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Item 1A. Risk Factors

2026-08-13 compared with 2025-08-15 · 415 added, 384 removed, 1246 unchanged (39% of the section changed)

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business operations.

If any of the following risks or the risks described elsewhere in this report actually occurs, our business, financial

If any of the following risks or the risks described elsewhere in this report actually occur, our business, financial

condition or operating results could be materially adversely affected.

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

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

that involve risks and uncertainties.

These statements can be identified by the use of forward-looking terminology such as “believes,”

“expects,” “intends,” “plans,” “may,” “will,” “should,” “predict”

or “anticipation” or the negative thereof or other variations thereon or comparable terminology.

Actual results could differ

materially from those discussed in the forward- looking statements as a result of certain factors, including those set forth below and

elsewhere in this Form 10-K.

In such case, the trading price of our Class A Common Stock, par

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

Risk Factor Summary

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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.

Risks Relating to Our Business and Industry

· 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 a certain financial institution 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.

· The loss or unavailability of our management could put us at a competitive disadvantage.

· 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.

Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

· Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate

amount of time.

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

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.

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

· We may become 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.

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.

· 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.

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

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· The lack of public company experience of our management team could negatively affect our business.

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 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.

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

· 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

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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 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.

and clinical trial principal investigators, contract laboratories, independent institutional review boards (“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.

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 us 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, we 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, we 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 we began the process of analyzing the trial

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

This highly unusual level of suspected improprieties led us 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

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.

Although we design the

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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.

As of June 30, 2026, we had cash deposited in

a certain financial institution in excess of federally insured levels.

We regularly monitor 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.

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.

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 markets.

While previous bank failures have not had a material direct impact on our operations, if further liquidity and financial stability concerns

arise with respect to banks and financial institutions, either nationally or in specific regions, our 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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For example, on January 19, 2024, a

purported shareholder class action complaint, captioned Eric Olmstead v.

3:24-cv-00035, was filed

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

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

purported securities class action complaint, captioned Eric Olmstead v.

3:24-cv-00035, was filed in the

District Court for the District of Nevada, naming us and certain of our officers as defendants.

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 Way v.

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

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.

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.

3:24-cv-00035 (the "Securities Class Action"), 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 our business, operations, compliance, and prospects, including information

related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, 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 our 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, and on March 27, 2025, the court denied that motion.

The parties are now engaged in fact discovery.

On February 13, 2026, the

plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint.

Defendants opposed the motion

for leave to amend.

On June 5, 2026, the court granted the plaintiffs’ motion for leave to amend, and the same day the plaintiffs

filed their Second Amended Complaint.

On June 15, 2026, the defendants filed a Notice of Non-Opposition and Reservation of Rights in response

to the motion for class certification, and on June 18, 2026, the Court granted the plaintiffs’ motion and certified the class subject

to the defendants’ reservation of rights.

The defendants answered the Second Amended Complaint on June 22, 2026.

The Company believes

that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.

Three shareholder derivative lawsuits piggy-backing

on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company,

by three putative stockholders:

Andrew Hulm on December 30, 2024;

William Settel on April 28, 2025 and Cline Wilkerson on September 11,

2025, (collectively the “Related Derivative Lawsuits”).

Each Related Derivative Lawsuit names the same current and former

officers and directors as defendants and alleges essentially the same claims:

that the defendants breached their fiduciary duties by causing

or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste

of corporate assets, gross mismanagement, and abuse of control.

On September 29, 2025, at the request of the parties, the court consolidated

all three Related Derivative Lawsuits under the caption In re BioVie Inc.

Derivative Litigation, Case No.

3:24-cv-0602-CSD (the “Consolidated

Derivative Action”).

On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending

resolution of a summary judgment motion by defendants in the Securities Class Action.

The Company believes that the 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

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That means that we are responsible for the first $2 million

of loss arising from these actions, which includes both defense costs and damages, before any insurance coverage will apply.

of loss arising from these actions, which includes both defense costs and damages, before any insurance coverage applies.

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

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There are no assurances

that we will achieve any of the forgoing objectives.

that we will achieve any of the foregoing objectives.

Furthermore, our product candidates are in the development stage, and have not been

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

Although our Company was incorporated on April

Although the Company was incorporated on April

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

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ability to continue as a going concern.

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

The financial statements included elsewhere in this report 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.

have a difficult time evaluating our business and your investment in the 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

alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and

distribution.

our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our R&D

efforts, including the timing and cost of clinical trials;

and our ability to enter into favorable alliances with third-parties who can

provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.

Even if we successfully develop and market BIV201

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be adversely affected.

Once an NDA is approved, the product covered thereby

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

Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.

Other manufacturers may seek approval of generic versions

of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”) in the United States.

of an ANDA, a generic manufacturer need not conduct clinical trials.

Rather, the applicant generally must show that its product has the

same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug

and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to

the same extent as the RLD.

Generic products may be significantly less costly to bring to market than the reference listed drug and companies

that produce generic products are generally able to offer them at lower prices.

Moreover, generic versions of RLDs are often automatically

substituted for the RLD by pharmacies when dispensing a prescription written for the RLD.

Thus, following the introduction of a generic

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

Once a New Drug Application (“NDA”)

is approved, the product covered thereby becomes a “reference listed drug” (“RLD”), in the FDA’s publication,

“Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.

Other manufacturers

may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”)

in the United States.

In support of an ANDA, a generic manufacturer need not conduct clinical trials.

Rather, the applicant generally

must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or

labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed

in the body at the same rate and to the same extent as the RLD.

Generic products may be significantly less costly to bring to market than

the reference listed drug and companies that produce generic products are generally able to offer them at lower prices.

Moreover, generic

versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing a prescription written for the RLD.

following the introduction of a generic 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 Federal Food, Drug and Cosmetic

Act (“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.

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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(terlipressin) in the U.S.

for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies

except cancer on September 8, 2016.

Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended

to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S.

In the European Union

(“EU”), Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically

debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria.

company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of

marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition.

Orphan Drug Exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or

of an application for a different drug for the same rare disease or condition.

Orphan Drug exclusive marketing rights may be lost under

several circumstances, including a later determination by the FDA that the request for designation was materially defective or if the

manufacturer is unable to assure sufficient quantity of the drug.

Similar regulations are available in the EU with a ten-year period of

market exclusivity.

for the treatment of HRS on November 21, 2018 and treatment of ascites due to all etiologies except cancer

on September 8, 2016.

Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended to treat a

rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S.

In the European Union (“EU”),

Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically debilitating

disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria.

The company that

first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of marketing exclusivity

during which time FDA may not approve another application for the same drug for the same orphan disease or condition.

Orphan Drug Exclusivity

does not prevent FDA approval of another application for the same drug for a different disease or condition, or of an application for

a different drug for the same rare disease or condition.

Orphan Drug exclusive marketing rights may be lost under several circumstances,

including a later determination by the FDA that the request for designation was materially defective or if the manufacturer is unable

to assure sufficient quantity of the drug.

Similar regulations are available in the EU with a ten-year period of 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.

Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of HRS, 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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Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin

for the treatment of Hepatorenal Syndrome.

Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin acetate

for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022.

PharmaIN Corporation received

Orphan Drug Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer.

In addition, Ferring

Pharmaceuticals Inc.

for the treatment of Hepatorenal Syndrome (HRS).

Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin

acetate for bolus intravenous administration for the treatment of HRS Type 1 in September 2022.

PharmaIN Corporation received Orphan Drug

Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer.

In addition, Ferring Pharmaceuticals

received Orphan Drug designation in 1986 for terlipressin for the treatment of bleeding esophageal varices.

of those or any other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives

FDA approval and Orphan Drug Exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked

for seven years by the other company’s Orphan Exclusivity and they may obtain a competitive advantage even after the exclusivity

period expires associated with being the first to market.

If one of those or any

other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives FDA approval

and Orphan Drug Exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked for seven

years by the other company’s Orphan Exclusivity and they may obtain a competitive advantage even after the exclusivity period expires

associated with being the first to market.

We will need to raise substantial additional

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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.

financing will be required to fund the R&D 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

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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.

This will delay or require termination of R&D 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.

on many factors, including the progress, timing and scope of our R&D 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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enter into arrangements with third parties to manufacture our products on our behalf;

into arrangements with third parties to provide sales and marketing functions.

If we are unable to achieve these objectives we will be

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

and enter into arrangements

with third parties to provide sales and marketing functions.

If we are unable to achieve these objectives we will be forced to cease operations

and you will lose all of your investment.

Development of pharmaceutical products is

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ascites fluid accumulation during treatment versus pre-treatment.

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.

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.

In June 2023 and December 2024, we 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

We are 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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Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities.

spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially

viable drugs.

If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish

valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have

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

spending on current and future R&D programs and drug candidates for specific indications may not yield any commercially viable drugs.

If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish valuable

rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have 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

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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.

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.

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

On June 23, 2021, we announced that FDA had

provided guidance on our planned Phase 3 clinical trial of BIV201 in Ascites and have since reached agreement on the key elements of the

trial design.

Thereafter, we deprioritized the program due to funding.

Mallinckrodt gained FDA approval for its product, lyophilized terlipressin

acetate for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022.

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

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facilities that could be used to manufacture any products that might be developed by us, and have contracted with an experienced Contract

Manufacturing Organization (“CMO”) to perform the manufacturing of our new product candidates BIV201 and bezisterim (NE3107).

Manufacturing Organization (“CMO”) to perform the manufacturing of our investigational product candidates BIV201 and bezisterim

In addition, we do not have the resources at this time to acquire or lease suitable facilities.

If we or our CMO fail to comply with regulations,

to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable regulations and

to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations, which would cause

you to lose all of your investment.

If we or our CMO fail to comply

with regulations, to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable

regulations and to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations,

which would cause you to lose all of your investment.

In addition, the FDA and other regulatory authorities

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If we need to find another source of drug substance or drug product manufacturing for BIV201 and bezisterim (NE3107), we may

not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonably terms, or at all.

not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonable terms, or at all.

unable to do so, we will need to develop our own commercial-scale manufacturing capabilities, which would:

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product for its recommended use;

and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug product or a BLA

for a biological product to allow commercial distribution of the drug or biologic.

A delay in one or more of the procedural steps outlined

above could be harmful to us in terms of getting our product candidates through clinical testing and to market, which could have a materially

adverse effect on our business.

and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug product or a Biologics

License Application (a “BLA”) for a biological product to allow commercial distribution of the drug or biologic.

one or more of the procedural steps outlined above could be harmful to us in terms of getting our product candidates through clinical

testing and to market, which could have a materially adverse effect on our business.

The FDA, clinical investigators, Data Safety Monitoring

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We currently depend upon the efforts and abilities

of our executive management team of Cuong Do, our Chief Executive Officer–President;

of our executive and senior management team of Cuong Do, our Chief Executive Officer-President;

Wendy Kim, our Chief Financial Officer;

Joseph Palumbo, our Executive Vice President - Chief Medical Officer;

Penelope Markham, our Senior Vice Ascites Programs & Strategic

Initiatives–;

Penelope Markham, our Senior Vice President - Liver Disease

and Long COVID Programs;

Chris Reading, our Senior Vice President - Alzheimer’s Disease Program;

Clarence Ahlem, our Senior Vice

President – Operations President–Operations, Discovery and Parkinson’s Disease Program;

and David Morse, our Senior

Vice President–Chief Regulatory Officer;

President - Operations;

and David Morse, our Senior Vice President - Chief Regulatory Officer;

who all serve the Company full-time.

The loss or unavailability of the services of any

of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition

and results of operations which may cause you to lose all of your investment.

We have not obtained, do not own, nor are we the beneficiary

of key-person life insurance.

loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect

on our business, prospects, financial condition and results of operations which may cause you to lose all of your investment.

not obtained, do not own, nor are we the beneficiary of key-person life insurance.

We may not be able to attract and retain

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are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological

These factors include the availability of patent and other protection for technology and products, the ability to commercialize

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

factors, including the availability of patent and other protection for technology and products, the ability to commercialize technological

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

We compete with biopharmaceutical firms in the

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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).

competitive and market risks could have a material adverse effect on our business, prospects, financial condition and results of operations

which may cause you to lose all of your investment.

are ultimately approved by the FDA, there is no guarantee that once they are 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).

These competitive and market risks could have a material adverse effect on our business, prospects, financial condition and results of

operations which may cause you to lose all of your investment.

Our competition will be determined in part by

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Insofar as indemnification for liabilities arising under the Securities

Act may be permitted to our officers, directors, or control persons, the Commission has advised that such indemnification is against

public policy and is therefore unenforceable.

Act of 1933, as amended, may be permitted to our officers, directors, or control persons, the Commission has advised that such indemnification

is against public policy and is therefore unenforceable.

Risks Relating to Our Intellectual Property

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or circumvented.

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.

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 have seven (7) granted and six (6) pending

patent applications for our liquid formulations of terlipressin that claim priority to International Patent Application Number PCT/US2020/034269

filed on May 22, 2020 and published as WO2020/237170.

Also, we own two (2) U.S.

patents and one (1) European

patent directed to various methods of treating ascites with BIV201, and we are pursuing additional patent coverage in other jurisdictions.

We also have twelve (12) issued U.S.

patents, seven (7) pending U.S.

applications,

three (3) pending Patent Cooperation Treaty (“PCT”) applications, four (4) issued foreign patents and nine (9) pending foreign

patent applications directed to protecting bezisterim (NE3107) and related compounds and methods of making and using thereof.

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

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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.

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

If a third-party patent or patent application

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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.

patentable aspects of our R&D 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.

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· 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;

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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.

were unaware of 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.

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

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Any of the foregoing events could harm our business, financial condition,

results of operation and prospects.

results of operations and prospects.

We may not identify relevant third-party

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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;

· 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 R&D 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.

· 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

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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.

stockholders were to bring such a lawsuit against us (in addition to the already-filed, consolidated Securities Class Action described

above), 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

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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, 2026 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.

to purchase an aggregate of 8,282,037 shares (including 380,000 pre-funded warrants) of our Common Stock at exercise prices ranging from

$2.50 to $582.00 per share, 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.31 to $774.00

per share and restricted stock units totaling 300.

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.

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

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(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.

Company, NeurMedix and Acuitas Group Holdings, LLC (“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,

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as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 7,545,474 shares of our Common Stock issued and 7,542,638

shares of our Common Stock issued and outstanding.

shares of our Common Stock outstanding.

Accordingly, we may issue up to an additional 792,454,526 shares of Common Stock.

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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.

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

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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.

including in response to the risk factors described in this report 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.

This type of litigation could result in substantial costs and could divert our management and other resources.

Any failure to maintain effective internal

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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.

generally accepted accounting principles.

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.

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

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continue as a U.S.

public company would be in jeopardy in which event you could lose your entire investment in our Company.

public company would be in jeopardy in which event you could lose your entire investment in the Company.

We are considered a smaller reporting company

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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.

· 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 principal 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 audited 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

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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

registered auditors have to review our financial statements on a quarterly basis and audit our financial statements on an annual basis.

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.

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

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· the inability of stockholders to call special meetings;

the “business combinations” and “control share acquisitions” provisions of Nevada law, to the extent applicable, could discourage attempts to acquire our stockholders stock even on terms above the prevailing market price;

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 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.

· the “business combinations” and “control share acquisitions” provisions of Nevada

law, to the extent applicable, could discourage attempts to acquire our stockholders stock even on terms above the prevailing market price;

· 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 foregoing 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.

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