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Item 1A. Risk Factors

2020-07-31 compared with 2020-05-13 · 1275 added, 1342 removed, 131 unchanged (95% of the section changed)

6 unchanged sentences

the market price of our common stock would likely decline.

Risks Related to Our Financial Condition

We have a very limited operating

history and have never generated any revenues.

We are an early-stage biopharmaceutical

company with a very limited operating history that may make it difficult to evaluate the success of our business to date and to

assess our future viability.

Our operations, with respect to the entity that operationally survived the Merger, have been limited

to organizing and staffing the company, business planning, raising capital, developing our pipeline assets (TARA-002 and IV Choline

Chloride), identifying product candidates, and other research and development.

We have not yet demonstrated an ability to successfully

complete any clinical trials and have never completed the development of any product candidate, nor have we ever generated any

revenue from product sales or otherwise.

Consequently, we have no meaningful operations upon which to evaluate our business, and

predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history

or a history of successfully developing and commercializing biopharmaceutical products.

We expect to incur significant losses for the foreseeable

future and may never achieve or maintain profitability.

Investment in biopharmaceutical product

development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product

candidate will fail to gain regulatory approval or become commercially viable.

We have never generated any revenues, and cannot

estimate with precision the extent of our future losses.

We expect to incur increasing levels of operating losses for the foreseeable

future as we execute on the plan to continue research and development activities, including the ongoing and planned clinical development

of our product candidates, potentially acquire new products and/or product candidates, seek regulatory approvals of and potentially

commercialize any approved product candidates, hire additional personnel, protect our intellectual property, and incur the additional

costs of operating as a public company.

We expect to continue to incur significant and increasing operating losses and negative

cash flows for the foreseeable future.

These losses have had and will continue to have an adverse effect on our financial position

and working capital.

To become and remain profitable, we must

develop or acquire and eventually commercialize a product with significant market potential.

This will require the Company to

be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing

approval, manufacturing, marketing and selling any product candidate for which we obtain marketing approval, and satisfying post-marketing

requirements, if any.

We may never succeed in these activities and, even if we succeed in obtaining approval for and commercializing

one or more products, we may never generate revenues that are significant enough to achieve profitability.

In addition, as a young

business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges.

because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately

predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.

If we achieve profitability,

we may not be able to sustain or increase profitability on a quarterly or annual basis and may continue to incur substantial research

and development and other expenditures to develop and market additional product candidates.

Our failure to become and remain profitable

would decrease the value of the company and could impair our ability to raise capital, maintain our research and development efforts,

expand the business or continue operations.

A decline in the value of the Company could also cause you to lose all or part of

your investment.

The COVID-19 coronavirus could adversely impact our business,

including our clinical development plans.

In December 2019, a novel coronavirus

disease (“COVID-19”) was reported and in January 2020, the World Health Organization (the “WHO”) declared

it a Public Health Emergency of International Concern.

On February 28, 2020, the WHO raised its assessment of the COVID-19 threat

from high to very high at a global level due to the continued increase in the number of cases and affected countries, and on March

11, 2020, the WHO characterized COVID-19 as a pandemic.

As COVID-19 continues to spread in the United States and around the world,

we may experience disruptions that could severely impact our business, including:

interruption of key

manufacturing, research and clinical development activities, due to limitations on work and travel imposed or recommended

Related to Our Financial Condition

have a very limited operating history and have never generated any revenues.

are an early-stage biopharmaceutical company with a very limited operating history that may make it difficult to evaluate the

success of our business to date and to assess our future viability.

Our operations, with respect to the entity that operationally

survived the Merger, have been limited to organizing and staffing the company, business planning, raising capital, developing

our pipeline assets (TARA-002 and IV Choline Chloride), identifying product candidates, and other research and development.

have not yet demonstrated an ability to successfully complete any clinical trials and have never completed the development of

any product candidate, nor have we ever generated any revenue from product sales or otherwise.

Consequently, we have no meaningful

operations upon which to evaluate our business, and predictions about our future success or viability may not be as accurate as

they could be if we had a longer operating history or a history of successfully developing and commercializing biopharmaceutical

expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and

significant risk that a product candidate will fail to gain regulatory approval or become commercially viable.

We have never generated

any revenues, and cannot estimate with precision the extent of our future losses.

We expect to incur increasing levels of operating

losses for the foreseeable future as we execute on the plan to continue research and development activities, including the ongoing

and planned clinical development of our product candidates, potentially acquire new products and/or product candidates, seek regulatory

approvals of and potentially commercialize any approved product candidates, hire additional personnel, protect our intellectual

property, and incur the additional costs of operating as a public company.

We expect to continue to incur significant and increasing

operating losses and negative cash flows for the foreseeable future.

These losses have had and will continue to have an adverse

effect on our financial position and working capital.

become and remain profitable, we must develop or acquire and eventually commercialize a product with significant market potential.

This will require the Company to be successful in a range of challenging activities, including completing preclinical studies

and clinical trials, obtaining marketing approval, manufacturing, marketing and selling any product candidate for which we obtain

marketing approval, and satisfying post-marketing requirements, if any.

We may never succeed in these activities and, even if

we succeed in obtaining approval for and commercializing one or more products, we may never generate revenues that are significant

enough to achieve profitability.

In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications,

delays and other known and unknown challenges.

Furthermore, because of the numerous risks and uncertainties associated with biopharmaceutical

product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be

able to achieve profitability.

If we achieve profitability, we may not be able to sustain or increase profitability on a quarterly

or annual basis and may continue to incur substantial research and development and other expenditures to develop and market additional

product candidates.

Our failure to become and remain profitable would decrease the value of the company and could impair our ability

to raise capital, maintain our research and development efforts, expand the business or continue operations.

A decline in the

value of the Company could also cause you to lose all or part of your investment.

COVID-19 coronavirus could adversely impact our business, including our clinical development plans.

December 2019, a novel coronavirus disease (“COVID-19”) was reported and in January 2020, the World Health Organization

(the “WHO”) declared it a Public Health Emergency of International Concern.

On February 28, 2020, the WHO raised its

assessment of the COVID-19 threat from high to very high at a global level due to the continued increase in the number of cases

and affected countries, and on March 11, 2020, the WHO characterized COVID-19 as a pandemic.

As COVID-19 continues to spread in

the United States and around the world, we may experience disruptions that could severely impact our business, including:

of key manufacturing, research and clinical development activities, due to limitations on work and travel imposed or recommended

by federal or state governments, employers and others;

delays or difficulties

in clinical trial site operations, including difficulties in recruiting clinical site investigators and clinical site staff

and difficulties in enrolling patients;

interruption of key

business activities, due to illness and/or quarantine of key individuals and delays associated with recruiting, hiring and

training new temporary or permanent replacements for such key individuals, both internally and at our third party service

delays in research

and clinical trial sites receiving the supplies and materials needed to conduct preclinical studies and clinical trials, due

to work stoppages, travel and shipping interruptions or restrictions or other reasons;

difficulties in raising

additional capital needed to pursue the development of our programs due to the slowing of our economy and near term and/or

long term negative effects of the pandemic on the financial, banking and capital markets;

changes in local

regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which research,

including clinical development, is conducted, which may result in unexpected costs;

delays in necessary

interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee

resources, travel restrictions or forced furlough of government employees.

The global outbreak of COVID- continues

to rapidly evolve.

The extent to which the COVID-19 coronavirus may impact our business will depend on future developments, which

are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration

of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business

disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the virus.

duration and extent of the impact from the COVID-19 pandemic depends on future developments that cannot be accurately predicted

at this time, such as the severity and transmission rate of the virus, the extent and effectiveness of containment actions and

the impact of these and other factors on our operations, employees, partners and vendors.

If we are not able to respond to and

manage the impact of such events effectively, our business will be harmed.

In addition, while the potential economic

impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it has significantly disrupted global

financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity.

or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our common stock.

To the extent the COVID-19 pandemic adversely

affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties

described elsewhere in this “Risk Factors”

We will need to raise additional financing in the future

to fund our operations, which may not be available to it on favorable terms or at all.

We will require substantial additional

funds to conduct the costly and time-consuming clinical efficacy trials necessary to pursue regulatory approval of each potential

product candidate and to continue the development of TARA-002 and IV Choline Chloride in new indications or uses.

Our future capital

requirements will depend upon a number of factors, including:

the number and timing of future product candidates in the pipeline;

or difficulties in clinical trial site operations, including difficulties in recruiting clinical site investigators and clinical

site staff and difficulties in enrolling patients;

of key business activities, due to illness and/or quarantine of key individuals and delays associated with recruiting, hiring

and training new temporary or permanent replacements for such key individuals, both internally and at our third party service

in research and clinical trial sites receiving the supplies and materials needed to conduct preclinical studies and clinical

trials, due to work stoppages, travel and shipping interruptions or restrictions or other reasons;

in raising additional capital needed to pursue the development of our programs due to the slowing of our economy and near

term and/or long term negative effects of the pandemic on the financial, banking and capital markets;

in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in

which research, including clinical development, is conducted, which may result in unexpected costs;

in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources, travel restrictions or forced furlough of government employees.

global outbreak of COVID- continues to rapidly evolve.

The extent to which the COVID-19 coronavirus may impact our business will

depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic

spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other

countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries

to contain and treat the virus.

The duration and extent of the impact from the COVID-19 pandemic depends on future developments

that cannot be accurately predicted at this time, such as the severity and transmission rate of the virus, the extent and effectiveness

of containment actions and the impact of these and other factors on our operations, employees, partners and vendors.

not able to respond to and manage the impact of such events effectively, our business will be harmed.

addition, while the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict,

it has significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future

negatively affect our liquidity.

A recession or market correction resulting from the spread of COVID-19 could materially affect

our business and the value of our common stock.

the extent the COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening

many of the other risks and uncertainties described elsewhere in this “Risk Factors’’

will need to raise additional financing in the future to fund our operations, which may not be available to us on favorable terms

will require substantial additional funds to conduct the costly and time-consuming clinical efficacy trials necessary to pursue

regulatory approval of each potential product candidate and to continue the development of TARA-002 and IV Choline Chloride in

new indications or uses.

Our future capital requirements will depend upon a number of factors, including:

the number and timing

of future product candidates in the pipeline;

progress with and results from preclinical testing and clinical trials;

the ability to manufacture sufficient drug supplies to

complete preclinical and clinical trials;

the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing

patent and other intellectual property claims;

and the time and costs involved in obtaining regulatory approvals and favorable

reimbursement or formulary acceptance.

Raising additional capital may be costly or difficult to obtain and could significantly

dilute stockholders’

ownership interests or inhibit our ability to achieve our business objectives.

As a result of economic

conditions, general global economic uncertainty, political change, and other factors, including uncertainty associated with the

COVID-19 pandemic, we do not know whether additional capital will be available when needed, or that, if available, we will be

able to obtain additional capital on reasonable terms.

Specifically, the COVID-19 pandemic has significantly disrupted global

financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity.

If we raise additional funds through public

or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect

the rights of our common stockholders.

Further, to the extent that we raise additional capital through the sale of common stock

or securities convertible or exchangeable into common stock, the ownership interests of our common stock holders will be diluted.

In addition, any debt financing may subject us to fixed payment obligations and covenants limiting or restricting our ability

to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional

capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements

with third parties, we may have to relinquish certain valuable intellectual property or other rights to our product candidates,

technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

we were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to us or our stockholders.

Clinical drug development is very expensive, time-consuming

and uncertain.

Clinical development for our product candidates

is very expensive, time-consuming, difficult to design and implement, and the outcomes are inherently uncertain.

candidates that commence clinical trials are never approved by regulatory authorities for commercialization and of those that

are approved many do not cover their costs of development.

In addition, the Company, any partner with which we may in the future

collaborate, the FDA, an institutional review board (IRB), or other regulatory authorities, including state and local agencies

and counterpart agencies in foreign countries, may suspend, delay, require modifications to or terminate our clinical trials at

Risks Related to Drug/Biologics Development

Our business depends on the successful clinical development,

regulatory approval and commercialization of TARA-002 and IV Choline Chloride.

The success of our business, including

our ability to finance our self and generate revenue in the future, primarily depends on the successful development, regulatory

approval and commercialization of TARA-002 and IV Choline Chloride.

The clinical and commercial success of TARA-002 and IV Choline

Chloride depends on a number of factors, including the following:

timely and successful

completion of required clinical trials not yet initiated, which may be significantly slower or costlier than we currently

anticipate and/or produce results that do not achieve the endpoints of the trials;

whether we are required

by the FDA or similar foreign regulatory agencies to conduct additional studies beyond those planned to support the approval

and commercialization of TARA-002 and IV Choline Chloride;

achieving and maintaining,

and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with their contractual obligations

and with all regulatory requirements applicable to TARA-002 and IV Choline Chloride;

ability of third

parties with whom we contract to manufacture adequate clinical trial and commercial supplies of TARA-002 and IV Choline Chloride,

to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing

to manufacture sufficient drug supplies to complete preclinical and clinical trials;

the costs involved in preparing, filing,

acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims;

and the time and costs involved

in obtaining regulatory approvals and favorable reimbursement or formulary acceptance.

Raising additional capital may be costly

or difficult to obtain and could significantly dilute stockholders’

ownership interests or inhibit our ability to achieve

our business objectives.

As a result of economic conditions, general global economic uncertainty, political change, and other

factors, including uncertainty associated with the COVID-19 pandemic, we do not know whether additional capital will be available

when needed, or that, if available, we will be able to obtain additional capital on reasonable terms.

Specifically, the COVID-19

pandemic has significantly disrupted global financial markets, and may limit our ability to access capital, which could in the

future negatively affect our liquidity.

we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or

other preferences that adversely affect the rights of our common stockholders.

Further, to the extent that we raise additional

capital through the sale of common stock or securities convertible or exchangeable into common stock, the ownership interests

of our common stock holders will be diluted.

In addition, any debt financing may subject us to fixed payment obligations and covenants

limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or

declaring dividends.

If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic

alliances or licensing arrangements with third parties, we may have to relinquish certain valuable intellectual property or other

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

not be favorable to us.

Even if we were to obtain sufficient funding, there can be no assurance that it will be available on terms

acceptable to us or our stockholders.

drug development is very expensive, time-consuming and uncertain.

development for our product candidates is very expensive, time-consuming, difficult to design and implement, and the outcomes

are inherently uncertain.

Most product candidates that commence clinical trials are never approved by regulatory authorities for

commercialization and of those that are approved many do not cover their costs of development.

In addition, the Company, any partner

with which we may in the future collaborate, the FDA, an institutional review board (IRB), or other regulatory authorities, including

state and local agencies and counterpart agencies in foreign countries, may suspend, delay, require modifications to or terminate

our clinical trials at any time.

Related to Drug/Biologics Development

business depends on the successful clinical development, regulatory approval and commercialization of TARA-002 and IV Choline

success of our business, including our ability to finance our self and generate revenue in the future, primarily depends on the

successful development, regulatory approval and commercialization of TARA-002 and IV Choline Chloride.

The clinical and commercial

success of TARA-002 and IV Choline Chloride depends on a number of factors, including the following:

and successful completion of required clinical trials not yet initiated, which may be significantly slower or costlier than

we currently anticipate and/or produce results that do not achieve the endpoints of the trials;

we are required by the FDA or similar foreign regulatory agencies to conduct additional studies beyond those planned to support

the approval and commercialization of TARA-002 and IV Choline Chloride;

and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with their

contractual obligations and with all regulatory requirements applicable to TARA-002 and IV Choline Chloride;

of third parties with whom we contract to manufacture adequate clinical trial and commercial supplies of TARA-002 and IV Choline

Chloride, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing

processes that are compliant with current good manufacturing practices (“cGMP”);

a continued acceptable

safety profile during clinical development and following approval of TARA-002 and IV Choline Chloride;

ability to obtain

favorable labeling for TARA-002 and IV Choline Chloride through regulators that allows for successful commercialization, given

the drugs may be marketed only to the extent approved by these regulatory authorities (unlike with most other industries);

ability to successfully

commercialize TARA-002 and IV Choline Chloride in the United States and internationally, if approved for marketing, sale and

distribution in such countries and territories, whether alone or in collaboration others;

acceptance by physicians,

insurers and payors, and patients of the quality, benefits, safety and efficacy of TARA-002 and IV Choline Chloride, if either

is approved, including relative to alternative and competing treatments;

existence of a regulatory

environment conducive to the success of TARA-002 and IV Choline Chloride;

ability to price

TARA-002 and IV Choline Chloride to recover our development costs and generate a satisfactory profit margin;

our ability and our

partners’

ability to establish and enforce intellectual property rights in and to TARA-002 and IV Choline Chloride.

If we do not achieve one or more of these

factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability

to obtain regulatory approvals or commercialize TARA-002 and IV Choline Chloride.

Even if regulatory approvals are obtained, we

may never be able to successfully commercialize TARA-002 and IV Choline Chloride.

Accordingly, we cannot assure you that we will

be able to generate sufficient revenue through the sale of TARA-002 and IV Choline Chloride to continue our business.

The COVID-19 pandemic is impacting our

business and the business of the third-parties with which we contract for key services related to our clinical development plans.

If the crisis persists, it is likely to have a significant delay in our development timelines and result in additional and unexpected

Presently, we anticipate that the stress of COVID-19 on healthcare systems around the globe will negatively impact our

ability to conduct clinical trials in the near term due primarily to the lack of resources at clinical trial sites and the resulting

inability to enroll patients in these trials.

In addition, it is possible that the stress of the COVID-19 pandemic on regulatory

agencies may make it more difficult to collaborate with, and receive guidance from, such agencies, which could delay our development

timelines and negatively impact our business.

We have never made an IND, BLA or NDA submission or conducted

a clinical trial and may be unable to successfully do so for TARA-002 or IV Choline Chloride.

The conduct of a clinical trials is a long,

expensive, complicated and highly regulated process.

Although our employees have made regulatory submissions and conducted successful

clinical trials in the past across many therapeutic areas while employed at other companies, we, as a company, have not submitted

an investigational new drug application (IND), conducted any clinical trials, or submitted a BLA or new drug application (NDA),

and as a result may require more time and incur greater costs than we anticipate.

Failure to commence or complete, or delays in,

our planned regulatory submissions or clinical trials would prevent us from, or delay us, in obtaining regulatory approval of and

commercializing TARA-002 and IV Choline Chloride, which would adversely impact our financial performance, as well as subjecting

us to significant contract liabilities.

TARA-002 is an immunotherapy, the first indication for

which we plan to pursue is the treatment of lymphatic malformations, an indication for which there are no FDA-approved therapies.

This makes it difficult to predict the timing and costs of clinical development for TARA-002, as well as the regulatory approval

To date, there are no FDA-approved therapies

for the treatment of lymphatic malformations and the standard of care is surgery.

The regulatory approval process for novel product

candidates such as TARA-002 can be more expensive and take longer than for other, better known or extensively studied therapeutic

In addition, the clinical trials conducted on TARA-002 in the United States to date, included a control arm in which

treatment was initially delayed.

It is unclear whether this trial design could support FDA approval or whether a placebo-control

or other randomization will be required by the FDA.

Delay or failure to obtain, or unexpected costs in obtaining, the regulatory

approval necessary to bring TARA-002 to market could decrease our ability to generate sufficient revenue to maintain our business.

The regulatory path to approval of TARA-002 in LMs is

dependent on FDA acceptance on prior clinical data from OK-432.

continued acceptable safety profile during clinical development and following approval of TARA-002 and IV Choline Chloride;

to obtain favorable labeling for TARA-002 and IV Choline Chloride through regulators that allows for successful commercialization,

given the drugs may be marketed only to the extent approved by these regulatory authorities (unlike with most other industries);

to successfully commercialize TARA-002 and IV Choline Chloride in the United States and internationally, if approved for marketing,

sale and distribution in such countries and territories, whether alone or in collaboration others;

by physicians, insurers and payors, and patients of the quality, benefits, safety and efficacy of TARA-002 and IV Choline

Chloride, if either is approved, including relative to alternative and competing treatments;

of a regulatory environment conducive to the success of TARA-002 and IV Choline Chloride;

to price TARA-002 and IV Choline Chloride to recover our development costs and generate a satisfactory profit margin;

ability and our partners’

ability to establish and enforce intellectual property rights in and to TARA-002 and IV Choline

we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience

significant delays or an inability to obtain regulatory approvals or commercialize TARA-002 and IV Choline Chloride.

Even if regulatory

approvals are obtained, we may never be able to successfully commercialize TARA-002 and IV Choline Chloride.

Accordingly, we cannot

assure you that we will be able to generate sufficient revenue through the sale of TARA-002 and IV Choline Chloride to continue

our business.

COVID-19 pandemic is impacting our business and the business of the third-parties with which we contract for key services related

to our clinical development plans.

If the crisis persists, it is likely to have a significant delay in our development timelines

and result in additional and unexpected costs.

Presently, we anticipate that the stress of COVID-19 on healthcare systems around

the globe will negatively impact our ability to conduct clinical trials in the near term due primarily to the lack of resources

at clinical trial sites and the resulting inability to enroll patients in these trials.

In addition, it is possible that the stress

of the COVID-19 pandemic on regulatory agencies may make it more difficult to collaborate with, and receive guidance from, such

agencies, which could delay our development timelines and negatively impact our business.

have never made an IND, BLA or NDA submission or conducted a clinical trial and may be unable to successfully do so for TARA-002

or IV Choline Chloride.

conduct of a clinical trials is a long, expensive, complicated and highly regulated process.

Although our employees have made

regulatory submissions and conducted successful clinical trials in the past across many therapeutic areas while employed at other

companies, we, as a company, have not submitted an investigational new drug application (IND), conducted any clinical trials,

or submitted a BLA or new drug application (NDA), and as a result may require more time and incur greater costs than we anticipate.

Failure to commence or complete, or delays in, our planned regulatory submissions or clinical trials would prevent us from, or

delay us, in obtaining regulatory approval of and commercializing TARA-002 and IV Choline Chloride, which would adversely impact

our financial performance, as well as subjecting us to significant contract liabilities.

is an immunopotentiator, the first indication for which we plan to pursue is the treatment of lymphatic malformations, an indication

for which there are no FDA-approved therapies.

This makes it difficult to predict the timing and costs of clinical development

for TARA-002, as well as the regulatory approval path.

date, there are no FDA-approved therapies for the treatment of lymphatic malformations and the standard of care is surgery.

regulatory approval process for novel product candidates such as TARA-002 can be more expensive and take longer than for other,

better known or extensively studied therapeutic approaches.

In addition, the clinical trials conducted on TARA-002 in the United

States to date, included a control arm in which treatment was initially delayed.

It is unclear whether this trial design could

support FDA approval or whether a placebo-control or other randomization will be required by the FDA.

Delay or failure to obtain,

or unexpected costs in obtaining, the regulatory approval necessary to bring TARA-002 to market could decrease our ability to

generate sufficient revenue to maintain our business.

regulatory path to approval of TARA-002 in LMs is dependent on FDA acceptance of prior clinical data from OK-432.

The proposed regulatory strategy for the

6 unchanged sentences

If comparability is demonstrated and accepted by regulatory authorities,

we will attempt to rely on existing OK-432 safety and efficacy data to file the BLA.

no example to date of a biologic product that was approved utilizing this regulatory approach that we are aware of.

Our product candidates may cause undesirable side effects

or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an

approved label, or result in post-approval regulatory action.

Unforeseen side effects from TARA-002

or IV Choline Chloride could arise either during clinical development or, if approved, after it has been marketed.

side effects could cause us, any partners with which we may collaborate, or regulatory authorities to interrupt, extend, modify,

delay or halt clinical trials and could result in a more restrictive or narrower label or the delay or denial of regulatory approval

by the FDA or comparable foreign authorities.

Results of clinical trials could reveal

a high and unacceptable severity and prevalence of side effects.

In such an event, trials could be suspended or terminated, and

the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product

candidate for any or all targeted indications.

The drug-related side effects could affect patient recruitment or the ability of

enrolled patients to complete the trial or result in product liability claims.

Any of these occurrences may harm our business,

financial condition, operating results and prospects.

Additionally, if we or others identify

undesirable side effects, or other previously unknown problems, caused by a product after obtaining U.S.

or foreign regulatory

approval, a number of potentially negative consequences could result, which could prevent us or our potential partners from achieving

or maintaining market acceptance of the product and could substantially increase the costs of commercializing such product.

Even if a product candidate obtains regulatory approval,

it may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

The commercial success of both TARA-002

and IV Choline Chloride, if approved, will depend significantly on the broad adoption and use of them by physicians and patients

for approved indications, and neither may be commercially successful even though the product is shown to be safe and effective.

The degree and rate of physician and patient adoption of a product, if approved, will depend on a number of factors, including

but not limited to:

patient demand for

approved products that treat the indication for which a product is approved;

the effectiveness

of the product compared to other available therapies;

the availability

of coverage and adequate reimbursement from managed care plans and other healthcare payors;

the cost of treatment

in relation to alternative treatments and willingness to pay on the part of patients;

in the case of TARA-002,

overcoming physician or patient biases toward surgery for the treatment of lymphatic malformations;

we will attempt to rely on existing OK-432 safety and efficacy data to submit the BLA.

There is no example to date of a biologic

product that was approved utilizing this regulatory approach that we are aware of.

product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory

approval, limit the commercial profile of an approved label, or result in post-approval regulatory action.

side effects from TARA-002 or IV Choline Chloride could arise either during clinical development or, if approved, after it has

been marketed.

Undesirable side effects could cause us, any partners with which we may collaborate, or regulatory authorities

to interrupt, extend, modify, delay or halt clinical trials and could result in a more restrictive or narrower label or the delay

or denial of regulatory approval by the FDA or comparable foreign authorities.

of clinical trials could reveal a high and unacceptable severity and prevalence of side effects.

In such an event, trials could

be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development

of or deny approval of a product candidate for any or all targeted indications.

The drug-related side effects could affect patient

recruitment or the ability of enrolled patients to complete the trial or result in product liability claims.

Any of these occurrences

may harm our business, financial condition, operating results and prospects.

Additionally,

if we or others identify undesirable side effects, or other previously unknown problems, caused by a product after obtaining U.S.

or foreign regulatory approval, a number of potentially negative consequences could result, which could prevent us or our potential

partners from achieving or maintaining market acceptance of the product and could substantially increase the costs of commercializing

such product.

A fast track designation by the FDA may not actually lead

to a faster development or regulatory review or approval process for IV Choline Chloride for the treatment of IFALD.

The FDA has granted fast track designation

to IV Choline Chloride for the treatment of IFALD.

If a drug is intended for the treatment of a serious or life-threatening condition

and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for fast

track designation.

Even though we have received fast track designation for IV Choline Chloride for the treatment of IFALD, we may

not experience a faster development process, review or approval.

The FDA may withdraw fast track designation if it believes that

the designation is no longer supported by data from our clinical development program.

Although the FDA has granted Rare Pediatric Disease Designation

for TARA-002 for the treatment of LMs, a BLA for TARA-002, if approved, may not meet the eligibility criteria for a priority

review voucher.

Rare Pediatric Disease Designation has

been granted for TARA-002 for the treatment of LMs.

In 2012, Congress authorized the FDA to award priority review vouchers to sponsors

of certain rare pediatric disease product applications.

This provision is designed to encourage development of new drug and biological

products for prevention and treatment of certain rare pediatric diseases.

Specifically, under this program, a sponsor who receives

an approval for a drug or biologic for a “rare pediatric disease”

may qualify for a voucher that can be redeemed to

receive a priority review of a subsequent marketing application for a different product.

The sponsor of a rare pediatric disease

drug product receiving a priority review voucher may transfer (including by sale) the voucher to another sponsor.

The voucher may

be further transferred any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted

the application.

The FDA may also revoke any priority review voucher if the rare pediatric disease drug for which the voucher was

awarded is not marketed in the U.S.

within one year following the date of approval.

For the purposes of this program, a “rare

pediatric disease”

is a (a) serious or life-threatening disease in which the serious or life-threatening manifestations

primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents;

and (b) rare disease or conditions within the meaning of the Orphan Drug Act.

Congress has only authorized the Rare Pediatric

Disease Priority Review Voucher program until September 30, 2020.

However, if a drug candidate receives Rare Pediatric Disease

Designation before October 1, 2020, it is eligible to receive a voucher if it is approved before October 1, 2022.

However, TARA-002 for the treatment of

LMs may not be approved by that date, or at all, and, therefore, we may not be in a position to obtain a priority review voucher

prior to expiration of the program, unless Congress further reauthorizes the program.

Additionally, designation of a drug for a

rare pediatric disease does not guarantee that a BLA will meet the eligibility criteria for a rare pediatric disease

priority review voucher at the time the application is approved.

Finally, a Rare Pediatric Disease Designation does not lead

to faster development or regulatory review of the product, or increase the likelihood that it will receive marketing approval.

We may or may not realize any benefit from receiving a voucher.

if a product candidate obtains regulatory approval, it may fail to achieve the broad degree of physician and patient adoption

and use necessary for commercial success.

commercial success of both TARA-002 and IV Choline Chloride, if approved, will depend significantly on the broad adoption and

use of them by physicians and patients for approved indications, and neither may be commercially successful even though the product

is shown to be safe and effective.

The degree and rate of physician and patient adoption of a product, if approved, will depend

on a number of factors, including but not limited to:

demand for approved products that treat the indication for which a product is approved;

effectiveness of the product compared to other available therapies;

availability of coverage and adequate reimbursement from managed care plans and other healthcare payors;

cost of treatment in relation to alternative treatments and willingness to pay on the part of patients;

the case of TARA-002, overcoming physician or patient biases toward surgery for the treatment of lymphatic malformations;

insurers’

to see the applicable indication as a disease worth treating;

proper administration;

patient satisfaction

with the results, administration and overall treatment experience;

limitations or contraindications,

warnings, precautions or approved indications for use different than those sought by us that are contained in the final FDA-approved

labeling for the applicable product;

any FDA requirement

to undertake a risk evaluation and mitigation strategy;

the effectiveness

of our sales, marketing, pricing, reimbursement and access, government affairs, and distribution efforts;

adverse publicity

about a product or favorable publicity about competitive products;

new government regulations

and programs, including price controls and/or limits or prohibitions on ways to commercialize drugs, such as increased scrutiny

on direct-to-consumer advertising of pharmaceuticals;

potential product

liability claims or other product-related litigation.

If either TARA-002 or IV Choline Chloride

is approved for use but fails to achieve the broad degree of physician and patient adoption necessary for commercial success,

our operating results and financial condition will be adversely affected, which may delay, prevent or limit our ability to generate

revenue and continue our business.

Any adverse developments that occur in patients undergoing

treatment with OK-432 / Picibanil or in patients participating in clinical trials conducted by third parties may affect our ability

to obtain regulatory approval or commercialize TARA-002.

Chugai Pharmaceutical Co., Ltd., over

which we have no control, has the rights to commercialize TARA-002 and it is currently marketed in Japan and Taiwan, under the

name Picibanil for various indications.

In addition, clinical trials using Picibanil are currently ongoing in various countries

around the world.

If serious adverse events occur with patients using Picibanil or during any clinical trials of Picibanil conducted

by third parties, the FDA may delay, limit or deny approval of TARA-002 or require us to conduct additional clinical trials as

a condition to marketing approval, which would increase our costs.

If we receive FDA approval for TARA-002 and a new and serious

safety issue is identified in connection with use of Picibanil or in clinical trials of Picibanil conducted by third parties,

the FDA may withdraw their approval of the product or otherwise restrict our ability to market and sell TARA-002.

treating physicians may be less willing to administer TARA-002 due to concerns over such adverse events, which would limit our

ability to commercialize TARA-002.

We may in the future conduct clinical trials for our

product candidates outside the United States, and the FDA and applicable foreign regulatory authorities may not accept data from

We may in the future choose to conduct

one or more of our clinical trials outside of the United States.

Although the FDA or applicable foreign regulatory authority may

accept data from clinical trials conducted outside the United States or the applicable jurisdiction, acceptance of such study

data by the FDA or applicable foreign regulatory authority may be subject to certain conditions or exclusion.

Where data from

foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will not approve

the application on the basis of foreign data alone unless such data are applicable to the U.S.

population and U.S.

willingness to see the applicable indication as a disease worth treating;

administration;

satisfaction with the results, administration and overall treatment experience;

or contraindications, warnings, precautions or approved indications for use different than those sought by us that are contained

in the final FDA-approved labeling for the applicable product;

FDA requirement to undertake a risk evaluation and mitigation strategy;

effectiveness of our sales, marketing, pricing, reimbursement and access, government affairs, and distribution efforts;

publicity about a product or favorable publicity about competitive products;

government regulations and programs, including price controls and/or limits or prohibitions on ways to commercialize drugs,

such as increased scrutiny on direct-to-consumer advertising of pharmaceuticals;

product liability claims or other product-related litigation.

either TARA-002 or IV Choline Chloride is approved for use but fails to achieve the broad degree of physician and patient adoption

necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent

or limit our ability to generate revenue and continue our business.

adverse developments that occur in patients undergoing treatment with OK-432 / Picibanil or in patients participating in clinical

trials conducted by third parties may affect our ability to obtain regulatory approval or commercialize TARA-002.

Chugai Pharmaceutical Co., Ltd., over which

we have no control, has the rights to commercialize TARA-002 and it is currently marketed in Japan and Taiwan, under the name Picibanil,

for various indications.

In addition, clinical trials using Picibanil are currently ongoing in various countries around the world.

If serious adverse events occur with patients using Picibanil or during any clinical trials of Picibanil conducted by third parties,

the FDA may delay, limit or deny approval of TARA-002 or require us to conduct additional clinical trials as a condition to marketing

approval, which would increase our costs.

If we receive FDA approval for TARA-002 and a new and serious safety issue is identified

in connection with use of Picibanil or in clinical trials of Picibanil conducted by third parties, the FDA may withdraw their approval

of the product or otherwise restrict our ability to market and sell TARA-002.

In addition, treating physicians may be less willing

to administer TARA-002 due to concerns over such adverse events, which would limit our ability to commercialize TARA-002.

may in the future conduct clinical trials for our product candidates outside the United States, and the FDA and applicable foreign

regulatory authorities may not accept data from such trials.

may in the future choose to conduct one or more of our clinical trials outside of the United States.

Although the FDA or applicable

foreign regulatory authority may accept data from clinical trials conducted outside the United States or the applicable jurisdiction,

acceptance of such study data by the FDA or applicable foreign regulatory authority may be subject to certain conditions or exclusion.

Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA

will not approve the application on the basis of foreign data alone unless such data are applicable to the U.S.

population and

medical practice;

the studies were performed by clinical investigators of recognized competence;

and the data are considered valid without the need

for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate

the data through an on-site inspection or other appropriate means.

Many foreign regulatory bodies have similar requirements.

addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are

There can be no assurance the FDA or applicable foreign regulatory authority will accept data from trials conducted

outside of the United States or the applicable home country.

If the FDA or applicable foreign regulatory authority does not accept

such data, it would likely result in the need for additional trials, which would be costly and time-consuming and delay aspects

of our business plan.

We may choose not to continue developing or commercializing

any of our product candidates at any time during development or after approval, which would reduce or eliminate the potential

return on investment for those product candidates.

and the data are considered

valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA

is able to validate the data through an on-site inspection or other appropriate means.

Many foreign regulatory bodies have similar

requirements.

In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where

the studies are conducted.

There can be no assurance the FDA or applicable foreign regulatory authority will accept data from

trials conducted outside of the United States or the applicable home country.

If the FDA or applicable foreign regulatory authority

does not accept such data, it would likely result in the need for additional trials, which would be costly and time-consuming

and delay aspects of our business plan.

may choose not to continue developing or commercializing any of our product candidates at any time during development or after

approval, which would reduce or eliminate the potential return on investment for those product candidates.

At any time, we may decide to discontinue

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our product obsolete, competition from a competing product or changes in or failure to comply with applicable regulatory requirements.

If we terminate a program in which we have invested significant resources, we will not receive any return on our investment and

we will have missed the opportunity to have allocated those resources to potentially more productive uses.

Our or third party’s clinical trials may fail to

demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified

during their development, which could prevent or delay marketing approval and commercialization, increase our costs or necessitate

the abandonment or limitation of the development of the product candidate.

Before obtaining marketing approvals for

the commercial sale of any product candidate, we must demonstrate through lengthy, complex and expensive preclinical testing and

clinical trials that such product candidate is both safe and effective for use in the applicable indication, and failures can

occur at any stage of testing.

Clinical trials often fail to demonstrate safety and are associated with side effects or have characteristics

that are unexpected.

Based on the safety profile seen in clinical testing, we may need to abandon development or limit development

to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more tolerable from

a risk-benefit perspective.

The FDA or an IRB may also require that we suspend, discontinue, or limit clinical trials based on

safety information.

Such findings could further result in regulatory authorities failing to provide marketing authorization for

the product candidate.

Many pharmaceutical candidates that initially showed promise in early stage testing and which were efficacious

have later been found to cause side effects that prevented further development of the drug candidate and, in extreme cases, the

side effects were not seen until after the drug was marketed, causing regulators to remove the drug from the market post-approval.

For example, we are reviewing the research and preclinical and clinical data of vonapanitase and have not yet determined whether

to pursue further development of this product candidate in the future.

If we terminate a program in which we

have invested significant resources, we will not receive any return on our investment and we will have missed the opportunity

to have allocated those resources to potentially more productive uses.

or our third party’s clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious

adverse or unacceptable side effects may be identified during their development, which could prevent or delay marketing approval

and commercialization, increase our costs or necessitate the abandonment or limitation of the development of the product candidate.

obtaining marketing approvals for the commercial sale of any product candidate, we must demonstrate through lengthy, complex and

expensive preclinical testing and clinical trials that such product candidate is both safe and effective for use in the applicable

indication, and failures can occur at any stage of testing.

Clinical trials often fail to demonstrate safety and are associated

with side effects or have characteristics that are unexpected.

Based on the safety profile seen in clinical testing, we may need

to abandon development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent,

less severe or more tolerable from a risk-benefit perspective.

The FDA or an IRB may also require that we suspend, discontinue,

or limit clinical trials based on safety information.

Such findings could further result in regulatory authorities failing to

provide marketing authorization for the product candidate.

Many pharmaceutical candidates that initially showed promise in early

stage testing and which were efficacious have later been found to cause side effects that prevented further development of the

drug candidate and, in extreme cases, the side effects were not seen until after the drug was marketed, causing regulators to

remove the drug from the market post-approval.

Our regulatory strategy for TARA-002 requires

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If we can demonstrate

comparability, we plan to engage with the FDA to seek its agreement to use OK-432’s safety and efficacy data from clinical

trials previously conducted by third parties for our BLA filing.

There can be no assurances that our contract manufacturer will

be able to produce a sufficiently comparable product or that the FDA will find such substances comparable or permit us to use

any of the data from prior clinical trials as part of the BLA filing for TARA-002.

Further, due to the COVID-19 pandemic and the

associated government-imposed stay-at-home orders, the third-party contract manufacturer with which we have contracted for the

initial comparability study had to stop the study prior to its completion.

When the stay-at-home orders are lifted, we anticipated

that this third-party will be able to initiate a new comparability study but we cannot predict when that will occur or how long

of a delay the stoppage will cause for our development timelines for TARA-002.

Other Risks Related to Our Business

Our product candidates, if approved, will face significant

competition and their failure to compete effectively may prevent them from achieving significant market penetration.

The pharmaceutical industry is characterized

by rapidly advancing technologies, intense competition, less effective patent terms, and a strong emphasis on developing newer,

fast-to-market proprietary therapeutics.

Numerous companies are engaged in the development, patenting, manufacturing and marketing

of healthcare products competitive with those that we are developing, including TARA-002 and IV Choline Chloride.

competition from a number of sources, such as pharmaceutical companies, generic drug companies, biotechnology companies and academic

and research institutions, many of which have greater financial resources, marketing capabilities, sales forces, manufacturing

capabilities, research and development capabilities, regulatory expertise, clinical trial expertise, intellectual property portfolios,

more international reach, experience in obtaining patents and regulatory approvals for product candidates and other resources

than we have.

Some of the companies that offer competing products also have a broad range of other product offerings, large direct

sales forces and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts.

comparability, through our engagement with the FDA, we will seek the FDA’s agreement to use OK-432’s safety and efficacy

data from clinical trials previously conducted by third parties for our BLA filing.

There can be no assurances that our contract

manufacturer will be able to produce a sufficiently comparable product or that the FDA will find such substances comparable or

permit us to use any of the data from prior clinical trials as part of the BLA filing for TARA-002.

Further, due to the COVID-19

pandemic and the associated government-imposed stay-at-home orders, a third-party lab with which we have contracted for some of

the initial comparability testing had to stop studies prior to its completion.

When the stay-at-home orders are lifted, we anticipate

that this third-party will be able to initiate new testing but we cannot predict when that will occur or how long of a delay the

stoppage will cause for our development timelines for TARA-002.

Risks Related to Our Business

product candidates, if approved, will face significant competition and their failure to compete effectively may prevent them from

achieving significant market penetration.

pharmaceutical industry is characterized by rapidly advancing technologies, intense competition, less effective patent terms,

and a strong emphasis on developing newer, fast-to-market proprietary therapeutics.

Numerous companies are engaged in the development,

patenting, manufacturing and marketing of healthcare products competitive with those that we are developing, including TARA-002

and IV Choline Chloride.

We will face competition from a number of sources, such as pharmaceutical companies, generic drug companies,

biotechnology companies and academic and research institutions, many of which have greater financial resources, marketing capabilities,

sales forces, manufacturing capabilities, research and development capabilities, regulatory expertise, clinical trial expertise,

intellectual property portfolios, more international reach, experience in obtaining patents and regulatory approvals for product

candidates and other resources than we have.

Some of the companies that offer competing products also have a broad range of other

product offerings, large direct sales forces and long-term customer relationships with our target physicians, which could inhibit

our market penetration efforts.

With respect to our lead product candidate,

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In addition, TARA-002 is likely to have seven years

of Orphan Drug Designation exclusivity if deemed comparable to OK-432 by the FDA or based on the prevalence of the disease.

are no pharmacotherapies currently available for the treatment of LMs and the current standard of care is a high-risk surgical

There are a handful of drug development companies and academic researchers exploring oral formulations of various agents

including macrolides, phosphodiesterase inhibitors, and calcineurin/ mTOR inhibitors.

These are in early development and earlier

experiments in LMs utilizing other compounds utilizing these mechanisms have not produced conclusive evidence of safety or efficacy.

There are no treatments currently available

With respect to IV Choline Chloride for the treatment of IFALD, IV Choline Chloride is the only sterile injectable

form of choline chloride that can be combined with parenteral nutrition.

Further, if approved, IV Choline Chloride will be protected

by Orphan Drug Designation exclusivity for seven years.

TARA-002 and any future product candidates for which

we intend to seek approval as biologic products may face competition sooner than anticipated.

The Patient Protection and Affordable

Care Act, or Affordable Care Act, signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition

and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar

to or interchangeable with an FDA-licensed reference biological product.

Under the BPCIA, an application for a biosimilar product

may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA.

In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the

reference product was first licensed.

During this 12-year period of exclusivity, another company may still market a competing

version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical

data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

of concurrent Orphan Drug Designation exclusivity if deemed comparable to OK-432 by the FDA or based on the prevalence of the disease.

There are no approved pharmacotherapies currently available for the treatment of LMs and the current standard of care is a high-risk

surgical procedure.

There are a handful of drug development companies and academic researchers exploring oral formulations of various

agents including macrolides, phosphodiesterase inhibitors, and calcineurin/ mTOR inhibitors.

These are in early development and

earlier experiments in LMs utilizing other compounds utilizing these mechanisms have not produced conclusive evidence of safety

are no treatments currently available for IFALD.

With respect to IV Choline Chloride for the treatment of IFALD, IV Choline Chloride

is the only sterile injectable form of choline chloride that can be combined with parenteral nutrition.

Further, if approved,

IV Choline Chloride will be protected by Orphan Drug Designation exclusivity for seven years.

and any future product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

Patient Protection and Affordable Care Act, or Affordable Care Act, signed into law on March 23, 2010, includes a subtitle called

the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological

products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

Under the BPCIA, an application

for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first

licensed by the FDA.

In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from

the date on which the reference product was first licensed.

During this 12-year period of exclusivity, another company may still

market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s

own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency

of their product.

The law is complex and is still being interpreted and implemented by the FDA.

As a result, its ultimate impact, implementation

and meaning are subject to uncertainty.

While it is uncertain when such processes are intended to implement BPCIA may be fully

adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our biological

We believe that any of our product candidates

approved as a biological product under a BLA should qualify for the 12-year period of exclusivity.

However, there is a risk that

this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates

to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated.

Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation.

Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way

that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number

of marketplace and regulatory factors that are still developing.

We expect to rely on third-party CROs and other third

parties to conduct and oversee our clinical trials.

If these third parties do not meet our requirements or otherwise conduct the

trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize,

our product candidates.

We expect to rely on third-party contract

research organizations (CROs) to conduct and oversee our TARA-002 and IV Choline Chloride clinical trials and other aspects of

product development.

We also expect to rely on various medical institutions, clinical investigators and contract laboratories

to conduct our trials in accordance with our clinical protocols and all applicable regulatory requirements, including the FDA’s

regulations and good clinical practice (GCP) requirements, which are an international standard meant to protect the rights and

health of patients and to define the roles of clinical trial sponsors, administrators and monitors, and state regulations governing

the handling, storage, security and recordkeeping for drug and biologic products.

These CROs and other third parties will play

a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials.

We will rely heavily on these parties for the execution of our clinical trials and preclinical studies and will control only certain

aspects of their activities.

We and our CROs and other third-party contractors will be required to comply with GCP and good laboratory

practice (GLP) requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities.

Regulatory authorities enforce these GCP and GLP requirements through periodic inspections of trial sponsors, principal investigators

and trial sites.

If we or any of these third parties fail to comply with applicable GCP and GLP requirements, or reveal noncompliance

from an audit or inspection, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other

regulatory authorities may require us to perform additional clinical trials before approving our or our partners’

applications.

We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine

that any of our clinical or preclinical trials comply with applicable GCP and GLP requirements.

In addition, our clinical trials

generally must be conducted with product produced under cGMP regulations.

Our failure to comply with these regulations and policies

may require us to repeat clinical trials, which would delay the regulatory approval process.

If any of our CROs or clinical trial sites

terminate their involvement in one of our clinical trials for any reason, we may not be able to enter into arrangements with alternative

CROs or clinical trial sites or do so on commercially reasonable terms.

In addition, if our relationship with clinical trial sites

is terminated, we may experience the loss of follow-up information on patients enrolled in our clinical trials unless we are able

to transfer the care of those patients to another qualified clinical trial site.

In addition, principal investigators for our

clinical trials may serve as scientific advisors or consultants to us from time to time and could receive cash or equity compensation

in connection with such services.

If these relationships and any related compensation result in perceived or actual conflicts

of interest, the integrity of the data generated at the applicable clinical trial site may be questioned by the FDA.

We currently have no marketing capabilities and no sales

organization.

If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable

to successfully commercialize our product candidates, if approved, or generate product revenue.

We currently have no marketing capabilities

and no sales organization.

To commercialize our product candidates, if approved, in the United States, Canada, the European Union,

Latin America and other jurisdictions we seek to enter, we must build our marketing, sales, distribution, managerial and other

non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in

Although our employees have experience in the marketing, sale and distribution of pharmaceutical products, and business

development activities involving external alliances, from prior employment at other companies, we, as a company, have no prior

experience in the marketing, sale and distribution of pharmaceutical products, and there are significant risks involved in building

and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient

sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales

and marketing team.

Any failure or delay in the development of our internal sales, marketing, distribution and pricing/reimbursement/access

capabilities would impact adversely the commercialization of these products.

We have only received the exclusive rights to the materials

required to commercialize TARA-002 in territories other than Japan and Taiwan until June 17, 2024, or an earlier date if Chugai

terminates the agreement with us for any number of reasons, including for convenience after June 2020, following which such rights

become nonexclusive.

Pursuant to an agreement with Chugai Pharmaceutical

dated June 17, 2019, Chugai agreed to provide us with exclusive access to the starting material necessary to manufacture

TARA-002 as well as technical support necessary for us to develop and commercialize TARA-002 anywhere in the world other than

Japan and Taiwan.

However, this agreement does not prevent Chugai from providing such materials and support to any third party

for medical, compassionate use and/or non-commercial research purposes and this agreement is not exclusive following June 17,

2024 or following any termination of the agreement by either party, which includes a termination by Chugai for convenience, which

it has the right to do upon 90 days’

As a result, its ultimate impact,

implementation and meaning are subject to uncertainty.

While it is uncertain when such processes are intended to implement BPCIA

may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for

our biological products.

believe that any of our product candidates approved as a biological product under a BLA should qualify for the 12-year period

of exclusivity.

However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or

that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the

opportunity for biosimilar competition sooner than anticipated.

Other aspects of the BPCIA, some of which may impact the BPCIA

exclusivity provisions, have also been the subject of recent litigation.

Moreover, the extent to which a biosimilar, once approved,

will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological

products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

expect to rely on third-party CROs and other third parties to conduct and oversee our clinical trials.

If these third parties

do not meet our requirements or otherwise conduct the trials as required, we may not be able to satisfy our contractual obligations

or obtain regulatory approval for, or commercialize, our product candidates.

expect to rely on third-party contract research organizations (CROs) to conduct and oversee our TARA-002 and IV Choline Chloride

clinical trials and other aspects of product development.

We also expect to rely on various medical institutions, clinical investigators

and contract laboratories to conduct our trials in accordance with our clinical protocols and all applicable regulatory requirements,

including the FDA’s regulations and good clinical practice (GCP) requirements, which are an international standard meant

to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors,

and state regulations governing the handling, storage, security and recordkeeping for drug and biologic products.

These CROs and

other third parties will play a significant role in the conduct of these trials and the subsequent collection and analysis of

data from the clinical trials.

We will rely heavily on these parties for the execution of our clinical trials and preclinical

studies and will control only certain aspects of their activities.

We and our CROs and other third-party contractors will be required

to comply with GCP and good laboratory practice (GLP) requirements, which are regulations and guidelines enforced by the FDA and

comparable foreign regulatory authorities.

Regulatory authorities enforce these GCP and GLP requirements through periodic inspections

of trial sponsors, principal investigators and trial sites.

If we or any of these third parties fail to comply with applicable

GCP and GLP requirements, or reveal noncompliance from an audit or inspection, the clinical data generated in our clinical trials

may be deemed unreliable and the FDA or other regulatory authorities may require us to perform additional clinical trials before

approving our or our partners’

marketing applications.

We cannot assure that upon inspection by a given regulatory authority,

such regulatory authority will determine that any of our clinical or preclinical trials comply with applicable GCP and GLP requirements.

In addition, our clinical trials generally must be conducted with product produced under cGMP regulations.

Our failure to comply

with these regulations and policies may require us to repeat clinical trials, which would delay the regulatory approval process.

any of our CROs or clinical trial sites terminate their involvement in one of our clinical trials for any reason, we may not be

able to enter into arrangements with alternative CROs or clinical trial sites or do so on commercially reasonable terms.

if our relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients enrolled

in our clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site.

addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time

and could receive cash or equity compensation in connection with such services.

If these relationships and any related compensation

result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site

may be questioned by the FDA.

currently have no marketing capabilities and no sales organization.

If we are unable to establish sales and marketing capabilities

on our own or through third parties, we will be unable to successfully commercialize our product candidates, if approved, or generate

product revenue.

currently have no marketing capabilities and no sales organization.

To commercialize our product candidates, if approved, in the

United States, Canada, the European Union, Latin America and other jurisdictions we seek to enter, we must build our marketing,

sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these

services, and we may not be successful in doing so.

Although our employees have experience in the marketing, sale and distribution

of pharmaceutical products, and business development activities involving external alliances, from prior employment at other companies,

we, as a company, have no prior experience in the marketing, sale and distribution of pharmaceutical products, and there are significant

risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified

individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage

a geographically dispersed sales and marketing team.

Any failure or delay in the development of our internal sales, marketing,

distribution and pricing/reimbursement/access capabilities would impact adversely the commercialization of these products.

have only received the exclusive rights to the materials required to commercialize TARA-002 in territories other than Japan and

Taiwan until June 17, 2030, or an earlier date if Chugai terminates the agreement with us for any number of reasons, including

for convenience after June 30, 2021, following which such rights become nonexclusive.

to an agreement with Chugai Pharmaceutical Co., Ltd.

dated June 17, 2019, as amended on July 14, 2020 (effective June 30,

2020), Chugai agreed to provide us with exclusive access to the starting material necessary to manufacture TARA-002 as well

as technical support necessary for us to develop and commercialize TARA-002 anywhere in the world other than Japan and

However, this agreement does not prevent Chugai from providing such materials and support to any third party for

medical, compassionate use and/or non-commercial research purposes and this agreement is not exclusive following June 17,

2030 or following any termination of the agreement by either party, which includes a termination by Chugai for convenience,

which it has the right to do upon 90 days’

notice after June 30, 2021.

Once our rights to the materials and technology necessary to

manufacture, develop and commercialize TARA-002 are not exclusive, third parties, including those with greater expertise and greater

resources, could obtain such materials and technology and develop a competing therapy, which would adversely affect our ability

to generate revenue and achieve or maintain profitability.

We currently have no products approved for sale, and

we may never obtain regulatory approval to commercialize any of our product candidates.

The research, testing, manufacturing,

safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, sale, marketing, distribution,

import, export and reporting of safety and other post-market information related to our biopharmaceutical products are subject

to extensive regulation by the FDA and other regulatory authorities in the United States and in foreign countries, and such regulations

differ from country to country and frequently are revised.

Even after we achieve U.S.

approval for a product candidate, if any, we will be subject to continued regulatory review and compliance obligations.

with respect to our product candidates, the FDA may impose significant restrictions on the approved indicated uses for which the

product may be marketed or on the conditions of approval.

A product candidate’s approval may contain requirements for potentially

costly post-approval studies and surveillance, including Phase 4 clinical trials, to monitor the safety and efficacy of the product.

We also will be subject to ongoing FDA obligations and continued regulatory review with respect to, among other things, the manufacturing,

processing, labeling, packaging, distribution, pharmacovigilance and adverse event reporting, storage, advertising, promotion

and recordkeeping for our product candidates.

Once our rights to the materials and technology

necessary to manufacture, develop and commercialize TARA-002 are not exclusive, third parties, including those with greater

expertise and greater resources, could obtain such materials and technology and develop a competing therapy, which would

adversely affect our ability to generate revenue and achieve or maintain profitability.

currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our product

research, testing, manufacturing, safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging, storage,

approval, sale, marketing, distribution, import, export and reporting of safety and other post-market information related to our

biopharmaceutical products are subject to extensive regulation by the FDA and other regulatory authorities in the United States

and in foreign countries, and such regulations differ from country to country and frequently are revised.

after we achieve U.S.

regulatory approval for a product candidate, if any, we will be subject to continued regulatory review and

compliance obligations.

For example, with respect to our product candidates, the FDA may impose significant restrictions on the

approved indicated uses for which the product may be marketed or on the conditions of approval.

A product candidate’s approval

may contain requirements for potentially costly post-approval studies and surveillance, including Phase 4 clinical trials, to

monitor the safety and efficacy of the product.

We also will be subject to ongoing FDA obligations and continued regulatory review

with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution, pharmacovigilance and adverse

event reporting, storage, advertising, promotion and recordkeeping for our product candidates.

These requirements include submissions

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by laws and government regulators in those countries.

In addition, manufacturers of drug and

biologic products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory

authorities for compliance with cGMP regulations.

If we or a regulatory agency discovers previously unknown problems with a product,

such as adverse events of unanticipated severity or frequency, or problems with the manufacturing, processing, distribution or

storage facility where, or processes by which, the product is made, a regulatory agency may impose restrictions on that product

or us, including requesting that we initiate a product recall, or requiring notice to physicians or the public, withdrawal of

the product from the market, or suspension of manufacturing.

If we, our product candidates or the manufacturing

facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections

by the FDA and other regulatory authorities for compliance with cGMP regulations.

If we or a regulatory agency discovers previously

unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the manufacturing,

processing, distribution or storage facility where, or processes by which, the product is made, a regulatory agency may impose

restrictions on that product or us, including requesting that we initiate a product recall, or requiring notice to physicians

or the public, withdrawal of the product from the market, or suspension of manufacturing.

we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory

requirements, a regulatory agency may:

restrictions on the sale, marketing or manufacturing of the product, amend, suspend or withdraw product approvals or revoke

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or detain products or require us or our partners to initiate a product recall.

The regulations, policies or guidance

of the FDA and other applicable government agencies may change, and new or additional statutes or government regulations may be

enacted, including at the state and local levels, which can differ by geography and could prevent or delay regulatory approval

of our product candidates or further restrict or regulate post-approval activities.

We cannot predict the likelihood, nature or

extent of adverse government regulations that may arise from future legislation or administrative action, either in the United

States or abroad.

If we are not able to achieve and maintain regulatory compliance, we may not be permitted to commercialize our

product candidates, which would adversely affect our ability to generate revenue and achieve or maintain profitability.

We may face product liability exposure, and if successful

claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.

We face an inherent risk of product liability

or similar causes of action as a result of the clinical testing of our product candidates and will face an even greater risk if

we commercialize any products.

This risk exists even if a product is approved for commercial sale by the FDA and manufactured

in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority and notwithstanding that we comply

with applicable laws on promotional activity.

Our products and product candidates are designed to affect important bodily functions

and processes.

Any side effects, manufacturing defects, misuse or abuse associated with our product candidates could result in

injury to a patient or potentially even death.

We cannot offer any assurance that we will not face product liability suits in

the future, nor can we assure you that our insurance coverage will be sufficient to cover our liability under any such cases.

In addition, a liability claim may be

brought against us even if our product candidates merely appear to have caused an injury.

Product liability claims may be brought

against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with

our product candidates, among others, and under some circumstances even government agencies.

If we cannot successfully defend

our self against product liability or similar claims, we will incur substantial liabilities, reputational harm and possibly injunctions

and punitive actions.

In addition, regardless of merit or eventual outcome, product liability claims may result in:

withdrawal or delay

of recruitment or decreased enrollment rates of clinical trial participants;

termination or increased

government regulation of clinical trial sites or entire trial programs;

the inability to

commercialize our product candidates;

decreased demand

for our product candidates;

impairment of our

business reputation;

product recall or

withdrawal from the market or labeling, marketing or promotional restrictions;

substantial costs

of any related litigation or similar disputes;

distraction of management’s

attention and other resources from our primary business;

significant delay

in product launch;

substantial monetary

awards to patients or other claimants against us that may not be covered by insurance;

withdrawal of reimbursement

or formulary inclusion;

loss of revenue.

We intend to obtain product liability

insurance coverage for our clinical trials.

Large judgments have been awarded in class action or individual lawsuits based on

drugs that had unanticipated side effects.

Our insurance coverage may not be sufficient to cover all of our product liability-related

expenses or losses and may not cover us for any expenses or losses we may suffer.

Moreover, insurance coverage is becoming increasingly

expensive, restrictive and narrow, and, in the future, we may not be able to maintain adequate insurance coverage at a reasonable

cost, in sufficient amounts or upon adequate terms to protect us against losses due to product liability or other similar legal

We will need to increase our product liability coverage if any of our product candidates receive regulatory approval,

which will be costly, and we may be unable to obtain this increased product liability insurance on commercially reasonable terms

or at all and for all geographies in which we wish to launch.

A successful product liability claim or series of claims brought

against us, if judgments exceed our insurance coverage, could decrease our cash and harm our business, financial condition, operating

results and future prospects.

Our employees, independent contractors, principal investigators,

other clinical trial staff, consultants, vendors, CROs and any partners with whom we may collaborate may engage in misconduct

or other improper activities, including noncompliance with regulatory standards and requirements.

regulations, policies or guidance of the FDA and other applicable government agencies may change, and new or additional statutes

or government regulations may be enacted, including at the state and local levels, which can differ by geography and could prevent

or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities.

We cannot predict

the likelihood, nature or extent of adverse government regulations that may arise from future legislation or administrative action,

either in the United States or abroad.

If we are not able to achieve and maintain regulatory compliance, we may not be permitted

to commercialize our product candidates, which would adversely affect our ability to generate revenue and achieve or maintain

profitability.

may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our

insurance coverage for those claims is inadequate.

face an inherent risk of product liability or similar causes of action as a result of the clinical testing of our product candidates

and will face an even greater risk if we commercialize any products.

This risk exists even if a product is approved for commercial

sale by the FDA and manufactured in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority

and notwithstanding that we comply with applicable laws on promotional activity.

Our products and product candidates are designed

to affect important bodily functions and processes.

Any side effects, manufacturing defects, misuse or abuse associated with our

product candidates could result in injury to a patient or potentially even death.

We cannot offer any assurance that we will not

face product liability suits in the future, nor can we assure you that our insurance coverage will be sufficient to cover our

liability under any such cases.

addition, a liability claim may be brought against us even if our product candidates merely appear to have caused an injury.

liability claims may be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise

coming into contact with our product candidates, among others, and under some circumstances even government agencies.

successfully defend our self against product liability or similar claims, we will incur substantial liabilities, reputational

harm and possibly injunctions and punitive actions.

In addition, regardless of merit or eventual outcome, product liability claims

may result in:

or delay of recruitment or decreased enrollment rates of clinical trial participants;

or increased government regulation of clinical trial sites or entire trial programs;

inability to commercialize our product candidates;

demand for our product candidates;

of our business reputation;

recall or withdrawal from the market or labeling, marketing or promotional restrictions;

costs of any related litigation or similar disputes;

of management’s attention and other resources from our primary business;

delay in product launch;

monetary awards to patients or other claimants against us that may not be covered by insurance;

of reimbursement or formulary inclusion;

intend to obtain product liability insurance coverage for our clinical trials.

Large judgments have been awarded in class action

or individual lawsuits based on drugs that had unanticipated side effects.

Our insurance coverage may not be sufficient to cover

all of our product liability-related expenses or losses and may not cover us for any expenses or losses we may suffer.

insurance coverage is becoming increasingly expensive, restrictive and narrow, and, in the future, we may not be able to maintain

adequate insurance coverage at a reasonable cost, in sufficient amounts or upon adequate terms to protect us against losses due

to product liability or other similar legal actions.

We will need to increase our product liability coverage if any of our product

candidates receive regulatory approval, which will be costly, and we may be unable to obtain this increased product liability

insurance on commercially reasonable terms or at all and for all geographies in which we wish to launch.

A successful product

liability claim or series of claims brought against us, if judgments exceed our insurance coverage, could decrease our cash and

harm our business, financial condition, operating results and future prospects.

employees, independent contractors, principal investigators, other clinical trial staff, consultants, vendors, CROs and any partners

with whom we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards

and requirements.

We are exposed to the risk that our employees,

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rules, or laws that require the true, complete and accurate reporting of financial information or data, books and records.

any such or similar actions are instituted against us and we are not successful in defending our self or asserting our rights,

those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative

such or similar actions are instituted against us and we are not successful in defending our self or asserting our rights, those

actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative

and punitive penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal

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and our operating results.

We may be subject to risks related to off-label use of

our product candidates.

The FDA strictly regulates the advertising

and promotion of drug products, and drug products may only be marketed or promoted for their FDA approved uses, consistent with

the product’s approved labeling.

Advertising and promotion of any product candidate that obtains approval in the United

States will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the Department of

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

Violations, including promotion of our

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

and/or administrative sanctions by the FDA.

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

outside of the United States will be heavily scrutinized by relevant foreign regulatory authorities.

Even if we obtain regulatory approval

for our product candidates, the FDA or comparable foreign regulatory authorities may require labeling changes or impose significant

restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval

studies or post-market surveillance.

may be subject to risks related to off-label use of our product candidates.

FDA strictly regulates the advertising and promotion of drug products, and drug products may only be marketed or promoted for

their FDA approved uses, consistent with the product’s approved labeling.

Advertising and promotion of any product candidate

that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector

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

including promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations,

and civil, criminal and/or administrative sanctions by the FDA.

Additionally, advertising and promotion of any product candidate

that obtains approval outside of the United States will be heavily scrutinized by relevant foreign regulatory authorities.

if we obtain regulatory approval for our product candidates, the FDA or comparable foreign regulatory authorities may require

labeling changes or impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements

for potentially costly post-approval studies or post-market surveillance.

In the United States, engaging in impermissible

promotion of our product candidates for off-label uses can also subject us to false claims litigation under federal and state

statutes, which can lead to civil, criminal and/or administrative penalties and fines and agreements, such as a corporate integrity

promotion of our product candidates for off-label uses can also subject us to false claims litigation under federal and state statutes,

which can lead to significant civil, criminal and/or administrative penalties and fines and agreements, such as a corporate integrity

agreement, that materially restrict the manner in which we promote or distribute our product candidates.

If we do not lawfully

promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not

successful in defending against such actions, those actions could have a material adverse effect on our business, financial condition

and operating results and even result in having an independent compliance monitor assigned to audit our ongoing operations for

a lengthy period of time.

If we or any partners with which we may collaborate are

unable to achieve and maintain coverage and adequate levels of reimbursement for TARA-002 or IV Choline Chloride following regulatory

approval, their commercial success may be hindered severely.

If TARA-002 and IV Choline Chloride only

becomes available by prescription, successful sales by us or by any partners with which we may collaborate depend on the availability

of coverage and adequate reimbursement from third-party payors.

Patients who are prescribed medicine for the treatment of their

conditions generally rely on third-party payors to reimburse most or part of the costs associated with their prescription drugs.

The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid in

the United States, and private third-party payors is often critical to new product acceptance.

Coverage decisions may depend on

clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are

already available or subsequently become available, or may be affected by the budgets and demands on the various entities responsible

for providing health insurance to patients who will use TARA-002 and IV Choline Chloride.

Even if we obtain coverage for our products,

the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high.

Patients are unlikely to use a product unless coverage is provided, and reimbursement is adequate to cover a significant portion

In addition, the market for our products

will depend significantly on access to third-party payors’

drug formularies or lists of medications for which third-party

payors provide coverage and reimbursement.

The industry competition to be included in such formularies often leads to downward

pricing pressures on pharmaceutical companies and there may be time limitations on when a new drug may even apply for formulary

Also, third-party payors may refuse to include products in their formularies or otherwise restrict patient access to

such products when a less costly generic equivalent or other treatment alternative is available in the discretion of the formulary.

Third-party payors, whether foreign or

domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

addition, in the United States, although private third-party payors tend to follow Medicare practices, no uniform or consistent

policy of coverage and reimbursement for drug products exists among third-party payors.

Therefore, coverage and reimbursement

for drug products can differ significantly from payor to payor as well as state to state.

Consequently, the coverage determination

process is often a time-consuming and costly process that must be played out across many jurisdictions and different entities

and which will require us to provide scientific, clinical and health economics support for the use of our products compared to

current alternatives and do so to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained

and in what time frame.

Further, we believe that future coverage

and reimbursement likely will be subject to increased restrictions both in the United States and in international markets.

coverage and reimbursement for our products may not be available or adequate in either the United States or international markets,

which could harm our business, financial condition, operating results and prospects.

Healthcare reform measures could hinder or prevent the

commercial success of our product candidates.

promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not successful

in defending against such actions, those actions could have a material adverse effect on our business, financial condition and

operating results and even result in having an independent compliance monitor assigned to audit our ongoing operations for a lengthy

period of time.

we or any partners with which we may collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement

for TARA-002 or IV Choline Chloride following regulatory approval, their commercial success may be hindered severely.

TARA-002 and IV Choline Chloride only becomes available by prescription, successful sales by us or by any partners with which

we may collaborate depend on the availability of coverage and adequate reimbursement from third-party payors.

Patients who are

prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse most or part of the

costs associated with their prescription drugs.

The availability of coverage and adequate reimbursement from governmental healthcare

programs, such as Medicare and Medicaid in the United States, and private third-party payors is often critical to new product

Coverage decisions may depend on clinical and economic standards that disfavor new drug products when more established

or lower-cost therapeutic alternatives are already available or subsequently become available, or may be affected by the budgets

and demands on the various entities responsible for providing health insurance to patients who will use TARA-002 and IV Choline

Even if we obtain coverage for our products, the resulting reimbursement payment rates might not be adequate or may

require co-payments that patients find unacceptably high.

Patients are unlikely to use a product unless coverage is provided,

and reimbursement is adequate to cover a significant portion of the cost.

addition, the market for our products will depend significantly on access to third-party payors’

drug formularies or lists

of medications for which third-party payors provide coverage and reimbursement.

The industry competition to be included in such

formularies often leads to downward pricing pressures on pharmaceutical companies and there may be time limitations on when a

new drug may even apply for formulary inclusion.

Also, third-party payors may refuse to include products in their formularies

or otherwise restrict patient access to such products when a less costly generic equivalent or other treatment alternative is

available in the discretion of the formulary.

payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling

healthcare costs.

In addition, in the United States, although private third-party payors tend to follow Medicare practices, no

uniform or consistent policy of coverage and reimbursement for drug products exists among third-party payors.

Therefore, coverage

and reimbursement for drug products can differ significantly from payor to payor as well as state to state.

Consequently, the

coverage determination process is often a time-consuming and costly process that must be played out across many jurisdictions

and different entities and which will require us to provide scientific, clinical and health economics support for the use of our

products compared to current alternatives and do so to each payor separately, with no assurance that coverage and adequate reimbursement

will be obtained and in what time frame.

we believe that future coverage and reimbursement likely will be subject to increased restrictions both in the United States and

in international markets.

Third-party coverage and reimbursement for our products may not be available or adequate in either the

United States or international markets, which could harm our business, financial condition, operating results and prospects.

reform measures could hinder or prevent the commercial success of our product candidates.

The current presidential administration

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to determine whether the remaining provisions of the ACA are invalid as well.

The impact of this ruling is stayed as it is appealed

to the Fifth Circuit Court of Appeals.

While the ruling will have no immediate effect, it is unclear how this decision, future

decisions, and subsequent appeals, if any, will impact the law.

In 2020 and beyond, we may face additional uncertainties as a

result of likely federal and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions

of the Affordable Care Act.

There is no assurance that the Affordable Care Act, as amended in the future, will not adversely affect

our business and financial results.

On March 2, 2020, the United States Supreme Court

granted the petitions for writs of certiorari to review this case, and has allotted one hour for oral arguments, which are expected

to occur in the fall.

It is unclear how such litigation and other efforts to repeal and replace the Affordable Care Act will impact

the Affordable care Act and our business.

Additionally, there has been increasing

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previously released a “Blueprint,”

or plan, to lower drug prices and reduce out of pocket costs of drugs that contains

additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs,

incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid

by consumers, and the Trump administration’s budget proposal for fiscal year 2021 includes a $135 billion allowance to support

legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase

patient access to lower-cost generic and biosimilar drugs in October 2018, the U.S.

President proposed to lower Medicare Part

B drug prices, in addition to contemplating other measures to lower prescription drug prices.

While these and other measures in

the proposal may require additional authorization to become effective, we expect that additional state and federal healthcare

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

for healthcare products and services, which could result in reduced demand for our product candidates if approved or additional

pricing pressures.

There are also calls to place additional

restrictions on or to ban all direct-to-consumer advertising of pharmaceuticals, which would limit our ability to market our product

The United States is in a minority of jurisdictions that allow this kind of advertising and its removal could limit

the potential reach of a marketing campaign.

We may also be subject to stricter healthcare laws, regulation

and enforcement, and our failure to comply with those laws could adversely affect our business, operations and financial condition.

or plan, to lower drug prices and reduce out of pocket costs of drugs that contained

proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize

manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers,

and the Trump administration’s budget proposal for fiscal year 2021 includes a $135 billion allowance to support legislative

proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient

access to lower-cost generic and biosimilar drugs.

On March 10, 2020, the Trump administration sent “principles”

drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket

pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical

price increases.

Further, on June 24 , 2020, President Trump signed four (4) executive orders designed to lower drug

costs, including measures to increase drug importation from abroad;

finalize the rulemaking process on modifying the

anti-kickback law safe harbor on discounts for plans, pharmacies and pharmaceutical benefit managers;

require the Medicare

program to purchase certain drug products at the same price available in other countries;

and require federally qualified

health centers to pass discounts on the cost of insulin and epipens to patients.

While these and other measures may require additional

authorization to become effective, we expect that additional state and federal healthcare reform measures will be adopted in the

future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services,

which could result in reduced demand for our product candidates if approved or additional pricing pressures.

are also calls to place additional restrictions on or to ban all direct-to-consumer advertising of pharmaceuticals, which would

limit our ability to market our product candidates.

The United States is in a minority of jurisdictions that allow this kind of

advertising and its removal could limit the potential reach of a marketing campaign.

may also be subject to stricter healthcare laws, regulation and enforcement, and our failure to comply with those laws could adversely

affect our business, operations and financial condition.

Certain federal and state healthcare laws

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to regulation by both the federal government and the states in which we or our partners conduct business.

The healthcare laws

and regulations that may affect our ability to operate include:

The healthcare laws and

regulations that may affect our ability to operate include but are not limited to:

the federal Anti-Kickback Statute;

federal civil and criminal

false claims laws and civil monetary penalty laws;

the federal Health Insurance Portability and Accountability Act of 1996, as

amended by the Health Information Technology for Economic and Clinical Health Act;

the Prescription Drug Marketing Act (for sampling

of drug product among other things);

federal civil

and criminal false claims laws and civil monetary penalty laws;

the federal Health Insurance Portability and Accountability Act

of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act;

the Prescription Drug Marketing

Act (for sampling of drug product among other things);

the federal physician sunshine requirements under the Affordable Care Act;

the Foreign Corrupt

Practices Act as it applies to activities outside of the United States;

the Foreign Corrupt Practices Act as it applies to activities outside of the United States;

the new federal Right-to-Try legislation;

and state law

equivalents of many of the above federal laws.

Because of the breadth of these laws and

the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could

be subject to challenge under one or more of such laws.

In addition, recent healthcare reform legislation has strengthened these

For example, the recently enacted Affordable Care Act, among other things, amended the intent requirement of the federal

Anti-Kickback Statute and certain criminal healthcare fraud statutes.

A person or entity no longer needs to have actual knowledge

of the statute or specific intent to violate it.

In addition, the Affordable Care Act provided that the government may assert

that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or

fraudulent claim for purposes of the federal civil False Claims Act.

and state law equivalents of many of the above federal laws.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some

of our business activities could be subject to challenge under one or more of such laws.

In addition, recent healthcare reform

legislation has strengthened these laws.

For example, the recently enacted Affordable Care Act, among other things, amended the

intent requirement of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes.

A person or entity no

longer needs to have actual knowledge of the statute or specific intent to violate it.

In addition, the Affordable Care Act provided

that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback

Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Achieving and sustaining compliance with

4 unchanged sentences

If our operations are found to be in violation of any of the laws described above or any other

governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal

penalties, damages, including punitive damages, fines, disgorgement, the exclusion from participation in federal and state healthcare

programs, imprisonment or the curtailment or restructuring of our operations, and injunctions, any of which could adversely affect

our ability to operate our business and financial results.

We intend to in-license and acquire product candidates

and may engage in other strategic transactions, which could impact our liquidity, increase our expenses and present significant

distractions to our management.

Our strategy is to in-license and acquire

product candidates and we may engage in other strategic transactions.

Additional potential transactions that we may consider include

a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures,

business combinations and investments.

Any such transaction may require us to incur non-recurring or other charges, may increase

our near- and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which

could adversely affect our operations and financial results.

Accordingly, there can be no assurance that we will undertake or

successfully complete any transactions of the nature described above, and any transaction that we do complete could harm our business,

financial condition, operating results and prospects.

We have no current plan, commitment or obligation to enter into any transaction

described above, and we are not engaged in discussions related to additional partnerships.

Our failure to successfully in-license, acquire, develop

and market additional product candidates or approved products would impair our ability to grow our business.

We intend to in-license, acquire, develop

and market additional products and product candidates.

Because our internal research and development capabilities are limited,

we may be dependent on pharmaceutical companies, academic or government scientists and other researchers to sell or license products

or technology to us.

The success of this strategy depends partly on our ability to identify and select promising pharmaceutical

product candidates and products, negotiate licensing or acquisition agreements with their current owners, and finance these arrangements.

The process of proposing, negotiating

and implementing a license or acquisition of a product candidate or approved product is lengthy and complex.

Other companies,

including some with substantially greater financial, marketing, sales and other resources, may compete with us for the license

or acquisition of product candidates and approved products.

We have limited resources to identify and execute the acquisition

or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure.

we may devote resources to potential acquisitions or licensing opportunities that are never completed, or we may fail to realize

the anticipated benefits of such efforts.

We may not be able to acquire the rights to additional product candidates on terms that

we find acceptable or at all.

Further, any product candidate that we

acquire may require additional development efforts prior to commercial sale, including preclinical or clinical testing and approval

by the FDA and applicable foreign regulatory authorities.

All product candidates are prone to risks of failure typical of pharmaceutical

product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective

for approval by regulatory authorities.

In addition, we cannot provide assurance that any approved products that we acquire will

be manufactured or sold profitably or achieve market acceptance.

We expect to rely on collaborations with third parties

for the successful development and commercialization of our product candidates.

We expect to rely upon the efforts of

third parties for the successful development and commercialization of our current and future product candidates.

and commercial success of our product candidates may depend upon maintaining successful relationships with third-party partners

which are subject to a number of significant risks, including the following:

our partners’

governmental laws or regulations that apply to us, we may be subject to significant penalties, including administrative, civil

and criminal penalties, damages, including punitive damages, fines, disgorgement, the exclusion from participation in federal

and state healthcare programs, imprisonment or the curtailment or restructuring of our operations, and injunctions, any of which

could adversely affect our ability to operate our business and financial results.

intend to in-license and acquire product candidates and may engage in other strategic transactions, which could impact our liquidity,

increase our expenses and present significant distractions to our management.

strategy is to in-license and acquire product candidates and we may engage in other strategic transactions.

Additional potential

transactions that we may consider include a variety of different business arrangements, including spin-offs, strategic partnerships,

joint ventures, restructurings, divestitures, business combinations and investments.

Any such transaction may require us to incur

non-recurring or other charges, may increase our near- and long-term expenditures and may pose significant integration challenges

or disrupt our management or business, which could adversely affect our operations and financial results.

Accordingly, there can

be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transaction

that we do complete could harm our business, financial condition, operating results and prospects.

We have no current plan, commitment

or obligation to enter into any transaction described above, and we are not engaged in discussions related to additional partnerships.

failure to successfully in-license, acquire, develop and market additional product candidates or approved products would impair

our ability to grow our business.

intend to in-license, acquire, develop and market additional products and product candidates.

Because our internal research and

development capabilities are limited, we may be dependent on pharmaceutical companies, academic or government scientists and other

researchers to sell or license products or technology to us.

The success of this strategy depends partly on our ability to identify

and select promising pharmaceutical product candidates and products, negotiate licensing or acquisition agreements with their

current owners, and finance these arrangements.

process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy

Other companies, including some with substantially greater financial, marketing, sales and other resources, may compete

with us for the license or acquisition of product candidates and approved products.

We have limited resources to identify and

execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current

infrastructure.

Moreover, we may devote resources to potential acquisitions or licensing opportunities that are never completed,

or we may fail to realize the anticipated benefits of such efforts.

We may not be able to acquire the rights to additional product

candidates on terms that we find acceptable or at all.

any product candidate that we acquire may require additional development efforts prior to commercial sale, including preclinical

or clinical testing and approval by the FDA and applicable foreign regulatory authorities.

All product candidates are prone to

risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be

shown to be sufficiently safe and effective for approval by regulatory authorities.

In addition, we cannot provide assurance that

any approved products that we acquire will be manufactured or sold profitably or achieve market acceptance.

expect to rely on collaborations with third parties for the successful development and commercialization of our product candidates.

expect to rely upon the efforts of third parties for the successful development and commercialization of our current and future

product candidates.

The clinical and commercial success of our product candidates may depend upon maintaining successful relationships

with third-party partners which are subject to a number of significant risks, including the following:

partners’

ability to execute their responsibilities in a timely, cost-efficient and compliant manner;

reduced control over

delivery and manufacturing schedules;

price increases and

product reliability;

manufacturing deviations

from internal or regulatory specifications;

quality incidents;

the failure of partners

to perform their obligations for technical, market or other reasons;

control over delivery and manufacturing schedules;

increases and product reliability;

manufacturing

deviations from internal or regulatory specifications;

failure of partners to perform their obligations for technical, market or other reasons;

misappropriation

of our current or future product candidates;

other risks in potentially

meeting our current and future product commercialization schedule or satisfying the requirements of our end-users.

We cannot assure you that we will be able

to establish or maintain third-party relationships in order to successfully develop and commercialize our product candidates.

We rely completely on third-party contractors to supply,

manufacture and distribute clinical drug supplies for our product candidates, which may include sole-source suppliers and manufacturers;

we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive

regulatory approval;

and we expect to rely on third parties for supply, manufacturing and distribution of preclinical, clinical

and commercial supplies of any future product candidates.

We do not currently have, nor does we

plan to acquire, the infrastructure or capability to supply, store, manufacture or distribute preclinical, clinical or commercial

quantities of drug substances or products.

Additionally, we have not entered into a long-term commercial supply agreement to provide

us with such drug substances or products.

As a result, our ability to develop our product candidates is dependent, and our ability

to supply our products commercially will depend, in part, on our ability to obtain the APIs and other substances and materials

used in our product candidates successfully from third parties and to have finished products manufactured by third parties in

accordance with regulatory requirements and in sufficient quantities for preclinical and clinical testing and commercialization.

If we fail to develop and maintain supply and other technical relationships with these third parties, we may be unable to continue

to develop or commercialize our products and product candidates.

We do not have direct control over whether

our contract suppliers and manufacturers will maintain current pricing terms, be willing to continue supplying us with API and

finished products or maintain adequate capacity and capabilities to serve our needs, including quality control, quality assurance

and qualified personnel.

We are dependent on our contract suppliers and manufacturers for day-to-day compliance with applicable

laws and cGMPs for production of both APIs and finished products.

If the safety or quality of any product or product candidate

or component is compromised due to a failure to adhere to applicable laws or for other reasons, we may not be able to commercialize

or obtain regulatory approval for the affected product or product candidate successfully, and we may be held liable for injuries

sustained as a result.

In order to conduct larger or late-stage

clinical trials for our product candidates and supply sufficient commercial quantities of the resulting drug product and its components,

if that product candidate is approved for sale, our contract manufacturers and suppliers will need to produce our drug substances

and product candidates in larger quantities, more cost-effectively and, in certain cases, at higher yields than they currently

If our third-party contractors are unable to scale up the manufacture of any of our product candidates successfully in

sufficient quality and quantity and at commercially reasonable prices, or are shut down or put on clinical hold by government

regulators, and we are unable to find one or more replacement suppliers or manufacturers capable of production at a substantially

equivalent cost in substantially equivalent volumes and quality, and we are unable to transfer the processes successfully on a

timely basis, the development of that product candidate and regulatory approval or commercial launch for any resulting products

may be delayed, or there may be a shortage in supply, either of which could significantly harm our business, financial condition,

operating results and prospects.

We expect to continue to depend on third-party

contract suppliers and manufacturers for the foreseeable future.

Our supply and manufacturing agreements, if any, do not guarantee

that a contract supplier or manufacturer will provide services adequate for our needs.

Additionally, any damage to or destruction

of our third-party manufacturer’s or suppliers’

facilities or equipment, even by force majeure, may significantly

impair our ability to have our products and product candidates manufactured on a timely basis.

Our reliance on contract manufacturers

and suppliers further exposes us to the possibility that they, or third parties with access to their facilities, will have access

to and may misappropriate our trade secrets or other proprietary information.

In addition, the manufacturing facilities of certain

of our suppliers may be located outside of the United States.

This may give rise to difficulties in importing our products or

product candidates or their components into the United States or other countries.

In addition, we cannot be certain that

any prolonged, intensified or worsened effect from the COVID-19 pandemic would not impact our supply chain.

The manufacture of biologics is complex and our third-party

manufacturers may encounter difficulties in production.

If our CMO encounters such difficulties, the ability to provide supply

of TARA-002 for clinical trials, our ability to obtain marketing approval, or our ability to obtain commercial supply of TARA-002,

if approved, could be delayed or stopped.

We have no experience in biologic manufacturing

and do not own or operate, and we do not expect to own or operate, facilities for product manufacturing, storage and distribution,

We are completely dependent on CMOs to fulfill our clinical and commercial supply of TARA-002.

The process of manufacturing

biologics is complex, highly regulated and subject to multiple risks.

Manufacturing biologics is highly susceptible to product

loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency

in yields, variability in product characteristics and difficulties in scaling the production process.

Even minor deviations from

normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions and higher

If microbial, viral or other contaminations are discovered at the facilities of our manufacturer, such facilities may need

to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials, result

in higher costs of drug product and adversely harm our business.

Moreover, if the FDA determines that our manufacturer is not

in compliance with FDA laws and regulations, including those governing cGMPs, the FDA may deny BLA approval until the deficiencies

are corrected or we replace the manufacturer in our BLA with a manufacturer that is in compliance.

In addition, there are risks associated

with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems

with process scale-up, process reproducibility, stability issues, compliance with cGMPs, lot consistency and timely availability

of raw materials.

Even if we obtain regulatory approval for TARA-002 or any future product candidates, there is no assurance that

our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory

authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product or to meet

potential future demand.

If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization,

commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results

of operations and growth prospects.

Scaling up a biologic manufacturing process is a difficult and uncertain task, and any CMO

we contracts may not have the necessary capabilities to complete the implementation and development process of further scaling

up production, transferring production to other sites, or managing its production capacity to timely meet product demand.

We expect our stock price to be highly volatile.

The market price of our shares could be

subject to significant fluctuations.

Market prices for securities of biotechnology and other life sciences companies historically

have been particularly volatile subject even to large daily price swings.

Some of the factors that may cause the market price

of our shares to fluctuate include, but are not limited to:

our ability to

obtain timely regulatory approvals for TARA-002, IV Choline Chloride or future product candidates, and delays or failures

to obtain such approvals;

failure of TARA-002

or IV Choline Chloride, if approved, to achieve commercial success;

issues in manufacturing

TARA-002, IV Choline Chloride or future product candidates;

the results of current

and any future clinical trials of TARA-002 or IV Choline Chloride;

failure of other

of our product candidates, if approved, to achieve commercial success;

the entry into, or

termination of, or breach by partners of key agreements, including key commercial partner agreements;

the initiation of,

material developments in, or conclusion of any litigation to enforce or defend any intellectual property rights or defend

against the intellectual property rights of others;

announcements of

any dilutive equity financings;

announcements by

commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts,

risks in potentially meeting our current and future product commercialization schedule or satisfying the requirements of our

cannot assure you that we will be able to establish or maintain third-party relationships in order to successfully develop and

commercialize our product candidates.

rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates,

which may include sole-source suppliers and manufacturers;

we intend to rely on third parties for commercial supply, manufacturing

and distribution if any of our product candidates receive regulatory approval;

and we expect to rely on third parties for supply,

manufacturing and distribution of preclinical, clinical and commercial supplies of any future product candidates.

do not currently have, nor does we plan to acquire, the infrastructure or capability to supply, store, manufacture or distribute

preclinical, clinical or commercial quantities of drug substances or products.

Additionally, we have not entered into a long-term

commercial supply agreement to provide us with such drug substances or products.

As a result, our ability to develop our product

candidates is dependent, and our ability to supply our products commercially will depend, in part, on our ability to obtain the

APIs and other substances and materials used in our product candidates successfully from third parties and to have finished products

manufactured by third parties in accordance with regulatory requirements and in sufficient quantities for preclinical and clinical

testing and commercialization.

If we fail to develop and maintain supply and other technical relationships with these third parties,

we may be unable to continue to develop or commercialize our products and product candidates.

do not have direct control over whether our contract suppliers and manufacturers will maintain current pricing terms, be willing

to continue supplying us with API and finished products or maintain adequate capacity and capabilities to serve our needs, including

quality control, quality assurance and qualified personnel.

We are dependent on our contract suppliers and manufacturers for day-to-day

compliance with applicable laws and cGMPs for production of both APIs and finished products.

If the safety or quality of any product

or product candidate or component is compromised due to a failure to adhere to applicable laws or for other reasons, we may not

be able to commercialize or obtain regulatory approval for the affected product or product candidate successfully, and we may

be held liable for injuries sustained as a result.

order to conduct larger or late-stage clinical trials for our product candidates and supply sufficient commercial quantities of

the resulting drug product and its components, if that product candidate is approved for sale, our contract manufacturers and

suppliers will need to produce our drug substances and product candidates in larger quantities, more cost-effectively and, in

certain cases, at higher yields than they currently achieve.

If our third-party contractors are unable to scale up the manufacture

of any of our product candidates successfully in sufficient quality and quantity and at commercially reasonable prices, or are

shut down or put on clinical hold by government regulators, and we are unable to find one or more replacement suppliers or manufacturers

capable of production at a substantially equivalent cost in substantially equivalent volumes and quality, and we are unable to

transfer the processes successfully on a timely basis, the development of that product candidate and regulatory approval or commercial

launch for any resulting products may be delayed, or there may be a shortage in supply, either of which could significantly harm

our business, financial condition, operating results and prospects.

expect to continue to depend on third-party contract suppliers and manufacturers for the foreseeable future.

Our supply and manufacturing

agreements, if any, do not guarantee that a contract supplier or manufacturer will provide services adequate for our needs.

Additionally,

any damage to or destruction of our third-party manufacturer’s or suppliers’

facilities or equipment, even by force

majeure, may significantly impair our ability to have our products and product candidates manufactured on a timely basis.

reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access

to their facilities, will have access to and may misappropriate our trade secrets or other proprietary information.

the manufacturing facilities of certain of our suppliers may be located outside of the United States.

This may give rise to difficulties

in importing our products or product candidates or their components into the United States or other countries.

addition, we cannot be certain that any prolonged, intensified or worsened effect from the COVID-19 pandemic would not impact

our supply chain.

manufacture of biologics is complex and our third-party manufacturers may encounter difficulties in production.

If our CMO encounters

such difficulties, the ability to provide supply of TARA-002 for clinical trials, our ability to obtain marketing approval, or

our ability to obtain commercial supply of TARA-002, if approved, could be delayed or stopped.

have no experience in biologic manufacturing and do not own or operate, and we do not expect to own or operate, facilities for

product manufacturing, storage and distribution, or testing.

We are completely dependent on CMOs to fulfill our clinical and commercial

supply of TARA-002.

The process of manufacturing biologics is complex, highly regulated and subject to multiple risks.

Manufacturing

biologics is highly susceptible to product loss due to contamination, equipment failure, improper installation or operation of

equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling

the production process.

Even minor deviations from normal manufacturing processes could result in reduced production yields, product

defects and other supply disruptions and higher costs.

If microbial, viral or other contaminations are discovered at the facilities

of our manufacturer, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination,

which could delay clinical trials, result in higher costs of drug product and adversely harm our business.

Moreover, if the FDA

determines that our manufacturer is not in compliance with FDA laws and regulations, including those governing cGMPs, the FDA

may deny BLA approval until the deficiencies are corrected or we replace the manufacturer in our BLA with a manufacturer that

is in compliance.

addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,

cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with cGMPs, lot

consistency and timely availability of raw materials.

Even if we obtain regulatory approval for TARA-002 or any future product

candidates, there is no assurance that our manufacturers will be able to manufacture the approved product to specifications acceptable

to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential

launch of the product or to meet potential future demand.

If our manufacturers are unable to produce sufficient quantities for

clinical trials or for commercialization, commercialization efforts would be impaired, which would have an adverse effect on our

business, financial condition, results of operations and growth prospects.

Scaling up a biologic manufacturing process is a difficult

and uncertain task, and any CMO we contracts may not have the necessary capabilities to complete the implementation and development

process of further scaling up production, transferring production to other sites, or managing its production capacity to timely

meet product demand.

expect our stock price to be highly volatile.

market price of our shares could be subject to significant fluctuations.

Market prices for securities of biotechnology and other

life sciences companies historically have been particularly volatile subject even to large daily price swings.

Some of the factors

that may cause the market price of our shares to fluctuate include, but are not limited to:

ability to obtain timely regulatory approvals for TARA-002, IV Choline Chloride or future product candidates, and

delays or failures to obtain such approvals;

of TARA-002 or IV Choline Chloride, if approved, to achieve commercial success;

in manufacturing TARA-002, IV Choline Chloride or future product candidates;

results of current and any future clinical trials of TARA-002 or IV Choline Chloride;

of other of our product candidates, if approved, to achieve commercial success;

entry into, or termination of, or breach by partners of key agreements, including key commercial partner agreements;

initiation of, material developments in, or conclusion of any litigation to enforce or defend any intellectual property rights

or defend against the intellectual property rights of others;

announcements

of any dilutive equity financings;

announcements

by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts,

commercial relationships or capital commitments;

failure to elicit

meaningful stock analyst coverage and downgrades of the company’s stock by analysts;

the loss of key employees.

Moreover, the stock markets in general

have experienced substantial volatility in our industry that has often been unrelated to the operating performance of individual

companies or a certain industry segment.

These broad market fluctuations may also adversely affect the trading price of our shares.

In the past, following periods of volatility

in the market price of a company’s securities, shareholders have often instituted class action securities litigation against

those companies.

Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources,

which could significantly harm our profitability and reputation.

In addition, such securities litigation often has ensued after

a reverse merger or other merger and acquisition activity.

Such litigation if brought could impact negatively our business.

We incur costs and demands upon management as a result

of complying with the laws and regulations affecting public companies.

We incur significant legal, accounting

and other expenses that ArTara Subsidiary Inc.

did not incur as a private company, including costs associated with public company

reporting and other SEC requirements.

We will also incur costs associated with corporate governance requirements, including requirements

under the Sarbanes-Oxley Act, as well as new rules implemented by the SEC and Nasdaq.

These rules and regulations are expected

to increase our legal and financial compliance costs and to make some activities more time-consuming and costly.

Our executive

officers and other personnel will need to devote substantial time to gaining expertise regarding operations as a public company

and compliance with applicable laws and regulations.

These rules and regulations may also make it expensive for us to operate

our business.

We are able to take advantage of reduced disclosure and

governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive

to investors.

We have a public float of less than $250

million and therefore qualify as a smaller reporting company under the rules of the SEC.

As a smaller reporting company, we are

able to take advantage of reduced disclosure requirements, such as simplified executive compensation disclosures and reduced financial

statement disclosure requirements in our SEC filings.

Decreased disclosures in our SEC filings due to our status as a smaller

reporting company may make it harder for our investors to analyze our results of operations and financial prospects.

predict if investors will find our common stock less attractive due to our reliance on these exemptions.

If some investors find

our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price

may be more volatile.

We may take advantage of the reporting exemptions applicable to a smaller reporting company until we are

no longer a smaller reporting company, which status would end once we have a public float greater than $250 million.

In that event,

we could still be a smaller reporting company if our annual revenues were below $100 million and we have a public float of less

than $700 million.

We do not anticipate paying any dividends in the foreseeable

The current expectation is that we will

retain our future earnings to fund the development and growth of the Company’s business.

As a result, capital appreciation,

if any, of your shares of the Company will be your sole source of gain, if any, for the foreseeable future.

If we fail to attract and retain management and other

key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement

our business plan.

Our ability to compete in the highly competitive

pharmaceuticals industry depends on our ability to attract and retain highly qualified managerial, scientific, medical, legal,

sales and marketing and other personnel.

We are highly dependent on our management and scientific personnel.

The loss of the services

of any of these individuals could impede, delay or prevent the successful development of our product pipeline, completion of our

planned clinical trials, commercialization of our product candidates or in-licensing or acquisition of new assets and could impact

negatively our ability to implement successfully our business plan.

If we lose the services of any of these individuals, we might

not be able to find suitable replacements on a timely basis or at all, and our business could be harmed as a result.

not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for

qualified personnel among biotechnology, pharmaceutical and other businesses.

Our ability to use our net operating loss carry-forwards

to offset future taxable income may be subject to certain limitations.

to elicit meaningful stock analyst coverage and downgrades of the company’s stock by analysts;

loss of key employees.

the stock markets in general have experienced substantial volatility in our industry that has often been unrelated to the operating

performance of individual companies or a certain industry segment.

These broad market fluctuations may also adversely affect the

trading price of our shares.

the past, following periods of volatility in the market price of a company’s securities, shareholders have often instituted

class action securities litigation against those companies.

Such litigation, if instituted, could result in substantial costs

and diversion of management attention and resources, which could significantly harm our profitability and reputation.

such securities litigation often has ensued after a reverse merger or other merger and acquisition activity.

Such litigation if

brought could impact negatively our business.

incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.

incur significant legal, accounting and other expenses that ArTara Subsidiary Inc.

did not incur as a private company, including

costs associated with public company reporting and other SEC requirements.

We will also incur costs associated with corporate

governance requirements, including requirements under the Sarbanes-Oxley Act, as well as new rules implemented by the SEC and

rules and regulations are expected to increase our legal and financial compliance costs and to make some activities more time-consuming

Our executive officers and other personnel will need to devote substantial time to gaining expertise regarding operations

as a public company and compliance with applicable laws and regulations.

These rules and regulations may also make it expensive

for us to operate our business.

are able to take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which

could result in our common stock being less attractive to investors.

have a public float of less than $250 million and therefore qualify as a smaller reporting company under the rules of the SEC.

As a smaller reporting company, we are able to take advantage of reduced disclosure requirements, such as simplified executive

compensation disclosures and reduced financial statement disclosure requirements in our SEC filings.

Decreased disclosures in

our SEC filings due to our status as a smaller reporting company may make it harder for our investors to analyze our results of

operations and financial prospects.

We cannot predict if investors will find our common stock less attractive due to our reliance

on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market

for our common stock and our stock price may be more volatile.

We may take advantage of the reporting exemptions applicable to

a smaller reporting company until we are no longer a smaller reporting company, which status would end once we have a public float

greater than $250 million.

In that event, we could still be a smaller reporting company if our annual revenues were below $100

million and we have a public float of less than $700 million.

do not anticipate paying any dividends in the foreseeable future.

current expectation is that we will retain our future earnings to fund the development and growth of the Company’s business.

As a result, capital appreciation, if any, of your shares of the Company will be your sole source of gain, if any, for the foreseeable

we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize

our product candidates or otherwise implement our business plan.

ability to compete in the highly competitive pharmaceuticals industry depends on our ability to attract and retain highly qualified

managerial, scientific, medical, legal, sales and marketing and other personnel.

We are highly dependent on our management and

scientific personnel.

The loss of the services of any of these individuals could impede, delay or prevent the successful development

of our product pipeline, completion of our planned clinical trials, commercialization of our product candidates or in-licensing

or acquisition of new assets and could impact negatively our ability to implement successfully our business plan.

If we lose the

services of any of these individuals, we might not be able to find suitable replacements on a timely basis or at all, and our

business could be harmed as a result.

We might not be able to attract or retain qualified management and other key personnel in

the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

ability to use our net operating loss carry-forwards to offset future taxable income may be subject to certain limitations.

of December 31, 2019, for U.S.

federal and state income tax reporting purposes, Private ArTara had approximately $11.4 million

of unused net operating losses (“NOLs”) available for carry forward to future years.

The 2019 and 2018 federal and

New York City NOLs may be carried forward indefinitely, but utilization will be subject to an annual deduction limitation of 80%

of taxable income.

These 2019 and 2018 losses will not be allowed to be carried back.

The 2019 state NOLs may be carried forward

through the year 2039 and may be applied against future taxable income.

The 2017 federal and New York City NOLs will begin

to expire during the year ended December 31, 2037.

as of December 31, 2019, for U.S.

and state income tax reporting purposes, Private ArTara had approximately $11.4 million of unused net operating losses (“NOLs”)

available for carry forward to future years.

The 2019 and 2018 federal and New York City NOLs may be carried forward indefinitely,

but utilization will be subject to an annual deduction limitation of 80% of taxable income.

These 2019 and 2018 losses will not

be allowed to be carried back.

The 2019 state NOLs may be carried forward through the year 2039 and may be applied against future

taxable income.

The 2017 federal and New York City NOLs will begin to expire during the year ended December 31, 2037.

Furthermore, as of December 31, 2019, for

federal and state income tax reporting purposes, Proteon had approximately $41.7 million of unused NOLs available to carry

forward to future years.

The pre-2018 federal net operating loss carryforwards expire at various dates through 2037.

operating loss carryforwards generated in 2018 and forward will have an unlimited carryforward period as part of the Tax Cuts

and Jobs Act.

The indefinite lived net operating loss carryforwards as of December 31, 2019 are approximately $30.6 million.

of December 31, 2019, Proteon had state net operating loss carryforwards of approximately $37.2 million to offset future state

taxable income, which will expire at various dates through 2039.

As of December 31, 2019, Proteon has tax credit carryforwards

of approximately $3.6 million to offset future federal and state income taxes, which will expire at various dates through 2039.

Because United States tax laws limit the

time during which NOL carry forwards may be applied against future taxable income, we may be unable to take full advantage of

our NOLs for federal income tax purposes when we do generate taxable income.

Further, net operating loss carryforwards of both

Private ArTara and Proteon entities will be limited since there was a more than 50% ownership change for each entity.

We may be adversely affected by natural disasters, pandemics

and other catastrophic events and by man-made problems such as terrorism that could disrupt our business operations, and our business

continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Our corporate office is located in New

York, New York.

If a disaster, power outage, computer hacking, or other event occurred that prevented us from using all or a significant

portion of an office, that damaged critical infrastructure, such as enterprise financial systems, IT systems, manufacturing resource

planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible

for us to continue our business for a substantial period of time.

As an example, New York City has been the hardest hit of US

cities by the COVID-19 pandemic and, due to government restrictions including stay-at-home orders, we do not know when we will

be able to use our office facilities located there.

federal and state income tax reporting purposes, Proteon had approximately $41.7 million of

unused NOLs available to carry forward to future years.

The pre-2018 federal net operating loss carryforwards expire at various

dates through 2037.

Federal net operating loss carryforwards generated in 2018 and forward will have an unlimited carryforward

period as part of the Tax Cuts and Jobs Act.

The indefinite lived net operating loss carryforwards as of December 31, 2019 are

approximately $30.6 million.

As of December 31, 2019, Proteon had state net operating loss carryforwards of approximately $37.2

million to offset future state taxable income, which will expire at various dates through 2039.

As of December 31, 2019, Proteon

has tax credit carryforwards of approximately $3.6 million to offset future federal and state income taxes, which will expire

at various dates through 2039.

United States tax laws limit the time during which NOL carry forwards may be applied against future taxable income, we may be

unable to take full advantage of our NOLs for federal income tax purposes when we do generate taxable income.

Further, net operating

loss carryforwards of both Private ArTara and Proteon entities will be limited since there was a more than 50% ownership change

for each entity.

may be adversely affected by natural disasters, pandemics and other catastrophic events and by man-made problems such as terrorism

that could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect

us from a serious disaster.

corporate office is located in New York, New York.

If a disaster, power outage, computer hacking, or other event occurred that

prevented us from using all or a significant portion of an office, that damaged critical infrastructure, such as enterprise financial

systems, IT systems, manufacturing resource planning or enterprise quality systems, or that otherwise disrupted operations, it

may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.

As an example,

New York City has been significantly impacted by the COVID-19 pandemic and, due to safety considerations for our employees and

government restrictions, including stay-at-home orders, we do not know when we will be able to use our office facilities located

Our contract manufacturer’s and suppliers’

facilities are located

in multiple locations where there are similar stay-at-home orders in place for the current crisis and where other natural disasters

or similar events, such as tornadoes, fires, explosions or large-scale accidents or power outages, or IT threats, pandemic, acts

of terrorism and other geo-political unrest, could severely disrupt our operations and have a material adverse effect on our business,

financial condition, operating results and prospects.

As an example, due to the COVID-19 pandemic and the associated government-imposed

stay-at-home orders, the third-party contract manufacturer with which we have contracted for the initial comparability study had

to stop the study prior to its completion.

facilities are located in multiple locations where there are similar

stay-at-home orders in place for the current crisis and where other natural disasters or similar events, such as tornadoes, fires,

explosions or large-scale accidents or power outages, or IT threats, pandemic, acts of terrorism and other geo-political unrest,

could severely disrupt our operations and have a material adverse effect on our business, financial condition, operating results

and prospects.

As an example, due to the COVID-19 pandemic and the associated government-imposed stay-at-home orders, the third-party

contract manufacturer with which we have contracted for the initial comparability study had to stop the study prior to its completion.

We do not know when they will be able to return to work or initiate a new study.

of the aforementioned risks may be further increased if we do not implement a disaster recovery plan or our partners’

manufacturers’

disaster recovery plans prove to be inadequate.

To the extent that any of the above should result in delays

in the regulatory approval, manufacture, distribution or commercialization of TARA-002 or IV Choline Chloride, our business, financial

condition, operating results and prospects would suffer.

Our business and operations would suffer in the event

of system failures, cyber-attacks or a deficiency in our cyber-security.

Despite the implementation of security

measures, our internal computer systems and those of our current and future CROs and other contractors and consultants are vulnerable

to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers,

foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks

and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations,

it could result in a material disruption of our development programs and our business operations.

In the first quarter of 2020,

our email server was compromised in a cyber-attack.

We quickly isolated the incident and have, since, implemented additional risk

prevention measures.

In addition, since the Company sponsors clinical trials, any breach that compromises patient data and identities

causing a breach of privacy could generate significant reputational damage and legal liabilities and costs to recover and repair,

including affecting trust in the company to recruit for future clinical trials.

For example, the loss of clinical trial data from

completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs

to recover or reproduce the data.

To the extent that any disruption or security breach were to result in a loss of, or damage

to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability

and the further development and commercialization of our products and product candidates could be delayed.

Anti-takeover provisions in our charter documents and

under Delaware law could make an acquisition of the Company more difficult and may prevent attempts by our stockholders to replace

or remove management.

Provisions in our certificate of incorporation

and bylaws may delay or prevent an acquisition or a change in management.

In addition, because we are incorporated in Delaware,

we are governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of the outstanding

voting stock from merging or combining with the Company.

These provisions may frustrate or prevent any attempts by our stockholders

to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors,

which is responsible for appointing the members of management.

The certificate of incorporation of the Company provides

that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between the Company

and our stockholders, which could limit our stockholders’

ability to obtain a favorable judicial forum for disputes with

us or our directors, officers or other employees.

The certificate of incorporation of the

Company provides that the Court of Chancery of the State of Delaware is the sole and exclusive forum for any derivative action

or proceeding brought on our behalf, any action asserting a breach of fiduciary duty owed by any of our directors, officers or

other employees to the Company or our stockholders, any action asserting a claim against us arising pursuant to any provisions

of the DGCL, our certificate of incorporation or our bylaws, or any action asserting a claim against us that is governed by the

internal affairs doctrine.

The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial

forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits

against us and our directors, officers and other employees.

If a court were to find the choice of forum provision contained in

the certificate of incorporation to be inapplicable or unenforceable in an action, Awe may incur additional costs associated with

resolving such action in other jurisdictions.

Certain stockholders have the ability to control or significantly

influence certain matters submitted to our stockholders for approval.

Certain stockholders have consent rights

over certain significant matters of our business.

These include decisions to effect a merger or other similar transaction, changes

to the principal business of the Company, and the sale or other transfer of TARA-002 or other assets with an aggregate value of

more than $2,500,000.

As a result, these stockholders, have significant influence over certain matters that require approval by

our stockholders.

If equity research analysts do not publish research or

reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume

could decline.

The trading market for our common stock

is influenced by the research and reports that equity research analysts publish about us and our business.

Equity research analysts

may elect not to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market

price of our common stock.

In the event we do have equity research analyst coverage, we will not have any control over the analysts

or the content and opinions included in their reports.

The price of our common stock could decline if one or more equity research

analysts downgrade our stock or issue other unfavorable commentary or research.

If one or more equity research analysts ceases

coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause

our stock price or trading volume to decline.

If we fail to maintain proper and effective internal

controls, our ability to produce accurate financial statements on a timely basis could be impaired.

We are subject to the reporting requirements

of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of Nasdaq.

The Sarbanes-Oxley Act requires, among other

things, that we maintain effective disclosure controls and procedures and internal control over financial reporting.

We must perform

system and process evaluation and testing of our internal control over financial reporting to allow management to report on the

effectiveness of our internal controls over financial reporting in our Annual Report on Form 10-K filing for that year, as required

by Section 404 of the Sarbanes-Oxley Act.

As a private company, ArTara Subsidiary was not required to test its internal controls

within a specified period.

This will require that we incur substantial professional fees and internal costs to expand our accounting

and finance functions and that we expend significant management efforts.

We may experience difficulty in meeting these reporting

requirements in a timely manner.

We may discover weaknesses in our system

of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements.

Our internal control over financial reporting will not prevent or detect all errors and all fraud.

A control system, no matter

how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance

that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we are not able to comply with the

requirements of Section 404 of the Sarbanes-Oxley Act, or if we are unable to maintain proper and effective internal controls,

we may not be able to produce timely and accurate financial statements.

If that were to happen, the market price of our common

stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

Risks Related to Intellectual Property Rights

We may not be able to obtain, maintain or enforce global

patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient

breadth to prevent third parties from competing against us.

Our success with respect to our product

candidates will depend, in part, on our ability to obtain and maintain patent protection in both the United States and other countries,

to preserve our trade secrets and to prevent third parties from infringing on our proprietary rights.

Our ability to protect our

product candidates from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and

maintain valid and enforceable patents around the world.

The patent application process, also known

as patent prosecution, is expensive and time-consuming, and we and our current or future licensors and licensees may not be able

to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner in all

the countries that are desirable.

It is also possible that we or our current licensors, or any future licensors or licensees,

will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before

it is too late to obtain patent protection on them.

Therefore, these and any of our patents and applications may not be prosecuted

and enforced in a manner consistent with the best interests of our business.

Moreover, our competitors independently may develop

equivalent knowledge, methods and know-how or discover workarounds to our patents that would not constitute infringement.

of these outcomes could impair our ability to enforce the exclusivity of our patents effectively, which may have an adverse impact

on our business, financial condition and operating results.

Due to legal standards relating to patentability,

validity, enforceability and claim scope of patents covering pharmaceutical inventions, our ability to obtain, maintain and enforce

patents is uncertain and involves complex legal and factual questions especially across countries.

Accordingly, rights under any

existing patents or any patents we might obtain or license may not cover our product candidates or may not provide us with sufficient

protection for our product candidates to afford a sustainable commercial advantage against competitive products or processes,

including those from branded, generic and over-the-counter pharmaceutical companies.

In addition, we cannot guarantee that any

patents or other intellectual property rights will issue from any pending or future patent or other similar applications owned

by or licensed to us.

Even if patents or other intellectual property rights have issued or will issue, we cannot guarantee that

the claims of these patents and other rights are or will be held valid or enforceable by the courts, through injunction or otherwise,

or will provide us with any significant protection against competitive products or otherwise be commercially valuable to us in

every country of commercial significance that we may target.

Competitors in the field of immunology

and oncology therapeutics have created a substantial amount of prior art, including scientific publications, posters, presentations,

patents and patent applications and other public disclosures including on the Internet.

Our ability to obtain and maintain valid

and enforceable patents depends on whether the differences between our technology and the prior art allow our technology to be

patentable over the prior art.

We do not have outstanding issued patents covering all of the recent developments in our technology

and are unsure of the patent protection that we will be successful in obtaining, if any.

Even if the patents do successfully issue,

third parties may design around or challenge the validity, enforceability or scope of such issued patents or any other issued

patents we own or license, which may result in such patents being narrowed, invalidated or held unenforceable.

If the breadth

or strength of protection provided by the patents we hold or pursue with respect to our product candidates is challenged, it could

dissuade companies from collaborating with us to develop or threaten our ability to commercialize or finance our product candidates.

The laws of some foreign jurisdictions

do not provide intellectual property rights to the same extent or duration as in the United States, and many companies have encountered

significant difficulties in acquiring, maintaining, protecting, defending and especially enforcing such rights in foreign jurisdictions.

If we encounter such difficulties in protecting, or are otherwise precluded from effectively protecting, our intellectual property

in foreign jurisdictions, our business prospects could be substantially harmed, especially internationally.

Proprietary trade secrets and unpatented

know-how are also very important to our business.

Although we have taken steps to protect our trade secrets and unpatented know-how

by entering into confidentiality agreements with third parties, and intellectual property protection agreements with officers,

directors, employees, and certain consultants and advisors, there can be no assurance that binding agreements will not be breached

or enforced by courts, that we would have adequate remedies for any breach, including injunctive and other equitable relief, or

that our trade secrets and unpatented know-how will not otherwise become known, inadvertently disclosed by us or our agents and

representatives, or be independently discovered by our competitors.

If trade secrets are independently discovered, we would not

be able to prevent their use and if we and our agents or representatives inadvertently disclose trade secrets and/or unpatented

know-how, we may not be allowed to retrieve this and maintain the exclusivity we previously enjoyed.

We may not be able to protect our intellectual property

rights throughout the world.

Filing, prosecuting and defending patents

on our product candidates does not guarantee exclusivity.

The requirements for patentability differ in certain countries, particularly

developing countries.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same

extent as laws in the United States, especially when it comes to granting use and other kinds of patents and what kind of enforcement

rights will be allowed, especially injunctive relief in a civil infringement proceeding.

Consequently, we may not be able to prevent

third parties from practicing our inventions in all countries outside the United States and even in launching an identical version

of our product notwithstanding we have a valid patent in that country.

Competitors may use our technologies in jurisdictions where

we have not obtained patent protection to develop their own products, or produce copy products, and, further, may export otherwise

infringing products to territories where we have patent protection but enforcement on infringing activities is inadequate or where

we have no patents.

These products may compete with our products, and our patents or other intellectual property rights may not

be effective or sufficient to prevent them from competing.

Many companies have encountered significant

problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries,

particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection,

particularly those relating to pharmaceuticals, and the judicial and government systems are often corrupt, which could make it

difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our

efforts and attention from other aspects of our business, could put our global patents at risk of being invalidated or interpreted

narrowly and our global patent applications at risk of not issuing, and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate or infringement actions brought against us, and the damages or other remedies

awarded, if any, may not be commercially meaningful when we are the plaintiff.

When we are the defendant we may be required to

post large bonds to stay in the market while we defend ourselves from an infringement action.

In addition, certain countries in Europe

and certain developing countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses

to third parties, especially if the patent owner does not enforce or use its patents over a protracted period of time.

cases, the courts will force compulsory licenses on the patent holder even when finding the patent holder’s patents are

valid if the court believes it is in the best interests of the country to have widespread access to an essential product covered

by the patent.

In these situations, the royalty the court requires to be paid by the license holder receiving the compulsory license

is not calculated at fair market value and can be inconsequential, thereby disaffecting the patent holder’s business.

these countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license to our patents

to a third party, which could also materially diminish the value of those patents.

This would limit our potential revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant

commercial advantage from the intellectual property that we own or license, especially in comparison to what we enjoy from enforcing

our intellectual property rights in the Unites States.

Finally, our ability to protect and enforce our intellectual property rights

may be adversely affected by unforeseen changes in both U.S.

and foreign intellectual property laws, or changes to the policies

in various government agencies in these countries, including but not limited to the patent office issuing patents and the health

agency issuing pharmaceutical product approvals For example, in Brazil, pharmaceutical patents require initial approval of the

Brazilian health agency (ANVISA).

Finally, many countries have large backlogs in patent prosecution, and in some countries in

Latin America it can take years, even decades, just to get a pharmaceutical patent application reviewed notwithstanding the merits

of the application.

Obtaining and maintaining patent protection depends on

compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies,

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

Periodic maintenance and annuity fees

on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment

and other similar provisions during the patent application process.

While an inadvertent lapse can, in many cases, be cured by

payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can

result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in

the relevant jurisdiction just for failure to know about and/or timely pay a prosecution fee.

Non-compliance events that could

result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed

time limits, non-payment of fees in prescribed time periods, and failure to properly legalize and submit formal documents in the

format and style the country requires.

If we or our licensors fail to maintain the patents and patent applications covering our

product candidates for any reason, our competitors might be able to enter the market, which would have an adverse effect on our

If we fail to comply with our obligations under our intellectual

property license agreements, we could lose license rights that are important to our business.

Additionally, these agreements may

be subject to disagreement over contract interpretation, which could narrow the scope of our rights to the relevant intellectual

property or technology or increase our financial or other obligations to our licensors.

We have entered into in-license arrangements

with respect to certain of our product candidates.

These license agreements impose various diligence, milestone, royalty, insurance

and other obligations on us.

If we fail to comply with these obligations, the respective licensors may have the right to terminate

the license, in which event we may not be able to develop or market the affected product candidate.

The loss of such rights could

materially adversely affect our business, financial condition, operating results and prospects.

If we are sued for infringing intellectual property rights

of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing

our product candidates.

Our commercial success depends on our

ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing

the proprietary rights of third parties.

We cannot assure that marketing and selling such candidates and using such technologies

will not infringe existing or future patents.

Numerous U.S.- and foreign-issued patents and pending patent applications owned

by third parties exist in the fields relating to our product candidates.

As the biotechnology and pharmaceutical industries expand

and more patents are issued, the risk increases that others may assert that our product candidates, technologies or methods of

delivery or use infringe their patent rights.

Moreover, it is not always clear to industry participants, including us, which patents

and other intellectual property rights cover various drugs, biologics, drug delivery systems or their methods of use, and which

of these patents may be valid and enforceable.

Thus, because of the large number of patents issued and patent applications filed

in our fields across many countries, there may be a risk that third parties may allege they have patent rights encompassing our

product candidates, technologies or methods.

In addition, there may be issued patents

of third parties that are infringed or are alleged to be infringed by our product candidates or proprietary technologies notwithstanding

patents we may possess.

Because some patent applications in the United States may be maintained in secrecy until the patents are

issued, because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months

after filing and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that

others have not filed patent applications for technology covered by our own and in-licensed issued patents or our pending applications.

Our competitors may have filed, and may in the future file, patent applications covering our product candidates or technology

similar to our technology.

Any such patent application may have priority over our own and in-licensed patent applications or patents,

which could further require us to obtain rights to issued patents covering such technologies, which may mean paying significant

licensing fees or the like.

All of the aforementioned risks may be further

increased if we do not implement a disaster recovery plan or our partners’

or manufacturers’

disaster recovery plans

prove to be inadequate.

To the extent that any of the above should result in delays in the regulatory approval, manufacture, distribution

or commercialization of TARA-002 or IV Choline Chloride, our business, financial condition, operating results and prospects would

business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.

the implementation of security measures, our internal computer systems and those of our current and future CROs and other contractors

and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication

and electrical failures.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including

by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication

of attempted attacks and intrusions from around the world have increased.

If such an event were to occur and cause interruptions

in our operations, it could result in a material disruption of our development programs and our business operations.

quarter of 2020, our email server was compromised in a cyber-attack.

We quickly isolated the incident and have, since, implemented

additional risk prevention measures.

In addition, since the Company sponsors clinical trials, any breach that compromises patient

data and identities causing a breach of privacy could generate significant reputational damage and legal liabilities and costs

to recover and repair, including affecting trust in the company to recruit for future clinical trials.

For example, the loss of

clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly

increase our costs to recover or reproduce the data.

To the extent that any disruption or security breach were to result in a

loss of, or damage to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could

incur liability and the further development and commercialization of our products and product candidates could be delayed.

Anti-takeover

provisions in our charter documents and under Delaware law could make an acquisition of the Company more difficult and may prevent

attempts by our stockholders to replace or remove management.

in our certificate of incorporation and bylaws may delay or prevent an acquisition or a change in management.

In addition, because

we are incorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning

in excess of 15% of the outstanding voting stock from merging or combining with the Company.

These provisions may frustrate or

prevent any attempts by our stockholders to replace or remove then current management by making it more difficult for stockholders

to replace members of the board of directors, which is responsible for appointing the members of management.

certificate of incorporation of the Company provides that the Court of Chancery of the State of Delaware is the exclusive forum

for substantially all disputes between the Company and our stockholders, which could limit our stockholders’

obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

certificate of incorporation of the Company provides that the Court of Chancery of the State of Delaware is the sole and exclusive

forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty owed by any

of our directors, officers or other employees to the Company or our stockholders, any action asserting a claim against us arising

pursuant to any provisions of the DGCL, our certificate of incorporation or our bylaws, or any action asserting a claim against

us that is governed by the internal affairs doctrine.

The choice of forum provision may limit a stockholder’s ability to

bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees,

which may discourage such lawsuits against us and our directors, officers and other employees.

If a court were to find the choice

of forum provision contained in the certificate of incorporation to be inapplicable or unenforceable in an action, Awe may incur

additional costs associated with resolving such action in other jurisdictions.

stockholders have the ability to control or significantly influence certain matters submitted to our stockholders for approval.

stockholders have consent rights over certain significant matters of our business.

These include decisions to effect a merger

or other similar transaction, changes to the principal business of the Company, and the sale or other transfer of TARA-002 or

other assets with an aggregate value of more than $2,500,000.

As a result, these stockholders, have significant influence over

certain matters that require approval by our stockholders.

equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business

or our market, our stock price and trading volume could decline.

trading market for our common stock is influenced by the research and reports that equity research analysts publish about us and

our business.

Equity research analysts may elect not to provide research coverage of our common stock, and such lack of research

coverage may adversely affect the market price of our common stock.

In the event we do have equity research analyst coverage,

we will not have any control over the analysts or the content and opinions included in their reports.

The price of our common

stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research.

If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common

stock could decrease, which in turn could cause our stock price or trading volume to decline.

we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis

could be impaired.

are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of Nasdaq.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal

control over financial reporting.

We must perform system and process evaluation and testing of our internal control over financial

reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual Report

on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act.

As a private company, ArTara Subsidiary

was not required to test its internal controls within a specified period.

This will require that we incur substantial professional

fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts.

experience difficulty in meeting these reporting requirements in a timely manner.

may discover weaknesses in our system of internal financial and accounting controls and procedures that could result in a material

misstatement of our financial statements.

Our internal control over financial reporting will not prevent or detect all errors

and all fraud.

A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance

that the control system’s objectives will be met.

Because of the inherent limitations in all control systems, no evaluation

of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues

and instances of fraud will be detected.

we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if we are unable to maintain proper

and effective internal controls, we may not be able to produce timely and accurate financial statements.

If that were to happen,

the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or

other regulatory authorities.

Related to Intellectual Property Rights

may not be able to obtain, maintain or enforce global patent rights or other intellectual property rights that cover our product

candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.

success with respect to our product candidates will depend, in part, on our ability to obtain and maintain patent protection in

both the United States and other countries, to preserve our trade secrets and to prevent third parties from infringing on our

proprietary rights.

Our ability to protect our product candidates from unauthorized or infringing use by third parties depends

in substantial part on our ability to obtain and maintain valid and enforceable patents around the world.

patent application process, also known as patent prosecution, is expensive and time-consuming, and we and our current or future

licensors and licensees may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable

cost or in a timely manner in all the countries that are desirable.

It is also possible that we or our current licensors, or any

future licensors or licensees, will fail to identify patentable aspects of inventions made in the course of development and commercialization

activities before it is too late to obtain patent protection on them.

Therefore, these and any of our patents and applications

may not be prosecuted and enforced in a manner consistent with the best interests of our business.

Moreover, our competitors independently

may develop equivalent knowledge, methods and know-how or discover workarounds to our patents that would not constitute infringement.

Any of these outcomes could impair our ability to enforce the exclusivity of our patents effectively, which may have an adverse

impact on our business, financial condition and operating results.

to legal standards relating to patentability, validity, enforceability and claim scope of patents covering pharmaceutical inventions,

our ability to obtain, maintain and enforce patents is uncertain and involves complex legal and factual questions especially across

Accordingly, rights under any existing patents or any patents we might obtain or license may not cover our product

candidates or may not provide us with sufficient protection for our product candidates to afford a sustainable commercial advantage

against competitive products or processes, including those from branded, generic and over-the-counter pharmaceutical companies.

In addition, we cannot guarantee that any patents or other intellectual property rights will issue from any pending or future

patent or other similar applications owned by or licensed to us.

Even if patents or other intellectual property rights have issued

or will issue, we cannot guarantee that the claims of these patents and other rights are or will be held valid or enforceable

by the courts, through injunction or otherwise, or will provide us with any significant protection against competitive products

or otherwise be commercially valuable to us in every country of commercial significance that we may target.

in the field of immunology and oncology therapeutics have created a substantial amount of prior art, including scientific publications,

posters, presentations, patents and patent applications and other public disclosures including on the Internet.

Our ability to

obtain and maintain valid and enforceable patents depends on whether the differences between our technology and the prior art

allow our technology to be patentable over the prior art.

We do not have outstanding issued patents covering all of the recent

developments in our technology and are unsure of the patent protection that we will be successful in obtaining, if any.

the patents do successfully issue, third parties may design around or challenge the validity, enforceability or scope of such

issued patents or any other issued patents we own or license, which may result in such patents being narrowed, invalidated or

held unenforceable.

If the breadth or strength of protection provided by the patents we hold or pursue with respect to our product

candidates is challenged, it could dissuade companies from collaborating with us to develop or threaten our ability to commercialize

or finance our product candidates.

laws of some foreign jurisdictions do not provide intellectual property rights to the same extent or duration as in the United

States, and many companies have encountered significant difficulties in acquiring, maintaining, protecting, defending and especially

enforcing such rights in foreign jurisdictions.

If we encounter such difficulties in protecting, or are otherwise precluded from

effectively protecting, our intellectual property in foreign jurisdictions, our business prospects could be substantially harmed,

especially internationally.

trade secrets and unpatented know-how are also very important to our business.

Although we have taken steps to protect our trade

secrets and unpatented know-how by entering into confidentiality agreements with third parties, and intellectual property protection

agreements with officers, directors, employees, and certain consultants and advisors, there can be no assurance that binding agreements

will not be breached or enforced by courts, that we would have adequate remedies for any breach, including injunctive and other

equitable relief, or that our trade secrets and unpatented know-how will not otherwise become known, inadvertently disclosed by

us or our agents and representatives, or be independently discovered by our competitors.

If trade secrets are independently discovered,

we would not be able to prevent their use and if we and our agents or representatives inadvertently disclose trade secrets and/or

unpatented know-how, we may not be allowed to retrieve this and maintain the exclusivity we previously enjoyed.

may not be able to protect our intellectual property rights throughout the world.

prosecuting and defending patents on our product candidates does not guarantee exclusivity.

The requirements for patentability

differ in certain countries, particularly developing countries.

In addition, the laws of some foreign countries do not protect

intellectual property rights to the same extent as laws in the United States, especially when it comes to granting use and other

kinds of patents and what kind of enforcement rights will be allowed, especially injunctive relief in a civil infringement proceeding.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States

and even in launching an identical version of our product notwithstanding we have a valid patent in that country.

may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products, or produce

copy products, and, further, may export otherwise infringing products to territories where we have patent protection but enforcement

on infringing activities is inadequate or where we have no patents.

These products may compete with our products, and our patents

or other intellectual property rights may not be effective or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and

other intellectual property protection, particularly those relating to pharmaceuticals, and the judicial and government systems

are often corrupt, which could make it difficult for us to stop the infringement of our patents or marketing of competing products

in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions could result

in substantial costs and divert our efforts and attention from other aspects of our business, could put our global patents at

risk of being invalidated or interpreted narrowly and our global patent applications at risk of not issuing, and could provoke

third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate or infringement actions brought

against us, and the damages or other remedies awarded, if any, may not be commercially meaningful when we are the plaintiff.

we are the defendant we may be required to post large bonds to stay in the market while we defend ourselves from an infringement

addition, certain countries in Europe and certain developing countries have compulsory licensing laws under which a patent owner

may be compelled to grant licenses to third parties, especially if the patent owner does not enforce or use its patents over a

protracted period of time.

In some cases, the courts will force compulsory licenses on the patent holder even when finding the

patent holder’s patents are valid if the court believes it is in the best interests of the country to have widespread access

to an essential product covered by the patent.

In these situations, the royalty the court requires to be paid by the license holder

receiving the compulsory license is not calculated at fair market value and can be inconsequential, thereby disaffecting the patent

holder’s business.

In these countries, we may have limited remedies if our patents are infringed or if we are compelled

to grant a license to our patents to a third party, which could also materially diminish the value of those patents.

limit our potential revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world

may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license, especially

in comparison to what we enjoy from enforcing our intellectual property rights in the Unites States.

Finally, our ability to protect

and enforce our intellectual property rights may be adversely affected by unforeseen changes in both U.S.

and foreign intellectual

property laws, or changes to the policies in various government agencies in these countries, including but not limited to the

patent office issuing patents and the health agency issuing pharmaceutical product approvals For example, in Brazil, pharmaceutical

patents require initial approval of the Brazilian health agency (ANVISA).

Finally, many countries have large backlogs in patent

prosecution, and in some countries in Latin America it can take years, even decades, just to get a pharmaceutical patent application

reviewed notwithstanding the merits of the application.

and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements

imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these

requirements.

maintenance and annuity fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages

over the lifetime of the patent.

The USPTO and various foreign governmental patent agencies require compliance with a number of

procedural, documentary, fee payment and other similar provisions during the patent application process.

While an inadvertent

lapse can, in many cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are

situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial

or complete loss of patent rights in the relevant jurisdiction just for failure to know about and/or timely pay a prosecution

Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond

to official actions within prescribed time limits, non-payment of fees in prescribed time periods, and failure to properly legalize

and submit formal documents in the format and style the country requires.

If we or our licensors fail to maintain the patents

and patent applications covering our product candidates for any reason, our competitors might be able to enter the market, which

would have an adverse effect on our business.

we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are

important to our business.

Additionally, these agreements may be subject to disagreement over contract interpretation, which could

narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations

to our licensors.

have entered into in-license arrangements with respect to certain of our product candidates.

These license agreements impose various

diligence, milestone, royalty, insurance and other obligations on us.

If we fail to comply with these obligations, the respective

licensors may have the right to terminate the license, in which event we may not be able to develop or market the affected product

The loss of such rights could materially adversely affect our business, financial condition, operating results and

we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and

could prevent or delay us from developing or commercializing our product candidates.

commercial success depends on our ability to develop, manufacture, market and sell our product candidates and use our proprietary

technologies without infringing the proprietary rights of third parties.

We cannot assure that marketing and selling such candidates

and using such technologies will not infringe existing or future patents.

Numerous U.S.- and foreign-issued patents and pending

patent applications owned by third parties exist in the fields relating to our product candidates.

As the biotechnology and pharmaceutical

industries expand and more patents are issued, the risk increases that others may assert that our product candidates, technologies

or methods of delivery or use infringe their patent rights.

Moreover, it is not always clear to industry participants, including

us, which patents and other intellectual property rights cover various drugs, biologics, drug delivery systems or their methods

of use, and which of these patents may be valid and enforceable.

Thus, because of the large number of patents issued and patent

applications filed in our fields across many countries, there may be a risk that third parties may allege they have patent rights

encompassing our product candidates, technologies or methods.

addition, there may be issued patents of third parties that are infringed or are alleged to be infringed by our product candidates

or proprietary technologies notwithstanding patents we may possess.

Because some patent applications in the United States may

be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions

are typically not published until 18 months after filing and because publications in the scientific literature often lag behind

actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our own and

in-licensed issued patents or our pending applications.

Our competitors may have filed, and may in the future file, patent applications

covering our product candidates or technology similar to our technology.

Any such patent application may have priority over our

own and in-licensed patent applications or patents, which could further require us to obtain rights to issued patents covering

such technologies, which may mean paying significant licensing fees or the like.

If another party has filed a U.S.

patent application on inventions similar to those owned or in-licensed

to us, or, in the case of in-licensed technology, the licensor may have to participate, in the United States, in an interference

proceeding to determine priority of invention.

We may be exposed to, or threatened with,

future litigation by third parties having patent or other intellectual property rights alleging that our product candidates or

proprietary technologies infringe such third parties’

intellectual property rights, including litigation resulting from

filing under Paragraph IV of the Hatch-Waxman Act or other countries’

laws similar to the Hatch-Waxman Act.

These lawsuits

could claim that there are existing patent rights for such drug, and this type of litigation can be costly and could adversely

affect our operating results and divert the attention of managerial and technical personnel, even if we do not infringe such patents

or the patents asserted against us is ultimately established as invalid.

There is a risk that a court would decide that we are

infringing the third party’s patents and would order us to stop the activities covered by the patents.

In addition, there

is a risk that a court will order us to pay the other party significant damages for having violated the other party’s patents.

Because we rely on certain third-party

licensors and partners and will continue to do so in the future, if one of our licensors or partners is sued for infringing a

third party’s intellectual property rights, our business, financial condition, operating results and prospects could suffer

in the same manner as if we were sued directly.

In addition to facing litigation risks, we have agreed to indemnify certain third-party

licensors and partners against claims of infringement caused by our proprietary technologies, and we have entered or may enter

into cost-sharing agreements with some our licensors and partners that could require us to pay some of the costs of patent litigation

brought against those third parties whether or not the alleged infringement is caused by our proprietary technologies.

instances, these cost-sharing agreements could also require us to assume greater responsibility for infringement damages than

would be assumed just on the basis of our technology.

The occurrence of any of the foregoing

could adversely affect our business, financial condition or operating results.

We may be subject to claims that our officers, directors,

employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former

employers or their former or current customers.

As is common in the biotechnology and

pharmaceutical industries, certain of our employees were formerly employed by other biotechnology or pharmaceutical companies,

including our competitors or potential competitors.

Moreover, we engage the services of consultants to assist us in the development

of our products and product candidates, many of whom were previously employed at, or may have previously been or are currently

providing consulting services to, other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We may be subject to claims that these employees and consultants or the Company has inadvertently or otherwise used or disclosed

trade secrets or other proprietary information of their former employers or their former or current customers.

Although we have

no knowledge of any such claims being alleged to date, if such claims were to arise, litigation may be necessary to defend against

any such claims.

Even if we are successful in defending against any such claims, any such litigation could be protracted, expensive,

a distraction to our management team, not viewed favorably by investors and other third parties, and may potentially result in

an unfavorable outcome.

patent application

on inventions similar to those owned or in-licensed to us, or, in the case of in-licensed technology, the licensor may have to

participate, in the United States, in an interference proceeding to determine priority of invention.

may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights

alleging that our product candidates or proprietary technologies infringe such third parties’

intellectual property rights,

including litigation resulting from filing under Paragraph IV of the Hatch-Waxman Act or other countries’

laws similar to

the Hatch-Waxman Act.

These lawsuits could claim that there are existing patent rights for such drug, and this type of litigation

can be costly and could adversely affect our operating results and divert the attention of managerial and technical personnel,

even if we do not infringe such patents or the patents asserted against us is ultimately established as invalid.

There is a risk

that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered

by the patents.

In addition, there is a risk that a court will order us to pay the other party significant damages for having

violated the other party’s patents.

we rely on certain third-party licensors and partners and will continue to do so in the future, if one of our licensors or partners

is sued for infringing a third party’s intellectual property rights, our business, financial condition, operating results

and prospects could suffer in the same manner as if we were sued directly.

In addition to facing litigation risks, we have agreed

to indemnify certain third-party licensors and partners against claims of infringement caused by our proprietary technologies,

and we have entered or may enter into cost-sharing agreements with some our licensors and partners that could require us to pay

some of the costs of patent litigation brought against those third parties whether or not the alleged infringement is caused by

our proprietary technologies.

In certain instances, these cost-sharing agreements could also require us to assume greater responsibility

for infringement damages than would be assumed just on the basis of our technology.

occurrence of any of the foregoing could adversely affect our business, financial condition or operating results.

may be subject to claims that our officers, directors, employees, consultants or independent contractors have wrongfully used

or disclosed to us alleged trade secrets of their former employers or their former or current customers.

is common in the biotechnology and pharmaceutical industries, certain of our employees were formerly employed by other biotechnology

or pharmaceutical companies, including our competitors or potential competitors.

Moreover, we engage the services of consultants

to assist us in the development of our products and product candidates, many of whom were previously employed at, or may have

previously been or are currently providing consulting services to, other biotechnology or pharmaceutical companies, including

our competitors or potential competitors.

We may be subject to claims that these employees and consultants or the Company has

inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or their

former or current customers.

Although we have no knowledge of any such claims being alleged to date, if such claims were to arise,

litigation may be necessary to defend against any such claims.

Even if we are successful in defending against any such claims,

any such litigation could be protracted, expensive, a distraction to our management team, not viewed favorably by investors and

other third parties, and may potentially result in an unfavorable outcome.

Unregistered Sales of Equity Securities and Use of Proceeds

of Proceeds from Unregistered Securities

of Equity Securities

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What changed 10-Q

Item 1A. Risk Factors