What changed in this filing

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Item 1A. Risk Factors

2022-11-04 compared with 2022-05-11 · 301 added, 38 removed, 3 unchanged (99% of the section changed)

face business disruption and related risks resulting from the outbreak of the novel coronavirus 2019 (COVID-19) pandemic, which could

have a material adverse effect on our business plan.

continual widespread health emergencies or pandemics such as the coronavirus (COVID-19) pandemic (and its related variants),

has led to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability,

which could materially adversely affect the clinical trials, supply chain, financial condition and financial performance of our company.

Although some jurisdictions have relaxed these measures, others have not or have reinstated them as COVID-19 cases surge and its variants

continue to emerge.

The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial

markets and the overall economy are highly uncertain and cannot be predicted at this time.

If the financial markets and/or the overall

economy are impacted for an extended period, the Companys ability to raise funds may be materially adversely affected.

the COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may

continue to impact the potential patient participation in our studies of which may adversely impact our ability to continue or complete

our clinical trials in the planned timeline.

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.

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 at prices that may not be the same as the price per share in this offering.

We may sell shares or

other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering,

and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.

The price per

share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future

transactions may be higher or lower than the price per share paid by investors in this offering.

addition, as of March 31, 2022, there were warrants outstanding to purchase an aggregate of 511,463 shares of common stock at exercise

prices ranging from $1.88 to $75.00 per share and 2,438,044 shares issuable upon exercise of outstanding options at exercise prices ranging

from $2.74 to $42.09 per share.

Our Loan Agreement entered into on November 30, 2021, contains a conversion feature whereby at the option

of lender, up to $5 million of the outstanding loan amount maybe converted to shares of common stock at a conversion price of $6.98 per

We may grant additional options, warrants or stock awards.

To the extent such shares are issued, the interest of holders of our

common stock will be diluted.

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, NE3789) pursuant to the asset purchase agreement, dated April 27, 2021,

by and among the Company, NeurMedix, Inc.

and Acuitas Group Holdings, LLC, 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.

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

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.

Once a new drug application (“NDA”) is

approved, the product covered thereby becomes a “reference listed drug” or 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

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.

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.

The FDA may not approve an ANDA for a generic product

until any applicable period of non-patent exclusivity for the RLD has expired.

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”).

is an active ingredient that has not previously been approved by FDA alone or in combination with other substances.

Specifically, in cases

where such exclusivity has been granted, an ANDA may not be submitted to the FDA until the expiration of five years unless the submission

is accompanied by a Paragraph IV Certification that a patent covering the reference listed drug is either invalid or will not be infringed

by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug.

If an ANDA is submitted to FDA with a Paragraph IV Certification, the generic applicant must also provide a Paragraph IV Notification

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

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

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

approval of the ANDA will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application

was filed between 4 years and 5 years after the NDA approval.

Any such stay will be terminated earlier if the court rules that the patent

is invalid or would not be infringed.

Competition that our products may face from generic

versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit

our ability to obtain a return on the investments we have made in those product candidates.

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, which

may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.

We have obtained Orphan Drug Designation for BIV201

(terlipressin) in the U.S.

for the treatment of hepatorenal syndrome (received November 21, 2018) and treatment of ascites due to all

etiologies except cancer (received 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 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 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.

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 fact, Mallinckrodt recently received an NDA approval

for its terlipressin product for the hepatorenal syndrome (“HRS”) indication in September 2022, which is the same indication

for which we had received an Orphan Designation.

FDA granted Mallinckrodt and its approved drug a new chemical entity exclusivity.

if another company with an 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 drug exclusivity and they may obtain a competitive advantage even after the exclusivity period

expires associated with being the first to market.

We may face business disruption and related

risks if there is another surge ofCOVID-19 or if there is another pandemic caused by other bacteria or viruses, which could have a material

adverse effect on our business plan.

Health emergencies or pandemics, whether from COVID-19

or other viruses or bacteria, may lead to regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and

overall economic instability, which could materially and adversely affect the clinical trials, supply chain, financial condition and financial

performance of our company.

The duration and spread of a pandemic and its long-term impact on the financial markets and the overall economy

are highly uncertain and cannot be predicted.

If the financial markets and/or the overall economy are impacted for an extended period,

the Company’s ability to raise funds may be materially adversely affected.

In addition, such health emergencies or pandemics may

create a widespread labor shortage, including a shortage of medical professionals, and may impact potential patient participation in our

studies which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

We can provide no assurance that our product

candidates will obtain regulatory approval or that the results of clinical studies will be favorable.

The business plan we have developed through June 2024

for the liver disease program is to complete the Phase 2b clinical development program for our lead new product candidate BIV201 for treatment

of ascites, conduct a single pivotal Phase 3 trial of BIV201 for ascites, and to pursue other key milestones such as additional patent

For NE3107, we have commenced a potentially pivotal 18-month Phase 3 trial in Alzheimer’s disease, commenced a Phase

2 study of NE3017 in Parkinson’s disease.

Due to our financial constraints, we do not have the resources necessary to complete all

of these clinical studies.

Subject to FDA guidance, we plan to commence additional Phase 2 and potentially Phase 3 clinical trials upon

receipt of a successful capital raise.

There is no guarantee the FDA will approve the commencement of a Phase 3 trial for BIV201, and

even if it does, our financial constraints may prevent us from undertaking clinical trials.

We may be unable to obtain or protect intellectual

property rights relating to our product candidates, and we may be liable for infringing upon the intellectual property rights of others,

which could have a materially adverse effect on our business.

Our ability to compete effectively will depend on

our ability to maintain the proprietary nature of our technologies.

We cannot assure investors that we will continue to innovate and file

new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology

owned by us or licensed to us.

Further, we cannot predict how long it will take for such patents to issue, if at all.

The patent position

of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations

and, therefore, validity and enforceability cannot be predicted with certainty.

Patents may be challenged, deemed unenforceable, invalidated

or circumvented.

BioVie has also filed a PCT (“Patent Cooperation

Treaty”) application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269

published as WO2020/237170) and we are seeking patent protection in the United States, Europe, China, Japan and eight other jurisdictions.

As of August 22, 2022, we have fifteen (15) issued U.S.

patents, one (1) pending U.S.

patent application, one (1) pending PCT application

and six (6) issued foreign patents directed to protecting 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, NE3107, or any other product candidates or to provide us with

competitive advantages.

Any patents we do obtain may be challenged by re-examination

or otherwise invalidated or eventually found unenforceable.

Both the patent application process and the process of managing patent disputes

can be time consuming and expensive.

If we were to initiate legal proceedings against a third party to enforce a patent related to one

of our products, the defendant in such litigation could counterclaim that our patent is invalid and/or unenforceable.

In patent litigation

in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, as are validity challenges by the defendant

against the subject patent or other patents before the United States Patent and Trademark Office (the “USPTO”).

a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness

or non-enablement, failure to meet the written description requirement, indefiniteness, and/or failure to claim patent eligible subject

Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent intentionally

withheld material information from the USPTO, or made a misleading statement, during prosecution.

Additional grounds for an unenforceability

assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect inventorship with deceptive

Third parties may also raise similar claims before the USPTO even outside the context of litigation.

The outcome is unpredictable

following legal assertions of invalidity and unenforceability.

With respect to the validity question, for example, we cannot be certain

that no invalidating prior art existed of which we and the patent examiner were unaware during prosecution.

These assertions may also

be based on information known to us or the Patent Office.

If a defendant or third party were to prevail on a legal assertion of invalidity

and/or unenforceability, we would lose at least part, and perhaps all, of the claims of the challenged patent.

Such a loss of patent protection

would or could have a material adverse impact on our business.

The standards that the United States Patent and Trademark

Office (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change.

There is also no uniform,

worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents.

we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents

issued to us or to others.

Further, we rely on a combination of trade secrets,

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

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

our business and financial condition could be materially adversely affected.

The laws of some foreign countries do not protect our proprietary

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

We do not believe that either BIV201 or NE3107, the

product candidates we are currently developing, infringe upon the rights of any third parties nor are they infringed upon by third parties.

However, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed

upon by others.

Moreover, patent applications are in some cases maintained in secrecy until patents are issued.

The publication of discoveries

in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made

and patent applications were filed.

Because patents can take many years to issue, there may be currently pending applications of which

we are unaware that may later result in issued patents that our products or product candidates infringe.

For example, pending applications

may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes.

In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise

impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are

found to have willfully infringed on such parties’ patent rights.

In addition to any damages we might have to pay, we may be required

to obtain licenses from the holders of this intellectual property.

We may fail to obtain any of these licenses or intellectual property

rights on commercially reasonable terms.

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

access to the same technologies licensed to us.

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

or license replacement technology.

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

could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting

our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation.

Conversely, we

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

Thus, the proprietary nature

of our technology or technology licensed by us may not provide adequate protection against competitors.

The pharmaceutical industry is characterized by extensive

litigation regarding patents and other intellectual property rights.

Moreover, the cost to us of any litigation or other proceeding relating

to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would

divert our management’s efforts.

We may not have sufficient resources to bring any such action to a successful conclusion.

Uncertainties

resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and you could lose

all of your investment.

There may be conflicts of interest among our

officers, directors and stockholders.

Certain of our executive officers and directors and

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

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

In particular, our executive

officers or directors or their affiliates may have an economic interest in or other business relationship with partner companies that

invest in us or are engaged in competing drug development.

Our executive officers or directors may have conflicting fiduciary duties to

us and third parties.

The terms of transactions with third parties may not be subject to arm’s length negotiations and therefore

may be on terms less favorable to us than those that could be procured through arm’s length negotiations.

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

under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, by and among the

Company, Cantor Fitzgerald & Co.

Riley Securities, Inc.

(collectively, the “Agents”), pursuant to which the Company

may issue and sell from time to time shares of common stock through the Agents.

We may sell shares or other securities in any other offering

at a price per share that is less than the current market price of our securities, and investors purchasing shares or other securities

in the future could have rights superior to existing stockholders.

The sale of additional shares of common stock or other securities convertible

into or exchangeable for our common stock would dilute all of our stockholders, and if such sales of convertible securities into or exchangeable

into our common stock occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold

to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022, the exercise price for those warrants would adjust downward to

the deemed issuance price pursuant to price adjustment protection contained within those warrants.

In addition, as of November 3, 2022, there were

warrants outstanding to purchase an aggregate of 7,778,285 shares of common stock at exercise prices ranging from $1.82 to $12.50

per share and 3,345,530 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per

Our Loan Agreement entered into on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million

of the outstanding loan amount maybe converted to shares of common stock at a conversion price of $6.98 per share.

We may grant additional

options, warrants or stock awards.

To the extent such shares are issued, the interest of holders of our common stock will be diluted.

Moreover, we are obligated to issue shares of 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,

and Acuitas, as amended on May 9, 2021 (the “Asset Purchase Agreement”).

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 November 3, 2022, our directors and executive

officers currently own an aggregate shares of our common

stock, which currently constitutes 76.7% of our issued and outstanding common stock.

As a result, directors and executive officers may

have a significant influence on our affairs and management, as well as on all matters requiring member approval, including electing and

removing members of our board of directors, causing us to engage in transactions with affiliated entities, causing or restricting our

sale or merger, and certain other matters.

Our Chairman, Mr.

Terren Peizer, may be deemed to beneficially own the shares held by Acuitas.

Such concentration of ownership and control could have the effect of delaying, 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.

There is a limited trading market for our common

stock, which could make it difficult to liquidate an investment in our common stock, in a timely manner.

Our common stock is currently traded on the Nasdaq

Capital Market.

Because there is a limited public market for our common stock, investors may not be able to liquidate their investment

whenever desired.

We cannot assure that there will be an active trading market for our common stock and the lack of an active public trading

market could mean that investors may be exposed to increased risk.

In addition, if we failed to meet the criteria set forth in SEC regulations,

various requirements would be imposed by law on broker dealers who sell our securities to persons other than established customers and

accredited investors.

Consequently, such regulations may deter broker-dealers from recommending or selling our common stock, which may

further affect its liquidity.

We may, in the future, issue additional common

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

As of November 3, 2022 our Articles of Incorporation,

as amended, authorize the issuance of 800,000,000 shares of common stock, and we had 30,532,830 shares of common stock outstanding.

Accordingly, we may issue up to an additional 769,467,170 shares of common stock.

The future issuance of common stock may result

in substantial dilution in the percentage of our common stock held by our then existing stockholders.

We may value any common stock in

the future on an arbitrary basis.

The issuance of common stock for future services or acquisitions or other corporate actions may have

the effect of diluting the value of the shares held by our investors, might have an adverse effect on any trading market for our common

stock and could impair our ability to raise capital in the future through the sale of equity securities.

Unregistered sales of equity securities

Other than equity securities issued in transactions disclosed on our Current Report on Form 8-K/A filed with the SEC on July 18, 2022, there were no unregistered sales of equity securities during the period.

Defaults Upon Senior Securities

1 unchanged sentence

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