BIVI US Equity☆

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934.

FOR THE FISCAL YEAR ENDED

JUNE 30, 2021

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________to

_____________

Commission File Number: 001-39015

BIOVIE INC.

(Exact name of registrant

as specified in its charter)

(State or other jurisdiction of (I.R.S. Employer Identification Number)

incorporation or organization)

(Address of principal executive offices, Zip Code)

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Securities registered pursuant to Section

12(g) of the Act:

None

Indicate by check mark if the registrant is

a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes

☐No☒

Indicate by check mark if the registrant is

not required to file reports pursuant to Section 13 or Section 15(d) of the Act

Yes

☐No☒

Indicate by check mark whether the registrant

(1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such

shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for

the past 90 days.

Yes☒

No ☐

Indicate by check mark whether the registrant

has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§

232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit

such files).

Yes☒

No ☐

Indicate by check mark whether the registrant

is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth

company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting

company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer ☐ Accelerated Filer ☐

Non-Accelerated Filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If an

emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark if the registrant has

filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial

reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7362(b)) by the registered public accounting firm that prepared

or issued its audit report.

Yes ☐

No ☒

Indicate by check mark whether the registrant

is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes

☐No☒

The aggregate market value of the voting and

non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or

the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed

second fiscal quarter was $18,143,043.

There were 24,833,324 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of August 27, 2021.

DOCUMENTS

INCORPORATED BY REFERENCE

Portions

of the 2021 definitive Proxy Statement are incorporated by reference into Part III of this Form 10-K.

BIOVIE INC.

FORM 10-K INDEX

PART I

Item 1. Business 2

Item 1A. Risk Factors 14

Item 1B. Unresolved Staff Comments 29

Item 2. Properties 29

Item 3. Legal Proceedings 29

Item 4. Mine Safety Disclosures 29

PART II

Item 6. [Reserved] 30

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 33

Item 8. Financial Statements and Supplementary Data 33

Item 9A Controls and Procedures 33

Item 9B. Other Information 34

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 34

PART III

Item 10. Directors, Executive Officers and Corporate Governance 35

Item 11. Executive Compensation 35

Item 14. Principal Accountant Fees and Services 35

PART IV

Item 15. Exhibits and Financial Statement Schedules 36

Item 16. Form 10-K Summary

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BIOVIE INC.

FORWARD-LOOKING STATEMENTS

This report contains forward-looking statements within the meaning

of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this

report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,”

“predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,”

“believes,” “should,” “could,” “may,” “will” or the negative of these terms

or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties,

which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking

statements. These factors include our research and development activities, distributor channel; compliance with regulatory impositions;

and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot

guarantee future results, levels of activity, performance or achievements.

Except as may be required by applicable law, we do not undertake or

intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained

in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time

means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider

the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to

advise interested parties of the risks, uncertainties and other factors that may affect our business.

All statements other than statements of historical fact are statements

that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking

statements, except as required by law. When used in this report, the terms “BioVie”, “Company”, “we”,

“our”, and “us” refer to BioVie, Inc.

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Table of Contents

PART I

ITEM 1. BUSINESS

BioVie Inc. is a clinical-stage company developing innovative drug

therapies to overcome unmet medical needs in chronic debilitating conditions.

In liver disease, our orphan drug candidate BIV201 (continuous

infusion terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening

complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is refractory

ascites. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs,

and have an estimated 50% mortality rate within 6 to 12 months. The FDA has never approved any drugs to treat refractory ascites. A Phase

2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized and controlled Phase 2b trial is currently underway

at several US medical centers including Vanderbilt University, the Mayo Clinic, and University of Pennsylvania (NCT NCT04112199). Top-line

results are expected in early 2022, to be followed by a proposed single pivotal Phase 3 trial beginning in 2022. In June 2021, BioVie

received written feedback from the FDA in response to a Type B meeting request to conduct a pivotal US Phase 3 clinical trial in HRS-AKI,

which is a life-threatening complication of advanced ascites. Based on the guidance received, we are revising certain elements of our

proposed study and are planning to initiate this study in late 2021.

In neurodegenerative disease, BioVie acquired the biopharmaceutical assets of NeurMedix, Inc., a privately held

clinical-stage pharmaceutical company, in June 2021. The acquired assets include NE3107, a potentially selective inhibitor of inflammatory

ERK signaling which, based on animal studies is believed to reduce neuroinflammation. NE3107 is a novel orally administered small molecule

that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism

of action. There is emerging scientific consensus that both inflammation and insulin resistance play fundamental roles in the development

of Alzheimer’s and Parkinson’s Disease, and NE3107 could, if approved, represent an entirely new medical approach to treating

these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s.

The FDA has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study

to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). BioVie is planning to initiate this

trial in the second half of 2021 and is targeting primary completion in late 2022. In addition to Alzheimer’s disease, the Company

plans to advance NE3107 in Parkinson’s based on promising results from preclinical studies. Inflammation-driven insulin resistance

is implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these

opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase.

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Pipeline Overview

The following diagram shows our clinical development pipeline as of

mid- 2021:

Liver Cirrhosis Program

BioVie’s orphan drug candidate BIV201 (continuous infusion

terlipressin) represents a novel investigational approach to the treatment of ascites due to chronic liver cirrhosis. BIV201 is

based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease

pathway as ascites), but not yet available in the United States. The active agent in BIV201, terlipressin, is a potent

vasoconstrictor and is marketed in multiple foreign countries. The goal of the BIV201 development program is focused on interrupting

the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

BioVie

completed a Phase 2a clinical trial of BIV201 in six patients with refractory as cites due to advanced liver cirrhosis at the

McGuire Research Institute in Richmond, VA. In April 2019, we announced top-line results for this clinical trial. The following

results were observed:

In June 2019, we met with representatives of the FDA for a Type C

Guidance Meeting to plan our next clinical study in ascites. We discussed our clinical development program with the FDA and proposed

safety and efficacy endpoints required for future marketing approval. In September 2019, the FDA granted our Type B meeting request and

committed to providing feedback in early 2020 for our proposed clinical trial design. In April 2020, we received the FDA’s written response

to our Type B meeting questions which required changes to our clinical trial design. Subsequently we received further guidance from the

FDA. Based on this guidance, the Company finalized the clinical trial protocol and began preparing for a randomized 30-patient Phase

2b study. The IND for this study was submitted and has become effective. As of July 2021, seven of nine planned US study centers have

been activated and are actively screening patients, and two patients have been enrolled in the study. We plan to follow this study with

a larger potentially pivotal Phase 3 clinical trial expected to begin in 2022. The FDA communicated that pending positive Phase 2 study

results, a sufficiently large and well-controlled Phase 3 trial, with supportive trend data from the Phase 2b (statistical significance

not required), could potentially yield the clinical data needed to apply for BIV201 marketing approval. The Phase 2b clinical trial protocol

is summarized on www.clinicaltrials.gov, trial identifier NCT04112199.

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We have invented a proprietary novel liquid formulation of terlipressin that is intended to improve convenience

for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the powder version. In November 2019,

we announced the completion of quality control testing and released the batch for use in our next clinical trial pending FDA clearance.

In March 2020, we submitted a detailed information package to the FDA’s CMC division. In May 2020, we received CMC division clearance

to use the new BIV201 prefilled terlipressin syringe in the current Phase 2b trial subject to conducting certain additional standard

analytical testing which has been successfully completed. As of June 2021, analytical testing results have confirmed room temperature

stability of the prefilled syringe in storage for 18 months, with the potential for up to two years of stability (yet to be confirmed).

Room temperature storage presents a key product differentiation versus terlipressin products in countries where the drug is approved.

To the best of the Company’s knowledge, all other terlipressin products sold globally must be stored under refrigeration and there

is no prefilled syringe format of terlipressin available for treating patients in these countries. BioVie has also filed a Patent Cooperation

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

published as WO2020/237170) and we plan to seek patent protection in at least the United States, Europe, China and Japan.

BIV201 (continuous infusion terlipressin) has the potential to improve

the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism.

The FDA has granted Fast-Track status and Orphan Drug designation for the most common of these complications, ascites, which represents

a significant unmet medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually,

with frequent early readmissions. Those requiring paracentesis (removal of ascites fluid) experience an average hospital stay lasting

8 days incurring over $86,000 in medical costs (HCUP Nationwide Readmissions Database 2016). This translates into a total addressable

ascites market size for BIV201 therapy exceeding $650 million based on Company estimates. The FDA has never approved any drug specifically

for treating ascites. For patients with refractory ascites the mean one-year survival rate is only 50% (Bureau et al. 2017). BIV201

has also received Orphan Drug designation for hepatorenal syndrome (“HRS”). Patients with refractory ascites often progress

to HRS which is the onset of kidney failure and requires emergency hospitalization. About one-half of these patients typically succumb

within only 2 to 4 weeks and no drug therapies have been FDA approved specifically to treat HRS.

The BIV201 development program began at LAT Pharma LLC. On April 11,

2016, we acquired LAT Pharma LLC and the rights to its BIV201 development program and currently own all development and marketing rights

to the product candidate. We and PharmaIN, LAT Pharma’s former partner focused on the development of new modified product candidates

in the same therapeutic field but not including BIV201, have agreed to pay royalties equal to less than 1% of future net sales of each

company’s ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company’s

net license revenues. On December 24, 2018, we returned our partial ownership rights to the PharmaIN modified terlipressin development

program and simultaneously paid the remaining balance due on a related debt. PharmaIN’s rights to our program remain unchanged.

We have a pending U.S. patent application 16/379,446 (a continuation application related to the ’945 Patent) for the use of BIV201

for the treatment of patients diagnosed with ascites due to liver cirrhosis in the outpatient setting using ambulatory pump infusion,

and have corresponding patent applications pending in Japan, Europe, China and Hong Kong.

About Ascites and Liver Cirrhosis

About 600,000 Americans and millions worldwide suffer from liver

cirrhosis. Cirrhosis is the 11th leading cause of death due to disease in the US, killing more than 40,000 people each year. The condition

results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Ascites is a common complication of advanced

liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity.

The Need for an Ascites Therapy

With no medications approved by the FDA specifically for treating

ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses such as diuretics may

provide initial relief, but patients may fail to respond to treatment as ascites worsens. This represents a critical unmet medical need.

U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually.

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The Ascites Development Pathway

Most experts agree that ascites develops through a sequence of events

illustrated by the above diagram. High blood pressure in the vein that supplies blood to the liver, called “portal hypertension,”

occurs as increasing liver damage (fibrosis) impedes blood flow through the liver. This causes vasodilation and blood pooling in

the central or “splanchnic” region of the body and low blood volume in the arteries. The decrease in effective blood volume

activates a signaling pathway (“neurohormonal systems”) which tells the kidneys to retain large amounts of salt and water

in an effort to increase blood volume. Ultimately the retention of excess sodium and water leads to the formation of ascites as these

substances “weep” from the liver and lymph system and collect in the patient’s abdomen.

The BIV201 Mechanism of Action

BIV201 is being developed with the goal of alleviating the portal

hypertension and correcting splanchnic vasodilation, thereby increasing effective blood volume and reducing the signals to

the kidneys to retain excess salt and water. If successful, BIV201 could halt the cycle of accelerating fluid generation in ascites patients

and reduce the need for the frequent and painful paracentesis procedures many of these patients currently require.

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Future Possible BIV201 Indications

Based on international investigative studies of the active agent in

BIV201, terlipressin, our new drug candidate has potential future applications in other life-threatening conditions due to liver cirrhosis,

such as those listed below. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy

the FDA and/or other countries’ regulatory requirements, none of which have commenced at this time. The Company may be unable to,

or chose not to, pursue the development BIV201 for these indications.

Neurodegenerative Disease Program

In June 2021, BioVie purchased the assets of NeurMedix, Inc., a privately

held clinical-stage biopharmaceutical company focused on developing novel therapeutic products for the treatment of neurodegenerative

and neurological disorders and certain cancers. NeurMedix was formed in November 2014 to acquire and commercialize intellectual property

and know-how. In December 2014, NeurMedix’s parent entity purchased all the assets related to NE3107 from Harbor Therapeutics, Inc.

and these assets were transferred to NeurMedix in February 2015. NE3107 is believed to be a selective inhibitor of inflammatory ERK signaling

that reduces neuroinflammation. It is an orally administered potentially first-in-class small molecule that may inhibit inflammation-driven

insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus

that both inflammation and insulin resistance play fundamental roles in the development of Alzheimer’s and Parkinson’s Disease,

and NE3107 could, if approved, represent an entirely new medical approach to treating these devastating conditions. The FDA has authorized

a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects

who have mild to moderate Alzheimer’s disease (NCT04669028).

Alzheimer’s Disease

Alzheimer’s disease (AD), which affects an estimated 6 million

Americans, is a neuroinflammatory and neurodegenerative condition characterized by progressive deterioration of cognitive function and

loss of short-term memory and executive function. Cognitive tests quantifying AD severity have been exhaustively developed. Formal diagnosis

of AD has historically been dependent on the presence of extraneuronal amyloid beta (Aβ)

plaques, which can only be observed at autopsy or with the aid of sophisticated radioimaging techniques. However, diagnostic methods have

recently been approved that quantify Aβ in peripheral blood and correlate well

with imaging results. Aβ plaques can also be found in people without apparent

AD symptoms, which has cast doubt about the role of Aβ as the central mediator

of disease pathology.

Scientific investigations in the past twenty years have provided strong

evidence that inflammation, type 2 diabetes (T2D), and inflammation-driven insulin resistance (IR) are drivers of AD. The link between

these factors and cognitive impairment are described by relatively new terms, type 3 diabetes and metabolic-cognitive syndrome.

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A large body of evidence supports inflammation as a primary driver

of pathology in AD. The major inflammation signaling node, NFkB, and the cytokine tumor necrosis factor (TNF) are important initiators

of inflammatory signaling in AD pathology. NE3107 is believed to inhibit extracellular signal regulated kinase (ERK)/NFkB activation and

TNF production stimulated by inflammatory mediators, such as lipopolysaccharide. Inhibition of NFkB activation and TNF production from

this type of stimulation has broad potential implications for reduction of pathological peripheral and central nervous system (CNS) inflammatory

signaling in AD, which include reduction of inflammation-driven insulin resistance, decreased inflammatory cell infiltration into the

CNS, and decreased microglia activation. Reduction of systemic inflammation and inflammation driven insulin resistance are also predicted

to have beneficial effects on hypothalamus-pituitary-adrenal (HPA) axis dysregulation and hippocampal dysregulation of cortisol secretion

that are consequences of adipose inflammation and insulin resistance, and known to promote cognitive impairment, and are also forward-feeding

for insulin resistance.

Inflammation, insulin resistance, and associated

metabolic dysregulation in the brain contribute to Aβ oligomerization and aggregation,

phospho-tau formation, reduced neuron survival stimulus, and a forward-feeding cycle of neuronal energy deficit and oxidative stress,

causing neuronal dysfunction (cognitive impairment) and neurodegeneration. NE3107’s combination of anti-inflammatory and insulin

sensitizing activity has the potential to disrupt this forward-feeding cycle of AD pathology.

Insulin has a major role in metabolic regulation and neuron survival,

while insulin resistance and T2D are closely linked to AD pathology. Insulin signaling is involved in synaptic plasticity, learning, and

memory. Exogenous insulin enhances cognition in normal and cognitively impaired subjects. Insulin resistance is linked to cognitive impairment.

The multifactorial influence of insulin signaling on neuron survival

and cognition suggests that correction of insulin signaling deficits in the target population may provide significant benefits

on both cognition and disease progression. Additional rationale for targeting metabolic dysregulation with NE3107 has come from recent

work showing peripheral insulin resistance promotes insulin resistance and senescence in the CNS.

There is also extensive literature on the complex role of adipose

tissue inflammation in systemic inflammation, insulin resistance, hypothalamus-pituitary-adrenal axis (HPA) dysregulation and chronic

cortisol excess in cognitive impairment in AD. Obesity and inflammation are closely linked in expanding adipose tissue, where the production

of inflammatory cytokines and increased cortisol are driven though up-regulation of 11β-hydroxysteroid

dehydrogenase type 1 and adipocyte mineralocorticoid receptor activation. Inflamed adipose tissue interacts with the HPA axis and hippocampus

to increase systemic cortisol, and promote hippocampal inflammation through chronically elevated cortisol, which freely penetrates the

blood-brain barrier. Hyperglycemia (secondary to insulin resistance) exacerbates adrenal cortisol production and promotes forward feeding

of inflammation and HPA-hippocampal dysregulation.

Systemic inflammation from inflamed adipose and associated mononuclear cells, promotes CNS inflammation with associated

cognitive decline and neurodegeneration. A therapy with anti-inflammatory activity against systemic/adipose inflammation and factors

that dysregulate cortisol secretion, such as hyperglycemia, has the potential to decrease cognitive impairment and neurodegenerative

mechanisms that have been linked to cortisol excess.

Parkinson’s Disease

Neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly

tumor necrosis factor (TNF)) play a pivotal role in Parkinson’s Disease (PD), which affects an estimated 1 million Americans. Daily

administration of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder,

but prolonged daily administration often leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly

referred to as LID. Recent evidence demonstrates that daily administration of levodopa further increases neuroinflammation, microglia

activation, and TNF inflammatory damage in neurons.

We have observed that in a mouse model of PD, NE3107 decreased inflammation and TNF in the brain and increased

neuron survival (Nicoletti, 2012 Parkinson’s Disease 969418.) In this neurotoxin induced model, NE3107 decreased clinical signs

of disease and neuronal death compared to placebo treated mice.

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An unpublished study in a neurotoxin induced marmoset model of Parkinson’s

disease reported that administration of NE3107 decreased movement abnormalities that are the clinical signs of the disease. In the same

study, NE3107 in combination with levodopa had a stronger effect on clinical signs of disease than levodopa or NE3107 alone, while marmosets

treated with NE3107 developed less LID. NE3107-treated monkeys also exhibited neuroprotective activity that promoted the survival of twice

as many neurons in the substantia nigra (primary region of the brain that degenerates to cause parkinsonism) as monkeys treated with placebo.

The results from the marmoset study suggest that NE3107 may decrease clinical signs of disease in humans (improve motor function), which

if true could enable a straightforward clinical development strategy to test NE3107 in PD patients needing promotoric therapy.

If approved as a promotoric agent, NE3107 could provide a non-dopaminergic

alternative to Parkinson’s patients, and an opportunity to significantly delay the need to start levodopa therapy. This could represent

a first step toward supplanting levodopa as the primary PD therapy, and in addition to delaying the emergence of LID, could also imply

a slowing of disease progression, the most important and still unmet objective of PD drug development.

Oncology

In certain types of cancers, inflammatory cell signaling is at the

heart of disease progression. NE3107 has been observed to decrease inflammatory cell signaling in vitro, in animal models and in human

clinical trials. Recently, evidence has developed that cancers are dependent on inflammatory cell signaling, not only in the tumor cells,

but also in immune, stromal and hematopoietic cells in the tumor microenvironment.

The inflammatory pathways that have been elucidated in non-cancerous

cells in the tumor microenvironment are similar to those NE3107 decrease in inflammatory cells in metabolic disorders and neurodegeneration.

BioVie is developing clinical trial-enabling data for Multiple Myeloma and Prostate cancers.

Intellectual Property

BioVie relies on a combination of patent, trade secret, other intellectual

property laws (such as FDA data exclusivity), nondisclosure agreements, and other measures to protect our proposed products. We require

our employees, consultants, and advisors to execute confidentiality agreements and to agree to disclose and assign to us all inventions

conceived during the workday, using our property, or which relate to our business. Despite any measures taken to protect our intellectual

property (IP), unauthorized parties may attempt to copy aspects of our products or to obtain and use information that we regard as proprietary.

BIV201 was awarded Orphan Drug Designations 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). We also filed a PCT application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269,

published as WO2020/237170) and we will seek patent protection in at least the United States, Europe, China and Japan. In April 2020,

we elected certain claims in our pending U.S. patent application 16/379,446 (a continuation application related to the ’945 Patent,

which was canceled pursuant to an inter partes review proceeding, discussed above). In addition, we have applied for patent coverage

for a method of treating ascites with BIV201 in Japan, Europe, China and Hong Kong.

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As of August 5, 2021, we have fifteen (15) issued U.S. patents, one

(1) pending U.S. patent application, one (1) pending U.S. provisional application (provisional application filed May 18, 2021) and six

(6) issued foreign patents directed to protecting NE3107 and related compounds and methods of making and using thereof. The U.S. patents

and pending patent applications and their expiration dates are provided below.

Title Patent Application Number Patent Number Expiration Date

** Foreign counterparts issued in Europe and Japan expire 6/5/2029.

Government Regulation

Government authorities in the United States, at the federal, state

and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality

control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting,

marketing and export and import of products such as those we are developing. Any pharmaceutical candidate that we develop must be approved

by the FDA before it may be legally marketed in the United States and by the appropriate foreign regulatory agency before it may be legally

marketed in foreign countries.

United States Drug Development Process

In the United States, the FDA regulates drugs under the Federal Food,

Drug and Cosmetic Act, or FDCA, and implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations.

Biologics are subject to regulation by the FDA under the FDCA, the Public Health Service Act, or the PHSA, and related regulations, and

other federal, state and local statutes and regulations. Biological products include, among other things, viruses, therapeutic serums,

vaccines and most protein products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,

state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply

with the applicable United States requirements at any time during the product development process, approval process or after approval,

may subject an applicant to administrative or judicial sanctions. FDA sanctions could include refusal to approve pending applications,

withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production

or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency

or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a drug or biological product

may be marketed in the United States generally involves the following:

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● FDA review and approval of the NDA or BLA.

The lengthy process of seeking required approvals and the continuing

need for compliance with applicable statutes and regulations require the expenditure of substantial resources. There can be no certainty

that approvals will be granted.

Clinical trials involve the administration of the drug or biological

candidate to healthy volunteers or patients having the disease being studied under the supervision of qualified investigators, generally

physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols detailing, among other

things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used

to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted in accordance

with the FDA’s good clinical practices requirements. Further, each clinical trial must be reviewed and approved by an independent institutional

review board, or IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting

the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical

trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must

be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until it is completed.

Human clinical trials prior to approval are typically conducted in

three sequential phases that may overlap or be combined:

Post-approval studies, or Phase 4 clinical trials, may be conducted

after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended

therapeutic indication and may be required by the FDA as part of the approval process.

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Progress reports detailing the results of the clinical trials must

be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA by the investigators for serious

and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. Phase 1,

Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the

sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds, including a finding that the

research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of

a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug

or biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually complete additional

animal studies and develop additional information about the chemistry and physical characteristics of the drug or biologic as well as

finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process

must be capable of consistently producing quality batches of the drug or biological candidate and, among other things, must include methods

for testing the identity, strength, quality and purity of the final drug or biologic. Additionally, appropriate packaging must be selected

and tested and stability studies must be conducted to demonstrate that the drug or biological candidate does not undergo unacceptable

deterioration over its shelf life.

U.S. Review and Approval Processes

The results of product development, preclinical studies and clinical

trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug or biologic, proposed

labeling and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product. The

submission of an NDA or BLA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited

circumstances.

The FDA reviews all NDAs and BLAs submitted before it accepts them

for filing and may request additional information rather than accepting an NDA or BLA for filing. Once the submission is accepted for

filing, the FDA begins an in-depth review of the NDA or BLA.

After the NDA or BLA submission is accepted for filing, the FDA reviews

the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product

is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. The FDA

reviews a BLA to determine, among other things, whether the product is safe, pure and potent and the facility in which it is manufactured,

processed, packaged or held meets standards designed to assure the product’s continued safety, purity and potency. In addition to

its own review, the FDA may refer applications for novel drug or biological products or drug or biological products which present difficult

questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation

and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations

of an advisory committee, but it considers such recommendations carefully when making decisions. During the approval process, the FDA

also will determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure the safe use of the drug or biologic.

If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA will not approve the NDA

or BLA without a REMS, if required.

Before approving an NDA or BLA, the FDA will inspect the facilities

at which the product is to be manufactured. The FDA will not approve the product unless it determines that the manufacturing processes

and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with cGMP.

If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable it will outline the deficiencies

in the submission and often will request additional testing or information.

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The NDA or BLA review and approval process is lengthy and difficult

and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical

data or other data and information. Even if such data and information is submitted, the FDA may ultimately decide that the NDA or BLA

does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and may be susceptible to varying

interpretations, which could delay, limit or prevent regulatory approval. The FDA will issue a “complete response” letter

if the agency decides not to approve the NDA or BLA. The complete response letter usually describes all of the specific deficiencies in

the NDA or BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for

example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant

might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit

the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory approval, the approval may be limited

to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the

product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. In

addition, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a product’s safety

and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan designation to

a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer

than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable

expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease

or condition will be recovered from sales of the product. Orphan product designation must be requested before submitting an NDA or BLA.

After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly

by the FDA. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval

process.

If a product that has Orphan designation subsequently receives the

first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity,

which means that the FDA may not approve any other applications to market the same drug or biological product for the same indication

for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Competitors,

however, may receive approval of different products for the indication for which the Orphan product has exclusivity or obtain approval

for the same product but for a different indication for which the Orphan product has exclusivity. Orphan product exclusivity also could

block the approval of one of our products for seven years if a competitor obtains approval of the same drug or biological product as defined

by the FDA or if our drug or biological candidate is determined to be contained within the competitor’s product for the same indication

or disease. If a drug or biological product designated as an orphan product receives marketing approval for an indication broader than

what is designated, it may not be entitled to orphan product exclusivity. Orphan Drug status in the European Union has similar but not

identical benefits in the European Union.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended to expedite or facilitate

the process for reviewing new drug and biological products that meet certain criteria. Specifically, new drug and biological products

are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential

to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product and the specific indication

for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections of the NDA or BLA on a rolling

basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA

or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule is acceptable, and the sponsor pays any

required user fees upon submission of the first section of the NDA or BLA.

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Any product submitted to the FDA for marketing approval, including

those submitted to a Fast Track program, may also be eligible for other types of FDA programs intended to expedite development and review,

such as priority review and accelerated approval. Any product is eligible for priority review if it has the potential to provide safe

and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention

of a disease compared with marketed products. The FDA will attempt to direct additional resources to the evaluation of an application

for a new drug or biological product designated for priority review in an effort to facilitate the review. Additionally, a product may

be eligible for accelerated approval. Drug or biological products studied for their safety and effectiveness in treating serious or life-threatening

illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means that

they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate

endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival

or irreversible morbidity. As a condition of approval, the FDA generally requires that a sponsor of a drug or biological product receiving

accelerated approval perform adequate and well-controlled post-marketing clinical studies to establish safety and efficacy for the approved

indication. Failure to conduct such studies or conducting such studies that do not establish the required safety and efficacy may result

in revocation of the original approval. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of

promotional materials, which could adversely impact the timing of the commercial launch or subsequent marketing of the product. Fast Track

designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval

process.

Post-Approval Requirements

Any drug or biological products for which we receive FDA approvals

are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences

with the product, providing the FDA with updated safety and efficacy information on an annual basis or as required more frequently for

specific events, product sampling and distribution requirements, complying with certain electronic records and signature requirements

and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising,

prohibitions against promoting drugs and biologics for uses or in patient populations that are not described in the drug’s or biologic’s

approved labeling (known as “off-label use”), rules for conducting industry-sponsored scientific and educational activities,

and promotional activities involving the internet. Failure to comply with FDA requirements can have negative consequences, including the

immediate discontinuation of noncomplying materials, adverse publicity, enforcement letters from the FDA, mandated corrective advertising

or communications with doctors, and civil or criminal penalties. Although physicians may prescribe legally available drugs and biologics

for off-label uses, manufacturers may not market or promote such off-label uses.

We will need to rely, on third parties for the production of our product

candidates. Manufacturers of our product candidates are required to comply with applicable FDA manufacturing requirements contained in

the FDA’s cGMP regulations. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding

maintenance of comprehensive records and documentation. Drug and biologic manufacturers and other entities involved in the manufacture

and distribution of approved drugs and biologics are also required to register their establishments and list any products made there with

the FDA and comply with related requirements in certain states, and are subject to periodic unannounced inspections by the FDA and certain

state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the

area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in

serious and extensive restrictions on a product, manufacturer, or holder of an approved NDA or BLA, including suspension of a product

until the FDA is assured that quality standards can be met, continuing oversight of manufacturing by the FDA under a “consent decree,”

which frequently includes the imposition of costs and continuing inspections over a period of many years, and possible withdrawal of the

product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented

and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to

further FDA review and approval.

The FDA also may require post-marketing testing, known as Phase 4

testing, risk minimization action plans and surveillance to monitor the effects of an approved product or place conditions on an approval

that could otherwise restrict the distribution or use of the product.

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Employees

Our

business is managed by our officers. The Company’s Chairman, Terren Peizer, served as Chief Executive Officer from July 2018 and

devoted his part-time efforts to the Company’s activities through April 27, 2021. On April 27, 2021, the board of directors appointed

Cuong Do as Chief Executive Officer & President. Mr. Do; Wendy Kim, our Chief Financial Officer and Corporate Secretary; Jonathan

Adams, who previously served as President and Chief Operating Officer, serving as our Company’s Executive Vice President –

Liver Cirrhosis Programs; and Penelope Markham, PhD, Executive Vice President - Liver Cirrhosis R&D; devote their full-time efforts

to the Company activities. Chris Reading, PhD, Executive Vice President - Neuroscience R&D; and Clarence Alhem, Executive Vice President

- Neuroscience Product Development began their employment with the Company on July 1, 2021 and devotes their full-time efforts to the

Company’s Neuroscience programs. We also rely on a team of highly experienced scientific, medical, and regulatory consultants to

conduct its product development activities.

ITEM 1A. RISK FACTORS

Our

business, financial condition, operating results and prospects are subject to the following risks. Additional risks and uncertainties

not presently foreseeable to us may also impair our business operations. If any of the following risks or the risks described elsewhere

in this report actually occurs, our business, financial condition or operating results could be materially adversely affected. In such

case, the trading price of our common stock could decline, and our stockholders may lose all or part of their investment in the shares

of our common stock.

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.

Risks

Relating to Our Business and Industry

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

have no products approved for commercial sale and, to date, we have not generated any revenue. Our ability to generate revenue depends

heavily on (a) successful completion of one or more development programs demonstrating in human clinical trials that BIV201 and NE3107,

our product candidates, are safe and effective; (b) our ability to seek and obtain regulatory approvals, including, without limitation,

with respect to the indications we are seeking; (c) successful commercialization of our product candidates; and (d) market acceptance

of our products. There are no assurances that we will achieve any of the forgoing objectives. Furthermore, our product candidates are

in the development stage, and have not been fully evaluated in human clinical trials. If we do not successfully develop and commercialize

our product candidates we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate

revenues or achieve profitability, we may be unable to continue our operations.

We

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

BioVie

Inc. was incorporated on April 10, 2013. We are a development stage biopharmaceutical company with potential therapies that have not

been fully evaluated in clinical trials, and our operations are subject to all of the risks inherent in the establishment of a new business

enterprise, including but not limited to the absence of an operating history, the lack of commercialized products, insufficient capital,

expected substantial and continual losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack

of manufacturing experience and limited marketing experience, possible reliance on third parties for the development and commercialization

of our proposed products, a competitive environment characterized by numerous, well-established and well capitalized competitors and

reliance on key personnel.

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Since

inception, we have not established any revenues or operations that would provide financial stability in the long term, and there can

be no assurance that we will realize our plans on our projected timetable in order to reach sustainable or profitable operations.

Investors

are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand

a complete loss of his, her or its investment. Furthermore, the accompanying financial statements have been prepared assuming that we

will continue as a going concern. We have not emerged from the development stage, and may be unable to raise further equity. These factors