What changed in this filing

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Item 1. Business

2026-08-13 compared with 2025-08-15 · 280 added, 216 removed, 320 unchanged (61% of the section changed)

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disorders and advanced liver disease.

Neurodegenerative Disease Program

Neurodegenerative Disease Programs

The Company acquired the biopharmaceutical assets

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(“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021.

acquired assets included NE3107 (or “bezisterim”).

The acquired assets included NE3107 (“bezisterim”).

Bezisterim, the approved generic name for NE3107 is an investigational,

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Food and Drug Administration (“FDA”), represent an entirely new medical approach

to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD , 1 million Americans suffering

from PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide.

In neurodegenerative disease, the Company’s

drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, and anti-inflammatory agent that

is an insulin-sensitizer.

In addition, it is not immunosuppressive and has a low risk of drug-drug interaction.

Bezisterim inhibits activation

of inflammatory extracellular single regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B

cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory

pathways) that lead to neuroinflammation and insulin resistance.

By binding to ERK and selectively modulating NFκB activation and

TNF-α production bezisterim does not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical

improvements in several disease indications, including PD, AD and long COVID.

BioVie has conducted and reported efficacy data

on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who

have mild-to-moderate AD (NCT04669028).

Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients

experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference

in December 2022.

A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International

Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023

showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients

treated with a combination of bezisterim and levodopa vs.

patients treated with levodopa alone, and no drug-related adverse events.

In long COVID, bezisterim has the potential to

reduce neurological symptoms including fatigue and cognitive dysfunction.

Persistently circulating viral spike proteins are believed to

trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg).

Parkinson’s Disease (NCT05083260)

Parkinson’s disease (PD) is a progressive

neurodegenerative disease most often characterized by tremors, muscle rigidity, slowness of movement, postural instability, and difficulties

Compelling evidence implicates inflammation and insulin resistance in the initiation and progression of the disease –

likely both due to their respective roles in dopamine dysfunction in the brain and neurodegeneration.

Current therapeutic approaches provide

only symptomatic relief, but do not modify disease progression.

to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from

PD, and approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide.

With respect to the mechanism of action, we believe

bezisterim inhibits activation of inflammatory extracellular signal-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer

of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other

relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.

By binding to ERK and selectively modulating NFκB

activation and TNF-α production without interfering with their homeostatic functions (e.g., insulin signaling and neuron growth

and survival), we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID.

Chronic neuroinflammation, insulin resistance,

and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and

Amyotrophic lateral sclerosis.

Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential

anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated

inflammation.

Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s

work testing the molecule in AD, PD, and long COVID patients.

Bezisterim (NE3107) is patented in the United States, Australia, Canada,

Europe and South Korea.

Parkinson’s Disease

PD is driven in large part by neuroinflammation

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provides symptomatic benefit, it does not slow PD progression.

The Company designed a new Phase 2b study of bezisterim

as a potential first line therapy to treat patients with new onset PD.

This trial will be evaluating the safety and efficacy of bezisterim

on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa.

The PD Phase 2b study comprises

a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial

screening phase to the safety follow up.

In July 2024, the Company submitted the new protocol and received a response from the FDA permitting

the Company to proceed with the study.

The trial commenced in April 2025.

The Phase 2 study of bezisterim for the treatment

of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics

study in PD participants treated with carbidopa/levodopa and bezisterim.

Forty-five patients with a defined L-dopa “off state”

were randomized 1:1 to placebo:

bezisterim 20 mg twice daily for 28 days.

In August 2026, we

announced topline results from our Phase 2b SUNRISE-PD clinical trial (NCT06757010), a multicenter, randomized, double-blind, placebo-controlled

study evaluating bezisterim (20 mg twice daily) in 57 patients with early-stage PD who were naïve to symptomatic dopaminergic therapy

(carbidopa/levodopa).

The trial was designed to establish proof-of-mechanism and proof-of-concept for bezisterim in this patient population

and to inform the design of a potentially pivotal Phase 3 registrational trial.

Over a 12-week treatment period, the study prospectively

evaluated a predefined battery of biologic, clinical, and quality of life assessments to examine motor and non-motor endpoints consistent

with bezisterim’s expected metabolic and anti-inflammatory actions.

The trial’s primary pharmacodynamic endpoint assessed

the effect of bezisterim on hematologic inflammatory biomarker indices, specifically the monocyte-to-lymphocyte ratio (MLR), Systemic

Inflammation Response Index (SIRI), neutrophil-to-lymphocyte ratio (NLR), systemic immune-inflammation index (SII), platelet-to-lymphocyte

ratio (PLR), and aggregate index of systemic inflammation (AISI), as well as a composite of those markers.

The study’s primary

pharmacodynamic assessment focused on changes in this predefined panel of blood-based inflammatory markers of disease.

The trial successfully

met this prespecified primary endpoint, with bezisterim demonstrating a statistically significant reduction in the composite neuroinflammation

measure, changing by -0.28 in patients treated with bezisterim compared with +0.19 for placebo (Cohen’s d =-1.06, nominal p=0.0018),

further supporting an effect of bezisterim on neuroinflammatory pathways.

Secondary and exploratory

endpoints evaluated motor and non-motor clinical outcomes, biomarkers of neurodegeneration, and safety and tolerability.

of patients treated with bezisterim showed improvement on the Early Parkinson’s Neuro-Inflammatory Composite 15(EPNIC-15), a composite

endpoint encompassing 15 clinically relevant motor and non-motor measures of PD.

In contrast, patients receiving placebo showed a change

in the opposite direction (bezisterim = -0.04, placebo = +0.18, Cohen’s d = -0.94, nominal p=0.0006).

EPNIC-15 aligns clinical

outcome measurements from UPDRS Parts I, II, and III, as well as PDSS-2 (sleep) with bezisterim’s proposed mechanism of action

providing a sensitive tool to evaluate anti-inflammatory treatment effects in early PD.

Bezisterim treatment

was also associated with improvements across a range of neurodegeneration biomarkers from mid-study (week 4) to end-of-study (week 12),

including neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1(UCHL1), BN02,

and microtubule-associated protein tau (MAPT).

These biomarker observations are exploratory in nature, and bezisterim’s potential

to influence underlying disease progression will require confirmation in future clinical trials.

Bezisterim was well

tolerated and demonstrated a safety profile comparable to placebo.

The incidence of adverse events was similar between treatment groups

(39.3% with bezisterim vs.

51.7% with placebo), with no severe or serious adverse events and only one treatment-related adverse event

reported in each group.

Most adverse events were mild in severity, while patients receiving placebo experienced a higher number of total

adverse events and a greater proportion of moderate adverse events than those treated with bezisterim.

All p-values reported

in these results are nominal and unadjusted for multiplicity, consistent with the exploratory, signal-finding objectives of this Phase

The FDA has not validated the biomarker endpoints used in this trial as surrogate endpoints for PD.

These results are preliminary

and based on a small patient population studied over a limited duration;

results observed in this study may not be replicated in larger

or longer-duration trials.

We intend to use these results to inform the design of a potentially pivotal Phase 3 registrational trial

of bezisterim in PD.

The previous Phase 2 study of bezisterim

(NE3107) for the treatment of PD (NCT05083260) that we completed in December 2022, was a double-blind, placebo-controlled, safety,

tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).

patients with a defined L-dopa “off state” were randomized 1:1 to placebo:

bezisterim (NE3107) 20 mg twice daily for 28

This trial was launched with two design objectives:

1) the primary

objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim

with carbidopa/ levodopa;

and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent

enhancement of levodopa activity could be seen in humans.

1) the primary objective was safety and a drug-drug interaction study as

requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa;

secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity

could be seen in humans.

Both objectives were met.

Long COVID Program

About Long COVID

Long COVID is a condition in which symptoms of

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and respiratory problems, muscle weakness, and neurologic issues have also been documented.

Approximately 20 million individuals in the U.S.

currently or previously have long COVID, with millions more impacted worldwide.

Studies estimate that approximately 10-30% of individuals

who contract COVID-19 experience lingering symptoms for months or even years, with fatigue, brain fog, and cognitive impairment significantly

impacting daily functioning and quality of life.

Despite the growing recognition of long COVID as a serious condition, treatment options

remain limited, and many patients struggle to find effective relief for their symptoms.

The loss in quality of life and earnings and increased

medical costs has an enormous economic impact estimated to be $3.7 trillion.

To date there are no non-pharmacological or pharmacological

therapies proven effective for treatment of long COVID.

In April 2024, the Company was awarded a clinical

trial grant of $13.1 million from the U.S.

Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research

Program of the Congressionally Directed Medical Research Programs.

In August 2024, the FD&A and the U.S.

Army Medical Research and

Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving

the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms

that are associated with long COVID.

The Phase 2 ADDRESS-LC study, which is fully funded

by a grant from the DOD, is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability

of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue.

Individuals who have been diagnosed

with long COVID and have neurocognitive dysfunction and self-reported fatigue may meet qualification criteria and can visit www.addressLC.com

to learn more.

The trial commenced in May 2025.

Alzheimer’s Disease (NCT05083260)

Department of War (“DOW”), formerly known as the Department of Defense, awarded

through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs.

In August 2024, the U.S.

Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan

to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational

New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment

of the debilitating neurocognitive symptoms associated with long COVID.

The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled,

multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive

impairment sequelae and fatigue.

The trial commenced in May 2025 and completed enrollment in May 2026.

The Company currently expects to

report topline results in late summer of 2026.

Alzheimer’s Disease

In AD, BioVie has conducted both Phase 2 and Phase

Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its

potential as a therapy for the six million Americans living with AD.

Results of a Phase 2 investigator-initiated

trial (NCT05227820) showing bezisterim treated patients experienced improved cognition and biomarker levels were presented at the

Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022.

On November 29, 2023, the Company announced the

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In liver disease, our investigational drug candidate

BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being

evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis

caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism.

The initial target for BIV201 therapy was 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.

BIV201 (continuous infusion terlipressin) was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all

etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical

BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and

ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism.

treatment costs for liver cirrhosis, including ascites and

other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months.

FDA has never approved any drug specifically for treating ascites.

After receiving guidance from the FDA regarding

the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting

a broader ascites patient population.

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

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

and ascites who have recently recovered from acute kidney injury (“AKI”).

This patient population is not limited to those

having refractory ascites.

BIV201 is administered as a patent-pending liquid formulation with patents issued in the U.S., China, Japan,

Chile and India to date.

Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid

in the abdomen, often exceeding five liters, due to liver and kidney dysfunction.

BIV201 is a continuous infusion of terlipressin, a drug

used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal varices)

that was approved in the U.S.

in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function)

but is not approved in Japan.

With its novel room temperature stable formulation in a pre-filled syringe, we believe BIV201 could potentially

provide a superior terlipressin drug delivery system throughout the world.

The goal of BIV201 therapy is to target the pathophysiology

that contributes to ascites production, acute kidney injury and complications of cirrhosis that are associated with significant mortality.

the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is currently finalizing

the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint

of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”).

Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often

exceeding five liters, due to liver and kidney dysfunction.

BIV201 is administered in a continuous infusion of terlipressin as a patent-pending

liquid formulation with patents issued in the U.S., China, Japan, Chile, Australia, Mexico and India to date.

Terlipressin is used in

over 40 countries to treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and

was approved in the U.S.

in 2022 to improve kidney function in adults with hepatorenal syndrome experiencing a rapid reduction in kidney

it is not currently approved in Japan.

In June 2021, BioVie initiated a Phase 2 study

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regarding the design and endpoints for definitive Phase 3 clinical testing of BIV201.

Our proprietary novel liquid formulation of terlipressin

is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute

the current powder version of terlipressin.

To date, analytical testing results have confirmed room temperature stability of the prefilled

syringe in storage for 2 years, with the potential for up two years stability.

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 to date patents have

been granted in the U.S.

Our proprietary novel

liquid formulation of terlipressin is designed to improve convenience for outpatient administration and avoid potential formulation errors

when pharmacists reconstitute the current powder version of terlipressin.

To date, analytical testing results have confirmed room temperature

stability of the prefilled syringe in storage for up to two years.

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 PCT application covering our novel liquid formulations of terlipressin (international patent

application PCT/US2020/034269, published as WO2020/237170) and to date patents have been granted in the U.S.

India (Patent No.

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68965), China (Patent No.

ZL 202080050758.X),

and Japan (7579811).

We believe 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, nonalcoholic steatohepatitis, and alcoholism.

The FDA has granted Fast-Track status and Orphan Drug designation for ascites

(due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet

medical need.

ZL 202080050758.X), Australia (Patent No.

2020279395), Mexico

432332) and Japan (Patent No.

We believe BIV201 (continuous infusion

terlipressin) has the potential to benefit thousands of patients suffering from life-threatening complications of liver cirrhosis

due to hepatitis, nonalcoholic steatohepatitis, and alcoholism.

The FDA has granted Fast-Track status and Orphan Drug designation

for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and 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.

According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience

an average hospital stay lasting eight days incurring over $86,000 in medical costs.

This translates into a total potentially 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.

After receiving guidance from FDA in 2023 and again in 2025, the Company is currently finalizing the protocol design

for a Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and

disease progression in patients with cirrhosis and ascites who have recently recovered from AKI.

hospital discharges

annually, with frequent early readmissions.

In an analysis of the 2018 HCUP Nationwide Readmissions Database patients hospitalized

with cirrhosis, ascites and paracentesis had an average length of stay of 8.0 days and average hospital charges of $89,136 per

This translates into a total potentially 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.

After receiving guidance from the FDA

in 2023 and again in 2025, the Company is currently finalizing the protocol design for a Phase 3 study of BIV201 with a focus on

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

cirrhosis and ascites who have recently recovered from AKI.

The BIV201 development program was initiated by

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of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will

be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,

and The Barrett Edge, Inc.

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

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.

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 with layered strategy.

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.

Neither we nor any

other company has composition of matter patent protection for terlipressin since, as a chemical compound, it is in the public domain

and no longer under a patent.

We filed a PCT application covering our novel liquid formulations of terlipressin (international patent

application PCT/US2020/034269, published as WO2020/237170) and are seeking patent protection in the U.S., Europe, China, Japan and other

jurisdictions.

To date patents have been granted in the U.S.

12,156,898), India (Patent No.

540813), Chile (Patent No.

China (Patent No.

ZL 202080050758.X), Japan (Patent No.

7579811), Australia (Patent No.

2020279395) and Mexico (Patent No.

11,364,277 and 12,685,756, and European Patent No.

EP3347032, which are directed to various methods of treating

ascites with BIV201, and we are pursuing additional patent coverage in the U.S., Japan, Europe, China and others.

The patents and pending

patent applications and their projected expiration dates are provided below.

Patent Family

Application Number

Expiration Date

BR112021023274-5

202080050758.X

ZL 202080050758.X

European Patent

62022061386.8

Korea, Republic of (KR)

10-2021-7041832

MX/a/2021/014310

United States of America

Treatment of Ascites

United States of America

European Patent

United States of America

202510468211.6

European Patent

United States of America

10-2024-7025858

MX/a/2024/009566

BIV201 was awarded Orphan Drug Designations in

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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 are seeking patent protection in U.S., Europe, China, Japan and other jurisdictions.

To date patents have been granted in U.S.

12,156,898), India (Patent No.

540813), Chile (Patent No.

68.965), China (Patent

ZL 202080050758.X), and Japan (7579811) Also, we own U.S.

Patent 11,364,277, and European patent EP3347032, which is directed to a

method of treating ascites with BIV201, and we are pursuing additional patent coverage in U.S., Japan, Europe, and China.

If a drug receives Orphan Drug Designation and subsequently gains FDA approval for the designated rare disease, it

earns seven years of market exclusivity in the U.S.

(10 years in the EU).

During this period, the FDA cannot approve another application

for the same drug for the same indication, except under limited circumstances.

This exclusivity is independent of patents, meaning even

if a patent expires, orphan exclusivity can still block competitors.

Bezisterim (NE3107) and related compounds

As of July 31, 2026, we have twelve (12) issued

patents, six (6) pending U.S.

patents, seven (7) pending U.S.

patent applications, three (3) pending U.S.

PCT applications, six (6) issued foreign patents, and six

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

PCT applications, four (4) issued foreign patents, and

nine (9) pending foreign patent applications directed to protecting NE3107 and related compounds and methods of making and using thereof.

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

Patent Application

Unsaturated Steroid Compounds

Solid State Forms of a Pharmaceutical

Crystalline Anhydrate Forms of a Pharmaceutical

Crystalline Solvate Forms of a Pharmaceutical

Treatment Methods Using Pharmaceutical Solid State Forms

Pharmaceutical Solid State Forms

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Drug Identification and Treatment Method

Methods for Preparing 17-Alkynyl-7-Hydroxy Steroids and Related Compounds

Methods for Preparing 17-Alkynyl-7-Hydroxy Steroids and Related Compounds-2

Method for Preparing Substituted 3,7-Dihydroxy Steroids

Treatment Methods Using Pharmaceutical Solid State Forms

Compositions for Treatment of Neurodegenerative Conditions

Methods of Treating Long COVID

Modified C19 Steroids and Methods of Using the Same

Compositions and Methods for the Treatment of Diseases and Conditions Associated with Amyloid Beta Peptides

Methods for the Treatment of Biological Aging

Methods for the Treatment of Mild Cognitive Impairment

Assay and Methods for Drug Discovery

Bezisterim-Associated Anti-Inflammatory Epigenetic Modulation of Age Acceleration and Alzheimer’s Disease Genes

* Foreign counterparts issued in Australia, Canada, Europe and South

Korea projected to expire 4/3/2029.

** Foreign counterparts issued in Europe and Japan projected to expire

Government Regulation

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In the United States, the FDA regulates the development

of drugs and biologic products under the Federal Food, Drug and Cosmetic Act (“FDCA”) and the Public Health Services Act ("PHSA"),

respectively.

Drugs, biologics and medical devices are also subject to other federal, state and local statutes and regulations.

of drugs and biologic products under the FDCA and the Public Health Services Act ("PHSA"), respectively.

Drugs, biologics and

medical devices are also subject to other federal, state and local statutes and regulations.

Biologics are subject to regulation by the FDA

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or biological product may be marketed in the United States generally involves the following:

Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other applicable regulations;

Submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before human clinical trials may begin;

Performance of adequate and well-controlled human clinical trials according to the FDA’s GCPs, to establish the safety and efficacy of the proposed drug or biologic for its intended use;

Submission to the FDA of a New Drug Application (an “NDA”), for a new drug product, or a Biologics License Application (a “BLA”), for a new biological product;

Satisfactory completion of FDA inspection of the manufacturing facility or facilities where the drug or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity;

Potential FDA inspections of the nonclinical and clinical trial sites that generated the data in support of the NDA or BLA;

· Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory

Practices or other applicable regulations;

· Submission to the FDA of an IND application, which must become effective before human clinical trials

· Performance of adequate and well-controlled human clinical trials according to the FDA’s GCPs, to

establish the safety and efficacy of the proposed drug or biologic for its intended use;

· Submission to the FDA of an NDA, for a new drug product, or a BLA, for a new biological product;

· Satisfactory completion of FDA inspection of the manufacturing facility or facilities where the drug or

biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure

that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and

· Potential FDA inspections of the nonclinical and clinical trial sites that generated the data in support

of the NDA or BLA;

· FDA review and approval of the NDA or BLA.

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be conducted in accordance with the FDA’s cGCP requirements.

Further, each clinical trial must be reviewed and approved by an independent

institutional review board (“IRB”), at or servicing each institution at which the clinical trial will be conducted.

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.

Further, each clinical trial must be reviewed and approved by an 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:

The drug or biologic is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients having the specific disease.

The drug or biologic is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine optimal dosage and dosing schedule for patients having the specific disease.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites.

These clinical trials, which usually involve more subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.

Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or BLA.

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.

The drug or biologic is initially introduced into healthy human subjects and tested for

safety, dosage tolerance, absorption, metabolism, distribution and excretion.

In the case of some products for severe or life-threatening

diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing

is often conducted in patients having the specific disease.

The drug or biologic is evaluated in a limited patient population to identify possible

adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine

optimal dosage and dosing schedule for patients having the specific disease.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety

in an expanded patient population at geographically dispersed clinical trial sites.

These clinical trials, which usually involve more

subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for

product labeling.

Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or

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.

Progress reports detailing the results of the

2 unchanged sentences

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.

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

88 unchanged sentences

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.

Orphan Drug status in the EU has similar but not

identical benefits in the EU.

Expedited Development and Review Programs

70 unchanged sentences

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.

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.

Our business is managed by our officers who consist

1 unchanged sentence

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

Kim, our Chief Financial Officer and Corporate Secretary.

These individuals devote their full-time efforts to the Company activities.

The Company has 13 employees which are all full time.

We also rely on a team of highly experienced scientific, medical, and regulatory

consultants to conduct product development activities.

Wendy Kim, Chief Financial Officer and Corporate Secretary.

These individuals devote their full-time efforts to Company activities.

Company has 13 employees which are all full time.

We also rely on a team of highly experienced scientific, medical, and regulatory consultants

to conduct product development activities.

Available Information

We maintain a website at www.biovie.com.

Information on our website is not incorporated by reference into this Form 10-K and does not constitute a part of this Form 10-K.

We make available, free of charge, on our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports

on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act

of 1934, as amended, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

reports are also available at the SEC’s website at www.sec.gov.

We maintain a website at www.bioviepharma.com.

Information on our website is not incorporated by reference into this report and does not constitute a part of this report.

available, free of charge, on our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form

8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934,

as amended, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

These reports

are also available at the SEC’s website at www.sec.gov.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business