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Item 1A. Risk Factors

2025-03-31 compared with 2024-03-28 · 764 added, 831 removed, 878 unchanged (64% of the section changed)

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deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

If any of the

following events occur, our business, financial condition and results of operations could be materially adversely affected.

In such case,

the value and trading price of our common stock could decline, and you may lose all or part of your investment.

If any of the following

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

In such case, the value

and trading price of our common stock could decline, and you may lose all or part of your investment.

Risks Related to our Financial Position and

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date and our future profitability is uncertain.

We were incorporated in August 2016 and have

a limited operating history, and our business is subject to all of the risks inherent in the establishment of a new business enterprise.

We were incorporated in August 2016 and have a

limited operating history, and our business is subject to all of the risks inherent in the establishment of a new business enterprise.

Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered

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trials and develop manufacturing, sales, marketing and distribution capabilities.

Our net loss for the years ended December 31, 2022

and 2023 was $18.1 million and $30.5 million, and our accumulated deficit as of December 31, 2023 was $64.5 million.

There can be no

assurance that the product candidates currently under development or that may be under development by us in the future will be approved

for sale in the U.S.

Our net loss for the years ended December 31, 2023 and

2024 was $30.5 million and $36.7million, and our accumulated deficit as of December 31, 2024 was $1013 million.

There can be no assurance

that the product candidates currently under development or that may be under development by us in the future will be approved for sale

or elsewhere.

Furthermore, there can be no assurance that if such products are approved, they will be successfully

commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve

profitability, we may be unable to continue our operations.

Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized,

and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve profitability,

we may be unable to continue our operations.

If we fail to obtain the capital necessary

to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.

We will need to continue to seek capital from time to time to continue

development of our product candidates.

As of December 31, 2022 and 2023, we had cash of $0.5 million and $9.7 million, respectively.

March 3, 2023, the Company signed a securities purchase agreement with certain healthcare-focused institutional investors that will provide

up to $130 million in gross proceeds to Unicycive through a private placement that included initial upfront funding of $30 million.

expect our existing cash as of December 31, 2023 plus the $50 million funding received in March 2024 will enable us to fund our operating

expenses and capital expenditure requirements for at least 12 months from the date of filing of this Form 10-K.

We believe that we

will need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization

of our current product candidates and future product candidates.

Our business or operations may change in a manner that would consume

available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations, fund expansion,

develop new or enhanced products, acquire complementary products, businesses or technologies or otherwise respond to competitive pressures

and opportunities, such as a change in the regulatory environment.

In addition, we may need to accelerate the growth of our sales capabilities

and distribution beyond what is currently envisioned, and this would require additional capital.

However, we may not be able to secure

funding when we need it or on favorable terms.

We may not be able to raise sufficient funds to commercialize our current and future product

candidates we intend to develop.

If we cannot raise adequate funds to satisfy

our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical studies or

future operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements may require us

to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights to future

product candidates or certain major geographic markets.

We will need to continue to seek capital from

time to time to continue development of our product candidates.

As of December 31, 2023 and 2024, we had cash of $9.7 million and $26.1

million, respectively.

On March 3, 2023, the entered into a securities purchase agreement with certain healthcare-focused institutional

investors that will provide up to $130 million in gross proceeds to us through a private placement that included initial upfront funding

of $30 million.

On March 13, 2024, we entered into a securities

purchase agreement with certain accredited investors pursuant to which sold 50,000 shares of our Series B Convertible Preferred Stock

at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, for an aggregate purchase price of $50.0

In addition, on November 13, 2024, we entered

into a Sales Agreement, with Guggenheim Securities, LLC pursuant to which, we may offer and sell shares of our common stock having an

aggregate offering price of up to $50 million, subject to certain limitations and in accordance with the terms of the Sales Agreement,

from time to time through or to Guggenheim Securities, acting as sales agent or principal.

We believe that we will need to raise substantial

additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates

and future product candidates.

Our business or operations may change in a manner that would consume available funds more rapidly than

anticipated and substantial additional funding may be required to maintain operations, fund expansion, develop new or enhanced products,

acquire complementary products, businesses or technologies or otherwise respond to competitive pressures and opportunities, such as a

change in the regulatory environment.

In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond

what is currently envisioned, and this would require additional capital.

However, we may not be able to secure funding when we need it

or on favorable terms.

We may not be able to raise sufficient funds to commercialize our current and future product candidates we intend

If we cannot raise adequate funds to satisfy our

capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical studies or future

We may also be required to obtain funds through arrangements with collaborators, which arrangements may require us to relinquish

rights to certain technologies or products that we otherwise would not consider relinquishing, including rights to future product candidates

or certain major geographic markets.

This could result in sharing revenues which we might otherwise retain for ourselves.

Any of these actions may harm our business, financial condition and results of operations.

The amount of capital we may need depends on

many factors, including the progress, timing and scope of our product development programs;

actions may harm our business, financial condition and results of operations.

The amount of capital we may need depends on many

factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our pre-clinical

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and our partners’ commitment of time and resources to the development and commercialization of our products.

We may consider strategic alternatives

in order to maximize stockholder value, including financings, strategic alliances, acquisitions or the possible sale of our business.

We may not be able to identify or consummate any suitable strategic alternatives.

We may consider strategic alternatives in

order to maximize stockholder value, including financings, strategic alliances, acquisitions or the possible sale of our business.

may not be able to identify or consummate any suitable strategic alternatives.

We may consider all strategic alternatives that

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various strategic alternatives may not result in any specific action or transaction.

To the extent that this engagement results in a

transaction, our business objectives may change depending upon the nature of the transaction.

There can be no assurance that we will

enter into any transaction as a result of the engagement.

Furthermore, if we determine to engage in a strategic transaction, we cannot

predict the impact that such strategic transaction might have on our operations or stock price.

We also cannot predict the impact on

our stock price if we fail to enter into a transaction.

To the extent that this engagement results in a transaction,

our business objectives may change depending upon the nature of the transaction.

There can be no assurance that we will enter into any

transaction as a result of the engagement.

Furthermore, if we determine to engage in a strategic transaction, we cannot predict the impact

that such strategic transaction might have on our operations or stock price.

We also cannot predict the impact on our stock price if we

fail to enter into a transaction.

Raising additional capital may cause dilution

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or other preferences, anti-dilution rights, conversion and exercise price adjustments and other provisions that adversely affect

the rights of our stockholders, including rights, preferences and privileges that are senior to those of our holders of common stock

in the event of a liquidation.

In addition, debt financing, if available, could include covenants limiting or restricting our ability

to take certain actions, such as incurring additional debt, making capital expenditures, entering into licensing arrangements, or declaring

the rights of our stockholders, including rights, preferences and privileges that are senior to those of our holders of common stock in

the event of a liquidation.

In addition, debt financing, if available, could include covenants limiting or restricting our ability to

take certain actions, such as incurring additional debt, making capital expenditures, entering into licensing arrangements, or declaring

dividends and may require us to grant security interests in our assets.

If we raise additional funds through 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, product or product candidates or grant licenses on terms that may not be favorable to us.

are unable to raise additional funds through equity or debt financings when needed, we may need to curtail or cease our operations.

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

future revenue streams, product 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 need to curtail or cease our operations.

You will experience dilution, subordination

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Such Series A-1 Preferred Stock and the securities issuable upon conversion of the Series A-1 Preferred Stock are potentially dilutive

instruments and the conversion of these securities upon Stockholder Approval resulted in dilution to our existing stockholders:

Stockholder Approval, the Series A-1 Preferred Stock was converted into 19,516,205 shares of common stock as well as 43,649 shares of

Series A-2 Preferred Stock.

In addition, on March 13, 2024, we entered into a securities purchase agreement with certain accredited investors,

pursuant to which we agreed to issue and sell, in a private placement, 50,000 shares of our Series B Convertible Preferred Stock, par

value $0.001 per share, at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, subject to adjustment,

for an aggregate purchase price of $50 million.

As a result, these stockholders, acting together, may have the ability to control the

outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale

of all or substantially all of our assets.

In addition, these stockholders, acting together, may have the ability to control the management

and affairs of our company.

instruments and the conversion of these securities upon Stockholder Approval in 2023 resulted in dilution to our existing stockholders:

On July 11, 2023, the Series A-1 Preferred Stock was converted into 19,516,205 shares of common stock as well as 43,649 shares of Series

A-2 Preferred Stock and Tranche A Warrants exercisable for Series A-3 Preferred Stock convertible into 47,852,430 shares of common stock,

Tranche B Warrants exercisable for Series A-4 Preferred Stock convertible into 43,502,206 shares of common stock and Tranche C warrants

exercisable for Series A-5 Preferred Stock convertible into 69,609,531 shares of commons stock.

In March 2024, the 43,649 shares of Series

A-2 Preferred Stock was exchanged for 21,388.01 shares of Series A-2 Prime Preferred Stock convertible into 43,649,000 shares of common

In addition, on March 13, 2024, we entered into

a securities purchase agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in a private placement,

50,000 shares of our Series B Convertible Preferred Stock, par value $0.001 per share, at a purchase price of $1,000 per share with an

initial conversion price of $1.00 per share, subject to adjustment, for an aggregate purchase price of $50 million.

Such Series B-1 Preferred

Stock and the securities issuable upon conversion of the Series B-1 Preferred Stock are potentially dilutive instruments and the conversion

of these securities upon Stockholder Approval in 2024 resulted in dilution to our existing stockholders:

Following stockholder approval,

the Series B-1 Preferred Stock was converted into 42,118,000 shares of common stock as well as 7,882 shares of Series B-2 Preferred Stock

which are convertible into 7,882,000 shares of our common stock.

As a result of the agreements, these stockholders,

acting together, may have the ability to control the outcome of matters submitted to our stockholders for approval, including the election

of directors and any merger, consolidation or sale of all or substantially all of our assets.

In addition, these stockholders, acting

together, may have the ability to control the management and affairs of our company.

Our cash could be adversely impacted if

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approval from the FDA to market each product candidate.

Our product candidates could face substantial delays or even fail to receive

marketing approval for many reasons, including among others:

The FDA may decide that

additional CMC, nonclinical and clinical studies would be needed for the approval of Oxylanthanum Carbonate;

the FDA may disagree with

the design, implementation, or interpretation of data of our CMC, preclinical, or clinical studies;

the FDA could determine

that we cannot rely on specific regulatory approval pathway, e.g., Section 505(b)(2), for our current or future product candidates;

the FDA may determine that

we have identified the wrong reference listed drug or drugs or that approval of our regulatory application for any of our product

candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

Our product candidates could face substantial delays or even fail to receive marketing

approval for many reasons, including among others:

The FDA may decide that additional CMC, nonclinical and clinical studies would be needed for the approval of Oxylanthanum Carbonate;

the FDA may disagree with the design, implementation, or interpretation of data of our CMC, preclinical, or clinical studies;

the FDA could determine that we cannot rely on specific regulatory approval pathway, e.g., Section 505(b)(2), for our current or future product candidates;

the FDA may determine that we have identified the wrong reference listed drug or drugs or that approval of our regulatory application for any of our product candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

In addition, the process of seeking regulatory

clearance or approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the

effort and expense incurred, clearance or approval is never guaranteed.

If we are not successful in obtaining timely clearance or approval

of our product candidates from the FDA, we may never be able to generate anticipated revenue and may be forced to cease operations.

NDA process is costly, lengthy and uncertain.

Any NDA application filed by us will have to be supported by extensive data, including,

but not limited to, technical, pre-clinical, clinical, manufacturing, and labeling data, to demonstrate to the FDA’s satisfaction

the safety and efficacy of the product for its intended use.

clearance or approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort

and expense incurred, clearance or approval is never guaranteed.

If we are not successful in obtaining timely clearance or approval of

our product candidates from the FDA, we may never be able to generate anticipated revenue and may be forced to cease operations.

process is costly, lengthy and uncertain.

Any NDA application filed by us will have to be supported by extensive data, including, but

not limited to, technical, pre-clinical, clinical, manufacturing, and labeling data, to demonstrate to the FDA’s satisfaction the

safety and efficacy of the product for its intended use.

Obtaining clearances or approvals from the FDA

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for the specific indications that are most necessary or desirable for successful commercialization or profitability.

We may encounter substantial delays in

completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy

to the satisfaction of applicable regulatory authorities.

We may encounter substantial delays in completing

our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction

of applicable regulatory authorities.

It is impossible to predict if or when our current

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Events that may prevent successful or timely completion of clinical development include:

in reaching, or failing to reach, a consensus with regulatory agencies on study design;

in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations

(“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly

among different CROs and trial sites;

in recruiting a sufficient number of suitable patients to participate in our clinical studies;

of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

to perform in accordance with the FDA’s good clinical practices (“GCPs”) or applicable regulatory guidelines in other

in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

in having patients complete participation in a study or return for post-treatment follow-up;

study sites or patients dropping out of a study;

or failure to address any patient safety concerns that arise during the course of a trial;

● unanticipated

costs or increases in costs of clinical trials of our product candidates;

of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits;

in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could also encounter delays if a clinical

trial is suspended or terminated by us, by the Institutional Review Board (“IRB”) or Ethics Commission (“EC”)

of the institutions in which such trials are being conducted, by an independent Safety Review Board (“SRB”) for such trial

or by the FDA or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of

factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection

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

unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations

or administrative actions or lack of adequate funding to continue the clinical trial.

delays in reaching, or failing to reach, a consensus with regulatory agencies on study design;

delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

delays in recruiting a sufficient number of suitable patients to participate in our clinical studies;

imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

failure by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

failure to perform in accordance with the FDA’s good clinical practices (“GCPs”) or applicable regulatory guidelines in other countries;

delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

delays in having patients complete participation in a study or return for post-treatment follow-up;

clinical study sites or patients dropping out of a study;

delay or failure to address any patient safety concerns that arise during the course of a trial;

unanticipated costs or increases in costs of clinical trials of our product candidates;

occurrence of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits;

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could also encounter delays if a clinical trial

is suspended or terminated by us, by the Institutional Review Board (“IRB”) or Ethics Commission (“EC”) of the

institutions in which such trials are being conducted, by an independent Safety Review Board (“SRB”) for such trial or by

the FDA or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors,

including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the

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

safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative

actions or lack of adequate funding to continue the clinical trial.

Any inability to successfully complete pre-clinical

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we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

Clinical study delays could also shorten any

periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products

to market before we do, which could impair our ability to successfully commercialize our product candidates.

In addition, 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.

Any of these occurrences may significantly harm our

business, financial condition and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement or

completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Clinical study delays could also shorten any periods

during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market

before we do, which could impair our ability to successfully commercialize our product candidates.

In addition, 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.

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

and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may

also ultimately lead to the denial of regulatory approval of our product candidates.

The outcome of pre-clinical studies and early

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failed to obtain marketing approval.

If the results of our clinical studies are inconclusive or if there are safety concerns or

adverse events associated with our product candidates, we may:

delayed in obtaining marketing approval for our product candidates, if approved at all;

approval for indications or patient populations that are not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings;

required to change the way the product is administered;

required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk

evaluation and mitigation strategy;

damage to our reputation.

If the results of our clinical studies are inconclusive or if there are safety concerns or adverse

events associated with our product candidates, we may:

be delayed in obtaining marketing approval for our product candidates, if approved at all;

obtain approval for indications or patient populations that are not as broad as intended or desired;

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

be required to change the way the product is administered;

be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;

experience damage to our reputation.

Additionally, our product candidates could potentially

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If we are not able to obtain, or if there

are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing,

our product candidates and our ability to generate revenue will be impaired.

are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, our

product candidates and our ability to generate revenue will be impaired.

Our product candidates and the activities associated

with its development and commercialization, including its design, testing, manufacture, release, safety, efficacy, regulatory filings,

recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, is subject to comprehensive regulation by

the FDA and other regulatory authorities in the United States and by comparable authorities in other countries.

For example, in order

to commence clinical trials of our product candidates in the United States, we must file an IND and obtain FDA agreement to proceed.

The FDA may place our development program on clinical hold and require further pre-clinical testing prior to allowing our clinical trials

recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, is subject to comprehensive regulation by the

FDA and other regulatory authorities in the United States and by comparable authorities in other countries.

For example, in order to commence

clinical trials of our product candidates in the United States, we must file an IND and obtain FDA agreement to proceed.

The FDA may place

our development program on clinical hold and require further pre-clinical testing prior to allowing our clinical trials to proceed.

We must obtain marketing approval in each jurisdiction

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of an application.

The FDA and comparable authorities in other countries 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 pre-clinical or other

studies, changes in the manufacturing process or facilities or clinical trials.

Moreover, approval by the FDA or an equivalent foreign

authority, including the HSA, does not ensure approval by regulatory authorities in any other countries or jurisdictions, but a failure

to obtain marketing approval in one jurisdiction may adversely impact the likelihood of approval in other jurisdictions.

varying interpretations of the data obtained from pre-clinical testing, manufacturing and product testing and clinical trials could delay,

limit or prevent marketing approval of a product candidate.

Additionally, any marketing approval we ultimately obtain may be limited

or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

The FDA and comparable authorities in other countries 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 pre-clinical or other studies,

changes in the manufacturing process or facilities or clinical trials.

Moreover, approval by the FDA or an equivalent foreign authority,

including the HSA, does not ensure approval by regulatory authorities in any other countries or jurisdictions, but a failure to obtain

marketing approval in one jurisdiction may adversely impact the likelihood of approval in other jurisdictions.

In addition, varying interpretations

of the data obtained from pre-clinical testing, manufacturing and product testing and clinical trials could delay, limit or prevent marketing

approval of a product candidate.

Additionally, any marketing approval we ultimately obtain may be limited or subject to restrictions or

post-approval commitments that render the approved product not commercially viable.

Modifications to our products may require

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adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

Additional delays to the completion of

clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted

and/or required by the occurrences in the given trial .

Additional delays to the completion of clinical

studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or

required by the occurrences in the given trial .

Each modification to the protocol during a clinical

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or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial,

and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an

increase in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval

and commercialization of our products or result in the failure of the clinical trial, which could adversely affect our business, operating

results and prospects.

Conducting successful clinical studies

may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase

in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization

of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

Conducting successful clinical studies may

require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

Patient enrollment in clinical trials and completion

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not attractive or involve unacceptable risks or discomforts.

Patients may also not participate in our clinical trials if they choose

to participate in contemporaneous clinical trials of competitive products.

Patients may also not participate in our clinical trials if they choose to

participate in contemporaneous clinical trials of competitive products.

The future results of our current or future

clinical trials may not support our product candidates claims or may result in the discovery of unexpected adverse side effects.

Even if our clinical trials are completed as

planned, we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will

agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical

trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses.

If the FDA concludes that the clinical trials for any product for which we might seek clearance, has failed to demonstrate safety and

effectiveness, we would not receive FDA clearance to market that product in the United States for the indications sought.

Even if our clinical trials are completed as planned,

we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will agree with

our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will

be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.

trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses.

If the FDA concludes

that the clinical trials for any product for which we might seek clearance, has failed to demonstrate safety and effectiveness, we would

not receive FDA clearance to market that product in the United States for the indications sought.

In addition, such an outcome could cause us to

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deficiency in a product is found.

A government-mandated or voluntary recall by us or one of our distributors could occur as a result

of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies

A government-mandated or voluntary recall by us or one of our distributors could occur as a result of

adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies

Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial

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after the recall is initiated.

Companies are required to maintain certain records of recalls, even if they are not reportable to the

Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.

We may initiate voluntary recalls involving our products in the future.

A future recall announcement could harm our reputation with

customers and negatively affect our sales.

In addition, the FDA and/or other regulatory agencies could take enforcement action for failing

to report the recalls when they were conducted.

Even if our product candidates receive

marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in

the medical community necessary for commercial success.

A future recall announcement could harm our reputation with customers

and negatively affect our sales.

In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report

the recalls when they were conducted.

Even if our product candidates receive marketing

approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical

community necessary for commercial success.

If our product candidates receive marketing approval,

they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical

community for us to achieve commercial success.

If our product candidates do not achieve an adequate level of acceptance, we may not

generate sufficient product revenue to become profitable.

The degree of market acceptance of our product candidates, if approved for

commercial sale, will depend on a number of factors, including:

efficacy and potential advantages compared to alternative therapies;

size of the markets in the countries in which approvals are obtained;

limitations, or warnings contained in any labeling approved by the FDA or other regulatory authority;

ability to offer any approved products for sale at competitive prices;

● convenience

and ease of administration compared to alternative treatments;

willingness of the target patient population to try new therapies or dosing regimens;

willingness of physicians to prescribe these therapies;

strength of marketing and distribution support;

success of competing products and the marketing efforts of our competitors;

third-party payor coverage and adequate reimbursement;

prevalence and severity of any side effects.

they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community

for us to achieve commercial success.

If our product candidates do not achieve an adequate level of acceptance, we may not generate sufficient

product revenue to become profitable.

The degree of market acceptance of our product candidates, if approved for commercial sale, will

depend on a number of factors, including:

the efficacy and potential advantages compared to alternative therapies;

the size of the markets in the countries in which approvals are obtained;

terms, limitations, or warnings contained in any labeling approved by the FDA or other regulatory authority;

our ability to offer any approved products for sale at competitive prices;

convenience and ease of administration compared to alternative treatments;

the willingness of the target patient population to try new therapies or dosing regimens;

the willingness of physicians to prescribe these therapies;

the strength of marketing and distribution support;

the success of competing products and the marketing efforts of our competitors;

sufficient third-party payor coverage and adequate reimbursement;

the prevalence and severity of any side effects.

Even if we are able to commercialize our

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to continuing governmental control even after initial marketing approval is granted.

As a result, we might obtain marketing approval

for a drug in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time

periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country.

Adverse pricing limitations

may hinder our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing

Our ability to commercialize our current and

any future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these

products and related treatments will be available from government health programs, private health insurers, integrated delivery networks

and other third-party payors.

As a result, we might obtain marketing approval for

a drug in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time periods,

and negatively impact the revenue we are able to generate from the sale of the drug in that country.

Adverse pricing limitations may hinder

our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize our current and any

future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products

and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other

third-party payors.

Third-party payors decide which medications they will pay for and establish reimbursement levels.

A significant

trend in the U.S.

A significant trend

healthcare industry and elsewhere is cost containment.

Government authorities and third-party payors have attempted

to control costs by limiting coverage and the amount of payment for particular medications.

Increasingly, third-party payors are requiring

that drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products.

and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement

may not be sufficient for commercial success.

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 is not available or is available only to limited levels, we may

not be able to successfully commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining

coverage and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product

is approved by the FDA or similar regulatory authorities outside the United States.

Moreover, eligibility for coverage and reimbursement

does not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,

Government authorities and third-party payors have attempted to control

costs by limiting coverage and the amount of payment for particular medications.

Increasingly, third-party payors are requiring that drug

companies provide predetermined discounts from list prices and are challenging the prices charged for medical products.

Coverage and reimbursement

may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient

for commercial success.

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 is not available or is available only to limited levels, we may not be able to successfully

commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining coverage

and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved

by the FDA or similar regulatory authorities outside the United States.

Moreover, eligibility for coverage and reimbursement does not

imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,

sale and distribution.

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payments for other services.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare

programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may

be sold at lower prices than in the United States.

Commercial third-party payors often rely upon Medicare coverage policies and payment

limitations in setting their own reimbursement policies.

Our inability to promptly obtain coverage and profitable payment rates from

both government-funded programs and private payors for any approved products that we develop could have a material adverse effect on

our operating results, our ability to raise capital needed to commercialize our approved products and our overall financial condition.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs

or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold

at lower prices than in the United States.

Commercial third-party payors often rely upon Medicare coverage policies and payment limitations

in setting their own reimbursement policies.

Our inability to promptly obtain coverage and profitable payment rates from both government-funded

programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our

ability to raise capital needed to commercialize our approved products and our overall financial condition.

Any product candidate for which we obtain

marketing approval could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we

fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

marketing approval could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail

to comply with regulatory requirements or if we experience unanticipated problems with our products.

Any product candidate for which we obtain marketing

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may result in, among other things:

● restrictions

on such products, manufacturers or manufacturing processes or facilities;

● restrictions

on the labeling, marketing, distribution or use of a product;

● requirements

to conduct post-approval clinical trials, other studies or other post-approval commitments;

or untitled letters;

or recall of the products from the market;

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

restitution or disgorgement of profits or revenue;

or withdrawal of marketing approvals;

to permit the import or export of our products;

● injunctions

or the imposition of civil or criminal penalties.

We may expend our limited resources to

pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable

or for which there is a greater likelihood of success.

restrictions on such products, manufacturers or manufacturing processes or facilities;

restrictions on the labeling, marketing, distribution or use of a product;

requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;

warning or untitled letters;

withdrawal or recall of the products from the market;

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

fines, restitution or disgorgement of profits or revenue;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of our products;

product seizure;

injunctions or the imposition of civil or criminal penalties.

We may expend our limited resources to pursue

a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or

for which there is a greater likelihood of success.

We have limited financial resources.

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sole development and commercialization rights to such product candidate or opportunity.

We may be adversely affected by the coronavirus-type

The outbreak of the novel coronavirus (“COVID-19”)

has evolved into a global pandemic.

The extent to which COVID-19 impacts our business and operating results will depend on future developments

that are highly uncertain and cannot be accurately predicted.

Due to COVID-19, our planned project timelines may be delayed due

to reduced availability of human resources or critical supplies needed to carry out such plans.

Moreover, our clinical trials may be affected

Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of clinical trial

materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state

or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to COVID-19.

The ultimate impact of COVID-19, or any other

health epidemic, is highly uncertain and subject to change.

We do not yet know the full extent of potential delays or impacts on our

business, our clinical trials, our research programs, healthcare systems or the global economy as a whole.

However, these effects could

have a material impact on our operations, and we will continue to monitor the situation closely.

Our reliance on

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In addition, if any of these third parties fails to

comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held

responsible for such violations as well.

This risk is particularly serious in emerging markets, where corruption is often prevalent and

where many of the third parties on which we rely do not have internal compliance resources comparable to our own.

Any such failures by

third parties, in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible

for such violations as well.

This risk is particularly serious in emerging markets, where corruption is often prevalent and where many

of the third parties on which we rely do not have internal compliance resources comparable to our own.

Any such failures by third parties,

in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

We intend to rely on third parties to conduct

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including failing to meet deadlines for the completion of such trials, research or testing.

We expect to rely on third parties, such as CROs (contract research

organizations), CMOs (contract manufacturers) of clinical supplies, clinical data management organizations, medical institutions and clinical

investigators, to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing.

These third parties

may terminate their engagements with us at any time.

If these third parties do not successfully carry out their duties, meet expected

deadlines or conduct our studies 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 candidates.

Furthermore, these third parties may also have relationships with other entities,

some of which may be our competitors.

If we are required to enter into alternative arrangements, it could delay our product development

We expect to rely on third parties, such as CROs

(contract research organizations), CMOs (contract manufacturers) of clinical supplies, clinical data management organizations, medical

institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing.

These third parties may terminate their engagements with us at any time.

If these third parties do not successfully carry out their duties,

meet expected deadlines or conduct our studies 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 candidates.

Furthermore, these third parties may also have relationships with other

entities, some of which may be our competitors.

If we are required to enter into alternative arrangements, it could delay our product

development activities.

Our reliance on third parties for research and

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If we fail to reach an agreement

with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it

may have a negative impact on our business, financial condition and results of operations.

We have no experience manufacturing product

candidates on a clinical or commercial scale and will be dependent on third parties for the manufacture of our product candidates.

we experience problems with any of these third parties, they could delay clinical development or marketing approval of our product candidates

or our ability to sell any approved products.

with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it may

have a negative impact on our business, financial condition and results of operations.

We have no experience manufacturing

product candidates on a clinical or commercial scale and will be dependent on third parties for the manufacture of our product

If we experience problems with any of these third parties or their subcontractors or vendors, they could delay clinical

development or marketing approval of our product candidates or our ability to sell any approved products.

We do not have any manufacturing facilities.

We expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply

expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply

of any product candidate for which we obtain marketing approval.

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with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

on the third party for regulatory compliance and quality assurance;

possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet

quality standards or timelines;

possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

reliance on the third party for regulatory compliance and quality assurance;

the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines;

the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to

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cGMPs or similar regulatory requirements outside the United States.

Our failure, or the failure of our third-party manufacturers,

to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates or approved

products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays,

suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal

prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.

Any product that we develop may compete with

other product candidates and products for access to these manufacturing facilities.

There are a limited number of manufacturers that

operate under cGMPs and that might be capable of manufacturing for us.

Our failure, or the failure of our third-party

manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, even if such failures do not relate

specifically to our product candidates or approved products, could result in sanctions being imposed on us or the manufacturers,

including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or

recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our

product candidates and harm our business and results of operations.

Any product that we develop may compete with other

product candidates and products for access to these manufacturing facilities.

There are a limited number of manufacturers that operate

under cGMPs and that might be capable of manufacturing for us.

Any performance failure on the part of our manufacturers,

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and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

Furthermore, we expect to rely on third parties

to release, label, store and distribute drug supplies for our clinical trials.

Any performance failure on the part of these third parties,

including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development

or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue.

Furthermore, we expect to rely on third

parties to release, label, store and distribute drug supplies for our clinical trials.

Any performance failure on the part of these

third parties, including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely

impact clinical development or marketing approval of our product candidates or commercialization of our drug, producing losses and

depriving us of potential revenue.

Our supplier Shilpa Medicare Ltd was reviewd by the FDA in March 2025.

Moreover, our manufacturers and suppliers may

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and future product candidates, and in turn prevent us from generating revenues:

unwillingness on the part

of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership

of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner

to cooperate in the development or manufacture of the product, including providing us with product data or materials;

unwillingness on the part

of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure

of the results of those activities;

initiating of litigation

or alternative dispute resolution options by either party to resolve the dispute;

attempts by either party

to terminate the agreement.

unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;

initiating of litigation or alternative dispute resolution options by either party to resolve the dispute;

attempts by either party to terminate the agreement.

Our products will face significant competition,

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We compete in an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging

competition and (iv) new product introductions.

Our competitors have existing products and technologies that will compete with our products

and technologies and may develop and commercialize additional products and technologies that will compete with our products and technologies.

Because several competing companies and institutions have greater financial resources than us, they may be able to:

(i) provide broader

services and product lines, (ii) make greater investments in research and development and (iii) carry on larger research and development

initiatives than us.

Our competitors also have greater development capabilities than we do and have substantially greater experience

in undertaking pre-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical

They also have greater name recognition and better access to customers than us.

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition

and (iv) new product introductions.

Our competitors have existing products and technologies that will compete with our products and technologies

and may develop and commercialize additional products and technologies that will compete with our products and technologies.

Because several

competing companies and institutions have greater financial resources than us, they may be able to:

(i) provide broader services and product

lines, (ii) make greater investments in research and development and (iii) carry on larger research and development initiatives than us.

Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking pre-clinical

and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.

They also have

greater name recognition and better access to customers than us.

Product liability lawsuits against us could

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an even greater risk if we commercially sell any products that we may develop.

Product liability claims may be brought against us by

subjects enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product.

cannot successfully defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial

Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any

product candidates or products that we may develop;

termination of clinical

trial sites or entire clinical trial programs;

injury to our reputation

and significant negative media attention;

withdrawal of clinical

trial participants;

significant costs to defend

the related litigation;

substantial monetary awards

to trial subjects or patients;

Product liability claims may be brought against us by subjects

enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product.

If we cannot successfully

defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial liabilities.

of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidates or products that we may develop;

termination of clinical trial sites or entire clinical trial programs;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend the related litigation;

substantial monetary awards to trial subjects or patients;

loss of revenue;

diversion of management

and scientific resources from our business operations;

the inability to commercialize

any products that we may develop.

Prior to engaging in future clinical trials,

we intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and

adequate to provide us with insurance coverage for foreseeable risks;

however, we may be unable to obtain such coverage at a reasonable

cost, if at all.

If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable

cost or in an amount adequate to satisfy any liability that may arise, and such insurance may not be adequate to cover all liabilities

that we may incur.

Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if

we obtain regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product

liability insurance for any products that receive regulatory approval.

Large judgments have been awarded in class action lawsuits

based on drugs that had unanticipated side effects.

A successful product liability claim or series of claims brought against us, particularly

if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

diversion of management and scientific resources from our business operations;

the inability to commercialize any products that we may develop.

Prior to engaging in future clinical trials, we

intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate

to provide us with insurance coverage for foreseeable risks;

however, we may be unable to obtain such coverage at a reasonable cost, if

If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable cost or

in an amount adequate to satisfy any liability that may arise, and such insurance may not be adequate to cover all liabilities that we

Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain

regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability

insurance for any products that receive regulatory approval.

Large judgments have been awarded in class action lawsuits based on

drugs that had unanticipated side effects.

A successful product liability claim or series of claims brought against us, particularly if

judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

We may engage in acquisitions that could

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viewed negatively by customers or investors.

We may decide to incur debt in connection with an acquisition or issue our common stock

or other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.

We may decide to incur debt in connection with an acquisition or issue our common stock or

other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.

We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we

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into our existing business in an effective, timely and non-disruptive manner.

Acquisitions may also divert management attention from

day-to-day responsibilities, increase our expenses and reduce our cash available for operations and other uses.

We cannot predict the

number, timing or size of future acquisitions or the effect that any such transactions might have on our operating results.

Acquisitions may also divert management attention from day-to-day

responsibilities, increase our expenses and reduce our cash available for operations and other uses.

We cannot predict the number, timing

or size of future acquisitions or the effect that any such transactions might have on our operating results.

Security threats to our information technology

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to be secure.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other

security threats.

We may face cyber-attacks that attempt to penetrate our network security, sabotage, or otherwise disable our research,

products and services, misappropriate our or our customers’ and partners’ proprietary information, which may include personally

identifiable information, or cause interruptions of our internal systems and services.

Despite security measures, we also cannot guarantee

security of our physical buildings.

Physical building penetration or any cyber-attacks could negatively affect our reputation, damage

our network infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that

are affected, and expose us to financial liability.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security

We may face cyber-attacks that attempt to penetrate our network security, sabotage, or otherwise disable our research, products

and services, misappropriate our or our customers’ and partners’ proprietary information, which may include personally identifiable

information, or cause interruptions of our internal systems and services.

Despite security measures, we also cannot guarantee security

of our physical buildings.

Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network

infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that are affected,

and expose us to financial liability.

Additionally, there are a number of state, federal

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penalties for non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.

As part of the American Recovery and Reinvestment Act of 2009 (“ARRA”) the privacy and security provisions of HIPAA were

ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s health information

under HIPAA and extended enforcement authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule

adopted in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been

inappropriately accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification

to local and national media.

Notification is not required under HIPAA if the health information that is improperly used or disclosed

is deemed secured in accordance with encryption or other standards developed by the U.S.

As part of the American Recovery and Reinvestment Act of 2009 (“ARRA”) the privacy and security provisions of HIPAA were amended.

ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s health information under

HIPAA and extended enforcement authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted

in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been inappropriately

accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national

Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance

with encryption or other standards developed by the U.S.

Department of Health and Human Services.

states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of personal information,

which is a broader class of information than the health information protected by HIPAA.

Many state laws impose significant data security

requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.

Activities outside

implicate local and national data protection standards, impose additional compliance requirements and generate additional

risks of enforcement for non-compliance.

We may be required to expend significant capital and other resources to

ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate

problems caused by such breaches.

Most states have laws requiring notification

of affected individuals and/or state regulators in the event of a breach of personal information, which is a broader class of information

than the health information protected by HIPAA.

Many state laws impose significant data security requirements, such as encryption or mandatory

contractual terms, to ensure ongoing protection of personal information.

Activities outside of the U.S.

implicate local and national data

protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.

be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws,

to protect against security breaches and hackers or to alleviate problems caused by such breaches.

We will need to grow the size of our organization

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in place may not be adequate to support this future growth.

Future growth would impose significant added responsibilities on members

of management, including:

managing our clinical trials

identifying, recruiting,

maintaining, motivating and integrating additional employees;

managing our internal development

efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial,

development, operational, information technology, and finance systems;

Future growth would impose significant added responsibilities on members of

management, including:

managing our clinical trials effectively;

identifying, recruiting, maintaining, motivating and integrating additional employees;

managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial, development, operational, information technology, and finance systems;

expanding our facilities.

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manage additional relationships with various strategic partners, suppliers and other third parties.

Our future financial performance

and our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any

future growth effectively, as well as our ability to develop a sales and marketing force when appropriate.

To that end, we must be able

to manage our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,

Our future financial performance and

our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future

growth effectively, as well as our ability to develop a sales and marketing force when appropriate.

To that end, we must be able to manage

our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,

research and development, manufacturing, administrative and sales and marketing personnel.

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his time to such other business thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.

Furthermore, certain members of our Board of Directors are members of the board of directors of Globavir and may allocate their time

to, among other ventures, the business of Globavir which may cause conflicts of interest with respect to their determination as to how

much time to devote to our affairs.

Furthermore, certain members of our Board of Directors are members of the board of directors of Globavir and may allocate their time to,

among other ventures, the business of Globavir which may cause conflicts of interest with respect to their determination as to how much

time to devote to our affairs.

This could have a negative impact on our ability to implement our plan of operation.

Our Chief Executive

Shalabh Gupta, is also the Chief Executive Officer of Globavir and may not commit his full time to our affairs, which may

result in a conflict of interest in allocating his time between our business and the other business.

Similarly, certain members of our

Board of Directors are members of the board of directors of Globavir and may not commit their full time to our affairs, which may result

in a conflict of interest in allocating their time between our business and the other business.

Furthermore, neither our Chief Executive

Officer, our executive team, nor our directors are obligated to contribute any specific number of his hours per week to our affairs.

If other business affairs require our Chief Executive Officer and/or directors to devote more amounts of time to other affairs, including

the business of Globavir, it could limit their ability to devote time to our affairs and could have a negative impact on our ability

to implement our plan of operation.

Our Chief Executive Officer,

Shalabh Gupta, is also the Chief Executive Officer of Globavir and may not commit his full time to our affairs, which may result in

a conflict of interest in allocating his time between our business and the other business.

Similarly, certain members of our Board of

Directors are members of the board of directors of Globavir and may not commit their full time to our affairs, which may result in a conflict

of interest in allocating their time between our business and the other business.

Furthermore, neither our Chief Executive Officer, our

executive team, nor our directors are obligated to contribute any specific number of his hours per week to our affairs.

If other business

affairs require our Chief Executive Officer and/or directors to devote more amounts of time to other affairs, including the business of

Globavir, it could limit their ability to devote time to our affairs and could have a negative impact on our ability to implement

our plan of operation.

Inadequate funding for the FDA, the U.S.

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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.

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

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owned or controlled by Sphaera and/or any of its affiliates, related to UNI 494 (the “UNI 494 Rights”).

We also acquired

a non-exclusive license to certain know-how and technology related to the UNI 494 Rights.

We also acquired a

non-exclusive license to certain know-how and technology related to the UNI 494 Rights.

In the event that either party to the Sphaera

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No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S.

or in foreign

jurisdictions outside of the U.S.

or in foreign jurisdictions

outside of the U.S.

Changes in either the patent laws or interpretations of patent laws in the U.S.

and other countries

may diminish the value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be enforced in the

patents that may be issued from the applications we currently license or may in the future own or license from third parties.

if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates

or technology could be adversely affected.

Others may file patent applications covering

products and technologies that are similar, identical or competitive to ours or important to our business.

We cannot be certain that

any patent application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that

we or our licensors will not be involved in interference, opposition, reexamination, review, reissue, post grant review or invalidity

proceedings before U.S.

and other countries may diminish the

value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be enforced in the patents that may

be issued from the applications we currently license or may in the future own or license from third parties.

Further, if any patents we

obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates or technology could

be adversely affected.

Others may file patent applications covering products

and technologies that are similar, identical or competitive to ours or important to our business.

We cannot be certain that any patent

application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our

licensors will not be involved in interference, opposition, reexamination, review, reissue, post grant review or invalidity proceedings

patent offices.

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or keep our competitive advantage.

others may be able to make

compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;

any patents that we obtain

from licensing or otherwise may not provide us with any competitive advantages;

any granted patents that

we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

the patents of others may

have an adverse effect on our business.

others may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;

any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;

any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

the patents of others may have an adverse effect on our business.

If we fail to comply with our obligations

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If we fail to comply with

any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole

increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case

our ability to develop or commercialize products covered by the license agreement will be impaired.

any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole or

increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case our

ability to develop or commercialize products covered by the license agreement will be impaired.

In addition, disputes may arise regarding intellectual

property subject to a license agreement, including:

the scope of rights granted

under the license agreement and other interpretation-related issues;

the extent to which our

technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our diligence obligations

under the license agreement and what activities satisfy those obligations;

if a third-party expresses

interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required

to sublicense rights in that area to a third party, and that sublicense could harm our business;

the ownership of inventions

and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

the scope of rights granted under the license agreement and other interpretation-related issues;

the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our diligence obligations under the license agreement and what activities satisfy those obligations;

if a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required to sublicense rights in that area to a third party, and that sublicense could harm our business;

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

If disputes over intellectual property that we

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or use of our product candidates, will not infringe third-party patents.

Furthermore, a third party may claim that we are using

inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and

activities, including making or selling our product candidates.

These lawsuits are costly and could affect our results of operations

and divert the attention of managerial and scientific personnel.

Some of these third parties may be better capitalized and have more

resources than us.

There is a risk that a court would decide that we are infringing the third party’s patents and would order us

to stop the activities covered by the patents.

In that event, we may not have a viable way around the patent and may need to halt commercialization

of our product candidates.

In addition, there is a risk that a court will order us to pay the other party damages for having violated

the other party’s patents.

In addition, we may be obligated to indemnify our licensors and collaborators against certain intellectual

property infringement claims brought by third parties, which could require us to expend additional resources.

The pharmaceutical

and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including

us, which patents cover various types of products or methods of use.

The coverage of patents is subject to interpretation by the courts,

and the interpretation is not always uniform.

Furthermore, a third party may claim that we are using inventions

covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities,

including making or selling our product candidates.

These lawsuits are costly and could affect our results of operations and divert the

attention of managerial and scientific personnel.

Some of these third parties may be better capitalized and have more resources than us.

There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities

covered by the patents.

In that event, we may not have a viable way around the patent and may need to halt commercialization of our product

In addition, there is a risk that a court will order us to pay the other party damages for having violated the other party’s

In addition, we may be obligated to indemnify our licensors and collaborators against certain intellectual property infringement

claims brought by third parties, which could require us to expend additional resources.

The pharmaceutical and biotechnology industries

have produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various

types of products or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not

always uniform.

If we are sued for patent infringement, we would

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If we are unable to avoid infringing the patent rights of others, we may

be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in

be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court.

Patent litigation is costly and time consuming.

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disclosure of trade secrets and other proprietary information, the value of our technology and product could be significantly diminished.

We also rely on trade secrets to protect our

proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets are

difficult to protect.

We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators,

sponsored researchers and other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively

prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential

We also rely on trade secrets to protect our proprietary

technologies, especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets are difficult

We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored

researchers and other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent

disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential

In addition, others may independently discover our trade secrets and proprietary information.

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or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against

these claims.

If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property

rights or personnel, which could adversely impact our business.

Even if we are successful in defending against these claims, litigation

could result in substantial costs and be a distraction to management.

Litigation may be necessary to defend against these

If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights

or personnel, which could adversely impact our business.

Even if we are successful in defending against these claims, litigation could

result in substantial costs and be a distraction to management.

Our intellectual property may not be sufficient

to protect our product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition

We may be subject to competition despite the

existence of intellectual property we license or may in the future own.

We can give no assurances that our intellectual property claims

will be sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive

The existence of competitive products that avoid our intellectual property could materially adversely affect our operating

results and financial condition.

Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest

of third parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization

We may be subject to competition despite the existence

of intellectual property we license or may in the future own.

We can give no assurances that our intellectual property claims will be

sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive products.

The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and

financial condition.

Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third

parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization

of our product candidates or future product candidates.

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property rights in this type of litigation, we may be subject to:

paying monetary damages

related to the legal expenses of the third party;

facing additional competition

that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the

commercial viability of our product;

restructuring our company

or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial,

and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

paying monetary damages related to the legal expenses of the third party;

facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product;

restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

A third party may also challenge the validity,

enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the

scope or claims of or invalidate patents that are integral to our product candidates in the future.

There can be no assurance that we

will be able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation

and the high costs associated with intellectual property litigation, amongst other factors.

Intellectual property rights and enforcement

may be less extensive in jurisdictions outside of the U.S.

Therefore, we may not be able to protect our intellectual property and third

parties may be able to market competitive products that may use some or all of our intellectual property.

enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope

or claims of or invalidate patents that are integral to our product candidates in the future.

There can be no assurance that we will be

able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and

the high costs associated with intellectual property litigation, amongst other factors.

Intellectual property rights and enforcement may

be less extensive in jurisdictions outside of the U.S.

Therefore, we may not be able to protect our intellectual property and third parties

may be able to market competitive products that may use some or all of our intellectual property.

Changes to patent law, including the Leahy-Smith America

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The laws include:

the federal healthcare

program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly

or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or

service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

federal false claims laws

which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment

from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which

provide coding and billing information to customers;

HIPAA which prohibits executing

a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes

certain requirements relating to the privacy, security and transmission of individually identifiable health information;

the FDCA which among other

things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and

regulates the distribution of drug samples;

state law equivalents of

each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any

third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain

circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating

compliance efforts.

● the federal healthcare program anti-kickback law, which prohibits,

among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral

of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal

healthcare programs such as the Medicare and Medicaid programs;

● federal false claims laws which prohibit, among other things,

individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party

payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;

● HIPAA which prohibits executing a scheme to defraud any healthcare

benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the

privacy, security and transmission of individually identifiable health information;

● the FDCA which among other things, strictly regulates drug

manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates

the distribution of drug samples;

● state law equivalents of each of the above federal laws,

such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial

insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from

each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

If our operations are found to be in violation

of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil

and criminal penalties, damages, fines and the curtailment or restructuring of our operations.

of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and

criminal penalties, damages, fines and the curtailment or restructuring of our operations.

Any penalties, damages, fines, curtailment

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Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry are the

an annual, nondeductible

fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities

according to their market share in certain government healthcare programs;

implementation of the federal

physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for follow-on biologic

a new Patient-Centered

Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with

funding for such research;

establishment of a Center

for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery

models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

an increase in the statutory

minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price

for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer

a new methodology by which

rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our

product candidates, that are inhaled, infused, instilled, implanted or injected;

extension of manufacturers’

Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility

criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by

adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially

increasing manufacturers’ Medicaid rebate liability;

a new Medicare Part D coverage

gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable

brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs

to be covered under Medicare Part D;

expansion of the entities

eligible for discounts under the Public Health program.

● an annual, nondeductible fee on any entity that manufactures

or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in

certain government healthcare programs;

● implementation of the federal physician payment transparency

requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

● a licensure framework for follow-on biologic products;

● a new Patient-Centered Outcomes Research Institute to oversee,

identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

● establishment of a Center for Medicare Innovation at the

Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid

spending, potentially including prescription drug spending;

● an increase in the statutory minimum rebates a manufacturer

must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs,

respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;

● a new methodology by which rebates owed by manufacturers

under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled,

infused, instilled, implanted or injected;

● extension of manufacturers’ Medicaid rebate liability

to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

● expansion of eligibility criteria for Medicaid programs by,

among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories

for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid

rebate liability;

● a new Medicare Part D coverage gap discount program, in which

manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries

during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

● expansion of the entities eligible for discounts under the

Public Health program.

Some of the provisions of the ACA have yet to

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Congress considered legislation that would repeal or repeal and replace all or part of the ACA.

While Congress has not passed repeal

legislation, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared

responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a

year that is commonly referred to as the “individual mandate.” Congress may consider other legislation to repeal or replace

elements of the ACA.

While Congress has not passed repeal legislation,

the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared responsibility

payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly

referred to as the “individual mandate.” Congress may consider other legislation to repeal or replace elements of the ACA.

Many of the details regarding the implementation

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is heightened by President Biden’s January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act, which

indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump

administration.

indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump administration.

The FDA has issued several guidance documents,

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A number of biosimilar applications have been approved over the past few years.

regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical

manufacturers conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly

similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically

meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

The regulations

that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers

conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly similar to an

approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences

between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

Individual states have become increasingly aggressive

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Legally mandated price controls on payment amounts by

third-party payors or other restrictions could harm a pharmaceutical manufacturer’s business, results of operations, financial

condition and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures

to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

This could reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical

manufacturer’s business, results of operations, financial condition and prospects.

third-party payors or other restrictions could harm a pharmaceutical manufacturer’s business, results of operations, financial condition

and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine

what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical manufacturer’s

business, results of operations, financial condition and prospects.

It is also possible that President Biden will

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In addition, given recent federal and state government

initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely

continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

For example, there have been several recent U.S.

congressional inquiries and proposed federal and proposed and enacted state legislation

designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient

programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

in July 2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug products

including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts for plans,

pharmacies, and pharmaceutical benefit managers.

initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely continue

to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

example, there have been several recent U.S.

congressional inquiries and proposed federal and proposed and enacted state legislation designed

to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs,

reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

Further, in July

2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug products including

one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts for plans, pharmacies,

and pharmaceutical benefit managers.

No assurance can be given whether these orders will remain in effect under the Biden administration.

While no one can predict the full outcome of

any such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure

While no one can predict the full outcome of any

such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure

to reduce prescription drug prices.

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or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure on

a pharmaceutical manufacturer’s ability to profitably price products, which, in turn, could adversely affect business, results

of operations, financial condition and prospects.

A pharmaceutical manufacturer might elect not to seek approval for or market products

in foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated from

product sales.

a pharmaceutical manufacturer’s ability to profitably price products, which, in turn, could adversely affect business, results of

operations, financial condition and prospects.

A pharmaceutical manufacturer might elect not to seek approval for or market products in

foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated from product

It is also possible that other legislative proposals having similar effects will be adopted.

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levels and statutory, regulatory and policy changes.

Our employees may engage in misconduct

or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability

Our employees may engage in misconduct or

other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability

for us and harm our reputation.

We are exposed to the risk of employee fraud

or other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory

We are exposed to the risk of employee fraud or

other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory

authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards

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and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities

Employee misconduct 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.

It is not always possible to identify and deter employee misconduct,

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 be in compliance with such

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 and results of operations, including the imposition of significant

civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such

as Medicare and Medicaid, and integrity oversight and reporting obligations.

Employee misconduct 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.

It is not always possible to identify and deter employee misconduct, 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 be in compliance with such 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 and results of operations, including the imposition of significant civil,

criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare

and Medicaid, and integrity oversight and reporting obligations.

We are subject to U.S.

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laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing,

promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or

private sector.

We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we

enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities

and other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors and

other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities.

Any violations of the

laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export

or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private

We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a

commercialization phase and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and

other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors and other

collaborators, even if we do not explicitly authorize or have actual knowledge of such activities.

Any violations of the laws and

regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import

privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Risks Related to Owning our Common Stock

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risks mentioned in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, are:

sale of our common stock

by our stockholders, executives, and directors;

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business

possible delays in the

expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;

the timing and success

of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry, including

consolidation among competitors, customers or strategic partners;

network outages or security

our ability to secure resources

and the necessary personnel to conduct clinical trials on our desired schedule;

commencement, enrollment

or results of our clinical trials for our product candidates or any future clinical trials we may conduct;

changes in the development

status of our product candidates;

any delays or adverse developments

or perceived adverse developments with respect to the FDA’s review of our planned pre-clinical and clinical trials;

any delay in our submission

for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our product

unanticipated safety concerns

related to the use of our product candidates;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

● sale of our common stock by our stockholders, executives,

and directors;

● volatility and limitations in trading volumes of our shares

of common stock;

● our ability to obtain financings to conduct and complete

research and development activities including, but not limited to, our clinical trials, and other business activities;

● possible delays in the expected recognition of revenue due

to lengthy and sometimes unpredictable sales timelines;

● the timing and success of introductions of new products by

us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors, customers

or strategic partners;

● network outages or security breaches;

● our ability to secure resources and the necessary personnel

to conduct clinical trials on our desired schedule;

● commencement, enrollment or results of our clinical trials

for our product candidates or any future clinical trials we may conduct;

● changes in the development status of our product candidates;

● any delays or adverse developments or perceived adverse developments

with respect to the FDA’s review of our planned pre-clinical and clinical trials;

● any delay in our submission for studies or product approvals

or adverse regulatory decisions, including failure to receive regulatory approval for our product candidates;

● unanticipated safety concerns related to the use of our product

● failures to meet external expectations or management guidance;

● changes in our capital structure or dividend policy, future

issuances of securities, sales of large blocks of common stock by our stockholders;

● our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new products;

● announcements and events surrounding financing efforts, including

debt and equity securities;

● our inability to enter into new markets or develop new products;

● reputational issues;

competition from existing

technologies and products or new technologies and products that may emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

changes in general economic,

political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual property, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

In addition, if the market for stocks in our

industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading

price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations.

of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly

to defend and a distraction to management.

We do not intend to pay cash dividends

on our shares of common stock so any returns will be limited to the value of our shares, except we have agreed to pay cash dividends

in the event Oxylanthanum Carbonate is approved by the FDA and commercial sales is commenced.

competition from existing technologies and products or new technologies and products that may emerge;

announcements of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

changes in general economic, political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions or perceptions;

changes in valuations of similar companies or groups of companies;

analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions of key personnel;

disputes and litigations related to intellectual property, proprietary rights, and contractual obligations;

changes in applicable laws, rules, regulations, or accounting practices and other dynamics;

other events or factors, many of which may be out of our control.

In addition, if the market for stocks in our industry

or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading price of

our common stock could decline for reasons unrelated to our business, financial condition and results of operations.

If any of the foregoing

occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and

a distraction to management.

We do not intend to pay cash dividends on

our shares of common stock so any returns will be limited to the value of our shares, except we have agreed to pay cash dividends in the

event Oxylanthanum Carbonate is approved by the FDA and commercial sales is commenced.

We currently anticipate that we will retain future

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the foreseeable future, except that in March 2023,we agreed with certain investors to modify our dividend policy to state that we intend

to pay dividends to all stockholders on a quarterly basis in an amount of which the aggregate of all quarterly dividends shall equal

at least seventy-five percent (75%) of our annual net cash flow from operations following the approval of Oxylanthanum Carbonate by the

FDA if obtained, and the commencement of commercial sales.

to pay dividends to all stockholders on a quarterly basis in an amount of which the aggregate of all quarterly dividends shall equal at

least seventy-five percent (75%) of our annual net cash flow from operations following the approval of Oxylanthanum Carbonate by the FDA

if obtained, and the commencement of commercial sales.

Market and economic conditions may negatively

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it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive.

Failure to secure any

necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial

performance, and share price and could require us to delay or abandon development or commercialization plans.

Failure to secure any necessary

financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance,

and share price and could require us to delay or abandon development or commercialization plans.

If securities or industry analysts do not

publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.

The trading market for our common stock will

rely in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our competitors.

The trading market for our common stock will rely

in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our competitors.

We do not control these analysts.

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us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price would likely

If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose visibility

in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline and may

also impair our ability to expand our business with existing customers and attract new customers.

Our common stock may be delisted from The

Nasdaq Capital Market if we fail to comply with continued listing standards.

If we fail to meet any of the continued listing

standards of The Nasdaq Capital Market, our common stock could be delisted from The Nasdaq Capital Market.

These continued listing standards

include specifically enumerated criteria, such as:

a $1.00 minimum closing

stockholders’ equity

of $2.5 million;

500,000 shares of publicly-held

common stock with a market value of at least $1 million;

300 round-lot stockholders;

compliance with Nasdaq’s

corporate governance requirements, as well as additional or more stringent criteria that may be applied in the exercise of Nasdaq’s

discretionary authority.

On September 19, 2023,

we received written notification (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market LLC

(“Nasdaq”) indicating that, for the last thirty consecutive business days, the market value of our Common Stock, had closed

below the minimum $35 million requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the

“Minimum Market Value Requirement”).

In addition, on September

19, 2023, we received a Notice from Nasdaq indicating that the bid price for the Common Stock, for the last 30 consecutive business

days for the last thirty consecutive business days, had closed below the minimum $1.00 per share and, as a result, we were not in

compliance with the $1.00 minimum bid price requirement (the “Minimum Bid Price Requirement”) for the continued listing on

the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2).

On February 21, 2024,

we received a letter from Nasdaq that we had regained compliance with the Minimum Market Value Requirement and the Minimum Bid Price

Requirement and the matters are now closed.

If we fail to comply

with Nasdaq’s continued listing standards, we may be delisted and our common stock will trade, if at all, only on the over-the-counter

market, such as the OTC Bulletin Board or OTCQX market, and then only if one or more registered broker-dealer market makers comply with

quotation requirements.

In addition, delisting of our common stock could depress our stock price, substantially limit liquidity of our

common stock and materially adversely affect our ability to raise capital on terms acceptable to us, or at all.

Finally, delisting of

our common stock could result in our common stock becoming a “penny stock” under the Exchange Act.

Because certain of our stockholders control

a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval.

If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose visibility in

the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline and may also

impair our ability to expand our business with existing customers and attract new customers.

If we fail to comply with the continued

listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability

to access the capital markets could be negatively impacted.

Our Common Stock is currently listed on the Nasdaq

Capital Market and the continued listing of our Common Stock on the Nasdaq Capital Market is contingent on our continued compliance with

a number of listing requirements.

If we are unable to comply with the continued listing requirements of the Nasdaq Capital Market, our

Common Stock would be delisted from the Nasdaq Capital Market, which would limit investors’ ability to effect transactions in our

Common Stock and subject us to additional trading restrictions.

In order to maintain our listing, we must maintain certain share prices,

financial and share distribution targets, including maintaining a minimum amount of stockholders’ equity and a minimum number of

public stockholders, as well as satisfy other listing requirements of the Nasdaq Capital Market.

In addition to these objective standards,

Nasdaq Capital Market may delist the securities of any issuer for other reasons involving the judgment of Nasdaq Capital Market.

On July 9, 2024, we received written notice from

the Nasdaq Stock Market, LLC (“Nasdaq”) that we were not in compliance with Nasdaq Listing Rule 5550(a)(2),

as the minimum bid price of our common stock had been below $1.00 per share for 30 consecutive business days.

In accordance with

Nasdaq Listing Rule 5810, we have a period of 180 calendar days, or until January 6, 2025, to regain compliance with the minimum

bid price requirement and market value of common stock requirement.

To regain compliance with the Nasdaq bid price requirement, the closing

bid price of our common stock must meet or exceed $1.00 per share for at least 10 consecutive business days during this 180 calendar day

In the event we do not regain compliance by January 6, 2025, we may be eligible for an additional 180 calendar day grace period;

however, there can be no assurance that we will regain compliance with the Nasdaq continued listing requirements.

As of January

6, 2025, we had not regained compliance with the minimum bid price requirement.

On January 7, 2025, Nasdaq notified us that we would have

an additional 180 calendar days, or until July 7, 2025, to regain compliance.

There is no assurance that we will be able to

maintain compliance with the Nasdaq Capital Market continued listing standards and/or continue our listing on the Nasdaq Capital Market

in the future.

If the Nasdaq Capital Market delists our Common

Stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect the Common

Stock would qualify to be quoted on an over-the-counter market.

If this were to occur, we could face significant material adverse consequences,

● a limited availability of market quotations for our securities;

● reduced liquidity for our securities;

● substantially impair our ability to raise additional funds;

● the loss of institutional investor interest and a decreased

ability to issue additional securities or obtain additional financing in the future;

● a determination that our Common Stock is a “penny stock,”

which will require brokers trading in our Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading

activity in the secondary trading market for our securities;

● a limited amount of news and analyst coverage;

● potential breaches of representations or covenants of our

agreements pursuant to which we made representations or covenants relating to our compliance with applicable listing requirements, which,

regardless of merit, could result in costly litigation, significant liabilities and diversion of our management’s time and attention

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

Because certain of our stockholders control a significant number

of shares of our common stock, they may have effective control over actions requiring stockholder approval.

As of December 31, 2024, our directors, executive

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concentration of ownership might harm the market price of our common stock by:

delaying, deferring, or

preventing a change in corporate control;

impeding a merger, consolidation,

takeover or other business combination involving us;

discouraging a potential

acquirer from making a tender offer or otherwise attempting to obtain control of us.

delaying, deferring, or preventing a change in corporate control;

impeding a merger, consolidation, takeover or other business combination involving us;

discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

We are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our

common stock less attractive to investors.

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common

stock less attractive to investors.

We are an “emerging growth company,”

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of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.2 billion or more;

last day of our fiscal year following the fifth anniversary of the date of the completion of this offering;

(iii) the date on which

we have issued more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are

deemed to be a large accelerated filer under the rules of the SEC.

(ii) the last

day of our fiscal year following the fifth anniversary of the date of the completion of this offering;

(iii) the date on which we

have issued more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are deemed

to be a large accelerated filer under the rules of the SEC.

We may be at risk of securities class action

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further action by stockholders.

The terms of any series of preferred stock may include voting rights (including the right to vote as

a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions.

The terms of any series of preferred stock may include voting rights (including the right to vote as a

series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore, reduce

the value of our common stock.

In particular, specific rights granted to future holders of preferred stock could be used to restrict

our ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.

In particular, specific rights granted to future holders of preferred stock could be used to restrict our

ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.

Provisions of our Amended and Restated Certificate

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and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:

provide the board of directors

with the ability to alter the bylaws without stockholder approval;

place limitations on the

removal of directors;

establish advance notice

requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder

provide that vacancies

on the board of directors may be filled by a majority of directors in office, although less than a quorum.

provide the board of directors with the ability to alter the bylaws without stockholder approval;

place limitations on the removal of directors;

establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Financial reporting obligations of being

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additional legal, accounting and other expenses that we did not incur as a privately held company.

The obligations of being a public

company in the U.S.

require significant expenditures and will place significant demands on our management and other personnel, including

costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance

The obligations of being a public company

require significant expenditures and will place significant demands on our management and other personnel, including costs

resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance

practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and

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Our Amended and Restated Certificate of Incorporation,

provides that unless we consent in writing to the selection of an alternative forum, the State of Delaware is the sole and exclusive

(i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim of breach of a fiduciary

duty owed by any director, officer or other employee of our Company to us or our stockholders, (iii) any action asserting a claim against

us, our directors, officers or employees arising pursuant to any provision of the Delaware General Corporation Law (the “DGCL”)

provides that unless we consent in writing to the selection of an alternative forum, the State of Delaware is the sole and exclusive forum

(i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim of breach of a fiduciary duty

owed by any director, officer or other employee of our Company to us or our stockholders, (iii) any action asserting a claim against us,

our directors, officers or employees arising pursuant to any provision of the Delaware General Corporation Law (the “DGCL”)

or our Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws or (iv) any action asserting a claim against

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above, any claim as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of

the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten

days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery,

or for which the Court of Chancery does not have subject matter jurisdiction.

This exclusive forum provision would not apply to suits

brought to enforce any liability or duty created by the Securities Act, the Exchange Act, or other federal securities laws or any other

claim for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims,

Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created

by the Exchange Act or the rules and regulations thereunder.

the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days

following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or

for which the Court of Chancery does not have subject matter jurisdiction.

This exclusive forum provision would not apply to suits brought

to enforce any liability or duty created by the Securities Act, the Exchange Act, or other federal securities laws or any other claim

for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section

27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange

Act or the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrent

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be uncertainty, however, as to whether courts of other jurisdictions would enforce this provision, if applicable.

These choice of forum provisions may limit a

stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers

or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.

Alternatively, if

a court were to find our choice of forum provisions contained in our Amended and Restated Certificate of Incorporation to be inapplicable

or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could

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

These choice of forum provisions may limit a stockholder’s

ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees,

which may discourage such lawsuits against us and our directors, officers and other employees.

Alternatively, if a court were to find

our choice of forum provisions contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable

in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business,

results of operations, and financial condition.

Failure to maintain

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In connection with the preparation

of our financial statements for the years ended December 31, 2022 and 2023, we concluded that there were material weaknesses in

our internal control over financial reporting.

A material weakness is a significant deficiency, or a combination of significant deficiencies,

in internal control over financial reporting such that it is reasonably possible that a material misstatement of the annual or interim

financial statements will not be prevented or detected on a timely basis.

Specifically, we lack a sufficient number of professionals

with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters

timely and accurately while maintaining appropriate segregation of duties.

While we are taking steps to remediate the material weaknesses

in our internal control over financial reporting, we may not be successful in remediating such weaknesses which may undermine our ability

to provide accurate, timely and reliable reports on our financial and operating results.

Furthermore, if we remediate our current material

weaknesses but identify new material weaknesses in our internal control over financial reporting investors may lose confidence in the

accuracy and completeness of our financial reports and the market price of our common stock may be negatively affected.

As a result of

such failures, we could also become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other

regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation, financial

of our financial statements for the years ended December 31, 2024, we concluded that our internal control over financial reporting

was effective.

However, in connection with the preparation of our financial statements for the years ended December 31, 2023, we

concluded that there were material weaknesses in our internal control over financial reporting.

A material weakness is a significant deficiency,

or a combination of significant deficiencies, in internal control over financial reporting such that it is reasonably possible that a

material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

Specifically,

in 2023, we lacked a sufficient number of professionals with an appropriate level of accounting knowledge, training and experience to

appropriately analyze, record and disclose accounting matters timely and accurately while maintaining appropriate segregation of duties.

While we have taken steps to remediate the material weaknesses in 2023 and have determined our internal controls were effective for 2024,

we may identify new material weaknesses in our internal control over financial reporting in future years, and investors may lose confidence

in the accuracy and completeness of our financial reports and the market price of our common stock may be negatively affected.

of such failures, we could also become subject to investigations by the stock exchange on which our securities are listed, the SEC, or

other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation, financial

condition or divert financial and management resources from our core 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