What changed in this filing

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Item 1A. Risk Factors

2025-08-15 compared with 2024-09-30 · 1159 added, 1221 removed, 471 unchanged (83% of the section changed)

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In such case, the trading price of our Company’s Class A

Common Stock, par value $0.0001 (“Common Stock”) Common Stock could decline, and our stockholders may lose all or part of

their investment in the shares of our Common Stock.

Common Stock, par value $0.0001 (“Common Stock”) could decline, and our stockholders may lose all or part of their investment.

This Form 10-K contains forward-looking statements

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Risk Factor Summary

Our business operations are subject to numerous risks,

factors and uncertainties, including those outside of our control, which could cause our actual results to be harmed, including risks

regarding the following:

Risks Relating to Our Business and Industry

· If these third parties contractors do not successfully carry out their contractual duties or meet expected deadlines or do not successfully

perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

· Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our

· The concentration of our assets within certain financial institutions could have a material adverse effect on its business, financial

condition and results of operations.

· We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which

may have a material adverse effect on our business.

· We have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability,

which could cause us to cease operations.

· We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your

· If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing

approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of

our products, the sales of our products could be adversely affected.

· If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity

and on our intellectual property rights.

· We will need to raise substantial additional capital in the future to fund our operations, which could have a materially adverse effect

on our business.

· We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease

· Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our

· We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates

or indications that may be more profitable or for which there is a greater likelihood of success.

· We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could

have a materially adverse effect on our business.

· We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff

could have a materially adverse effect on our business.

· Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers

fail to comply with manufacturing regulations.

· We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization

of our product candidates.

Our business operations are subject to numerous

risks, factors and uncertainties, including those outside of our control, which could cause our actual results to be harmed, including

risks regarding the following:

Risks Relating to Our Business and

If our third party contractors do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

The concentration of our assets within certain financial institutions could have a material adverse effect on its business, financial condition and results of operations.

We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which may have a material adverse effect on our business.

We have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability, which could cause us to cease operations.

We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity and on our intellectual property rights.

We will need to raise substantial additional capital in the future to fund our operations, which could have a materially adverse effect on our business.

We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations.

Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control.

We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.

We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.

Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations.

We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates.

We may face business disruption and related risks if there is another pandemic.

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We may not be able to attract and retain highly skilled personnel.

· We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical industries and those equipped

with more substantial resources than us.

We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical industries and those equipped with more substantial resources than us.

There may be conflicts of interest among our officers, directors and stockholders.

· We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase

our operating costs.

We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs.

Risks Relating to Our Intellectual Property

We may be unable to obtain or protect intellectual property rights relating to our product candidates.

· If we fail to comply with our obligations in the licensing and collaboration agreements, our competitive position, business, financial

condition, results of operations and prospects could be harmed.

· Compliance with federal regulations such as “march-in” rights may limit our exclusive rights and our ability to contract

with non-U.S.

If we fail to comply with our obligations in the licensing and collaboration agreements, our competitive position, business, financial condition, results of operations and prospects could be harmed.

Compliance with federal regulations such as “march-in” rights may limit our exclusive rights and our ability to contract with non-U.S.

manufacturers.

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Changes in patent law could diminish the value of our patents and impair our ability to protect our drug candidate.

· We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming

and unsuccessful, and our patents could be found invalid or unenforceable.

· Our failure to identify relevant third-party patents or correctly interpret the relevance, scope or expiration of patents, we may

be subject to infringement claims or may not be able to develop our drug candidates.

· Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual

property rights.

· We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated

their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and our patents could be found invalid or unenforceable.

Our failure to identify relevant third-party patents or correctly interpret the relevance, scope or expiration of patents, we may be subject to infringement claims or may not be able to develop our drug candidates.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights.

We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

Intellectual property rights do not necessarily address all potential threats.

· Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares

of our Common Stock to decline.

Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.

Risks Relating to Our Common Stock

Our stock price is and may continue to be volatile and you may not be able to resell our Common Stock at or above the price you paid.

· You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock

awards or other arrangements.

· Certain stockholder of the Company may have significant control over our Company.

· The reverse stock split effected on August 6, 2024 may not result in positive outcomes.

You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

The reverse stock split effected on July 7, 2025 has caused and could further cause our stock price to decline relative to its value before the reverse stock split and decrease the liquidity of shares of our common stock.

The market price and trading volume of our Common Stock may be volatile.

· The large number of restricted shares outstanding may reduce the market price of our Common Stock.

Any failure to maintain effective internal control over financial reporting could harm us.

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Investors may be less attracted to our Common Stock because we are as a smaller reporting company.

· Additional audit and legal costs associated with periodic reporting requirements of the Securities Exchange Act of 1934, as amended

(the “Exchange Act”) will negatively affect our ability to earn a profit.

· Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their

shares unless they sell them.

· We are authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the

rights of holders of our securities.

· Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of

our company or changes in our management and, therefore, depress the trading price of our Common Stock.

Additional audit and legal costs associated with periodic reporting requirements of the Exchange Act will negatively affect our ability to earn a profit.

Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them.

We are authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.

Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.

Risks Relating to Our Business and Industry

We rely and will continue to rely on third parties

to conduct our clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines

or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize

our product candidates.

We depend, and will

continue to depend, on third parties, including, but not limited to, contract research organizations (“CROs”), clinical

trial sites and clinical trial principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third

parties to conduct our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201.

We rely heavily on

these third parties over the course of our clinical trials, and we control only certain aspects of their activities.

Nevertheless,

we retain ultimate responsibility for ensuring that each of our studies is conducted in accordance with the protocol and applicable

legal, regulatory, and scientific standards and regulations, and our reliance on third parties does not relieve us of our regulatory

responsibilities.

We and these third parties are required to comply with cGCPs, which are regulations and guidelines enforced by the

FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections of clinical trial principal

investigators and trial sites.

If, due to the failure of either the Company or a third party, a clinical trial fails to comply with

applicable cGCPs, FDA’s IND requirements, other applicable regulatory requirements, or requirements set forth in the

applicable IRB-approved protocol, the Company may be required to conduct additional clinical trials to support our marketing

applications, which would delay the regulatory approval process.

For example, our drug product candidate bezisterim (NE3107) was

cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in subjects who

have mild to moderate AD.

Enrollment in that trial began in August 2021, with a planned primary completion in late 2022/early 2023.

We rely and will continue to rely on third

parties to conduct our clinical trials.

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

deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of

or commercialize our product candidates.

We depend, and will continue

to depend, on third parties, including, but not limited to, contract research organizations (“CROs”), clinical trial sites

and clinical trial principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct

our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201.

We rely heavily on these third parties over

the course of our clinical trials, and we control only certain aspects of their activities.

Nevertheless, we retain ultimate responsibility

for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards

and regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties

are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities

for the conduct of clinical trials on product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic

inspections and for-cause inspections of clinical trial principal investigators and trial sites.

If, due to the failure of either the

Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory

requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical

trials to support our marketing applications, which would delay the regulatory approval process.

For example, our drug product candidate

bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter

study in subjects who have mild to moderate AD.

Enrollment in that trial began in August 2021, with a planned primary completion in late

2022/early 2023.

On November 29, 2023, the Company announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim

(NE3107) in the treatment of mild to moderate AD.

Upon trial completion, as the Company began the process of analyzing the trial

data, the Company found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were

from one geographic area).

This highly unusual level of suspected improprieties led the Company to exclude all patients from these

We subsequently notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and

the study sites involved.

The identification of significant deviations from study protocol and numerous GCP violations at multiple

study sites raised questions regarding the validity and robustness of data from these study sites.

The unplanned exclusion of so

many patients left the trial underpowered for its primary endpoints.

However, based on the remaining dataset from those other sites

determined to be in compliance with the protocol and GCP’s, a preliminary signal of efficacy was detected.

The Company is

(1) employing the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical

significance;

and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most recent scientific literature

relating to AD along with the company's understanding regarding the effects of bezisterim (NE3107) in persons with mild-moderate

Although we design the clinical

trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials.

Upon trial completion, as the Company began the process of analyzing the trial data,

the Company found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one

geographic area).

This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites.

We subsequently

notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and the study sites involved.

The identification of significant deviations from study protocol and numerous GCP violations at multiple study sites raised questions

regarding the validity and robustness of data from these study sites.

The unplanned exclusion of so many patients left the trial underpowered

for its primary endpoints.

However, based on the remaining dataset from those other sites determined to be in compliance with the protocol

and GCP’s, a preliminary signal of efficacy was detected.

The Company is considering:

(1) employing the adaptive trial feature of

the protocol to continue enrolling patients to achieve statistical significance;

and/or (2) designing a new Phase 3 study of bezisterim

(NE3107) that leverages the most recent scientific literature relating to AD along with the company's understanding regarding the effects

of bezisterim (NE3107) in persons with mild-moderate AD.

Although we design the

clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials.

As a result, many aspects

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is outside our direct control, either partially or in whole.

Our reliance on third parties to conduct clinical trials also results

in less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if

we were relying entirely upon our own employees.

Our reliance on third parties to conduct clinical trials also results in

less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we

were relying entirely upon our own employees.

Communicating with third parties can also be challenging, potentially leading to mistakes

as well as difficulties in coordinating activities.

Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including

but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws,

or provide us or government agencies with inaccurate, misleading, or incomplete data.

Our business may be impacted if any of these third parties violates applicable federal,

state, or foreign laws and/or regulations, including but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims

laws, healthcare privacy and data security laws, or provide us or government agencies with inaccurate, misleading, or incomplete data.

Successful development of biopharmaceuticals

is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

Product candidates that appear promising in the early

phases of development may fail to reach the market for several reasons.

Pre-clinical study results may show the product candidate to be

less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects.

candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals.

Among other things, such

delays may be caused by slow enrollment in clinical studies;

Product candidates that appear promising in the

early phases of development may fail to reach the market for several reasons.

Pre-clinical study results may show the product candidate

to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects.

Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals.

Among other things,

such delays may be caused by slow enrollment in clinical studies;

length of time to achieve study endpoints;

additional time requirements for

data analysis;

additional time requirements

for data analysis;

IND and later new drug application preparation;

discussions with the FDA;

an FDA request for additional pre-clinical or

clinical data;

an FDA request for additional pre-clinical

or clinical data;

unexpected safety or manufacturing issues;

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The concentration of our assets within a

certain financial institution could have a material adverse effect on its business, financial condition and results of

As of August 30, 2024, the Company had cash

deposited in a certain financial institution in excess of federally insured levels.

The Company regularly monitors the financial

stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash

Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect

financial institutions, or concerns or rumors about such events, may lead to liquidity constraints.

certain financial institution could have a material adverse effect on its business, financial condition and results of operations.

As of July 31, 2025, the Company had cash deposited

in a certain financial institution in excess of federally insured levels.

The Company regularly monitors the financial stability of these

financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.

Bank failures,

events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions, or concerns

or rumors about such events, may lead to liquidity constraints.

In 2023, certain U.S.

banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which

caused general heightened uncertainties in financial markets.

While previous bank failures have not had a material direct impact on

the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial

institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing

arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of

government banking regulators took steps to intervene

in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial

While previous bank failures have not had a material direct impact on the Company’s operations, if further liquidity and

financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s

ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business,

financial condition and results of operations.

We are currently subject to securities class

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our business, operating results and financial condition, and negatively affect the price of our Common Stock.

We are, and may in the future become, subject to

various legal proceedings and claims that arise in or outside the ordinary course of business.

We are, and may in the future become, subject

to various legal proceedings and claims that arise in or outside the ordinary course of business.

For example, On January 19, 2024, a

purported shareholder class action complaint, captioned Eric Olmstead v.

3:24-cv-00035, was

filed in the U.S.

3:24-cv-00035, was filed

District Court for the District of Nevada, naming the Company and certain of its officers as defendants.

February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against

the same defendants, captioned Way v.

On February 22, 2024,

a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned

2:24-cv-00361.

On April 15, 2024, the court consolidated these

two actions under the caption In re BioVie Inc.

On April 15, 2024, the court consolidated these two actions under the caption In

re BioVie Inc.

Securities Litigation , No.

3:24-cv-00035, appointed the lead plaintiff, and

approved selection of the lead counsel.

On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the

defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations,

compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to

moderate probable Alzheimer’s Disease, in violation of Sections 10(b) and 20(a) of

the Exchange Act, and Rule 10b-5 promulgated thereunder.

The class action is on behalf of purchasers of the

Company’s securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages

on behalf of the putative class and an award of costs and expenses, including attorney’s fees.

The defendants filed a motion

to dismiss the amended complaint on August 21, 2024.

The defendants believe that the claims are without merit and intend to

defend vigorously against them, but there can be no assurances as to the outcome.

It is possible that additional lawsuits will be filed,

or allegations received from stockholders, with respect to these same or other matters and also naming us and/or our officers and directors

as defendants.

Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition

costs will depend upon many unknown factors.

3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.

On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or

omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related

to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable Alzheimer’s Disease, in

violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.

The class action is on behalf

of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified

monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.

2024, the defendants filed a motion to dismiss the amended complaint, and that motion was fully briefed in December 2024.

2025, the court denied the motion to dismiss, and the parties are now engaged in the early stages of the discovery process.

addition, on December 30, 2024 and April 28, 2025, respectively, two shareholder derivative lawsuits were filed in the United States District

Court for the District of Nevada by putative stockholders, allegedly on behalf of the Company, that piggy-back on the securities class

action, alleging, among other things, that the defendants breached their fiduciary duties by causing or failing to prevent the securities

violations alleged in the securities class action.

The Company believes that all of these claims are without merit and intends to defend

vigorously against them, but there can be no assurances as to the outcome.

It is possible that additional lawsuits will be

filed, or allegations received from stockholders, with respect to these same or other matters and also naming us and/or our officers and

directors as defendants.

Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and

disposition costs will depend upon many unknown factors.

The outcome of such lawsuits is necessarily uncertain.

We could be forced to expend significant

resources in the defense of the pending lawsuit and any additional lawsuits, and we may not prevail.

In addition, we may incur substantial

legal fees and costs in connection with such lawsuits.

We currently are not able to estimate the possible cost to us from this matter,

as the pending lawsuit is currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuit or

the possible amount of any damages that we may be required to pay.

Monitoring, initiating and defending against legal actions is time-consuming

for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities.

We could be forced to expend significant resources in the settlement or defense of the pending lawsuit and any potential future lawsuits,

and we may not prevail in such lawsuits.

We could be forced to

expend significant resources in the defense of the pending lawsuits and any additional lawsuits, and we may not prevail.

we may incur substantial legal fees and costs in connection with such lawsuits.

We currently are not able to estimate the possible cost

to us from these matters, as the pending lawsuits are currently at an early stage, and we cannot be certain how long it may take to resolve

the pending lawsuits or the possible amount of any damages that we may be required to pay.

Monitoring, initiating and defending against

legal actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal

resources on our business activities.

We could be forced to expend significant resources in the settlement or defense of the pending lawsuit

and any potential future lawsuits, and we may not prevail in such lawsuits.

Although we have insurance coverage that we believe

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our insurance coverage may be insufficient, and our assets may be insufficient to cover any amounts that exceed our insurance coverage,

and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claim.

and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claims.

A decision adverse

to our interests in the pending lawsuit, or in similar or related litigation, could result in the payment of substantial damages, or possibly

fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial condition.

We have not established any reserve for any potential liability relating to the pending lawsuit or any potential future lawsuits.

such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, operating

to our interests in the pending lawsuits, or in similar or related litigation, could result in the payment of substantial damages, or

possibly fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial

We have not established any reserve for any potential liability relating to the pending lawsuits or any potential future lawsuits.

Any such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, operating

results or financial condition.

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sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.

We have no products approved for commercial sale and,

to date, we have not generated any revenue.

Our ability to generate revenue depends heavily on (a) successful completion of one or more

development programs demonstrating in human clinical trials that BIV201 and bezisterim (NE3107), our product candidates, are safe and

(b) our ability to seek and obtain regulatory approvals, including, without limitation, with respect to the indications we

We have no products approved for commercial sale

and, to date, we have not generated any revenue.

Our ability to generate revenue depends heavily on (a) successful completion of one or

more development programs demonstrating in human clinical trials that BIV201 and bezisterim (NE3107), our product candidates, are safe

and effective;

(b) our ability to seek and obtain regulatory approvals, including, without limitation, with respect to the indications

we are seeking;

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be unable to continue our operations.

We are a development stage company with a limited

operating history, making it difficult for you to evaluate our business and your investment.

We are a development stage company with

a limited operating history, making it difficult for you to evaluate our business and your investment.

Although our Company was incorporated on April

2013, we are a development stage biopharmaceutical company with potential therapies that have not been fully evaluated in clinical trials,

and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited

to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual

10, 2013, we are a development stage biopharmaceutical company with potential therapies that have not been fully evaluated in clinical

trials, and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not

limited to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual

losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and limited

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our projected timetable in order to reach sustainable or profitable operations.

Investors are subject to all the risks incident to

the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its investment.

Investors are subject to all the risks incident

to the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its

Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern.

We have not emerged

from the development stage, and may be unable to raise further equity.

These factors raise substantial doubt about our ability to continue

as a going concern.

The financial statements included elsewhere in this Form 10-K do not include any adjustments that might result from

the outcome of this uncertainty.

Because we are subject to these risks, you may have

a difficult time evaluating our business and your investment in our Company.

Our ability to become profitable depends primarily on our

ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research and

development (“R&D”) efforts, including the timing and cost of clinical trials;

have not emerged from the development stage, and may be unable to raise further equity.

These factors raise substantial doubt about our

ability to continue as a going concern.

The financial statements included elsewhere in this Form 10-K do not include any adjustments that

might result from the outcome of this uncertainty.

Because we are subject to these risks, you may

have a difficult time evaluating our business and your investment in our Company.

Our ability to become profitable depends primarily on

our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research

and development (“R&D”) efforts, including the timing and cost of clinical trials;

and our ability to enter into favorable

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be adversely affected.

Once a NDA is approved, the product covered thereby

Once an NDA is approved, the product covered thereby

becomes a “reference listed drug” (“RLD”), in the FDA’s publication, “Approved Drug Products with

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drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve an ANDA for a generic product

until any applicable period of non-patent exclusivity for the reference listed drug has expired.

The FDCA provides a period of five years

of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”).

An NCE is an active ingredient that has

not previously been approved by FDA in any other NDA.

Specifically, in cases where such exclusivity has been granted, an ANDA may not

be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that

a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant

may submit its application four years following approval of the reference listed drug.

If an ANDA is submitted to FDA with a Paragraph

IV Certification, the generic applicant must also provide a “Paragraph IV Notification” to the holder of the NDA for the RLD

and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of the basis for

the ANDA applicant’s position that the relevant patent(s) is invalid or would not be infringed.

If the patent owner brings a patent

infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA will be automatically

stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4 years and 5 years after

the NDA approval.

Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed.

The FDA may not approve an ANDA for a generic

product until any applicable period of non-patent exclusivity for the reference listed drug has expired.

The FDCA provides a period of

five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”).

An NCE is an active ingredient

that has not previously been approved by FDA in any other NDA.

Specifically, in cases where such exclusivity has been granted, an ANDA

may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification

that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the

applicant may submit its application four years following approval of the reference listed drug.

If an ANDA is submitted to FDA with a

Paragraph IV Certification, the generic applicant must also provide a “Paragraph IV Notification” to the holder of the NDA

for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of

the basis for the ANDA applicant’s position that the relevant patent(s) is invalid or would not be infringed.

If the patent owner

brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA

will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4

years and 5 years after the NDA approval.

Any such stay will be terminated earlier if the court rules that the patent is invalid or would

not be infringed.

Competition that our products may face from generic

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market exclusivity.

Even though BioVie has obtained two Orphan Drug Designations

for its lead product candidate, terlipressin, for treatment of ascites and for treatment of hepatorenal syndrome, and may seek other Orphan

Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie will be the

first to obtain marketing approval for any particular rare indication.

Further, even though BioVie has obtained Orphan Drug Designations

for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates, such designation

may not effectively protect BioVie from competition because different drugs can be approved for the same condition and the same drug can

be approved for different conditions and potentially used off-label in the Orphan indication.

Even after an Orphan Drug is approved, the

FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several reasons, including,

if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it makes a major contribution

to patient care.

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

any advantage in the regulatory review or approval process.

Even though BioVie has obtained two Orphan Drug

Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of hepatorenal syndrome, and may

seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie

will be the first to obtain marketing approval for any particular rare indication.

Further, even though BioVie has obtained Orphan Drug

Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates,

such designation may not effectively protect BioVie from competition because different drugs can be approved for the same condition and

the same drug can be approved for different conditions and potentially used off-label in the Orphan indication.

Even after an Orphan Drug

is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several

reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it

makes a major contribution to patient care.

Orphan Drug Designation neither shortens the development time or regulatory review time of

a drug, nor gives the drug any advantage in the regulatory review or approval process.

In addition, other companies have received Orphan

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have a materially adverse effect on our business.

Developing biopharmaceutical products, including conducting

pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires substantial funding.

Additional financing

will be required to fund the research and development of our product candidates.

We have not generated any product revenues, and do not

expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the FDA and other

regulatory authorities for our product candidates.

We may not have the resources to complete the development

and commercialization of any of our proposed product candidates.

We will require additional financing to further the clinical development

of our product candidates.

In the event that we cannot obtain the required financing, we will be unable to complete the development necessary

to file an NDA with the FDA for BIV201 or bezisterim (NE3107).

This will delay or require termination of research and development programs,

preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own laboratory

or a search for third party marketing partners to market our products for us, which could have a materially adverse effect on our business.

The amount of capital we may need will depend on many

factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of our preclinical

studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to establish our

own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market developments,

changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative, licensing

and other commercial relationships that we may establish.

Developing biopharmaceutical products, including

conducting pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires substantial funding.

financing will be required to fund the research and development of our product candidates.

We have not generated any product revenues,

and do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the

FDA and other regulatory authorities for our product candidates.

We may not have the resources to complete the

development and commercialization of any of our proposed product candidates.

We will require additional financing to further the clinical

development of our product candidates.

In the event that we cannot obtain the required financing, we will be unable to complete the development

necessary to file an NDA with the FDA for BIV201 or bezisterim (NE3107).

This will delay or require termination of research and development

programs, preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own

laboratory or a search for third party marketing partners to market our products for us, which could have a materially adverse effect

on our business.

The amount of capital we may need will depend

on many factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of

our preclinical studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to

establish our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market

developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative,

licensing and other commercial relationships that we may establish.

Until we can generate a sufficient amount of product

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and may not be able to successfully develop any drugs, which would cause us to cease operations.

We have never successfully developed a new drug and

brought it to market.

We have never successfully developed a new drug

and brought it to market.

Our management and clinical teams have experience in drug development but they may not be able to successfully

develop any drugs.

Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability

to develop products internally or to obtain rights to them from others on favorable terms;

Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability to

develop products internally or to obtain rights to them from others on favorable terms;

complete laboratory testing and human studies;

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forced to cease operations and you will lose all of your investment.

Development of pharmaceutical products is a

time-consuming process, subject to a number of risks, many of which are outside of our control.

Development of pharmaceutical products is

a time-consuming process, subject to a number of risks, many of which are outside of our control.

Consequently, we can provide no assurance

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ascites fluid accumulation during treatment versus pre-treatment.

In June 2023, the Company requested and subsequently received guidance

from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic

In June 2023 and December 2025, the Company requested and subsequently

received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of chronic

liver cirrhosis.

Over three years since the initial enrollment of this clinical trial, the Company is continuing to finalize protocol

designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating

clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites

who have recently recovered from AKI.

The proposed development schedules for our product

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bezisterim (NE3107), and the commercial viability of bezisterim (NE3107) if it were to be approved and marketed.

Any delay or further delay in the development, introduction

or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance characteristics

would not be competitive in the marketplace or in the shortening of their commercial lives.

In light of the long-term nature of our projects

and other risk factors described elsewhere in this document, we may not be able to successfully complete the development or marketing

of any drugs, which could cause us to cease operations.

Any delay or further delay in the development,

introduction or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance

characteristics would not be competitive in the marketplace or in the shortening of their commercial lives.

In light of the long-term

nature of our projects and other risk factors described elsewhere in this document, we may not be able to successfully complete the development

or marketing of any drugs, which could cause us to cease operations.

From time to time, the FDA may have feedback on

our clinical trial designs, including for example certain of our endpoints and outcome measures.

As a result, we may consider

revisions to our protocols which may delay progress in implementing our trials.

We may fail to successfully develop and

commercialize our product candidate(s) if it is found to be unsafe or ineffective in clinical trials;

does not receive necessary

approval from the FDA or foreign regulatory agencies;

fails to conform to a changing standard of care for the disease it seeks to

or is less effective or more expensive than current or alternative treatment methods.

Drug development failure can occur at any stage of

clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated clinical

Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses, and

we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could

be required before we submit our product candidates for approval.

We cannot guarantee that the FDA or comparable foreign regulatory authorities

will view our product candidates as having efficacy even if positive results are observed in clinical trials.

In some instances, there

can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous

factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes

in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants.

If the results of our ongoing

or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical endpoints

with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates, we may

be delayed in obtaining marketing approval, if at all.

Additionally, any safety concerns observed in any one of our clinical trials in

our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications.

also do not know what the long-term effects of exposure to our product candidates will be.

Furthermore, our product candidates may be

used in combination with other treatments and there can be no assurance that such use will not lead to unique or unexpected safety issues.

Failure to complete clinical trials or to prove that

our product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require

As a result, we may consider revisions

to our protocols which may delay progress in implementing our trials.

We may fail to successfully develop and commercialize our product

candidate(s) if it is found to be unsafe or ineffective in clinical trials;

does not receive necessary approval from the FDA or foreign

regulatory agencies;

fails to conform to a changing standard of care for the disease it seeks to treat;

or is less effective or more expensive

than current or alternative treatment methods.

Drug development failure can occur at any stage

of clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated

clinical targets.

Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses,

and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials

could be required before we submit our product candidates for approval.

We cannot guarantee that the FDA or comparable foreign regulatory

authorities will view our product candidates as having efficacy even if positive results are observed in clinical trials.

In some instances,

there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due

to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations,

changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants.

If the results of

our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical

endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates,

we may be delayed in obtaining marketing approval, if at all.

Additionally, any safety concerns observed in any one of our clinical trials

in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications.

We also do not know what the long-term effects of exposure to our product candidates will be.

Furthermore, our product candidates may

be used in combination with other treatments and there can be no assurance that such use will not lead to unique or unexpected safety

Failure to complete clinical trials or to prove

that our product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require

us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.

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been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

At any time and for any reason, we may determine that

one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to warrant

the allocation of resources toward such program or drug candidate.

Accordingly, we may choose not to develop a potential drug candidate

or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates or programs.

At any time and for any reason, we may determine

that one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to

warrant the allocation of resources toward such program or drug candidate.

Accordingly, we may choose not to develop a potential drug

candidate or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates

For example, BIV201 has received Orphan Drug designation for HRS.

On June 23, 2021, we announced that FDA has provided guidance on our

planned Phase 3 clinical trial of BIV201 in (HRS-AKI) and have since reached agreement on the key elements of the trial design.

we deprioritized HRS-AKI program to focus on bezisterim (NE3107).

When we suspend, deprioritize or terminate a program or drug candidate

in which we have invested significant resources, we will have expended resources on a program that will not provide a full return on our

investment and may have missed the opportunity to have allocated those resources to potentially more productive uses, including existing

or future programs or drug candidates.

We have no manufacturing experience, and the

failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.

On June 23, 2021, we announced that FDA has provided guidance

on our planned Phase 3 clinical trial of BIV201 in (HRS-AKI) and have since reached agreement on the key elements of the trial design.

Thereafter, we deprioritized HRS-AKI program to focus on bezisterim (NE3107).

When we suspend, deprioritize or terminate a program or

drug candidate in which we have invested significant resources, we will have expended resources on a program that will not provide a full

return on our investment and may have missed the opportunity to have allocated those resources to potentially more productive uses, including

existing or future programs or drug candidates.

We have no manufacturing experience, and

the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.

We have never manufactured products in the highly

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and increase our operating expenses.

If our existing third-party manufacturers, or the

third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to continue

to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to meet commercial

demand or to advance our clinical trials while we identify and qualify replacement suppliers.

If for any reason we are unable to obtain

adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture it, it will be

more difficult for us to compete effectively, generate revenue, and further develop our products.

In addition, if we are unable to assure

a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity to which the

product otherwise would be entitled.

If our existing third-party manufacturers, or

the third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to

continue to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to

meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers.

If for any reason we are

unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture

it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products.

In addition, if we are

unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity

to which the product otherwise would be entitled.

We do not currently have the sales and marketing

personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.

We are an early stage development company with limited

Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff at this

early stage of operations to sell products.

We cannot generate sales without sales or marketing staff and must rely on others to provide

any sales or marketing services until such personnel are secured, if ever.

If we fail to hire and retain the requisite expertise in order

to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff, then we could

be forced to cease operations and you could lose all of your investment.

Even if we were to successfully develop approvable

drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations, which

could have a materially adverse effect on our business.

If we were to successfully develop approvable drugs,

before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing

We are an early stage development company with

limited resources.

Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff

at this early stage of operations to sell products.

We cannot generate sales without sales or marketing staff and must rely on others

to provide any sales or marketing services until such personnel are secured, if ever.

If we fail to hire and retain the requisite expertise

in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff,

then we could be forced to cease operations and you could lose all of your investment.

Even if we were to successfully develop

approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations,

which could have a materially adverse effect on our business.

If we were to successfully develop approvable

drugs, before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing

facility and process of the third party or parties with whom we may outsource our manufacturing activities.

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materially adverse effect on our business.

The R&D, manufacture and marketing of drug product

candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries.

national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing

in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and promotion

of the product that we are developing.

Noncompliance with applicable requirements can result in various adverse consequences, including

approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations, revocation

of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping

drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts.

The process of obtaining FDA approval is costly and

time consuming.

The R&D, manufacture and marketing of drug

product candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries.

These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including

testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and

promotion of the product that we are developing.

Noncompliance with applicable requirements can result in various adverse consequences,

including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations,

revocation of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions

against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply

The process of obtaining FDA approval is costly

and time consuming.

Current FDA requirements for a new human drug or biological product to be marketed in the United States include, among

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process takes several years and requires significant resources.

If we experience delays or discontinuations of our

clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of our

products or devices then we could be forced to cease our operations and you will lose all of your investment.

Even if we are successful in developing BIV201 and

bezisterim (NE3107), our product candidates, we have limited experience in conducting or supervising clinical trials that must be performed

to obtain data to submit in concert with applications for approval by the FDA.

The regulatory process to obtain approval for drugs for

commercial sale involves numerous steps.

Drugs are subjected to clinical trials that allow development of case studies to examine safety,

efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the

In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials

to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved

for sale which could have a materially adverse effect on our business.

We depend upon our management and their loss

or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business.

If we experience delays or discontinuations of

our clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of

our products or devices then we could be forced to cease our operations and you will lose all of your investment.

Even if we are successful in developing BIV201

and bezisterim (NE3107), our product candidates, we have limited experience in conducting or supervising clinical trials that must be

performed to obtain data to submit in concert with applications for approval by the FDA.

The regulatory process to obtain approval for

drugs for commercial sale involves numerous steps.

Drugs are subjected to clinical trials that allow development of case studies to examine

safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including

In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such

trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be

approved for sale which could have a materially adverse effect on our business.

We depend upon our management and their

loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business.

We currently depend upon the efforts and abilities

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of key-person life insurance.

We may not be able to attract and retain highly

skilled personnel, which could have a materially adverse effect on our business.

Our ability to attract and retain highly skilled personnel

is critical to our operations and expansion.

We face competition for these types of personnel from other pharmaceutical companies and

more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources

We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all.

If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition and results of operations

will be materially and adversely affected.

The biotechnology and biopharmaceutical industries

are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with enterprises equipped

with more substantial resources than us, which could cause us to curtail or cease operations.

We may not be able to attract and retain

highly skilled personnel, which could have a materially adverse effect on our business.

Our ability to attract and retain highly skilled

personnel is critical to our operations and expansion.

We face competition for these types of personnel from other pharmaceutical companies

and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other

resources than us.

We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or

If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition and results

of operations will be materially and adversely affected.

The biotechnology and biopharmaceutical

industries are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with enterprises

equipped with more substantial resources than us, which could cause us to curtail or cease operations.

The biotechnology and biopharmaceutical industries

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technological developments and the ability to obtain government approval for testing, manufacturing and marketing.

We compete with biopharmaceutical firms in the United

States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations.

We compete with biopharmaceutical firms in the

United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to

their operations.

Many biopharmaceutical companies have focused their development efforts in the human therapeutics area.

Many major pharmaceutical companies

have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies.

These companies, as well as academic institutions, government agencies and private research organizations, also compete with us in recruiting

and retaining highly qualified scientific personnel and consultants.

Our ability to compete successfully with other companies in the pharmaceutical

field will also depend to a considerable degree on the continuing availability of capital to us.

Although there are not currently any therapies approved

by the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market risk.

companies, such as Ocelot Bio, are developing therapies for severe complications of advanced liver cirrhosis, which may in the future

be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our product candidate.

other companies, such as Biogen and Eli Lilly, are developing treatments for AD and PD, which could compete indirectly or directly with

our product candidate.

Many major pharmaceutical

companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical

These companies, as well as academic institutions, government agencies and private research organizations, also compete with

us in recruiting and retaining highly qualified scientific personnel and consultants.

Our ability to compete successfully with other companies

in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us.

Although there are not currently any therapies

approved by the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market

Other companies, such as Ocelot Bio, are developing therapies for severe complications of advanced liver cirrhosis, which may in

the future be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our product candidate.

Similarly, other companies, such as Biogen and Eli Lilly, are developing treatments for AD and PD, which could compete indirectly or directly

with our product candidate.

There may be other competitive development programs of which we are unaware.

Even if our product candidates are

ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt them in favor of current ascites

Even if our product candidates

are ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt them in favor of current ascites

treatment procedures such as diuretics and paracentesis with respect to BIV201 and AD and PD with respect to bezisterim (NE3107).

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which may cause you to lose all of your investment.

Our competition will be determined in part by the

potential indications for which drugs are developed and ultimately approved by regulatory authorities.

Additionally, the timing of the

market introduction of some of our potential product candidate or of competitors’ products may be an important competitive factor.

Our competition will be determined in part by

the potential indications for which drugs are developed and ultimately approved by regulatory authorities.

Additionally, the timing of

the market introduction of some of our potential product candidate or of competitors’ products may be an important competitive factor.

Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and

2 unchanged sentences

be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.

The successful development of biopharmaceuticals is

highly uncertain.

A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon the development

of our product candidates.

There may be conflicts of interest among our

officers, directors and stockholders.

Certain of our executive officers and directors and

their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons.

The successful development of biopharmaceuticals

is highly uncertain.

A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon the

development of our product candidates.

There may be conflicts of interest among

our officers, directors and stockholders.

Certain of our executive officers and directors

and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons.

Neither we nor any of our shareholders will have any rights in these ventures or their income or profits.

9 unchanged sentences

policies in place to deal with such conflicting fiduciary duties should such a conflict arise.

We indemnify our officers and directors against

liability to us and our security holders, and such indemnification could increase our operating costs.

Our Articles of Incorporation and Bylaws require us

to indemnify our officers and directors against claims associated with carrying out the duties of their offices.

We indemnify our officers and directors

against liability to us and our security holders, and such indemnification could increase our operating costs.

Our Articles of Incorporation and Bylaws require

us to indemnify our officers and directors against claims associated with carrying out the duties of their offices.

We are also required

18 unchanged sentences

or circumvented.

We have pending patent applications for our

liquid formulations of terlipressen the following jurisdictions which claim priority to PCT/US2020/034269 filed on May 22, 2020 and published

We have five (5) granted and seven (7) pending

patent applications for our liquid formulations of terlipressen that claim priority to PCT/US2020/034269 filed on May 22, 2020 and published

as WO2020/237170.

US, Europe, China, and Japan and 6 other jurisdictions.

In two jurisdictions, we have patents for our liquid formulations

of terlipressen which claim priority to PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170.

We also have thirteen

(13) issued U.S.

patents, six (6) pending U.S.

applications, three (3) pending Patent Cooperation Treaty applications, six (6) issued

foreign patents, and six (6) pending foreign patent applications directed to protecting bezisterm (NE3107) and related compounds and

methods of making and using thereof.

However, there can be no assurance that our pending patent applications will result in issued patents,

or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, bezisterim

(NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance

that any issued patents will provide us with any competitive advantage.

We cannot be certain that there is no invalidating prior art of

which we and the patent examiner are unaware or that our interpretation of the relevance of prior art is correct.

If a third-party patent

or patent application is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing

in a form that provides any competitive advantage for our drug candidates.

Failure to obtain additional issued patents could have a material

adverse effect on our ability to develop and commercialize our drug candidates.

Even if our patent applications do issue as patents, third

parties may be able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s

patents and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one

or more licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug

We seek to protect our proprietary

positions by, among other things, filing patent applications in the United States and abroad related to our current drug candidates and

other drug candidates that we may identify.

Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming

and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license

any patents that may issue from such patent applications, at a reasonable cost or in a timely manner.

It is also possible that we will

fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

under certain of our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and

maintenance of patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee

of a number of U.S.

We also have thirteen (13) issued U.S.

patents, five (5) pending U.S.

applications, three(3) pending Patent Cooperation

Treaty applications four (4) issued foreign patents and eight (8) pending foreign patent applications directed to protecting bezisterim

(NE3107) and related compounds and methods of making and using thereof.

However, there can be no assurance that our pending patent applications

will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad

to protect BIV201, bezisterim (NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance that any issued patents

will provide us with any competitive advantage.

We cannot be certain that there is no invalidating prior art of which we and the patent

examiner are unaware or that our interpretation of the relevance of prior art is correct.

If a third-party patent or patent application

is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides

any competitive advantage for our drug candidates.

Failure to obtain additional issued patents could have a material adverse effect on

our ability to develop and commercialize our drug candidates.

Even if our patent applications do issue as patents, third parties may be

able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s patents

and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more

licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by,

among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates

that we may identify.

Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming and complex, and

we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents

that may issue from such patent applications, at a reasonable cost or in a timely manner.

It is also possible that we will fail to identify

patentable aspects of our research and development output before it is too late to obtain patent protection.

Moreover, under certain of

our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of

patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee of a number of U.S.

provisional patent applications.

provisional patent applications are not eligible to become issued patents until,

among other things, we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent

applications.

With regard to such U.S.

provisional patent applications, if we do not timely file any non-provisional patent applications,

we may lose our priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed

in our provisional patent applications.

Further, in the event that we do timely file non-provisional patent applications relating to our

provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such

issued patents will provide us with any competitive advantage.

As to our material inventions,

trade secrets, and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose

and assign to us all inventions conceived during the workday, using our property, or which relate to our business.

However, any of these

parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to

seek patent protection.

Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications

in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all.

we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications,

or that we were the first to file for patent protection of such inventions.

The patent position of pharmaceutical

companies generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the

subject of much debate and litigation throughout the world.

In addition, the laws of foreign countries may not protect our rights to the

same extent as the laws of the United States, or vice versa.

provisional patent applications are not eligible to become issued patents until, among other things,

we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications.

regard to such U.S.

provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our

priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional

patent applications.

Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent

applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents

will provide us with any competitive advantage.

As to our material inventions, trade secrets,

and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose and assign

to us all inventions conceived during the workday, using our property, or which relate to our business.

However, any of these parties

may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent

Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United

States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all.

Therefore, we cannot

know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we

were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies

generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject

of much debate and litigation throughout the world.

In addition, the laws of foreign countries may not protect our rights to the same

extent as the laws of the United States, or vice versa.

The standards that the United States Patent and Trademark Office (the “USPTO”)

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patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is

not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices

in the United States and abroad.

We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved

in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent

rights or the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention

or other features of patentability.

An adverse determination in any such submission, proceeding or litigation could result in loss of

exclusivity or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated

or held unenforceable, in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all

of which could limit our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete

directly with us, without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products

(if any) without infringing third-party patent rights.

In addition, if the breadth or strength of the claims of our patents and patent

applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize

current or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research

programs or clinical trials.

Such proceedings also may result in substantial cost and require significant time from our scientists and

management, even if the eventual outcome is favorable to us.

In addition, given the amount

of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire

before or shortly after such candidates are commercialized.

As a result, our patent portfolio may not provide us with sufficient rights

to exclude others from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all.

Moreover, some of our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties.

we are unable to obtain exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners

may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products

and technology.

In addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties,

and such cooperation may not be provided to us.

Any of the foregoing could harm our competitive position, business, financial condition,

results of operations and prospects.

we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures

to protect our rights in the technology.

If any trade secret, know-how or other technology not protected by a patent were to be disclosed

to or independently developed by a competitor, our business and financial condition could be materially and adversely affected.

of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant

problems in protecting our proprietary rights in these countries.

depends in significant part on our ability to obtain, maintain, enforce and defend patents and other intellectual property rights with

respect to our drug candidates and technology and to operate our business without infringing, misappropriating, or otherwise violating

the intellectual property rights of others.

If we are unable to obtain and maintain sufficient intellectual property protection for our

drug candidates or other drug candidates that we may identify, or if the scope of the intellectual property protection obtained is not

sufficiently broad, our competitors and other third parties could develop and commercialize drug candidates similar or identical to ours,

and our ability to successfully commercialize our drug candidates and other drug candidates that we may pursue may be impaired.

Confidentiality agreements with employees and

others may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets or

proprietary information could compromise any competitive advantage that we have, which could have a materially adverse effect on our business.

Our success depends, in part,

on our ability to protect our proprietary rights to the technologies used in our product candidates.

We depend heavily upon confidentiality

agreements with our officers, employees, consultants and subcontractors to maintain the proprietary nature of our technology.

These measures

may not afford us complete or even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure

of confidential information.

If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more

effectively against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our

attempts to recover or restrict use of our intellectual property.

In addition, others may independently develop technology similar to

ours, otherwise avoiding the confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects,

financial condition and results of operations, in which event you could lose all of your investment.

The issuance of a patent is not conclusive as

to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United

States and abroad.

We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition,

derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or

the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other

features of patentability.

An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity

or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable,

in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit

our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us,

without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without

infringing third-party patent rights.

In addition, if the breadth or strength of the claims of our patents and patent applications is

threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current

or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs

or clinical trials.

Such proceedings also may result in substantial cost and require significant time from our scientists and management,

even if the eventual outcome is favorable to us.

In addition, given the amount of time required

for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly

after such candidates are commercialized.

As a result, our patent portfolio may not provide us with sufficient rights to exclude others

from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all.

Moreover, some of

our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties.

If we are unable to obtain

exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners may be able to license

their rights to other third parties, including our competitors, and our competitors could market competing products and technology.

addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties, and such cooperation

may not be provided to us.

Any of the foregoing could harm our competitive position, business, financial condition, results of operations

and prospects.

Further, we rely on a combination of trade secrets,

know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology.

If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor,

our business and financial condition could be materially and adversely affected.

The laws of some foreign countries do not protect our

proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary

rights in these countries.

Our success depends in significant part on our

ability to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to our drug candidates and

technology and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights of

If we are unable to obtain and maintain sufficient intellectual property protection for our drug candidates or other drug candidates

that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors and

other third parties could develop and commercialize drug candidates similar or identical to ours, and our ability to successfully commercialize

our drug candidates and other drug candidates that we may pursue may be impaired.

Confidentiality agreements with employees

and others may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets

or proprietary information could compromise any competitive advantage that we have, which could have a materially adverse effect on our

Our success depends, in part, on our ability to

protect our proprietary rights to the technologies used in our product candidates.

We depend heavily upon confidentiality agreements with

our officers, employees, consultants and subcontractors to maintain the proprietary nature of our technology.

These measures may not afford

us complete or even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential

If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively against

us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts to recover

or restrict use of our intellectual property.

In addition, others may independently develop technology similar to ours, otherwise avoiding

the confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition

and results of operations, in which event you could lose all of your investment.

We may enter into licensing and collaboration

3 unchanged sentences

with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be

It may be necessary for us to

use the patented or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required

to obtain a license from these third parties.

The licensing of third-party intellectual property rights is a competitive area, and more

established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive

or necessary.

More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical

development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign

or license rights to us.

We also may be unable to license or acquire third-party intellectual property rights on terms that would allow

us to make an appropriate return on our investment or at all.

If we are unable to license such technology, or if we are forced to license

such technology on unfavorable terms, our business could be materially harmed.

We may fail to obtain any of

these licenses or intellectual property rights on commercially reasonable terms.

Even if we are able to obtain a license, it may be non-exclusive,

thereby giving our competitors access to the same technologies licensed to us.

Licenses may not provide us with exclusive rights to use

the applicable intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop

or commercialize our drug candidates, products (if approved) and technology in the future.

In that event, we may be required to expend

significant time and resources to develop or license replacement technology.

If we are unable to do so, we may be unable to develop or

commercialize the affected products, which could materially harm our business and the third parties owning such intellectual property

rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties

and/or other forms of compensation.

Conversely, we may not always be able to successfully pursue our claims against others that infringe

upon our technology.

Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against

competitors, and we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances,

we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce

the patents that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities.

current or future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents

and other intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our

drug candidates or technology that are the subject of such licensed rights could be adversely affected.

In addition, our licensors may

own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their

merit, that we are infringing or otherwise violating the licensor’s rights.

If we fail to comply with our

obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which

we license intellectual property rights from third parties, the licensor may have the right to terminate the license.

If any of our license

agreements is terminated, the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions

to our business relationships with our licensors, we could lose intellectual property rights that are important to our business or be

prevented from developing and commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval

of, and to market, products identical to ours.

Termination of these agreements or reduction or elimination of our rights under these agreements

may also result in our having to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these

agreements, including our rights to important intellectual property or technology, or impede, delay or prohibit the further development

or commercialization of one or more drug candidates that rely on such agreements.

It is possible that we may be unable to obtain any additional

licenses at a reasonable cost or on reasonable terms, if at all.

In that event, we may be required to expend significant time and resources

to redesign our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may

not be feasible on a technical or commercial basis

Licensing of intellectual property

is of critical importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual

property license agreements may be susceptible to multiple interpretations.

It may be necessary for us to use the patented

or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required to obtain a

license from these third parties.

The licensing of third-party intellectual property rights is a competitive area, and more established

companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary.

More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development

and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights

We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate

return on our investment or at all.

If we are unable to license such technology, or if we are forced to license such technology on unfavorable

terms, our business could be materially harmed.

We may fail to obtain any of these licenses or

intellectual property rights on commercially reasonable terms.

Even if we are able to obtain a license, it may be non-exclusive, thereby

giving our competitors access to the same technologies licensed to us.

Licenses may not provide us with exclusive rights to use the applicable

intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize

our drug candidates, products (if approved) and technology in the future.

In that event, we may be required to expend significant time

and resources to develop or license replacement technology.

If we are unable to do so, we may be unable to develop or commercialize the

affected products, which could materially harm our business and the third parties owning such intellectual property rights could seek

either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms

of compensation.

Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology.

Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors, and

we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances, we may not

have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce the patents

that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities.

If our current or

future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents and other

intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our drug candidates

or technology that are the subject of such licensed rights could be adversely affected.

In addition, our licensors may own or control

intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that

we are infringing or otherwise violating the licensor’s rights.

If we fail to comply with our obligations, including

the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual

property rights from third parties, the licensor may have the right to terminate the license.

If any of our license agreements is terminated,

the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions to our business relationships

with our licensors, we could lose intellectual property rights that are important to our business or be prevented from developing and

commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval of, and to market, products identical

Termination of these agreements or reduction or elimination of our rights under these agreements may also result in our having

to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these agreements, including our

rights to important intellectual property or technology, or impede, delay or prohibit the further development or commercialization of

one or more drug candidates that rely on such agreements.

It is possible that we may be unable to obtain any additional licenses at a

reasonable cost or on reasonable terms, if at all.

In that event, we may be required to expend significant time and resources to redesign

our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible

on a technical or commercial basis

Licensing of intellectual property is of critical

importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual property

license agreements may be susceptible to multiple interpretations.

Disputes may arise between us and our licensing partners regarding

1 unchanged sentence

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

· whether and the extent to which technology and processes of one party infringe intellectual property of

the other party that are not subject to the licensing agreement;

whether and the extent to which technology and processes of one party infringe intellectual property of the other party that are not subject to the licensing agreement;

rights to sublicense patent and other rights to third parties;

· any diligence obligations with respect to the use of the licensed technology in relation to development

and commercialization of our drug candidates, and what activities satisfy those diligence obligations;

any diligence obligations with respect to the use of the licensed technology in relation to development and commercialization of our drug candidates, and what activities satisfy those diligence obligations;

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property;

1 unchanged sentence

the effects of termination.

The resolution of any contract

interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property

or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could

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

If disputes over intellectual property that we have licensed

prevent or impair our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully

develop and commercialize the affected drug candidates.

Moreover, any dispute or disagreement with our licensing partners may result in

the delay or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may

result in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which

may adversely affect our business, financial condition, results of operations and prospects.

Furthermore, current and future

collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the

products or potential products that are the subject of these collaborations.

Competing products, either developed by our collaborators

or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support

for our drug candidates.

The resolution of any contract interpretation

disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology,

or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could harm our business,

financial condition, results of operations and prospects.

If disputes over intellectual property that we have licensed prevent or impair

our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully develop and

commercialize the affected drug candidates.

Moreover, any dispute or disagreement with our licensing partners may result in the delay

or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may result

in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which may adversely

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

Furthermore, current and future collaborators

or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential

products that are the subject of these collaborations.

Competing products, either developed by our collaborators or strategic partners

or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our drug candidates.

Any of these developments could harm our product development efforts.

In addition, if our licensors

fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or

other rights are found to be invalid or unenforceable, our business, competitive position, financial condition, results of operations

and prospects could be materially harmed.

Some of our intellectual property may be subject

to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies

In addition, if our licensors fail to abide by

the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or other rights are

found to be invalid or unenforceable, our business, competitive position, financial condition, results of operations and prospects could

be materially harmed.

Some of our intellectual property may be

subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies

if it is determined that our intellectual property has been discovered through government-funded programs.

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manufacturers.

Some of the intellectual property

rights we have acquired or licensed or may acquire or license in the future may have been generated through the use of U.S.

funding and may therefore be subject to certain federal regulations.

government rights include a non-exclusive, non-transferable,

irrevocable worldwide license to use inventions for any governmental purpose.

Some of the intellectual property rights we have

acquired or licensed or may acquire or license in the future may have been generated through the use of U.S.

government funding and may

therefore be subject to certain federal regulations.

government rights include a non-exclusive, non-transferable, irrevocable

worldwide license to use inventions for any governmental purpose.

In addition, the U.S.

government has the right, under certain

limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to

a third party if it determines that:

government has the right, under certain limited

circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third

party if it determines that:

(i) adequate steps have not been taken to commercialize the invention;

(ii) government action is

necessary to meet public health or safety needs;

or (iii) government action is necessary to meet requirements for public use under federal

regulations (also referred to as “march-in rights”).

government also has the right to take title to these inventions

if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual

property within specified time limits.

Intellectual property generated under a government funded program is also subject to certain reporting

requirements, compliance with which may require us to expend substantial resources.

(ii) government action is necessary

to meet public health or safety needs;

or (iii) government action is necessary to meet requirements for public use under federal regulations

(also referred to as “march-in rights”).

government also has the right to take title to these inventions if the grant

recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within

specified time limits.

Intellectual property generated under a government funded program is also subject to certain reporting requirements,

compliance with which may require us to expend substantial resources.

In addition, the U.S.

government requires that any

products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the

United States.

This preference for U.S.

industry may be waived by the federal agency that provided the funding if the owner or assignee

of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential

licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture

is not commercially feasible.

government requires that any products embodying

any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States.

preference for U.S.

industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual

property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that

would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially

This preference for U.S.

industry may limit our ability to contract with non-U.S.

product manufacturers

for products relating to such intellectual property.

To the extent any of our future intellectual property is also generated through the

government funding, the provisions of the Bayh-Dole Act may similarly apply.

product manufacturers for products relating

to such intellectual property.

To the extent any of our future intellectual property is also generated through the use of U.S.

funding, the provisions of the Bayh-Dole Act may similarly apply.

Patent terms may be inadequate to establish

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Patents have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest

non-provisional filing date.

In the United

States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional

Various extensions may be available, but the life of a patent, and the protection it affords, is limited.

Even if patents directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to

competition from competitive medications, including generic versions.

Given the amount of time required for the development, testing and

regulatory review of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug

candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude

others from commercializing drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration

and conditions of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S.

patents may be eligible

for limited patent term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries.

The Hatch-Waxman

Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent

term lost during product development and the FDA regulatory review process.

However, we may not receive an extension if we fail to exercise

due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to

expiration of relevant patents or otherwise fail to satisfy applicable requirements.

Moreover, the length of the extension could be less

than we request.

Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years

from approval and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended.

we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can

enforce our patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing

products sooner.

Even if patents

directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from

competitive medications, including generic versions.

Given the amount of time required for the development, testing and regulatory review

of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing

drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions

of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S.

patents may be eligible for limited patent

term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries.

The Hatch-Waxman Act permits

a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during

product development and the FDA regulatory review process.

However, we may not receive an extension if we fail to exercise due diligence

during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of

relevant patents or otherwise fail to satisfy applicable requirements.

Moreover, the length of the extension could be less than we request.

Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval

and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended.

If we are unable

to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our

patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products

As a result, our revenue from applicable products could be reduced.

Further, if this occurs, our competitors may take

advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier

than might otherwise be the case, and our competitive position, business, financial condition, results of operations and prospects could

be materially harmed.

Further, if this occurs, our competitors may take advantage

of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might

otherwise be the case, and our competitive position, business, financial condition, results of operations and prospects could be materially

We may not be able to protect our intellectual

property rights throughout the world.

Filing, prosecuting, maintaining,

defending and enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently

our intellectual property rights in some countries outside the United States may be less extensive than those in the United States.

addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws

in the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside

the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export

otherwise infringing products to territories where we have patents, but enforcement rights are not as strong as those in the United States.

These products may compete with our drug candidates and our patents or other intellectual property rights may not be effective or sufficient

to prevent them from competing.

Many companies have encountered

significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of some countries

do not favor the enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for

us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary

rights generally.

Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and

divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted

narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail

in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including

some EU countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified

circumstances to grant licenses to third parties.

In addition, many countries limit the enforceability of patents against government agencies

or government contractors.

In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a

license to a third party, which could materially diminish the value of the applicable patents and limit our potential revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial

advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results

of operations and prospects.

In 2012, the European Patent

Package, or EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European

Unified Patent Court (“UPC”), for litigation involving European patents.

Implementation of the EU Patent Package occurred

Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by default

automatically fall under the jurisdiction of the UPC.

The UPC will provide our competitors with a new forum to centrally revoke our European

patents, and allow for the possibility of a competitor to obtain pan-European injunctions.

It will be several years before we will understand

the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC.

Patent Package as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court’s

existence, but doing so may preclude us from realizing the benefits of the new unified court.

Changes in patent law could diminish the value

of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents

in the pharmaceutical industry is inherently uncertain, due in part to ongoing changes in the patent laws.

For example, in the United

States, depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation

thereof, could change in unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new

patents or to enforce existing or future patents.

Filing, prosecuting, maintaining, defending and

enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently our

intellectual property rights in some countries outside the United States may be less extensive than those in the United States.

the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States,

or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may

use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export otherwise infringing

products to territories where we have patents, but enforcement rights are not as strong as those in the United States.

These products

may compete with our drug candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent

them from competing.

Many companies have encountered significant problems

in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of some countries do not favor the

enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the

infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally.

Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts

and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent

applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that

we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including some EU countries,

India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant

licenses to third parties.

In addition, many countries limit the enforceability of patents against government agencies or government contractors.

In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party,

which could materially diminish the value of the applicable patents and limit our potential revenue opportunities.

Accordingly, our efforts

to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual

property that we develop or license, which could adversely affect our business, financial condition, results of operations and prospects.

In 2012, the European Patent Package, or EU Patent

Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court

(“UPC”), for litigation involving European patents.

Implementation of the EU Patent Package occurred in 2023.

Under the UPC,

all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall

under the jurisdiction of the UPC.

The UPC will provide our competitors with a new forum to centrally revoke our European patents, and

allow for the possibility of a competitor to obtain pan-European injunctions.

It will be several years before we will understand the scope

of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC.

Under the EU Patent Package

as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court’s existence,

but doing so may preclude us from realizing the benefits of the new unified court.

Changes in patent law could diminish the

value of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents in the pharmaceutical

industry is inherently uncertain, due in part to ongoing changes in the patent laws.

For example, in the United States, depending on decisions

by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in

unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new patents or to enforce

existing or future patents.

For example, the U.S.

Supreme Court has ruled on several patent cases in recent years,

either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain

Therefore, there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain

patents in the future, as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could

increase the uncertainties and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications

and the enforcement or defense of our or our collaborators’ or licensors’ issued patents.

For example, assuming that other

requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled

to the patent, while outside the United States, the first to file a patent application was entitled to the patent.

After March 2013, under

the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), enacted in September 2011, the United States transitioned to

a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent

application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.

The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications are prosecuted and may also

affect patent litigation.

These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional

procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes

review and derivation proceedings.

The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act,

and many of the substantive changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions.

Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business.

However, the Leahy-Smith

Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our or our licensors’ patent

applications and the enforcement or defense of our or our licensors’ issued patents.

Similarly, statutory or judicial changes to

the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the

enforcement or defense of issued patents.

Any of the foregoing could harm our business, financial condition, results of operations and

Supreme Court has ruled on several patent cases in recent years, either narrowing the

scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.

there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain patents in the future,

as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties

and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications and the enforcement

or defense of our or our collaborators’ or licensors’ issued patents.

For example, assuming that other requirements for patentability

are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside

the United States, the first to file a patent application was entitled to the patent.

After March 2013, under the Leahy-Smith America

Invents Act (the “Leahy-Smith Act”), enacted in September 2011, the United States transitioned to a first inventor to file

system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled

to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.

The Leahy-Smith Act also

includes a number of significant changes that affect the way patent applications are prosecuted and may also affect patent litigation.

These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge

the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation

The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive

changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions.

Accordingly, it is not

clear what, if any, impact the Leahy-Smith Act will have on the operation of our business.

However, the Leahy-Smith Act and its implementation

could increase the uncertainties and costs surrounding the prosecution of our or our licensors’ patent applications and the enforcement

or defense of our or our licensors’ issued patents.

Similarly, statutory or judicial changes to the patent laws of other countries

may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.

Any of the foregoing could harm our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect

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towards our technology and drug candidates could be found invalid or unenforceable if challenged.

We are not aware that our patents

directed to either BIV201 or bezisterim (NE3107), the product candidates we are currently developing, are infringed by third parties.

However, there can be no assurance that our patents will not be found in the future to be infringed by others.

Any patents we do obtain

may be challenged by reexamination or otherwise invalidated or eventually found unenforceable.

Both the patent application process and

the process of managing patent disputes can be time-consuming and expensive.

Significantly, our pending patent

applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent

issues from such applications.

We are not aware that our patents directed to

either BIV201 or bezisterim (NE3107), the product candidates we are currently developing, are infringed by third parties.

However, there

can be no assurance that our patents will not be found in the future to be infringed by others.

Any patents we do obtain may be challenged

by reexamination or otherwise invalidated or eventually found unenforceable.

Both the patent application process and the process of managing

patent disputes can be time-consuming and expensive.

Significantly, our pending patent applications

cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from

such applications.

Our ability to enforce patent rights also depends on our ability to identify infringement.

It may be difficult

to identify infringers who do not advertise the components or methods that are used in connection with their products and services.

it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that

we infringe their patents or that our patents are invalid or unenforceable.

In a patent infringement proceeding, a court may decide that

a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other

party from using the technology at issue on the grounds that our patents do not cover the technology.

An adverse result in any litigation

proceeding could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly.

We may find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal

proceedings against a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant

could counterclaim that our patent is invalid or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging

invalidity or unenforceability are commonplace.

Grounds for a validity challenge could be an alleged failure to meet any of several statutory

requirements, including lack of novelty, obviousness, non-enablement or insufficient written description.

Grounds for a presentability

assertion could be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or

made a misleading statement during prosecution.

Third parties may also raise similar claims before the USPTO or an equivalent foreign

body, even outside the context of litigation.

Potential proceedings include reexamination, post-grant review, inter partes review,

interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our

technology or any drug candidates that we may develop.

It may be difficult to identify

infringers who do not advertise the components or methods that are used in connection with their products and services.

Moreover, it may

be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe

their patents or that our patents are invalid or unenforceable.

In a patent infringement proceeding, a court may decide that a patent

of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party

from using the technology at issue on the grounds that our patents do not cover the technology.

An adverse result in any litigation proceeding

could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly.

find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal proceedings against

a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim

that our patent is invalid or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity or

unenforceability are commonplace.

Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements,

including lack of novelty, obviousness, non-enablement or insufficient written description.

Grounds for a presentability assertion could

be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or made a misleading

statement during prosecution.

Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside

the context of litigation.

Potential proceedings include reexamination, post-grant review, inter partes review, interference proceedings,

derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

Such proceedings could result

in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug

candidates that we may develop.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent

examiner were unaware during prosecution.

to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner

were unaware during prosecution.

These assertions may also be based on information known to us or the USPTO.

If a defendant were

to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights

directed towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable.

Such a loss of

patent rights would materially harm our business, financial condition, results of operations and prospects.

Interference proceedings provoked

by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our

patents or patent applications.

An unfavorable outcome could require us to cease using the related technology or to attempt to license

rights to it from the prevailing party.

Our business could be materially harmed if the prevailing party does not offer us a license on

commercially reasonable terms or at all.

Furthermore, because of the

substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential

information could be compromised by disclosure during this type of litigation.

The pharmaceutical industry

is characterized by extensive litigation regarding patents and other intellectual property rights.

Moreover, the cost to us of any litigation

or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial,

and the litigation would divert our management’s efforts.

We may not have sufficient resources to bring any such action to a successful

Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations

and you could lose all of your investment.

Some of our competitors are

larger than we are and have substantially greater resources.

They are, therefore, likely to be able to sustain the costs of complex patent

litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual

property portfolios.

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or

otherwise violating our intellectual property.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual

property claims could result in substantial costs and diversion of management resources, which could harm our business.

In addition, the

uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue

our internal research programs, or in-license needed technology or other drug candidates.

There could also be public announcements of

the results of the hearing, motions, or other interim proceedings or developments.

If securities analysts or investors perceive those

results to be negative, it could cause the price of shares of our Common Stock to decline.

Any of the foregoing events could harm our

business, financial condition, results of operation and prospects.

We may not identify relevant third-party patents

or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims

or adversely affect our ability to develop and market our drug candidates.

We cannot guarantee that any

of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims

or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party

patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our

drug candidates in any jurisdiction.

If a defendant were to prevail

on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards

the applicable drug candidates or technology related to the patent rendered invalid or unenforceable.

Such a loss of patent rights would

materially harm our business, financial condition, results of operations and prospects.

Interference proceedings provoked by third parties

or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent

applications.

An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from

the prevailing party.

Our business could be materially harmed if the prevailing party does not offer us a license on commercially reasonable

terms or at all.

Furthermore, because of the substantial amount

of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could

be compromised by disclosure during this type of litigation.

The pharmaceutical industry is characterized by

extensive litigation regarding patents and other intellectual property rights.

Moreover, the cost to us of any litigation or other proceeding

relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation

would divert our management’s efforts.

We may not have sufficient resources to bring any such action to a successful conclusion.

Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and

you could lose all of your investment.

Some of our competitors are larger than we are

and have substantially greater resources.

They are, therefore, likely to be able to sustain the costs of complex patent litigation or

proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or otherwise

violating our intellectual property.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property

claims could result in substantial costs and diversion of management resources, which could harm our business.

In addition, the uncertainties

associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal

research programs, or in-license needed technology or other drug candidates.

There could also be public announcements of the results of

the hearing, motions, or other interim proceedings or developments.

If securities analysts or investors perceive those results to be negative,

it could cause the price of shares of our Common Stock to decline.

Any of the foregoing events could harm our business, financial condition,

results of operation and prospects.

We may not identify relevant third-party

patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement

claims or adversely affect our ability to develop and market our drug candidates.

We cannot guarantee that any of our or our licensors’

patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant

patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending patent

application in the United States and abroad that is relevant to or necessary for the commercialization of our drug candidates in any jurisdiction.

For example, U.S.

patent applications filed before November 29, 2000 and certain U.S.

patent applications

filed after that date that will not be filed outside the United States remain confidential until patents issue.

As mentioned above, patent

applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is

claimed, with such earliest filing date being commonly referred to as the priority date.

Therefore, patent applications covering our drug

candidates could have been filed by third parties without our knowledge.

Additionally, pending patent applications that have been published

can, subject to certain limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution

Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively

impact our ability to market our drug candidates.

We may incorrectly determine that our drug candidates are not covered by a third-party

patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.

Our determination

of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact

our ability to develop and market our drug candidates.

Our failure to identify and correctly interpret relevant patents may negatively

impact our ability to develop and market our drug candidates.

In addition, if we fail to identify

and correctly interpret relevant patents, we may be subject to infringement claims.

We cannot guarantee that we will be able to successfully

settle or otherwise resolve such infringement claims.

If we fail in any such dispute, in addition to being forced to pay damages, which

may be significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be

We might, if possible, also be forced to redesign drug candidates so that they no longer infringe the third-party intellectual

property rights.

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management

resources that we would otherwise be able to devote to our business and could adversely affect our business, financial condition, results

of operations and prospects.

patent applications filed after that date that will

not be filed outside the United States remain confidential until patents issue.

As mentioned above, patent applications in the United

States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest

filing date being commonly referred to as the priority date.

Therefore, patent applications covering our drug candidates could have been

filed by third parties without our knowledge.

Additionally, pending patent applications that have been published can, subject to certain

limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates.

The scope of a patent

claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history.

interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability

to market our drug candidates.

We may incorrectly determine that our drug candidates are not covered by a third-party patent or may incorrectly

predict whether a third party’s pending application will issue with claims of relevant scope.

Our determination of the expiration

date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability

to develop and market our drug candidates.

Our failure to identify and correctly interpret relevant patents may negatively impact our

ability to develop and market our drug candidates.

In addition, if we fail to identify and correctly

interpret relevant patents, we may be subject to infringement claims.

We cannot guarantee that we will be able to successfully settle

or otherwise resolve such infringement claims.

If we fail in any such dispute, in addition to being forced to pay damages, which may be

significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be infringing.

We might, if possible, also be forced to redesign drug candidates so that they no longer infringe the third-party intellectual property

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources

that we would otherwise be able to devote to our business and could adversely affect our business, financial condition, results of operations

and prospects.

Third parties may initiate legal proceedings

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be uncertain and could negatively impact the success of our business.

Our commercial success depends

upon our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing,

misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties.

There is considerable

intellectual property litigation in the pharmaceutical industry.

We may become party to, or be threatened with, future adversarial proceedings

or litigation regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology,

including reexamination, interference, post-grant review, inter partes review or derivation proceedings before the USPTO or an

equivalent foreign body.

Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the

fields in which we are developing our drug candidates.

Third parties may assert infringement claims against us based on existing patents

or patents that may be granted in the future, regardless of their merit.

We do not believe that either

BIV201 or bezisterim (NE3107), the product candidates we are currently developing, infringe the patents of any third parties.

there can be no assurance that our technology will not be found in the future to infringe the patents of others.

Moreover, patent applications

are in some cases maintained in secrecy until patents are issued.

The publication of discoveries in the scientific or patent literature

frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed.

Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result

in issued patents that our products or product candidates infringe.

For example, pending applications may exist that provide support or

can be amended to provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party

intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope,

infringement, validity, enforceability or priority.

A court of competent jurisdiction could hold that third-party patents asserted against

us are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any drug candidates

we may develop and any other drug candidates or technologies covered by the asserted third-party patents.

In order to successfully challenge

the validity of any such U.S.

Our commercial success depends upon our ability

to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating

or otherwise violating the intellectual property and other proprietary rights of third parties.

There is considerable intellectual property

litigation in the pharmaceutical industry.

We may become party to, or be threatened with, future adversarial proceedings or litigation

regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology, including reexamination,

interference, post-grant review, inter partes review or derivation proceedings before the USPTO or an equivalent foreign body.

Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing

our drug candidates.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted

in the future, regardless of their merit.

We do not believe that either BIV201 or bezisterim

(NE3107), the product candidates we are currently developing, infringe the patents of any third parties.

However, there can be no assurance

that our technology will not be found in the future to infringe the patents of others.

Moreover, patent applications are in some cases

maintained in secrecy until patents are issued.

The publication of discoveries in the scientific or patent literature frequently occurs

substantially later than the date on which the underlying discoveries were made and patent applications were filed.

Because patents can

take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents

that our products or product candidates infringe.

For example, pending applications may exist that provide support or can be amended to

provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party intellectual property

claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity,

enforceability or priority.

A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable

and infringed, which could materially and adversely affect our ability to commercialize any drug candidates we may develop and any other

drug candidates or technologies covered by the asserted third-party patents.

In order to successfully challenge the validity of any such

patent in federal court, we would need to overcome a presumption of validity.

As this burden is a high one

requiring us to present clear and convincing evidence as to the invalidity of any such U.S.

patent claim, there is no assurance that a

court of competent jurisdiction would invalidate the claims of any such U.S.

If we are found to infringe,

misappropriate or otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that

such rights are invalid or unenforceable, we could be required to obtain a license from such a third party in order to continue developing

and marketing our products and technology.

However, we may not be able to obtain any required license on commercially reasonable terms

Even if we were able to obtain a license, it could be or may become non-exclusive, thereby giving our competitors access to

the same technologies licensed to us.

We could be forced, including by court order, to cease commercializing the infringing technology

A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business

In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages

and attorneys’ fees for willful infringement, pay royalties and other fees, redesign our infringing drug candidate or obtain one

or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

Claims that we have

misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

of the foregoing events would harm our business, financial condition, results of operations and prospects.

As this burden is a high one requiring us to present

clear and convincing evidence as to the invalidity of any such U.S.

patent claim, there is no assurance that a court of competent jurisdiction

would invalidate the claims of any such U.S.

If we are found to infringe, misappropriate or

otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid

or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products

and technology.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were

able to obtain a license, it could be or may become non-exclusive, thereby giving our competitors access to the same technologies licensed

We could be forced, including by court order, to cease commercializing the infringing technology or product.

A finding of infringement

could prevent us from commercializing our drug candidates or force us to cease some of our business operations.

In the event of a successful

claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful

infringement, pay royalties and other fees, redesign our infringing drug candidate or obtain one or more licenses from third parties,

which may be impossible or require substantial time and monetary expenditure.

Claims that we have misappropriated the confidential information

or trade secrets of third parties could have a similar negative impact on our business.

Any of the foregoing events would harm our business,

financial condition, results of operations and prospects.

We may be subject to claims by third parties

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ownership of what we regard as our own intellectual property.

Many of our employees were previously

employed at other biotechnology or pharmaceutical companies.

Although we try to ensure that our employees, consultants and advisors do

not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals

have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s

former employer.

We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf

by our employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former

or concurrent employer.

Many of our employees were previously employed

at other biotechnology or pharmaceutical companies.

Although we try to ensure that our employees, consultants and advisors do not use

the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have

used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s former

We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf by our

employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former or

concurrent employer.

Litigation may be necessary to defend against these claims

If we fail in prosecuting or

defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs, delay development

of our drug candidates and be a distraction to management.

Any of the foregoing events would harm our business, financial condition, results

of operations and prospects.

We may be subject to claims challenging the

inventorship of our patents and other intellectual property.

We or our licensors may be subject

to claims that former employees, collaborators or other third parties have an interest (including co-ownership or ownership) in our owned

or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor.

For example, we or our licensors

or collaborators may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved

in developing our drug candidates.

While it is our policy to require our employees and contractors who may be involved in the development

of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an

agreement with each party who in fact develops intellectual property that we regard as our own.

Our and their assignment agreements may

not be self-executing or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship

or our or our licensors’ or collaborators’ ownership of our owned or in-licensed patents, trade secrets or other intellectual

If we or our licensors or collaborators fail in defending any such claims, in addition to paying monetary damages, we may lose

valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our

drug candidates.

Even if we are successful in defending against such claims, these claims may create considerable distraction to management

and other employees of the company.

Any of the foregoing could have a material adverse effect on our business, financial condition, results

of operations and prospects.

If we fail in prosecuting or defending any such

claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

Even if we are successful

in prosecuting or defending against such claims, litigation could result in substantial costs, delay development of our drug candidates

and be a distraction to management.

Any of the foregoing events would harm our business, financial condition, results of operations and

We may be subject to claims challenging

the inventorship of our patents and other intellectual property.

We or our licensors may be subject to claims that

former employees, collaborators or other third parties have an interest (including co-ownership or ownership) in our owned or in-licensed

patents, trade secrets, or other intellectual property as an inventor or co-inventor.

For example, we or our licensors or collaborators

may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing

our drug candidates.

While it is our policy to require our employees and contractors who may be involved in the development of intellectual

property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with

each party who in fact develops intellectual property that we regard as our own.

Our and their assignment agreements may not be self-executing

or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’

or collaborators’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property.

If we or our licensors

or collaborators fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property

rights, such as exclusive ownership of, or right to use, intellectual property that is important to our drug candidates.

Even if we are

successful in defending against such claims, these claims may create considerable distraction to management and other employees of the

Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily

address all potential threats.

The degree of future protection,

if any, afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately

protect our business or permit us to maintain our competitive advantage.

· others may be able to make products that are similar to any drug candidates we may develop or utilize

similar technology but that are not covered by the claims of the patents that we license or may own in the future;

· we, or our current or future licensors or collaborators, might not have been the first to make the inventions

covered by the issued patent or pending patent application that we license or may own in the future;

· we, or our current or future licensors or collaborators might not have been the first to file patent applications

covering certain of our or their inventions;

· others may independently develop similar or alternative technologies or duplicate any of our technologies

without infringing our owned or licensed intellectual property rights;

· it is possible that our pending owned or licensed patent applications or those that we may own or license

in the future will not lead to issued patents;

· issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal

challenges by our competitors;

· our competitors might conduct research and development activities in countries where we do not have patent

rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

The degree of future protection, if any, afforded

by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect

our business or permit us to maintain our competitive advantage.

others may be able to make products that are similar to any drug candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future;

we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;

we, or our current or future licensors or collaborators might not have been the first to file patent applications covering certain of our or their inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

it is possible that our pending owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents;

issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

we may not develop additional proprietary technologies that are patentable;

the intellectual property rights of others may harm our business;

· we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third

party may subsequently file a patent directed to such intellectual property.

Should any of these events occur,

they could harm our business, financial condition, results of operations and prospects.

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent directed to such intellectual property.

Should any of these events occur, they could harm

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

Intellectual property

litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.

the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as

results of hearings, rulings on motions, and other interim proceedings in the litigation.

If securities analysts or investors regard these

announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished.

the market price of shares of our Common Stock may decline.

Such announcements could also harm our reputation or the market for our future

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

During the course of

any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings,

rulings on motions, and other interim proceedings in the litigation.

If securities analysts or investors regard these announcements as

negative, the perceived value of our existing products, programs or intellectual property could be diminished.

Accordingly, the market

price of shares of our Common Stock may decline.

Such announcements could also harm our reputation or the market for our future products,

which could have a material adverse effect on our business.

Risks Relating to Our Common Stock

Our stock price is and may continue to be volatile

and you may not be able to resell our Common Stock at or above the price you paid.

The market price for our Common

Stock is volatile and may fluctuate significantly in response to a number of factors, many of which we cannot control, such as quarterly

fluctuations in financial results, the timing and our ability to advance the development of our product candidates or changes in securities

analysts’ recommendations could cause the price of our stock to fluctuate substantially.

In addition, stock markets generally have

recently experienced volatility.

Our stock price is and may continue to be

volatile and you may not be able to resell our Common Stock at or above the price you paid.

The market price for our Common Stock is volatile

and may fluctuate significantly in response to a number of factors, many of which we cannot control, such as quarterly fluctuations in

financial results, the timing and our ability to advance the development of our product candidates or changes in securities analysts’

recommendations could cause the price of our stock to fluctuate substantially.

In addition, stock markets generally have recently experienced

Our stock price is likely to experience significant volatility in the future.

The price of our Common

Stock may decline and the value of any investment in our Common Stock may be reduced regardless of our performance.

Further, the daily

trading volume of our Common Stock has historically been relatively low.

As a result of the historically low volume, our shareholders

may be unable to sell significant quantities of Common Stock in the public trading markets without a significant reduction in the price

of our shares of Common Stock.

Each of these factors, among others, could harm your investment in our Common Stock and could result in

your being unable to resell the shares of our Common Stock that you purchase at a price equal to or above the price you paid.

In the past, when the market price

of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer.

any of our stockholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention

of our management would be diverted from the operation of our business.

You may experience future dilution as a result

of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

As of June 30, 2024, our Articles

of Incorporation, as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 6,216,398 shares of Common

Stock issued and 6,190,072 issued and outstanding.

The price of our Common Stock may decline and

the value of any investment in our Common Stock may be reduced regardless of our performance.

Further, the daily trading volume of our

Common Stock has historically been relatively low.

As a result of the historically low volume, our shareholders may be unable to sell

significant quantities of Common Stock in the public trading markets without a significant reduction in the price of our shares of Common

Each of these factors, among others, could harm your investment in our Common Stock and could result in your being unable to resell

the shares of our Common Stock that you purchase at a price equal to or above the price you paid.

In the past, when the market price of a stock

has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer.

If any of our

stockholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention of our

management would be diverted from the operation of our business.

You may experience future dilution as a

result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

In order to raise additional capital, we may in

the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock in any

other offering at a price per share that is less than the current market price of our securities, and investors purchasing shares or other

securities in the future could have rights superior to existing stockholders.

The sale of additional shares of our Common Stock or other

securities convertible into or exchangeable for our Common Stock would dilute all of our stockholders, and if such sales of convertible

securities into or exchangeable into our Common Stock occur at a deemed issuance price that is lower than the current exercise price of

our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022 (the “Acuitas Warrants”),

the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained

within those warrants.

As of June 30, 2025, there were warrants outstanding

to purchase an aggregate of 960,098 shares of our Common Stock at exercise prices ranging from $13.70 to $1,250.00 per share, 84,872 shares

issuable upon exercise of outstanding options at exercise prices ranging from $19.00 to $4,209.00 per share and restricted stock units

totaling 7,212.

We may also grant additional options, warrants or equity awards.

To the extent such shares are issued, the interest of

holders of our Common Stock will be diluted.

Moreover, we are obligated to issue shares of

our Common Stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates

(i.e., bezisterim (NE3107), NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the

Company, NeurMedix and Acuitas, as amended on May 9, 2021.

The achievement of these milestones could result in the issuance of up to 180,000

shares of our Common Stock, further diluting the interest of holders of our Common Stock.

We may, in the future, issue additional shares of Common Stock,

which would reduce investors’ percent of ownership and may dilute our share value.

As of June 30, 2025, our Articles of Incorporation,

as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 1,917,061 shares of our Common Stock issued and 1,914,224

shares of our Common Stock issued and outstanding.

Accordingly, we may issue up to an additional 798,082,939 shares of Common Stock.

The future issuance of Common Stock may result in substantial dilution in the percentage of our Common Stock held by our then existing

stockholders.

future issuance of Common Stock may result in substantial dilution in the percentage of our Common Stock held by our then existing stockholders.

We may value any Common Stock in the future on an arbitrary basis.

The issuance of Common Stock for future services or acquisitions

or other corporate actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect

on any trading market for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities.

In order to raise additional capital,

we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock,

including under the Controlled Equity Offering Sales Agreement (the “ATM Agreement”), dated as of August 31, 2022, between

the Company and Cantor Fitzgerald & Co.

(the “Cantor”), pursuant to which the Company may issue and sell from time to

time shares of our Common Stock through Cantor.

We may sell shares or other securities in any other offering at a price per share that

is less than the current market price of our securities, and investors purchasing shares or other securities in the future could have

rights superior to existing stockholders.

The sale of additional shares of our Common Stock or other securities convertible into or exchangeable

for our Common Stock would dilute all of our stockholders, and if such sales of convertible securities into or exchangeable into our Common

Stock occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold to Acuitas Group

Holdings, LLC (“Acuitas”) in August 2022, the exercise price for those warrants would adjust downward to the deemed issuance

price pursuant to price adjustment protection contained within those warrants.

As of June 30, 2024, there were

warrants outstanding to purchase an aggregate of 1,932,029 shares of our Common Stock at exercise prices ranging from $10.00 to $125.00

per share and 518,076 shares issuable upon exercise of outstanding options at exercise prices ranging from $4.74 to $420.90 per share

and restricted stock units totaling 40,291.

In addition, pursuant to the Loan and Security Agreement and the Supplement to the Loan and

Security Agreement, each entered into on November 30, 2021, with Avenue Venture Opportunities Fund II, L.P.

and Avenue Venture Opportunities

Fund, L.P., the lenders have the option to convert up to $5 million of the outstanding loan amount into shares of our Common Stock at

a conversion price of $58.20 per share.

We may also grant additional options, warrants or equity awards.

To the extent such shares are

issued, the interest of holders of our Common Stock will be diluted.

Moreover, we are obligated to

issue shares of our Common Stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of

our drug candidates (i.e., bezisterim (NE3107), NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27,

2021, by and among the Company, NeurMedix and Acuitas, as amended on May 9, 2021.

The achievement of these milestones could result in

the issuance of up to 1.8 million shares of our Common Stock, further diluting the interest of holders of our Common Stock.

Certain stockholder of the Company may have

significant control over our Company.

As of August 30, 2024, Acuitas beneficially owns 3,050,397

shares of our Common Stock, which includes warrants to purchase 727,273 shares of our Common Stock and options to purchase 6,500 shares

of our Common Stock that are exercisable within 60 days of August 30, 2024 and currently constitutes 43.2% of our issued and outstanding

The issuance of Common Stock for future services or acquisitions or

other corporate actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect on

any trading market for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities.

We effected a reverse stock split on July

7, 2025, and such reverse stock split has caused and could further cause our stock price to decline relative to its value before the reverse

stock split and decrease the liquidity of shares of our common stock.

At a special meeting of the Company’s stockholders

held on June 23, 2025, the Company’s stockholders approved a proposal to grant the Board authority, in its sole discretion, prior

to the one-year anniversary of such special meeting, to effect a reverse stock split of the outstanding shares of Common Stock, at a ratio

between 1-for-5 and 1-for-10.

On June 26, 2025, pursuant to the authority granted by the Company’s stockholders, the Board approved

a reverse stock split of our Common Stock at a ratio of 1-for-10 (the “Reverse Stock Split”).

The Reverse Stock Split

became effective at 12:01 a.m.

Eastern Time on July 7, 2025.

The Reverse Stock split has caused a decline in the value of our outstanding

Common Stock and there is no assurance that the Reverse Stock Split will not cause further decline in the value of our outstanding

Common Stock.

As a result, Acuitas has substantially influence over the management and affairs of our Company, as well as the ability

to control the outcome of matters submitted to our stockholders for approval, including the election of directors, the approval of significant

corporate transactions, including any merger, consolidation or sale of all or substantially all of our assets, the issuance or redemption

of equity interests in certain circumstances, and any other significant transaction.

The interests of Acuitas may not always align with,

and in some cases may conflict with, our interests or the interests of our other stockholders.

For instance, this concentration of ownership

may have the effect of delaying or preventing a change of control otherwise favored by our other stockholders and could deprive our other

stockholders of an opportunity to receive a premium for their Common Stock.

This concentration of ownership may also negatively affect

the prevailing market price of our Common Stock due to investors’ perceptions that conflicts of interest may exist or arise.

a result, this concentration of ownership may not be in your best interests.

We effected a reverse stock split on August

6, 2024, and we cannot predict the effect that such reverse stock split will have on the market price for shares of our Common Stock.

Our board of directors approved

a one-for-ten (1:10) reverse stock split of our Common Stock, which became effective at 12:01 a.m.

Eastern Time on August 6, 2024.

cannot predict the effect that the reverse stock split will have on the market price for shares of our Common Stock, and the history of

similar reverse stock splits for companies in like circumstances has varied.

Some investors may have a negative view of a reverse stock

Even if the reverse stock split has a positive effect on the market price for shares of our Common Stock, performance of our business

and financial results, general economic conditions and the market perception of our business, and other adverse factors which may not

be in our control could lead to a decrease in the price of our Common Stock following the reverse stock split.

Furthermore, even if the reverse

stock split does result in an increased market price per share of our Common Stock, the market price per share following the reverse stock

split may not increase in proportion to the reduction of the number of shares of our Common Stock outstanding before the implementation

of the reverse stock split.

Accordingly, even with an increased market price per share, the total market capitalization of shares of our

Common Stock after a reverse stock split could be lower than the total market capitalization before the reverse stock split.

if there is an initial increase in the market price per share of our Common Stock after a reverse stock split, the market price many not

remain at that level.

If the market price of shares

of our Common Stock declines following the reverse stock split, the percentage decline as an absolute number and as a percentage of our

overall market capitalization may be greater than would occur in the absence of the reverse stock split due to decreased liquidity in

the market for our Common Stock.

Accordingly, the total market capitalization of our Common Stock following the reverse stock split could

be lower than the total market capitalization before the reverse stock split.

The liquidity of the shares of our Common Stock may be affected adversely by the Reverse Stock Split given the

reduced number of shares that are outstanding following the Reverse Stock Split, especially if the market price of our Common Stock

does not increase as a result of the Reverse Stock Split.

In addition, the Reverse Stock Split has increased the number

of stockholders who own odd lots (less than 100 shares) of our Common Stock, creating the potential for such stockholders to experience

an increase in the cost of selling their shares and greater difficulty effecting such sales

The market price and trading volume of our

Common Stock may be volatile.

The market price and trading volume of our Common

Stock may be volatile.

The market price and trading volume

of our Common Stock has been volatile.

We expect that the market price of our Common Stock will continue to fluctuate significantly for

many reasons, including in response to the risk factors described in this prospectus or for reasons unrelated to our specific performance.

In recent years, the stock market has experienced extreme price and volume fluctuations.

This volatility has affected the market prices

of securities issued by many companies for reasons unrelated to their operating performance and may adversely affect the market price

and trading volume of our Common Stock.

Prices for our Common Stock may also be influenced by the depth and liquidity of the market for

our Common Stock, investor perceptions about us and our business, our future financial results, the absence of cash dividends on our Common

Stock and general economic and market conditions.

In the past, securities class action litigation has often been instituted against companies

following periods of volatility in their stock price.

Stock has been volatile.

We expect that the market price of our Common Stock will continue to fluctuate significantly for many reasons,

including in response to the risk factors described in this prospectus or for reasons unrelated to our specific performance.

years, the stock market has experienced extreme price and volume fluctuations.

This volatility has affected the market prices of securities

issued by many companies for reasons unrelated to their operating performance and may adversely affect the market price and trading volume

of our Common Stock.

Prices for our Common Stock may also be influenced by the depth and liquidity of the market for our Common Stock,

investor perceptions about us and our business, our future financial results, the absence of cash dividends on our Common Stock and general

economic and market conditions.

In the past, securities class action litigation has often been instituted against companies following

periods of volatility in their stock price.

This type of litigation could result in substantial costs and could divert our management

and other resources.

Any failure to maintain effective internal control

over financial reporting could harm us.

Our management is responsible

for establishing and maintaining adequate internal control over financial reporting.

Internal control over financial reporting is a process

designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements

in accordance with U.S.

Any failure to maintain effective internal

control over financial reporting could harm us.

Our management is responsible for establishing

and maintaining adequate internal control over financial reporting.

Internal control over financial reporting is a process designed to

provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance

generally accepted accounting principles (“GAAP”).

Under standards established by the Public Company

Accounting Oversight Board (“PCAOB”), a deficiency in internal control over financial reporting exists when the design or

operation of a control does not allow management or personnel, in the normal course of performing their assigned functions, to prevent

or detect misstatements on a timely basis.

The PCAOB defines a material weakness as a deficiency, or combination of deficiencies, in internal

control over financial reporting, such that there is a reasonable possibility that a material misstatement of annual or interim financial

statements will not be prevented, or detected and corrected, on a timely basis.

If we are unable to assert that

our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting

firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may

lose confidence in the accuracy and completeness of our financial reports, the market price of our Common Stock could be adversely affected

and we could become subject to litigation or investigations by the stock exchange on which our securities are listed, the Commission or

other regulatory authorities, which could require additional financial and management resources.

There is a limited trading market for our

Common Stock, which could make it difficult to liquidate an investment in our Common Stock, in a timely manner.

Our Common Stock is currently

traded on the Nasdaq Capital Market.

Because there is a limited public market for our Common Stock, investors may not be able to liquidate

their investment whenever desired.

We cannot assure that there will be an active trading market for our Common Stock and the lack of an

active public trading market could mean that investors may be exposed to increased risk.

In addition, if we failed to meet the criteria

set forth in the regulations of the Commission, various requirements would be imposed by law on broker dealers who sell our securities

to persons other than established customers and accredited investors.

Consequently, such regulations may deter broker-dealers from recommending

or selling our Common Stock, which may further affect its liquidity.

The lack of public company experience of our

management team could adversely impact our ability to comply with the reporting requirements of U.S.

securities laws, which could have

a materially adverse effect on our business.

Our officers have limited public

company experience, which could impair our ability to comply with legal and regulatory requirements such as those imposed by Sarbanes-Oxley

Such responsibilities include complying with federal securities laws and making required disclosures on a timely basis.

such deficiencies, weaknesses or lack of compliance could have a materially adverse effect on our ability to comply with the reporting

requirements of the Exchange Act, which is necessary to maintain our public company status.

If we were to fail to fulfill those obligations,

our ability to continue as a U.S.

Under standards established by the Public Company Accounting

Oversight Board (“PCAOB”), a deficiency in internal control over financial reporting exists when the design or operation of

a control does not allow management or personnel, in the normal course of performing their assigned functions, to prevent or detect misstatements

on a timely basis.

The PCAOB defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial

reporting, such that there is a reasonable possibility that a material misstatement of annual or interim financial statements will not

be prevented, or detected and corrected, on a timely basis.

If we are unable to assert that our internal control

over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable

to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence

in the accuracy and completeness of our financial reports, the market price of our Common Stock could be adversely affected and we could

become subject to litigation or investigations by the stock exchange on which our securities are listed, the Commission or other regulatory

authorities, which could require additional financial and management resources.

There is a limited trading market for

our Common Stock, which could make it difficult to liquidate an investment in our Common Stock, in a timely manner.

Our Common Stock is currently traded on the Nasdaq

Capital Market.

Because there is a limited public market for our Common Stock, investors may not be able to liquidate their investment

whenever desired.

We cannot assure that there will be an active trading market for our Common Stock and the lack of an active public trading

market could mean that investors may be exposed to increased risk.

In addition, if we failed to meet the criteria set forth in the regulations

of the Commission, various requirements would be imposed by law on broker dealers who sell our securities to persons other than established

customers and accredited investors.

Consequently, such regulations may deter broker-dealers from recommending or selling our Common Stock,

which may further affect its liquidity.

The lack of public company experience of

our management team could adversely impact our ability to comply with the reporting requirements of U.S.

securities laws, which could

have a materially adverse effect on our business.

Our officers have limited public company experience,

which could impair our ability to comply with legal and regulatory requirements such as those imposed by Sarbanes-Oxley Act of 2002.

responsibilities include complying with federal securities laws and making required disclosures on a timely basis.

Any such deficiencies,

weaknesses or lack of compliance could have a materially adverse effect on our ability to comply with the reporting requirements of the

Exchange Act, which is necessary to maintain our public company status.

If we were to fail to fulfill those obligations, our ability to

continue as a U.S.

public company would be in jeopardy in which event you could lose your entire investment in our Company.

1 unchanged sentence

that is exempt from certain disclosure requirements, which could make our stock less attractive to potential investors.

Rule 12b-2 of the Exchange Act

defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned

subsidiary of a parent that is not a smaller reporting company and that:

Had a public float of less than $250 million as of the last business day of its most recently completed fiscal quarter, computed by multiplying the aggregate number of worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principle market for the common equity;

Rule 12b-2 of the Exchange Act defines a “smaller

reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent

that is not a smaller reporting company and that:

● Had a public float of less than $250 million as of the last business

day of its most recently completed fiscal quarter, computed by multiplying the aggregate number of worldwide number of shares of its

voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the

bid and asked prices of common equity, in the principle market for the common equity;

In the case of an initial registration statement under the Securities Act or the Exchange Act for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated public offering price of the shares;

In the case of an issuer who had annual revenue of less than $100 million during the most recently completed fiscal year for which audit financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million.

As a “smaller reporting

company” we are not required and may not include a Compensation Discussion and Analysis section in our proxy statements;

only 3 years of business development information;

and have other “scaled” disclosure requirements that are less comprehensive

than issuers that are not “smaller reporting companies” which could make our stock less attractive to potential investors,

which could make it more difficult for you to sell your shares.

We are subject to the periodic reporting requirements

of the Exchange Act, which require us to incur audit fees and legal fees in connection with the preparation of such reports.

These additional

costs will negatively affect our ability to earn a profit.

We are required to file periodic

reports with the Commission pursuant to the Exchange Act and the rules and regulations thereunder.

In order to comply with such requirements,

our independent registered auditors have to review our financial statements on a quarterly basis and audit our financial statements on an

annual basis.

As a “smaller reporting company” we

are not required and may not include a Compensation Discussion and Analysis section in our proxy statements;

we provide only 3 years of

business development information;

and have other “scaled” disclosure requirements that are less comprehensive than issuers

that are not “smaller reporting companies” which could make our stock less attractive to potential investors, which could

make it more difficult for you to sell your shares.

We are subject to the periodic reporting

requirements of the Exchange Act, which require us to incur audit fees and legal fees in connection with the preparation of such reports.

These additional costs will negatively affect our ability to earn a profit.

We are required to file periodic reports with

the Commission pursuant to the Exchange Act and the rules and regulations thereunder.

In order to comply with such requirements, our independent

registered auditors have to review our financial statements on a quarterly basis and audit our financial statements on an annual

Moreover, our legal counsel has to review and assist in the preparation of such reports.

Factors such as the number and

type of transactions that we engage in and the complexity of our reports cannot accurately be determined at this time and may have a major

negative effect on the cost and amount of time to be spent by our auditors and attorneys.

However, the incurrence of such costs is an

expense to our operations and thus has a negative effect on our ability to meet our overhead requirements and earn a profit.

Because we do not intend to pay any cash dividends

on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them.

We intend to retain any future

earnings to finance the development and expansion of our business.

We do not anticipate paying any cash dividends on our Common Stock

in the foreseeable future.

Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they

There is no assurance that stockholders will be able to sell shares when desired.

We are authorized to issue “blank check”

preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.

Our Articles of Incorporation

authorize us to issue up to 10,000,000 shares of blank check preferred stock.

Any preferred stock that we issue in the future may rank

ahead of our Common Stock in terms of dividend priority or liquidation premiums and may have greater voting rights than our Common Stock.

Any preferred stock issued may contain provisions allowing those shares to be converted into shares of Common Stock, which could dilute

the value of our Common Stock to current stockholders and could adversely affect the market price, if any, of our Common Stock.

The preferred

stock could be utilized, under certain circumstances, as a method of discouraging, delaying, or preventing a change in control of our

Although we have no present intention to issue any shares of our authorized preferred stock, there can be no assurance that we

will not do so in the future.

Factors such as the number and type of

transactions that we engage in and the complexity of our reports cannot accurately be determined at this time and may have a major negative

effect on the cost and amount of time to be spent by our auditors and attorneys.

However, the incurrence of such costs is an expense to

our operations and thus has a negative effect on our ability to meet our overhead requirements and earn a profit.

Because we do not intend to pay any cash

dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them.

We intend to retain any future earnings to finance

the development and expansion of our business.

We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future.

Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them.

There is no assurance

that stockholders will be able to sell shares when desired.

We are authorized to issue “blank

check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.

Our Articles of Incorporation authorize us to

issue up to 10,000,000 shares of blank check preferred stock.

Any preferred stock that we issue in the future may rank ahead of our Common

Stock in terms of dividend priority or liquidation premiums and may have greater voting rights than our Common Stock.

Any preferred stock

issued may contain provisions allowing those shares to be converted into shares of Common Stock, which could dilute the value of our Common

Stock to current stockholders and could adversely affect the market price, if any, of our Common Stock.

The preferred stock could be utilized,

under certain circumstances, as a method of discouraging, delaying, or preventing a change in control of our company.

Although we have

no present intention to issue any shares of our authorized preferred stock, there can be no assurance that we will not do so in the future.

Provisions in our Articles of Incorporation,

1 unchanged sentence

depress the trading price of our Common Stock.

Provisions of our Articles of

Incorporation, our Bylaws, and Nevada law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in

control of our company or changes in our management, including transactions in which our stockholders might otherwise receive a premium

for their shares over then current market prices.

In addition, these provisions may limit the ability of stockholders to approve transactions

that they may deem to be in their best interests.

Provisions of our Articles of Incorporation, our

Bylaws, and Nevada law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our company

or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over

then current market prices.

In addition, these provisions may limit the ability of stockholders to approve transactions that they may

deem to be in their best interests.

These provisions include:

2 unchanged sentences

the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our board of directors.

The existence of the forgoing

provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our Common

They could also deter potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for

your Common Stock in an acquisition.

The existence of the forgoing provisions and anti-takeover

measures could limit the price that investors might be willing to pay in the future for shares of our Common Stock.

They could also deter

potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for your Common Stock in an acquisition.

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