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Item 1A. Risk Factors

2026-03-12 compared with 2025-03-18 · 588 added, 546 removed, 1064 unchanged (52% of the section changed)

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Our business is subject to numerous risks.

You should consider carefully the risks and uncertainties described below, in addition to other information contained in this Annual Report

should consider carefully the risks and uncertainties described below, in addition to other information contained in this Annual Report

as well as our other public filings with the Securities and Exchange Commission.

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effect on our business, financial condition, results of operations and prospects and cause the trading price of our common stock to decline.

Risks Related to Our Financial Condition and

Capital Requirements

Risks Related to Our Financial Condition and Capital

We have never been profitable and may never

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focus is now on advancing our DNase technology via partnering opportunities or through regulatory approval and commercialization.

We expect to continue to incur significant research and development and other expenses related to our ongoing operations.

we have never been profitable and we may not achieve profitability in the foreseeable future, if at all.

Our ability to generate profits

in the future will depend on a number of factors, including:

to continue to incur significant research and development and other expenses related to our ongoing operations.

As a result, we have never

been profitable and we may not achieve profitability in the foreseeable future, if at all.

Our ability to generate profits in the future

will depend on a number of factors, including:

Funding the costs relating to the research and development, regulatory approval, commercialization and sale and marketing of our drug candidates and technologies;

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Our ability to raise additional capital.

As of December 31, 2024, we had an accumulated

deficit of approximately $197.2 million.

As of December 31, 2025, we had an accumulated deficit

of approximately $199.9 million.

We expect to incur additional significant operating losses as we expand our research and development

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Additional funds may not be available when we need them, on terms and at a cost that are acceptable to us, or at all.

Any additional fundraising efforts may divert

our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our drug candidates.

Any additional fundraising efforts may divert our

management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our drug candidates.

In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

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property rights and other operating restrictions that could adversely impact our ability to conduct our business.

If we are unable to obtain funding on a timely

basis, we may be required to significantly curtail, delay or discontinue our pre-clinical development program or the commercialization

of any drug candidates.

We may also be unable to expand our operations or otherwise capitalize on our business opportunities, as desired,

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

If we are unable to obtain funding on a timely basis,

we may be required to significantly curtail, delay or discontinue our pre-clinical development program or the commercialization of any

drug candidates.

We may also be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which

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

Raising additional capital may cause dilution

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or a portion of our assets.

If we raise funds by selectively continuing to

enter into collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish additional valuable

rights to our technologies, future revenue streams, research programs or drug candidates, or we may have to grant licenses on terms that

may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required

to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market

drug candidates that we would otherwise prefer to develop and market ourselves.

If we raise funds by selectively continuing to enter

into collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish additional valuable rights

to our technologies, future revenue streams, research programs or drug candidates, or we may have to grant licenses on terms that may

not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to

delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug

candidates that we would otherwise prefer to develop and market ourselves.

If we are unable to raise additional funds through collaborations,

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of our Pharmaceutical Products

Our business is substantially dependent

on the success of the DNase technology.

Our business will substantially depend on the

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

It will require substantial

clinical development and regulatory approval efforts before we are permitted to commence its commercialization, if ever.

plan to continue to pursue our clinical development strategy through academic and strategic collaborations.

If we have difficulty maintaining,

obtaining, or are unable to obtain these collaborations and additional academic collaborations as planned, we may need to delay, limit

or terminate any ongoing or planned clinical development, which would have an adverse effect on our business.

The clinical trials and

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

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

our product candidates.

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

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

in specific patient populations.

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

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

Of the large number of drugs in development

for approval in the U.S.

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

processes, as applicable, and are commercialized.

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

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

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

Our business is substantially dependent on the

success of the DNase technology.

Our business substantially depends on the successful

clinical development, regulatory approval and commercialization of the DNase technology.

It will require substantial clinical development

and regulatory approval efforts before we are permitted to commence its commercialization, if ever.

We have, and plan to continue to pursue

our clinical development strategy through academic and strategic collaborations.

If we have difficulty maintaining, obtaining, or are

unable to obtain these collaborations and additional academic collaborations as planned, we may need to delay, limit or terminate any

ongoing or planned clinical development, which would have an adverse effect on our business.

The clinical trials and manufacturing and

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

authorities in the U.S., the European Union and other jurisdictions where we intend to test and, if approved, market our product candidates.

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

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

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

of substantial resources beyond the proceeds we have currently raised.

Of the large number of drugs in development for approval in the

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

as applicable, and are commercialized.

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

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

other product candidates will be successfully developed or commercialized.

We are an early stage company in the business

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Experience damage to our reputation.

As described above, any of these events could

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

If we complete the necessary preclinical

and clinical studies, we cannot predict when or if we will obtain regulatory approval to commercialize a drug candidate, or the approval

may be for a more narrow indication than we expect.

A drug candidate cannot be commercialized until

the appropriate regulatory authorities have reviewed and approved the drug candidate.

Even if our drug candidates demonstrate safety and

efficacy in clinical studies, the regulatory agencies may not complete their review processes in a timely manner, or we may not be able

to obtain regulatory approval.

Additional delays may result if an FDA Advisory Committee or other regulatory advisory group or authority

recommends non-approval or restrictions on approval.

In addition, we may experience delays or rejections based upon additional government

regulation from future legislation or administrative action or changes in regulatory agency policy during the period of product development,

clinical studies and the review process.

Regulatory agencies also may approve a drug candidate for fewer or more limited indications than

requested or may grant approval subject to the performance of post-marketing studies.

In addition, regulatory agencies may not approve

the labeling claims that are necessary or desirable for the successful commercialization of our drug candidates.

Failure to obtain, or

a delay in obtaining, regulatory approval to commercialize a drug candidate will impair our ability to generate revenues and harm our

business prospects.

As described above, any of these events could prevent

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

If we complete the necessary preclinical and

clinical studies, we cannot predict when or if we will obtain regulatory approval to commercialize a drug candidate, or the approval may

be for a more narrow indication than we expect.

A drug candidate cannot be commercialized until the

appropriate regulatory authorities have reviewed and approved the drug candidate.

Even if our drug candidates demonstrate safety and efficacy

in clinical studies, the regulatory agencies may not complete their review processes in a timely manner, or we may not be able to obtain

regulatory approval.

Additional delays may result if an FDA Advisory Committee or other regulatory advisory group or authority recommends

non-approval or restrictions on approval.

In addition, we may experience delays or rejections based upon additional government regulation

from future legislation or administrative action or changes in regulatory agency policy during the period of product development, clinical

studies and the review process.

Regulatory agencies also may approve a drug candidate for fewer or more limited indications than requested

or may grant approval subject to the performance of post-marketing studies.

In addition, regulatory agencies may not approve the labeling

claims that are necessary or desirable for the successful commercialization of our drug candidates.

Failure to obtain, or a delay in obtaining,

regulatory approval to commercialize a drug candidate will impair our ability to generate revenues and harm our business prospects.

If we obtain regulatory approval for a drug

candidate, our drug candidate will remain subject to regulatory scrutiny.

If our drug candidates are approved, they will

be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,

If our drug candidates are approved, they will be

subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,

reporting, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal

and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturing facilities are

required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control

and manufacturing procedures conform to cGMP regulations.

As such, we will be subject to continual review and inspections to assess compliance

with cGMP and adherence to commitments made in any NDA, BLA or marketing authorization application (“MAA”).

Accordingly, we

and our collaborators and suppliers must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing,

Manufacturers and manufacturing facilities are required

to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing

procedures conform to cGMP regulations.

As such, we will be subject to continual review and inspections to assess compliance with cGMP

and adherence to commitments made in any NDA, BLA or marketing authorization application (“MAA”).

Accordingly, we and our

collaborators and suppliers must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing,

production and quality control.

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will be negatively impacted.

The commercial success of any current or

future pharmaceutical products will depend upon the degree of market acceptance by physicians, patients, third-party payors and others

in the medical community.

The commercial success of any current or future

pharmaceutical products will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the

medical community.

Even with the requisite approvals, the commercial

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Potential product liability claims.

Even if a potential product displays a favorable

efficacy and safety profile in preclinical and clinical studies, market acceptance of the product will not be known until after it is

Our efforts to educate the medical community and third-party payors on the benefits of the pharmaceutical products may require

a significant amount of resources and may never be successful.

If these products do not achieve an adequate level of acceptance, we may

not generate significant product revenue and may not become profitable.

Even if a potential product displays a favorable efficacy

and safety profile in preclinical and clinical studies, market acceptance of the product will not be known until after it is launched.

Our efforts to educate the medical community and third-party payors on the benefits of the pharmaceutical products may require a significant

amount of resources and may never be successful.

If these products do not achieve an adequate level of acceptance, we may not generate

significant product revenue and may not become profitable.

The commercial potential of a pharmaceutical

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we anticipate, it could significantly and negatively impact our revenue, results of operations and financial condition.

It is very difficult to estimate the commercial

potential of pharmaceutical products due to important factors, such as safety and efficacy compared to other available technologies or

treatments, including changing standards of care, third-party payor reimbursement standards, patient and physician preferences, the availability

of competitive alternatives that may emerge either during the long drug development process or after commercial introduction and the availability

It is very difficult to estimate the commercial potential

of pharmaceutical products due to important factors, such as safety and efficacy compared to other available technologies or treatments,

including changing standards of care, third-party payor reimbursement standards, patient and physician preferences, the availability of

competitive alternatives that may emerge either during the long drug development process or after commercial introduction and the availability

of generic versions of our successful drug candidates following approval by government health authorities, based on the expiration of

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and reimbursement for our drug candidates, if approved, could limit our ability to market those products and decrease our ability to generate

The success of our drug candidates, if approved,

depends on the availability of adequate coverage and reimbursement from third-party payors.

The success of our drug candidates, if approved, depends

on the availability of adequate coverage and reimbursement from third-party payors.

In addition, because our drug candidates represent

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we may develop.

Patients who are provided medical treatment for

their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.

coverage and reimbursement from federal health care programs, such as Medicare and Medicaid, and commercial payors are critical to new

product acceptance.

Government authorities and third-party payors,

such as private health insurers and health maintenance organizations, as well as their pharmacy benefit managers decide which drugs and

treatments they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party payor may depend upon a number

of factors, including the third-party payor’s determination that use of a product is:

Patients who are provided medical treatment for their

conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.

Adequate coverage

and reimbursement from federal health care programs, such as Medicare and Medicaid, and commercial payors are critical to new product

Government authorities and third-party payors, such

as private health insurers and health maintenance organizations, as well as their pharmacy benefit managers decide which drugs and treatments

they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party payor may depend upon a number of factors,

including the third-party payor’s determination that use of a product is:

A covered benefit under its health plan;

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time what third-party payors will decide with respect to the coverage and reimbursement for our drug candidates.

Moreover, increasing efforts by governmental and

third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage

and the level of reimbursement for newly-approved products and, as a result, they may not cover or provide adequate payment for our drug

We expect to experience pricing pressures in connection with the sale of any of our drug candidates due to the trend toward

managed healthcare, value-based pricing, the increasing influence of health maintenance organizations, cost containment initiatives and

additional legislative changes.

We intend to seek approval to market our drug

candidates in both the United States and in select foreign jurisdictions.

If we obtain approval in one or more foreign jurisdictions for

our drug candidates, we will be subject to rules and regulations in those jurisdictions.

Moreover, increasing efforts by governmental and third-party

payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level

of reimbursement for newly-approved products and, as a result, they may not cover or provide adequate payment for our drug candidates.

We expect to experience pricing pressures in connection with the sale of any of our drug candidates due to the trend toward managed healthcare,

value-based pricing, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative

We intend to seek approval to market our drug candidates

in both the United States and in select foreign jurisdictions.

If we obtain approval in one or more foreign jurisdictions for our drug

candidates, we will be subject to rules and regulations in those jurisdictions.

In some foreign countries, the pricing of pharmaceutical

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or for which there is a greater likelihood of success.

Because we have limited resources, we may forego

or delay pursuit of opportunities with certain programs, drug candidates or for indications that later prove to have greater commercial

Because we have limited resources, we may forego or

delay pursuit of opportunities with certain programs, drug candidates or for indications that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

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our business, results of operations and prospects.

We may not be successful in our efforts

to identify or discover additional pharmaceutical products.

The success of our business depends primarily

upon our ability to identify and develop pharmaceutical products.

Our research programs may fail to identify potential pharmaceutical

products for clinical development for a number of reasons.

We may not be successful in our efforts to identify

or discover additional pharmaceutical products.

The success of our business depends primarily upon

our ability to identify and develop pharmaceutical products.

Our research programs may fail to identify potential pharmaceutical products

for clinical development for a number of reasons.

Our research methodology may be unsuccessful in identifying potential pharmaceutical

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make the products unmarketable or unlikely to receive marketing approval.

If any of these events occur, we may be forced

to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially

If any of these events occur, we may be forced to

abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially

cause us to cease operations.

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may be limited to those patients who are ineligible for or have failed prior treatments and may be small.

Cancer therapies are sometimes characterized as

first line, second line or third line, and the FDA often approves new therapies initially only for third line use.

When cancer is detected

early enough, first line therapy is sometimes adequate to cure the cancer or prolong life without a cure.

Whenever first line therapy,

which usually consists of chemotherapy, hormone therapy, surgery or a combination of these, proves unsuccessful, second line therapy may

be administered.

Second line therapies often consist of more chemotherapy, radiation, antibody drugs, tumor targeted small molecules or

a combination of these.

Third line therapies can include bone marrow transplantation, antibody and small molecule targeted therapies,

more invasive forms of surgery and new technologies.

In markets with approved therapies, we expect to initially seek approval of our drug

candidates as a later stage therapy for patients who have failed other approved treatments.

Subsequently, for those drugs that prove to

be sufficiently beneficial, if any, we would expect to seek approval as a second line therapy and potentially as a first line therapy,

but there is no guarantee that our drug candidates, even if approved, would be approved for second line or first line therapy.

we may have to conduct additional clinical trials prior to gaining approval for second line or first line therapy.

Our projections of both the number of people who

have the cancers we are targeting, as well as the subset of people with these cancers in a position to receive later stage therapy and

who have the potential to benefit from treatment with our drug candidates, are based on our beliefs and estimates.

These estimates have

been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and

may prove to be incorrect.

Cancer therapies are sometimes characterized as first

line, second line or third line, and the FDA often approves new therapies initially only for third line use.

When cancer is detected early

enough, first line therapy is sometimes adequate to cure the cancer or prolong life without a cure.

Whenever first line therapy, which

usually consists of chemotherapy, hormone therapy, surgery or a combination of these, proves unsuccessful, second line therapy may be

administered.

Second line therapies often consist of more chemotherapy, radiation, antibody drugs, tumor targeted small molecules or a

combination of these.

Third line therapies can include bone marrow transplantation, antibody and small molecule targeted therapies, more

invasive forms of surgery and new technologies.

In markets with approved therapies, we expect to initially seek approval of our drug candidates

as a later stage therapy for patients who have failed other approved treatments.

Subsequently, for those drugs that prove to be sufficiently

beneficial, if any, we would expect to seek approval as a second line therapy and potentially as a first line therapy, but there is no

guarantee that our drug candidates, even if approved, would be approved for second line or first line therapy.

In addition, we may have

to conduct additional clinical trials prior to gaining approval for second line or first line therapy.

Our projections of both the number of people who have

the cancers we are targeting, as well as the subset of people with these cancers in a position to receive later stage therapy and who

have the potential to benefit from treatment with our drug candidates, are based on our beliefs and estimates.

These estimates have been

derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and may

prove to be incorrect.

Further, new studies may change the estimated incidence or prevalence of these cancers.

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

Clinical trials may fail to demonstrate

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

Clinical trials may fail to demonstrate the

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

Before receiving NDA or BLA approval to commercialize

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

In addition, the design of a clinical trial can

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

until the clinical trial is well advanced.

In addition, the design of a clinical trial can determine

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

clinical trial is well advanced.

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

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

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

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

In some instances,

there can be significant variability in safety or efficacy results between different trials of the same drug candidate due to numerous

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

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

Because of these risks, our research and development

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is unable to assure sufficient product quantity.

We may seek to obtain orphan drug designation

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

We may seek to obtain orphan drug designation for

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

Even if we obtain such designations,

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

Healthcare legislative reform measures may

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

In both the United States and certain foreign

jurisdictions, there have been a number of legislative and regulatory enactments in recent years that change the healthcare system in

ways that could impact our future ability to sell our drug candidates profitably.

Furthermore, there have been and continue to be

a number of initiatives at the federal and state level that seek to reduce healthcare costs.

Healthcare legislative reform measures may have

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

In both the United States and certain foreign jurisdictions,

there have been a number of legislative and regulatory enactments in recent years that change the healthcare system in ways that could

impact our future ability to sell our drug candidates profitably.

Furthermore, there have been and continue to be a

number of initiatives at the federal and state level that seek to reduce healthcare costs.

Most significantly, in March 2010, the Patient

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On October 13, 2017, the Department

of Justice announced that HHS was immediately stopping its cost sharing reduction payments to insurance companies based on the determination

that those payments had not been appropriated by Congress.

Furthermore, on December 22, 2017, President Trump signed the Tax Cuts and

Jobs Act (the “TCJA”) into law that, in addition to overhauling the federal tax system, also, effective as of January 1, 2019,

repealed the penalties associated with the individual mandate.

Congress or the President of the United States also could consider subsequent

legislation or executive action to replace, eliminate or reaffirm elements of the ACA.

We will continue to evaluate the effect that the

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

of Justice announced that the United States Department of Health and Human Services (“HHS”) was immediately stopping its cost

sharing reduction payments to insurance companies based on the determination that those payments had not been appropriated by Congress.

Furthermore, on December 22, 2017, President Trump signed the Tax Cuts and Jobs Act (the “TCJA”) into law that, in addition

to overhauling the federal tax system, also, effective as of January 1, 2019, repealed the penalties associated with the individual mandate.

Congress or the President of the United States also could consider subsequent legislation or executive action to replace, eliminate or

reaffirm elements of the ACA.

We will continue to evaluate the effect that the ACA and any future measures to modify, repeal, replace

or reaffirm the ACA have on our business.

Additionally, the Inflation Reduction Act of 2022

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In a 2024 U.S.

Supreme Court ruling ( Loper

Bright Enterprises v.

Raimondo ) (the “ Loper decision”), the Supreme Court overturned the long-standing Chevron

doctrine, which had accorded deference to an agency’s interpretation of ambiguous laws since 1984.

Following the Loper decision,

the healthcare space may face increased judicial scrutiny of agency regulations, as courts are no longer required to defer to federal

agencies’ interpretations of ambiguous statutes.

This change could lead to significant alterations in how healthcare laws and regulations

are applied and enforced.

While the full impact of this reversal has yet to be examined, the Loper decision could lead to material

changes to the healthcare system, particularly concerning the FDA, CMS, HHS, and other agencies.

We will continue to evaluate the effects

that the Loper decision will have on our business.

We are not able to provide any assurance that

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

the United States that is adverse to our business.

Supreme Court ruling ( Loper Bright

Enterprises v.

Raimondo ) (the “ Loper decision”), the Supreme Court overturned the long-standing Chevron doctrine,

which had accorded deference to an agency’s interpretation of ambiguous laws since 1984.

Following the Loper decision, the

healthcare space may face increased judicial scrutiny of agency regulations, as courts are no longer required to defer to federal agencies’

interpretations of ambiguous statutes.

This change could lead to significant alterations in how healthcare laws and regulations are applied

and enforced.

While the full impact of this reversal has yet to be examined, the Loper decision could lead to material changes

to the healthcare system, particularly concerning the FDA, CMS, HHS, and other agencies.

We will continue to evaluate the effects that

the Loper decision will have on our business.

We are not able to provide any assurance that the

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

United States that is adverse to our business.

Moreover, we are not, at this time, able to evaluate any potential legislative, regulatory

or Executive Order actions that the new presidential administration may take which could have a material impact on our business.

or Executive Order actions that the current presidential administration may take which could have a material impact on our business.

Laws and other reform and cost containment measures

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rights, may result in the withdrawal of partner support for our drug candidates.

Some of our collaborators or strategic partners

could also become our competitors in the future.

Our collaborators or strategic partners could develop competing products, preclude us

from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with

us prematurely, or fail to devote sufficient resources to the development and commercialization of products.

Any of these developments

could harm our product development efforts, which may adversely affect our business, results of operations and prospects.

Some of our collaborators or strategic partners could

also become our competitors in the future.

Our collaborators or strategic partners could develop competing products, preclude us from

entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely,

or fail to devote sufficient resources to the development and commercialization of products.

Any of these developments could harm our

product development efforts, which may adversely affect our business, results of operations and prospects.

We expect to rely on third parties to conduct,

supervise and monitor our clinical studies, and if these third parties perform in an unsatisfactory manner, it may harm our business.

We rely on CROs, clinical investigators

and clinical study sites to ensure our clinical studies are conducted properly and on time.

We rely on CROs, clinical investigators and

clinical study sites to ensure our clinical studies are conducted properly and on time.

We will have limited influence over the performance

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as a result of additional required FDA approvals, and may have a material adverse effect on our business.

We, our clinical investigators, and our CROs are

required to comply with the FDA’s GCPs for conducting, recording and reporting the results of clinical trials to assure that the

data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants

are protected.

The FDA enforces these GCPs through periodic inspections of study sponsors, principal investigators and clinical trial

If we, our CROs or the clinical investigators fail to comply with applicable GCPs, the clinical data generated in our clinical

trials may be deemed unreliable, and the FDA may require us to perform additional clinical trials before approving any marketing applications.

Upon inspection, the FDA may determine that our clinical trials did not comply with GCPs.

In addition, our future clinical trials will

require a sufficient number of test subjects to evaluate the safety and efficacy of our drug candidates.

Accordingly, if our CROs or clinical

investigators fail to comply with these regulations or fail to recruit a sufficient number of patients, we may be required to repeat such

clinical trials, which would delay the regulatory approval process.

We, our clinical investigators, and our CROs are required

to comply with the FDA’s GCPs for conducting, recording and reporting the results of clinical trials to assure that the data and

reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected.

The FDA enforces these GCPs through periodic inspections of study sponsors, principal investigators and clinical trial sites.

CROs or the clinical investigators fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed

unreliable, and the FDA may require us to perform additional clinical trials before approving any marketing applications.

Upon inspection,

the FDA may determine that our clinical trials did not comply with GCPs.

In addition, our future clinical trials will require a sufficient

number of test subjects to evaluate the safety and efficacy of our drug candidates.

Accordingly, if our CROs or clinical investigators

fail to comply with these regulations or fail to recruit a sufficient number of patients, we may be required to repeat such clinical trials,

which would delay the regulatory approval process.

Our CROs are not our employees, and we are therefore

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pharmaceutical products would be harmed, our costs could increase and our ability to generate revenues could be delayed.

We may also rely on other third parties to store

and distribute our products for any clinical studies that we may conduct.

Any performance failure on the part of our distributors could

delay clinical development or marketing approval of our pharmaceutical products or commercialization of our products, if approved, producing

We may also rely on other third parties to store and

distribute our products for any clinical studies that we may conduct.

Any performance failure on the part of our distributors could delay

clinical development or marketing approval of our pharmaceutical products or commercialization of our products, if approved, producing

additional losses and depriving us of potential product revenue.

Our collaborators or strategic partners

may decide to adopt alternative technologies or may be unable to develop commercially viable products with our technology, which would

negatively impact our revenues and our strategy to develop these products.

Our collaborators or strategic partners may

decide to adopt alternative technologies or may be unable to develop commercially viable products with our technology, which would negatively

impact our revenues and our strategy to develop these products.

Our collaborators or strategic partners may adopt

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

Our drug candidate development programs and the

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

For some of our drug candidates,

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

Our drug candidate development programs and the potential

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

For some of our drug candidates, we

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

of those drug candidates.

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

We are a party to, and may enter into one

or more collaborations in the future, pursuant to which we may be required to relinquish important rights to and control over the development

of our drug candidates or otherwise be subject to unfavorable terms.

Any current and future collaborations we enter

into could subject us to a number of risks, including:

We are a party to certain collaboration agreements,

and may enter into one or more collaborations in the future, pursuant to which we may be required to relinquish important rights to and

control over the development of our drug candidates or otherwise be subject to unfavorable terms.

Any current and future collaborations we enter into

could subject us to a number of risks, including:

We may not be able to control the amount and timing of resources that our collaborators devote to the development or commercialization of our drug candidates;

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

We have no manufacturing, sales, marketing

or distribution capabilities, and we may have to invest a significant amount of resources to develop these capabilities.

We have no manufacturing, sales, marketing or

distribution capabilities, and we may have to invest a significant amount of resources to develop these capabilities.

We have no internal manufacturing capabilities.

As a result, for manufacturing we depend on third-party manufacturers.

Our strategy is based on leveraging the ability of collaboration

partners to develop and manufacture our products for commercialization in the pharmaceutical marketplace, and we will be dependent on

collaborations with drug development and manufacturing capabilities.

If we are not able to maintain existing collaborative arrangements

or establish new arrangements on commercially acceptable terms, we would be required to undertake product manufacturing and development

activities at our own expense.

a result, for manufacturing we depend on third-party manufacturers.

Our strategy is based on leveraging the ability of collaboration partners

to develop and manufacture our products for commercialization in the pharmaceutical marketplace, and we will be dependent on collaborations

with drug development and manufacturing capabilities.

If we are not able to maintain existing collaborative arrangements or establish

new arrangements on commercially acceptable terms, we would be required to undertake product manufacturing and development activities

at our own expense.

This would increase our capital requirements or require us to limit the scope of our development activities.

Moreover, we have limited or no experience in conducting full-scale bioequivalence or other clinical studies, preparing and submitting

regulatory applications and distributing and marketing pharmaceutical products.

we have limited or no experience in conducting full-scale bioequivalence or other clinical studies, preparing and submitting regulatory

applications and distributing and marketing pharmaceutical products.

As such, we are reliant on contract parties for such efforts.

We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing and

distribution functions on acceptable financial terms, or at all.

If any of our developmental collaborators breach

or terminate their agreements with us or otherwise fail to conduct their collaborative activities in a timely manner, the preclinical

and/or clinical development and/or commercialization of our pharmaceutical products will be delayed and we would be required to devote

additional resources to product development and commercialization or terminate certain development programs.

Also, a license relationship

may be terminated at the discretion of our collaborator, or at the end of contract terms, and in some cases with only limited notice to

The termination of the collaborative arrangement could have a material adverse effect on our business, financial condition and results

of operations.

may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing and distribution

functions on acceptable financial terms, or at all.

If any of our developmental collaborators breach or

terminate their agreements with us or otherwise fail to conduct their collaborative activities in a timely manner, the preclinical and/or

clinical development and/or commercialization of our pharmaceutical products will be delayed and we would be required to devote additional

resources to product development and commercialization or terminate certain development programs.

Also, a license relationship may be

terminated at the discretion of our collaborator, or at the end of contract terms, and in some cases with only limited notice to us.

termination of the collaborative arrangement could have a material adverse effect on our business, financial condition and results of

There also can be no assurance that disputes will not arise with respect to the ownership of rights to any technology developed

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

Our reliance on third parties requires us

to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated

Our reliance on third parties requires us to

share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated

or disclosed.

Because we rely on third parties to manufacture

our pharmaceutical products, and because we collaborate with various organizations and academic institutions on the development of our

pharmaceutical products, we must, at times, share trade secrets with them.

We seek to protect our proprietary technology in part by entering

into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements

or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary

These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as

trade secrets.

The need to share trade secrets and other confidential information when working with third parties increases the risk that

such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used

in violation of these agreements.

Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s

discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse

effect on our business.

In addition, these agreements typically restrict

the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets.

Because we rely on third parties to manufacture our

pharmaceutical products, and because we collaborate with various organizations and academic institutions on the development of our pharmaceutical

products, we must, at times, share trade secrets with them.

We seek to protect our proprietary technology in part by entering into confidentiality

agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar

agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information.

These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets.

The need to share trade secrets and other confidential information when working with third parties increases the risk that such trade

secrets become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation

of these agreements.

Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery

of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect

on our business.

In addition, these agreements typically restrict the

ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets.

collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified

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

Our contract manufacturers are subject to

significant regulation with respect to manufacturing our products.

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

regulatory requirements and have limited capacity.

We currently have relationships with a limited

number of suppliers for the manufacturing of our pharmaceutical products.

Each supplier may require licenses to manufacture components

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

property rights we may have with respect to such activities.

Our contract manufacturers are subject to significant

regulation with respect to manufacturing our products.

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

requirements and have limited capacity.

We currently have relationships with a limited number

of suppliers for the manufacturing of our pharmaceutical products.

Each supplier may require licenses to manufacture components if such

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

rights we may have with respect to such activities.

All entities involved in the preparation of pharmaceutical

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

The regulatory authorities also may, at any time

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

If any such inspection or

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

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

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

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

Any such remedial measures imposed upon third parties with

whom we contract could materially harm our business.

The regulatory authorities also may, at any time following

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

If any such inspection or audit identifies

a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent

of such an inspection or audit, we, or the relevant regulatory authority, may require remedial measures that may be costly and/or time-consuming

for us or a third party to implement and that may include the temporary or permanent suspension of a clinical study or commercial sales

or the temporary or permanent closure of a facility.

Any such remedial measures imposed upon third parties with whom we contract could

materially harm our business.

If our third-party manufacturers fail to maintain

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

These factors could cause the delay of clinical

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

costs and prevent us from commercializing our products successfully.

Furthermore, if our suppliers fail to meet contractual requirements,

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

These factors could cause the delay of clinical studies,

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

prevent us from commercializing our products successfully.

Furthermore, if our suppliers fail to meet contractual requirements, and we

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

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

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USPTO, which could result in a loss of the patent and/or substantial cost to us.

We have filed patent applications and plan to

file additional patent applications covering various aspects of our drug candidates and technologies.

There can be no assurance that the

patent applications for which we apply would actually be issued as patents, or do so with commercially relevant and/or broad coverage.

The coverage claimed in a patent application can be significantly reduced before the patent is issued.

The scope of our claim coverage

can be critical to our ability to enter into licensing transactions with third parties and our right to receive royalties from our collaboration

partnerships.

Since publication of discoveries in scientific or patent literature often lags behind the date of such discoveries, we cannot

be certain that we were the first inventor of inventions covered by our patents or patent applications.

In addition, there is no guarantee

that we will be the first to file a patent application directed to an invention.

An adverse outcome in any judicial proceeding

involving IP, including patents, could subject us to significant liabilities to third parties, require disputed rights to be licensed

from or to third parties or require us to cease using the technology in dispute.

In those instances where we seek an IP license from another,

we may not be able to obtain the license on a commercially reasonable basis, if at all, thereby raising concerns on our ability to freely

We have filed patent applications and plan to file

additional patent applications covering various aspects of our drug candidates and technologies.

There can be no assurance that the patent

applications for which we apply would actually be issued as patents, or do so with commercially relevant and/or broad coverage.

claimed in a patent application can be significantly reduced before the patent is issued.

The scope of our claim coverage can be critical

to our ability to enter into licensing transactions with third parties and our right to receive royalties from our collaboration partnerships.

Since publication of discoveries in scientific or patent literature often lags behind the date of such discoveries, we cannot be certain

that we were the first inventor of inventions covered by our patents or patent applications.

In addition, there is no guarantee that we

will be the first to file a patent application directed to an invention.

An adverse outcome in any judicial proceeding involving

IP, including patents, could subject us to significant liabilities to third parties, require disputed rights to be licensed from or to

third parties or require us to cease using the technology in dispute.

In those instances where we seek an IP license from another, we

may not be able to obtain the license on a commercially reasonable basis, if at all, thereby raising concerns on our ability to freely

commercialize our technologies and/or products.

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could be found invalid or unenforceable if challenged in court.

If we or one of our licensing partners initiated

legal proceedings against a third-party to enforce a patent covering one of our drug candidates, the defendant could counterclaim that

the patent covering our drug candidate is invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims

alleging invalidity and/or unenforceability are commonplace.

Grounds for a validity challenge could be an alleged failure to meet any

of several statutory requirements, including lack of novelty, obviousness or non-enablement.

Grounds for an unenforceability assertion

could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading

statement, during prosecution.

Third parties may also raise similar claims before administrative bodies in the United States or abroad,

even outside the context of litigation.

Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign

jurisdictions (e.g., opposition proceedings).

Such proceedings could result in revocation or amendment to our patents in such a way that

they no longer cover our drug candidates.

If we or one of our licensing partners initiated legal

proceedings against a third-party to enforce a patent covering one of our drug candidates, the defendant could counterclaim that the patent

covering our drug candidate is invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging

invalidity and/or unenforceability are commonplace.

Grounds for a validity challenge could be an alleged failure to meet any of several

statutory requirements, including lack of novelty, obviousness or non-enablement.

Grounds for an unenforceability assertion could be an

allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement,

during prosecution.

Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside

the context of litigation.

Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions

(e.g., opposition proceedings).

Such proceedings could result in revocation or amendment to our patents in such a way that they no longer

cover our drug candidates.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the

patent examiner were unaware during prosecution.

If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability,

we would lose at least part, and perhaps all, of the patent protection on our drug candidates.

Such a loss of patent protection would

have a material adverse impact on our business.

With respect to

the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner

were unaware during prosecution.

If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose

at least part, and perhaps all, of the patent protection on our drug candidates.

Such a loss of patent protection would have a material

adverse impact on our business.

We may not be able to protect our intellectual

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to obtain a significant commercial advantage from the intellectual property that we develop or license.

Failure to adequately protect our intellectual

property rights throughout the world could have a material adverse impact on our business, results of operations and prospects.

Failure to adequately protect our intellectual property

rights throughout the world could have a material adverse impact on our business, results of operations and prospects.

If we infringe on the intellectual property

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of which could have a material adverse effect on our business.

If we fail to comply with our obligations

in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business

If we fail to comply with our obligations in

the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business

relationships with our licensors, we could lose license rights that are important to our business.

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The priority of invention of patented technology.

If disputes over intellectual property that we

have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully

If disputes over intellectual property that we have

licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully

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

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

We may be subject to claims challenging

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

We may be subject to claims challenging the

inventorship or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees,

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and other employees.

Our inability to protect our confidential

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

In addition to seeking patents for some of our

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

maintain our competitive position.

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

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

manufacturers, consultants, advisors and other third parties.

We also enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

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

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

Enforcing a claim that a party illegally disclosed

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

In addition, some courts

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

If a competitor lawfully obtained

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

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

We may be involved in lawsuits to protect

or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Our inability to protect our confidential information

and trade secrets would harm our business and competitive position.

In addition to seeking patents for some of our technology

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

our competitive position.

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

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

consultants, advisors and other third parties.

We also enter into confidentiality and invention or patent assignment agreements with our

employees and consultants.

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

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

Enforcing a claim that a party illegally disclosed or misappropriated

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

In addition, some courts both within and

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

If a competitor lawfully obtained or independently

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

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

We may be involved in lawsuits to protect or

enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents or the patents

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rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount

of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could

Furthermore, because of the substantial amount of

discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could

be compromised by disclosure during this type of litigation.

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Changes in U.S.

patent law could diminish

the value of patents in general, thereby impairing our ability to protect our products.

patent law could diminish the

value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies,

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agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity

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

Periodic maintenance fees, renewal fees, annuity fees

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

agencies outside of the U.

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Risks Related to Our Business Operations

We operate in an extremely competitive

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

We may not be successful in identifying and implementing any potential

strategic alternatives in a timely manner, or at all, and the strategic review process and any strategic transactions that we may consummate

could have negative consequences.

We have initiated a strategic review process to with

the assistance of outside financial and legal advisors.

We are considering a wide range of alternatives to maximize shareholder value,

including, but not limited to, the sale of all or part of the Company or its assets or a business combination, including a “reverse

An independent committee of the Board has engaged in preliminary discussions with third parties regarding potential transactions.

Any such completed transaction could have a significant impact on the Company’s stockholders, including if the transaction would

result in the current investors of the counterparty holding a substantial majority of the Company’s outstanding common stock following

consummation of the potential transaction.

Despite management devoting significant efforts to identify and evaluate potential strategic

alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that we will

be able to successfully consummate any particular strategic transaction on attractive terms, on a timely basis, or at all.

Given the preliminary

stage of such discussions, at this time there is no way to quantify the potential impact of a transaction, if any.

There is no deadline

or definitive timetable set for the completion of the strategic alternatives process, and there can be no assurance any proposal will

be made or accepted, any agreement will be executed, or any transaction will be consummated in connection with this review.

if we do enter into definitive agreements with respect to a potential transaction, we expect that consummation of the potential transaction

would be subject to a number of conditions, including approval by our stockholders and Nasdaq, and other customary conditions, which would

be out of our control and may never be satisfied.

The process of continuing to evaluate our strategic alternatives may be

costly, time-consuming and complex, and we may incur significant legal, accounting and advisory fees and other expenses, some of which

may be incurred regardless of whether we successfully enter into a transaction.

We may also incur additional unanticipated expenses in

connection with this process.

Any such expenses will decrease the remaining cash available for use in our business.

In addition, potential counterparties in a strategic transaction involving

us may place minimal or no value on our assets and our public listing.

Consequently, any potential counterparty in a strategic transaction

involving us may choose not to spend additional resources to resume or continue development of our future drug candidates and may attribute

little or no value, in such a transaction, to our future drug candidates.

Further, any strategic transactions that we may pursue could have a variety

of negative consequences, and we may enter into a transaction that yields unexpected results that adversely affect our business and decrease

the remaining cash available for use in our business.

Any potential transaction would be dependent on a number of factors that may be

beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction

with us, obtaining stockholder approval and the availability of financing to third parties in a potential transaction with us on reasonable

There can be no assurance that any particular course of action, business arrangement or transaction, or series of transactions,

will be pursued, successfully consummated, lead to increased stockholder value, or achieve the anticipated results.

If we are not successful in setting forth a new strategic

path for us, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value

of our securities may be adversely impacted.

In addition, speculation regarding any developments related to the review of strategic alternatives

and perceived uncertainties related to the future of us could cause our stock price to fluctuate significantly.

We operate in an extremely competitive environment

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

We are engaged in a rapidly-evolving field.

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

Our future success depends on our ability

to retain principal members of our executive team, consultants and advisors and to attract, retain and motivate qualified personnel.

We are highly dependent on principal members of

our executive team, the loss of whose services may adversely impact the achievement of our objectives.

Recruiting and retaining other

qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to

Our future success depends on our ability to

retain principal members of our executive team, consultants and advisors and to attract, retain and motivate qualified personnel.

We are highly dependent on principal members of our

executive team, the loss of whose services may adversely impact the achievement of our objectives.

Recruiting and retaining other qualified

employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success.

Competition for skilled personnel is intense and the turnover rate can be high.

We may not be able to attract and retain

personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar

In addition, failure to succeed in preclinical or clinical studies may make it more challenging to recruit and retain qualified

The inability to recruit or loss of the services of any executive, consultant or advisor may impede the progress of our research

and development objectives.

We will need to expand our organization

and we may experience difficulties in managing this growth, which could disrupt our operations.

As of December 31, 2024, we had two full-time

We may not be able to attract and retain personnel on

acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets.

In addition, failure to succeed in preclinical or clinical studies may make it more challenging to recruit and retain qualified personnel.

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

We will need to expand our organization and

we may experience difficulties in managing this growth, which could disrupt our operations.

As of December 31, 2025, we had two full-time employees.

As we mature, we may need to expand our full-time employee base and to hire more consultants and contractors.

Our management

may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time

to managing these growth activities.

We may not be able to effectively manage the expansion of our operations, which may result in weaknesses

in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining

employees, all of which may have a material adverse effect on our business, results of operations and prospects.

Any future growth could

require significant capital expenditures and may divert financial resources from other projects, such as the development of additional

drug candidates.

If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability

to generate and/or grow revenues could be reduced and we may not be able to implement our business strategy.

Our future financial performance

and our ability to commercialize drug candidates and compete effectively will depend, in part, on our ability to effectively manage any

future growth.

We are a party to collaboration agreements

and other significant agreements which contain complex commercial terms that could result in disputes, litigation or indemnification liability

Our management may need

to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing

these growth activities.

We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our

infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees,

all of which may have a material adverse effect on our business, results of operations and prospects.

Any future growth could require

significant capital expenditures and may divert financial resources from other projects, such as the development of additional drug candidates.

If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or

grow revenues could be reduced and we may not be able to implement our business strategy.

Our future financial performance and our ability

to commercialize drug candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.

We are a party to collaboration agreements and

other significant agreements which contain complex commercial terms that could result in disputes, litigation or indemnification liability

that could adversely affect our business, results of operations and financial condition.

We currently derive, and expect to derive in the

foreseeable future, all or much of our revenue from collaboration agreements with biotechnology and pharmaceutical companies.

We currently derive, and expect to derive in the foreseeable

future, all or much of our revenue from collaboration agreements with biotechnology and pharmaceutical companies.

These collaboration

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Indemnity obligations for intellectual property infringement, product liability and certain other claims.

From time to time, we may have informal dispute

resolution discussions with third parties regarding the appropriate interpretation of the complex commercial terms contained in our agreements.

One or more disputes may arise or escalate in the future regarding our collaboration agreements, transaction documents or third-party

license agreements that may ultimately result in costly litigation and unfavorable interpretation of contract terms, which would have

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

From time to time, we may have informal dispute resolution

discussions with third parties regarding the appropriate interpretation of the complex commercial terms contained in our agreements.

or more disputes may arise or escalate in the future regarding our collaboration agreements, transaction documents or third-party license

agreements that may ultimately result in costly litigation and unfavorable interpretation of contract terms, which would have a material

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

Market conditions and changing circumstances,

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timely pay collaborators and others.

Market conditions and changing circumstances,

some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to

timely pay key vendors and others.

If banks and financial institutions with whom we have banking relationships enter receivership or become

insolvent in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments

to the extent those funds are not insured or otherwise protected by the FDIC.

In addition, in such circumstances we might not be able

to make timely payments to our collaborators or others.

The Company maintains its primary banking relationship with one large financial

institution and all cash on deposit is federally insured.

The Company has not experienced any losses on its accounts, and does not believe

it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships.

any delay in our ability to access our cash, cash equivalents and investments or to timely pay our collaborators and others could have

a material adverse effect on our operations and cause us to need to seek additional capital sooner than planned.

Market conditions and changing circumstances, some

of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely

pay key vendors and others.

If banks and financial institutions with whom we have banking relationships enter receivership or become insolvent

in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments to the

extent those funds are not insured or otherwise protected by the FDIC.

In addition, in such circumstances we might not be able to make

timely payments to our collaborators or others.

The Company maintains its primary banking relationship with one large financial institution

and all cash on deposit is federally insured.

The Company has not experienced any losses on its accounts, and does not believe it is exposed

to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships.

However, any delay

in our ability to access our cash, cash equivalents and investments or to timely pay our collaborators and others could have a material

adverse effect on our operations and cause us to need to seek additional capital sooner than planned.

Potential new accounting standards or legislative

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

Future changes in financial accounting standards

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

Future changes in financial accounting standards may

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

or results of operations.

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

We have limited capital resources and currently

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

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

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

As a result, we intend to invest all reasonably

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

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

We have limited capital resources and currently have

only one full-time employee in our finance department.

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

to maintaining high standards of corporate governance and public disclosure.

As a result, we intend to invest all reasonably necessary

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

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

Risks Related to Our Common Stock

We may not continue to meet the continued

listing requirements of Nasdaq, which could result in a delisting of our common shares.

We may not continue to meet the continued listing

requirements of Nasdaq, which could result in a delisting of our common shares.

Our common shares are listed on the Nasdaq.

we are currently in compliance, we have in the past been, and may in the future be, unable to comply with certain listing standards that

we are required to meet to maintain the listing of our common shares on the Nasdaq.

For instance, on June 3, 2022, we received written

notification from the Listing Qualifications Department of Nasdaq notifying us that the closing bid price for our common stock had been

below $1.00 for 30 consecutive business days and that we, therefore, were not in compliance with the Nasdaq minimum bid price requirement.

After approval from the Company’s Board of Directors, on May 15, 2023, we effected a reduction, on a 1-for-10 basis, in our authorized

common stock, par value $0.001, along with a corresponding and proportional decrease in the number of shares issued and outstanding(the

“Reverse Stock Split”).

On May 30, 2023, we received a letter from Nasdaq notifying us that we had regained compliance with

the minimum bid price requirement as a result of the closing bid price of our common stock being at $1.00 per share or greater for the

10 consecutive business days from May 15, 2023 through May 26, 2023 and that this matter was closed.

The market price of our securities may be

highly volatile, and you may not be able to sell our securities.

Companies trading in the stock market in general

have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance

of these companies.

Broad market and industry factors may negatively affect the market price of our securities, regardless of our actual

operating performance.

in the past been, and may in the future be, unable to comply with certain listing standards that we are required to meet to maintain the

listing of our common shares on the Nasdaq.

For instance, on December 11, 2025, we announced that our 2025 Annual Meeting of Stockholders

(the “Annual Meeting”), originally scheduled for December 11, 2025, had been adjourned until January 8, 2026 in order to achieve

a quorum and allow additional time to solicit proxies on behalf of the Company’s board of directors.

On January 8, 2026, we reconvened

and again adjourned the Annual Meeting, without any business being conducted, due to lack of a requisite quorum.

We intend to reconvene

the Annual Meeting at a new date and time that has yet to be determined, and will provide stockholders with requisite advance notice of

such meeting date and time;

however, at this time, the Company has not held its Annual Meeting.

There is no assurance that we will be

able to continue to maintain the continued listing requirements for Nasdaq.

If Nasdaq delists our common shares from trading on its exchange

for failure to meet the listing standards, an investor would likely find it significantly more difficult to dispose of or obtain our shares,

and our ability to raise future capital through the sale of our shares could be severely limited.

Delisting could also have other negative

results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development

opportunities.

The market price of our securities may be highly

volatile, and you may not be able to sell our securities.

Companies trading in the stock market in general have

experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these

Broad market and industry factors may negatively affect the market price of our securities, regardless of our actual operating

The market price of our securities may be volatile.

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Trading volume of our securities.

Actions of activist shareholders could

cause us to incur substantial costs, divert management's attention and resources, and have an adverse effect on our business.

Actions of activist shareholders could cause

us to incur substantial costs, divert management's attention and resources, and have an adverse effect on our business.

We actively engage in discussions with our shareholders

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These risks could adversely affect our financial performance.

Our preferred stockholders have rights,

preferences and privileges that are not held by, and are preferential to, the rights of our common stockholders, which could result in

the interests of our preferred stockholders differing from those of our common stockholders.

Our preferred stockholders have rights, preferences

and privileges that are not held by, and are preferential to, the rights of our common stockholders, which could result in the interests

of our preferred stockholders differing from those of our common stockholders.

The holders of our preferred stock have the right

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and holders of our common stock.

The issuance of future shares of common

stock may result in dilution to our stockholders.

As of March 7, 2025, we had approximately 1.5

million shares of common stock outstanding, excluding approximately 0.3 million of potentially dilutive common stock related to outstanding

preferred stock, warrants and options.

The issuance of these shares of common stock and

the sale of these shares of common stock, or even the potential of such issuance and sale, may have a depressive effect on the market

price of our common stock, and the issuance of such common stock will cause dilution to our stockholders.

We could be subject to securities class

action litigation.

In the past, securities class action litigation

has often been brought against a company following a decline in the market price of its securities.

This risk is especially relevant for

us because we have experienced significant stock price volatility in recent years.

The issuance of future shares of common stock

may result in dilution to our stockholders.

As of March 6, 2026, we had approximately 2.3 million

shares of common stock outstanding, excluding approximately 0.2 million of potentially dilutive common stock related to outstanding preferred

stock, warrants and options.

The issuance of these shares of common stock and the

sale of these shares of common stock, or even the potential of such issuance and sale, may have a depressive effect on the market price

of our common stock, and the issuance of such common stock will cause dilution to our stockholders.

We could be subject to securities class action

In the past, securities class action litigation has

often been brought against a company following a decline in the market price of its securities.

This risk is especially relevant for us

because we have experienced significant stock price volatility in recent years.

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.

An active, liquid and orderly market for

our common stock may not develop.

Our common stock trades on the Nasdaq Capital

An active, liquid and orderly market for our

common stock may not develop.

Our common stock trades on the Nasdaq Capital Market.

An active, liquid trading market for our common stock may never develop or be sustained.

If an active, liquid market for our common

stock does not continue to develop or is not sustained, it may be difficult for investors to sell shares or purchase warrants without

depressing the market price, and investors may not be able to sell the shares at all.

An inactive or illiquid market may also impair our

ability to raise capital by selling common stock and may impair our ability to acquire other businesses, applications or technologies

using our common stock or purchase warrants as consideration, which, in turn, could materially adversely affect our business.

We have entered into agreements with our

stockholders.

We have in the past, and may continue to enter

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

In addition, these arrangements may

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

We do not intend to pay dividends on our

common stock or preferred stock so any returns will be limited to the value of our stock.

If an active, liquid market for our common stock

does not continue to develop or is not sustained, it may be difficult for investors to sell shares or purchase warrants without depressing

the market price, and investors may not be able to sell the shares at all.

An inactive or illiquid market may also impair our ability

to raise capital by selling common stock and may impair our ability to acquire other businesses, applications or technologies using our

common stock or purchase warrants as consideration, which, in turn, could materially adversely affect our business.

We have entered into agreements with our stockholders.

We have in the past, and may continue to enter into

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

In addition, these arrangements may not

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

We do not intend to pay dividends on our common

stock or preferred stock so any returns will be limited to the value of our stock.

We have never declared or paid any cash dividends

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Decreased demand for our drug candidates, if approved for commercial sale,

all of which may have a material adverse effect

on our business, results of operations and prospects.

all of which may have a material adverse effect on

our business, results of operations and prospects.

Our financial condition, results of operations,

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or global economic conditions.

Our financial condition, results of operations,

business and cash flow may be negatively affected by general conditions in the global economy and in the global financial markets and

uncertainty about economic stability.

The global economy has experienced extreme volatility and disruptions, including as a result of

public health epidemics and pandemics, or other outbreaks of communicable diseases, such as the COVID-19 pandemic, as well as from international

conflicts, terrorism or other geopolitical events, such as the conflicts in the Ukraine and the Middle East, and related sanctions and

other economic disruptions or concerns.

Additionally, the global economy and financial

markets may also be adversely affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events,

such as the conflicts in Ukraine and the Middle East.

Our financial condition, results of operations, business

and cash flow may be negatively affected by general conditions in the global economy and in the global financial markets and uncertainty

about economic stability.

The global economy has experienced extreme volatility and disruptions, including as a result of public health

epidemics and pandemics, or other outbreaks of communicable diseases, such as the COVID-19 pandemic, as well as from international conflicts,

terrorism or other geopolitical events, such as the conflicts in the Ukraine and the Middle East, and related sanctions and other economic

disruptions or concerns.

Additionally, the global economy and financial markets

may also be adversely affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events, such

as the conflicts in Ukraine and the Middle East.

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

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Our ability to use potential future operating

losses and our federal and state NOL carryforwards to offset taxable income from revenue generated from operations or corporate collaborations

could be limited.

losses and our federal and state net operating loss (“NOL”) carryforwards to offset taxable income from revenue generated

from operations or corporate collaborations could be limited.

The use of our NOL carryforwards may have limitations

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position and financial results.

Tax reform may significantly affect the

Company and our stockholders.

Due to the potential for changes to tax laws and

regulations or changes to the interpretation thereof, the ambiguity of tax laws and regulations, the subjectivity of factual interpretations

and other factors, our estimates of effective tax rate and income tax assets and liabilities may be incorrect and our financial statements

could be adversely affected.

The impact of these factors referenced in the first sentence of this paragraph may be substantially different

from period-to-period.

In addition, the amount of income taxes we pay

is subject to ongoing audits by U.S.

Tax reform may significantly affect the Company

and our stockholders.

Due to the potential for changes to tax laws and regulations

or changes to the interpretation thereof, the ambiguity of tax laws and regulations, the subjectivity of factual interpretations and other

factors, our estimates of effective tax rate and income tax assets and liabilities may be incorrect and our financial statements could

be adversely affected.

The impact of these factors referenced in the first sentence of this paragraph may be substantially different from

period-to-period.

In addition, the amount of income taxes we pay is

subject to ongoing audits by U.S.

federal, state and local tax authorities and by non-U.S.

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may adversely affect our future profitability.

We intend to seek approval to market our drug

candidates in both the United States and in foreign jurisdictions.

In some foreign countries and jurisdictions, particularly in the European

Union, the pricing of prescription pharmaceuticals is subject to governmental control.

We intend to seek approval to market our drug candidates

in both the United States and in foreign jurisdictions.

In some foreign countries and jurisdictions, particularly in the European Union,

the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations with governmental

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or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

Our employees, principal investigators,

consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards

and requirements and insider trading.

Our employees, principal investigators, consultants

and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and

requirements and insider trading.

We are exposed to the risk of fraud or other misconduct

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with adverse side effects.

As with most biopharmaceutical products, use of

our drug candidates could be associated with side effects or adverse events which can vary in severity and frequency.

Side effects or

adverse events associated with the use of our drug candidates may be observed at any time, including in clinical trials or once a product

is commercialized, and any such side effects or adverse events may negatively affect our ability to obtain regulatory approval or market

our drug candidates.

Side effects such as toxicity or other safety issues associated with the use of our drug candidates could require

us to perform additional studies or halt development or sale of these drug candidates or expose us to product liability lawsuits which

will harm our business.

As with most biopharmaceutical products, use of our

drug candidates could be associated with side effects or adverse events which can vary in severity and frequency.

Side effects or adverse

events associated with the use of our drug candidates may be observed at any time, including in clinical trials or once a product is commercialized,

and any such side effects or adverse events may negatively affect our ability to obtain regulatory approval or market our drug candidates.

Side effects such as toxicity or other safety issues associated with the use of our drug candidates could require us to perform additional

studies or halt development or sale of these drug candidates or expose us to product liability lawsuits which will harm our business.

The emergence of unforeseen safety issues or adverse

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the imposition of civil monetary penalties, seizure of our products, or delay in approval or clearance of future products.

If we fail to comply with environmental,

health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse

effect on the success of our business.

We are subject to numerous environmental, health

and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal

of hazardous materials and wastes.

If we fail to comply with environmental, health

and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect

on the success of our business.

We are subject to numerous environmental, health and

safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of

hazardous materials and wastes.

Our operations involve the use of hazardous and flammable materials, including chemicals and biological

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standards and rules have occurred with frequency and may cause us to have to restate previously reported result of operations.

Varying interpretations of existing standards

of accounting policies or accounting treatments of existing transactions may cause us to have to restate previously reported result of

Our disclosure controls and procedures may

not prevent or detect all errors or acts of fraud.

Varying interpretations of existing standards of accounting

policies or accounting treatments of existing transactions may cause us to have to restate previously reported result of operations.

Our disclosure controls and procedures may not

prevent or detect all errors or acts of fraud.

We are subject to the periodic reporting requirements

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disrupt our operations.

Our operations depend, in part, on the continued

performance of our information technology systems, which are cloud-based and maintained by third-party service providers.

Our information

technology systems are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptions.

our information technology systems could adversely affect our business, profitability and financial condition.

A successful cybersecurity attack or other data

security incident could result in the misappropriation and/or loss of confidential or personal information, create system interruptions

or deploy malicious software that attacks our systems.

It is possible that a cybersecurity attack might not be noticed for some period

The occurrence of a cybersecurity attack or incident could result in business interruptions from the disruption of our information

technology systems, or negative publicity resulting in reputational damage with our clinical trial participants, customers, stockholders

and other stakeholders and/or increased costs to prevent, respond to or mitigate cybersecurity events.

Our operations depend, in part, on the continued performance

of our information technology systems, which are cloud-based and maintained by third-party service providers.

Our information technology

systems are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptions.

Failure of our information

technology systems could adversely affect our business, profitability and financial condition.

A successful cybersecurity attack or other data security

incident could result in the misappropriation and/or loss of confidential or personal information, create system interruptions or deploy

malicious software that attacks our systems.

It is possible that a cybersecurity attack might not be noticed for some period of time.

The occurrence of a cybersecurity attack or incident could result in business interruptions from the disruption of our information technology

systems, or negative publicity resulting in reputational damage with our clinical trial participants, customers, stockholders and other

stakeholders and/or increased costs to prevent, respond to or mitigate cybersecurity events.

In addition, the unauthorized dissemination

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or penalties, litigation and potential liability, or otherwise harm our business.

We are a smaller reporting company, and

the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a smaller reporting company, and the

reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a smaller reporting company (“SRC”),

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

What changed 10-K

Item 1A. Risk Factors