our product candidates.

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish

and maintain pricing sufficient to realize a meaningful return on our investment.

is significant uncertainty related to third-party payor coverage and reimbursement of newly approved drugs.

Marketing approvals, pricing

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

Some countries require approval of the sale price of a drug

before it can be marketed.

In many countries, the pricing review period begins after marketing or product licensing approval is granted.

In some non-U.S.

markets, prescription pharmaceutical

pricing remains subject to continuing governmental control even after initial approval is granted.

As a result, we might obtain marketing

approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product,

possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product

candidates obtain marketing approval.

We depend on obtaining certain patents and

protecting our proprietary rights.

Our success will depend, in part, on our ability

to obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third parties or having

third parties circumvent our rights.

We have filed and are actively pursuing a patent application for our product candidates.

positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal and factual

Thus, there can be no assurance that our patent application will result in the issuance of a patent, that we will develop additional

proprietary products that are patentable, that any patents issued to us will provide us with any competitive advantages or will not be

challenged by any third parties, that the patents of others will not impede our ability to do business or that third parties will not

be able to circumvent our patents.

Furthermore, there can be no assurance that others will not independently develop similar products,

duplicate any of our products not under patent protection, or, if patents are issued to us, design around the patented products we developed

or will develop.

We may be required to obtain licenses from third

parties to avoid infringing patents or other proprietary rights.

No assurance can be given that any licenses required under any such patents

or proprietary rights would be made available, if at all, on terms we find acceptable.

If we do not obtain such licenses, we could encounter

delays in the introduction of products or could find that the development, manufacture or sale of products requiring such licenses could

be prohibited.

A number of pharmaceutical, biopharmaceutical

and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received

patents on various technologies that may be related to or affect our business.

Some of these technologies, applications or patents may

conflict with our technologies or patent applications.

Such conflict could limit the scope of the patents, if any, that we may be able

to obtain or result in the denial of our patent applications.

In addition, if patents that cover our activities are issued to other companies,

there can be no assurance that we would be able to obtain licenses to these patents at a reasonable cost or be able to develop or obtain

alternative technology.

If we do not obtain such licenses, we could encounter delays in the introduction of products, or could find that

the development, manufacture or sale of products requiring such licenses could be prohibited.

In addition, we could incur substantial

costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits against others to have such patents

declared invalid.

Much of our know-how and technology may not be

To protect our rights, we plan to require employees, consultants, advisors and collaborators to enter into confidentiality

There can be no assurance, however, that these agreements will provide meaningful protection for our trade secrets, know-how

or other proprietary information in the event of any unauthorized use or disclosure.

Further, our business may be adversely affected by

competitors who independently develop competing technologies, especially if we obtain no, or only narrow, patent protection.

We are subject to various government regulations.

The manufacture and sale of human therapeutic

products in the U.S.

markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval

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

that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able

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

Adverse pricing limitations may hinder our ability to recoup our investment

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

depend on obtaining certain patents and protecting our proprietary rights.

success will depend, in part, on our ability to obtain patents, maintain trade secret protection and operate without infringing on the

proprietary rights of third parties or having third parties circumvent our rights.

We have filed and are actively pursuing a patent application

for our product candidates.

The patent positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain

and involve complex legal and factual questions.

Thus, there can be no assurance that our patent application will result in the issuance

of a patent, that we will develop additional proprietary products that are patentable, that any patents issued to us will provide us

with any competitive advantages or will not be challenged by any third parties, that the patents of others will not impede our ability

to do business or that third parties will not be able to circumvent our patents.

Furthermore, there can be no assurance that others will

not independently develop similar products, duplicate any of our products not under patent protection, or, if patents are issued to us,

design around the patented products we developed or will develop.

may be required to obtain licenses from third parties to avoid infringing patents or other proprietary rights.

No assurance can be given

that any licenses required under any such patents or proprietary rights would be made available, if at all, on terms we find acceptable.

If we do not obtain such licenses, we could encounter delays in the introduction of products or could find that the development, manufacture

or sale of products requiring such licenses could be prohibited.

number of pharmaceutical, biopharmaceutical and biotechnology companies and research and academic institutions have developed technologies,

filed patent applications or received patents on various technologies that may be related to or affect our business.

Some of these technologies,

applications or patents may conflict with our technologies or patent applications.

Such conflict could limit the scope of the patents,

if any, that we may be able to obtain or result in the denial of our patent applications.

In addition, if patents that cover our activities

are issued to other companies, there can be no assurance that we would be able to obtain licenses to these patents at a reasonable cost

or be able to develop or obtain alternative technology.

If we do not obtain such licenses, we could encounter delays in the introduction

of products, or could find that the development, manufacture or sale of products requiring such licenses could be prohibited.

we could incur substantial costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits against

others to have such patents declared invalid.

of our know-how and technology may not be patentable.

To protect our rights, we plan to require employees, consultants, advisors and

collaborators to enter into confidentiality agreements.

There can be no assurance, however, that these agreements will provide meaningful

protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure.

our business may be adversely affected by competitors who independently develop competing technologies, especially if we obtain no, or

only narrow, patent protection.

are subject to various government regulations.

manufacture and sale of human therapeutic products in the U.S.

and foreign jurisdictions are governed by a variety of statutes and regulations.

These laws require approval of manufacturing

facilities, controlled research and testing of products and government review and approval of a submission containing manufacturing, preclinical

and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the product for each use sought,

including adherence to current cGMP during production and storage, and control of marketing activities, including advertising and labeling.

The products we are currently developing will

require significant development, preclinical and clinical testing and investment of substantial funds prior to its commercialization.

The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that we develop successfully

this product or any future products, or that this product or any future products we develop will prove to be safe and effective in clinical

trials or receive applicable regulatory approvals.

Potential investors and shareholders should be aware of the risks, problems, delays,

expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.

If we are unable to keep up with rapid technological

changes in our field or compete effectively, we will be unable to operate profitably.

We are engaged in a rapidly changing field.

products and therapies that will compete directly with the product that we are seeking to develop and market currently exist or are being

Competition from fully integrated pharmaceutical companies and more established biotechnology companies is intense and is expected

Most of these companies have significantly greater financial resources and expertise in discovery and development, manufacturing,

preclinical and clinical testing, obtaining regulatory approvals and marketing than us.

Smaller companies may also prove to be significant

competitors, particularly through collaborative arrangements with large pharmaceutical and established biopharmaceutical or biotechnology

Many of these competitors have significant products that have been approved or are in development and operate large, well-funded

discovery and development programs.

Academic institutions, governmental agencies and other public and private research organizations also

conduct research, seek patent protection and establish collaborative arrangements for therapeutic products and clinical development and

These companies and institutions compete with us in recruiting and retaining highly qualified scientific and management personnel.

In addition to the above factors, we will face competition based on product efficacy and safety, the timing and scope of regulatory approvals,

availability of supply, marketing and sales capability, reimbursement coverage, price and patent position.

There is no assurance that

our competitors will not develop more effective or more affordable products, or achieve earlier patent protection or product commercialization,

than our own.

Other companies may succeed in developing products

earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”) approvals for such products more rapidly than

we will, or in developing products that are more effective than products we propose to develop.

While we will seek to expand our technological

capabilities in order to remain competitive, there can be no assurance that research and development by others will not render our technology

or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop, or that any therapy we develop

will be preferred to any existing or newly developed technologies.

We may request priority review for our product

candidate in the future.

These laws require approval of manufacturing facilities, controlled research and testing of products and government review and approval

of a submission containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the

safety and efficacy of the product for each use sought, including adherence to current cGMP during production and storage, and control

of marketing activities, including advertising and labeling.

products we are currently developing will require significant development, preclinical and clinical testing and investment of substantial

funds prior to its commercialization.

The process of obtaining required approvals can be costly and time-consuming, and there can be

no assurance that we develop successfully this product or any future products, or that this product or any future products we develop

will prove to be safe and effective in clinical trials or receive applicable regulatory approvals.

Potential investors and shareholders

should be aware of the risks, problems, delays, expenses and difficulties which we may encounter in view of the extensive regulatory

environment which controls our business.

we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.

are engaged in a rapidly changing field.

Other products and therapies that will compete directly with the product that we are seeking

to develop and market currently exist or are being developed.

Competition from fully integrated pharmaceutical companies and more established

biotechnology companies is intense and is expected to increase.

Most of these companies have significantly greater financial resources

and expertise in discovery and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing

Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical

and established biopharmaceutical or biotechnology companies.

Many of these competitors have significant products that have been approved

or are in development and operate large, well-funded discovery and development programs.

Academic institutions, governmental agencies

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

for therapeutic products and clinical development and marketing.

These companies and institutions compete with us in recruiting and retaining

highly qualified scientific and management personnel.

In addition to the above factors, we will face competition based on product efficacy

and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage,

price and patent position.

There is no assurance that our competitors will not develop more effective or more affordable products, or

achieve earlier patent protection or product commercialization, than our own.

companies may succeed in developing products earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”)

approvals for such products more rapidly than we will, or in developing products that are more effective than products we propose to

While we will seek to expand our technological capabilities in order to remain competitive, there can be no assurance that research

and development by others will not render our technology or products obsolete or non-competitive or result in treatments or cures superior

to any therapy we develop, or that any therapy we develop will be preferred to any existing or newly developed technologies.

may request priority review for our product candidate in the future.

The FDA may not grant priority review for our product candidate.

Moreover, even if the FDA designates such product

for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, would not assure

FDA approval.

We may be eligible for priority review designation

for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides a treatment where

no adequate therapy exists.

A priority review designation means that the goal for the FDA to review an application in six months, rather

than the standard review period of ten months.

The FDA has broad discretion with respect to whether or not to grant priority review status

to a product candidate, so even if we believe a particular product candidate is eligible for such designation or status, the FDA may decide

not to grant it.

Thus, while the FDA has granted priority review to other oncology disease products, our product candidate, should we

determine to seek priority review, may not receive similar designation.

Moreover, even if our product candidate is designated for priority

review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer any advantage with respect

to approval compared to conventional FDA procedures.

Receiving priority review from the FDA does not guarantee approval within an accelerated

timeline or thereafter.

We believe we may in some instances be able to secure

approval from the FDA or comparable non-U.S.

regulatory authorities to use accelerated development pathways.

If we are unable to obtain

such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which

could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.

We anticipate that we may seek an accelerated

approval pathway for our product candidates.

Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, or

FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed to treat a serious or

life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product

has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.

considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such

as irreversible morbidity or mortality.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory

measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure

of clinical benefit.

An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible

morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct

therapeutic advantage but is a clinically important improvement from a patient and public health perspective.

If granted, accelerated

approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory

studies to verify and describe the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s clinical

benefit, the FDA may withdraw its approval of the drug.

Prior to seeking such accelerated approval, we

will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval.

There can be no

assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application, or NDA,

for accelerated approval or any other form of expedited development, review or approval.

Similarly, there can be no assurance that after

subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development, review

or approval, even if we initially decide to do so.

Furthermore, if we decide to submit an application for accelerated approval or under

another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission or application

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

The FDA or other

authorities could also require us to conduct further studies prior to considering our application or granting approval of any

A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate

would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product

candidate and could harm our competitive position in the marketplace.

Clinical drug development involves a lengthy

and expensive process with an uncertain outcome.

We may incur additional costs or experience delays in completing, or ultimately be unable

to complete the development and commercialization of our product candidate.

Our product candidates are either in early clinical

development or have not entered into clinical trials and are in development stage.

Therefore, the risk of failure of our product candidates

It is impossible to predict when or if our product candidates will prove effective or safe in humans or will receive regulatory

Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical

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

testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome.

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

The clinical development of our product candidates is susceptible to the

risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy in a clinical trial or across a broad

population of patients, the occurrence of severe or medically or commercially unacceptable adverse events, failure to comply with protocols

or applicable regulatory requirements and determination by the FDA or any comparable non-U.S.

regulatory authority that a drug product

is not safe or effective for its intended uses.

It is possible that even if our product candidate has a beneficial effect, that effect

will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design,

measurements, conduct or analysis of our clinical trials.

Conversely, as a result of the same factors, our clinical trials may indicate

an apparent positive effect of a product candidate that is greater than the actual positive effect, if any.

Similarly, in our clinical

trials we may fail to detect toxicity of, or intolerability caused by our product candidates, or mistakenly believe that our product candidates

are toxic or not well tolerated when that is not in fact the case.

The outcome of preclinical studies and early 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

Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical

trials after achieving positive results in earlier development, and we cannot be certain that we will not face additional setbacks.

The design of a clinical trial can determine whether

its results will support approval of a product;

however, flaws in the design of a clinical trial may not become apparent until the clinical

trial is well advanced or completed.

In addition, preclinical and clinical data are often susceptible to varying interpretations and analyses.

Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless

failed to obtain marketing approval for the product candidates.

Even if we believe that the results of clinical trials for our product

candidate warrant marketing approval, the FDA or comparable non-U.S.

regulatory authorities may disagree and may not grant marketing approval

of our product candidate.

In some instances, there can be significant variability

in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes

in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the

clinical trial protocols and the rate of dropout among clinical trial participants.

Any clinical trials that we may conduct may not demonstrate

the efficacy and safety necessary to obtain regulatory approval to market our product candidate.

The results of preclinical studies and

early-stage clinical trials may not be predictive of future results.

Initial success in clinical trials may not be indicative of results

obtained when these trials are completed or in later-stage trials.

The results of preclinical studies may not be predictive of the results

of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage

Moreover, even if the FDA designates such product for priority review, that designation may not lead to a faster regulatory review or

approval process and, in any event, would not assure FDA approval.

may be eligible for priority review designation for our product candidate if the FDA determines such product candidate offers major advances

in treatment or provides a treatment where no adequate therapy exists.

A priority review designation means that the goal for the FDA

is to take action on an application in six months, rather than the standard review period of ten months.

The FDA has broad discretion

with respect to whether or not to grant priority review status to a product candidate, so even if we believe a particular product candidate

is eligible for such designation or status, the FDA may decide not to grant it.

Thus, while the FDA has granted priority review to other

oncology disease products, our product candidate, should we determine to seek priority review, may not receive similar designation.

even if our product candidate is designated for priority review, such a designation does not necessarily mean a faster regulatory review

process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures.

Receiving priority review

from the FDA does not guarantee approval within an accelerated timeline or thereafter.

believe we may in some instances be able to secure approval from the FDA or comparable non-U.S.

regulatory authorities to use accelerated

development pathways.

If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical

trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing

anticipate that we may seek an accelerated approval pathway for our product candidates.

Under the accelerated approval provisions in

the Federal Food, Drug, and Cosmetic Act, or FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval

to a product designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies

upon a determination that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely

to predict clinical benefit.

The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in

the context of a given disease, such as irreversible morbidity or mortality.

For the purposes of accelerated approval, a surrogate endpoint

is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical

benefit, but is not itself a measure of clinical benefit.

An intermediate clinical endpoint is a clinical endpoint that can be measured

earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity

or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a new drug over

available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health

If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner,

additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit.

If such post-approval studies

fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.

to seeking such accelerated approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive

such accelerated approval.

There can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue

or submit a New Drug Application, or NDA, for accelerated approval or any other form of expedited development, review or approval.

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

form of expedited development, review or approval, even if we initially decide to do so.

Furthermore, if we decide to submit an application

for accelerated approval or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no

assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted

on a timely basis, or at all.

The FDA or other non-U.S.

authorities could also require us to conduct further studies prior to considering

our application or granting approval of any type.

A failure to obtain accelerated approval or any other form of expedited development,

review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could

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

drug development involves a lengthy and expensive process with an uncertain outcome.

We may incur additional costs or experience delays

in completing, or ultimately be unable to complete the development and commercialization of our product candidate.

product candidates are either in early clinical development or have not entered into clinical trials and are in development stage.

the risk of failure of our product candidates is high.

It is impossible to predict when or if our product candidates will prove effective

or safe in humans or will receive regulatory approval.

Before obtaining marketing approval from regulatory authorities for the sale of

any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety

and efficacy of our product candidate in humans.

Clinical testing is expensive, difficult to design and implement, can take many years

to complete and is uncertain as to outcome.

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

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

to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of severe or medically or commercially

unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any

comparable non-U.S.

regulatory authority that a drug product is not safe or effective for its intended uses.

It is possible that even

if our product candidate has a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more

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

as a result of the same factors, our clinical trials may indicate an apparent positive effect of a product candidate that is greater

than the actual positive effect, if any.

Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused

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

outcome of preclinical studies 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.

Many companies in the pharmaceutical and biotechnology industries have

suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier development, and we cannot be

certain that we will not face additional setbacks.

design of a clinical trial can determine whether its results will support approval of a product;

however, flaws in the design of a clinical

trial may not become apparent until the clinical trial is well advanced or completed.

In addition, preclinical and clinical data are

often susceptible to varying interpretations and analyses.

Many companies that believed their product candidates performed satisfactorily

in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for the product candidates.

believe that the results of clinical trials for our product candidate warrant marketing approval, the FDA or comparable non-U.S.

authorities may disagree and may not grant marketing approval of our product candidate.

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

candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of

the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Any clinical trials that we may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market

our product candidate.

results of preclinical studies and early-stage clinical trials may not be predictive of future results.

Initial success in clinical trials

may not be indicative of results obtained when these trials are completed or in later-stage trials.

results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials

we commence may not be predictive of the results of the later-stage clinical trials.

In addition, initial success in clinical trials

may not be indicative of results obtained when such trials are completed.

In particular, the small number of patients in our planned

early clinical trials may make the results of these trials less predictive of the outcome of later clinical trials.

For example, even

if successful, the results of our initial clinical trials for XPro may not be predictive of the results of further clinical trials of

this drug candidate or any of our other drug candidates.

Moreover, preclinical and clinical data often are susceptible to varying interpretations

and analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical

trials nonetheless have failed to obtain marketing approval of their products.

Our future clinical trials may not ultimately be successful

or support further clinical development of any of our drug candidates.

There is a high failure rate for drug candidates proceeding through

clinical trials.

In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed.

In particular, the small number of patients in our planned early clinical trials may make the results of these trials less predictive

of the outcome of later clinical trials.

For example, even if successful, the results of our initial clinical trials for XPro may not

be predictive of the results of further clinical trials of this drug candidate or any of our other drug candidates.

Moreover, preclinical

and clinical data often are susceptible to varying interpretations and analyses, and many companies that have believed their drug candidates

performed satisfactorily in preclinical studies and clinical trials nonetheless have failed to obtain marketing approval of their products.

Our future clinical trials may not ultimately be successful or support further clinical development of any of our drug candidates.

is a high failure rate for drug candidates proceeding through clinical trials.

A number of companies in the pharmaceutical and biotechnology

industries have suffered significant setbacks in clinical development even after achieving encouraging results in earlier studies.

such setbacks in our clinical development could materially harm our business, results of operations, financial condition and prospects.

Interim top-line and preliminary data

from our planned clinical trials that we announce or publish from time to time may change as more patient data become available and are

subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we

may publish interim top-line or preliminary data from our planned clinical trials.

Interim data from clinical trials that we may complete

are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient

data become available.

Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final

data being materially different from the preliminary data we previously published.

As a result, interim and preliminary data should be

viewed with caution until the final data are available.

Adverse differences between preliminary or interim data and final data could significantly

harm our reputation and business prospects.

If clinical trials of our product candidates

fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S.

regulators, we may incur additional costs

or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

We are not permitted to commercialize, market,

promote or sell any product candidate in the United States without obtaining marketing approval from the FDA.

A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical

development even after achieving encouraging results in earlier studies.

Any such setbacks in our clinical development could materially

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

top-line and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient

data become available and are subject to audit and verification procedures that could result in material changes in the final data.

time to time, we may publish interim top-line or preliminary data from our planned clinical trials.

Interim data from clinical trials

that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues

and more patient data becomes available.

Preliminary or top-line data also remain subject to audit and verification procedures that may

result in the final data being materially different from the preliminary data we previously published.

As a result, interim and preliminary

data should be viewed with caution until the final data is available.

Adverse differences between preliminary or interim data and final

data could significantly harm our reputation and business prospects.

clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S.

regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and

commercialization of our product candidates.

are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval

from the FDA.

Comparable non-U.S.

authorities, such as the EMA, impose similar restrictions.

regulatory authorities, such as the EMA, impose similar restrictions.

We may never receive such approvals.

We must complete extensive preclinical

development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be able to obtain

these approvals.

Clinical testing is expensive, difficult to design

and implement, can take many years to complete and is inherently uncertain as to outcome.

We have not previously submitted an NDA to the

FDA or similar drug approval filings to comparable non-U.S.

regulatory authorities for any product candidate.

Any inability to successfully complete preclinical

and clinical development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory

and commercialization milestones and royalties.

In addition, if (1) we are required to conduct additional clinical trials or other testing

of our product candidate beyond the trials and testing than we contemplate, (2) we are unable to successfully complete clinical trials

of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain or are only modestly favorable,

or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to incurring additional costs, may:

be delayed in obtaining marketing approval for our product candidate;

not obtain marketing approval at all;

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

obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;

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

be required to remove the product from the market after obtaining marketing approval.

If we experience any of a number of possible

unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization

of that product candidate could be delayed or prevented.

We may experience numerous unforeseen events during,

or as a result of, clinical trials that could delay or prevent marketing approval of any of our product candidates, including:

clinical trials of our product candidate may produce unfavorable or inconclusive results;

we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

the number of patients required for clinical trials of our product

candidate may be larger than we anticipate, patient enrollment in these clinical trials may be slower than we anticipate, or participants

may drop out of these clinical trials at a higher rate than we anticipate;

data safety monitoring committees may recommend suspension, termination or a clinical hold for various reasons, including concerns about patient safety;

regulators or institutional review boards, or IRBs, may suspend or terminate the trial or impose a clinical hold for various reasons, including noncompliance with regulatory requirements or concerns about patient safety;

patients with serious, life-threatening diseases included in our clinical trials may die or suffer other adverse medical events for reasons that may not be related to our product candidate;

participating patients may be subject to unacceptable health risks;

patients may not complete clinical trials due to safety issues, side effects, or other reasons;

changes in regulatory requirements and guidance may occur, which require us to amend clinical trial protocols to reflect these changes;

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

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

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

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

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

the FDA or comparable non-U.S.

regulatory authorities may disagree with our clinical trial design or our interpretation of data from preclinical studies and clinical trials;

the FDA or comparable non-U.S.

regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;

the supply or quality of raw materials or manufactured product candidate or other materials necessary to conduct clinical trials of our product candidate may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience interruptions in supply;

the approval policies or regulations of the FDA or comparable non-U.S.

regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.

Product development costs for us will increase

if we experience delays in testing or pursuing marketing approvals and we may be required to obtain additional funds to complete clinical

trials and prepare for possible commercialization of our product candidates.

We do not know whether any preclinical tests or clinical

trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.

Significant preclinical or clinical

trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow

our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and

may harm our business and results of operations.

In addition, many of the factors that cause, or lead to, clinical trial delays may ultimately

lead to the denial of marketing approval of our product candidates.

If we experience delays or difficulties

in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all,

and our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical

trials for INKmune our DN-TNF product platform or any other product candidate if we are unable to locate and enroll a sufficient number

of eligible patients to participate in clinical trials.

Patient enrollment is a significant factor in the timing of clinical trials, and

is affected by many factors, including:

have the FDA clinical hold on XPro lifted;

the size and nature of the patient population;

the severity of the disease under investigation;

the proximity of patients to clinical sites;

the eligibility criteria for the trial;

the design of the clinical trial;

efforts to facilitate timely enrollment;

competing clinical trials;

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

Our inability to enroll a sufficient number of

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

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, delay or halt the development

of and approval processes for our product candidates and jeopardize our ability to achieve our clinical development timeline and goals,

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

Enrollment delays may also delay or

jeopardize our ability to commence sales and generate revenues from our product candidates.

Any of the foregoing could cause the value

of the Company to decline and limit our ability to obtain additional financing, if needed.

We will need to obtain FDA approval of any

proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.

A pharmaceutical product cannot be marketed in

or other countries until we have completed rigorous and extensive regulatory review processes, including approval of a brand

Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured

a formal trademark registration from the U.S.

We must complete extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate

in humans before we will be able to obtain these approvals.

testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

have not previously submitted an NDA to the FDA or similar drug approval filings to comparable non-U.S.

regulatory authorities for any

product candidate.

inability to successfully complete preclinical and clinical development could result in additional costs to us and impair our ability

to generate revenues from product sales, regulatory and commercialization milestones and royalties.

In addition, if (1) we are required

to conduct additional clinical trials or other testing of our product candidate beyond the trials and testing than we contemplate, (2)

we are unable to successfully complete clinical trials of our product candidate or other testing, (3) the results of these trials or

tests are unfavorable, uncertain or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product

candidate, we, in addition to incurring additional costs, may:

delayed in obtaining marketing approval for our product candidate;

obtain marketing approval at all;

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

approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed

subject to additional post-marketing testing or other requirements;

required to remove the product from the market after obtaining marketing approval.

we experience any of a number of possible unforeseen events in connection with clinical trials of any of our product candidates, potential

marketing approval or commercialization of that product candidate could be delayed or prevented.

may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent marketing approval of

any of our product candidates, including:

trials of our product candidate may produce unfavorable or inconclusive results;

may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

number of patients required for clinical trials of our product candidate may be larger than we anticipate, patient enrollment in

these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than

we anticipate;

safety monitoring committees may recommend suspension, termination or a clinical hold for various reasons, including concerns about

patient safety;

or institutional review boards, or IRBs, may suspend or terminate the trial or impose a clinical hold for various reasons, including

noncompliance with regulatory requirements or concerns about patient safety;

with serious, life-threatening diseases included in our clinical trials may die or suffer other adverse medical events for reasons

that may not be related to our product candidate;

participating

patients may be subject to unacceptable health risks;

may not complete clinical trials due to safety issues, side effects, or other reasons;

in regulatory requirements and guidance may occur, which require us to amend clinical trial protocols to reflect these changes;

third-party contractors, including those manufacturing our product candidate or components or ingredients thereof or conducting clinical

trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner

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

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

prospective trial sites;

who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol,

resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or

extend the clinical trial’s duration;

may have to suspend or terminate clinical trials of our product candidate for various reasons, including a finding that the participants

are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of a product candidate;

FDA or comparable non-U.S.

regulatory authorities may disagree with our clinical trial design or our interpretation of data from

preclinical studies and clinical trials;

FDA or comparable non-U.S.

regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes

or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;

supply or quality of raw materials or manufactured product candidate or other materials necessary to conduct clinical trials of our

product candidate may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience interruptions

approval policies or regulations of the FDA or comparable non-U.S.

regulatory authorities may significantly change in a manner rendering

our clinical data insufficient to obtain marketing approval.

development costs for us will increase if we experience delays in testing or pursuing marketing approvals and we may be required to obtain

additional funds to complete clinical trials and prepare for possible commercialization of our product candidates.

We do not know whether

any preclinical tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at

Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to

commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully

commercialize our product candidates and may harm our business and results of operations.

In addition, many of the factors that cause,

or lead to, clinical trial delays may ultimately lead to the denial of marketing approval of our product candidates.

we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development on

our anticipated timeline, or at all, and our receipt of necessary regulatory approvals could be delayed or prevented.

may not be able to initiate or continue clinical trials for INKmune our DN-TNF product platform or any other product candidate if we

are unable to locate and enroll a sufficient number of eligible patients to participate in clinical trials.

Patient enrollment is a significant

factor in the timing of clinical trials, and is affected by many factors, including:

size and nature of the patient population;

severity of the disease under investigation;

proximity of patients to clinical sites;

eligibility criteria for the trial;

design of the clinical trial;

to facilitate timely enrollment;

clinical trials;

and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available

therapies, including any new drugs that may be approved for the indications we are investigating.

inability to enroll a sufficient number of patients for our clinical trials could result in significant delays or may require us to abandon

one or more clinical trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product

candidates, delay or halt the development of and approval processes for our product candidates and jeopardize our ability to achieve

our clinical development timeline and goals, including the dates by which we will commence, complete and receive results from clinical

Enrollment delays may also delay or jeopardize our ability to commence sales and generate revenues from our product candidates.

Any of the foregoing could cause the value of the Company to decline and limit our ability to obtain additional financing, if needed.

will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely

impact our business.

pharmaceutical product cannot be marketed in the U.S.

or other countries until we have completed rigorous and extensive regulatory review

processes, including approval of a brand name.

Any brand names we intend to use for our product candidates will require approval from

the FDA regardless of whether we have secured a formal trademark registration from the U.S.

Patent and Trademark Office, or the USPTO.

The FDA typically conducts a review of proposed

product brand names, including an evaluation of potential for confusion with other product names.

The FDA may also object to a product

brand name if it believes the name inappropriately implies medical claims.

If the FDA objects to any of our proposed product brand names,

we may be required to adopt an alternative brand name for our product candidates.

If we adopt an alternative brand name, we will lose

the benefit of our existing trademark applications for such product candidate and may be required to expend significant additional resources

in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe the existing rights

of third parties and be acceptable to the FDA.

We may be unable to build a successful brand identity for a new trademark in a timely manner

or at all, which would limit our ability to commercialize our product candidates.

We may rely on orphan drug status to develop

and commercialize our product candidates, but orphan drug designation, if obtained, may not confer marketing exclusivity or other expected

commercial benefits as anticipated.

Market exclusivity afforded by orphan drug designation

is generally offered as an incentive to drug developers to invest in developing and commercializing products for unique diseases that

impact a limited number of patients.

The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition,

which is generally a disease or condition that affects fewer than 200,000 individuals in the United States.

Qualification to maintain

orphan drug status is generally monitored by the regulatory authorities during the orphan drug exclusivity period, currently seven years

from the date of approval in the United States.

We intend to seek orphan drug designation in the

United States for our product candidate for the treatment of AML and ovarian cancer and we expect to rely on orphan drug exclusivity for

our product candidate.

Even if granted, orphan drug designation, and related market exclusivity, in the United States could be lost.

even if we are granted orphan drug status, the FDA can still approve different drugs for use in treating the same indication or disease,

which would create a more competitive market for us, and our revenues will be diminished.

Further, for our product candidate, it is possible

that another company also holding orphan drug designation for the same product candidate will receive marketing approval for the same

indication before we do.

If that were to happen, our applications for that indication may not be approved until the competing company’s

period of exclusivity expires.

Even if we are the first to obtain marketing authorization for an orphan drug indication, there are circumstances

under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as

if the later product is shown to be clinically superior to the orphan product, or if the later product is deemed a different product than

Further, the seven-year marketing exclusivity would not prevent competitors from obtaining approval of the same product candidate

as ours for indications other than those in which we have been granted orphan drug designation, or for the use of other types of products

in the same indications as our orphan product.

If the market opportunities for our product

candidates are smaller than we believe they are, our revenues may be adversely affected, and our business may suffer.

Because the target

patient populations of our product candidates are small, we must be able to successfully identify patients and capture a significant market

The FDA typically conducts a review of proposed product brand names, including an evaluation of potential for confusion with other product

The FDA may also object to a product brand name if it believes the name inappropriately implies medical claims.

If the FDA objects

to any of our proposed product brand names, we may be required to adopt an alternative brand name for our product candidates.

an alternative brand name, we will lose the benefit of our existing trademark applications for such product candidate and may be required

to expend significant additional resources in an effort to identify a suitable product brand name that would qualify under applicable

trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.

We may be unable to build a successful

brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our product candidates.

may rely on orphan drug status to develop and commercialize our product candidates, but orphan drug designation, if obtained, may not

confer marketing exclusivity or other expected commercial benefits as anticipated.

exclusivity afforded by orphan drug designation is generally offered as an incentive to drug developers to invest in developing and commercializing

products for unique diseases that impact a limited number of patients.

The FDA may grant orphan drug designation to drugs intended to

treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United

Qualification to maintain orphan drug status is generally monitored by the regulatory authorities during the orphan drug exclusivity

period, currently seven years from the date of approval in the United States.

intend to seek orphan drug designation in the United States for our product candidate for the treatment of AML and ovarian cancer and

we expect to rely on orphan drug exclusivity for our product candidate.

Even if granted, orphan drug designation, and related market

exclusivity, in the United States could be lost.

Further, even if we are granted orphan drug status, the FDA can still approve different

drugs for use in treating the same indication or disease, which would create a more competitive market for us, and our revenues will

be diminished.

for our product candidate, it is possible that another company also holding orphan drug designation for the same product candidate will

receive marketing approval for the same indication before we do.

If that were to happen, our applications for that indication may not

be approved until the competing company’s period of exclusivity expires.

Even if we are the first to obtain marketing authorization

for an orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during

the seven-year period of marketing exclusivity, such as if the later product is shown to be clinically superior to the orphan product,

or if the later product is deemed a different product than ours.

Further, the seven-year marketing exclusivity would not prevent competitors

from obtaining approval of the same product candidate as ours for indications other than those in which we have been granted orphan drug

designation, or for the use of other types of products in the same indications as our orphan product.

the market opportunities for our product candidates are smaller than we believe they are, our revenues may be adversely affected, and

our business may suffer.

Because the target patient populations of our product candidates are small, we must be able to successfully

identify patients and capture a significant market share to achieve and maintain profitability.

focus our research and product development on treatments for certain cancer indications.

Our projections of both the number of people

who have failed other therapies or have limited medical options for such indications, are based on estimates.

These estimates may prove

to be incorrect and new studies may change the estimated incidence or prevalence.

The number of patients with such diseases in the United

States, Europe and elsewhere may turn out to be lower than expected or may not be otherwise amenable to treatment with our products,

or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations

and our business.

Additionally, because our target patient populations are small, we will be required to capture a significant market

share to achieve and maintain profitability.

We focus our research and product development

on treatments for certain cancer indications.

Our projections of both the number of people who have failed other therapies or have limited

medical options for such indications, are based on estimates.

These estimates may prove to be incorrect and new studies may change the

estimated incidence or prevalence.

The number of patients with such diseases in the United States, Europe and elsewhere may turn out to

be lower than expected or may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult

to identify or gain access to, all of which would adversely affect our results of operations and our business.

Additionally, because our

target patient populations are small, we will be required to capture a significant market share to achieve and maintain profitability.

We may fail to comply with regulatory requirements .

Our success will be dependent upon our ability,

and our collaborative partners’ abilities, to maintain compliance with regulatory requirements, including cGMP, and safety reporting

The failure to comply with applicable regulatory requirements can result in, among other things, fines, injunctions, civil

penalties, total or partial suspension of regulatory approvals, refusal to approve pending applications, recalls or seizures of products,

operating and production restrictions and criminal prosecutions.

Even if our product candidates receive marketing

approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical

community necessary for commercial success and the market opportunity for the product candidates may be smaller than we estimate.

We have never commercialized a product.

INKmune, our DN-TNF product platform (INB03 or XPro), or any other product candidate we develop is approved by the appropriate regulatory

authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party

payors and others in the medical community.

For example, physicians are often reluctant to switch their patients from existing therapies

even when new and potentially more effective or convenient treatments enter the market.

Further, patients often acclimate to the therapy

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

switch therapies due to lack of reimbursement for existing therapies.

Efforts to educate the medical community and third-party

payors on the benefits of our product candidate may require significant resources and may not be successful.

If our product candidate

is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become

The degree of market acceptance of INmune or any other product candidate we develop, if approved for commercial sale, will

depend on a number of factors, including:

the efficacy and safety of the product;

the potential advantages of the product compared to alternative treatments;

the prevalence and severity of any side effects;

the clinical indications for which the product is approved;

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

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

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

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

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

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

the strength of sales, marketing and distribution support;

the approval of other new products for the same indications;

changes in the standard of care for the targeted indications for the product;

the timing of market introduction of our approved products as well as competitive products and other therapies;

availability and amount of reimbursement from government payors, managed care plans and other third-party payors;

adverse publicity about the product or favorable publicity about competitive products;

potential product liability claims.

The potential market opportunities for our product

candidate are difficult to estimate precisely.

Our estimates of the potential market opportunities are predicated on many assumptions,

including industry knowledge and publications, third-party research reports and other surveys.

While we believe that our internal assumptions

are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain

and the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions proves to be inaccurate,

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

Even if we obtain regulatory approvals for

INKmune and/or any product from our DN-TNF platform (INB03, XPro) those approvals and ongoing regulation of our products may limit how

we manufacture and market our products, which could prevent us from realizing the full benefit of our efforts.

If we obtain regulatory approvals, INKmune and/or

the DN-TNF product platform, and the manufacturing facilities used for its production will be subject to continual review, including periodic

inspections, by the FDA and other United States and foreign regulatory authorities.

In addition, regulatory authorities may impose significant

restrictions on the indicated uses or marketing of INKmune or other products that we may develop.

These and other factors may significantly

restrict our ability to successfully commercialize INKmune.

We and many of our vendors and suppliers will

be required to comply with current Good Manufacturing Practices, or GMP, which include requirements relating to quality control and quality

assurance as well as to the corresponding maintenance of records and documentation.

Furthermore, any manufacturing facilities will need

to be approved by regulatory agencies before these facilities can be used to manufacture, and they will also be subject to additional

regulatory inspections.

Any material changes we may make to our manufacturing process may require approval by the FDA and state or foreign

regulatory authorities.

Failure to comply with FDA or other applicable regulatory requirements may result in criminal prosecution, civil

penalties, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.

We must also report adverse events that occur

when our products are used.

The discovery of previously unknown problems with INKmune, the DN-TNF product platform or manufacturing facilities

used to manufacture INKmune, or the DN-TNF product platform may result in restrictions or sanctions on our products or manufacturing facilities,

including withdrawal of our products from the market.

Regulatory agencies may also require us to reformulate our products, conduct additional

clinical trials, make changes in the labeling of our product or obtain re-approvals.

This may cause our reputation in the marketplace

to suffer or subject us to lawsuits, including class action suits.

If our product candidates receive marketing approval and

we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not

previously identified, our ability to market the drugs could be compromised.

Clinical trials of our product candidates will

be conducted in carefully defined subsets of patients who have agreed to enter into clinical trials.

Consequently, it is possible that

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

any, or alternatively fail to identify undesirable side effects.

If, following approval of our product candidate, we, or others, discover

that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, any of

the following adverse events could occur:

regulatory authorities may withdraw their approval of the drug or seize the drug;

we may be required to recall the drug or change the way the drug is administered;

additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;

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

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

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

we could be sued and held liable for harm caused to patients;

the drug may become less competitive;

our reputation may suffer.

Any of these events could have a material and

adverse effect on our operations and business.

Any product candidate for which we obtain

marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional

activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities.

These requirements include submissions of safety

and other post-marketing information, reports, registration and listing requirements, good manufacturing practices, or GMP requirements

relating to quality control, quality assurance and corresponding maintenance of records and documents, and recordkeeping.

Even if marketing

approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may

be marketed or to conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the safety

or efficacy of the product.

The FDA closely regulates the post-approval marketing and promotion of pharmaceutical products to ensure such

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

In addition, later discovery of previously unknown

problems with our products, manufacturing processes, or failure to comply with regulatory requirements, may lead to various adverse results,

restrictions on such products, manufacturers or manufacturing processes;

restrictions on the labeling or marketing of a product;

restrictions on product distribution or use;

requirements to conduct post-marketing clinical trials;

requirements to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval;

warning letters issued by the FDA or other regulatory authorities;

withdrawal of the products from the market;

refusal to approve pending applications or supplements to approved applications that we submit;

recall of products, fines, restitution or disgorgement of profits or revenue;

suspension, revocation or withdrawal of marketing approvals;

refusal to permit the import or export of our products;

injunctions or the imposition of civil or criminal penalties.

We currently have no marketing and sales

organization and have no experience in marketing products.

If we are unable to establish marketing and sales capabilities or enter into

agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

We currently have no sales, marketing or distribution

capabilities and have no experience as a company in marketing products.

If we develop internal sales, marketing and distribution organization,

this will require significant capital expenditures, management resources and time, and we would have to compete with other pharmaceutical

and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decide not to establish internal

sales, marketing and distribution capabilities, we expect to pursue collaborative arrangements regarding the sales, marketing and distribution

of our products.

However, we may not be able to establish or maintain such collaborative arrangements, or if we are able to do so, their

sales forces may not be successful in marketing our products.

Any revenue we receive would depend upon the efforts of such third parties,

which may not be successful.

We may have little or no control over the sales, marketing and distribution efforts of such third parties

and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves.

We also face competition

in our search for third parties to assist us with the sales, marketing and distribution efforts of our product candidates.

no assurance that we will be able to develop internal sales, marketing distribution capabilities or establish or maintain relationships

with third-party collaborators to commercialize any product in the United States or overseas.

We face substantial competition from other

pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.

The development and commercialization of new drug

products is highly competitive.

We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical

companies and biotechnology companies worldwide with respect to INKmune, our DN-TNF product platform, and any other of our product candidates

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

Specifically, due to the large unmet medical need, global demographics and

relatively attractive reimbursement dynamics, the oncology market is fiercely competitive and there are a number of large pharmaceutical

and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment

Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective, have

fewer or more tolerable side effects or are less costly than any product candidates that we are currently developing or that we may develop,

which could render our product candidates obsolete and noncompetitive.

We rely on key personnel and, if we are

unable to retain or motivate key personnel or hire qualified personnel, we may not be able to grow effectively.

We are dependent on certain members of our management,

the loss of services of one or more of whom could materially adversely affect us.

In particular, our success depends to a significant

extent upon the continued services of Dr.

may fail to comply with regulatory requirements .

success will be dependent upon our ability, and our collaborative partners’ abilities, to maintain compliance with regulatory requirements,

including cGMP, and safety reporting obligations.

The failure to comply with applicable regulatory requirements can result in, among

other things, fines, injunctions, civil penalties, total or partial suspension of regulatory approvals, refusal to approve pending applications,

recalls or seizures of products, operating and production restrictions and criminal prosecutions.

if our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients,

third-party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidates

may be smaller than we estimate.

have never commercialized a product.

Even if INKmune, our DN-TNF product platform (INB03 or XPro), or any other product candidate we

develop is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market

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

For example, physicians are often reluctant

to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market.

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

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

to educate the medical community and third-party payors on the benefits of our product candidate may require significant resources and

may not be successful.

If our product candidate is approved but does not achieve an adequate level of market acceptance, we may not generate

significant revenues and we may not become profitable.

The degree of market acceptance of INmune or any other product candidate we develop,

if approved for commercial sale, will depend on a number of factors, including:

efficacy and safety of the product;

potential advantages of the product compared to alternative treatments;

prevalence and severity of any side effects;

clinical indications for which the product is approved;

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

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

ability to offer the product for sale at competitive prices;

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

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

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

strength of sales, marketing and distribution support;

approval of other new products for the same indications;

in the standard of care for the targeted indications for the product;

timing of market introduction of our approved products as well as competitive products and other therapies;

and amount of reimbursement from government payors, managed care plans and other third-party payors;

publicity about the product or favorable publicity about competitive products;

product liability claims.

potential market opportunities for our product candidate are difficult to estimate precisely.

Our estimates of the potential market opportunities

are predicated on many assumptions, including industry knowledge and publications, third-party research reports and other surveys.

we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of

our management, are inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions prove to be inaccurate, the actual markets for our product candidate could be smaller than our estimates of

the potential market opportunities.

if we obtain regulatory approvals for INKmune and/or any product from our DN-TNF platform (INB03, XPro) those approvals and ongoing regulation

of our products may limit how we manufacture and market our products, which could prevent us from realizing the full benefit of our efforts.

we obtain regulatory approvals, INKmune and/or the DN-TNF product platform, and the manufacturing facilities used for its production

will be subject to continual review, including periodic inspections, by the FDA and other United States and foreign regulatory authorities.

In addition, regulatory authorities may impose significant restrictions on the indicated uses or marketing of INKmune or other products

that we may develop.

These and other factors may significantly restrict our ability to successfully commercialize INKmune.

and many of our vendors and suppliers will be required to comply with current Good Manufacturing Practices, or GMP, which include requirements

relating to quality control and quality assurance as well as to the corresponding maintenance of records and documentation.

any manufacturing facilities will need to be approved by regulatory agencies before these facilities can be used to manufacture, and

they will also be subject to additional regulatory inspections.

Any material changes we may make to our manufacturing process may require

approval by the FDA and state or foreign regulatory authorities.

Failure to comply with FDA or other applicable regulatory requirements

may result in criminal prosecution, civil penalties, recall or seizure of products, partial or total suspension of production or withdrawal

of a product from the market.

must also report adverse events that occur when our products are used.

The discovery of previously unknown problems with INKmune, the

DN-TNF product platform or manufacturing facilities used to manufacture INKmune, or the DN-TNF product platform may result in restrictions

or sanctions on our products or manufacturing facilities, including withdrawal of our products from the market.

Regulatory agencies may

also require us to reformulate our products, conduct additional clinical trials, make changes in the labeling of our product or obtain

re-approvals.

This may cause our reputation in the marketplace to suffer or subject us to lawsuits, including class action suits.

our product candidates receive marketing approval and we, or others, later discover that the drug is less effective than previously believed

or causes undesirable side effects that were not previously identified, our ability to market the drugs could be compromised.

trials of our product candidates will be conducted in carefully defined subsets of patients who have agreed to enter into clinical trials.

Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater

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

If, following approval of our product

candidate, we, or others, discover that the drug is less effective than previously believed or causes undesirable side effects that were

not previously identified, any of the following adverse events could occur:

authorities may withdraw their approval of the drug or seize the drug;

may be required to recall the drug or change the way the drug is administered;

restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;

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

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

may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to

could be sued and held liable for harm caused to patients;

drug may become less competitive;

reputation may suffer.

of these events could have a material and adverse effect on our operations and business.

product candidate for which we obtain marketing approval, along with the manufacturing processes, qualification testing, post-approval

clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the

FDA and other regulatory authorities.

requirements include submissions of safety and other post-marketing information, reports, registration and listing requirements, good

manufacturing practices, or GMP requirements relating to quality control, quality assurance and corresponding maintenance of records

and documents, and recordkeeping.

Even if marketing approval of our product candidate is granted, the approval may be subject to limitations

on the indicated uses for which the product may be marketed or to conditions of approval or contain requirements for costly post-marketing

testing and surveillance to monitor the safety or efficacy of the product.

The FDA closely regulates the post-approval marketing and

promotion of pharmaceutical products to ensure such products are marketed only for the approved indications and in accordance with the

provisions of the approved labeling.

addition, later discovery of previously unknown problems with our products, manufacturing processes, or failure to comply with regulatory

requirements, may lead to various adverse results, including:

on such products, manufacturers or manufacturing processes;

on the labeling or marketing of a product;

on product distribution or use;

to conduct post-marketing clinical trials;

to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval;

letters issued by the FDA or other regulatory authorities;

of the products from the market;

to approve pending applications or supplements to approved applications that we submit;

of products, fines, restitution or disgorgement of profits or revenue;

revocation or withdrawal of marketing approvals;

to permit the import or export of our products;

or the imposition of civil or criminal penalties.

currently have no marketing and sales organization and have no experience in marketing products.

If we are unable to establish marketing

and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate

product revenue.

currently have no sales, marketing or distribution capabilities and have no experience as a company in marketing products.

If we develop

internal sales, marketing and distribution organization, this will require significant capital expenditures, management resources and

time, and we would have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing

and sales personnel.

we are unable or decide not to establish internal sales, marketing and distribution capabilities, we expect to pursue collaborative arrangements

regarding the sales, marketing and distribution of our products.

However, we may not be able to establish or maintain such collaborative

arrangements, or if we are able to do so, their sales forces may not be successful in marketing our products.

Any revenue we receive

would depend upon the efforts of such third parties, which may not be successful.

We may have little or no control over the sales, marketing

and distribution efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product

candidates ourselves.

We also face competition in our search for third parties to assist us with the sales, marketing and distribution

efforts of our product candidates.

There can be no assurance that we will be able to develop internal sales, marketing distribution capabilities

or establish or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas.

face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to

compete effectively.

development and commercialization of new drug products is highly competitive.

We expect that we will face significant competition from

major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to INKmune, our

DN-TNF product platform, and any other of our product candidates that we may seek to develop or commercialize in the future.

Specifically,

due to the large unmet medical need, global demographics and relatively attractive reimbursement dynamics, the oncology market is fiercely

competitive and there are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are

pursuing the development of product candidates for the treatment of cancer.

Our competitors may succeed in developing, acquiring or licensing

technologies and drug products that are more effective, have fewer or more tolerable side effects or are less costly than any product

candidates that we are currently developing or that we may develop, which could render our product candidates obsolete and noncompetitive.

rely on key personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to grow

are dependent on certain members of our management, the loss of services of one or more of whom could materially adversely affect us.

In particular, our success depends to a significant extent upon the continued services of Dr.

Tesi, our President and CEO.

Tesi has overseen INmune Bio since inception and

provides leadership for our growth and operations strategy as well as being an inventor of our patents.

Although we have entered into

an employment agreement with Dr.

Tesi, if he were to nevertheless terminate his employment with us, the loss of the services of Dr.

would have a material adverse effect on our growth, revenues, and prospective business.

We are also highly dependent on the other principal

members of our management and scientific team.

We are not aware of any present intention of any of our key personnel to leave our company

or to retire.

The loss of any of our key personnel, or the inability to attract and retain qualified personnel, may significantly delay

or prevent the achievement of our research, development or business objectives and could materially adversely affect our business, financial

condition and results of operations.

Our ability to manage growth effectively will

require us to continue to implement and improve our management systems and to recruit and train new employees.

There can be no assurance

that we will be able to successfully attract and retain skilled and experienced personnel.

Product liability lawsuits against us could

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

We face an inherent risk of product liability

claims as a result of the clinical testing of our product candidate despite obtaining appropriate informed consents from our clinical

trial participants.

We will face an even greater risk if we commercially sell any product that we may develop.

For example, we may be

sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing,

marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure

to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.

Claims could also be asserted under

state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial

liabilities or be required to limit commercialization of our product candidate.

Regardless of the merits or eventual outcome, liability

claims may result in:

decreased demand for our product candidate or products that we may develop;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend resulting litigation;

substantial monetary awards to trial participants or patients;

loss of revenue;

reduced resources of our management to pursue our business strategy;

the inability to commercialize any products that we may develop.

Although we plan to maintain general liability

insurance, this insurance may not fully cover potential liabilities that we may incur.

The cost of any product liability litigation or

other proceeding, even if resolved in our favor, could be substantial.

In addition, insurance coverage is becoming increasingly expensive.

If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product

liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate, which could

adversely affect our business, financial condition, results of operations and prospects.

We will need to grow the size and capabilities

of our organization, and we may experience difficulties in managing this growth.

To execute our business plan, we will need to

rapidly add other management, accounting, regulatory, manufacturing and scientific staff.

We currently have 11 full time employees and

retain the services of additional personnel on an independent contractor basis.

We will need to attract, retain and motivate a significant

number of new additional managerial, operational, sales, marketing, financial, and other personnel, as well as highly skilled scientific

and medical personnel, and to expand our capabilities to successfully pursue our research, development, manufacturing and commercialization

efforts and secure collaborations to market and distribute our products.

This growth may strain our existing managerial, operational,

financial and other resources.

We also intend to add personnel in our research and development and manufacturing departments as we expand

our clinical trial and research capabilities.

Any inability to attract and retain qualified employees to enable our planned growth and

establish additional capabilities or our failure to manage our growth effectively could delay or curtail our product development and commercialization

efforts and harm our business.

If we or any of our third-party manufacturers

do not maintain high standards of manufacturing, our ability to develop and commercialize our product candidate could be delayed or curtailed.

We and any third parties that we may use in the

future to manufacture our products must continuously adhere to cGMP regulations rigorously enforced by the FDA through its facilities

inspection program.

If our facilities or the facilities of third parties who produce our products do not pass a pre-approval inspection,

the FDA will not grant market approval for our product candidates.

In complying with cGMP, we and any third-party manufacturers will need

to expend significant time, money and effort in production, record-keeping and quality control to assure that each component of our product

candidates meets applicable specifications and other requirements.

We or any of these third-party manufacturers may also be subject to

comparable or more stringent regulations of foreign regulatory authorities.

If we or any of our third-party manufacturers fail to comply

with these requirements, we may be subject to regulatory action, which could delay or curtail our ability to develop, obtain regulatory

approval of, and commercialize our product candidates.

If our component part manufacturers and suppliers fail to provide components of

sufficient quality, and that meet our required specifications, our clinical trials or commercialization of our product candidates could

be delayed or halted, and we could face product liability claims.

There can be no assurance we can manufacture a scalable quantity of

our product for clinical trials or commercialization.

If we or our third-party manufacturers use

hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development activities involve

the controlled use of potentially hazardous substances, including chemical and biological materials, by us and any third-party manufacturers.

We and such manufacturers will be subject to federal, state and local laws and regulations in the United States governing the use, manufacture,

storage, handling and disposal of medical and hazardous materials.

Although we will seek to ensure that our procedures for using, storing

and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or

injury resulting from medical or hazardous materials.

As a result of any such contamination or injury, we may incur liability or local,

city, state or federal authorities may curtail the use of these materials and interrupt our business operations.

In the event of an accident,

we could be held liable for damages or penalized with fines, and the liability could exceed our resources.

We do not have any insurance

for liabilities arising from medical or hazardous materials.

Compliance with applicable environmental laws and regulations is expensive,

and current or future environmental regulations may impair our research, development and production efforts, which could harm our business,

prospects, financial condition or results of operations.

We plan to rely on third parties to conduct

clinical trials for our product candidates.

Any failure by a third party to meet its obligations with respect to the clinical development

of our product candidate may delay or impair our ability to obtain regulatory approval for our product candidates.

We plan to rely on academic institutions and private

oncology centers to conduct clinical trials relating to our product candidates.

Our reliance on third parties to conduct clinical trials

could, depending on the actions of such third parties, jeopardize the validity of the clinical data generated and adversely affect our

ability to obtain marketing approval from the FDA or other applicable regulatory authorities.

Such clinical trial arrangements will provide

us with information rights with respect to the clinical data, including access to and the ability to use and reference the data, including

for our own regulatory filings, resulting from the clinical trials.

If investigators or institutions breach their obligations with respect

to the clinical trials of our product candidate, or if the data proves to be inadequate, then our ability to design and conduct any future

clinical trials may be adversely affected.

Our reliance on these third parties for research

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

we will design our clinical trials and will remain responsible for ensuring that each of our clinical trials is conducted in accordance

with the general investigational plan and protocols for the trial.

Moreover, the FDA requires us to comply with standards, commonly referred

to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and

reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.

reliance on third parties that we do not control will not relieve us of these responsibilities and requirements.

We also are required

to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov,

within specified timeframes.

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

Furthermore, these third parties may also have

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

If these third parties do not successfully carry out their contractual

duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we

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

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

We also expect to rely on other third parties

to store and distribute drug supplies for our clinical trials.

Any performance failure on the part of our distributors could delay clinical

development or marketing approval of our product candidate or commercialization of our products, producing additional losses and depriving

us of potential product revenue.

Recent legislative and regulatory activity

may exert downward pressure on potential pricing and reimbursement for our products, if approved, could materially affect our opportunity

to commercialize such products.

The United States and several other jurisdictions

are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that

could affect our ability to sell any of our products profitably, if approved.

Among policy-makers and payors in the United States and

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

improving quality and/or expanding access to healthcare.

In the United States, the pharmaceutical industry has been a particular focus

of these efforts and has been significantly affected by major legislative initiatives.

There have been, and likely will continue to be,

legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing

or lowering the cost of healthcare.

We cannot predict the initiatives that may be adopted in the future.

The continuing efforts of the

government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare

may adversely affect:

the demand for any of our products, if approved;

our ability to set a price that we believe is fair for any of our products, if approved;

our ability to generate revenues and achieve or maintain profitability;

the level of taxes that we are required to pay;

the availability of capital.

In March 2010, the Affordable Care Act, or the

ACA, became law in the United States (see “Business — Government Regulation”).

The goal of ACA is to reduce the cost

of healthcare, broaden access to health insurance, constrain healthcare spending, enhance remedies against fraud and abuse, add transparency

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

policy reforms, and substantially change the way healthcare is financed by both governmental and private insurers.

While we cannot predict

what impact on federal reimbursement policies this legislation will have in general or on our business specifically, ACA may result in

downward pressure on pharmaceutical reimbursement, which could negatively affect market acceptance of any of our products, if they are

We cannot predict what healthcare reform initiatives

may be adopted in the future.

Further federal, state and foreign legislative and regulatory developments are likely, and we expect ongoing

initiatives to increase pressure on drug pricing.

Such reforms could have an adverse effect on anticipated revenues from product candidates

that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability

to develop product candidates.

Changes in U.S.

patent law could diminish

the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other pharmaceutical companies,

our success is heavily dependent on intellectual property, particularly on obtaining and enforcing patents.

Obtaining and enforcing patents

in the pharmaceutical industry involves both technological and legal complexity, and therefore, is costly, time-consuming and inherently

In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation.

Supreme Court rulings have either narrowed the scope of patent protection available in certain circumstances or weakened the

rights of patent owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain patents in the

future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

In September 2011, the Leahy-Smith America Invents

Act, or the American Invents Act, or AIA, was signed into law.

The AIA includes a number of significant changes to U.S.

patent law, including

provisions that affect the way patent applications will be prosecuted and may also affect patent litigation.

The USPTO is currently developing

regulations and procedures to govern administration of the AIA, and many of the substantive changes to patent law associated with the

It is not clear what other, if any, impact the AIA will have on the operation of our business.

Moreover, the AIA and its implementation

could increase the uncertainties and costs surrounding the prosecution of our patent application, which could have a material adverse

effect on our business and financial condition.

An important change introduced by the AIA is that,

as of March 16, 2013, the United States transitioned to a “first-to-file” system for deciding which party should be granted

a patent when two or more patent applications are filed by different parties claiming the same invention.

A third party that files a patent

application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we had

made the invention before it was made by the third party.

This will require us to be cognizant going forward of the time from invention

to filing of a patent application.

Furthermore, our ability to obtain and maintain valid and enforceable patents depends on whether the

differences between our technology and the prior art allow our technology to be patentable over the prior art.

Since patent applications

in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we were the

first to either (1) file any patent application related to our product candidates or (2) invent any of the inventions claimed in our patents

or patent applications.

Among some of the other changes introduced by

the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge

any issued patent in the USPTO.

Tesi has overseen INmune Bio since inception and provides leadership for our growth and operations strategy as well as being an inventor

of our patents.

Although we have entered into an employment agreement with Dr.

Tesi, if he were to nevertheless terminate his employment

with us, the loss of the services of Dr.

Tesi, would have a material adverse effect on our growth, revenues, and prospective business.

We are also highly dependent on the other principal members of our management and scientific team.

We are not aware of any present intention

of any of our key personnel to leave our company or to retire.

The loss of any of our key personnel, or the inability to attract and

retain qualified personnel, may significantly delay or prevent the achievement of our research, development or business objectives and

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

ability to manage growth effectively will require us to continue to implement and improve our management systems and to recruit and train

new employees.

There can be no assurance that we will be able to successfully attract and retain skilled and experienced personnel.

liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any

products that we may develop.

face an inherent risk of product liability claims as a result of the clinical testing of our product candidate despite obtaining appropriate

informed consent from our clinical trial participants.

We will face an even greater risk if we commercially sell any product that we

For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during

clinical testing, manufacturing, marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing,

defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.

could also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims,

we may incur substantial liabilities or be required to limit commercialization of our product candidate.

Regardless of the merits or

eventual outcome, liability claims may result in:

demand for our product candidate or products that we may develop;

to our reputation and significant negative media attention;

of clinical trial participants;

costs to defend resulting litigation;

monetary awards to trial participants or patients;

resources of our management to pursue our business strategy;

inability to commercialize any products that we may develop.

we plan to maintain general liability insurance, this insurance may not fully cover potential liabilities that we may incur.

of any product liability litigation or other proceeding, even if resolved in our favor, could be substantial.

In addition, insurance

coverage is becoming increasingly expensive.

If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost

or to otherwise protect against potential product liability claims, it could prevent or inhibit the development and commercial production

and sale of our product candidate, which could adversely affect our business, financial condition, results of operations and prospects.

will need to increase the size and capabilities of our organization, and we may experience difficulties in managing this growth.

execute our business plan, we will need to rapidly add other management, accounting, regulatory, manufacturing and scientific staff.

We currently have 11 full-time employees, 6 part-time employees and retain the services of additional personnel on an independent contractor

We will need to attract, retain and motivate a significant number of new additional managerial, operational, sales, marketing,

financial, and other personnel, as well as highly skilled scientific and medical personnel, and to expand our capabilities to successfully

pursue our research, development, manufacturing and commercialization efforts and secure collaborations to market and distribute our

This growth may strain our existing managerial, operational, financial and other resources.

We also intend to add personnel

in our research and development and manufacturing departments as we expand our clinical trial and research capabilities.

Any inability

to attract and retain qualified employees to enable our planned growth and establish additional capabilities or our failure to manage

our growth effectively could delay or curtail our product development and commercialization efforts and harm our business.

we or any of our third-party manufacturers do not maintain high standards of manufacturing, our ability to develop and commercialize

our product candidate could be delayed or curtailed.

and any third parties that we may use in the future to manufacture our products must continuously adhere to cGMP regulations rigorously

enforced by the FDA through its facilities inspection program.

If our facilities or the facilities of third parties who produce our products

do not pass a pre-approval inspection, the FDA will not grant market approval for our product candidates.

In complying with cGMP, we

and any third-party manufacturers will need to expend significant time, money and effort in production, record-keeping and quality control

to assure that each component of our product candidates meets applicable specifications and other requirements.

We or any of these third-party

manufacturers may also be subject to comparable or more stringent regulations of foreign regulatory authorities.

If we or any of our

third-party manufacturers fail to comply with these requirements, we may be subject to regulatory action, which could delay or curtail

our ability to develop, obtain regulatory approval of, and commercialize our product candidates.

If our component part manufacturers

and suppliers fail to provide components of sufficient quality, and that meet our required specifications, our clinical trials or commercialization

of our product candidates could be delayed or halted, and we could face product liability claims.

There can be no assurance we can manufacture

a scalable quantity of our product for clinical trials or commercialization.

we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law,

we may be liable for damages.

research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological

materials, by us and any third-party manufacturers.

We and such manufacturers will be subject to federal, state and local laws and regulations

in the United States governing the use, manufacture, storage, handling and disposal of medical and hazardous materials.

Although we will

seek to ensure that our procedures for using, storing and disposing of these materials comply with legally prescribed standards, we cannot

completely eliminate the risk of contamination or injury resulting from medical or hazardous materials.

As a result of any such contamination

or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our

business operations.

In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could

exceed our resources.

We do not have any insurance for liabilities arising from medical or hazardous materials.

Compliance with applicable

environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development

and production efforts, which could harm our business, prospects, financial condition or results of operations.

plan to rely on third parties to conduct clinical trials for our product candidates.

Any failure by a third party to meet its obligations

with respect to the clinical development of our product candidate may delay or impair our ability to obtain regulatory approval for our

product candidates.

plan to rely on academic institutions and private oncology centers to conduct clinical trials relating to our product candidates.

reliance on third parties to conduct clinical trials could, depending on the actions of such third parties, jeopardize the validity of

the clinical data generated and adversely affect our ability to obtain marketing approval from the FDA or other applicable regulatory

clinical trial arrangements will provide us with information rights with respect to the clinical data, including access to and the ability

to use and reference the data, including for our own regulatory filings, resulting from the clinical trials.

If investigators or institutions

breach their obligations with respect to the clinical trials of our product candidate, or if the data proves to be inadequate, then our

ability to design and conduct any future clinical trials may be adversely affected.

reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve

us of our responsibilities.

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

clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.

Moreover, the FDA requires

us to comply with standards, commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results

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

of trial participants are protected.

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

and requirements.

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

database, ClinicalTrials.gov, within specified timeframes.

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

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

If these third parties do

not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory

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

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

also expect to rely on other third parties to store and distribute drug supplies for our clinical trials.

Any performance failure on

the part of our distributors could delay clinical development or marketing approval of our product candidate or commercialization of

our products, producing additional losses and depriving us of potential product revenue.

legislative and regulatory activity may exert downward pressure on potential pricing and reimbursement for our products, if approved,

could materially affect our opportunity to commercialize such products.

United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals

to change the healthcare system in ways that could affect our ability to sell any of our products profitably, if approved.

Among policy-makers

and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated

goals of containing healthcare costs, improving quality and/or expanding access to healthcare.

In the United States, the pharmaceutical

industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

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

availability of healthcare and containing or lowering the cost of healthcare.

We cannot predict the initiatives that may be adopted in

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare

services to contain or reduce costs of healthcare may adversely affect:

demand for any of our products, if approved;

ability to set a price that we believe is fair for any of our products, if approved;

ability to generate revenues and achieve or maintain profitability;

level of taxes that we are required to pay;

availability of capital.

March 2010, the Affordable Care Act, or the ACA, became law in the United States (see “Business — Government Regulation”).

The goal of ACA is to reduce the cost of healthcare, broaden access to health insurance, constrain healthcare spending, enhance remedies

against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the

health industry, impose additional health policy reforms, and substantially change the way healthcare is financed by both governmental

and private insurers.

While we cannot predict what impact on federal reimbursement policies this legislation will have in general or

on our business specifically, ACA may result in downward pressure on pharmaceutical reimbursement, which could negatively affect market

acceptance of any of our products, if they are approved.

cannot predict what healthcare reform initiatives may be adopted in the future.

Further federal, state and foreign legislative and regulatory

developments are likely, and we expect ongoing initiatives to increase pressure on drug pricing.

Such reforms could have an adverse effect

on anticipated revenues from product candidates that we may successfully develop and for which we may obtain regulatory approval and

may affect our overall financial condition and ability to develop product candidates.

patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly on obtaining

and enforcing patents.

Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity,

and therefore, is costly, time-consuming and inherently uncertain.

In addition, the United States has recently enacted and is currently

implementing wide-ranging patent reform legislation.

Further, recent U.S.

Supreme Court rulings have either narrowed the scope of patent

protection available in certain circumstances or weakened the rights of patent owners in certain situations.

In addition to increasing

uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect

to the value of patents, once obtained.

September 2011, the Leahy-Smith America Invents Act, or the American Invents Act, or AIA, was signed into law.

The AIA includes a number

of significant changes to U.S.

patent law, including provisions that affect the way patent applications will be prosecuted and may also

affect patent litigation.

The USPTO is currently developing regulations and procedures to govern the administration of the AIA, and many

of the substantive changes to patent law associated with the AIA.

It is not clear what other, if any, impact the AIA will have on the

operation of our business.

Moreover, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution

of our patent application, which could have a material adverse effect on our business and financial condition.

important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-to-file”

system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming

the same invention.

A third party that files a patent application in the USPTO after that date but before us could therefore be awarded

a patent covering an invention of ours even if we had made the invention before it was made by the third party.

This will require us

to be cognizant going forward of the time from invention to filing of a patent application.

Furthermore, our ability to obtain and maintain

valid and enforceable patents depends on whether the differences between our technology and the prior art allow our technology to be

patentable over the prior art.

Since patent applications in the United States and most other countries are confidential for a period

of time after filing, we cannot be certain that we were the first to either (1) file any patent application related to our product candidates

or (2) invent any of the inventions claimed in our patents or patent applications.

some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and provide

opportunities for third parties to challenge any issued patent in the USPTO.

This applies to all of our U.S.

patents, even those issued before March 16, 2013.

Because of a lower evidentiary

standard in USPTO proceedings compared to the evidentiary standard in United States federal court necessary to invalidate a patent claim,

a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the

same evidence would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party

may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the

third party as a defendant in a district court action.

Deterioration in general economic conditions

in the United States, Canada and globally, including the effect of prolonged periods of inflation on our suppliers, third-party

service providers and potential partners, could harm our business and results of operations.

Our business and results

of operations could be adversely affected by changes in national or global economic conditions.

These conditions include but are not limited

to inflation, rising interest rates, availability of capital markets, energy availability and costs, the negative impacts caused

by pandemics and public health crises, negative impacts resulting from the military conflict between Russia and the Ukraine, and the effects

of governmental initiatives to manage economic conditions.

Impacts of such conditions could be passed on to our business in the form of

higher costs for labor and materials, higher investigator fees, possible reductions in pharmaceutical industry-wide spending on research

and development and acquisitions and higher costs of capital.

Public health threats could have an

adverse effect on our operations and financial results.

Public health threats,

such as the novel coronavirus (COVID-19), influenza and other highly communicable diseases or viruses could adversely impact our operations

and disrupt our ongoing or planned research and development activities.

We cannot presently predict the scope and severity of any potential

future business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the suppliers, clinical

trial sites, regulators and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions,

our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted.

We are exposed to risks related to currency

exchange rates.

We conduct a significant

portion of our operations outside of the United States.

patents, even those issued

before March 16, 2013.

Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States

federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient

for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented

in a district court action.

Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would

not have been invalidated if first challenged by the third party as a defendant in a district court action.

regulations could impact our ability to price our products

and international governmental regulations that mandate price controls or limitations on patient access to our drugs under development,

create coverage criteria or establish prices paid by government entities or programs for our potential products could impact our business,

and our future results could be adversely affected by changes in such regulations or policies.

In addition to the recent expansion of

price controls in the U.S.

in the IRA, the adoption of restrictive coverage policies and price controls in new jurisdictions, more restrictive

controls in existing jurisdictions or the failure to obtain or maintain timely or adequate coverage and pricing could also adversely

impact future revenue.

We expect pricing pressures and other cost containment measures for drugs and vaccines will continue globally.

the U.S., pharmaceutical product pricing is subject to government and public scrutiny and calls for reform, and many of our products

are subject to increasing pricing pressures as a result.

We expect to see continued focus by the U.S.

Congress and the Biden Administration

on regulating pricing and access to medicine.

For example, in August 2022, the drug pricing provisions of the IRA were signed into law,

which, among other things, require manufacturers of certain drugs to engage in price negotiations with Medicare which will permit the

CMS to set a maximum fair price for selected drugs, impose rebates under Medicare Part B and Medicare Part D to penalize price increases

that outpace inflation, and replace the Part D coverage gap discount program with a new discounting program.

The drug pricing provisions

of the IRA began to be implemented in 2022 and implementation efforts are expected to continue over the next several years.

2023, the Biden Administration unveiled the first round of medicines subject to the Medicare Drug Pricing Negotiation Program.

plans may also require rebates in addition to the maximum fair price for preferred placement on a Medicare plan formulary.

Drug Price Negotiation Program is currently subject to legal challenges and therefore, the outcome of the 340B Program remains uncertain.

may promote generic drugs and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition.

In addition, we expect that consolidation and integration among pharmacy chains, wholesalers and PBMs will increase pricing pressures

in the industry.

Some states have implemented, and others are considering, patient access constraints or cost cutting under state regulated

programs including the Medicaid program.

State legislatures also have continued to focus on addressing drug costs, generally by increasing

price transparency or attempting to limit drug price increases for state regulated insurance.

Measures to regulate prices or payment

for pharmaceutical products, including legislation on drug importation, such as Florida’s drug importation program which was recently

approved by the FDA, could adversely affect our business.

may encounter similar regulatory and legislative issues in other countries in which we may operate.

In certain markets, such as in EU

member states, the U.K., Japan, China, Canada and South Korea, governments have significant power as large single payors to regulate

prices, access criteria, or impose other means of cost control, particularly as a result of recent global financing pressures.

Deterioration

in general economic conditions in the United States, Canada and globally, including the effect of prolonged periods of inflation on

our suppliers, third-party service providers and potential partners, could harm our business and results of operations.

business and results of operations could be adversely affected by changes in national or global economic conditions.

These conditions

include but are not limited to inflation, rising interest rates, availability of capital markets, energy availability and costs,

the negative impacts caused by pandemics and public health crises, negative impacts resulting from the military conflict between Russia

and the Ukraine, and the effects of governmental initiatives to manage economic conditions.

Impacts of such conditions could be passed

on to our business in the form of higher costs for labor and materials, higher investigator fees, possible reductions in pharmaceutical

industry-wide spending on research and development and acquisitions and higher costs of capital.

health threats could have an adverse effect on our operations and financial results.

health threats, such as the novel coronavirus (COVID-19), influenza and other highly communicable diseases or viruses could adversely

impact our operations and disrupt our ongoing or planned research and development activities.

We cannot presently predict the scope and

severity of any potential future business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including

the suppliers, clinical trial sites, regulators and other third parties with whom we conduct business, were to experience shutdowns or

other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially

and negatively impacted.

are exposed to risks related to currency exchange rates.

conduct a significant portion of our operations outside of the United States.

Because our financial statements are presented in U.S.

dollars, changes in currency

exchange rates have had and could have in the future a significant effect on our operating results when our operating results are translated

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including

dollars, changes in currency exchange rates have had and could have in the future a significant effect on our operating results when

our operating results are translated into U.S.

employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including

noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm

our reputation.

We are exposed to the

risk of fraud or other misconduct by our employees, principal investigators, consultants and collaborators, including intentional failures

to comply with FDA or Office of Inspector General regulations or similar regulations of comparable non-U.S.

regulatory authorities, provide

accurate information to the FDA or comparable non-U.S.

regulatory authorities, comply with manufacturing standards we have established,

comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced

by comparable non-U.S.

regulatory authorities, report financial information or data accurately or disclose unauthorized activities to

Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could

result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter misconduct, and the

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

protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws,

standards or regulations.

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

of significant fines or other sanctions.

A cybersecurity incident and other technology

disruptions could negatively affect our business and our relationships with customers.

We use technology in substantially all aspects

of our business operations.

The widespread use of technology, including mobile devices, cloud computing, and the internet, give rise to

cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information.

involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property, including

information relating to suppliers, private information about employees, and financial and strategic information about us and our business

If we fail to effectively assess and identify cybersecurity risks associated with the use of technology in our business operations,

we may become increasingly vulnerable to such risks.

Additionally, while we have implemented measures to prevent security breaches and

cyber incidents, our preventative measures and incident response efforts may not be entirely effective.

The theft, destruction, loss,

misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference with our information

technology systems or the technology systems of third parties on which we rely, could result in business disruption, negative publicity,

brand damage, violation of privacy laws, loss of customers, potential liability and competitive disadvantage.

Use of social media platforms presents

We believe that our potential

patient population is active on social media.

Social media practices in the pharmaceutical and biotechnology industries are evolving,

which creates uncertainty and risk of noncompliance with regulations applicable to our business.

For example, patients may use social

media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could result in reporting

In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments

about us or our product candidates on any social networking website.

In addition, our employees or third parties with whom we contract,

such as our CROs or CMOs, may knowingly or inadvertently make use of social media in a manner that may give rise to liability, lead to

the loss of trade secrets or other intellectual property or result in public exposure of personal information of our employees, clinical

trial patients, customers and others or information regarding our product candidates or clinical trials.

Any of these events could have

a material adverse effect on our business, prospects, operating results and financial condition and could adversely affect the price of

our common shares.

Risks Related to our Common Stock

We do not intend to pay dividends for the

are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and collaborators, including

intentional failures to comply with FDA or Office of Inspector General regulations or similar regulations of comparable non-U.S.

authorities, provide accurate information to the FDA or comparable non-U.S.

regulatory authorities, comply with manufacturing standards

we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established

and enforced by comparable non-U.S.

regulatory authorities, report financial information or data accurately or disclose unauthorized

activities to us.

Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials,

which could result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter misconduct,

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

or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such

laws, standards or regulations.

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

imposition of significant fines or other sanctions.

cybersecurity incident and other technological disruptions could negatively affect our business and our relationships with customers.

use technology in substantially all aspects of our business operations.

The widespread use of technology, including mobile devices, cloud

computing, and the internet, gives rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent

release of information.

Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information

and intellectual property, including information relating to suppliers, private information about employees, and financial and strategic

information about us and our business partners.

If we fail to effectively assess and identify cybersecurity risks associated with the

use of technology in our business operations, we may become increasingly vulnerable to such risks.

Additionally, while we have implemented

measures to prevent security breaches and cyber incidents, our preventative measures and incident response efforts may not be entirely

The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property,

or interference with our information technology systems or the technology systems of third parties on which we rely, could result in

business disruption, negative publicity, brand damage, violation of privacy laws, loss of customers, potential liability and competitive

disadvantage.

of social media platforms presents new risks.

believe that our potential patient population is active on social media.

Social media practices in the pharmaceutical and biotechnology

industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business.

patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could

result in reporting obligations.

In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate

posts or comments about us or our product candidates on any social networking website.

In addition, our employees or third parties with

whom we contract, such as our CROs or CMOs, may knowingly or inadvertently make use of social media in a manner that may give rise to

liability, lead to the loss of trade secrets or other intellectual property or result in public exposure of personal information of our

employees, clinical trial patients, customers and others or information regarding our product candidates or clinical trials.

events could have a material adverse effect on our business, prospects, operating results and financial condition and could adversely

affect the price of our common shares.

shares previously sold under our Sales Agreement with BTIG LLC with respect to our At-the-Market Offering may have been sold in violation

of federal and state securities laws and may be subject to rescission rights and other penalties, requiring us to repurchase shares sold

connection with our Sales Agreement, we became aware that our shelf registration statement on Form S-3 (file number 333-237368) (the

“Prior Registration Statement”) expired on April 2, 2023.

Prior to becoming aware of the expiration, we sold an aggregate

of 75,697 shares of our common stock following the expiration of the Prior Registration Statement and through July 17, 2023 at an average

price of approximately $10.56 per share for an aggregate of approximately $799,212 under the Prior Registration Statement pursuant to

the Sales Agreement (the “Sales”).

Because the Prior Registration Statement had already expired, the Sales could be determined

to be unregistered sales of securities and, in accordance with Section 5 of the Securities Act, direct purchasers in the Sales may have

rescission rights pursuant to which they may be entitled to recover the amount paid for such shares, plus statutory interest, upon returning

the shares to us within one year from the transaction date.

In addition, we could be subject to enforcement actions or penalties and

fines by federal and/or state regulatory authorities.

We cannot predict the likelihood of any claims or actions being brought against

us or the amount of any penalties or fines in connection with the Sales.

Related to our Common Stock

do not intend to pay dividends for the foreseeable future.

have paid no dividends on our common stock to date, and we do not anticipate paying any dividends to holders of our common stock in the

foreseeable future.

We have paid no dividends on our common stock to date, and we do not

anticipate paying any dividends to holders of our common stock in the foreseeable future.

While our future dividend policy will be based

on the operating results and capital needs of the business, we anticipate that we will retain any earnings to finance our future expansion

and for the implementation of our business plan.

As an investor, you should take note of the fact that a lack of a dividend can further

affect the market value of our common stock and could significantly affect the value of any investment in our Company.

We are subject to the reporting requirements

of federal securities laws, which can be expensive and may divert resources from other projects, thus impairing our ability grow.

We are a public reporting company and, accordingly,

subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including compliance with

the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

The costs of preparing and filing annual and quarterly reports,

proxy statements and other information with the SEC and furnishing audited reports to stockholders would cause our expenses to be higher

than they would be if we remained privately held.

It may be time consuming, difficult and costly

for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act.

We may need to hire

additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate internal controls

and reporting procedures.

We are an “emerging growth company”

within the meaning of the Securities Act of 1933, as amended, or the Securities Act, and if we decide to take advantage of certain exemptions

from various reporting requirements applicable to emerging growth companies, our common stock could be less attractive to investors.

We will remain an emerging growth company until

the earliest of (1) the last day of the fiscal year during which we have total annual gross revenues of $1.07 billion or more, (2) December

31, 2024 (the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering), (3) the date

on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt, and (4) the date on which

we are deemed to be a “large accelerated filer” under the Securities Exchange Act of 1934, as amended, or the Exchange Act

(i.e., the first day of the fiscal year after we have (a) more than $700.0 million in outstanding common equity held by our non-affiliates,

measured each year on the last day of our second fiscal quarter, and (b) been public for at least 12 months).

Even after we no longer qualify as an emerging

growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the

same exemptions from disclosure requirements including exemption from compliance with the auditor attestation requirements of Section

404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.

We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.

If some investors find

our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be

more volatile.

Our stock price may be volatile.

The market price of our common stock is likely

to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including

the following:

changes in our industry;

competitive pricing pressures;

our ability to obtain working capital financing;

additions or departures of key personnel;

limited “public float” in the hands of a small number of persons whose sales or lack of sales could result in positive or negative pricing pressure on the market price for our common stock;

While our future dividend policy will be based on the operating results and capital needs of the business, we anticipate

that we will retain any earnings to finance our future expansion and for the implementation of our business plan.

As an investor, you

should take note of the fact that a lack of a dividend can further affect the market value of our common stock and could significantly

affect the value of any investment in our Company.

are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other projects,

thus impairing our ability grow.

are a public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other

federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports

to stockholders would cause our expenses to be higher than they would be if we remained privately held.

may be time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by

the Sarbanes-Oxley Act.

We may need to hire additional financial reporting, internal controls and other finance personnel in order to

develop and implement appropriate internal controls and reporting procedures.

are an “emerging growth company” within the meaning of the Securities Act of 1933, as amended, or the Securities Act, and

if we decide to take advantage of certain exemptions from various reporting requirements applicable to emerging growth companies, our

common stock could be less attractive to investors.

will remain an emerging growth company until the earliest of (1) the last day of the fiscal year during which we have total annual gross

revenues of $1.235 billion or more, (2) December 31, 2024 (the last day of the fiscal year following the fifth anniversary of the completion

of our initial public offering), (3) the date on which we have, during the previous three-year period, issued more than $1.0 billion

in non-convertible debt, and (4) the date on which we are deemed to be a “large accelerated filer” under the Securities Exchange

Act of 1934, as amended, or the Exchange Act (i.e., the first day of the fiscal year after we have (a) more than $700.0 million in outstanding

common equity held by our non-affiliates, measured each year on the last day of our second fiscal quarter, and (b) been public for

at least 12 months).

after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would

allow us to take advantage of many of the same exemptions from disclosure requirements including exemption from compliance with the auditor

attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation

in our periodic reports and proxy statements.

We cannot predict if investors will find our common stock less attractive because we may

rely on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market

for our common stock and our stock price may be more volatile.

stock price may be volatile.

market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors,

many of which are beyond our control, including the following:

in our industry;

pricing pressures;

our ability to obtain working

capital financing;

additions or departures

of key personnel;

limited “public float”

in the hands of a small number of persons whose sales or lack of sales could result in positive or negative pricing pressure on the

market price for our common stock;

sales of our common stock;

our ability to execute our business plan;

operating results that fall below expectations;

our ability to execute

our business plan;

operating results that

fall below expectations;

loss of any strategic relationship;

regulatory developments;

economic and other external factors;

period-to-period fluctuations in our financial results;

inability to develop or acquire new or needed technology or products.

In addition, the securities markets have from time-to-time experienced

significant price and volume fluctuations that are unrelated to the operating performance of particular companies.

These market fluctuations

may also materially and adversely affect the market price of our Common Stock.

You may have difficulty trading and obtaining

quotations for our common stock.

Our securities are not actively traded, and the

bid and asked prices for our common stock may fluctuate widely.

As a result, investors may find it difficult to dispose of, or to obtain

accurate quotations of the price of, our securities.

This severely limits the liquidity of the common stock and would likely reduce the

market price of our common stock and hamper our ability to raise additional capital.

economic and other external

period-to-period fluctuations

in our financial results;

inability to develop or

acquire new or needed technology or products.

addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the

operating performance of particular companies.

These market fluctuations may also materially and adversely affect the market price of

our Common Stock.

may have difficulty trading and obtaining quotations for our common stock.

securities are not actively traded, and the bid and asked prices for our common stock may fluctuate widely.

As a result, investors may

find it difficult to dispose of, or to obtain accurate quotations of the price of, our securities.

This severely limits the liquidity

of the common stock and would likely reduce the market price of our common stock and hamper our ability to raise additional capital.

There is a limited market for our securities.

investors may therefore bear the economic risk of an investment in the Securities thereof, for an indefinite period of time.

Additional stock offerings in the future

may dilute your percentage ownership of our company.

Given our plans and expectations that we may need

additional capital and personnel, we may need to issue additional shares of common stock or securities convertible or exercisable for

shares of common stock, including convertible preferred stock, convertible notes, stock options or warrants.

The issuance of additional

securities in the future will dilute the percentage ownership of then current stockholders.

Anti-takeover provisions in our stockholder

rights plan could make a third-party acquisition of us difficult.

We have a stockholder rights plan that may have the effect of discouraging

unsolicited takeover proposals.

Specifically, the rights issued under the stockholder rights plan could cause significant dilution to

a person or group that attempts to acquire us on terms not approved in advance by our board of directors.

The rights plan is not intended

to prevent a takeover, and we believe it will enable all our stockholders to realize the full potential value of their investment in the

Company and protect the Company and its stockholders from efforts to obtain control of the Company that are inconsistent with the best

interests of the Company and its stockholders.

The rights under the plan will expire on December 30, 2023, subject to a possible earlier

expiration to the extent provided in the stockholder rights plan, unless extended.

UNRESOLVED STAFF COMMENTS

Not applicable.

The Company leases approximately

5,000 square feet of office space in Boca Raton, Florida from a third-party, which serves as the headquarters of the Company.

pay approximately $15,000 per month for this lease which expires in January 2027.

We believe our current facilities are suitable

and adequate to meet our current needs.

LEGAL PROCEEDINGS

We currently are not a party to any material litigation

or other material legal proceedings.

We may, from time to time, be subject to legal proceedings and claims arising in the normal course

MINE SAFETY DISCLOSURES

Not applicable.

Accordingly, investors may therefore bear the economic risk of an investment in our securities

for an indefinite period of time.

stock offerings in the future may dilute your percentage ownership of our company.

our plans and expectations that we may need additional capital and personnel, we may need to issue additional shares of common stock

or securities convertible or exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock

options or warrants.

The issuance of additional securities in the future will dilute the percentage ownership of then current stockholders.

Anti-takeover

provisions in our stockholder rights plan could make a third-party acquisition of us difficult.

have a stockholder rights plan that may have the effect of discouraging unsolicited takeover proposals.

Specifically, the rights issued

under the stockholder rights plan could cause significant dilution to a person or group that attempts to acquire us on terms not approved

in advance by our board of directors.

The rights plan is not intended to prevent a takeover, and we believe it will enable all our stockholders

to realize the full potential value of their investment in the Company and protect the Company and its stockholders from efforts to obtain

control of the Company that are inconsistent with the best interests of the Company and its stockholders.

The rights under the plan will

expire on December 30, 2024, subject to a possible earlier expiration to the extent provided in the stockholder rights plan, unless extended.

of our common shares by our employees, including our executive officers, could cause the trading price of our common shares to fall or

prevent it from increasing for numerous reasons, and sales by such persons could be viewed negatively by other investors.

accordance with the guidelines specified under Rule 10b5-1 under the Exchange Act, as amended, equivalent legislation in applicable jurisdictions,

and our policies regarding equity transactions, a number of our employees, including executive officers, may adopt share trading plans

pursuant to which they have arranged to sell common shares from time to time in the future.

Generally, sales of common shares, including

sales under such plans, by our executive officers and directors require public filings.

Sales of our common shares by such persons could

cause the price of our common shares to fall or prevent it from increasing.

If sales by employees, executive officers, or directors cause

a substantial number of our common shares to become available for purchase in the public market, the price of our common shares could

fall or may not increase.

Also, sales by such personnel could be viewed negatively by holders and potential purchasers of our common

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