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Item 1A. Risk Factors

2026-04-01 compared with 2025-03-28 · 3232 added, 3059 removed, 34 unchanged (99% of the section changed)

investment in our securities carries a significant degree of risk.

You should carefully consider the following risks, as well as the

other information contained in this Annual Report on Form 10-K, including our historical financial statements and related notes included

elsewhere in this Annual Report on Form 10-K, before you decide to purchase our securities.

Any one of these risks and uncertainties

has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could

cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value

of our common shares.

Refer to “Cautionary Statement Regarding Forward-Looking Statements.”

may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause.

These potential

risks and uncertainties may not be a complete list of the risks and uncertainties facing us.

There may be additional risks and uncertainties

that we are presently unaware of, or presently consider immaterial, that may become material in the future and have a material adverse

effect on us.

You could lose all or a significant portion of your investment due to any of these risks and uncertainties.

is a summary of material risks, uncertainties and other factors that could have a material effect on the Company and its operations:

are early in our development efforts, with a limited operating history, and have no products approved for commercial sale.

have not generated any revenue from product sales to date, have incurred significant net losses since our inception, and expect to

continue to incur significant net losses for the foreseeable future.

ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating

to the discovery, development and commercialization of our product candidate.

will require substantial additional capital to finance our operations.

substantial amount of indebtedness may adversely affect our cash flow and our ability to operate our business, remain in compliance

with debt covenants and make payments on our indebtedness.

are substantially dependent on the success of our product candidate, JOTROL.

If we are unable to complete development of, obtain

approval for and commercialize JOTROL for one or more indications in a timely manner, our business will be harmed.

prospects depend upon developing product candidate JOTROL for particular indications and possibly discovering, developing other product

candidates in future programs.

drug development involves a lengthy and expensive process with an uncertain outcome.

The clinical trials of our product candidate

JOTROL may not demonstrate safety and efficacy to the satisfaction of the U.S.

Food and Drug Administration (FDA), European Medicines

Agency (EMA) or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical

studies and early clinical trials may not be predictive of future results.

have limited resources and are currently focusing the majority of our efforts on developing JOTROL for particular indications.

a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that

are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively

In particular, we face competition for patients with MPS-I, Friedreich’s ataxia, MELAS, Parkinson’s Disease,

Mild Cognitive Impairment, and early Alzheimer’s disease from companies that produce drugs to treat such diseases.

information regarding competition we face, see the section titled “Business — Competition.

rely on third parties to conduct our preclinical studies, clinical trials, and manufacturing and these third parties may not perform

satisfactorily.

we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders,

cause us to incur debt or assume contingent liabilities, and subject us to other risks.

rely on our management team and other key employees, and the loss of one or more key employees could harm our business.

failure to attract and retain additional qualified personnel could prevent us from executing our business strategy.

can be no assurance that we will be able to comply with Nasdaq Capital Market’s continued listing standards.

price of our common stock could be subject to rapid and substantial volatility.

As a relatively small-capitalization company with

relatively small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and

less liquidity than large-capitalization companies.

Such volatility, including any stock-run up, may be unrelated to our actual or

expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the

rapidly changing value of our common stock.

In addition, if the trading volumes of our common stock are low, persons buying or selling

in relatively small quantities may easily influence prices of our common stock.

This low volume of trades could also cause the price

of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session.

our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low

volume trading.

Related to Our Financial Position, Need for Additional Capital and Limited Operating History

are early in our development efforts, with a limited operating history, and we have no products approved for commercial sale, which may

make it difficult for you to evaluate our current business and likelihood of success and future viability.

are an early clinical stage pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects.

We are developing one medication to treat rare diseases (MPS I, Friedreich’s ataxia, and MELAS) as well as larger indications,

Parkinson’s Disease and Mild Cognitive Impairment / early Alzheimer’s disease, which is an unproven and highly uncertain

undertaking and involves a substantial degree of risk.

We commenced operations in January 2016, have no products approved for commercial

sale and have not generated any revenue.

We initiated and completed our Phase I clinical trial for our sole product candidate, JOTROL,

in March 2021.

Since our inception in 2016, we have devoted substantially all of our focus and financial resources to discovering, identifying

and developing our product candidate, JOTROL, including advancing our development program, conducting a preclinical study of our product

candidate and initiating a clinical trial, organizing and staffing our company, business planning, raising capital and securing related

intellectual property rights.

have not yet demonstrated our ability to successfully complete efficacy clinical trials that can lead to a New Drug Application (“NDA”)

submission, obtain marketing approvals, manufacture a commercial-scale product, or obtain a proposal for any out-licensing or distribution

As a result, it may be more difficult for investors to accurately predict our likelihood of success and viability than it

could be if we had a longer operating history.

addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently

experienced by clinical-stage biopharmaceutical companies in rapidly evolving fields.

We also may need to transition from a company with

a research and development focus to a company capable of supporting commercial activities.

We have not yet demonstrated an ability to

successfully overcome such risks and difficulties, or to make such a transition.

If we do not adequately address these risks and difficulties

or successfully make such a transition, our business will suffer.

have not generated any revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue

to incur significant net losses for the foreseeable future.

do not have any products approved for sale, and consequently we have not generated any revenue.

We have incurred significant net losses

since our inception and have financed our operations principally through private placements of our common stock.

To date, we have not

been profitable and have incurred significant losses and cash flow deficits.

the fiscal years ended December 31, 2024 and 2023, we generated no revenues from product sales and reported net losses of $2,439,625

and $4,783,689, respectively, and negative cash flow from operating activities of $3,911,004 and $480,953, respectively.

our financial statements, as of December 31, 2024, we had an accumulated deficit of $26,022,129.

sole product candidate, JOTROL, recently completed Phase I clinical trial that commenced in December 2020.

As a result, we expect that

it will be several years, if ever, before we receive approval to commercialize our product and generate revenue from product sales.

if we succeed in receiving marketing approval for and commercializing of our approved product candidate, we expect that we will continue

to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

The net losses we incur

may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a

good indication of our future performance, particularly since we expect our expenses to increase if and when our product candidate progresses

through clinical development as a product candidate in later stages of clinical development generally have higher development costs than

those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials.

The size of our future net

losses will depend, in part, on the rate of future growth of our expenses and our ability to have our product candidates approved for

marketing and to generate revenue.

Our prior losses and expected future losses have had and will continue to have an adverse effect on

our working capital, our ability to fund the development of our product candidate and our ability to achieve and maintain profitability

and the performance of our stock.

management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included

an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December

31, 2024 and 2023.

management has concluded that our historical recurring losses from operations and negative cash flows from operations as well as our

dependence on private equity and other financings raise substantial doubt about our ability to continue as a going concern and our auditor

has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal year

An investment in our securities carries a significant degree

You should carefully consider the following risks, as well as the other information contained in this Annual Report on Form 10-K,

including our historical financial statements and related notes included elsewhere in this Annual Report on Form 10-K, before you decide

to purchase our securities.

Any one of these risks and uncertainties has the potential to cause material adverse effects on our business,

prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements

expressed by us and a significant decrease in the value of our common shares.

Refer to “Cautionary Statement Regarding Forward-Looking

We may not be successful in preventing the material adverse

effects that any of the following risks and uncertainties may cause.

These potential risks and uncertainties may not be a complete list

of the risks and uncertainties facing us.

There may be additional risks and uncertainties that we are presently unaware of, or presently

consider immaterial, that may become material in the future and have a material adverse effect on us.

You could lose all or a significant

portion of your investment due to any of these risks and uncertainties.

Below is a summary of material risks, uncertainties and other

factors that could have a material effect on the Company and its operations:

substantial amount of indebtedness may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants

and make payments on our indebtedness.

trading volume in our common stock may limit or prevent our ability to draw on the Standby Equity Purchase Agreement to pay down

the convertible promissory notes.

have not generated any meaningful revenue from product sales to date, have incurred significant net losses since our inception, and

expect to continue to incur significant net losses for the foreseeable future;

management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has

included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years

ended December 31, 2025 and 2024.

financial statements do not include any adjustments that might result from the outcome of this uncertainty.

These adjustments would likely

include substantial impairment of the carrying amount of our assets and potential contingent liabilities that may arise if we are unable

to fulfill various operational commitments.

In addition, the value of our securities would be greatly impaired.

Our ability to continue

as a going concern is dependent upon generating sufficient cash flow from operations and obtaining additional capital and financing.

If our ability to generate cash flow from operations is delayed or reduced and we are unable to raise additional funding from other sources,

we may be unable to continue in business.

For further discussion about our ability to continue as a going concern and our plan for future

liquidity, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Ability to Continue

as a Going Concern.”

ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to

the discovery, development and commercialization of our product candidates, if approved.

business depends entirely on the successful discovery, development, regulatory approval and commercialization of product candidates.

We have no products approved for commercial sale and do not anticipate generating any revenue from product sales for the next several

years, if ever.

Our ability to generate revenue and achieve profitability depends significantly on our ability, or any future collaborator’s

ability, to achieve several objectives, including:

and timely completion of clinical development of JOTROL research program, and our other future product candidates and programs;

and maintaining relationships with CROs and clinical sites for the clinical development of JOTROL and any other future product candidates

and programs;

initiation and successful patient enrollment and completion of additional clinical trials on a timely basis;

frequency and severity of adverse events in the clinical trials;

efficacy and safety profiles that are satisfactory to the U.S.

Food and Drug Administration (FDA) or any comparable foreign regulatory

authority for marketing approval;

receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete

clinical development;

with any required post-marketing approval commitments to applicable regulatory authorities;

an efficient and scalable manufacturing process for our product candidates;

and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both

amount and quality, products and services to support clinical development and meet the market demand for our product candidate, if

commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or

with one or more collaborators;

continued acceptable safety profile following any marketing approval of our product candidate;

acceptance of our product candidate by patients, the medical community and third-party payors;

any required post-marketing approval commitments to applicable regulatory authorities;

assessing and developing new product candidates;

maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

our rights in our intellectual property portfolio;

against third-party infringement claims, if any;

into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture

or commercialize our product candidate;

coverage and adequate reimbursement by third-party payors for our products and patients’ willingness to pay in the absence

of such coverage and adequate reimbursement;

additional funding to develop and potentially manufacture and commercialize our product candidates;

any competing therapies and technological and market developments;

costs, including any unforeseen costs, that we may incur as a result of nonclinical study or clinical trial delays;

hiring and retaining qualified personnel including clinical, scientific, management and administrative personnel.

may never be successful in achieving our objectives and, even if we do, we may never generate revenue that is significant or large enough

to achieve profitability.

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

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

further our research and development efforts, raise additional necessary capital, grow our business and continue our operations.

may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process

to commercial partners, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely

or profitable basis, if at all.

Changes in the manufacturing process or facilities will require further comparability analysis and approval

by the FDA before implementation, which could delay our clinical trials and product candidate development, and could require additional

clinical trials, including bridging studies, to demonstrate consistent and continued safety and efficacy.

will require substantial additional capital to finance our operations.

If we are unable to raise such capital when needed, or on acceptable

terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization

of December 31, 2024, we had $3,769,510 in cash.

Our estimate as to how long we expect

our existing cash and cash equivalents to be able to continue to fund our operations is based on assumptions that may prove to be wrong,

and we could use our available capital resources sooner than we currently expect.

Changing circumstances, some of which may be beyond

our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional

funds sooner than planned.

pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain

process that takes years to complete.

Our operations have consumed substantial amounts of cash since inception, and we expect our expenses

to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for,

JOTROL as well as develop our proprietary drug delivery platform.

Even if one or more of the product candidates that we develop is approved

for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities.

Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency (EMA) or other regulatory

agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate.

Other unanticipated costs

may also arise.

Because the design and outcome of our planned and anticipated preclinical studies and clinical trials are highly uncertain,

we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development

If we are unable to raise such capital when needed, or on

acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or

future commercialization efforts.

additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights

to our technologies or product candidates.

The actual number of shares of common stock we will issue pursuant to the SEPA, if not terminated and if and when

available, at any one time or in total, is uncertain.

business and future prospects with the Nugevia brand and our pharmaceutical products are significantly dependent on our exclusive,

worldwide license agreement with Aquanova.

Any adverse development related to this license agreement could materially and adversely

affect our operations, financial condition, and results of operations.

We have entered into Service Agreements with the Asian Partners with respect to services to be provided by the Asian

Partners to us in Asia for the clinical development of JOTROL™ in the Southeast Asian territory immediately following the

completion of the initial public offering;

the shares issued by us in advance for the specific services could have a material negative

impact on our business, financial condition and operating results in case the Asian Partners’ will not perform the services per

the agreements.

We entered into a Strategic Service Agreement with DOMINANT TREASURE HEALTH COMPANY LIMITED with respect to strategic

services in Asia, the fees paid by the Company pursuant to which, are non-refundable and not tied to any milestones or performance, and

the foregoing nature of such fees, could have a material negative impact on our business, financial condition and operating results.

have limited resources and are currently focusing the majority of our efforts on developing JOTROL™ for particular indications.

As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

face significant competition and if our competitors develop and market technologies or products more rapidly than we do or that are

more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.

may not be successful in our efforts to develop our proprietary drug delivery platform, JOTROL™, to build a pipeline of indications.

FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their

jurisdiction.

may face difficulties from changes to current regulations and future legislation.

success is highly dependent on our ability to attract and retain highly skilled executive officers and employees;

Company’s failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of its

Risks Related to Our Financial Position, Need for Additional

Capital and Limited Operating History

We are early in our development efforts, with a limited

operating history, and we have no prescription products approved for commercial sale, which may make it difficult for you to evaluate

our current business and likelihood of success and future viability.

We are an early clinical stage pharmaceutical company

with a limited operating history upon which you can evaluate our business and prospects.

We are advancing a therapeutic pipeline

targeting CNS disorders and rare disease, while also expanding into the consumer longevity market with our Nugevia product line.

are developing one medication to treat rare diseases (MPS I and MELAS) as well as larger indications, Parkinson’s Disease and

MCI / early Alzheimer’s disease, which is an unproven and highly uncertain undertaking and involves a substantial degree of

We commenced operations in January 2016, have no

prescription or therapeutic products approved for commercial sale and have not generated any revenue through our pharmaceutical

We initiated and completed our Phase I clinical trial for our sole product candidate, JOTROL™, in March 2021.

Subject to additional discussions with and approval from FDA, we hope to use the results of this study as a cross-reference for

other indications where JOTROL™ will be used in Phase IIa and potentially Phase III clinical trials.

FDA accepted this

cross-reference in the approval of the IND application for the Parkinson’s Phase IIa trial.

The Company has not discussed the

use of cross-referencing in this manner with the FDA or other comparable regulatory authorities for any other indications, and FDA

(or any comparable regulatory authorities) may preclude us from the use of cross-referencing with respect to the results of this

As a result, we are presently unable to rely on potential cross-referencing besides in the already approved Parkinson’s

inception in 2016, we have devoted substantially all of our focus and financial resources to discovering, identifying and developing

our product candidate, JOTROL™, including advancing our development program, conducting a preclinical study of our product

candidate and initiating a clinical trial, organizing and staffing our company, business planning, raising capital and securing

related intellectual property rights.

We have not yet demonstrated our ability to successfully complete

efficacy clinical trials that can lead to a NDA submission, obtain marketing approvals, manufacture a commercial-scale product, or obtain

a proposal for any out-licensing or distribution agreements.

As a result, it may be more difficult for investors to accurately predict

our likelihood of success and viability than it could be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties,

complications, delays and other known and unknown factors and risks frequently experienced by clinical-stage biopharmaceutical companies

in rapidly evolving fields.

We also may need to transition from a company with a research and development focus to a company capable of

supporting commercial activities.

We have not yet demonstrated an ability to successfully overcome such risks and difficulties, or to

make such a transition.

If we do not adequately address these risks and difficulties or successfully make such a transition, our business

We have not generated any meaningful revenue from

product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net

losses for the foreseeable future.

2025, the Company launched a new strategic initiative to introduce Nugevia, a consumer-focused product line centered on longevity and

This initiative is intended to address growing demand for wellness solutions through the development

of nutritional products.

The Company completed product formulations and commenced initial

direct-to-consumer sales in the fourth quarter of 2025.

To date, however, the Company has not generated any meaningful revenue and has

incurred significant net losses since inception.

Operations have been funded primarily through private placements of common stock.

Company has not achieved profitability and continues to experience significant losses and cash flow deficits

For the fiscal years ended December 31, 2025 and 2024, we

generated net revenues of $21,796 and $0, respectively from product sales and reported net losses of $8,644,897 and $2,439,625, respectively,

and negative cash flow from operating activities of $5,413,736 and $3,911,004, respectively.

As noted in our financial statements, as

of December 31, 2025 and 2024, we had an accumulated deficit of $34,667,026 and $26,022,129, respectively.

Our product candidate, JOTROL™, recently completed Phase

I clinical trial that commenced in December 2020.

As a result, we expect that it will be several years, if ever, before we receive approval

to commercialize our product and generate revenue from pharmaceutical product sales.

Even if we succeed in receiving marketing approval

for and commercializing of our approved product candidate, we expect that we will continue to incur substantial research and development

and other expenses in order to discover, develop and market additional potential products.

We expect to continue to incur significant expenses and increasing

operating losses for the foreseeable future.

The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period

comparison of our results of operations may not be a good indication of our future performance, particularly since we expect our expenses

to increase if and when our product candidate progresses through clinical development as a product candidate in later stages of clinical

development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of

later-stage clinical trials.

The size of our future net losses will depend, in part, on the rate of future growth of our expenses and

our ability to have our product candidates approved for marketing and to generate revenue.

Our prior losses and expected future losses

have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidate

and our ability to achieve and maintain profitability and the performance of our stock.

Our management has concluded that factors raise substantial

doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to

continue as a going concern in its audit report for the fiscal years ended December 31, 2025 and 2024.

Our management has concluded that our historical recurring

losses from operations and negative cash flows from operations as well as our dependence on private equity and other financings raise

substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our

ability to continue as a going concern in its audit report for the fiscal year ended December 31, 2025 and 2024.

Our financial statements do not include any adjustments that

might result from the outcome of this uncertainty.

These adjustments would likely include substantial impairment of the carrying amount

of our assets and potential contingent liabilities that may arise if we are unable to fulfill various operational commitments.

the value of our securities would be greatly impaired.

Our ability to continue as a going concern is dependent upon generating sufficient

cash flow from operations and obtaining additional capital and financing.

If our ability to generate cash flow from operations is delayed

or reduced and we are unable to raise additional funding from other sources, we may be unable to continue in business.

For further discussion

about our ability to continue as a going concern and our plan for future liquidity, see “Management’s Discussion and Analysis

of Financial Condition and Results of Operations—Ability to Continue as a Going Concern.”

Our ability to generate revenue and achieve profitability

depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of our

product candidates, if approved.

Our business depends entirely on the successful

discovery, development, regulatory approval and commercialization of product candidates for therapeutic uses and/or the

commercialization of products in our DTC Nugevia line.

We have no prescription drug products approved for commercial sale and do not

anticipate generating any revenue from sales of prescription drugs for the next several years, if ever.

We have not generated meaningful revenue from Nugevia product sales to date.

Our ability to generate revenue and achieve profitability

depends on successfully completing clinical development of the JOTROL™ program and future candidates, establishing relationships

with CROs and clinical sites, initiating and completing clinical trials on time, ensuring acceptable safety and efficacy profiles for

FDA or foreign regulatory approval, and obtaining timely marketing approvals.

We must also comply with post-marketing commitments, develop

scalable manufacturing processes, and secure reliable supply chains to meet clinical and market demands.

Additionally, we need to launch

commercially viable products, ensure continued safety post-approval, gain acceptance from patients, medical professionals, and payors,

and secure adequate reimbursement.

We must also develop new candidates, protect our intellectual property, defend against infringement

claims, and enter favorable collaboration agreements.

Further, we need additional funding, the ability to address competing therapies

and market developments, manage costs, and attract and retain qualified personnel.

We may never be successful in achieving our objectives and,

even if we do, we may never generate revenue that is significant or large enough to achieve profitability.

If we do achieve profitability,

we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become and remain profitable would

decrease the value of our company and could impair our ability to maintain or further our research and development efforts, raise additional

necessary capital, grow our business and continue our operations.

We may also experience delays in developing a sustainable,

reproducible and scalable manufacturing process or transferring that process to commercial partners, which may prevent us from completing

our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all.

Changes in the manufacturing

process or facilities will require further comparability analysis and approval by the FDA before implementation, which could delay our

clinical trials and product candidate development, and could require additional clinical trials, including bridging studies, to demonstrate

consistent and continued safety and efficacy.

We will require substantial additional capital to finance

our operations.

If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate

one or more of our research and drug development programs or future commercialization efforts.

As of December 31, 2025, we had $3,789,342 in cash.

as to how long we expect our existing cash and cash equivalents to be able to continue to fund our operations is based on assumptions

that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

Changing circumstances,

some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may

need to seek additional funds sooner than planned.

Developing pharmaceutical products, including conducting

preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.

operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing

activities, particularly as we conduct clinical trials of, and seek marketing approval for, JOTROL™ as well as develop our proprietary

drug delivery platform.

Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate

incurring significant costs associated with sales, marketing, manufacturing and distribution activities.

Our expenses could increase

beyond expectations if we are required by the FDA, the European Medicines Agency (the “EMA”) or other regulatory agencies

to perform clinical trials or preclinical studies in addition to those that we currently anticipate.

Other unanticipated costs may also

Because the design and outcome of our planned and anticipated preclinical studies and clinical trials are highly uncertain, we

cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development

and commercialization of any product candidate we develop.

We are not permitted to market or promote JOTROL, or any other product candidate,

before we receive marketing approval from the FDA.

We are not permitted to market or promote JOTROL™, or any other product

candidate, before we receive marketing approval from the FDA.

We also incur additional costs associated with operating as a public company.

we will need to obtain substantial additional funding in order to continue our operations.

future capital requirements will depend on may factors, including, but not limited to:

scope, progress, results and costs of researching and developing our product candidates including conducting preclinical studies

and clinical trials;

costs, timing and outcome of regulatory review of our product candidates;

number and characteristics of other product candidates that we pursue;

costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product

candidates for which we receive marketing approval;

costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

cost and timing of hiring new employees to support our continued growth;

costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending

intellectual property-related claims;

effect of competing products that may limit market penetration of our products;

ability to establish and maintain collaborations on favorable terms, if at all;

extent to which we acquire or in-license other product candidates and technologies;

timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates,

need to implement additional internal systems and infrastructure, including financial and reporting systems;

compliance and administrative costs associated with being a public company;

extent to which we acquire or invest in businesses, products, or technologies, although we currently have no commitments or agreements

relating to any of these types of transactions.

change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly

change the costs and timing associated with the development of that product candidate.

currently plan to initiate a Phase II clinical trial with JOTROL in patients with Parkinson’s Disease, establish a presence in

South-East Asia through service agreements and advancing the manufacturing of JOTROL clinical trial supplies.

in support of activities

leading up to clinical trials in targeted indications.

Remaining proceeds will be used for general research and development activities,

working capital and other general corporate activities.

Advancing the development of JOTROL program will require a significant amount

Our cash and cash equivalents and grants will not be sufficient for us to fund our product candidates through the completion

of its development, Phase III clinical trials, entire regulatory approval process and commercialization.

We will need to raise additional

capital to fund such activities.

may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds

for our current or future operating plans.

Attempting to secure additional financing may divert our management from our day-to-day activities,

which may adversely affect our ability to develop our product candidates.

Our failure to raise capital as and when needed or on acceptable

terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay,

reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trials or future commercialization efforts.

additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights to

our technologies or product candidates.

such time, if ever, as we can generate substantial revenues, we will be required to obtain further funding through public or private

equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict

our operating activities.

Adequate additional financing may not be available to us on acceptable terms, or at all.

To the extent that

we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the

terms may include liquidation or other preferences that adversely affect your rights as a stockholder.

Debt financing and preferred equity

financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions,

such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing

our assets, making capital expenditures, redeeming our stock, making certain investments, declaring dividends or encumbering our assets

to secure future indebtedness.

Such restrictions could adversely impact our ability to conduct our operations and execute our business

we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations, strategic alliances or

marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies,

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

unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate

our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise

prefer to develop and market ourselves.

substantial amount of indebtedness may adversely affect our cash flow and our ability to operate our business, remain in compliance with

debt covenants and make payments on our indebtedness.

of December 31, 2024, we had outstanding indebtedness in the principal amount of $146,432 and accrued interest of approximately $1,064.

Our substantial level of indebtedness increases the possibility that we may be unable to generate sufficient cash to pay, when due, the

principal of, interest on or other amounts due with respect to our indebtedness.

Our indebtedness could have other important consequences

to you as a stockholder.

Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

Our future capital needs will hinge on multiple factors, including

the scope, progress, and costs of researching and developing our product candidates through preclinical studies and clinical trials, as

well as the timing and outcome of regulatory reviews.

The number and nature of additional product candidates we pursue, along with costs

for marketing, manufacturing, and distributing approved products, will also impact funding requirements.

Revenue from potential commercial

sales, expenses for building inventory, and costs of hiring staff to support growth will further influence our needs.

Additionally, expenses

for patent applications, intellectual property enforcement, and defending related claims, alongside costs to establish collaborations

or in-license new technologies, will play a role.

Competing products, milestone payments, royalties, and investments in businesses or

technologies, as well as the costs of implementing internal systems and meeting public company compliance obligations, will also shape

our financial demands.

A change in the outcome of any of these or other factors with respect to the development of any of our product

candidates could significantly change the costs and timing associated with the development of that product candidate.

We currently plan to initiate a Phase II clinical trial

with JOTROL™ in patients with Parkinson’s Disease, establish a presence in Southeast Asia through service agreements and

advancing the manufacturing of JOTROL™ clinical trial supplies.

in support of activities leading up to clinical trials in targeted

Remaining proceeds will be used for general research and development activities, working capital and other general corporate

Advancing the development of JOTROL™ program will require a significant amount of capital.

Our cash and cash equivalents

and grants will not be sufficient for us to fund our product candidates through the completion of its development, Phase III clinical

trials, entire regulatory approval process and commercialization.

We will need to raise additional capital to fund such activities.

We may seek additional capital due to favorable market conditions

or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Attempting to secure

additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop our product

Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition

and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our

research-stage programs, clinical trials or future commercialization efforts.

Raising additional capital may cause substantial dilution

to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial revenues,

we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing

arrangements or other sources, which may dilute our stockholders or restrict our operating activities.

Adequate additional financing may

not be available to us on acceptable terms, or at all.

To the extent that we raise additional capital through the sale of equity or convertible

debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect

your rights as a stockholder.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants

limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition,

merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain

investments, declaring dividends or encumbering our assets to secure future indebtedness.

Such restrictions could adversely impact our

ability to conduct our operations and execute our business plan.

If we raise additional funds through upfront payments or milestone

payments pursuant to strategic collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,

we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant

licenses on terms that may not be favorable to us.

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

we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to

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

The actual number of shares of common stock we will

issue pursuant to the SEPA, if not terminated and if and when available, at any one time or in total, is uncertain.

Subject to the terms and conditions of the standby equity

purchase agreement, dated October 24, 2025 (the “SEPA”), by and between the Company and YA II PN, LTD, a Cayman Islands exempt

limited partnership (“Yorkville”), we issued two convertible notes to Yorkville in connection with advances under the SEPA.

These convertible notes are convertible into shares of our common stock from time to time during their term.

The number of shares of common

stock that may be issued upon conversion of the convertible notes will depend on a number of factors, including the market price of our

common stock at the time of conversion.

As a result, we cannot predict the total number of shares that may ultimately be issued upon conversion

of the convertible notes, which could result in substantial dilution to our existing stockholders.

trading volume in our common stock may limit or prevent our ability to draw on the Standby Equity Purchase Agreement.

have entered into a SEPA pursuant to which Yorkville has committed to purchase up to $20 million of shares of our common stock,

subject to certain conditions and limitations.

The maximum amount of any individual advance notice under the SEPA is 100% of the

average of the daily traded dollar volume of our common stock on Nasdaq during the five consecutive trading days immediately

preceding an advance notice.

if the trading volume of our common stock is low during any such measurement period, the amount we may draw in any single advance, and

the aggregate capital we can raise within any given timeframe, will be correspondingly reduced.

There can be no assurance that our common

stock will maintain sufficient trading volume to allow us to access the full commitment under the SEPA when needed.

The amount of capital

that may be raised under the SEPA will depend on market conditions, trading volumes, the price of our common stock, and the continued

satisfaction of the applicable limitations and conditions under the SEPA.

It is not possible to predict the actual number of shares we

will sell under the SEPA or the actual gross proceeds resulting from those sales.

inability to utilize the SEPA could have a material adverse effect on our liquidity and financial condition.

Our substantial amount of indebtedness may adversely

affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.

As of December 31, 2025, we had outstanding indebtedness in

the principal amount of $6,000,000 and accrued interest of approximately $39,829.

Our substantial level of indebtedness increases the

possibility that we may be unable to generate sufficient cash to pay, when due, the principal of, interest on or other amounts due with

respect to our indebtedness.

Our indebtedness could have other important consequences to you as a stockholder.

For example, it could:

it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations

of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the

debt instruments;

us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government

us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability

of our cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes;

our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

us at a competitive disadvantage compared to our competitors that have less debt;

our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution

of our business strategy or other purposes.

of the above listed factors could materially adversely affect our business, financial condition and results of operations.

we are at any time unable to generate sufficient cash flow from operations to service our indebtedness when payment is due, we may be

required to attempt to renegotiate the terms of the instruments relating to the indebtedness, seek to refinance all or a portion of the

indebtedness, or obtain additional financing.

There can be no assurance that we would be able to successfully renegotiate such terms,

that any such refinancing would be possible or that any additional financing could be obtained on terms that are favorable or acceptable

to us, if at all.

Any debt financing that is available could cause us to incur substantial costs and subject us to covenants that significantly

restrict our ability to conduct our business.

If we seek to complete additional equity financings, the interests of existing equity holders

may be diluted.

ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.

net operating loss (NOL) carryforwards may be unavailable to offset future taxable income because of restrictions under U.S.

Our NOLs generated in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 taxable years

under applicable U.S.

federal tax law, and therefore could expire unused.

Under tax legislation commonly referred to as the Tax Cuts

and Jobs Act (Tax Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), our federal NOLs generated in

tax years beginning after December 31, 2017 may be carried forward indefinitely, but for taxable years beginning after December 31, 2021,

the deductibility of federal NOLs generated in tax years beginning after December 31, 2017 is limited to 80% of our current year taxable

It is uncertain if and to what extent various states will conform to the Tax Act.

As of December 31, 2024, the Company had federal

and state (post-apportioned basis) net operating losses of $26.0 million, as well as federal orphan drug tax credit carryforwards of

approximately $1.06 million.

Approximately $10.0 million of the foregoing federal and state NOLs will expire at various dates from 2026

through 2043, if not limited by triggering events prior to such time.

addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (Code), if a corporation undergoes an “ownership

change” (generally defined as a cumulative change in the corporation’s ownership by “5-percent shareholders”

that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain

other pre-change tax attributes to offset its post-change taxable income may be limited.

make it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the debt instruments;

make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation;

require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes;

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

place us at a competitive disadvantage compared to our competitors that have less debt;

limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business strategy or other purposes.

Any of the above listed factors could materially adversely

affect our business, financial condition and results of operations.

If we are at any time unable to generate sufficient cash flow

from operations to service our indebtedness when payment is due, we may be required to attempt to renegotiate the terms of the instruments

relating to the indebtedness, seek to refinance all or a portion of the indebtedness, or obtain additional financing.

There can be no

assurance that we would be able to successfully renegotiate such terms, that any such refinancing would be possible or that any additional

financing could be obtained on terms that are favorable or acceptable to us, if at all.

Any debt financing that is available could cause

us to incur substantial costs and subject us to covenants that significantly restrict our ability to conduct our business.

to complete additional equity financings, the interests of existing equity holders may be diluted.

Our ability to utilize our net operating loss carryforwards

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

Our net operating loss (NOL) carryforwards may be unavailable

to offset future taxable income because of restrictions under U.S.

Our NOLs generated in tax years ending on or prior to December

31, 2017 are only permitted to be carried forward for 20 taxable years under applicable U.S.

federal tax law, and therefore could expire

Under tax legislation commonly referred to as the Tax Cuts and Jobs Act (Tax Act) as amended by the Coronavirus Aid, Relief, and

Economic Security Act (CARES Act), our federal NOLs generated in tax years beginning after December 31, 2017 may be carried forward indefinitely,

but for taxable years beginning after December 31, 2021, the deductibility of federal NOLs generated in tax years beginning after December

31, 2017 is limited to 80% of our current year taxable income.

It is uncertain if and to what extent various states will conform to the

As of December 31, 2025, the Company had federal and state (post-apportioned

basis) net operating losses (“NOLs”) of $42.83 million, as well as federal orphan drug credit and research and development

tax credit carryforwards of approximately $1.72 million.

Approximately $22.1 million of the foregoing federal and state NOLs will expire

at various dates from 2036 through 2045, if not limited by triggering events prior to such time.

In addition, under Sections 382 and 383 of the Internal Revenue

Code of 1986, as amended (Code), if a corporation undergoes an “ownership change” (generally defined as a cumulative change

in the corporation’s ownership by “5% stockholders” that exceeds 50 percentage points over a rolling three-year

period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset its post-change

taxable income may be limited.

Similar rules may apply under state tax laws.

We may have experienced such ownership changes in the past, and we may experience ownership changes in the future as a result of shifts

in our stock ownership, some of which are outside our control.

We have not conducted any studies to determine annual limitations, if

any, that could result from such changes in ownership.

Our ability to utilize our NOLs and certain other tax attributes could be limited

by an “ownership change” as described above and consequently, we may not be able to utilize a material portion of our NOLs

and certain other tax attributes, which could have a material adverse effect on our cash flows and results of operations.

Related to the Discovery, Development and Commercialization of Our Product Candidate

are substantially dependent on the success of our lead product candidate, JOTROL, which will be undergoing Phase II clinical trials.

If we are unable to complete development of, obtain approval for and commercialize JOTROL for one or more indications in a timely manner,

our business will be harmed.

future success is dependent on our ability to timely and successfully complete clinical trials, obtain marketing approval for and successfully

commercialize JOTROL, our lead product candidate, through distribution deals with larger pharmaceutical companies.

We are investing the

majority of our efforts and financial resources in the research and development of JOTROL.

We have several pre-clinical trials and one

completed Phase I clinical trial to evaluate the safety and tolerability of JOTROL in healthy volunteers.

We are preparing for Phase

II clinical trials.

This will be our first clinical efficacy trial, and JOTROL has not previously been tested in humans with a specific

disease although we can rely on data that exist for resveratrol.

The reason for this is that once JOTROL is ingested the formulation

excipients will be separated and it is only the active resveratrol that will be circulating in blood plasma.

JOTROL will require additional

clinical development, expansion of manufacturing capabilities, marketing approval from government regulators, substantial investment

and significant marketing efforts to obtain established distributors before we can generate any revenues from product sales.

permitted to market or promote JOTROL, or any other product candidate, before we receive marketing approval from the FDA and comparable

foreign regulatory authorities, and we may never receive such marketing approvals.

success of JOTROL will depend on several factors, including the following:

successful and timely completion of our clinical trials of JOTROL;

initiation and successful patient enrollment and completion of additional clinical trials of JOTROL on a timely basis;

and establishing relationships with CROs and clinical sites for the clinical development of JOTROL;

frequency and severity of adverse events in clinical trials;

demonstrating

efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for

marketing approval;

timely receipt of marketing approvals for JOTROL from applicable regulatory authorities;

extent of any required post-marketing approval commitments to applicable regulatory authorities;

maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers

for clinical development and, if approved, commercialization of JOTROL;

and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

our rights in our intellectual property portfolio;

ability to expand JOTROL into multiple indications;

ability to find partners handling all aspects of commercialization;

successful launch of commercial sales following any marketing approval;

continued acceptable safety profile following any marketing approval;

actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may

be different than expected;

acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be

ability to compete with other therapies.

do not have control over many of these factors, including certain aspects of clinical development and the regulatory submission process,

potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future

collaborator.

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience

significant delays or an inability to successfully commercialize JOTROL, which would materially harm our business.

If we do not receive

marketing approvals for JOTROL, we may not be able to continue our operations.

addition to JOTROL, our prospects depend in part upon discovering, developing and commercializing product candidates in future programs,

which may fail or suffer delays that adversely affect their commercial viability.

future operating results are dependent on our ability to successfully develop, obtain regulatory approval for and commercialize product

candidates from our research programs, in addition to our lead product candidate, JOTROL.

However, research and development related to

novel therapeutics is inherently risky.

A product candidate can unexpectedly fail at any stage of preclinical and/or clinical development.

The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards

of medical care and other unpredictable variables.

The results from preclinical testing or early clinical trials of a product candidate

may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

success of other product candidates we may develop will depend on many factors, including the following:

sufficient data to support the initiation or continuation of clinical trials;

regulatory permission to initiate clinical trials;

with the necessary parties to conduct clinical trials;

enrollment of patients in, and the completion of, clinical trials on a timely basis;

timely manufacture of sufficient quantities of a product candidate for use in clinical trials;

events in clinical trials.

if we successfully discover and advance any other product candidates into clinical development, their success will be subject to all

of the clinical, regulatory and commercial risks described elsewhere in this “Risk Factors” section.

Accordingly, we cannot

assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue

from any product candidates.

drug development involves a lengthy and expensive process with an uncertain outcome.

The clinical trials of our product candidate may

not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise

produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results.

may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization

of our product candidates.

lead product candidate, JOTROL, is entering into Phase II clinical trials after completing a Phase I clinical trial in March 2021 and

its risk of failure is high.

It is impossible to predict when or if JOTROL or any product candidate that we develop will prove effective

or safe in humans or will receive marketing approval.

Before obtaining marketing approval from the FDA, EMA or other comparable foreign

regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials

to demonstrate with substantial evidence the safety and efficacy of such product candidates.

testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain.

guarantee that any of our clinical trials will be conducted as planned or completed on schedule, or at all.

Clinical trials can fail

at any stage of testing and failure may result from a multitude of factors, including, among other things, flaws in study design, dose

selection issues, placebo effects, patient enrollment criteria and failure to demonstrate favorable safety or efficacy traits.

of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials.

For example, our

product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies

or having successfully advanced through initial clinical trials.

We may also discover that the half-life of our product candidates renders

them unsuitable for the therapeutic applications we have chosen.

As a result, we cannot assure you that any clinical trials that we conduct

will demonstrate consistent or adequate efficacy and safety to support marketing approval.

companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after

achieving promising results in preclinical testing and earlier-stage clinical trials, and we cannot be certain that we will not face

similar setbacks.

Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies

that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed

to obtain marketing approval of their drugs.

Furthermore, the failure of any of our product candidates to demonstrate safety and efficacy

in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory

authorities to require additional testing before approving any of our product candidates.

have experienced delays in completing our clinical trial and may experience additional delays in initiating or completing additional

clinical trials.

We may also experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent

receipt of marketing approval or our ability to commercialize our product candidates, including:

of feedback from regulatory authorities that requires us to modify the design of our clinical trials;

trial observations or results that require us to modify the design of our clinical trials;

or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development

approval from one or more institutional review boards (IRB);

number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than

anticipated or participants dropping out of these clinical trials at a higher rate than anticipated;

failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation

and may vary significantly among different CROs and trial sites;

suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a

finding that our product candidates have undesirable side effects or other unexpected characteristics or risks;

to clinical trial protocol;

sites deviating from trial protocol or dropping out of a trial;

cost of clinical trials of our product candidates being greater than anticipated;

supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being

insufficient or inadequate;

experiencing severe or unexpected drug-related adverse selection of clinical end points that require prolonged periods of clinical

observation or analysis of the resulting data;

facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory

authorities to temporarily or permanently shut down due to violations of current good manufacturing practice (cGMPs), regulations

or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;

changes to our manufacturing process that may be necessary or desired;

clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials

on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices (GCP) or other regulatory requirements;

contractors not performing data collection or analysis in a timely or accurate manner;

contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations

of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all

of the data produced by such contractors in support of our marketing applications;

revising the requirements for approving our product candidates.

we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate,

if we are unable to successfully complete clinical trials of our product candidates or other testing in a timely manner, if the results

of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may incur unplanned costs,

be delayed in seeking and obtaining marketing approval, if we receive such approval at all, receive more limited or restrictive marketing

approval, be subject to additional post-marketing testing requirements or have the drug removed from the market after obtaining marketing

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

and receive compensation in connection with such services.

Under certain circumstances, we may be required to report some of these relationships

to the FDA or comparable foreign regulatory authorities.

The FDA or comparable foreign regulatory authority may conclude that a financial

relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study.

The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical

trial site and the utility of the clinical trial itself may be jeopardized.

This could result in a delay in approval, or rejection, of

our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the

denial of marketing approval of one or more of our product candidates.

we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects

of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed.

Moreover, our product development costs will also increase if we experience delays in preclinical studies or clinical trials or in obtaining

marketing approvals.

We do not know whether any of our preclinical studies or clinical trials will begin as planned, will need to be

restructured or will be completed on schedule, or at all.

We may also determine to change the design or protocol of one or more of our

clinical trials, which could result in increased costs and expenses and/or delays.

Any delays in completing our clinical trials will

increase our costs, slow down our product candidates development and approval process and jeopardize our ability to commence product

sales and generate revenues.

addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of,

clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

Any delays to our clinical trials

that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates

and our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could

be significantly reduced.

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

have entered into Service Agreements with the Asian Partners with respect to services to be provided by the Asian Partners

to us in Asia for the development of our product in the South-East Asian territory immediately following the completion of the public

offering, the shares issued by us in advance for the specific services could have a material negative impact on our business, financial

condition and operating results in case the Asian Partners’ will not perform the services per the agreements.

have entered into service agreements for development of our product in the South-East Asian territory.

The agreements are with three

contracted companies, namely, Longevity Technology Group Limited, Regis Healthcare Group Limited, and Optimized Wellness Limited (collectively,

the “Asian Partners”) that will handle CMC (Chemistry, Manufacturing, and Controls), regulatory affairs and clinical

trial management, respectively.

As consideration for these services, on June 3, 2024, the Company issued 1,162,500 shares of common stock

(“Issued Shares”) to each of the Asian Partners with a fair market value of $1.33 per share (3,487,500 shares in aggregate,

with an aggregate fair market value of $4,638,375), as pre-payment for three years of services.

The Issued Shares are based on certain

specified and agreed upon performances to be executed by each of the Asian Partners.

However, if the Asian Partners fail

to perform, or underperform, under their respective service agreements with the Company, their Issued Shares will still be issued and

outstanding and registered for sale.

If the Company tries to recover some or all of these Issued Shares, or the cash equivalent if the

Issued Shares have been sold by the Asian Partners, based on any type of non-performance of the agreed services, there is no assurance

We may have experienced such ownership changes in the past,

and we may experience ownership changes in the future as a result of shifts in our stock ownership, some of which are outside our control.

We have not conducted any studies to determine annual limitations, if any, that could result from such changes in ownership.

to utilize our NOLs and certain other tax attributes could be limited by an “ownership change” as described above and consequently,

we may not be able to utilize a material portion of our NOLs and certain other tax attributes, which could have a material adverse effect

on our cash flows and results of operations.

Changes in U.S.

tax laws and regulations and those which

we are subject to in various tax jurisdictions could adversely affect our business, financial condition and results of operations.

We operate in multiple jurisdictions and are subject to tax

laws and regulations of the U.S.

federal, state and local and foreign governments.

New income, sales, use, digital service or other tax

laws, statutes, rules, regulations, or ordinances could be enacted at any time.

Those enactments could harm our domestic and international

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

Further, existing tax laws, statutes, rules, regulations

or ordinances could be interpreted, changed, modified or applied adversely to us.

These events could require us to pay additional tax

amounts on a prospective or retroactive basis, as well as require us to pay fines and/or penalties and interest for past amounts deemed

Additionally, new, changed, modified or newly interpreted or applied tax laws could increase our compliance, operating and

other costs, as well as the costs of our offerings.

Further, these events could decrease the capital we have available to operate our

Any or all of these events may harm our business, financial condition and results of operations.

If we expand the scale of our international business activities,

any changes in the U.S.

or foreign taxation of such activities may increase our worldwide effective tax rate and harm our business, financial

condition and results of operations.

We may be subject to taxation in several jurisdictions around the world with increasingly complex

tax laws, the application of which can be uncertain.

The amount of taxes we pay in these jurisdictions could increase substantially as

a result of changes in the applicable tax principles, including increased tax rates, new tax laws or revised interpretations of existing

tax laws and precedents.

An increase in our tax liabilities could harm our liquidity and results of operations.

In addition, the authorities

in these jurisdictions could review our tax returns and impose additional tax, interest and penalties, and the authorities could claim

that various withholding requirements apply to us or assert that benefits of tax treaties are not available to us, any of which may harm

us and our results of operations.

Any shares of common stock we issue under the SEPA,

if not terminated and if and when available, will further dilute our stockholders.

We have issued shares of our common stock to Yorkville pursuant

to the SEPA and we may issue additional shares of our common stock under the SEPA in the future.

These issuances have resulted, and any

future issuances will result, in dilution to the ownership interests of our existing stockholders.

The number of shares that may be issued

under the SEPA is variable and depends on factors such as the prevailing market price of our common stock and any applicable discounts

under the SEPA, and shares may be issued at prices below the market price, resulting in significant dilution.

Risks Related to the Launch of the Nugevia Brand

The launch of the Nugevia brand exposes the Company

to a number of business and operational risks that could materially and adversely impact its business

The launch of the Nugevia brand exposes us to a number of

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

Successfully introducing

a new brand requires significant investment in marketing, product development, supply chain management, and regulatory compliance, and

there can be no assurance that Nugevia will achieve market acceptance or generate anticipated sales.

If we fail to execute the launch

effectively, experience delays in product availability, or encounter challenges in maintaining product quality and regulatory standards,

our ability to establish Nugevia as a recognized and trusted brand may be compromised.

Additionally, the introduction of Nugevia may provoke competitive

responses from established market participants, potentially resulting in increased pricing pressure or heightened marketing costs.

the Nugevia brand does not gain sufficient traction or if we are unable to recover our investment in its development and promotion, our

growth prospects and overall financial performance could be negatively impacted.

Our business and future prospects with the Nugevia brand

and our pharmaceutical products are significantly dependent on our exclusive, worldwide license agreement with Aquanova.

Any adverse development

related to this license agreement could materially and adversely affect our operations, financial condition, and results of operations.

Our business and future prospects are significantly dependent

on our exclusive, worldwide license agreement with Aquanova AG, a German company (“Aquanova”) which grants us rights to develop,

manufacture, distribute, and sell key products, including JOTROL™.

Any adverse development related to this agreement could materially

and adversely affect our operations, financial condition, and results of operations.

If the license agreement with Aquanova were to be terminated,

limited, or materially altered, we could lose access to essential proprietary technologies, such as Aquanova’s NovaSOL® formulation

technology, which is critical for the bioavailability and effectiveness of our Nugevia brand.

Disputes over contract terms, intellectual

property rights, or performance obligations could result in costly litigation, delays in product development, or loss of commercialization

Additionally, our obligation to pay license fees and royalties under the license agreement represents a significant financial

commitment, and any inability to meet these obligations could jeopardize our rights under the license agreement.

The loss or impairment

of this license would require us to seek alternative technologies or partners, which may not be available on favorable terms, if at all,

and could delay or prevent the development and commercialization of our products.

Should we fail to maintain a productive relationship with

Aquanova or if Aquanova experiences operational or financial difficulties, our ability to deliver products to market could be compromised,

negatively impacting our growth prospects and competitive position.

If the Company or its suppliers fails to comply with

FDA or other regulations, it could result in enforcement actions or delays in the Nugevia brand product launch.

The Company is subject to various federal, state, and local

laws, regulations and administrative practices that affect its business.

Our suppliers and contract manufacturers are also subject to

such laws and regulations.

The safety, formulation, manufacturing, processing, packaging, importation, labeling, promotion, advertising,

and distribution of the Nugevia brand products are subject to regulation by several federal agencies, including the FDA, the FTC, the

USDA, the CPSC and the EPA, as well as by various state and local agencies.

If these laws and regulations were violated by our management,

suppliers or distributors, we could be subject to regulatory enforcement action, public warning letters, product recalls, fines, penalties

and sanctions, including injunctions against the future shipment and sale of products, restitution and disgorgement of profits, operating

restrictions.

In addition, other public and private actors are increasingly targeting supplement retailers and manufacturers with class

action lawsuits for selling products that allegedly fail to adhere to the requirements of FDCA, DSHEA, and other federal and state statutes

and requirements, including for failing to adhere to current GPMs, making false or misleading product statements, providing inaccurate

ingredient identity and potency, and failing to control or disclose allergens, contaminants, residues and adulterants, as well as for

state common and statutory laws regarding deceptive trade practices.

We could also be the target of claims relating to false or

deceptive advertising in connection with the marketing and advertising of the products we sell, including under the auspices of the FTC,

the consumer protection statutes of some states as well as certain non-government watchdog groups and class action law firms.

the FDA has aggressively enforced its regulations with respect to structure/function claims ( e.g., “calcium builds strong

bones”), nutrient content claims ( e.g., “high in antioxidants”) and other claims that impermissibly suggest therapeutic

benefits In addition, the number of private consumer class actions relating to false or deceptive advertising against cosmetic, food,

beverage and nutritional supplement manufacturers has increased in recent years.

These events could interrupt the marketing and sales

of products in our stores, including our private label products, severely damage our brand reputation and public image, increase the cost

of products in our stores, result in product recalls or litigation, and impede our ability to deliver merchandise in sufficient quantities

or quality to our stores, which could result in a material adverse effect on our business, financial condition, results of operations

and cash flows.

The global nutraceutical market is highly competitive,

with many brands offering products that are similar to Nugevia.

Failure to differentiate from competitors could limit market penetration

and revenue potential.

The global nutraceutical market, valued at $458.55

billion in 2024, is highly competitive, with established players like Nestlé Health Science, Amway, and smaller niche brands

vying for market share.

Nugevia’s reliance on resveratrol, despite JOTROL™’s potential for enhanced

bioavailability, faces skepticism due to past studies questioning resveratrol’s efficacy and may require additional clinical

Convincing consumers and healthcare professionals of Nugevia’s superior performance will require effective marketing.

Failure to differentiate from competitors offering similar longevity or beauty-from-within products could limit market penetration

and revenue potential.

The Company is dependent on certain proprietary supply-chain

vulnerabilities with operational and supply chain risks.

The Company’s dependence on proprietary technology like

JOTROL™ and partnerships, such as with Aquanova for NovaSOL® Astaxanthin, introduces supply chain vulnerabilities.

in raw material availability, manufacturing delays, or quality control issues could hinder production timelines and product consistency.

Scaling up manufacturing to meet demand while maintaining pharmaceutical-grade standards poses additional operational challenges.

failure to deliver product in a timely manner could erode consumer trust and investor confidence.

If there are intellectual property disputes relating

to the JOTROL™ technology, it could threaten Nugevia’s market position

The Company’s competitive edge hinges on its

patented JOTROL™ technology.

However, intellectual property disputes or challenges to JOTROL™ patent validity could

threaten Nugevia’s market position.

Competitors may attempt to develop similar bioavailability-enhancing technologies, which

circumvent the JOTROL™ patented technology.

Furthermore, any adverse events linked to Nugevia’s ingredients, even if rare,

could result in product liability claims, damaging the brand’s reputation and financial stability.

Risks Related to the Discovery, Development and Commercialization

of Our Product Candidate

We are substantially dependent on the success of our

lead product candidate, JOTROL ™ , which will be undergoing Phase II clinical trials, subject to FDA’s review and agreement.

If we are unable to complete development of, obtain approval for and commercialize JOTROL™ for one or more indications in a timely

manner, our business will be harmed.

Our future success is dependent on our ability to timely

and successfully complete clinical trials, obtain marketing approval for and successfully commercialize JOTROL™, our lead product

candidate, through distribution deals with larger pharmaceutical companies.

We are investing the majority of our efforts and financial

resources in the research and development of JOTROL™.

We have several pre-clinical trials and one completed Phase I clinical trial

to evaluate the safety and tolerability of JOTROL™ in healthy volunteers.

We are preparing for Phase II clinical trials.

be our first clinical efficacy trial, and JOTROL™ has not previously been tested in humans with a specific disease although we

can rely on data that exist for resveratrol.

The reason for this is that once JOTROL™ is ingested the formulation excipients will

be separated and it is only the active resveratrol that will be circulating in blood plasma.

JOTROL™ will require additional clinical

development, expansion of manufacturing capabilities, marketing approval from government regulators, substantial investment and significant

marketing efforts to obtain established distributors before we can generate any revenues from product sales.

We are not permitted to

market or promote JOTROL™, or any other product candidate, before we receive marketing approval from the FDA and comparable foreign

regulatory authorities, and we may never receive such marketing approvals.

The success of JOTROL™ will depend on several factors, including

the following:

the successful and timely completion

of our clinical trials of JOTROL™;

the initiation and successful patient enrollment and completion of additional clinical trials of JOTROL™ on a timely basis;

maintaining and establishing relationships with CROs and clinical sites for the clinical development of JOTROL™;

the frequency and severity of adverse events in clinical trials;

demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval;

the timely receipt of any marketing approvals for JOTROL™ from applicable regulatory authorities;

the extent of any required post-marketing approval commitments to applicable regulatory authorities;

the maintenance of existing or

the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and,

if approved, commercialization of JOTROL™;

obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

protecting our rights in our intellectual property portfolio;

our ability to expand JOTROL™ into multiple indications;

our ability to find partners handling all aspects of commercialization;

the successful launch of commercial sales following any marketing approval;

a continued acceptable safety profile following any marketing approval;

the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected;

commercial acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be novel;

our ability to compete with other therapies.

We do not have control over many of these factors, including

certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights

and the manufacturing, marketing, distribution and sales efforts of any future collaborator.

If we are not successful with respect to

one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize

JOTROL™, which would materially harm our business.

If we do not receive marketing approvals for JOTROL™, we may not be able to

continue our operations.

In addition to JOTROL™, our prospects depend in part

upon discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely

affect their commercial viability.

Our future operating results are dependent on our ability

to successfully develop, obtain regulatory approval for and commercialize product candidates from our research programs, in addition

to our lead product candidate, JOTROL™.

However, research and development related to novel therapeutics is inherently risky.

product candidate can unexpectedly fail at any stage of preclinical and/or clinical development.

The historical failure rate for product

candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable

The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results

that will be obtained in later stage clinical trials of the product candidate.

The success of other product candidates we may develop will

depend on many factors, including the following:

generating sufficient data to support the initiation or continuation of clinical trials;

obtaining regulatory permission to initiate clinical trials;

contracting with the necessary parties to conduct clinical trials;

successful enrollment of patients in, and the completion of, clinical trials on a timely basis;

the timely manufacture of sufficient quantities of a product candidate for use in clinical trials;

adverse events in clinical trials.

Even if we successfully discover and advance any other product

candidates into clinical development, their success will be subject to all of the clinical, regulatory and commercial risks described

elsewhere in this “Risk Factors” section.

Accordingly, we cannot assure you that we will ever be able to discover, develop,

obtain regulatory approval of, commercialize or generate significant revenue from any product candidates.

Clinical drug development involves a lengthy and

expensive process with an uncertain outcome.

The clinical trials of our product candidate may not demonstrate safety and efficacy to the

satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results and the results

of preclinical studies and early clinical trials may not be predictive of future results.

We may incur additional costs or experience

delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Our lead product candidate, JOTROL™ , is

entering into Phase II clinical trials after completing a Phase I clinical trial in March 2021 and its risk of failure is high.

impossible to predict when or if JOTROL™ or any product candidate that we develop will prove effective or safe in humans or will

receive marketing approval.

Before obtaining marketing approval from the FDA, EMA or other comparable foreign regulatory authorities

for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate with substantial

evidence the safety and efficacy of such product candidates.

Clinical testing is expensive, difficult to design and implement,

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

We cannot guarantee that any of our clinical trials will be conducted

as planned or completed on schedule, or at all.

Clinical trials can fail at any stage of testing and failure may result from a multitude

of factors, including, among other things, flaws in study design, dose selection issues, placebo effects, patient enrollment criteria

and failure to demonstrate favorable safety or efficacy traits.

The outcome of preclinical studies and early-stage clinical trials may

not be predictive of the success of later clinical trials.

For example, our product candidates may fail to show the desired safety and

efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical

We may also discover that the half-life of our product candidates renders them unsuitable for the therapeutic applications we

As a result, we cannot assure you that any clinical trials that we conduct will demonstrate consistent or adequate efficacy

and safety that is necessary to support marketing approval.

Many companies in the pharmaceutical and biotechnology industries

have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage

clinical trials, and we cannot be certain that we will not face similar setbacks.

Moreover, preclinical and clinical data are often susceptible

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

studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.

Furthermore, the failure of any of our

product candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other product

candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates.

We have experienced delays in completing our clinical trial

research and may experience additional delays in initiating or completing additional clinical trials.

We may also experience numerous

unforeseen events during, or as a result of, clinical trials that could delay or prevent receipt of marketing approval or our ability

to commercialize our product candidates, including:

receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials;

clinical trial observations or results that require us to modify the design of our clinical trials;

negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development programs;

obtaining approval from one or more institutional review boards (IRB);

the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated;

any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks;

changes to clinical trial protocol;

clinical sites deviating from trial protocol or dropping out of a trial;

the cost of clinical trials of our product candidates being greater than anticipated;

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate;

subjects experiencing severe or unexpected drug-related adverse selection of clinical end points that require prolonged periods of clinical observation or analysis of the resulting data;

a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of current good manufacturing practice (cGMPs), regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;

any changes to our manufacturing process that may be necessary or desired;

third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices (GCP) or other regulatory requirements;

third-party contractors not performing data collection or analysis in a timely or accurate manner;

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications;

regulators revising the requirements for approving our product candidates.

If we are required to conduct additional clinical trials or

other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical

trials of our product candidates or other testing in a timely manner, if the results of these trials or tests are not positive or are

only modestly positive or if there are safety concerns, we may incur unplanned costs, be delayed in seeking and obtaining marketing approval,

if we receive such approval at all, receive more limited or restrictive marketing approval, be subject to additional post-marketing testing

requirements or have the drug removed from the market after obtaining marketing approval.

Moreover, in the future, principal investigators for our clinical

trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.

Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities.

The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator

has created a conflict of interest or otherwise affected interpretation of the study.

The FDA or comparable foreign regulatory authority

may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial

itself may be jeopardized.

This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable

foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product

If we experience delays in the completion of, or termination

of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to

generate product revenues from any of these product candidates will be delayed.

Moreover, our product development costs will also increase

if we experience delays in preclinical studies or clinical trials or in obtaining marketing approvals.

We do not know whether any of our

preclinical studies or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.

We may also determine to change the design or protocol of one or more of our clinical trials, which could result in increased costs and

expenses and/or delays.

Any delays in completing our clinical trials will increase our costs, slow down our product candidates development

and approval process and jeopardize our ability to commence product sales and generate revenues.

In addition, many of the factors that cause, or lead to, termination

or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory

approval of a product candidate.

Any delays to our clinical trials that occur as a result could shorten any period during which we may

have the exclusive right to commercialize our product candidates and our competitors may be able to bring products to market before we

do, and the commercial viability of our product candidates could be significantly reduced.

Any of these occurrences may harm our business,

financial condition and prospects significantly.

We have entered into Service Agreements with the Asian

Partners with respect to services to be provided by the Asian Partners to us in Asia for the clinical development of JOTROL™ in the Southeast

Asian territory immediately following the completion of the initial public offering;

the shares issued by us in advance for the specific

services could have a material negative impact on our business, financial condition and operating results in case the Asian Partners’

will not perform the services per the agreements.

We have entered into service agreements for development of

JOTROL™ in the Southeast Asian territory.

The agreements are with three contracted companies, namely, Longevity Technology Group Limited,

Regis Healthcare Group Limited, and Optimized Wellness Limited (collectively, the “Asian Partners”) that will handle CMC,

regulatory affairs and clinical trial management, respectively.

As consideration for these services, on June 3, 2024, the Company issued

1,162,500 shares of common stock (“Issued Shares”) to each of the Asian Partners with a fair market value of $1.33 per share

(3,487,500 shares in aggregate, with an aggregate fair market value of $4,638,375), as pre-payment for three years of services.

Shares are based on certain specified and agreed upon performances to be executed by each of the Asian Partners.

However, if the Asian

Partners fail to perform, or underperform, under their respective service agreements with the Company, their Issued Shares will still

be issued and outstanding and registered for sale.

If the Company tries to recover some or all of these Issued Shares, or the cash equivalent

if the Issued Shares have been sold by the Asian Partners, based on any type of non-performance of the agreed services, there is no assurance

that the Company’s attempt to recover will be successful.

Accordingly, the Company may be in a position where it issued shares

to the Asian Partners under the service agreements even if the Asian Partners failed to perform, or underperform, without

any ability to have the shares forfeited to the Company.

The requirement by the Company to issue the Issued Shares under the service

agreements, without any specific protection against non-performance, could have a material negative impact on our business, financial

condition and operating results.

entered into a Strategic Service Agreement with DOMINANT TREASURE HEALTH COMPANY LIMITED with respect to strategic services

in Asia, the fees paid by the Company pursuant to which, are non-refundable

Accordingly, the Company may be in a position where it issued shares to

the Asian Partners under the service agreements even if the Asian Partners failed to perform, or underperform, without any ability to

have the shares forfeited to the Company.

The requirement by the Company to issue the Issued Shares under the service agreements, without

any specific protection against non-performance, could have a material negative impact on our business, financial condition and operating

We entered into a Strategic Service Agreement with DOMINANT

TREASURE HEALTH COMPANY LIMITED with respect to strategic services in Asia, the fees paid by the Company pursuant to which, are non-refundable

and not tied to any milestones or performance, and the foregoing nature of such fees, could have a material negative impact on our business,

financial condition and operating results.

Company entered into a Strategic Service Agreement with DOMINANT TREASURE HEALTH COMPANY LIMITED (“Strategic Services

Partner”) to provide services to advance the business objectives of the Company in China and Southeast Asia.

As consideration

for these services, the Company paid $2,300,000 (the “Fees”).

The Fees are non-refundable and are not based on

performance by the Strategic Services Partner or milestones that must be reached by the Strategic Services Partner.

Accordingly, if

the Strategic Services Partner fails to perform, or underperforms, under the Strategic Service Agreement, the Company would still be

obligated to pay the Fees and would not be entitled for any return of the Fees.

Accordingly, the Company is without any ability to

get its money back if the Strategic Services Partner fails to perform, or underperforms.

The requirement by the Company to pay the Fees under the Strategic Service Agreement, regardless of any milestones or

performance by Strategic Services Partner, and the non-refundable nature of such Fees could have a material negative impact on our

business, financial condition and operating results.

product candidates may cause serious adverse events, toxicities or other undesirable side effects when used alone or in combination with

other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent

market acceptance, limit their commercial potential or result in significant negative consequences.

are developing a novel biologically active small molecule for neurological disorders.

As a result, there is uncertainty as to the safety

profile of the product candidates we are developing.

In addition, our product candidates may be used in combination with certain other

therapies which may have undesirable side effects.

If our product candidates are associated with undesirable side effects or have unexpected

characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational

new drugs we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in

which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result

in potential product liability claims.

Any of these occurrences may prevent us from achieving or maintaining market acceptance of the

affected product candidates and may harm our business, financial condition and prospects significantly.

in our ongoing and planned clinical trials may in the future suffer other serious adverse events or other side effects not observed in

our preclinical studies or previous clinical trials.

JOTROL or other product candidates may be used in pediatric populations for which

safety concerns may be particularly scrutinized by regulatory agencies.

In addition, if JOTROL is studied in combination with other therapies,

it may exacerbate adverse events associated with the therapy.

Patients treated with JOTROL or our other product candidates may also be

undergoing other therapies which can cause side effects or adverse events that are unrelated to our product candidates but may still

impact the success of our clinical trials.

The inclusion of critically ill patients in our clinical trials may result in deaths or other

adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’

For example, it is expected that some of the patients enrolled in our JOTROL clinical trial will die or experience major clinical

events either during the course of our clinical trials or after participating in such trials.

further serious adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty

recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development

efforts of that product candidate altogether.

We, the FDA, EMA, other comparable regulatory authorities or an IRB may suspend clinical

trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable

health risks or adverse side effects.

Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic

promise in early-stage trials have later been found to cause side effects that prevented their further development.

Even if the side

effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit

market acceptance due to its tolerability versus other therapies.

Any of these developments could materially harm our business, financial

condition and prospects.

Further, if any of our product candidates obtains marketing approval, toxicities associated with such product

candidates previously not seen during clinical testing may also develop after such approval and lead to a requirement to conduct additional

clinical safety trials, additional contraindications, warnings and precautions being added to the drug label, significant restrictions

on the use of the product or the withdrawal of the product from the market.

We cannot predict whether our product candidates will cause

toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early-stage

clinical trials.

outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results

of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.

will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe

and effective for use in a diverse population before we can seek marketing approvals for their commercial sale.

Success in preclinical

studies and early-stage clinical trials does not mean that future clinical trials will be successful.

For instance, we do not know whether

JOTROL will perform in current or future clinical trials as JOTROL has performed in preclinical studies or earlier clinical trials.

candidates in clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA and other comparable

foreign regulatory authorities despite having progressed through preclinical studies.

Regulatory authorities may also limit the scope

of later-stage trials until we have demonstrated satisfactory safety, which could delay regulatory approval, limit the size of the patient

population to which we may market our product candidates, or prevent regulatory approval.

some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product

candidates due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences

in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants.

Patients treated with our product candidates may also be undergoing other therapies and may be using other approved products or investigational

new drugs, which can cause side effects or adverse events that are unrelated to our product candidates.

As a result, assessments of efficacy

can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial.

This subjectivity can

increase the uncertainty of, and adversely impact, our clinical trial outcomes.

do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain

approval to market any of our product candidates.

we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our regulatory submissions

or receipt of necessary marketing approvals could be delayed or prevented.

may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient

number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA, EMA or other comparable

foreign regulatory authorities.

Patient enrollment is a significant factor in the timing of clinical trials.

Our ability to enroll eligible

patients may be limited or may result in slower enrollment than we anticipate.

may encounter difficulties in identifying and enrolling subjects with a stage of disease appropriate for our planned clinical trials

and monitoring such subjects adequately during and after treatment.

We may not be able to initiate or continue clinical trials if we

are unable to locate a sufficient number of eligible subjects to participate in the clinical trials required by the FDA or comparable

foreign regulatory authorities.

In addition, the process of finding and diagnosing subjects may prove costly.

Further, the treating physicians

in our clinical trials may also use their medical discretion in advising patients enrolled in our clinical trials to withdraw from our

studies to try alternative therapies.

expect patient enrollment to be affected because our competitors have ongoing clinical trials for programs that are under development

for the same indications as our product candidates, and patients who would otherwise be eligible for our clinical trials could instead

enroll in clinical trials of our competitors’ programs.

Patient enrollment for our current or any future clinical trials may be

affected by other factors, including:

and nature of the patient population;

risks and benefits of novel, unproven approaches;

of the disease under investigation;

and efficacy of approved drugs for the disease under investigation;

eligibility criteria for the trial in question as defined in the protocol;

risks and benefits of the product candidates under study;

and patients’ perceptions as to the potential advantages of the product candidates being studied in relation to other available

therapies, including any new products that may be approved or other product candidates being investigated for the indications we

are investigating;

referral practices of physicians;

ability to monitor patients adequately during and after treatment;

activities of key opinion leaders (KOLs) and patient advocacy groups;

and availability of clinical trial sites for prospective patients;

risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may have an advanced

disease, will not survive the full terms of the clinical trials.

inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon

one or more clinical trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product

candidates and jeopardize our ability to obtain marketing approval for the sale of our product candidates.

Furthermore, even if we are

able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining participation in our clinical

trials through the treatment and any follow-up periods.

have limited resources and are currently focusing the majority of our efforts on developing JOTROL for particular indications.

we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

are currently focusing the majority of our resources and efforts on developing JOTROL.

As a result, because we have limited resources,

we may forgo or delay the pursuit of opportunities for other indications or with other product candidates that may have greater commercial

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

Our spending on current and future research and development activities for JOTROL may not yield any commercially viable products.

we do not accurately evaluate the commercial potential or target markets for JOTROL, we may relinquish valuable rights to our product

candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous

for us to retain sole development and commercialization rights to such product candidates or program.

face significant competition and if our competitors develop and market technologies or products more rapidly than we do or that are more

effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.

biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong

emphasis on proprietary and novel products and product candidates.

Our competitors have developed, are developing or may develop products,

product candidates and processes competitive with our product candidate.

Any product candidates that we successfully develop and commercialize

will compete with existing therapies and new therapies that may become available in the future.

We believe that a significant number

of products are currently under development, and may become commercially available in the future, for the treatment of conditions for

which we may attempt to develop product candidates.

have competitors both in the United States and internationally, including major multinational pharmaceutical companies, established biotechnology

companies, specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions.

compete with other organizations to recruit management, scientists and clinical development personnel, which could negatively affect

our level of expertise and our ability to execute our business plan.

We will also face competition in establishing clinical trial sites,

enrolling subjects for clinical trials and in identifying and in-licensing new product candidates.

expect to face competition from existing products and products in development for each of our programs.

Many of these current and potential

competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources and commercial

expertise than we do.

Large pharmaceutical and biotechnology companies, in particular, have extensive experience in clinical testing,

obtaining regulatory approvals, recruiting patients and manufacturing biotechnology products.

These companies also have significantly

greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of development,

and collaborative arrangements in our target markets with leading companies and research institutions.

Established pharmaceutical and

biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds

that could make the product candidates that we develop obsolete.

Smaller or early-stage companies may also prove to be significant competitors,

particularly through collaborative arrangements with large and established companies, as well as in acquiring technologies complementary

to, or necessary for, our programs.

As a result of all of these factors, our competitors may succeed in obtaining approval from the FDA,

EMA or other comparable foreign regulatory authorities or in discovering, developing and commercializing products in our field before

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer side effects, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or are

less expensive than any products that we may develop.

Our competitors also may obtain marketing approval from the FDA, EMA or other comparable

foreign regulatory authorities for their products more rapidly than we may obtain approval for ours, which could result in our competitors

establishing a strong market position before we are able to enter the market.

Even if the product candidates we develop achieve marketing

approval, they may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced

competitiveness.

Technological advances or products developed by our competitors may render our technologies or product candidates obsolete,

less competitive or not economical.

If we are unable to compete effectively, our opportunity to generate revenue from the sale of our

products we may develop, if approved, could be adversely affected.

topline and preliminary data from our clinical trials that we announce or publish 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.

time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from our

Phase I clinical trial of JOTROL.

These interim updates are based on a preliminary analysis of then-available data, and the results and

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

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

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

As a result, the topline 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.

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

different from the preliminary data we previously published.

As a result, topline data should be viewed with caution until the final

data are available.

In addition, we may report interim analyses of only certain endpoints rather than all endpoints.

Interim data from

clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient

enrollment continues and more patient data become available.

Adverse changes between interim data and final data could significantly

harm our business and prospects.

Further, additional disclosure of interim data by us or by our competitors in the future could result

in volatility in the price of our securities.

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 candidates 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 is material or otherwise appropriate information to include in our disclosure.

If the preliminary

or topline data that we report differ from late, final or actual results, or if others, including regulatory authorities, disagree with

the conclusions reached, our ability to obtain approval for, and commercialize, JOTROL or any other product candidates may be harmed,

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

may not be successful in our efforts to develop our proprietary drug delivery platform to build a pipeline of indications.

key element of our strategy is to leverage our proprietary drug delivery platform and our ability to expand our pipeline of indications.

We are leveraging our proprietary drug delivery platform and capabilities to create precision medicines for neurological disorders with

high levels of unmet need.

Although our research and development efforts to date have resulted in a pipeline product candidate JOTROL,

this product candidate may not be safe and effective.

In addition, although we expect that our proprietary drug delivery platform will

allow us to develop a diverse pipeline across multiple therapeutic areas, we may not prove to be successful at doing so.

we may also find that the uses of our proprietary drug delivery platform are limited because alternative uses of our therapeutics prove

not to be safe or effective.

Even if we are successful in building our pipeline, JOTROL may not be suitable for clinical development,

including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to receive

marketing approval or achieve market acceptance.

Further, because our product candidate and development programs are based on our proprietary

drug delivery platform, adverse developments with respect to one of our programs may have a significant adverse impact on the actual

or perceived likelihood of success and value of our other programs.

addition, the biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies.

Our future success will

depend in part on our ability to maintain a competitive position with our approach.

If we fail to stay at the forefront of technological

change in utilizing our proprietary drug delivery platform to create and develop product candidates, we may be unable to compete effectively.

Our competitors may render our approach obsolete or limit the commercial value of our product candidates, by advances in existing technological

approaches or the development of new or different approaches, potentially eliminating the advantages in our drug delivery process that

we believe we derive from our research approach and proprietary technologies.

By contrast, adverse developments with respect to other

companies that attempt to use a similar approach to our approach may adversely impact the actual or perceived value of our proprietary

drug delivery platform and potential of our product candidates.

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

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

may develop JOTROL and potentially other programs in combination with other therapies, which would expose us to additional risks.

may develop JOTROL and potentially other programs, in combination with one or more currently approved therapies or therapies in development.

Patients may not be able to tolerate JOTROL or any other product candidates in combination with other therapies or dosing of JOTROL in

combination with other therapies may have unexpected consequences.

Even if any of our product candidates were to receive marketing approval

or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA,

EMA or other comparable foreign regulatory authorities could revoke approval of the therapy used in combination with any of our product

candidates, or safety, efficacy, manufacturing or supply issues could arise with these existing therapies.

In addition, it is possible

that existing therapies with which our product candidates are approved for use could themselves fall out of favor.

This could result

in the need to identify other combination therapies for our product candidates or our own products being removed from the market or being

less successful commercially.

may also evaluate our product candidates in combination with one or more other therapies that have not yet been approved for marketing

by the FDA, EMA or comparable foreign regulatory authorities.

We will not be able to market and sell any product candidates in combination

with any such unapproved therapies that do not ultimately obtain marketing approval.

the FDA, EMA or other comparable foreign regulatory authorities do not approve or revoke their approval of these other therapies, or

if safety, efficacy, commercial adoption, manufacturing or supply issues arise with the therapies we may choose to evaluate in combination

with JOTROL or any other product candidate, we may be unable to obtain approval of or successfully market any one or all of the product

candidates we develop.

Additionally,

if the third-party providers of therapies or therapies in development used in combination with our product candidates are unable to produce

sufficient quantities for clinical trials or for commercialization of our product candidate, or if the cost of combination therapies

are prohibitive, our development and commercialization efforts would be impaired, which would have an adverse effect on our business,

financial condition, results of operations and growth prospects.

manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production.

If any of our third-party

manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our

products for patients, if approved, could be delayed or prevented.

Manufacturing

drugs, especially in large quantities, is complex and may require the use of innovative technologies.

Each lot of an approved drug product

must undergo thorough testing for identity, strength, quality, purity and potency.

Manufacturing drugs requires facilities specifically

designed for and validated for this purpose, as well as sophisticated quality assurance and quality control procedures.

Slight deviations

anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping and quality control and testing,

may result in lot failures or product recalls.

When changes are made to the manufacturing process, we may be required to provide preclinical

and clinical data showing the comparable quality and efficacy of the products before and after such changes.

If our third-party manufacturers

are unable to produce sufficient quantities for clinical trials or for commercialization as a result of these challenges, or otherwise,

our development and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition,

results of operations and growth prospects.

product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical

community necessary for commercial success.

if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party

payors and others in the medical community.

The degree of market acceptance of any of our approved product candidates will depend on

a number of factors, including:

efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;

timing of market introduction of the product candidates as well as competitive products;

clinical indications for which a product candidate is approved;

on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications

in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor

potential and perceived advantages of our product candidates over alternative treatments;

cost of treatment in relation to alternative treatments;

availability of an approved product candidate for use as a combination therapy;

convenience and ease of administration;

willingness of the target patient population or their caregivers to try new therapies and of physicians to prescribe these therapies;

availability of coverage and adequate reimbursement by third-party payors, including government authorities;

willingness to pay for these therapies in the absence of such coverage and adequate reimbursement;

effectiveness of sales and marketing efforts;

from KOLs and patient advocacy groups;

publicity relating to our product candidates;

approval of other new therapies for the same indications.

any of our product candidates are approved but do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors

and patients, we may not generate or derive sufficient revenue from that product candidate and our financial results could be negatively

patient population suffering from MPS I, Friedreich’s ataxia, and MELAS is small and has not been established with precision.

the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected.

Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must

be able to successfully identify patients and capture a significant market share to achieve profitability and growth.

I, Friedreich’s ataxia, and MELAS are rare, genetic neuromuscular disorders.

We estimate that MPS I occurs in approximately one

in every 100,000 live births and that the patient population is approximately 2,000 to 3,000 in the United States and approximately 4,000

Friedreich’s ataxia has a higher incidence of approximately 1 in every 50,000 live births.

We estimate there are between

5,000 and 6,000 patients with Friedreich’s ataxia in the United States, with slightly higher patient population estimated in Europe.

MELAS is one of the most common mitochondrial diseases, with an estimated incidence of 1 in 4000.

The Company entered into a Strategic Service Agreement with

DOMINANT TREASURE HEALTH COMPANY LIMITED (“Strategic Services Partner”) to provide services to advance the business objectives

of the Company in China and Southeast Asia.

As consideration for these services, the Company paid $2,300,000 (the “Fees”).

The Fees are non-refundable and are not based on performance by the Strategic Services Partner or milestones that must be reached by the

Strategic Services Partner.

Accordingly, if the Strategic Services Partner fails to perform, or underperforms, under the Strategic Service

Agreement, the Company would still be obligated to pay the Fees and would not be entitled for any return of the Fees.

Accordingly, the

Company is without any ability to get its money back if the Strategic Services Partner fails to perform, or underperforms.

The requirement

by the Company to pay the Fees under the Strategic Service Agreement, regardless of any milestones or performance by Strategic Services

Partner, and the non-refundable nature of such Fees could have a material negative impact on our business, financial condition and operating

Our product candidates may cause serious adverse events,

toxicities or other undesirable side effects when used alone or in combination with approved products or investigational new drugs that

may result in a safety or risk profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential

or result in significant negative consequences.

We are developing a novel biologically active small molecule

for neurological disorders.

As a result, there is uncertainty as to the safety profile of the product candidates we are developing.

addition, our product candidates could be used in combination with certain other therapies which may have undesirable side effects.

our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical

trials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay or

abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics

are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Treatment-related side effects could also affect patient

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

Any of these occurrences

may prevent us from achieving or maintaining market acceptance of the affected product candidates and may harm our business, financial

condition and prospects significantly.

Patients in our ongoing and planned clinical trials may in

the future suffer other serious adverse events or other side effects not observed in our preclinical studies or previous clinical trials.

JOTROL™ or other product candidates may be used in pediatric populations for which safety concerns may be particularly scrutinized by regulatory

In addition, if JOTROL™ is studied in combination with other therapies, it may exacerbate adverse events associated with the

Patients treated with JOTROL™ or our other product candidates may also be undergoing other therapies which can cause side effects

or adverse events that are unrelated to our product candidates but may still impact the success of our clinical trials.

The inclusion

of critically ill patients in our clinical trials may result in deaths or other adverse medical events due to other therapies or medications

that such patients may be using or due to the gravity of such patients’ illnesses.

For example, it is expected that some of the

patients enrolled in our JOTROL™ clinical trial will die or experience major clinical events either during the course of our clinical trials

or after participating in such trials.

If further serious adverse events or other side effects are

observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients

may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether.

We, the FDA, EMA, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for

various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects.

Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have

later been found to cause side effects that prevented their further development.

Even if the side effects do not preclude the product

candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to its tolerability

versus other therapies.

Any of these developments could materially harm our business, financial condition and prospects.

Further, if any

of our product candidates obtains marketing approval, toxicities associated with such product candidates previously not seen during clinical

testing may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional contraindications,

warnings and precautions being added to the drug label, significant restrictions on the use of the product or the withdrawal of the product

from the market.

We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation

of regulatory approval based on preclinical studies or early-stage clinical trials.

The outcome of preclinical testing and early clinical

trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements

of the FDA, EMA or other comparable foreign regulatory authorities.

We will be required to demonstrate with substantial evidence

through rigorous, well-designed, and well-controlled clinical trials that our product candidates are safe and effective for use in a diverse

population before we can seek marketing approvals to commercialize any such product candidates.

Success in preclinical studies and early-stage

clinical trials does not mean that future clinical trials will be successful.

For instance, we do not know whether JOTROL™ will perform

in current or future clinical trials as JOTROL™ has performed in preclinical studies or earlier clinical trials.

Product candidates in

clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA and other comparable foreign

regulatory authorities despite having progressed through preclinical studies.

Regulatory authorities may also limit the scope of later-stage

trials until we have demonstrated satisfactory safety, which could delay regulatory approval, limit the size of the patient population

to which we may market our product candidates, or prevent regulatory approval.

In some instances, there can be significant variability in

safety and efficacy results between different clinical trials of the same product candidates due to numerous factors, including changes

in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dose and dosing regimen

and other trial protocols and the rate of dropout among clinical trial participants.

Patients treated with our product candidates may

also be undergoing other therapies and may be using other approved products or investigational new drugs, which can cause side effects

or adverse events that are unrelated to our product candidates.

As a result, assessments of efficacy can vary widely for a particular

patient, and from patient to patient and site to site within a clinical trial.

This subjectivity can increase the uncertainty of, and

adversely impact, our clinical trial outcomes.

We do not know whether any clinical trials we may conduct

will demonstrate consistent or adequate efficacy and safety sufficient to obtain approval to market any of our product candidates.

If we experience delays or difficulties in the enrollment

and/or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed

or prevented.

We may not be able to initiate or continue clinical trials

for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials

to such trial’s conclusion as required by the FDA, EMA or other comparable foreign regulatory authorities.

Patient enrollment is

a significant factor in the timing of clinical trials.

Our ability to enroll eligible patients may be limited or may result in slower

enrollment than we anticipate.

We may encounter difficulties in identifying and enrolling

subjects with a stage of disease appropriate for our planned clinical trials and monitoring such subjects adequately during and after

We may not be able to initiate or continue clinical trials if we are unable to locate a sufficient number of eligible subjects

to participate in the clinical trials required by the FDA or comparable foreign regulatory authorities.

In addition, the process of finding

and diagnosing subjects may prove costly.

Further, the treating physicians in our clinical trials may also use their medical discretion

in advising patients enrolled in our clinical trials to withdraw from our studies to try alternative therapies.

We expect patient enrollment to be affected because our competitors

have ongoing clinical trials for programs that are under development for the same indications as our product candidates, and patients

who would otherwise be eligible for our clinical trials could instead enroll in clinical trials of our competitors’ programs.

enrollment for our current or any future clinical trials may be affected by other factors, including:

size and nature of the patient population;

perceived risks and benefits of novel, unproven approaches;

severity of the disease under investigation;

availability and efficacy of approved drugs for the disease under investigation;

patient eligibility criteria for the trial in question as defined in the protocol;

perceived risks and benefits of the product candidates under study;

clinicians’ and patients’ perceptions as to the potential advantages of the product candidates being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating;

patient referral practices of physicians;

the ability to monitor patients adequately during and after treatment;

the activities of KOLs and patient advocacy groups;

proximity and availability of clinical trial sites for prospective patients;

the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may have an advanced disease, will not survive the full terms of the clinical trials.

Our inability to enroll a sufficient number of patients for

our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.

delays in our clinical trials may result in increased development costs for our product candidates and jeopardize our ability to obtain

marketing approval for the sale of our product candidates.

Furthermore, even if we are able to enroll a sufficient number of patients

for our clinical trials, we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up

We have limited resources and are currently focusing

the majority of our efforts on developing JOTROL™ for particular indications.

As a result, we may fail to capitalize on other indications

or product candidates that may ultimately have proven to be more profitable.

We are currently focusing the majority of our resources and

efforts on developing JOTROL™.

As a result, because we have limited resources, we may forgo or delay the pursuit of opportunities

for other indications or with other product candidates that may have greater commercial potential.

Our resource allocation decisions

may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities.

Our spending on current and future

research and development activities for JOTROL™ may not yield any commercially viable products.

If we do not accurately evaluate

the commercial potential or target markets for JOTROL™, we may relinquish valuable rights to our product candidates or programs

through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain

sole development and commercialization rights to such product candidates or program.

We face significant competition and if our competitors

develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the products

we develop, our commercial opportunities will be negatively impacted.

The biotechnology and biopharmaceutical industries are characterized

by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates.

Our competitors have developed, are developing or may develop products, product candidates and processes competitive with our product

Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies

that may become available in the future.

We believe that a significant number of products are currently under development, and may become

commercially available in the future, for the treatment of conditions for which we may attempt to develop product candidates.

We have competitors both in the United States and internationally,

including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging

and start-up companies, universities and other research institutions.

We also compete with other organizations to recruit management,

scientists and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business

We will also face competition in establishing clinical trial sites, enrolling subjects for clinical trials and in identifying and

in-licensing new product candidates.

We expect to face competition from existing products and products

in development for each of our programs.

Many of these current and potential competitors have significantly greater financial, manufacturing,

marketing, drug development, technical and human resources and commercial expertise than we do.

Large pharmaceutical and biotechnology

companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing

biotechnology products.

These companies also have significantly greater research and marketing capabilities than we do and may also have

products that have been approved or are in late stages of development, and collaborative arrangements in our target markets with leading

companies and research institutions.

Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery

and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete.

or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and

established companies, as well as in acquiring technologies complementary to, or necessary for, our programs.

As a result of all these

factors, our competitors may succeed in obtaining approval from the FDA, EMA or other comparable foreign regulatory authorities or in

discovering, developing and commercializing products in our field before we do.

Our commercial opportunity could be reduced or eliminated

if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient, have

a broader label, are marketed more effectively, are more widely reimbursed or are less expensive than any products that we may develop.

Our competitors also may obtain marketing approval from the FDA, EMA or other comparable foreign regulatory authorities for their products

more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before

we are able to enter the market.

Even if the product candidates we develop achieve marketing approval, they may be priced at a significant

premium over competitive products if any have been approved by then, resulting in reduced competitiveness.

Technological advances or products

developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.

unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be

adversely affected.

Interim, topline and preliminary data from our clinical

trials that we announce or publish 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 preliminary,

interim or topline data from our clinical trials, such as the interim data from our Phase I clinical trial of JOTROL™.

These interim

updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject

to change following a more comprehensive review of the data related to the particular study or 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 topline 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.

Topline data also remains subject

to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously

As a result, topline data should be viewed with caution until the final data are available.

In addition, we may report interim

analyses of only certain endpoints rather than all endpoints.

Interim data from clinical trials that we may complete are subject to the

risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

Adverse changes between interim data and final data could significantly harm our business and prospects.

Further, additional disclosure

of interim data by us or by our competitors in the future could result in volatility in the price of our securities.

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 candidates 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 is material or otherwise

appropriate information to include in our disclosure.

If the preliminary or topline data that we report differ from late, final or actual

results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and

commercialize, JOTROL™ or any other product candidates may be harmed, which could harm our business, financial condition, results of operations

and prospects.

We may not be successful in our efforts to develop

our proprietary drug delivery platform, JOTROL™, to build a pipeline of indications.

A key element of our strategy is to leverage our proprietary

drug delivery platform and our ability to expand our pipeline of indications.

We are leveraging our proprietary drug delivery platform

and capabilities to create precision medicines for neurological disorders with high levels of unmet need.

Although our research and development

efforts to date have resulted in a pipeline product candidate JOTROL™, this product candidate may not be safe and effective.

addition, although we expect that our proprietary drug delivery platform will allow us to develop a diverse pipeline across multiple

therapeutic areas, we may not prove to be successful at doing so.

Furthermore, we may also find that the uses of our proprietary drug

delivery platform are limited because alternative uses of our therapeutics prove not to be safe or effective.

Even if we are successful

in building our pipeline, JOTROL™ may not be suitable for clinical development, including as a result of being shown to have harmful

side effects or other characteristics that indicate that they are unlikely to receive marketing approval or achieve market acceptance.

Further, because our product candidate and development programs are based on our proprietary drug delivery platform, adverse developments

with respect to one of our programs may have a significant adverse impact on the actual or perceived likelihood of success and value

of our other programs.

In addition, the biotechnology and pharmaceutical industries

are characterized by rapidly advancing technologies.

Our future success will depend in part on our ability to maintain a competitive position

with our approach.

If we fail to stay at the forefront of technological change in utilizing our proprietary drug delivery platform to

create and develop product candidates, we may be unable to compete effectively.

Our competitors may render our approach obsolete or limit

the commercial value of our product candidates, by advances in existing technological approaches or the development of new or different

approaches, potentially eliminating the advantages in our drug delivery process that we believe we derive from our research approach and

proprietary technologies.

By contrast, adverse developments with respect to other companies that attempt to use a similar approach to

our approach may adversely impact the actual or perceived value of our proprietary drug delivery platform and potential of our product

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have

a material adverse effect on our business and could potentially cause us to cease operations.

We may develop JOTROL™ and potentially other programs

in combination with other therapies, which would expose us to additional risks.

We may develop JOTROL™ and potentially other programs, in combination

with one or more currently approved therapies or therapies in development.

Patients may not be able to tolerate JOTROL™ or any other

product candidates in combination with other therapies or dosing of JOTROL™ in combination with other therapies may have unexpected

consequences.

Even if any of our product candidates were to receive marketing approval or be commercialized for use in combination with

other existing therapies, we would continue to be subject to the risks that the FDA, EMA or other comparable foreign regulatory authorities

could revoke approval of the therapy used in combination with any of our product candidates, or safety, efficacy, manufacturing or supply

issues could arise with these existing therapies.

In addition, it is possible that existing therapies with which our product candidates

are approved for use could themselves fall out of favor.

This could result in the need to identify other combination therapies for our

product candidates or our own products being removed from the market or being less successful commercially.

We may also evaluate our product candidates in combination

with one or more other therapies that have not yet been approved for marketing by the FDA, EMA or comparable foreign regulatory authorities.

We will not be able to market and sell any product candidates in combination with any such unapproved therapies that do not ultimately

obtain marketing approval.

If the FDA, EMA or other comparable foreign regulatory authorities

do not approve or revoke their approval of these other therapies, or if safety, efficacy, commercial adoption, manufacturing or supply

issues arise with the therapies we may choose to evaluate in combination with JOTROL™ or any other product candidate, we may be unable

to obtain approval of or successfully market any one or all of the product candidates we develop.

Additionally, if the third-party providers of therapies or

therapies in development used in combination with our product candidates are unable to produce sufficient quantities for clinical trials

or for commercialization of our product candidate, or if the cost of combination therapies are prohibitive, our development and commercialization

efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

The manufacture of drugs is complex, and our third-party

manufacturers may encounter difficulties in production.

If any of our third-party manufacturers encounter such difficulties, our ability

to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or

Manufacturing drugs, especially in large quantities, is complex

and may require the use of innovative technologies.

Each lot of an approved drug product must undergo thorough testing for identity, strength,

quality, purity and potency.

Manufacturing drugs requires facilities specifically designed for and validated for this purpose, as well

as sophisticated quality assurance and quality control procedures.

Slight deviations anywhere in the manufacturing process, including

filling, labeling, packaging, storage and shipping and quality control and testing, may result in lot failures or product recalls.

changes are made to the manufacturing process, we may be required to provide preclinical and clinical data showing the comparable quality

and efficacy of the products before and after such changes.

If our third-party manufacturers are unable to produce sufficient quantities

for clinical trials or for commercialization as a result of these challenges, or otherwise, our development and commercialization efforts

would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

Our product candidates may not achieve adequate market

acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

Even if our product candidates receive regulatory approval,

they may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community.

of market acceptance of any of our approved product candidates will depend on a number of factors, including:

the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;

the timing of market introduction of the product candidates as well as competitive products;

the clinical indications for which a product candidate is approved;

restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products;

the potential and perceived advantages of our product candidates over alternative treatments;

the cost of treatment in relation to alternative treatments;

the availability of an approved product candidate for use as a combination therapy;

relative convenience and ease of administration;

the willingness of the target patient population or their caregivers to try new therapies and of physicians to prescribe these therapies;

the availability of coverage and adequate reimbursement by third-party payors, including government authorities;

patients’ willingness to pay for these therapies in the absence of such coverage and adequate reimbursement;

the effectiveness of sales and marketing efforts;

support from KOLs and patient advocacy groups;

unfavorable publicity relating to our product candidates;

the approval of other new therapies for the same indications.

If any of our product candidates are approved but do not achieve

an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate or derive sufficient revenue

from that product candidate and our financial results could be negatively impacted.

patient population suffering from MPS I and MELAS syndrome is small and has not been established with precision.

If the actual

number of patients is smaller than we estimate, our potential revenue and ability to achieve profitability may be adversely

Because the target patient populations of our programs are small and the addressable patient population may be even

smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and

I and MELAS are rare, genetic neuromuscular disorders.

We estimate that MPS I occurs in approximately one in every 100,000 live births

and that the patient population is approximately 2,000 to 3,000 in the United States and approximately 4,000 in Europe.

of the most common mitochondrial diseases, with an estimated incidence of 1 in 4000.

We estimate that there are approximately 80,000

patients with MELAS in the United States.

estimates of the size of these patient populations are based on published studies.

Given the small number of patients who have the diseases

that we are targeting, it is critical to our ability to grow and become profitable that we continue to successfully identify patients

with these rare diseases.

The effort to identify patients with diseases we seek to treat is in early stages, and we cannot accurately

predict the number of patients for whom treatment might be possible.

Various factors may decrease the market size of our product and

product candidates, including the severity of the disease, patient demographics and the response of patients’ immune systems to

our product candidates.

If the results of these studies or our analysis of them do not accurately reflect the relevant patient population,

our assessment of the market may be inaccurate, making it difficult or impossible for us to meet our revenue goals, or to obtain and

maintain profitability.

Additionally,

the potentially addressable patient population for each of our product candidates may be limited or may not be amenable to treatment

with our product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely

affect our results of operations and our business.

Further, even if we obtain significant market share for our product candidates, because

the potential target populations are very small, we may never achieve profitability despite obtaining such significant market share.

product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing

availability and extent of coverage and adequate reimbursement by third-party payors including government health administration authorities,

private health coverage insurers, managed care organizations and other third-party payors is essential for most patients to be able to

afford expensive treatments.

The initial targets in our pipeline are indications with small patient populations.

For product candidates

that are designed to treat smaller patient populations to be commercially viable, the reimbursement for such product candidates must

be higher, on a relative basis, to account for the lack of volume.

Accordingly, we will need to implement a coverage and reimbursement

strategy for any approved product candidate that accounts for the smaller potential market size.

of any of our product candidates that receive marketing approval will depend substantially, both in the United States and internationally,

on the extent to which the costs of such product candidates will be covered and reimbursed by third-party payors.

If reimbursement is

not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates.

if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient

to realize an adequate return on our investment.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate

for which we obtain marketing approval.

If coverage and reimbursement are not available or reimbursement is available only to limited

levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.

is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products.

In the United States,

for example, principal decisions about reimbursement for new products are typically made by the Centers for Medicare & Medicaid Services

(CMS), an agency within the U.S.

Department of Health and Human Services (HHS).

CMS decides whether and to what extent a new product

will be covered and reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and

reimbursement to a substantial degree.

However, one third-party payor’s determination to provide coverage for a product candidate

does not assure that other payors will also provide coverage for the product candidate or at the same level of reimbursement.

the coverage determination process is often time-consuming and costly.

This process will require us to provide scientific and clinical

support for the use of our products to each third-party payor separately, with no assurance that coverage and adequate reimbursement

will be applied consistently or obtained in the first instance.

Increasingly,

third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the

prices charged for medical products.

Further, such payors are increasingly challenging the price, examining the medical necessity and

reviewing the cost effectiveness of medical product candidates.

There may be especially significant delays in obtaining coverage and

reimbursement for newly approved drugs.

Third-party payors may limit coverage to specific product candidates on an approved list, known

as a formulary, which might not include all FDA-approved drugs for a particular indication.

We may need to conduct expensive pharmaco-economic

studies to demonstrate the medical necessity and cost effectiveness of our products.

Nonetheless, our product candidates may not be considered

medically necessary or cost effective.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize

and, if reimbursement is available, what the level of reimbursement will be.

the United States, the commercialization of therapeutics is generally subject to extensive governmental price controls and other market

regulations, and we believe the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will

continue to put pressure on the pricing and usage of therapeutics such as our product candidates.

In many countries, particularly the

countries of the European Union (EU), medical product prices are subject to varying price control mechanisms as part of national health

In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares

the cost-effectiveness of our product candidate to other available therapies.

In general, product prices under such systems are substantially

lower than in the United States.

Other countries allow companies to fix their own prices for products but monitor and control company

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge

for our product candidates.

Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared

with the United States and may be insufficient to generate commercially reasonable revenue and profits.

we are unable to establish or sustain coverage and adequate reimbursement for any product candidates from third-party payors, the adoption

of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell

those product candidates, if approved.

Coverage policies and third-party payor reimbursement rates may change at any time.

Even if favorable

coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage

policies and reimbursement rates may be implemented in the future.

business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability

could have an adverse effect on our business and financial condition.

If product liability lawsuits are brought against us, we may incur

substantial liabilities and may be required to limit commercialization of our products.

business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic

We currently have product liability insurance that we believe is appropriate for our stage of development and may need to

obtain higher levels prior to marketing any of our product candidates, if approved.

Any insurance we have or may obtain may not provide

sufficient coverage against potential liabilities.

Furthermore, clinical trial and product liability insurance is becoming increasingly

As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product

liability claims that could have an adverse effect on our business and financial condition.

Also, our insurance policies may have various

exclusions, and we may be subject to a product liability claim for which we have no coverage.

We may have to pay any amounts awarded

by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not

have, or be able to obtain, sufficient capital to pay such amounts.

Even if our agreements with any future corporate collaborators entitle

us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

may be sued if any of our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical

testing, manufacturing, marketing, or sale post-approval.

Any such product liability claims may include allegations of defects in manufacturing,

defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, or a breach of warranties.

could also be asserted under state consumer protection laws.

If we cannot successfully defend ourselves against product liability claims,

we may incur substantial liabilities or be required to limit testing and commercialization of our products.

Even successful defense would

require significant financial and management resources.

of the merits or eventual outcome, liability claims may result in:

in the development of our product candidates;

EMA or other regulatory authority investigation of the safety and effectiveness of our products, our manufacturing processes and

facilities or our marketing programs;

or interrupted demand for our products;

to our reputation;

of clinical trial participants and inability to continue clinical trials;

of investigations by regulators;

to defend the related litigation;

diversion of management’s time and our resources;

monetary awards to trial participants or patients;

recalls, withdrawals or labeling, marketing, or promotional restrictions;

of any available insurance and our capital resources;

inability to commercialize any products.

Related to Regulatory Approval and Other Legal Compliance Matters

regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently

unpredictable.

If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product

revenue and our business will be substantially harmed.

product candidates are and will continue to be subject to extensive governmental regulations relating to, among other things, research,

testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising

and promotion, pricing, marketing and distribution of drugs.

Rigorous preclinical testing and clinical trials and an extensive regulatory

approval process must be successfully completed in the United States and in many foreign jurisdictions before a new drug can be approved

for marketing.

Obtaining approval by the FDA, EMA and other comparable foreign regulatory authorities is costly, unpredictable, typically

takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and

novelty of the product candidates involved.

In addition, approval policies, regulations or the type and amount of clinical data necessary

to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which

may cause delays in the approval or the decision not to approve an application.

Regulatory authorities have substantial discretion in

the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional

preclinical, clinical or other data.

Even if we eventually complete clinical testing and receive approval for our product candidates,

the FDA, EMA and other comparable foreign regulatory authorities may approve our product candidates for a more limited indication or

a narrower patient population than we originally requested or may impose other prescribing limitations or warnings that limit the product’s

commercial potential.

We have not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that

none of our product candidates will ever obtain regulatory approval.

Further, development of our product candidates and/or regulatory

approval may be delayed for reasons beyond our control.

We cannot provide any assurance that any product candidates we may develop will

progress through required clinical testing and obtain the regulatory approvals necessary for us to begin selling them.

have not conducted, managed or completed large-scale or pivotal clinical trials nor managed the regulatory approval process with the

FDA or any other regulatory authority.

Applications for our product candidates could fail to receive regulatory approval for many reasons,

including the following:

FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical

FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective,

are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our

obtaining marketing approval or prevent or limit commercial use;

population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full

population for which we seek approval;

FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies

or clinical trials;

may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s

risk-benefit ratio for its proposed indication is acceptable;

FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and

specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a

manner rendering our clinical data insufficient for approval.

lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory

approval to market any of our product candidates, which would significantly harm our business, results of operations and prospects.

delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue

from any particular product candidates we are developing and for which we are seeking approval.

Furthermore, any regulatory approval

to market a drug may be subject to significant limitations on the approved uses or indications for which we may market, promote and advertise

the drug or the labeling or other restrictions.

In addition, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy

(REMS) plan as part of approving an NDA, or after approval, which may impose further requirements or restrictions on the distribution

or use of an approved drug.

These requirements or restrictions might include limiting prescribing to certain physicians or medical centers

that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients

to enroll in a registry.

These limitations and restrictions may significantly limit the size of the market for the drug and affect reimbursement

by third-party payors.

are also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing

and marketing authorization, pricing and third-party reimbursement.

The foreign regulatory approval process varies among countries, and

generally includes all of the risks associated with FDA and EMA approval described above as well as risks attributable to the satisfaction

of local regulations in foreign jurisdictions.

Moreover, the time required to obtain approval may differ from that required to obtain

FDA approval.

FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their

jurisdiction.

ongoing clinical trials are being undertaken in the United States.

Our estimates of the size of these patient populations are

based on published studies.

Given the small number of patients who have the diseases that we are targeting, it is critical to our ability

to grow and become profitable that we continue to successfully identify patients with these rare diseases.

The effort to identify patients

with diseases we seek to treat is in early stages, and we cannot accurately predict the number of patients for whom treatment might be

Various factors may decrease the market size of our product and product candidates, including the severity of the disease, patient

demographics and the response of patients’ immune systems to our product candidates.

If the results of these studies or our analysis

of them do not accurately reflect the relevant patient population, our assessment of the market may be inaccurate, making it difficult

or impossible for us to meet our revenue goals, or to obtain and maintain profitability.

Additionally, the potentially addressable patient population

for each of our product candidates may be limited or may not be amenable to treatment with our product candidates, and new patients may

become increasingly difficult to identify or gain access to, which would adversely affect our results of operations and our business.

Further, even if we obtain significant market share for our product candidates, because the potential target populations are very small,

we may never achieve profitability despite obtaining such significant market share.

Any product candidates we develop may become subject

to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.

The availability and extent of coverage and adequate reimbursement

by third-party payors including government health administration authorities, private health coverage insurers, managed care organizations

and other third-party payors is essential for most patients to be able to afford expensive treatments.

The initial targets in our pipeline

are indications with small patient populations.

For product candidates that are designed to treat smaller patient populations to be commercially

viable, the reimbursement for such product candidates must be higher, on a relative basis, to account for the lack of volume.

we will need to implement a coverage and reimbursement strategy for any approved product candidate that accounts for the smaller potential

Sales of any of our product candidates that receive marketing

approval will depend substantially, both in the United States and internationally, on the extent to which the costs of such product candidates

will be covered and reimbursed by third-party payors.

If reimbursement is not available, or is available only to limited levels, we may

not be able to successfully commercialize our product candidates.

Even if coverage is provided, the approved reimbursement amount may

not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment.

reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.

If coverage and

reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product

candidate for which we obtain marketing approval.

There is significant uncertainty related to third-party payor

coverage and reimbursement of newly approved products.

In the United States, for example, principal decisions about reimbursement for

new products are typically made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S.

Department of Health

and Human Services (HHS).

CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private

third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree.

However, one third-party

payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for

the product candidate or at the same level of reimbursement.

As a result, the coverage determination process is often time-consuming and

This process will require us to provide scientific and clinical support for the use of our products to each third-party payor

separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Increasingly, third-party payors are requiring that drug companies

provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

Further, such

payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product

There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs.

Third-party payors

may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved

drugs for a particular indication.

We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and

cost effectiveness of our products.

Nonetheless, our product candidates may not be considered medically necessary or cost effective.

cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available,

what the level of reimbursement will be.

Outside the United States, the commercialization of therapeutics

is generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on

cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics

such as our product candidates.

In many countries, particularly the countries of the European Union (EU), medical product prices are subject

to varying price control mechanisms as part of national health systems.

In these countries, pricing negotiations with governmental authorities

can take considerable time after a product receives marketing approval.

To obtain reimbursement or pricing approval in some countries,

we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies.

In general, product prices under such systems are substantially lower than in the United States.

Other countries allow companies to fix

their own prices for products but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation

could restrict the amount that we are able to charge for our product candidates.

Accordingly, in markets outside the United States, the

reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable

revenue and profits.

If we are unable to establish or sustain coverage and adequate

reimbursement for any product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected,

which, in turn, could adversely affect the ability to market or sell those product candidates, if approved.

Coverage policies and third-party

payor reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products

for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Our business entails a significant risk of product liability

and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our products.

Our business exposes us to significant product liability risks

inherent in the development, testing, manufacturing and marketing of therapeutic treatments.

We currently have product liability insurance

that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product

candidates, if approved.

Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities.

clinical trial and product liability insurance are becoming increasingly expensive.

As a result, we may be unable to obtain sufficient

insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our

business and financial condition.

Also, our insurance policies may have various exclusions, and we may be subject to a product liability

claim for which we have no coverage.

We may have to pay any amount awarded by a court or negotiated in a settlement that exceeds our coverage

limitations or that is not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may

not be available or adequate should any claim arise.

We may be sued if any of our product candidates cause or are

perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing, or sale post-approval.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers

inherent in the product, negligence, strict liability, or a breach of warranties.

Claims could also be asserted under state consumer protection

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required

to limit testing and commercialization of our products.

Even successful defense would require significant financial and management resources.

Regardless of the merits or eventual outcome, liability claims

may result in:

delays in the development of our product candidates;

FDA, EMA or other regulatory authority investigation of the safety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs;

decreased or interrupted demand for our products;

injury to our reputation;

withdrawal of clinical trial participants and inability to continue clinical trials;

initiation of investigations by regulators;

costs to defend the related litigation;

a diversion of management’s time and our resources;

substantial monetary awards to trial participants or patients;

product recalls, withdrawals or labeling, marketing, or promotional restrictions;

loss of revenue;

exhaustion of any available insurance and our capital resources;

the inability to commercialize any products.

Risks Related to Regulatory Approval and Other Legal Compliance

The regulatory approval processes of the FDA, EMA and

other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.

If we are ultimately unable

to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially

We currently have no products authorized for commercial distribution

in either the United States, Europe or any other country.

All of our product candidates require regulatory clearance or approval.

begin marketing and selling product candidates until we obtain applicable authorizations from the applicable regulatory agencies.

Our product candidates are and will continue to be subject

to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy,

approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of drugs.

Rigorous preclinical testing and clinical trials and an extensive regulatory approval process must be successfully completed in the United

States and in many foreign jurisdictions before a new drug can be approved for marketing.

We are not permitted to market JOTROL™ or any

other product candidates as medicines in the United States or other countries until we receive approval of an NDA from the FDA.

to submitting any NDA to the FDA for approval of JOTROL™ we will need to have completed our pre-clinical studies and clinical trials and

demonstrate that JOTROL™ meets all applicable standards of identity, strength, quality, and purity throughout their expiration date.

completing any clinical program and obtaining approval of an NDA is a complex, lengthy, expensive, and uncertain process, and the FDA

(or other country medicines regulatory body) may delay, limit, or deny approval of product candidates for many reasons.

Obtaining approval

by the FDA, EMA and other comparable foreign regulatory authorities is costly, unpredictable, typically takes many years following the

commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates

In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during

the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval

or the decision not to approve an application.

Regulatory authorities have substantial discretion in the approval process and may refuse

to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other

Even if we eventually complete clinical testing and receive approval for our product candidates, the FDA, EMA and other comparable

foreign regulatory authorities may approve our product candidates for a more limited indication or a narrower patient population than

we originally requested or may impose other prescribing limitations or warnings that limit the product’s commercial potential.

have not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that none of our product candidates

will ever obtain regulatory approval.

Further, development of our product candidates and/or regulatory approval may be delayed for reasons

beyond our control.

We cannot provide any assurance that any product candidates we may develop will progress through required clinical

testing and obtain the regulatory approvals necessary for us to begin selling them.

We have not conducted, managed or completed large-scale or

pivotal clinical trials nor managed the regulatory approval process with the FDA or any other regulatory authority.

As a result, applications

for our product candidates could fail to receive regulatory approval for many reasons, including the following:

the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, size, conduct, implementation or results of our clinical trials;

the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;

the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable;

the FDA, EMA or other comparable foreign regulatory authorities may conclude that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity

the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

This lengthy approval process, as well as the unpredictability

of the results of clinical trials, may result in our failing to obtain regulatory approval to market any of our product candidates, which

would significantly harm our business, results of operations and prospects.

Any delay or failure in seeking or obtaining required approvals

would have a material and adverse effect on our ability to generate revenue from any particular product candidates we are developing and

for which we are seeking approval.

Furthermore, any regulatory approval to market a drug may be subject to significant limitations on

the approved uses or indications for which we may market, promote and advertise the drug or the labeling or other restrictions.

the FDA has the authority to require a REMS plan as part of approving an NDA, or after approval, which may impose further requirements

or restrictions on the distribution or use of an approved drug.

These requirements or restrictions might include limiting prescribing

to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use

criteria and requiring treated patients to enroll in a registry.

These limitations and restrictions may significantly limit the size of

the market for the drug and affect reimbursement by third-party payors.

We are also subject to numerous foreign regulatory requirements

governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement.

The foreign regulatory approval process varies among countries, and generally includes all of the risks associated with FDA and EMA approval

described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.

Moreover, the time required

to obtain approval may differ from that required to obtain FDA approval.

The FDA, EMA and other comparable foreign regulatory

authorities may not accept data from trials conducted in locations outside of their jurisdiction.

Our clinical trials are planned for undertaking in the

United States.

We may choose to conduct additional clinical trials internationally.

The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authority from clinical trials conducted outside

of their respective jurisdictions may be subject to certain conditions.

In cases where data from United States clinical trials are intended

to serve as the basis for marketing approval in the foreign countries outside the United States, the standards for clinical trials and

approval may be different.

There can be no assurance that any United States or foreign regulatory authority would accept data from trials

conducted outside of its applicable jurisdiction.

If the FDA, EMA or any applicable foreign regulatory authority does not accept such

data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan,

and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining

regulatory approval of our product candidates in other jurisdictions.

and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or

maintain regulatory approval in any other jurisdiction.

For example, even if the FDA or EMA grants marketing approval of a product candidate,

comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion and reimbursement

of the product candidate in those countries.

However, a failure or delay in obtaining regulatory approval in one jurisdiction may have

a negative effect on the regulatory approval process in others.

Approval procedures vary among jurisdictions and can involve requirements

and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials

as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions

outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we intend to charge for our products is also subject to approval.

foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant

delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries.

future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicable marketing

approvals, our target market will be reduced and our ability to realize the full market potential of our potential product candidates

will be harmed.

regulatory approval processes for product candidates that target rare diseases, including MPS I, Friedreich’s ataxia, and MELAS

are uncertain.

The acceptance of study data by the FDA,

EMA or other comparable foreign regulatory authorities from clinical trials conducted outside of their respective jurisdictions may

be subject to certain conditions.

In cases where data from United States clinical trials are intended to serve as the basis for

marketing approval in the foreign countries outside the United States, the standards for clinical trials and approval may be

There can be no assurance that any United States or foreign regulatory authority would accept data from trials conducted

outside of its applicable jurisdiction.

If the FDA, EMA or any applicable foreign regulatory authority does not accept such data, it

would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and

which may result in our product candidates not receiving approval or clearance for commercialization in the applicable

jurisdiction.

Obtaining and maintaining regulatory approval of our

product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates

in other jurisdictions.

Obtaining and maintaining regulatory approval of our product

candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction.

For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions

must also approve the manufacturing, marketing and promotion and reimbursement of the product candidate in those countries.

failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in

Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those

in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may

not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a product candidate

must be approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we intend to

charge for our products is also subject to approval.

Obtaining foreign regulatory approvals and establishing and

maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could

delay or prevent the introduction of our products in certain countries.

If we or any future collaborator fail to comply with the regulatory

requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced and our ability

to realize the full market potential of our potential product candidates will be harmed.

regulatory approval processes for any product candidates that target rare diseases, including MPS I and MELAS are uncertain.

to the lack of precedent, broad discretion of regulatory authorities, and a multitude of unique factors that impact the regulatory approval

process, the likelihood of the approval of any of our product candidates that target rare diseases, such as MPS I, Friedreich’s

ataxia, and MELAS is uncertain, and we may not be able to anticipate, prepare for or satisfy requests or requirements from regulatory

authorities, including completing and submitting planned Investigational New Drug (IND) and new drug applications (NDA) for our product

candidates, in a timely manner, or at all.

process, the likelihood of the approval of any product candidates that target rare diseases, such as MPS I and MELAS is uncertain,

and we may not be able to anticipate, prepare for or satisfy requests or requirements from regulatory authorities, including completing

and submitting planned Investigational New Drug (IND) and new drug applications (NDA) for our product candidates, in a timely manner,

For example, MPS I is a rare disease for which there is only one FDA approved therapeutics.

In addition, no therapies are currently approved for MELAS in the United States or the EU.

Further, the FDA may determine, after evaluation

of our data and analyses, that such data and analyses do not support an NDA submission, filing or approval.

Due to this lack of predictability,

we may not have the resources necessary to meet regulatory requirements and successfully complete a potentially protracted, expensive

and wide-ranging approval process for commercialization of product candidates for rare diseases.

if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and

regulatory approvals that we may receive for our product candidates will require the submission of reports to regulatory authorities

and on-going surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to

use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study

or risk management requirements and regulatory inspection.

For example, the FDA may require a REMS in order to approve our product candidates,

which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe

use, such as restricted distribution methods, patient registries and other risk minimization tools.

In addition, if the FDA or foreign

regulatory authorities approve our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event

reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive

and ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports,

registration, as well as on-going compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.

manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA

and other regulatory authorities for compliance with cGMP regulations and standards.

If we or a regulatory agency discover previously

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

the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including

requiring recall or withdrawal of the product from the market or suspension of manufacturing.

In addition, failure to comply with FDA,

EMA and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including:

in or the rejection of product approvals;

on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;

on the products, manufacturers or manufacturing process;

or untitled letters;

and criminal penalties;

or withdrawal of regulatory approvals;

seizures, detentions or import bans;

or mandatory product recalls and publicity requirements;

or partial suspension of production;

of restrictions on operations, including costly new manufacturing requirements.

occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates, if approved, and

generate revenue.

Furthermore, non-compliance by us or any future collaborator with regulatory requirements, including safety monitoring

and with requirements related to the development of products for the pediatric population can also result in significant financial penalties.

may not be able to obtain orphan drug designation or obtain or maintain orphan drug exclusivity for our product candidates and, even

if we do, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing

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

as orphan drugs.

Under the Orphan Drug Act, the FDA may designate a product 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 annually in the United States,

or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing

the drug will be recovered from sales in the United States.

However, there can be no assurances that we will be able to obtain orphan

designations for our product candidates.

the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical

trial costs, tax advantages and user-fee waivers.

In addition, if a product that has orphan drug designation subsequently receives the

first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity.

exclusivity in the United States provides that the FDA may not approve any other applications, including a full NDA, to market the same

drug for the same indication for seven years, except in limited circumstances.

The applicable exclusivity period is 10 years in Europe.

The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if

the drug is sufficiently profitable so that market exclusivity is no longer justified.

submitted a request to FDA and received orphan drug designation for Friedreich’s ataxia.

We intend to seek orphan drug designation

for JOTROL in MPS I and may seek orphan drug designation for other product candidates.

Even if we obtain orphan drug designation for

a product candidate, we may not be able to obtain or maintain orphan drug exclusivity for that product candidate.

We may not be the first

to obtain marketing approval of any product candidate for which we have obtained orphan drug designation for the orphan-designated indication

due to the uncertainties associated with developing pharmaceutical products.

In addition, exclusive marketing rights in the United States

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

that the request for designation was materially defective or if we are unable to ensure that we will be able to manufacture 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 active

moieties may be approved for the same condition.

Even after an orphan drug is approved, the FDA can subsequently approve the same drug

with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown

to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity

is unable to maintain sufficient product quantity.

Orphan drug designation neither shortens the development time or regulatory review

time of a drug nor gives the product candidate any advantage in the regulatory review or approval process or entitles the product candidate

to priority review.

appropriate, we plan to secure approval from the FDA or comparable foreign regulatory authorities through the use of accelerated registration

If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond

those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.

if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with

rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval.

possible, we plan to pursue accelerated development strategies in areas of high unmet need.

We may seek an accelerated approval pathway

for our one or more of our product candidates.

Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act,

and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product candidate designed to treat a serious

or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product

candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.

The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease,

such as irreversible morbidity or mortality.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory

measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure

of clinical benefit.

An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible

morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct

therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.

If granted, accelerated

approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory

studies to verify and describe the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s clinical

benefit, the FDA may withdraw its approval of the drug.

to seeking such accelerated approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive

such accelerated approval.

There can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue

or submit an NDA for accelerated approval or any other form of expedited development, review or approval.

Similarly, there can be no

assurance that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited

development, review or approval, even if we initially decide to do so.

Furthermore, if we decide to submit an application for accelerated

approval or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such

submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or

The FDA or other comparable foreign regulatory authorities could also require us to conduct further studies prior to considering

our application or granting approval of any type.

A failure to obtain accelerated approval or any other form of expedited development,

review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could

increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

may face difficulties from changes to current regulations and future legislation.

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

of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation

or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements

or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval

that we may have obtained, and we may not achieve or sustain profitability.

also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative

or executive action, either in the United States or abroad.

In addition, no therapies are

currently approved for MELAS in the United States or the EU.

Further, the FDA may determine, after evaluation of our data and analyses,

that such data and analyses do not support an NDA submission, filing or approval.

Due to this lack of predictability, we may not have

the resources necessary to meet regulatory requirements and successfully complete a potentially protracted, expensive and wide-ranging

approval process for commercialization of product candidates for rare diseases.

Even if our product candidates receive regulatory approval,

they will be subject to significant post-marketing regulatory requirements and oversight.

Any regulatory approvals that we may receive for our product

candidates will likely require on-going post-marketing surveillance to monitor the safety and efficacy of any such approved product.

regulatory approval may also contain significant limitations related to use restrictions for specified age groups, warnings, precautions

or contraindications, and may include burdensome post-approval study or risk management requirements and regulatory inspection.

the FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician

training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries

and other risk minimization tools.

In addition, if the FDA or foreign regulatory authorities approve our product candidates, the manufacturing

processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping

for our product candidates will be subject to extensive and ongoing regulatory requirements.

These requirements include submissions of

safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMP regulations and GCPs for

any clinical trials that we conduct post-approval.

In addition, manufacturers of drug products and their facilities are subject to continual

review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and standards.

If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or

frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product,

the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject our company to administrative

or judicially imposed sanctions, including:

restrictions on the products, manufacturers or manufacturing process;

warning or untitled letters;

civil and criminal penalties;

suspension or withdrawal of regulatory approvals, or debarment;

product seizures, detentions, import refusals, or import alerts;

voluntary or mandatory product recalls and publicity requirements;

total or partial suspension of production;

imposition of restrictions on operations, including costly new manufacturing requirements.

The occurrence of any event or penalty described above may

inhibit our ability to commercialize our product candidates, if approved, and generate revenue.

Furthermore, non-compliance by us or any

future collaborator with regulatory requirements, including safety monitoring and with requirements related to the development of products

for the pediatric population can also result in significant financial penalties.

We may not be able to obtain orphan drug designation

or obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA,

EMA or other comparable foreign regulatory authorities, from approving competing products.

Regulatory authorities in some jurisdictions, including the

United States and the EU, may designate drugs for relatively small patient populations as orphan drugs.

Under the Orphan Drug Act, the

FDA may designate a product 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 annually in the United States, or a patient population greater than 200,000

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

United States.

However, there can be no assurances that we will be able to obtain orphan designations for any of our product candidates.

In the United States, orphan drug designation entitles a party

to financial incentives such as opportunities for grant funding towards clinical trial costs, tax credits for qualified clinical testing

expenses, and user-fee waivers.

In addition, if a product that has orphan drug designation subsequently receives the first FDA approval

for the indication for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may

not subsequently approve another application, including a full NDA, to market the same drug for the same indication or use within the

such rare disease indication for seven years, except in limited circumstances.

We intend to seek orphan drug designation for JOTROL™ in MPS I and may seek orphan drug

designation for other product candidates.

Even if we obtain orphan drug designation for a product candidate, we may not be able to obtain

or maintain orphan drug exclusivity for that product candidate, nor can we guarantee that any orphan-drug-designated product candidate

will obtain regulatory approval from FDA.

Even if we obtain FDA approval, we may not be the first to obtain marketing approval of any

product candidate for which we have obtained orphan drug designation for the same indication or use due to the uncertainties associated

with developing pharmaceutical products.

In addition, exclusive marketing rights in the United States may be limited if we seek approval

for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation

was materially defective or if we are unable to ensure that we will be able to manufacture 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 drugs with different active moieties may be approved for the same condition.

Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition

if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution

to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity.

designation neither shortens the development time or regulatory review time of a drug nor gives the product candidate any advantage in

the regulatory review or approval process or entitles the product candidate to priority review.

Where appropriate, we plan to help expedite the product

development and approval process by requesting that FDA or comparable foreign regulatory authorities designate product candidates for

the use of accelerated registration or approval pathways.

If we are unable to obtain such designations, we may be required to conduct

additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and

delay the receipt of, necessary marketing approvals.

Even if we receive an accelerated development designation from the FDA, if our confirmatory

trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw

accelerated approval.

Where possible, we plan to pursue accelerated development

strategies in areas of high unmet need.

We may seek an accelerated approval pathway for one or more of our product candidates.

accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, and the FDA’s implementing regulations, the FDA may

grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic

benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate

clinical endpoint that is reasonably likely to predict clinical benefit.

The FDA considers a clinical benefit to be a positive therapeutic

effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality.

For the purposes

of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other

measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.

An intermediate clinical endpoint

is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to

predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases

in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement

from a patient and public health perspective.

If granted, accelerated approval is contingent on the sponsor’s agreement to conduct

post-approval confirmatory studies to verify and describe the drug’s clinical benefit.

Such studies must be commenced prior to or

not later than the time of approval, and the sponsor must conduct such studies with due diligence.

If such post-approval studies fail

to confirm the drug’s clinical benefit, or if the sponsor fails to conduct such studies with due diligence, the FDA may use expedited

procedures to withdraw its approval of the drug.

Prior to seeking such accelerated approval, we will seek feedback

from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval.

There can be no assurance that after

our evaluation of the feedback and other factors we will decide to pursue or submit an NDA for accelerated approval or any other form

of expedited development, review or approval.

Similarly, there can be no assurance that after subsequent FDA feedback we will continue

to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if we initially decide

Furthermore, if we decide to submit an application for accelerated approval or under another expedited regulatory designation

(e.g., breakthrough therapy designation), there can be no assurance that such submission or application will be accepted or that any expedited

development, review or approval will be granted on a timely basis, or at all.

The FDA or other comparable foreign regulatory authorities

could also require us to conduct further studies prior to considering our application or granting approval of any type.

A failure to obtain

accelerated approval or any other form of expedited development, review or approval for our product candidate would result in a longer

time period to commercialization of such product candidate, could increase the cost of development of such product candidate and could

harm our competitive position in the marketplace.

If our Nugevia nutritional supplement products do not

have the effects intended or cause undesirable side effects, our business may suffer.

Although the ingredients in our current Nugevia supplement

products are substances for which there is a history of human consumption, they also contain innovative ingredients or combinations of

Although we believe all of such products and the combinations of ingredients in them are safe when taken as directed,

the products could have certain undesirable side effects if not taken as directed or if taken by a consumer that has certain medical conditions.

In addition, such products may not have the effect intended if they are not taken in accordance with certain instructions, which include

certain dietary restrictions.

Furthermore, there can be no assurance that any of the products, even when used as directed, will have the

effects intended or will not have harmful side effects in an unforeseen way or affect populations differently.

If any of our products

or products we develop or commercialize in the future are shown to be harmful or generate negative publicity from perceived harmful effects,

our business, financial condition, results of operations and prospects would be harmed significantly.

Our competitors may develop nutritional supplement

products that are less expensive, safer or otherwise more appealing, which may diminish or eliminate the commercial success of any potential

product that we may commercialize.

If our competitors (most of whom are larger and have more

resources than we do) develop and bring to market competing nutritional supplement products that are less expensive, safer or otherwise

more appealing than our current Nugevia products and potential future products, or that reach the market before our products, we may not

achieve commercial success.

The market may choose to continue utilizing existing products for a number of reasons, including familiarity

with or pricing of these existing products.

The failure of any of Nugevia products to compete with products marketed by our competitors

would impair our ability to generate revenue, which could have a material adverse effect on our future business, financial condition,

results of operations, and cash flows.

Our competitors may:

● develop and market products that are less expensive, safer, or otherwise more appealing than our products;

● commercialize competing products before we or our partners can launch our products;

● initiate or withstand substantial price competition more successfully than we can.

Our Nugevia products are subject to regulatory requirements

and failure to comply with any regulations could lead to significant penalties or claims, which could materially harm our financial condition

and operating results.

For example, we are subject to FDA requirements, including

for cGMPs for dietary supplements.

Any failure by us or any contract manufacturer to comply with the cGMPs could negatively impact our

reputation and ability to sell our products even after the situation has been resolved.

In addition, FDA and other governmental authorities

limit the types of claims that we can make about our products, including nutrition content claims, health claims, and therapeutic claims

and otherwise regulate the marketing of our products.

It is possible that our marketing materials, including testimonials about our products,

may be significantly impacted by laws, rules, and regulations governing the marketing of our products and therefore might negatively impact

We may face difficulties from changes to current regulations

and future legislation.

Governmental agencies throughout the world, including in the

United States, strictly regulate the pharmaceutical, dietary and nutritional supplement and drug and medical product industries.

involves the clinical testing and development of drug product candidates and the marketing and sale of nutritional supplements.

Existing regulatory policies may change, and additional government

regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

We cannot predict the likelihood,

nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if

we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve

or sustain profitability.

We also cannot predict the likelihood, nature or extent of

government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

For example, certain policies of the current U.S.

administration may impact

our business and industry, which could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage

in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and

approval of marketing applications.

It is difficult to predict how current and future legislation, executive actions, and litigation,

including the executive orders referenced below, will be implemented, and the extent to which they will impact our business, our clinical

development, and the FDA’s and other agencies’ ability to exercise their regulatory authority, including FDA’s pre-approval

inspection and timely review of any regulatory filings or applications we submit to the FDA.

If these executive actions impose constraints

on FDA’s ability to engage in oversight and implementation activities in the normal course or constraints on our business operations,

including operations of our contractors, our business may be negatively impacted.

example, in March 2010, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation

Act of 2010 (collectively, the ACA), was passed, which substantially changed the way healthcare is financed by both the government and

private insurers, and continues to significantly impact the U.S.

pharmaceutical industry.

Since its enactment, there have been judicial

and Congressional challenges to certain aspects of the ACA.

For example, various portions of the ACA are currently undergoing legal and

constitutional challenges in the United States Supreme Court.

Although the Supreme Court has not yet ruled on the constitutionality of

the ACA, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period from February 15, 2021

through May 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace.

The executive order also instructs

certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among

others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary

barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

We cannot predict how the Supreme Court will rule

on these challenges, how future litigation will impact our business, or what other healthcare measures and regulations will ultimately

be implemented at the federal or state level or the effect of any future legislation or regulation may have on our business.

addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.

These changes included

aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, effective April 1, 2013, which will remain in effect

through 2030.

In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced

Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to

providers from three to five years.

These laws may result in additional reductions in Medicare and other healthcare funding, which could

have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations.

there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products,

which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other

things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform

government program reimbursement methodologies for drug products.

For example, in May 2019, CMS issued a final rule to allow Medicare

Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

This final rule codified CMS’s policy

change that was effective January 1, 2019.

At the federal level, the Trump administration used several means to propose or implement

drug pricing reform, including through federal budget proposals, executive orders and policy initiatives.

For example, in 2020, HHS and

CMS issued various rules that are expected to impact, among others, price reductions from pharmaceutical manufacturers to plan sponsors

under Part D, fee arrangements between pharmacy benefit managers and manufacturers, manufacturer price reporting requirements under the

Medicaid Drug Rebate Program, including regulations that affect manufacturer-sponsored patient assistance programs subject to pharmacy

benefit manager accumulator programs and Best Price reporting related to certain value-based purchasing arrangements.

Multiple lawsuits

have been brought against the HHS challenging various aspects of the rules.

In January 2021, the Biden administration issued a “regulatory

freeze” memorandum that directs department and agency heads to review new or pending rules of the prior administration.

It is unclear

whether these new regulations will be withdrawn or when they will become fully effective under the Biden administration.

The impact of

these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical

industry as a whole is unclear.

the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical 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.

We are unable

to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability

of healthcare and containing or lowering the cost of healthcare.

These and any further changes in the law or regulatory framework that

reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results

of operations.

expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage

criteria and in additional downward pressure on the price that we receive for any approved product.

Any reduction in reimbursement from

Medicare or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment

measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product

and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for biotechnology

We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations

will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.

increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as

subject us to more stringent product labeling and post-marketing testing and other requirements.

regulatory framework for privacy and personal information security issues worldwide is rapidly evolving and is likely to remain uncertain

for the foreseeable future.

federal and various state, local and foreign government bodies and agencies have adopted or are

considering adopting laws and regulations limiting, or laws and regulations regarding, the collection, distribution, use, disclosure,

storage, security and other processing of personal information.

administration may impact our business and industry, which could impose significant

burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing

statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.

It is difficult to predict how current

and future legislation, executive actions, and litigation, including the executive orders referenced below, will be implemented, and the

extent to which they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise

their regulatory authority, including FDA’s pre-approval inspection and timely review of any regulatory filings or applications

we submit to the FDA.

If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities

in the normal course or constraints on our business operations, including operations of our contractors, our business may be negatively

For example, in March 2010, the Patient Protection and Affordable

Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), was passed, which substantially

changed the way healthcare is financed by both the government and private insurers, and continues to significantly impact the U.S.

pharmaceutical

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA.

For example, various

portions of the ACA are currently undergoing legal and constitutional challenges in the United States Supreme Court.

Although the Supreme

Court has not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued an executive order to initiate

a special enrollment period from February 15, 2021 through May 15, 2021 for purposes of obtaining health insurance coverage through the

ACA marketplace.

The executive order also instructs certain governmental agencies to review and reconsider their existing policies and

rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include

work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or

We cannot predict how the Supreme Court will rule on these challenges, how future litigation will impact our business, or what

other healthcare measures and regulations will ultimately be implemented at the federal or state level or the effect of any future legislation

or regulation may have on our business.

In addition, other legislative changes have been proposed

and adopted in the United States since the ACA was enacted.

These changes included aggregate reductions to Medicare payments to providers

of up to 2% per fiscal year, effective April 1, 2013, which will remain in effect through 2030.

In January 2013, President Obama signed

into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased

the statute of limitations period for the government to recover overpayments to providers from three to five years.

These laws may result

in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs,

if approved, and accordingly, our financial operations.

Moreover, there has been heightened governmental scrutiny

recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional

inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing,

review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for

drug products.

For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy for

Part B drugs beginning January 1, 2020.

This final rule codified CMS’s policy change that was effective January 1, 2019.

federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget

proposals, executive orders and policy initiatives.

For example, in 2020, HHS and CMS issued various rules that are expected to impact,

among others, price reductions from pharmaceutical manufacturers to plan sponsors under Part D, fee arrangements between pharmacy benefit

managers and manufacturers, manufacturer price reporting requirements under the Medicaid Drug Rebate Program, including regulations that

affect manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager accumulator programs and Best Price reporting

related to certain value-based purchasing arrangements.

Multiple lawsuits have been brought against the HHS challenging various aspects

of the rules.

In January 2021, the Biden administration issued a “regulatory freeze” memorandum that directs department and

agency heads to review new or pending rules of the prior administration.

It is unclear whether these new regulations will be withdrawn

or when they will become fully effective under the Biden administration.

The impact of these lawsuits as well as legislative, executive,

and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole is unclear.

At the state level, legislatures have increasingly passed

legislation and implemented regulations designed to control pharmaceutical 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.

We are unable to predict the future course of federal or state healthcare

legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.

These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material

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

We expect that the ACA, as well as other healthcare reform

measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price

that we receive for any approved product.

Any reduction in reimbursement from Medicare or other government programs may result in a similar

reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us

from being able to generate revenue, attain profitability or commercialize our product candidates.

Legislative and regulatory proposals have been made to expand

post-approval requirements and restrict sales and promotional activities for biotechnology products.

We cannot be sure whether additional

legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such

changes on the marketing approvals of our product candidates, if any, may be.

In addition, increased scrutiny by Congress of the FDA’s

approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing

testing and other requirements.

In addition, recent and potential future courts decisions and administrative law cases may result in additional

legal challenges to regulations and guidance issued by federal regulatory agencies, including the FDA, that we have relied on and intend

to rely on in the future.

Any such challenges, if successful, could have a material impact on our business.

In addition to potential changes

to regulations and agency guidance as a result of legal challenges, these decisions may result in increased regulatory uncertainty and

delays in and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations.

Additionally,

the collection and use of health data and other personal data is governed in the EU by the General Data Protection Regulation (GDPR),

which extends the geographical scope of EU data protection law to entities and operations outside of the EU under certain conditions

and imposes substantial obligations upon companies and new rights for individuals, and by certain EU Member State-level legislation.

Failure to comply with the GDPR may result in fines up to €20,000,000 or up to 4% of the total worldwide annual turnover of the

preceding financial year, whichever is higher, and other administrative penalties.

The GDPR may increase our responsibility and liability

in relation to personal data that we may process, and we may be required to put in place additional measures in an effort to comply with

the GDPR and with other laws and regulations in the EU, including those of EU Member States, relating to privacy and data protection.

This may be onerous and if our efforts to comply with GDPR or other applicable EU laws and regulations are not successful, or are perceived

to be unsuccessful, it could adversely affect our business in the EU.

Further, the European Court of Justice (ECJ) invalidated the EU-U.S.

Privacy Shield, which had enabled the transfer of personal data from the EU to the U.S.

for companies that had self-certified to the

Privacy Shield in July 2020.

The ECJ decision also raised questions about the continued validity of one of the primary alternatives to

Privacy Shield, namely the European Commission’s Standard Contractual Clauses, and EU regulators have issued additional

guidance regarding considerations and requirements that we and other companies must consider and undertake when using the Standard Contractual

Although the EU has presented a new draft set of contractual clauses, at present, there are few, if any, viable alternatives

to the EU-U.S.

Privacy Shield and the Standard Contractual Clauses.

To the extent that we were to rely on the EU-U.S.

or Swiss-U.S.

Shield programs, we will not be able to do so in the future, and the ECJ’s decision and other regulatory guidance or developments

otherwise may impose additional obligations with respect to the transfer of personal data from the EU and Switzerland to the U.S., each

of which could restrict our activities in those jurisdictions, limit our ability to provide our products and services in those jurisdictions,

or increase our costs and obligations and impose limitations upon our ability to efficiently transfer personal data from the EU and Switzerland

the exit of the United Kingdom (UK) from the EU, often referred to as Brexit, has created uncertainty with regard to data protection

regulation in the UK.

Specifically, the UK exited the EU on January 1, 2020, subject to a transition period that ended December 31, 2020.

Under the post-Brexit Trade and Cooperation Agreement between the EU and the UK, the UK and EU have agreed that transfers of personal

data to the UK from EEA member states will not be treated as ‘restricted transfers’ to a non-EEA country for a period of

up to four months from January 1, 2021, plus a potential further two-month extension (the “Extended Adequacy Assessment Period”).

Although the current maximum duration of the Extended Adequacy Assessment Period is six months, it may end sooner, for example, in the

event that the European Commission adopts an ‘adequacy decision’ in respect of the UK, or the UK amends the UK GDPR and/or

makes certain changes regarding data transfers under the UK GDPR/Data Protection Act 2018 without the consent of the EU (unless those

amendments or decisions are made simply to keep relevant UK laws aligned with the EU’s data protection regime).

If the European

Commission does not adopt an ‘adequacy decision’ in respect of the UK prior to the expiry of the Extended Adequacy Assessment

Period, from that point onwards the UK will be an ‘inadequate third country’ under the GDPR and transfers of personal data

from the EEA to the UK will require a ‘transfer mechanism’ such as the Standard Contractual Clauses.

The UK has implemented

legislation similar to the GDPR, referred to as the UK GDPR, which provides for fines of up to the greater of £17.5 million or

4% of global turnover.

As of January 1, 2021, the UK is a “third country” under the GDPR, and the relationship between the

UK and EU in relation to aspects of data protection law in the medium and longer term remains unclear, including with respect to cross-border

data transfers and the role of the UK Information Commissioner’s Office with respect to the EU, which exposes us to further compliance

We may incur liabilities, expenses, costs, and other operational losses relating to the GDPR, the UK GDPR, and other laws and regulations

in the EU and UK relating to privacy and data protection, including those of applicable EU Member States in connection with any measures

we take to comply with them.

Finally, state and foreign laws may apply generally to the privacy and security of information we maintain,

and may differ from each other in significant ways, thus complicating compliance efforts and potentially requiring us to undertake additional

measures to comply with them.

the United States, there are a broad variety of data protection laws and regulations that may apply to our activities such as state data

breach notification laws, state personal data privacy laws (for example, the California Consumer Privacy Act of 2018 (CCPA)), state health

information privacy laws, and federal and state consumer protection laws.

A range of enforcement agencies exist at both the state and

federal levels that can enforce these laws and regulations.

For example, the CCPA requires covered businesses that process personal information

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 certain disclosures of personal data), imposes new operational requirements

for covered businesses, provides for civil penalties for violations as well as a private right of action for data breaches and statutory

damages (that is expected to increase data breach class action litigation and result in significant exposure to costly legal judgements

and settlements).

Aspects of the CCPA and its interpretation and enforcement remain uncertain.

In addition, it is anticipated that the

CCPA will be expanded on January 1, 2023, when the California Privacy Rights Act of 2020 (CPRA) becomes operative.

The CPRA will, among

other things, give California residents the ability to limit use of certain sensitive personal information, further restrict the use

of cross-contextual advertising, establish restrictions on the retention of personal information, expand the types of data breaches subject

to the CCPA’s private right of action, provide for increased penalties for CPRA violations concerning California residents under

the age of 16, and establish a new California Privacy Protection Agency to implement and enforce the new legislation.

Although there

are limited exemptions for clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities,

depending on their interpretation.

the GDPR, CCPA, CRPA and other laws, regulations and other obligations relating to privacy and data protection imposing new and relatively

burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may

face challenges in addressing their requirements and making necessary changes to our policies and practices, and may incur significant

costs and expenses in an effort to do so.

Additionally, if third parties we work with, such as vendors or service providers, violate

applicable laws or regulations or our policies, such violations may also put our or our customers’ data at risk and could in turn

have an adverse effect on our business.

Any failure or perceived failure by us or our service providers to comply with our applicable

policies or notices relating to privacy or data protection, our contractual or other obligations to third parties, or any of our other

legal obligations relating to privacy or data protection, may result in governmental investigations or enforcement actions, litigation,

claims and other proceedings, harm our reputation, and could result in significant liability.

funding for the FDA, the U.S.

Securities and Exchange Commission (SEC) and other government agencies could hinder their ability to hire

and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner

or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which

could negatively impact our business.

ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding

levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the SEC and other

government agencies on which our operations may rely, including those that fund research and development activities is subject to the

political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies,

which would adversely affect our business.

For example, in recent years, including in 2018 and 2019, the U.S.

government shut down several

times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory

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

Further, in our operations as a public company, future government

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

our operations.

relationships with healthcare professionals, clinical investigators, CROs and third-party payors in connection with our current and future

business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government

price reporting, and health information privacy and security laws, which could expose us to significant losses, including, among other

things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm,

administrative burdens and diminished profits and future earnings.

providers and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtain

marketing approval.

Our current and future arrangements with healthcare professionals, clinical investigators, CROs, third-party payors

and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business

or financial arrangements and relationships through which we research, as well as market, sell and distribute our products for which

we obtain marketing approval.

Restrictions under applicable federal and state healthcare laws and regulations may include the following:

federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering,

receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the

referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under

a federal healthcare program such as Medicare and Medicaid;

federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower

or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting,

or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement

to avoid, decrease or conceal an obligation to pay money to the federal government;

federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting

to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations,

also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses,

and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors,

with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies

for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions,

to annually report to CMS information regarding payments and other transfers of value to physicians, defined to include doctors,

dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment

interests held by physicians and their immediate family members.

Beginning in 2022, reporting obligations with respect to covered

recipients will be expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered

nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during

the previous year;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements

and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance regulations promulgated by the federal government and may require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing;

our ability to develop and market new drug products may be impacted based on current or future litigation in the federal court system

challenging the FDA’s approval of other companies’ drugs.

Depending on the outcome of this type of litigation, our ability

to develop new drug product candidates and to maintain approval of existing drug products could be at risk and our efforts to develop

and market new drug products could be delayed, undermined or subject to protracted litigation.

Further, artificial intelligence (AI)-based platforms and

tools are increasingly being used in the medical industry, including by regulatory authorities, such as the FDA to assist with the review

of regulatory filings and other activities.

With new and evolving AI comes a continually changing AI regulatory environment, which may

create additional costs, challenges, and risks that could adversely impact our ability to timely develop and seek approval of our drug

product candidates with FDA, or otherwise have a material adverse impact on our business.

Risks Related to Data Privacy and Security

We are subject to an evolving array of U.S.

privacy, and data protection, and data security laws regulations, and standards, and any failure or perceived failure to comply could

result in regulatory investigations, litigation, significant fines and penalties, operational restrictions, and reputational harm.

We collect and process personal information in the course

of operating our business, including in connection with our clinical programs and the direct-to-consumer marketing and sale of our Nugevia

In the United States, we may be subject to a patchwork of federal and state laws and regulations governing the privacy and security

of personal information, including state breach notification laws, consumer privacy laws (for example, the California Consumer Privacy

Act of 2018, as amended by the California Privacy Rights Act of 2020 (CCPA)), health information privacy laws, and federal and state consumer

protection laws enforced by regulators such as the Federal Trade Commission and state attorneys general.

Businesses that process personal

information of consumers in several states are required, among other things, to make certain disclosures regarding their data collection,

use, and sharing practices, and to honor requests from consumers to exercise rights over their personal information, including the right

to opt out of certain disclosures and the right to limit the use of sensitive personal information.

These requirements continue to expand

and diverge across states, increasing the cost and complexity of compliance and the risk of civil penalties for violations thereof.

To the extent we act as a covered entity or business associate,

we are subject to the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively,

HIPAA), which impose privacy, security, and breach notification obligations with respect to protected health information, as well as contractual

requirements and potential civil and criminal penalties for violations.

Even where our clinical trial data may benefit from limited exemptions

under certain state consumer privacy laws, our broader activities, such as recruiting, employee information processing, and marketing,

may still be in scope.

Internationally, the collection and use of health data and

other personal information is governed in the EU by the General Data Protection Regulation (GDPR) and by certain EU Member State-level

The GDPR extends its geographical scope to entities outside of the EU that offer goods or services to, or monitor the behavior

of, individuals within the EU.

While our clinical operations are currently based in the United States, we maintain significant business

relationships with international partners, including our exclusive license agreement with Aquanova AG, a German company.

To the extent

personal information is exchanged in connection with these relationships, the GDPR and the UK General Data Protection Regulation (UK GDPR),

Failure to comply with the GDPR may result in fines up to €20,000,000 or up to 4% of total worldwide annual turnover of

the preceding financial year, whichever is higher, and other administrative penalties.

The UK GDPR provides for fines of up to the greater

of £17.5 million or 4% of global turnover.

While the EU-U.S.

Data Privacy Framework and other transfer mechanisms currently provide

pathways for transatlantic data flows, these frameworks are subject to change and legal challenge, which may require us to implement additional

safeguards at increased cost and with residual risk.

Furthermore, as we pursue our stated plans for international

clinical trials, regulatory submissions to the EMA, out-licensing opportunities in European and Asian markets, and potential commercialization

in foreign jurisdictions, we expect that we will become subject to additional data protection requirements in those jurisdictions.

may include, among others, data protection laws in China (the Personal Information Protection Law, or PIPL), Singapore (the Personal Data

Protection Act, or PDPA), and Australia (the Privacy Act 1988), each of which imposes distinct compliance obligations, restrictions on

cross-border data transfers, and significant penalties for noncompliance.

With the GDPR, CCPA, state comprehensive privacy laws, and

other laws, regulations and other obligations imposing new and burdensome obligations, and with substantial uncertainty over the interpretation

and application of these evolving requirements, we may face challenges in addressing their requirements and making necessary changes to

our policies and practices, and may incur significant costs and expenses in an effort to do so.

Additionally, our reliance on third parties,

such as CROs, CMOs, clinical sites, vendors, or other service providers, creates additional risk and could have an adverse effect on our

business and data if such parties fail to comply with applicable privacy and security requirements or our policies, or otherwise suffer

a security incident.

Any failure or perceived failure by us or our service providers to comply with applicable privacy or data protection

obligations, or to protect personal information against unauthorized access, use, or disclosure, could result in investigations, enforcement

actions, litigation (including class actions), significant fines and damages, the suspension of data processing, orders to change our

practices, and reputational harm, any of which could adversely affect our business, financial condition, and results of operations.

Inadequate funding for the FDA, the U.S.

and Exchange Commission (SEC) and other government agencies could hinder their ability to hire and retain key leadership and other personnel,

prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing

normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products

can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and

accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated in

recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may rely, including

those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the

time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

For example, in recent years, the U.S.

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

had to furlough critical employees and stop critical activities.

In addition, in 2025, the federal government implemented workforce reductions

across the Department of Health and Human Services, including layoffs affecting FDA employees and resulting in a reduction in the FDA’s

full-time workforce.

Although FDA review staff were described as exempt from direct cuts, the loss of personnel may have contributed to

reported slowdowns, reduced responsiveness, and operational strain within the FDA.

If a prolonged government shutdown or personnel reduction

occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have

a material adverse effect on our business.

Further, in our operations as a public company, future government shutdowns or personnel reductions

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

Our relationships with healthcare professionals, clinical

investigators, CROs and third-party payors in connection with our current and future business activities may be subject to federal and

state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy

and security laws, which could expose us to significant losses, including, among other things, criminal sanctions, civil penalties, contractual

damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future

Healthcare providers and third-party payors play a primary

role in the recommendation and prescription of any product candidates for which we obtain marketing approval.

Our current and future arrangements

with healthcare professionals, clinical investigators, CROs, third-party payors and customers may expose us to broadly applicable fraud

and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through

which we research, as well as market, sell and distribute our products for which we obtain marketing approval.

Restrictions under applicable

federal and state healthcare laws and regulations may include the following:

the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians, defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members.

Beginning in 2022, reporting obligations with respect to covered recipients will be expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during the previous year;

analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance regulations promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing;

state and local laws that require the registration of pharmaceutical sales and medical representatives;

state laws that govern the

privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often

are not preempted by HIPAA, thus complicating compliance efforts.

to ensure that our current and future business arrangements with third parties will comply with applicable healthcare and data privacy

laws and regulations will involve substantial ongoing costs, and may require us to undertake or implement additional policies or measures.

We may face claims and proceedings by private parties, and claims, investigations and other proceedings by governmental authorities,

relating to allegations that our business practices do not comply with current or future statutes, regulations or case law involving

applicable fraud and abuse or other healthcare laws and regulations, and it is possible that courts or governmental authorities may conclude

that we have not complied with them, or that we may find it necessary or appropriate to settle any such claims or other proceedings.

In connection with any such claims, proceedings, or settlements, we may be subject to significant penalties, including civil, criminal

and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare

programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished

profits and future earnings and the curtailment or restructuring of our operations.

Defending against any such actions can be costly,

time-consuming and may require significant financial and personnel resources.

Therefore, even if we are successful in defending against

any such actions that may be brought against us, our business may be impaired.

Further, if any of the physicians or other healthcare

providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to

criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage

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

are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators,

CROs, suppliers and vendors may engage in misconduct or other improper activities.

Misconduct by these parties could include failures

to comply with FDA regulations, provide accurate information to the FDA, comply with federal and state health care fraud and abuse laws

and regulations, accurately report financial information or data or disclose unauthorized activities to us.

In particular, research,

sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent

fraud, misconduct, kickbacks, self-dealing and other abusive practices.

These laws and regulations may restrict or prohibit a wide range

of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in

regulatory sanctions and serious harm to our reputation.

We will adopt a code of conduct, which will become effective as of the date

of the effectiveness of the registration statement of which this prospectus forms a part, but it is not always possible to identify and

deter misconduct by these parties, and the precautions we take to detect and prevent this activity may not be effective in controlling

unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from

a failure to comply with these laws or regulations.

If any such 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

penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation

in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages,

reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations.

we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur

costs that could have a material adverse effect on our business.

are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the

handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations involve the use of hazardous and flammable

materials, including chemicals and biological materials.

state laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our current and future business arrangements

with third parties will comply with applicable healthcare and data privacy laws and regulations will involve substantial ongoing costs,

and may require us to undertake or implement additional policies or measures.

We may face claims and proceedings by private parties, and

claims, investigations and other proceedings by governmental authorities, relating to allegations that our business practices do not comply

with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations,

and it is possible that courts or governmental authorities may conclude that we have not complied with them, or that we may find it necessary

or appropriate to settle any such claims or other proceedings.

In connection with any such claims, proceedings, or settlements, we may

be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment,

exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting

obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our

Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources.

Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance

with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded

healthcare programs.

Our employees, independent contractors, consultants,

commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities,

including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent

contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other

improper activities.

Misconduct by these parties could include failures to comply with FDA regulations, provide accurate information to

the FDA, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or data

or disclose unauthorized activities to us.

In particular, research, sales, marketing and business arrangements in the health care industry

are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer

incentive programs and other business arrangements.

Misconduct by these parties could also involve the improper use of information obtained

in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

We have adopted a code

of conduct, but it is not always possible to identify and deter misconduct by these parties, and the precautions we take to detect and

prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations

or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

If any such 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 penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement,

imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight

and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring

of our operations.

I f we fail to comply with environmental, health

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

on our business.

We are subject to numerous environmental, health and safety

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

materials and wastes.

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

Our operations also produce hazardous waste products.

We generally contract

with third parties for the disposal of these materials and wastes.

We cannot eliminate the risk of contamination or injury from these

In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting

damages, and any liability could exceed our resources.

We also could incur significant costs associated with civil or criminal fines

and penalties.

we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting

from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

We do not maintain

insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal

of hazardous and flammable materials, including chemicals and biological materials.

addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

These current or future laws and regulations may impair our research, development or commercialization efforts.

Failure to comply with

these laws and regulations also may result in substantial fines, penalties or other sanctions.

business activities may be subject to the U.S.

Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws of other

countries in which we operate, as well as U.S.

and certain foreign export controls, trade sanctions, and import laws and regulations.

Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate

business activities are subject to the U.S.

Foreign Corrupt Practices Act of 1977, as amended (FCPA), the U.S.

domestic bribery statute

contained in 18 U.S.C.

We generally contract with third parties for the disposal of these materials and

We cannot eliminate the risk of contamination or injury from these materials.

In the event of contamination or injury resulting

from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources.

We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance

to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this

insurance may not provide adequate coverage against potential liabilities.

We do not maintain insurance for environmental liability or

toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials, including

chemicals and biological materials.

In addition, we may incur substantial costs in order to comply

with current or future environmental, health and safety laws and regulations.

These current or future laws and regulations may impair

our research, development or commercialization efforts.

Failure to comply with these laws and regulations also may result in substantial

fines, penalties or other sanctions.

Our business activities may be subject to the U.S.

Corrupt Practices Act and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S.

foreign export controls, trade sanctions, and import laws and regulations.

Compliance with these legal requirements could limit our ability

to compete in foreign markets and subject us to liability if we violate them.

Our business activities are subject to the U.S.

Foreign Corrupt

Practices Act of 1977, as amended (FCPA), the U.S.

domestic bribery statute contained in 18 U.S.C.

§ 201, the U.S.

Travel Act, and similar anti-bribery or anti-corruption laws, regulations or rules of other

countries in which we operate.

These laws generally prohibit companies and their employees, agents, representatives, business partners,

and third-party intermediaries from, directly or indirectly, offering, promising, giving or authorizing others to give anything of value,

either directly or indirectly, to recipients in the public or private sector in order to influence official action or otherwise obtain

or retain business.

Our business is heavily regulated and therefore involves significant interaction with public officials, including

officials of non-U.S.

Additionally, in many other countries, hospitals are owned and operated by the government, and doctors

and other hospital employees would be considered foreign officials under the FCPA.

Recently, the SEC and DOJ have increased their FCPA

enforcement activities with respect to biotechnology and pharmaceutical companies.

sometimes leverage third parties to assist with the conduct of our business abroad.

We, our employees, agents, representatives, business

partners and our third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies

or state-owned or affiliated entities and may be held liable for the corrupt or other illegal activities of these employees, agents,

representatives, business partners or third-party intermediaries even if we do not explicitly authorize such activities.

We cannot assure

you that all of our employees, agents, representatives, business partners and third-party intermediaries will not take actions in violation

of applicable law for which we may be ultimately held responsible.

As we increase our international sales and business, our risks under

these laws may increase.

laws also require that we make and keep books and records that accurately and fairly reflect the transactions of the corporation and

to devise and maintain an adequate system of internal accounting controls and compliance procedures designed to prevent violations of

anti-corruption laws.

There is no certainty that all of our employees, agents, representatives, business partners and third-party intermediaries,

or those of our affiliates, will comply with applicable laws and regulations, for which we may be ultimately held responsible.

of these laws and regulations could result in whistleblower complaints, fines, severe civil or criminal sanctions, settlements, prosecution,

enforcement actions, damages, adverse media coverage, investigations, loss of export privileges, disgorgement, and other remedial measures

and prohibitions on the conduct of our business including our ability to offer our products in one or more countries.

Responding to any

investigation or action will likely result in a materially significant diversion of management’s attention and resources and significant

defense costs and other professional fees.

As a general matter, investigations, enforcement actions and sanctions could damage our reputation,

our brand, our international activities, our ability to attract and retain employees and our business, prospects, operating results and

financial condition.

addition, our products may be subject to U.S.

and foreign export controls, trade sanctions and import laws and regulations.

regulation of the import or export of our products, or our failure to obtain any required import or export authorization for our products,

when applicable, could harm our international sales and adversely affect our revenue.

Compliance with applicable regulatory requirements

regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases,

prevent the export of our products to some countries altogether.

Travel Act, and

similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate.

These laws generally prohibit

companies and their employees, agents, representatives, business partners, and third-party intermediaries from, directly or indirectly,

offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to recipients in the public

or private sector in order to influence official action or otherwise obtain or retain business.

Our business is heavily regulated and

therefore involves significant interaction with public officials, including officials of non-U.S.

Additionally, in many other

countries, hospitals are owned and operated by the government, and doctors and other hospital employees would be considered foreign officials

under the FCPA.

Recently, the SEC and DOJ have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical

We sometimes leverage third parties to assist with the conduct

of our business abroad.

We, our employees, agents, representatives, business partners and our third-party intermediaries may have direct

or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities and may be held liable

for the corrupt or other illegal activities of these employees, agents, representatives, business partners or third-party intermediaries

even if we do not explicitly authorize such activities.

We cannot assure you that all of our employees, agents, representatives, business

partners and third-party intermediaries will not take actions in violation of applicable law for which we may be ultimately held responsible.

As we increase our international sales and business, our risks under these laws may increase.

These laws also require that we make and keep books and records

that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting

controls and compliance procedures designed to prevent violations of anti-corruption laws.

There is no certainty that all of our employees,

agents, representatives, business partners and third-party intermediaries, or those of our affiliates, will comply with applicable laws

and regulations, for which we may be ultimately held responsible.

Violations of these laws and regulations could result in whistleblower

complaints, fines, severe civil or criminal sanctions, settlements, prosecution, enforcement actions, damages, adverse media coverage,

investigations, loss of export privileges, disgorgement, and other remedial measures and prohibitions on the conduct of our business including

our ability to offer our products in one or more countries.

Responding to any investigation or action will likely result in a materially

significant diversion of management’s attention and resources and significant defense costs and other professional fees.

matter, investigations, enforcement actions and sanctions could damage our reputation, our brand, our international activities, our ability

to attract and retain employees and our business, prospects, operating results and financial condition.

In addition, our products may be subject to U.S.

export controls, trade sanctions and import laws and regulations.

Governmental regulation of the import or export of our products, or

our failure to obtain any required import or export authorization for our products, when applicable, could harm our international sales

and adversely affect our revenue.

Compliance with applicable regulatory requirements regarding the export of our products may create delays

in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether.

Furthermore, U.S.

export control laws and economic sanctions prohibit

the shipment of certain products and services to countries, governments, and persons targeted by U.S.

If we fail to comply

with export and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain

export privileges.

Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope

of existing regulations, or in the countries, persons, or products targeted by such regulations, could result in decreased use of our

products by, or in our decreased ability to export our products to, existing or potential customers with international operations.

decreased use of our products or limitation on our ability to export or sell our products would likely adversely affect our business.

Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business

success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.

succeed, we must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel, and we face

significant competition for experienced personnel.

We are highly dependent on the principal members of our management and scientific

and medical staff, particularly Marshall Hayward, our Co-Founder and Chief Scientific Officer.

If we do not succeed in attracting and

retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan

and harm our operating results.

In particular, the loss of one or more of our executive officers could be detrimental to us if we cannot

recruit suitable replacements in a timely manner.

We do not maintain “key person” insurance for any of our executives or

other employees.

We could in the future have difficulty attracting and retaining experienced personnel and may be required to expend

significant financial resources in our employee recruitment and retention efforts.

of the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different

risk profiles and a longer history in the industry than we do.

They also may provide higher compensation, more diverse opportunities

and better prospects for career advancement.

Some of these characteristics may be more appealing to high-quality candidates than what

we have to offer.

If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover,

develop and commercialize our product candidates will be limited and the potential for successfully growing our business will be harmed.

Additionally,

we rely on our scientific founders and other scientific and clinical advisors and consultants to assist us in formulating our research,

development and clinical strategies.

These advisors and consultants are not our employees and may have commitments to, or consulting

or advisory contracts with, other entities that may limit their availability to us.

In addition, these advisors and consultants typically

will not enter into non-compete agreements with us.

If a conflict of interest arises between their work for us and their work for another

entity, we may lose their services.

Furthermore, our advisors may have arrangements with other companies to assist those companies in

developing products or technologies that may compete with ours.

In particular, if we are unable to maintain consulting relationships

with our scientific founders or if they provide services to our competitors, our development and commercialization efforts will be impaired

and our business will be significantly harmed.

we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product

candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.

currently do not have and have never had a marketing or sales team.

In order to commercialize any product candidates, if approved, we

must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to

perform these services for each of the territories in which we may have approval to sell or market our product candidates.

be successful in accomplishing these required tasks.

an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates

will be expensive and time-consuming and will require significant attention of our executive officers to manage.

Any failure or delay

in the development of our internal sales, marketing and distribution capabilities could adversely impact the commercialization of any

of our product candidates that we obtain approval to market, if we do not have arrangements in place with third parties to provide such

services, which is our preferred marketing and sales strategy, on our behalf.

Alternatively, if we choose to collaborate, either globally

or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to

augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems, we will be required

to negotiate and enter into arrangements with such third parties relating to the proposed collaboration and such arrangements may prove

to be less profitable than commercializing the product on our own.

If we are unable to enter into such arrangements when needed, on acceptable

terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or

any such commercialization may experience delays or limitations.

If we are unable to successfully commercialize our approved product

candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we

may incur significant additional losses.

order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties

in managing this growth.

of December 31, 2024, we had a total of four full-time employees, two full-time consultants and one part-time consultant,

plus our six Scientific Advisory Board members.

Of these, three were primarily engaged in research or product development and clinical

In order to successfully implement our development and commercialization plans and strategies, and as we transition into

operating as a public company, we expect to hire additional managerial, operational, sales, marketing, financial and other personnel,

as reflected in our organization chart represented in our Operation and Organization section.

Future growth would impose significant

added responsibilities on members of management, including:

recruiting, integrating, maintaining and motivating additional employees;

our internal development efforts effectively, including the clinical, FDA, EMA and other comparable foreign regulatory agencies’

review process for JOTROL and any other product candidates, while complying with any contractual obligations to contractors and other

third parties we may have;

our operational, financial and management controls, reporting systems and procedures.

future financial performance and our ability to successfully develop and, if approved, commercialize JOTROL and other product candidates

will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate

amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors

and consultants to provide certain services, including key aspects of our research and development, clinical development and manufacturing.

We cannot assure you that the services of independent organizations, advisors and consultants will continue to be available to us on

a timely basis when needed, or that we can find qualified replacements.

In addition, if we are unable to effectively manage our outsourced

activities or if the quality or accuracy of the services provided by third-party service providers is compromised for any reason, our

clinical trials may be extended, delayed or terminated, and we may not be able to obtain marketing approval of JOTROL and any other product

candidates or otherwise advance our business.

We cannot assure you that we will be able to manage our existing third-party service providers

or find other competent outside contractors and consultants on economically reasonable terms, or at all.

we are not able to effectively expand our organization by hiring new employees and/or engaging additional third-party service providers,

we may not be able to successfully implement the tasks necessary to further develop and commercialize JOTROL and other product candidates

and, accordingly, may not achieve our research, development and commercialization goals.

computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may

fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary

or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities,

harm to our brand and material disruption of our operations.

the implementation of security measures in an effort to protect systems that store our information, given their size and complexity and

the increasing amounts of information maintained on our internal information technology systems, and those of our third-party CROs, other

contractors (including sites performing our clinical trials) and consultants, these systems are potentially vulnerable to breakdown or

other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication

and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants,

business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including supply chain cyber attacks

or the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability

and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure or lead

to the loss, destruction, alteration, prevention of access to, disclosure, or dissemination of, or damage or unauthorized access to,

our data (including trade secrets or other confidential information, intellectual property, proprietary business information, and personal

information) or data that is processed or maintained on our behalf, or other assets, which could result in financial, legal, business

and reputational harm to us.

For example, in 2019, one our CROs experienced a cybersecurity breach which resulted in unauthorized access

to certain of our preclinical data.

We have received phishing attacks, and companies have, in general, experienced an increase in phishing

and social engineering attacks from third parties, and the increase in remote working further increases security threats.

To the extent

that any disruption or security incident were to result in any loss, destruction, unavailability, alteration, disclosure, or dissemination

of, or damage or unauthorized access to, our applications, any other data processed or maintained on our behalf or other assets, or for

it to be believed or reported that any of these occurred, we could incur liability, financial harm and reputational damage and the development

and commercialization of our product candidates could be delayed.

We cannot assure you that our data protection efforts and our investment

in information technology, or the efforts or investments of CROs, consultants or other third parties, will prevent significant breakdowns

or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage

or unauthorized access to, our data and other data processed or maintained on our behalf or other assets that could have a material adverse

effect upon our reputation, business, operations or financial condition.

For example, if such an event were to occur and cause interruptions

in our operations, it could result in a material disruption of our programs and the development of our product candidates could be delayed.

In addition, the loss of clinical trial data for our product candidates could result in delays in our marketing approval efforts and

significantly increase our costs to recover or reproduce the data.

Further, any such event that leads to loss, damage, or unauthorized

access to, or use, alteration, or disclosure or dissemination of, personal information, including personal information regarding our

clinical trial subjects or employees, could harm our reputation directly, compel us to comply with federal and/or state breach notification

laws and foreign law equivalents, subject us to mandatory corrective action, and otherwise subject us to liability under laws and regulations

that protect the privacy and security of personal information, which could result in significant legal and financial exposure and reputational

damages that could potentially have an adverse effect on our business.

Notifications

and follow-up actions related to a security incident could impact our reputation and cause us to incur significant costs, including legal

expenses and remediation costs.

For example, the loss of clinical trial data from completed or future clinical trials could result in

delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data.

We expect to incur

significant costs in an effort to detect and prevent security incidents, and we may face increased costs and requirements to expend substantial

resources in the event of an actual or perceived security incident.

We also rely on third parties to manufacture our product candidates,

and similar events relating to their computer systems could also have a material adverse effect on our business.

To the extent that any

disruption or security incident were to result in any loss, destruction, or alteration of, or damage or unauthorized access to, our data

or other information that is processed or maintained on our behalf, or inappropriate disclosure of or dissemination of any such information,

we could be exposed to litigation and governmental investigations, the further development and commercialization of our product candidates

could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or

international privacy and security laws.

insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in or, failure or security

breach of our systems or third-party systems where information important to our business operations or commercial development is stored.

In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all.

Further, our insurance

may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit,

could be costly and divert management attention.

operations are vulnerable to interruption by fire, earthquakes, power loss, telecommunications failure, terrorist activity, pandemics

and other events beyond our control, which could harm our business.

facilities are located in Jupiter, Florida.

We have not undertaken a systematic analysis of the potential consequences to our business

and financial results from a major flood, blizzard, fire, earthquake, power loss, terrorist activity, pandemics or other disasters and

do not have a recovery plan for such disasters.

In addition, we do not carry sufficient insurance to compensate us for actual losses

from interruption of our business that may occur, and any losses or damages incurred by us could harm our business.

Also, our contract

development and manufacturing organizations’ (CDMOs) and suppliers’ facilities are located in multiple locations where other

natural disasters or similar events which could severely disrupt our operations, could expose us to liability and could have a material

adverse effect on our business.

The occurrence of any of these business disruptions could seriously harm our operations and financial

condition and increase our costs and expenses.

variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.

may seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject

to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:

regulatory requirements and reimbursement regimes in foreign countries;

changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

weakness, including inflation, or political instability in particular foreign economies and markets;

with tax, employment, immigration and labor laws for employees living or traveling abroad;

taxes, including withholding of payroll taxes;

currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to

doing business in another country;

staffing and managing foreign operations;

uncertainty in countries where labor unrest is more common than in the United States;

liability under the FCPA or comparable foreign regulations;

enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect

intellectual property rights to the same extent as the United States;

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

interruptions resulting from geo-political actions, including war and terrorism.

and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable

certificate of incorporation, as amended, and amended and restated bylaws provides that state or federal court located within the state

of Delaware will be the sole and exclusive forum for substantially all disputes between us and our shareholders, which could limit its

stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

IX of our certificate of incorporation, as amended, and Section 7.4 of our amended and restated bylaws provides that “unless the

corporation consents in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action

or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director,

officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a

claim arising pursuant to any provision of the DGCL, or (iv) any action asserting a claim governed by the internal affairs doctrine shall

be a state or federal court located in the county in which the principal office of the corporation in the State of Delaware is established,

in all cases subject to the court’s having personal jurisdiction over the indispensable parties named as defendants.

Notwithstanding

the foregoing, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange

of 1934, as amended, the Securities Act of 1933, as amended, or any claim for which the federal courts have exclusive or concurrent jurisdiction.”

Therefore, the exclusive forum provision in our certificate of incorporation, as amended, and our amended and restated bylaws will not

relieve us of our duty to comply with the federal securities laws and the rules and regulations thereunder, and shareholders will not

be deemed to have waived our compliance with these laws, rules and regulations.

exclusive forum provision may limit a shareholder’s ability to bring a claim in a judicial forum of its choosing for disputes with

us or our directors, officers or other employees, which may discourage lawsuits against us or our directors, officers or other employees.

In addition, shareholders who do bring a claim in the state or federal court in the State of Delaware could face additional litigation

costs in pursuing any such claim, particularly if they do not reside in or near Delaware.

The state or federal court of the State of

Delaware may also reach different judgments or results than would other courts, including courts where a shareholder would otherwise

choose to bring the action, and such judgments or results may be more favorable to us than to our shareholders.

However, the enforceability

of similar exclusive forum provisions in other companies’ certificates of incorporation have been challenged in legal proceedings,

and it is possible that a court could find this type of provision to be inapplicable to, or unenforceable in respect of, one or more

of the specified types of actions or proceedings.

If a court were to find the exclusive forum provision contained in our certificate

of incorporation, as amended, and our amended and restated bylaws to be inapplicable or unenforceable in an action, we might incur additional

costs associated with resolving such action in other jurisdictions.

purchasing our common stock, you are bound by the fee-shifting provision contained in our amended and restated bylaws, which may discourage

you to pursue actions against us and could discourage shareholder lawsuits that might otherwise benefit the Company and its shareholders.

7.4 of our amended and restated bylaws provides that “[i]f any action is brought by any party against another party, relating to

or arising out of these Bylaws, or the enforcement hereof, the prevailing party shall be entitled to recover from the other party reasonable

attorneys’ fees, costs and expenses incurred in connection with the prosecution or defense of such action.”

amended and restated bylaws provide that for this section, the term “attorneys’ fees” or “attorneys’ fees

and costs” means the fees and expenses of counsel to the Company and any other parties asserting a claim subject to Section 7.4

of the amended and restated bylaws, which may include printing, photocopying, duplicating and other expenses, air freight charges, and

fees billed for law clerks, paralegals and other persons not admitted to the bar but performing services under the supervision of an

attorney, and the costs and fees incurred in connection with the enforcement or collection of any judgment obtained in any such proceeding.

adopted the fee-shifting provision to eliminate or decrease nuisance and frivolous litigation.

We intend to apply the fee-shifting provision

broadly to all actions except for claims brought under the Exchange Act and Securities Act.

is no set level of recovery required to be met by a plaintiff to avoid payment under this provision.

Instead, whoever is the prevailing

party is entitled to recover the reasonable attorneys’ fees, costs and expenses incurred in connection with the prosecution or

defense of such action.

Any party who brings an action, and the party against whom such action is brought under Section 7.4 of our amended

and restated bylaws, which could include, but is not limited to former and current shareholders, Company directors, officers, affiliates,

legal counsel, expert witnesses and other parties, are subject to this provision.

Additionally, any party who brings an action, and the

export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments,

and persons targeted by U.S.

If we fail to comply with export and import regulations and such economic sanctions, penalties

could be imposed, including fines and/or denial of certain export privileges.

Moreover, any new export or import restrictions, new legislation

or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or products targeted by such

regulations, could result in decreased use of our products by, or in our decreased ability to export our products to, existing or potential

customers with international operations.

Any decreased use of our products or limitation on our ability to export or sell our products

would likely adversely affect our business.

Risks Related to Employee Matters, Managing Our Growth

and Other Risks Related to Our Business

Our success is highly dependent on our ability to attract

and retain highly skilled executive officers and employees.

To succeed, we must recruit, retain, manage and motivate qualified

clinical, scientific, technical and management personnel, and we face significant competition for experienced personnel.

We are highly

dependent on the principal members of our management and scientific and medical staff, particularly Marshall Hayward, our Co-Founder and

Chief Scientific Officer.

If we do not succeed in attracting and retaining qualified personnel, particularly at the management level,

it could adversely affect our ability to execute our business plan and harm our operating results.

In particular, the loss of one or more

of our executive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner.

We do not maintain

“key person” insurance for any of our executives or other employees.

We could in the future have difficulty attracting and

retaining experienced personnel and may be required to expend significant financial resources in our employee recruitment and retention

Many of the other biotechnology companies that we compete

against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry

They also may provide higher compensation, more diverse opportunities and better prospects for career advancement.

these characteristics may be more appealing to high-quality candidates than what we have to offer.

If we are unable to continue to attract

and retain high-quality personnel, the rate and success at which we can discover, develop and commercialize our product candidates will

be limited and the potential for successfully growing our business will be harmed.

Additionally, we rely on our scientific founders and other

scientific and clinical advisors and consultants to assist us in formulating our research, development and clinical strategies.

advisors and consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that

may limit their availability to us.

In addition, these advisors and consultants typically will not enter into non-compete agreements with

If a conflict of interest arises between their work for us and their work for another entity, we may lose their services.

our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete

In particular, if we are unable to maintain consulting relationships with our scientific founders or if they provide services

to our competitors, our development and commercialization efforts will be impaired and our business will be significantly harmed.

If we are unable to establish sales or marketing capabilities

or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market

our product candidates that obtain regulatory approval.

We currently do not have and have never had a marketing or

In order to commercialize any product candidates, if approved, we must build marketing, sales, distribution, managerial and

other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which

we may have approval to sell or market our product candidates.

We may not be successful in accomplishing these required tasks.

Establishing an internal sales or marketing team with technical

expertise and supporting distribution capabilities to commercialize our product candidates will be expensive and time-consuming and will

require significant attention of our executive officers to manage.

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

and distribution capabilities could adversely impact the commercialization of any of our product candidates that we obtain approval to

market, if we do not have arrangements in place with third parties to provide such services, which is our preferred marketing and sales

strategy, on our behalf.

Alternatively, if we choose to collaborate, either globally or on a territory-by-territory basis, with third

parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems

or in lieu of our own sales force and distribution systems, we will be required to negotiate and enter into arrangements with such third

parties relating to the proposed collaboration and such arrangements may prove to be less profitable than commercializing the product

If we are unable to enter into such arrangements when needed, on acceptable terms, or at all, we may not be able to successfully

commercialize any of our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations.

If we are unable to successfully commercialize our approved product candidates, either on our own or through collaborations with one or

more third parties, our future product revenue will suffer, and we may incur significant additional losses.

In order to successfully implement our plans and strategies,

we will need to grow the size of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2025, we had a total of five full-time

employees, two full-time consultants and one part-time consultant, plus our six Scientific Advisory Board members.

Of these, three were

primarily engaged in research or product development and clinical activities.

In order to successfully implement our development and commercialization

plans and strategies, and as we transition into operating as a public company, we expect to hire additional managerial, operational, sales,

marketing, financial and other personnel, as reflected in our organization chart represented in our Operation and Organization section.

Future growth would impose significant added responsibilities on members of management, including:

identifying, recruiting, integrating, maintaining and motivating additional employees;

managing our internal development efforts effectively, including the clinical, FDA, EMA and other comparable foreign regulatory agencies’ review process for JOTROL™ and any other product candidates, while complying with any contractual obligations to contractors and other third parties we may have;

improving our operational, financial and management controls, reporting systems and procedures.

Our future financial performance and our ability to successfully

develop and, if approved, commercialize JOTROL™ and other product candidates will depend, in part, on our ability to effectively manage

any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities

in order to devote a substantial amount of time to managing these growth activities.

We currently rely, and for the foreseeable future will continue

to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including key

aspects of our research and development, clinical development and manufacturing.

We cannot assure you that the services of independent

organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified

replacements.

In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services

provided by third-party service providers is compromised for any reason, our clinical trials may be extended, delayed or terminated, and

we may not be able to obtain marketing approval of JOTROL™ and any other product candidates or otherwise advance our business.

assure you that we will be able to manage our existing third-party service providers or find other competent outside contractors and consultants

on economically reasonable terms, or at all.

If we are not able to effectively expand our organization

by hiring new employees and/or engaging additional third-party service providers, we may not be able to successfully implement the tasks

necessary to further develop and commercialize JOTROL™ and other product candidates and, accordingly, may not achieve our research, development

and commercialization goals.

Risks Related to Cybersecurity and Information Technology

Our information technology systems and those of

any of our CROs, clinical sites, manufacturers, vendors, and other partners are subject to cybersecurity threats and other disruptions

that could adversely affect our operations and the development and commercialization of our product candidates.

We and our third-party partners rely on information

technology systems to conduct research and development, manage clinical and manufacturing operations, and support corporate functions.

Despite the implementation of security measures designed to protect these systems, given their size and complexity and the increasing

amounts of information maintained on our internal information technology systems, and those of our third-party CROs, contract development

and manufacturing organizations (“CDMOs”), other contractors (including sites performing our clinical trials) and consultants,

these systems are vulnerable to damage, disruption or unauthorized access arising from service interruptions, system malfunction, natural

disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional

actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious

third parties.

Such cyber-attacks may include supply chain attacks, the deployment of harmful malware, ransomware (including ransomware-as-a-service),

denial-of-service attacks, social engineering, credential harvesting, business email compromise, and other means designed to affect service

reliability and threaten the confidentiality, integrity and availability of information.

The frequency, sophistication, and severity of

such threats continue to increase and those of our third-party service providers remain at risk.

Any such incident may compromise our system infrastructure

or lead to the loss, unavailability, destruction, alteration, prevention of access to, disclosure, or dissemination of, or damage or unauthorized

access to, our data (including trade secrets or other confidential information, intellectual property, proprietary business information,

and personal information) or data that is processed or maintained on our behalf, or other assets, which could result in financial, legal,

business and reputational harm to us.

We have also received phishing attacks, and companies have, in general, experienced an increase

in phishing and social engineering attacks from third parties.

The increase in remote and hybrid working arrangements further increases

security threats.

A material cybersecurity incident or other significant disruption

affecting us or our third parties could result in the loss, unavailability, alteration, or unauthorized access to confidential, proprietary,

or personal information;

liability, financial harm and reputational damage;

increased costs, including incident response and remediation;

regulatory investigations and enforcement actions;

and the delay in development and commercialization of our product candidates.

assure you that our data protection efforts and our investment in information technology, or the efforts or investments of CROs, CDMOs,

consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss,

destruction, unavailability, alteration or dissemination of, or damage or unauthorized access to, our data and other data processed or

maintained on our behalf or other assets that could have a material adverse effect upon our reputation, business, operations or financial

In addition, the growing use of artificial intelligence and

machine learning technologies, both by malicious actors seeking to circumvent security measures and by us and our service providers in

the course of business operations, introduces new and evolving cybersecurity risks.

AI-powered attacks may be more difficult to detect

and may circumvent traditional security controls.

Furthermore, if we or our third-party service providers use AI tools that process or

have access to our confidential information, clinical trial data, or other sensitive data, the use of such tools could create additional

vectors for data exposure if not properly secured and governed.

Notifications and follow-up actions related to a security

incident could impact our reputation and cause us to incur significant costs, including legal expenses and remediation costs.

to incur significant costs in an effort to detect and prevent security incidents, and we may face increased costs and requirements to

expend substantial resources in the event of an actual or perceived security incident.

In addition, the SEC’s cybersecurity disclosure

rules require us to disclose material cybersecurity incidents and describe our cybersecurity risk management, strategy, and governance,

which may increase the costs and complexity of managing cybersecurity events and could result in reputational harm if we are required

to disclose a material incident.

While we maintain a cybersecurity risk management program

and seek to implement and require appropriate security measures, we cannot eliminate all risk, and our insurance coverage may not be adequate

to cover all losses or liabilities..

In addition, such insurance may not be available to us in the future on economically reasonable terms,

Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending

a suit, regardless of its merit, could be costly and divert management attention.

In addition, we have recently launched our Nugevia direct-to-consumer

nutraceutical business, which involves the collection, storage, and processing of consumer personal information, including names, shipping

addresses, email addresses, and payment card data through our e-commerce platform.

A security breach affecting our e-commerce systems

or those of our third-party payment processors, fulfillment providers, or website hosting services could result in the unauthorized access

to or theft of customer payment information and personal data, exposing us to liability under the Payment Card Industry Data Security

Standard (PCI DSS), state consumer protection and data breach notification laws, and potential claims from affected consumers.

Our direct-to-consumer

marketing efforts may also rely on social media platforms and third-party brand ambassadors, and any security incident affecting those

channels or relationships could harm our brand reputation and customer trust.

employees and executives may use artificial intelligence tools in ways that expose our confidential information, intellectual property,

or clinical data to third parties, and the evolving regulatory and legal landscape around artificial intelligence could adversely affect

our business.

employees and executives may use commercially available artificial intelligence tools, including generative AI platforms, in connection

with their work.

If our personnel inadvertently submit confidential information, proprietary research data, clinical trial data, or trade

secrets to external AI platforms, that information may be exposed to third parties or incorporated into publicly accessible AI outputs,

potentially compromising our intellectual property, our patent position, or our obligations under confidentiality agreements.

and regulatory framework governing AI tools remains uncertain and rapidly evolving, including with respect to ownership of AI-generated

outputs and potential infringement of third-party intellectual property rights.

We have not adopted a formal AI use policy, and any failure

to manage these risks appropriately could have a material adverse effect on our business, financial condition, and results of operations.

Our operations are vulnerable to interruption by fire,

earthquakes, power loss, telecommunications failure, terrorist activity, pandemics and other events beyond our control, which could harm

our business.

Our facilities are located in Jupiter, Florida.

undertaken a systematic analysis of the potential consequences to our business and financial results from a major flood, blizzard, fire,

earthquake, power loss, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters.

we do not carry sufficient insurance to compensate us for actual losses from interruption of our business that may occur, and any losses

or damages incurred by us could harm our business.

Also, our contract development and manufacturing organizations’ (CDMOs) and suppliers’

facilities are located in multiple locations where other natural disasters or similar events which could severely disrupt our operations,

could expose us to liability and could have a material adverse effect on our business.

The occurrence of any of these business disruptions

could seriously harm our operations and financial condition and increase our costs and expenses.

A variety of risks associated with marketing our product

candidates internationally could materially adversely affect our business.

We may seek regulatory approval of our product candidates

outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries.

These risks include navigating differing regulatory requirements and reimbursement systems, as well as coping with unexpected changes

in tariffs, trade barriers, price and exchange controls, and other regulatory demands.

We may also encounter economic challenges such

as inflation or political instability in certain foreign markets.

Compliance with local tax, employment, immigration, and labor laws for

employees living or traveling abroad will be necessary, alongside managing foreign taxes, including payroll withholding.

Foreign currency fluctuations could increase our operating

expenses and reduce revenue, adding further complexity to our international operations.

We may experience difficulties in staffing and

managing foreign operations, particularly in countries where labor unrest is more common than in the United States, leading to workforce

There is also the potential for liability under the Foreign Corrupt Practices Act (FCPA) or similar foreign regulations.

Enforcing our contractual and intellectual property rights may be challenging, especially in countries that do not provide the same level

of protection as the United States.

Additionally, production shortages could arise from disruptions in raw material supply or manufacturing

capabilities abroad, and business interruptions could result from geopolitical actions such as war and terrorism.

Collectively, these

and other risks related to international operations could materially and adversely affect our ability to achieve or maintain profitable

The certificate of incorporation, as amended, and amended

and restated bylaws provides that state or federal court located within the state of Delaware will be the sole and exclusive forum for

substantially all disputes between us and our stockholders, which could limit its stockholders’ ability to obtain a favorable judicial

forum for disputes with us or our directors, officers or other employees.

Section IX of our certificate of incorporation, as

amended, and Section 7.4 of our amended and restated bylaws provides that “unless the corporation consents in writing to the

selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the

Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the

Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any

provision of the DGCL, or (iv) any action asserting a claim governed by the internal affairs doctrine shall be a state or federal

court located in the county in which the principal office of the corporation in the State of Delaware is established, in all cases

subject to the court’s having personal jurisdiction over the indispensable parties named as defendants.

Notwithstanding the

foregoing, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange

Act of 1934, as amended, the Securities Act of 1933, as amended, or any claim for which the federal courts have exclusive or

concurrent jurisdiction.” Therefore, the exclusive forum provision in our certificate of incorporation, as amended, and our

amended and restated bylaws will not relieve us of our duty to comply with the federal securities laws and the rules and regulations

thereunder, and stockholders will not be deemed to have waived our compliance with these laws, rules and regulations.

This exclusive forum provision may limit a stockholder’s

ability to bring a claim in a judicial forum of its choosing for disputes with us or our directors, officers or other employees, which

may discourage lawsuits against us or our directors, officers or other employees.

In addition, stockholders who do bring a claim in the

state or federal court in the State of Delaware could face additional litigation costs in pursuing any such claim, particularly if they

do not reside in or near Delaware.

The state or federal court of the State of Delaware may also reach different judgments or results than

would other courts, including courts where a stockholder would otherwise choose to bring the action, and such judgments or results may

be more favorable to us than to our stockholders.

However, the enforceability of similar exclusive forum provisions in other companies’

certificates of incorporation have been challenged in legal proceedings, and it is possible that a court could find this type of provision

to be inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings.

If a court were to

find the exclusive forum provision contained in our certificate of incorporation, as amended, and our amended and restated bylaws to be

inapplicable or unenforceable in an action, we might incur additional costs associated with resolving such action in other jurisdictions.

By purchasing our common stock, you are bound by the

fee-shifting provision contained in our amended and restated bylaws, which may discourage you to pursue actions against us and could discourage

stockholder lawsuits that might otherwise benefit the Company and its stockholders.

Section 7.4 of our amended and restated bylaws provides that

“if any action is brought by any party against another party, relating to or arising out of these Bylaws, or the enforcement hereof,

the prevailing party shall be entitled to recover from the other party reasonable attorneys’ fees, costs and expenses incurred in

connection with the prosecution or defense of such action.”

Our amended and restated bylaws provide that for this section,

the term “attorneys’ fees” or “attorneys’ fees and costs” means the fees and expenses of counsel to

the Company and any other parties asserting a claim subject to Section 7.4 of the amended and restated bylaws, which may include printing,

photocopying, duplicating and other expenses, air freight charges, and fees billed for law clerks, paralegals and other persons not admitted

to the bar but performing services under the supervision of an attorney, and the costs and fees incurred in connection with the enforcement

or collection of any judgment obtained in any such proceeding.

We adopted the fee-shifting provision to eliminate or decrease

nuisance and frivolous litigation.

We intend to apply the fee-shifting provision broadly to all actions except for claims brought under

the Exchange Act and Securities Act.

There is no set level of recovery required to be met by a

plaintiff to avoid payment under this provision.

Instead, whoever is the prevailing party is entitled to recover the reasonable attorneys’

fees, costs and expenses incurred in connection with the prosecution or defense of such action.

Any party who brings an action, and the

party against whom such action is brought under Section 7.4 of our amended and restated bylaws, which could include, but is not limited

to former and current shareholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, would

be able to recover fees under this provision.

the event you initiate or assert a claims against us, in accordance with the dispute resolution provisions contained in our amended and

restated Bylaws, and you do not, in a judgment prevail, you will be obligated to reimburse us for all reasonable costs and expenses incurred

in connection with such claim, including, but not limited to, reasonable attorney’s fees and expenses and costs of appeal, if any.

Additionally, this provision in Section 7.4 of our amended and restated bylaws could discourage shareholder lawsuits that might otherwise

benefit the Company and its shareholders.

FEE SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED BYLAWS IS NOT INTENDED TO BE DEEMED A WAIVER BY ANY HOLDER OF COMMON STOCK

OF THE COMPANY’S COMPLIANCE WITH THE U.S.

FEDERAL SECURITIES LAWS AND THE RULES AND REGULATIONS PROMULGATED THEREUNDER.

SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED BYLAWS DO NOT APPLY TO CLAIMS BROUGHT UNDER THE EXCHANGE ACT AND SECURITIES

Related to Our Intellectual Property

success depends on our ability to protect our intellectual property and our proprietary technologies.

commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our product

candidates, proprietary technologies and their uses as well as our ability to operate without infringing upon the proprietary rights

We generally seek to protect our proprietary position by filing patent applications in the United States and abroad related

to our product candidates, proprietary technologies and their uses that are important to our business.

We also seek to protect our proprietary

position by acquiring or in-licensing relevant issued patents or pending applications from third parties.

patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until,

patents issue from such applications, and then only to the extent the issued claims cover the technology.

There can be no assurance that

our patent applications or the patent applications of our licensor will result in additional patents being issued or that issued patents

will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued

will not be infringed, designed around or invalidated by third parties.

issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before

various patent offices or in courts.

The degree of future protection for our and our licensor’s proprietary rights is uncertain.

Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage.

These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates

could have a material adverse effect on our financial condition and results of operations.

we have a worldwide license for use of JOTROL from Aquanova AG, the patent holder of a micellar technology (“NovaSol TM ”).

Aquanova AG, a German company, filed an international patent on January 29, 2017 entitled “Resveratrol solubilization product for

pharmaceutical purposes” (PCT/EP2017/O51659).

The patent in jointly owned by the Company and Aquanova AG.

The priority date of

the patent was June 16, 2016 with expiration in 2036.

The patent has been examined by the International Preliminary Examining Authority

of the Patent Cooperation Treaty (PCT), and 15 claims of this patent are deemed Novel, have an Inventive Step, and have Industrial Applicability.

In accordance with the Patent Cooperation Treaty’s procedures and with this favorable examination report, this patent has been

granted in USA, specific EU countries, Japan, China and Hong Kong.

license agreement with Aquanova AG is our most important agreement and critical to maintain as long as JOTROL remains our main and only

A loss of this agreement will cause the Company a delay in its plans and would cause the Company to seek out other similar licensing

Accordingly, the loss of this agreement will have a material adverse effect on our business.

patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential

future collaborators will be successful in protecting our product candidates by obtaining and defending patents.

These risks and uncertainties

include the following:

USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and

other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent

application, and partial or complete loss of patent rights in the relevant jurisdiction;

applications may not result in any patents being issued;

may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive

competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing

technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use

and sell our potential product candidates;

may be significant pressure on the U.S.

government and international governmental bodies to limit the scope of patent protection

both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide

health concerns;

other than the United States may have patent laws less favorable to patentees than those upheld by U.S.

courts, allowing foreign

competitors a better opportunity to create, develop and market competing product candidates.

patent prosecution process is also expensive and time-consuming, and we and our licensor may not be able to file and prosecute all necessary

or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially

advantageous.

It is also possible that we or our licensor will fail to identify patentable aspects of our research and development output

before it is too late to obtain patent protection.

addition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of

our research and development output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants,

advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application

is filed, thereby jeopardizing our ability to seek patent protection.

the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates

might expire before or shortly after such candidates are commercialized.

As a result, our intellectual property may not provide us with

sufficient rights to exclude others from commercializing products similar or identical to ours.

the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent

our competitors from commercializing similar or identical product candidates would be adversely affected.

patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been

the subject of much litigation in recent years.

As a result, the issuance, scope, validity, enforceability and commercial value of our

patent rights are highly uncertain.

Our pending and future patent applications and those of our licensor may not result in patents being

issued which protect our product candidates or which effectively prevent others from commercializing competitive product candidates.

the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted

after issuance.

Even if patent applications we own or in-license currently or in the future issue as patents, they may not issue in a

form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise

provide us with any competitive advantage.

Any patents that we own or in-license may be challenged or circumvented by third parties or

may be narrowed or invalidated as a result of challenges by third parties.

Consequently, we do not know whether our product candidates

will be protectable or remain protected by valid and enforceable patents.

Our competitors or other third parties may be able to circumvent

our patents or the patents of our licensors by developing similar or alternative technologies or products in a non-infringing manner

which could materially adversely affect our business, financial condition, results of operations and prospects.

issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents or the patents of our

licensor may be challenged in the courts or patent offices in the United States and abroad.

We may be subject to a third-party pre-issuance

submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review (PGR)

and inter partes review (IPR), or other similar proceedings challenging our owned patent rights.

An adverse determination in any

such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow

third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability

to manufacture or commercialize products without infringing third-party patent rights.

Moreover, our patents or the patents of our licensor

may become subject to post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our priority of

invention or other features of patentability with respect to our patents and patent applications and those of our licensor.

Such challenges

may result in loss of patent rights, loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, which

could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration

of the patent protection of our product candidates.

Such proceedings also may result in substantial cost and require significant time

from our scientists and management, even if the eventual outcome is favorable to us.

In addition, if the breadth or strength of protection

provided by our patents and patent applications or the patents and patent applications of our licensor is threatened, regardless of the

outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

property rights do not necessarily address all potential threats to our competitive advantage.

degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations

and may not adequately protect our business or permit us to maintain our competitive advantage.

may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents

that we own or license;

or our licensor or collaborators might not have been the first to make the inventions covered by the patent applications that we

own or license;

or our licensor or collaborators might not have been the first to file patent applications covering certain of our inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual

property rights;

is possible that the pending patent applications we own or license will not lead to issued patents;

competitors might conduct research and development activities in countries where we do not have patent rights and then use the information

learned from such activities to develop competitive products for sale in our major commercial markets;

may not develop additional proprietary technologies that are patentable;

patents of others may have an adverse effect on our business;

may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a

patent covering such intellectual property.

any of these events occur, it could significantly harm our business, results of operations and prospects.

commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third

Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our

developmental and commercialization efforts.

commercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties.

However, our research,

development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual

property rights owned or controlled by third parties.

Other entities may have or obtain patents or proprietary rights that could limit

our ability to make, use, sell, offer for sale or import our product candidates and products that may be approved in the future, or impair

our competitive position.

There is a substantial amount of litigation, both within and outside the United States, involving patent and

other intellectual property rights in the biopharmaceutical industry, including patent infringement lawsuits, oppositions, reexaminations,

IPR proceedings and PGR proceedings before the USPTO and/or corresponding foreign patent offices.

to former and current stockholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, are subject

to this provision.

Additionally, any party who brings an action, and the party against whom such action is brought under Section 7.4 of

our amended and restated bylaws, which could include, but is not limited to former and current stockholders, Company directors, officers,

affiliates, legal counsel, expert witnesses and other parties, would be able to recover fees under this provision.

In the event you initiate or assert a claims against us, in

accordance with the dispute resolution provisions contained in our amended and restated Bylaws, and you do not, in a judgment prevail,

you will be obligated to reimburse us for all reasonable costs and expenses incurred in connection with such claim, including, but not

limited to, reasonable attorney’s fees and expenses and costs of appeal, if any.

Additionally, this provision in Section 7.4 of

our amended and restated bylaws could discourage stockholder lawsuits that might otherwise benefit the Company and its stockholders.

THE FEE SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED

BYLAWS IS NOT INTENDED TO BE DEEMED A WAIVER BY ANY HOLDER OF COMMON STOCK OF THE COMPANY’S COMPLIANCE WITH THE U.S.

FEDERAL SECURITIES

LAWS AND THE RULES AND REGULATIONS PROMULGATED THEREUNDER.

THE FEE SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED BYLAWS DO

NOT APPLY TO CLAIMS BROUGHT UNDER THE EXCHANGE ACT AND SECURITIES ACT.

Risks Related to Our Intellectual Property

Our worldwide exclusive license agreement with Aquanova

for JOTROL™ is critical to our business.

If we were to lose the license agreement, it could disrupt our ability to commercialize

our Nugevia product line or pharmaceutical drug candidates.

We hold a worldwide license for JOTROL™, utilizing Aquanova’s

proprietary micellar technology.

Aquanova jointly owns with us an international patent filed on January 29, 2017, titled “Resveratrol

Solubilization Product for Pharmaceutical Purposes” (PCT/EP2017/051659).

The patent, with a priority date of June 16, 2016, and

an expiration in 2036, has been examined by the International Preliminary Examining Authority of the Patent Cooperation Treaty (PCT).

All 15 claims were deemed novel, inventive, and industrially applicable, leading to the patent’s approval in the United States,

select European Union countries, Japan, China, and Hong Kong.

The JOTROL™ license agreement with Aquanova is

critical to our operations, as JOTROL™ is a proprietary, enhanced resveratrol formulation that has demonstrated the potential

for significantly improved bioavailability.

Termination or loss of this license agreement would significantly disrupt our ability to

commercialize our Nugevia product line or pharmaceutical drug candidates.

Such a disruption could delay our development and

commercialization efforts, resulting in a material adverse effect on our business, financial condition, and operational results.

Our success depends on our ability to protect our intellectual

property and our proprietary technologies.

Our commercial success depends in part on our ability to obtain

and maintain patent protection and trade secret protection for JOTROL™ and other product candidates, proprietary technologies and

their uses as well as our ability to operate without infringing upon the proprietary rights of others.

We generally seek to protect our

proprietary position by filing patent applications in the United States and abroad related to our product candidates, proprietary technologies

and their uses that are important to our business.

We also seek to protect our proprietary position by acquiring or in-licensing relevant

issued patents or pending applications from third parties.

Pending patent applications cannot be enforced against third

parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only

to the extent the issued claims cover the technology.

There can be no assurance that our patent applications or the patent applications

of our licensor will result in additional patents being issued or that issued patents will afford sufficient protection against competitors

with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated

by third parties.

Even issued patents may later be found invalid or unenforceable

or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts.

The degree of future

protection for our and our licensor’s proprietary rights is uncertain.

Only limited protection may be available and may not adequately

protect our rights or permit us to gain or keep any competitive advantage.

These uncertainties and/or limitations in our ability to properly

protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition

and results of operations

Obtaining and maintaining patent protection involves significant

risks and uncertainties.

The USPTO and foreign patent agencies require strict compliance with procedural, documentary, fee payment, and

other provisions during the patent process, and noncompliance can lead to the abandonment or lapse of a patent or application, resulting

in partial or complete loss of patent rights in the relevant jurisdiction.

There is no guarantee that patent applications will result

in issued patents.

Even if granted, patents may be challenged, invalidated, modified, revoked, circumvented, or deemed unenforceable,

potentially offering no competitive advantage.

Competitors, often with substantially greater resources and significant investments in

competing technologies, may seek or already hold patents that could limit, interfere with, or eliminate our ability to develop, use, and

sell our potential product candidates.

Additionally, public policy pressures on the U.S.

government and international bodies may push

to restrict patent protection scopes for successful disease treatments due to global health concerns.

Furthermore, patent laws in countries

outside the United States may be less favorable to patentees compared to those upheld by U.S.

courts, enabling foreign competitors to

more easily create, develop, and market competing products.

The patent prosecution process is also expensive and time-consuming,

and we and our licensor may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in

a timely manner or in all jurisdictions where protection may be commercially advantageous.

It is also possible that we or our licensor

will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

In addition, although we enter into non-disclosure and confidentiality

agreements with parties who have access to patentable aspects of our research and development output, such as our employees, outside scientific

collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements

and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

Given the amount of time required for the development, testing

and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates

are commercialized.

As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing

products similar or identical to ours.

If the scope of any patent protection we obtain is not

sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or

identical product candidates would be adversely affected.

The patent position of biopharmaceutical companies generally

is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years.

the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent

applications and those of our licensor may not result in patents being issued which protect our product candidates or which effectively

prevent others from commercializing competitive product candidates.

Moreover, the coverage claimed in a patent application can

be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance.

Even if patent applications we

own or in-license currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection,

prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage.

that we own or in-license may be challenged or circumvented by third parties or may be narrowed or invalidated as a result of challenges

by third parties.

Consequently, we do not know whether our product candidates will be protectable or remain protected by valid and enforceable

Our competitors or other third parties may be able to circumvent our patents or the patents of our licensors by developing similar

or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition,

results of operations and prospects.

The issuance of a patent is not conclusive as to its inventorship,

scope, validity or enforceability, and our patents or the patents of our licensor may be challenged in the courts or patent offices in

the United States and abroad.

We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved

in opposition, derivation, revocation, reexamination, post-grant review (PGR) and inter partes review (IPR), or other similar proceedings

challenging our owned patent rights.

An adverse determination in any such submission, proceeding or litigation could reduce the scope

of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates and compete

directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party

patent rights.

Moreover, our patents or the patents of our licensor may become subject to post-grant challenge proceedings, such as oppositions

in a foreign patent office, that challenge our priority of invention or other features of patentability with respect to our patents and

patent applications and those of our licensor.

Such challenges may result in loss of patent rights, loss of exclusivity or in patent claims

being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar

or identical technology and products, or limit the duration of the patent protection of our product candidates.

Such proceedings also

may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable

In addition, if the breadth or strength of protection provided by our patents and patent applications or the patents and patent

applications of our licensor is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license,

develop or commercialize current or future product candidates.

Intellectual property rights do not necessarily address

all potential threats to our competitive advantage.

The future strength of our intellectual property protection

is uncertain, as IP rights have inherent limitations and may not fully safeguard our business or competitive position.

For instance, others

may develop similar products that fall outside the scope of our patents, or we or our licensors may not have been the first to invent

or file for certain technologies.

Competitors could independently develop or replicate our technologies without infringing our rights,

and some of our pending patent applications may never be granted.

Additionally, research conducted by others in countries where we lack

patent protection could lead to competing products in key markets.

We may also fail to develop new patentable technologies, be adversely

affected by third-party patents, or choose to rely on trade secrets that others later patent.

Any of these outcomes could materially harm

our business, operations, and future prospects.

Our commercial success depends significantly on our

ability to operate without infringing the patents and other proprietary rights of third parties.

Claims by third parties that we infringe

their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.

Our commercial success depends in part on avoiding infringement

of the patents and proprietary rights of third parties.

However, our research, development and commercialization activities may be subject

to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties.

entities may have or obtain patents or proprietary rights that could limit our ability to make, use, sell, offer for sale or import our

product candidates and products that may be approved in the future, or impair our competitive position.

There is a substantial amount

of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biopharmaceutical

industry, including patent infringement lawsuits, oppositions, reexaminations, IPR proceedings and PGR proceedings before the USPTO and/or

corresponding foreign patent offices.

Numerous third-party U.S.

issued patents and pending patent applications exist in the fields in which we are developing product candidates.

There may be third-party

patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the

use or manufacture of our product candidates.

the biopharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject to

claims of infringement of the patent rights of third parties.

Because patent applications are maintained as confidential for a certain

period of time, until the relevant application is published, we may be unaware of third-party patents that may be infringed by commercialization

of any of our product candidates, and we cannot be certain that we were the first to file a patent application related to a product candidate

or technology.

Moreover, because patent applications can take many years to issue, there may be currently-pending patent applications

that may later result in issued patents that our product candidates may infringe.

In addition, identification of third-party patent rights

that may be relevant to our technology is difficult because patent searching is imperfect due to differences in terminology among patents,

incomplete databases and the difficulty in assessing the meaning of patent claims.

There is also no assurance that there is not prior

art of which we are aware, but which we do not believe is relevant to our business, which may, nonetheless, ultimately be found to limit

our ability to make, use, sell, offer for sale or import our products that may be approved in the future, or impair our competitive position.

In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

claims of patent infringement asserted by third parties would be time consuming and could:

in costly litigation that may cause negative publicity;

the time and attention of our technical personnel and management;

development delays;

us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed

in a court of law;

us to develop non-infringing technology, which may not be possible on a cost-effective basis;

us to significant liability to third parties;

us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which

might be non-exclusive, which could result in our competitors gaining access to the same technology.

no third-party has asserted a claim of patent infringement against us as of the date of this prospectus, others may hold proprietary

rights that could prevent our product candidates from being marketed.

These claims could be alleged to cover JOTROL in certain treatment

While we believe that these patents are difficult to enforce and that we would have valid defenses to these claims of patent

infringement, we cannot be certain that we would prevail in any dispute and we cannot be certain how an adverse determination would affect

our business.

is possible that a third party may assert a claim of patent infringement directed at any of our product candidates.

Any patent-related

legal action against us claiming damages and seeking to enjoin commercial activities relating to our products, treatment indications,

or processes could subject us to significant liability for damages, including treble damages if we were determined to willfully infringe,

and require us to obtain a license to manufacture or market our product candidates.

Defense of these claims, regardless of their merit,

would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

predict whether we would prevail in any such actions or that any license required under any of these patents would be made available

on commercially acceptable terms, if at all.

Moreover, even if we or our future strategic partners were able to obtain a license, the

rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property.

In addition, we cannot

be certain that we could redesign our product candidates, treatment indications, or processes to avoid infringement, if necessary.

an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from

developing and commercializing our product candidates, which could harm our business, financial condition and operating results.

intellectual property litigation, regardless of its outcome, may cause negative publicity and could prohibit us from marketing or otherwise

commercializing our product candidates and technology.

making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have

substantially greater resources.

Furthermore, because of the substantial amount of discovery required in connection with intellectual

property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse

effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial

condition and prospects.

may in the future pursue invalidity proceedings with respect to third-party patents.

The outcome following legal assertions of invalidity

is unpredictable.

Even if resolved in our favor, these legal proceedings may cause us to incur significant expenses and could distract

our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results

of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be

negative, it could have a substantial adverse effect on the price of our common stock.

Such proceedings could substantially increase

our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

We may not have sufficient financial or other resources to conduct such proceedings adequately.

Some of these third parties may be able

to sustain the costs of such proceedings more effectively than we can because of their greater financial resources.

Uncertainties resulting

from the initiation and continuation of patent proceedings could compromise our ability to compete in the marketplace.

If we do not prevail

in the patent proceedings the third parties may assert a claim of patent infringement directed at our product candidates.

may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.

pharmaceutical companies, biotechnology companies, and academic institutions may have patents and patent applications potentially relevant

to our business.

We may find it necessary or prudent to obtain licenses to such patents from such third-party intellectual property holders,

for example, in order to avoid infringing these third-party patents.

We may also require licenses from third parties for certain technologies

for use with future product candidates.

We may be unable to acquire or in-license any compositions, methods of use, processes or other

third-party intellectual property rights from third parties that we identify as necessary for our product candidates.

The licensing and

acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue

strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary.

These established

companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization

capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return

on our investment or at all.

If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain

the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which

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

may be involved in lawsuits to protect or enforce our patents or our licensor’s patents, which could be expensive, time consuming

and unsuccessful.

Further, our issued patents or our licensor’s patents could be found invalid or unenforceable if challenged in

may infringe our intellectual property rights.

To prevent infringement or unauthorized use, we may be required to file infringement claims,

which can be expensive and time-consuming.

In addition, in a patent infringement proceeding, a court may decide that a patent we own

or in-license is not valid, is unenforceable and/or is not infringed.

If we or any of our potential future collaborators were to initiate

legal proceedings against a third-party to enforce a patent directed at one of our product candidates, the defendant could counterclaim

that our patent or the patent of our licensor is invalid and/or unenforceable in whole or in part.

In patent litigation in the United

States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.

Grounds for a validity challenge include

an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, lack of sufficient written

description, non-enablement, or obviousness-type double patenting.

Grounds for an unenforceability assertion could include an allegation

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

parties may also raise similar invalidity claims before the USPTO or patent offices abroad, even outside the context of litigation.

mechanisms include re-examination, PGR, IPR, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition

proceedings).

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

With respect to the validity

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

are unaware during prosecution.

and foreign issued patents and pending patent applications exist in the

fields in which we are developing product candidates.

There may be third-party patents or patent applications with claims to materials,

formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.

As the biopharmaceutical industry expands and more patents

are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.

Because patent applications are maintained as confidential for a certain period of time, until the relevant application is published,

we may be unaware of third-party patents that may be infringed by commercialization of any of our product candidates, and we cannot be

certain that we were the first to file a patent application related to a product candidate or technology.

Moreover, because patent applications

can take many years to issue, there may be currently-pending patent applications that may later result in issued patents that our product

candidates may infringe.

In addition, identification of third-party patent rights that may be relevant to our technology is difficult

because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing

the meaning of patent claims.

There is also no assurance that there is not prior art of which we are aware, but which we do not believe

affects the validity or enforceability of a claim in our patents and patent applications or the patents and patent applications of our

licensor, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim.

If a third-party were to prevail

on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our

technology or proprietary drug delivery platform, or any product candidates that we may develop.

Such a loss of patent protection would

have a material adverse impact on our business, financial condition, results of operations and prospects.

addition, if the breadth or strength of protection provided by our patents and patent applications or the patents and patent applications

of our licensor is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or

future product candidates.

if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant

expenses, and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public

announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors

perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Such litigation or

proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future

sales, marketing or distribution activities.

We may not have sufficient financial or other resources to conduct such litigation or proceedings

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because

of their greater financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings

could compromise our ability to compete in the marketplace.

Furthermore, because of the substantial amount of discovery required in connection

with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some

of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.

addition, the issuance of a patent does not give us the right to practice the patented invention.

Third parties may have blocking patents

that could prevent us from marketing our own patented product and practicing our own patented technology.

property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.

the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as

results of hearings, rulings on motions, and other interim proceedings in the litigation.

If securities analysts or investors regard

these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished.

Accordingly, the market price of shares of our common stock may decline.

Such announcements could also harm our reputation or the market

for our future products, which could have a material adverse effect on our business.

proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related

technology or to attempt to license rights from the prevailing party.

proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions

with respect to our patents or patent applications or those of our licensor.

An unfavorable outcome could require us to cease using the

related technology or to attempt to license rights to it from the prevailing party.

Our business could be harmed if the prevailing party

does not offer us a license on commercially reasonable terms.

Our defense of derivation proceedings may fail and, even if successful,

may result in substantial costs and distract our management and other employees.

In addition, the uncertainties associated with such

proceedings could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue

our research programs, license necessary technology from third parties or enter into development or manufacturing partnerships that would

help us bring our product candidates to market.

patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect

our product candidates.

is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity.

Therefore, obtaining

and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain.

Changes in either the patent laws or in the

interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and may increase

the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.

predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents.

In addition, Congress or other

foreign legislative bodies may pass patent reform legislation that is unfavorable to us.

example, the U.S.

Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available

in certain circumstances or weakening the rights of patent owners in certain situations.

In addition to increasing uncertainty with regard

to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents,

once obtained.

Depending on decisions by the U.S.

Congress, the U.S.

federal courts, the USPTO, or similar authorities in foreign jurisdictions,

the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or

to enforce our existing patent and the patents we might obtain or license in the future.

may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

may also be subject to claims that former employees or other third parties have an ownership interest in our patents or other intellectual

Litigation may be necessary to defend against these and other claims challenging inventorship or ownership.

If we fail in defending

any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights.

Such an outcome could have

a material adverse effect on our business.

Even if we are successful in defending against such claims, litigation could result in substantial

costs and distraction to management and other employees.

terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally

20 years from its earliest U.S.

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection

it affords, is limited.

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open

to competition from competitive products.

Given the amount of time required for the development, testing and regulatory review of new

product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical

we do not obtain patent term extension for our product candidates, our business may be materially harmed.

upon the timing, duration and specifics of FDA marketing approval of our product candidates, one or more of our U.S.

patents or those

of our licensor may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act

of 1984 (Hatch-Waxman Amendments).

The Hatch- Waxman Amendments permit a patent restoration term of up to five years as compensation

for patent term lost during product development and the FDA regulatory review process.

A maximum of one patent may be extended per FDA

approved product as compensation for the patent term lost during the FDA regulatory review process.

A patent term extension cannot extend

the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved

drug product, a method for using it or a method for manufacturing it may be extended.

Patent term extension may also be available in

certain foreign countries upon regulatory approval of our product candidates.

However, we may not be granted an extension because of,

for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing

to satisfy applicable requirements.

Moreover, the applicable time period or the scope of patent protection afforded could be less than

If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request,

our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly

Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our

clinical and preclinical data and launch their product earlier than might otherwise be the case.

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

prosecuting and defending patents in all countries throughout the world would be prohibitively expensive, and our intellectual property

rights in some countries outside the United States can be less extensive than those in the United States.

In addition, the laws of some

foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

Consequently,

we may not be able to prevent third parties from practicing our inventions in all countries outside the United States or from selling

or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies

in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing

products to territories where we have patent protection, but enforcement is not as strong as that in the United States.

These products

may compete with our product candidates, and our patents, the patents of our licensors, or other intellectual property rights may not

be effective or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

legal systems of many foreign countries do not favor the enforcement of patents and other intellectual property protection, which could

make it difficult for us to stop the infringement of our patents or our licensor’s patents or marketing of competing products in

violation of our proprietary rights.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs

and divert our efforts and attention from other aspects of our business, could put our patents or the patents of our licensors at risk

of being invalidated or interpreted narrowly and our patent applications or the patent applications of our licensor 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, and the damages or

other remedies awarded, if any, may not be commercially meaningful.

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 develop or license.

countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

many countries limit the enforceability of patents against government agencies or government contractors.

In these countries, the patent

owner may have limited remedies, which could materially diminish the value of such patent.

If we are forced to grant a license to third

parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition,

results of operations and prospects may be adversely affected.

and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements

imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance

with these requirements.

maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the USPTO

and various foreign patent offices at various points over the lifetime of our patents and/or applications and those of our licensors.

We have systems in place to remind us to pay these fees, and we rely on our outside patent annuity service to pay these fees when due.

Additionally, the USPTO and various foreign patent offices require compliance with a number of procedural, documentary, fee payment and

other similar provisions during the patent application process.

We employ reputable law firms and other professionals to help us comply,

and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to

the particular jurisdiction.

However, there are situations in which noncompliance can result in abandonment or lapse of the patent or

patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

If such an event were to occur,

it could have a material adverse effect on our business.

our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest

and our business may be adversely affected.

intend to use registered or unregistered trademarks or trade names to brand and market ourselves and our products.

Our trademarks or

trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or

customers in our markets of interest.

At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our

ability to build brand identity and possibly leading to market confusion.

In addition, there could be potential trade name or trademark

infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered

trademarks or trade names.

Over the long term, if we are unable to establish name recognition based on our trademarks and trade names,

then we may not be able to compete effectively, and our business may be adversely affected.

Our efforts to enforce or protect our proprietary

rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result

in substantial costs and diversion of resources and could adversely affect our financial condition or results of operations.

we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

addition, we rely on the protection of our trade secrets, including unpatented know-how, technology and other proprietary information

to maintain our competitive position.

Although we have taken steps to protect our trade secrets and unpatented know-how, including entering

into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants

and advisors, we cannot provide any assurances that all such agreements have been duly executed, and any of these parties may breach

the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies

for such breaches.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming,

and the outcome is unpredictable.

In addition, some courts inside and outside the United States are less willing or unwilling to protect

trade secrets.

third parties may still obtain this information or may come upon this or similar information independently, and we would have no right

to prevent them from using that technology or information to compete with us.

If any of these events occurs or if we otherwise lose protection

for our trade secrets, the value of this information may be greatly reduced, and our competitive position would be harmed.

apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology

and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.

may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets.

have entered into and may enter in the future into non-disclosure and confidentiality agreements to protect the proprietary positions

of third parties, such as outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors, potential partners,

lessees of shared multi-company property and other third parties.

We may become subject to litigation where a third-party asserts that

we or our employees inadvertently or otherwise breached the agreements and used or disclosed trade secrets or other information proprietary

to the third parties.

Defense of such matters, regardless of their merit, could involve substantial litigation expense and be a substantial

is relevant to our business, which may, nonetheless, ultimately be found to limit our ability to make, use, sell, offer for sale or import

our products that may be approved in the future, or impair our competitive position.

In addition, third parties may obtain patents in

the future and claim that use of our technologies infringes upon these patents.

Any claims of patent infringement asserted by third parties

would be time consuming and could:

result in costly litigation that may cause negative publicity;

divert the time and attention of our technical personnel and management;

cause development delays;

prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;

require us to develop non-infringing technology, which may not be possible on a cost-effective basis;

subject us to significant liability to third parties;

require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology.

Although no third-party has asserted a claim of patent infringement

against us as of the date of this Annual Report, others may hold proprietary rights that could prevent our product candidates from being

These claims could be alleged to cover JOTROL™ in certain treatment indications.

While we believe that these patents are difficult

to enforce and that we would have valid defenses to these claims of patent infringement, we cannot be certain that we would prevail in

any dispute and we cannot be certain how an adverse determination would affect our business.

It is possible that a third party may assert a claim of patent

infringement directed at any of our product candidates.

Any patent-related legal action against us claiming damages and seeking to enjoin

commercial activities relating to our products, treatment indications, or processes could subject us to significant liability for damages,

including treble damages if we were determined to willfully infringe, and require us to obtain a license to manufacture or market our

product candidates.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial

diversion of employee resources from our business.

We cannot predict whether we would prevail in any such actions.

Moreover, intellectual

property litigation, regardless of its outcome, may cause negative publicity and could prohibit us from marketing or otherwise commercializing

our product candidates and technology.

Failure to defend against any such claim could subject us to significant liability for monetary

damages or prevent or delay our developmental and commercialization efforts, which could adversely affect our business.

Even if we are

successful in defending against these claims, litigation could result in substantial costs and be a distraction to our management team

We cannot predict whether we would prevail in any such actions or that any license

required under any of these patents would be made available on commercially acceptable terms, if at all.

Moreover, even if we or our future

strategic partners were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access

to the same intellectual property.

In addition, we cannot be certain that we could redesign our product candidates, treatment indications,

or processes to avoid infringement, if necessary.

Accordingly, an adverse determination in a judicial or administrative proceeding, or

the failure to obtain necessary licenses, could prevent us from developing and commercializing our product candidates, which could harm

our business, financial condition and operating results.

In addition, intellectual property litigation, regardless of its outcome, may

cause negative publicity and could prohibit us from marketing or otherwise commercializing our product candidates and technology.

Parties making claims against us may be able to sustain the

costs of complex patent litigation more effectively than we can because they have substantially greater resources.

Furthermore, because

of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there

is a risk that some of our confidential information could be compromised by disclosure.

In addition, any uncertainties resulting from

the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise

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

We may in the future pursue invalidity proceedings with respect

to third-party patents.

The outcome following legal assertions of invalidity is unpredictable.

Even if resolved in our favor, these legal

proceedings may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and

if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of

our common stock.

Such proceedings could substantially increase our operating losses and reduce the resources available for development

activities or any future sales, marketing or distribution activities.

We may not have sufficient financial or other resources to conduct

such proceedings adequately.

Some of these third parties may be able to sustain the costs of such proceedings more effectively than we

can because of their greater financial resources.

Uncertainties resulting from the initiation and continuation of patent proceedings could

compromise our ability to compete in the marketplace.

If we do not prevail in the patent proceedings the third parties may assert a claim

of patent infringement directed at our product candidates.

We may not be successful in obtaining or maintaining

necessary rights to our product candidates through acquisitions and in-licenses.

Many pharmaceutical companies, biotechnology companies, and

academic institutions may have patents and patent applications potentially relevant to our business.

We may find it necessary or prudent

to obtain licenses to such patents from such third-party intellectual property holders, for example, in order to avoid infringing these

third-party patents.

We may also require licenses from third parties for certain technologies for use with future product candidates.

We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights

from third parties that we identify as necessary for our product candidates.

The licensing and acquisition of third-party intellectual

property rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party

intellectual property rights that we may consider attractive or necessary.

These established companies may have a competitive advantage

over us due to their size, capital resources and greater clinical development and commercialization capabilities.

In addition, companies

that perceive us to be a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party

intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all.

If we are unable

to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights

we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on

our business, financial condition, results of operations, and prospects.

We may be involved in lawsuits to protect or enforce

our patents or our licensor’s patents, which could be expensive, time consuming and unsuccessful.

Further, our issued patents or

our licensor’s patents could be found invalid or unenforceable if challenged in court.

Competitors may infringe our intellectual property rights.

To prevent infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

In addition, in a patent infringement proceeding, a court may decide that a patent we own or in-license is not valid, is unenforceable

and/or is not infringed.

If we or any of our potential future collaborators were to initiate legal proceedings against a third-party to

enforce a patent directed at one of our product candidates, the defendant could counterclaim that our patent or the patent of our licensor

is invalid and/or unenforceable in whole or in part.

In patent litigation in the United States, defendant counterclaims alleging invalidity

and/or unenforceability are commonplace.

Grounds for a validity challenge include an alleged failure to meet any of several statutory

requirements, including lack of novelty, obviousness, lack of sufficient written description, non-enablement, or obviousness-type double

Grounds for an unenforceability assertion could include an allegation that someone connected with prosecution of the patent

withheld relevant information from the USPTO or made a misleading statement during prosecution.

Third parties may also raise similar invalidity claims before

the USPTO or patent offices abroad, even outside the context of litigation.

Such mechanisms include re-examination, PGR, IPR, derivation

proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

The outcome following legal assertions

of invalidity and/or unenforceability is unpredictable.

With respect to the validity question, for example, we cannot be certain that

there is no invalidating prior art, of which we, our licensor, and the patent examiners are unaware during prosecution.

There is also

no assurance that there is not prior art of which we are aware, but which we do not believe affects the validity or enforceability of

a claim in our patents and patent applications or the patents and patent applications of our licensor, which may, nonetheless, ultimately

be found to affect the validity or enforceability of a claim.

If a third-party were to prevail on a legal assertion of invalidity or unenforceability,

we would lose at least part, and perhaps all, of the patent protection on our technology or proprietary drug delivery platform, or any

product candidates that we may develop.

Such a loss of patent protection would have a material adverse impact on our business, financial

condition, results of operations and prospects.

In addition, if the breadth or strength of protection provided

by our patents and patent applications or the patents and patent applications of our licensor is threatened, it could dissuade companies

from collaborating with us to license, develop or commercialize current or future product candidates.

Even if resolved in our favor, litigation or other legal proceedings

relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical and management

personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or

other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have

a substantial adverse effect on the price of our common stock.

Such litigation or proceedings could substantially increase our operating

losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

Some of our competitors may be

able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to

compete in the marketplace.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property

litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information

could be compromised by disclosure during this type of litigation or other proceedings.

In addition, the issuance of a patent does not give us the

right to practice the patented invention.

Third parties may have blocking patents that could prevent us from marketing our own patented

product and practicing our own patented technology.

Intellectual property litigation may lead to unfavorable

publicity that harms our reputation and causes the market price of our common stock to decline.

During the course of any intellectual property litigation,

there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other

interim proceedings in the litigation.

If securities analysts or investors regard these announcements as negative, the perceived value

of our existing products, programs or intellectual property could be diminished.

Accordingly, the market price of shares of our common

stock may decline.

Such announcements could also harm our reputation or the market for our future products, which could have a material

adverse effect on our business.

Derivation proceedings may be necessary to determine

priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights

from the prevailing party.

Derivation proceedings provoked by third parties or brought

by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications

or those of our licensor.

An unfavorable outcome could require us to cease using the related technology or to attempt to license rights

to it from the prevailing party.

Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable

Our defense of derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management

and other employees.

making claims against us may be able to sustain the costs of complex intellectual property litigation more effectively than we can because

they have substantially greater resources.

Furthermore, because of the substantial amount of discovery required in connection with intellectual

property litigation, there is a risk that some of our confidential information could be compromised by disclosure.

In addition, any uncertainties

resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional

funds or otherwise have a material adverse effect on our business, operating results, financial condition and prospects.

may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used

or disclosed alleged confidential information or trade secrets of their former employers.

is common in the pharmaceutical industry, in addition to our employees, we engage the services of consultants to assist us in the development

of our product candidates.

Many of these consultants, and many of our employees, were previously employed at, or may have previously

provided or may be currently providing consulting services to, other pharmaceutical companies including our competitors or potential

We may become subject to claims that we, our employees or a consultant inadvertently or otherwise used or disclosed trade

secrets or other information proprietary to their former employers or their former or current clients.

Litigation may be necessary to

defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual

property rights or personnel, which could adversely affect our business.

Even if we are successful in defending against these claims,

litigation could result in substantial costs and be a distraction to our management team and other employees.

rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of licenses

granted to us by others.

have entered into a license agreement with Aquanova AG, a German company, pursuant to which we have acquired the exclusive right to certain

patents and patent applications in micellar technologies that revolutionizes the bioavailability profile of resveratrol to treat certain

rare diseases and Alzheimer’s disease by eliminating the severe gastro-intestinal side effects experienced at effective dose levels

of resveratrol.

We may enter into additional license agreements in the future with others to advance our research or allow commercialization

of product candidates.

These and other licenses may not provide exclusive rights to use such intellectual property and technology in

all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the

addition, subject to the terms of any such license agreements, we may not have the right to control the preparation, filing, prosecution,

maintenance, enforcement, and defense of patents and patent applications covering the technology that we license from third parties.

In such an event, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced,

and defended in a manner consistent with the best interests of our business.

If our licensor fails to prosecute, maintain, enforce, and

defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated,

and our right to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected.

licensor may have relied on third-party consultants or collaborators or on funds from third parties such that our licensor are not the

sole and exclusive owners of the patents we in-licensed.

If other third parties have ownership rights to our in-licensed patents, they

may be able to license such patents to our competitors, and our competitors could market competing products and technology.

have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

is possible that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all.

Even if we are

able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

that event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods

for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial

If we are unable to do so, we may be unable to develop or commercialize the affected product candidates, which could harm our

business, financial condition, results of operations, and prospects significantly.

We cannot provide any assurances that third-party

patents do not exist which might be enforced against our current technology, manufacturing methods, product candidates, or future methods

or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation

on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.

we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise

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

may arise between us and our licensor or potential licensors regarding intellectual property subject to a license agreement, including:

scope of rights granted under the license agreement and other interpretation-related issues;

and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the

licensing agreement;

right to sublicense patents and other rights to third parties;

diligence obligations under the license agreement and what activities satisfy those diligence obligations;

right to transfer or assign the license;

inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors

and us and our partners;

priority of invention of patented technology.

addition, the agreements under which we license intellectual property or technology from third parties are complex, and certain provisions

in such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may

arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what

we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect

on our business, financial condition, results of operations, and prospects.

Moreover, if disputes over intellectual property that we

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

unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business,

financial conditions, results of operations, and prospects.

spite of our best efforts, our licensor or potential licensors might conclude that we have materially breached our license agreements

and might therefore terminate the license agreements, thereby removing our ability to develop and commercialize products and technology

covered by these license agreements.

If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity,

competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours.

This could have a material

adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

patent protection and patent prosecution for some of our product candidates may be dependent on third parties.

we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates,

there may be times when the filing and prosecution activities for patents relating to our product candidates are controlled by our licensor,

potential licensors or collaboration partners.

If any of our licensor, potential licensors or collaboration partners fail to prosecute,

maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by

payment of all applicable fees for patents covering our product candidates, we could lose our rights to the intellectual property or

our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates may be adversely affected

and we may not be able to prevent competitors from making, using and selling competing products.

In addition, even where we have the

right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely

affected or prejudiced by actions or inactions of our licensees, our licensors and their counsel that took place prior to the date upon

which we assumed control over patent prosecution.

property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain

reporting requirements and a preference for U.S.-based companies.

Compliance with such regulations may limit our exclusive rights and

limit our ability to contract with non-U.S.

In addition, the uncertainties associated with such proceedings could have a material adverse effect on our ability

to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third

parties or enter into development or manufacturing partnerships that would help us bring our product candidates to market.

Changes in U.S.

patent law, or laws in other countries,

could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other pharmaceutical companies, our success

is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the pharmaceutical industry involve

a high degree of technological and legal complexity.

Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming

and inherently uncertain.

Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries

may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent

applications and the enforcement or defense of issued patents.

We cannot predict the breadth of claims that may be allowed or enforced

in our patents or in third-party patents.

In addition, Congress or other foreign legislative bodies may pass patent reform legislation

that is unfavorable to us.

For example, the U.S.

Supreme Court has ruled on several patent

cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent

owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination

of events has created uncertainty with respect to the value of patents, once obtained.

Depending on decisions by the U.S.

Congress, the

federal courts, the USPTO, or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change

in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patent and the patents we might obtain

or license in the future.

We may be subject to claims challenging the inventorship

or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees or

other third parties have an ownership interest in our patents or other intellectual property.

Litigation may be necessary to defend against

these and other claims challenging inventorship or ownership.

If we fail in defending any such claims, in addition to paying monetary

damages, we may lose valuable intellectual property rights.

Such an outcome could have a material adverse effect on our business.

if we are successful in defending against such claims, litigation could result in substantial costs and distraction to management and

other employees.

Patent terms may be inadequate to protect our

competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan.

In the United States, if

all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional

Various extensions may be available, but the life of a patent, and the protection it affords, is limited.

Even if patents

covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products.

Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such

candidates might expire before or shortly after such candidates are commercialized.

As a result, our patent portfolio may not provide

us with sufficient rights to exclude others from commercializing products similar or identical to ours.

If we do not obtain patent term extension for our product

candidates, our business may be materially harmed.

Depending upon the timing, duration and specifics of FDA marketing

approval of our product candidates, one or more of our U.S.

patents or those of our licensor may be eligible for limited patent term restoration

under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).

The Hatch- Waxman Amendments permit

a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review

A maximum of one patent may be extended per FDA approved product as compensation for the patent term lost during the FDA regulatory

review process.

A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product

approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended.

Patent term extension may also be available in certain foreign countries upon regulatory approval of our product candidates.

we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration

of relevant patents or otherwise failing to satisfy applicable requirements.

Moreover, the applicable time period or the scope of patent

protection afforded could be less than we request.

If we are unable to obtain patent term extension or restoration or the term of any

such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and

our revenue could be reduced, possibly materially.

Further, if this occurs, our competitors may take advantage of our investment in development

and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

We may not be able to protect our intellectual property

rights throughout the world.

Filing, prosecuting and defending patents in all countries

throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States

can be less extensive than those in the United States.

In addition, the laws of some foreign countries do not protect intellectual property

rights to the same extent as federal and state laws in the United States.

Consequently, we may not be able to prevent third parties from

practicing our inventions in all countries outside the United States or from selling or importing products made using our inventions in

and into the United States or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patent

protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection,

but enforcement is not as strong as that in the United States.

These products may compete with our product candidates, and our patents,

the patents of our licensors, 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 many foreign countries do not favor the enforcement

of patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or

our licensor’s patents or marketing of competing products in violation of our proprietary rights.

Proceedings to enforce our patent

rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business,

could put our patents or the patents of our licensors at risk of being invalidated or interpreted narrowly and our patent applications

or the patent applications of our licensor at risk of not issuing and could provoke third parties to assert claims against us.

not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

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 develop or license.

Many countries have compulsory licensing laws under which

a patent owner may be compelled to grant licenses to third parties.

In addition, many countries limit the enforceability of patents against

government agencies or government contractors.

In these countries, the patent owner may have limited remedies, which could materially

diminish the value of such patent.

If we are forced to grant a license to third parties with respect to any patents relevant to our business,

our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely

Obtaining and maintaining our patent protection depends

on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent

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

Periodic maintenance fees, renewal fees, annuity fees and

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

points over the lifetime of our patents and/or applications and those of our licensors.

We have systems in place to remind us to pay these

fees, and we rely on our outside patent annuity service to pay these fees when due.

Additionally, the USPTO and various foreign patent

offices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application

We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured

by payment of a late fee or by other means in accordance with rules applicable to the particular jurisdiction.

However, there are situations

in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of

patent rights in the relevant jurisdiction.

If such an event were to occur, it could have a material adverse effect on our business.

If our trademarks and trade names are not adequately

protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

We intend to use registered or unregistered trademarks for

JOTROL™ and Nugevia, to brand and market ourselves and our products.

Our trademarks applications for JOTROL™ and Nugevia,

may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

We may not be able to protect

our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets

At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity

and possibly leading to market confusion.

In addition, there could be potential trade name or trademark infringement claims brought by

owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade

Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be

able to compete effectively, and our business may be adversely affected.

Our efforts to enforce or protect our proprietary rights related

to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial

costs and diversion of resources and could adversely affect our financial condition or results of operations.

If we are unable to protect the confidentiality of our

trade secrets, our business and competitive position would be harmed.

We rely on trade secrets, unpatented know-how, and proprietary

information to maintain our competitive edge, taking steps like entering confidentiality agreements with third parties and invention agreements

with employees, consultants, and advisors, but there is no guarantee these agreements are fully executed or will prevent breaches.

claims against illegal disclosure or misappropriation of trade secrets is costly, time-consuming, and uncertain, especially as some courts,

both in the U.S.

and abroad, may be reluctant to protect trade secrets, and third parties could independently obtain or develop similar

information, using it to compete against us without restriction.

Failure to secure patent protection before disclosure or to maintain

confidentiality could diminish the value of our proprietary information, jeopardize patentability, and harm our competitive position.

Our Nugevia product line may have limited intellectual property

protection, which could make it easier for competitors to replicate our products and harm our competitive position.

Our Nugevia product

line operates outside the scope of our pharmaceutical license with Aquanova AG and may have different or lesser intellectual property

protections than JOTROL™.

The nutraceutical and dietary supplement industry is highly competitive, with relatively low barriers

Unlike our pharmaceutical product candidate JOTROL™, which benefits from patent protection, the Nugevia product line

may rely primarily on trade secrets, trade dress, and trademarks for intellectual property protection.

These forms of intellectual property

are generally more difficult to enforce than patents and may not provide the same level of exclusivity or protection against competitors.

Competitors may be able to develop and market substantially similar products without infringing our intellectual property rights.

a result, we may be unable to prevent competitors from eroding our market share in the nutraceutical space, which could have a material

adverse effect on our business, financial condition, and results of operations related to the Nugevia product line.

We may be subject to claims that we or our employees

have wrongfully used or disclosed alleged confidential information or trade secrets.

We enter into non-disclosure and confidentiality agreements

with third parties, such as scientific collaborators, CROs, manufacturers, consultants, and potential partners, to protect proprietary

information, but we may face litigation if a third party claims we or our employees breached these agreements by misusing or disclosing

their trade secrets.

Defending such claims, regardless of merit, could incur significant legal costs, divert employee resources, cause

negative publicity, and potentially halt commercialization of our product candidates.

Even if successful, litigation could be costly,

distract management, and risk compromising our confidential information during discovery, while larger adversaries with greater resources

may sustain complex intellectual property litigation more effectively.

Such disputes could lead to substantial damages, delay development

efforts, and hinder our ability to raise funds, materially impacting our business, financial condition, and prospects.

We may be subject to claims that we have wrongfully

hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or

trade secrets of their former employers.

As is common in the pharmaceutical industry, in addition to

our employees, we engage the services of consultants to assist us in the development of our product candidates.

Many of these consultants,

and many of our employees, were previously employed at, or may have previously provided or may be currently providing consulting services

to, other pharmaceutical companies including our competitors or potential competitors.

We may become subject to claims that we, our employees

or a consultant inadvertently or otherwise used or disclosed trade secrets or other information proprietary to their former employers

or their former or current clients.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims,

in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely affect our

Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction

to our management team and other employees.

Our rights to develop and commercialize our technology

and product candidates may be subject, in part, to the terms and conditions of licenses granted to us by others.

We have entered into a license agreement with Aquanova pursuant

to which we have acquired the exclusive right to certain patents and patent applications in micellar technologies that revolutionizes

the bioavailability profile of resveratrol to treat certain rare diseases and Alzheimer’s disease by eliminating the severe gastro-intestinal

side effects experienced at effective dose levels of resveratrol.

We may enter into additional license agreements in the future with others

to advance our research or allow commercialization of product candidates.

These and other licenses may not provide exclusive rights to

use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or

commercialize our technology and products in the future.

In addition, subject to the terms of any such license agreements,

we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent

applications covering the technology that we license from third parties.

In such an event, we cannot be certain that these patents and

patent applications will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests

of our business.

If our licensor fails to prosecute, maintain, enforce, and defend such patents, or lose rights to those patents or patent

applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products

that are subject of such licensed rights could be adversely affected.

Our licensor may have relied on third-party consultants or

collaborators or on funds from third parties such that our licensor are not the sole and exclusive owners of the patents we in-licensed.

If other third parties have ownership rights to our in-licensed patents, they may be able to license such patents to our competitors,

and our competitors could market competing products and technology.

This could have a material adverse effect on our competitive position,

business, financial conditions, results of operations, and prospects.

It is possible that we may be unable to obtain additional

licenses at a reasonable cost or on reasonable terms, if at all.

Even if we are able to obtain a license, it may be non-exclusive, thereby

giving our competitors access to the same technologies licensed to us.

In that event, we may be required to expend significant time and

resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology,

all of which may not be feasible on a technical or commercial basis.

If we are unable to do so, we may be unable to develop or commercialize

the affected product candidates, which could harm our business, financial condition, results of operations, and prospects significantly.

We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing

methods, product candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales,

or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties,

which could be significant.

If we fail to comply with our obligations in the agreements

under which we license intellectual property rights from Aquanova or otherwise experience disruptions to our business relationships with

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

Disputes with our licensor.

Aquanova, or potential licensors,

particularly regarding our complex licensing agreement with Aquanova, may arise over issues such as the scope of rights granted, potential

infringement of the licensor’s intellectual property not covered by the agreement, our ability to sublicense or assign rights, our

diligence obligations, or the inventorship, ownership, and priority of inventions created jointly with licensors or partners.

These disagreements

could lead to interpretations that narrow our rights to intellectual property or increase our financial and operational obligations, significantly

impacting our business, financial condition, and prospects.

If licensors conclude we have breached these agreements, they may terminate

them, stripping us of the ability to develop and commercialize affected products.

Termination or failure of underlying patents to provide

intended exclusivity could allow competitors to market identical products, severely harming our competitive position, business, and operational

The patent protection and patent prosecution for some

of our product candidates may be dependent on third parties.

While we normally seek to obtain the right to control prosecution,

maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities

for patents relating to our product candidates are controlled by our licensor, potential licensors or collaboration partners.

our licensor, potential licensors or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications

in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering our product

candidates, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop

and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using

and selling competing products.

In addition, even where we have the right to control patent prosecution of patents and patent applications

we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees,

our licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

Intellectual property discovered through government

funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference

for U.S.-based companies.

Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S.

manufacturers.

have patent applications, in addition to the in-licensed patent from Aquanova AG, that were generated through the use of U.S.

funding or grants, and may acquire or license in the future intellectual property rights that have been generated through the use of

We have patent applications, in addition to the in-licensed

patent from Aquanova, that were generated through the use of U.S.

government funding or grants, and may acquire or license in the future

intellectual property rights that have been generated through the use of U.S.

government funding or grants.

Pursuant to the Bayh-Dole Act of 1980, the U.S.

government has certain rights in inventions developed

with government funding.

government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use

inventions for any governmental purpose.

Pursuant to the Bayh-Dole

Act of 1980, the U.S.

government has certain rights in inventions developed with government funding.

government rights include

a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

In addition, the U.S.

government has the right, under certain limited circumstances, to require

us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third-party if it determines that:

(1) adequate steps have not been taken to commercialize the invention;

(2) government action is necessary to meet public health or safety

or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in

government exercised its march-in rights in our future intellectual property rights that are generated through

the use of U.S.

government funding or grants, we could be forced to license or sublicense intellectual property developed by us or that

we license on terms unfavorable to us, and there can be no assurance that we would receive compensation from the U.S.

government for

the exercise of such rights.

government also has the right to take title to these inventions if the grant recipient fails to

disclose the invention to the government or fails to file an application to register the intellectual property within specified time

Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance

with which may require us to expend substantial resources.

government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive

licenses to any of these inventions to a third-party if it determines that:

(1) adequate steps have not been taken to commercialize the

(2) government action is necessary to meet public health or safety needs;

or (3) government action is necessary to meet requirements

for public use under federal regulations (also referred to as “march-in rights”).

government exercised its march-in

rights in our future intellectual property rights that are generated through the use of U.S.

government funding or grants, we could be

forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be

no assurance that we would receive compensation from the U.S.

government for the exercise of such rights.

government also has

the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file

an application to register the intellectual property within specified time limits.

Intellectual property generated under a government

funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources.

In addition, the U.S.

government requires that any products embodying any

of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States.

This preference

industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property

can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would

be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially

government requires that any products embodying any of these inventions or produced through the use of any of these

inventions be manufactured substantially in the United States.

This preference for U.S.

industry may limit our ability to contract with non-U.S.

product manufacturers for products covered

by such intellectual property.

Related to Our Dependence on Third Parties

rely, and expect to continue to rely, on third parties to conduct our clinical trials and those third parties may not perform satisfactorily,

including failing to meet deadlines for the completion of such trials, research and studies, which may harm our business.

do not have the ability to independently conduct our clinical trials.

We currently rely on third parties, such as CROs, clinical data

management organizations, medical institutions and clinical investigators, to conduct our current and planned clinical trials of JOTROL

and we expect to continue to rely upon third parties to conduct additional clinical trials for JOTROL and other product candidates.

parties have a significant role in the conduct of our clinical trials and the subsequent collection and analysis of data.

parties are not our employees, and except for remedies available to us under our agreements with such third parties, we have limited

ability to control the amount or timing of resources that any such third-party will devote to our clinical trials.

The third parties

we rely on for these services may also have relationships with other entities, some of which may be our competitors.

Some of these third

parties may terminate their engagements with us at any time.

If we need to enter into alternative arrangements with a third-party, it

would delay our drug development activities.

reliance on these third parties for such drug development activities will reduce our control over these activities but will not relieve

us of our regulatory responsibilities.

For example, we will remain responsible for ensuring that each of our clinical trials is conducted

in accordance with the general investigational plan and protocols for the trial.

Moreover, the FDA requires us to comply with GCP standards,

regulations for conducting, recording and reporting the results of clinical trials to assure that data and reported results are reliable

and accurate and that the rights, integrity and confidentiality of trial participants are protected.

The EMA also requires us to comply

with similar standards.

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

investigators and trial sites.

If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated

in our clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform

additional clinical trials before approving our marketing applications.

We cannot assure you that upon inspection by a given regulatory

authority, such regulatory authority will determine that any of our clinical trials substantially comply with GCP regulations.

our clinical trials must be conducted with product produced under current cGMP regulations.

Our failure to comply with these regulations

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

these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in

accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing

approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product

also expect to rely on third parties to store and distribute drug supplies for our clinical trials.

Any performance failure on the part

of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products,

producing additional losses and depriving us of potential product revenue.

contract with third parties for the production of our product candidates for preclinical studies and, in the case of JOTROL, our ongoing

clinical trial, and expect to continue to do so for additional clinical trials and ultimately for commercialization.

This reliance on

third parties increases the risk that we will not have sufficient quality and quantities of our product candidates or such quantities

at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

do not currently have the infrastructure or internal capability to manufacture supplies of our product candidates for use in development

and commercialization.

We rely, and expect to continue to rely, on third-party manufacturers for the production of our product candidates

for preclinical studies and clinical trials under the guidance of members of our organization.

We are presently relying on a single third-party

manufacturer and are presently evaluating a second source alternative manufacturer.

Changing our third-party manufacturer could result

in delays in our manufacturing supply chain which could delay or otherwise impact our development of JOTROL and result in increased costs

related to JOTROL.

We do not have long-term supply agreements, and we purchase our required drug product on a purchase order basis, which

means that aside from any binding purchase orders we have from time to time, our supplier could cease supplying to us or change the terms

on which it is willing to continue supplying to us at any time.

If we were to experience an unexpected loss of supply of JOTROL or any

other product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience

delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

expect to continue to rely on third-party manufacturers for the commercial supply of any of our product candidates for which we obtain

marketing approval.

We may be unable to maintain or establish required agreements with third-party manufacturers or to do so on acceptable

Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional

risks, including:

failure of the third-party to manufacture our product candidates according to our schedule and specifications, or at all, including

if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do

not satisfactorily perform according to the terms of the agreements between us and them;

termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for

breach by the third-party contractors of our agreements with them;

failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs;

failure of the third-party to manufacture our product candidates according to our specifications;

mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being

properly identified;

supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed

to commercial vendors in a timely manner, resulting in lost sales;

misappropriation of our proprietary information, including our trade secrets and know-how.

do not have complete control over all aspects of the manufacturing process of our CDMOs and are dependent on these CDMOs for compliance

with cGMP regulations for manufacturing both active pharmaceutical ingredients (API) and finished drug products.

We are in the process

of developing our supply chain for each of our product candidates and intend to put in place framework agreements under which CDMOs will

generally provide us with necessary quantities of API and drug product on a project-by-project basis based on our development needs.

As we advance our product candidates through development, we will consider our lack of redundant supply for the API and drug product

for each of our product candidates to protect against any potential supply disruptions.

However, we may be unsuccessful in putting in

place such framework agreements or protecting against potential supply disruptions.

manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States.

CDMOs cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA,

EMA or others, they will not be able to secure and/or maintain marketing approval for their manufacturing facilities.

In addition, we

do not have control over the ability of our CDMOs to maintain adequate quality control, quality assurance and qualified personnel.

the FDA, EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates

or if it withdraws any such approval in the future, we will need to find alternative manufacturing facilities, and those new facilities

would need to be inspected and approved by FDA, EMA or comparable regulatory authority prior to commencing manufacturing, which would

significantly impact our ability to develop, obtain marketing approval for or market our product candidates, if approved.

or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us,

including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls

of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect

supplies of our product candidates or drugs and harm our business and results of operations.

current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit

margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover

them or that our trade secrets will be misappropriated or disclosed.

we currently rely on third parties in the course of our business, we may share our proprietary technology and confidential information,

including trade secrets, with them.

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

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

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

agreements typically limit the rights of the third parties to use or disclose our confidential information.

Despite the contractual provisions

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

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

are disclosed or used in violation of these agreements.

Given that our proprietary position is based, in part, on our know-how and trade

secrets and despite our efforts to protect our trade secrets, a competitor’s discovery of our proprietary technology and confidential

information or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our

business, financial condition, results of operations and prospects.

we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause

us to incur debt or assume contingent liabilities, and subject us to other risks.

time to time, we may evaluate various acquisition opportunities and strategic partnerships, including licensing or acquiring complementary

products, intellectual property rights, technologies or businesses.

Any potential acquisition or strategic partnership may entail numerous

risks, including:

operating expenses and cash requirements;

assumption of additional indebtedness or contingent liabilities;

issuance of our equity securities;

of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new

diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition;

of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing

products or product candidates and marketing approvals;

inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition

or even to offset the associated acquisition and maintenance costs.

addition, if we undertake acquisitions or pursue partnerships in the future, we may issue dilutive securities, assume or incur debt obligations,

industry may be waived by the federal agency that

provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been

made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States

or that under the circumstances domestic manufacture is not commercially feasible.

This preference for U.S.

industry may limit our ability

to contract with non-U.S.

product manufacturers for products covered by such intellectual property.

Risks Related to Our Dependence on Third Parties

We rely, and expect to continue to rely, on third parties

to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion

of such trials, research and studies, which may harm our business.

We rely on third parties, such as CROs, clinical data management

organizations, medical institutions, and clinical investigators, to conduct our clinical trials for JOTROL™ and other product candidates,

as we lack the ability to independently manage these trials.

These third parties, who are not our employees, play a significant role in

trial execution and data analysis, but we have limited control over their resource allocation, and they may prioritize other entities,

including competitors, or terminate engagements, potentially delaying our drug development.

Despite reduced control, we remain responsible

for ensuring trials comply with GCP standards enforced by the FDA and EMA, and failure to meet these or cGMP requirements for trial products

could render data unreliable, necessitating additional trials and delaying marketing approvals.

Performance failures by these third parties

or distributors, who handle drug storage and distribution for our Company, could further hinder clinical development, approval, or commercialization,

leading to losses and reduced revenue potential.

We contract with Aquanova and Catalent for the production

of JOTROL™ for our ongoing clinical trial and other product candidates, and expect to continue to do so for additional clinical

trials and ultimately for commercialization.

This reliance on Aquanova and Catalent increases the risk that we will not have sufficient

quality and quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development

or commercialization efforts.

We lack the internal infrastructure to manufacture our product

candidates for development and commercialization, relying entirely on Aquanova and Catalent to manufacture our preclinical and clinical

trial supplies of JOTROL™.

Currently, we depend on these companies as our only third-party manufacturer while evaluating possible

other suppliers, but switching manufacturers could delay our supply chain, impacting JOTROL™’s development and increasing

Without long-term supply agreements, we purchase drug products on a purchase order basis, leaving us vulnerable to suppliers ceasing

or altering terms at any time.

An unexpected loss of supply due to manufacturing, storage, or other issues could disrupt, delay, or terminate

ongoing clinical trials, requiring us to restart or repeat studies.

Our reliance on third-party manufacturers for commercial supply,

if our product candidates gain marketing approval, introduces risks such as failure to meet our schedule or specifications, prioritization

of other products by contractors, termination of agreements at inconvenient times, or breaches of contract.

Additional risks include non-compliance

with current Good Manufacturing Practices (cGMPs), mislabeling of clinical supplies, delayed delivery to trial sites or commercial vendors,

and misappropriation of our proprietary information, including trade secrets.

These issues could lead to clinical trial interruptions,

lost sales, or compromised intellectual property, significantly affecting our operations.

We are developing our supply chain by establishing framework

agreements with CDMOs to secure necessary quantities of active pharmaceutical ingredients and drug products.

However, we may fail to establish

these agreements or ensure redundant supply to mitigate disruptions.

Our CDMOs’ compliance with cGMP regulations and other regulatory

requirements is critical, as their failure to meet FDA, EMA, or similar standards could prevent or revoke manufacturing approvals, forcing

us to seek alternative facilities.

Such transitions would require new regulatory inspections, delaying development, approval, or market

entry of our product candidates.

Non-compliance by us or our manufacturers with regulations

could result in sanctions like fines, injunctions, civil penalties, approval withdrawals, license revocations, product seizures, or criminal

prosecutions, all of which could severely impact our product supply and business.

Our dependence on third-party manufacturers may reduce

future profit margins and hinder our ability to commercialize approved product candidates in a timely and competitive manner.

We rely on Catalent Pharmaceutical Services, Inc.

sole manufacturer for JOTROL™ clinical trial supplies, and any disruption to this relationship could significantly delay our clinical

development programs.

We currently rely on Catalent Pharmaceutical Services, Inc.

as our sole contract manufacturer for JOTROL™

clinical trial supplies.

We do not have a backup manufacturer for JOTROL™, and establishing relationships with alternative manufacturers

would require significant time and resources, including the need to transfer manufacturing technology and obtain regulatory approval

for any new manufacturing facility.

If Catalent is unable or unwilling to continue manufacturing JOTROL™ for any reason, including

due to capacity constraints, regulatory compliance issues, natural disasters, business disruptions, financial difficulties, or a change

in Catalent’s business priorities, we may be unable to obtain sufficient quantities of JOTROL™ to conduct our clinical trials

on schedule or at all.

Any delay or inability to obtain clinical trial supplies could significantly delay our clinical development programs,

increase our costs, and have a material adverse effect on our business, financial condition, and prospects.

We rely on third parties, including a network of collaborators

and brand ambassadors, an advertising agency, and social media content creators to help promote and accelerate sales of our recently launched

Nugevia product line, and our business could be adversely affected if these third parties fail to comply with applicable FDA (and other)

regulatory requirements or are ineffective in their ability to help promote the Nugevia products to customers.

We depend in part on collaborators, social media content creators,

two celebrity brand ambassadors, and other third parties to help drive traffic to our website and the sale of our products.

our ability to maintain and increase commercial interest in our Nugevia products is not entirely within our control, and it is possible

that these third parties may fail to successfully or meaningfully help drive sales of our products.

Further, a failure by these third

parties to comply with FDA, FTC, or other applicable regulatory requirements, such as requirements regarding the promotion, marketing

and sale of our products, could result in regulatory enforcement action by FDA (or other governmental authorities) or other adverse events,

which could interrupt the marketing and sales of our products, severely damage our brand reputation and public image, increase the cost

of our products, result in product recalls, market withdrawals or litigation and impede our ability to deliver our products, any of which

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

We may rely on third-party manufacturers and distributors

for our Nugevia product line, and any failure by these third parties to perform could adversely affect our business.

To the extent we rely on third-party manufacturers or distributors

for the production and distribution of our Nugevia products, our business could be adversely affected if these third parties fail to meet

their contractual obligations, experience manufacturing delays or disruptions, fail to comply with applicable regulatory requirements,

or otherwise fail to perform satisfactorily.

Any such failures could result in product shortages, delays in product delivery, quality

control issues, or regulatory enforcement actions, any of which could harm our reputation, reduce sales of our Nugevia products, and have

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

Our reliance on third parties may require us to

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

or disclosed.

Because we currently rely on third parties in the course

of our business, we may share our proprietary technology and confidential information, including trade secrets, with them.

protect our proprietary technology, in part, by entering into confidentiality agreements, and, if applicable, material transfer agreements,

collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants

prior to beginning research or disclosing proprietary information.

These agreements typically limit the rights of the third parties to

use or disclose our confidential information.

Despite the contractual provisions employed when working with third parties, the need to

share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are

intentionally or inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements.

that our proprietary position is based, in part, on our know-how and trade secrets and despite our efforts to protect our trade secrets,

a competitor’s discovery of our proprietary technology and confidential information or other unauthorized use or disclosure would

impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and

If we engage in future acquisitions or strategic

partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities,

and subject us to other risks.

We may periodically explore acquisition opportunities and

strategic partnerships, such as licensing or acquiring complementary products, intellectual property, technologies, or businesses.

endeavors carry significant risks, including increased operating expenses and cash needs, assumption of additional debt or liabilities,

and the issuance of equity securities.

Integrating acquired operations, intellectual property, or personnel may pose challenges, diverting

management’s focus from existing programs.

Retaining key employees, maintaining critical business relationships, and uncertainties

about the other party’s prospects, products, or regulatory approvals present further risks.

Additionally, we may fail to generate

sufficient revenue from acquired technologies or products to achieve our objectives or offset acquisition and maintenance costs.

if we undertake acquisitions or pursue partnerships in the future, we may issue dilutive securities, assume or incur debt obligations,

incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.

we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have

to alter our development and commercialization plans.

drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fund

We may seek to selectively form collaborations to expand our capabilities, potentially accelerate research and development

activities and provide for commercialization activities by third parties.

In addition, we intend to explore strategic partnering and

collaboration opportunities to out-license rights to our research programs and drug candidates for indications in which we are unlikely

to pursue development and commercialization.

In parallel, we will also evaluate select external opportunities to strategically expand

our portfolio.

Any of these relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures,

issue securities that dilute our existing stockholders, or disrupt our management and business.

would face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex.

we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s

resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a

number of factors.

Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, EMA or

comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing

and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to our

ownership of intellectual property and industry and market conditions generally.

The potential collaborator may also consider alternative

product candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration could

be more attractive than the one with us for our product candidate.

Further, we may not be successful in our efforts to establish a collaboration

or other alternative arrangements for product candidates because they may be deemed to be at too early of a stage of development for

collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted

in a reduced number of potential future collaborators.

Even if we are successful in entering into a collaboration, the terms and conditions

of that collaboration may restrict us from entering into future agreements on certain terms with potential collaborators.

and when we seek to enter into collaborations, we may not be able to negotiate collaborations on a timely basis, on acceptable terms,

If we are unable to do so, we may have to curtail the development of a product candidate, reduce or delay its development

program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing

activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we elect to

increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which

may not be available to us on acceptable terms or at all.

If we do not have sufficient funds, we may not be able to further develop our

product candidates or bring them to market and generate product revenue.

may enter into collaborations with third parties for the development and commercialization of product candidates.

If those collaborations

are not successful, we may not be able to capitalize on the market potential of these product candidates.

we enter into any collaboration arrangements with any third parties, we will likely have limited control over the amount and timing of

resources that our collaborators dedicate to the development or commercialization of our product candidates.

Our ability to generate

revenues from these arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functions

assigned to them in these arrangements.

Collaborations involving our product candidates would pose numerous risks to us, including the

collaborators

have significant discretion in determining the efforts and resources that they will apply to, and the manner in which they perform

their obligations under, these collaborations and may not perform their obligations as expected;

collaborators

may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development

or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as

a result of a business combination or sale or disposition of a business unit or development function, or available funding or external

factors such as an acquisition that diverts resources or creates competing priorities;

collaborators

may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product

candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

collaborators

could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates

if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under

terms that are more economically attractive than ours;

collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and

distribution of our product relative to other products;

may grant exclusive rights to our collaborators that would prevent us from collaborating with others;

collaborators

may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and

intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize

or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property

related proceedings;

may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization

of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources;

collaborations

may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization

of the applicable product candidates;

collaboration

agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;

collaborators

may not provide us with timely and accurate information regarding development progress and activities under the collaboration or

may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and

otherwise plan our own development of our product candidates;

collaborators

may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we

would not have the exclusive right to develop or commercialize such intellectual property;

collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in

civil or criminal proceedings.

also collaborate with a network of experts who advise and support our development efforts.

In the future, such experts may not collaborate

with us which could affect our ability to develop our product candidates and proprietary delivery platform as such experts potentially

provide us with access to ideas to address the needs of muscle diseases.

Related to Ownership of Our Common Stock

The Company’s

failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of its securities.

stock is currently listed for trading on Nasdaq.

On March 21, 2025, the Company received Notice from Nasdaq stating that the Company it

is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2) for continued listing of

its common stock on the NASDAQ.

Listing Rule 5550(a)(2) requires the registrant to maintain a minimum bid price of $1.00 USD per share

for its securities listed on the NASDAQ, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement

exists if the deficiency continues for a period of 30 consecutive business days.

Based on the closing bid price of the Company’s shares

for the 30 consecutive business days prior to the Notice (February 6, 2025 through March 20, 2025), the Company no longer meets the minimum

bid price requirement.

Pursuant to Nasdaq Listing Rules,

the Company has been provided 180 calendar days, or until September 17, 2025, to regain compliance with NASDAQ Listing Rule 5550(a)(2).

In addition, the Company may have an opportunity for an additional extension of time to meet the minimum bid price requirement, if certain

conditions are met.

If the Company is not able to demonstrate compliance with the minimum bid price required by September 17, 2025, it

may be delisted from Nasdaq.

If Nasdaq takes steps to de-list the Company’s common stock, it would likely have a negative effect

on the price of the Company’s common stock and may impair a stockholder’s ability to sell or purchase shares of our common

In addition, delisting could impair our ability to raise additional capital.

price of our common stock could be subject to rapid and substantial volatility.

have been instances of extreme stock price run-ups followed by rapid price declines and strong stock price volatility with recent initial

public offerings, especially among those with relatively smaller public floats.

As a relatively small-capitalization company with relatively

small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and less liquidity

than large-capitalization companies.

In particular, the common stock may be subject to rapid and substantial price volatility, low volumes

of trades and large spreads in bid and ask prices.

Such volatility, including any stock-run up, may be unrelated to our actual or expected

operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing

value of our common stock.

addition, if the trading volumes of our common stock are low, persons buying or selling in relatively small quantities may easily influence

prices of our common stock.

This low volume of trades could also cause the price of our common stock to fluctuate greatly, with large

percentage changes in price occurring in any trading day session.

Holders of our common stock may also not be able to readily liquidate

their investment or may be forced to sell at depressed prices due to low volume trading.

Broad market fluctuations and general economic

and political conditions may also adversely affect the market price of our common stock.

As a result of this volatility, investors may

experience losses on their investment in our common stock.

A decline in the market price of our common stock also could adversely affect

our ability to sell additional shares or common stock or other securities and our ability to obtain additional financing in the future.

No assurance can be given that an active market in our common stock will develop or be sustained.

If an active market does not develop,

holders of our common stock may be unable to readily sell the common stock they hold or may not be able to sell their common stock at

market price of our common stock may be volatile, and you could lose all or part of your investment.

cannot predict the prices at which our common stock will trade.

The market price of our common stock may fluctuate substantially.

market price of our common stock will depend on a number of factors, including those described in this “Risk Factors” section,

many of which are beyond our control and may not be related to our operating performance.

In addition, the limited public float of our

common stock will tend to increase the volatility of the trading price of our common stock.

The stock market in general, and pharmaceutical

and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate

to the operating performance of these companies.

These fluctuations could cause you to lose all or part of your investment in our common

Factors that could cause fluctuations in the market price of our common stock include, but are not limited to, the following:

timing and results of preclinical studies and clinical trials of our product candidates, those conducted by third parties or those

of our competitors;

success of competitive products or announcements by potential competitors of their product development efforts;

actions with respect to our products or our competitors’ products;

or anticipated changes in our growth rate relative to our competitors;

or legal developments in the United States and other countries;

or disputes concerning patent applications, issued patents or other proprietary rights;

recruitment or departure of key personnel;

announcements

by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;

or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

in the valuation of companies perceived by investors to be comparable to us;

conditions in the pharmaceutical and biotechnology sector;

in the structure of healthcare payment systems;

price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

or expectation of additional financing efforts;

of our common stock by us, our insiders or our other stockholders;

of market stand-off or lock-up agreements;

impact of any natural disasters or public health emergencies;

economic, political, industry and market conditions.

realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors”

section, could have a dramatic and adverse impact on the market price of our common stock.

securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding

us, our business or our market, our stock price and trading volume could decline.

trading market for our common stock will be influenced by the research and reports that securities or industry analysts publish about

us, our business or our market.

We do not currently have and may never obtain research coverage by securities or industry analysts.

no or few securities or industry analysts commence coverage of us, the stock price would be negatively impacted.

In the event we obtain

securities or industry analyst coverage, if any of the analysts who cover us issue adverse or misleading research or reports regarding

us, our business model, our intellectual property, our stock performance or our market, or if our operating results fail to meet the

expectations of analysts, our stock price would likely decline.

If one or more of these analysts cease coverage of us or fail to publish

reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume

operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating

results to fall below expectations or our guidance.

quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future

operating results.

From time to time, we may enter into license or collaboration agreements or strategic partnerships with other companies

that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source

of our revenue.

These upfront and milestone payments may vary significantly from period to period and any such variance could cause a

significant fluctuation in our operating results from one period to the next.

addition, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value

of the award as determined by our board of directors, and recognize the cost as an expense over the employee’s requisite service

As the variables that we use as a basis for valuing these awards change over time, including, after the closing of our initial

public offering, our underlying stock price and stock price volatility, the magnitude of the expense that we must recognize may vary

significantly.

our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult

to predict, including the following:

timing and cost of, and level of investment in, research and development activities relating to our current product candidates and

any future product candidates and research-stage programs, which will change from time to time;

ability to enroll patients in clinical trials and the timing of enrollment;

cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other

comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of our agreements with

manufacturers;

that we will or may incur to acquire or develop additional product candidates and technologies or other assets;

timing and outcomes of clinical trials for JOTROL and any of our other possible future product candidates, or competing product candidates;

need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated;

from existing and potential future products that compete with JOTROL and any of our other future product candidates or programs,

and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;

delays in regulatory review or approval of JOTROL or any of our other product candidates;

level of demand for JOTROL and any of our other product candidates, if approved, which may fluctuate significantly and be difficult

risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential

future products that compete with JOTROL and any of our other product candidates;

ability to commercialize JOTROL and any of our other product candidates, if approved, inside and outside of the United States, either

independently or working with third parties;

ability to establish and maintain collaborations, licensing or other arrangements;

ability to adequately support future growth;

unforeseen business disruptions that increase our costs or expenses;

accounting pronouncements or changes in our accounting policies;

changing and volatile global economic and political environment.

cumulative effect of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.

As a result, comparing our operating results on a period-to-period basis may not be meaningful.

Investors should not rely on our past

results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the

expectations of industry or financial analysts or investors for any period.

If our revenue or operating results fall below the expectations

of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below

the expectations of analysts or investors, the price of our common stock could decline substantially.

Such a stock price decline could

occur even when we have met any previously publicly stated guidance we may provide.

principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters

subject to stockholder approval.

of December 31, 2024, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially

owned approximately 77% our common stock.

These stockholders, acting together, may be able to control matters requiring stockholder

For example, they may be able to control elections of directors, amendments of our organizational documents or approval of

any merger, sale of assets or other major corporate transactions.

This concentration of ownership control may delay, discourage or prevent

a change of control, including unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest

as one of our stockholders, entrench our management and board of directors or delay or prevent a merger, consolidation, takeover or other

business combination involving us that other stockholders may desire.

The interests of this group of stockholders may not always coincide

with your interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily

those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for

our common stock.

common stock may be subject to the “penny stock” rules in the future.

It may be more difficult to resell securities classified

as “penny stock.”

common stock may be subject to “penny stock” rules (generally defined as non-exchange traded stock with a per-share price

below $5.00) in the future.

While our common stock is not currently considered “penny stock” since it is listed on the Nasdaq

Capital Market, if we are unable to maintain that listing and our common stock is no longer listed on the Nasdaq Capital Market, unless

we maintain a per-share price above $5.00, our common stock will become “penny stock.” These rules impose additional sales

practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons other than those who qualify as

“established customers” or “accredited investors.” For example, broker-dealers must determine the appropriateness

for non-qualifying persons of investments in penny stocks.

Broker-dealers must also provide, prior to a transaction in a penny stock

not otherwise exempt from the rules, a standardized risk disclosure document that provides information about penny stocks and the risks

in the penny stock market.

The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock,

disclose the compensation of the broker-dealer and its salesperson in the transaction, furnish monthly account statements showing the

market value of each penny stock held in the customer’s account, provide a special written determination that the penny stock is

a suitable investment for the purchaser, and receive the purchaser’s written agreement to the transaction.

remedies available to an investor in “penny stocks” may include the following:

If a “penny stock” is sold to the investor in violation of the requirements listed above, or other federal or states securities

laws, the investor may be able to cancel the purchase and receive a refund of the investment.

If a “penny stock” is sold to the investor in a fraudulent manner, the investor may be able to sue the persons and firms

that committed the fraud for damages.

requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes

subject to the penny stock rules.

The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers

from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities.

These requirements

may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.

brokerage firms will discourage or refrain from recommending investments in penny stocks.

Most institutional investors will not invest

in penny stocks.

In addition, many individual investors will not invest in penny stocks due, among other reasons, to the increased financial

risk generally associated with these investments.

If we decide to establish collaborations, but are not

able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our drug development programs and potential commercialization

of product candidates require significant additional funding, which may lead us to pursue collaborations to enhance capabilities, accelerate

research, or out-license rights for certain indications.

These relationships could involve non-recurring charges, increased expenditures,

issuance of dilutive securities, or management disruptions.

We face intense competition in securing collaborators, and the complex, time-consuming

negotiation process depends on factors like the collaborator’s resources, expertise, and evaluation of clinical trial results, regulatory

approval likelihood, market potential, manufacturing complexities, competing drugs, intellectual property uncertainties, and general market

Alternative candidates or technologies may be deemed more attractive, and our early-stage candidates may not be viewed as

viable for collaboration, potentially limiting our ability to form partnerships.

If we cannot secure collaborations on acceptable terms or

at all, we may need to curtail development, delay programs, reduce marketing efforts, or fund activities independently, requiring additional

capital that may not be available.

Recent consolidations among large pharmaceutical companies have reduced potential collaborators, and

even successful collaborations may impose restrictions on future agreements.

Failure to secure sufficient funds or partnerships could

hinder our ability to develop or commercialize product candidates, impacting our ability to generate revenue.

We may enter into collaborations with third parties

for the development and commercialization of product candidates.

If those collaborations are not successful, we may not be able to capitalize

on the market potential of these product candidates.

Collaborations with third parties for the development or commercialization

of our product candidates involve limited control over the resources and efforts our collaborators dedicate, posing risks such as inadequate

performance, deprioritization, or termination of programs due to clinical trial outcomes, strategic shifts, acquisitions, or competing

Collaborators may delay trials, underfund programs, abandon candidates, or develop competing products, potentially undermining

our candidates’ success.

Exclusive rights granted to collaborators could restrict our ability to partner with others, and their

failure to properly manage our intellectual property may invite litigation or jeopardize proprietary information.

Disputes, termination

of agreements, or non-compliance with laws by collaborators could delay development, necessitate additional capital, or lead to costly

legal proceedings, while their control over shared intellectual property may limit our exclusivity.

Additionally, reliance on a network

of expert advisors for our development efforts carries the risk that these experts may cease collaboration, hindering our ability to address

muscle disease needs and develop our proprietary delivery platform.

Even if we are able to commercialize our product candidates,

the products may not receive coverage and adequate reimbursement from third-party payers, which could harm our business.

Our ability to commercialize any products successfully will

depend, in part, on the extent to which coverage and adequate reimbursement for these products and related treatments will be available

from government authorities, private health insurers, health maintenance organizations and third-party payers.

Patients who are prescribed

medications for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated

with their prescription drugs.

Coverage and adequate reimbursement from government health care programs, such as Medicare and Medicaid,

and private insurers are essential to new product acceptance of any approved product.

In the event we obtain marketing approval, patients

are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of

the cost of our product candidates.

A key trend in the United States healthcare industry and elsewhere is cost containment.

authorities and other third-party payers have attempted to control costs by limiting coverage and the amount of reimbursement for particular

We cannot be sure that coverage and adequate reimbursement will be available for any product that we commercialize and, if

reimbursement is available, what the level of reimbursement will be.

Coverage and reimbursement may impact the demand for, or the price

of, any product candidate for which we obtain marketing approval.

If coverage and reimbursement are not available or are available only

at limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

may also be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than

the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities.

Moreover, obtaining coverage does

not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,

sales and distribution.

Interim reimbursement levels for new drugs, if applicable, may also be insufficient to cover our costs, and may

only be temporary.

Risks Related to Ownership of Our Securities

The Company’s failure to meet the continued listing

requirements of The Nasdaq Capital Market could result in a delisting of its securities.

Our common stock is currently listed for trading on The Nasdaq

Stock Market LLC (“Nasdaq”).

On March 21, 2025, the Company received a written notice from the Listing Qualifications Department

of Nasdaq indicating that the Company was not in compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule

5550(a)(2) (the “Minimum Bid Price Requirement”), as the closing bid price of the Company’s common stock was below $1.00

per share for 30 consecutive business days..

Listing Rule 5550(a)(2) requires the registrant to maintain a minimum bid price of $1.00

USD per share for its securities listed on the NASDAQ, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid

price requirement exists if the deficiency continues for a period of 30 consecutive business days.

Based on the closing bid price of the

Company’s shares for the 30 consecutive business days prior to that notice (February 6, 2025 through March 20, 2025), the Company

did not meet the Minimum Bid Price Requirement.

Subsequently, on February 26, 2026, the Company received additional

written notices (the “Notices”) from Nasdaq indicating that the Company is not in compliance with (i) the Minimum Bid Price

Requirement and (ii) the minimum market value of listed securities requirement set forth under Nasdaq Listing Rule 5550(b)(2) (the “MVLS

Requirement”).

Based on the closing bid price of the Company’s common stock for the 30 consecutive business days prior to

the Notices (January 13, 2026 through February 25, 2026), the Company did not meet the Minimum Bid Price Requirement.

In addition, based

on Nasdaq’s review of the Company’s market value of listed securities for the 30 consecutive business days ended February

26, 2026, the Company did not meet the MVLS Requirement.

Pursuant to Nasdaq Listing Rules 5810(c)(3)(A) and 5810(c)(3)(C),

the Company has 180 calendar days, or until August 25, 2026, to regain compliance with both the Minimum Bid Price Requirement and the

MVLS Requirement.

To regain compliance with the Minimum Bid Price Requirement, the Company’s common stock must have a closing bid

price of at least $1.00 per share for a minimum of 10 consecutive business days (or such longer period, up to 20 consecutive business

days, as Nasdaq may require).

To regain compliance with the MVLS Requirement, the Company’s market value of listed securities must

be at least $35 million for a minimum of 10 consecutive business days.

If the Company does not regain compliance with the Minimum

Bid Price Requirement by August 25, 2026, the Company may be eligible for an additional 180-day compliance period, provided that it meets

all other initial listing standards for The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and provides written

notice of its intention to cure the deficiency, including, if necessary, by effecting a reverse stock split.

If the Company does not regain

compliance with the MVLS Requirement within the applicable compliance period, Nasdaq will provide notice that the Company’s common

stock is subject to delisting.

In such event, the Company may appeal the delisting determination to a hearings panel.

The receipt of the Notices has no immediate effect on the

listing of the Company’s common stock, and the common stock will continue to trade on Nasdaq under the symbol “JUNS”

during the applicable compliance periods.

The Company intends to actively monitor its compliance with Nasdaq continued listing requirements

and may consider available options to regain compliance, including, without limitation, effecting a reverse stock split.

However, there

can be no assurance that the Company will be successful in regaining or maintaining compliance with the Nasdaq continued listing requirements.

If Nasdaq delists the Company’s common stock,

the Company’s liquidity and market price could be affected.

Our common stock is currently listed on Nasdaq.

regain compliance, our common stock may begin trading on an over-the-counter market, such as the OTCQB or the OTC Pink.

Trading on such

markets is characterized by lower trading volumes, fewer market makers and greater price volatility compared to trading on a national

securities exchange.

As a result, a delisting could reduce the liquidity of our common stock, result in decreased institutional investor

interest and may impair a stockholder’s ability to sell or purchase shares of our common stock.

In addition, delisting could impair

our ability to raise additional capital.

The price of our common stock could be subject to rapid

and substantial volatility.

There have been instances of extreme stock price run-ups followed

by rapid price declines and strong stock price volatility with recent initial public offerings, especially among those with relatively

smaller public floats.

As a relatively small-capitalization company with relatively small public float, we may experience greater stock

price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies.

In particular, the

common stock may be subject to rapid and substantial price volatility, low volumes of trades and large spreads in bid and ask prices.

Such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance and financial condition

or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.

In addition, if the trading volumes of our common stock are

low, persons buying or selling in relatively small quantities may easily influence prices of our common stock.

This low volume of trades

could also cause the price of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day

Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed

prices due to low volume trading.

Broad market fluctuations and general economic and political conditions may also adversely affect the

market price of our common stock.

As a result of this volatility, investors may experience losses on their investment in our common stock.

A decline in the market price of our common stock also could adversely affect our ability to sell additional shares or common stock or

other securities and our ability to obtain additional financing in the future.

No assurance can be given that an active market in our

common stock will develop or be sustained.

If an active market does not develop, holders of our common stock may be unable to readily

sell the common stock they hold or may not be able to sell their common stock at all.

A “short squeeze” due to a sudden increase

in demand for shares of our common stock could lead to extreme price volatility in shares of our common stock .

Investors may purchase shares of our common stock to hedge

existing exposure or to speculate on the price of our common stock.

Speculation of the price of our common stock may lead to long and

short exposures.

To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase on the

open market, investors with short exposure may have to pay a premium to repurchase shares of our common stock for delivery to lenders

of our common stock.

Those repurchases may in turn, dramatically increase the price of our common stock until additional shares of our

common stock are available for trading or borrowing.

This is often referred to as a “short squeeze.” A proportion of our

common stock has been, and may continue to be, traded by short sellers which may increase the likelihood that our common stock will be

the target of a short squeeze.

A short squeeze could lead to volatile price movements in shares of our common stock that are unrelated

or disproportionate to our operating performance and, once investors purchase the shares of our common stock necessary to cover their

short positions, the price of our common stock may rapidly decline.

Investors that purchase shares of our common stock during a short

squeeze may lose a significant portion of their investment.

The market price of our common stock may be volatile,

and you could lose all or part of your investment.

The market price of our common stock may fluctuate significantly

due to factors often beyond our control and unrelated to our operating performance, including the timing and results of preclinical studies

and clinical trials for our product candidates or those of competitors, the success or announcements of competitive products, regulatory

actions, changes in our growth rate compared to competitors, developments or disputes over patents or proprietary rights, key personnel

changes, significant acquisitions or collaborations, changes in financial estimates or analyst recommendations, market conditions in the

pharmaceutical and biotechnology sectors, changes in healthcare payment systems, additional financing efforts, sales of our stock by insiders

or other stockholders, and general economic, political, industry, and market conditions.

The limited public float of our stock may increase

price volatility, and the stock market, particularly for pharmaceutical and biotechnology companies, has historically experienced extreme

price and volume fluctuations, which could lead to substantial losses for investors.

Any of these risks could materially and adversely

affect our stock price.

If securities or industry analysts do not publish research

or reports, or if they publish adverse or misleading research or reports, regarding us, our business or our market, our stock price and

trading volume could decline.

The trading market for our common stock will be influenced

by the research and reports that securities or industry analysts publish about us, our business or our market.

We do not currently have

and may never obtain research coverage by securities or industry analysts.

If no or few securities or industry analysts commence coverage

of us, the stock price would be negatively impacted.

In the event we obtain securities or industry analyst coverage, if any of the analysts

who cover us issue adverse or misleading research or reports regarding us, our business model, our intellectual property, our stock performance

or our market, or if our operating results fail to meet the expectations of analysts, our stock price would likely decline.

more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets,

which in turn could cause our stock price or trading volume to decline.

Our operating results may fluctuate significantly, which

makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.

Our operating results may fluctuate significantly due to factors

such as variable upfront and milestone payments from license or collaboration agreements, changes in stock-based compensation expenses

driven by stock price volatility, and costs related to research and development, clinical trial enrollment, and manufacturing.

factors include expenditures for acquiring new technologies, outcomes and timing of clinical trials for JOTROL™ or other product

candidates, competition, regulatory delays, demand variability, reimbursement policies, and our ability to commercialize products or maintain

partnerships.

Global economic and political volatility, unforeseen disruptions, and accounting changes may further contribute to fluctuations.

These factors make our future operating results unpredictable, rendering period-to-period comparisons unreliable and potentially causing

our results or guidance to fall below analyst or investor expectations, which could lead to a substantial decline in our stock price,

even if we meet previously stated guidance

Our principal stockholders and management own a significant

percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

As of December 31, 2025, our executive officers, directors,

holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 59% of our common stock.

stockholders, acting together, may be able to control matters requiring stockholder approval.

For example, they may be able to control

elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate

transactions.

This concentration of ownership control may delay, discourage or prevent a change of control, including unsolicited acquisition

proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders, entrench our management

and board of directors or delay or prevent a merger, consolidation, takeover or other business combination involving us that other stockholders

The interests of this group of stockholders may not always coincide with your interests or the interests of other stockholders

and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium

value for their common stock, and might affect the prevailing market price for our common stock.

Our common stock may be subject to the “penny

stock” rules in the future.

It may be more difficult to resell securities classified as “penny stock.”

Our common stock may be subject to “penny stock”

rules (generally defined as non-exchange traded stock with a per-share price below $5.00) in the future.

While our common stock is not

currently considered “penny stock” since it is listed on the Nasdaq, if we are unable to maintain that listing and our common

stock is no longer listed on the Nasdaq, unless we maintain a per-share price above $5.00, our common stock will become “penny stock.”

These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons

other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers

must determine the appropriateness for non-qualifying persons of investments in penny stocks.

Broker-dealers must also provide, prior

to a transaction in a penny stock not otherwise exempt from the rules, a standardized risk disclosure document that provides information

about penny stocks and the risks in the penny stock market.

The broker-dealer also must provide the customer with current bid and offer

quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the transaction, furnish monthly

account statements showing the market value of each penny stock held in the customer’s account, provide a special written determination

that the penny stock is a suitable investment for the purchaser, and receive the purchaser’s written agreement to the transaction.

Legal remedies available to an investor in “penny stocks”

include the ability to seek cancellation of the purchase and a refund of the investment if the stock was sold in violation of federal

or state securities laws, such as the requirements outlined above.

Additionally, if the “penny stock” was sold through fraudulent

means, the investor may have the right to pursue legal action against the individuals or firms responsible for the fraud, seeking damages

for any losses incurred.

These requirements may have the effect of reducing the level of trading activity, if any, in the secondary market

for a security that becomes subject to the penny stock rules.

The additional burdens imposed upon broker-dealers by such requirements

may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity

of our securities.

These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability

to resell our common stock.

Many brokerage firms will discourage or refrain from recommending

investments in penny stocks.

Most institutional investors will not invest in penny stocks.

In addition, many individual investors will

not invest in penny stocks due, among other reasons, to the increased financial risk generally associated with these investments.

these reasons, penny stocks may have a limited market and, consequently, limited liquidity.

1 unchanged sentence

ever, our common stock will not be classified as a “penny stock” in the future.

the benefits of any proposed acquisition do not meet the expectations of investors, stockholders or financial analysts, the market price

of our Common Stock may decline.

the benefits of any proposed acquisition do not meet the expectations of investors or securities analysts, the market price of our common

stock prior to the closing of the proposed acquisition may decline.

The market values of our common stock at the time of the proposed

acquisition may vary significantly from their prices on the date the acquisition target was identified.

addition, broad market and industry factors may materially harm the market price of our common stock irrespective of our operating performance.

The stock market in general has experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating

performance of the particular companies affected.

The trading prices and valuations of these stocks, and of our securities, may not be

A loss of investor confidence in the market for retail stocks or the stocks of other companies which investors perceive

to be similar to us could depress our stock price regardless of our business, prospects, financial conditions or results of operations.

A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability

to obtain additional financing in the future.

in accounting principles and guidance, or their interpretation, could result in unfavorable accounting charges or effects, including

changes to our previously filed financial statements, which could cause our stock price to decline.

prepare our financial statements in accordance with GAAP.

These principles are subject to interpretation by the SEC and various bodies

formed to interpret and create appropriate accounting principles and guidance.

A change in these principles or guidance, or in their

interpretations, may have a significant effect on our reported results and retroactively affect previously reported results.

an “emerging growth company” under the JOBS Act, we are permitted to rely on exemptions from certain disclosure requirements.

qualify as an “emerging growth company” under the JOBS Act.

As a result, we are permitted to, and intend to, rely on exemptions

from certain disclosure requirements.

For so long as we are an emerging growth company, we will not be required to:

an auditor report on our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation

or a supplement to the auditors’ report providing additional information about the audit and the financial statements (i.e.,

an auditor discussion and analysis);

certain executive compensation matters to stockholder advisory votes, such as “say-on-pay” and “say-on-frequency”;

certain executive compensation related items such as the correlation between executive compensation and performance and comparisons

of the chief executive officer’s compensation to median employee compensation.

addition, Section 102 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period

provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

In other words, an emerging

growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We have elected to take advantage of the benefits of this extended transition period.

Our financial statements may therefore not be comparable

to those of companies that comply with such new or revised accounting standards.

will remain an emerging growth company until the earliest to occur of:

(i) the end of the first fiscal year in which our annual gross

revenue is $1.235 billion or more;

(ii) the end of the fiscal year in which the market value of our shares of common stock that are held

by non-affiliates is at least $700.0 million as of the last business day of our most recently completed second fiscal quarter;

the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt;

end of the fiscal year during which the fifth anniversary of our initial public offering occurs.

such time, however, we cannot predict if investors will find our securities less attractive because we may rely on these exemptions.

If some investors find our securities less attractive as a result, there may be a less active trading market for our securities and the

price of our securities may be more volatile.

we are unable to maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness

of our financial reports and have an adverse effect on the value of our securities.

a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such

internal control.

Further, we are required to report any changes in internal controls on a quarterly basis.

In addition, we are required

to furnish a report by management on the effectiveness of internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley

We will design, implement, and test the internal controls over financial reporting required to comply with these obligations.

we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of

Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered

public accounting firm is unable to express an opinion as to the effectiveness of its internal control over financial reporting when

required, investors may lose confidence in the accuracy and completeness of our financial reports and the value of our securities could

be negatively affected.

We also could become subject to investigations by the Commission or other regulatory authorities, which could

require additional financial and management resources.

an emerging growth company, our auditor will not be required to attest to the effectiveness of our internal controls.

independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial

reporting while we are an emerging growth company.

This means that the effectiveness of our financial operations may differ from our

peer companies in that they may be required to obtain independent registered public accounting firm attestations as to the effectiveness

of their internal controls over financial reporting and we are not.

While our management will be required to attest to internal control

over financial reporting and we will be required to detail changes to our internal controls on a quarterly basis, we cannot provide assurance

that the independent registered public accounting firm’s review process in assessing the effectiveness of our internal controls

over financial reporting, if obtained, would not find one or more material weaknesses or significant deficiencies.

Further, once we cease

to be an emerging growth company and cease to be a smaller reporting company (as described below), we will be subject to independent

registered public accounting firm attestation regarding the effectiveness of our internal controls over financial reporting.

management finds such controls to be effective, our independent registered public accounting firm may decline to attest to the effectiveness

of such internal controls and issue a qualified report.

believe we will be considered a smaller reporting company and will be exempt from certain disclosure requirements, which could make our

Common Stock less attractive to potential investors.

12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed

issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that:

a public float of less than $250 million as of the last business day of its most recently completed second fiscal quarter, computed

by multiplying the aggregate worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the

price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principal market

for the common equity;

the case of an initial registration statement under the Securities Act, or the Exchange Act of 1934, as amended, which we refer to

as the Exchange Act, for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of

the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held

by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares

included in the registration statement by the estimated public offering price of the shares;

the case of an issuer whose public float as calculated under paragraph (1) or (2) of this definition was zero or whose public float

was less than $700 million, had annual revenues of less than $100 million during the most recently completed fiscal year for which

audited financial statements are available.

a smaller reporting company, we will not be required and may not include a Compensation Discussion and Analysis section in our proxy

we will provide only two years of financial statements;

and we need not provide the table of selected financial data.

also will have other “scaled” disclosure requirements that are less comprehensive than issuers that are not smaller reporting

companies which could make our common stock less attractive to potential investors, which could make it more difficult for our stockholders

to sell their shares.

incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial

time to new compliance initiatives.

incur significant legal, accounting and other expenses as a public company.

In addition, the Sarbanes-Oxley Act has imposed various requirements

on public companies including requiring establishment and maintenance of effective disclosure and financial controls.

Our management

and other personnel need to devote a substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations

have increased and will continue to increase our legal and financial compliance costs and will make some activities more time-consuming

For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain directors’

and officers’ liability insurance, which could make it more difficult for us to attract and retain qualified members of our board

of directors.

We cannot predict or estimate the amount of additional costs we will incur as a public company or the timing of such costs.

Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting and disclosure

controls and procedures.

In particular, we must perform system and process evaluation and testing of our internal control over financial

reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section

404 of the Sarbanes-Oxley Act.

In addition, we will be required to have our independent registered public accounting firm attest to the

effectiveness of our internal control over financial reporting the later of our second Annual Report on Form 10-K or the first Annual

Report on Form 10-K following the date on which we are no longer an emerging growth company or a smaller reporting company.

Our compliance

with Section 404 of the Sarbanes-Oxley Act will require that we incur substantial accounting expense and expend significant management

We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate

public company experience and technical accounting knowledge.

If we are not able to comply with the requirements of Section 404 in a

timely manner, or if we or our independent registered public accounting firm identify deficiencies in our internal control over financial

reporting that are deemed to be material weaknesses, the value of our securities could decline and we could be subject to sanctions or

investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

ability to successfully implement our business plan and comply with Section 404 requires us to be able to prepare timely and accurate

financial statements.

We expect that we will need to continue to improve existing, and implement new operational and financial systems,

procedures and controls to manage our business effectively.

Any delay in the implementation of, or disruption in the transition to, new

or enhanced systems, procedures or controls, may cause our operations to suffer and we may be unable to conclude that our internal control

over financial reporting is effective and to obtain an unqualified report on internal controls from our auditors as required under Section

404 of the Sarbanes-Oxley Act.

This, in turn, could have an adverse impact on value of our securities, and could adversely affect our

ability to access the capital markets.

eligible for future sale may adversely affect the market.

time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage

transactions in the open market pursuant to Rule 144 promulgated under the Securities Act, subject to certain limitations.

pursuant to Rule 144, non-affiliate stockholders may sell freely after six months, subject only to the current public information requirement.

Affiliates may sell after six months, subject to the Rule 144 volume, manner of sale (for equity securities), current public information,

and notice requirements.

Of the approximately 33,103,760 shares of our common stock and 1,626,037 restricted stock units outstanding as

of December 31, 2024, 6,350,000 shares are tradable without restrictions.

Given the limited trading of our common stock, resale of even

a small number of shares of our common stock pursuant to Rule 144 or an effective registration statement may adversely affect the market

price of our common stock.

Anti-takeover

provisions contained in our certificate of incorporation, as amended, and amended and restated bylaws, as well as provisions of Delaware

law, could impair a takeover attempt.

Company’s certificate of incorporation, as amended, and amended and restated bylaws contain provisions that could have the effect

of delaying or preventing changes in control or changes in our management without the consent of our board of directors.

These provisions

cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors

or the resignation, death, or removal of a director, which prevents stockholders from being able to fill vacancies on our board of

ability of our board of directors to determine whether to issue shares of our preferred stock and to determine the price and other

terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly

dilute the ownership of a hostile acquirer;

the liability of, and providing indemnification to, our directors and officers;

that a special meeting of the stockholders may only be called by a majority of the board of directors;

that directors may be removed prior to the expiration of their terms by the affirmative vote of the holders of not less than two-thirds

(2/3) of the voting power of the issued and outstanding stock entitled to vote;

notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters

to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation

of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of the Company.

provisions, alone or together, could delay hostile takeovers and changes in control of the Company or changes in our board of directors

and management.

provision of our certificate of incorporation, as amended, or amended and restated bylaws or Delaware law that has the effect of delaying

or deterring a change in control could limit the opportunity for our security holders to receive a premium for their securities and could

also affect the price that some investors are willing to pay for our securities.

may be subject to securities litigation, which is expensive and could divert management attention.

market price of our common stock may be volatile and, in the past, companies that have experienced volatility in the market price of

their stock have been subject to securities class action litigation.

This risk is especially relevant for us because biotechnology companies

have experienced significant stock price volatility in recent years and we may be the target of this type of litigation in the future.

Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns,

which could seriously harm our business.

have never paid dividends on our common stock and have no plans to do so in the future.

of shares of our common stock are entitled to receive such dividends as may be declared by our board of directors.

To date, we have paid

no cash dividends on our shares of common stock and we do not expect to pay cash dividends on our common stock in the foreseeable future.

We intend to retain future earnings, if any, to provide funds for operations of our business.

Therefore, any return investors in our

common stock may have will be in the form of appreciation, if any, in the market value of their shares of common stock.

See “Dividend

will indemnify and hold harmless our officers and directors to the maximum extent permitted by Delaware law.

certificate of incorporation provide that we will indemnify and hold harmless our officers and directors against claims arising from

our activities, to the maximum extent permitted by Delaware law.

If we were called upon to perform under our indemnification obligations,

then the portion of our assets expended for such purpose would reduce the amount otherwise available for our business.

If the benefits of any proposed acquisition do not meet

the expectations of investors, stockholders or financial analysts, the market price of our Common Stock may decline.

If the benefits of any proposed acquisition do not meet the

expectations of investors or securities analysts, the market price of our common stock prior to the closing of the proposed acquisition

The market values of our common stock at the time of the proposed acquisition may vary significantly from their prices on

the date the acquisition target was identified.

In addition, broad market and industry factors may materially

harm the market price of our common stock irrespective of our operating performance.

The stock market in general has experienced price

and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the particular companies affected.

The trading prices and valuations of these stocks, and of our securities, may not be predictable.

A loss of investor confidence in the

market for retail stocks or the stocks of other companies which investors perceive to be similar to us could depress our stock price regardless

of our business, prospects, financial conditions or results of operations.

A decline in the market price of our securities also could

adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future.

Changes in accounting principles and guidance, or their

interpretation, could result in unfavorable accounting charges or effects, including changes to our previously filed financial statements,

which could cause our stock price to decline.

We prepare our financial statements in accordance with GAAP.

These principles are subject to interpretation by the SEC and various bodies formed to interpret and create appropriate accounting principles

and guidance.

A change in these principles or guidance, or in their interpretations, may have a significant effect on our reported results

and retroactively affect previously reported results.

As an “emerging growth company” under the

JOBS Act, we are permitted to rely on exemptions from certain disclosure requirements.

As an “emerging growth company” under the JOBS

Act, we are permitted to rely on exemptions from certain disclosure requirements, which we intend to utilize.

For as long as we maintain

this status, we are not required to obtain an auditor’s report on our internal control over financial reporting pursuant to Section

404(b) of the Sarbanes-Oxley Act.

Additionally, we are exempt from complying with any Public Company Accounting Oversight Board requirements

regarding mandatory audit firm rotation or providing a supplement to the auditors’ report with additional information about the

audit and financial statements, such as an auditor discussion and analysis.

Furthermore, we are not obligated to submit certain executive

compensation matters to stockholder advisory votes, including “say-on-pay” and “say-on-frequency” votes, nor are

we required to disclose specific executive compensation details, such as the correlation between executive compensation and company performance

or comparisons of the chief executive officer’s compensation to the median employee compensation.

As an emerging growth company under the JOBS Act, we have

elected to use the extended transition period for adopting new or revised accounting standards, delaying compliance until required for

private companies.

This may make our financial statements less comparable to those of companies adhering to these standards.

We will remain

an emerging growth company until the earliest of:

(i) annual gross revenue reaching $1.235 billion;

(ii) the market value of our non-affiliate-held

common stock reaching $700.0 million as of the last business day of our most recently completed second fiscal quarter;

(iii) issuing over

$1.0 billion in non-convertible debt in the prior three years;

or (iv) the fifth anniversary of our initial public offering.

these exemptions may reduce the attractiveness of our securities, potentially leading to a less active trading market and increased price

If we are unable to maintain effective internal control

over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and have an adverse

effect on the value of our securities.

As a public company, we are required to maintain internal

control over financial reporting and to report any material weaknesses in such internal control.

Further, we are required to report any

changes in internal controls on a quarterly basis.

In addition, we are required to furnish a report by management on the effectiveness

of internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act.

We will design, implement, and test the

internal controls over financial reporting required to comply with these obligations.

If we identify material weaknesses in our internal

control over financial reporting, if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our

internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an

opinion as to the effectiveness of its internal control over financial reporting when required, investors may lose confidence in the accuracy

and completeness of our financial reports and the value of our securities could be negatively affected.

We also could become subject to

investigations by the Commission or other regulatory authorities, which could require additional financial and management resources

As an emerging growth company, our auditor will not

be required to attest to the effectiveness of our internal controls.

Our independent registered public accounting firm will not

be required to attest to the effectiveness of our internal control over financial reporting while we are an emerging growth company.

means that the effectiveness of our financial operations may differ from our peer companies in that they may be required to obtain independent

registered public accounting firm attestations as to the effectiveness of their internal controls over financial reporting and we are

While our management will be required to attest to internal control over financial reporting and we will be required to detail changes

to our internal controls on a quarterly basis, we cannot provide assurance that the independent registered public accounting firm’s

review process in assessing the effectiveness of our internal controls over financial reporting, if obtained, would not find one or more

material weaknesses or significant deficiencies.

Further, once we cease to be an emerging growth company and cease to be a smaller reporting

company (as described below), we will be subject to independent registered public accounting firm attestation regarding the effectiveness

of our internal controls over financial reporting.

Even if management finds such controls to be effective, our independent registered

public accounting firm may decline to attest to the effectiveness of such internal controls and issue a qualified report.

We believe we will be considered a smaller reporting

company and will be exempt from certain disclosure requirements, which could make our Common Stock less attractive to potential investors.

We qualify as a “smaller reporting company” under

Rule 12b-2 of the Exchange Act, defined as an issuer (not an investment company, asset-backed issuer, or majority-owned subsidiary of

a non-smaller reporting company parent) with either:

a public float of less than $250 million as of the last business day of its most

recently completed second fiscal quarter, or, for initial registration statements, a public float of less than $250 million within 30

days of filing, or annual revenues of less than $100 million with a public float of zero or less than $700 million for the most recent

fiscal year with audited financial statements.

As a smaller reporting company, we benefit from scaled disclosure requirements, including

no Compensation Discussion and Analysis in proxy statements, providing only two years of financial statements, and omitting the selected

financial data table.

These reduced disclosures may make our common stock less attractive to investors, potentially impacting our stockholders’

ability to sell shares.

We incur significant increased costs as a result of

operating as a public company, and our management is required to devote substantial time to new compliance initiatives.

As a public company, we incur significant legal, accounting,

and compliance costs, particularly under the Sarbanes-Oxley Act, which requires effective disclosure and financial controls.

These obligations

demand substantial management time and increase our legal and financial expenses, including challenges in obtaining directors’ and

officers’ liability insurance, potentially hindering our ability to attract qualified board members.

Compliance with Section 404

of the Sarbanes-Oxley Act requires evaluating and testing our internal controls over financial reporting, and, after our emerging growth

company or smaller reporting company status ends, obtaining an auditor’s attestation.

This necessitates additional accounting staff

and resources.

Failure to comply with Section 404, or identification of material weaknesses in our controls, could lead to SEC sanctions,

investigations, or a decline in our securities’ value.

Delays or disruptions in implementing enhanced systems and controls may impair

our ability to prepare accurate financial statements, potentially affecting our internal control effectiveness, auditor reports, and access

to capital markets.

Shares eligible for future sale may adversely affect

From time to time, certain of our stockholders may be eligible

to sell all or some of their shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144

promulgated under the Securities Act, subject to certain limitations.

In general, pursuant to Rule 144, non-affiliate stockholders may

sell freely after six months, subject only to the current public information requirement.

Affiliates may sell after six months, subject

to the Rule 144 volume, manner of sale (for equity securities), current public information, and notice requirements.

Of the approximately

34,446,455 shares of our common stock and 1,626,037 restricted stock units outstanding as of December 31, 2025, 6,350,000 shares are tradable

without restrictions.

Given the limited trading of our common stock, resale of even a small number of shares of our common stock pursuant

to Rule 144 or an effective registration statement may adversely affect the market price of our common stock.

Anti-takeover provisions contained in our certificate

of incorporation, as amended, and amended and restated bylaws, as well as provisions of Delaware law, could impair a takeover attempt.

Our Certificate of Incorporation and amended bylaws include

provisions that could delay or prevent changes in control or management without board approval, such as prohibiting cumulative voting

in director elections, limiting minority stockholders’ ability to elect candidates, and granting the board exclusive authority to

fill director vacancies, preventing stockholder appointments.

The board can issue preferred stock with terms set without stockholder approval,

potentially diluting hostile acquirers, and directors are protected by limited liability and indemnification provisions.

Only the board’s

majority can call special stockholder meetings, and removing directors requires a two-thirds stockholder vote.

Advance notice requirements

for nominating directors or proposing matters at meetings may deter potential acquirers from pursuing control.

These provisions could

delay hostile takeovers or management changes, potentially limiting opportunities for stockholders to receive a premium for their securities

and affecting the price investors are willing to pay.

We may be subject to securities litigation, which is

expensive and could divert management attention.

The market price of our common stock may be volatile and,

in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action

This risk is especially relevant for us because biotechnology companies have experienced significant stock price volatility

in recent years and we may be the target of this type of litigation in the future.

Securities litigation against us could result in substantial

costs and divert our management’s attention from other business concerns, which could seriously harm our business.

We have never paid dividends on our common stock and

have no plans to do so in the future.

Holders of shares of our common stock are entitled to receive

such dividends as may be declared by our board of directors.

To date, we have paid no cash dividends on our shares of common stock and

we do not expect to pay cash dividends on our common stock in the foreseeable future.

We intend to retain future earnings, if any, to

provide funds for operations of our business.

Therefore, any return investors in our common stock may have will be in the form of appreciation,

if any, in the market value of their shares of common stock.

See “Dividend Policy.”

We will indemnify and hold harmless our officers and

directors to the maximum extent permitted by Delaware law.

Our certificate of incorporation provides that we will indemnify

and hold harmless our officers and directors against claims arising from our activities, to the maximum extent permitted by Delaware law.

If we were called upon to perform under our indemnification obligations, then the portion of our assets expended for such purpose would

reduce the amount otherwise available for our business.

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

What changed 10-K

Item 1A. Risk Factors