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Item 1A. Risk Factors

2025-03-28 compared with 2024-03-28 · 1533 added, 1718 removed, 144 unchanged (96% of the section changed)

An investment in our common stock involves

a high degree of risk.

You should carefully consider the following risk factors and the other information in this Annual Report on Form

10-K before investing in our common stock.

Our business and results of operations could be seriously harmed by any of the following risks.

investment in our common stock involves a high degree of risk.

You should carefully consider the following risk factors and the other

information in this Annual Report before investing in our common stock.

Our business and results of operations could be seriously harmed

by any of the following risks.

The risks set out below are not the only risks we face.

Additional risks and uncertainties not currently known to us or that we currently

deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

If any of the

following events occur, our business, financial condition and results of operations could be materially adversely affected.

In such case,

the value and trading price of our common stock could decline, and you may lose all or part of your investment.

Risks Related to Our Financial Position and

Need for Capital

We have generated no revenue from commercial

sales to date and our future profitability is uncertain.

Additional risks and uncertainties not currently

known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or

operating results.

If any of the following events occur, our business, financial condition and results of operations could be materially

adversely affected.

In such case, the value and trading price of our common stock could decline, and you may lose all or part of your

Risks Related to Our Financial Position, Financial

Reporting Matters and Need for Capital

have generated no revenue from commercial sales to date and our future profitability is uncertain.

We were incorporated in May 2017 and have a limited

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of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection

with development and expansion of a new business enterprise.

with the development and expansion of a new business enterprise.

Since inception, we have incurred losses and expect to continue to operate

at a net loss for at least the next several years as we commence our research and development efforts, conduct clinical trials and develop

at a net loss for at least the next several years as we continue our research and development efforts, conduct clinical trials and develop

manufacturing, sales, marketing and distribution capabilities.

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to continue our operations.

If we fail to obtain the capital necessary

to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.

we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and

you will likely lose your entire investment.

We will need to continue to seek capital from

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to fund our operations and the development and commercialization of our product candidates.

Our business or operations may change in a manner

that may consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations,

fund expansion, commercialize our product candidates, develop new or enhanced products, acquire complementary products, business or technologies

or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred

treatment modalities.

In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently

envisioned, and this would require additional capital.

However, we may not be able to secure funding on favorable terms, if at all.

If we cannot raise adequate funds to satisfy

our capital requirements, we may have to delay, scale back or eliminate our research and development activities, clinical studies or

We may also be required to obtain funds through arrangements with collaborators, which arrangements may require us to relinquish

rights to certain intellectual property, technologies or products that we otherwise would not consider relinquishing, including rights

to future product candidates or certain major geographic markets.

This could result in sharing revenues which we might otherwise retain

for ourselves.

business or operations may change in a manner that may consume available funds more rapidly than anticipated and substantial additional

funding may be required to maintain operations, fund expansion, commercialize our product candidates, develop new or enhanced products,

acquire complementary products, business or technologies or otherwise respond to competitive pressures and opportunities, such as a change

in the regulatory environment or a change in preferred treatment modalities.

In addition, we may need to accelerate the growth of our

sales capabilities and distribution beyond what is currently envisioned, and this would require additional capital.

However, we may not

be able to secure funding on favorable terms, if at all.

we cannot raise adequate funds to satisfy our capital requirements, we may have to delay, scale back or eliminate our research and development

activities, clinical studies or operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements

may require us to relinquish rights to certain intellectual property, technologies or products that we otherwise would not consider relinquishing,

including rights to future product candidates or certain major geographic markets.

This could result in sharing revenues which we might

otherwise retain for ourselves.

Any of these actions may harm our business, financial condition and results of operations.

The amount of capital we may need depends on

many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our pre-clinical

studies and clinical trials;

amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our pre-clinical studies and clinical trials;

the time and cost necessary to obtain regulatory approvals;

the time and cost necessary to further develop

manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative, licensing and other

commercial relationships;

and our partners’ commitment of time and resources to the development and commercialization of our products.

Even if we can raise additional funding,

we may be required to do so on terms that are dilutive to you.

The capital markets have been unpredictable in

the recent past for unprofitable companies such as ours.

The amount of capital that a company such as ours is able to raise often depends

on variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive to us, or at all.

we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds

are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued

viability will be materially adversely affected.

Risks Related to Product Development, Regulatory

Approval, Manufacturing and Commercialization

We are dependent upon the clinical success

of our licensed products and technologies.

If we are unable to generate revenues from our licensed products and technologies, our ability

to create shareholder value may be limited.

We do not currently generate revenues from any

of our product candidates, and we may not be successful in obtaining regulatory approvals to commence our clinical trials.

obtain such approvals, the time in which we expect to commence clinical programs for our product candidates will be extended and such

extension may increase our expenses and our need for additional capital.

Moreover, there is no guarantee that our clinical trials will

be successful or that we will continue clinical development in support of an approval from the regulatory agencies for any indication.

We note that most drug candidates never reach the clinical stage and even those that do commence clinical development have only a small

chance of successfully completing clinical development and gaining regulatory approval.

Therefore, our business currently depends entirely

on the successful development, regulatory approval and commercialization of our product candidates, which may never occur.

Although we have entered into the Voltron

Agreement pursuant to which we and HaloVax, LLC (“HaloVax”) intend to jointly develop products to prevent COVID-19, no assurance

can be given as to when, if ever, we will be able to develop any products for such purpose and if developed that such products will be

successfully commercialized.

In March 2020, we entered into the Voltron Agreement

pursuant to which we and HaloVax will work to jointly develop potential products candidates to prevent COVID-19;

however, no assurance

can be given as to when, if ever, we will be able to develop any products for such purpose.

Furthermore, we are subject to risks including,

but not limited to, the following with respect to the development of a treatment for COVID-19:

the EUA marketing approval

processes of the FDA are lengthy, time consuming and inherently unpredictable, and we cannot guarantee that we will ever have a marketable

we may encounter substantial

delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety

and efficacy to the satisfaction of applicable regulatory authorities;

conducting successful clinical

studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit;

to be commercially successful,

physicians must be persuaded that using our products are effective alternatives to other existing therapies and treatments;

we may depend on third

parties for manufacturing our proposed product candidates and any conflicts with such partners could delay or prevent the development

or commercialization of such product candidates;

if third-party contract

manufacturers upon whom we rely to formulate and manufacture our product candidates do not perform, fail to manufacture according

to our specifications or fail to comply with strict regulations, our clinical studies could be adversely affected and the development

of our product candidates could be delayed or terminated or we could incur significant additional expenses;

adverse events involving

our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could harm our reputation,

business and financial results;

if we fail to comply with

healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations

and financial condition could be adversely affected.

Although the federal government had previously

declared COVID-19 a national emergency, that declaration expired on May 11, 2023, at which time the favorable payment provisions available

to healthcare providers during the declared national emergency ended.

The FDA issued EUAs for several COVID-19 related products in 2020

EUAs are authorized pursuant to an EUA declaration under the U.S.

Food, Drug, and Cosmetic Act and remain in effect until the

Secretary of the U.S.

Department of Health and Human Services terminates the EUA declaration or unless sooner terminated or revoked.

If our joint venture with HaloVax is not

successful or if we fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on the full

market potential of our potential products.

In March 2020, we entered into the Voltron Agreement

to form a joint venture entity named HaloVax to jointly develop potential product candidates for the prevention of the COVID-19.

to the terms of the Voltron Agreement we are entitled to receive sales-based royalties at low single digit percentages and shall contribute

proceeds of the development of products to prevent COVID-19.

In addition, in 2020, we purchased 6% of HaloVax’s outstanding membership

however, during the fourth quarter of 2022, we identified indicators of impairment for the HaloVax investment as a result

of adverse changes in HaloVax’s business operations, including liquidity concerns.

As a result, our investment in HaloVax was valued

at $0 as of December 31, 2023 and 2022.

If and to the extent we and HaloVax are unable to develop potential product candidates for the

prevention of COVID-19, we will not be entitled to any sale-based royalties.

While Voltron has agreed to cooperate and use

commercially reasonable efforts to exchange information and resources that will lead to the development activities and established a

Joint Development Committee consisting of seven members, two of which were selected by us, to plan, review, coordinate and oversee the

performance of the development activities and timelines with respect to development activities, we have limited contractual rights to

direct its activities.

Moreover, we will not have any other control with respect to the operations of HaloVax.

Therefore, HaloVax will

have a greater influence with respect to its commercialization efforts and other operations.

In general, our joint venture with HaloVax

subjects us to a number of related risks including that:

we may not receive sales-based

royalties pursuant to the terms of the Voltron Agreement;

we may not be successful

in the development of any product candidates;

HaloVax may not commit

sufficient resources to the marketing and distribution of our products;

HaloVax may infringe the

intellectual property rights of third parties, which may expose us to litigation and other potential liability;

disputes may arise between

us and HaloVax that result in the delay or termination of the commercialization of our products or product candidates or that result

in costly litigation or arbitration that diverts management attention and resources including, but not limited to, disputes with

respect to commercializing products upon terms mutually agreeable or beneficial to us and HaloVax;

any products, if developed,

will be sold or licensed on terms that are beneficial to us;

HaloVax may not provide

us with timely and accurate information regarding commercialization status or results, which could adversely impact our ability to

manage our own commercialization efforts, accurately forecast financial results or provide timely information to our shareholders

regarding our commercialization efforts;

if any product candidates

are successfully developed that we will be able to commercialize such products upon terms mutually agreeable or beneficial to us

If HT-005 is not commercialized by Zylö

or otherwise acquired by a third-party, we may not be able to capitalize on the full market potential of our interests with respect to

In December 2021, we licensed HT-005 back to

Zylö and are entitled to receive a low single digit percent of the net proceeds attributable to the sale of HT-005 to a third-party,

a low single digit percent of the net proceeds from the sale of HT-005 in the United States and Canada and their respective territories

(collectively, the “Territory”) and a low double digit percent of any royalty Zylö receives through the sublicense to

a third-party based on the net sales of HT-005 in the Territory.

In connection with the license of HT-005 back to Zylö, we acquired

100,000 shares of Zylö’s Class B common stock.

As of December 31, 2023, we own 220,000 shares of Zylö’s Class B

common stock.

If Zylö is unable to sell or otherwise commercialize HT-005, we will not be entitled to any proceeds or sale-based

royalties and the value of our ownership interest in Zylö could decline in which case we may lose all or part of our investment

The marketing approval process of the FDA

is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for the product

candidates we intend to develop, our business may be substantially harmed.

None of the product candidates we intend to develop

have gained marketing authorization, approval or clearance in the U.S.

or elsewhere, and we cannot guarantee that we will ever have marketable

Our business is substantially dependent on our ability to complete the development of, obtain marketing approval for, and successfully

commercialize our product candidates in a timely manner.

We cannot commercialize our product candidates in the United States or elsewhere

without first obtaining approval from regulatory agencies such as the FDA to market each product candidate.

Our product candidates could

fail to receive marketing approval for many reasons, including among others:

the FDA or other regulatory

agencies may disagree with the design or implementation of our clinical trials;

the FDA could determine

that we cannot rely on Section 505(b)(2) for any of our product candidates;

the FDA may determine that

we have identified the wrong reference listed drug or drugs or that approval of our Section 505(b)(2) application for any of our

product candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

In addition, the process of seeking regulatory

clearance or approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the

effort and expense incurred, clearance or approval is never guaranteed.

If we are not successful in obtaining timely clearance or approval

of our product candidates from the FDA or other foreign regulatory agencies, we may never be able to generate significant revenue and

may be forced to cease operations.

the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into

and maintain collaborative, licensing and other commercial relationships;

and our partners’ commitment of time and resources to

the development and commercialization of our products.

if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

capital markets have been unpredictable in the recent past for unprofitable companies such as ours.

The amount of capital that a company

such as ours is able to raise often depends on variables that are beyond our control.

As a result, we may not be able to secure financing

on terms attractive to us, or at all.

If we are able to consummate a financing arrangement, the amount raised may not be sufficient to

meet our future needs.

If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations,

financial condition and our continued viability will be materially adversely affected.

The Restatement of our financial

statements may affect shareholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties,

including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.

We have incurred, and may continue to incur, substantial

unanticipated costs for accounting and legal fees in connection with, or related to, the Restatement.

The Restatement could

also subject us to other risks and uncertainties, including the increased possibility of legal proceedings and inquiries, sanctions, or

investigations by the SEC or other regulatory authorities relating to the Restatement.

Any of the foregoing may adversely affect

our reputation, the accuracy and timing of our financial reporting, or our business, results of operations, liquidity, and financial condition,

or cause shareholders and investors to lose confidence in the accuracy and completeness of our financial reports or cause the market price

of our common stock to decline.

Any such legal proceedings or regulatory inquiries, sanctions, or investigation, whether successful or

not, could adversely affect our business, financial condition, and results of operations.

Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

are dependent upon the clinical success of our licensed products and technologies.

If we are unable to generate revenues from our licensed

products and technologies, our ability to create shareholder value may be limited.

do not currently generate revenues from any of our product candidates, and we may not be successful in obtaining regulatory approvals

to commence our clinical trials.

If we do not obtain such approvals, the time in which we expect to commence clinical programs for our

product candidates will be extended and such extension may increase our expenses and our need for additional capital.

Moreover, there

is no guarantee that our clinical trials will be successful or that we will continue clinical development in support of an approval from

the regulatory agencies for any indication.

We note that most drug candidates never reach the clinical stage and even those that do commence

clinical development have only a small chance of successfully completing clinical development and gaining regulatory approval.

our business currently depends entirely on the successful development, regulatory approval and commercialization of our product candidates,

which may never occur.

marketing approval process of the FDA is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain

marketing approval for the product candidates we intend to develop, our business may be substantially harmed.

of the product candidates we intend to develop have gained marketing authorization, approval or clearance in the U.S.

or elsewhere, and

we cannot guarantee that we will ever have marketable products.

Our business is substantially dependent on our ability to complete the

development of, obtain marketing approval for, and successfully commercialize our product candidates in a timely manner.

We cannot commercialize

our product candidates in the United States or elsewhere without first obtaining approval from regulatory agencies such as the FDA to

market each product candidate.

Our product candidates could fail to receive marketing approval for many reasons, including among others:

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

FDA could determine that we cannot rely on Section 505(b)(2) for any of our product candidates;

FDA may determine that we have identified the wrong reference listed drug or drugs or that approval of our Section 505(b)(2) application

for any of our product candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

addition, the process of seeking regulatory clearance or approval to market the product candidates we intend to develop is expensive

and time consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed.

If we are not successful

in obtaining timely clearance or approval of our product candidates from the FDA or other foreign regulatory agencies, we may never be

able to generate significant revenue and may be forced to cease operations.

The NDA process is costly, lengthy and uncertain.

Any NDA application filed by us will have to be

supported by extensive data, including, but not limited to, technical, pre-clinical, clinical, manufacturing and labeling data, to demonstrate

to the FDA’s satisfaction the safety and efficacy of the product for its intended use.

Obtaining clearances or approvals from the FDA

and from regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome.

other agencies could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in

other time-consuming actions, or it could simply deny our applications.

In addition, even if we obtain an NDA approval or pre-market

approvals in other countries, the approval could be revoked or other restrictions imposed if post-market data demonstrates safety issues

or lack of effectiveness.

We cannot predict with certainty how, or when, the FDA or other regulatory agencies will act.

If we are unable

to obtain the necessary regulatory approvals, our financial condition and cash flow may be adversely affected, and our ability to grow

domestically and internationally may be limited.

Additionally, even if cleared or approved, our products may not be approved for the

specific indications that are most necessary or desirable for successful commercialization or profitability.

We may encounter substantial delays in

completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy

to the satisfaction of applicable regulatory authorities.

It is impossible to predict if or when any of

our product candidates will prove safe or effective in humans or will receive regulatory approval.

Before obtaining marketing approval

from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety

and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming and uncertain as to outcome.

guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all.

A failure of one or more clinical

studies can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical development include:

delays in reaching, or

failing to reach, a consensus with regulatory agencies on study design;

delays in reaching, or

failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”)

and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs

and trial sites;

application filed by us will have to be supported by extensive data, including, but not limited to, technical, pre-clinical, clinical,

manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its intended

clearances or approvals from the FDA and from regulatory agencies in other countries is an expensive and time-consuming process and is

uncertain as to outcome.

The FDA and other agencies could ask us to supplement our submissions, collect non-clinical data, conduct additional

clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

In addition, even if we obtain an

NDA approval or pre-market approvals in other countries, the approval could be revoked or other restrictions imposed if post-market data

demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or when, the FDA or other regulatory agencies

If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be adversely affected,

and our ability to grow domestically and internationally may be limited.

Additionally, even if cleared or approved, our products may

not be approved for the specific indications that are most necessary or desirable for successful commercialization or profitability.

may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate

adequate safety and efficacy to the satisfaction of applicable regulatory authorities.

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

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct

extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans.

Clinical testing is

expensive, time-consuming and uncertain as to the outcome.

We cannot guarantee that any clinical studies will be conducted as

planned or completed on schedule, if at all.

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

that may prevent successful or timely completion of clinical development include:

in reaching, or failing to reach, a consensus with regulatory agencies on study design;

in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations

(“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly

among different CROs and trial sites;

in obtaining required IRB or Ethics Committee (“EC”) approval at each clinical study site;

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by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

failure to perform in accordance

with the FDA’s GCP or applicable regulatory guidelines in other countries;

to perform in accordance with the FDA’s GCP or applicable regulatory guidelines in other countries;

in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

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in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could also encounter delays if a clinical

trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted, by an independent

Safety Review Board for such trial or by the FDA, Therapeutics Goods Administration (“TGA”), European Medicines Agency (“EMA”),

or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure

to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial

operations or trial site by the FDA, TGA, or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen

safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative

actions or lack of adequate funding to continue the clinical trial.

Any inability to successfully complete pre-clinical

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

and commercialization milestones and royalties.

In addition, if we make manufacturing or formulation changes to our product candidates,

we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

Clinical study delays could also 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, which could impair our ability to successfully commercialize our product candidates.

In addition, any delays

in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize

our ability to commence product sales and generate revenues.

Any of these occurrences may significantly harm our business, financial

condition and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical

trials may also ultimately lead to the denial of regulatory approval of our product candidates.

The outcome of pre-clinical 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.

Further, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many

companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless

failed to obtain marketing approval.

If the results of our clinical studies are inconclusive or if there are safety concerns or adverse

events associated with our other product candidates, we may:

be delayed in obtaining

marketing approval for our product candidates, if approved at all;

obtain approval for indications

or patient populations that are not as broad as intended or desired;

obtain approval with labeling

that includes significant use or distribution restrictions or safety warnings;

be required to change the

way the product is administered;

be required to perform

additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities

withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation

experience damage to our

Additionally, our product candidates could potentially

cause other adverse events that have not yet been predicted.

The inclusion of ill patients in our clinical studies may result in deaths

or other adverse medical events due to other therapies or medications that such patients may be using.

As described above, any of these

events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize

our products.

If we are not able to obtain any required

regulatory approvals for our product candidates, we will not be able to commercialize our product candidates and our ability to generate

revenue will be limited.

We must successfully complete clinical trials

for our product candidates before we can apply for marketing approval.

Even if we complete our clinical trials, it does not assure marketing

Our pre-clinical trials may be unsuccessful, which would materially harm our business.

Even if our initial pre-clinical trials

are successful, we are required to conduct clinical trials to establish our product candidates’ safety and efficacy, before a marketing

application (NDA or BLA or their foreign equivalents) can be filed with the FDA, the EMA, or comparable foreign regulatory authorities

for marketing approval of our product candidates.

Clinical testing is expensive, is difficult to

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

Success in early phases of pre-clinical and clinical

trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict

final results.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such

trials are being conducted, by an independent Safety Review Board for such trial or by the FDA, Therapeutics Goods Administration (“TGA”),

European Medicines Agency (“EMA”), or other regulatory authorities.

Such authorities may suspend or terminate a clinical

trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical

protocols, inspection of the clinical trial operations or trial site by the FDA, TGA, or other regulatory authorities resulting in the

imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug,

changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

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

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

In addition, if we make manufacturing

or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified product candidates

to earlier versions.

study delays could also 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, which could impair our ability to successfully commercialize our product candidates.

In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval

process and jeopardize our ability to commence product sales and generate revenues.

Any of these occurrences may significantly harm our

business, financial condition and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement or

completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

outcome of pre-clinical 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.

Further, pre-clinical and clinical data are often susceptible to

various interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in pre-clinical

studies and clinical trials have nonetheless failed to obtain marketing approval.

If the results of our clinical studies are inconclusive

or if there are safety concerns or adverse events associated with our other product candidates, we may:

delayed in obtaining marketing approval for our product candidates, if approved at all;

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

approval with labeling that includes significant use or distribution restrictions or safety warnings;

required to change the way the product is administered;

required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified

risk evaluation and mitigation strategy;

damage to our reputation.

Additionally,

our product candidates could potentially cause other adverse events that have not yet been predicted.

The inclusion of ill patients in

our clinical studies may result in deaths or other adverse medical events due to other therapies or medications that such patients may

As described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates

and impair our ability to commercialize our products.

we are not able to obtain any required regulatory approvals for our product candidates, we will not be able to commercialize our product

candidates and our ability to generate revenue will be limited.

must successfully complete clinical trials for our product candidates before we can apply for marketing approval.

Even if we complete

our clinical trials, it does not assure marketing approval.

Our pre-clinical trials may be unsuccessful, which would materially harm

our business.

Even if our initial pre-clinical trials are successful, we are required to conduct clinical trials to establish our product

candidates’ safety and efficacy, before a marketing application (NDA or BLA or their foreign equivalents) can be filed with the

FDA, the EMA, or comparable foreign regulatory authorities for marketing approval of our product candidates.

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

Success in early

phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical

trial do not necessarily predict final results.

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

We may experience numerous unforeseen

events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive regulatory approval or

commercialize our product candidates.

The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing,

advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA,

EMA, and other regulatory authorities in the United States, European Union, and other countries, where regulations differ from country

We are not permitted to market our product candidates as prescription pharmaceutical products in the United States until

we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries.

In the United States, the FDA generally requires the completion of clinical trials of each drug to establish its safety and efficacy

and extensive pharmaceutical development to ensure its quality before an NDA is approved.

Regulatory authorities in other jurisdictions

impose similar requirements.

Of the large number of drugs in development, only a small percentage result in the submission of an NDA

to the FDA or other regulatory authorities and even fewer are eventually approved for commercialization.

We have not submitted an NDA

to the FDA or comparable applications to other regulatory authorities.

If our development efforts for our product candidates, including

regulatory approval, are not successful for their planned indications, or if adequate demand for our product candidates is not generated,

our business will be materially adversely affected.

Our success depends on the

receipt of regulatory approval and the issuance of such regulatory approvals is uncertain and subject to a number of risks, including

the following:

the results of nonclinical

or toxicology studies may not support the filing of an IND or foreign equivalent for our product candidates;

the FDA, EMA, or comparable

foreign regulatory authorities or IRBs or ECs may disagree with the design or implementation of our clinical trials;

we may not be able to provide

acceptable evidence of our product candidates’ safety and efficacy;

the results of our clinical

trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, EMA, or other

regulatory agencies for marketing approval;

the dosing of our product

candidates in a particular clinical trial may not be at an optimal level;

patients in our clinical

trials may suffer adverse effects for reasons that may or may not be related to our product candidates;

the data collected from

clinical trials may not be sufficient to support the submission of an NDA, BLA or other marketing application or to obtain regulatory

approval in the United States or elsewhere;

the requirement for additional

the FDA, EMA, or comparable

foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which

we contract for clinical and commercial supplies;

the approval policies or

regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical

data insufficient for approval;

the FDA, EMA, or comparable

foreign regulatory authorities may disagree on the design or implementation of our clinical trials, including the methodology used

in our studies, our chosen endpoints, our statistical analysis, or our proposed product indication;

our failure to demonstrate

to the satisfaction of the FDA, EMA, or comparable regulatory authorities that a product candidate is safe and effective for its

proposed indication;

we may fail to demonstrate

that a product candidate’s clinical and other benefits outweigh its safety risks;

immunogenicity might affect

a product candidate’s efficacy and/or safety;

the FDA, EMA, or comparable

foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;

data collected from clinical

trials of our product candidates may be insufficient to support the submission and filing of a marketing application or to obtain

marketing approval.

For example, the FDA may require additional studies to show that our product candidates are safe or effective;

we may fail to obtain approval

of the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies;

there may be changes in

the approval policies or regulations that render our nonclinical and clinical data insufficient for approval;

the FDA, EMA or comparable

foreign regulatory authority may require more information, including additional nonclinical or clinical data to support approval,

which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program.

Failure to obtain regulatory approval for our

product candidates for the foregoing, or any other reasons, will prevent us from commercializing our product candidates, and our ability

to generate revenue will be materially impaired.

We cannot guarantee that regulators will agree with our assessment of the results of

the clinical trials we intend to conduct in the future or that such trials will be successful.

The FDA, EMA and other regulators have

substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for

approval and require additional clinical trials, or pre-clinical or other studies.

In addition, varying interpretations of the data obtained

from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of our product candidates.

We have only limited experience in filing the

applications necessary to gain regulatory approvals and expect to rely on consultants and third-party CROs with expertise in this area

to assist us in this process.

Securing regulatory approvals to market a product requires the submission of pre-clinical, clinical, and/or

pharmacokinetic data, information about product manufacturing processes and inspection of facilities, proposed product labeling and supporting

information to the appropriate regulatory authorities for each therapeutic indication to establish a product candidate’s safety

and efficacy for each indication.

Our product candidates may prove to have undesirable or unintended side effects, toxicities or other

characteristics that may preclude us from obtaining regulatory approval or prevent or limit commercial use with respect to one or all

intended indications.

may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability

to receive regulatory approval or commercialize our product candidates.

The research, testing, manufacturing, labeling, packaging, storage,

approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive

regulation by the FDA, EMA, and other regulatory authorities in the United States, European Union, and other countries, where regulations

differ from country to country.

We are not permitted to market our product candidates as prescription pharmaceutical products in the

United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from

such countries.

In the United States, the FDA generally requires the completion of clinical trials of each drug to establish its safety

and efficacy and extensive pharmaceutical development to ensure its quality before an NDA is approved.

Regulatory authorities in other

jurisdictions impose similar requirements.

Of the large number of drugs in development, only a small percentage result in the submission

of an NDA to the FDA or other regulatory authorities and even fewer are eventually approved for commercialization.

We have not submitted

an NDA to the FDA or comparable applications to other regulatory authorities.

If our development efforts for our product candidates,

including regulatory approval, are not successful for their planned indications, or if adequate demand for our product candidates is

not generated, our business will be materially adversely affected.

success depends on the receipt of regulatory approval and the issuance of such regulatory approvals is uncertain and subject to a number

of risks, including the following:

results of nonclinical or toxicology studies may not support the filing of an IND or foreign equivalent for our product candidates;

FDA, EMA, or comparable foreign regulatory authorities or IRBs or ECs may disagree with the design or implementation of our clinical

may not be able to provide acceptable evidence of our product candidates’ safety and efficacy;

results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required

by the FDA, EMA, or other regulatory agencies for marketing approval;

dosing of our product candidates in a particular clinical trial may not be at an optimal level;

in our clinical trials may suffer adverse effects for reasons that may or may not be related to our product candidates;

data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA or other marketing application

or to obtain regulatory approval in the United States or elsewhere;

requirement for additional studies;

FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party

manufacturers with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner

rendering our clinical data insufficient for approval;

FDA, EMA, or comparable foreign regulatory authorities may disagree on the design or implementation of our clinical trials, including

the methodology used in our studies, our chosen endpoints, our statistical analysis, or our proposed product indication;

failure to demonstrate to the satisfaction of the FDA, EMA, or comparable regulatory authorities that a product candidate is safe

and effective for its proposed indication;

may fail to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

immunogenicity

might affect a product candidate’s efficacy and/or safety;

FDA, EMA, or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical

collected from clinical trials of our product candidates may be insufficient to support the submission and filing of a marketing

application or to obtain marketing approval.

For example, the FDA may require additional studies to show that our product candidates

are safe or effective;

may fail to obtain approval of the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical

and commercial supplies;

may be changes in the approval policies or regulations that render our nonclinical and clinical data insufficient for approval;

FDA, EMA or comparable foreign regulatory authority may require more information, including additional nonclinical or clinical data

to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development

to obtain regulatory approval for our product candidates for the foregoing, or any other reasons, will prevent us from commercializing

our product candidates, and our ability to generate revenue will be materially impaired.

We cannot guarantee that regulators will agree

with our assessment of the results of the clinical trials we intend to conduct in the future or that such trials will be successful.

The FDA, EMA and other regulators have substantial discretion in the approval process and may refuse to accept any application or may

decide that our data is insufficient for approval and require additional clinical trials, or pre-clinical or other studies.

varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval

of our product candidates.

have only limited experience in filing the applications necessary to gain regulatory approvals and expect to rely on consultants and

third-party CROs with expertise in this area to assist us in this process.

Securing regulatory approvals to market a product requires

the submission of pre-clinical, clinical, and/or pharmacokinetic data, information about product manufacturing processes and inspection

of facilities, proposed product labeling and supporting information to the appropriate regulatory authorities for each therapeutic indication

to establish a product candidate’s safety and efficacy for each indication.

Our product candidates may prove to have undesirable

or unintended side effects, toxicities or other characteristics that may preclude us from obtaining regulatory approval or prevent or

limit commercial use with respect to one or all intended indications.

The process of obtaining regulatory approvals

is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the

type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial

is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the type,

complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial

discretion of the regulatory authorities.

Changes in regulatory approval policies during the development period, changes in or the enactment

of additional statutes or regulations, or changes in regulatory review for a submitted product application may cause delays in the approval

or rejection of an application.

Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will

receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction

may negatively impact our ability to seek approval in a different jurisdiction.

Failure to obtain regulatory marketing approval for our

product candidates in any indication will prevent us from commercializing our product candidates, and our ability to generate revenue

will be materially impaired.

If we are unable to submit an application

for product candidate approval under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to the safety

and efficacy of a product candidate in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development

and commercialization timelines.

Regulatory approval through the FDA specifically may be further impacted or delayed by the ongoing

cuts to the federal budget under the Trump Administration.

Changes in regulatory approval policies during the development period, changes

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

delays in the approval or rejection of an application.

Regulatory approval obtained in one jurisdiction does not necessarily mean that

a product candidate will receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval

in one jurisdiction may negatively impact our ability to seek approval in a different jurisdiction.

Failure to obtain regulatory marketing

approval for our product candidates in any indication will prevent us from commercializing our product candidates, and our ability to

generate revenue will be materially impaired.

we are unable to submit an application for product candidate approval under Section 505(b)(2) of the FDCA or if we are required to generate

additional data related to the safety and efficacy of a product candidate in order to obtain approval under Section 505(b)(2), we may

be unable to meet our anticipated development and commercialization timelines.

We may seek marketing authorization in the United

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from such additional activities would be sufficient to obtain approval.

If the data to be relied upon in a 505(b)(2)

application is related to drug products previously approved by the FDA and covered by patents that are listed in the FDA’s Orange

Book, we would be required to submit with our 505(b)(2) application a Paragraph IV Certification in which we must certify that we do

not infringe the listed patents or that such patents are invalid or unenforceable, and provide notice to the patent owner or the holder

of the approved NDA.

The patent owner or NDA holder would have 45 days from receipt of the notification of our Paragraph IV Certification

to initiate a patent infringement action against us.

If an infringement action is initiated, the approval of our NDA would be subject

to a stay of up to 30 months or more while we defend against such a suit.

Approval of our product candidates under Section 505(b)(2)

may therefore be delayed until patent exclusivity expires or until we successfully challenge the applicability of those patents to our

product candidates.

Alternatively, we may elect to generate sufficient clinical data so that we would no longer need to rely on third-party

data, which would be costly and time consuming and there would be no assurance that such data generated from such additional activities

would be sufficient to obtain approval.

We may not be able to obtain shortened review

of our applications, and the FDA may not agree that a product candidate qualifies for marketing approval.

If we are required to generate

additional data to support approval, we may be unable to meet anticipated or reasonable development and commercialization timelines,

may be unable to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing approval.

FDA changes its interpretation of Section 505(b)(2) allowing reliance on data in a previously approved drug application owned by a third-party,

or there is a change in the law affecting Section 505(b)(2), this could delay or even prevent the FDA from approving any Section 505(b)(2)

application that we submit.

We may not be able to obtain or maintain

ODD or exclusivity for our product candidates.

Regulatory authorities in some jurisdictions,

including the United States, may designate drugs for relatively small patient populations as “orphan drugs.” Under the Orphan

Drug Act, the FDA may designate a drug candidate as an orphan drug if it is intended to treat a rare disease or condition, which is generally

defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease or condition affects more than

200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug product

available in the United States for the type of disease or condition will be recovered from sales of the product.

ODD entitles a party to financial incentives,

such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

Additionally, if a product

that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation,

the product is entitled to orphan drug exclusivity.

This means that the FDA may not approve any other applications to market the same

drug or biological product for the same indication for seven years, except in certain circumstances, including proving clinical superiority

(i.e., another product is safer, more effective or makes a major contribution to patient care) to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity, or

obtain approval for the same product but for a different indication than that for which the orphan product has exclusivity.

exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated

indication or may be lost if the FDA later determines that the request for designation was materially defective.

Modifications to our products may require

new drug approvals.

Once a particular product receives FDA approval

or clearance, expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory

approvals or clearances, including additional IND and NDA/BLA submissions or premarket approvals before we can begin clinical development,

and/or prior to marketing and sales.

If the FDA requires new clearances or approvals for a particular use or indication, we may be required

to conduct additional clinical studies, which would require additional expenditures and harm our operating results.

If the products are

already being promoted for these new indications, we may also be subject to significant enforcement actions.

Conducting clinical trials

and obtaining clearances and approvals can be a time-consuming process, and delays in obtaining required future clearances or approvals

could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

Conducting successful clinical studies

may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

Patient enrollment in clinical trials and completion

of patient participation and follow-up depends on many factors, including the size of the patient population;

the nature of the trial

the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects;

the availability

of appropriate clinical trial investigators;

the data to be relied upon in a 505(b)(2) application is related to drug products previously approved by the FDA and covered by patents

that are listed in the FDA’s Orange Book, we would be required to submit with our 505(b)(2) application a Paragraph IV Certification

in which we must certify that we do not infringe the listed patents or that such patents are invalid or unenforceable, and provide notice

to the patent owner or the holder of the approved NDA.

The patent owner or NDA holder would have 45 days from receipt of the notification

of our Paragraph IV Certification to initiate a patent infringement action against us.

If an infringement action is initiated, the approval

of our NDA would be subject to a stay of up to 30 months or more while we defend against such a suit.

Approval of our product candidates

under Section 505(b)(2) may therefore be delayed until patent exclusivity expires or until we successfully challenge the applicability

of those patents to our product candidates.

Alternatively, we may elect to generate sufficient clinical data so that we would no longer

need to rely on third-party data, which would be costly and time consuming and there would be no assurance that such data generated from

such additional activities would be sufficient to obtain approval.

may not be able to obtain shortened review of our applications, and the FDA may not agree that a product candidate qualifies for marketing

If we are required to generate additional data to support approval, we may be unable to meet anticipated or reasonable development

and commercialization timelines, may be unable to generate the additional data at a reasonable cost, or at all, and may be unable to

obtain marketing approval.

If the FDA changes its interpretation of Section 505(b)(2) allowing reliance on data in a previously approved

drug application owned by a third-party, or there is a change in the law affecting Section 505(b)(2), this could delay or even prevent

the FDA from approving any Section 505(b)(2) application that we submit.

may not be able to obtain or maintain ODD or exclusivity for our product candidates.

authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as “orphan

drugs.” Under the Orphan Drug Act, the FDA may designate a drug candidate as an orphan drug if it is intended to treat a rare disease

or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease

or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing

and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product.

entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee

Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition

for which it has such designation, the product is entitled to orphan drug exclusivity.

This means that the FDA may not approve any other

applications to market the same drug or biological product for the same indication for seven years, except in certain circumstances,

including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care)

to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for the indication for which

the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan

product has exclusivity.

In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication

broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially

Modifications

to our products may require new drug approvals.

a particular product receives FDA approval or clearance, expanded uses or uses in new indications of our products may require additional

human clinical trials and new regulatory approvals or clearances, including additional IND and NDA/BLA submissions or premarket approvals

before we can begin clinical development, and/or prior to marketing and sales.

If the FDA requires new clearances or approvals for a

particular use or indication, we may be required to conduct additional clinical studies, which would require additional expenditures

and harm our operating results.

If the products are already being promoted for these new indications, we may also be subject to significant

enforcement actions.

Conducting clinical trials and obtaining clearances and approvals can be a time-consuming process, and delays in

obtaining required future clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely

manner, which in turn would harm our future growth.

successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify

enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the

patient population;

the nature of the trial protocol;

the attractiveness of, or the discomforts and risks associated with, the treatments

received by enrolled subjects;

the availability of appropriate clinical trial investigators;

support staff;

proximity of patients to clinical sites;

ability to comply with the eligibility

and exclusion criteria for participation in the clinical trial;

proximity of patients to

clinical sites;

ability to comply with the eligibility and exclusion criteria for participation in the clinical trial;

and patient compliance.

For example, patients may be discouraged from

enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess

the safety and effectiveness of our product candidates or if they determine that the treatments received under the trial protocols are

not attractive or involve unacceptable risks or discomforts.

Patients may also not participate in our clinical trials if they choose

to participate in contemporaneous clinical trials of competitive products.

Additional delays to the completion of

clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted

and/or required by the occurrences in the given trial .

Each modification to the protocol during a clinical

trial has to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the modification is evaluated.

In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the

clinical trial is not poolable because the same protocol was not used throughout the trial.

This might require the enrollment of additional

subjects, which could result in the extension of the clinical trial and the FDA delaying clearance or approval of a product.

delay could have a material adverse effect on our business and results of operations.

There can be no assurance that the data

generated from our clinical trials using modified protocols will be acceptable to FDA.

There can be no assurance that the data generated

using modified protocols will be acceptable to the FDA or that if future modifications during the trial are necessary, that any such

modifications will be acceptable to the FDA.

If the FDA believes that its prior approval is required for a particular modification, it

can delay or halt a clinical trial while it evaluates additional information regarding the change.

Serious injury or death resulting from a failure

of one of our drug candidates during clinical trials could also result in the FDA delaying our clinical trials or denying or delaying

clearance or approval of a product candidate.

Even though an adverse event may not be the result of the failure of our drug candidate,

the FDA or an IRB could delay or halt a clinical trial for an indefinite period of time while an adverse event is reviewed, and likely

would do so in the event of multiple such events.

Any delay or termination of our current or future

clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from IRBs,

delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays or termination of clinical

trials as a result of protocol modifications or adverse events during the trials, may cause an increase in costs and delays in the filing

of any product submissions with the FDA, delay the approval and commercialization of our products or result in the failure of the clinical

trial, which could adversely affect our business, operating results and prospects.

We rely on and intend to rely on

third-parties to conduct our clinical trials and to assist us with pre-clinical development.

If these third-parties do not perform

as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

We do not have the ability to independently conduct

our pre-clinical and clinical trials for our product candidates, and we must rely on third-parties, such as CROs, medical institutions,

clinical investigators and contract laboratories to conduct such trials.

If these third-parties do not successfully carry out their contractual

duties or regulatory obligations, meet expected deadlines or need to be replaced, or if the quality or accuracy of the data they obtain

is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical

development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory

approval for, or successfully commercialize, our products on a timely basis, if at all.

Furthermore, our third-party clinical trial investigators

may be delayed in conducting our clinical trials for reasons outside of their control.

The occurrence of any of the foregoing may adversely

affect our business, operating results and prospects.

We rely on and intend to rely on third parties

to manufacture our clinical product supplies, and to produce and process our product candidates, if approved.

Our commercialization of

any of our product candidates could be stopped, delayed, or made less profitable if those third parties fail to obtain approval of government

regulators, fail to provide us with sufficient quantities of drug product, devices, or device components, or fail to do so at acceptable

quality levels or prices.

For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive

post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine that the

treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts.

Patients may also not

participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products.

delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial, if such

modifications are warranted and/or required by the occurrences in the given trial .

modification to the protocol during a clinical trial has to be submitted to the FDA.

This could result in the delay or halt of a clinical

trial while the modification is evaluated.

In addition, depending on the quantity and nature of the changes made, the FDA could take

the position that the data generated by the clinical trial is not poolable because the same protocol was not used throughout the trial.

This might require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying

clearance or approval of a product.

Any such delay could have a material adverse effect on our business and results of operations.

can be no assurance that the data generated from our clinical trials using modified protocols will be acceptable to FDA.

can be no assurance that the data generated using modified protocols will be acceptable to the FDA or that if future modifications during

the trial are necessary, that any such modifications will be acceptable to the FDA.

If the FDA believes that its prior approval is required

for a particular modification, it can delay or halt a clinical trial while it evaluates additional information regarding the change.

injury or death resulting from a failure of one of our drug candidates during clinical trials could also result in the FDA delaying our

clinical trials or denying or delaying clearance or approval of a product candidate.

Even though an adverse event may not be the result

of the failure of our drug candidate, the FDA or an IRB could delay or halt a clinical trial for an indefinite period of time while an

adverse event is reviewed, and likely would do so in the event of multiple such events.

delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining

or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical

trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause

an increase in costs and delays in the filing of any product submissions with the FDA, delay the approval and commercialization of our

products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

rely on and intend to rely on third-parties to conduct our clinical trials and to assist us with pre-clinical development.

If these third-parties

do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

do not have the ability to independently conduct our pre-clinical and clinical trials for our product candidates, and we must rely on

third-parties, such as CROs, medical institutions, clinical investigators and contract laboratories to conduct such trials.

third-parties do not successfully carry out their contractual duties or regulatory obligations, meet expected deadlines or need to be

replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols

or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed,

suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely

basis, if at all.

Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons

outside of their control.

The occurrence of any of the foregoing may adversely affect our business, operating results and prospects.

rely on and intend to rely on third parties to manufacture our clinical product supplies, and to produce and process our product candidates,

Our commercialization of any of our product candidates could be stopped, delayed, or made less profitable if those third

parties fail to obtain approval of government regulators, fail to provide us with sufficient quantities of drug product, devices, or

device components, or fail to do so at acceptable quality levels or prices.

We do not currently have, nor do we currently

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plan to continue relying on third parties to manufacture our product candidates, devices, or device components on a commercial scale,

In particular, we rely upon single-sourced manufacturing with one third-party contract development and manufacturing organization

(a “CDMO”), WuXi AppTec (“WuXi”) for HT-KIT.

In January 2024, the BIOSECURE Act (H.R.

was introduced in the House of Representatives and a substantially similar bill (S.3558) was introduced in the Senate.

If these bills

became law, or similar laws are passed, they would have the potential to severely restrict the ability of U.S.

biopharmaceutical companies

to contract with certain Chinese biotechnology companies “of concern” without losing the ability to contract with, or otherwise

receive funding from, the U.S.

We do business with companies in China and it is possible some of our contractual counterparties

could be impacted by this legislation.

The prominent regulatory standard used by the FDA to ensure pharmaceutical quality is the Current Good Manufacturing Practice

The FDA can and will take regulatory action against drug manufacturers based on lack of CGMP, which can cause production

delays and incur additional costs.

In particular, we rely upon single-sourced manufacturing with one third-party contract development

and manufacturing organization (a “CDMO”), WuXi AppTec (“WuXi”), for HT-KIT.

January 2024, the BIOSECURE Act (H.R.

7085) was introduced in the House of Representatives and a substantially similar bill (S.3558)

was introduced in the Senate.

Although the House of Representatives of the prior Congress (the 118 th Congress) passed the

BIOSECURE Act on September 9, 2024, the legislation ultimately did not become law in the 118 th Congress.

It is unclear whether

the current Congress (the 119 th Congress) will introduce the BIOSECURE Act or similar legislation in this congressional session.

If these bills became law, or similar laws are passed, they would have the potential to severely restrict the ability of U.S.

biopharmaceutical

companies to contract with certain Chinese biotechnology companies “of concern” without losing the ability to contract with,

or otherwise receive funding from, the U.S.

We do business with companies in China and it is possible some of our contractual

counterparties could be impacted by this legislation.

reliance on third-party manufacturers exposes us to the following additional risks:

● We may be unable to identify manufacturers of our product

candidates on acceptable terms or at all.

● Our third-party manufacturers might be unable to timely formulate

and manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any.

● Contract manufacturers may not be able to execute our manufacturing

procedures appropriately.

● Our future third-party manufacturers may not perform as agreed

or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce,

store, and distribute our commercial products, if approved.

● Our reliance on single-sourced manufacturing with WuXi increases

the risk that any problems or delays with WuXi could materially, negatively affect the development of our product candidates.

● Manufacturers are subject to ongoing periodic unannounced

inspection by the FDA and some state agencies to ensure strict compliance with cGMPs and other government regulations and corresponding

foreign standards.

We do not have control over third-party manufacturers’ compliance with these regulations and standards.

● We may not own, or may have to share, the intellectual property

rights to any improvements made by our third-party manufacturers in the manufacturing process for our product candidates.

● Our third-party manufacturers could breach or terminate their

agreement with us.

● Our third-party manufacturers’ performance, available

capacity and ability to manufacture clinical or commercial products may be impacted by mergers and or acquisitions.

● We and our third-party manufacturers may be impacted by global

conflicts, including any potential conflict involving China and Taiwan, and any resulting trade sanctions.

● Foreign third-party manufacturers may be subject to U.S.

legislation or investigations, including the proposed BIOSECURE Act, trade restrictions and other foreign regulatory requirements, which

could increase the cost or reduce the supply of HT-KIT, delay the procurement or supply of HT-KIT or delay clinical trials.

Each of these risks could delay our clinical trials,

as well as the approval, if any, of our product candidates by the FDA, or the commercialization of our product candidates, or could result

in higher costs, or could deprive us of potential product revenue.

We currently rely on foreign CROs and CDMOs, including

WuXi, to manufacture HT-KIT, and will likely continue to rely on foreign CROs and CDMOs in the future.

Foreign CDMOs may be subject to

legislation or investigations, including the proposed BIOSECURE Act, sanctions, trade restrictions and other foreign regulatory

requirements, which could increase the cost or reduce the supply of HT-KIT, delay the procurement or supply of HT-KIT, delay or impact

clinical trials and could adversely affect our financial condition and business prospects.

While we assume we could replace WuXi, this

could be time consuming and expensive, which may adversely affect our financial condition and business prospects.

The future results of our current or future

clinical trials may not support our product candidate claims or may result in the discovery of unexpected adverse side effects.

Even if our clinical trials are completed as

planned, we cannot be certain that their results will support our drug candidate claims or that the FDA or foreign regulatory agencies

will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that later

clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical

The clinical trial process may fail to demonstrate that our drug candidates are safe and effective for the proposed indicated

If the FDA or other regulatory agencies conclude that the clinical trials for any of our product candidates has failed to demonstrate

safety and effectiveness, we would not receive clearance from the FDA or other regulatory agencies to market that product in the United

States or internationally for the indications sought.

In addition, such an outcome could cause us to

abandon the product candidate and might delay development of other product candidates.

Any delay or termination of our clinical trials

will delay the filing of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and

generate revenues.

It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently

part of the product candidate’s profile.

In addition, our clinical trials may involve a relatively small patient population.

of the small sample size, our results may not be indicative of future results.

Even if our product candidates are approved

by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulations or if we experience unanticipated problems

with our products, these products could be subject to restrictions or withdrawal from the market.

The manufacturing processes, reporting requirements,

post-approval clinical data and promotional activities for any product candidate for which we obtain regulatory approval will be subject

to continued regulatory review, oversight and periodic inspections by the FDA.

In particular, we and our suppliers are required to comply

with FDA’s Quality System Regulations and International Standards Organization (“ISO”) regulations for the manufacture

of our products and other regulations which cover the methods and documentation of the design, testing, production, control, quality

assurance, labeling, packaging, storage and shipping of any product for which we obtain clearance or approval.

Regulatory bodies, such

as the FDA, enforce these regulations through periodic inspections.

The failure by us or one of our suppliers to comply with applicable

statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any

adverse inspectional observations or product safety issues, could result in, among other things, enforcement actions by the FDA.

If any of these actions were to occur it would

harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue.

our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements

which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

Even if regulatory clearance or approval of a

product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be marketed

and reduce the potential to successfully commercialize the product and generate revenue from the product.

If the FDA determines that

the product promotional materials, labeling, training or other marketing or educational activities constitute promotion of an unapproved

use, it could request that we or our commercialization partners cease or modify our training or promotional materials or subject us to

regulatory enforcement actions.

It is also possible that other federal, state or foreign enforcement authorities might take action if

they consider such training or other promotional materials to constitute promotion of an unapproved use, which could result in significant

fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In addition, we may be required to conduct costly

post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with adverse event and

pharmacovigilance reporting requirements, including the reporting of adverse events which occur in connection with, and whether or not

directly related to, our products.

Later discovery of previously unknown problems with our products, including unanticipated adverse

events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements,

may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market,

voluntary or mandatory recalls, a requirement to recall, replace or refund the cost of any product we manufacture or distribute, fines,

suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely

affect our business, operating results and prospects.

Our revenue stream will depend upon third-party

may be unable to identify manufacturers of our product candidates on acceptable terms or at all.

third-party manufacturers might be unable to timely formulate and manufacture our product or produce the quantity and quality required

to meet our clinical and commercial needs, if any.

manufacturers may not be able to execute our manufacturing procedures appropriately.

future third-party manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time

required to supply our clinical trials or to successfully produce, store, and distribute our commercial products, if approved.

reliance on single-sourced manufacturing with WuXi increases the risk that any problems or delays with WuXi could materially, negatively

affect the development of HT-KIT.

Manufacturers

are subject to ongoing periodic unannounced inspection by the FDA and some state agencies to ensure strict compliance with cGMPs

and other government regulations and corresponding foreign standards.

We do not have control over third-party manufacturers’

compliance with these regulations and standards.

may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in

the manufacturing process for our product candidates.

third-party manufacturers could breach or terminate their agreement with us.

third-party manufacturers’ performance, available capacity and ability to manufacture clinical or commercial products may be

impacted by mergers and or acquisitions.

and our third-party manufacturers may be impacted by global conflicts, including any potential conflict involving China and Taiwan,

and any resulting trade sanctions.

third-party manufacturers may be subject to U.S.

legislation or investigations, trade restrictions and other foreign regulatory requirements,

which could increase the cost or reduce the supply of HT-KIT, delay the procurement or supply of HT-KIT or delay clinical trials.

of these risks could delay our clinical trials, as well as the approval, if any, of our product candidates by the FDA, or the commercialization

of our product candidates, or could result in higher costs, or could deprive us of potential product revenue.

currently rely on foreign CROs and CDMOs, including WuXi to manufacture HT-KIT, and will likely continue to rely on foreign CROs and

CDMOs in the future.

Foreign CDMOs may be subject to U.S.

legislation or investigations, sanctions, trade restrictions and other foreign

regulatory requirements, which could increase the cost or reduce the supply of HT-KIT, delay the procurement or supply of HT-KIT, delay

or impact clinical trials and could adversely affect our financial condition and business prospects.

While we believe we may be able

to replace WuXi, this could be time-consuming and expensive, which may adversely affect our financial condition and business prospects.

future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery of

unexpected adverse side effects.

if our clinical trials are completed as planned, we cannot be certain that their results will support our drug candidate claims or that

the FDA or foreign regulatory agencies will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical

trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the

results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our drug candidates are safe

and effective for the proposed indicated uses.

If the FDA or other regulatory agencies conclude that the clinical trials for any of our

product candidates has failed to demonstrate safety and effectiveness, we would not receive clearance from the FDA or other regulatory

agencies to market that product in the United States or internationally for the indications sought.

addition, such an outcome could cause us to abandon the product candidate and might delay development of other product candidates.

delay or termination of our clinical trials will delay the filing of any product submissions with the FDA and, ultimately, our ability

to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience

adverse side effects that are not currently part of the product candidate’s profile.

In addition, our clinical trials may involve

a relatively small patient population.

Because of the small sample size, our results may not be indicative of future results.

if our product candidates are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulations

or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the

manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for any product candidate for

which we obtain regulatory approval will be subject to continued regulatory review, oversight and periodic inspections by the FDA.

particular, we and our suppliers are required to comply with FDA’s Quality System Regulations and International Standards Organization

(“ISO”) regulations for the manufacture of our products and other regulations which cover the methods and documentation of

the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain

clearance or approval.

Regulatory bodies, such as the FDA, enforce these regulations through periodic inspections.

The failure by us

or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the

failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other

things, enforcement actions by the FDA.

any of these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent

us from generating revenue.

Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with

all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in the required

quantities, if at all.

if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended

uses for which the product may be marketed and reduce the potential to successfully commercialize the product and generate revenue from

If the FDA determines that the product promotional materials, labeling, training or other marketing or educational activities

constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify our training or

promotional materials or subject us to regulatory enforcement actions.

It is also possible that other federal, state or foreign enforcement

authorities might take action if they consider such training or other promotional materials to constitute promotion of an unapproved

use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for

reimbursement.

The commercial success of our products in both

domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement is available for

patients that use our products.

However, the availability of insurance coverage and reimbursement for newly approved therapies is uncertain,

and therefore, third-party coverage may be particularly difficult to obtain even if our products are approved by the FDA as safe and

Patients using existing approved therapies are generally reimbursed all or part of the product cost by Medicare or other

third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to

contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as a result, they may not cover

or provide adequate payment for these products.

Submission of applications for reimbursement approval generally does not occur prior

to the filing of an NDA for that product and may not be granted for as long as many months after NDA approval.

In order to obtain reimbursement

arrangements for these products, we or our commercialization partners may have to agree to a net sales price lower than the net sales

price we might charge in other sales channels.

The continuing efforts of government and third-party payors to contain or reduce the costs

of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may make our revenues particularly

susceptible to any cost containment or reduction efforts.

Current and future legislation may increase

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

obtain for such product candidates.

In the United States and some foreign jurisdictions,

there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent

or delay marketing approval for our product candidates, restrict or regulate post-approval activities and affect our ability to profitably

sell our product candidates.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales

and promotional activities for pharmaceutical products.

We do not know whether additional legislative changes will be enacted, or whether

the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our

product candidates, if any, may be.

addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products,

and we must comply with adverse event and pharmacovigilance reporting requirements, including the reporting of adverse events which occur

in connection with, and whether or not directly related to, our products.

Later discovery of previously unknown problems with our products,

including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to

comply with regulatory requirements, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal

of the products from the market, voluntary or mandatory recalls, a requirement to recall, replace or refund the cost of any product we

manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal

penalties which would adversely affect our business, operating results and prospects.

revenue stream will depend upon third-party reimbursement.

commercial success of our products in both domestic and international markets will be substantially dependent on whether third-party

coverage and reimbursement is available for patients that use our products.

However, the availability of insurance coverage and reimbursement

for newly approved therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products

are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part of the

product cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party payors

are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as

a result, they may not cover or provide adequate payment for these products.

Submission of applications for reimbursement approval generally

does not occur prior to the filing of an NDA for that product and may not be granted for as long as many months after NDA approval.

order to obtain reimbursement arrangements for these products, we or our commercialization partners may have to agree to a net sales

price lower than the net sales price we might charge in other sales channels.

The continuing efforts of government and third-party payors

to contain or reduce the costs of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may

make our revenues particularly susceptible to any cost containment or reduction efforts.

and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates

and affect the prices we may obtain for such product candidates.

the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes

regarding the healthcare system that could prevent or delay marketing approval for our product candidates, restrict or regulate post-approval

activities and affect our ability to profitably sell our product candidates.

Legislative and regulatory proposals have been made to expand

post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

We do not know whether additional

legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact

of such changes on the marketing approvals of our product candidates, if any, may be.

In addition, increased scrutiny by the U.S.

Congress of the FDA’s approval process may significantly

delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

In the United States, the Medicare Modernization

Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical products.

The legislation expanded Medicare coverage

for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for drugs.

this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that

will be covered in any therapeutic class.

As a result of this legislation and the expansion of federal coverage of drug products, we

expect that there will be additional pressure to contain and reduce costs.

These cost reduction initiatives and other provisions of this

legislation could decrease the coverage and price that we receive for our product candidates and could seriously harm our business.

the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations

in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction

in payments from private payors.

The Patient Protection and Affordable Care Act,

as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Health Care Reform Law”)

is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies

against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees

on the health industry and impose additional health policy reforms.

The Health Care Reform Law revised the definition of “average

manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states.

Further, the law

imposed a significant annual fee on companies that manufacture or import branded prescription drug products.

The Health Care Reform Law remains subject to

legislative efforts to repeal, modify or delay the implementation of the law.

However, if the Health Care Reform Law is repealed or modified,

or if implementation of certain aspects of the Health Care Reform Law are delayed, such repeal, modification or delay may materially

adversely impact our business, strategies, prospects, operating results or financial condition.

We are unable to predict the full impact

of any repeal, modification or delay in the implementation of the Health Care Reform Law on us at this time.

Due to the substantial regulatory

changes that will need to be implemented by the Centers for Medicare & Medicaid Services and others, and the numerous processes required

to implement these reforms, we cannot predict which healthcare initiatives will be implemented at the federal or state level, the timing

of any such reforms, or the effect such reforms or any other future legislation or regulation will have on our business.

In addition, other legislative changes have been

proposed and adopted in the United States since the Health Care Reform Law was enacted.

We expect that additional federal healthcare

reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare

products and services, and in turn could significantly reduce the projected value of certain development projects and reduce or eliminate

our profitability.

We are dependent on third parties for manufacturing

and marketing of our proposed product candidates.

If we are not able to secure favorable arrangements with such third parties, our business

and financial condition could be harmed.

We will not manufacture any of our proposed product

candidates for commercial sale nor do we have the resources necessary to do so.

In addition, we currently do not have the capability

to market our drug products ourselves.

In addition to our internal sales force efforts, we have contracted with and intend to continue

to contract with specialized manufacturing companies to manufacture our proposed product candidates and partner with larger pharmaceutical

companies for commercialization of our products.

In connection with our efforts to commercialize our proposed product candidates, we

will seek to secure favorable arrangements with third parties to distribute, promote, market and sell our proposed product candidates.

If our internal sales force is unable to successfully distribute, market and promote our product candidates and we are not able to secure

favorable commercial terms or arrangements with third parties for the distribution, marketing, promotion and sales of our proposed product

candidates, we may have to retain promotional and marketing rights and seek to develop the commercial resources necessary to promote

or co-promote or co-market certain or all of our proposed drug candidates to the appropriate channels of distribution in order to reach

the specific medical market that we are targeting.

We may not be able to enter into any partnering arrangements on this or any other

If we are not able to secure favorable partnering arrangements or are unable to develop the appropriate resources necessary for

the commercialization of our proposed product candidates, our business and financial condition could be harmed.

In addition, we will

have to hire additional employees or consultants, since our current employees have limited experience in these areas.

Sufficient employees

with relevant skills may not be available to us.

Any increase in the number of our employees would increase our expense level and could

have an adverse effect on our financial position.

In addition, we, or our potential commercial

partners, may not successfully introduce our proposed product candidates or such candidates may not achieve acceptance by patients, health

care providers and insurance companies.

Further, it is possible that we may not be able to secure arrangements to manufacture, market,

distribute, promote and sell our proposed product candidates at favorable commercial terms that would permit us to make a profit.

the extent that corporate partners conduct clinical trials, we may not be able to control the design and conduct of these clinical trials.

We may have conflicts with our partners

that could delay or prevent the development or commercialization of our product candidates.

We may have conflicts with our partners, such

as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement of milestones, the interpretation of contractual

obligations, payments for services, development obligations or the ownership of intellectual property developed during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is averse to our best interests.

Any such disagreement

could result in one or more of the following, each of which could delay or prevent the development or commercialization of our product

candidates, and in turn prevent us from generating revenues:

unwillingness on the part of a partner to pay us milestone payments or royalties

we believe are due to us under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative

activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development

or manufacture of the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep

us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results

of those activities;

initiating of litigation or alternative dispute resolution options by either party to resolve the dispute;

by either party to terminate the agreement.

Even if we receive regulatory approval

for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from

its sales, if any, may be limited.

If approved for marketing, the commercial success

of our product candidates will depend upon each product’s acceptance by the medical community, including physicians, patients and

health care payors.

The degree of market acceptance for any of our product candidates will depend on a number of factors, including:

demonstration of clinical

safety and efficacy;

relative convenience, dosing

burden and ease of administration;

the prevalence and severity

of any adverse effects;

the willingness of physicians

to prescribe our product candidates, and the target patient population to try new therapies;

efficacy of our product

candidates compared to competing products;

the introduction of any

new products that may in the future become available targeting indications for which our product candidates may be approved;

new procedures or therapies

that may reduce the incidences of any of the indications in which our product candidates may show utility;

pricing and cost-effectiveness;

the inclusion or omission

of our product candidates in applicable therapeutic and vaccine guidelines;

the effectiveness of our

own or any future collaborators’ sales and marketing strategies;

limitations or warnings

contained in approved labeling from regulatory authorities;

our ability to obtain and

maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid,

private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating

the pricing and usage of therapeutics;

the willingness of patients

to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

If any of our product candidates are approved,

but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate sufficient revenue

and we may not be able to achieve or sustain profitability.

Our efforts to educate the medical community and third-party payors on the

benefits of our product candidates may require significant resources and may never be successful.

In addition, even if we obtain regulatory approvals,

the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully.

if the approval process takes too long, we may miss market opportunities thereby giving other companies the ability to develop competing

products or establish market dominance.

Any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval

commitments that render our product candidates not commercially viable.

For example, regulatory authorities may approve any of our product

candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing

clinical trials, or may approve any of our product candidates with a label that does not include the labeling claims necessary or desirable

for the successful commercialization for that indication.

Further, the FDA or comparable foreign regulatory authorities may place conditions

on approvals or require risk management plans or a REMS to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the

sponsor of the NDA must submit a proposed REMS.

The FDA will not approve the NDA without an approved REMS, if required.

include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient

registries and other risk minimization tools.

The FDA may also require a REMS for an approved product when new safety information emerges.

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of

our product candidates.

Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur

following the initial marketing of the product.

Any of the foregoing scenarios could materially harm the commercial success of our product

Our products will face significant competition,

and if they are unable to compete successfully, our business will suffer.

Our product candidates face, and will continue

to face, intense competition from large pharmaceutical companies, as well as academic and research institutions.

We compete in an industry

that is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product

introductions.

Our competitors have and may develop products and technologies that will compete with our products and technologies.

several competing companies and institutions have greater financial resources than us, they may be able to:

(i) provide broader services

and product lines, (ii) make greater investments in research and development and (iii) carry on larger research and development initiatives.

Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking pre-clinical

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

have greater name recognition and better access to customers than us.

Adverse events involving our products may

lead the FDA or other regulatory agencies to delay or deny clearance for our products or result in product recalls that could harm our

reputation, business and financial results.

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

labeling and post-marketing testing and other requirements.

the United States, the Medicare Modernization Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical products.

The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on

average sales prices for drugs.

In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies where

they can limit the number of drugs that will be covered in any therapeutic class.

As a result of this legislation and the expansion of

federal coverage of drug products, we expect that there will be additional pressure to contain and reduce costs.

These cost reduction

initiatives and other provisions of this legislation could decrease the coverage and price that we receive for our product candidates

and could seriously harm our business.

While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow

Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results

from the MMA may result in a similar reduction in payments from private payors.

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively,

the “Health Care Reform Law”) is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth

of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance

industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

The Health Care Reform Law

revised the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid

drug rebates to states.

Further, the law imposed a significant annual fee on companies that manufacture or import branded prescription

drug products.

Health Care Reform Law remains subject to legislative efforts to repeal, modify or delay the implementation of the law.

However, if the

Health Care Reform Law is repealed or modified, or if implementation of certain aspects of the Health Care Reform Law are delayed, such

repeal, modification or delay may materially adversely impact our business, strategies, prospects, operating results or financial condition.

We are unable to predict the full impact of any repeal, modification or delay in the implementation of the Health Care Reform Law on

us at this time.

Due to the substantial regulatory changes that will need to be implemented by the Centers for Medicare & Medicaid

Services and others, and the numerous processes required to implement these reforms, we cannot predict which healthcare initiatives will

be implemented at the federal or state level, the timing of any such reforms, or the effect such reforms or any other future legislation

or regulation will have on our business.

addition, other legislative changes have been proposed and adopted in the United States since the Health Care Reform Law was enacted.

We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that

federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value

of certain development projects and reduce or eliminate our profitability.

are dependent on third parties for manufacturing and marketing of our proposed product candidates.

If we are not able to secure favorable

arrangements with such third parties, our business and financial condition could be harmed.

will not manufacture any of our proposed product candidates for commercial sale nor do we have the resources necessary to do so.

we currently do not have the capability to market our drug products ourselves.

In addition to our internal sales force efforts, we have

contracted with and intend to continue to contract with specialized manufacturing companies to manufacture our proposed product candidates

and partner with larger pharmaceutical companies for commercialization of our products.

In connection with our efforts to commercialize

our proposed product candidates, we will seek to secure favorable arrangements with third parties to distribute, promote, market and

sell our proposed product candidates.

If our internal sales force is unable to successfully distribute, market and promote our product

candidates and we are not able to secure favorable commercial terms or arrangements with third parties for the distribution, marketing,

promotion and sales of our proposed product candidates, we may have to retain promotional and marketing rights and seek to develop the

commercial resources necessary to promote or co-promote or co-market certain or all of our proposed drug candidates to the appropriate

channels of distribution in order to reach the specific medical market that we are targeting.

We may not be able to enter into any partnering

arrangements on this or any other basis.

If we are not able to secure favorable partnering arrangements or are unable to develop the

appropriate resources necessary for the commercialization of our proposed product candidates, our business and financial condition could

In addition, we will have to hire additional employees or consultants, since our current employees have limited experience

in these areas.

Sufficient employees with relevant skills may not be available to us.

Any increase in the number of our employees would

increase our expense level and could have an adverse effect on our financial position.

addition, we, or our potential commercial partners, may not successfully introduce our proposed product candidates or such candidates

may not achieve acceptance by patients, health care providers and insurance companies.

Further, it is possible that we may not be able

to secure arrangements to manufacture, market, distribute, promote and sell our proposed product candidates at favorable commercial terms

that would permit us to make a profit.

To the extent that corporate partners conduct clinical trials, we may not be able to control the

design and conduct of these clinical trials.

may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.

may have conflicts with our partners, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement

of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual

property developed during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is

averse to our best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent

the development or commercialization of our product candidates, and in turn prevent us from generating revenues:

unwillingness on the

part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership

of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data

or materials;

unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization

activities or to permit public disclosure of the results of those activities;

initiating of litigation or alternative dispute resolution

options by either party to resolve the dispute;

or attempts by either party to terminate the agreement.

if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and

the revenue that we generate from its sales, if any, may be limited.

approved for marketing, the commercial success of our product candidates will depend upon each product’s acceptance by the medical

community, including physicians, patients and health care payors.

The degree of market acceptance for any of our product candidates will

depend on a number of factors, including:

demonstration

of clinical safety and efficacy;

convenience, dosing burden and ease of administration;

prevalence and severity of any adverse effects;

willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;

of our product candidates compared to competing products;

introduction of any new products that may in the future become available targeting indications for which our product candidates may

procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility;

and cost-effectiveness;

inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;

effectiveness of our own or any future collaborators’ sales and marketing strategies;

or warnings contained in approved labeling from regulatory authorities;

ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare

and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government

bodies regulating the pricing and usage of therapeutics;

willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and

patients, we may not generate sufficient revenue and we may not be able to achieve or sustain profitability.

Our efforts to educate the

medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be

addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize

our product candidates successfully.

For example, if the approval process takes too long, we may miss market opportunities thereby giving

other companies the ability to develop competing products or establish market dominance.

Any regulatory approval we ultimately obtain

may be limited or subject to restrictions or post-approval commitments that render our product candidates not commercially viable.

example, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may

grant approval contingent on the performance of costly post-marketing clinical trials, or may approve any of our product candidates with

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

the FDA or comparable foreign regulatory authorities may place conditions on approvals or require risk management plans or a REMS to

assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS.

not approve the NDA without an approved REMS, if required.

A REMS could include medication guides, physician communication plans, or

elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

also require a REMS for an approved product when new safety information emerges.

Any of these limitations on approval or marketing could

restrict the commercial promotion, distribution, prescription or dispensing of our product candidates.

Moreover, product approvals may

be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product.

the foregoing scenarios could materially harm the commercial success of our product candidates.

products will face significant competition, and if they are unable to compete successfully, our business will suffer.

product candidates face, and will continue to face, intense competition from large pharmaceutical companies, as well as academic and

research institutions.

We compete in an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry standards,

(iii) emerging competition and (iv) new product introductions.

Our competitors have and may develop products and technologies that will

compete with our products and technologies.

Because several competing companies and institutions have greater financial resources than

us, they may be able to:

(i) provide broader services and product lines, (ii) make greater investments in research and development and

(iii) carry on larger research and development initiatives.

Our competitors also have greater development capabilities than we do and

have substantially greater experience in undertaking pre-clinical and clinical testing of products, obtaining regulatory approvals, and

manufacturing and marketing pharmaceutical products.

They also have greater name recognition and better access to customers than us.

events involving our products may lead the FDA or other regulatory agencies to delay or deny clearance for our products or result in

product recalls that could harm our reputation, business and financial results.

Once a product receives clearance or approval,

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or defects in design or manufacture.

With respect to the FDA, the authority to require a recall must be based on an FDA finding that

there is a reasonable probability that the product would cause serious injury or death.

Manufacturers may, under their own initiative,

recall a product if any material deficiency in a product is found.

With respect to the FDA, the authority to require a recall must be based on an FDA finding that there

is a reasonable probability that the product would cause serious injury or death.

Manufacturers may, under their own initiative, recall

a product if any material deficiency in a product is found.

A government-mandated or voluntary recall by us or one of our distributors

could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling

defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and have an

adverse effect on our financial condition and results of operations.

In addition, the FDA requires that certain classifications of recalls

be reported to FDA within ten working days after the recall is initiated.

Companies are required to maintain certain records of recalls,

even if they are not reportable to the FDA.

We may initiate voluntary recalls involving our products in the future that we determine

could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects

or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and have an adverse effect

on our financial condition and results of operations.

In addition, the FDA requires that certain classifications of recalls be reported

to FDA within ten working days after the recall is initiated.

Companies are required to maintain certain records of recalls, even if they

are not reportable to the FDA.

We may initiate voluntary recalls or market withdrawal involving our products in the future that we determine

do not require notification of the FDA.

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A future recall announcement could harm our reputation with customers and negatively affect our sales.

In addition, the FDA

could take enforcement action for failing to report the recalls when they were conducted.

If we fail to comply with healthcare regulations,

we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition

could be adversely affected.

Sales of our product candidates, if approved,

or any other future product candidate will be subject to healthcare regulation and enforcement by the federal government and the states

and foreign governments in which we might conduct our business.

The healthcare laws and regulations that may affect our ability to operate

include the following:

the federal Anti-Kickback

Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or

pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order, lease of any good,

facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

“remuneration” has been broadly interpreted to include anything of value;

the Omnibus Budget Reconciliation

Act of 1993 (42 U.S.C.

§ 1395nn) (the “Stark Law”) prohibit referrals by a physician of “designated health

services” which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s

immediate family member has an investment interest or other financial relationship, subject to several exceptions.

The Stark Law

also prohibits billing for services rendered pursuant to a prohibited referral.

Several states have enacted laws similar to the Stark

In addition, the FDA could

take enforcement action for failing to report the recalls when they were conducted.

we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties

and our business, operations and financial condition could be adversely affected.

of our product candidates, if approved, or any other future product candidate will be subject to healthcare regulation and enforcement

by the federal government and the states and foreign governments in which we might conduct our business.

The healthcare laws and regulations

that may affect our ability to operate include the following:

the federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The term “remuneration” has been broadly interpreted to include anything of value, including gifts, discounts, credit arrangements, payments of cash, ownership interests and providing anything at less than its fair market value.

Recognizing that the federal Anti- Kickback Statute is broad and may prohibit certain common activities within the healthcare industry, the Office of Inspector General for HHS has issued a series of statutory exceptions and regulatory “safe harbors.” However, these exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection from prosecution under the federal Anti-Kickback Statute;

Omnibus Budget Reconciliation Act of 1993 (42 U.S.C.

§ 1395nn) (the “Stark Law”) prohibit referrals by a physician

of “designated health services” which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which

the physician or the physician’s immediate family member has an investment interest or other financial relationship, subject

to several exceptions.

The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral.

Several states

have enacted laws similar to the Stark Law.

These state laws may cover all (not just Medicare and Medicaid) patients.

Many federal healthcare reform proposals in the past

few years have attempted to expand the Stark Law to cover all patients as well.

We consider the Stark Law in planning our products,

marketing and other activities, and believe that our operations are in compliance with the Stark Law.

If we violate the Stark Law,

our financial results and operations could be adversely affected.

Penalties for violations include denial of payment for the services,

significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs;

federal false claims and

false statement laws, including the federal civil False Claims Act and the Civil Monetary Penalties Law (“CMPL”), prohibits,

among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal

programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent;

HIPAA, created additional

federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme

to defraud any healthcare benefit program, including private third-party payors or making any false, fictitious or fraudulent statement

in connection with the delivery of or payment for healthcare benefits, items or services;

HIPAA, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, impose obligations

on certain types of individuals and entities regarding the electronic exchange of information in common healthcare transactions,

as well as standards relating to the privacy and security of individually identifiable health information;

the FDCA which among other

things, strictly regulates drug and biologics manufacturing, sales, distribution, prohibits the adulteration or misbranding of drugs

and biologics prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

the federal Physician Payments

Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under

Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers

for Medicare & Medicaid Services information related to payments or other transfers of value made to physicians and teaching

hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Also, many states have similar laws and regulations,

such as Stark Law, anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to

items and services reimbursed under Medicaid and other state programs.

Additionally, we may be subject to state laws that require pharmaceutical

companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state

laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare

providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many

of which differ from each other in significant ways and often are not preempted by HIPAA.

The laws and regulations applicable to our business

are complex, changing and often subject to varying interpretations.

As a result, we may not be able to adhere to all applicable laws

and regulations.

Any violation or alleged violation of any of these laws or regulations by us could have a material adverse effect on

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

We may be a party to various lawsuits, demands, claims, qui

tam suits, government investigations and audits, of which any could result in, among other things, substantial financial penalties

or awards against us, reputational harm, termination of relationships or contracts related to our business, mandated refunds, substantial

payments made by us, required changes to our business practices, exclusion from future participation in Medicare and other healthcare

programs, seizure of product and possible criminal penalties.

If we are found in violation of applicable laws

or regulations, we could suffer severe consequences that would have a material adverse effect on our business, results of operations,

financial condition, cash flows, reputation and stock price, including:

suspension or termination

of our participation in federal healthcare programs;

criminal or civil liability,

fines, damages or monetary penalties for violations of healthcare fraud and abuse laws, including the federal False Claims Act, CMPL,

and Anti-Kickback Statute;

enforcement actions by

governmental agencies or claims for monetary damages by patients under federal or state patient privacy laws, including HIPAA;

repayment of amounts received

in violation of law or applicable payment program requirements, and related monetary penalties;

mandated changes to our

practices or procedures that materially increase operating expenses;

imposition of corporate

integrity agreements that could subject us to ongoing audits and reporting requirements as well as increased scrutiny of our business

termination of various

relationships or contracts related to our business;

harm to our reputation

which could negatively affect our business relationships, decrease our ability to attract or retain patients and physicians, decrease

access to new business opportunities and impact our ability to obtain financing, among other things.

Responding to lawsuits and other proceedings

as well as defending ourselves in such matters will continue to require management’s attention and cause us to incur significant

legal expense.

It is also possible that criminal proceedings may be initiated against us or individuals in our business in connection

with investigations by the federal government.

Furthermore, to the extent that our product is sold in a foreign country,

we may be subject to similar foreign laws.

healthcare reform proposals in the past few years have attempted to expand the Stark Law to cover all patients as well.

the Stark Law in planning our products, marketing and other activities, and believe that our operations are in compliance with the

If we violate the Stark Law, our financial results and operations could be adversely affected.

Penalties for violations

include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs;

false claims and false statement laws, including the federal civil False Claims Act and the Civil Monetary Penalties Law (“CMPL”),

prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval

by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent;

HIPAA, created additional federal criminal statutes that prohibit,

among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program,

including private third-party payors or making any false, fictitious or fraudulent statement in connection with the delivery of or payment

for healthcare benefits, items or services;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations,

impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare

transactions, as well as standards relating to the privacy and security of individually identifiable health information;

FDCA which among other things, strictly regulates drug and biologics manufacturing, sales, distribution, prohibits the adulteration

or misbranding of drugs and biologics prohibits manufacturers from marketing drug products for off-label use and regulates the distribution

of drug samples;

federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which

payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report

annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to

physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family

Foreign Corrupt Practices Act (“FCPA”) prohibits

corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official,

government staff member, political party or political candidate in an attempt to obtain or retain business abroad.

The scope of the FCPA

includes interactions with certain healthcare professionals in many countries.

Other countries have enacted similar anti-corruption laws

and/or regulations.

The future of FCPA enforcement remains uncertain, as there has already been a temporary enforcement suspension under

the Trump Administration, and future changes are possible.

many states have similar laws and regulations, such as Stark Law, anti-kickback and false claims laws that may be broader in scope and

may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, we

may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical

industry’s voluntary compliance guidelines, state laws that require drug manufacturers to report information related to payments

and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws

governing the privacy and security of health information, many of which differ from each other in significant ways and often are not

preempted by HIPAA.

laws and regulations applicable to our business are complex, changing and often subject to varying interpretations.

As a result, we may

not be able to adhere to all applicable laws and regulations.

Any violation or alleged violation of any of these laws or regulations

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

We may be a party

to various lawsuits, demands, claims, qui tam suits, government investigations and audits, of which any could result in, among

other things, substantial financial penalties or awards against us, reputational harm, termination of relationships or contracts related

to our business, mandated refunds, substantial payments made by us, required changes to our business practices, exclusion from future

participation in Medicare and other healthcare programs, seizure of product and possible criminal penalties.

we are found in violation of applicable laws or regulations, we could suffer severe consequences that would have a material adverse effect

on our business, results of operations, financial condition, cash flows, reputation and stock price, including:

or termination of our participation in federal healthcare programs;

or civil liability, fines, damages or monetary penalties for violations of healthcare fraud and abuse laws, including the federal

False Claims Act, CMPL, and Anti-Kickback Statute;

actions by governmental agencies or claims for monetary damages by patients under federal or state patient privacy laws, including

of amounts received in violation of law or applicable payment program requirements, and related monetary penalties;

changes to our practices or procedures that materially increase operating expenses;

of corporate integrity agreements that could subject us to ongoing audits and reporting requirements as well as increased scrutiny

of our business practices;

of various relationships or contracts related to our business;

to our reputation which could negatively affect our business relationships, decrease our ability to attract or retain patients and

physicians, decrease access to new business opportunities and impact our ability to obtain financing, among other things.

to lawsuits and other proceedings as well as defending ourselves in such matters will continue to require management’s attention

and cause us to incur significant legal expense.

It is also possible that criminal proceedings may be initiated against us or individuals

in our business in connection with investigations by the federal government.

to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

If a third-party contract manufacturing

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affected, and the development of our product candidates could be delayed or terminated, or we could incur significant additional expenses.

We do not own or operate any manufacturing facilities.

We rely on and intend to continue to rely on CMOs to formulate and manufacture our pre-clinical and clinical materials.

on a CMO exposes us to a number of risks, any of which could delay or prevent the completion of our pre-clinical studies or clinical

trials, or the regulatory approval or commercialization of our product candidates, result in higher costs, or deprive us of potential

product revenues.

do not own or operate any manufacturing facilities.

We rely on and intend to continue to rely on CMOs to formulate and manufacture our

pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks, any of which could delay or prevent the completion

of our pre-clinical studies or clinical trials, or the regulatory approval or commercialization of our product candidates, result in

higher costs, or deprive us of potential product revenues.

Some of these risks include:

our CMO failing to develop

an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates;

our CMO failing to manufacture

our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise manufacturing material that

we or the FDA may deem to be unsuitable in our clinical trials;

our CMO being unable to

increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience a shortage

in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of our product

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale, or we will

be able to find alternative manufacturers acceptable to us that can do so;

our CMO placing a priority

on the manufacture of their own products, or other customers’ products;

our CMO failing to perform

as agreed upon or not remain in business;

our CMOs’ plants

being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

Manufacturers of pharmaceutical products are

subject to ongoing periodic inspections by the FDA, the U.S.

Drug Enforcement Administration and corresponding state and foreign agencies

to ensure strict compliance with FDA mandated cGMPs, other government regulations and corresponding foreign standards.

While we are obligated

to audit their performance, we do not have control over our CMO’s compliance with these regulations and standards.

Failure by any

of our CMOs, or us, to comply with applicable regulations could result in sanctions being imposed on us or the CMOs.

These sanctions

may include fines, injunctions, civil penalties, failure of the government to grant pre-market approval of drugs, delays, suspension

or withdrawal of approvals, seizures or recalls of product, operating restrictions and criminal prosecutions, any of which could significantly

and adversely affect our business.

In the event that we need to change our

CMOs, our pre-clinical studies, clinical trials or the commercialization of our product candidates could be delayed, adversely affected

or terminated, or such a change may result in significantly higher costs.

Various steps in the manufacture of our product

candidates may need to be sole-sourced.

In accordance with cGMP, changing manufacturers may require the re-validation of manufacturing

processes and procedures, and may require further pre-clinical studies or clinical trials to show comparability between the materials

produced by different manufacturers.

Changing our current or future CMOs may be difficult for us and could be costly, which could result

in our inability to manufacture our product candidates for an extended period of time and therefore a delay in the development of our

product candidates.

Further, in order to maintain our development time lines in the event of a change in our CMOs, we may incur significantly

higher costs to manufacture our product candidates.

Healthcare Reform in the United States.

In the United States, there have been, and continue

to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future results

of pharmaceutical manufactures’ operations.

In particular, there have been and continue to be a number of initiatives at the federal

and state levels that seek to reduce healthcare costs.

On the federal level, the Affordable Care Act (“ACA”) was enacted

in March 2010, and included measures to significantly change the way healthcare is financed by both governmental and private insurers.

Among the provisions of the ACA that have been of greatest importance to the pharmaceutical and biotechnology industry are the following:

an annual, nondeductible

fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities

according to their market share in certain government healthcare programs;

implementation of the federal

physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for

follow-on biologic products;

creation of Patient-Centered

Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with

funding for such research;

establishment of a Center

for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models

to lower Medicare and Medicaid spending, potentially including prescription drug spending;

an increase in the statutory

minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price

for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer

adoption of methodology

by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including

our product candidates, that are inhaled, infused, instilled, implanted or injected;

extension of manufacturers’

Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility

criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by

adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially

increasing manufacturers’ Medicaid rebate liability;

creation of a Medicare

Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices

of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s

CMO failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product

CMO failing to manufacture our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise

manufacturing material that we or the FDA may deem to be unsuitable in our clinical trials;

CMO being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience

a shortage in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of

our product candidates.

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale,

or we will be able to find alternative manufacturers acceptable to us that can do so;

CMO placing a priority on the manufacture of their own products, or other customers’ products;

CMO failing to perform as agreed upon or not remain in business;

CMOs’ plants being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

Manufacturers

of pharmaceutical products are subject to ongoing periodic inspections by the FDA, the U.S.

Drug Enforcement Administration and corresponding

state and foreign agencies to ensure strict compliance with FDA mandated cGMPs, other government regulations and corresponding foreign

While we are obligated to audit their performance, we do not have control over our CMO’s compliance with these regulations

and standards.

Failure by any of our CMOs, or us, to comply with applicable regulations could result in sanctions being imposed on us

These sanctions may include fines, injunctions, civil penalties, failure of the government to grant pre-market approval

of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of product, operating restrictions and criminal prosecutions,

any of which could significantly and adversely affect our business.

the event that we need to change our CMOs, our pre-clinical studies, clinical trials or the commercialization of our product candidates

could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs.

steps in the manufacture of our product candidates may need to be sole-sourced.

In accordance with cGMP, changing manufacturers may require

the re-validation of manufacturing processes and procedures, and may require further pre-clinical studies or clinical trials to show

comparability between the materials produced by different manufacturers.

Changing our current or future CMOs may be difficult for us

and could be costly, which could result in our inability to manufacture our product candidates for an extended period of time and therefore

a delay in the development of our product candidates.

Further, in order to maintain our development timelines in the event of a change

in our CMOs, we may incur significantly higher costs to manufacture our product candidates.

Reform in the United States.

the United States, there have been, and continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare

system that could affect the future results of pharmaceutical manufactures’ operations.

In particular, there have been and continue

to be a number of initiatives at the federal and state levels that seek to reduce healthcare costs.

On the federal level, the Affordable

Care Act (“ACA”) was enacted in March 2010, and included measures to significantly change the way healthcare is financed

by both governmental and private insurers.

Among the provisions of the ACA that have been of greatest importance to the pharmaceutical

and biotechnology industry are the following:

annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned

among these entities according to their market share in certain government healthcare programs;

implementation

of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

licensure framework for follow-on biologic products;

of Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness

research, along with funding for such research;

establishment

of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery

models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the

average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs

at 100% of the Average Manufacturer Price;

of methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and

biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;

of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed

care organizations;

of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals

and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby

potentially increasing manufacturers’ Medicaid rebate liability;

of a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated

prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s

outpatient drugs to be covered under Medicare Part D;

expansion of the entities

eligible for discounts under the Public Health program.

Although there have been legal and political

challenges to certain aspects of the ACA, the Biden Administration has affirmed support for the law and, entered its own executive orders

to enforce and strengthen it.

Because of the volatility surrounding the implementation and enforcement of the ACA since its passage,

and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains unclear.

This uncertainty is heightened

by President Biden’s January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act which indicates that

the Biden Administration may significantly modify the ACA and further reform the ACA and other federal programs in manner that may impact

our operations.

The Biden Administration has indicated that a goal of its administration is to expand and support Medicaid and the ACA

and to make high-quality healthcare accessible and affordable.

The potential increase in patients covered by government funded insurance

may impact our pricing.

Further, it is possible that the Biden Administration may further increase scrutiny of drug pricing.

the Biden Administration has been vocal that lowering prescription drug prices is a priority for the Biden Administration.

In addition, we cannot predict the likelihood,

nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the

United States or abroad.

We expect that additional state and federal health care reform measures will be adopted in the future, any of

which could limit the amounts that federal and state governments will pay for health care products and services.

Further, there is uncertainty surrounding the

applicability of the biosimilars provisions under the ACA.

The FDA has issued several guidance documents, but no implementing regulations,

on biosimilars.

of the entities eligible for discounts under the Public Health program.

Although there have been legal and political challenges

to certain aspects of the ACA, the Biden Administration affirmed support for the law and, entered its own executive orders to enforce

and strengthen it.

Because of the volatility surrounding the implementation and enforcement of the ACA since its passage, and at this

time, the full effect that the ACA would have on a pharmaceutical manufacturer remains unclear.

This uncertainty is heightened by actions

taken under the Trump Administration.

On January 20, 2025, President Trump issued Executive Order 14148, which revoked Executive Order

14009 issued by President Biden on January 28, 2021, that had initiated a special enrollment period for purposes of obtaining health insurance

coverage through the ACA marketplace.

It is possible that the ACA will be subject to judicial or Congressional challenges in the future.

It is unclear what healthcare reform measures will be implemented by the Trump Administration, but significant changes are anticipated.

The potential changes in patient coverage by government funded insurance may impact our pricing.

The first Trump Administration, on July 24, 2020

and September 13, 2020, announced several executive orders related to prescription drug pricing.

As a result, the FDA concurrently released

a final rule and guidance in September 2020 providing pathways for states to build and submit importation plans for drugs from Canada.

Further, on November 20, 2020, the HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical

manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction

is required by law.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe

harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

The implementation of the rule was delayed

until 2032 by the Inflation Reduction Act of 2022.

On November 20, 2020, CMS issued an interim final rule implementing President Trump’s

Most Favored Nation executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price

paid in other economically advanced countries.

The Most Favored Nation regulations mandate participation by identified Medicare Part B

providers and will apply in all U.S.

states and territories for a seven-year period beginning January 1, 2021, and ending December 31,

As a result of litigation challenging the Most Favored Nation model, on December 27, 2021 CMS published a final rule that rescinds

the Most Favored Nation model interim final rule.

Further, in July 2021, the Biden administration released an executive order that included

multiple provisions aimed at prescription drugs.

In response to President Biden’s executive order, on September 9, 2021, the HHS

released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform.

The plan sets out a variety

of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these

No legislation or administrative actions have been finalized to implement these principles.

It is unclear how the current

Trump Administration will further address drug pricing.

In August 2022, the Inflation Reduction Act of

2022 was signed into law by President Biden.

The new legislation has implications for Medicare Part D, which is a program available to

individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for

outpatient prescription drug coverage.

Among other things, the Inflation Reduction Act of 2022 requires manufacturers of certain drugs

to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;

imposes rebates

under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part

D coverage gap discount program with a new discounting program (beginning in 2025).

The Inflation Reduction Act of 2022 permits the Secretary

of the HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

There is uncertainty

surrounding this program with the new administration, especially in light of the administration’s budget cuts which impact an agency’s

ability to regulate through guidance.

Further, it is unclear how the new leadership of HHS, CMS, etc.

will approach the issue of drug

In addition, we cannot predict the likelihood, nature or extent of

government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad,

but the Trump administration has shown a tendency to govern through executive action.

We expect that additional state and federal health

care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for

health care products and services.

there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.

The FDA has issued several guidance documents,

but no implementing regulations, on biosimilars.

A number of biosimilar applications have been approved over the past few years.

The regulations that are ultimately promulgated

and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers conduct their business and may

require changes to current strategies.

A biosimilar is a biological product that is highly similar to an approved drug notwithstanding

minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological

product and the approved drug in terms of the safety, purity, and potency of the product.

regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical

manufacturers conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly

similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically

meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

Individual states have become increasingly aggressive

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to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

This could reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical

This could reduce ultimate demand for certain products or put pressure on product pricing, which could negatively affect a pharmaceutical

manufacturer’s business, results of operations, financial condition and prospects.

In addition, given recent federal and state government

initiatives directed at lowering the total cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare

reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

While no one cannot predict

the full outcome of any such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate

industry-wide pressure to reduce prescription drug prices.

This could harm a pharmaceutical manufacturer’s ability to generate

Increases in importation or re-importation of pharmaceutical products from foreign countries into the United States could put

competitive pressure on a pharmaceutical manufacturer’s ability to profitably price products, which, in turn, could adversely affect

business, results of operations, financial condition and prospects.

A pharmaceutical manufacturer might elect not to seek approval for

or market products in foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated

from product sales.

It is also possible that other legislative proposals having similar effects will be adopted.

Furthermore, regulatory authorities’ assessment

of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as

the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership.

be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects.

average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding

levels and statutory, regulatory and policy changes.

Our business may be adversely affected

by cybersecurity threats, information systems interruptions and/or threats to our physical buildings.

It is essential to our business strategy that

our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners

to be secure.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other

security threats.

We may face cybersecurity threats that attempt to penetrate our network security, sabotage or otherwise disable our

research, products and services, misappropriate our or our customers’ and partners’ proprietary information, which may include

personally identifiable information, or cause interruptions or failures of our internal systems and services.

Despite security measures,

we also cannot guarantee security of our physical buildings.

Physical building penetration or any cybersecurity threats could negatively

affect our reputation, damage our network infrastructure and our ability to deploy our products and services, harm our relationship with

customers and partners that are affected, and expose us to financial liability.

Although we continue to review and enhance our

systems and cybersecurity controls, we may experience cybersecurity threats, including threats to our information technology infrastructure

and attempts to gain access to our sensitive information, as do our customers and suppliers.

Although we maintain information security

policies and procedures to prevent, detect, and mitigate these threats, information system disruptions, equipment failures or cybersecurity

attacks, such as unauthorized access, malicious software and other intrusions, could still occur and may lead to potential data corruption,

exposure of proprietary and confidential information.

Further, while we work cooperatively with our customers and suppliers to seek to

minimize the impacts of cybersecurity threats, other security threats or business disruptions, in addition to our internal processes,

procedures and systems, we must also rely on the safeguards put in place by those entities.

Any intrusion, disruption, breach or similar

event may cause operational stoppages, fines, penalties, diminished competitive advantages through reputational damages and increased

operational costs.

The costs related to cybersecurity or other security threats or disruptions may not be fully mitigated by insurance

or other means.

In addition to existing risks, any adoption or deployment of new technologies may increase our exposure to risks, breaches,

or failures, which could materially adversely affect our results of operations or financial condition.

Additionally, there are a number of state, federal

and international laws protecting the privacy and security of health information and personal data.

For example, HIPAA imposes limitations

on the use and disclosure of an individual’s healthcare information by healthcare providers, healthcare clearinghouses, and health

insurance plans, or, collectively, covered entities, and also grants individuals rights with respect to their health information.

also imposes compliance obligations and corresponding penalties for non-compliance on individuals and entities that provide services

to healthcare providers and other covered entities.

As part of the American Recovery and Reinvestment Act of 2009 (“ARRA”)

the privacy and security provisions of HIPAA were amended.

ARRA also made significant increases in the penalties for improper use or

disclosure of an individual’s health information under HIPAA and extended enforcement authority to state attorneys general.

amended by ARRA and subsequently by the final omnibus rule adopted in 2013, HIPAA also imposes notification requirements on covered entities

in the event that certain health information has been inappropriately accessed or disclosed, notification requirements to individuals,

federal regulators, and in some cases, notification to local and national media.

Notification is not required under HIPAA if the health

information that is improperly used or disclosed is deemed secured in accordance with encryption or other standards developed by the

In addition, given past federal and state government initiatives directed

at lowering the total cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare reform, the cost

of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

While no one cannot predict the full outcome

of any such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide

pressure to reduce prescription drug prices.

This could harm a pharmaceutical manufacturer’s ability to generate revenue.

in importation or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure

on a pharmaceutical manufacturer’s ability to profitably price products, which, in turn, could adversely affect business, results

of operations, financial condition and prospects.

The new administration’s recent introduction of tariffs on foreign nations may

also have an impact on business operations.

A pharmaceutical manufacturer might elect not to seek approval for or market products in foreign

jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated from product sales.

also possible that other legislative proposals having similar effects will be adopted.

regulatory authorities’ assessment of the data and results required to demonstrate safety and efficacy can change over time and

can be affected by many factors, such as the emergence of new information, including on other products, changing policies and agency

funding, staffing and leadership.

We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable

to our business prospects.

For example, average review times at the FDA for marketing approval applications can be affected by a variety

of factors, including budget and funding levels and statutory, regulatory and policy changes.

business may be adversely affected by cybersecurity threats, information systems interruptions and/or threats to our physical buildings.

is essential to our business strategy that our technology and network infrastructure and our physical buildings remain secure and are

perceived by our customers and corporate partners to be secure.

Despite security measures, however, any network infrastructure may be

vulnerable to cyber-attacks by hackers and other security threats.

We may face cybersecurity threats that attempt to penetrate our network

security, sabotage or otherwise disable our research, products and services, misappropriate our or our customers’ and partners’

proprietary information, which may include personally identifiable information, or cause interruptions or failures of our internal systems

and services.

Despite security measures, we also cannot guarantee security of our physical buildings.

Physical building penetration or

any cybersecurity threats could negatively affect our reputation, damage our network infrastructure and our ability to deploy our products

and services, harm our relationship with customers and partners that are affected, and expose us to financial liability.

we continue to review and enhance our systems and cybersecurity controls, we may experience cybersecurity threats, including threats

to our information technology infrastructure and attempts to gain access to our sensitive information, as do our customers and suppliers.

Although we maintain information security policies and procedures to prevent, detect, and mitigate these threats, information system

disruptions, equipment failures or cybersecurity attacks, such as unauthorized access, malicious software and other intrusions, could

still occur and may lead to potential data corruption, exposure of proprietary and confidential information.

Further, while we work cooperatively

with our customers and suppliers to seek to minimize the impacts of cybersecurity threats, other security threats or business disruptions,

in addition to our internal processes, procedures and systems, we must also rely on the safeguards put in place by those entities.

intrusion, disruption, breach or similar event may cause operational stoppages, fines, penalties, diminished competitive advantages through

reputational damages and increased operational costs.

The costs related to cybersecurity or other security threats or disruptions may

not be fully mitigated by insurance or other means.

In addition to existing risks, any adoption or deployment of new technologies may

increase our exposure to risks, breaches, or failures, which could materially adversely affect our results of operations or financial

Additionally,

there are a number of state, federal and international laws protecting the privacy and security of health information and personal data.

For example, HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers,

healthcare clearinghouses, and health insurance plans, or, collectively, covered entities, and also grants individuals rights with respect

to their health information.

HIPAA also imposes compliance obligations and corresponding penalties for non-compliance on individuals

and entities that provide services to healthcare providers and other covered entities.

As part of the American Recovery and Reinvestment

Act of 2009 (“ARRA”) the privacy and security provisions of HIPAA were amended.

ARRA also made significant increases in the

penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement authority to

state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted in 2013, HIPAA also imposes notification

requirements on covered entities in the event that certain health information has been inappropriately accessed or disclosed, notification

requirements to individuals, federal regulators, and in some cases, notification to local and national media.

Notification is not required

under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance with encryption or other standards

developed by the U.S.

Department of Health and Human Services.

Most states have laws requiring notification of affected individuals and/or state regulators

in the event of a breach of personal information, which is a broader class of information than the health information protected by HIPAA.

Many state laws impose significant data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection

of personal information.

Most states have laws requiring notification of affected individuals and/or

state regulators in the event of a breach of personal information, which is a broader class of information than the health information

protected by HIPAA.

Many state laws impose significant data security requirements, such as encryption or mandatory contractual terms,

to ensure ongoing protection of personal information.

Activities outside of the U.S.

implicate local and national data protection standards, impose additional compliance

requirements and generate additional risks of enforcement for non-compliance.

We may be required to expend significant capital and other

resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers

or to alleviate problems caused by such breaches.

Risks Related to Our Intellectual Property

We rely upon licenses granted to us by

various licensors, and if such licensors do not adequately defend such licenses, our business may be harmed.

We have entered into and may, in the future,

enter into license and sublicense agreements with respect to our product candidates.

We have limited control over the activities of our

licensors, and we rely upon our licensors to protect their intellectual property, including the patents covered by our licenses.

be certain that activities conducted by our licensors have been or will be conducted in compliance with applicable laws and regulations.

Furthermore, we have no or limited control or input over whether, and in what manner, our licensors may enforce or defend the patents

that we license against a third-party.

Our licensors may defend the patents we license less vigorously than if we had enforced or defended

the patents ourselves.

Furthermore, our licensors may not necessarily seek enforcement in scenarios in which we would feel that enforcement

was in our best interests.

For example, our licensors may not enforce the patents against a competitor of ours who is not a direct competitor

of such licensor.

If our in-licensed intellectual property is found to be invalid or unenforceable, then our licensors may not be able

to enforce the patents against a competitor of ours.

Moreover, if we fail to meet our obligations under our license agreements, the licensor

may terminate the license agreement.

Furthermore, if we fail to meet our obligations under our sublicense agreements or our sublicensor

fails to meet its obligations to the licensor, such licensor may terminate the license agreement thereby terminating our sublicense agreement.

Our business depends upon us securing and

protecting critical intellectual property.

To the extent we develop intellectual property,

our commercial success will depend in part on obtaining and maintaining patent, trade secret, copyright and trademark protection of our

technologies in the United States and other jurisdictions as well as successfully enforcing and defending such intellectual property

rights against third-party challenges.

We will only be able to protect our intellectual property from unauthorized use by third parties

to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them.

In particular,

we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and processes.

Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection

and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

Moreover, the degree of future protection

of our proprietary rights is uncertain for products that are currently in the early stages of development because we cannot predict which

of these products will ultimately reach the commercial market or whether the commercial versions of these products will incorporate proprietary

technologies.

Patent positions in our industry are highly

uncertain and involve complex legal and factual questions.

Patent positions in our industry are highly uncertain

and involve complex legal and factual questions.

Accordingly, we cannot predict the breadth of claims that may be allowed or enforced

in our patents or in third-party patents.

For example, we or our licensors might not have been the first to make the inventions covered

by our pending patent applications and issued patents, as applicable;

we or our licensors might not have been the first to file patent

applications for these inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies;

it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued

our issued patents and issued patents of our licensors may not provide a basis for commercially viable technologies, or may

not provide us with any competitive advantages, or may be challenged and invalidated by third parties;

and, we may not develop additional

proprietary technologies that are patentable.

As a result, our owned and licensed patents may not be valid, and we may not be able to

obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology.

The extent to which

we are unable to do so could materially harm our business.

We and/or our licensors have applied for and

will continue to apply for patents for certain products.

Such applications may not result in the issuance of any patents, and any patents

now held or that may be issued may not provide us with adequate protection from competition.

Furthermore, it is possible that patents

issued or licensed to us may be challenged successfully.

In that event, if we have a preferred competitive position because of such patents,

any preferred position held by us would be lost.

If we are unable to secure or to continue to maintain a preferred position, we could

become subject to competition from the sale of generic products.

Failure to receive, inability to protect, or expiration of our patents

for medical use, manufacture, conjugation and labeling of any of our product candidates may adversely affect our business and operations.

Patents issued or licensed to us may be infringed

by the products or processes of others.

The cost of enforcing our patent rights against infringers, if such enforcement is required,

could be significant, and we do not currently have the financial resources to fund such litigation.

Further, such litigation can go on

for years and the time demands could interfere with our normal operations.

There has been substantial litigation and other proceedings

regarding patent and other intellectual property rights in the pharmaceutical industry.

We may become a party to patent litigation and

other proceedings.

implicate local and national data protection standards,

impose additional compliance requirements and generate additional risks of enforcement for non-compliance.

We may be required to expend

significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against

security breaches and hackers or to alleviate problems caused by such breaches.

Related to Our Intellectual Property Rights

rely upon licenses granted to us by various licensors, and if such licensors do not adequately defend such licenses, our business may

have entered into and may, in the future, enter into license and sublicense agreements with respect to our product candidates.

limited control over the activities of our licensors, and we rely upon our licensors to protect their intellectual property, including

the patents covered by our licenses.

We cannot be certain that activities conducted by our licensors have been or will be conducted in

compliance with applicable laws and regulations.

Furthermore, we have no or limited control or input over whether, and in what manner,

our licensors may enforce or defend the patents that we license against a third-party.

Our licensors may defend the patents we license

less vigorously than if we had enforced or defended the patents ourselves.

Furthermore, our licensors may not necessarily seek enforcement

in scenarios in which we would feel that enforcement was in our best interests.

For example, our licensors may not enforce the patents

against a competitor of ours who is not a direct competitor of such licensor.

If our in-licensed intellectual property is found to be

invalid or unenforceable, then our licensors may not be able to enforce the patents against a competitor of ours.

Moreover, if we fail

to meet our obligations under our license agreements, the licensor may terminate the license agreement.

Furthermore, if we fail to meet

our obligations under our sublicense agreements or our sublicensor fails to meet its obligations to the licensor, such licensor may terminate

the license agreement thereby terminating our sublicense agreement.

business depends upon us securing and protecting critical intellectual property.

the extent we develop intellectual property, our commercial success will depend in part on obtaining and maintaining patent, trade secret,

copyright and trademark protection of our technologies in the United States and other jurisdictions as well as successfully enforcing

and defending such intellectual property rights against third-party challenges.

We will only be able to protect our intellectual property

from unauthorized use by third parties to the extent that valid and enforceable intellectual property protection, such as patents or

trade secrets, cover them.

In particular, we place considerable emphasis on obtaining patent and trade secret protection for significant

new technologies, products and processes.

Furthermore, the degree of future protection of our proprietary rights is uncertain because

legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

Moreover, the degree of future protection of our proprietary rights is uncertain for products that are currently in the early stages

of development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial

versions of these products will incorporate proprietary technologies.

positions in our industry are highly uncertain and involve complex legal and factual questions.

Accordingly, we cannot predict the breadth

of claims that may be allowed or enforced in our patents or in third-party patents.

For example, we or our licensors might not have been

the first to make the inventions covered by our pending patent applications and issued patents, as applicable;

we or our licensors might

not have been the first to file patent applications for these inventions;

others may independently develop similar or alternative technologies

or duplicate any of our technologies;

it is possible that none of our pending patent applications or the pending patent applications

of our licensors will result in issued patents;

our issued patents and issued patents of our licensors may not provide a basis for commercially

viable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties;

we may not develop additional proprietary technologies that are patentable.

As a result, our owned and licensed patents may not be valid,

and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology.

The extent to which we are unable to do so could materially harm our business.

and/or our licensors have applied for and will continue to apply for patents for certain products.

Such applications may not result in

the issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.

Furthermore, it is possible that patents issued or licensed to us may be challenged successfully.

In that event, if we have a preferred

competitive position because of such patents, any preferred position held by us would be lost.

If we are unable to secure or to continue

to maintain a preferred position, we could become subject to competition from the sale of generic products.

Failure to receive, inability

to protect, or expiration of our patents for medical use, manufacture, conjugation and labeling of any of our product candidates may

adversely affect our business and operations.

issued or licensed to us may be infringed by the products or processes of others.

The cost of enforcing our patent rights against infringers,

if such enforcement is required, could be significant, and we may not have the financial resources to fund such litigation.

such litigation can go on for years and the time demands could interfere with our normal operations.

There has been substantial litigation

and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry.

We may become a party to

patent litigation and other proceedings.

The cost to us of any patent litigation, even if resolved in our favor, could be substantial.

Some of our competitors

may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financial resources.

Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially

greater financial resources.

Litigation may also absorb significant management time.

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or similar information.

If we are found to be infringing on patents

or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the

development or sale of our products, and/or pay damages.

Our manufacturing processes and potential products

may violate proprietary rights of patents that have been or may be granted to competitors, universities or others, or the trade secrets

of those persons and entities.

As the pharmaceutical industry expands and more patents are issued, the risk increases that our processes

and potential products may give rise to claims that they infringe the patents or trade secrets of others.

These other persons could bring

legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the affected product

If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain

a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process.

licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain.

If we become involved in litigation

or other proceedings, it could consume a substantial portion of our financial resources and the efforts of our personnel.

Our ability to protect and enforce any

patents we may obtain does not guaranty that we will secure the right to commercialize such patents.

A patent is a limited monopoly right conferred

upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention.

This monopoly

is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using his invention.

a patent gives the holder this right to exclude others, it is not a license to commercialize the invention, where other permissions may

be required for permissible commercialization to occur.

For example, a drug cannot be marketed without the appropriate authorization

from the FDA, regardless of the existence of a patent covering the product.

Further, the invention, even if patented itself, cannot be

commercialized if it infringes the valid patent rights of another party.

We rely on confidentiality agreements to

protect our trade secrets.

If these agreements are breached by our employees or other parties, our trade secrets may become known to

our competitors.

We rely on trade secrets which we seek to protect

through confidentiality agreements with our employees and other parties.

If these agreements are breached, our competitors may obtain

and use our trade secrets to gain a competitive advantage over us.

We may not have any remedies against our competitors and any remedies

that may be available to us may not be adequate to protect our business or compensate us for the damaging disclosure.

In addition, we

may have to expend resources to protect our interests from possible infringement by others.

Risks Related to the Company

We have expanded and may continue to expand,

our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial condition and

may also dilute current shareholders’ ownership interests in our Company.

Our business strategy includes expanding our

products and capabilities, and we may seek acquisitions of additional drug candidates or technologies to do so.

Acquisitions involve

numerous risks, including substantial cash expenditures;

we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development

efforts, obtain a license to continue the development or sale of our products, and/or pay damages.

manufacturing processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors,

universities or others, or the trade secrets of those persons and entities.

As the pharmaceutical industry expands and more patents are

issued, the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade

secrets of others.

These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing,

manufacturing and marketing of the affected product or process.

If any of these actions are successful, in addition to any potential

liability for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market

the affected product or use the affected process.

Required licenses may not be available on acceptable terms, if at all, and the results

of litigation are uncertain.

If we become involved in litigation or other proceedings, it could consume a substantial portion of our

financial resources and the efforts of our personnel.

ability to protect and enforce any patents we may obtain does not guarantee that we will secure the right to commercialize such patents.

patent is a limited monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing of

a new and non-obvious invention.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others

from making and/or using his invention.

While a patent gives the holder this right to exclude others, it is not a license to commercialize

the invention, where other permissions may be required for permissible commercialization to occur.

For example, a drug cannot be marketed

without the appropriate authorization from the FDA, regardless of the existence of a patent covering the product.

Further, the invention,

even if patented itself, cannot be commercialized if it infringes the valid patent rights of another party.

rely on confidentiality agreements to protect our trade secrets.

If these agreements are breached by our employees or other parties,

our trade secrets may become known to our competitors.

rely on trade secrets which we seek to protect through confidentiality agreements with our employees and other parties.

If these agreements

are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us.

We may not have any remedies

against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate us for

the damaging disclosure.

In addition, we may have to expend resources to protect our interests from possible infringement by others.

Related to the Company

have expanded and may continue to expand our business through the acquisition of rights to new drug candidates that could disrupt our

business, harm our financial condition and may also dilute current shareholders’ ownership interests in our Company.

business strategy includes expanding our products and capabilities, and we may seek acquisitions of additional drug candidates or technologies

Acquisitions involve numerous risks, including substantial cash expenditures;

potentially dilutive issuance of equity securities;

incurrence of debt and contingent

liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

difficulties in assimilating the acquired

technologies or the operations of the acquired companies;

diverting our management’s attention away from other business concerns;

incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

in assimilating the acquired technologies or the operations of the acquired companies;

diverting our management’s attention away

from other business concerns;

risks of entering markets in which we have limited or no direct experience;

and the potential loss of our key employees or key employees

of the acquired companies.

We cannot assure you that any acquisition will

result in short-term or long-term benefits to us.

We may misjudge the value or worth of an acquired product, company or business.

addition, our future success would depend in part on our ability to manage the rapid growth associated with acquisitions.

We cannot assure

you that we will be able to make the combination of our business with that of acquired products, businesses or companies work or be successful.

Furthermore, the development or expansion of our business or any acquired products, business or companies may require a substantial capital

investment by us.

We may not have these necessary funds or they might not be available to us on acceptable terms or at all.

seek to raise funds by selling shares of our preferred or common stock, which could dilute each current shareholder’s ownership

interest in the Company.

Any international operations we undertake

may subject us to risks inherent with operations outside of the United States.

We may seek to obtain market clearance for in

foreign markets that we deem to generate significant opportunities.

However, even with the cooperation of a commercialization partner,

conducting drug development in foreign countries involves inherent risks, including, but not limited to:

difficulties in staffing, funding

and managing foreign operations;

and the potential loss of our

key employees or key employees of the acquired companies.

cannot assure you that any acquisition will result in short-term or long-term benefits to us.

We may misjudge the value or worth of an

acquired product, company or business.

In addition, our future success would depend in part on our ability to manage the rapid growth

associated with acquisitions.

We cannot assure you that we will be able to make the combination of our business with that of acquired

products, businesses or companies work or be successful.

Furthermore, the development or expansion of our business or any acquired products,

business or companies may require a substantial capital investment by us.

We may not have these necessary funds, or they might not be

available to us on acceptable terms, or at all.

We may also seek to raise funds by selling shares of our preferred or common stock, which

could dilute each current shareholder’s ownership interest in the Company.

international operations we undertake may subject us to risks inherent with operations outside of the United States.

may seek to obtain market clearance in foreign markets that we deem to generate significant opportunities.

However, even with the cooperation

of a commercialization partner, conducting drug development in foreign countries involves inherent risks, including, but not limited

difficulties in staffing, funding and managing foreign operations;

unexpected changes in regulatory requirements;

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difficulties in protecting, acquiring, enforcing and litigating intellectual property rights;

fluctuations in currency exchange rates;

in currency exchange rates;

and potentially adverse tax consequences.

If we were to experience any of the difficulties listed above, or any other difficulties, our

international development activities and our overall financial condition may suffer and cause us to reduce or discontinue our international

development and registration efforts.

We may not be successful in hiring and

retaining key employees, including executive officers.

Our future operations and successes depend in

large part upon the strength of our management team.

We rely heavily on the continued service of each member of our management team.

Accordingly, if any member of our management team were to terminate their employment with us, such departure may have a material adverse

effect on our business.

In addition, our future success depends on our ability to identify, attract, hire or engage, retain and motivate

other well-qualified financial, managerial, technical, clinical and regulatory personnel.

There can be no assurance that these professionals

will be available in the market, or that we will be able to retain existing professionals or to meet or to continue to meet their compensation

requirements.

Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly,

which could have a material adverse effect on us.

Failure to establish and maintain an effective management team and work force could

adversely affect our ability to operate, grow and manage our business.

Managing our growth as we expand operations

may strain our resources.

We expect to grow rapidly in order to support

additional, larger, and potentially international, pivotal clinical trials of our drug candidates, which will place a significant strain

on our financial, managerial and operational resources.

In order to achieve and manage growth effectively, we must continue to improve

and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to train, motivate

and manage our employees.

All of these activities will increase our expenses and may require us to raise additional capital sooner than

If we were to experience any of the difficulties listed above,

or any other difficulties, our international development activities and our overall financial condition may suffer and cause us to reduce

or discontinue our international development and registration efforts.

may not be successful in hiring and retaining key employees, including executive officers.

future operations and successes depend in large part upon the strength of our management team.

We rely heavily on the continued service

of each member of our management team.

Accordingly, if any member of our management team were to terminate their employment with us,

such departure may have a material adverse effect on our business.

In addition, our future success depends on our ability to identify,

attract, hire or engage, retain and motivate other well-qualified financial, managerial, technical, clinical and regulatory personnel.

There can be no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals

or to meet or to continue to meet their compensation requirements.

Furthermore, the cost base in relation to such compensation, which

may include equity compensation, may increase significantly, which could have a material adverse effect on us.

Failure to establish and

maintain an effective management team and workforce could adversely affect our ability to operate, grow and manage our business.

our growth as we expand operations may strain our resources.

expect to grow rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our drug candidates,

which will place a significant strain on our financial, managerial and operational resources.

In order to achieve and manage growth effectively,

we must continue to improve and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing

and to train, motivate and manage our employees.

All of these activities will increase our expenses and may require us to raise additional

capital sooner than expected.

Failure to manage growth effectively could harm our business, financial condition or results of operations.

If a product liability claim is successfully

brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage

awards that could materially harm our business.

The use of any of our existing or future product

candidates in clinical trials and the sale of any approved pharmaceutical products may expose us to significant product liability claims.

We currently do not have product liability insurance coverage but we intend to obtain such insurance.

Such insurance coverage may not

protect us against any or all of the product liability claims that may be brought against us in the future.

We may not be able to acquire

or maintain adequate product liability insurance coverage at a commercially reasonable cost or in sufficient amounts or scope to protect

us against potential losses.

In the event a product liability claim is brought against us, we may be required to pay legal and other

expenses to defend the claim, as well as uncovered damage awards resulting from a claim brought successfully against us.

our product candidate is approved for sale by the FDA or other regulatory agency and commercialized, we may need to substantially increase

the amount of our product liability coverage.

Defending any product liability claim or claims could require us to expend significant

financial and managerial resources, which could have an adverse effect on our business.

Our business may be adversely affected

by public health crises, such as pandemics and epidemics, including the COVID-19 pandemic, which may have a material adverse effect on

our business.

The nature and extent of future impacts are highly uncertain and unpredictable.

We are subject to risks associated with public

health crises, such as pandemics and epidemics, including the COVID-19 pandemic.

While many countries around the world have removed or

reduced the restrictions taken in response to the COVID-19 pandemic, the emergence of new variants of COVID-19 virus could result in

new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus.

In addition, any such measures

could also impact the global economy more broadly, for example by leading to further economic slowdowns.

While COVID-19 case volumes

have decreased in the U.S and certain other countries, the global outlook remains uncertain as case counts fluctuate and vaccination

and booster rates remain relatively low in many parts of the world.

If we were to experience shutdowns or other significant business

disruptions, our ability to conduct our business in the manner presently planned could be materially and negatively impacted.

a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage,

we could be forced to pay substantial damage awards that could materially harm our business.

use of any of our existing or future product candidates in clinical trials and the sale of any approved pharmaceutical products may expose

us to significant product liability claims.

Any product liability insurance coverage we obtain may not protect us against any or all

of the product liability claims that may be brought against us in the future.

We may not be able to acquire or maintain adequate product

liability insurance coverage at a commercially reasonable cost or in sufficient amounts or scope to protect us against potential losses.

In the event a product liability claim is brought against us, we may be required to pay legal and other expenses to defend the claim,

as well as uncovered damage awards resulting from a claim brought successfully against us.

In the event our product candidate is approved

for sale by the FDA or other regulatory agency and commercialized, we may need to substantially increase the amount of our product liability

Defending any product liability claim, or claims, could require us to expend significant financial and managerial resources,

which could have an adverse effect on our business.

business may be adversely affected by public health crises, such as pandemics and epidemics, which may have a material adverse effect

on our business.

We are subject to the risks associated with public

health crises, such as pandemics and epidemics.

Any governmental lockdowns, quarantine requirements or other restrictions as a result

of a pandemic or epidemic may cause shutdowns or other significant business disruptions, thereby effecting our ability to conduct our

business in the manner presently planned which could have a material adverse effect on us.

In addition, any pandemic or epidemic may

impact the global economy which may have a material adverse effect on our business.

For example, staffing issues related to a public

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product candidates for our clinical trials and research and development operations.

Furthermore, we may be at a risk of delaying, defaulting

Furthermore, we may be at risk of delaying, defaulting

and/or not performing under existing agreements, which may increase our costs.

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regulatory systems which could divert healthcare resources away from or materially delay FDA review and/or approval of our product candidates.

The scope and duration of any future public health

crisis, including the potential emergence of new variants of the COVID-19 virus, the pace at which government restrictions are imposed

and lifted, global vaccination and booster rates, the speed and extent to which global markets fully recover from the disruptions caused

by such public health crisis, and the impact of these factors on our business, financial condition and results of operations, will depend

on future developments that are highly uncertain and cannot be predicted with confidence.

Significant disruptions

of information technology systems or breaches of data security could adversely affect our business.

Our business is increasingly dependent on critical,

complex, and interdependent information technology systems, including Internet-based systems, to support business processes as well as

internal and external communications.

These systems are also critical to enable remote working arrangements, which have been growing

in importance.

The size and complexity of our computer systems make us potentially vulnerable to IT system breakdowns, internal and external

malicious intrusion, and computer viruses and ransomware, which may impact product production and key business processes.

outsourced significant elements of our information technology infrastructure and operations to third parties, which may allow them to

access our confidential information and may also make our systems vulnerable to service interruptions or to security breaches from inadvertent

or intentional actions by such third parties or others.

scope and duration of any future public health crisis, the pace at which government restrictions are imposed and lifted, global vaccination

and booster rates, the speed and extent to which global markets fully recover from the disruptions caused by such public health crisis,

and the impact of these factors on our business, financial condition and results of operations, will depend on future developments that

are highly uncertain and cannot be predicted with confidence.

disruptions of information technology systems or breaches of data security could adversely affect our business.

business is increasingly dependent on critical, complex, and interdependent information technology systems, including Internet-based

systems, to support business processes as well as internal and external communications.

These systems are also critical to enable remote

working arrangements, which have been growing in importance.

The size and complexity of our computer systems make us potentially vulnerable

to IT system breakdowns, internal and external malicious intrusion, and computer viruses and ransomware, which may impact product production

and key business processes.

We also have outsourced significant elements of our information technology infrastructure and operations

to third parties, which may allow them to access our confidential information and may also make our systems vulnerable to service interruptions

or to security breaches from inadvertent or intentional actions by such third parties or others.

In addition, our systems are potentially vulnerable

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Data security breaches

could lead to the loss of trade secrets or other intellectual property, result in demands for ransom or other forms of blackmail, or

lead to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients,

customers, and others.

Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide

range of motives (including industrial espionage or extortion) and expertise, including by organized criminal groups, “hacktivists,”

nation states, and others.

could lead to the loss of trade secrets or other intellectual property, result in demands for ransom or other forms of blackmail, or lead

to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, customers,

Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives

(including industrial espionage or extortion) and expertise, including by organized criminal groups, “hacktivists,” nation

states, and others.

As a company with an increasingly global presence, our systems are subject to frequent attacks.

potential that our systems may be directly or indirectly affected as nation-states conduct global cyberwarfare, including in connection

with the current Russia-Ukraine or Hamas-Israel armed conflict.

Due to the nature of some of these attacks, there

is a risk that an attack may remain undetected for a period of time.

While we continue to make investments to improve the protection

of data and information technology, and to oversee and monitor the security measures of our suppliers and/or service providers, there

can be no assurance that our efforts will prevent service interruptions or security breaches.

In addition, we depend in part on third-party

security measures over which we do not have full control to protect against data security breaches.

If we or our suppliers and/or service providers

fail to maintain or protect our information technology systems and data security effectively and in compliance with U.S.

laws, or fail to anticipate, plan for, or manage significant disruptions to these systems, we or our suppliers and/or service providers

could have difficulty preventing, detecting, or controlling such disruptions or security breaches, which could result in legal proceedings,

liability under U.S.

and foreign laws that protect the privacy of personal information, disruptions to our operations, government investigations,

breach of contract claims, and damage to our reputation (in each case in the U.S.

or globally), which could have a material adverse effect

on our business, prospects, operating results, and financial condition.

Risks Related to Our Common Stock

The price of our common stock may fluctuate substantially.

You should consider an investment in our common

stock to be risky, and you should invest in our common stock only if you can withstand a significant loss and wide fluctuations in the

market value of your investment.

Some factors that may cause the market price of our common stock to fluctuate, in addition to the other

risks mentioned in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, are:

sale of our common stock

by our shareholders, executives, and directors;

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

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

the timing and success

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

consolidation among competitors;

our ability to attract

new customers;

our ability to secure resources

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

commencement, enrollment

or results of our clinical trials for our product candidates;

changes in the development

status of our product candidates;

any delays or adverse developments

or perceived adverse developments with respect to a regulatory agency’s review of our planned pre-clinical and clinical trials;

any delay in our submission

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

unanticipated safety concerns

related to the use of our product candidates;

changes in our capital

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

our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new products;

reputational issues;

announcements of acquisitions,

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

changes in general economic,

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

changes in industry conditions

or perceptions;

analyst research reports,

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

departures and additions

of key personnel;

disputes and litigations

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

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control, including, but not limited to, pandemics, war, or other acts of God.

In addition, if the market for stocks in our

industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading

price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations.

of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly

to defend and a distraction to management.

We may acquire other companies or technologies,

which could divert our management’s attention, result in dilution to our shareholders and otherwise disrupt our operations and

There is the potential

that our systems may be directly or indirectly affected as nation-states conduct global cyberwarfare.

to the nature of some of these attacks, there is a risk that an attack may remain undetected for a period of time.

While we continue

to make investments to improve the protection of data and information technology, and to oversee and monitor the security measures of

our suppliers and/or service providers, there can be no assurance that our efforts will prevent service interruptions or security breaches.

In addition, we depend in part on third-party security measures over which we do not have full control to protect against data security

we or our suppliers and/or service providers fail to maintain or protect our information technology systems and data security effectively

and in compliance with U.S.

and foreign laws, or fail to anticipate, plan for, or manage significant disruptions to these systems, we

or our suppliers and/or service providers could have difficulty preventing, detecting, or controlling such disruptions or security breaches,

which could result in legal proceedings, liability under U.S.

and foreign laws that protect the privacy of personal information, disruptions

to our operations, government investigations, breach of contract claims, and damage to our reputation (in each case in the U.S.

or globally),

which could have a material adverse effect on our business, prospects, operating results, and financial condition.

Related to Our Common Stock

price of our common stock may fluctuate substantially.

should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand a

significant loss and wide fluctuations in the market value of your investment.

Some factors that may cause the market price of our common

stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section and elsewhere in this Annual

Report on Form 10-K, are:

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

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

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

trials, and other business activities;

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

industry, including consolidation among competitors;

ability to attract new customers;

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

commencement,

enrollment or results of our clinical trials for our product candidates;

in the development status of our product candidates;

delays or adverse developments or perceived adverse developments with respect to a regulatory agency’s review of our planned

pre-clinical and clinical trials;

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

approval for our product candidates;

unanticipated

safety concerns related to the use of our product candidates;

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

cash position;

announcements

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

inability to enter new markets or develop new products;

announcements

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

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

in industry conditions or perceptions;

analyst research reports, recommendations and changes in recommendations,

price targets, and withdrawals of coverage;

and additions of key personnel;

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

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

or anticipated fluctuations in our operating results;

in market valuations of other similar companies;

events or factors, many of which may be out of our control, including, but not limited to, pandemics, war, or other acts of God.

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

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition

and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that,

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

may acquire other companies or technologies which could divert our management’s attention, result in dilution to our shareholders

and otherwise disrupt our operations and adversely affect our operating results.

may in the future seek to acquire or invest in businesses, applications and services or technologies that we believe could complement

or expand our services, enhance our technical capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions

may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions,

whether or not they are consummated.

addition, we do not have any experience in acquiring other businesses.

If we acquire additional businesses, we may not be able to integrate

the acquired personnel, operations and technologies successfully, or effectively manage the combined business following the acquisition.

We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated

costs or liabilities associated with the acquisition;

integrating the accounting systems, operations and personnel of the acquired business;

and additional expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

converting the customers of the acquired business onto our platform and contract terms, including disparities in the revenue, licensing,

support or professional services model of the acquired company;

of management’s attention from other business concerns;

effects to our existing business relationships with business partners and customers as a result of the acquisition;

potential loss of key employees;

of resources that are needed in other parts of our business;

of substantial portions of our available cash to consummate the acquisition.

addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible

assets, which must be assessed for impairment at least annually.

In the future, if our acquisitions do not yield expected returns, we

may be required to take charges to our operating results based on this impairment assessment process, which could adversely affect our

results of operations.

Acquisitions could also result in dilutive issuances of equity securities or the incurrence of debt, which could

adversely affect our operating results.

We may in the future seek to acquire or invest

in businesses, applications and services or technologies that we believe could complement or expand our services, enhance our technical

capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions may divert the attention of management and

cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we do not have any experience in

acquiring other businesses.

If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and

technologies successfully, or effectively manage the combined business following the acquisition.

We also may not achieve the anticipated

benefits from the acquired business due to a number of factors, including:

inability to integrate

or benefit from acquired technologies or services in a profitable manner;

unanticipated costs or

liabilities associated with the acquisition;

difficulty integrating

the accounting systems, operations and personnel of the acquired business;

difficulties and additional

expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

difficulty converting the

customers of the acquired business onto our platform and contract terms, including disparities in the revenue, licensing, support

or professional services model of the acquired company;

diversion of management’s

attention from other business concerns;

adverse effects to our

existing business relationships with business partners and customers as a result of the acquisition;

the potential loss of key

use of resources that are

needed in other parts of our business;

use of substantial portions

of our available cash to consummate the acquisition.

In addition, a significant portion of the purchase

price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment

at least annually.

In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating

results based on this impairment assessment process, which could adversely affect our results of operations.

Acquisitions could also

result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.

if an acquired business fails to meet our expectations, our operating results, business and financial position may suffer.

Unstable market and economic conditions

and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on

our business, financial condition and stock price.

The global credit and

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

declines in consumer confidence, declines in economic growth, inflationary pressure and interest rate changes, increases in unemployment

rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely affected by the current

or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events.

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

impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate

market and economic instability.

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

with the Federal Deposit Insurance Corporation (“FDIC”) created bank-specific and broader financial institution liquidity

risk and concerns.

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

at SVB and Signature Bank would have access to their funds, even those in excess of the standard FDIC insurance limits, under a systemic

risk exception, future adverse developments with respect to specific financial institutions or the broader financial services industry

may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs, and create additional

market and economic uncertainty.

We have significant cash balances at financial institutions which, throughout the year, regularly exceed

the federally insured limit of $250,000.

Any loss incurred or a lack of access to such funds could have a significant adverse impact

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

There can be no assurance that future credit

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

Our general business strategy

may be adversely affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable

and unstable market conditions.

If the equity and credit markets deteriorate, or if adverse developments are experienced by financial

institutions, it may cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly

and more dilutive.

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

effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans.

In addition, there is a risk that one or more of our financial institutions, manufacturers and other third parties with whom we engage

may be adversely affected by the foregoing risks, which may have a material adverse effect on our business.

Future sales and issuances of our securities

could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.

We expect that significant additional capital

will be needed in the future to continue our planned operations, including research and development, increased marketing, hiring new

personnel, commercializing our products, and continuing activities as an operating public company.

To the extent we raise additional

capital by issuing equity securities, our shareholders may experience substantial dilution.

We may sell common stock, convertible securities

or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock,

convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing shareholders, and new investors could gain rights superior to our existing

shareholders.

We do not intend to pay cash dividends

on our shares of common stock so any returns will be limited to the value of our shares.

We have never paid or declared any cash dividends

on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

We currently anticipate

that we will retain future earnings for the development, operation and expansion of our business.

Any future determination to pay dividends

will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial

condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors that our board of directors

deems relevant.

Therefore, any return to shareholders will be limited to the increase, if any, of our share price.

We are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our

common stock less attractive to investors.

We are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to take advantage of certain

exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”

including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002,

as amended (“Sarbanes-Oxley”), reduced disclosure obligations regarding executive compensation in our periodic reports and

proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder

approval of any golden parachute payments not previously approved.

In addition, pursuant to Section 107 of the JOBS Act, as an “emerging

growth company” we intend to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities

Act, for complying with new or revised accounting standards.

In other words, an “emerging growth company” can delay the adoption

of certain accounting standards until those standards would otherwise apply to private companies.

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.

We may take advantage

of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth

company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion

(ii) the last day of our fiscal year following the fifth anniversary of the date of our initial public offering;

(iii) the date

on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are

deemed to be a large accelerated filer under the rules of the SEC.

We may be at risk of securities class action litigation.

We may be at risk of securities class action

In the past, biotechnology and pharmaceutical companies have experienced significant stock price volatility, particularly

when associated with binary events such as clinical trials and product approvals.

If we face such litigation, it could result in substantial

costs and a diversion of management’s attention and resources, which could harm our business and results in a decline in the market

price of our common stock.

We are currently

listed on The Nasdaq Capital Market (“Nasdaq”).

If we are unable to maintain listing of our securities on Nasdaq or any stock

exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired

and it may be more difficult for our shareholders to sell their securities.

Although our common

stock is currently listed on Nasdaq, we may not be able to continue to meet the exchange’s minimum listing requirements or those

of any other national exchange.

The Listing Rules of Nasdaq require listing issuers to comply with certain standards in order to remain

listed on its exchange.

If, for any reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist

our securities from trading on its exchange and we are unable to obtain listing on another national securities exchange, a reduction

in some or all of the following may occur, each of which could have a material adverse effect on our shareholders:

the liquidity of our common stock;

the market price of our common stock;

our ability to obtain financing for the continuation

of our operations;

the number of investors that will consider investing

in our common stock;

the number of market makers in our common stock;

the availability of information concerning the trading

prices and volume of our common stock;

the number of broker-dealers willing to execute trades

in shares of our common stock.

Our Articles of Incorporation, as amended

(“Articles of Incorporation”), our Amended and Restated Bylaws, and Nevada law may have anti-takeover effects that could

discourage, delay or prevent a change in control, which may cause our stock price to decline.

In addition, if an acquired business fails to meet our expectations, our operating results, business

and financial position may suffer.

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

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

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

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

increases in unemployment rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely

affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events.

Sanctions imposed by the

United States and other countries in response to such conflicts, may also adversely impact the financial markets and the global economy,

and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

Moreover, the

2023 closures of Silicon Valley Bank and Signature Bank and their placement into receivership with the Federal Deposit Insurance Corporation

(“FDIC”) created bank-specific and broader financial institution liquidity risk and concerns.

Although the Department of

the Treasury, the Federal Reserve, and the FDIC jointly released a statement that depositors at SVB and Signature Bank would have access

to their funds, even those in excess of the standard FDIC insurance limits, under a systemic risk exception, future adverse developments

with respect to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages,

impair the ability of companies to access near-term working capital needs, and create additional market and economic uncertainty.

have significant cash balances at financial institutions which, throughout the year, regularly exceed the federally insured limit of

Any loss incurred or a lack of access to such funds could have a significant adverse impact on our financial condition, results

of operations, and cash flow.

can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will

Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business

environment or continued unpredictable and unstable market conditions.

If the equity and credit markets deteriorate, or if adverse developments

are experienced by financial institutions, it may cause short-term liquidity risk and make any necessary debt or equity financing more

difficult, more costly and more dilutive.

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

a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical

development plans.

In addition, there is a risk that one or more of our financial institutions, manufacturers and other third parties

with whom we engage may be adversely affected by the foregoing risks, which may have a material adverse effect on our business.

sales and issuances of our securities could result in additional dilution of the percentage ownership of our shareholders and could cause

our share price to fall.

expect that significant additional capital will be needed in the future to continue our planned operations, including research and development,

increased marketing, hiring new personnel, commercializing our products, and continuing activities as an operating public company.

the extent we raise additional capital by issuing equity securities, our shareholders may experience substantial dilution.

common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from

time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may

be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing shareholders, and new investors

could gain rights superior to our existing shareholders.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common

stock in the foreseeable future.

We currently anticipate that we will retain future earnings for the development, operation and expansion

of our business.

Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a

number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions

imposed by applicable law and other factors that our board of directors deems relevant.

Therefore, any return to shareholders will be

limited to the increase, if any, of our share price.

are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may

make our common stock less attractive to investors.

are a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act.

We would cease to be a smaller reporting

company if (i) we have a public float of $250 million or more and have annual revenues in excess of $100 million or (ii) if we have a

public float of $700 million or more, determined on an annual basis.

a smaller reporting company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable

to other public companies that are not smaller reporting companies.

These exemptions include:

being required to furnish a stock performance graph in our annual report;

disclosure obligations regarding executive compensation;

permitted to provide only two years of audited financial statements in our Annual Report

on Form 10-K, with corresponding reduced “Management’s Discussion and Analysis

of Financial Condition and Results of Operations” disclosure;

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley

cannot predict whether investors will find our common stock less attractive as a result of any reliance by us on these exemptions.

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.

may be at risk of securities class action litigation.

In the past, biotechnology and pharmaceutical companies have experienced significant

stock price volatility, particularly when associated with binary events such as clinical trials and product approvals.

If we face such

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

business and result in a decline in the market price of our common stock.

are currently listed on The Nasdaq Capital Market (“Nasdaq”).

If we are unable to maintain listing of our securities on Nasdaq

or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing

could be impaired and it may be more difficult for our shareholders to sell their securities.

our common stock is currently listed on Nasdaq and we are in compliance with the exchange’s minimum listing requirement, we may

not be able to continue to meet Nasdaq’s minimum listing requirements or those of any other national exchange.

The Listing Rules

of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

If, for any reason, we

should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its exchange

and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may occur, each

of which could have a material adverse effect on our shareholders:

liquidity of our common stock;

market price of our common stock;

ability to obtain financing for the continuation of our operations;

number of investors that will consider investing in our common stock;

number of market makers in our common stock;

availability of information concerning the trading prices and volume of our common stock;

number of broker-dealers willing to execute trades in shares of our common stock.

Articles of Incorporation, as amended (“Articles of Incorporation”), our Amended and Restated Bylaws, and Nevada law may

have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Our Articles of Incorporation, Amended and Restated

10 unchanged sentences

offering and 1,897,520 shares of Series A Preferred Stock remain authorized.

The issuance of any preferred stock could materially adversely

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

In particular, specific rights

granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third-party

and thereby preserve control by the present management.

Provisions of our Articles of Incorporation,

our Amended and Restated Bylaws and Nevada law also could have the effect of discouraging potential acquisition proposals or making a

tender offer or delaying or preventing a change in control, including changes a shareholder might consider favorable.

Such provisions

may also prevent or frustrate attempts by our shareholders to replace or remove our management.

In particular, the Articles of Incorporation,

our Amended and Restated Bylaws and Nevada law, as applicable, among other things:

provide the board of directors

with the ability to alter the Amended and Restated Bylaws without shareholder approval;

place limitations on the

removal of directors;

establish advance notice

requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at shareholder

provide that vacancies

on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Our Amended and Restated Bylaws provide

that the Eighth Judicial District Court of Clark County, Nevada will be the sole and exclusive forum for certain disputes which could

limit shareholders’ ability to obtain a favorable judicial forum for disputes with us or its directors, officers, employees or

Our Amended and Restated Bylaws provide that

unless we consent in writing to the selection of an alternative forum, the Eighth Judicial District Court of Clark County, Nevada shall

be the sole and exclusive forum for state law claims with respect to:

(i) any derivative action or proceeding brought in the name or

right of us or on our behalf, (ii) any action asserting a claim for breach of any fiduciary duty owed by any director, officer, employee

or agent to us or our shareholders, (iii) any action arising or asserting a claim arising pursuant to any provision of Nevada Revised

Statutes Chapters 78 or 92A or any provision of our Articles of Incorporation or Amended and Restated Bylaws or (iv) any action asserting

a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret, apply, enforce or determine

the validity of our Articles of Incorporation or Amended and Restated Bylaws.

This exclusive forum provision would not apply to suits

brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim for which the federal courts

have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act

creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules

and regulations thereunder.

Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts

over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

This choice of forum provision may limit a shareholder’s

ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, other employees

or agents and may result in increased costs to our shareholders, which may discourage such lawsuits against us and our directors, officers,

other employees and agents.

Alternatively, if a court were to find the choice of forum provision contained in our Amended and Restated

Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other

jurisdictions, which could have a material adverse effect on our business, results of operations, and financial condition.

General Risk Factors

If securities or industry analysts do not

publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.

The trading market for our common stock will

rely in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our competitors.

As of March 28, 2025, 2,000,000 shares of our preferred

stock have been designated as Series B Preferred Stock of which 2,000,000 shares of Series B Preferred Stock were previously issued and

The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore

reduce the value of our common stock.

In particular, specific rights granted to future holders of preferred stock could be used to restrict

our ability to merge with, or sell our assets to, a third-party and thereby preserve control by the present management.

of our Articles of Incorporation, our Amended and Restated Bylaws and Nevada law also could have the effect of discouraging potential

acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a shareholder might consider

Such provisions may also prevent or frustrate attempts by our shareholders to replace or remove our management.

In particular,

the Articles of Incorporation, our Amended and Restated Bylaws and Nevada law, as applicable, among other things:

the board of directors with the ability to alter the Amended and Restated Bylaws without shareholder approval;

limitations on the removal of directors;

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

at shareholder meetings;

that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Amended and Restated Bylaws provide that the Eighth Judicial District Court of Clark County, Nevada will be the sole and exclusive forum

for certain disputes which could limit shareholders’ ability to obtain a favorable judicial forum for disputes with us or its directors,

officers, employees or agents.

Amended and Restated Bylaws provide that unless we consent in writing to the selection of an alternative forum, the Eighth Judicial District

Court of Clark County, Nevada shall be the sole and exclusive forum for state law claims with respect to:

(i) any derivative action or

proceeding brought in the name or right of us or on our behalf, (ii) any action asserting a claim for breach of any fiduciary duty owed

by any director, officer, employee or agent to us or our shareholders, (iii) any action arising or asserting a claim arising pursuant

to any provision of Nevada Revised Statutes Chapters 78 or 92A or any provision of our Articles of Incorporation or Amended and Restated

Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret,

apply, enforce or determine the validity of our Articles of Incorporation or Amended and Restated Bylaws.

This exclusive forum provision

would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim

for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section

27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the

Exchange Act or the rules and regulations thereunder.

Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for

federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations

choice of forum provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes

with us or our directors, officers, other employees or agents and may result in increased costs to our shareholders, which may discourage

such lawsuits against us and our directors, officers, other employees and agents.

Alternatively, if a court were to find the choice of

forum provision contained in our Amended and Restated Bylaws to be inapplicable or unenforceable in an action, we may incur additional

costs associated with resolving such action in other jurisdictions, which could have a material adverse effect on our business, results

of operations, and financial condition.

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

stock price and trading volume may decline.

trading market for our common stock will rely in part on the research and reports that industry or financial analysts publish about us,

our business, our markets and our competitors.

We do not control these analysts.

If securities analysts do not cover our common stock, the lack of research coverage may adversely affect

the market price of our common stock.

Furthermore, if one or more of the analysts who do cover us downgrade our stock or if those analysts

issue other unfavorable commentary about us or our business, our stock price would likely decline.

If one or more of these analysts cease

coverage of us or fails to regularly publish reports on us, we could lose visibility in the market and interest in our stock could decrease,

which in turn could cause our stock price or trading volume to decline and may also impair our ability to expand our business with existing

customers and attract new customers.

Financial reporting obligations of being

a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial time

to compliance matters.

As a publicly traded company we incur significant

legal, accounting and other expenses.

The obligations of being a public company in the United States require significant expenditures

and places significant demands on our management and other personnel, including costs resulting from public company reporting obligations

under the Exchange Act and the rules and regulations regarding corporate governance practices, including those under Sarbanes-Oxley,

the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements of Nasdaq.

These rules require the establishment

and maintenance of effective disclosure and financial controls and procedures, internal control over financial reporting and changes

in corporate governance practices, among many other complex rules that are often difficult to implement, monitor and maintain compliance

Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations will make some

activities more time-consuming and costly, particularly after we are no longer an “emerging growth company.” Our management

and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements and to keep

pace with new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other

potential problems.

Failure to maintain effective internal

controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock.

If our internal

controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

Section 404 of Sarbanes-Oxley requires annual

management assessments of the effectiveness of our internal controls over financial reporting.

If we fail to comply with the rules under

Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover material weaknesses and other deficiencies

in our internal controls over financial reporting, our stock price could decline significantly and raising capital could be more difficult.

If material weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and maintain the adequacy of our

internal controls, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal controls over

financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal controls are necessary for us to produce

reliable financial reports and are important to helping prevent financial fraud.

If we cannot provide reliable financial reports or prevent

fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and

the trading price of our common stock could drop significantly.

If securities analysts do not cover our common stock,

the lack of research coverage may adversely affect the market price of our common stock.

Furthermore, if one or more of the analysts

who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price

would likely decline.

If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose

visibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline

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

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

to devote substantial time to compliance matters.

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

The obligations of being a public company in the

United States require significant expenditures and places significant demands on our management and other personnel, including costs

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

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

These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal

control over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult

to implement, monitor and maintain compliance with.

Moreover, despite reforms made possible by the JOBS Act, the reporting requirements,

rules, and regulations will make some activities more time-consuming and costly, since we are no longer an “emerging growth company.”

Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements

and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted,

among other potential problems.

We identified a material weakness

in our internal control over financial reporting, which resulted in the restatement of our consolidated financial statements for several

prior annual and quarterly and year-to-date periods.

If remediation of this material weakness is not effective, or if we fail to maintain

an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our

financial condition or operating results, which may adversely affect investor confidence in our company and, as a result, the value of

our common stock.

We identified a material weakness in our internal

control over financial reporting as of March 21, 2025.

As defined in the standards established by the U.S.

Public Company Accounting Oversight

Board, a “material weakness” is a deficiency, or combination of deficiencies, in internal control over financial reporting,

such that there is a reasonable possibility that a material misstatement of our Company’s annual or interim financial statements

will not be prevented or detected on a timely basis.

The material weakness identified related to the

proper classification of research and development expenses, which impacted our previously issued consolidated financial statements and

condensed consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and for each of the quarterly

and year to date periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023.

As further described

in Note 8 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, there were material amounts

inappropriately classified as research and development expense which should have been classified as prepaid assets and other assets.

are taking steps to remediate the material weakness and are in the process of supplementing our existing internal controls related to

the proper classification of research and development expenses.

In response to the material weakness, we are enhancing our review procedures

over significant contracts with contract manufacturing organizations and contract research organizations, augmenting existing staff and

strengthening our review process.

The incremental internal controls created to respond to this material weakness are being integrated

into our internal controls testing plan and they will be tested during 2025 and beyond.

Although we plan to complete the above

remediation process and associated evaluation and testing as quickly as possible, we may not be able to do so and our initiatives may

prove not to be successful.

If our remedial measures are insufficient to address the material weakness, or if additional material weaknesses

or significant deficiencies in our internal control over financial reporting are discovered during the evaluation and testing process,

we will be unable to assert that our internal control over financial reporting is effective and our independent registered public accounting

firm will be unable to express an opinion on the effectiveness of our internal control.

If we fail to maintain an effective system of

internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.

shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of

our common stock.

The restatement of our prior

quarterly financial statements may affect investor confidence and raise reputational issues and may subject us to additional risks and

uncertainties, including increased professional costs and the increased possibility of legal proceedings and regulatory inquiries.

As discussed in Note 8 to our consolidated financial

statements included elsewhere in this Annual Report on Form 10-K, we determined to restate our previously issued audited consolidated

financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and our unaudited condensed consolidated financial

statements as of and for the years ended December 31, 2023, 2022 and 2021, and for each of the quarterly and year to date periods ended

March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023, after we identified material amounts inappropriately

classified as research and development expense which should have been classified as prepaid assets and other assets.

As a result of this

error and the resulting restatement of our consolidated financial statements and condensed consolidated financial statements for the impacted

periods, we have incurred, and may continue to incur, unanticipated costs for accounting and legal fees in connection with or related

to the restatement and have become subject to a number of additional risks and uncertainties, including the increased possibility of litigation

and regulatory inquiries.

Any of the foregoing may affect investor confidence in the accuracy of our financial disclosures and may raise

reputational risks for our business, both of which could harm our business and financial results.

to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our

common stock.

If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

404 of Sarbanes-Oxley requires annual management assessments of the effectiveness of our internal controls over financial reporting.

If we fail to comply with the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover

material weaknesses and other deficiencies in our internal controls over financial reporting, our stock price could decline significantly

and raising capital could be more difficult.

If material weaknesses or significant deficiencies are discovered or if we otherwise fail

to achieve and maintain the adequacy of our internal controls, we may not be able to ensure that we can conclude on an ongoing basis

that we have effective internal controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective

internal controls are necessary for us to produce reliable financial reports and are important to prevent financial fraud.

provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence

in our reported financial information, and the trading price of our common stock could drop significantly.

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