What changed in this filing

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Item 1A. Risk Factors

2024-05-14 compared with 2024-02-13 · 149 added, 145 removed, 57 unchanged (84% of the section changed)

Except as described below, there have been no

material changes to the Risk Factors previously disclosed in our Form 10-K.

The risks described in our Form 10-K and below are not the

only risks facing our company.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial

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

Except as described below, there have been no material

changes to the Risk Factors previously disclosed in our Form 10-K.

The risks described in our Form 10-K and below are not the only risks

facing our company.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially

adversely affect our business, financial condition, and/or operating results.

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, 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

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 Investigational New Drug (“IND”) requirements, other applicable regulatory requirements,

or requirements set forth in the applicable IRB-approved protocol, including failure to enroll a sufficient number of patients, the Company

may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval

Moreover, our business may be implicated 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, 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.

For example, during routine monitoring

of blinded data from our Phase 3 study (NCT04669028) of NE3107, we uncovered what appears to be potential scientific misconduct and significant

deviation from study protocol and GCP violations at fifteen sites, which resulted in the Company excluding all patients from these sites

and referring them to the FDA’s OSI for further action.

The unplanned exclusion of so many patients left our Phase 3 study underpowered

for the primary endpoints.

These findings of potential scientific misconduct, significant deviation from protocol and GCP violations may

call into question the rigor, robustness and validity of the entire data set for this study (NCT04669028).

Although we design the

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

As a result, many

important aspects of our clinical development programs, including site and investigator selection, and the conduct, timing, and monitoring

of the study, is often 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.

Communicating with third parties can also be challenging, potentially

leading to mistakes as well as difficulties in coordinating activities.

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.

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;

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, 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.

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 Investigational

New Drug (“IND”) requirements, other applicable regulatory requirements, or requirements set forth in the applicable IRB-approved

protocol, including failure to enroll a sufficient number of patients, the Company may be required to conduct additional clinical trials

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

Moreover, our business may be implicated 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, 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.

For example, during routine monitoring of blinded data from our Phase 3 study (NCT04669028)

of bezisterim (NE3107), we uncovered what appears to be potential scientific misconduct and significant deviation from study protocol

and GCP violations at fifteen sites, which resulted in the Company excluding all patients from these sites and referring them to the FDA’s

OSI for further action.

The unplanned exclusion of so many patients left our Phase 3 study underpowered for the primary endpoints.

findings of potential scientific misconduct, significant deviation from protocol and GCP violations may call into question the rigor,

robustness and validity of the entire data set for this study (NCT04669028).

Although we design the clinical trials for our product

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

As a result, many important aspects of our clinical

development programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is often 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.

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

difficulties in coordinating activities.

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;

length of time to achieve study endpoints;

time requirements for data analysis;

additional time requirements for

data analysis;

IND and later NDA preparation;

discussions with the FDA;

an FDA request for additional pre-clinical

or clinical data;

unexpected safety or manufacturing issues;

an FDA request for additional pre-clinical or clinical data;

safety or manufacturing issues;

manufacturing costs;

pricing or reimbursement issues;

clinical sites

deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements – which can

render data from those sites unusable in support of regulatory approval;

clinical sites deviating from the trial protocol,

committing scientific misconduct, or other violations of regulatory requirements – which can render data from those sites unusable

in support of regulatory approval;

or other factors that make the product not economical.

rights of others and their competing products and technologies may also prevent the product from being commercialized.

Success in pre-clinical

and early clinical studies does not ensure that large-scale clinical studies will be successful.

Clinical results are frequently susceptible

to varying interpretations that may delay, limit or prevent regulatory approvals.

The length of time necessary to complete clinical studies

and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product

to the next, and may be difficult to predict.

There can be no assurance that any of our products will develop successfully, and the failure

to develop our products will have a materially adverse effect on our business and will cause you to lose all of your investment.

Proprietary rights of others and their competing

products and technologies may also prevent the product from being commercialized.

Success in pre-clinical and early clinical studies

does not ensure that large-scale clinical studies will be successful.

Clinical results are frequently susceptible to varying interpretations

that may delay, limit or prevent regulatory approvals.

The length of time necessary to complete clinical studies and to submit an application

for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult

There can be no assurance that any of our products will develop successfully, and the failure to develop our products will

have a materially adverse effect on our business and will cause you to lose all of your investment.

Adverse Developments Affecting the Financial

Services Industry and Concentration of Risk

As of December 31, 2023, the Company had cash

deposited in certain financial institutions 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.

in March and April 2023, certain U.S.

As of March 31, 2024, the Company had cash deposited

in certain financial institutions 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.

However, in March

and April 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 markets.

While these events 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 action litigation

and may be subject to similar or other litigation in the future, all of which will require significant management time and attention,

result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on our business,

operating results and financial condition, and negatively affect the price of our common stock.

While these and other current events 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

action litigation and may be subject to similar or other litigation in the future, all of which will require significant management time

and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on

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.

For example, on January 19, 2024, a securities class action complaint,

captioned Eric Olmstead v.

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.

District Court for the District of Nevada against

the company and certain of its officers and/or directors, asserting violations of Sections 10(b) and 20(a) of the Securities and Exchange

Act of 1934, as amended (the "Exchange Act") stemming from the company’s disclosures and series of events from August

5, 2021 through November 29, 2023 regarding the company's Phase 3 study of NE3107 in Alzheimer’s Disease.

The complaint alleges

that the statements previously made during the time period mentioned were materially false and misleading statements and/or omitted material

adverse facts regarding the Phase 3 study of NE3107 and the company's business, operations, prospects.

See Part II, Item 1 of this Quarterly

Report on Form 10-Q, entitled “Legal Proceedings” for more information regarding this litigation.

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.

District Court for the District

of Nevada, naming the Company and certain of its officers and/or directors as defendants.

On April 15, 2024 the court ordered the motion

to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned Olmstead

BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v.

BioVie Inc., et al., Case No.

2:24-cv-00361-LRH-CSD.

The lawsuit alleges

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

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

violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder.

action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and

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

See Part II, Item 1 of this Quarterly Report on Form 10-Q, entitled “Legal Proceedings” for more information regarding this

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 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.

Although we have insurance coverage that we believe applies to these

actions, the coverage is subject to a $2 million deductible.

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.

Furthermore, 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.

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.

not established any reserve for any potential liability relating to the pending lawsuit 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.

In addition, such lawsuits may make it more difficult to finance our operations and affect our ability to make payments

Although we have insurance coverage that we believe

applies to these actions, the coverage is subject to a $2 million deductible.

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.

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.

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

results or financial condition.

In addition, such lawsuits may make it more difficult to finance our operations and affect our ability

to make payments for damages.

Risks Relating To Our Common Stock

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, including

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, including

under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, with Cantor Fitzgerald

7 unchanged sentences

protection contained within those warrants.

In addition, as of December 31, 2023, there

were warrants outstanding to purchase an aggregate of 7,770,285 shares of common stock at exercise prices ranging from $1.82 to

In addition, as of March 31, 2024, there were

warrants outstanding to purchase an aggregate of 19,320,285 shares of common stock at exercise prices ranging from $1.25 to

$12.50 per share and 4,022,758 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per

6 unchanged sentences

of holders of our common stock will be diluted.

Moreover, we are obligated to issue shares of

common stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates

(i.e., NE3107, NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix,

Moreover, we are obligated to issue shares of 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, Inc.

and Acuitas, as amended on May 9, 2021.

The achievement of these milestones could result in the issuance of up to 18 million shares

of our common stock, further diluting the interest of holders of our common stock.

Certain stockholders who are also officers

and directors of the Company may have significant control over our management.

As of December 31, 2023, our directors and executive

The achievement of these milestones could result in the issuance of up to 18 million

shares of our common stock, further diluting the interest of holders of our common stock.

Certain stockholders who are also officers and

directors of the Company may have significant control over our management.

As of March 31, 2024, our directors and executive

officers and affiliates currently own aggregate 23,631,735 shares of our Common Stock, which currently constitutes 38.8% of our issued

7 unchanged sentences

deferring or preventing a change in control of us even when such a change of control would be in the best interests of our stockholders.

We may, in the future, issue additional

common stock, which would reduce investors’ percent of ownership and may dilute our share value.

As of December 31, 2023, our Articles of Incorporation,

We may, in the future, issue additional common

stock, which would reduce investors’ percent of ownership and may dilute our share value.

As of March 31, 2024, our Articles of Incorporation,

as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 61,018,606 shares of Common Stock issued and

11 unchanged sentences

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-Q

Item 1A. Risk Factors