Protara Therapeutics, Inc. (TARA) Risk Factors

Item 1A. Risk Factors.

You should consider carefully
the following information about the risks described below, together with the other information contained in this Annual Report on Form
10-K and in our other public filings, in evaluating our business. If any of the following risks actually occurs, our business, financial
condition, results of operations, and future growth prospects would likely be materially and adversely affected. In these circumstances,
the market price of our common stock would likely decline.

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Risks Related to Our Financial Condition

We have a limited operating history and
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 expect to incur significant expenses
and significant losses for the foreseeable future and may never generate revenue or achieve or maintain profitability.

Investment in biopharmaceutical
product development is highly speculative because it entails substantial upfront capital and significant risk that a product candidate
will fail to gain regulatory approval or become commercially viable. We have never generated any revenues, and cannot estimate with precision
the extent of our future losses. We expect to incur increasing levels of operating losses for the foreseeable future as we execute on
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
candidates, hire additional personnel, protect our intellectual property, and incur the additional costs of operating as a public company.
We expect to continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future. These losses
have had and will continue to have an adverse effect on our financial position and working capital.

To become and remain profitable,
we must develop or acquire and eventually commercialize a product with significant market potential. This will require us to be successful
in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval, manufacturing,
marketing and selling any product candidate for which we obtain marketing approval, and satisfying post-marketing requirements, if any.
We may never succeed in these activities and, even if we succeed in obtaining approval for and commercializing one or more products, we
may never generate revenues that are significant enough to achieve profitability. In addition, as a young business, we may encounter unforeseen
expenses, difficulties, complications, delays and other known and unknown challenges. Furthermore, because of the numerous risks and uncertainties
associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses
or when, or if, we will be able to achieve profitability. If we achieve profitability, we may not be able to sustain or increase profitability
on a quarterly or annual basis and may continue to incur substantial research and development and other expenditures to develop and market
additional product candidates. Our failure to become and remain profitable would decrease the value of 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.

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
or uses. 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; 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 objectives. 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.

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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. 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.

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 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. 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 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.

The
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
trial. 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.

The
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.

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

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If any one of these factors
is not present, many of which are beyond our control, we could experience significant delays or an inability to obtain regulatory approval
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.

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.

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. 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. Similar initiatives
may also be directed towards other agencies. These initiatives could prevent, limit or delay development and regulatory approval of our
product candidates, which would adversely affect our business.

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. 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. Similar
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.

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In addition, FDA-regulated
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 FDA. 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
current U.S. 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
current U.S. 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.
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:

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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
approvals are obtained, we may never be able to successfully commercialize TARA-002 or IV Choline Chloride, or the FDA or comparable foreign
regulatory authorities may require labeling changes or impose significant restrictions on a product’s indicated uses or marketing
or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. Accordingly, we cannot assure
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 involves
lengthy and expensive processes with uncertain outcomes. We may incur additional expenses or experience delays in completing, or ultimately
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 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.

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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 we enroll; the proximity of patients to clinical sites; 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. 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; 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 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
will increase if we experience delays in clinical testing or regulatory approvals. We do not know whether any of our clinical trials will
begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also could
shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors
to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming
our business and results of operations. Any delays in our clinical development programs may harm our business, financial condition and
results of operations significantly.

We rely, and expect to continue to rely,
on third-party CROs and other third parties to conduct and oversee our clinical trials. If these third parties do not meet our requirements
or otherwise conduct the 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.

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If any of our CROs or clinical
trial sites fail to comply with their contractual commitments or terminate their involvement in one of our clinical trials for any reason,
we may not be able to enter into arrangements with alternative CROs or clinical trial sites or do so on commercially reasonable terms.
In addition, if our relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients
enrolled in our clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In
addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and
could receive cash or equity compensation in connection with such services. If these relationships and any related compensation result
in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be questioned
by the FDA.

Interim, topline and preliminary data from
our clinical trials may change as more patient data become available, and are subject to audit and verification procedures that could
result in material changes in the final data.

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. 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. 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
regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or
weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization
of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose
regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with
what we determine to be material or otherwise appropriate information to include in our disclosure.

The clinical development of our product
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. Many foreign regulatory bodies have similar requirements. In addition, such foreign studies would be subject
to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance the FDA or applicable
foreign regulatory authority will accept data from clinical trials conducted outside of the U.S. 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.

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TARA-002 is an immunopotentiator, and one
indication that we are pursuing is the treatment of LMs. There are no FDA-approved therapies for the treatment of LMs and it is difficult
to predict the timing and costs of clinical development for TARA-002 for LMs.

To date, there are no FDA-approved
therapies for the treatment of LMs. The regulatory approval process for novel product candidates such as TARA-002 can be more expensive
and take longer than for other, better known or extensively studied therapeutic approaches or diseases. Delay or failure to obtain, or
unexpected costs in obtaining, the regulatory approval necessary to bring TARA-002 to market in LMs could decrease our ability to generate
sufficient revenue to maintain our business.

Certain disorders we seek to treat have
low incidence and prevalence, and it may be difficult to identify patients with these disorders, which may lead to delays in enrollment
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 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. Further, we expect to rely in part on our relationships with patient advocacy groups to assist in identifying
eligible patients, and any deterioration of those relationships could impede our ability to successfully enroll patients. Patient enrollment
may be affected by other factors including:

Our inability to enroll a
sufficient number of patients with these diseases for our planned clinical trials, including LMs, would result in significant delays and
could require us to not initiate or abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result
in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability
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 certain patients who enroll
in our clinical trials may have complete resolution of their LM and never require additional treatment on a commercial basis.

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Our product candidates may cause undesirable
or unforeseen side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial
profile of an approved label, or result in post-approval regulatory action.

Undesirable or unforeseen
side effects from our product candidates, including TARA-002 or IV Choline Chloride could arise either during clinical development or,
if approved, after the product has been marketed. Undesirable side effects could cause us, any partners with which we may collaborate,
or regulatory authorities to interrupt, extend, modify, delay or halt clinical trials and could result in a more restrictive or narrower
label or the delay or denial of regulatory approval by the FDA or comparable foreign authorities.

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
identify undesirable side effects, or other previously unknown problems, in connection with a product after obtaining U.S. or foreign
regulatory approval, a number of potentially negative consequences could result, including:

Any of these occurrences
could prevent us or our potential partners from achieving or maintaining market acceptance of the product and could substantially increase
the costs of commercializing such product.

A Fast Track Designation by the FDA may
not lead to a faster development or regulatory review or approval process.

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.

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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 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
U.S. 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.

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.

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Designation as a breakthrough
therapy is at the discretion of the FDA. Accordingly, even if we believe that a product candidate meets the criteria for designation as
a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. 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
as a breakthrough therapy, the FDA may later decide that the product candidate no longer meets the conditions for qualification or that
the time period for FDA review.

Although the FDA has granted Rare Pediatric
Disease Designation for TARA-002 for the treatment of LMs, a BLA for TARA-002, if approved, may not meet the eligibility criteria for
a PRV.

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; 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
undergoing treatment with OK-432 / Picibanil or in patients participating in clinical trials conducted by third parties may affect our
ability to obtain regulatory approval or commercialize TARA-002.

Chugai Pharmaceutical, over
which we have no control, has the rights to commercialize TARA-002 and the originator therapy to TARA-002, OK-432, which is currently
marketed under the name Picibanil, in Japan for various indications. In addition, clinical trials using Picibanil are currently ongoing
in various countries around the world. 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.

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We may choose to delay or discontinue developing
or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate the
potential return on investment for those product candidates.

At any time, we may decide
to 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
in which we have invested significant resources, we will not receive any return on our investment and we will have missed the opportunity
to have allocated those resources to potentially more productive uses.

Other Risks Related to Our Business

Our product candidates,
if approved, will face significant competition and their failure to compete effectively may prevent them from achieving significant market
penetration.

The pharmaceutical industry
is characterized by rapidly advancing technologies, intense competition, uncertain and complex patent terms, and a strong emphasis on
developing newer, fast-to-market proprietary therapeutics. Numerous companies are engaged in the development, patenting, manufacturing
and marketing of healthcare products competitive with those that we are developing, including TARA-002 and IV Choline Chloride. We will
face competition from a number of sources, such as pharmaceutical companies, biotechnology companies, generic drug companies, consumer
products companies and academic and research institutions, many of which have greater financial resources, marketing capabilities, sales
forces, manufacturing capabilities, research and development capabilities, regulatory expertise, clinical trial expertise, intellectual
property portfolios, international reach, experience in obtaining patents and regulatory approvals for product candidates and other resources
than we have. Some of the companies that offer competing products also have a broad range of other product offerings, large direct sales
forces and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts.

With respect to our lead
product candidate, 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
of LMs. 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
currently available for the treatment of LMs and the current treatment options include a high-risk surgical procedure and off-label use
of sclerosants, including doxycycline, bleomycin, ethanol and sodium tetradecyl sulfate. There are a number of drug development companies
and academic researchers exploring oral and topical formulations of various agents for the treatment of LMs including macrolides, phosphodiesterase
inhibitors, and calcineurin/mTOR inhibitors. These are in early development.

TARA-002, if approved for
the treatment of NMIBC, would be subject to competition from existing treatment methods of surgery, chemotherapy and immunomodulatory
therapy. For example, the current standard of care for NMIBC includes intravesical BCG TICE (manufactured by Merck & Co., Inc.). Other
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. Ltd., Shionogi & Co. Ltd., Rapamycin Holdings, Inc.,
Vaxiion Therapeutics Inc., Incyte Corporation, LiPac Oncology, Inc., Anika Therapeutics Inc., Surge Pharmaceuticals Pvt. Ltd., and Istari
Oncology, Inc.

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There are no treatments currently
available for patients on PS who are choline-deficient. IV Choline Chloride is the only sterile injectable form of choline chloride that
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.

We currently have limited marketing capabilities
and no sales organization. If we are unable to grow our sales and marketing capabilities on our own or through third parties, we will
be unable to successfully commercialize our product candidates, if approved, or generate product revenue.

We currently have limited
marketing capabilities and no sales organization. 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 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
to the materials required to commercialize TARA-002 in territories other than Japan and Taiwan until June 17, 2030, or an earlier date
if Chugai 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.

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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, 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 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:

53

We face product liability exposure, and
if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.

We face an inherent risk
of product liability or similar causes of action as a result of the clinical testing of our product candidates and will face an even greater
risk if we commercialize any products. This risk exists even if a product is approved for commercial sale by the FDA and manufactured
in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority and notwithstanding that we comply with
applicable laws on promotional activity. Our products and product candidates are designed to affect important bodily functions and processes.
Any side effects, manufacturing defects, misuse or abuse associated with our product candidates could result in injury to a patient or
potentially even death. We cannot offer any assurance that we will not face product liability suits in the future, nor can we assure you
that our insurance coverage will be sufficient to cover our liability under any such cases.

In addition, a liability
claim may be brought against us even if our product candidates merely appear to have caused an injury. Product liability claims may be
brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with
our product candidates, among others, and under some circumstances even government agencies. If we cannot successfully defend ourselves
against product liability or similar claims, we will incur substantial liabilities, reputational harm and possibly injunctions and punitive
actions. In addition, regardless of merit or eventual outcome, product liability claims may result in:

We have obtained product
liability insurance coverage for our clinical trials. 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
prospects.

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Our employees, independent contractors,
principal investigators, other clinical trial staff, consultants, vendors, CROs and any partners with whom we may collaborate may engage
in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk
that our employees, independent contractors, principal investigators, other clinical trial staff, consultants, vendors, CROs and any partners
with which we may collaborate may engage in fraudulent or other illegal activity. Misconduct by these persons could include intentional,
reckless, gross or negligent misconduct or unauthorized activity that violates: laws or regulations, including those laws requiring the
reporting of true, complete and accurate information to the FDA or foreign regulatory authorities; manufacturing standards; federal, state
and foreign healthcare fraud and abuse laws and data privacy; anticorruption laws, anti-kickback and Medicare/Medicaid rules, or laws
that require the true, complete and accurate reporting of financial information or data, books and records. If any such or similar actions
are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant
impact on our business, including the imposition of significant civil, criminal and administrative and punitive penalties, damages, monetary
fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, debarments, contractual damages,
imprisonment, reputational harm, diminished profits and future earnings, injunctions, and curtailment or cessation of our operations,
any of which could adversely affect our ability to operate our business and our operating results.

We may
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 U.S. will
be heavily scrutinized by the FDA, the DOJ, the Office of Inspector General of the HHS, 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. 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
of the U.S. 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
integrity agreement, that materially restrict the manner in which we promote or distribute our product candidates. If we do not lawfully
promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not successful
in defending against such actions, those actions could have a material adverse effect on our business, financial condition and operating
results and even result in having an independent compliance monitor assigned to audit our ongoing operations for a lengthy period of
time.

If we or any partners with which we may
collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement for TARA-002 or IV Choline Chloride following
regulatory approval, their commercial success may be hindered severely.

If TARA-002 or IV Choline
Chloride only becomes available by prescription, successful sales by us or by any partners with which we may collaborate depend on the
availability of coverage and adequate reimbursement from third-party payors. Patients who are prescribed medicine for the treatment of
their conditions generally rely on third-party payors to reimburse most or part of the costs associated with their prescription drugs.
The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the 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.

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In addition, the market for
our products will depend significantly on access to third-party payors’ drug formularies or lists of medications for which third-party
payors provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing
pressures on pharmaceutical companies and there may be time limitations on when a new drug may even apply for formulary inclusion. Also,
third-party payors may refuse to include products in their formularies or otherwise restrict patient access to such products when a less
costly biosimilar or generic equivalent or other treatment alternative is available in the discretion of the formulary.

Third-party payors, whether
foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.
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 U.S. and in international markets. Third-party
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.

Healthcare
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 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. 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.

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Additionally, several healthcare
reform initiatives culminated in the enactment of the IRA in 2022, which, among other things, eliminated, beginning in 2025, the coverage
gap under Medicare Part D by significantly lowering the enrollee maximum out-of-pocket costs and requiring manufacturers to subsidize,
through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the
out-of-pocket limit, and 20% once the out-of-pocket limit has been reached. 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. For 2029
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
years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

These provisions may be subject
to legal challenges. For example, the provisions related to the negotiation of selling prices of high-expenditure single-source drugs
and biologics have been challenged in multiple lawsuits brought by pharmaceutical manufacturers. Although full economic effect of the
IRA on our business and the pharmaceutical industry in general is unknown at this time, it will likely have a significant impact on the
pharmaceutical industry and the pricing of our products and product candidates. Similarly, the adoption of restrictive price controls
in new jurisdictions, more restrictive controls in existing jurisdictions or the failure to obtain or maintain timely or adequate pricing
could also reduce our profitability. 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
agencies. 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.

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At the state level, legislatures
are increasingly enacting legislation and implementing regulations designed to control pharmaceutical and biological product pricing,
including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition,
the FDA released a final rule in 2020 providing guidance for states to build and submit importation proposals for drugs from Canada. The
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
U.S. 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.

We are subject to strict
healthcare laws, regulation and enforcement, and our failure to comply with those laws could adversely affect our business, operations
and financial condition.

Certain federal and state
healthcare laws 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; 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 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 FCA.

Achieving and sustaining
compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend
against it, could cause us to incur significant legal expenses and divert management’s attention from the operation of our business
and result in reputational damage. If our operations are found to be in violation of any of the laws described above or any other governmental
laws or regulations that apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties,
damages, including punitive damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, imprisonment,
additional oversight and reporting obligations, or the curtailment or restructuring of our operations, and injunctions, any of which could
adversely affect our ability to operate our business and financial results.

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We may in-license and acquire product candidates
and may engage in other strategic transactions, which could impact our liquidity, increase our expenses and present significant distractions
to our management.

Part of our strategy is to
in-license and acquire product candidates and we may engage in other strategic transactions. Additional potential transactions that we
may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings,
divestitures, business combinations and investments. Any such transaction may require us to incur non-recurring or other charges, may
increase our near- and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which
could adversely affect our operations and financial results. Accordingly, there can be no assurance that we will undertake or successfully
complete any transactions of the nature described above, and any transaction that we complete could harm our business, financial condition,
operating results and prospects.

Our failure to successfully in-license,
acquire, develop and market additional product candidates or approved products would impair our ability to grow our business.

We may in-license, acquire,
develop and market additional products and product candidates. Because our internal research and development capabilities are limited,
we may be dependent on pharmaceutical and biotechnology companies, academic or government scientists and other researchers to sell or
license products or technology to us. The success of this strategy depends partly on our ability to identify and select promising pharmaceutical
and biologic product candidates and products, negotiate licensing or acquisition agreements with their current owners, and finance these
arrangements.

The process of proposing,
negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies,
including some with substantially greater financial, marketing, sales and other resources, may compete with us for the license or acquisition
of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party
products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential
acquisitions or licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.
We may not be able to acquire the rights to additional product candidates on terms that we find acceptable or at all.

Further, any product candidate
that we acquire may require additional development efforts prior to commercial sale, including preclinical or clinical testing and approval
by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical
product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval
by regulatory authorities. In addition, we cannot provide assurance that any approved products that we acquire will be manufactured or
sold profitably or achieve market acceptance.

We expect to rely on agreements with third
parties for the successful development and commercialization of our product candidates.

We expect to rely upon the
efforts of third parties for the successful development and commercialization of our current and future product candidates. The clinical
and commercial success of our product candidates may depend upon maintaining successful relationships with third-party partners which
are subject to a number of significant risks, including the following:

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We cannot assure you that
we will be able to establish or maintain third-party relationships in order to successfully develop and commercialize our product candidates.

We rely completely on third-party contractors
to supply, manufacture and distribute clinical drug supplies for our product candidates, which may include sole-source suppliers and manufacturers;
we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive regulatory
approval; and we expect to rely on third parties for supply, manufacturing and distribution of preclinical, non-clinical, clinical and
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 have direct control
over whether our contract suppliers and manufacturers will maintain current pricing terms, be willing to continue supplying us with API
and finished products or maintain adequate capacity and capabilities to serve our needs, including quality control, quality assurance
and qualified personnel. We are dependent on our contract suppliers and manufacturers for day-to-day compliance with applicable laws and
cGMP for production of both API and finished products. If the safety or quality of any product or product candidate or component is compromised
due to a failure to adhere to applicable laws or for other reasons, we may not be able to commercialize or obtain regulatory approval
for the affected product or product candidate successfully, and we may be held liable for injuries sustained as a result.

In order to conduct larger
or late-stage clinical trials for our product candidates and supply sufficient commercial quantities of any of our products, if approved,
our contract manufacturers and suppliers will need to produce our API and other substances and materials used in our product candidates
in larger quantities, more cost-effectively and, in certain cases, at higher yields than they currently achieve. If our third-party contractors
are unable to scale up the 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
suppliers or manufacturers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality, and
we are unable to transfer the processes successfully on a timely basis, the development of that product candidate and regulatory approval
or commercial launch for any resulting products may be delayed, or there may be a shortage in supply, either of which could significantly
harm our business, financial condition, operating results and prospects.

We expect to continue to depend on third-party contract suppliers and
manufacturers for the foreseeable future. Our supply and manufacturing agreements, if any, do not guarantee that a contract supplier or
manufacturer will provide services adequate for our needs. Additionally, any damage to or destruction of our third-party 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 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.

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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. If our CDMO encounters such difficulties, the ability to provide
supply of TARA-002 for clinical trials, our ability to obtain marketing approval, or our ability to obtain commercial supply of TARA-002,
if approved, could be delayed or stopped.

We have no experience in
biologic manufacturing and do not own or operate, and we do not expect to own or operate, facilities for product manufacturing, storage
and distribution, or testing. We are completely dependent on CDMOs to fulfill our clinical and commercial supply of TARA-002. The process
of manufacturing biologics is complex, highly regulated and subject to multiple risks. Manufacturing biologics is highly susceptible to
product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency
in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal
manufacturing processes could result in reduced production yields, product defects and other supply disruptions and higher costs. If microbial,
viral or other contaminations are discovered at the facilities of our manufacturer, such facilities may need to be closed for an extended
period of time to investigate and remedy the contamination, which could delay clinical trials, result in higher costs of drug product
and adversely harm our business. Moreover, if the FDA determines that our manufacturer is not in compliance with FDA laws and regulations,
including those governing cGMP, the FDA may deny BLA approval until the deficiencies are corrected or we replace the manufacturer in our
BLA with a manufacturer that is in compliance.

In addition, there are risks
associated with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems
with process scale-up, process reproducibility, stability issues, compliance with cGMP, lot consistency and timely availability of raw
materials. Even if we obtain regulatory approval for TARA-002 or any future product candidates, there is no assurance that our manufacturers
will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it
in sufficient quantities to meet the requirements for the potential launch of the product or to meet potential future demand. If our manufacturers
are unable to produce sufficient quantities for clinical trials or for commercialization, commercialization efforts would be impaired,
which would have an adverse effect on our business, financial condition, results of operations and growth prospects. Scaling up a biologic
manufacturing process is a difficult and uncertain task, and any CDMO we contract may not have the necessary capabilities to complete
the implementation and development process of further scaling up production, transferring production to other sites, or managing its production
capacity to timely meet product demand.

Our CDMOs and suppliers use biological materials
and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time-consuming
or costly.

Our CDMOs and suppliers may
use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or
the environment. The operations of our third-party manufacturers and suppliers also produce hazardous waste products. Federal, state,
and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes.
Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations
may impair our product development efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from
these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general
liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or
contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in
an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended.

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Changes in methods of product candidate
manufacturing or formulation may result in additional costs or delay.

As product candidates proceed
through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various
aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize
processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause
our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted
with the materials manufactured using altered processes. Such changes may also require additional testing, FDA notification or FDA approval.
This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical
trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence sales and generate
revenue.

If we fail to attract and retain management
and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement
our business plan.

Our ability to compete in
the highly competitive biopharmaceuticals industry depends on our ability to attract and retain highly qualified managerial, scientific,
medical, legal, sales and marketing and other personnel. We are highly dependent on our management and scientific personnel. The loss
of the services of any of these individuals could impede, delay or prevent the successful development of our product pipeline, completion
of our planned clinical trials, commercialization of our product candidates or in-licensing or acquisition of new assets and could impact
negatively our ability to implement successfully our business plan. If we lose the services of any of these individuals, we might not
be able to find suitable replacements on a timely basis or at all, and our business could be harmed as a result. We might not be able
to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel
among biotechnology, pharmaceutical and other businesses.

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. We are uncertain as to the employment environment
in the future, or how that environment will impact our workforce, including our ability to attract and retain qualified management and
other key personnel.

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
disaster.

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
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.

The effects of epidemics and pandemics and
their corresponding macroeconomic impacts could materially and adversely impact our business, including our clinical development plans
and non-clinical research.

As a result of the COVID-19
pandemic and the associated health and safety measures that were imposed, we had and, in the event of a resurgence of the pandemic or
the onset of another public health crisis, may again experience, disruptions that could severely impact our business, including but not
limited to delays or difficulties in clinical trial site operations and in the enrollment, scheduling and retention of patients in our
clinical trials; interruption of key manufacturing, research and clinical development and other activities; and delays or difficulties
conducting and completing non-clinical studies.

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In addition, macroeconomic
factors, including supply chain disruptions, rising inflation and resulting increases in interest rates, which were, in part, tied to
the impacts of the COVID-19 pandemic, had an impact on our operations, and any future pandemic or public health crisis may have the same
effects. Similarly, if banks and financial institutions enter receivership or become insolvent in the future due to financial conditions
affecting the banking system and financial markets, there could be an adverse effect on our ability to access our cash and cash equivalents
and investments, including transferring funds, making payments or receiving funds, any of which could have a material adverse effect on
our business and financial condition.

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

Risks Related to Our Common Stock

We expect
our stock price to be highly volatile.

The market price of our shares
could be subject to significant fluctuations. Market prices for securities of biotechnology and other life sciences companies historically
have been particularly volatile, even subject to large daily price swings. For example, the closing price of our common stock from the
period January 1, 2025 to December 31, 2025 has ranged from a low of $2.78 to a high of $7.56. Some of the factors that may cause the
market price of our shares to fluctuate include, but are not limited to:

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Moreover, the stock markets
in general have experienced substantial volatility in our industry that has often been unrelated to the operating performance of individual
companies or a certain industry segment. These broad market fluctuations may also adversely affect the trading price of our shares.

In the past, following periods
of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation
against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources,
which could significantly harm our profitability and reputation. In addition, such securities litigation often has ensued after a reverse
merger or other merger and acquisition activity. Such litigation if brought could impact negatively our business.

We incur costs and demands upon management
as a result of complying with the laws and regulations affecting public companies.

As a public company, we have
incurred, and will continue to incur, significant legal, accounting and other expenses, including costs associated with public company
reporting and other SEC requirements. We have also incurred, and will continue to incur, costs associated with corporate governance requirements,
including requirements under the Exchange Act, the Sarbanes-Oxley Act and other applicable legislation, as well as rules implemented by
the SEC and Nasdaq.

We expect the rules and regulations
applicable to public companies will continue to substantially increase our legal and financial compliance costs and to make some activities
more time-consuming and costly. Our executive officers and other personnel will need to continue to devote substantial time to managing
operations as a public company and compliance with applicable laws and regulations. These rules and regulations may also make it expensive
for us to operate our business.

If we fail to maintain proper and effective
internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, investors may lose confidence
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 may discover weaknesses
in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial
statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter
how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be
met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements
due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we are not able to comply
with the requirements of Section 404 of the Sarbanes-Oxley Act, or if we are unable to maintain proper and effective internal controls,
we may not be able to produce timely and accurate financial statements. If that were to happen, the market price of our common stock could
decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities or by Nasdaq.

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We are able to take advantage of reduced
disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive
to investors.

We qualify as a smaller reporting
company under the rules of the SEC. As a smaller reporting company, we are able to take advantage of reduced disclosure requirements,
such as certain simplified executive compensation disclosures and reduced financial statement disclosure requirements in our SEC filings.
Comparatively reduced disclosures in our SEC filings due to our status as a smaller reporting company may make it harder for our investors
to analyze our results of operations and financial prospects. We cannot predict if investors will find our common stock less attractive
due to our reliance on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active
trading market for our common stock and our stock price may be more volatile. We may take advantage of the reporting exemptions applicable
to a smaller reporting company until we are no longer a smaller reporting company, which status would end once we have a public float
greater than $250 million. In that event, we could still be a smaller reporting company if our annual revenues were below $100 million
and we have a public float of less than $700 million.

We do not
anticipate paying any dividends in the foreseeable future.

The current expectation is
that we will retain our future earnings to fund the development and growth of our business. As a result, capital appreciation, if any,
of your shares of our stock will be your sole source of gain, if any, for the foreseeable future.

If equity research analysts do not publish
research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume
could decline.

The trading market for our
common stock is influenced by the research and reports that equity research analysts publish about us and our business. Equity research
analysts may elect not to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market
price of our common stock. In the event we do have equity research analyst coverage, we will not have any control over the analysts or
the content and opinions included in their reports. The price of our common stock could decline if one or more equity research analysts
downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of us or
fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause our stock price or trading
volume to decline.

We will not receive
a significant amount, or potentially any, additional funds upon the exercise of our April 2024 Pre-Funded Warrants and December 2024 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.

In
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. Each
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.

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The number of shares
of common stock underlying our outstanding warrants is significant in relation to our currently outstanding common stock, which could
have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future equity
offerings. In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders of our
outstanding warrants would be entitled to receive consideration in excess of their reported beneficial ownership of our common stock and
this could adversely impact the consideration our other stockholders would receive.

In
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 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.

Although
these warrants are subject to beneficial ownership limitations, upon exercise in full of the warrants, the shares issuable upon exercise
would represent a significant portion of our outstanding common stock. As a result, the holders of these warrants may be able to exert
substantial influence over our business. The concentration of voting power resulting from the exercise of the warrants could delay, defer
or prevent a change of control, entrench our management and our board of directors or delay or prevent a merger, consolidation, takeover
or other business combination involving us on terms that other stockholders may desire. In addition, conflicts of interest could arise
in the future between us and the holders of these warrants concerning potential competitive business activities, business opportunities,
the issuance of additional securities and other matters. In addition, sales of these shares could cause the market price of our common
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.

Given the amount and terms of these warrants,
we may find it more difficult to raise additional equity capital on favorable terms or at all while these warrants are outstanding.

Risk Related
to Our Ownership Structure and Governance

Certain stockholders have the ability to
control or significantly influence certain matters submitted to our stockholders for approval.

Certain stockholders have
consent rights over certain significant matters of our business. These include decisions to effect a merger or other similar transaction,
changes to our principal business, and the sale or other transfer of TARA-002 or other assets with an aggregate value of more than $2,500,000.
As a result, these stockholders have significant influence over certain matters that require approval by our stockholders.

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Anti-takeover provisions in our charter
documents and under Delaware law could make an acquisition of our business more difficult and may prevent attempts by our stockholders
to replace or remove management.

Provisions in our certificate
of incorporation and bylaws may delay or prevent an acquisition or a change in management. In addition, because we are incorporated in
Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or DGCL, which prohibits stockholders
owning in excess of 15% of the outstanding voting stock from merging or combining with us. These provisions may frustrate or prevent any
attempts by our stockholders to replace or remove then current management by making it more difficult for stockholders to replace members
of the board of directors, which is responsible for appointing the members of management.

Our certificate of incorporation provides
that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which
could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other
employees.

Our certificate of incorporation
provides that the Court of Chancery of the State of Delaware is the sole and exclusive forum for any derivative action or proceeding brought
on our behalf, any action asserting a breach of fiduciary duty owed by any of our directors, officers or other employees to us or our
stockholders, any action asserting a claim against us arising pursuant to any provisions of the DGCL, our certificate of incorporation
or our bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine. The choice of forum provision
may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for certain disputes with us or our
directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.
If a court were to find the choice of forum provision contained in the certificate of incorporation to be inapplicable or unenforceable
in an action, we may incur additional costs associated with resolving such action in other jurisdictions.

Risks Related to Intellectual Property Rights

We may not be able to obtain, maintain or
enforce global patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient
breadth to prevent third parties from competing against us.

Our success with respect to our product candidates will depend, in
part, on our ability to obtain and maintain patent protection in both the 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 world.

The patent application process,
also known as patent prosecution, is expensive and time-consuming, and we and our current or future licensors and licensees may not be
able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner in all the
countries that are desirable. It is also possible that we or our current licensors, or any future licensors or licensees, will fail to
identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to
obtain patent protection on them. Therefore, these and any of our patents and applications may not be prosecuted and enforced in a manner
consistent with the best interests of our business. Moreover, our competitors independently may develop equivalent knowledge, methods
and know-how or discover workarounds to our patents that would not constitute infringement. Any of these outcomes could impair our ability
to enforce the exclusivity of our patents effectively, which may have an adverse impact on our business, financial condition and operating
results.

Due to legal standards relating
to patentability, validity, enforceability and claim scope of patents covering pharmaceutical inventions, our ability to obtain, maintain
and enforce patents is uncertain and involves complex legal and factual questions especially across countries. Accordingly, rights under
any existing patents or any patents we might obtain or license may not cover our product candidates or may not provide us with sufficient
protection for our product candidates to afford a sustainable commercial advantage against competitive products or processes, including
those from branded, generic and over-the-counter pharmaceutical companies. In addition, we cannot guarantee that any patents or other
intellectual property rights will issue from any pending or future patent or other similar applications owned by or licensed to us. Even
if patents or other intellectual property rights have issued or will issue, we cannot guarantee that the claims of these patents and other
rights are or will be held valid or enforceable by the courts, through injunction or otherwise, or will provide us with any significant
protection against competitive products or otherwise be commercially valuable to us in every country of commercial significance that we
may target.

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Competitors in the field
of immunology and oncology therapeutics have created a substantial amount of prior art, including scientific publications, posters, presentations,
patents and patent applications and other public disclosures including on the Internet. Our ability to obtain and maintain valid and enforceable
patents depends on whether the differences between our technology and the prior art allow our technology to be patentable over the prior
art. We do not have outstanding issued patents covering all of the recent developments in our technology and are unsure of the patent
protection that we will be successful in obtaining, if any. Even if the patents do successfully issue, third parties may design around
or challenge the validity, enforceability or scope of such issued patents or any other issued patents we own or license, which may result
in such patents being narrowed, invalidated or held unenforceable. If the breadth or strength of protection provided by the patents we
hold or pursue with respect to our product candidates is challenged, it could dissuade companies from collaborating with us to develop
or threaten our ability to commercialize or finance our product candidates.

The laws of some foreign
jurisdictions do not provide intellectual property rights to the same extent or duration as in the 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. If
we encounter such difficulties in protecting, or are otherwise precluded from effectively protecting, our intellectual property in foreign
jurisdictions, our business prospects could be substantially harmed, especially internationally.

Proprietary trade secrets
and unpatented know-how are also very important to our business. Although we have taken steps to protect our trade secrets and unpatented
know-how by entering into confidentiality agreements with third parties, and intellectual property protection agreements with officers,
directors, employees, and certain consultants and advisors, there can be no assurance that binding agreements will not be breached or
will be enforced by courts, that we would have adequate remedies for any breach, including injunctive and other equitable relief, or that
our trade secrets and unpatented know-how will not otherwise become known, inadvertently disclosed by us or our agents and representatives,
or be independently discovered by our competitors. If trade secrets are independently discovered, we would not be able to prevent their
use and if we and our agents or representatives inadvertently disclose trade secrets and/or unpatented know-how, we may not be allowed
to retrieve this and maintain the exclusivity we previously enjoyed.

We may
not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending
patents on our product candidates does not guarantee exclusivity. The requirements for patentability differ in certain countries, particularly
developing countries. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as
laws in the 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
significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries,
particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly
those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing
products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result
in substantial costs and divert our efforts and attention from other aspects of our business, could put our global patents at risk of
being invalidated or interpreted narrowly and our global patent applications at risk of not issuing, and could provoke third parties to
assert claims against us. We may not prevail in any lawsuits that we initiate or infringement actions brought against us, and the damages
or other remedies awarded, if any, may not be commercially meaningful when we are the plaintiff. When we are the defendant we may be required
to post large bonds to stay in the market while we defend ourselves from an infringement action.

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In addition, certain countries
in Europe and certain developing countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses
to third parties, especially if the patent owner does not enforce or use its patents over a protracted period of time. In some cases,
the courts will force compulsory licenses on the patent holder even when finding the patent holder’s patents are valid if the court
believes it is in the best interests of the country to have widespread access to an essential product covered by the patent. In these
situations, the royalty the court requires to be paid by the license holder receiving the compulsory license is not calculated at fair
market value and can be inconsequential, thereby adversely affecting the patent holder’s business. In these countries, we may have
limited remedies if our patents are infringed or if we are compelled to grant a license to our patents to a third-party, which could also
materially diminish the value of those patents. This would limit our potential revenue opportunities. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we own or license, especially in comparison to what we enjoy from enforcing our intellectual property rights in the Unites
States. Finally, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in
both U.S. and foreign intellectual property laws, or changes to the policies in various government agencies in these countries, including
but not limited to the patent office issuing patents and the health agency issuing pharmaceutical product approvals. For example, in Brazil,
pharmaceutical patents require initial approval of the Brazilian health agency (ANVISA). Finally, many countries have large backlogs in
patent prosecution, and in some countries in Latin America it can take years, even decades, just to get a pharmaceutical patent application
reviewed notwithstanding the merits of the application.

Obtaining and maintaining patent protection
depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent
agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and
annuity fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the
patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment
and other similar provisions during the patent application process. While an inadvertent lapse can, in many cases, be cured by payment
of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment
or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction just
for failure to know about and/or timely pay a prosecution fee. Non-compliance events that could result in abandonment or lapse of a patent
or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees in prescribed
time periods, and failure to properly legalize and submit formal documents in the format and style the country requires. If we or our
licensors fail to maintain the patents and patent applications covering our product candidates for any reason, our competitors might be
able to enter the market, which could materially adversely affect our business, financial condition, operating results and prospects.

If we fail to comply with our obligations
under our intellectual property license agreements, we could lose license rights that are important to our business. Additionally, these
agreements may be subject to disagreement over contract interpretation, which could narrow the scope of our rights to the relevant intellectual
property or technology or increase our financial or other obligations to our licensors.

We have entered into in-license
arrangements with respect to certain of our product candidates. These license agreements impose various diligence, milestone, royalty,
insurance and other obligations on us. If we fail to comply with these obligations, the respective licensors may have the right to terminate
the license, in which event we may not be able to develop or market the affected product candidate. The loss of such rights could materially
adversely affect our business, financial condition, operating results and prospects.

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If
we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could
prevent or delay us from developing or commercializing our product candidates.

Our
commercial success depends on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies
without infringing the proprietary rights of third parties. We cannot assure that marketing and selling such candidates and using such
technologies will not infringe existing or future patents. Numerous U.S.- and foreign-issued patents and pending patent applications
owned by third parties exist in the fields relating to our product candidates. As the biotechnology and pharmaceutical industries expand
and more patents are issued, the risk increases that others may assert that our product candidates, technologies or methods of delivery
or use infringe their patent rights. Moreover, it is not always clear to industry participants, including us, which patents and other
intellectual property rights cover various drugs, biologics, drug delivery systems or their methods of use, and which of these patents
may be valid and enforceable. Thus, because of the large number of patents issued and patent applications filed in our fields across
many countries, there may be a risk that third parties may allege they have patent rights encompassing our product candidates, technologies
or methods.

In addition, there may be
issued patents of third parties that are infringed or are alleged to be infringed by our product candidates or proprietary technologies
notwithstanding patents we may possess. Because some patent applications in the 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. Any
such patent application may have priority over our own and in-licensed patent applications or patents, which could further require us
to obtain rights to issued patents covering such technologies, which may mean paying significant licensing fees or the like. If another
party has filed a U.S. patent application on inventions similar to those owned or in-licensed to us, or, in the case of in-licensed technology,
the licensor may have to participate, in the U.S., 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.

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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.

General
Risk Factors

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; litigation; fines and penalties; 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 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; limit our ability to develop or commercialize our products; or require
us to revise or restructure our operations, or each, a material adverse impact.

We are, or may become, subject
to U.S. privacy laws. 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.

A
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
California residents with new data privacy rights (including the ability to opt out of the sale of personal data), imposes new operational
requirements for covered businesses, provides for civil penalties for violations (up to $7,500 per violation), as well as a private right
of action for certain data breaches (that is expected to increase data breach class action litigation and result in significant exposure
to costly legal judgements and settlements). The CPRA, among other things, gives California residents the ability to limit use of certain
sensitive personal data, establishes restrictions on the retention of personal data, expands the types of data breaches subject to the
CCPA’s private right of action, and establishes a new California Privacy Protection Agency to implement and enforce the new law.
Although there are limited exemptions for clinical trial data under the CCPA and the CPRA, the CCPA and the CPRA may increase compliance
costs and potential liability with respect to other personal data we maintain about California residents. The federal government is also
considering comprehensive privacy legislation.

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The DSP preventing access
to bulk U.S. 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; 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; 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; 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
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 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.

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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.
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.

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. 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
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; litigation;
fines and penalties; disruptions of our business operations; loss of revenue or profits; 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. 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 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. 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.

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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); denial-of-service attacks (such as credential stuffing); 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 assets; adware; natural disasters; terrorism; war; 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. These consequences may include: 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); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary
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.

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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.