What changed in this filing

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Item 1A. Risk Factors

2026-03-10 compared with 2025-03-05 · 1157 added, 1150 removed, 892 unchanged (72% of the section changed)

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have never generated any revenues.

We are a clinical stage biopharmaceutical company with a 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

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 no products approved for commercial

sale and have not generated any revenue from commercial product sales.

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 have not yet demonstrated an

ability to successfully complete registrational clinical trials and have never completed the development or commercialization 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 are a clinical stage biopharmaceutical

company with a 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 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.

products approved for commercial sale and have not generated any revenue from commercial product sales.

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

or commercialization 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

We expect to incur significant expenses

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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,

our plans 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

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additional product candidates.

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

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

A decline in our value could

also cause you to lose all or part of your investment.

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

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

A decline in our

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

We will need to

raise additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all.

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

pursue regulatory approval of each current and future product candidate and to continue the development of TARA-002 and IV Choline Chloride,

including in new indications or uses.

We will require substantial

additional funds to conduct the costly and time-consuming preclinical studies and clinical trials necessary to pursue regulatory approval

of each current and future product candidate and to continue the development of TARA-002 and IV Choline Chloride, including in new indications

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

the number and

timing of current and future product candidates in the pipeline;

the number and timing of current and 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 and divert our management’s focus on achieving our business

As a result of economic conditions, general global economic uncertainty, U.S.

and foreign political conditions, and other

factors, 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.

Further, in recent years, rising inflation, in part, caused a disruption in the capital markets and an increase

in interest rates.

Despite recent declines in interest rates, further inflation and/or the continuation of elevated interest rates may

lead to a recession or market correction that could impact our access to capital, increase the cost of capital, and could in the future

negatively affect our liquidity.

A recession or market correction, inflation and/or increases in interest rates could materially affect

our business and the value of our common stock.

April 2024, we entered into a Subscription Agreement to sell (i) 9,143,380 shares of common stock, (ii) pre-funded warrants to purchase

1,700,000 shares of common stock, or the April 2024 Pre-Funded Warrants, and (iii) warrants to purchase an aggregate of 10,843,380 shares

of common stock, or the Common Warrants.

The April 2024 Pre-Funded Warrants are immediately exercisable upon issuance at an exercise price

of $0.001 per share and do not expire.

The Common Warrants are exercisable upon issuance at an exercise price of $5.25 per share and may

be exercised at any time on or prior to the earlier of (i) April 10, 2027 and (ii) the date that is 90 days after the public announcement

that the Company has demonstrated a six-month complete response rate of minimum 42% from at least 25 BCG-Unresponsive patients in the

ADVANCED-2 (Cohort B) clinical trial.

December 2024, we entered into an underwriting agreement, or the Underwriting Agreement, to sell (i) 13,690,000 shares of common stock,

and (ii) pre-funded warrants to purchase 2,325,372 shares of common stock, or the December 2024 Pre-Funded Warrants and together with

the April 2024 Pre-Funded Warrants, the Pre-Funded Warrants.

In January 2025, the underwriters partially exercised their option to purchase

a portion of the 2,402,305 additional shares of common stock pursuant to the Underwriting Agreement.

The December 2024 Pre-Funded Warrants

are immediately exercisable upon issuance at an exercise price of $0.001 per share and do not expire.

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 stockholders will be

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.

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 and divert our management’s focus on achieving our business objectives.

of economic conditions, general global economic uncertainty, U.S.

and foreign political conditions, and other factors, 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

Further, in recent years, rising inflation, in part, caused a disruption in the capital markets and an increase in interest rates.

Despite recent declines in interest rates, further inflation and/or the continuation of elevated interest rates may lead to a recession

or market correction that could impact our access to capital, increase the cost of capital, and could in the future negatively affect

our liquidity.

A recession or market correction, inflation and/or increases in interest rates could materially affect our business and

the value of our common stock.

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 stockholders will be diluted.

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.

Our ability to use our net operating loss

carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.

Under current law, federal

net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility

of such federal net operating losses in tax years beginning after December 31, 2020 is limited to 80% of taxable income.

It is uncertain

if and to what extent various states and localities will conform to federal tax laws.

In addition, under Sections 382 and 383 of the Internal

Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change”

which is generally defined as a greater than 50% change in its equity ownership value over a three-year period, the corporation’s

ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post- change income or

taxes may be limited.

We have experienced ownership changes in the past and we may also experience additional ownership changes in the

future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control.

If an ownership change occurs

and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively

increasing our future tax obligations.

In addition, at the state level, there may be periods during which the use of net operating loss

carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.

As a result, if we earn

net taxable income, we may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes,

which could potentially result in increased future tax liability to us and adversely affect our future cash flows.

The Common Warrants

are speculative in nature.

Common Warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends,

but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time.

Specifically, the

Common Warrants are exercisable upon issuance at an exercise price of $5.25 per share and may be exercised at any time on or prior to

the earlier of (i) April 10, 2027 and (ii) the date that is 90 days after the public announcement that the Company has demonstrated a

six-month complete response rate of minimum 42% from at least 25 BCG-Unresponsive patients in the ADVANCED-2 (Cohort B) clinical trial.

There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the Common Warrants

and consequently, whether it will ever be profitable for holders of the Common Warrants to exercise the warrants.

if the outstanding Common Warrants are exercised in full, we would be entitled to receive the cash exercise price of $5.25 per warrant.

Under current federal tax

law, net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility

of such net operating losses arising in tax years beginning after December 31, 2020 is limited to 80% of taxable income.

Not all states

and localities fully conform to federal tax laws.

In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended,

and corresponding provisions of state law, if a corporation undergoes an “ownership change” which is generally defined as

a greater than 50% change in its equity ownership value over a three-year period, the corporation’s ability to use its pre-change

net operating loss carryforwards and other pre-change tax attributes to offset its post- change income or taxes may be limited.

experienced ownership changes in the past and we may also experience additional ownership changes in the future as a result of subsequent

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

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

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

In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended

or otherwise limited, which could accelerate or permanently increase state taxes owed.

As a result, if we earn net taxable income, we

may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes to offset such income,

which could potentially result in increased future cash tax liability to us and adversely affect our future cash flows.

The April 2024

Common Warrants are speculative in nature.

April 2024 Common Warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to

receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time.

Specifically, the April 2024 Common Warrants are exercisable upon issuance at an exercise price of $5.25 per share and may be exercised

at any time on or prior to the earlier of (i) April 10, 2027 and (ii) the date that is 90 days after the public announcement that the

Company has demonstrated a six-month CR rate of minimum 42% from at least 25 BCG-Unresponsive patients in the ADVANCED-2 (Cohort B) clinical

There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the April 2024

Common Warrants and consequently, whether it will ever be profitable for holders of the April 2024 Common Warrants to exercise the warrants.

exercise of some or all of the April 2024 Common Warrants will dilute the ownership interests of existing stockholders and increase the

number of shares of common stock eligible for resale in the public market.

Any sales in the public market of the shares of common stock

issuable upon such exercise of the April 2024 Common Warrants, or the anticipation of such exercises and sales, could adversely affect

the prevailing market prices of our common stock.

Additionally, the existence of the April 2024 Common Warrants may encourage short selling

by market participants because the exercise of the April 2024 Common Warrants could be used to satisfy short positions, or because the

anticipated exercise of the April 2024 Common Warrants for shares of common stock could depress the price of our common stock.

if the outstanding April 2024 Common Warrants are exercised in full, we would be entitled to receive the cash exercise price of $5.25

We would be able to use these additional proceeds to fund our operations.

To the extent the market price of our common stock does not

equal or exceed the exercise price of the Common Warrants before they expire, we would not be entitled to these proceeds, and we may be

required to pursue additional financing alternatives.

To the extent the market price of our common stock

does not equal or exceed the exercise price of the April 2024 Common Warrants before they expire, we would not be entitled to these proceeds,

and we may be required to pursue additional financing alternatives.

Risks Related to Drug/Biologics Development and Commercialization

Our business depends on the successful

preclinical and clinical development, regulatory approval and commercialization of our product candidates, including TARA-002 and IV

Choline Chloride.

The success of our business, including our ability to finance our operations

and generate revenue in the future, primarily depends on the successful development, regulatory approval and commercialization of our

product candidates, including of TARA-002 and IV Choline Chloride.

The clinical and commercial success of our product candidates, including

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

the timely and successful completion of planned and ongoing non-clinical studies and clinical trials,

including our ongoing Phase 2 clinical trial of TARA-002 in NMIBC, our ongoing Phase 2 clinical trial of TARA-002 in LMs and our planned

Phase 2b/3 clinical trial of IV Choline Chloride, which may be significantly slower or costlier than we currently anticipate and/or produce

results that do not achieve the endpoints of the trials;

INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials

for our product candidates;

● positive results from our current and future clinical programs

that support a finding of safety and effectiveness and an acceptable benefit-risk profile of our product candidates in the intended populations;

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 our product candidates;

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 our product candidates;

the ability of third parties with whom we contract to manufacture adequate clinical trial and commercial

supplies of our product candidates, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially

viable manufacturing processes that are compliant with cGMP;

Our business depends on the successful preclinical

and clinical development, regulatory approval and commercialization of our product candidates, including TARA-002 and IV Choline Chloride.

The success of our business,

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

approval and commercialization of our product candidates, including of TARA-002 and IV Choline Chloride.

The clinical and commercial success

of our product candidates, including TARA-002 and IV Choline Chloride, depend on a number of factors, including the following:

the timely and successful completion of planned and ongoing non-clinical studies and clinical trials, including our ongoing Phase 2 clinical trial of TARA-002 in NMIBC, our ongoing Phase 2 clinical trial of TARA-002 in LMs and our ongoing Phase 2b/3 clinical trial of IV Choline Chloride, which may be significantly slower or costlier than we currently anticipate and/or produce results that do not achieve the endpoints of the trials;

effective INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;

positive results from our current and future clinical programs that support a finding of safety and effectiveness and an acceptable benefit-risk profile of our product candidates in the intended populations;

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 our product candidates;

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 our product candidates;

the ability of third parties with whom we contract to manufacture adequate clinical trial and commercial supplies of our product candidates, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing processes that are compliant with cGMP;

receipt of marketing approvals from applicable regulatory authorities;

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commercial launch of our product candidates, if approved, whether alone or in collaboration with others;

● a continued acceptable safety, tolerability and efficacy profile during

clinical development and following approval of our product candidates;

a continued acceptable safety, tolerability and efficacy profile during clinical development and following approval of our product candidates;

acceptance of the benefits and use of our product candidates, including method of administration, if and when approved, by patients, the medical community and third-party payors;

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establishment and maintenance of healthcare coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement;

the existence of a regulatory environment conducive to the successful development of our product

candidates, including in the event of a potential or actual government shutdown affecting Federal agencies, or in the event of any changes

and/or additional regulations relating to the FDA as a result of the new U.S.

presidential administration, which could impact the FDA’s

staffing, resources and ability to timely review and process regulatory submissions, prevent, limit or delay regulatory approval of our

product candidates, limit the marketability of our product candidates, or that could impose additional regulatory obligations on us.

the existence of a regulatory environment conducive to the successful development of our product candidates, including in the event of a potential or actual government shutdown affecting Federal agencies, or in the event of any changes and/or additional regulations relating to the FDA as a result of the current U.S.

Presidential Administration, which could impact the FDA’s staffing, resources and ability to timely review and process regulatory submissions, prevent, limit or delay regulatory approval of our product candidates, limit the marketability of our product candidates, or that could impose additional regulatory obligations on us.

If any one of these factors

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of our product candidates, including TARA-002 or IV Choline Chloride.

Our clinical trials may take longer to enroll than anticipated

due to competing clinical trials or otherwise or 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 increase our costs or necessitate the abandonment

or limitation of the development of the product candidate.

Our clinical trials may take

longer to enroll than anticipated due to competing clinical trials or otherwise or 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 increase

our costs or necessitate the abandonment or limitation of the development of the product candidate.

We have never completed a registrational

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

The conduct of a clinical trial

is a long, expensive, complicated and highly regulated process.

Although our employees have conducted successful clinical trials and made

regulatory submissions in the past across many therapeutic areas while employed at other companies, we, as a company, have not completed

any registrational clinical trials, or submitted a BLA or NDA and as a result may require more time and incur greater costs than we anticipate.

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

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

impact our financial performance.

The conduct of a clinical

trial is a long, expensive, complicated and highly regulated process.

Although our employees have conducted successful clinical trials

and made regulatory submissions in the past across many therapeutic areas while employed at other companies, we, as a company, have not

completed any registrational clinical trials, or submitted a BLA or NDA and as a result may require more time and incur greater costs

than we anticipate.

Failure to commence or complete, or delays in registrational clinical trials or planned regulatory submissions would

prevent us from, or delay us, in obtaining potential regulatory approval of and commercializing TARA-002 or IV Choline Chloride, which

would adversely impact our financial performance.

Disruptions at the FDA or other comparable

foreign regulatory authorities may also slow the time necessary for new products to be reviewed and/or approved, which would adversely

affect our business.

In addition, there is substantial uncertainty regarding the new U.S.

Presidential Administration’s initiatives

foreign regulatory authorities may extend the time necessary for new products to be reviewed and/or approved, which would adversely affect

our business.

In addition, there is substantial uncertainty regarding new initiatives under the current U.S.

Presidential Administration

and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel.

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product candidates, which would adversely affect our business.

Disruptions at the FDA or other

comparable foreign regulatory authorities may also slow the time necessary for new products to be reviewed and/or approved, which would

Disruptions at the FDA or

other comparable foreign regulatory authorities may extend the time necessary for new products to be reviewed and/or approved, which would

adversely affect our business.

Changes in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review

submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at

Similar consequences would also result in the event of another significant shutdown of the federal government.

For example, in 2024,

government was on the verge of a shutdown and has previously shut down several times, and certain regulatory agencies, such as

the FDA, had to furlough critical employees and stop critical activities.

If a prolonged government shutdown occurs, or if geopolitical

or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other

regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process

our regulatory submissions, which could have a material adverse effect on our business.

Further, future government shutdowns or delays

could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

If the FDA is constrained in its ability to engage in oversight and implementation activities in the normal course, our business may be

negatively impacted.

For example, starting in January 2025, the current U.S.

Presidential Administration has reduced the number

of federal employees, including at the FDA, by establishing voluntary termination programs, by position eliminations and by involuntary

terminations.

Changes in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions

or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

consequences may also occur as a result of a significant shutdown of the federal government.

For example, over the last several years,

and most recently in late 2025, the U.S.

government has shut down several times, and certain regulatory agencies, such as the FDA, had

to furlough critical employees and stop critical activities.

If a prolonged government shutdown occurs, or if geopolitical or global health

concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities,

or if the volume of applications to the FDA for new product candidates increases materially, it could significantly impact the ability

of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse

effect on our business.

Further, future government shutdowns or delays could impact our ability to access the public markets and obtain

necessary capital in order to properly capitalize and continue our operations.

If the FDA is constrained in its ability to engage in oversight

and implementation activities in the normal course, our business may be negatively impacted.

In addition, FDA-regulated

industries, such as ours, face substantial uncertainty in regard to the regulatory environment we will face as we proceed with research

and development efforts following the inauguration of President Trump in January 2025.

Some of these efforts have manifested to date in

the form of personnel measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays

or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory

approvals in the future.

Moreover, the new U.S.

Presidential Administration has proposed action to freeze or reduce the budget of the

National Institutes of Health, or NIH, as related to its funding for medical research, which could decrease the ability of facilities

that rely on NIH funding to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials.

There remains

general uncertainty regarding future activities.

Presidential Administration could issue or promulgate executive orders,

regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development

of new therapeutic products.

Alternatively, state governments may attempt to address or react to changes at the federal level with changes

to their own regulatory frameworks in a manner that is adverse to our operations.

If we become negatively impacted by future governmental

orders, regulations, policies or guidance as a result of the new U.S.

Presidential Administration, there could be a material adverse effect

on us and our business.

industries, such as ours, face substantial uncertainty in regard to the regulatory environment we face as we proceed with research and

development efforts following the inauguration of the current U.S.

Presidential Administration in January 2025.

Some of these

efforts have manifested to date as efforts to reduce the size of the federal government, including large-scale reductions in force at

The loss of key personnel at the FDA, including those in leadership positions, is likely to impact operations at the FDA, which

could result in, among other things, delays or limitations on our ability to obtain guidance from the FDA on our product candidates in

development, longer review times, and delays in obtaining the requisite regulatory approvals of our product candidates.

Moreover, the

Presidential Administration has paused payments by, reduced the budget of, and terminated grants provided by the National

Institutes of Health, or NIH, as related to its funding for medical research, which has decreased, and may continue to decrease, the ability

of facilities that rely on NIH funding to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials.

Some of these actions have been challenged in court and there remains general uncertainty regarding future activities.

The current U.S.

Presidential Administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us

or create a more challenging or costly environment to pursue the development of new therapeutic products.

Alternatively, state governments

may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse

to our operations.

If we become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the

Presidential Administration, there could be a material adverse effect on us and our business.

Even if a product candidate

obtains regulatory approval, it may fail to achieve the broad degree of 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.

and rate of physician and patient adoption of a product, if approved, and successful commercialization will depend on a number of factors,

including but not limited to:

efficacy, durability and safety of such product as demonstrated in clinical trials;

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

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, and successful commercialization will depend on a number

of factors, including but not limited to:

the efficacy, durability and safety of such product as demonstrated in clinical trials;

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

the willingness of the target population to try new therapies;

the safety and effectiveness and potential and perceived advantages of the product compared to other available therapies;

the availability of coverage and adequate reimbursement from managed care plans and other healthcare payors and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement;

the availability of coverage and adequate reimbursement from third-party payors such as private health insurers, managed care plans, and other healthcare payors and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement;

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

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patient satisfaction with the results, administration and overall treatment experience;

the ability to successfully commercialize the product in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others;

the ability to

successfully commercialize the product in the U.S.

and internationally, if approved for marketing, sale and distribution in such

countries and territories, whether alone or in collaboration with others;

our ability and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates;

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;

any FDA requirement to undertake a REMS;

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

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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 market acceptance by physicians, patients, third-party payors and

others in the medical community 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.

If either TARA-002 or IV

Choline Chloride is approved for use but fails to achieve the broad degree of market acceptance by physicians, patients, third-party payors

and others in the medical community 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.

Further, even if regulatory

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you that we will be able to generate sufficient revenue through the sale of TARA-002 or IV Choline Chloride to continue our business.

Preclinical and clinical development involve

Preclinical and clinical development involves

lengthy and expensive processes with uncertain outcomes.

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be unable to complete, the development of our current product candidates or any future product candidates.

All of our current product candidates are in clinical development

and their risk of failure is high.

It is impossible to predict when or if any of our product candidates will receive regulatory approval.

To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive non-clinical

studies and lengthy, complex and expensive clinical trials that our product candidates are safe and effective in humans.

Clinical testing

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

Failure can occur at any time during the clinical trial

The results of non-clinical studies and early clinical trials or early cohorts of our clinical trials of our product candidates

may not be predictive of the results of later-stage clinical trials or later cohorts of our clinical trials.

Moreover, a clinical trial

can fail at any stage of testing.

Differences in clinical trial design between early-stage clinical trials and later-stage clinical trials

make it difficult to extrapolate the results of earlier clinical trials to later clinical trials.

Additionally, clinical data are often

susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily

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

A number of companies in the biotechnology

industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or to unfavorable safety profiles, notwithstanding

promising results in earlier clinical trials.

There is typically a high rate of failure of product candidates proceeding through clinical

Most product candidates that commence clinical trials are never approved as products and there can be no assurance that any of

our future clinical trials will ultimately be successful or support clinical development of our current or any of our future product candidates.

Patient enrollment, a significant factor in the timing of clinical

trials, is affected by many factors including:

All of our current product

candidates are in clinical development and their risk of failure is high.

It is impossible to predict when or if any of our product candidates

will receive regulatory approval.

To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate

through extensive non-clinical studies and lengthy, complex and expensive clinical trials that our product candidates are safe and effective

Clinical testing can take many years to complete, and its outcome is inherently uncertain.

Failure can occur at any time

during the clinical trial process.

The results of non-clinical studies and early clinical trials or early cohorts of our clinical trials

of our product candidates may not be predictive of the results of later-stage clinical trials or later cohorts of our clinical trials.

Moreover, a clinical trial can fail at any stage of testing.

Differences in clinical trial design between early-stage clinical trials

and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials.

Additionally,

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

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

A number of companies

in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or to unfavorable

safety profiles, notwithstanding promising results in earlier clinical trials.

There is typically a high rate of failure of product candidates

proceeding through clinical trials.

Most product candidates that commence clinical trials are never approved as products and there can

be no assurance that any of our current or future clinical trials will ultimately be successful or support clinical development of our

current or any of our future product candidates.

Patient enrollment, a significant

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

the size and nature of the patient population;

the number and location of clinical sites

and location of clinical sites we enroll;

the proximity of patients to clinical sites;

the eligibility and exclusion criteria for the clinical trial;

the design of the

the eligibility and exclusion criteria for the

clinical trial;

the design of the clinical trial;

the inability to obtain and maintain patient consents;

the risk that enrolled participants will drop out before completion;

and competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product candidate

being studied in relation to other available therapies, including any new drugs or therapeutic biologics that may be approved for the

indications being investigated by us.

Furthermore, we expect to rely on our collaborators, contract research organizations, or CROs, and

clinical trial sites to ensure the proper and timely conduct of our future clinical trials, including the patient enrollment process,

and we have limited influence over their performance.

These factors could increase our costs or necessitate the abandonment or limitation

of the development of our product candidates.

We could also encounter delays if a clinical trial is suspended

or terminated by us, the IRBs of the institutions in which such clinical trials are being conducted, or the FDA or other regulatory authorities,

or if a clinical trial is recommended for suspension or termination by the independent data monitoring committee for such clinical trial.

the risk that enrolled participants

will drop out before completion;

and competing clinical trials and clinicians’ and patients’ perceptions as to the potential

advantages of the product candidate being studied in relation to other available therapies, including any new drugs or therapeutic biologics

that may be approved for the indications being investigated by us.

Furthermore, we expect to rely on our collaborators, contract research

organizations, or CROs, and clinical trial sites to ensure the proper and timely conduct of our future clinical trials, including the

patient enrollment process, and we have limited influence over their performance.

These factors could increase our costs or necessitate

the abandonment or limitation of the development of our product candidates.

We could also encounter delays

if a clinical trial is suspended or terminated by us, the IRBs of the institutions in which such clinical trials are being conducted,

or the FDA or other regulatory authorities, or if a clinical trial is recommended for suspension or termination by the independent data

monitoring committee for such clinical trial.

A suspension or termination may be imposed due to a number of factors, including:

failure to conduct the clinical trial in accordance

with regulatory requirements or our clinical protocols;

inspection of the clinical trial operations or clinical trial site by the FDA

or other regulatory authorities resulting in the imposition of a clinical hold;

unforeseen safety issues or adverse side effects;

to demonstrate a benefit from using a product or treatment;

failure to establish or achieve clinically meaningful clinical trial endpoints;

to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

inspection of the clinical trial operations

or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

unforeseen safety issues

or adverse side effects;

failure to demonstrate a benefit from using a product or treatment;

failure to establish or achieve clinically

meaningful clinical trial endpoints;

changes in governmental regulations or administrative actions;

or lack of adequate funding to continue the clinical trial.

Clinical studies

may also be delayed or terminated as a result of ambiguous or negative interim results.

Many of the factors that cause, or lead to, a

delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product

Further, the FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation of data

from clinical trials, or may change the requirements for approval even after they have reviewed and commented on the design for our clinical

or lack of adequate funding to continue

the clinical trial.

Clinical studies may also be delayed or terminated as a result of ambiguous or negative interim results.

factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of

regulatory approval of our product candidates.

Further, the FDA or other regulatory authorities may disagree with our clinical trial design

and our interpretation of data from clinical trials, or may change the requirements for approval even after they have reviewed and commented

on the design for our clinical trials.

Our product development expenses

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If these third parties do not meet our requirements

or otherwise conduct the clinical trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory

approval for, or commercialize, our product candidates.

We rely, and expect to continue to rely, on third-party CROs to

conduct and oversee our TARA-002 and IV Choline Chloride clinical trials and studies and other aspects of product development.

rely on various medical institutions, clinical investigators and contract laboratories to conduct our clinical trials in accordance with

our clinical protocols and all applicable regulatory requirements, including the FDA’s regulations and cGCP, 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 record-keeping for drug and biologic products.

CROs and other third parties have and will continue to play a significant role in the conduct of these clinical 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,

preclinical and non-clinical 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 cGCP and cGLP, requirements, which are regulations and guidelines enforced by the FDA and

comparable foreign regulatory authorities.

Regulatory authorities enforce these cGCP and cGLP requirements through periodic inspections

of clinical trial sponsors, principal investigators and clinical trial sites.

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

applicable cGCP and cGLP requirements, or reveal non-compliance 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 trials or preclinical studies comply with applicable cGCP and cGLP requirements.

or otherwise conduct the clinical trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval

for, or commercialize, our product candidates.

We rely, and expect to continue

to rely, on third-party CROs to conduct and oversee our TARA-002 and IV Choline Chloride clinical trials and studies and other aspects

of product development.

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

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

and cGCP, 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 record-keeping

for drug and biologic products.

These CROs and other third parties have and will continue to play a significant role in the conduct of

these clinical 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, preclinical and non-clinical 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 cGCP and cGLP, requirements, which are regulations and

guidelines enforced by the FDA and comparable foreign regulatory authorities.

Regulatory authorities enforce these cGCP and cGLP requirements

through periodic inspections of clinical trial sponsors, principal investigators and clinical trial sites.

If we or any of these third

parties fail to comply with applicable cGCP and cGLP requirements, or reveal non-compliance 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 trials or preclinical studies comply with applicable cGCP

and cGLP requirements.

In addition, our clinical trials generally must be conducted with product candidate 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.

Our failure to comply with these regulations and policies may require us to repeat clinical trials, which would delay the regulatory approval

If any of our CROs or clinical

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result in material changes in the final data.

In 2024, we released preliminary data from our clinical trials.

From time to time, we may publicly disclose further preliminary, interim or topline data from our preclinical, non-clinical studies and

clinical trials, which is based on a preliminary analysis of then-available data.

The results and related findings and conclusions of

any interim or preliminary data, including from our 2024 data releases, as well as any future releases of any interim or preliminary data

are subject to change as patient enrollment and treatment continues and more patient data become available.

Adverse differences between

previous preliminary or interim data and future interim or final data could significantly harm our business prospects.

We may also announce

topline data following the completion of a preclinical study or clinical trial, which may be subject to change following a more comprehensive

review of the data related to the particular study or clinical trial.

We also make assumptions, estimations, calculations and conclusions

as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.

the interim, topline or preliminary results that we report may differ from future results of the same studies, or different conclusions

or considerations may qualify such results, once additional data have been received and fully evaluated.

Preliminary, interim, or topline

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

we previously published.

Accordingly, preliminary, interim, and topline data should be viewed with caution until the final data are available.

From time to time, we may

publicly disclose further preliminary, interim or topline data from our preclinical, non-clinical studies and clinical trials, which is

based on a preliminary analysis of then-available data.

For example, in 2026, we released interim data from our clinical trials and expect

to continue to release interim data from such trials in advance of releasing final, fully-evaluated data.

The results and related findings

and conclusions of any interim or preliminary data, including from our 2026 data release, as well as any future releases of any interim

or preliminary data are subject to change as patient enrollment and treatment continues and more patient data become available.

differences between previous preliminary or interim data and future interim or final data could significantly harm our business prospects.

We may also announce topline data following the completion of a preclinical study or clinical trial, which may be subject to change following

a more comprehensive review of the data related to the particular study or clinical trial.

We also make assumptions, estimations, calculations

and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all

As a result, the interim, topline or preliminary results that we report may differ from future results of the same studies, or different

conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.

Preliminary, interim,

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

from the data we previously published.

Accordingly, preliminary, interim, and topline data should be viewed with caution until the final

data are available.

Further, others, including

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The clinical development of our product

candidates has included and may continue to include clinical trial sites outside the United States, and the FDA and applicable foreign

regulatory authorities may not accept data from such sites.

The clinical development of our product candidates has included

and may continue to include clinical trial sites outside the United States and we may in the future choose to conduct one or more of our

full clinical trials outside of the United States.

For example, our ongoing Phase 2 ADVANCED-2 clinical trial of TARA-002 in NMIBC is

being conducted in the U.S., Canada, Argentina and Ukraine.

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 authorities may be subject to certain conditions or exclusions.

Where data from foreign clinical trials or clinical

trial sites 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.

candidates has included and may continue to include clinical trial sites outside the U.S., and the FDA and applicable foreign regulatory

authorities may not accept data from such sites.

The clinical development

of our product candidates has included and may continue to include clinical trial sites outside the U.S.

and we may in the future choose

to conduct one or more of our full clinical trials outside of the U.S.

For example, our ongoing Phase 2 ADVANCED-2 clinical trial of TARA-002

in NMIBC is being conducted in the U.S., and in a number of other countries.

Although the FDA or applicable foreign regulatory authority

may accept data from clinical trials conducted outside the U.S.

or the applicable jurisdiction, acceptance of such study data by the FDA

or applicable foreign regulatory authorities may be subject to certain conditions or exclusions.

Where data from foreign clinical trials

or clinical trial sites are intended to serve as the basis for marketing approval in the U.S., 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.

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.

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.

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There can be no assurance the FDA or applicable

foreign regulatory authority will accept data from clinical 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 clinical

trials, which would be costly and time-consuming and delay aspects of our business plan.

foreign regulatory authority will accept data from clinical trials conducted outside of the U.S.

or the applicable home country.

FDA or applicable foreign regulatory authority does not accept such data, it would likely result in the need for additional clinical trials,

which would be costly and time-consuming and delay aspects of our business plan.

TARA-002 is an immunopotentiator, and one

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for our clinical trials or slower commercial revenue if approved.

Our current product candidates are targeting certain disorders

that have low incidence and prevalence.

For example, we estimate the prevalence of LMs in the United States is approximately 1,400-1,800

Our current product candidates

are targeting certain disorders that have low incidence and prevalence.

For example, we estimate the incidence of LMs in the U.S.

is approximately

1,400-1,800 cases per year.

This could be a significant obstacle to the timely recruitment and enrollment of a sufficient number of eligible patients

into our clinical trial.

This could be a significant obstacle to the timely recruitment and enrollment of a sufficient number of eligible

patients into our clinical trial.

Further, we expect to rely in part on our relationships with patient advocacy groups to assist in identifying

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may be affected by other factors including:

severity of the disease under investigation;

of the study protocol;

the severity of the disease under investigation;

design of the study protocol;

the eligibility criteria for the clinical trial;

perceived risks, benefits and convenience of administration of the product candidate being studied;

efforts to facilitate timely enrollment in clinical trials;

availability of other clinical trials being conducted for the same indication;

patient referral practices of physicians;

proximity and availability of clinical trial sites to prospective patients.

the perceived risks, benefits and convenience of administration of the product candidate being studied;

our efforts to facilitate timely enrollment in clinical trials;

the availability of other clinical trials being conducted for the same indication;

the patient referral practices of physicians;

the proximity and availability of clinical trial sites to prospective patients.

Our inability to enroll a

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to obtain additional financing.

Additionally, our projections of the number of people who have these

disorders, including LMs, are based on estimates, including third-party analyses commissioned by us.

The total addressable market opportunity

for our product candidates will ultimately depend upon, among other things, the final approved product labeling for each of our product

candidates, if our product candidates are approved for sale in our target indications, acceptance by the medical community and patient

access, drug pricing and reimbursement.

The number of patients globally may turn out to be lower than expected, patients may not be otherwise

amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which

would adversely affect our results of operations and our business.

Our products may potentially be dosed on a one-time basis, which means

that patients who enroll in our clinical trials may not be eligible to receive our products on a commercial basis if they are

Additionally, our

projections of the number of people who have these disorders, including LMs, are based on estimates, including third-party analyses

commissioned by us.

The total addressable market opportunity for our product candidates will ultimately depend upon, among other

things, the final approved product labeling for each of our product candidates, if our product candidates are approved for sale in

our target indications, acceptance by the medical community and patient access, drug pricing and reimbursement.

The number of

patients globally may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products, or

new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of

operations and our business.

Our products may potentially be dosed on a one-time basis, which means that certain patients who enroll

in our clinical trials may have complete resolution of their LM and never require additional treatment on a commercial basis.

Our product candidates may cause undesirable

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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, clinical 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

Any side effects could affect patient recruitment or the ability of enrolled patients to complete the clinical trial or result

in product liability claims.

Any of these occurrences may harm our business, financial condition, operating results and prospects.

Results of clinical trials

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

In such an event, clinical 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.

Any side effects could affect patient recruitment or the ability of enrolled

patients to complete the clinical 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

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regulatory approval, a number of potentially negative consequences could result, including:

authorities may suspend or withdraw approvals of such product candidate;

authorities may require additional warnings in the labeling;

may be required to change the way a product candidate is administered or conduct additional clinical trials;

could be sued and held liable for harm caused to patients;

reputation may suffer.

regulatory authorities may suspend or withdraw approvals of such product candidate;

regulatory authorities may require additional warnings in the labeling;

we may be required to change the way a product candidate is administered or conduct additional clinical trials;

we could be sued and held liable for harm caused to patients;

our reputation may suffer.

Any of these occurrences

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not lead to a faster development or regulatory review or approval process.

The FDA has granted Fast Track Designation to IV Choline Chloride

as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.

We may seek Fast Track Designation

for other potential indications for IV Choline Chloride or for our other product candidates.

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.

The FDA has broad discretion whether or not to grant this designation, so even if we

believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it.

if we receive Fast Track Designation, we may not experience a faster development process, review or approval, including for IV Choline

Chloride as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated or any other indication.

The FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development

An Orphan Drug Designation by the FDA or European Commission

does not increase the likelihood that our product candidates will receive marketing exclusivity.

We have obtained Orphan Drug

Designation from the FDA for TARA-002 for the treatment of LMs and for IV Choline Chloride for the prevention and/or treatment of choline

deficiency in patients on long-term PN.

We have also obtained Orphan Drug Designation from the European Commission for TARA-002 for the

The FDA has granted FTD to

IV Choline Chloride as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated and TARA-002

for the treatment of pediatric patients with macrocystic and mixed cystic LMs.

We may seek FTD for other potential indications for IV

Choline Chloride or TARA-002 or for our other product candidates.

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 FTD.

The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible

for this designation, we cannot assure you that the FDA would decide to grant it.

Even if we receive FTD, we may not experience a faster

development process, review or approval, including for IV Choline Chloride as a source of choline when oral or enteral nutrition is not

possible, insufficient, or contraindicated or TARA-002 for pediatric patients with macrocystic and mixed cystic LMs or any other indication.

The FDA may withdraw FTD if it believes that the designation is no longer supported by data from our clinical development program.

An Orphan Drug Designation by the FDA or

European Commission does not increase the likelihood that our product candidates will receive marketing exclusivity.

We have obtained ODD from

the FDA for TARA-002 for the treatment of LMs and for IV Choline Chloride for the prevention and/or treatment of choline deficiency in

patients on long-term PN.

We have also obtained Orphan Medicinal Product Designation from the European Commission for TARA-002 for the

treatment of LMs .

We may seek Orphan Drug Designation for future product candidates or other indications, and we may be unsuccessful.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient

populations as orphan drugs and provide them with marketing exclusivity upon approval.

Under the Orphan Drug Act, the FDA may designate

a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population

of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 in the United States where there

is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.

In the United States,

Orphan Drug Designation entitles a party to financial incentives such as tax advantages and user-fee waivers.

Opportunities for grant

funding toward clinical trial costs may also be available for clinical trials of drugs for rare diseases, regardless of whether the drugs

are designated for the orphan use.

In addition, if a product that has Orphan Drug Designation subsequently receives the first FDA approval

for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not

approve any other applications to market the same product for the same indication for seven years, except in limited circumstances.

Although we have obtained Orphan Drug Designation for TARA-002 for

the treatment of LMs and IV Choline Chloride for the prevention and/or treatment of choline deficiency in patients on long-term PN, and

even if we obtain Orphan Drug Designation for additional product candidates or other indications, we may not be the first to obtain marketing

approval of these product candidates for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical

If a competitor with a product that is determined by the FDA to be the same as one of our product candidates obtains marketing

approval before us for the same indication we are pursuing and obtains orphan drug exclusivity, our product candidate may not be approved

until the period of exclusivity ends unless we are able to demonstrate that our product candidate is clinically superior.

Even after obtaining

approval, we may be limited in our ability to market our product.

In addition, exclusive marketing rights in the United States may be

limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines

that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product

to meet the needs of patients with the rare disease or condition.

Further, even if we obtain orphan drug exclusivity for a product, that

exclusivity may not effectively protect the product from competition because different drugs with different principal molecular structural

features can be approved for the same condition.

Even after a product is approved with orphan drug exclusivity, the FDA can subsequently

approve the same drug for the same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution

to patient care.

Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug

any advantage in the regulatory review or approval process.

We may seek ODD for future product candidates or other indications, and we may be unsuccessful in those efforts.

Regulatory authorities in some jurisdictions, including the U.S.

and Europe, may designate drugs for relatively small patient populations

as orphan drugs and provide them with marketing exclusivity upon approval.

Under the Orphan Drug Act, the FDA may designate a drug as

an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer

than 200,000 individuals in the U.S., or a patient population greater than 200,000 in the U.S.

where there is no reasonable expectation

that the cost of developing the drug will be recovered from sales in the U.S.

In the U.S., ODD entitles a party to financial incentives

such as tax advantages and user-fee waivers.

Opportunities for grant funding toward clinical trial costs may also be available for clinical

trials of drugs for rare diseases, regardless of whether the drugs are designated for the orphan use.

In addition, if a product that has

ODD subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan

drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for

seven years, except in limited circumstances.

Although we have obtained

ODD for TARA-002 for the treatment of LMs and IV Choline Chloride for the prevention and/or treatment of choline deficiency in patients

on long-term PN, and even if we obtain ODD for additional product candidates or other indications, we may not be the first to obtain

marketing approval of these product candidates for the orphan-designated indication due to the uncertainties associated with developing

pharmaceutical products.

If a competitor with a product that is determined by the FDA to be the same as one of our product candidates

obtains marketing approval before us for the same indication we are pursuing and obtains orphan drug exclusivity, our product candidate

may not be approved until the period of exclusivity ends unless we are able to demonstrate that our product candidate is clinically superior.

Even after obtaining approval, we may be limited in our ability to market our product.

In addition, exclusive marketing rights in the

may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later

determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities

of the product to meet the needs of patients with the rare disease or condition.

Further, even if we obtain orphan drug exclusivity for

a product, that exclusivity may not effectively protect the product from competition because different drugs with different principal

molecular structural features can be approved for the same condition.

Even after a product is approved with orphan drug exclusivity,

the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is safer, more effective

or makes a major contribution to patient care.

ODD neither shortens the development time or regulatory review time of a drug nor gives

the drug any advantage in the regulatory review or approval process.

A Breakthrough Therapy Designation by the

FDA may not lead to a faster development or regulatory review or approval process.

We may seek a Breakthrough Therapy Designation for TARA-002 for

the treatment of NMIBC.

A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or

more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug

may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment

effects observed early in clinical development.

For drugs that have been designated as breakthrough therapies, interaction and communication

between the FDA and the sponsor of the clinical trial can help to identify the most efficient path for clinical development while minimizing

the number of patients placed in ineffective control regimens.

Drugs designated as breakthrough therapies by the FDA are also eligible

for priority review if supported by clinical data at the time of the submission of the marketing application.

The FDA has granted BTD for

TARA-002 for the treatment of pediatric patients with macrocystic and mixed cystic LMs.

We may seek BTD for TARA-002 for other indications

or for our other product candidates.

A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination

with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates

that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints, such as

substantial treatment effects observed early in clinical development.

For drugs that have been designated as breakthrough therapies, interaction

and communication between the FDA and the sponsor of the clinical trial can help to identify the most efficient path for clinical development

while minimizing the number of patients placed in ineffective control regimens.

Drugs designated as breakthrough therapies by the FDA

are also eligible for priority review if supported by clinical data at the time of the submission of the marketing application.

Designation as a breakthrough

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a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event, the receipt of a Breakthrough

Therapy Designation for a drug may not result in a faster development process, review, or approval compared to drugs considered for approval

under conventional FDA procedures and it would not assure ultimate approval by the FDA.

In any event, the receipt of a BTD for

a drug may not necessarily result in a faster development process, review, or approval compared to drugs considered for approval under

conventional FDA procedures and it would not assure ultimate approval by the FDA.

In addition, even if the product candidate qualifies

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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 by the FDA for

TARA-002 for the treatment of LMs.

In 2012, Congress authorized the FDA to award PRVs 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 PRV 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 PRV if the rare pediatric disease drug for which the voucher

was awarded is not marketed in the U.S.

RPDD has been granted by

the FDA for TARA-002 for the treatment of LMs.

In 2012, Congress authorized the FDA to award PRVs 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 PRV 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 PRV 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;

rare disease or conditions within the meaning of the Orphan Drug Act.

As of December 20, 2024, and unless the law is extended, the FDA

may no longer award any PRVs under the Rare Pediatric Disease Priority Review Voucher program, unless the rare pediatric disease product

application (a) is for a drug that, not later than December 20, 2024, is designated as a drug for a rare pediatric disease and (b) is,

not later than September 30, 2026, approved under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the

Public Health Service Act.

We understand that the FDA has continued to grant Rare Pediatric Disease Designations after December 20, 2024;

however, unless the program is extended by Congress, a product that was designated after December 20, 2024 may not be awarded a PRV upon

approval, even if approved prior to September 30, 2026.

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

Additionally, designation of a drug for a rare pediatric disease does not guarantee that an NDA or 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

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

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.

Under current law, after September 30,

2029, the FDA may not award any RPDD PRVs, although the FDA’s authority to do so could be extended by Congress in the future.

If TARA-002 is approved,

it may not be approved by September 30, 2029, and, therefore, we may not be in a position to obtain a PRV 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 an NDA or BLA will meet the eligibility criteria for a rare pediatric disease PRV at the time the application is approved, including

the requirement that the NDA or BLA was granted priority review.

Finally, a RPDD 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 designation.

Any adverse developments that occur in patients

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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 the 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.

If SAEs 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 the 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 AEs, which would limit our ability to commercialize TARA-002.

We may choose to delay or discontinue developing

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potential return on investment for those product candidates.

At any time, we may decide to delay or discontinue the development

of any of our product candidates for a variety of reasons, including the appearance of new technologies that make our product candidates

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

At any time, we may decide

to delay or discontinue the development of any of our product candidates for a variety of reasons, including the appearance of new technologies

that make our product candidates obsolete, competition from a competing product or changes in or failure to comply with applicable regulatory

requirements.

If we terminate a program

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

With respect to our lead product candidate, TARA-002, for the treatment

of NMIBC and LMs, the active ingredient in TARA-002 is a genetically distinct strain of Streptococcus pyogenes (group A, type 3) Su strain,

which is inactivated during the manufacturing process.

TARA-002 is produced through a proprietary manufacturing process.

We anticipate

that, if approved by the FDA, TARA-002 will be protected by 12 years of biologic exclusivity.

In addition, based on the prevalence of

the disease, TARA-002 is likely to have seven years of concurrent Orphan Drug Designation exclusivity for the treatment of LMs.

With respect to our lead

product candidate, TARA-002, for the treatment of NMIBC and LMs, the active ingredient in TARA-002 is a genetically distinct strain of

Streptococcus pyogenes (group A, type 3) Su strain, which is inactivated during the manufacturing process.

TARA-002 is produced through

a proprietary manufacturing process.

We anticipate that, if approved by the FDA, TARA-002 will be protected by 12 years of biologic exclusivity.

In addition, based on the prevalence of the disease, TARA-002 is likely to have seven years of concurrent ODD exclusivity for the treatment

Further, the USPTO issued to us Patent No.

12,551,514 claiming a method of treating non-muscle invasive bladder cancer with a

combination of non-viable cells of streptococcus pyogenes and an immune checkpoint inhibitor, with a term expiring in 2044.

There are no approved pharmacotherapies

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For example, the current standard of care for NMIBC includes intravesical BCG TICE (manufactured by Merck & Co., Inc.).

products approved for the treatment of NMIBC include Merck & Co., Inc.’s Keytruda, Endo International plc’s Valstar, and

Ferring B.V.’s Adstiladrin and ImmunityBio, Inc.’s VesAnktiva in combination with BCG.

Additional product candidates in development

include but may not be limited to Japanese BCG Laboratory’s BCG Tokyo, Pfizer Inc.’s Sasanlimab in combination with BCG, CG

Oncology Inc.’s CG0070, enGene Inc.’s, EG-70, Pfizer Inc’s PADCEV, Janssen’s TAR200 combined with gemcitabine

plus or minus Cetrelimab, Urogen Pharma Ltd.’s Jelmyto, Theralase Technologies Inc.’s Ruvidar, and Auro BioSciences, Inc.’s

Additional pharmaceutical and biotechnology companies with product candidates in development for the treatment of NMIBC include

but may not be limited to Verity, AstraZeneca PLC, Bristol-Myers Squibb Company, Roche Group, Asieris Pharmaceuticals, BeiGene, Ltd, NanOlogy,

products approved for the treatment of NMIBC include Merck & Co., Inc.’s Keytruda, Endo International plc’s Valstar, Ferring

B.V.’s Adstiladrin, ImmunityBio, Inc.’s VesAnktiva in combination with BCG and Janssen’s Inlexzo.

Additional product

candidates in development include but may not be limited to Japanese BCG Laboratory’s BCG Tokyo, Pfizer Inc.’s Sasanlimab

in combination with BCG, CG Oncology Inc.’s CG0070, enGene Inc.’s, EG-70, Pfizer Inc.’s PADCEV, Janssen’s TAR-200

plus Cetrelimab, Urogen Pharma Ltd.’s Jelmyto, Theralase Technologies Inc.’s Ruvidar, and Auro BioSciences, Inc.’s Aura-0011.

Additional pharmaceutical and biotechnology companies with product candidates in development for the treatment of NMIBC include but may

not be limited to Verity, AstraZeneca PLC, Bristol-Myers Squibb Company, Roche Group, Asieris Pharmaceuticals, BeiGene, Ltd, NanOlogy,

LLC, Linton Pharm Co., Ltd., Lindis Biotech GmbH, Taizhou Hanzhong biomedical co.

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IV Choline Chloride is the only sterile injectable form of choline chloride that

can be combined with parenteral nutrition.

can be combined with PN.

Further, the USPTO, issued to us Patent No.

US 11,311,503 claiming a sterile aqueous choline

salt composition, and Patent No.

US 12,083,081 claiming a method of treating choline deficiency with a choline composition, each with

a term expiring in 2041.

US 11,311,503 claiming a sterile aqueous choline salt composition,

and Patent No.

US 12,083,081 claiming a method of treating choline deficiency with a choline composition, each with a term expiring in

We currently have limited marketing capabilities

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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 may 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.

To commercialize our product candidates, if approved, in the U.S., Canada, the European

Union, Latin America and other jurisdictions we may 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.

TARA-002 and any future product candidates

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

The BPCIA, 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.

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 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

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.

The BPCIA, 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 its

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 its 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.

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 the FDA will not consider our product candidates eligible for reference product exclusivity, 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 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 have only received the exclusive rights

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if Chugai Pharmaceutical terminates the agreement with us for any number of reasons, following which such rights become non-exclusive.

Pursuant to an agreement with Chugai Pharmaceutical dated June 17,

2019, as amended on July 14, 2020 (effective as of June 30, 2020), Chugai Pharmaceutical 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 Pharmaceutical from providing such

materials and support to any third-party for medical, compassionate use and/or non-commercial research purposes and this agreement is

exclusive only through June 17, 2030 or, the earlier termination of the agreement by either party.

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.

Pursuant to an agreement

with Chugai Pharmaceutical dated June 17, 2019, as amended on July 14, 2020 (effective as of June 30, 2020), Chugai Pharmaceutical 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 Pharmaceutical from providing such materials and support to any third-party for medical, compassionate use and/or non-commercial

research purposes and this agreement is exclusive only through June 17, 2030 or, the earlier termination of the agreement by either party.

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.

Even if we obtain regulatory approval to

begin commercializing any of our products, we would remain subject to ongoing regulatory review, which could subsequently result in a

suspension or termination of sale of these products or other penalties if we fail to comply with regulatory requirements.

suspension or termination of sale of these products, limitations on the approved indication or additional warnings, or, if we fail to

comply with regulatory requirements, other penalties.

Even 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

A product candidate’s approval may contain requirements for potentially costly post-approval studies and surveillance

to monitor the safety and efficacy of the product.

We will also 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.

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:

● restrictions

on such product candidates, manufacturers or manufacturing processes;

● restrictions

on the labeling or marketing of a product;

● restrictions

on product distribution or use;

● requirements

to conduct post-marketing studies or clinical trials;

or untitled letters;

of any approved product from the market;

to approve pending applications or supplements to approved applications that we submit;

of product candidates;

restitution or disgorgement of profits or revenues;

or withdrawal of marketing approvals;

to permit the import or export of our product candidates;

● injunctions

or the imposition of civil or criminal penalties.

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

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 to monitor the safety and efficacy of the product.

We will also be subject to ongoing FDA

obligations and continued regulatory review with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution,

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

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 AEs 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:

restrictions on such product candidates, manufacturers or manufacturing processes;

restrictions on the labeling or marketing of a product;

restrictions on product distribution or use;

requirements to conduct post-marketing studies or clinical trials;

warning or untitled letters;

withdrawal of any approved product from the market;

refusal to approve pending applications or supplements to approved applications that we submit;

recall of product candidates;

fines, restitution or disgorgement of profits or revenues;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of our product candidates;

product seizure;

injunctions or the imposition of civil or criminal penalties.

We face product liability exposure, and

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

termination or increased

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

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

the inability to commercialize our product candidates;

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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 actions.

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.

Large judgments have been awarded in class action or individual lawsuits against

other pharmaceutical companies 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 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

Our employees, independent contractors,

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be subject to risks related to off-label use of our product candidates, if approved.

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.

For example, the FDA and other agencies actively enforce the laws and regulations prohibiting the promotion

of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

physicians may prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s choice

of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies

or their sales force with respect to off-label uses of products for which marketing clearance has not been issued.

Companies may only

share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.

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.

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

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 U.S.

be heavily scrutinized by the FDA, the DOJ, the Office of Inspector General of the HHS, state attorneys general, members of Congress and

For example, the FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses,

and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Although physicians may

prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment

made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales

force with respect to off-label uses of products for which marketing clearance has not been issued.

Companies may only share truthful

and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.

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

will be heavily scrutinized by relevant foreign regulatory authorities.

In the U.S., 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 significant civil, criminal and/or administrative penalties and fines and agreements, such as a corporate

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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.

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

If we or any partners with which we may

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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 or 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 of the cost.

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

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 or 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 of the cost.

In addition, the market for

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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 from 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 that 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.

In addition, in the U.S., 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 from 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 that 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.

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.

Further, coverage policies and third-party

reimbursement rates may change at any time.

Therefore, even if favorable coverage and reimbursement status is attained, less favorable

coverage policies and reimbursement rates may be implemented in the future.

future coverage and reimbursement likely will be subject to increased restrictions both in the U.S.

and in international markets.

coverage and reimbursement for our products may not be available or adequate in either the U.S.

or international markets, which could

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

Further, coverage policies and third-party reimbursement rates

may change at any time.

Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and

reimbursement rates may be implemented in the future.

reform measures could hinder or prevent the commercial success of our product candidates.

Existing regulatory policies may change, and additional government

regulations may be enacted that could prevent, limit or delay regulatory approval of any future product candidates we may develop, or

affect pricing and third-party payment for our product candidates, which could negatively affect our business, financial condition and

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs.

example, in 2010, the ACA was enacted to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance

remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes

and fees on the health industry and impose additional health policy reforms.

Additionally, there has been increasing legislative and enforcement

interest in the United States with respect to drug pricing practices since the ACA was enacted.

For example, in November 2020, the HHS

finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part

D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The rule also creates a new safe

harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy

benefit managers and manufacturers.

The implementation of the rule was delayed until January 1, 2032 by the IRA.

In addition, under the

American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers

pay to state Medicaid programs has been eliminated.

Elimination of this cap has, in some cases, required pharmaceutical manufacturers

to pay more in rebates than they have received on the sale of products.

In 2024, CMS issued a final rule that decreased Medicare reimbursement

for physician services by 2.8%, effective January 1, 2025.

If federal spending is further reduced, anticipated budgetary shortfalls may

also impact the ability of relevant agencies, such as the FDA, to continue to function at current levels.

Amounts allocated to federal

grants and contracts may be reduced or eliminated.

These reductions may also impact the ability of relevant agencies to timely review

and approve research and development, manufacturing, and marketing activities, which may delay our ability to develop, market and sell

any products we may develop.

Existing regulatory policies

may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of any future

product candidates we may develop, or affect pricing and third-party payment for our product candidates, which could negatively affect

our business, financial condition and prospects.

In the U.S., there have been and continue to be a number of legislative initiatives to

contain healthcare costs.

For example, in 2010, the ACA was enacted to broaden access to health insurance, reduce or constrain the growth

of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance

industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Additionally, there has

been increasing legislative and enforcement interest in the U.S.

with respect to drug pricing practices since the ACA was enacted.

example, in November 2020, the HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers

to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed

fee arrangements between pharmacy benefit managers and manufacturers.

The implementation of the rule was delayed until January 1, 2032

In addition, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate

Program rebates that manufacturers pay to state Medicaid programs has been eliminated.

Elimination of this cap has, in some cases, required

pharmaceutical manufacturers to pay more in rebates than they have received on the sale of products.

In 2024, CMS issued a final rule

that decreased Medicare reimbursement for physician services by 2.8%, effective January 1, 2025.

If federal spending is further reduced,

anticipated budgetary shortfalls may also impact the ability of relevant agencies, such as the FDA, to continue to function at current

Amounts allocated to federal grants and contracts may be reduced or eliminated.

These reductions may also impact the ability

of relevant agencies to timely review and approve research and development, manufacturing, and marketing activities, which may delay

our ability to develop, market and sell any products we may develop.

Additionally, several healthcare

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out-of-pocket limit, and 20% once the out-of-pocket limit has been reached.

The IRA also allows HHS to directly negotiate the selling

price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

The negotiated

price may not exceed a statutory ceiling price.

Only high-expenditure single-source biologics that have been approved for at least 11

years (seven years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect

two years after the selection year.

For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare

Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced.

negotiations resulted in significant price reductions for the products from their 2023 list prices, ranging from 38 to 79 percent, with

an average price reduction of 59.4 percent.

CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in

For 2028, an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and

subsequent years, 20 Part B or D drugs will be selected.

A drug or biological product that has an orphan drug designation for only one

rare disease or condition are excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it receives

designations for more than one rare disease or condition, or if is approved for an indication that is not within that single designated

rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates

the drug for selection for negotiation.

The negotiated prices have represented, and will continue to represent, a significant discount

from average prices to wholesalers and direct purchasers.

The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices

have increased at a rate greater than the rate of inflation, and in 2024, CMS finalized regulations for the Medicare Part B and Part D

inflation rebates.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation,

for the initial years.

The IRA also extended enhanced subsidies for individuals purchasing

health insurance coverage in ACA marketplaces through plan year 2025, but those subsidies expired at the end of 2025.

The IRA also allows

HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under

Medicare Part B and Part D.

The negotiated price may not exceed a statutory ceiling price.

Only high-expenditure single-source biologics

that have been approved for at least 11 years (seven years for single-source drugs) are eligible to be selected by CMS for negotiation,

with the negotiated price taking effect two years after the selection year.

For 2026, the first year in which negotiated prices become

effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price

for each product has been announced.

These negotiations resulted in significant price reductions for the products from their 2023 list

prices, ranging from 38 to 79 percent, with an average price reduction of 59.4 percent.

In addition, CMS has selected and announced the

negotiated maximum fair price for 15 additional Medicare Part D drugs which will become effective in 2027.

For 2028, CMS has selected

an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs under Medicare Part B.

and subsequent years, 20 Part B or Part D drugs will be selected.

A drug or biological product that has an ODD for only one rare disease

or condition are excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it receives designations

for more than one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease

or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for

selection for negotiation.

The negotiated prices have represented, and will continue to represent, a significant discount from average

prices to wholesalers and direct purchasers.

The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices have increased

at a rate greater than the rate of inflation, and in 2024, CMS finalized regulations for the Medicare Part B and Part D inflation rebates.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

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We expect pricing pressures will continue globally.

The current federal administration

is pursuing policies to reduce regulations and expenditures across government including at HHS, which include the FDA and CMS, and related

These actions included, for example, directives to reduce agency workforce which include the FDA and CMS, and related agencies.

In addition, on May 12, 2025, President Trump issued an Executive Order that, among other things, required HHS, within 30 days, to establish

and communicate to drug manufacturers MFN price targets designed to bring drug prices for American patients in line with those in comparably

developed nations.

If significant progress towards MFN pricing is not achieved, the Executive Order requires HHS to propose a rulemaking

to implement MFN pricing.

Recently, on December 23, 2025, CMS issued proposed regulations to establish, under CMMI, two mandatory MFN

demonstration models under Medicare Parts B and D, respectively.

If these rules or other MFN pricing rules are finalized, they are likely

to reduce prices of at least some drugs in the U.S., if they are also sold in comparably developed countries.

Even if we do not market

drugs in such countries, we will be indirectly affected if our drugs competed with drugs whose prices were reduced as a result of MFN

pricing initiatives.

At the state level, legislatures

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and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

the FDA released a final rule in 2020 providing guidance for states to build and submit importation proposals for drugs from Canada, and

the FDA authorized the first such plan in Florida in 2024.

It is unclear how this program will be implemented, including which drugs will

be chosen, and whether it will be subject to legal challenges in the United States or Canada.

Other states have also submitted proposals

that are pending review by the FDA.

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.

the FDA released a final rule in 2020 providing guidance for states to build and submit importation proposals for drugs from Canada.

FDA authorized the first such plan in Florida in 2024, but the implementation of Florida’s plan has been extended.

It is unclear

how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the

Other states have also submitted proposals that are pending review by the FDA.

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.

We are subject to strict

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and financial condition.

Certain federal and state healthcare laws and regulations pertaining

to fraud and abuse, privacy, transparency, and patients’ rights are and will be applicable to our business.

We are subject 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 but are not limited to:

Certain federal and state

healthcare laws and regulations pertaining to fraud and abuse, privacy, transparency, and patients’ rights are and will be applicable

to our business.

We are subject 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 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

federal civil and criminal false claims laws and civil monetary penalty laws;

HIPAA, as amended by HITECH;

the Prescription Drug Marketing

Act (for sampling of drug product among other things);

the federal physician sunshine requirements under the ACA;

the Foreign Corrupt Practices Act as it applies to activities outside

of the United States;

the FCPA as it applies

to activities outside of the U.S.;

the federal Right-to-Try legislation;

and similar state laws of such federal laws, which may be broader in scope.

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 laws.

For example, the ACA, 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 ACA 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 similar state laws of such federal laws, which may be broader

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 ACA, 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 ACA 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 FCA.

Achieving and sustaining

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commercial supplies of any future product candidates.

We do not currently have the infrastructure or capability to supply,

store, manufacture or distribute preclinical, non-clinical, 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 active pharmaceutical ingredient, or API, 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, non-clinical 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 currently have

the infrastructure or capability to supply, store, manufacture or distribute preclinical, non-clinical, 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 active pharmaceutical ingredient, or API, 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, non-clinical and clinical testing and commercialization.

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

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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

are unable to scale up the manufacturing 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

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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 manufacturers’ 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.

Furthermore, as we depend on third-party suppliers and manufacturers,

some of which may be located outside of the U.S., any future additional or new tariffs or other changes in trade measures adopted by the

government could adversely impact the Company’s business, financial condition, and results of operations, particularly where

supply chain delays adversely impact availability of materials, components or manufacturing of our product candidates.

Any decision by

government to adopt such actions, such as an increase in customs duties or tariffs, the renegotiation of U.S.

trade agreements

or any other action that could have a negative impact on international trade, including corresponding actions taken by other countries

in response to U.S.

governmental actions, could adversely impact our supply chain, manufacturing and availability of our product candidates.

The manufacture of biologics is complex

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 manufacturers’

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

In addition, the manufacturing facilities of certain of our suppliers may be located outside of the U.S.

This may give rise

to difficulties in importing our products or product candidates or their components into the U.S.

or other countries.

Furthermore, as we depend

on third-party suppliers and manufacturers, some of which may be located outside of the U.S., any future additional or new tariffs or

other changes in trade measures adopted by the U.S.

government could adversely impact the Company’s business, financial condition,

and results of operations, particularly where supply chain delays adversely impact availability of materials, components or manufacturing

of our product candidates.

Any decision by the U.S.

government to adopt such actions, such as an increase in customs duties or tariffs,

the renegotiation of U.S.

trade agreements or any other action that could have a negative impact on international trade, including corresponding

actions taken by other countries in response to U.S.

governmental actions, could adversely impact our supply chain, manufacturing and

availability of our product candidates.

The manufacturing of biologics is complex

and our third-party manufacturers may encounter difficulties in production.

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among biotechnology, pharmaceutical and other businesses.

From time to time, the United

States has experienced a decrease in unemployment rates and an increasingly competitive labor market, which has at times resulted in difficulties

From time to time, the U.S.

has experienced a decrease in unemployment rates and an increasingly competitive labor market, which has at times resulted in difficulties

in hiring or retaining sufficient qualified personnel to maintain and grow our business.

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We or the third parties upon which we depend

may be adversely affected by natural disasters and other catastrophic events and by man-made problems such as terrorism and war that

could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a serious

Our 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.

For example, we have expanded our clinical development of TARA-002 in NMBIC to clinical trial sites outside the United

States, including in Ukraine, Canada, Argentina and may expand to other geographies.

If political or civil conditions require it, our

sites may need to delay or suspend clinical trial activities.

In addition, enrollment and retention of patients at such sites could be

disrupted by geopolitical events, including civil or political unrest, such as the current ongoing conflict between Russia and Ukraine.

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 research, development,

regulatory approval, manufacture, distribution or commercialization of TARA-002 or IV Choline Chloride, our business, financial condition,

operating results and prospects would suffer.

may be adversely affected by natural disasters and other catastrophic events and by man-made problems such as terrorism and war that could

disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a serious

Our 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.

For example, we have expanded our clinical development of TARA-002

in NMBIC to clinical trial sites outside the U.S.

and may continue expanding to other geographies.

If political or civil conditions require

it, our sites may need to delay or suspend clinical trial activities.

In addition, enrollment and retention of patients at such sites

could be disrupted by geopolitical events, including civil or political unrest, such as the current ongoing conflict between Russia and

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 research, development, regulatory approval, manufacture, distribution or commercialization of TARA-002 or IV Choline Chloride, our

business, financial condition, operating results and prospects would suffer.

The effects of epidemics and pandemics and

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market price of our shares to fluctuate include, but are not limited to:

the results of current

and any future clinical trials of TARA-002 or IV Choline Chloride and any clinical trial failure, including any failure resulting from

difficulties or delays in identifying patients, enrolling patients, retaining patients, meeting specific clinical trial endpoints or

completing and timely reporting the results of any clinical trial;

the results of current and any future clinical trials of TARA-002 or IV Choline Chloride and any clinical trial failure, including any failure resulting from difficulties or delays in identifying patients, enrolling patients, retaining patients, meeting specific clinical trial endpoints or completing and timely reporting the results of any clinical trial;

our ability to obtain regulatory approvals for TARA-002, IV Choline Chloride or future product candidates, and delays of, or failures to obtain such approvals;

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in our financial reporting and the trading price of our common stock may decline.

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 evaluations 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.

While we remain

a smaller reporting company and non-accelerated filer, we will not be required to include an attestation report on internal control over

financial reporting issued by our independent registered public accounting firm.

When we cease to be a smaller reporting company and no

longer qualify as a non-accelerated filer, we would incur substantial professional fees and internal costs to expand our accounting and

finance functions.

We may experience difficulty in meeting these reporting requirements in a timely manner.

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 evaluations 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.

While we remain a smaller reporting company and non-accelerated filer, we will not be required to include an attestation

report on internal control over financial reporting issued by our independent registered public accounting firm.

When we cease to be a

smaller reporting company and no longer qualify as a non-accelerated filer, we would incur substantial professional fees and internal

costs to expand our accounting and finance functions.

We may experience difficulty in meeting these reporting requirements in a timely

We may discover weaknesses

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We will not receive

a significant amount, or potentially any, additional funds upon the exercise of our Pre-Funded Warrants;

however, any exercise would increase

the number of shares eligible for future resale in the public market and result in substantial dilution to our stockholders.

April 2024 and December 2024, we issued Pre-Funded Warrants to purchase a total of 1,700,000 and 2,325,372 shares of our common stock,

respectively, all of which are outstanding as of the date of this report.

Each Pre-Funded Warrant is exercisable for $0.001 per share

of common stock underlying such Pre-Funded Warrant.

Accordingly, we will not receive a significant amount of additional funds upon the

exercise of the Pre-Funded Warrants.

To the extent such Pre-Funded Warrants are exercised, additional shares of common stock will be issued

for nominal consideration, which will result in dilution to the then existing holders of our common stock and will increase the number

of shares eligible for resale in the public market.

Sales of substantial numbers of such shares in the public market could adversely affect

the market price of the common stock, causing our stock price to decline.

a significant amount, or potentially any, additional funds upon the exercise of our April 2024 Pre-Funded Warrants and December 2024 Pre-Funded

however, any exercise would increase the number of shares eligible for future resale in the public market and result in substantial

dilution to our stockholders.

April 2024 and December 2024, we issued the April 2024 Pre-Funded Warrants and December 2024 Pre-Funded Warrants to purchase a total of

1,700,000 and 2,325,372 shares of our common stock, respectively, 3,400,272 of which are outstanding as of the date of this report.

April 2024 Pre-Funded Warrant and December 2024 Pre-Funded Warrant is exercisable for $0.001 per share of common stock underlying such

Pre-Funded Warrant.

Accordingly, we will not receive a significant amount of additional funds upon the exercise of the April 2024 Pre-Funded

Warrants and December 2024 Pre-Funded Warrants.

To the extent such Pre-Funded Warrants are exercised, additional shares of common stock

will be issued for nominal consideration, which will result in dilution to the then existing holders of our common stock and will increase

the number of shares eligible for resale in the public market.

Sales of substantial numbers of such shares in the public market could

adversely affect the market price of the common stock, causing our stock price to decline.

The number of shares

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this could adversely impact the consideration our other stockholders would receive.

In April 2024 and December 2024, we issued the Pre-Funded Warrants

and the Common Warrants.

Each Common Warrant is exercisable solely by means of a cash exercise, except that the Common Warrant is exercisable

April 2024 and December 2024, we issued the April 2024 Pre-Funded Warrants, December 2024 Pre-Funded Warrants and April 2024 Common Warrants.

Each April 2024 Common Warrant is exercisable solely by means of a cash exercise, except that the April 2024 Common Warrant is exercisable

via cashless exercise if at the time of exercise, a registration statement registering the issuance of the shares of common stock underlying

the common stock warrants under the Securities Act of 1933, as amended, is not then effective.

The Common Warrants include certain rights

upon “fundamental transactions” as described in the Common Warrants.

Additionally, each holder of warrants will not be entitled

to exercise any portion of any Pre-Funded Warrant or Common Warrant, which, upon giving effect to such exercise, would cause (A) for the

holders of the April 2024 Pre-Funded Warrants and Common Warrants, (i) the aggregate number of shares of our common stock beneficially

owned by the holder (together with its affiliates) to exceed 9.99%, or for certain holders, 4.99%, of the number of shares of our common

stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned

by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of all of our securities then outstanding immediately

after giving effect to the exercise and (B) for the holders of the December 2024 Pre-Funded Warrants, the aggregate number of shares of

our common stock beneficially owned by the holder (together with its affiliates) to exceed 4.99% of the number of shares of our common

stock outstanding immediately after giving effect to the exercise.

However, for the April 2024 Pre-Funded Warrants, December 2024 Pre-Funded

Warrants and Common Warrants, any holder may increase or decrease such percentage to any other percentage (not in excess of 19.99%) upon

prior notice from the holder to us.

the common stock warrants under the Securities Act is not then effective.

The April 2024 Common Warrants include certain rights upon “fundamental

transactions” as described in the April 2024 Common Warrants.

Additionally, each holder of warrants will not be entitled to exercise

any portion of any April 2024 Pre-Funded Warrant, December 2024 Pre-Funded Warrant or April 2024 Common Warrant, which, upon giving effect

to such exercise, would cause (A) for the holders of the April 2024 Pre-Funded Warrants and April 2024 Common Warrants, (i) the aggregate

number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99%, or for certain holders,

4.99%, of the number of shares of our common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting

power of our securities beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of

all of our securities then outstanding immediately after giving effect to the exercise and (B) for the holders of the December 2024 Pre-Funded

Warrants, the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed

4.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise.

However, for the April

2024 Pre-Funded Warrants, December 2024 Pre-Funded Warrants and April 2024 Common Warrants, any holder may increase or decrease such percentage

to any other percentage (not in excess of 19.99%) upon prior notice from the holder to us.

these warrants are subject to beneficial ownership limitations, upon exercise in full of the warrants, the shares issuable upon exercise

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stock to decline significantly.

We have registered the issuance and/or resale of shares issuable upon

exercise of these warrants under an effective registration statement.

As a result, the shares issuable upon exercise of these warrants

can be freely sold in the public market upon issuance.

Sales of these shares could cause the market price of our common stock to decline

significantly.

Furthermore, if our stock price rises, the holders of these warrants may be more likely to exercise their warrants and

sell a large number of shares, which could negatively impact the market price of our common stock and reduce or eliminate any appreciation

in our stock price that might otherwise occur.

have registered the issuance and/or resale of shares issuable upon exercise of these warrants under an effective registration statement.

As a result, the shares issuable upon exercise of these warrants can be freely sold in the public market upon issuance.

Sales of these

shares could cause the market price of our common stock to decline significantly.

Furthermore, if our stock price rises, the holders of

these warrants may be more likely to exercise their warrants and sell a large number of shares, which could negatively impact the market

price of our common stock and reduce or eliminate any appreciation in our stock price that might otherwise occur.

Given the amount and terms of these warrants,

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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.

Our success with respect to our product candidates will depend, in

part, on our ability to obtain and maintain patent protection in both the U.S.

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 patent application process,

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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.

jurisdictions do not provide intellectual property rights to the same extent or duration as in the U.S., and many companies have encountered

significant difficulties in acquiring, maintaining, protecting, defending and especially enforcing such rights in foreign jurisdictions.

International and U.S.

free trade agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPs Agreement,

administered by the World Trade Organization provide global protection of certain intellectual property rights, but in a number of markets

we may be unable to patent our products or to enforce the patents that we receive for our products.

Further, many developing countries,

and some developed countries, do not provide effective data package protection even though it is specified in the TRIPs Agreement.

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

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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.

laws in the U.S., 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 U.S.

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

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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.

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

In addition, there may be

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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.

Because some patent applications in the U.S.

may be maintained in secrecy until the patents are

issued, because patent applications in the U.S.

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.

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.

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 are 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 would 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.

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.

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 we have 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.

We are subject to stringent and changing

obligations related to data privacy and security.

Our actual or perceived failure to comply with such obligations could lead to regulatory

investigations or actions;

the licensor may have to participate, in the U.S., 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.

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 are 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 would 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

We may be subject to claims that these employees and consultants or we have 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.

Pharmaceutical

companies are subject to stringent and changing obligations related to data privacy and security.

Our actual or perceived failure to

comply with such obligations could lead to regulatory investigations or actions;

fines and penalties;

a disruption of our business operations, including our clinical trials;

to our reputation;

a disruption of our

business operations, including our clinical trials;

harm to our reputation;

and other adverse effects on our business or prospects.

In the ordinary course of business,

we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share,

or collectively, Process (or Processing of), personal data and other sensitive and confidential information, including information we

collect about patients in connection with clinical trials, sensitive third-party data or, as necessary to operate our business, for legal

and marketing purposes, and for other business-related purposes.

Accordingly, we are, or may

become, subject to numerous federal, state, local and international data privacy and security laws, regulations, guidance and industry

standards as well as external and internal privacy and security policies, contracts and other obligations that apply to the Processing

of personal data by us and on our behalf, collectively, Data Protection Requirements.

The number and scope of Data Protection Requirements

are changing, subject to differing applications and interpretations, and may be inconsistent between jurisdictions or in conflict with

If we fail, or are perceived to have failed, to address or comply with Data Protection Requirements, we could face significant

consequences.

These consequences may include, but are not limited to, government enforcement actions against us that could include investigations,

fines, penalties, audits and inspections, additional reporting requirements and/or oversight, temporary or permanent bans on all or some

Processing of personal data, orders to destroy or not use personal data.

Further, individuals or other relevant stakeholders could bring

a variety of claims against us for our actual or perceived failure to comply with the Data Protection Requirements.

Any of these events

could have a material adverse effect on our reputation, business, or financial condition, and could lead to a loss of actual or prospective

customers, collaborators or partners;

the ordinary course of business, we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure,

dispose of, transmit, and share, or collectively, Process (or Processing of), personal data and other sensitive and confidential information,

including information we collect about patients in connection with clinical trials, sensitive third-party data or, as necessary to operate

our business, for legal and marketing purposes, and for other business-related purposes.

we are, or may become, subject to numerous federal, state, local and international data privacy and security laws, regulations, guidance

and industry standards as well as external and internal privacy and security policies, contracts and other obligations that apply to

the Processing of personal data by us and on our behalf, collectively, Data Protection Requirements.

The number and scope of Data Protection

Requirements are changing, subject to differing applications and interpretations, and may be inconsistent between jurisdictions or in

conflict with each other.

If we fail, or are perceived to have failed, to address or comply with Data Protection Requirements, we could

face significant consequences.

These consequences may include, but are not limited to, government enforcement actions against us that

could include investigations, fines, penalties, audits and inspections, additional reporting requirements and/or oversight, temporary

or permanent bans on all or some Processing of personal data, orders to destroy or not use personal data.

Further, individuals or other

relevant stakeholders could bring a variety of claims against us for our actual or perceived failure to comply with the Data Protection

Requirements.

Any of these events could have a material adverse effect on our reputation, business, or financial condition, and could

lead to a loss of actual or prospective customers, collaborators or partners;

interrupt or stop clinical trials;

result in an inability to Process personal data or to operate

in certain jurisdictions;

result in an inability

to Process personal data or to operate in certain jurisdictions;

limit our ability to develop or commercialize our products;

or require us to revise or restructure our operations,

or each, a material adverse impact.

us to revise or restructure our operations, or each, a material adverse impact.

We are, or may become, subject

privacy laws.

For example, in the United States, there are a broad variety of data protection laws and regulations that may apply

to our activities such as state data breach notification laws, state personal data privacy laws (for example, the California Consumer

Privacy Act of 2018, or CCPA), state health information privacy laws, and federal and state consumer protection laws.

A number of U.S.

enacted data privacy laws.

In particular, the CCPA, together with the California Privacy Rights Act, or CPRA, requires covered businesses

that process personal data of California residents to disclose their data collection, use and sharing practices.

For example, in the U.S., there are a broad variety of data protection laws and regulations that may apply to our

activities such as state data breach notification laws, state personal data privacy laws (for example, the CCPA), state health information

privacy laws, and federal and state consumer protection laws.

number of U.S.

states have enacted data privacy laws.

In particular, the CCPA, together with the CPRA, requires covered businesses that

process personal data of California residents to disclose their data collection, use and sharing practices.

Further, the CCPA provides

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considering comprehensive privacy legislation.

Outside the United States,

an increasing number of laws, regulations, and industry standards apply to data privacy and security.

For example, the European Union’s

General Data Protection Regulation, or EU GDPR, the United Kingdom’s GDPR, or UK GDPR, Japan’s Act on the Protection of Personal

Information, or APPI, China’s Personal Information Protection Law, or PIPL, and Brazil’s General Data Protection Law (Lei

Geral de Proteção de Dados Pessoais, or LGPD) (Law No.

The DSP preventing access

sensitive personal data by certain countries or persons is new, complex and only recently enforceable, and as such, there

is a risk that our interpretation of its applicability, scope, and requirements is incorrect, incomplete, or misapplied.

Compliance with

the DSP may now, or in the future, require us to invest heavily in data security and compliance measures, such as implementing and complying

with the Cybersecurity and Infrastructure Security Agency’s guidelines and other burdensome recordkeeping, reporting, and auditing

requirements.

It may also require us to implement new processes, stop or restrict certain data transfers, alter the geographic scope of

our operations, cease doing business with certain third parties or using certain tools or vendors, or change how data flows throughout

our business, any of which could materially impact our business operations or hinder our ability to grow our business.

Finally, non-compliance

with the DSP could result in significant civil or criminal penalties, which could materially adversely affect our business, results of

operations, and financial condition.

Outside the U.S., an increasing

number of laws, regulations, and industry standards apply to data privacy and security.

For example, the European Union’s General

Data Protection Regulation, or EU GDPR, the United Kingdom’s GDPR, or UK GDPR, Japan’s Act on the Protection of Personal Information,

or APPI, China’s Personal Information Protection Law, or PIPL, and Brazil’s General Data Protection Law (Lei Geral de Proteção

de Dados Pessoais, or LGPD) (Law No.

13,709/2018) impose strict requirements for processing personal data.

Under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million

euros or 4% of annual global revenue, whichever is greater.

Further, individuals may initiate litigation related to processing of their

personal data.

European data protection laws

(including the EU GDPR and UK GDRP) are wide-ranging in scope and impose numerous, significant and complex compliance burdens in relation

to the Processing of personal data, such as:

limiting permitted Processing of personal data to only that which is necessary for specified,

explicit and legitimate purposes;

Under the EU GDPR, government

regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million euros or 4% of annual global

revenue, whichever is greater.

Further, individuals may initiate litigation related to processing of their personal data.

data protection laws (including the EU GDPR and UK GDRP) are wide-ranging in scope and impose numerous, significant and complex compliance

burdens in relation to the Processing of personal data, such as:

limiting permitted Processing of personal data to only that which is

necessary for specified, explicit and legitimate purposes;

requiring the establishment of a legal basis for Processing personal data;

broadening the definition

of personal data;

creating obligations for controllers and processors to appoint data protection officers in certain circumstances;

transparency obligations to data subjects;

requiring data protection impact assessments in certain circumstances;

establishing limitations

on the collection and retention of personal data through “data minimization” and “storage limitation” principles;

broadening the definition of personal data;

creating obligations for controllers and processors to appoint data protection officers in

certain circumstances;

increasing transparency obligations to data subjects;

requiring data protection impact assessments in certain

circumstances;

establishing limitations on the collection and retention of personal data through “data minimization” and

“storage limitation” principles;

honoring data subject rights;

formalizing a heightened standard to obtain data subject consent;

establishing obligations to implement

certain technical and organizational safeguards to protect the security and confidentiality of personal data;

introducing the obligation

to provide notice of certain significant personal data breaches to the relevant supervisory authority(ies) and affected individuals;

mandating the appointment of representatives in the UK and/or EU in certain circumstances.

In particular, the Processing of “special

categor[ies] [of] personal data” (such as personal data related to health and genetic information), which could be relevant to our

operations in the context of our clinical trials, imposes heightened compliance burdens under European data protection laws and is a topic

of active interest among relevant regulators.

Certain jurisdictions have

enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information

across jurisdictions (such as transferring or receiving personal data that originates in the EU or in other foreign jurisdictions).

mechanisms that facilitate cross-border personal data transfers may change or be invalidated.

For example, absent appropriate safeguards

or other circumstances, the EU GDPR generally restricts the transfer of personal data to countries outside of the European Economic Area,

or EEA, that the European Commission does not consider to provide an adequate level of data privacy and security, such as the United States.

The European Commission released a set of “Standard Contractual Clauses,” or SCCs, that are designed to be a valid mechanism

to facilitate personal data transfers out of the EEA to these jurisdictions.

Currently, these SCCs are a valid mechanism to transfer personal

data outside of the EEA, but there exists a possibility that the validity of SCCs will be challenged in European courts.

Additionally,

the SCCs impose additional compliance burdens, such as conducting transfer impact assessments to determine whether additional security

measures are necessary to protect the at-issue personal data.

In addition, Switzerland and

the UK similarly restrict personal data transfers outside of those jurisdictions to countries that they do not consider to provide an

adequate level of personal data protection, such as the United States, and certain countries outside Europe (e.g., Brazil) have also passed

or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders, any of which

could increase the cost and complexity of doing business.

establishing obligations to implement certain technical and organizational safeguards to protect the security and confidentiality of

personal data;

introducing the obligation to provide notice of certain significant personal data breaches to the relevant supervisory

authority(ies) and affected individuals;

and mandating the appointment of representatives in the UK and/or EU in certain circumstances.

In particular, the Processing of “special categor[ies] [of] personal data” (such as personal data related to health and genetic

information), which could be relevant to our operations in the context of our clinical trials, imposes heightened compliance burdens

under European data protection laws and is a topic of active interest among relevant regulators.

Certain jurisdictions have enacted data localization laws and cross-border

personal data transfer laws, which could make it more difficult to transfer information across jurisdictions (such as transferring or

receiving personal data that originates in the EU or in other foreign jurisdictions).

Existing mechanisms that facilitate cross-border

personal data transfers may change or be invalidated.

For example, absent appropriate safeguards or other circumstances, the EU GDPR generally

restricts the transfer of personal data to countries outside of the European Economic Area, or EEA, that the European Commission does

not consider to provide an adequate level of data privacy and security, such as the U.S.

The European Commission released a set of “Standard

Contractual Clauses,” or SCCs, that are designed to be a valid mechanism to facilitate personal data transfers out of the EEA to

these jurisdictions.

Currently, these SCCs are a valid mechanism to transfer personal data outside of the EEA, but there exists a possibility

that the validity of SCCs will be challenged in European courts.

Additionally, the SCCs impose additional compliance burdens, such as

conducting transfer impact assessments to determine whether additional security measures are necessary to protect the at-issue personal

In addition, Switzerland and the UK similarly restrict personal data

transfers outside of those jurisdictions to countries that they do not consider to provide an adequate level of personal data protection,

such as the U.S., and certain countries outside Europe (e.g., Brazil) have also passed or are considering laws requiring local data residency

or otherwise impeding the transfer of personal data across borders, any of which could increase the cost and complexity of doing business.

While we use SCCs for transfers

of personal data from the EEA, UK and Switzerland to recipients in non-adequate countries, in the event we are unable to implement a valid

compliance mechanism for cross-border data transfers (e.g., SCCs are invalidated), we may face increased exposure to regulatory actions,

substantial fines, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions.

to import personal data to the United States may significantly and negatively impact our business operations, including by limiting our

ability to conduct clinical trial activities in Europe and elsewhere;

limiting our ability to collaborate with parties subject to European

and other data protection laws or requiring us to increase our personal data processing capabilities in Europe and/or elsewhere at significant

These laws exemplify the vulnerability

of our business to the evolving regulatory environment related to personal data and may require us to modify our Processing practices

at substantial costs and expenses in an effort to comply.

Given the breadth and evolving nature of Data Protection Requirements, preparing

for and complying with these requirements is rigorous, time-intensive and requires significant resources and a review of our technologies,

systems and practices, as well as those of any third-party collaborators, service providers, contractors or consultants that Process personal

data on our behalf.

We may publish privacy policies

and other documentation regarding our Processing of personal data and/or other confidential, proprietary or sensitive information.

we endeavor to comply with our published policies and other documentation, we may at times fail to do so or may be perceived to have

failed to do so.

Moreover, despite our efforts, we may not be successful in achieving compliance if our employees, third-party collaborators,

service providers, contractors or consultants fail to comply with our policies and documentation.

Such failures can subject us to potential

regulatory action if they are found to be deceptive, unfair, or misrepresentative of our actual practices.

Moreover, subjects about whom

we or our partners obtain information, as well as the providers who share this information with us, may contractually limit our ability

to use and disclose the information.

Claims that we have violated individuals’ privacy rights or failed to comply with data protection

laws or applicable privacy notices even if we are not found liable, could be expensive and time-consuming to defend and could result

in adverse publicity that could harm our business or have other material adverse impacts.

If our information

technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences

resulting from such compromise, including, but not limited to, regulatory investigations or actions;

of personal data from the EEA, UK and Switzerland to recipients in non-adequate countries, in the event we are unable to implement a

valid compliance mechanism for cross-border data transfers (e.g., SCCs are invalidated), we may face increased exposure to regulatory

actions, substantial fines, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions.

Inability to import personal data to the U.S.

may significantly and negatively impact our business operations, including by limiting

our ability to conduct clinical trial activities in Europe and elsewhere;

limiting our ability to collaborate with parties subject to

European and other data protection laws or requiring us to increase our personal data processing capabilities in Europe and/or elsewhere

at significant expense.

laws exemplify the vulnerability of our business to the evolving regulatory environment related to personal data and may require us to

modify our Processing practices at substantial costs and expenses in an effort to comply.

Given the breadth and evolving nature of Data

Protection Requirements, preparing for and complying with these requirements is rigorous, time-intensive and requires significant resources

and a review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors

or consultants that Process personal data on our behalf.

may publish privacy policies and other documentation regarding our Processing of personal data and/or other confidential, proprietary

or sensitive information.

Although we endeavor to comply with our published policies and other documentation, we may at times fail to

do so or may be perceived to have failed to do so.

Moreover, despite our efforts, we may not be successful in achieving compliance if

our employees, third-party collaborators, service providers, contractors or consultants fail to comply with our policies and documentation.

Such failures can subject us to potential regulatory action if they are found to be deceptive, unfair, or misrepresentative of our actual

Moreover, subjects about whom we or our partners obtain information, as well as the providers who share this information with

us, may contractually limit our ability to use and disclose the information.

Claims that we have violated individuals’ privacy

rights or failed to comply with data protection laws or applicable privacy notices even if we are not found liable, could be expensive

and time-consuming to defend and could result in adverse publicity that could harm our business or have other material adverse impacts.

our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience

adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations or actions;

fines and penalties;

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loss of revenue or profits;

interruptions to our operations such as our clinical trials;

to our reputation;

interruptions to our operations such as our

clinical trials;

harm to our reputation;

loss of customers or sales;

and other adverse consequences.

In the ordinary course of

our business, we may collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of,

transmit, and share, or collectively, Process, proprietary, confidential and sensitive information, including personal data (including,

key-coded data, health information and other special categories of personal data), intellectual property, trade secrets, and proprietary

business information owned or controlled by ourselves or other parties, or collectively, Sensitive Information.

We may use third-party service

providers and subprocessors to help us operate critical business systems to Process Sensitive Information on our behalf in a variety of

contexts, including without limitation, encryption and authentication technology, employee email, and other functions.

Our ability to

monitor these third parties’ information security practices is limited, and these third parties may not have adequate information

security measures in place.

the ordinary course of our business, we may collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect,

secure, dispose of, transmit, and share, or collectively, Process, proprietary, confidential and sensitive information, including personal

data (including, key-coded data, health information and other special categories of personal data), intellectual property, trade secrets,

and proprietary business information owned or controlled by ourselves or other parties, or collectively, Sensitive Information.

may use third-party service providers and subprocessors to help us operate critical business systems to Process Sensitive Information

on our behalf in a variety of contexts, including without limitation, encryption and authentication technology, employee email, and other

Our ability to monitor these third parties’ information security practices is limited, and these third parties may not

have adequate information security measures in place.

We may share or receive Sensitive Information with or from third parties.

If we, our service providers,

partners or other relevant third parties have experienced, or in the future experience, any security incident(s) that result in, any data

we, our service providers, partners or other relevant third parties have experienced, or in the future experience, any security incident(s)

that result in, any data loss;

deletion or destruction;

unauthorized access to;

loss, unauthorized acquisition, disclosure, or exposure of, Sensitive Information,

or compromise related to the security, confidentiality, integrity or availability of our (or their) information technology, software,

services, communications or data, or collectively, a Security Incident, it may materially adversely affect our business, financial condition,

operating results and prospects, including the diversion of funds to address the breach, and interruptions, delays, or outages in our

operations and development programs.

loss, unauthorized acquisition, disclosure, or exposure

of, Sensitive Information, or compromise related to the security, confidentiality, integrity or availability of our (or their) information

technology, software, services, communications or data, or collectively, a Security Incident, it may materially adversely affect our

business, financial condition, operating results and prospects, including the diversion of funds to address the breach, and interruptions,

delays, or outages in our operations and development programs.

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.

Cyberattacks, malicious internet-based

activity and online and offline fraud are prevalent and continue to increase.

These threats are becoming increasingly difficult to detect

especially as more advanced artificial intelligence and machine learning become available and increasingly used.

These threats come from

a variety of sources, including traditional computer “hackers”, threat actors, employee error, theft or misuse, sophisticated

nation-states, and nation-state supported actors.

We and the third parties upon which we rely may be subject to a variety of evolving

threats, including but not limited to social-engineering attacks (including through phishing attacks);

software bugs;

malicious code (such

as viruses and worms);

We quickly isolated the incident and have, since, implemented additional risk prevention measures.

Cyberattacks,

malicious internet-based activity and online and offline fraud are prevalent and continue to increase.

These threats are becoming increasingly

difficult to detect especially as more advanced artificial intelligence and machine learning become available and increasingly used.

These threats come from a variety of sources, including traditional computer “hackers”, threat actors, employee error, theft

or misuse, sophisticated nation-states, and nation-state supported actors.

We and the third parties upon which we rely may be subject

to a variety of evolving threats, including but not limited to social-engineering attacks (including through phishing attacks);

malicious code (such as viruses and worms);

denial-of-service attacks (such as credential stuffing);

malware (including as a result of advanced persistent

threat intrusions);

malware (including as a result

of advanced persistent threat intrusions);

supply-chain attacks, server malfunctions, software and hardware failures;

loss of data or other information technology

loss of data or

other information technology assets;

natural disasters;

telecommunication and electrical failures;

ransomware attacks;

and other similar threats.

Ransomware attacks, including

those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and

severe and can lead to significant interruptions, delays, or outages in our operations, loss of data, loss of income, significant extra

expenses to restore data or systems, reputational loss and the diversion of funds.

To alleviate the financial, operational and reputational

impact of a ransomware attack, it may be preferable to make extortion payments, but we may be unwilling or unable to do so (including,

for example, if applicable laws or regulations prohibit such payments).

Similarly, supply chain attacks

have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain have not been

compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our systems and

networks or the systems and networks of third parties that support us and our services.

We may also be the subject of server malfunction,

software or hardware failures, loss of data or other computer assets, and other similar issues.

A significant portion of our workforce

and third-party partners work remotely from time to time, and reliance on remote working technologies and the prevalent use of mobile

devices that access confidential and personal data information increase the risk of Security Incidents, which could lead to the loss confidential

information, personal data, trade secrets or other intellectual property.

We may be required to expend

additional, significant resources, fundamentally change our business activities and practices, or modify our operations, including our

clinical trial activities, or information technology in an effort to protect against Security Incidents and to mitigate, detect, and remediate

actual and potential vulnerabilities.

Certain data privacy and security obligations may require us to implement specific security measures

or use industry-standard or reasonable measures to protect our information technology systems and Sensitive Information.

Even if we were

to take and have taken security measures designed to protect against Security Incidents, there can be no assurance that such security

measures or those of our service providers, partners and other third parties will be effective in protecting against all Security Incidents

and material adverse impacts that may arise from such Security Incidents.

We may be unable in the future to detect vulnerabilities in

our information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not

be detected until after a Security Incident has occurred.

Despite our efforts to identify and remediate vulnerabilities, if any, in our

information technology systems, our efforts may not be successful.

Further, we may experience delays in developing and deploying remedial

measures designed to address any such identified vulnerabilities.

If we (or a third-party upon

whom we rely) experience a Security Incident or are perceived to have experienced a Security Incident, we may experience adverse consequences.

attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly

prevalent and severe and can lead to significant interruptions, delays, or outages in our operations, loss of data, loss of income, significant

extra expenses to restore data or systems, reputational loss and the diversion of funds.

To alleviate the financial, operational and

reputational impact of a ransomware attack, it may be preferable to make extortion payments, but we may be unwilling or unable to do

so (including, for example, if applicable laws or regulations prohibit such payments).

supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply

chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption

to our systems and networks or the systems and networks of third parties that support us and our services.

We may also be the subject

of server malfunction, software or hardware failures, loss of data or other computer assets, and other similar issues.

A significant

portion of our workforce and third-party partners work remotely from time to time, and reliance on remote working technologies and the

prevalent use of mobile devices that access confidential and personal data information increase the risk of Security Incidents, which

could lead to the loss confidential information, personal data, trade secrets or other intellectual property.

may be required to expend additional, significant resources, fundamentally change our business activities and practices, or modify our

operations, including our clinical trial activities, or information technology in an effort to protect against Security Incidents and

to mitigate, detect, and remediate actual and potential vulnerabilities.

Certain data privacy and security obligations may require us

to implement specific security measures or use industry-standard or reasonable measures to protect our information technology systems

and Sensitive Information.

Even if we were to take and have taken security measures designed to protect against Security Incidents, there

can be no assurance that such security measures or those of our service providers, partners and other third parties will be effective

in protecting against all Security Incidents and material adverse impacts that may arise from such Security Incidents.

We may be unable

in the future to detect vulnerabilities in our information technology systems because such threats and techniques change frequently,

are often sophisticated in nature, and may not be detected until after a Security Incident has occurred.

Despite our efforts to identify

and remediate vulnerabilities, if any, in our information technology systems, our efforts may not be successful.

Further, we may experience

delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.

we (or a third-party upon whom we rely) experience a Security Incident or are perceived to have experienced a Security Incident, we may

experience adverse consequences.

These consequences may include:

government enforcement actions (for example, investigations, fines, penalties, audits, and inspections);

government enforcement actions (for example, investigations, fines,

penalties, audits, and inspections);

additional reporting requirements and/or oversight;

restrictions on processing sensitive information (including personal data);

(including class claims);

restrictions on processing sensitive information

(including personal data);

litigation (including class claims);

indemnification obligations;

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reputational harm;

monetary fund diversions;

interruptions

in our operations (including availability of data);

fund diversions;

interruptions in our operations (including availability of data);

financial loss;

and other similar harms.

In addition, our actual or prospective customers,

collaborators, partners and/or clinical trial participants may stop using our product candidates or working with us.

This discontinuance,

or failure to meet the expectations of such third parties, could result in material harm to our operations, financial performance or reputation

and affect our ability to grow and operate our business.

Failures or significant downtime

of our information technology or telecommunication systems or those used by our third-party service providers could cause significant

interruptions in our operations and adversely impact the confidentiality, integrity and availability of Sensitive Information, including

preventing us from conducting clinical trials, tests or research and development activities and prevent us from managing the administrative

aspects of our business.

Applicable Data Protection

Requirements (as defined below) may require us to notify relevant stakeholders of Security Incidents, including affected individuals,

partners, collaborators, customers, regulators, law enforcement agencies, credit reporting agencies and others.

Such disclosures are costly,

and the disclosures or the failure to comply with such requirements could materially adversely affect our business, financial condition,

operating results and prospects.

Our contracts may not contain

limitations of liability, and even where they do, there can be no assurance that any limitations or exclusions of liability in our contracts

would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with Data Protection Requirements

related to information security or Security Incidents.

We cannot be sure that our

insurance coverage will be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims,

costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or material adverse impacts arising out of

our Processing operations, privacy and security practices, or Security Incidents we may experience.

The successful assertion of one or

more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance policies (including

premium increases or the imposition of large excess or deductible or co-insurance requirements), could materially adversely affect our

business, financial condition, operating results and prospects.

our actual or prospective customers, collaborators, partners and/or clinical trial participants may stop using our product candidates

or working with us.

This discontinuance, or failure to meet the expectations of such third parties, could result in material harm to

our operations, financial performance or reputation and affect our ability to grow and operate our business.

or significant downtime of our information technology or telecommunication systems or those used by our third-party service providers

could cause significant interruptions in our operations and adversely impact the confidentiality, integrity and availability of Sensitive

Information, including preventing us from conducting clinical trials, tests or research and development activities and prevent us from

managing the administrative aspects of our business.

Data Protection Requirements (as defined below) may require us to notify relevant stakeholders of Security Incidents, including affected

individuals, partners, collaborators, customers, regulators, law enforcement agencies, credit reporting agencies and others.

Such disclosures

are costly, and the disclosures or the failure to comply with such requirements could materially adversely affect our business, financial

condition, operating results and prospects.

contracts may not contain limitations of liability, and even where they do, there can be no assurance that any limitations or exclusions

of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to

comply with Data Protection Requirements related to information security or Security Incidents.

cannot be sure that our insurance coverage will be adequate or otherwise protect us from or adequately mitigate liabilities or damages

with respect to claims, costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or material adverse

impacts arising out of our Processing operations, privacy and security practices, or Security Incidents we may experience.

The successful

assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance

policies (including premium increases or the imposition of large excess or deductible or co-insurance requirements), could materially

adversely affect our business, financial condition, operating results and prospects.

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

What changed 10-K

Item 1A. Risk Factors