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

The acquired assets included NE3107.

In April 2024, the Company announced that the United States Adopted Names Council, and the World

Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic)

name for NE3107.

Bezisterim (NE3107) is an investigational, 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 may play fundamental roles in the development of Alzheimer’s disease (“AD”)

and Parkinson’s disease (“PD”), and bezisterim (NE3107) could, if approved by U.S.

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 and 1 million Americans suffering from PD.

In neurodegenerative disease, bezisterim (NE3107)

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.

Bezisterim (NE3107) does not interfere with their

homeostatic functions (e.g., insulin signaling and neuron growth and survival).

Both inflammation and insulin resistance are drivers of

About Inflammation and Bezisterim’s (NE3107’s)

Mechanism of Action

Neuroinflammation, insulin resistance, and oxidative

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

sclerosis (“ALS”).

Bezisterim (NE3107) is an orally bioavailable, blood-brain permeable, small molecule, 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’s) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s

work testing the molecule in AD and PD patients.

Parallels exist between AD and PD, among them activated

microglia driving inflammation, involvement of TNFα, oxidative stress, protein misfolding, mitochondrial dysfunction, and insulin

In preclinical and clinical studies, bezisterim (NE3107) reduced inflammation and enhanced insulin sensitivity, both of which

are important to PD pathology.

Preclinical studies in marmoset monkeys have shown bezisterim (NE3107) administered alone to be as pro-motoric

as levodopa, underscoring the apparently critical role of inflammation in expression of PD motor symptoms.

When bezisterim (NE3107) was

administered with levodopa, the combination improved motor control better than either drug alone.

Furthermore, in the marmoset study,

bezisterim (NE3107) reduced the severity of levodopa induced dyskinesia (“LID”) concurrent with pro-motoric benefit and decreased

neurodegeneration, preserving twice as many dopaminergic neurons compared to control.

Alzheimer’s Disease

AD Pathophysiology and Bezisterim (NE3107) Treatment

Alzheimer’s disease, 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.

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 are drivers

of AD through interplay with the major inflammation signaling node, NFkB, and the cytokine, TNF, the activities of which are modulated

by bezisterim (NE3107).

The link between inflammation, T2D, and inflammation-driven insulin resistance and cognitive impairment are described

by relatively new terms, type 3 diabetes and metabolic-cognitive syndrome.

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.

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 and senescence in the central nervous system (“CNS”).

Systemic inflammation from inflamed adipose tissue

and associated mononuclear cells promotes CNS inflammation and is linked to cognitive decline and neurodegeneration.

In addition to the

afore mentioned factors contributing to AD pathophysiology, there is an 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.

Bezisterim (NE3107) is believed to inhibit ERK/NFkB

activation and TNF production stimulated by inflammatory stimuli, which includes oxidative stress.

Inhibition of NFkB activation and TNF

production from this type of stimulation has broad potential implications for reduction of pathological peripheral and CNS inflammatory

signaling in AD, which includes 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 HPA axis dysregulation and hippocampal dysregulation of cortisol secretion that are consequences of adipose

inflammation and insulin resistance, and as described above, are known to promote cognitive impairment and forward-feeding insulin resistance.

We believe bezisterim’s (NE3107’s) combination of anti-inflammatory and insulin sensitizing activity has the potential to

disrupt this forward-feeding cycle of AD pathology.

The multifactorial influence of insulin signaling on neuron survival and cognition

suggests that correction of insulin signaling deficits with bezisterim (NE3107) in the target population may provide significant benefits

on both cognition and disease progression.

Company’s Progress with Alzheimer’s

Disease Clinical Trial

On November 29, 2023, the Company announced topline

efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild to moderate AD.

had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function

using the Clinical Dementia Rating-Sum of Boxes.

Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of

bezisterim (NE3107) orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice

Upon trial completion, as the Company began the process

of analyzing the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)

violations at 15 study sites (virtually all of which were from one geographic area).

This highly unusual level of suspected improprieties

led the Company to exclude all patients from these sites and to refer the sites to the FDA’s Office of Scientific Investigations

(“OSI”) for potential action.

After the patient exclusions, 81 patients remained

in the Modified Intent-to-Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial

and were verified to take study drug based on pharmacokinetic data.

The trial was originally designed to be 80% powered with 125 patients

in each of the treatment and placebo arms.

The unplanned exclusion of so many patients left the trial underpowered for its primary endpoints.

In the Per-Protocol population, which includes those

patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetics data), an observed

but not statistically significant change from baseline appeared to suggest a slowing of cognitive loss;

these same patients experienced

an advantage in age deceleration vs.

placebo as measured by deoxyribonucleic acid (“DNA”) epigenetic change.

Age deceleration

is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the

Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.

This test was a non-primary/secondary

endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).

Based on the efficacy signal seen in this trial, the

Company is exploring (1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling

patients to achieve statistical significance;

and/or (2) the design of a new Phase 3 study of bezisterim (NE3107) that leverages the most

recent data and understanding of the potential effects bezisterim (NE3107) may have in persons with AD.

Parkinson’s Disease

Parkinson’s disease (PD), which affects an estimated

1 million Americans, is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory

cytokines (particularly TNF).

Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard

of care treatment for this movement disorder, but levodopa effectiveness diminishes over time necessitating increased dosage and prolonged

daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID,

which is exacerbated by high dose levodopa.

Although levodopa provides symptomatic benefit, it does not slow PD progression.

The Company’s Phase 2 study of bezisterim (NE3107)

for the treatment of PD (NCT05083260), completed in January 2023, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics

study in PD participants treated with carbidopa/levodopa and NE3107.

acquired assets included NE3107 (or “bezisterim”).

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

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 may play

fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”),

and bezisterim could, if approved by the U.S.

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.

PD is driven in large part by neuroinflammation

and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF).

Multiple daily administrations of

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

However, levodopa

effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled

movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa.

Although levodopa

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 or bezisterim (NE3107) 20 mg twice daily for 28 days.

were randomized 1:1 to placebo:

bezisterim 20 mg twice daily for 28 days.

This trial was launched with two design objectives:

(1) the primary objective was safety and drug-drug interaction, as requested by the FDA, to assess the potential for adverse interactions

between bezisterim (NE3107) and 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

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.

Both objectives were met.

Results of the study include:

Five (26%) of the 19 patients treated with NE3107 vs zero of 19 placebo treated patients, experienced a morning ON state prior to receiving their initial morning C/L medications at the end of the study (day 28);

this difference was statistically significant (p=0.046).

Patients treated with NE3107 + C/L experienced greater improvements in their Motor Disease Society- Unified Parkinson’s Disease Rating Scale (MDS UPDRS) Part III score than patients treated with placebo + C/L at the 2- and 3-hour marks after administration of the first daily dose of C/L.

Patients <70 years old treated with NE3107 + C/L experienced improvements that were ~6 points better than those who received placebo + C/L.

The study met its endpoints;

investigators concluded that NE3107 + C/L combination treatment was associated with clinically meaningful and superior improvements (3+ points) on the motor examination part (Part III) of the MDS UPDRS.

NE3107 produced statistically significant improvements in nonmotor symptoms scale assessments (NMSS) for fatigue (Q4) p=0.02, urge to move legs (Q6) p=0.0036, and saliva dribbling (Q19) p= 0.0395.

To extend this Phase 2 data in progressed patients,

the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset

In July 2024, the Company submitted the protocol for this new study to the FDA for regulatory review.

Bezisterim (NE3107) may have the potential to become

a non-dopaminergic alternative to PD patients.

There are numerous scientific reports that support the critical role of inflammation in

the manifestation of PD symptoms in addition to the essential role of inflammation in driving disease progression.

We have shown in a

mouse model of PD that bezisterim (NE3107) decreases inflammation and TNF in the brain and increases neuron survival (Nicoletti, 2012

Parkinson’s Disease 969418).

In this neurotoxin induced model, bezisterim (NE3107) decreased clinical signs of disease and neuronal

death compared to placebo treated mice.

An unpublished study of a neurotoxin induced marmoset model of PD reported that administration

of bezisterim (NE3107) decreased movement abnormalities that are the clinical signs of the disease.

In the same study, bezisterim (NE3107)

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

treated with bezisterim (NE3107) developed less LID.

Bezisterim (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 bezisterim (NE3107) may decrease clinical signs of disease

in humans (improve motor function), which if true could enable a straightforward clinical development strategy to test bezisterim (NE3107)

in PD patients needing promotoric therapy.

If approved as a promotoric agent, NE3107 would 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 slow disease progression, the most important

and still unmet objective of PD drug development.

Long COVID Program

In April 2024, the Company announced the grant of a clinical trial award of up to $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,

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

plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID.

had previously reviewed and approved the study as “Safe to Proceed” in August 2024.

The approval form OHRO is the last scientific

review milestone needed for the Company to receive the additional $12.6 million of the aggregate $13.1 million in grant funding from the

The award can provide up to 2 years of non-dilutive funding for a Phase 2 clinical trial that will assess bezisterim (NE3107) for

the treatment of neurological symptoms that are associated with long COVID.

The Company anticipates the trial to commence by early 2025.

The study protocol was finalized and submitted to the FDA for regulatory review in July 2024 and on August 22, 2024 the FDA authorized

our IND application for Bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating

neurocognitive symptoms associated with long covid.

Long COVID is a condition in which symptoms of COVID-19,

the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more.

The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently

or previously had long COVID.

Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating.

in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars.

there are no therapies proven effective for treatment.

Chronic inflammation is one of the main hypotheses

that researchers have proposed to explain the persistence of symptoms in long COVID.

Specifically in individuals with “brain fog,”

sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features.

Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the inhibition of NF-kB activation, thus representing

a novel oral treatment targeting an underlying cause of long COVID symptoms.

Chronic neuroinflammation, insulin resistance, and

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

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.

(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.

About Long COVID

Long COVID is a condition in which symptoms of

COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more.

Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular

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)

On November 29, 2023, the Company announced the

analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild

to moderate AD.

The study had co-primary endpoints measuring cognitive impairment using the Alzheimer’s Disease Assessment Scale-Cognitive

Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

Patients were randomly assigned, 1:1 versus

placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed

by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the

process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)

violations at 15 study sites (virtually all of which were from one geographic area).

This highly unusual level of suspected improprieties

led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)

for potential further action.

After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom

were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic

The trial was originally designed to be 80% powered

with 125 patients in each of the treatment and placebo arms.

The unplanned exclusion of so many patients left the trial underpowered for

the primary endpoints.

In the Per-Protocol population, which included those patients who completed the trial and who were further verified

to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing

of cognitive decline;

these same patients experienced an advantage in age deceleration vs.

placebo as measured by DNA epigenetic changes.

Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as

measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.

This test was a non-primary/secondary

endpoint, other-outcome measure, done via blood collected at week 30 (end of study).

Additional DNA methylation data continues to be collected

and analyzed.

Liver Cirrhosis Program

In liver disease, our investigational drug candidate

BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is

being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing for the treatment

of ascites due to chronic liver cirrhosis.

BIV201 is administered as a patent-pending liquid formulation.

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.

The FDA has never approved a drug to treat ascites, and once patients reach the refractory stage the estimated one-year survival rate

is only approximately 50% [10] .

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 recently approved in the U.S.

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.

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 the novel room temperature stable formulation in a pre-filled syringe, BIV201 could potentially provide

a superior terlipressin drug delivery system throughout the world.

The goal of BIV201 therapy is to interrupt the ascites disease pathway,

thereby halting the cycle of accelerated fluid generation in ascites patients.

In June 2021, the Company initiated a Phase 2 study

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.

In June 2021, BioVie initiated a Phase 2 study

(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment

cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites.

endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared

endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared

to a pre-treatment period.

In March 2023, the Company announced enrollment was

paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid

during the 28 days after treatment initiation compared to the 28 days prior to treatment.

The change in ascites volume was significantly

different from those patients receiving SOC treatment.

Patients who completed the treatment with BIV201 experienced a 53% reduction in

ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment

In June 2023, the Company requested and subsequently

received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites

due to chronic liver cirrhosis.

The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment

of ascites due to chronic liver cirrhosis.

While the active agent, terlipressin, is approved

and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these

authorizations.

Patients with refractory ascites 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 not approved any drug to treat refractory

By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment

on May 8, 2023.

In March 2023, enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to

show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.

The change in ascites volume was significantly different from those patients receiving SOC treatment.

Patients who completed the treatment

with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment

initiation as compared to the three-month pre-treatment period.

In June 2023 and December 2024, BioVie received guidance from the FDA

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

Our proprietary novel liquid formulation of terlipressin

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

syringe in storage for 18 months, with the potential for up two years stability.

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

Room temperature storage presents a key product differentiation

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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 are seeking patent

protection in at least the U.S., Europe, China, Japan and other jurisdictions.

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 the most common of

these complications, ascites, which represents a significant unmet medical need.

Patients with cirrhosis and ascites account for an estimated

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.

For patients with refractory ascites the

mean one-year survival rate is only 50% (Bureau et al.

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.

The BIV201 development program began at LAT Pharma

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

Bureau et al.

About Ascites and Liver Cirrhosis

Cirrhosis is a leading cause of death in the U.S.

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, reflected by the Fast Track designation granted to BIV201 by the FDA as a treatment for ascites refractory to or intolerant of diuretic

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

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 Proposed Mechanism of Action

BIV201 is being developed with the goal of alleviating

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.

Future Possible BIV201 Indications

Based on international investigative studies of the

active agent in BIV201, terlipressin, we believe our drug candidate has potential future applications in other life-threatening conditions

due to liver cirrhosis.

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 continues to evaluate

other indications for the use of terlipressin continuous infusion.

BioVie will discuss such indications if and when selected for testing.

formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have

been granted in the U.S.

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

540813), Chile (Patent No.

68.965), 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.

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.

The BIV201 development program was initiated by

LAT Pharma LLC.

On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns

all development and marketing rights to this drug candidate.

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,

between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales

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

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

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that we regard as proprietary.

BIV201 was awarded Orphan Drug Designations in the

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

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 India (Patent No.

540813) and Chile (Patent No.

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,

BIV201 was awarded Orphan Drug Designations in

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

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.

Bezisterim (NE3107) and related compounds

As of August 15, 2024, we have twelve (12) issued U.S.

patents, six (6)

As of July 31, 2025, we have twelve (12) issued

patents, six (6) 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.

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

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.

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

Patent Application

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Methods for the Treatment of Biological Aging

Foreign counterparts issued in Australia, Canada, Europe and South Korea projected to expire 4/3/2029.

* 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

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.

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 (“FDCA”), and implements 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 (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:

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.

Biologics are subject to regulation by the FDA

under the FDCA, the PHSA and related regulations, and other federal, state and local statutes and regulations.

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

The process required by the FDA before a drug

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;

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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 an 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 audit of the nonclinical and clinical trial sites that generated the data in support of the NDA or BLA;

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;

FDA review and approval of the NDA or BLA.

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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.

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 inclusion 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 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.

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

Clinical trials must

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.

Human clinical trials prior to approval are typically

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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.

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

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

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.

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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 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.

a waiver of such fees may be

obtained under certain limited circumstances.

The FDA reviews all NDAs and BLAs submitted before

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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

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.

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;

FDA will not approve the NDA or BLA without a REMS, if required.

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

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

the FDA will not approve the NDA or BLA without a REMS, if required.

Before approving an NDA or BLA, the FDA will inspect

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

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 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 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.

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 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 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

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

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and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

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

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.

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

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

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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

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

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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.

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.

Our business is managed by our officers who consist

Cuong Do, Chief Executive Officer & President;

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

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

Kim, our Chief Financial Officer and Corporate Secretary.

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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.

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