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Item 1A. Risk Factors

2023-03-22 compared with 2022-03-22 · 381 added, 378 removed, 318 unchanged (70% of the section changed)

Risks Relating to Our Business and Industry

Our business and operations may be materially

and adversely affected by the coronavirus pandemic.

Our business and operations may be materially and adversely affected by the ongoing coronavirus pandemic.

From the first signs of the

pandemic, we have taken proactive measures to protect the health and safety of our employees, such as working remotely and flexible scheduling,

and our facilities have remained largely operational.

The implementation of preventative and precautionary measures that we, companies

we do business with and government authorities have taken to mitigate the spread of coronavirus have impacted, and may further impact

or disrupt our business and operations.

The effects of these measures and the extent of their impact will depend, in part, on the length

and severity of the restrictions and the limitations on our ability to conduct our business in the ordinary course.

These and future measures

may negatively affect our business, results of operations, financial condition and cash flows.

As a result of the coronavirus pandemic, limited

availability of certain services and supplies required for our preclinical programs significantly impacted our operations, causing delays

to our clinical program timelines.

The Company has undertaken efforts to mitigate potential future impacts by identifying and engaging

alternative third-party service providers, however, if measures to overcome the pandemic continue or are insufficient, the availability

of required services and supplies could be further delayed, which may in turn further slow or delay our preclinical and clinical activities.

Additionally, the commencement of new clinical trials and the enrollment of patients in clinical trials have been affected by the coronavirus

pandemic and while the steps to initiate our clinical trials are continuing and ongoing, the Company does not yet know the full extent

of similar potential delays on our clinical trial activities.

We cannot predict the impact that the progression

of the pandemic will have on future operations or financial results due to a number of factors including, but not limited to, the health

and safety of our employees, the ability of the Company’s third-party providers to continue to operate, the availability of services

and supplies for our programs, the ability to commence our clinical trials and the clinical sites to enroll patients, and the length of

the coronavirus pandemic.

The extent to which the coronavirus impacts our business, preclinical studies and clinical trials will depend

on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the

severity of COVID-19, including mutations or variants, and the actions to contain the pandemic or treat its impact, among others.

a result, we may experience additional disruptions that could severely impact our business, preclinical studies and clinical trials, including

delays in regulatory approvals to initiate any planned clinical trials, delays or difficulties in enrolling patients, interruptions or

delays in preclinical studies due to limited operations at our facilities or the companies we do business with, and lack of availability

or delays in supplies needed to conduct our preclinical and clinical activities.

The pandemic has impacted and may further impact

the global economy and capital markets.

Moreover, it has led to significant uncertainty and increased volatility in the capital markets.

If these conditions in the capital markets continue it may reduce the Company’s ability to access capital and negatively affect

our future liquidity.

As a result, we may be compelled to take actions to preserve our cash flow.

The coronavirus pandemic continues to evolve and

change rapidly.

The ultimate impact of the coronavirus pandemic, or a similar public health emergency, is highly uncertain and subject

The Company does not yet know the full extent of potential delays or impacts on its business, financing activities, preclinical

studies, clinical trial activities or the global economy as a whole.

However, these effects could have a material impact on the Company’s

liquidity, results of operations and financial condition.

We are dependent on the success of our INTASYL

technology platform, and our product candidates based on this platform, which is unproven and may never lead to approved and marketable

Our research and development efforts have been

focused on the development of product candidates based on our INTASYL technology platform.

We have invested, and we expect to continue

to invest, significant financial resources and efforts developing our product candidates.

The ability to generate revenue is highly dependent

on the successful development, regulatory approval and commercialization of our INTASYL product candidates by us or by collaborative partners,

which may not occur for the foreseeable future, if ever, and is highly uncertain and depends on a number of factors, many of which are

beyond our control.

Therefore, it is difficult to accurately predict challenges we may face with our product candidates as they move through

the discovery, preclinical and clinical development stages.

We may spend large amounts of money trying to develop our INTASYL platform

technology and may never succeed in doing so.

In addition, our research methodology may be unsuccessful in identifying product candidates

and results from preclinical and clinical studies may not predict the results that will be obtained in later phase trials of our product

candidates or our product candidates may interact with patients in unforeseen or harmful ways that may make it impractical to manufacture,

market or receive regulatory approval.

If we are not successful in bringing an INTASYL product candidate to market, it could negatively

impact our business and financial condition and we may not be able to identify and successfully implement an alternative product development

Our efforts have been focused on the development

of product candidates based on our INTASYL technology platform.

We have invested, and we expect to continue to invest, significant financial

resources and efforts developing our product candidates.

Our ability to eventually generate revenue is highly dependent on the successful

development, regulatory approval and commercialization of our INTASYL product candidates by us or by collaborative partners, which may

not occur for the foreseeable future, if ever, and is highly uncertain and depends on a number of factors, many of which are beyond our

Therefore, it is difficult to accurately predict challenges we may face with our product candidates as they move through the

discovery, preclinical and clinical development stages.

We will spend large amounts of money developing our INTASYL platform technology

and may never succeed in obtaining regulatory approval.

In addition, our research methodology may be unsuccessful in identifying product

candidates and results from preclinical studies and clinical trials may not predict the results that will be obtained in later phase trials

of our product candidates or our product candidates may interact with patients in unforeseen or harmful ways that may make it impractical

or impossible to manufacture, receive regulatory approval or commercialize.

If we are not successful in bringing an INTASYL product candidate

to market, it could negatively impact our business and financial condition and we may not be able to identify and successfully implement

an alternative product development strategy.

Our product candidates

are in an early stage of development and we may fail, experience significant delays, never advance to the clinic or not be successful

are in an early stage of development and we may fail, experience significant delays, never advance clinical development or not be successful

in our efforts to identify or discover additional product candidates, which may materially and adversely impact our business.

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on the successful development of our product candidates, which may never occur.

Our product candidates could be delayed, not advance into

the clinic, or unexpectedly fail at any stage of development.

Our ability to identify, develop and commercialize product candidates is

dependent on extensive preclinical and other non-clinical tests in order to support an investigational new drug (“ IND ”)

application in the United States, or the equivalent with regulatory authorities in other jurisdictions.

These research programs to identify

new product candidates require substantial financial and human resources, are difficult to design and can take many years.

Our product candidates, which are in early stages of development,

could be delayed, not advance into the clinic, or unexpectedly fail at any stage of development.

Our ability to identify, develop and

commercialize product candidates is dependent on extensive preclinical and other non-clinical tests in order to support an IND application

in the United States, or the equivalent with regulatory authorities in other jurisdictions.

These research programs to identify new product

candidates require substantial financial and human resources, are difficult to design and can take many years to complete.

We cannot be certain of the outcome of our research

studies and the results from these studies may not predict the results that will be obtained in later stages of development and we may

focus our efforts and resources on product candidates that may prove to be unsuccessful.

There is no assurance that we will be able to

successfully develop our product candidates, and we may forego opportunities with certain product candidates or for indications that later

prove to have greater commercial potential.

If we are not able to successfully develop our product candidates, we may be forced to abandon

or delay our development efforts, which may materially and adversely affect our business, financial condition, and results of operations.

We are dependent on collaboration partners

studies and clinical trials and the results from these studies and clinical trials may not predict the results that will be obtained in

later stages of development and we may focus our efforts and resources on product candidates that may prove to be unsuccessful.

is no assurance that we will be able to successfully develop our product candidates, and we may forego opportunities with certain product

candidates or for indications that later prove to have greater commercial potential.

If we are not able to successfully develop our product

candidates, we may be forced to abandon or delay our development efforts, which may materially and adversely affect our business, financial

condition, and results of operations.

Further, the FDA, or equivalent foreign regulatory

authority, may not accept the results of our preclinical studies or clinical trials and may require us to complete additional studies

or impose stricter approval conditions than we expect, which could impact the value of a particular program, the approvability or commercialization

of the particular product candidate or product and our Company in general.

Because of these factors, it is difficult to predict the time

and cost of the development of our product candidates.

Any delay or failure in obtaining required approvals may prevent us from completing

our preclinical studies or clinical trials and could have a material adverse effect on our ability to initiate or commercialize any drug

candidate on a timely basis, or at all.

Additionally, preclinical studies and clinical trials are lengthy and expensive and if our cash

resources become limited we may not be able to commence, continue or complete such preclinical studies or clinical trials.

We are dependent on our collaboration partners

for the successful development of our adoptive cell therapy product candidates.

As we do not have direct access to the patient

or donor cells used in cell therapy, we are not considered a cell therapy company and expect to depend on third-party collaborators to

support the clinical development of our ACT product candidates.

We have entered into a clinical collaboration development agreement with

for the clinical development of our PH-762 product candidate in ACT and have entered into research agreements with our academic

and industry collaborators, each of which is terminable by the relevant party at any time, subject to applicable notice periods.

of our collaborations depends upon the efforts of our collaboration partners, and their performance in achieving the development activities

to the extent they are responsible under our collaboration agreements.

Each of our partners may not be successful in performing these

activities, including completing the required preclinical studies and other information to be included in an IND application (or foreign

equivalent), obtaining approval to initiate clinical trials, conducting the necessary clinical trials and arranging for the manufacturing

or contract research organization (“ CRO ”) relationships and obtaining marketing authorization.

Our partners work with

other companies, potentially including some of our competitors, and their corporate objectives may not align with ours, they may change

their strategic focus or pursue alternative technologies.

If our collaborations are not successful or a partner terminates our collaboration

agreement, our business, financial condition, results of operations could be materially and adversely affected.

We are dependent on third parties that have direct

access to the patient or donor cells used in cell therapy and expect to depend on third-party collaborators to support the clinical development

of our ACT product candidates.

We have entered into a clinical collaboration development agreement with AgonOx, Inc.

for the clinical

development of our PH-762 product candidate in ACT and have entered into other research agreements with academic and industry collaborators,

each of which is terminable by the relevant party at any time, subject to applicable notice periods.

The success of our collaborations

depends upon the efforts of our collaboration partners, and their performance in achieving the development activities to the extent they

are responsible under our collaboration agreements.

Each of our partners may not be successful in performing these activities, including

completing the required preclinical studies and other information to be included in an IND application (or foreign equivalent), obtaining

approval to initiate clinical trials, conducting the necessary clinical trials and arranging for the manufacturing or contract research

organization (“ CRO ”) relationships and obtaining marketing authorization.

Our partners work with other companies, potentially

including some of our competitors, their corporate objectives may not align with ours, and they may change their strategic focus or pursue

alternative technologies.

If our collaborations are not successful or a partner terminates our collaboration agreement, our business,

financial condition, and results of operations could be materially and adversely affected.

Further, we may not be successful in negotiating

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If we experience delays or difficulties in

identifying and enrolling patients in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary

identifying and enrolling subjects in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary

regulatory approvals.

Clinical trials of a new drug candidate require

the enrollment of a sufficient number of patients, including patients who are suffering from the disease or condition the drug candidate

is intended to treat and who meet other eligibility criteria.

Rates of subject enrollment are affected by many factors, and delays in

subject enrollment can result in increased costs and longer development times, which could materially and adversely impact our business

and financial condition.

We may experience slower than expected patient enrollment, including as a result of the coronavirus pandemic,

in our current or future clinical trials.

In addition, clinical trials for drug candidates that treat the same indications as our product

candidates may result in subjects who would otherwise be eligible for our clinical trials instead enrolling in clinical trials for other

drug candidates.

Clinical trials of a new drug candidate require the

enrollment of a sufficient number of subjects, including subjects who are suffering from the disease or condition the drug candidate is

intended to treat and who meet other eligibility criteria.

Rates of subject enrollment are affected by many factors, and delays in subject

enrollment can result in increased costs and longer development times, which could materially and adversely impact our business and financial

We may experience slower than expected subject enrollment, including as a result of the coronavirus pandemic, in our current

or future clinical trials.

In addition, clinical trials for drug candidates that treat the same indications as our product candidates

may result in subjects who would otherwise be eligible for our clinical trials instead enrolling in clinical trials for other drug candidates.

Topline data may not accurately reflect or

may materially differ from the complete results of a study or clinical trial.

may materially differ from the complete results of a clinical trial.

From time to time, we may publicly disclose topline

or interim data from our preclinical and clinical studies based on a preliminary analysis of then-available data, of which the results,

related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received

or had the opportunity to fully and carefully evaluate all data.

Preliminary observations made in early stages of preclinical studies

and clinical trials are not necessarily indicative of results that will be obtained when full data sets are analyzed or in subsequent

preclinical and clinical studies and may not be replicated in subsequent studies.

As a result, topline data may differ from future results

from the same studies or different conclusions may qualify such results once additional data has been received and evaluated.

or interim data also remain subject to audit and verification procedures that may result in the final data being materially different

from the preliminary data that we publicly disclose and should be viewed with caution until the complete data is available.

Further, the U.S.

Food and Drug Administration

(“ FDA ”), or equivalent foreign regulatory authority, may not accept the results of our preclinical or clinical studies

and may require us to complete additional studies or impose stricter approval conditions than we expect, which could impact the value

of a particular program, the approvability or commercialization of the particular product candidate or product and our Company in general.

Because of these factors, it is difficult to predict the time and cost of the development of our product candidates.

Any delay or failure

in obtaining required approvals may prevent us from completing our preclinical or clinical studies and could have a material adverse effect

on our ability to initiate or commercialize any drug candidate on a timely basis, or at all.

Additionally, preclinical studies and clinical

trials are lengthy and expensive and if our cash resources become limited we may not be able to commence, continue or complete our clinical

If the topline data we report differs from future analysis of results, or if others, including regulatory authorities, disagree

with the conclusions reached, our business, financial condition, and results of operations could be materially and adversely affected.

or interim data from our clinical trials based on a preliminary analysis of then-available data, of which the results, related findings

and conclusions are subject to change following a more comprehensive review of the data related to the particular trial.

assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity

to fully and carefully evaluate all data.

Preliminary observations made in early stages of clinical trials are not necessarily indicative

of results that will be obtained when full data sets are analyzed or in subsequent clinical trials.

As a result, topline data may differ

from future results from the same studies or different conclusions may qualify such results once additional data has been received and

Topline or interim data also remain subject to audit and verification procedures that may result in the final data being materially

different from the preliminary data that we publicly disclose and should be viewed with caution until the complete data is available.

If the topline data we report differs from future analysis of results, or if others, including regulatory authorities, disagree with the

conclusions reached, our business, financial condition, and results of operations could be materially and adversely affected.

We rely upon third-parties to conduct our

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If we or our CROs fail to comply with these applicable regulations, the FDA, or equivalent foreign regulatory authority, may not accept

these data and may require us to complete additional studies.

which could result in significant additional costs and delays to us.

these third parties may face disruptions due to the coronavirus pandemic that may affect our ability to initiate and complete our clinical

these data and may require us to complete additional preclinical studies and clinical trials, which could result in significant additional

costs and delays to us.

As we only control certain aspects of their activities,

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our product candidates and our business operations.

This could be difficult, costly or impossible, and our preclinical or clinical trials

may need to be extended, delayed, terminated or repeated, and we may not be able to obtain regulatory approval in a timely fashion, or

at all, for the applicable drug candidate, or to commercialize such drug candidate being tested in such trials.

This could be difficult, costly or impossible, and our preclinical studies or clinical

trials may need to be extended, delayed, terminated or repeated, and we may not be able to obtain regulatory approval in a timely fashion,

or at all, for the applicable drug candidate, or to commercialize such drug candidate being tested in such studies or trials.

France adopted the General Data Protection

Regulation, a data privacy regulation, and as we are conducting a clinical study in France we are required to follow this law, which,

Regulation, a data privacy regulation, and as we are conducting a clinical trial in France we are required to follow this law, which,

if violated, could subject us to significant fines.

The collection and use of personal health data

and other personal information in the European Union is governed by the provisions of the European General Data Protection Regulation

(EU) 2016/679 (“ GDPR ”), which came into force in May 2018 and related implementing laws in individual EU Member States.

The GDPR imposes a number of strict obligations

and restrictions on the ability to process (processing includes collection, analysis and transfer of) personal data of individuals within

the European Union and in the EEA, including health data from clinical trials and adverse event reporting.

The GDPR also includes requirements

relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals prior to processing

their personal data or personal health data, notification of data processing obligations to the national data protection authorities and

the security and confidentiality of the personal data.

EU Member States may also impose additional requirements in relation to health,

genetic and biometric data through their national implementing legislation.

The collection and use of personal health data and

other personal information in the European Union is governed by the provisions of the GDPR, which came into force in May 2018 and related

implementing laws in individual EU Member States.

The GDPR imposes a number of strict obligations and

restrictions on the ability to process (processing includes collection, analysis and transfer of) personal data of individuals within

the EU and in the EEA, including health data from clinical trials and adverse event reporting.

The GDPR also includes requirements relating

to the consent of the individuals to whom the personal data relates, the information provided to the individuals prior to processing their

personal data or personal health data, notification of data processing obligations to the national data protection authorities and the

security and confidentiality of the personal data.

EU Member States may also impose additional requirements in relation to health, genetic

and biometric data through their national implementing legislation.

Under the GDPR, personal data can only be transferred

within the EU Member States and the three additional European Economic Area countries (Norway, Iceland and Liechtenstein) that have adopted

a national law implementing the GDPR.

Appropriate safeguards are required to enable cross-border transfers of personal data from the EU

and EEA Member States to a “third country” (a country outside the EU or EEA).

This status has a number of significant practical

consequences, in particular for international data transfers, competent supervisory authorities and enforcement of the GDPR.

In conclusion, the GDPR prohibits the transfer

of personal data to countries outside of the European Union/EEA (including the United States) that are not considered by the European

Commission to provide an adequate level of data protection, except if the data controller meets very specific requirements such as the

use of standard contractual clauses (“ SCC s”), issued by the European Commission.

In this respect recent legal developments

in Europe have created complexity and compliance uncertainty regarding certain transfers of personal data from the EU/EEA.

following the Schrems II decision of the Court of Justice of the European Union on July 16, 2020, in which the Court invalidated the Privacy

Shield under which personal data could be transferred from the EU/EEA to United States entities who had self-certified under the Privacy

Shield scheme, there is uncertainty as to the general permissibility of international data transfers under the GDPR.

The Court did not

invalidate the then current SCCs, but ruled that data exporters relying on these SCCs are required to verify, on a case-by-case basis,

if the law of the third country ensures an adequate level of data protection that is essentially equivalent to that guaranteed in the

In light of the implications of this decision we may face difficulties regarding the transfer of personal data from the European

Union/EEA to third countries.

However, on June 4, 2021 the EU Commission issued a new set of SCCs for data transfers from controllers

or processors in the EU/EEA to controllers or processors established outside the EU/EEA.

These SCCs replace the old sets of SCCs that

were adopted under the previous European Data Protection Directive 95/46.

Since September 27, 2021, it is no longer possible to conclude

contracts incorporating these previous versions of the SCCs.

In addition, for contracts concluded before September 27, 2021, it is still

possible to rely on the previous SCCs until the end of an additional 15 months transitional period (until December 27, 2022), provided

that the processing operations which are the subject matter of the contract remain unchanged and reliance on previous SCCs ensures that

the transfer is subject to appropriate safeguards.

On November 11, 2021, the European Data Protection Board has adopted recommendations

on such appropriate safeguards that supplement transfer mechanisms.

These recommendations aim to assist data exporters with their duty

to identify and implement appropriate supplementary measures where they are needed to ensure an essentially equivalent level of protection

to the personal data they transfer to third countries.

within the EU Member States and the three additional EEA countries (Norway, Iceland and Liechtenstein) that have adopted a national law

implementing the GDPR.

Appropriate safeguards are required to enable cross-border transfers of personal data from the EU and EEA Member

States to a “third country” (a country outside the EU or EEA).

This status has a number of significant practical consequences,

in particular for international data transfers, competent supervisory authorities and enforcement of the GDPR.

The GDPR prohibits the transfer of personal data

to countries outside of the EU/EEA (including the United States) that are not considered by the EC to provide an adequate level of data

protection, except if the data controller meets very specific requirements such as the use of standard contractual clauses (“ SCC s”),

issued by the EC.

In this respect recent legal developments in Europe have created complexity and compliance uncertainty regarding

certain transfers of personal data from the EU/EEA.

For example, following the Schrems II decision of the Court of Justice of the EU on

July 16, 2020, in which the Court invalidated the Privacy Shield under which personal data could be transferred from the EU/EEA to United

States entities who had self-certified under the Privacy Shield scheme, there is uncertainty as to the general permissibility of international

data transfers under the GDPR.

The Court did not invalidate the then current SCCs, but ruled that data exporters relying on these SCCs

are required to verify, on a case-by-case basis, if the law of the third country ensures an adequate level of data protection that is

essentially equivalent to that guaranteed in the EU/EEA.

In light of the implications of this decision we may face difficulties regarding

the transfer of personal data from the EU/EEA to third countries, such as the United States.

However, on June 4, 2021 the EC issued a

new set of SCCs for data transfers from controllers or processors in the EU/EEA to controllers or processors established outside the EU/EEA.

These SCCs replace the old sets of SCCs that were adopted under the previous European Data Protection Directive 95/46.

Since September

27, 2021, it is no longer possible to conclude contracts incorporating these previous versions of the SCCs.

In addition, for contracts

concluded before September 27, 2021, it is still possible to rely on the previous SCCs until the end of an additional 15 months transitional

period (until December 27, 2022), provided that the processing operations which are the subject matter of the contract remain unchanged

and reliance on previous SCCs ensures that the transfer is subject to appropriate safeguards.

On November 11, 2021, the European Data

Protection Board adopted recommendations on such appropriate safeguards that supplement transfer mechanisms.

These recommendations aim

to assist data exporters with their duty to identify and implement appropriate supplementary measures where they are needed to ensure

an essentially equivalent level of protection to the personal data they transfer to third countries.

Failure to comply with the requirements of the

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EU Member States may still implement certain variations, enforce the GDPR and national data protection laws differently, and introduce

additional national regulations and guidelines, which adds to the complexity of processing personal data in the European Union.

developed at both EU level and at the national level in individual EU Member States concerning implementation and compliance practices

are often updated or otherwise revised.

Ensuring compliance with GDPR is time-intensive and may increase the cost of doing business, and

failure to comply with these laws may have a material impact on our operations and financial condition.

additional national regulations and guidelines, which adds to the complexity of processing personal data in the EU.

Guidance developed

at both EU level and at the national level in individual EU Member States concerning implementation and compliance practices are often

updated or otherwise revised.

Ensuring compliance with GDPR is time-intensive and may increase the cost of doing business, and failure

to comply with these laws may have a material impact on our operations and financial condition.

There is, moreover, a growing trend towards required

public disclosure of clinical trial data in the European Union which adds to the complexity of obligations relating to processing health

public disclosure of clinical trial data in the EU which adds to the complexity of obligations relating to processing health

data from clinical trials.

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On June 28, 2021 the European Commission adopted

two adequacy decisions for the United Kingdom – one under the GDPR and the other for the Law Enforcement Directive.

Personal data

may now freely flow from the European Union to the United Kingdom since the United Kingdom is deemed to have an adequate data protection

Additionally, following the UK's withdrawal from the European Union and the EEA, companies also have to comply with the UK’s

data protection laws (including the UK GDPR, which is based on the EU GDPR), the latter regime having the ability to separately fine up

to the greater of £17.5 million or 4% of global turnover.

The adequacy decisions include a ‘sunset clause’ which entails

that the decisions will automatically expire four years after their entry into force.

two adequacy decisions for the UK – one under the GDPR and the other for the Law Enforcement Directive.

data may now freely flow from the EU to the UK since the UK is deemed to have an adequate data protection level.

Additionally, following

the UK's withdrawal from the EU and the EEA, companies also have to comply with the UK’s data protection laws (including the UK

GDPR, which is based on the EU GDPR), the latter regime having the ability to separately fine up to the greater of £17.5 million

or 4% of global turnover.

The adequacy decisions include a ‘sunset clause’ which entails that the decisions will automatically

expire four years after their entry into force.

A number of different factors could prevent

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Clinical trials require the review and oversight

of Institutional Review Boards (“ IRB ”), which approve and continually review clinical investigations and protect the

rights and welfare of human subjects.

Before our clinical trials can begin, we must also submit to the FDA a clinical protocol accompanied

by the approval of the IRB at the institution(s) participating in the clinical trial.

An inability or delay in obtaining IRB approval

could prevent or delay the initiation and completion of our clinical trials, and the FDA may decide not to consider any data or information

derived from a clinical investigation not subject to initial and continuing IRB review and approval.

of IRBs, which approve and continually review clinical investigations and protect the rights and welfare of human subjects.

clinical trials can begin, we must also submit to the FDA a clinical protocol accompanied by the approval of the IRB at the institution(s)

participating in the clinical trial.

An inability or delay in obtaining IRB approval could prevent or delay the initiation and completion

of our clinical trials, and the FDA may decide not to consider any data or information derived from a clinical investigation not subject

to initial and continuing IRB review and approval.

Preclinical studies and clinical trials are lengthy

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Any delay or failure in obtaining required approvals may prevent us from completing our preclinical

or clinical studies and could have a material adverse effect on our ability to initiate or commercialize any drug candidate on a timely

basis, or at all.

Additionally, preclinical studies and clinical trials are lengthy and expensive and if our cash resources become limited

we may not be able to commence, continue or complete our clinical trials, which could have a material impact on our business, financial

condition, and results of operations.

studies or clinical trials and could have a material adverse effect on our ability to initiate or commercialize any drug candidate on

a timely basis, or at all.

Additionally, preclinical studies and clinical trials are lengthy and expensive and if our cash resources become

limited we may not be able to commence, continue or complete our clinical trials, which could have a material impact on our business,

financial condition, and results of operations.

We are subject to significant competition

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If we are not first to market or are

unable to demonstrate superiority, on a cost-effective basis or otherwise, any products for which we are able to obtain approval may

not be successful.

unable to demonstrate superiority, on a cost-effective basis or otherwise, any products for which we are able to obtain approval may not

be successful.

Our competitors also compete with us in acquiring

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or commercialize our product candidates, we may not be able to establish market share and generate revenues from our technology.

If we fail to attract, hire and retain

qualified personnel, we may not be able to design, develop, market or sell our products or successfully manage our business.

We have a small management team and are particularly

dependent on our core management team.

Accordingly, our business prospects are dependent on the principal members of our executive team,

the loss of whose services could make it difficult for us to manage our business successfully and achieve our business objectives.

we have entered into employment agreements with each of our executive officers, they could leave at any time, in addition to our other

employees, who are all “at will” employees.

Our ability to identify, attract, retain and integrate additional qualified key

personnel is also critical to our success.

Competition for skilled research, product development, regulatory and technical personnel is

intense, and we may not be able to recruit and retain the personnel we need.

The loss of the services of any key research, product development,

regulatory and technical personnel, or our inability to hire new personnel with the requisite skills, could restrict our ability to develop

our product candidates.

If we fail to attract, hire and retain qualified

personnel, we may not be able to design, develop, market or sell our products or successfully manage our business.

We have a small core management team and are particularly

dependent on them.

Accordingly, our business prospects are dependent on the principal members of our executive team, the loss of whose

services could make it difficult for us to manage our business successfully and achieve our business objectives.

While we have entered

into an employment agreement with our Chief Executive Officer, they could leave at any time, in addition to our other employees, who are

all “at will” employees.

Our ability to identify, attract, retain and integrate additional qualified key personnel is also

critical to our success.

Competition for skilled research, product development, regulatory and technical personnel is intense, and we

may not be able to recruit and retain the personnel we need.

The loss of the services of any key research, product development, regulatory

and technical personnel, or our inability to hire new personnel with the requisite skills, could restrict our ability to develop our product

We are subject to potential liabilities from

clinical testing and future product liability claims.

The use of our product candidates

in clinical trials and, if any of our product candidates receive regulatory approval, the sale of our product candidates for commercial

use expose us to the risk or product liability claims.

Product liability claims may be brought against us by patients, healthcare providers,

consumers or others who come into contact with our product candidates or approved products.

We will seek to obtain clinical trial insurance

for clinical trials that we conduct, as well as liability insurance for any products that we market.

However, there is no assurance that

we will be able to obtain insurance in the amounts we seek, or at all.

We anticipate that licensees who develop our products will carry

liability insurance covering the clinical testing of our product candidates and the marketing of those product candidates, if approved.

There is no assurance, however, that any insurance maintained by us or our licensees will prove adequate in the event of a claim against

If we cannot successfully defend against product liability claims, we could incur substantial liabilities.

Even if claims asserted

against us are unsuccessful, they may divert management’s attention from our operations and we may have to incur substantial costs

to defend such claims.

The use of our product candidates in clinical trials

and, if any of our product candidates receive regulatory approval, the sale of our product candidates for commercial use expose us to

the risk of product liability claims.

Product liability claims may be brought against us by patients, healthcare providers, consumers

or others who come into contact with our product candidates or approved products.

We will seek to obtain clinical trial insurance for

clinical trials that we conduct, as well as liability insurance for any products that we market.

However, there is no assurance that we

will be able to obtain insurance in the amounts we seek, or at all.

We anticipate that licensees who develop our products will carry liability

insurance covering the clinical testing of our product candidates and the marketing of those product candidates, if approved.

no assurance, however, that any insurance maintained by us or our licensees will prove adequate in the event of a claim against us.

we cannot successfully defend against product liability claims, we could incur substantial liabilities.

Even if claims asserted against

us are unsuccessful, they may divert management’s attention from our operations and we may have to incur substantial costs to defend

Any of these outcomes could materially impact our business and financial condition.

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for these supplies.

There are a limited number of manufacturers

that make oligonucleotides and we currently contract with multiple manufacturers for the supply of our product candidates to reduce

the risk of supply interruption or availability.

However, there is no assurance that our supply of our product candidates will not

be limited, interrupted, of satisfactory quality or be available at acceptable prices.

For example, constraints on the supply chain

and availability of resources due to the ongoing effort to address the coronavirus pandemic have resulted in delays and shortages at

manufacturing facilities.

While we have engaged with multiple manufacturers for the supply of our product candidates, there can be no

assurance that our efforts will be successful.

There are a limited number of manufacturers that make

oligonucleotides and we currently contract with multiple manufacturers for the supply of our product candidates to reduce the risk of

supply interruption or availability.

However, there is no assurance that our supply of our product candidates will not be limited, interrupted,

of satisfactory quality or be available at acceptable prices.

For example, constraints on the supply chain and availability of resources

due to the ongoing coronavirus pandemic have resulted in delays and shortages at manufacturing facilities.

While we have engaged with

multiple manufacturers for the supply of our product candidates in order to mitigate the impact of the loss or delay of any one manufacturer,

there can be no assurance that our efforts will be successful.

If for any reason we are unable to obtain the clinical supply of our product

candidates from our current manufacturers, we would have to seek to contract with another major manufacturer.

If we or any of these

manufacturers is unable or unwilling to increase its manufacturing capacity or if we are unable to establish alternative

arrangements on a timely basis or on acceptable terms, the development and commercialization of such an approved product may be

delayed or there may be a shortage in supply.

Any inability to manufacture our product candidates or future approved drugs in

sufficient quantities when needed would seriously harm our business.

Approval of any of our product candidates will

not occur unless the manufacturing facilities are in compliance with the FDA’s cGMP regulations, or a foreign equivalent’s

regulations, in order to ensure that drug products are safe and that they consistently meet applicable requirements and specifications.

These requirements are enforced by the FDA and other regulatory authorities through periodic inspections of the manufacturing facilities

and can result in enforcement action, such as warning letters, fines and suspension of production if they are found to not be in compliance

with the regulations.

If our suppliers or manufacturers do not comply with the FDA or foreign regulations for our product candidates,

we may experience delays in timing or supply, be forced to manufacture our product candidates ourselves or seek to enter contract with

another supplier or manufacturer.

If we are required to switch suppliers or manufacturers, we will be required to verify that the new

supplier or manufacturer maintains facilities and processes in line with cGMP regulations, which may result in delays, additional expenses,

and may have a material adverse effect on our ability to complete the development of our product candidates.

If we or any of these manufacturers

are unable or unwilling to increase its manufacturing capacity or if we are unable to establish alternative arrangements on a timely basis

or on acceptable terms, the development and commercialization of such an approved product may be delayed or there may be a shortage in

Any inability to manufacture our product candidates or future approved drugs in sufficient quantities when needed would seriously

harm our business.

Approval of any of our product candidates will not

occur unless the manufacturing facilities are in compliance with the FDA’s cGMP regulations, or a foreign equivalent’s regulations,

in order to ensure that drug products are safe and that they consistently meet applicable requirements and specifications.

These requirements

are enforced by the FDA and other regulatory authorities through periodic inspections of the manufacturing facilities and can result in

enforcement action, such as warning letters, fines and suspension of production if they are found to not be in compliance with the regulations.

If our suppliers or manufacturers do not comply with the FDA or foreign regulations for our product candidates, we may experience delays

in timing or supply, be forced to manufacture our product candidates ourselves or seek to contract with another supplier or manufacturer.

If we are required to switch suppliers or manufacturers, we will be required to verify that the new supplier or manufacturer maintains

facilities and processes in line with cGMP regulations, which may result in delays, additional expenses, and may have a material adverse

effect on our ability to complete the development of our product candidates.

Unstable market and economic conditions,

including elevated and sustained inflation, may have serious adverse consequences on our business, financial condition and stock price.

As has been widely reported, we are currently operating

in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by domestic and global monetary

and fiscal policy, geopolitical instability, an ongoing military conflict between Russia and Ukraine, and historically high domestic and

global inflation.

In particular, the conflict in Ukraine has exacerbated market disruptions, including significant volatility in commodity

prices, as well as supply chain interruptions, and has contributed to record inflation globally.

Federal Reserve and other central

banks may be unable to contain inflation through more restrictive monetary policy and inflation may increase or continue for a prolonged

period of time.

Inflationary factors, such as increases in the cost of clinical supplies, interest rates, overhead costs and transportation

costs may adversely affect our operating results.

We continue to monitor these events and the potential impact on our business.

we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may be adversely

affected in the future due to domestic and global monetary and fiscal policy, supply chain constraints, consequences associated with the

coronavirus pandemic and the ongoing conflict between Russia and Ukraine, and such factors may lead to increases in the cost of manufacturing

our product candidates and delays in initiating studies.

In addition, global credit and financial markets have experienced extreme volatility

and disruptions in the past several years and the foregoing factors have led to and may continue to cause diminished liquidity and credit

availability, declines in consumer confidence, declines in economic growth, uncertainty about economic stability and increased inflation.

There can be no assurance that further deterioration

in credit and financial markets and confidence in economic conditions will not occur.

Our general business strategy may be adversely affected

by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions.

If the current

equity and credit markets deteriorate, or do not improve, it may make any necessary debt or equity financing more difficult, more costly,

and more dilutive.

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

on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans.

addition, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive these difficult

economic times, which could directly affect our ability to attain our operating goals.

Natural disasters, epidemic or pandemic disease

outbreaks, trade wars, political unrest or other events could disrupt our business or operations or those of our development partners,

manufacturers, regulators or other third parties with whom we conduct business now or in the future.

A wide variety of events beyond our control, including

natural disasters, epidemic or pandemic disease outbreaks (such as the coronavirus pandemic), trade wars, political unrest or other events

could disrupt our business or operations or those of our manufacturers, regulatory authorities, or other third parties with whom we conduct

These events may cause businesses and government agencies to be shut down, supply chains to be interrupted, slowed, or rendered

inoperable, and individuals to become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental

restrictions.

These limitations could negatively affect our business operations and continuity, and could negatively impact our development

timelines and ability to timely perform basic business functions, including preparing and filing financial reports.

If our operations

or those of third parties with whom we have business are impaired or curtailed as a result of these events, the development and commercialization

of our products and product candidates could be impaired or halted, which could have a material adverse impact on our business.

Risks Relating to Our Intellectual Property

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their patents, which may result in substantial liabilities and prevent us from pursuing the development of our product candidates.

Because the field we operate in is relatively new,

is constantly changing and patent applications are still being processed by government patent offices around the world, there is a great

deal of uncertainty about which patents will issue, when, to whom and with what claims.

Although we are not aware of any blocking patents

or other proprietary rights, it is likely that there will be significant litigation and other proceedings, such as interference and opposition

proceedings in various patent offices, relating to patent rights in the field we operate.

Further, many patents in the fields we are pursuing

have already been exclusively licensed to third-parties, including our competitors.

It is possible that we may become a party to such

Because the field we operate in is constantly changing

and patent applications are still being processed by government patent offices around the world, there is a great deal of uncertainty

about which patents will issue, when, to whom and with what claims.

Although we are not aware of any blocking patents or other proprietary

rights, it is likely that there will be significant litigation and other proceedings, such as interference and opposition proceedings

in various patent offices, relating to patent rights in the field we operate.

Further, many patents in the fields we are pursuing have

already been exclusively licensed to third-parties, including our competitors.

It is possible that we may become a party to such proceedings.

If a claim should be brought against us and we

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Risks Relating to Our Financial Condition

We have a history

of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain profitability.

We have generated significant

losses to date, have not generated any product revenue and may not generate product revenue in the foreseeable future, or ever.

to incur significant operating losses as we advance our product candidates through drug development and the regulatory process.

ability to achieve profitability, if ever, will depend on, among other things, us or our collaborators, obtaining regulatory approvals

and successfully commercializing our drug candidates.

Even if we are able to successfully commercialize our drug candidates, we may not

be able to achieve or sustain profitability, which could have a material adverse effect on our business, financial condition and results

of operations.

will require substantial additional funds to complete our research and development activities.

substantial funds to develop our product candidates and will need to raise additional substantial funds to continue our drug development

efforts and support our operations.

Our future capital requirements and the period for which our existing resources are able to support

our operations may vary significantly from what we expect.

We anticipate that we will need to raise substantial amounts of

money to fund a variety of future activities integral to the development of our business, which may include but is not limited to the

We will require substantial additional funds

to complete our research and development activities.

We have used substantial funds to develop our product

candidates and will need to raise additional substantial funds to continue our drug development efforts and support our operations.

future capital requirements and the period for which our existing resources are able to support our operations may vary significantly

from what we expect.

We anticipate that we will need to raise substantial amounts of money to fund a variety of future activities integral

to the development of our business, which may include but is not limited to the following:

To conduct research and development to successfully develop our product candidates;

To obtain regulatory approval for our products;

To obtain regulatory approval for our product candidates;

To file and prosecute patent applications and to defend and assess patents to protect our technologies;

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To acquire new technologies, licenses or products.

In the future, we will be dependent on obtaining

funding from third parties, such as proceeds from the issuance of debt, sale of equity or strategic opportunities, in order to maintain

our operations.

We cannot assure you that additional financing will be available to us on acceptable terms, or at all.

If we cannot,

or are limited in the ability to, issue equity, incur debt or enter into strategic collaborations, we may be unable to fund the discovery

and development of our product candidates, address gaps in our product offerings or improve our technology.

If we fail to obtain additional

funding when needed, we may ultimately be unable to continue to develop and potentially commercialize our product candidates, and we

may be forced to scale back or terminate our operations or seek to merge with or be acquired by another company.

We are dependent on obtaining funding from third parties,

such as proceeds from the issuance of debt, sale of equity or strategic opportunities, in order to maintain our operations.

assure you that additional financing will be available to us on acceptable terms, or at all.

If we cannot, or are limited in the ability

to, issue equity, incur debt or enter into strategic collaborations, we may be unable to fund the discovery and development of our product

candidates or improve our technology.

If we fail to obtain additional funding when needed, we may ultimately be unable to continue to

develop and potentially commercialize our product candidates, and we may be forced to scale back or terminate our operations or seek to

merge with or be acquired by another company.

We have a history

of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain profitability.

We have generated significant

losses to date, have not generated any product revenue and may not generate product revenue in the foreseeable future, or ever.

to incur significant operating losses as we advance our product candidates through drug development and the regulatory process.

to achieve profitability, if ever, will depend on, among other things, us or our collaborators, obtaining regulatory approvals and successfully

commercializing our drug candidates.

Even if we are able to successfully commercialize our drug candidates, we may not be able to achieve

or sustain profitability, which could have a material adverse effect on our business, financial condition and results of operations.

Future financing may be obtained through,

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We expect to continue to incur significant

research and development expenses, which may make it difficult for us to attain profitability, and may lead to uncertainty as to our

ability to continue as a going concern.

research and development expenses, which may make it difficult for us to attain profitability, and may lead to uncertainty as to our ability

to continue as a going concern.

We expend substantial funds to develop our technologies,

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to become profitable.

our current operating plans and liquidity, we believe that our existing cash at December 31, 2021 will be sufficient to fund our currently

planned operations for at least the next 12 months from the date of release of the associated financial statements.

we are unable to achieve or sustain profitability or to secure additional financing, we may not be able to meet our obligations as they

come due, raising substantial doubts as to our ability to continue as a going concern.

Any such inability to continue as a going concern

may result in our common stockholders losing their entire investment.

There is no guarantee that we will become profitable or secure additional

Changes in our operating plans, our existing and anticipated working capital needs, the acceleration or modification of our

expansion plans, increased expenses, potential acquisitions or other events will all affect our ability to continue as a going concern.

Changes in our operating plans, our existing and

anticipated working capital needs, the acceleration or modification of our expansion plans, increased expenses, potential acquisitions

or other events will all affect our ability to continue as a going concern.

The Company has limited cash resources, has reported recurring

losses from operations since inception and has not yet received product revenues.

These factors raise substantial doubt regarding the

Company’s ability to continue as a going concern, and the Company’s current cash resources may not provide sufficient capital

to fund operations for at least the next 12 months from the date of the release of these financial statements.

The continuation of the

Company as a going concern depends upon the Company’s ability to raise additional capital through an equity offering, debt offering

or strategic opportunity to fund its operations.

There can be no assurance that the Company will be successful in accomplishing these

plans in order to continue as a going concern.

Any such inability to continue as a going concern may result in our common stockholders

losing their entire investment.

There is no guarantee that we will become profitable or secure additional financing.

Our ability to utilize

net operating loss carryforwards and other tax benefits may be limited.

We have historically incurred

net losses and may never achieve or sustain profitability.

Under the Internal Revenue Code of 1986, as amended (the “ Code ”),

a corporation is generally allowed a deduction for net operating losses carried forward from a prior taxable year.

Under that provision,

we can carryforward our net operating losses to offset our future taxable income, if any, until such net operating losses are used or

As a result of the Tax Cuts and Jobs Act of 2017 legislation, net operating losses incurred in tax years beginning after December

31, 2017 may be carried forward indefinitely and can offset up to 80% of future taxable income.

Under the Coronavirus Aid, Relief, and

Economic Security Act of 2020, net operating losses arising in years beginning 2018 through 2020 may be carried back five years and the

80% net operating loss deduction limit is temporarily lifted for net operating loss carryforwards to years beginning before January 1,

These net operating loss carryforwards could expire unused before offsetting potential future income tax liabilities.

We have historically

incurred net losses and may never achieve or sustain profitability.

Under the Internal Revenue Code of 1986, as amended (the

“ Code ”), a corporation is generally allowed a deduction for net operating losses carried forward from a prior

taxable year.

Under that provision, we can carryforward our net operating losses to offset our future taxable income, if any, until

such net operating losses are used or expire.

Net operating losses incurred in tax years beginning after December 31, 2017 may be

carried forward indefinitely, but are limited to offset up to 80% of future taxable income.

Certain of our net operating loss

carryforwards predating December 31, 2017 could expire unused before offsetting potential future income tax liabilities.

Additionally, an ownership

change, as defined by Section 382 of the Code, results from transactions increasing the ownership of certain stockholders or public groups

in the stock of a corporation by more than 50% over a three-year period.

If the Company has experienced a change of control, as defined

by Section 382 of the Code, at any time since inception, utilization of the Company’s net operating loss carryforwards would be

subject to an annual limitation.

Any limitation may result in expiration of a portion of the net operating loss carryforwards before utilization.

During 2021, the Company completed an assessment of the available net operating loss carryforwards under Section 382 and determined that

the Company underwent multiple ownership changes during the period from 2012 to 2021.

As a result, our net operating losses are subject

to substantial annual limitations under Section 382 due to these ownership changes.

The Company has adjusted its net operating loss carryforwards

to address the impact of the 382 ownership change.

We may experience ownership changes in the future as a result of subsequent shifts

in our stock ownership, some of which may be outside of our control.

If an ownership change occurs and our ability to use our net operating

loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations.

change, as defined by Section 382 and 383 of the Code, results from transactions increasing the ownership of certain stockholders or public

groups in the stock of a corporation by more than 50% over a three-year period.

Pursuant to Section 382 and 383 of the code, if the Company

has experienced a change of control at any time since inception, utilization of the Company’s net operating loss or tax credit carryforwards

then in existence would be subject to an annual limitation.

Any limitation may result in expiration of a portion of the net operating

loss or tax credit carryforwards before utilization.

During 2021, the Company completed

an assessment of the available net operating loss and tax credit carryforwards under Section 382 and 383 and determined that the Company

underwent multiple ownership changes during the period from 2012 to 2021.

As a result, our net operating losses and tax credit carryforwards

are subject to substantial annual limitations under Section 382 and 383 due to these ownership changes.

The Company has adjusted its net

operating loss and tax credit carryforwards to address the impact of the ownership changes.

The Company assesses the need to conduct an

ownership change analysis to determine whether any changes occurred in ownership that would limit net operating loss or tax credit carryforwards

on an annual basis.

We may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of

which may be outside of our control.

If an ownership change occurs and our ability to use our net operating loss and tax credit carryforwards

is materially limited, it could harm our future operating results by effectively increasing our future tax obligations.

Risks Relating to Our Securities

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General economic, industry and market conditions.

The stock markets, in general, and the markets

for drug delivery and pharmaceutical company stocks, in particular, have experienced extreme volatility, that has often been unrelated

to the operating performance of particular companies.

The stock markets, in general, and the markets for

drug delivery and pharmaceutical company stocks, in particular, have experienced extreme volatility, that has often been unrelated to

the operating performance of particular companies.

These broad market fluctuations may adversely affect the trading price of our common

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to its volatility.

Moreover, our stock has recently traded below $1.00 for an extended period of time.

If we are unable to trade above

$1.00 for a certain period of time (which may require a reverse split of our outstanding common stock), The Nasdaq Stock Market may delist

our common stock.

Delisting our common stock from Nasdaq would adversely affect our trading volume and would likely negatively impact

our trading price.

Moreover, if we are unable to trade above $1.00 for a certain period of time, or fulfill the other continued listing

standards, The Nasdaq Stock Market may delist our common stock.

Delisting our common stock from Nasdaq would adversely affect our trading

volume and would likely negatively impact our trading price.

Our Board of Directors has the authority

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We are authorized to issue up to 10,000,000 shares

of preferred stock in one or more series.

Our Board of Directors may determine the terms of future preferred stock offerings without further

action by our stockholders.

The issuance of our preferred stock could affect the rights of existing stockholders or reduce the value of

our outstanding preferred stock or common stock.

In particular, rights granted to holders of certain series of preferred stock may include

voting rights, preferences as to dividends and liquidation, conversion and redemption rights and restrictions on our ability to merge

with or sell our assets to a third party.

of preferred stock in one or more series and as of the year ended December 31, 2022 had one share of Series D Preferred Stock outstanding,

which was subsequently redeemed in full in January 2023 and is no longer outstanding.

Our Board of Directors (the “ Board ”)

may determine the terms of future preferred stock offerings without further action by our stockholders.

The issuance of our preferred

stock could affect the rights of existing stockholders or reduce the value of our outstanding preferred stock or common stock.

In particular,

rights granted to holders of certain series of preferred stock may include voting rights, preferences as to dividends and liquidation,

conversion and redemption rights and restrictions on our ability to merge with or sell our assets to a third party.

We may acquire other businesses or form joint

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These provisions:

Authorize the issuance of “blank check” preferred stock that our Board of Directors could issue to increase the number of outstanding shares and to discourage a takeover attempt;

Authorize the issuance of “blank check” preferred stock that our Board could issue to increase the number of outstanding shares and to discourage a takeover attempt;

Prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

Provide that the Board of Directors is expressly authorized to adopt, alter or repeal our bylaws;

Establish advance notice requirements for nominations for election to our Board of Directors or for proposing matters that can be acted upon by stockholders at stockholder meetings.

Although we believe these provisions collectively

provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our Board of Directors, they would

apply even if the offer may be considered beneficial by some stockholders.

In addition, these provisions may frustrate or prevent any

attempts by our stockholders to replace or remove our current management team by making it more difficult for stockholders to replace

members of our Board of Directors, which is responsible for appointing the members of our management.

Provide that the Board is expressly authorized to adopt, alter or repeal our bylaws;

Establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at stockholder meetings.

Although we believe these provisions collectively provide

for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our Board, they would apply even if the offer

may be considered beneficial by some stockholders.

In addition, these provisions may frustrate or prevent any attempts by our stockholders

to replace or remove our current management team by making it more difficult for stockholders to replace members of our Board, which is

responsible for appointing the members of our management.

Moreover, because we are incorporated in Delaware,

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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